chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Painful lymph node on left side of her neck; Swollen lymph node on left side of her neck; Headache; Cannot lift her arm; Almost diarrhea; Chills; Nausea; Fever; Body aches; Pain immediately spread all over her left arm to the elbow; This spontaneous case was reported by a pharmacist and describes the occurrence of LIMB DISCOMFORT (Cannot lift her arm), DIARRHOEA (Almost diarrhea), LYMPH NODE PAIN (Painful lymph node on left side of her neck), PAIN (Pain immediately spread all over her left arm to the elbow) and HEADACHE (Headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (Pain immediately spread all over her left arm to the elbow). On 01-Apr-2021, the patient experienced LIMB DISCOMFORT (Cannot lift her arm), DIARRHOEA (Almost diarrhea), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever) and MYALGIA (Body aches). On 02-Apr-2021, the patient experienced LYMPH NODE PAIN (Painful lymph node on left side of her neck) and LYMPHADENOPATHY (Swollen lymph node on left side of her neck). At the time of the report, LIMB DISCOMFORT (Cannot lift her arm), DIARRHOEA (Almost diarrhea), LYMPH NODE PAIN (Painful lymph node on left side of her neck), PAIN (Pain immediately spread all over her left arm to the elbow), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever), MYALGIA (Body aches) and LYMPHADENOPATHY (Swollen lymph node on left side of her neck) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient was experiencing all the symptoms, just to a lesser degree at the time of this case report.  No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Warm rash at injection site; Raised rash at injection site; Red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm rash at injection site), VACCINATION SITE RASH (Raised rash at injection site) and VACCINATION SITE ERYTHEMA (Red rash at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm rash at injection site), VACCINATION SITE RASH (Raised rash at injection site) and VACCINATION SITE ERYTHEMA (Red rash at injection site). At the time of the report, VACCINATION SITE WARMTH (Warm rash at injection site), VACCINATION SITE RASH (Raised rash at injection site) and VACCINATION SITE ERYTHEMA (Red rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include Medication for diabetes, Thyroid medication, Antibiotic for bladder infection (over a month since the patient has started). Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included RIZATRIPTAN for Migraine.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MIGRAINE (migraine). At the time of the report, MIGRAINE (migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ZINC, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.            Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Nausea, Peripheral swelling
Clinical narrative: A big red hot swollen lump on arm; A big red hot swollen lump on arm; A big red hot swollen lump on arm; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (A big red hot swollen lump on arm), ERYTHEMA (A big red hot swollen lump on arm), FEELING HOT (A big red hot swollen lump on arm), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 010A21A) for COVID-19 vaccination.     No medical history information reported .  Concomitant products included CITALOPRAM for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (A big red hot swollen lump on arm), ERYTHEMA (A big red hot swollen lump on arm) and FEELING HOT (A big red hot swollen lump on arm). 31-Mar-2021, the patient experienced NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (A big red hot swollen lump on arm), ERYTHEMA (A big red hot swollen lump on arm), FEELING HOT (A big red hot swollen lump on arm), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.            Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue for 11 days; 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 FATIGUE (Fatigue for 11 days) 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 FATIGUE (Fatigue for 11 days). At the time of the report, FATIGUE (Fatigue for 11 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe Pain in left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Severe Pain in left arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Severe Pain in left arm). At the time of the report, PAIN IN EXTREMITY (Severe Pain in left arm) outcome was unknown. Not Provided          Patient is taking concomitant medication (not specified). Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The healthcare facility had an power outage on 01 April 2021. This dropped the temperature of the vials stored in freezer and refrigerator to -  Frozen vaccine 47 minutes -13.79 degree celsius Refrigerator 59 minutes 12 degree Celsius  This report refers to a case of Product administration error and product storage error, for mRNA-1273, lot # 003B21A, with no associated AEs.  Treatment information was not provided.  Concomitant medications were not reported.   This case was linked to MODERNATX, INC.-MOD-2021-066742 (E2B Linked Report).; Sender's Comments: This report refers to a case of Product administration error and product storage error, for mRNA-1273, lot # 003B21A, with no associated AEs. MODERNATX, INC.-MOD-2021-066742:Crossed linked
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling of relaxation
Clinical narrative: slight bruise; Regained her sense of equilibrium that was lost 4 years ago; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF RELAXATION and CONTUSION in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FEELING OF RELAXATION. On an unknown date, the patient experienced CONTUSION. At the time of the report, FEELING OF RELAXATION outcome was unknown and CONTUSION had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-JUN-2021. TCR form attached. New event was added.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN) injection for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included SILDENAFIL CITRATE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TREPROSTINIL SODIUM (REMODULIN) (Intravenous) 1.0 mg/ml. On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (Difficulty breathing) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High temperature; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (High temperature) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-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 an unknown date, the patient experienced PYREXIA (High temperature). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, PYREXIA (High temperature) outcome was unknown. Not Provided          No concomitant medications were provided. Treatment medications includes Tylenol for fever.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash in the injection site; Itchy; Red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (rash in the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red). On 31-Mar-2021, the patient experienced VACCINATION SITE RASH (rash in the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (rash in the injection site) outcome was unknown.            Treatment information were not provided. Concomitant information were not reported.   This case was linked to MOD-2021-089302.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: the follow-up were received on 24-APR-2021 and include below following updated information;patient details were updated.event were updated.action item updated.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccination site warmth; Vaccination site pruritus; Vaccination site swelling; headache; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritus), HEADACHE (headache), MYALGIA (Myalgia) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Erythromycin.).    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced HEADACHE (headache) and MYALGIA (Myalgia). On 04-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site pruritus), HEADACHE (headache), MYALGIA (Myalgia) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Additional information included patient Contact details were  added.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PYREXIA (Fever). On 11-Mar-2021, PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included steroids. Patient's has known rare immune deficiency disease  which got better after receiving vaccine. Treatment information was not provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: arm was sore; super fatigued; mild frontal lobe headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), FATIGUE (super fatigued) and HEADACHE (mild frontal lobe headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Gastric bypass.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), FATIGUE (super fatigued) and HEADACHE (mild frontal lobe headache). At the time of the report, PAIN IN EXTREMITY (arm was sore), FATIGUE (super fatigued) and HEADACHE (mild frontal lobe headache) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-066678 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I have not received my 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have not received my 2nd dose yet) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), LOSARTAN POTASSIUM (COZAAR), LEVOTHYROXINE, CELECOXIB (CELEBREX), MONTELUKAST SODIUM (SINGULAIR), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), BUPROPION HYDROCHLORIDE (WELLBUTRIN), FLUOXETINE HYDROCHLORIDE (PROZAC), SOLIFENACIN SUCCINATE (VESICARE) and CLONIDINE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have not received my 2nd dose yet). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have not received my 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Due to bad weather in the month of February the patient could not schedule her second dose of vaccine. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Body temperature decreased, Chills, Injection site pain
Clinical narrative: Upset stomach; Low temperature; Shivering; Chills; Soreness at the site of the injection Left arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), BODY TEMPERATURE DECREASED (Low temperature), INJECTION SITE PAIN (Soreness at the site of the injection Left arm), CHILLS (Shivering) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE PAIN (Soreness at the site of the injection Left arm). On 30-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), BODY TEMPERATURE DECREASED (Low temperature), CHILLS (Shivering) and CHILLS (Chills). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), BODY TEMPERATURE DECREASED (Low temperature), INJECTION SITE PAIN (Soreness at the site of the injection Left arm), CHILLS (Shivering) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 96.3 f (Inconclusive) 96.3 F and 96.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Soreness; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), PYREXIA (Fever) and CHILLS (Chills) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (Soreness), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Soreness), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: Blood pressure increased; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL SODIUM for Pulmonary arterial hypertension, TADALAFIL for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED. At the time of the report, BLOOD PRESSURE INCREASED outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Formication
Clinical narrative: Strange sensation something crawling on my skin; This spontaneous case was reported by a consumer and describes the occurrence of FORMICATION (Strange sensation something crawling on my skin) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) 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 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FORMICATION (Strange sensation something crawling on my skin). At the time of the report, FORMICATION (Strange sensation something crawling on my skin) outcome was unknown.            Treatment information was not provided for this event. It was reported that the patient felt this sensation basically on trunk and head.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Invalid dose : 1cc was left during the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Invalid dose : 1cc was left during the vaccination) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced UNDERDOSE (Invalid dose : 1cc was left during the vaccination). At the time of the report, UNDERDOSE (Invalid dose : 1cc was left during the vaccination) had resolved.            No concomitant medicines were reported. No treatment information were reported.  Action taken with the drug in response to events was not applicable.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling hot, Headache, Influenza like illness, Oropharyngeal pain
Clinical narrative: Flu-like symptoms; Runny nose; Felt hot and feverish; A little achy; Sore throat; Headache; Felt hot and feverish; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Sore arm), INFLUENZA LIKE ILLNESS (Flu-like symptoms), RHINORRHOEA (Runny nose), FEELING HOT (Felt hot and feverish) and PAIN (A little achy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced CHEST PAIN (Sore arm). On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), RHINORRHOEA (Runny nose), FEELING HOT (Felt hot and feverish), PAIN (A little achy), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and PYREXIA (Felt hot and feverish). On 28-Mar-2021, CHEST PAIN (Sore arm) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), RHINORRHOEA (Runny nose), FEELING HOT (Felt hot and feverish), PAIN (A little achy), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and PYREXIA (Felt hot and feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not reported by the reporter. Treatment details were not included.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Flu-like symptoms; Runny nose; Felt hot and feverish; A little achy; Sore throat; Headache; Felt hot and feverish; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Sore arm), INFLUENZA LIKE ILLNESS (Flu-like symptoms), RHINORRHOEA (Runny nose), FEELING HOT (Felt hot and feverish) and PAIN (A little achy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced CHEST PAIN (Sore arm). On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), RHINORRHOEA (Runny nose), FEELING HOT (Felt hot and feverish), PAIN (A little achy), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and PYREXIA (Felt hot and feverish). On 28-Mar-2021, CHEST PAIN (Sore arm) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), RHINORRHOEA (Runny nose), FEELING HOT (Felt hot and feverish), PAIN (A little achy), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and PYREXIA (Felt hot and feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not reported by the reporter. Treatment details were not included.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Malaise, Somnolence
Clinical narrative: Feeling sick; Sleepy; Felt horrible,miserable; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), SOMNOLENCE (Sleepy), FEELING ABNORMAL (Felt horrible,miserable) and FATIGUE (Tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL DIOLAMIN (ORENITRAM) for Primary pulmonary hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension and Loose bowels. Concomitant products included METOPROLOL, WARFARIN, SILDENAFIL CITRATE and DILTIAZEM for an unknown indication.   On 05-Nov-2020, the patient TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.125 mg every eight hours. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 1 mg. On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .125 mg and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.5 mg. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tired). On 26-Mar-2021, the patient experienced MALAISE (Feeling sick), SOMNOLENCE (Sleepy) and FEELING ABNORMAL (Felt horrible,miserable). On 26-Mar-2021, MALAISE (Feeling sick), SOMNOLENCE (Sleepy), FEELING ABNORMAL (Felt horrible,miserable) and FATIGUE (Tired) had resolved.            26 Mar 2021, The patient has taken her first Orenitram dose at regular time of 8 am and at 10 am she was not sure what medication she has taken, it was either one metoprolol or two more Orenitram (wrong dose). The patient went back to bed around 11 or 11:30. Patient was feeling ok at the time of reporting.  The reporter assessed the causal relationship between PO Orenitram and the event of diarrhea as possible. The reporter did not provide causality for the event of dyspnea exertional. No treatment for the events was reported.  The action taken with mRNA-1273 in response to the event was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: Horrible pain in right arm, hands, shoulder and back area; Horrible pain in right arm, hands, shoulder and back area; Pain comes in waves; Feels like its poison; Horrible pain in right arm, hands, shoulder and back area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Horrible pain in right arm, hands, shoulder and back area), BACK PAIN (Horrible pain in right arm, hands, shoulder and back area), PAIN (Pain comes in waves), FEELING ABNORMAL (Feels like its poison) and ARTHRALGIA (Horrible pain in right arm, hands, shoulder and back area) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Horrible pain in right arm, hands, shoulder and back area), BACK PAIN (Horrible pain in right arm, hands, shoulder and back area), PAIN (Pain comes in waves), FEELING ABNORMAL (Feels like its poison) and ARTHRALGIA (Horrible pain in right arm, hands, shoulder and back area). At the time of the report, PAIN IN EXTREMITY (Horrible pain in right arm, hands, shoulder and back area), BACK PAIN (Horrible pain in right arm, hands, shoulder and back area), PAIN (Pain comes in waves), FEELING ABNORMAL (Feels like its poison) and ARTHRALGIA (Horrible pain in right arm, hands, shoulder and back area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included chemotherapy meds for an unknown indication. No treatment information was provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered the vaccine to a 17 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered the vaccine to a 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered the vaccine to a 17 year old). On 31-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered the vaccine to a 17 year old) 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 medications were reported.  No treatment information was provided.  This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Not Provided) with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Not Provided) with no associated AEs.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: All over her abdomen, chest and the front of her torso; Rash on chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on chest) and RASH (All over her abdomen, chest and the front of her torso) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).   On 30-Mar-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 01-Apr-2021, the patient experienced RASH (Rash on chest). On 02-Apr-2021, the patient experienced RASH (All over her abdomen, chest and the front of her torso). At the time of the report, RASH (Rash on chest) and RASH (All over her abdomen, chest and the front of her torso) was resolving.            Patient was taking other medications but no concomitant medications provided. No treatment information were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue after first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after first dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue after first dose). At the time of the report, FATIGUE (Fatigue after first dose) outcome was unknown.            Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown.        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.   Treatment information were not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TADALAFIL (ADCIRCA) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. and TREPROSTINIL SODIUM (unknown route) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown. Not Provided          Patient began therapy with IH Tyvaso, delivered by Tyvaso Inhalation Device (TD-300/A) (device only). The current dose was reported as 60-120 microgram (10-20 breaths) four times a day (QID) (off label use) via inhalation (IH) route.  The action taken with mRNA-1273 in response to the event was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Swelling face
Clinical narrative: After eating her left side of face swells up and then goes down; After the second shot that day it didn't make anything that day but on Sunday I hardly could get; Fatigue after second dose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (After eating her left side of face swells up and then goes down), FATIGUE (After the second shot that day it didn't make anything that day but on Sunday I hardly could get) and FATIGUE (Fatigue after second dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included LEVOTHYROXINE for Thyroid therapy.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (After the second shot that day it didn't make anything that day but on Sunday I hardly could get) and FATIGUE (Fatigue after second dose). On 31-Mar-2021, the patient experienced SWELLING FACE (After eating her left side of face swells up and then goes down). On 28-Mar-2021, FATIGUE (After the second shot that day it didn't make anything that day but on Sunday I hardly could get) and FATIGUE (Fatigue after second dose) had resolved. At the time of the report, SWELLING FACE (After eating her left side of face swells up and then goes down) outcome was unknown.            No treatment information were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: sore arm; rash all over stomach, thighs, one on her chest and one on neck; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and RASH (rash all over stomach, thighs, one on her chest and one on neck) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced MYALGIA (sore arm) and RASH (rash all over stomach, thighs, one on her chest and one on neck). At the time of the report, MYALGIA (sore arm) and RASH (rash all over stomach, thighs, one on her chest and one on neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Reporter details were updated which is non-significant
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Illness, Muscle spasms
Clinical narrative: Lost the appetite.; Fatigue, exhaustion; Fever; Felt pretty sick for two days; Spasm and cramping in both legs; Pain was like more than 10, screaming because of the pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt pretty sick for two days), MUSCLE SPASMS (Spasm and cramping in both legs), PAIN (Pain was like more than 10, screaming because of the pain), DECREASED APPETITE (Lost the appetite.) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, MULTIVITAMINS [VITAMINS NOS], AMLODIPINE BESILATE (NORVASC) and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ILLNESS (Felt pretty sick for two days), PAIN (Pain was like more than 10, screaming because of the pain) and PYREXIA (Fever). 04-Feb-2021, the patient experienced MUSCLE SPASMS (Spasm and cramping in both legs). On 05-Feb-2021, the patient experienced DECREASED APPETITE (Lost the appetite.) and FATIGUE (Fatigue, exhaustion). At the time of the report, ILLNESS (Felt pretty sick for two days), MUSCLE SPASMS (Spasm and cramping in both legs), PAIN (Pain was like more than 10, screaming because of the pain), DECREASED APPETITE (Lost the appetite.), PYREXIA (Fever) and FATIGUE (Fatigue, exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 99°f (High) 99°F.         Concomitant medication included blood pressure pill. Treatment information included lots of heat and blanket to make the patient more comfortable.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Non significant follow up appended and AE contact information updated