chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Limb discomfort, Pyrexia
Clinical narrative: Redness on arm; Sleepy; swelling in that arm; hot to touch; hardly lift my left arm; Fatigue; Chills; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jun-2021 and was forwarded to Moderna on 13-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on arm), SOMNOLENCE (Sleepy), SWELLING (swelling in that arm), SKIN WARM (hot to touch) and LIMB DISCOMFORT (hardly lift my left arm) in a 54-year-old female 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.     Previously administered products included for Product used for unknown indication: Flu vaccine (swelling in arm; redness at  the site for about 3 weeks; 4 inch diameter; hot to touch) in 2008 and Flu vaccine (swelling in arm; redness at the site for about 2 weeks; 3 inch diameter; hot to touch) in 2020. Concurrent medical conditions included Wasp sting (stung on bottom of right foot and leg was swollen and red to the knee in 5 mins; required emergency room visit and follow-up care/rx) since 1985, Bee sting (stung on left forearm; arm swelled really quickly and was taken to doctor immediately; treated and rx) since 1984, Hypersensitivity reaction, Hay fever, Hives, Hypertension since 1994, High cholesterol since 2003 and Drug allergy (allergic reaction verified by doctor; rash/hives on stomach) since 2011. Concomitant products included SIMVASTATIN for High cholesterol, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) and METOPROLOL TARTRATE for Hypertension.    On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness on arm), SOMNOLENCE (Sleepy), SWELLING (swelling in that arm), SKIN WARM (hot to touch), LIMB DISCOMFORT (hardly lift my left arm), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (fever). On 13-Jun-2021, ERYTHEMA (Redness on arm) and FATIGUE (Fatigue) had resolved. At the time of the report, SOMNOLENCE (Sleepy), SWELLING (swelling in that arm), SKIN WARM (hot to touch), LIMB DISCOMFORT (hardly lift my left arm), CHILLS (Chills) and PYREXIA (fever) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ERYTHEMA (Redness on arm), SOMNOLENCE (Sleepy), SWELLING (swelling in that arm), SKIN WARM (hot to touch), LIMB DISCOMFORT (hardly lift my left arm), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (fever) to be possibly related.    As treatment medication, the patient started taking Benadryl (25 mg/8 hours) on April 28, 2021. The patient still continues to take Benadryl.     Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Nonsignificant FU Appended
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Somnolence, Swelling
Clinical narrative: Redness on arm; Sleepy; swelling in that arm; hot to touch; hardly lift my left arm; Fatigue; Chills; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jun-2021 and was forwarded to Moderna on 13-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on arm), SOMNOLENCE (Sleepy), SWELLING (swelling in that arm), SKIN WARM (hot to touch) and LIMB DISCOMFORT (hardly lift my left arm) in a 54-year-old female 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.     Previously administered products included for Product used for unknown indication: Flu vaccine (swelling in arm; redness at  the site for about 3 weeks; 4 inch diameter; hot to touch) in 2008 and Flu vaccine (swelling in arm; redness at the site for about 2 weeks; 3 inch diameter; hot to touch) in 2020. Concurrent medical conditions included Wasp sting (stung on bottom of right foot and leg was swollen and red to the knee in 5 mins; required emergency room visit and follow-up care/rx) since 1985, Bee sting (stung on left forearm; arm swelled really quickly and was taken to doctor immediately; treated and rx) since 1984, Hypersensitivity reaction, Hay fever, Hives, Hypertension since 1994, High cholesterol since 2003 and Drug allergy (allergic reaction verified by doctor; rash/hives on stomach) since 2011. Concomitant products included SIMVASTATIN for High cholesterol, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) and METOPROLOL TARTRATE for Hypertension.    On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness on arm), SOMNOLENCE (Sleepy), SWELLING (swelling in that arm), SKIN WARM (hot to touch), LIMB DISCOMFORT (hardly lift my left arm), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (fever). On 13-Jun-2021, ERYTHEMA (Redness on arm) and FATIGUE (Fatigue) had resolved. At the time of the report, SOMNOLENCE (Sleepy), SWELLING (swelling in that arm), SKIN WARM (hot to touch), LIMB DISCOMFORT (hardly lift my left arm), CHILLS (Chills) and PYREXIA (fever) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ERYTHEMA (Redness on arm), SOMNOLENCE (Sleepy), SWELLING (swelling in that arm), SKIN WARM (hot to touch), LIMB DISCOMFORT (hardly lift my left arm), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (fever) to be possibly related.    As treatment medication, the patient started taking Benadryl (25 mg/8 hours) on April 28, 2021. The patient still continues to take Benadryl.     Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Nonsignificant FU Appended
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccination to a patient from a vial that was opened yesterday at 11 AM and refrigerated afterwards, then used again at 9 AM this morning to vaccinate another patient.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vaccination to a patient from a vial that was opened yesterday at 11 AM and refrigerated afterwards, then used again at 9 AM this morning to vaccinate another patient.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (vaccination to a patient from a vial that was opened yesterday at 11 AM and refrigerated afterwards, then used again at 9 AM this morning to vaccinate another patient.). At the time of the report, PRODUCT STORAGE ERROR (vaccination to a patient from a vial that was opened yesterday at 11 AM and refrigerated afterwards, then used again at 9 AM this morning to vaccinate another patient.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Peripheral swelling
Clinical narrative: excruciating pain in my left thigh/pain has spread past down my knee; swelling in my left thigh; constant spasms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (excruciating pain in my left thigh/pain has spread past down my knee), PERIPHERAL SWELLING (swelling in my left thigh) and MUSCLE SPASMS (constant spasms) 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 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. On an unknown date, the patient experienced PAIN IN EXTREMITY (excruciating pain in my left thigh/pain has spread past down my knee), PERIPHERAL SWELLING (swelling in my left thigh) and MUSCLE SPASMS (constant spasms). At the time of the report, PAIN IN EXTREMITY (excruciating pain in my left thigh/pain has spread past down my knee), PERIPHERAL SWELLING (swelling in my left thigh) and MUSCLE SPASMS (constant spasms) outcome was unknown.            No concomitant medications were provided.  No treatment was reported for the events.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Feeling sleepy and drowsy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Feeling sleepy and drowsy) 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) .5 milliliter. On an unknown date, the patient experienced SOMNOLENCE (Feeling sleepy and drowsy). At the time of the report, SOMNOLENCE (Feeling sleepy and drowsy) 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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Tremor
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of back pain (very bad backache) and tremor (shaking) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced back pain (very bad backache) and tremor (shaking). At the time of the report, back pain (very bad backache) and tremor (shaking) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis, Headache
Clinical narrative: Bloody nose; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Bloody nose) and HEADACHE (Mild headache) 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, 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 EPISTAXIS (Bloody nose) and HEADACHE (Mild headache). At the time of the report, EPISTAXIS (Bloody nose) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was reported .
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Sore chest; Stiff neck; Sore arm / shoulder; This spontaneous case was reported by a pharmacist and describes the occurrence of CHEST PAIN (Sore chest), MUSCULOSKELETAL STIFFNESS (Stiff neck) and PAIN IN EXTREMITY (Sore arm / shoulder) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMITRIPTYLINE for an unknown indication.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Sore chest), MUSCULOSKELETAL STIFFNESS (Stiff neck) and PAIN IN EXTREMITY (Sore arm / shoulder). At the time of the report, CHEST PAIN (Sore chest), MUSCULOSKELETAL STIFFNESS (Stiff neck) and PAIN IN EXTREMITY (Sore arm / shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Eye pain, Feeling abnormal, Headache, Swelling
Clinical narrative: It feels like swollen; sore in the eyes; head is haunted; high blood pressure; severe head ache between the neck and the head; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (It feels like swollen), EYE PAIN (sore in the eyes), FEELING ABNORMAL (head is haunted), BLOOD PRESSURE INCREASED (high blood pressure) and HEADACHE (severe head ache between the neck and the head) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (It feels like swollen), EYE PAIN (sore in the eyes), FEELING ABNORMAL (head is haunted), BLOOD PRESSURE INCREASED (high blood pressure) and HEADACHE (severe head ache between the neck and the head). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (It feels like swollen), EYE PAIN (sore in the eyes), FEELING ABNORMAL (head is haunted), BLOOD PRESSURE INCREASED (high blood pressure) and HEADACHE (severe head ache between the neck and the head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant medications were not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pains) 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 CHEST PAIN (Chest pains). At the time of the report, CHEST PAIN (Chest pains) 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.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Skin mass, Swelling
Clinical narrative: How long is it normal for the lump in the armpit to be swollen; How long is it normal for the lump in the armpit to be swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (How long is it normal for the lump in the armpit to be swollen) and SWELLING (How long is it normal for the lump in the armpit to be swollen) in a 61-year-old patient of an unknown 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (How long is it normal for the lump in the armpit to be swollen) and SWELLING (How long is it normal for the lump in the armpit to be swollen). At the time of the report, SKIN MASS (How long is it normal for the lump in the armpit to be swollen) and SWELLING (How long is it normal for the lump in the armpit to be swollen) 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.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Unusual side effect; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    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 VACCINATION COMPLICATION (Unusual side effect) 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 VACCINATION COMPLICATION (Unusual side effect). At the time of the report, VACCINATION COMPLICATION (Unusual side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medications reported. Treatment information not reported.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of that was left out for 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of that was left out for 24 hours) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 033B21) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS.   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 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of that was left out for 24 hours). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of that was left out for 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms; coming down with something; chills; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to the company on 11-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (coming down with something), CHILLS (chills) and PYREXIA (fever) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Nerve damage (The patient developed nerve damage in his feet after he took the antibiotic Levaquin,) and Burning sensation (Has not had burning sensation for the past 15-20 years (since about year 2000)). Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE and VALSARTAN for Hypertension.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (coming down with something), CHILLS (chills) and PYREXIA (fever). On 07-Feb-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (coming down with something), CHILLS (chills) and PYREXIA (fever) 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 treatment of events was reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: The first one I was sick one day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (The first one I was sick one day) 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 (The first one I was sick one day). At the time of the report, ILLNESS (The first one I was sick one day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications were provided.  No treatment details were provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used/undergone a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/undergone a temperature excursion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/undergone a temperature excursion). On 04-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/undergone a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up information received on 14 Jul 2021 event Description as reported and description to be coded were changed from Expired vaccine used to Expired vaccine used/undergone a temperature excursion
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Head aches that comes and goes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head aches that comes and goes) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 HEADACHE (Head aches that comes and goes). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at a dose of 1 UNK. At the time of the report, HEADACHE (Head aches that comes and goes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I received the Moderma shot Tuesday and have been sick ever since.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    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 ILLNESS (I received the Moderma shot Tuesday and have been sick ever since.) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I received the Moderma shot Tuesday and have been sick ever since.). At the time of the report, ILLNESS (I received the Moderma shot Tuesday and have been sick ever since.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medication was reported. Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: Increased urination; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Increased urination) 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 POLLAKIURIA (Increased urination). At the time of the report, POLLAKIURIA (Increased urination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.   Treatment information not reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Severe fatigue/ tiredness; MYALGIAS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Jun-2021 and was forwarded to Moderna on 12-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Severe fatigue/ tiredness) and MYALGIA (MYALGIAS) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021 at 8:00 AM, the patient experienced FATIGUE (Severe fatigue/ tiredness) and MYALGIA (MYALGIAS). On 12-Feb-2021, FATIGUE (Severe fatigue/ tiredness) and MYALGIA (MYALGIAS) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.     No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-019475 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Pain in extremity
Clinical narrative: Not able to concentrate as sharply on his work; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and DISTURBANCE IN ATTENTION (Not able to concentrate as sharply on his work) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity (during the pandemic gained additional weight due to inactivity).    On 16-Apr-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (Not able to concentrate as sharply on his work). On 17-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, DISTURBANCE IN ATTENTION (Not able to concentrate as sharply on his work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.      This case was linked to MOD-2021-219479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received and contains patient information, product information and events
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: alot of swelling under my armpit; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (alot of swelling under my armpit) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (alot of swelling under my armpit). At the time of the report, SWELLING (alot of swelling under my armpit) 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Mobility decreased, Pain in extremity, Ultrasound scan
Clinical narrative: Numbness in arm, wrist and hand of injection arm after 2nd dose; Hand hurts so bad she can't even make a fist after 2nd dose/Legs hurting after 2nd dose; Can't do anything with hand when first wakes up after 2nd dose/Legs started giving out upon walking after 2nd dose; Legs a problem after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in arm, wrist and hand of injection arm after 2nd dose), PAIN IN EXTREMITY (Hand hurts so bad she can't even make a fist after 2nd dose/Legs hurting after 2nd dose), MOBILITY DECREASED (Can't do anything with hand when first wakes up after 2nd dose/Legs started giving out upon walking after 2nd dose) and LIMB DISCOMFORT (Legs a problem after the 2nd dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hand injury. Concurrent medical conditions included Leg discomfort.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in arm, wrist and hand of injection arm after 2nd dose), PAIN IN EXTREMITY (Hand hurts so bad she can't even make a fist after 2nd dose/Legs hurting after 2nd dose), MOBILITY DECREASED (Can't do anything with hand when first wakes up after 2nd dose/Legs started giving out upon walking after 2nd dose) and LIMB DISCOMFORT (Legs a problem after the 2nd dose). At the time of the report, HYPOAESTHESIA (Numbness in arm, wrist and hand of injection arm after 2nd dose), MOBILITY DECREASED (Can't do anything with hand when first wakes up after 2nd dose/Legs started giving out upon walking after 2nd dose) and LIMB DISCOMFORT (Legs a problem after the 2nd dose) outcome was unknown and PAIN IN EXTREMITY (Hand hurts so bad she can't even make a fist after 2nd dose/Legs hurting after 2nd dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: unknown (Inconclusive) hasn't heard back regarding the results.         No relevant concomitant medications were reported.  No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Myalgia, Vaccination site pain
Clinical narrative: Shingles outbreak; Sore arm; Body aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles outbreak), VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to codeine) and Drug allergy (Allergy to fentanyl).   On 28-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches) and FATIGUE (Fatigue). On 13-Apr-2021, the patient experienced HERPES ZOSTER (Shingles outbreak). The patient was treated with VALACYCLOVIR [VALACICLOVIR] on 14-Apr-2021 for Shingles, at a dose of 500 milligram; PARACETAMOL (TYLENOL) on 28-Mar-2021 at a dose of 325 milligram and PARACETAMOL (TYLENOL) on 29-Mar-2021 at a dose of 325 milligram. On 31-Mar-2021, VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches) and FATIGUE (Fatigue) had resolved. On 22-Apr-2021, HERPES ZOSTER (Shingles outbreak) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HERPES ZOSTER (Shingles outbreak), VACCINATION SITE PAIN (Sore arm) and MYALGIA (Body aches) to be related. No further causality assessment was provided for FATIGUE (Fatigue).    No concomitant medications were reported.  The action taken with mRNA with the events was considered as not applicable.   This case was linked to MOD-2021-031311 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up was received on 30-JULY-2021 and patient demographics updated, Added drugs Allergy. Added newevents, dose 1 information updated, and treatment medications were added. Adverse events causality updated to related with suspect products.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-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 18-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On 18-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: young girl went in to get COVID 19 vaccine and she did not drink water and fell sick after the shot.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (young girl went in to get COVID 19 vaccine and she did not drink water and fell sick after the shot.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ILLNESS (young girl went in to get COVID 19 vaccine and she did not drink water and fell sick after the shot.). At the time of the report, ILLNESS (young girl went in to get COVID 19 vaccine and she did not drink water and fell sick after the shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling hot, Headache, Myalgia
Clinical narrative: Stomach pain; Sorta hot; Muscle ache; mild headache; 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 ABDOMINAL PAIN UPPER (Stomach pain), FEELING HOT (Sorta hot), MYALGIA (Muscle ache) and HEADACHE (mild headache) 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 ABDOMINAL PAIN UPPER (Stomach pain), FEELING HOT (Sorta hot), MYALGIA (Muscle ache) and HEADACHE (mild headache). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), FEELING HOT (Sorta hot), MYALGIA (Muscle ache) and HEADACHE (mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   Treatment information included 2 pm pii.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast tenderness, Feeling abnormal, Pain in extremity, Sensation of blood flow
Clinical narrative: pain in left arm; tenderness in left arm; both breasts were tender; discomfort and it felt like needles in her breasts; rush of more blood flow under the skin; horrible feeling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm), TENDERNESS (tenderness in left arm), BREAST TENDERNESS (both breasts were tender), BREAST DISCOMFORT (discomfort and it felt like needles in her breasts) and SENSATION OF BLOOD FLOW (rush of more blood flow under the skin) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTI VITAMINS & MINERALS and CALCIUM for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in left arm), TENDERNESS (tenderness in left arm), BREAST TENDERNESS (both breasts were tender), BREAST DISCOMFORT (discomfort and it felt like needles in her breasts), SENSATION OF BLOOD FLOW (rush of more blood flow under the skin) and FEELING ABNORMAL (horrible feeling). On 25-Apr-2021, PAIN IN EXTREMITY (pain in left arm) and TENDERNESS (tenderness in left arm) had resolved. At the time of the report, BREAST TENDERNESS (both breasts were tender), BREAST DISCOMFORT (discomfort and it felt like needles in her breasts), SENSATION OF BLOOD FLOW (rush of more blood flow under the skin) and FEELING ABNORMAL (horrible feeling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-219650 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: pain in left arm; tenderness in left arm; both breasts were tender; discomfort and it felt like needles in her breasts; rush of more blood flow under the skin; horrible feeling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm), TENDERNESS (tenderness in left arm), BREAST TENDERNESS (both breasts were tender), BREAST DISCOMFORT (discomfort and it felt like needles in her breasts) and SENSATION OF BLOOD FLOW (rush of more blood flow under the skin) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTI VITAMINS & MINERALS and CALCIUM for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in left arm), TENDERNESS (tenderness in left arm), BREAST TENDERNESS (both breasts were tender), BREAST DISCOMFORT (discomfort and it felt like needles in her breasts), SENSATION OF BLOOD FLOW (rush of more blood flow under the skin) and FEELING ABNORMAL (horrible feeling). On 25-Apr-2021, PAIN IN EXTREMITY (pain in left arm) and TENDERNESS (tenderness in left arm) had resolved. At the time of the report, BREAST TENDERNESS (both breasts were tender), BREAST DISCOMFORT (discomfort and it felt like needles in her breasts), SENSATION OF BLOOD FLOW (rush of more blood flow under the skin) and FEELING ABNORMAL (horrible feeling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-219650 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pain
Clinical narrative: got shot in march, since then sick with pain; got shot in march, since then sick with pain; romatoligust doctor and he said I have polymyalgia; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got shot in march, since then sick with pain), PAIN (got shot in march, since then sick with pain) and MYALGIA (romatoligust doctor and he said I have polymyalgia) 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 ILLNESS (got shot in march, since then sick with pain), PAIN (got shot in march, since then sick with pain) and MYALGIA (romatoligust doctor and he said I have polymyalgia). At the time of the report, ILLNESS (got shot in march, since then sick with pain), PAIN (got shot in march, since then sick with pain) and MYALGIA (romatoligust doctor and he said I have polymyalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information included steroids.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: No second dose of the Moderna Covid19 Vaccine after 8 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (No second dose of the Moderna Covid19 Vaccine after 8 weeks) 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 PRODUCT DOSE OMISSION ISSUE (No second dose of the Moderna Covid19 Vaccine after 8 weeks). At the time of the report, PRODUCT DOSE OMISSION ISSUE (No second dose of the Moderna Covid19 Vaccine after 8 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: still have a headache 1 week after my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (still have a headache 1 week after my vaccine) 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 HEADACHE (still have a headache 1 week after my vaccine). At the time of the report, HEADACHE (still have a headache 1 week after my vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  patient's lab test data not reported. No concomitant medication information was provided. No treatment information was provided.