chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: can't focus; can't remember things; can't work; not had a menstrual cycle in two weeks which they say is not normal; feels like crap; extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (can't focus), MEMORY IMPAIRMENT (can't remember things), IMPAIRED WORK ABILITY (can't work), POLYMENORRHOEA (not had a menstrual cycle in two weeks which they say is not normal) and MYALGIA (feels like crap) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DISTURBANCE IN ATTENTION (can't focus), MEMORY IMPAIRMENT (can't remember things), IMPAIRED WORK ABILITY (can't work), POLYMENORRHOEA (not had a menstrual cycle in two weeks which they say is not normal), MYALGIA (feels like crap) and FATIGUE (extremely fatigued). At the time of the report, DISTURBANCE IN ATTENTION (can't focus), MEMORY IMPAIRMENT (can't remember things), IMPAIRED WORK ABILITY (can't work), POLYMENORRHOEA (not had a menstrual cycle in two weeks which they say is not normal), MYALGIA (feels like crap) and FATIGUE (extremely fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter.  No treatment medication were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Muscle atrophy, Paraesthesia
Clinical narrative: Dizziness; Loose muscles in my legs; Tingling in my right hand; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MUSCLE ATROPHY (Loose muscles in my legs) and PARAESTHESIA (Tingling in my right hand) 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 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced DIZZINESS (Dizziness), MUSCLE ATROPHY (Loose muscles in my legs) and PARAESTHESIA (Tingling in my right hand). At the time of the report, DIZZINESS (Dizziness), MUSCLE ATROPHY (Loose muscles in my legs) and PARAESTHESIA (Tingling in my right hand) 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 reported.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Achiness in the legs; Jingling in the feet; 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 PAIN IN EXTREMITY (Achiness in the legs) and LIMB DISCOMFORT (Jingling in the feet) 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 09-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Achiness in the legs) and LIMB DISCOMFORT (Jingling in the feet). At the time of the report, PAIN IN EXTREMITY (Achiness in the legs) and LIMB DISCOMFORT (Jingling in the feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: "Side effects"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("Side effects") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION ("Side effects"). At the time of the report, VACCINATION COMPLICATION ("Side effects") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant was unknown No Treatment were reported
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive covid test after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive covid test after 1st dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive covid test after 1st dose). At the time of the report, COVID-19 (Positive covid test after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported  No Treatment information was reported
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Bad diziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Bad diziness) 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 DIZZINESS (Bad diziness). At the time of the report, DIZZINESS (Bad diziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose not applied after 36 days /first dose was applied in April.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not applied after 36 days /first dose was applied in April.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not applied after 36 days /first dose was applied in April.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not applied after 36 days /first dose was applied in April.) 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.   Concomitant product use was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: If I had a minor reaction to the first dose will the second be worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (If I had a minor reaction to the first dose will the second be worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (If I had a minor reaction to the first dose will the second be worse). At the time of the report, VACCINATION COMPLICATION (If I had a minor reaction to the first dose will the second be worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered after beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (vaccine was administered after beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was administered after beyond use date) had resolved. 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. No concomitant medications information was reported. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of swollen right eye lid 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 second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced a swollen right eye lid. At the time of the report, swollen right eye lid outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable. No concomitant medication or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: arm soreness; running fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and PYREXIA (running fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and PYREXIA (running fever). In 2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, PYREXIA (running fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported. No treatment medications were provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza, Pyrexia
Clinical narrative: All the normal like having the flu for a day or two after second dose; Fever after second dose; Chills after second dose; Headache after second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (All the normal like having the flu for a day or two after second dose), PYREXIA (Fever after second dose), CHILLS (Chills after second dose) and HEADACHE (Headache after second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 INFLUENZA (All the normal like having the flu for a day or two after second dose), PYREXIA (Fever after second dose), CHILLS (Chills after second dose) and HEADACHE (Headache after second dose). At the time of the report, INFLUENZA (All the normal like having the flu for a day or two after second dose), PYREXIA (Fever after second dose), CHILLS (Chills after second dose) and HEADACHE (Headache after second dose) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-281108 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of peripheral swelling (arm swelling after each dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 008B21A) for COVID-19 immunization. No medical history reported. On Apr 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced peripheral swelling (arm swelling after each dose). At the time of the report, peripheral swelling (arm swelling after each dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular): unknown. No concomitant medication or treatment information reported. This case linked to MOD-2021-281237 (patient link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Loss of personal independence in daily activities
Clinical narrative: couldn't work for 12 days; couldn't get out of bed; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't work for 12 days), BEDRIDDEN (couldn't get out of bed) and FATIGUE (extreme fatigue ) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't work for 12 days), BEDRIDDEN (couldn't get out of bed) and FATIGUE (extreme fatigue ). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't work for 12 days), BEDRIDDEN (couldn't get out of bed) and FATIGUE (extreme fatigue ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Myalgia, Pyrexia
Clinical narrative: extreme hunger pains like he didn't eat for days; energy drained/put down; really tired; fever; body aches/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (extreme hunger pains like he didn't eat for days), ASTHENIA (energy drained/put down), FATIGUE (really tired), PYREXIA (fever) and MYALGIA (body aches/sore arm) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-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 ABDOMINAL PAIN UPPER (extreme hunger pains like he didn't eat for days), ASTHENIA (energy drained/put down), FATIGUE (really tired), PYREXIA (fever) and MYALGIA (body aches/sore arm). The patient was treated with IBUPROFEN ongoing since an unknown date for Fever, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (extreme hunger pains like he didn't eat for days), ASTHENIA (energy drained/put down), FATIGUE (really tired), PYREXIA (fever) and MYALGIA (body aches/sore arm) outcome was unknown.            No concomitant medication were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of nasal congestion (nose is stopped-up) and fatigue (very tired) 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 nasal congestion (nose stopped-up) and fatigue (very tired). At the time of the report, nasal congestion (nose stopped-up) and fatigue (very tired) 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: Nasal congestion
Clinical narrative: Nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion) 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 NASAL CONGESTION (Nasal congestion). At the time of the report, NASAL CONGESTION (Nasal congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of heart palpitations 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), intramuscular; 1 dosage form. On an unknown date, patient experienced heart palpitations. At the time of the report, heart palpitations outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Nerve injury, Rash
Clinical narrative: The vaccine hit my nerves system/damage is already been done/effect my nerves system; A rash on my body/put a rash on on my body; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (The vaccine hit my nerves system/damage is already been done/effect my nerves system) and RASH (A rash on my body/put a rash on on my body) 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 NERVE INJURY (The vaccine hit my nerves system/damage is already been done/effect my nerves system) and RASH (A rash on my body/put a rash on on my body). At the time of the report, NERVE INJURY (The vaccine hit my nerves system/damage is already been done/effect my nerves system) and RASH (A rash on my body/put a rash on on my body) 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: Contusion
Clinical narrative: Lots of bruises on my left thigh; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Lots of bruises on my left thigh) 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 CONTUSION (Lots of bruises on my left thigh). At the time of the report, CONTUSION (Lots of bruises on my left thigh) 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.  No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after first dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 27-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 PAIN IN EXTREMITY (sore arm after first dose). At the time of the report, PAIN IN EXTREMITY (sore arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-281266, MOD-2021-128083 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Ear discomfort, Hypoaesthesia oral, Lip swelling, Paraesthesia
Clinical narrative: pressure on her left ear  going down inside the ear canal; jaw on the left side of her face started tingling; lips tingling; lips numb; lips puffy towards the midline; metallic taste; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a patient and describes the occurrence of EAR DISCOMFORT (pressure on her left ear  going down inside the ear canal), PARAESTHESIA (jaw on the left side of her face started tingling), PARAESTHESIA ORAL (lips tingling), HYPOAESTHESIA ORAL (lips numb) and LIP SWELLING (lips puffy towards the midline) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced EAR DISCOMFORT (pressure on her left ear  going down inside the ear canal), PARAESTHESIA (jaw on the left side of her face started tingling), PARAESTHESIA ORAL (lips tingling), HYPOAESTHESIA ORAL (lips numb), LIP SWELLING (lips puffy towards the midline) and DYSGEUSIA (metallic taste). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, EAR DISCOMFORT (pressure on her left ear  going down inside the ear canal) and HYPOAESTHESIA ORAL (lips numb) had not resolved and PARAESTHESIA (jaw on the left side of her face started tingling), PARAESTHESIA ORAL (lips tingling), LIP SWELLING (lips puffy towards the midline) and DYSGEUSIA (metallic taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported.   This case was linked to MOD-2021-281267 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: pressure on her left ear  going down inside the ear canal; jaw on the left side of her face started tingling; lips tingling; lips numb; lips puffy towards the midline; metallic taste; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a patient and describes the occurrence of EAR DISCOMFORT (pressure on her left ear  going down inside the ear canal), PARAESTHESIA (jaw on the left side of her face started tingling), PARAESTHESIA ORAL (lips tingling), HYPOAESTHESIA ORAL (lips numb) and LIP SWELLING (lips puffy towards the midline) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced EAR DISCOMFORT (pressure on her left ear  going down inside the ear canal), PARAESTHESIA (jaw on the left side of her face started tingling), PARAESTHESIA ORAL (lips tingling), HYPOAESTHESIA ORAL (lips numb), LIP SWELLING (lips puffy towards the midline) and DYSGEUSIA (metallic taste). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, EAR DISCOMFORT (pressure on her left ear  going down inside the ear canal) and HYPOAESTHESIA ORAL (lips numb) had not resolved and PARAESTHESIA (jaw on the left side of her face started tingling), PARAESTHESIA ORAL (lips tingling), LIP SWELLING (lips puffy towards the midline) and DYSGEUSIA (metallic taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported.   This case was linked to MOD-2021-281267 (Patient Link).
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic product ineffective
Clinical narrative: effecacy slowly decreases; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT INEFFECTIVE (effecacy slowly decreases) in a 72-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.   In February 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 an unknown date, the patient experienced THERAPEUTIC PRODUCT INEFFECTIVE (effecacy slowly decreases). At the time of the report, THERAPEUTIC PRODUCT INEFFECTIVE (effecacy slowly decreases) outcome was unknown.            No concomitant and treatment medication information was reported. Patient was fully vaccinated end of Feb. Patient would be going in for heart surgery and was worried about it.   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling in her left leg below the knee; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in her left leg below the knee) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (swelling in her left leg below the knee). At the time of the report, PERIPHERAL SWELLING (swelling in her left leg below the knee) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had X-Ray- No results were provided.  No concomitant medications information was reported. No treatment medications were provided.  For the event swelling in left leg, patient was prompted to seek medical attention at the local hospital.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received contains no new information.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chills, Cough, Headache, Influenza like illness
Clinical narrative: bad  coughing; flu like symptoms; Sore Throat; has been in the  bed  since last  night; Chills; Headache; achy body; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (bad  coughing), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (Sore Throat), BEDRIDDEN (has been in the  bed  since last  night) and CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021 at 10:00 AM, the patient experienced COUGH (bad  coughing), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (Sore Throat), BEDRIDDEN (has been in the  bed  since last  night), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (achy body). At the time of the report, COUGH (bad  coughing), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (Sore Throat), BEDRIDDEN (has been in the  bed  since last  night), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (achy body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information is not provided by the reporter.  Concomitant medication included Unspecified Blood pressure medication 10 mg.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain
Clinical narrative: bad  coughing; flu like symptoms; Sore Throat; has been in the  bed  since last  night; Chills; Headache; achy body; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (bad  coughing), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (Sore Throat), BEDRIDDEN (has been in the  bed  since last  night) and CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021 at 10:00 AM, the patient experienced COUGH (bad  coughing), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (Sore Throat), BEDRIDDEN (has been in the  bed  since last  night), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (achy body). At the time of the report, COUGH (bad  coughing), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (Sore Throat), BEDRIDDEN (has been in the  bed  since last  night), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (achy body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information is not provided by the reporter.  Concomitant medication included Unspecified Blood pressure medication 10 mg.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Bed rest, Chills, Headache, Pyrexia
Clinical narrative: Stayed in bed; fever after second dose for a day- day and a half; chills after second dose for a day- day and a half; headache after second dose for a day- day and a half; This spontaneous case was reported by a consumer and describes the occurrence of BED REST (Stayed in bed), PYREXIA (fever after second dose for a day- day and a half), CHILLS (chills after second dose for a day- day and a half) and HEADACHE (headache after second dose for a day- day and a half) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PYREXIA (fever after second dose for a day- day and a half), CHILLS (chills after second dose for a day- day and a half) and HEADACHE (headache after second dose for a day- day and a half). On an unknown date, the patient experienced BED REST (Stayed in bed). At the time of the report, BED REST (Stayed in bed), PYREXIA (fever after second dose for a day- day and a half), CHILLS (chills after second dose for a day- day and a half) and HEADACHE (headache after second dose for a day- day and a half) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-128083, MOD-2021-281251 (Patient Link).   Reporter did not allow further contact
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Accidentally vaccinated a child with the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidentally vaccinated a child with the Moderna vaccine) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidentally vaccinated a child with the Moderna vaccine). On 09-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidentally vaccinated a child with the Moderna vaccine) 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.   Concomitant medication product use was not provided by the reporter. No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: HIV test, T-lymphocyte count, Therapeutic response unexpected
Clinical narrative: Warts have disappeared; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Warts have disappeared) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection (Patient has HIV for the past 30 years) and Warts (Patient has 6 or 7 warts on his fingers for the past 20 years). Concomitant products included COBICISTAT, DARUNAVIR ETHANOLATE (PREZCOBIX), ABACAVIR SULFATE, LAMIVUDINE (ABACAVIR AND LAMIVUDINE), ACITRETIN, METFORMIN, ENALAPRIL and ATORVASTATIN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Warts have disappeared). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Warts have disappeared) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, T-lymphocyte count: 300 (Low) 37.5% and 300 count. In January 2021, T-lymphocyte count: 398 (Low) Percentage was 33.2% and count was 398. On 21-May-2021, T-lymphocyte count: 656 (normal) Increased to  38.6% and T cell count 656. On an unknown date, HIV test: positive (Positive) Positive for 30 years. On an unknown date, T-lymphocyte count: 300 (Low) typical count 300 for the past few years.         Patient had a blood test on 4JUN2021 but the results were not reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: never went back for my second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never went back for my second dose) 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 04-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 PRODUCT DOSE OMISSION ISSUE (never went back for my second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (never went back for my second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were provided by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Warm at Injection site; Pimple; Itchy at injection site; Soreness at Injection site; Rash at Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm at Injection site), ACNE (Pimple), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE PAIN (Soreness at Injection site) and VACCINATION SITE RASH (Rash at Injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concomitant products included ZINC, CALCIUM, VITAMIN D3 and LEVOFLOXACIN for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION SITE WARMTH (Warm at Injection site), ACNE (Pimple), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE PAIN (Soreness at Injection site) and VACCINATION SITE RASH (Rash at Injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In 2021, VACCINATION SITE WARMTH (Warm at Injection site), ACNE (Pimple), VACCINATION SITE PAIN (Soreness at Injection site) and VACCINATION SITE RASH (Rash at Injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included over the counter medications, heart pill and sleeping pills for an unknown indication.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Periarthritis
Clinical narrative: Frozen shoulder on the injection side; A lot of pain in the left arm; Inability to move the upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Frozen shoulder on the injection side), PAIN IN EXTREMITY (A lot of pain in the left arm) and MOBILITY DECREASED (Inability to move the upper arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included VITAMINS NOS for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced PERIARTHRITIS (Frozen shoulder on the injection side), PAIN IN EXTREMITY (A lot of pain in the left arm) and MOBILITY DECREASED (Inability to move the upper arm). At the time of the report, PERIARTHRITIS (Frozen shoulder on the injection side), PAIN IN EXTREMITY (A lot of pain in the left arm) and MOBILITY DECREASED (Inability to move the upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications was provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Dizziness main problem; 2-3 days of diarrhea; headache still there; fatigue; muscle and arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness main problem), DIARRHOEA (2-3 days of diarrhea), HEADACHE (headache still there), FATIGUE (fatigue) and MYALGIA (muscle and arm soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History provided.  Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and OMEPRAZOLE for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Dizziness main problem), DIARRHOEA (2-3 days of diarrhea), HEADACHE (headache still there), FATIGUE (fatigue) and MYALGIA (muscle and arm soreness). At the time of the report, DIZZINESS (Dizziness main problem) and HEADACHE (headache still there) had not resolved, DIARRHOEA (2-3 days of diarrhea) had resolved and FATIGUE (fatigue) and MYALGIA (muscle and arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not had any current conditions. No treatment information was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Impaired work ability, Product dose omission issue, Productive cough
Clinical narrative: terribly sick for about 10 days; hard to cough up the phlegm; phlegm was dark and hard; affected the patients sleep; affected their ability to work; made the patient throw up a lot; did not get the second dose of the vaccine; dry cough/cough was horrible; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine), COUGH (dry cough/cough was horrible), ILLNESS (terribly sick for about 10 days), SPUTUM RETENTION (hard to cough up the phlegm) and PRODUCTIVE COUGH (phlegm was dark and hard) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced COUGH (dry cough/cough was horrible). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine), ILLNESS (terribly sick for about 10 days), SPUTUM RETENTION (hard to cough up the phlegm), PRODUCTIVE COUGH (phlegm was dark and hard), SLEEP DISORDER (affected the patients sleep), IMPAIRED WORK ABILITY (affected their ability to work) and VOMITING (made the patient throw up a lot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine) had resolved, COUGH (dry cough/cough was horrible) was resolving and ILLNESS (terribly sick for about 10 days), SPUTUM RETENTION (hard to cough up the phlegm), PRODUCTIVE COUGH (phlegm was dark and hard), SLEEP DISORDER (affected the patients sleep), IMPAIRED WORK ABILITY (affected their ability to work) and VOMITING (made the patient throw up a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient explained the cough was better now but the patient still has a little bit of a cough.  The patient took cough medications to help with the symptoms.  The patient does not take any daily medications.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Sputum retention, Vomiting
Clinical narrative: terribly sick for about 10 days; hard to cough up the phlegm; phlegm was dark and hard; affected the patients sleep; affected their ability to work; made the patient throw up a lot; did not get the second dose of the vaccine; dry cough/cough was horrible; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine), COUGH (dry cough/cough was horrible), ILLNESS (terribly sick for about 10 days), SPUTUM RETENTION (hard to cough up the phlegm) and PRODUCTIVE COUGH (phlegm was dark and hard) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced COUGH (dry cough/cough was horrible). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine), ILLNESS (terribly sick for about 10 days), SPUTUM RETENTION (hard to cough up the phlegm), PRODUCTIVE COUGH (phlegm was dark and hard), SLEEP DISORDER (affected the patients sleep), IMPAIRED WORK ABILITY (affected their ability to work) and VOMITING (made the patient throw up a lot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine) had resolved, COUGH (dry cough/cough was horrible) was resolving and ILLNESS (terribly sick for about 10 days), SPUTUM RETENTION (hard to cough up the phlegm), PRODUCTIVE COUGH (phlegm was dark and hard), SLEEP DISORDER (affected the patients sleep), IMPAIRED WORK ABILITY (affected their ability to work) and VOMITING (made the patient throw up a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient explained the cough was better now but the patient still has a little bit of a cough.  The patient took cough medications to help with the symptoms.  The patient does not take any daily medications.