chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Rash, Tongue disorder
Clinical narrative: Bumps on tongue; Body rash; Feeling bad and lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Feeling bad and lethargic), TONGUE DISORDER (Bumps on tongue) and RASH (Body rash) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravascular) 1 dosage form. On 20-Mar-2021, the patient experienced LETHARGY (Feeling bad and lethargic). On 21-Mar-2021, the patient experienced TONGUE DISORDER (Bumps on tongue) and RASH (Body rash). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 21-Mar-2021, LETHARGY (Feeling bad and lethargic) had resolved. At the time of the report, TONGUE DISORDER (Bumps on tongue) and RASH (Body rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravascular) was unknown.       No relevant concomitant medication provided by Reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Lacrimation increased, Pain
Clinical narrative: Soreness; dizziness; weakness; watery eye; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), DIZZINESS (dizziness), ASTHENIA (weakness), LACRIMATION INCREASED (watery eye) and HEADACHE (headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (Soreness), DIZZINESS (dizziness), ASTHENIA (weakness), LACRIMATION INCREASED (watery eye) and HEADACHE (headache). At the time of the report, PAIN (Soreness), DIZZINESS (dizziness), ASTHENIA (weakness), LACRIMATION INCREASED (watery eye) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Lightheadedness). At the time of the report, DIZZINESS (Lightheadedness) outcome was unknown. Not Provided          Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-059278 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Chills, Dizziness, Feeling abnormal
Clinical narrative: Very little arm soreness; Sinus infection; Can hardly walk; Arthritis worse; Dizziness; Fibromyalgia got worse; Felt dazed; Body ache; Nausea; Vomiting; joint pain; headache; Chills; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very little arm soreness), SINUSITIS (Sinus infection), GAIT DISTURBANCE (Can hardly walk), ARTHRITIS (Arthritis worse) and DIZZINESS (Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Very little arm soreness), SINUSITIS (Sinus infection), GAIT DISTURBANCE (Can hardly walk), ARTHRITIS (Arthritis worse), DIZZINESS (Dizziness), FIBROMYALGIA (Fibromyalgia got worse), FEELING ABNORMAL (Felt dazed), PAIN (Body ache), NAUSEA (Nausea), VOMITING (Vomiting), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (Chills) and MYALGIA (Muscle pain). At the time of the report, PAIN IN EXTREMITY (Very little arm soreness), SINUSITIS (Sinus infection), GAIT DISTURBANCE (Can hardly walk), ARTHRITIS (Arthritis worse), DIZZINESS (Dizziness), FIBROMYALGIA (Fibromyalgia got worse), FEELING ABNORMAL (Felt dazed), PAIN (Body ache), NAUSEA (Nausea), VOMITING (Vomiting), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (Chills) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment details included antibiotics for sinus infection.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Gait disturbance, Headache, Myalgia, Nausea
Clinical narrative: Very little arm soreness; Sinus infection; Can hardly walk; Arthritis worse; Dizziness; Fibromyalgia got worse; Felt dazed; Body ache; Nausea; Vomiting; joint pain; headache; Chills; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very little arm soreness), SINUSITIS (Sinus infection), GAIT DISTURBANCE (Can hardly walk), ARTHRITIS (Arthritis worse) and DIZZINESS (Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Very little arm soreness), SINUSITIS (Sinus infection), GAIT DISTURBANCE (Can hardly walk), ARTHRITIS (Arthritis worse), DIZZINESS (Dizziness), FIBROMYALGIA (Fibromyalgia got worse), FEELING ABNORMAL (Felt dazed), PAIN (Body ache), NAUSEA (Nausea), VOMITING (Vomiting), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (Chills) and MYALGIA (Muscle pain). At the time of the report, PAIN IN EXTREMITY (Very little arm soreness), SINUSITIS (Sinus infection), GAIT DISTURBANCE (Can hardly walk), ARTHRITIS (Arthritis worse), DIZZINESS (Dizziness), FIBROMYALGIA (Fibromyalgia got worse), FEELING ABNORMAL (Felt dazed), PAIN (Body ache), NAUSEA (Nausea), VOMITING (Vomiting), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (Chills) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment details included antibiotics for sinus infection.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sinusitis, Vomiting
Clinical narrative: Very little arm soreness; Sinus infection; Can hardly walk; Arthritis worse; Dizziness; Fibromyalgia got worse; Felt dazed; Body ache; Nausea; Vomiting; joint pain; headache; Chills; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very little arm soreness), SINUSITIS (Sinus infection), GAIT DISTURBANCE (Can hardly walk), ARTHRITIS (Arthritis worse) and DIZZINESS (Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Very little arm soreness), SINUSITIS (Sinus infection), GAIT DISTURBANCE (Can hardly walk), ARTHRITIS (Arthritis worse), DIZZINESS (Dizziness), FIBROMYALGIA (Fibromyalgia got worse), FEELING ABNORMAL (Felt dazed), PAIN (Body ache), NAUSEA (Nausea), VOMITING (Vomiting), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (Chills) and MYALGIA (Muscle pain). At the time of the report, PAIN IN EXTREMITY (Very little arm soreness), SINUSITIS (Sinus infection), GAIT DISTURBANCE (Can hardly walk), ARTHRITIS (Arthritis worse), DIZZINESS (Dizziness), FIBROMYALGIA (Fibromyalgia got worse), FEELING ABNORMAL (Felt dazed), PAIN (Body ache), NAUSEA (Nausea), VOMITING (Vomiting), ARTHRALGIA (joint pain), HEADACHE (headache), CHILLS (Chills) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment details included antibiotics for sinus infection.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia
Clinical narrative: nausea; high temperature; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and PYREXIA (high temperature) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea) and PYREXIA (high temperature). At the time of the report, NAUSEA (nausea) and PYREXIA (high temperature) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: high (High) high.     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: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 DIZZINESS (Lightheadedness). At the time of the report, DIZZINESS (Lightheadedness) outcome was unknown. Not Provided          No concomitant medications or treatment details reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Limb discomfort, Malaise, Migraine, Nausea
Clinical narrative: massive migraine headache; Couldn't lift her arms.; Arms started to hurts; Veins in the arms popped out as bluish purplish color; Stomach pain as if punched by someone; Feels so sick; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (massive migraine headache), LIMB DISCOMFORT (Couldn't lift her arms.), PAIN IN EXTREMITY (Arms started to hurts), VEIN DISCOLOURATION (Veins in the arms popped out as bluish purplish color) and ABDOMINAL PAIN UPPER (Stomach pain as if punched by someone) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vertigo.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MIGRAINE (massive migraine headache), LIMB DISCOMFORT (Couldn't lift her arms.), PAIN IN EXTREMITY (Arms started to hurts), VEIN DISCOLOURATION (Veins in the arms popped out as bluish purplish color), ABDOMINAL PAIN UPPER (Stomach pain as if punched by someone), MALAISE (Feels so sick) and NAUSEA (Nauseated). On 20-Mar-2021, PAIN IN EXTREMITY (Arms started to hurts) had resolved. At the time of the report, MIGRAINE (massive migraine headache), LIMB DISCOMFORT (Couldn't lift her arms.), VEIN DISCOLOURATION (Veins in the arms popped out as bluish purplish color), ABDOMINAL PAIN UPPER (Stomach pain as if punched by someone), MALAISE (Feels so sick) and NAUSEA (Nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to had been used by the patient, within two weeks prior to the event, included medications for Vertigo.  Treatment for events included tylenol and other non specified prescribed medicines.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vein discolouration
Clinical narrative: massive migraine headache; Couldn't lift her arms.; Arms started to hurts; Veins in the arms popped out as bluish purplish color; Stomach pain as if punched by someone; Feels so sick; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (massive migraine headache), LIMB DISCOMFORT (Couldn't lift her arms.), PAIN IN EXTREMITY (Arms started to hurts), VEIN DISCOLOURATION (Veins in the arms popped out as bluish purplish color) and ABDOMINAL PAIN UPPER (Stomach pain as if punched by someone) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vertigo.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MIGRAINE (massive migraine headache), LIMB DISCOMFORT (Couldn't lift her arms.), PAIN IN EXTREMITY (Arms started to hurts), VEIN DISCOLOURATION (Veins in the arms popped out as bluish purplish color), ABDOMINAL PAIN UPPER (Stomach pain as if punched by someone), MALAISE (Feels so sick) and NAUSEA (Nauseated). On 20-Mar-2021, PAIN IN EXTREMITY (Arms started to hurts) had resolved. At the time of the report, MIGRAINE (massive migraine headache), LIMB DISCOMFORT (Couldn't lift her arms.), VEIN DISCOLOURATION (Veins in the arms popped out as bluish purplish color), ABDOMINAL PAIN UPPER (Stomach pain as if punched by someone), MALAISE (Feels so sick) and NAUSEA (Nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to had been used by the patient, within two weeks prior to the event, included medications for Vertigo.  Treatment for events included tylenol and other non specified prescribed medicines.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle spasms, Myalgia, Pain, Pain in extremity
Clinical narrative: I've been woken up every two hours with leg cramps; sleepiness; sore arm; muscle aches; chills; pain went to my wrist/pain went to my knee (had a knee replacement in 2019); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain went to my wrist/pain went to my knee (had a knee replacement in 2019)), MUSCLE SPASMS (I've been woken up every two hours with leg cramps), SOMNOLENCE (sleepiness), PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for Symptomatic treatment.    No medical history was reported.  Concomitant products included ALLOPURINOL for Uric acid, LISINOPRIL, ROSUVASTATIN and METOPROLOL for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced PAIN (pain went to my wrist/pain went to my knee (had a knee replacement in 2019)), SOMNOLENCE (sleepiness), PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches) and CHILLS (chills). On 18-Mar-2021, the patient experienced MUSCLE SPASMS (I've been woken up every two hours with leg cramps). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY NIGHTTIME) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN (pain went to my wrist/pain went to my knee (had a knee replacement in 2019)), MUSCLE SPASMS (I've been woken up every two hours with leg cramps), SOMNOLENCE (sleepiness), PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches) and CHILLS (chills) outcome was unknown.             She was told not to take any anti-inflammation   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: I've been woken up every two hours with leg cramps; sleepiness; sore arm; muscle aches; chills; pain went to my wrist/pain went to my knee (had a knee replacement in 2019); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain went to my wrist/pain went to my knee (had a knee replacement in 2019)), MUSCLE SPASMS (I've been woken up every two hours with leg cramps), SOMNOLENCE (sleepiness), PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for Symptomatic treatment.    No medical history was reported.  Concomitant products included ALLOPURINOL for Uric acid, LISINOPRIL, ROSUVASTATIN and METOPROLOL for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced PAIN (pain went to my wrist/pain went to my knee (had a knee replacement in 2019)), SOMNOLENCE (sleepiness), PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches) and CHILLS (chills). On 18-Mar-2021, the patient experienced MUSCLE SPASMS (I've been woken up every two hours with leg cramps). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY NIGHTTIME) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN (pain went to my wrist/pain went to my knee (had a knee replacement in 2019)), MUSCLE SPASMS (I've been woken up every two hours with leg cramps), SOMNOLENCE (sleepiness), PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches) and CHILLS (chills) outcome was unknown.             She was told not to take any anti-inflammation   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on his arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced RASH (rash on his arm). At the time of the report, RASH (rash on his arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Followup information was received on 10 May 2021 in which event related details were updated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lethargy, Pain, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm), vaccination site bruising (bruising around injection site), pain (aches), lethargy (feels lethargic) and vaccination site swelling (swollen at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 032N20A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 6, 2021, patient experienced pain in extremity (sore arm). On Mar 19, 2021, patient experienced vaccination site bruising (bruising around injection site), pain (aches), lethargy (feels lethargic), vaccination site swelling (swollen at the injection site), chills, fatigue (tired) and vaccination site pain (arm hurt at injection site). At the time of the report, pain in extremity (sore arm), vaccination site bruising (bruising around injection site), pain (aches), lethargy (feels lethargic), vaccination site swelling (swollen at the injection site), chills, fatigue (tired) and vaccination site pain (arm hurt at injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm), vaccination site bruising (bruising around injection site), pain (aches), lethargy (feels lethargic) and vaccination site swelling (swollen at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 032N20A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 6, 2021, patient experienced pain in extremity (sore arm). On Mar 19, 2021, patient experienced vaccination site bruising (bruising around injection site), pain (aches), lethargy (feels lethargic), vaccination site swelling (swollen at the injection site), chills, fatigue (tired) and vaccination site pain (arm hurt at injection site). At the time of the report, pain in extremity (sore arm), vaccination site bruising (bruising around injection site), pain (aches), lethargy (feels lethargic), vaccination site swelling (swollen at the injection site), chills, fatigue (tired) and vaccination site pain (arm hurt at injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Product dose omission issue, Urticaria, Vaccination site scab
Clinical narrative: Small scabs in the area; Has not received the 2nd vaccine; Hives goes from left side of back, bra and waist; Left arm and hand got tingly; Arm got sore; A spontaneous report was received from a 75-year-old elderly female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced small scabs in the area(vaccination site scab), hives goes from left side of back, bra and waist(urticaria), arm got sore(pain in extremity), left hand and arm got tingly(paresthesia) and had not received the 2nd vaccine(product dose omission issue).  The patient's medical history included allergic to aspirin, penicillin, cats and mold. Concomitant product use was not provided by the reporter.  On 09 Feb 2021, prior to the onset of the events, the patient received her first of the two planned vaccine doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09 Feb 2021, after the first dose of vaccine, the patient's arm got sore for 24 hours.  On 10 Feb 2021, the left arm and hand got tingly and reportedly this went away.   On 11 Feb 2021, she had hives that went from left side of back, bra and waist and reportedly went away. She had not received the 2nd vaccine dose.   On 22 mar 2021, it was reported that she still had small scabs in the area. No treatment medication was reported.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, arm got sore was unknown, small scabs in the area was not resolved, left arm and hand got tingly, hives goes from left side of back, bra and waist was resolved on an unspecified date in 2021, outcome of the event not received the 2nd vaccine was considered to be resolved on 09 Mar 2021.; Reporter's Comments: This report refers to a case of product dose omission issue for mRNA-1273, lot # Unknown, with no associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (light headed). At the time of the report, DIZZINESS (light headed) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine received by 17 year old; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by 17 year old) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by 17 year old) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided. No Treatment medication reported by the reporter. Reporter stated in the follow-up that they were not aware of any adverse events but have not had any further contact with this patient since the administration of the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2021-053788 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Follow up received on 04-JUL-2021 and it contains No New Information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-053788:cross linked case
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine received by 17 year old/ Inadvertant "off label administration of Moderna vaccine to 17 year old; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by 17 year old/ Inadvertant "off label administration of Moderna vaccine to 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by 17 year old/ Inadvertant "off label administration of Moderna vaccine to 17 year old). On 12-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by 17 year old/ Inadvertant "off label administration of Moderna vaccine to 17 year old) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant mediactaions were not reported. It was reported that the screening process did not pick up that the patient was under 18 years old.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-053780 (Linked Report). This case was linked to MOD-2021-053780, MOD-2021-053780 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Added patient initials, gender, not pregnant, date and site of administration of first dose with batch number, second dose details and physician information.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: X ) with no associated AEs. US-MODERNATX, INC.-MOD-2021-053780:Crosslinked case
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Wheezing
Clinical narrative: wheezing; coughing; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (wheezing) and COUGH (coughing) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced WHEEZING (wheezing) and COUGH (coughing). At the time of the report, WHEEZING (wheezing) had resolved and COUGH (coughing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details include Inhalers, nebulizer
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: bodyache; fever; chills; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (bodyache), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and #040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient experienced PAIN (bodyache), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN (bodyache), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia (97-99): Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-034402 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received Consentyx during Moderna COVID series; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Consentyx during Moderna COVID series) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) for COVID-19 vaccination.     Concomitant products included SECUKINUMAB (COSENTYX) from 21-Jan-2021 to an unknown date for an unknown indication.   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 2. On 21-Jan-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Consentyx during Moderna COVID series). On 21-Jan-2021, INTERCHANGE OF VACCINE PRODUCTS (Received Consentyx during Moderna COVID series) had resolved.            Concomitant product use included Consentyx. No Treatment information provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the right upper chest) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 01-Mar-2021, the patient experienced RASH (Rash on the right upper chest). At the time of the report, RASH (Rash on the right upper chest) outcome was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: NNI -Reporter reported
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Paraesthesia, Positron emission tomogram
Clinical narrative: numbness and tingling in both hands; numbness and tingling in both hands; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness and tingling in both hands), PARAESTHESIA (numbness and tingling in both hands) and FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Endometrial carcinoma and Arthritis. Concomitant products included LENVATINIB MESILATE (LENVIMA) from 08-Jan-2021 to an unknown date and PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HYPOAESTHESIA (numbness and tingling in both hands), PARAESTHESIA (numbness and tingling in both hands) and FATIGUE (fatigue). The patient was treated with DULOXETINE HYDROCHLORIDE (CYMBALTA) for Pain, at a dose of 10 mg. At the time of the report, HYPOAESTHESIA (numbness and tingling in both hands) and PARAESTHESIA (numbness and tingling in both hands) was resolving and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Positron emission tomogram: inconclusive (Inconclusive) Not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: My kid age almost 15 got moderna vaccine; A Spontaneous report was received from a consumer concerning,  a 14-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273)/product administered to patient of inappropriate age.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 on unknown date.  On 20 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19.  On 20 Mar 2021, the patient was doing well without any events. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of event, Inappropriate age at vaccine,  was considered resolved on 20 Mar 2021.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (14 year old male) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sorness at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sorness at the site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 007M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included IPRATROPIUM BROMIDE for Perennial rhinitis.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sorness at the site). On 25-Feb-2021, VACCINATION SITE PAIN (Sorness at the site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINATION SITE PAIN (Sorness at the site) to be possibly related.    Concomitant medications include bromide nasal solution. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event is Not applicable.   This case was linked to MOD-2021-011728 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: ADR  form added. Event onset date and event stop date added.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Vaccination complication
Clinical narrative: having trouble even walking, I need to walk with a cane; pretty bad reactions; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (having trouble even walking, I need to walk with a cane) and VACCINATION COMPLICATION (pretty bad reactions) 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 GAIT DISTURBANCE (having trouble even walking, I need to walk with a cane) and VACCINATION COMPLICATION (pretty bad reactions). At the time of the report, GAIT DISTURBANCE (having trouble even walking, I need to walk with a cane) and VACCINATION COMPLICATION (pretty bad reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported. Patient reported that " I am still going to ER (Emergency Room) and doctors to figure out what's going on because I was fine until I had Vaccine."
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Trouble breathing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    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 DYSPNOEA (Trouble breathing). At the time of the report, DYSPNOEA (Trouble breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Adverse event following immunisation
Clinical narrative: Skin Sensitivity; Every side effect mentioned; feeling like I have bronchitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (Skin Sensitivity), ADVERSE EVENT FOLLOWING IMMUNISATION (Every side effect mentioned) and ADVERSE DRUG REACTION (feeling like I have bronchitis) 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 ADVERSE EVENT FOLLOWING IMMUNISATION (Skin Sensitivity), ADVERSE EVENT FOLLOWING IMMUNISATION (Every side effect mentioned) and ADVERSE DRUG REACTION (feeling like I have bronchitis). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (Skin Sensitivity), ADVERSE EVENT FOLLOWING IMMUNISATION (Every side effect mentioned) and ADVERSE DRUG REACTION (feeling like I have bronchitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication reported. No treatment was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Pain in extremity, Vaccination site erythema
Clinical narrative: vertigo where the room was spinning really bad; sensation is still happening especially in the early morning as she changes positions from; headache; some nausea; soreness in the arm; little redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), VACCINATION SITE ERYTHEMA (little redness at injection site), VERTIGO (vertigo where the room was spinning really bad), FEELING ABNORMAL (sensation is still happening especially in the early morning as she changes positions from) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm) and VACCINATION SITE ERYTHEMA (little redness at injection site). On 10-Mar-2021, the patient experienced VERTIGO (vertigo where the room was spinning really bad), FEELING ABNORMAL (sensation is still happening especially in the early morning as she changes positions from), HEADACHE (headache) and NAUSEA (some nausea). On 22-Mar-2021, PAIN IN EXTREMITY (soreness in the arm), VACCINATION SITE ERYTHEMA (little redness at injection site), HEADACHE (headache) and NAUSEA (some nausea) had resolved. At the time of the report, VERTIGO (vertigo where the room was spinning really bad) and FEELING ABNORMAL (sensation is still happening especially in the early morning as she changes positions from) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo where the room was spinning really bad; sensation is still happening especially in the early morning as she changes positions from; headache; some nausea; soreness in the arm; little redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), VACCINATION SITE ERYTHEMA (little redness at injection site), VERTIGO (vertigo where the room was spinning really bad), FEELING ABNORMAL (sensation is still happening especially in the early morning as she changes positions from) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm) and VACCINATION SITE ERYTHEMA (little redness at injection site). On 10-Mar-2021, the patient experienced VERTIGO (vertigo where the room was spinning really bad), FEELING ABNORMAL (sensation is still happening especially in the early morning as she changes positions from), HEADACHE (headache) and NAUSEA (some nausea). On 22-Mar-2021, PAIN IN EXTREMITY (soreness in the arm), VACCINATION SITE ERYTHEMA (little redness at injection site), HEADACHE (headache) and NAUSEA (some nausea) had resolved. At the time of the report, VERTIGO (vertigo where the room was spinning really bad) and FEELING ABNORMAL (sensation is still happening especially in the early morning as she changes positions from) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.