chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Pregnancy, Pyrexia
Clinical narrative: Pregnant; Flu like symptoms; Pain; Fever; Tiredness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pain), PYREXIA (Fever) and FATIGUE (Tiredness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 25-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pain), PYREXIA (Fever) and FATIGUE (Tiredness). On 18-Jun-2021, the patient experienced PREGNANCY (Pregnant). At the time of the report, PREGNANCY (Pregnant), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Pain), PYREXIA (Fever) and FATIGUE (Tiredness) outcome was unknown.            Concomitant medication were not reported by reporter.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-235507 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: No new information. On 22-Jul-2021: Non-significant information, reporter's contact details added.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Depression, Dyskinesia, Feeling abnormal, Illness
Clinical narrative: Changes in his thinking process/Cloudiness; jerking in sleep; Severely depressed; sick/hurting; Feeling Cloudiness; Chills; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Changes in his thinking process/Cloudiness), DYSKINESIA (jerking in sleep), DEPRESSION (Severely depressed), ILLNESS (sick/hurting) and FEELING ABNORMAL (Feeling Cloudiness) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Depression.    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 THINKING ABNORMAL (Changes in his thinking process/Cloudiness), DYSKINESIA (jerking in sleep), DEPRESSION (Severely depressed), ILLNESS (sick/hurting), FEELING ABNORMAL (Feeling Cloudiness), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, THINKING ABNORMAL (Changes in his thinking process/Cloudiness), DYSKINESIA (jerking in sleep), DEPRESSION (Severely depressed), ILLNESS (sick/hurting), FEELING ABNORMAL (Feeling Cloudiness), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dose of concomitant medication was increased during the vaccination time.   This case was linked to MOD-2021-235712 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Non-significant follow up appended. Follow-up information received on 25 Jun 2021 and does not contain any new information.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Thinking abnormal
Clinical narrative: Changes in his thinking process/Cloudiness; jerking in sleep; Severely depressed; sick/hurting; Feeling Cloudiness; Chills; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Changes in his thinking process/Cloudiness), DYSKINESIA (jerking in sleep), DEPRESSION (Severely depressed), ILLNESS (sick/hurting) and FEELING ABNORMAL (Feeling Cloudiness) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Depression.    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 THINKING ABNORMAL (Changes in his thinking process/Cloudiness), DYSKINESIA (jerking in sleep), DEPRESSION (Severely depressed), ILLNESS (sick/hurting), FEELING ABNORMAL (Feeling Cloudiness), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, THINKING ABNORMAL (Changes in his thinking process/Cloudiness), DYSKINESIA (jerking in sleep), DEPRESSION (Severely depressed), ILLNESS (sick/hurting), FEELING ABNORMAL (Feeling Cloudiness), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dose of concomitant medication was increased during the vaccination time.   This case was linked to MOD-2021-235712 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Non-significant follow up appended. Follow-up information received on 25 Jun 2021 and does not contain any new information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Myalgia, Nerve compression, Pain in extremity
Clinical narrative: Pinched Nerve continued post second dose; She was Miserable; Numb Thumb and Forefinge; Excruciating pain in upper left arm/ Shoulder; Soreness Continued post second dose/ Pain; This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (Pinched Nerve continued post second dose), FEELING ABNORMAL (She was Miserable), HYPOAESTHESIA (Numb Thumb and Forefinge), PAIN IN EXTREMITY (Excruciating pain in upper left arm/ Shoulder) and MYALGIA (Soreness Continued post second dose/ Pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Neck pain (A couple of years ago and went through a Physical therapy for posture.). Concurrent medical conditions included Blood pressure abnormal and Thyroiditis. Concomitant products included LOSARTAN, AMLODIPINE and HYDROCHLOROTHIAZIDE for Blood pressure management, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, ZINC and COLECALCIFEROL (VIT D3) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced NERVE COMPRESSION (Pinched Nerve continued post second dose), FEELING ABNORMAL (She was Miserable), HYPOAESTHESIA (Numb Thumb and Forefinge), PAIN IN EXTREMITY (Excruciating pain in upper left arm/ Shoulder) and MYALGIA (Soreness Continued post second dose/ Pain). On 01-Mar-2021, NERVE COMPRESSION (Pinched Nerve continued post second dose), FEELING ABNORMAL (She was Miserable) and MYALGIA (Soreness Continued post second dose/ Pain) had resolved, HYPOAESTHESIA (Numb Thumb and Forefinge) had not resolved. At the time of the report, PAIN IN EXTREMITY (Excruciating pain in upper left arm/ Shoulder) had resolved with sequelae.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information includes Steroid shot two weeks after the second dose of vaccination.   This case was linked to MOD-2021-019393 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received on 26-Jul-2021 and included Patient's Demographics, Medical History, Vaccine dose information, Concomitant medications, Treatment medications and Event Pain in extremity were added.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose is past day 35; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is past day 35) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is past day 35). On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is past day 35) had resolved.            No concomitant medications reported. No treatment information was provided.    This case was linked to MOD21-054176, MOD21-115401  (Patient Link).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first dose of the Moderna vaccine while under 18 years of age) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first dose of the Moderna vaccine while under 18 years of age). On 26-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first dose of the Moderna vaccine while under 18 years of age) 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.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old had first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old had first shot) in a 15-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, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old had first shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old had first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Inflammation, Nerve compression
Clinical narrative: Inflammation after vaccination; Pinched Nerve after vaccination; 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 INFLAMMATION (Inflammation after vaccination) and NERVE COMPRESSION (Pinched Nerve after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation after vaccination) and NERVE COMPRESSION (Pinched Nerve after vaccination). At the time of the report, INFLAMMATION (Inflammation after vaccination) and NERVE COMPRESSION (Pinched Nerve after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient treatment data was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: numbness was on right arm, right leg, left arm, left leg and both sides of face; Pain; Tingling; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness was on right arm, right leg, left arm, left leg and both sides of face), PAIN (Pain), PARAESTHESIA (Tingling) and ASTHENIA (Weakness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-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 HYPOAESTHESIA (numbness was on right arm, right leg, left arm, left leg and both sides of face), PAIN (Pain), PARAESTHESIA (Tingling) and ASTHENIA (Weakness). At the time of the report, HYPOAESTHESIA (numbness was on right arm, right leg, left arm, left leg and both sides of face), PAIN (Pain), PARAESTHESIA (Tingling) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node on his neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node on his neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node on his neck). At the time of the report, LYMPHADENOPATHY (swollen lymph node on his neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. No treatment information provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Depression, Feeling abnormal, Illness, Myoclonus
Clinical narrative: Changes in his thinking process/Cloudiness; Feeling cloudy; Severely depressed; Arm swelled; Jerking in sleep; Sick/hurting; Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Changes in his thinking process/Cloudiness), FEELING ABNORMAL (Feeling cloudy), DEPRESSION (Severely depressed), PERIPHERAL SWELLING (Arm swelled) and MYOCLONUS (Jerking in sleep) in a 46-year-old male 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 was provided by the reporter.  Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Depression.   On 14-May-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THINKING ABNORMAL (Changes in his thinking process/Cloudiness), FEELING ABNORMAL (Feeling cloudy), DEPRESSION (Severely depressed), PERIPHERAL SWELLING (Arm swelled), MYOCLONUS (Jerking in sleep), ILLNESS (Sick/hurting), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN for Body temperature, at an unspecified dose and frequency. At the time of the report, THINKING ABNORMAL (Changes in his thinking process/Cloudiness), FEELING ABNORMAL (Feeling cloudy), DEPRESSION (Severely depressed), PERIPHERAL SWELLING (Arm swelled), MYOCLONUS (Jerking in sleep), ILLNESS (Sick/hurting), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No laboratory data was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-235660 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Significant Follow up. Added cross link case of dose 1. Patients picture received.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Thinking abnormal
Clinical narrative: Changes in his thinking process/Cloudiness; Feeling cloudy; Severely depressed; Arm swelled; Jerking in sleep; Sick/hurting; Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Changes in his thinking process/Cloudiness), FEELING ABNORMAL (Feeling cloudy), DEPRESSION (Severely depressed), PERIPHERAL SWELLING (Arm swelled) and MYOCLONUS (Jerking in sleep) in a 46-year-old male 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 was provided by the reporter.  Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Depression.   On 14-May-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THINKING ABNORMAL (Changes in his thinking process/Cloudiness), FEELING ABNORMAL (Feeling cloudy), DEPRESSION (Severely depressed), PERIPHERAL SWELLING (Arm swelled), MYOCLONUS (Jerking in sleep), ILLNESS (Sick/hurting), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN for Body temperature, at an unspecified dose and frequency. At the time of the report, THINKING ABNORMAL (Changes in his thinking process/Cloudiness), FEELING ABNORMAL (Feeling cloudy), DEPRESSION (Severely depressed), PERIPHERAL SWELLING (Arm swelled), MYOCLONUS (Jerking in sleep), ILLNESS (Sick/hurting), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No laboratory data was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-235660 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Significant Follow up. Added cross link case of dose 1. Patients picture received.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Sore Arm Injection Site Post Second Dose; Arm hurts a little Post Second Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore Arm Injection Site Post Second Dose) and LIMB DISCOMFORT (Arm hurts a little Post Second Dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm Injection Site Post Second Dose) and LIMB DISCOMFORT (Arm hurts a little Post Second Dose). At the time of the report, PAIN IN EXTREMITY (Sore Arm Injection Site Post Second Dose) and LIMB DISCOMFORT (Arm hurts a little Post Second Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacist gave the shot after 15 hours that the vial was opened; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist gave the shot after 15 hours that the vial was opened) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist gave the shot after 15 hours that the vial was opened). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist gave the shot after 15 hours that the vial was opened) 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 were provided  No treatment medications were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue
Clinical narrative: most of the vaccine went on the patient's arm; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (most of the vaccine went on the patient's arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced DEVICE CONNECTION ISSUE (most of the vaccine went on the patient's arm). On 23-Jun-2021, DEVICE CONNECTION ISSUE (most of the vaccine went on the patient's arm) 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.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st dose administered to 13 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 13 year old patient) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 13 year old patient). On 24-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 13 year old patient) 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.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Vaccination site pain
Clinical narrative: stiffness; body aches/"slight twinges" (not pain) in lower body (feet, ankles and shins); needle pain after the injection; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), VACCINATION SITE PAIN (needle pain after the injection) and MYALGIA (body aches/"slight twinges" (not pain) in lower body (feet, ankles and shins)) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concomitant products included FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced VACCINATION SITE PAIN (needle pain after the injection). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness) and MYALGIA (body aches/"slight twinges" (not pain) in lower body (feet, ankles and shins)). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), VACCINATION SITE PAIN (needle pain after the injection) and MYALGIA (body aches/"slight twinges" (not pain) in lower body (feet, ankles and shins)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included multivitamin.   This case was linked to MOD-2021-236083 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pruritus, Rash pruritic
Clinical narrative: an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash; an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash; her eyes are really red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash), RASH PRURITIC (an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash) and OCULAR HYPERAEMIA (her eyes are really red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), LEVOTHYROXINE SODIUM (SYNTHROID) and FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021 at 2:30 PM, the patient experienced PRURITUS (an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash), RASH PRURITIC (an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash) and OCULAR HYPERAEMIA (her eyes are really red). The patient was treated with PARACETAMOL (TYLENOL) in June 2021 at an unspecified dose and frequency. At the time of the report, PRURITUS (an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash), RASH PRURITIC (an hour later it started to itch her eyes, nose, her legs, feet, back, between her legs, a hell of a rash) and OCULAR HYPERAEMIA (her eyes are really red) outcome was unknown.            Concomitant medication also included an unspecified anxiety medication. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 0392KKOA) for COVID-19 vaccination.     The patient's past medical history included Epstein-Barr virus infection. Concurrent medical conditions included RA (suspected rheumatoid arthritis and patient has joint problems).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. This case concerns a 71-year-old female with serious unexpected event of pain in extremity. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-235912 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Medical history, labs and treatment details were corrected. Outcome of the event was corrected to resolved.; Sender's Comments: This case concerns a 71-year-old female with serious unexpected event of pain in extremity. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This event appears to be non-serious as it resolved with no medical intervention.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Circumoral oedema, Contusion, Hypoaesthesia, Perioral dermatitis, Raynaud's phenomenon
Clinical narrative: blue bruising at the base of right finger; Skin around my lips was red and swollen; skin around my lips was red and swollen; My right pinky finger was white and  numb- quite likely Reynaud's syndrome; my right pinky finger was white and numb; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (blue bruising at the base of right finger), CIRCUMORAL OEDEMA (Skin around my lips was red and swollen), PERIORAL DERMATITIS (skin around my lips was red and swollen), RAYNAUD'S PHENOMENON (My right pinky finger was white and  numb- quite likely Reynaud's syndrome) and HYPOAESTHESIA (my right pinky finger was white and numb) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Raynaud's syndrome (had Reynaud's several decades ago.).    On 11-Feb-2021 at 3:50 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced CIRCUMORAL OEDEMA (Skin around my lips was red and swollen), PERIORAL DERMATITIS (skin around my lips was red and swollen), RAYNAUD'S PHENOMENON (My right pinky finger was white and  numb- quite likely Reynaud's syndrome) and HYPOAESTHESIA (my right pinky finger was white and numb). On 07-Mar-2021 at 4:00 PM, the patient experienced CONTUSION (blue bruising at the base of right finger). At the time of the report, CONTUSION (blue bruising at the base of right finger), CIRCUMORAL OEDEMA (Skin around my lips was red and swollen), PERIORAL DERMATITIS (skin around my lips was red and swollen), RAYNAUD'S PHENOMENON (My right pinky finger was white and  numb- quite likely Reynaud's syndrome) and HYPOAESTHESIA (my right pinky finger was white and numb) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) with response to the events was not applicable.  No concomitant medications were reportd.  No treatment medications were reported.  On 07-Mar-21, patient noticed that his right pinky finger was white and numb - quite likely Reynaud's syndrome. She had another episode later that day at 4 pm in which the finger was again numb, this time it had blue bruising at the base. Both times it was very hard to warm up the finger. Because it is unusual to have two autoimmune reactions in one day, patient made note of it. The incidence of Reynaud's continued  2-3 times/day over the next week and then subsided. Patient stated that she had Reynaud's, several decades ago but never this many times or this severe.   This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Updated reporter's information and outcome of all events from unknown to  recovered/resolved.
Sex: U
Vaccine: COVID19
Symptoms: Influenza, Myalgia
Clinical narrative: occasionally feels achy almost like she has the flu; occasionally feels achy almost like she has the flu/occasionally has muscle pain in her right arm around to her back; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (occasionally feels achy almost like she has the flu) and MYALGIA (occasionally feels achy almost like she has the flu/occasionally has muscle pain in her right arm around to her back) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (occasionally feels achy almost like she has the flu) and MYALGIA (occasionally feels achy almost like she has the flu/occasionally has muscle pain in her right arm around to her back). At the time of the report, INFLUENZA (occasionally feels achy almost like she has the flu) and MYALGIA (occasionally feels achy almost like she has the flu/occasionally has muscle pain in her right arm around to her back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications  was reported. No treatment was reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 Vaccine) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021 at 11:53 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 Vaccine). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided by the reporter. No treatment information was provided by the reporter. No lab data was provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: cold chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (cold chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (cold chills). At the time of the report, CHILLS (cold chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No treatment medication details were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: magnet sticking to injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (magnet sticking to injection site) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (magnet sticking to injection site). At the time of the report, VACCINATION SITE REACTION (magnet sticking to injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose administered 3 months after the first dose; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 3 months after the first dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 3 months after the first dose). In June 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 3 months after the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants were provided by the reporter. No treatment details were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: FU received- no new information
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Fungal infection, Rash pruritic, Rash vesicular
Clinical narrative: Blistery rash; yeast infection; Itchy rash; Feeling hot; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash), FEELING HOT (Feeling hot), RASH VESICULAR (Blistery rash) and FUNGAL INFECTION (yeast infection) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced RASH PRURITIC (Itchy rash) and FEELING HOT (Feeling hot). On an unknown date, the patient experienced RASH VESICULAR (Blistery rash) and FUNGAL INFECTION (yeast infection). At the time of the report, RASH PRURITIC (Itchy rash), FEELING HOT (Feeling hot), RASH VESICULAR (Blistery rash) and FUNGAL INFECTION (yeast infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications was  provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad). At the time of the report, FEELING ABNORMAL (Feeling bad) outcome was unknown.            No concomitant medications were provided. No treatments were provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pruritus
Clinical narrative: left arm is still sore; sometimes itchy; was hard to move are in certain ways for a few days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (left arm is still sore), PRURITUS (sometimes itchy) and MOBILITY DECREASED (was hard to move are in certain ways for a few days) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-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 MYALGIA (left arm is still sore), PRURITUS (sometimes itchy) and MOBILITY DECREASED (was hard to move are in certain ways for a few days). At the time of the report, MYALGIA (left arm is still sore), PRURITUS (sometimes itchy) and MOBILITY DECREASED (was hard to move are in certain ways for a few days) 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.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes that looked like mosquito bites; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jun-2021 and was forwarded to Moderna on 24-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes that looked like mosquito bites) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided. .     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 RASH (Rashes that looked like mosquito bites). At the time of the report, RASH (Rashes that looked like mosquito bites) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-247899, MOD-2021-247929 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Additional information received contains no new information. On 16-Aug-2021: Follow-up received on 16-AUG-2021 ,containing no new information
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 78-year-old male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-023155 (Patient Link).   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Choking sensation, Dyspnoea, Increased bronchial secretion, Injection site pain, Neck pain
Clinical narrative: he woke up feeling a choking sensation; dyspnea; neck pain; falling asleep; increased secretions; Injection Site Pain; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING SENSATION (he woke up feeling a choking sensation), DYSPNOEA (dyspnea), NECK PAIN (neck pain), SOMNOLENCE (falling asleep) and INCREASED BRONCHIAL SECRETION (increased secretions) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung upper lobectomy (s/p left upper lobectomy). Previously administered products included for Neck pain: cortisone (spinal injection). Past adverse reactions to the above products included No adverse event with cortisone. Concurrent medical conditions included COPD and Lung cancer (lung cancer of unknown cell type).    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, the patient experienced CHOKING SENSATION (he woke up feeling a choking sensation), DYSPNOEA (dyspnea), NECK PAIN (neck pain), SOMNOLENCE (falling asleep), INCREASED BRONCHIAL SECRETION (increased secretions) and INJECTION SITE PAIN (Injection Site Pain). The patient was treated with OXYCODONE at a dose of 1 dosage form; HYDROCODONE at a dose of 1 dosage form; LORAZEPAM at a dose of 1 dosage form and OXYGEN at a dose of 1 dosage form. At the time of the report, CHOKING SENSATION (he woke up feeling a choking sensation), DYSPNOEA (dyspnea), SOMNOLENCE (falling asleep) and INCREASED BRONCHIAL SECRETION (increased secretions) had resolved and NECK PAIN (neck pain) and INJECTION SITE PAIN (Injection Site Pain) outcome was unknown.            No concomitant medication was reported. Treatment medication included IV rehydration. Patient drank vodka with cranberry juice of unknown amount. Patient received O2 by nasal cannula.