chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Muscle spasms, Musculoskeletal stiffness, Pain
Clinical narrative: extreme muscle spams everyday/started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back; lost appetite/barely eats; lost 20 pounds; Wakes up stiff as a rock/Every morning every day I wake up stiff as a lock; hurts so bad sometimes/pain; drives him crazy; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (extreme muscle spams everyday/started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back), DECREASED APPETITE (lost appetite/barely eats), WEIGHT DECREASED (lost 20 pounds), MUSCULOSKELETAL STIFFNESS (Wakes up stiff as a rock/Every morning every day I wake up stiff as a lock) and PAIN (hurts so bad sometimes/pain) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was provided.  Concomitant products included DULOXETINE for Antidepressant therapy, GABAPENTIN for Sleep disorder.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (extreme muscle spams everyday/started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back), DECREASED APPETITE (lost appetite/barely eats), WEIGHT DECREASED (lost 20 pounds), MUSCULOSKELETAL STIFFNESS (Wakes up stiff as a rock/Every morning every day I wake up stiff as a lock), PAIN (hurts so bad sometimes/pain) and FEELING ABNORMAL (drives him crazy). At the time of the report, MUSCLE SPASMS (extreme muscle spams everyday/started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back), DECREASED APPETITE (lost appetite/barely eats), WEIGHT DECREASED (lost 20 pounds), MUSCULOSKELETAL STIFFNESS (Wakes up stiff as a rock/Every morning every day I wake up stiff as a lock), PAIN (hurts so bad sometimes/pain) and FEELING ABNORMAL (drives him crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. Concomitant medications include antidepressants.   This case was linked to MOD-2021-255826 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13 Jul 2021- Route and administration site was updated. Concomitant drug Duloxetine was updated and indication for both the concomitant medications were updated.Verbatim term updated.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: extreme muscle spams everyday/started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back; lost appetite/barely eats; lost 20 pounds; Wakes up stiff as a rock/Every morning every day I wake up stiff as a lock; hurts so bad sometimes/pain; drives him crazy; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (extreme muscle spams everyday/started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back), DECREASED APPETITE (lost appetite/barely eats), WEIGHT DECREASED (lost 20 pounds), MUSCULOSKELETAL STIFFNESS (Wakes up stiff as a rock/Every morning every day I wake up stiff as a lock) and PAIN (hurts so bad sometimes/pain) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was provided.  Concomitant products included DULOXETINE for Antidepressant therapy, GABAPENTIN for Sleep disorder.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (extreme muscle spams everyday/started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back), DECREASED APPETITE (lost appetite/barely eats), WEIGHT DECREASED (lost 20 pounds), MUSCULOSKELETAL STIFFNESS (Wakes up stiff as a rock/Every morning every day I wake up stiff as a lock), PAIN (hurts so bad sometimes/pain) and FEELING ABNORMAL (drives him crazy). At the time of the report, MUSCLE SPASMS (extreme muscle spams everyday/started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back), DECREASED APPETITE (lost appetite/barely eats), WEIGHT DECREASED (lost 20 pounds), MUSCULOSKELETAL STIFFNESS (Wakes up stiff as a rock/Every morning every day I wake up stiff as a lock), PAIN (hurts so bad sometimes/pain) and FEELING ABNORMAL (drives him crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. Concomitant medications include antidepressants.   This case was linked to MOD-2021-255826 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13 Jul 2021- Route and administration site was updated. Concomitant drug Duloxetine was updated and indication for both the concomitant medications were updated.Verbatim term updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling, Pyrexia, Vaccination complication
Clinical narrative: The patient went to bed 3-4 hours after that time; fever; swelling in the arm extending down to the wrist; finger in the same arm have become numb; Pain in Palm/Pain On Top of Hand; The injection site is also warm to the touch; pain at the injection site (left); Swelling on inside of injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the arm extending down to the wrist), HYPOAESTHESIA (finger in the same arm have become numb), PAIN IN EXTREMITY (Pain in Palm/Pain On Top of Hand), VACCINATION COMPLICATION (The patient went to bed 3-4 hours after that time) and VACCINATION SITE WARMTH (The injection site is also warm to the touch) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) 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 DASATINIB MONOHYDRATE (SPRYCEL), ETHINYLESTRADIOL, LYNESTRENOL (OVOSTAT), FLECAINIDE, METOPROLOL, LORAZEPAM (ATIVAN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced PERIPHERAL SWELLING (swelling in the arm extending down to the wrist), HYPOAESTHESIA (finger in the same arm have become numb), PAIN IN EXTREMITY (Pain in Palm/Pain On Top of Hand), VACCINATION SITE WARMTH (The injection site is also warm to the touch), VACCINATION SITE PAIN (pain at the injection site (left)) and VACCINATION SITE SWELLING (Swelling on inside of injection arm). On an unknown date, the patient experienced VACCINATION COMPLICATION (The patient went to bed 3-4 hours after that time) and PYREXIA (fever). The patient was treated with NAPROXEN at a dose of 500 mg; MENTHOL (ICE [MENTHOL]) at an unspecified dose and frequency and EUGENOL, MENTHOL, METHYL SALICYLATE (HEAT) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in the arm extending down to the wrist), HYPOAESTHESIA (finger in the same arm have become numb), PAIN IN EXTREMITY (Pain in Palm/Pain On Top of Hand), VACCINATION COMPLICATION (The patient went to bed 3-4 hours after that time), VACCINATION SITE WARMTH (The injection site is also warm to the touch), VACCINATION SITE PAIN (pain at the injection site (left)), VACCINATION SITE SWELLING (Swelling on inside of injection arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The patient went to bed 3-4 hours after that time; fever; swelling in the arm extending down to the wrist; finger in the same arm have become numb; Pain in Palm/Pain On Top of Hand; The injection site is also warm to the touch; pain at the injection site (left); Swelling on inside of injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the arm extending down to the wrist), HYPOAESTHESIA (finger in the same arm have become numb), PAIN IN EXTREMITY (Pain in Palm/Pain On Top of Hand), VACCINATION COMPLICATION (The patient went to bed 3-4 hours after that time) and VACCINATION SITE WARMTH (The injection site is also warm to the touch) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) 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 DASATINIB MONOHYDRATE (SPRYCEL), ETHINYLESTRADIOL, LYNESTRENOL (OVOSTAT), FLECAINIDE, METOPROLOL, LORAZEPAM (ATIVAN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced PERIPHERAL SWELLING (swelling in the arm extending down to the wrist), HYPOAESTHESIA (finger in the same arm have become numb), PAIN IN EXTREMITY (Pain in Palm/Pain On Top of Hand), VACCINATION SITE WARMTH (The injection site is also warm to the touch), VACCINATION SITE PAIN (pain at the injection site (left)) and VACCINATION SITE SWELLING (Swelling on inside of injection arm). On an unknown date, the patient experienced VACCINATION COMPLICATION (The patient went to bed 3-4 hours after that time) and PYREXIA (fever). The patient was treated with NAPROXEN at a dose of 500 mg; MENTHOL (ICE [MENTHOL]) at an unspecified dose and frequency and EUGENOL, MENTHOL, METHYL SALICYLATE (HEAT) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in the arm extending down to the wrist), HYPOAESTHESIA (finger in the same arm have become numb), PAIN IN EXTREMITY (Pain in Palm/Pain On Top of Hand), VACCINATION COMPLICATION (The patient went to bed 3-4 hours after that time), VACCINATION SITE WARMTH (The injection site is also warm to the touch), VACCINATION SITE PAIN (pain at the injection site (left)), VACCINATION SITE SWELLING (Swelling on inside of injection arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rash macular
Clinical narrative: Mild pain in the arm; 3  to 4 purplish, blackish and  raised spots on his face, chin and lips; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild pain in the arm), RASH MACULAR (3  to 4 purplish, blackish and  raised spots on his face, chin and lips) and FATIGUE (Fatigue) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Tennis elbow. Concomitant products included GABAPENTIN and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, MELOXICAM for Tennis elbow.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced PAIN IN EXTREMITY (Mild pain in the arm), RASH MACULAR (3  to 4 purplish, blackish and  raised spots on his face, chin and lips) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Mild pain in the arm), RASH MACULAR (3  to 4 purplish, blackish and  raised spots on his face, chin and lips) and FATIGUE (Fatigue) outcome was unknown.            It was reported that the patient got 1st dose of the Moderna COVID-19 Vaccine on 03 Apr 2021 in left arm, intramuscularly. Initially, Patient developed mild pain in the arm and fatigue. After 3 to 4 days of the first dose, Patient developed 3 to 4 purplish, blackish and  raised spots on face, chin and lips.  Patient was not  given any medication to treat the symptoms.  Consent for safety follow-up was granted.  Consumer declined to provide HCP information and vaccination facility information.  Consent to contact the HCP for further followup was declined.   This case was linked to MOD-2021-254063 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site pain
Clinical narrative: sore arm/arm pain,sore right arm; patient received his first dose of Moderna from a vial that was punctured and left in room temperature for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received his first dose of Moderna from a vial that was punctured and left in room temperature for more than 12 hours) and VACCINATION SITE PAIN (sore arm/arm pain,sore right arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received his first dose of Moderna from a vial that was punctured and left in room temperature for more than 12 hours). On 10-Jul-2021, the patient experienced VACCINATION SITE PAIN (sore arm/arm pain,sore right arm). On 09-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patient received his first dose of Moderna from a vial that was punctured and left in room temperature for more than 12 hours) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm/arm pain,sore right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Additional information was received and Reporter information, patient initial and Date of birth, Vaccine information was updated. On 29-Jul-2021: Follow up received and contains no new information. On 29-Jul-2021: Patient Demographics were updated.Outcome of the event Sore right arm update from Unknown to Recovered.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Achiness; Chills; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Achiness), CHILLS (Chills) and FATIGUE (Feeling tired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 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 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Achiness), CHILLS (Chills) and FATIGUE (Feeling tired). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Achiness), CHILLS (Chills) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received for the first dose. No concomitant medication was received.   This case was linked to MOD-2021-254040 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint noise
Clinical narrative: joints are "popping"/ joints are "cracking"; a lot of pain in the hip joint/problems with his hip joint; This spontaneous case was reported by a consumer and describes the occurrence of JOINT NOISE (joints are "popping"/ joints are "cracking") and ARTHRALGIA (a lot of pain in the hip joint/problems with his hip joint) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-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 JOINT NOISE (joints are "popping"/ joints are "cracking") and ARTHRALGIA (a lot of pain in the hip joint/problems with his hip joint). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, JOINT NOISE (joints are "popping"/ joints are "cracking") and ARTHRALGIA (a lot of pain in the hip joint/problems with his hip joint) 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.   No concomitant medications were reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received Second Dose more than 60 days after the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Second Dose more than 60 days after the first dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Second Dose more than 60 days after the first dose). On 12-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Second Dose more than 60 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Influenza like illness
Clinical narrative: Tired; Flu like symptoms; Can't breath through his nose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), INFLUENZA LIKE ILLNESS (Flu like symptoms) and DYSPNOEA (Can't breath through his nose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and DYSPNOEA (Can't breath through his nose). On an unknown date, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired), INFLUENZA LIKE ILLNESS (Flu like symptoms) and DYSPNOEA (Can't breath through his nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller stated that patient received his 1st dose of the Moderna COVID 19 last week. No concomitant medications were mentioned. No treatment details were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Muscle spasms, Muscle tightness, Synovial cyst, Vaccination site pain
Clinical narrative: right knee still swollen; diagnosed with Baker's cyst; A lot of soreness in the arm; Tightness in upper back up to my neck/ tightness in the (right) calf; bad calf cramp; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (A lot of soreness in the arm), MUSCLE TIGHTNESS (Tightness in upper back up to my neck/ tightness in the (right) calf), MUSCLE SPASMS (bad calf cramp), SYNOVIAL CYST (diagnosed with Baker's cyst) and JOINT SWELLING (right knee still swollen) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included UBIDECARENONE (COQ 10), COLOSTRUM (COLOSTRUM 6), VITAMIN D NOS, AMOXICILLIN TRIHYDRATE, BROMHEXINE HYDROCHLORIDE (MOX BRO) from an unknown date to 09-Mar-2021 and DOCOSAHEXAENOIC ACID (DHA) for Immune system disorder (NOS).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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 (A lot of soreness in the arm), MUSCLE TIGHTNESS (Tightness in upper back up to my neck/ tightness in the (right) calf) and MUSCLE SPASMS (bad calf cramp). On 08-Jul-2021, the patient experienced SYNOVIAL CYST (diagnosed with Baker's cyst). On an unknown date, the patient experienced JOINT SWELLING (right knee still swollen). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Muscle tightness, at an unspecified dose and frequency; IBUPROFEN ongoing since an unknown date for Muscle tightness, at an unspecified dose and frequency and CORTISONE on 08-Jul-2021 for Baker's cyst, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (A lot of soreness in the arm) and MUSCLE SPASMS (bad calf cramp) had resolved and MUSCLE TIGHTNESS (Tightness in upper back up to my neck/ tightness in the (right) calf), SYNOVIAL CYST (diagnosed with Baker's cyst) and JOINT SWELLING (right knee still swollen) had not resolved.            TIce pad  treatment on the calf reported. In Jun-2021, patient underwent 3 X-rays, result unknown.   This case was linked to MOD-2021-027570 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information will be processed with the initial report. Updated information includes patient demographics, concomitant drugs and event of right knee still swollen. On 26-Jul-2021: Follow-up received on 26-Jul-2021 contained for event diagnosed with Baker's cyst outcome as not recovered (previously captured as unknown). Treatment drug cortisone used for bakers cyst (previously captured as back of the knee).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Taste disorder, Weight decreased
Clinical narrative: losing weight; nothing taste good; bitter sweet taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (bitter sweet taste), WEIGHT DECREASED (losing weight) and TASTE DISORDER (nothing taste good) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20) for COVID-19 vaccination.     No Medical History information was reported.   On 05-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) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced DYSGEUSIA (bitter sweet taste). On an unknown date, the patient experienced WEIGHT DECREASED (losing weight) and TASTE DISORDER (nothing taste good). At the time of the report, DYSGEUSIA (bitter sweet taste), WEIGHT DECREASED (losing weight) and TASTE DISORDER (nothing taste good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment details include he has tried home remedies to relive the symptoms and spoken with the doctor(has follow up appointment on 12-jun-2021).
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Swelling in ankle; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of JOINT SWELLING (Swelling in ankle) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 JOINT SWELLING (Swelling in ankle). At the time of the report, JOINT SWELLING (Swelling in ankle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  Action taken with the drug in response to events was not applicable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Dysphagia, Dyspnoea, Ear discomfort, Energy increased
Clinical narrative: Heartbeats increased; palpitations; Energy increased; lethargic; Missed dose; tingling mouth; numbness mouth; sore throat; swallowing difficulty; burning sensation in the ears; breathlessness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling mouth), HYPOAESTHESIA ORAL (numbness mouth), OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (swallowing difficulty) and EAR DISCOMFORT (burning sensation in the ears) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 VITAMINS NOS for an unknown indication.    On 25-Feb-1901, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling mouth), HYPOAESTHESIA ORAL (numbness mouth), OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (swallowing difficulty), EAR DISCOMFORT (burning sensation in the ears) and DYSPNOEA (breathlessness). On an unknown date, the patient experienced HEART RATE INCREASED (Heartbeats increased), PALPITATIONS (palpitations), ENERGY INCREASED (Energy increased), LETHARGY (lethargic) and PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date at a dose of 1 dosage form and STEROIDS ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PARAESTHESIA ORAL (tingling mouth), HYPOAESTHESIA ORAL (numbness mouth), OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (swallowing difficulty), EAR DISCOMFORT (burning sensation in the ears), DYSPNOEA (breathlessness), HEART RATE INCREASED (Heartbeats increased), PALPITATIONS (palpitations), ENERGY INCREASED (Energy increased), LETHARGY (lethargic) and PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Positive.     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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia oral, Lethargy, Oropharyngeal pain, Palpitations
Clinical narrative: Heartbeats increased; palpitations; Energy increased; lethargic; Missed dose; tingling mouth; numbness mouth; sore throat; swallowing difficulty; burning sensation in the ears; breathlessness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling mouth), HYPOAESTHESIA ORAL (numbness mouth), OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (swallowing difficulty) and EAR DISCOMFORT (burning sensation in the ears) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 VITAMINS NOS for an unknown indication.    On 25-Feb-1901, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling mouth), HYPOAESTHESIA ORAL (numbness mouth), OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (swallowing difficulty), EAR DISCOMFORT (burning sensation in the ears) and DYSPNOEA (breathlessness). On an unknown date, the patient experienced HEART RATE INCREASED (Heartbeats increased), PALPITATIONS (palpitations), ENERGY INCREASED (Energy increased), LETHARGY (lethargic) and PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date at a dose of 1 dosage form and STEROIDS ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PARAESTHESIA ORAL (tingling mouth), HYPOAESTHESIA ORAL (numbness mouth), OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (swallowing difficulty), EAR DISCOMFORT (burning sensation in the ears), DYSPNOEA (breathlessness), HEART RATE INCREASED (Heartbeats increased), PALPITATIONS (palpitations), ENERGY INCREASED (Energy increased), LETHARGY (lethargic) and PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Positive.     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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Product dose omission issue
Clinical narrative: Heartbeats increased; palpitations; Energy increased; lethargic; Missed dose; tingling mouth; numbness mouth; sore throat; swallowing difficulty; burning sensation in the ears; breathlessness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling mouth), HYPOAESTHESIA ORAL (numbness mouth), OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (swallowing difficulty) and EAR DISCOMFORT (burning sensation in the ears) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 VITAMINS NOS for an unknown indication.    On 25-Feb-1901, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling mouth), HYPOAESTHESIA ORAL (numbness mouth), OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (swallowing difficulty), EAR DISCOMFORT (burning sensation in the ears) and DYSPNOEA (breathlessness). On an unknown date, the patient experienced HEART RATE INCREASED (Heartbeats increased), PALPITATIONS (palpitations), ENERGY INCREASED (Energy increased), LETHARGY (lethargic) and PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date at a dose of 1 dosage form and STEROIDS ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PARAESTHESIA ORAL (tingling mouth), HYPOAESTHESIA ORAL (numbness mouth), OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (swallowing difficulty), EAR DISCOMFORT (burning sensation in the ears), DYSPNOEA (breathlessness), HEART RATE INCREASED (Heartbeats increased), PALPITATIONS (palpitations), ENERGY INCREASED (Energy increased), LETHARGY (lethargic) and PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Positive.     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.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I'd like to report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I'd like to report a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I'd like to report a side effect). At the time of the report, VACCINATION COMPLICATION (I'd like to report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 11 patients received vaccinations beyond the refrigerated expiration date, 8 of the patient's received the expired dose 6 days past the refrigerated expiration date, 3 of the patient's received the expired dose 13 days past the refigerated expira; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 patients received vaccinations beyond the refrigerated expiration date, 8 of the patient's received the expired dose 6 days past the refrigerated expiration date, 3 of the patient's received the expired dose 13 days past the refigerated expiration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 patients received vaccinations beyond the refrigerated expiration date, 8 of the patient's received the expired dose 6 days past the refrigerated expiration date, 3 of the patient's received the expired dose 13 days past the refigerated expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (11 patients received vaccinations beyond the refrigerated expiration date, 8 of the patient's received the expired dose 6 days past the refrigerated expiration date, 3 of the patient's received the expired dose 13 days past the refigerated expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The HCP reported there were two vials involved, that no patient has experienced any adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Influenza like illness, Nausea, Paraesthesia
Clinical narrative: flu-like symptoms; tingling pain; running nose; cough; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PARAESTHESIA (tingling pain), RHINORRHOEA (running nose), COUGH (cough) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jun-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 INFLUENZA LIKE ILLNESS (flu-like symptoms), PARAESTHESIA (tingling pain), RHINORRHOEA (running nose), COUGH (cough), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with GUAIFENESIN (ROBITUSSIN [GUAIFENESIN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at a dose of UNK, q4h. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PARAESTHESIA (tingling pain), RHINORRHOEA (running nose), COUGH (cough), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.   This case was linked to MOD-2021-254052 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: flu-like symptoms; tingling pain; running nose; cough; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PARAESTHESIA (tingling pain), RHINORRHOEA (running nose), COUGH (cough) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jun-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 INFLUENZA LIKE ILLNESS (flu-like symptoms), PARAESTHESIA (tingling pain), RHINORRHOEA (running nose), COUGH (cough), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with GUAIFENESIN (ROBITUSSIN [GUAIFENESIN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at a dose of UNK, q4h. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PARAESTHESIA (tingling pain), RHINORRHOEA (running nose), COUGH (cough), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.   This case was linked to MOD-2021-254052 (Patient Link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Rash
Clinical narrative: some sort of rash on the right side of my neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (some sort of rash on the right side of my neck) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 023C21A)) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced RASH (some sort of rash on the right side of my neck). At the time of the report, RASH (some sort of rash on the right side of my neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Body temperature: 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.   This case was linked to MOD-2021-254048..
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Got second dose more than 35 days after the first; felt a little headachy; tired; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose more than 35 days after the first), HEADACHE (felt a little headachy) and FATIGUE (tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 016CR1A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced HEADACHE (felt a little headachy) and FATIGUE (tired). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose more than 35 days after the first). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose more than 35 days after the first) had resolved and HEADACHE (felt a little headachy) and FATIGUE (tired) outcome 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.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was considered to be not applicable.   This case was linked to MOD-2021-017805 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Myalgia, Pain
Clinical narrative: Weak; achy; He symptoms has moved to his arm, muscles aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm; he started having pain in his right knee and right shoulder.; he started having pain in his right knee and right shoulder.; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), PAIN (achy), MYALGIA (He symptoms has moved to his arm, muscles aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm), the first episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.) and the second episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A12A) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weak), PAIN (achy), MYALGIA (He symptoms has moved to his arm, muscles aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm), the first episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.), the second episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.), FATIGUE (Tired) and PYREXIA (Fever). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency and STEROIDS at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weak), FATIGUE (Tired) and PYREXIA (Fever) had resolved and PAIN (achy), MYALGIA (He symptoms has moved to his arm, muscles aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm) and the last episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.) had not resolved.            Patient had symptoms  after second dose of Covid-19 Vaccination. Patient took treatment medication Nyquil . Patient went to Doctor for pain in his right knee and shoulder. He had the X-Ray and other labs done as reported. He was given steroid shot which gave relief from his symptoms for about 5 to 10 days. The pain returned later and Patient to urgent care and he was given steroid shot again for his symptoms. Patient had been to 5 different doctors and had repeated steroid treatments for his symptoms which had spread to his arm, muscle aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm as reported. No information is reported for the outcome of events.