chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Myalgia, Pyrexia, Tremor
Clinical narrative: Right hand has shaky tremor; Feels like he got hit by a semi; 104 Fever; Aching everywhere; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Right hand has shaky tremor), FEELING ABNORMAL (Feels like he got hit by a semi), PYREXIA (104 Fever) and MYALGIA (Aching everywhere) in a 52-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 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced TREMOR (Right hand has shaky tremor), FEELING ABNORMAL (Feels like he got hit by a semi), PYREXIA (104 Fever) and MYALGIA (Aching everywhere). At the time of the report, TREMOR (Right hand has shaky tremor), FEELING ABNORMAL (Feels like he got hit by a semi), PYREXIA (104 Fever) and MYALGIA (Aching everywhere) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Body temperature: 104 (High) 104.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Reportedly, when asked for the expiration date, the only date she had on the card was 28th July, however it was unclear if that was the expiration date or the incorrectly entered date of his 1st dose. She is going to verify with the pharmacy.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Muscle spasms
Clinical narrative: blood pressure was elevated, blood pressure was high; Leg cramps; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was elevated, blood pressure was high) and MUSCLE SPASMS (Leg cramps) in a 65-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (blood pressure was elevated, blood pressure was high) and MUSCLE SPASMS (Leg cramps). At the time of the report, HYPERTENSION (blood pressure was elevated, blood pressure was high) had not resolved and MUSCLE SPASMS (Leg cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was received by the patient.  Treatment medication reported as due of the high blood pressure,patient was medicated with a high blood pressure medication.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the Moderna COVID-19 vaccine that was expired by one day; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 vaccine that was expired by one day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 vaccine that was expired by one day). On 26-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 vaccine that was expired by one day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-271870.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow-up information included no new information
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Eye pain, Facial pain, Fatigue, Migraine
Clinical narrative: excruciating pain that goes shooting across his face into his jaw; excruciating pain that goes shooting across his face into his jaw; Eye pain; Exhausted; Entire body started hurting; Consistent Migraine; Back hurts (not sure if it is back or kidneys); Left eye pressure and excruciating pain (into his upper cheekbone).  It is like an electric jolt.; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Consistent Migraine), BACK PAIN (Back hurts (not sure if it is back or kidneys)), OCULAR DISCOMFORT (Left eye pressure and excruciating pain (into his upper cheekbone).  It is like an electric jolt.), PAIN IN JAW (excruciating pain that goes shooting across his face into his jaw) and FACIAL PAIN (excruciating pain that goes shooting across his face into his jaw) in a 38-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 information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced MIGRAINE (Consistent Migraine), BACK PAIN (Back hurts (not sure if it is back or kidneys)), OCULAR DISCOMFORT (Left eye pressure and excruciating pain (into his upper cheekbone).  It is like an electric jolt.), FATIGUE (Exhausted) and MYALGIA (Entire body started hurting). On an unknown date, the patient experienced PAIN IN JAW (excruciating pain that goes shooting across his face into his jaw), FACIAL PAIN (excruciating pain that goes shooting across his face into his jaw) and EYE PAIN (Eye pain). At the time of the report, MIGRAINE (Consistent Migraine), BACK PAIN (Back hurts (not sure if it is back or kidneys)), OCULAR DISCOMFORT (Left eye pressure and excruciating pain (into his upper cheekbone).  It is like an electric jolt.), PAIN IN JAW (excruciating pain that goes shooting across his face into his jaw), FACIAL PAIN (excruciating pain that goes shooting across his face into his jaw), EYE PAIN (Eye pain), FATIGUE (Exhausted) and MYALGIA (Entire body started hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment medications were reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Ocular discomfort, Pain in jaw
Clinical narrative: excruciating pain that goes shooting across his face into his jaw; excruciating pain that goes shooting across his face into his jaw; Eye pain; Exhausted; Entire body started hurting; Consistent Migraine; Back hurts (not sure if it is back or kidneys); Left eye pressure and excruciating pain (into his upper cheekbone).  It is like an electric jolt.; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Consistent Migraine), BACK PAIN (Back hurts (not sure if it is back or kidneys)), OCULAR DISCOMFORT (Left eye pressure and excruciating pain (into his upper cheekbone).  It is like an electric jolt.), PAIN IN JAW (excruciating pain that goes shooting across his face into his jaw) and FACIAL PAIN (excruciating pain that goes shooting across his face into his jaw) in a 38-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 information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced MIGRAINE (Consistent Migraine), BACK PAIN (Back hurts (not sure if it is back or kidneys)), OCULAR DISCOMFORT (Left eye pressure and excruciating pain (into his upper cheekbone).  It is like an electric jolt.), FATIGUE (Exhausted) and MYALGIA (Entire body started hurting). On an unknown date, the patient experienced PAIN IN JAW (excruciating pain that goes shooting across his face into his jaw), FACIAL PAIN (excruciating pain that goes shooting across his face into his jaw) and EYE PAIN (Eye pain). At the time of the report, MIGRAINE (Consistent Migraine), BACK PAIN (Back hurts (not sure if it is back or kidneys)), OCULAR DISCOMFORT (Left eye pressure and excruciating pain (into his upper cheekbone).  It is like an electric jolt.), PAIN IN JAW (excruciating pain that goes shooting across his face into his jaw), FACIAL PAIN (excruciating pain that goes shooting across his face into his jaw), EYE PAIN (Eye pain), FATIGUE (Exhausted) and MYALGIA (Entire body started hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment medications were reported.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered greater than 12 hours after initial vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) 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 reported.  No treatment medication was reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Fall, Gait disturbance
Clinical narrative: severe dizziness months after receiving Moderna vaccine/could barely keep himself up from dizziness/dizziness started after receiving the vaccine; stood up and tumbling; He couldn't stand up straight and kept falling to right hand side; He couldn't stand up straight and kept falling to right hand side; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (severe dizziness months after receiving Moderna vaccine/could barely keep himself up from dizziness/dizziness started after receiving the vaccine), GAIT DISTURBANCE (stood up and tumbling), FALL (He couldn't stand up straight and kept falling to right hand side) and DYSSTASIA (He couldn't stand up straight and kept falling to right hand side) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced DIZZINESS (severe dizziness months after receiving Moderna vaccine/could barely keep himself up from dizziness/dizziness started after receiving the vaccine), GAIT DISTURBANCE (stood up and tumbling), FALL (He couldn't stand up straight and kept falling to right hand side) and DYSSTASIA (He couldn't stand up straight and kept falling to right hand side). At the time of the report, DIZZINESS (severe dizziness months after receiving Moderna vaccine/could barely keep himself up from dizziness/dizziness started after receiving the vaccine), GAIT DISTURBANCE (stood up and tumbling), FALL (He couldn't stand up straight and kept falling to right hand side) and DYSSTASIA (He couldn't stand up straight and kept falling to right hand side) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient received first dose of Moderna COVID-19 vaccine on 21MAY2021 and as of 30JUL2021 had still not received the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received first dose of Moderna COVID-19 vaccine on 21MAY2021 and as of 30JUL2021 had still not received the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received first dose of Moderna COVID-19 vaccine on 21MAY2021 and as of 30JUL2021 had still not received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received first dose of Moderna COVID-19 vaccine on 21MAY2021 and as of 30JUL2021 had still not received the second dose) 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.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: gave a shot today to a lady and called us later to inform that there's a leakage to her injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (gave a shot today to a lady and called us later to inform that there's a leakage to her 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 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced UNDERDOSE (gave a shot today to a lady and called us later to inform that there's a leakage to her injection site). On 30-Jul-2021, UNDERDOSE (gave a shot today to a lady and called us later to inform that there's a leakage to her injection site) 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.   On 30-JUL-2021, the patient received the first dose of Moderna vaccine and informed that there was a leakage to injection site 20 to 30 minutes after vaccination.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Emotional disorder
Clinical narrative: Breathing problems at times; Does not feel secured; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing problems at times) and EMOTIONAL DISORDER (Does not feel secured) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Depression, Anxiety and Gastrointestinal disorder NOS.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Breathing problems at times) and EMOTIONAL DISORDER (Does not feel secured). At the time of the report, DYSPNOEA (Breathing problems at times) and EMOTIONAL DISORDER (Does not feel secured) outcome was unknown.            No concomitant and treatment were not  reported by reporter . patient did not remembered  reporting negative adverse events .   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow up information included no new information.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine had been in the refrigerator > 30days and was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.  Nurse states they realized today that the vaccine was good in the refrigerator for 30 days. No realized the vial in the refrigerator had expired and it was administered to 6 patients. This is the third of the six adverse event reports.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: hand the bit of sore arm; numbness on my rightside; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hand the bit of sore arm) and HYPOAESTHESIA (numbness on my rightside) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 027CZ1A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol from 2006 to 2021.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (hand the bit of sore arm) and HYPOAESTHESIA (numbness on my rightside). The patient was treated with CORTISONE for Vaccination adverse reaction, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (hand the bit of sore arm) and HYPOAESTHESIA (numbness on my rightside) had not resolved.            Concomitant medication was not reported   This case was linked to MOD-2021-075184 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 of the patients who got the vaccine were 16 and 17; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 of the patients who got the vaccine were 16 and 17) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 of the patients who got the vaccine were 16 and 17). On 29-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 of the patients who got the vaccine were 16 and 17) 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 relevant concomitant medications were reported.  So far, no adverse reactions was reported by either of the patients.   This case was linked to MOD-2021-272172.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects from first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects from first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 (Side effects from first dose). At the time of the report, VACCINATION COMPLICATION (Side effects from first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis, Fatigue, Gastrointestinal disorder, Headache, Injection site pain
Clinical narrative: Inflamed Colon; gastrointestinal problems/trouble digesting food; swimmers ear; "charley horse" in left shoulder; headache; Fatigue; sore injection site left arm shoulder.; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS (Inflamed Colon), GASTROINTESTINAL DISORDER (gastrointestinal problems/trouble digesting food), OTITIS EXTERNA (swimmers ear), MUSCLE SPASMS ("charley horse" in left shoulder) and INJECTION SITE PAIN (sore injection site left arm shoulder.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myalgia (The patient was predisposed to muscle and nerve problems prior to receiving the Moderna Covid-19 vaccine) since 03-Apr-2021 and Nerve damage (The patient was predisposed to muscle and nerve problems prior to receiving the Moderna Covid-19 vaccine) since 03-Apr-2021.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced INJECTION SITE PAIN (sore injection site left arm shoulder.). On an unknown date, the patient experienced COLITIS (Inflamed Colon), GASTROINTESTINAL DISORDER (gastrointestinal problems/trouble digesting food), OTITIS EXTERNA (swimmers ear), MUSCLE SPASMS ("charley horse" in left shoulder), HEADACHE (headache) and FATIGUE (Fatigue). At the time of the report, COLITIS (Inflamed Colon), GASTROINTESTINAL DISORDER (gastrointestinal problems/trouble digesting food), OTITIS EXTERNA (swimmers ear), MUSCLE SPASMS ("charley horse" in left shoulder), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown and INJECTION SITE PAIN (sore injection site left arm shoulder.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient calls and says that he thinks, he had experienced Covid-19 in early March 2021",however patient did not take any test to confirm whether he had Covid-19.   The patient was predisposed to muscle and nerve problems prior to receiving the Moderna Covid-19 vaccine. The patient also experienced a repeat of his Covid-19 symptoms after the first Moderna Covid-19 vaccination which includes headache, swimmers ear, fatigue,  gastrointestinal problems. Inflamed Colon and hard to digest foods.  First Moderna Covid-19 vaccine expiration date not provided. The patient' does not have a primary care physician.  No concomitant medication information provided. No treatment medication information provided.   This case was linked to MOD-2021-271806.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Otitis externa
Clinical narrative: Inflamed Colon; gastrointestinal problems/trouble digesting food; swimmers ear; "charley horse" in left shoulder; headache; Fatigue; sore injection site left arm shoulder.; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS (Inflamed Colon), GASTROINTESTINAL DISORDER (gastrointestinal problems/trouble digesting food), OTITIS EXTERNA (swimmers ear), MUSCLE SPASMS ("charley horse" in left shoulder) and INJECTION SITE PAIN (sore injection site left arm shoulder.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myalgia (The patient was predisposed to muscle and nerve problems prior to receiving the Moderna Covid-19 vaccine) since 03-Apr-2021 and Nerve damage (The patient was predisposed to muscle and nerve problems prior to receiving the Moderna Covid-19 vaccine) since 03-Apr-2021.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced INJECTION SITE PAIN (sore injection site left arm shoulder.). On an unknown date, the patient experienced COLITIS (Inflamed Colon), GASTROINTESTINAL DISORDER (gastrointestinal problems/trouble digesting food), OTITIS EXTERNA (swimmers ear), MUSCLE SPASMS ("charley horse" in left shoulder), HEADACHE (headache) and FATIGUE (Fatigue). At the time of the report, COLITIS (Inflamed Colon), GASTROINTESTINAL DISORDER (gastrointestinal problems/trouble digesting food), OTITIS EXTERNA (swimmers ear), MUSCLE SPASMS ("charley horse" in left shoulder), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown and INJECTION SITE PAIN (sore injection site left arm shoulder.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient calls and says that he thinks, he had experienced Covid-19 in early March 2021",however patient did not take any test to confirm whether he had Covid-19.   The patient was predisposed to muscle and nerve problems prior to receiving the Moderna Covid-19 vaccine. The patient also experienced a repeat of his Covid-19 symptoms after the first Moderna Covid-19 vaccination which includes headache, swimmers ear, fatigue,  gastrointestinal problems. Inflamed Colon and hard to digest foods.  First Moderna Covid-19 vaccine expiration date not provided. The patient' does not have a primary care physician.  No concomitant medication information provided. No treatment medication information provided.   This case was linked to MOD-2021-271806.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Metamorphopsia, Muscle spasms, Myalgia, Vision blurred
Clinical narrative: Blurred and distorted vision that has progressed; Full bloom pain and spasms in left arm in muscle; Blurred and distorted vision that has progressed; Blurred and distorted vision that has progressed; Full bloom pain and spasms in left arm in muscle; This spontaneous case was reported by a consumer and describes the occurrence of METAMORPHOPSIA (Blurred and distorted vision that has progressed), MYALGIA (Full bloom pain and spasms in left arm in muscle), MUSCLE SPASMS (Full bloom pain and spasms in left arm in muscle), VISION BLURRED (Blurred and distorted vision that has progressed) and CONDITION AGGRAVATED (Blurred and distorted vision that has progressed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A2A1 and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced METAMORPHOPSIA (Blurred and distorted vision that has progressed), MYALGIA (Full bloom pain and spasms in left arm in muscle), MUSCLE SPASMS (Full bloom pain and spasms in left arm in muscle), VISION BLURRED (Blurred and distorted vision that has progressed) and CONDITION AGGRAVATED (Blurred and distorted vision that has progressed). At the time of the report, METAMORPHOPSIA (Blurred and distorted vision that has progressed), MYALGIA (Full bloom pain and spasms in left arm in muscle), MUSCLE SPASMS (Full bloom pain and spasms in left arm in muscle), VISION BLURRED (Blurred and distorted vision that has progressed) and CONDITION AGGRAVATED (Blurred and distorted vision that has progressed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment included Tylenol and Using ointments   This case was linked to MOD-2021-272155.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: if it has been three months since first dose, do I need to take the first dose again; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (if it has been three months since first dose, do I need to take the first dose again) 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 PRODUCT DOSE OMISSION ISSUE (if it has been three months since first dose, do I need to take the first dose again). At the time of the report, PRODUCT DOSE OMISSION ISSUE (if it has been three months since first dose, do I need to take the first dose again) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Elevated resting heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Elevated resting heart rate) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     The patient's past medical history included Heart murmur (history of heart murmur/double beat).    On 26-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 HEART RATE INCREASED (Elevated resting heart rate). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Elevated resting heart rate) 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.   Concomitant products were not provided/unknown. Reportedly, patient's Blood Pressure was normally it's in the 70s and now in the 100s.Patient further stated this morning her heartrate was 100 and then it dropped to 98 after she sat down for a few minutes. Patient states she also also recorded a 102 resting heart rate.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: i feel very sick; Fever; Head pain; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (i feel very sick), PYREXIA (Fever), HEADACHE (Head pain), CHILLS (Chills) and FATIGUE (Fatigue) 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 MALAISE (i feel very sick), PYREXIA (Fever), HEADACHE (Head pain), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, MALAISE (i feel very sick), PYREXIA (Fever), HEADACHE (Head pain), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.   Reporter did not allow further contact
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: My 16 year old son received Moderna by mistake; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Jul-2021 and was forwarded to Moderna on 01-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My 16 year old son received Moderna by mistake) in a 16-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 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 (My 16 year old son received Moderna by mistake). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My 16 year old son received Moderna by mistake) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of the Moderna Covid-19 Vaccine on 5Feb2021 and got the second dose on 21Apr2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Jul-2021 and was forwarded to Moderna on 30-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first dose of the Moderna Covid-19 Vaccine on 5Feb2021 and got the second dose on 21Apr2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first dose of the Moderna Covid-19 Vaccine on 5Feb2021 and got the second dose on 21Apr2021). On 21-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first dose of the Moderna Covid-19 Vaccine on 5Feb2021 and got the second dose on 21Apr2021) had resolved.            Concomitant product information was not provided.  Treatment information was not provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Slight Fever; Body Aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight Fever), MYALGIA (Body Aches) and HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (Slight Fever), MYALGIA (Body Aches) and HEADACHE (Headache). At the time of the report, PYREXIA (Slight Fever), MYALGIA (Body Aches) and HEADACHE (Headache) had resolved.            No Concomitant medications were provided  No treatment medications were provided.   This case was linked to MOD-2021-271879 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administed 1 day after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administed 1 day after expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administed 1 day after expiration date). On 26-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Dose administed 1 day after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-271671 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine had been in the refrigerator > 30days and was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-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 EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed second Moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second Moderna dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stomach discomfort and Gallbladder operation NOS.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second Moderna dose). On 07-Feb-2021, PRODUCT DOSE OMISSION ISSUE (missed second Moderna dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Swelling face
Clinical narrative: mild swelling on right side of the face; Very mild headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (mild swelling on right side of the face) and HEADACHE (Very mild headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity, Allergy to topical drugs (fingers swelling, cracking and bleeding), Vitamin C (facial swelling), Allergy to topical drugs (eye swelling  and rash) and Hashimoto's disease in 2020. Concomitant products included FISH OIL for Joint ache, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) and THYROID (ARMOUR THYROID) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (mild swelling on right side of the face) and HEADACHE (Very mild headache). The patient was treated with METOPROLOL TARTRATE (METOPROLOL - 1 A PHARMA) (oral) on 06-Feb-2021 at an unspecified dose and frequency and FLECAINIDE ACETATE (TAMBOCOR) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (mild swelling on right side of the face) and HEADACHE (Very mild headache) outcome was unknown. Not Provided          This case was linked to MOD-2021-034347.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Improvement in tendinitis in knee and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Improvement in tendinitis in knee and shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Tendinitis (In shoulder and knee).   On 27-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 an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Improvement in tendinitis in knee and shoulder). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Improvement in tendinitis in knee and shoulder) outcome was unknown.            It was stated that after receiving the vaccine the tendinitis in both the knee and shoulder subsided for several month with no side effects. Just recently the tendinitis has begun to present itself but is not as the levels prior to vaccination.   Concomitant medications included unspecified allergy pill No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Headache; Chills; Aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Aches) 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 HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Aches). At the time of the report, HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ear haemorrhage, Otorrhoea, Pain in extremity
Clinical narrative: Felt her left ear draining; Bleeding in the left ear, "a little clotting" in the left ear; Pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of OTORRHOEA (Felt her left ear draining), EAR HAEMORRHAGE (Bleeding in the left ear, "a little clotting" in the left ear) and PAIN IN EXTREMITY (Pain in the left arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included IBUPROFEN for Headache.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left arm). On 30-Jul-2021, the patient experienced OTORRHOEA (Felt her left ear draining) and EAR HAEMORRHAGE (Bleeding in the left ear, "a little clotting" in the left ear). At the time of the report, OTORRHOEA (Felt her left ear draining), EAR HAEMORRHAGE (Bleeding in the left ear, "a little clotting" in the left ear) and PAIN IN EXTREMITY (Pain in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter. patient takes ibuprofen occasionally to treat occasional headache. he caller stated that she is scared to receive the second dose in the series. The caller stated she is concerned scheduled an appointment for evaluation. The appointment is scheduled for 02Aug2021 with her HCP.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Hot felling at base of neck; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING HOT (Hot felling at base of neck) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091021A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 FEELING HOT (Hot felling at base of neck). At the time of the report, FEELING HOT (Hot felling at base of neck) 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 relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest congestion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Chest congestion). At the time of the report, CHEST DISCOMFORT (Chest congestion) 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.