chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: the size of the shot of numbness from my face down; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (the size of the shot of numbness from my face down) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (the size of the shot of numbness from my face down). At the time of the report, HYPOAESTHESIA (the size of the shot of numbness from my face down) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: flu like symptoms; "went down for a day"; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and MALAISE ("went down for a day") in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and 025J20214) for COVID-19 vaccination.     The patient's past medical history included Heart attack (no recent change was observed in its status) on 14-Jul-2014. Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRINE) from 14-Jul-2014 to an unknown date, ATORVASTATIN CALCIUM (LIPITOR) and CARVEDILOL (COREG) 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 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and MALAISE ("went down for a day"). On 27-Jan-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) and MALAISE ("went down for a day") 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.   Treatment information was not provided.  Allergies to food, medications and other products were none.   This case was linked to MOD-2021-307592 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: significant Follow up was received which has updated patient's demographics: start date of medical history; revised date of dose 1; anatomical location; provided start date and dose information of concomitant medications.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days since first dose was received and still does not have the second; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose was received and still does not have the second) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose was received and still does not have the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose was received and still does not have the second) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: flu-like symptoms; body aches; fever; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (bad headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (bad headache). On 16-Mar-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (bad headache) had resolved.            It was reported that the patient had received Booster Dose of Moderna vaccine on 28 AUG 2021, which is 5.5 Months after the second dose of Moderna vaccine,  and he feels fine without experiencing any Adverse Events.  No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-307152 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Influenza like illness, Insomnia, Off label use
Clinical narrative: My body hurts all over with flu symptoms.; I could not sleep in  my bed.; Got a 3rd dose - not immunocompromised; arm hurt. He is still having problems with his left arm (injection site) and the left shoulder.; joints hurt, can hardly lift the arm up/ I could not lift my arm above my elbow; Feeling Abnormal; "really got sick"; ached all over/Very painfull; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Sep-2021. The most recent information was received on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling Abnormal), VACCINATION COMPLICATION ("really got sick"), PAIN (ached all over/Very painfull), INFLUENZA LIKE ILLNESS (My body hurts all over with flu symptoms.) and INSOMNIA (I could not sleep in  my bed.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack. Concomitant products included LISINOPRIL, Aspirin 81 mg, ATORVASTATIN CALCIUM (LIPITOR) and Col-Rite for an unknown indication.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced FEELING ABNORMAL (Feeling Abnormal), VACCINATION COMPLICATION ("really got sick"), PAIN (ached all over/Very painfull), OFF LABEL USE (Got a 3rd dose - not immunocompromised), VACCINATION SITE PAIN (arm hurt. He is still having problems with his left arm (injection site) and the left shoulder.) and ARTHRALGIA (joints hurt, can hardly lift the arm up/ I could not lift my arm above my elbow). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (My body hurts all over with flu symptoms.) and INSOMNIA (I could not sleep in  my bed.). On 01-Sep-2021, OFF LABEL USE (Got a 3rd dose - not immunocompromised) had resolved. On 02-Sep-2021, FEELING ABNORMAL (Feeling Abnormal), VACCINATION COMPLICATION ("really got sick") and PAIN (ached all over/Very painfull) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (My body hurts all over with flu symptoms.), INSOMNIA (I could not sleep in  my bed.), VACCINATION SITE PAIN (arm hurt. He is still having problems with his left arm (injection site) and the left shoulder.) and ARTHRALGIA (joints hurt, can hardly lift the arm up/ I could not lift my arm above my elbow) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-307560 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up received included events added.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination complication, Vaccination site pain
Clinical narrative: My body hurts all over with flu symptoms.; I could not sleep in  my bed.; Got a 3rd dose - not immunocompromised; arm hurt. He is still having problems with his left arm (injection site) and the left shoulder.; joints hurt, can hardly lift the arm up/ I could not lift my arm above my elbow; Feeling Abnormal; "really got sick"; ached all over/Very painfull; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Sep-2021. The most recent information was received on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling Abnormal), VACCINATION COMPLICATION ("really got sick"), PAIN (ached all over/Very painfull), INFLUENZA LIKE ILLNESS (My body hurts all over with flu symptoms.) and INSOMNIA (I could not sleep in  my bed.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack. Concomitant products included LISINOPRIL, Aspirin 81 mg, ATORVASTATIN CALCIUM (LIPITOR) and Col-Rite for an unknown indication.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced FEELING ABNORMAL (Feeling Abnormal), VACCINATION COMPLICATION ("really got sick"), PAIN (ached all over/Very painfull), OFF LABEL USE (Got a 3rd dose - not immunocompromised), VACCINATION SITE PAIN (arm hurt. He is still having problems with his left arm (injection site) and the left shoulder.) and ARTHRALGIA (joints hurt, can hardly lift the arm up/ I could not lift my arm above my elbow). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (My body hurts all over with flu symptoms.) and INSOMNIA (I could not sleep in  my bed.). On 01-Sep-2021, OFF LABEL USE (Got a 3rd dose - not immunocompromised) had resolved. On 02-Sep-2021, FEELING ABNORMAL (Feeling Abnormal), VACCINATION COMPLICATION ("really got sick") and PAIN (ached all over/Very painfull) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (My body hurts all over with flu symptoms.), INSOMNIA (I could not sleep in  my bed.), VACCINATION SITE PAIN (arm hurt. He is still having problems with his left arm (injection site) and the left shoulder.) and ARTHRALGIA (joints hurt, can hardly lift the arm up/ I could not lift my arm above my elbow) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-307560 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up received included events added.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: received the vaccination yesterday! I am currently dealing with me not being able to get warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (received the vaccination yesterday! I am currently dealing with me not being able to get warm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (received the vaccination yesterday! I am currently dealing with me not being able to get warm). At the time of the report, VACCINATION COMPLICATION (received the vaccination yesterday! I am currently dealing with me not being able to get warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) 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 ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.   Reporter did not allow further contact
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms (1st dose)) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms (1st dose)). On 16-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms (1st dose)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not reported Treatment information was not reported   This case was linked to MOD-2021-307667 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Bell's palsy, Erythema, Facial paralysis, Oropharyngeal pain
Clinical narrative: Sore throat; Bells palsy; Light thou painful paralysis of the face; Hand redness; Feet itchiness/Hand itchiness; Pain in the left armpit; Tingling sensation in hands/Tingling sensation in face; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Light thou painful paralysis of the face) and BELL'S PALSY (Bells palsy) in a 20-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.  Concurrent medical conditions included Hormone replacement therapy. Concomitant products included ESTRADIOL for Hormone replacement therapy.  On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced PARAESTHESIA (Tingling sensation in hands/Tingling sensation in face) and AXILLARY PAIN (Pain in the left armpit). On 27-Aug-2021, the patient experienced FACIAL PARALYSIS (Light thou painful paralysis of the face) (seriousness criterion medically significant), ERYTHEMA (Hand redness) and PRURITUS (Feet itchiness/Hand itchiness). On an unknown date, the patient experienced BELL'S PALSY (Bells palsy) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, FACIAL PARALYSIS (Light thou painful paralysis of the face), BELL'S PALSY (Bells palsy), PARAESTHESIA (Tingling sensation in hands/Tingling sensation in face), OROPHARYNGEAL PAIN (Sore throat), ERYTHEMA (Hand redness), PRURITUS (Feet itchiness/Hand itchiness) and AXILLARY PAIN (Pain in the left armpit) 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.   Additional concomitant medication included Polycaprolactone 25mg twice a day for Hormone replacement therapy. Treatment  included a Topical cream for itchiness.  Patient reportedly did not used it.  Patient was under hormone replacement treatment. Patient's endocrinologist told her that the adverse events are not linked to the hormone replacement treatment, but to the vaccine.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Sore throat; Bells palsy; Light thou painful paralysis of the face; Hand redness; Feet itchiness/Hand itchiness; Pain in the left armpit; Tingling sensation in hands/Tingling sensation in face; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Light thou painful paralysis of the face) and BELL'S PALSY (Bells palsy) in a 20-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.  Concurrent medical conditions included Hormone replacement therapy. Concomitant products included ESTRADIOL for Hormone replacement therapy.  On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced PARAESTHESIA (Tingling sensation in hands/Tingling sensation in face) and AXILLARY PAIN (Pain in the left armpit). On 27-Aug-2021, the patient experienced FACIAL PARALYSIS (Light thou painful paralysis of the face) (seriousness criterion medically significant), ERYTHEMA (Hand redness) and PRURITUS (Feet itchiness/Hand itchiness). On an unknown date, the patient experienced BELL'S PALSY (Bells palsy) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, FACIAL PARALYSIS (Light thou painful paralysis of the face), BELL'S PALSY (Bells palsy), PARAESTHESIA (Tingling sensation in hands/Tingling sensation in face), OROPHARYNGEAL PAIN (Sore throat), ERYTHEMA (Hand redness), PRURITUS (Feet itchiness/Hand itchiness) and AXILLARY PAIN (Pain in the left armpit) 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.   Additional concomitant medication included Polycaprolactone 25mg twice a day for Hormone replacement therapy. Treatment  included a Topical cream for itchiness.  Patient reportedly did not used it.  Patient was under hormone replacement treatment. Patient's endocrinologist told her that the adverse events are not linked to the hormone replacement treatment, but to the vaccine.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Is dizziness a common side effect?; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Is dizziness a common 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Is dizziness a common side effect?). At the time of the report, DIZZINESS (Is dizziness a common side effect?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye pain
Clinical narrative: Pink eye in both eyes; painful in the left eye; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVITIS (Pink eye in both eyes) and EYE PAIN (painful in the left eye) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-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 CONJUNCTIVITIS (Pink eye in both eyes) and EYE PAIN (painful in the left eye). At the time of the report, CONJUNCTIVITIS (Pink eye in both eyes) and EYE PAIN (painful in the left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Antibody test, Mastication disorder, Oral pain
Clinical narrative: I had a little bit allergy; pain when I opened my mouth and chewed/The pain in my mouth was in the left side; I couldn't eat; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (I had a little bit allergy), ORAL PAIN (pain when I opened my mouth and chewed/The pain in my mouth was in the left side) and MASTICATION DISORDER (I couldn't eat) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune thyroid disorder.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 ALLERGY TO VACCINE (I had a little bit allergy), ORAL PAIN (pain when I opened my mouth and chewed/The pain in my mouth was in the left side) and MASTICATION DISORDER (I couldn't eat). At the time of the report, ALLERGY TO VACCINE (I had a little bit allergy), ORAL PAIN (pain when I opened my mouth and chewed/The pain in my mouth was in the left side) and MASTICATION DISORDER (I couldn't eat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 192 192.         Treatment medications included anti-inflammatories for a week.  Patient reported that the dentist told he didn't think that it (Mouth pain) was from the Moderna shot.   This case was linked to MOD-2021-307545 (Patient Link).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms (2nd dose)) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms (2nd dose)). On 16-Mar-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms (2nd dose)) had resolved.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-307638 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose was missed; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose was missed) 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 (Second dose was missed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose was missed) had resolved.            The Treatment history was not reported .The concomitant medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: my husband goes a positive test result for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (my husband goes a positive test result for covid) 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 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced COVID-19 (my husband goes a positive test result for covid). At the time of the report, COVID-19 (my husband goes a positive test result for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, SARS-CoV-1 test: positive (Positive) positive test result.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant history was not reported.  Treatment history was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I got my 2nd shot yesterday and feel terrible today; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I got my 2nd shot yesterday and feel terrible today) 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 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced FEELING ABNORMAL (I got my 2nd shot yesterday and feel terrible today). At the time of the report, FEELING ABNORMAL (I got my 2nd shot yesterday and feel terrible today) outcome was unknown.            No concomitant medication information was provided.  Patient had no fever though No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Was 42 days too long/needed to get the second shot; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was 42 days too long/needed to get the second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was 42 days too long/needed to get the second shot). In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was 42 days too long/needed to get the second shot) had resolved.            No concomitant medications were provided. Treatment information was not provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine/Punctured Vial was used beyond 12 hour expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine/Punctured Vial was used beyond 12 hour expiration) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-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 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine/Punctured Vial was used beyond 12 hour expiration). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine/Punctured Vial was used beyond 12 hour expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Total amount of time vial was exposed to room temperature range 46° to 77° F a little over 24 hours. Concomitant medications were not provided. Treatment information was not provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Myalgia, Nausea
Clinical narrative: Really feeling sick; Chills; Nausea; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really feeling sick), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Body ache) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced ILLNESS (Really feeling sick), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, ILLNESS (Really feeling sick), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment information was provided
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Electric shock sensation, Fatigue, Hyperhidrosis, Insomnia
Clinical narrative: Entire body was shaking super bad/he had body trembling; Awake all night; Felt like somebody electrocuted him; Uncontrollable diarrhea; Sweating real bad; Back is tight; Whole body hurt; Upper body fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Entire body was shaking super bad/he had body trembling), INSOMNIA (Awake all night), ELECTRIC SHOCK SENSATION (Felt like somebody electrocuted him), DIARRHOEA (Uncontrollable diarrhea) and HYPERHIDROSIS (Sweating real bad) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced TREMOR (Entire body was shaking super bad/he had body trembling), INSOMNIA (Awake all night), ELECTRIC SHOCK SENSATION (Felt like somebody electrocuted him), DIARRHOEA (Uncontrollable diarrhea), HYPERHIDROSIS (Sweating real bad), MUSCLE TIGHTNESS (Back is tight), MYALGIA (Whole body hurt) and FATIGUE (Upper body fatigue). At the time of the report, TREMOR (Entire body was shaking super bad/he had body trembling), INSOMNIA (Awake all night), ELECTRIC SHOCK SENSATION (Felt like somebody electrocuted him), DIARRHOEA (Uncontrollable diarrhea), HYPERHIDROSIS (Sweating real bad), MUSCLE TIGHTNESS (Back is tight), MYALGIA (Whole body hurt) and FATIGUE (Upper body fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient wife thought he was having a seizure,which kept him awake all night.  No Concomitant and Treatment medication were reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Tremor
Clinical narrative: Entire body was shaking super bad/he had body trembling; Awake all night; Felt like somebody electrocuted him; Uncontrollable diarrhea; Sweating real bad; Back is tight; Whole body hurt; Upper body fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Entire body was shaking super bad/he had body trembling), INSOMNIA (Awake all night), ELECTRIC SHOCK SENSATION (Felt like somebody electrocuted him), DIARRHOEA (Uncontrollable diarrhea) and HYPERHIDROSIS (Sweating real bad) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced TREMOR (Entire body was shaking super bad/he had body trembling), INSOMNIA (Awake all night), ELECTRIC SHOCK SENSATION (Felt like somebody electrocuted him), DIARRHOEA (Uncontrollable diarrhea), HYPERHIDROSIS (Sweating real bad), MUSCLE TIGHTNESS (Back is tight), MYALGIA (Whole body hurt) and FATIGUE (Upper body fatigue). At the time of the report, TREMOR (Entire body was shaking super bad/he had body trembling), INSOMNIA (Awake all night), ELECTRIC SHOCK SENSATION (Felt like somebody electrocuted him), DIARRHOEA (Uncontrollable diarrhea), HYPERHIDROSIS (Sweating real bad), MUSCLE TIGHTNESS (Back is tight), MYALGIA (Whole body hurt) and FATIGUE (Upper body fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient wife thought he was having a seizure,which kept him awake all night.  No Concomitant and Treatment medication were reported.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received Pfizer as 1st dose and Moderna as 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer as 1st dose and Moderna as 2nd dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F2N) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 12-Aug-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer as 1st dose and Moderna as 2nd dose). On 02-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer as 1st dose and Moderna as 2nd dose) had resolved.            No concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) 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 RASH PRURITIC (Itchy rash). At the time of the report, RASH PRURITIC (Itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product administration interrupted, Product availability issue
Clinical narrative: More than 35 days after the first dose without receiving the second dose; More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (More than 35 days after the first dose without receiving the second dose) and PRODUCT AVAILABILITY ISSUE (More than 35 days after the first dose without receiving the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 PRODUCT ADMINISTRATION INTERRUPTED (More than 35 days after the first dose without receiving the second dose) and PRODUCT AVAILABILITY ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (More than 35 days after the first dose without receiving the second dose) and PRODUCT AVAILABILITY ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were not provided by the provider
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Vertigo
Clinical narrative: Dizziness; Vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 021C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Regulin) and Contrast media allergy (Allergic to some contrast dyes.).   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced DIZZINESS (Dizziness). On 18-Apr-2021, VERTIGO (Vertigo) had resolved. At the time of the report, DIZZINESS (Dizziness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Found no abnormalities.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.  Patient experienced the adverse reactions 15 days after the first and second dose of the vaccine. The patient went to the neurologist and underwent a CT scan.   This case was linked to MOD-2021-308538 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea
Clinical narrative: nauseated; having joint pains; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseated) and ARTHRALGIA (having joint pains) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced NAUSEA (nauseated) and ARTHRALGIA (having joint pains). At the time of the report, NAUSEA (nauseated) and ARTHRALGIA (having joint pains) outcome 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 information was provided.   This case was linked to MOD-2021-308441 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: follow-up document received and include no new information
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Had 1st shot was suppose to get 2nd last friday. Cant getbtgere until the 10th. Am i to late for 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Had 1st shot was suppose to get 2nd last friday. Cant getbtgere until the 10th. Am i to late for 2nd shot) 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 PRODUCT DOSE OMISSION ISSUE (Had 1st shot was suppose to get 2nd last friday. Cant getbtgere until the 10th. Am i to late for 2nd shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Had 1st shot was suppose to get 2nd last friday. Cant getbtgere until the 10th. Am i to late for 2nd shot) had resolved.            No concomitant medication were reported. The treatment information were unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Bladder disorder, Bone pain, Contusion, Fall
Clinical narrative: feels very rocky legs like rubbery legs; felt blocky; ache all over; hand was shaking while eating; felt so cold; Lost bowel control; Lost bladder control; fell on the floor 5x/fell on the bathroom/she fell on the chair; Bruises on outside the leg / Bruises on outside knee; sore left clavicle; broke 2 tooth; felt really scared; cannot neither crawl nor walk; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (felt so cold), ANAL INCONTINENCE (Lost bowel control), BLADDER DISORDER (Lost bladder control), FALL (fell on the floor 5x/fell on the bathroom/she fell on the chair) and CONTUSION (Bruises on outside the leg / Bruises on outside knee) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Clavicle fracture (Patient's left clavicle was sore when she fell but mentioned it could be because she had broke it a month ago.). Concurrent medical conditions included Drug allergy (Allergic to Biaxin.), Drug allergy (Allergic to Macrodantin.), Allergy to antibiotic (Allergic to Azithromycin.), Allergy to antibiotic (Allergic to Vantin.) and Drug allergy (Allergic to Travatan eye drops.). Concomitant products included GABAPENTIN, TIZANIDINE HCL and EZETIMIBE for an unknown indication.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced NASOPHARYNGITIS (felt so cold), ANAL INCONTINENCE (Lost bowel control), BLADDER DISORDER (Lost bladder control), FALL (fell on the floor 5x/fell on the bathroom/she fell on the chair), CONTUSION (Bruises on outside the leg / Bruises on outside knee), BONE PAIN (sore left clavicle), TOOTH INJURY (broke 2 tooth), FEAR (felt really scared) and GAIT INABILITY (cannot neither crawl nor walk). On 01-Sep-2021, the patient experienced TREMOR (hand was shaking while eating). On 04-Sep-2021, the patient experienced LIMB DISCOMFORT (feels very rocky legs like rubbery legs), FEELING ABNORMAL (felt blocky) and MYALGIA (ache all over). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, NASOPHARYNGITIS (felt so cold), ANAL INCONTINENCE (Lost bowel control), BLADDER DISORDER (Lost bladder control), FALL (fell on the floor 5x/fell on the bathroom/she fell on the chair), CONTUSION (Bruises on outside the leg / Bruises on outside knee), BONE PAIN (sore left clavicle), TOOTH INJURY (broke 2 tooth), FEAR (felt really scared), GAIT INABILITY (cannot neither crawl nor walk), TREMOR (hand was shaking while eating), LIMB DISCOMFORT (feels very rocky legs like rubbery legs), FEELING ABNORMAL (felt blocky) and MYALGIA (ache all over) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.