chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Discomfort, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Muscle aches intensified; Joint Pain intensified; Mild discomfort Intensified; Second dose after 26 days of first dose; SARS-COV-2 test: positive (Positive); This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Muscle aches intensified), ARTHRALGIA (Joint Pain intensified), DISCOMFORT (Mild discomfort Intensified), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 26 days of first dose) and COVID-19 (SARS-COV-2 test: positive (Positive)) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension, Obesity, Arthritis and Vitamin D deficiency.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2020, the patient experienced COVID-19 (SARS-COV-2 test: positive (Positive)). On 02-Feb-2021, the patient experienced MYALGIA (Muscle aches intensified), ARTHRALGIA (Joint Pain intensified), DISCOMFORT (Mild discomfort Intensified) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 26 days of first dose). At the time of the report, MYALGIA (Muscle aches intensified), ARTHRALGIA (Joint Pain intensified), DISCOMFORT (Mild discomfort Intensified), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 26 days of first dose) and COVID-19 (SARS-COV-2 test: positive (Positive)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) He had tested positive for COVID-19 during the time frame of Moderna Vaccination.         Concomitant product use was not provided.  Treatment information was not  provided.   This case was linked to MOD-2021-264449 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Non-significant Follow up appended.; 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. Concomitant medical conditions could be potentially confounders/co-suspects for the events. This report refers also to a case of Inappropriate schedule of product administration for mRNA-1273, with no associated reported AEs. This report refers also to a case of Covid-19 test positive. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Muscle aches intensified; Joint Pain intensified; Mild discomfort Intensified; Second dose after 26 days of first dose; SARS-COV-2 test: positive (Positive); This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Muscle aches intensified), ARTHRALGIA (Joint Pain intensified), DISCOMFORT (Mild discomfort Intensified), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 26 days of first dose) and COVID-19 (SARS-COV-2 test: positive (Positive)) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension, Obesity, Arthritis and Vitamin D deficiency.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2020, the patient experienced COVID-19 (SARS-COV-2 test: positive (Positive)). On 02-Feb-2021, the patient experienced MYALGIA (Muscle aches intensified), ARTHRALGIA (Joint Pain intensified), DISCOMFORT (Mild discomfort Intensified) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 26 days of first dose). At the time of the report, MYALGIA (Muscle aches intensified), ARTHRALGIA (Joint Pain intensified), DISCOMFORT (Mild discomfort Intensified), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 26 days of first dose) and COVID-19 (SARS-COV-2 test: positive (Positive)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) He had tested positive for COVID-19 during the time frame of Moderna Vaccination.         Concomitant product use was not provided.  Treatment information was not  provided.   This case was linked to MOD-2021-264449 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Non-significant Follow up appended.; 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. Concomitant medical conditions could be potentially confounders/co-suspects for the events. This report refers also to a case of Inappropriate schedule of product administration for mRNA-1273, with no associated reported AEs. This report refers also to a case of Covid-19 test positive. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Infection, Therapeutic response unexpected
Clinical narrative: I got a break through infection from my son; I think without your vaccine I would have been much worse; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (I got a break through infection from my son) and THERAPEUTIC RESPONSE UNEXPECTED (I think without your vaccine I would have been much worse) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (I got a break through infection from my son) and THERAPEUTIC RESPONSE UNEXPECTED (I think without your vaccine I would have been much worse). At the time of the report, INFECTION (I got a break through infection from my son) and THERAPEUTIC RESPONSE UNEXPECTED (I think without your vaccine I would have been much worse) outcome was unknown.            Concomitant product use was not provided by the reporter.    Treatment information was not provided.  The patient stated that he/she went through break through infection from his/her son after vaccination. The patient also stated that, it would have been worsen, if he/she would not been fully vaccinated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore right injection site Arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right injection site Arm) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore right injection site Arm) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Sore right injection site Arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   This case was linked to MOD-2021-265251 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Experienced dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Experienced dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Experienced dizziness). At the time of the report, DIZZINESS (Experienced dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reporter by the reporter.   Reporter did not allow further contact
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna Covid-19 vaccine at age 16; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at age 16) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at age 16). On 23-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at age 16) 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. Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Tingling that is going  very quickly throughout her body, one spot to another spot/Pins and needles; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling that is going  very quickly throughout her body, one spot to another spot/Pins and needles) and MYALGIA (Soreness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy (20 years ago). Concomitant products included COLESEVELAM HYDROCHLORIDE (WELCHOL) and EXEMESTANE for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling that is going  very quickly throughout her body, one spot to another spot/Pins and needles) and MYALGIA (Soreness). At the time of the report, PARAESTHESIA (Tingling that is going  very quickly throughout her body, one spot to another spot/Pins and needles) and MYALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Myalgia, Underdose
Clinical narrative: his arm was mildly sore for a few hours after first dose; contents of the vaccine leaked out during administration, drops on the chair and arm was wet; contents of the vaccine leaked out during administration, drops on the chair and arm was wet; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (contents of the vaccine leaked out during administration, drops on the chair and arm was wet), DEVICE CONNECTION ISSUE (contents of the vaccine leaked out during administration, drops on the chair and arm was wet) and MYALGIA (his arm was mildly sore for a few hours after first dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced UNDERDOSE (contents of the vaccine leaked out during administration, drops on the chair and arm was wet) and DEVICE CONNECTION ISSUE (contents of the vaccine leaked out during administration, drops on the chair and arm was wet). On an unknown date, the patient experienced MYALGIA (his arm was mildly sore for a few hours after first dose). At the time of the report, UNDERDOSE (contents of the vaccine leaked out during administration, drops on the chair and arm was wet), DEVICE CONNECTION ISSUE (contents of the vaccine leaked out during administration, drops on the chair and arm was wet) and MYALGIA (his arm was mildly sore for a few hours after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included Cholesterol medication. Treatment information was not provided.   This case was linked to MOD-2021-265307 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received 1st dose with Pfizer ,2nd dose received with Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received 1st dose with Pfizer ,2nd dose received with Moderna vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE in April 2021.    On 23-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received 1st dose with Pfizer ,2nd dose received with Moderna vaccine). On 23-Jul-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received 1st dose with Pfizer ,2nd dose received with Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No treatment medications were reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: his arm was sore for about two days after the second dose if he applied pressure to it; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (his arm was sore for about two days after the second dose if he applied pressure to it) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-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 MYALGIA (his arm was sore for about two days after the second dose if he applied pressure to it). At the time of the report, MYALGIA (his arm was sore for about two days after the second dose if he applied pressure to it) outcome was unknown.            Concomitant drugs includes cholesterol medication No treatment information was provided.   This case was linked to MOD-2021-265302 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Headache
Clinical narrative: Loss of taste; headache; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) and HEADACHE (headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced AGEUSIA (Loss of taste) and HEADACHE (headache). At the time of the report, AGEUSIA (Loss of taste) and HEADACHE (headache) outcome was unknown.            no concomitants medications was reported.   No treatments medications was reported
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: mistakenly, received her second dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (mistakenly, received her second dose of the Moderna Covid-19 vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) 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 06-May-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (mistakenly, received her second dose of the Moderna Covid-19 vaccine). On 03-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (mistakenly, received her second dose of the Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my arm is still sore at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (my arm is still sore at injection site) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (my arm is still sore at injection site). At the time of the report, VACCINATION SITE PAIN (my arm is still sore at injection site) outcome was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; Arm hurt at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VACCINATION SITE PAIN (Arm hurt at the vaccination site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Colon cancer. Concurrent medical conditions included Neuropathy.   On 19-Jun-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 19-Jun-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Arm hurt at the vaccination site). On 20-Jun-2021, HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm hurt at the vaccination site) had resolved.            Patient reported that her arm hurt at the vaccination site for a couple of days.  No concomitant medication information was reported.  No treatment medications were reported.     This case was linked to MOD-2021-162413 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Infection) 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 INFECTION (Infection). At the time of the report, INFECTION (Infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.  Reportedly, the patient had infection and had to go to the hospital. No treatment information was provided..   This case was linked to MOD-2021-265605.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: After getting the moderna shot 3/19/21 on my left lef, reported adverse event; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After getting the moderna shot 3/19/21 on my left lef, reported adverse event) 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 19-Mar-2021, 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 (After getting the moderna shot 3/19/21 on my left lef, reported adverse event). At the time of the report, VACCINATION COMPLICATION (After getting the moderna shot 3/19/21 on my left lef, reported adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination complication
Clinical narrative: Other side effects after vaccination; Sore arm after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Other side effects after vaccination) and MYALGIA (Sore arm after vaccination) 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) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Other side effects after vaccination) and MYALGIA (Sore arm after vaccination). At the time of the report, VACCINATION COMPLICATION (Other side effects after vaccination) and MYALGIA (Sore arm after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received the Moderna vaccines only 2 weeks apart.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient received the Moderna vaccines only 2 weeks apart.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 049C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient received the Moderna vaccines only 2 weeks apart.). On 23-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient received the Moderna vaccines only 2 weeks apart.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Eye irritation, Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: Got covid; Frontal sinus pressure; Eye Irritation; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Got covid), PARANASAL SINUS DISCOMFORT (Frontal sinus pressure) and EYE IRRITATION (Eye Irritation) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Sinusitis. Concurrent medical conditions included Glaucoma and Diabetes.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PARANASAL SINUS DISCOMFORT (Frontal sinus pressure) and EYE IRRITATION (Eye Irritation). On 25-Jan-2021, the patient experienced COVID-19 (Got covid). At the time of the report, COVID-19 (Got covid) and PARANASAL SINUS DISCOMFORT (Frontal sinus pressure) outcome was unknown and EYE IRRITATION (Eye Irritation) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID..     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 by the reporter.  Patient stated that he got prescribed an unspecified antibiotics and nasal spray on 15 Jan 2021.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3 weeks apart/Second dose was received 3 and half months ago; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 weeks apart/Second dose was received 3 and half months ago) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 weeks apart/Second dose was received 3 and half months ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 weeks apart/Second dose was received 3 and half months ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided No treatment medications were provided; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated adverse events reported. Reportedly, the patient received both doses of Moderna COVID 19 vaccine three weeks apart. The company causality for inappropriate schedule of vaccine administered is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm hurts after first dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (My arm hurts after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (My arm hurts after first dose). At the time of the report, VACCINATION SITE PAIN (My arm hurts after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were reported. No treatment information was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthritis, Dizziness, Pyrexia
Clinical narrative: sick to her stomach; arthritis, and the shot made it flare up; dizziness; fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to her stomach), ARTHRITIS (arthritis, and the shot made it flare up), DIZZINESS (dizziness) and PYREXIA (fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (surgery for intestinal blockage) in February 2021.    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 ABDOMINAL DISCOMFORT (sick to her stomach), ARTHRITIS (arthritis, and the shot made it flare up), DIZZINESS (dizziness) and PYREXIA (fever). At the time of the report, ABDOMINAL DISCOMFORT (sick to her stomach), ARTHRITIS (arthritis, and the shot made it flare up), DIZZINESS (dizziness) and PYREXIA (fever) outcome was unknown.            No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-051874 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Tinnitus
Clinical narrative: After my first dose the ringing in my ears started; few days of brain fog; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (After my first dose the ringing in my ears started) and FEELING ABNORMAL (few days of brain fog) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020821A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Septra). Concomitant products included RIZATRIPTAN BENZOATE (MAXALT) from 01-Jan-2010 to an unknown date for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced TINNITUS (After my first dose the ringing in my ears started) and FEELING ABNORMAL (few days of brain fog). At the time of the report, TINNITUS (After my first dose the ringing in my ears started) and FEELING ABNORMAL (few days of brain fog) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment medication include muscle relaxer, this did not help.   This case was linked to MOD-2021-184155 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: loss of appetite; Headache; Nausea; Fever; Body Aches; Large rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever) and MYALGIA (Body Aches) in a 56-year-old female 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced DECREASED APPETITE (loss of appetite), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever), MYALGIA (Body Aches) and VACCINATION SITE RASH (Large rash at the injection site). At the time of the report, DECREASED APPETITE (loss of appetite), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever), MYALGIA (Body Aches) and VACCINATION SITE RASH (Large rash at the injection site) outcome was unknown.            No concomitant medications were provided.  No treatment was reported for the events.   This case was linked to MOD-2021-265445 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: loss of appetite; Headache; Nausea; Fever; Body Aches; Large rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever) and MYALGIA (Body Aches) in a 56-year-old female 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced DECREASED APPETITE (loss of appetite), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever), MYALGIA (Body Aches) and VACCINATION SITE RASH (Large rash at the injection site). At the time of the report, DECREASED APPETITE (loss of appetite), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever), MYALGIA (Body Aches) and VACCINATION SITE RASH (Large rash at the injection site) outcome was unknown.            No concomitant medications were provided.  No treatment was reported for the events.   This case was linked to MOD-2021-265445 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) 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 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) 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.   This case was linked to MOD-2021-265450 (Patient Link).; Sender's Comments: This report refers to a case of product storage error for mRNA-1273 (batch no. 039B21A) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Headache, Vision blurred
Clinical narrative: Burning eyes; blurry vision; headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Burning eyes), VISION BLURRED (blurry vision) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced EYE IRRITATION (Burning eyes), VISION BLURRED (blurry vision) and HEADACHE (headache). At the time of the report, EYE IRRITATION (Burning eyes), VISION BLURRED (blurry vision) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was unknown.   This case was linked to MOD-2021-265369 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: got tested for COVID-19 and it came back positive; body aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (got tested for COVID-19 and it came back positive), PAIN (body aches) and FATIGUE (tired) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and COVID-19 since 21-Jul-2021.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (body aches) and FATIGUE (tired). On 21-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (got tested for COVID-19 and it came back positive). At the time of the report, SARS-COV-2 TEST POSITIVE (got tested for COVID-19 and it came back positive), PAIN (body aches) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, SARS-CoV-2 antibody test: Positive.         It was reported that on  Wednesday, 21-JUL-2021, the patient got tested for COVID-19 and it came back positive. The patient reported that he was exposed to a person who was positive and unvaccinated. The patient stated that after the first dose he had no side effects and the the evening of the second dose he was tired, body ached, and lasted for 18 hours.   No Treatment information was reported Concomitant drugs include diabetic medication; 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 pain and fatigue, a causal relationship cannot be excluded. The company causality for the event SARS-CoV-2 test positive is not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very  sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (very  sick) 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 ILLNESS (very  sick). At the time of the report, ILLNESS (very  sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided. Treatment to the events not reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Vaccination site pain
Clinical narrative: Medicine makes him feel bad; Arm was sore; Sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Medicine makes him feel bad), VACCINATION SITE PAIN (Arm was sore) and MYALGIA (Sore muscles) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease. Concomitant products included LISINOPRIL DIHYDRATE (PRINIVIL), BENZATROPINE MESILATE (COGENTIN), ARIPIPRAZOLE (ABILIFY) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-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 FEELING ABNORMAL (Medicine makes him feel bad), VACCINATION SITE PAIN (Arm was sore) and MYALGIA (Sore muscles). At the time of the report, FEELING ABNORMAL (Medicine makes him feel bad), VACCINATION SITE PAIN (Arm was sore) and MYALGIA (Sore muscles) outcome was unknown.            Treatment medications were not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Listless, Pyrexia
Clinical narrative: I was weak,had no energy; Listlessness; Fever of 103°F; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I was weak,had no energy), LISTLESS (listlessness) and PYREXIA (fever of 103°F) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced ASTHENIA (I was weak,had no energy), LISTLESS (listlessness) and PYREXIA (fever of 103°F). At the time of the report, ASTHENIA (I was weak,had no energy), LISTLESS (listlessness) and PYREXIA (fever of 103°F) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-265360 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Eye colour change, Eye pruritus, Eye swelling, Vision blurred
Clinical narrative: Eye is swollen; Eye is purple, Looks like black eye; Slight Itchy; Vision is blurred; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye is swollen), EYE COLOUR CHANGE (Eye is purple, Looks like black eye), EYE PRURITUS (Slight Itchy) and VISION BLURRED (Vision is blurred) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy and Gluten sensitivity.    On 20-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 EYE SWELLING (Eye is swollen), EYE COLOUR CHANGE (Eye is purple, Looks like black eye), EYE PRURITUS (Slight Itchy) and VISION BLURRED (Vision is blurred). At the time of the report, EYE SWELLING (Eye is swollen), EYE COLOUR CHANGE (Eye is purple, Looks like black eye), EYE PRURITUS (Slight Itchy) and VISION BLURRED (Vision is blurred) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant or treatment information were not provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever after second dose; Chills after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after second dose) and CHILLS (Chills after second dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever after second dose) and CHILLS (Chills after second dose). At the time of the report, PYREXIA (Fever after second dose) and CHILLS (Chills after second dose) outcome was unknown.            No concomitant medications were reported by the reporter. No treatment medications were provided by the reporter.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: fatigue; Soreness in injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in injection site left arm) and FATIGUE (fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness in injection site left arm). On 15-Jan-2021, the patient experienced FATIGUE (fatigue). On 15-Jan-2021, FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness in injection site left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-265396 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: really bad burning sensation in my for-head that is now down the back of my neck; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (really bad burning sensation in my for-head that is now down the back of my neck) in a male patient of an unknown age 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 23-Jul-2021, the patient experienced BURNING SENSATION (really bad burning sensation in my for-head that is now down the back of my neck). At the time of the report, BURNING SENSATION (really bad burning sensation in my for-head that is now down the back of my neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medication was received by the patient  No Treatment was received by the patient.