chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received the AstraZeneca COVID19 vaccine and then a dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received the AstraZeneca COVID19 vaccine and then a dose of the Moderna COVID19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication.    No Medical History information was reported.   In April 2021, the patient started COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) at an unspecified dose. On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received the AstraZeneca COVID19 vaccine and then a dose of the Moderna COVID19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received the AstraZeneca COVID19 vaccine and then a dose of the Moderna COVID19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Patient called the pharmacy to inquire if they could provide a second dose of the Moderna COVID-19 vaccine. Patient had received the AstraZeneca COVID-19 vaccine in Apr-2021 while in Canada, and received the Moderna COVID-19 vaccine on 26-Jun-2021.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION and 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION and PAIN. At the time of the report, VACCINATION COMPLICATION and PAIN outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported No concomitant medication was reported
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had almost as bad reaction as the first one to the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had almost as bad reaction as the first one to the 2nd shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 COMPLICATION (Had almost as bad reaction as the first one to the 2nd shot). At the time of the report, VACCINATION COMPLICATION (Had almost as bad reaction as the first one to the 2nd shot) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-080257 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Hypertension, Ocular hyperaemia, Peripheral swelling
Clinical narrative: both shots still itch and feels  scratchy  at  the injection sites; Headache; swollen right arm; itchy bumps; throat tightening,; blurry vision,; Runny nose; chest was hurting after the vaccination while she was at  the administration site; blood shot in patient's eye; blood pressure  was high; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (throat tightening,), VISION BLURRED (blurry vision,), RHINORRHOEA (Runny nose), CHEST PAIN (chest was hurting after the vaccination while she was at  the administration site) and OCULAR HYPERAEMIA (blood shot in patient's eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL /HCTZ) for an unknown indication.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced THROAT TIGHTNESS (throat tightening,), VISION BLURRED (blurry vision,), RHINORRHOEA (Runny nose), CHEST PAIN (chest was hurting after the vaccination while she was at  the administration site), OCULAR HYPERAEMIA (blood shot in patient's eye) and HYPERTENSION (blood pressure  was high). On 13-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen right arm) and RASH PRURITIC (itchy bumps). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (both shots still itch and feels  scratchy  at  the injection sites) and HEADACHE (Headache). The patient was treated with EPINEPHRINE (EPIPEN) on 11-Mar-2021 for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Headache, at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (throat tightening,), VISION BLURRED (blurry vision,), RHINORRHOEA (Runny nose), CHEST PAIN (chest was hurting after the vaccination while she was at  the administration site), OCULAR HYPERAEMIA (blood shot in patient's eye), PERIPHERAL SWELLING (swollen right arm), RASH PRURITIC (itchy bumps) and HEADACHE (Headache) outcome was unknown, HYPERTENSION (blood pressure  was high) had resolved and VACCINATION SITE PRURITUS (both shots still itch and feels  scratchy  at  the injection sites) had not resolved.            Concomitant medications taken were Diabetes medications (Unspecified name).   Treatment medications were Steroid Shot (NOS).      This case was linked to MOD-2021-037564 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Rhinorrhoea, Throat tightness, Vaccination site pruritus, Vision blurred
Clinical narrative: both shots still itch and feels  scratchy  at  the injection sites; Headache; swollen right arm; itchy bumps; throat tightening,; blurry vision,; Runny nose; chest was hurting after the vaccination while she was at  the administration site; blood shot in patient's eye; blood pressure  was high; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (throat tightening,), VISION BLURRED (blurry vision,), RHINORRHOEA (Runny nose), CHEST PAIN (chest was hurting after the vaccination while she was at  the administration site) and OCULAR HYPERAEMIA (blood shot in patient's eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL /HCTZ) for an unknown indication.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced THROAT TIGHTNESS (throat tightening,), VISION BLURRED (blurry vision,), RHINORRHOEA (Runny nose), CHEST PAIN (chest was hurting after the vaccination while she was at  the administration site), OCULAR HYPERAEMIA (blood shot in patient's eye) and HYPERTENSION (blood pressure  was high). On 13-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen right arm) and RASH PRURITIC (itchy bumps). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (both shots still itch and feels  scratchy  at  the injection sites) and HEADACHE (Headache). The patient was treated with EPINEPHRINE (EPIPEN) on 11-Mar-2021 for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Headache, at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (throat tightening,), VISION BLURRED (blurry vision,), RHINORRHOEA (Runny nose), CHEST PAIN (chest was hurting after the vaccination while she was at  the administration site), OCULAR HYPERAEMIA (blood shot in patient's eye), PERIPHERAL SWELLING (swollen right arm), RASH PRURITIC (itchy bumps) and HEADACHE (Headache) outcome was unknown, HYPERTENSION (blood pressure  was high) had resolved and VACCINATION SITE PRURITUS (both shots still itch and feels  scratchy  at  the injection sites) had not resolved.            Concomitant medications taken were Diabetes medications (Unspecified name).   Treatment medications were Steroid Shot (NOS).      This case was linked to MOD-2021-037564 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Severe Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Severe Vomiting) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High Blood Pressure), Cholesterol, Hernia and Anxiety. Concomitant products included CITALOPRAM for Anxiety, ATENOLOL, AMLODIPINE and POTASSIUM CHLORIDE for Blood pressure high, ROSUVASTATIN for Cholesterol, PANTOPRAZOLE for Hernia, VITAMIN D3 for Supplementation therapy.   In May 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In May 2021, the patient experienced VOMITING (Severe Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, VOMITING (Severe Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2020, SARS-CoV-2 test: positive (Positive) positive.         Patient was treated for nausea and discharged home   This case was linked to MOD-2021-089390 (Patient Link).   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Migraine
Clinical narrative: menstrual cycle didn't  came back this month; unbearable migraines around 6 or 7 in the morning and lingers for about an hour.; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (menstrual cycle didn't  came back this month) and MIGRAINE (unbearable migraines around 6 or 7 in the morning and lingers for about an hour.) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 051C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-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 AMENORRHOEA (menstrual cycle didn't  came back this month) and MIGRAINE (unbearable migraines around 6 or 7 in the morning and lingers for about an hour.). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. At the time of the report, AMENORRHOEA (menstrual cycle didn't  came back this month) had not resolved and MIGRAINE (unbearable migraines around 6 or 7 in the morning and lingers for about an hour.) outcome was unknown.            Concomitant product included unspecified medications for Anxiety.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (Slight headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (Slight headache). At the time of the report, CHILLS (chills) and HEADACHE (Slight headache) 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 reported.   This case was linked to MOD-2021-274270 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received on 09-AUG-2021 and included No New Information.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received their first shot of the Moderna Vaccine but never received their second shot due to the fact that they are overseas; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received their first shot of the Moderna Vaccine but never received their second shot due to the fact that they are overseas) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received their first shot of the Moderna Vaccine but never received their second shot due to the fact that they are overseas). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received their first shot of the Moderna Vaccine but never received their second shot due to the fact that they are overseas) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-273004 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Oropharyngeal pain, Pyrexia
Clinical narrative: I can hardly lift my arm; my throat is very spre; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (I can hardly lift my arm), OROPHARYNGEAL PAIN (my throat is very spre), HEADACHE (headache) and PYREXIA (fever) 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 LIMB DISCOMFORT (I can hardly lift my arm), OROPHARYNGEAL PAIN (my throat is very spre), HEADACHE (headache) and PYREXIA (fever). At the time of the report, LIMB DISCOMFORT (I can hardly lift my arm), OROPHARYNGEAL PAIN (my throat is very spre), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Terrible headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Terrible headache) and PYREXIA (Fever) 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-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Terrible headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Terrible headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Vaccination complication
Clinical narrative: Continued reduction in stamina; with a few lingering covid headaches; almost as bad a reaction; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Continued reduction in stamina), HEADACHE (with a few lingering covid headaches) and VACCINATION COMPLICATION (almost as bad a reaction) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Shingles. Concomitant products included GABAPENTIN for Shingles.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. 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 ASTHENIA (Continued reduction in stamina), HEADACHE (with a few lingering covid headaches) and VACCINATION COMPLICATION (almost as bad a reaction). At the time of the report, ASTHENIA (Continued reduction in stamina) and HEADACHE (with a few lingering covid headaches) outcome was unknown and VACCINATION COMPLICATION (almost as bad a reaction) had resolved.            No treatment medications were provided.   This case was linked to MOD-2021-033351 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fibromyalgia
Clinical narrative: Relationship between the vaccine and fibromyalgia like symptoms occurring 2-3 month after receiving the vaccine; 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 FIBROMYALGIA (Relationship between the vaccine and fibromyalgia like symptoms occurring 2-3 month after receiving the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (Relationship between the vaccine and fibromyalgia like symptoms occurring 2-3 month after receiving the vaccine). At the time of the report, FIBROMYALGIA (Relationship between the vaccine and fibromyalgia like symptoms occurring 2-3 month after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The event fibromyalgia occurred after 2-3 months.  No treatment medication provided by the reporter . No concomitant medication provided  by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: pain on lower left side; Have fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain on lower left side) and PYREXIA (Have fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain on lower left side) and PYREXIA (Have fever). At the time of the report, PAIN (pain on lower left side) and PYREXIA (Have fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patients received the Moderna vaccine which isn't approved for these patients' ages (<18); 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients received the Moderna vaccine which isn't approved for these patients' ages (<18)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients received the Moderna vaccine which isn't approved for these patients' ages (<18)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients received the Moderna vaccine which isn't approved for these patients' ages (<18)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received does not contain new information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She got infected with covid july24; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She got infected with covid july24) 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 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced COVID-19 (She got infected with covid july24). At the time of the report, COVID-19 (She got infected with covid july24) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2021, SARS-CoV-2 test: positive (Positive) Patient got infected with COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter said that patient's husband got infected with COVID. Concomitant product use was not provided. Treatment information was not provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after first dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03(0/6)A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (amoxicillin) and Blood pressure high. Concomitant products included METOPROLOL TARTRATE for Blood pressure high, FENOFIBRIC ACID for Triglycerides, OMEGA-3 FATTY ACIDS for an unknown indication.    On 25-Mar-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 PAIN IN EXTREMITY (Sore arm after first dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after first dose) outcome was unknown.            It was stated that batch number 03(0/6)A21A (was not clear if third figure was 0 or 6)  Other concomitant medication included zentrum silver vitamin, daily. No treatment information was provided by reporter.   This case was linked to MOD-2021-274594 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest 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 was provided by the reporter.     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 CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little soreness on the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little soreness on the arm of the injection) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (little soreness on the arm of the injection). At the time of the report, VACCINATION SITE PAIN (little soreness on the arm of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: experienced the reaction after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced the reaction after 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 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 COMPLICATION (experienced the reaction after second dose). At the time of the report, VACCINATION COMPLICATION (experienced the reaction after second dose) outcome was unknown.            No concomitant medication were provided by  the reporter  No treatment medication were provided by the reporter
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little soreness on the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little soreness on the arm of the injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (little soreness on the arm of the injection). At the time of the report, VACCINATION SITE PAIN (little soreness on the arm of the injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medication information was reported. No treatment medications were provided.  The event subsided in less than 24 hours. The second dose has scheduled on 28-AUG-2021.   This case was linked to MOD-2021-274563 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient who got his 1st Moderna Covid-19 Vaccine on 24May2021 & he wants his 2nd dose today; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient who got his 1st Moderna Covid-19 Vaccine on 24May2021 & he wants his 2nd dose today) 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 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient who got his 1st Moderna Covid-19 Vaccine on 24May2021 & he wants his 2nd dose today). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient who got his 1st Moderna Covid-19 Vaccine on 24May2021 & he wants his 2nd dose today) 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.   Concomitant product information was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Product dose omission issue
Clinical narrative: not receiving 2nd dose; pregnancy following vaccination; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy following vaccination) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy following vaccination). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose). On 17-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy following vaccination) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy and Product dose omission with no associated AEs for this 26-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Illness, Pain, Peripheral swelling, Product dose omission issue
Clinical narrative: Vaccination adverse reaction; dried up her body, her stomach and then her face; limbs swell; back swell; pretty extreme pain; very sick; It has been more than 36 days since the first dose and patient has not received a second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), DRY SKIN (dried up her body, her stomach and then her face), PERIPHERAL SWELLING (limbs swell), SWELLING (back swell) and PAIN (pretty extreme pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE for Allergy, CHLORTHALIDONE for Blood pressure management, ESCITALOPRAM for Depression NOS, LOSARTAN and VITAMINS NOS for an unknown indication.    On 26-Feb-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 VACCINATION COMPLICATION (Vaccination adverse reaction), DRY SKIN (dried up her body, her stomach and then her face), PERIPHERAL SWELLING (limbs swell), SWELLING (back swell), PAIN (pretty extreme pain), ILLNESS (very sick) and PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since the first dose and patient has not received a second dose). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), DRY SKIN (dried up her body, her stomach and then her face), PERIPHERAL SWELLING (limbs swell), SWELLING (back swell), PAIN (pretty extreme pain), ILLNESS (very sick) and PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since the first dose and patient has not received a second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not reported.  Lab data included an X-Ray which resulted normal (no infection).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination complication
Clinical narrative: Vaccination adverse reaction; dried up her body, her stomach and then her face; limbs swell; back swell; pretty extreme pain; very sick; It has been more than 36 days since the first dose and patient has not received a second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), DRY SKIN (dried up her body, her stomach and then her face), PERIPHERAL SWELLING (limbs swell), SWELLING (back swell) and PAIN (pretty extreme pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE for Allergy, CHLORTHALIDONE for Blood pressure management, ESCITALOPRAM for Depression NOS, LOSARTAN and VITAMINS NOS for an unknown indication.    On 26-Feb-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 VACCINATION COMPLICATION (Vaccination adverse reaction), DRY SKIN (dried up her body, her stomach and then her face), PERIPHERAL SWELLING (limbs swell), SWELLING (back swell), PAIN (pretty extreme pain), ILLNESS (very sick) and PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since the first dose and patient has not received a second dose). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), DRY SKIN (dried up her body, her stomach and then her face), PERIPHERAL SWELLING (limbs swell), SWELLING (back swell), PAIN (pretty extreme pain), ILLNESS (very sick) and PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since the first dose and patient has not received a second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not reported.  Lab data included an X-Ray which resulted normal (no infection).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose past 36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose past 36 days) 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 20-Apr-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose past 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose past 36 days) had resolved.            No Concomitant use was reported.  Reporter stated she had no adverse events after initial dose of vaccine.  No treatment were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Is dizziness normal 24 hours after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Is dizziness normal 24 hours after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Is dizziness normal 24 hours after vaccination). At the time of the report, DIZZINESS (Is dizziness normal 24 hours after vaccination) 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 reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 35 days after the first dose without receiving the second dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (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 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose without receiving the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (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 medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches) and HEADACHE (Headache) 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Not received the 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not received the 2nd dose yet) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included DULAGLUTIDE (TRULICITY), INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS), OMEPRAZOLE, SERTRALINE HYDROCHLORIDE (ZOLOFT), LISINOPRIL and ATORVASTATIN for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not received the 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not received the 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medications were reported
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: heart was racing; suddenly really weak; light headed; cheeks were really red and hot to touch; arm became sore for 2 weeks; Headaches; Tiredness/ fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was racing), ASTHENIA (suddenly really weak), DIZZINESS (light headed), ERYTHEMA (cheeks were really red and hot to touch) and MYALGIA (arm became sore for 2 weeks) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient history and concomitant medications were not reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced ERYTHEMA (cheeks were really red and hot to touch), MYALGIA (arm became sore for 2 weeks), HEADACHE (Headaches) and FATIGUE (Tiredness/ fatigue). On 17-Mar-2021, the patient experienced PALPITATIONS (heart was racing), ASTHENIA (suddenly really weak) and DIZZINESS (light headed). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Tiredness, at an unspecified dose and frequency. On 17-Mar-2021, PALPITATIONS (heart was racing), ASTHENIA (suddenly really weak) and DIZZINESS (light headed) had resolved. At the time of the report, ERYTHEMA (cheeks were really red and hot to touch), MYALGIA (arm became sore for 2 weeks), HEADACHE (Headaches) and FATIGUE (Tiredness/ fatigue) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow up received contain no new information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Palpitations
Clinical narrative: heart was racing; suddenly really weak; light headed; cheeks were really red and hot to touch; arm became sore for 2 weeks; Headaches; Tiredness/ fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was racing), ASTHENIA (suddenly really weak), DIZZINESS (light headed), ERYTHEMA (cheeks were really red and hot to touch) and MYALGIA (arm became sore for 2 weeks) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient history and concomitant medications were not reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced ERYTHEMA (cheeks were really red and hot to touch), MYALGIA (arm became sore for 2 weeks), HEADACHE (Headaches) and FATIGUE (Tiredness/ fatigue). On 17-Mar-2021, the patient experienced PALPITATIONS (heart was racing), ASTHENIA (suddenly really weak) and DIZZINESS (light headed). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Tiredness, at an unspecified dose and frequency. On 17-Mar-2021, PALPITATIONS (heart was racing), ASTHENIA (suddenly really weak) and DIZZINESS (light headed) had resolved. At the time of the report, ERYTHEMA (cheeks were really red and hot to touch), MYALGIA (arm became sore for 2 weeks), HEADACHE (Headaches) and FATIGUE (Tiredness/ fatigue) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow up received contain no new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Product dose omission issue, Sinusitis
Clinical narrative: I received my first vaccine shot March 26. Got sic two weeks later after first dose; Sinus infection; I have now waited too long . What do I do now? Start over with Vaccine 1 or go ahead a; Missed 2nd dose/More than 35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I received my first vaccine shot March 26. Got sic two weeks later after first dose), SINUSITIS (Sinus infection), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have now waited too long . What do I do now? Start over with Vaccine 1 or go ahead a) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose/More than 35 days since first dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I received my first vaccine shot March 26. Got sic two weeks later after first dose), SINUSITIS (Sinus infection), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have now waited too long . What do I do now? Start over with Vaccine 1 or go ahead a) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose/More than 35 days since first dose). At the time of the report, ILLNESS (I received my first vaccine shot March 26. Got sic two weeks later after first dose) and SINUSITIS (Sinus infection) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have now waited too long . What do I do now? Start over with Vaccine 1 or go ahead a) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose/More than 35 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Patient treatment medication was included with steroids to treat sinus infection. No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received and reporter details updated. patient demographics updated. added new events events outcome updated.