chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion/Vaccines administered to patients after temperature excursion; Expired vaccines/Vaccines administered to patients after being expired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion/Vaccines administered to patients after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccines/Vaccines administered to patients after being expired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion/Vaccines administered to patients after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccines/Vaccines administered to patients after being expired). In 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion/Vaccines administered to patients after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccines/Vaccines administered to patients after being expired) 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.   no concomitant and treatment medications are provided by the reporter. Some time ago the super cold freezer where the vaccines were stored in frozen condition, failed. The freezer went up to (+)21 degrees Fahrenheit so the vaccines were moved to a kitchen refrigerator freezer that kept the vaccines around (+) 18 degrees Fahrenheit. The vaccines were in that environment for 2-3 days because they were thawing out the original freezer per manufacturer's instructions. The vaccines in meantime were then placed in refrigerator because they were past the (+) 5 degrees Fahrenheit mark. The vaccines were maintained in the refrigerator between 36-46 degrees Fahrenheit. maximum 21 degrees Fahrenheit in frozen storage condition,Excursion duration is of  2-3 days,Number of vials impacted 150 vials.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: couldn't really sleep on it's side; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (couldn't really sleep on it's side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Small fiber neuropathy.    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 SLEEP DISORDER (couldn't really sleep on it's side). At the time of the report, SLEEP DISORDER (couldn't really sleep on it's side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-360203 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Therapeutic response unexpected
Clinical narrative: Period of better breathing, that last a few hours in each occasion/a positive side effect; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Period of better breathing, that last a few hours in each occasion/a positive side effect) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037f21a, 028a21a and 025a21a) for COVID-19 vaccination.     The patient's past medical history included Cancer (Patient is a cancer survivor.). Concurrent medical conditions included Asthma, Type 1 diabetes mellitus and Breathing difficult. Concomitant products included INSULIN (INSULIN, REGULAR) for Type 1 diabetes mellitus.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Period of better breathing, that last a few hours in each occasion/a positive side effect). On 20-Oct-2021, THERAPEUTIC RESPONSE UNEXPECTED (Period of better breathing, that last a few hours in each occasion/a positive side effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, Blood glucose: high (High) High blood pressure after meals. On 19-Oct-2021, Blood glucose: high (High) High blood pressure after meals. On 20-Oct-2021, Blood glucose: high (High) High blood pressure after meals.         Concomitant medication include hormone replacement, thyroid medication and asthma medication.   This case was linked to MOD-2021-063657 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Breakthrough COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakthrough COVID 19) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (Breakthrough COVID 19). At the time of the report, COVID-19 (Breakthrough COVID 19) outcome was unknown.            The  concomitant medications on use were not provided. No treatment information was provided.  The patient was qualified for the monoclonal antibodies.   This case was linked to MOD-2021-360105 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 73-year-old, female patient with unknown medical history,  who experienced the unexpected non serious (AESI) event of COVID 19. The event occurred on unknown latency after the second dose of Spikevax. No information regarding start dates of the first or second dose either latency were reported, so lack of efficacy is not captured. The rechallenge is not applicable. The Benefit-risk relationship of Spikevax is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: My arm was achy; I was tired for day, or so; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was achy) and FATIGUE (I was tired for day, or so) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (My arm was achy) and FATIGUE (I was tired for day, or so). At the time of the report, PAIN IN EXTREMITY (My arm was achy) and FATIGUE (I was tired for day, or so) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-360509 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Myalgia
Clinical narrative: Fast heart rate; General aches; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate) and MYALGIA (General aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced HEART RATE INCREASED (Fast heart rate) and MYALGIA (General aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date for Myalgia, at an unspecified dose and frequency. On 13-Mar-2021, HEART RATE INCREASED (Fast heart rate) had resolved. At the time of the report, MYALGIA (General aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Heart rate: increased (High) Heart rate increased and lasted for about a couple of hours.         Concomitant medications details were not reported by the reporter. The patient did not experienced any symptoms like this before Moderna COVID-19 vaccine. Patient did not have any medical history of myocarditis/pericarditis.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received dose from expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vaccine). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-360687 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose from expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from expired vaccine) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from expired vaccine). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose from expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported. Regarding dose it was reported as follows: The vial was initially stored in the refrigerator on 18Oct2021. The vial didn't undergo any temperature excursions.   This case was linked to MOD-2021-360642, MOD-2021-360723 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 29 Sep 2021 and 2nd dose on 20 Oct 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 29 Sep 2021 and 2nd dose on 20 Oct 2021) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 20-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 29 Sep 2021 and 2nd dose on 20 Oct 2021). On 20-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 29 Sep 2021 and 2nd dose on 20 Oct 2021) had resolved.        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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient got a booster dose from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got a booster dose from an expired vial) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A, 028L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got a booster dose from an expired vial). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient got a booster dose from an expired vial) 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.  Reporter mentioned 1 vial, carrying 10 doses, originally, only 3 doses were administered from it. Vial was left to thaw straight from the freezer right before being used.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Hypoaesthesia, Joint swelling
Clinical narrative: Joint pain on both legs which is also swollen and can not get up in the morning; Lower back pain; Left hand numbness; Joint pain on both legs which is also swollen and can not get up in the morning; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Joint pain on both legs which is also swollen and can not get up in the morning), BACK PAIN (Lower back pain), HYPOAESTHESIA (Left hand numbness) and ARTHRALGIA (Joint pain on both legs which is also swollen and can not get up in the morning) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     The patient's past medical history included Knee injury (she had injury back in 2009 on in her knees and fell down.) in 2009.    On 28-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Joint pain on both legs which is also swollen and can not get up in the morning), BACK PAIN (Lower back pain), HYPOAESTHESIA (Left hand numbness) and ARTHRALGIA (Joint pain on both legs which is also swollen and can not get up in the morning). At the time of the report, JOINT SWELLING (Joint pain on both legs which is also swollen and can not get up in the morning), BACK PAIN (Lower back pain), HYPOAESTHESIA (Left hand numbness) and ARTHRALGIA (Joint pain on both legs which is also swollen and can not get up in the morning) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had her last physical exam in August of 2021.  No Concomitant and Treatment medication were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever after 1st dose; soreness after 1st dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after 1st dose) and MYALGIA (soreness after 1st dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 16-Aug-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 PYREXIA (Fever after 1st dose) and MYALGIA (soreness after 1st dose). The patient was treated with HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE [HYDROXYZINE HYDROCHLORIDE]) at a dose of 50 mg four times per day; FAMOTIDINE (FAMOTIDINE TEVA) at a dose of 40 mg once a day; PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) at a dose of 10 mg and ONDANSETRON at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever after 1st dose) and MYALGIA (soreness after 1st dose) had not 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.   Lab data reported blood tests and EKG with inconclusive results. No Concomitant Medication was provided.   This case was linked to MOD-2021-339162 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: arm tight, arm hard; arm  sore; she woke up with her arm 3x its size; arm  itchy; arm  red; headache; arm where she got the injection became swollen; arm where she got the injection became sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (arm tight, arm hard), VACCINATION SITE PAIN (arm  sore), VACCINATION SITE SWELLING (she woke up with her arm 3x its size), VACCINATION SITE PRURITUS (arm  itchy) and VACCINATION SITE ERYTHEMA (arm  red) in a 26-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 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced VACCINATION SITE SWELLING (arm where she got the injection became swollen) and VACCINATION SITE PAIN (arm where she got the injection became sore). On 16-Oct-2021, the patient experienced HEADACHE (headache). On 21-Oct-2021, the patient experienced VACCINATION SITE INDURATION (arm tight, arm hard), VACCINATION SITE PAIN (arm  sore), VACCINATION SITE SWELLING (she woke up with her arm 3x its size), VACCINATION SITE PRURITUS (arm  itchy) and VACCINATION SITE ERYTHEMA (arm  red). At the time of the report, VACCINATION SITE INDURATION (arm tight, arm hard), VACCINATION SITE PAIN (arm  sore), VACCINATION SITE SWELLING (she woke up with her arm 3x its size), VACCINATION SITE PRURITUS (arm  itchy), VACCINATION SITE ERYTHEMA (arm  red), VACCINATION SITE SWELLING (arm where she got the injection became swollen), VACCINATION SITE PAIN (arm where she got the injection became sore) 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. No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: arm tight, arm hard; arm  sore; she woke up with her arm 3x its size; arm  itchy; arm  red; headache; arm where she got the injection became swollen; arm where she got the injection became sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (arm tight, arm hard), VACCINATION SITE PAIN (arm  sore), VACCINATION SITE SWELLING (she woke up with her arm 3x its size), VACCINATION SITE PRURITUS (arm  itchy) and VACCINATION SITE ERYTHEMA (arm  red) in a 26-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 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced VACCINATION SITE SWELLING (arm where she got the injection became swollen) and VACCINATION SITE PAIN (arm where she got the injection became sore). On 16-Oct-2021, the patient experienced HEADACHE (headache). On 21-Oct-2021, the patient experienced VACCINATION SITE INDURATION (arm tight, arm hard), VACCINATION SITE PAIN (arm  sore), VACCINATION SITE SWELLING (she woke up with her arm 3x its size), VACCINATION SITE PRURITUS (arm  itchy) and VACCINATION SITE ERYTHEMA (arm  red). At the time of the report, VACCINATION SITE INDURATION (arm tight, arm hard), VACCINATION SITE PAIN (arm  sore), VACCINATION SITE SWELLING (she woke up with her arm 3x its size), VACCINATION SITE PRURITUS (arm  itchy), VACCINATION SITE ERYTHEMA (arm  red), VACCINATION SITE SWELLING (arm where she got the injection became swollen), VACCINATION SITE PAIN (arm where she got the injection became sore) 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. No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Pneumonia, Pruritus
Clinical narrative: pneumonia; bruises on the chest, back, then all over the body; itchy; burning; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K206A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced CONTUSION (bruises on the chest, back, then all over the body), PRURITUS (itchy) and BURNING SENSATION (burning). In October 2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia), CONTUSION (bruises on the chest, back, then all over the body), PRURITUS (itchy) and BURNING SENSATION (burning) outcome was unknown.            No concomitant medications were reported. Patient has been treated with steroid shots, oral steroids, & steroid cream. The patient also got pneumonia last week.  Company Comment: This case concerns a 69-year-old male patient with no medical history reported, who experienced the unexpected serious event of pneumonia. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event occured after the second dose and no additional dosing will be given. The benefit-risk relationship of the vaccine in not affected by this report.; Sender's Comments: This case concerns a 69-year-old male patient with no medical history reported, who experienced the unexpected serious event of pneumonia. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event occured after the second dose and no additional dosing will be given. The benefit-risk relationship of the vaccine in not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: neurological syptoms; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (neurological syptoms) 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 NEUROLOGICAL SYMPTOM (neurological syptoms). At the time of the report, NEUROLOGICAL SYMPTOM (neurological syptoms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow up attached on 21-Oct-2021 contains no new information
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Chills, Condition aggravated, Influenza like illness
Clinical narrative: Chest kinda hearting when tries to breath; Had the same symptoms but worst; Flu like symptoms; Terminating back pain; Feels the arm like if it's dragging it; Shivering in the inside; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest kind of hurting when tries to breath), CONDITION AGGRAVATED (Had the same symptoms but worst), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Terminating back pain) and MOBILITY DECREASED (Feels the arm like if it's dragging it) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Oct-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. In October 2021, the patient experienced CHEST PAIN (Chest kinda hearting when tries to breath), CONDITION AGGRAVATED (Had the same symptoms but worst), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Terminating back pain), MOBILITY DECREASED (Feels the arm like if it's dragging it) and CHILLS (Shivering in the inside). At the time of the report, CHEST PAIN (Chest kinda hearting when tries to breath), CONDITION AGGRAVATED (Had the same symptoms but worst), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Terminating back pain), MOBILITY DECREASED (Feels the arm like if it's dragging it) and CHILLS (Shivering in the inside) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-361221 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: Chest kinda hearting when tries to breath; Had the same symptoms but worst; Flu like symptoms; Terminating back pain; Feels the arm like if it's dragging it; Shivering in the inside; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest kind of hurting when tries to breath), CONDITION AGGRAVATED (Had the same symptoms but worst), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Terminating back pain) and MOBILITY DECREASED (Feels the arm like if it's dragging it) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Oct-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. In October 2021, the patient experienced CHEST PAIN (Chest kinda hearting when tries to breath), CONDITION AGGRAVATED (Had the same symptoms but worst), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Terminating back pain), MOBILITY DECREASED (Feels the arm like if it's dragging it) and CHILLS (Shivering in the inside). At the time of the report, CHEST PAIN (Chest kinda hearting when tries to breath), CONDITION AGGRAVATED (Had the same symptoms but worst), INFLUENZA LIKE ILLNESS (Flu like symptoms), BACK PAIN (Terminating back pain), MOBILITY DECREASED (Feels the arm like if it's dragging it) and CHILLS (Shivering in the inside) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-361221 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired dose (expiration date of 8Oct2021) of the Moderna Covid-19 Vaccine was given to a patient on 21Oct2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired dose (expiration date of 8Oct2021) of the Moderna Covid-19 Vaccine was given to a patient on 21Oct2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired dose (expiration date of 8Oct2021) of the Moderna Covid-19 Vaccine was given to a patient on 21Oct2021). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired dose (expiration date of 8Oct2021) of the Moderna Covid-19 Vaccine was given to a patient on 21Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment drug details was reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was mistakenly given a dose of vaccine from a vial that was punctured yesterday morning, A patient was mistakenly given a dose of vaccine that was punctured more than 12 hours ago; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was mistakenly given a dose of vaccine from a vial that was punctured yesterday morning, A patient was mistakenly given a dose of vaccine that was punctured more than 12 hours ago) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: INFLUENZA VACCINE (Body site- left deltoid lot number- E9R44) on 24-Sep-2021. Concurrent medical conditions included Anemia, Gout, Anxiety and Substance use disorder. Concomitant products included LORATADINE for Allergy, BUSPIRONE, QUETIAPINE and PAROXETINE for Anxiety, ALLOPURINOL for Gout, FERROUS SULFATE for Iron deficiency anemia, BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for Substance use disorder, GABAPENTIN for an unknown indication.    On 21-Oct-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was mistakenly given a dose of vaccine from a vial that was punctured yesterday morning, A patient was mistakenly given a dose of vaccine that was punctured more than 12 hours ago). On 21-Oct-2021 at 11:00 AM, EXPIRED PRODUCT ADMINISTERED (patient was mistakenly given a dose of vaccine from a vial that was punctured yesterday morning, A patient was mistakenly given a dose of vaccine that was punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other medications include Vitamins (B12, folate, B1, MVI) 2500 mcg, 1 mg, 100 mg, 1 tab; all qd used for unknown indication taken orally.  Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.     Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow-up information included no new information. On 25-Oct-2021: significant follow up received and contains patients medical history and medications
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: more than 42 days for administration of second dose; patient younger than 18 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose). In June 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: patient received half the dose of a Moderna vaccine in error; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received half the dose of a Moderna vaccine in error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (patient received half the dose of a Moderna vaccine in error). At the time of the report, ACCIDENTAL UNDERDOSE (patient received half the dose of a Moderna vaccine in error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered from punctured Moderna Covid-19 vaccine vial > 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from punctured Moderna Covid-19 vaccine vial > 12 hours post puncture) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035221A and 035221A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from punctured Moderna Covid-19 vaccine vial > 12 hours post puncture). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from punctured Moderna Covid-19 vaccine vial > 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: Still down for a day; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Still down for a day) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DEPRESSED MOOD (Still down for a day). At the time of the report, DEPRESSED MOOD (Still down for a day) had resolved.            No concomitant products were reported. No treatment information was reported by the reporter.   This case was linked to MOD-2021-307765 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Erythema, Myalgia, Pain in extremity
Clinical narrative: Chills; Believes the vaccine exacerbated Fibromyalgia possibly; Arm has a knot in it; Muscle ache; Arm red, swollen, and itching; Arm red, swollen, and itching; Arm red, swollen, and itching; Arm sore; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3180) via an unspecified route of administration, administered Left deltoid on 30Aug2021 at 18:00 as dose 1, single for COVID-19 immunization (age at vaccination 61 years). The patients medical history included ongoing fibromyalgia Diagnosed 40 years ago believes the vaccine exacerbated this possibly. Concomitant medications were not reported. No vaccination was administered 4 weeks Prior Vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect was none. On 30Aug2021, the patient experienced arm sore. On 01Sep2021, had muscle ache, arm has a knot. On 31Aug2021, arm red, swollen, and itching. On an unspecified date, had chills, believes the vaccine exacerbated fibromyalgia possibly. It was reported that on Monday evening she had the vaccine and her arm is still sore, red, swollen, and she has a knot in it. She also had chills after the vaccine, muscle aches, and all that stuff which has gotten better. Arm Sore, she noticed the night she went to bed. It also did not help this was the same side she sleeps on. Arm swollen, red, and itching: She started to notice this the following day when woke up. Arm has a knot in it, confirmed it is not as prominent, it is better now. She mentioned she had to leave work yesterday early because she was hurting so bad. The adverse event did not require a visit to emergency room visit or physician office visit. Treatment/Intervention was she took Tylenol, Gabapentin, and used ice pack on arm. She later clarified the Tylenol is technically Acetaminophen, Mipap, Lot: 544785CS7 Exp: Aug2021. Treatment received for the events as Tylenol, Gabapentin, and used ice pack on arm. She later clarified the Tylenol is technically Acetaminophen, Mipap. The outcome of the events was reported as recovering for arm sore, muscle ache, arm has a knot in it and the outcome as not recovered for arm red, swollen, and itching and the outcome as unknown for chills and believes the vaccine exacerbated fibromyalgia. The patient provided information regarding the reported adverse event with the use of the product and consider the Pfizer product had a casual effect to the adverse event.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site mass
Clinical narrative: Chills; Believes the vaccine exacerbated Fibromyalgia possibly; Arm has a knot in it; Muscle ache; Arm red, swollen, and itching; Arm red, swollen, and itching; Arm red, swollen, and itching; Arm sore; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3180) via an unspecified route of administration, administered Left deltoid on 30Aug2021 at 18:00 as dose 1, single for COVID-19 immunization (age at vaccination 61 years). The patients medical history included ongoing fibromyalgia Diagnosed 40 years ago believes the vaccine exacerbated this possibly. Concomitant medications were not reported. No vaccination was administered 4 weeks Prior Vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect was none. On 30Aug2021, the patient experienced arm sore. On 01Sep2021, had muscle ache, arm has a knot. On 31Aug2021, arm red, swollen, and itching. On an unspecified date, had chills, believes the vaccine exacerbated fibromyalgia possibly. It was reported that on Monday evening she had the vaccine and her arm is still sore, red, swollen, and she has a knot in it. She also had chills after the vaccine, muscle aches, and all that stuff which has gotten better. Arm Sore, she noticed the night she went to bed. It also did not help this was the same side she sleeps on. Arm swollen, red, and itching: She started to notice this the following day when woke up. Arm has a knot in it, confirmed it is not as prominent, it is better now. She mentioned she had to leave work yesterday early because she was hurting so bad. The adverse event did not require a visit to emergency room visit or physician office visit. Treatment/Intervention was she took Tylenol, Gabapentin, and used ice pack on arm. She later clarified the Tylenol is technically Acetaminophen, Mipap, Lot: 544785CS7 Exp: Aug2021. Treatment received for the events as Tylenol, Gabapentin, and used ice pack on arm. She later clarified the Tylenol is technically Acetaminophen, Mipap. The outcome of the events was reported as recovering for arm sore, muscle ache, arm has a knot in it and the outcome as not recovered for arm red, swollen, and itching and the outcome as unknown for chills and believes the vaccine exacerbated fibromyalgia. The patient provided information regarding the reported adverse event with the use of the product and consider the Pfizer product had a casual effect to the adverse event.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood test, Chills, Headache
Clinical narrative: headache; chills; This is a Spontaneous report based on the information received by Pfizer f(Manufacturer Notification to Pfizer/ Report No: -4797-8196). A contactable consumer reported for a female patient (reporter's colleague) that:  A 56-year-old female patient received (Pfizer COVID-19 Vaccine, solution for injection, Batch/ Lot Number was not reported) via unspecified route of administration as dose number unknown, single for covid 19 immunization. The patient medical history included insomnia, restless legs, fatigue, tired, cholesterol from unknown date if unknown ongoing. Patient is fit do exercises and has happy life. Family medical history includes mother's cholesterol is fine as well and her father did not die of a heart attack. she is concerned that the cholesterol medication can cause hallucinations, which she reports her "father was a victim" of (AE Capture US-#-10Sep2021). Past drug history included generic for Synthroid (Levothyroxine) for unknown indication started in 40s and therapy ended. The patient's concomitant medication included CombiPatch 50/140 two patches a week  via transdermal route from 2 years ago, 2019 still ongoing . that since starting she has had no side effects and she feels great and new treatment for hormone replacement for hormone replacement and medication for my Kidneys from unknown date. Patient cardiologists want her to get off of the CombiPatch and wants her to take cholesterol medication. On 10Sep2021 patient experienced headache and chills after Pfizer COVID-19 vaccine. Patient still had headaches. Patient received Moderna Covid vaccine from mid-day approximately 5 months ago, Apr2021 by 23:00 and she almost died after the second dose. She received the second dose and had symptoms. She passed out three times after receiving the second dose. Caller reports that she fell two times after the second dose. She reports that she did not pass out due to "unhealth" and reports that she was "normal" prior to receiving the 2nd dose. She also experienced a "very strong headache" and vomiting. It was "hell night" for her following her 2nd dose. She did not go to the hospital because she was afraid of contracting COVID-19 but did speak to her provider about the reaction. Her headache had not gotten better she would have gone to the hospital. She had to take the vaccine due to her kidney issues. The patient underwent kidney study with result(s): 39%, heart study with no calcification on her heart, blood work with result was perfect, cholesterol level are normal. Caller reports that she has no calcification in her arteries. Caller reported patient would take a third dose after eight months. The outcome of events were unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.