chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after improper storage & handling; Vial Frozen got defrost then refrozen twice and then thawed.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR and EXPIRED PRODUCT ADMINISTERED in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced PRODUCT STORAGE ERROR and EXPIRED PRODUCT ADMINISTERED. On 06-Oct-2021, PRODUCT STORAGE ERROR and EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided.  Patient had given vial Frozen got defrost then refrozen twice and then thawed. After that given to 2 patients, Both are feeling fine. HCP did not provide HCP facility details, neither vaccination site details.   No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Rash pustular
Clinical narrative: More than 42 days for administration of second dose; Dermatologic reaction/Papulopustular rash; This spontaneous case was reported by a physician and describes the occurrence of RASH PUSTULAR (Dermatologic reaction/Papulopustular rash) and PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concomitant products included USTEKINUMAB (STELARA) for Psoriatic arthritis.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced RASH PUSTULAR (Dermatologic reaction/Papulopustular rash). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose). At the time of the report, RASH PUSTULAR (Dermatologic reaction/Papulopustular rash) had not resolved and PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants drugs were provided. Treatment drugs were oral and topical steroids.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Tendonitis, Ultrasound scan, Vaccination site movement impairment
Clinical narrative: Diagnosed with tendonitis/it was confirmed it was tendonitis; Cannot do movements with her shoulder; Shoulder pain, shoulder is painful; This spontaneous case was reported by a pharmacist and describes the occurrence of TENDONITIS (Diagnosed with tendonitis/it was confirmed it was tendonitis), VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot do movements with her shoulder) and ARTHRALGIA (Shoulder pain, shoulder is painful) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 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 TENDONITIS (Diagnosed with tendonitis/it was confirmed it was tendonitis), VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot do movements with her shoulder) and ARTHRALGIA (Shoulder pain, shoulder is painful). At the time of the report, TENDONITIS (Diagnosed with tendonitis/it was confirmed it was tendonitis), VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot do movements with her shoulder) and ARTHRALGIA (Shoulder pain, shoulder is painful) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: abnormal (abnormal) ultrasound was done, and it was confirmed it was tendonitis.     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 medication  were reported.  Patient received the first dose 2 months ago and he was hesitant on getting the second dose.  No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Follow up received contains confirmed tendonitis.
Sex: M
Vaccine: COVID19
Symptoms: Carditis
Clinical narrative: Rare cases of young male adults with symptoms of heart inflammation; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Rare cases of young male adults with symptoms of heart inflammation) in an adult 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDITIS (Rare cases of young male adults with symptoms of heart inflammation) (seriousness criterion medically significant). At the time of the report, CARDITIS (Rare cases of young male adults with symptoms of heart inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.  Company Comment: This case concerns a male patient of unknown age with no previous relevant medical history reported, who experienced the unexpected event of carditis. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age with no previous relevant medical history reported, who experienced the unexpected event of carditis. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, 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 (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-336820, MOD-2021-344336 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-344335, MOD-2021-336820 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: not feeling well for two days after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling well for two days after receiving vaccine) in a 36-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (not feeling well for two days after receiving vaccine). At the time of the report, VACCINATION COMPLICATION (not feeling well for two days after receiving vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided by the reporter. No treatment information provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis, Headache, Influenza like illness, Myalgia
Clinical narrative: like flu symptoms; feel woozy; whole body was in pain; heavy nose bleeding that lasted for about a minute; had a really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (heavy nose bleeding that lasted for about a minute), INFLUENZA LIKE ILLNESS (like flu symptoms), DIZZINESS (feel woozy), HEADACHE (had a really bad headache) and MYALGIA (whole body was in pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LABETALOL for Hypertension.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced HEADACHE (had a really bad headache). On 30-Sep-2021, the patient experienced EPISTAXIS (heavy nose bleeding that lasted for about a minute). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (like flu symptoms), DIZZINESS (feel woozy) and MYALGIA (whole body was in pain). The patient was treated with TRAMADOL for Headache, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE) for Adverse event, at an unspecified dose and frequency. On 30-Sep-2021, EPISTAXIS (heavy nose bleeding that lasted for about a minute) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (like flu symptoms), DIZZINESS (feel woozy), HEADACHE (had a really bad headache) and MYALGIA (whole body was in pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-344147 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to molds, Allergy to antibiotic, Drug allergy, Drug allergy and Drug allergy.    On 26-Feb-2021, 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 (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.   This case was linked to MOD-2021-336776, MOD-2021-344344 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site pain
Clinical narrative: Injection site soreness; Vaccine administered by IN route; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered by IN route) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007b21a and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Food allergy (yeast), Drug allergy (Clindamycin), Drug allergy (Codeine), Drug allergy (Morphine) and Drug allergy (Zofran).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intranodal) dosage was changed to 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered by IN route). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site soreness). On 26-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered by IN route) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intranodal), the reporter did not provide any causality assessments.   No concomitant medication listed.  No treatment information provided.   This case was linked to MOD-2021-344343, MOD-2021-336776 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: had some effects after the 2nd dose that lasted a day and a half; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE DRUG REACTION (had some effects after the 2nd dose that lasted a day and a half) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (had some effects after the 2nd dose that lasted a day and a half). At the time of the report, ADVERSE DRUG REACTION (had some effects after the 2nd dose that lasted a day and a half) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had some effects after the second dose that lasted a day and a half. No Treatment informations were reported.   This case was linked to MOD-2021-344368 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) in a 43-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 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
Sex: F
Vaccine: COVID19
Symptoms: Administration related reaction, Limb discomfort
Clinical narrative: some discomfort in arm; It was due to the way the pharmacist gave the shot; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (some discomfort in arm) and ADMINISTRATION RELATED REACTION (It was due to the way the pharmacist gave the 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 06-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced LIMB DISCOMFORT (some discomfort in arm) and ADMINISTRATION RELATED REACTION (It was due to the way the pharmacist gave the shot). On 06-Oct-2021, ADMINISTRATION RELATED REACTION (It was due to the way the pharmacist gave the shot) had resolved. At the time of the report, LIMB DISCOMFORT (some discomfort in arm) outcome was unknown.            No concomitant medication were reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Lymphoma
Clinical narrative: breast cancer; lymph node cancer on her left breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (breast cancer) and LYMPHOMA (lymph node cancer on her left breast) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced BREAST CANCER (breast cancer) (seriousness criterion medically significant) and LYMPHOMA (lymph node cancer on her left breast) (seriousness criterion medically significant). The patient was treated with Surgery (Lateral  Mastectomy) for Breast cancer and Surgery (Lateral  Mastectomy) for Lymphoma. At the time of the report, BREAST CANCER (breast cancer) and LYMPHOMA (lymph node cancer on her left breast) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. The patient got her first dose on left deltoid muscle (non dominant arm). The patient had surgery-lateral mastectomy on an unspecified date in Jun-2021. The patient mentioned that the lymph node cancer was on her left breast and that it was very minimal, small. She had cancer only in one but, she did not want to take a chance. The patient did not clarify whether she took the surgery on both breasts. She only mentioned later that her left breast was cut off.  Company Comment: This case concerns a 73-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of Breast cancer, and lymphoma. The event occurred after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. Elderly age remains a confounder.  The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-344364 (Patient Link).; Sender's Comments: This case concerns a 73-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of Breast cancer, and lymphoma. The event occurred after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. Elderly age remains a confounder.  The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Really intense dreams - hallucinatory dreams; chills; Fever; headache; Tired, fatigued, kind of "brohl"; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Really intense dreams - hallucinatory dreams), CHILLS (chills), PYREXIA (Fever), HEADACHE (headache) and FATIGUE (Tired, fatigued, kind of "brohl") in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 029620A) 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 ABNORMAL DREAMS (Really intense dreams - hallucinatory dreams), CHILLS (chills), PYREXIA (Fever) and HEADACHE (headache). 02-Mar-2021, the patient experienced FATIGUE (Tired, fatigued, kind of "brohl"). On 03-Mar-2021, ABNORMAL DREAMS (Really intense dreams - hallucinatory dreams), CHILLS (chills), PYREXIA (Fever) and HEADACHE (headache) had resolved. On 09-Mar-2021, FATIGUE (Tired, fatigued, kind of "brohl") had resolved.            Concomitant medication was not provided.  Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: had some effects after the first but they have lasted 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (had some effects after the first but they have lasted 4 days) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (had some effects after the first but they have lasted 4 days). At the time of the report, ADVERSE DRUG REACTION (had some effects after the first but they have lasted 4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. had some effects after the 2nd dose that lasted a day and a half. have since developed the same symptoms as the first but they have lasted 4 days. Treatment information was not provided   This case was linked to MOD-2021-344349 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contusion, Supraventricular tachycardia
Clinical narrative: arrythmia under control with medication; after second dose patient went into SVT; bruising from her deltoid to the bottom of her latissimus dorsi; anemic; periodic chest pain for a couple of months; This spontaneous case was reported by a physician and describes the occurrence of ARRHYTHMIA (arrythmia under control with medication) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (arrythmia under control with medication) (seriousness criterion medically significant), SUPRAVENTRICULAR TACHYCARDIA (after second dose patient went into SVT), MUSCLE CONTUSION (bruising from her deltoid to the bottom of her latissimus dorsi), ANAEMIA (anemic) and CHEST PAIN (periodic chest pain for a couple of months). At the time of the report, ARRHYTHMIA (arrythmia under control with medication) was resolving, SUPRAVENTRICULAR TACHYCARDIA (after second dose patient went into SVT), MUSCLE CONTUSION (bruising from her deltoid to the bottom of her latissimus dorsi) and ANAEMIA (anemic) outcome was unknown and CHEST PAIN (periodic chest pain for a couple of months) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: negative (Negative) Negative and negative (Negative) Negative. On an unknown date, Echocardiogram: negative (Negative) Negative.     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 provided. There was no diagnosis of myocarditis or pericarditis and no medical history of arrhythmia. Patient had seen a cardiologist.  Company Comment: This case concerns a 38-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of arrhythmia and supraventricular tachycardia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 38-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of arrhythmia and supraventricular tachycardia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Contusion, Pain in extremity, Swelling
Clinical narrative: whole arm of the injection is hurting really bad/hurting so bad behind arm/The patient was under a lot of pain and it was hard to understand her when she spoke; under armpit there's a big bruise that keeps growing and growing/purple bruising; under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise; under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise/This morning it started to swell; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise/This morning it started to swell), PAIN IN EXTREMITY (whole arm of the injection is hurting really bad/hurting so bad behind arm/The patient was under a lot of pain and it was hard to understand her when she spoke), CONTUSION (under armpit there's a big bruise that keeps growing and growing/purple bruising) and AXILLARY MASS (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise) in a 30-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced SWELLING (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise/This morning it started to swell). On an unknown date, the patient experienced PAIN IN EXTREMITY (whole arm of the injection is hurting really bad/hurting so bad behind arm/The patient was under a lot of pain and it was hard to understand her when she spoke), CONTUSION (under armpit there's a big bruise that keeps growing and growing/purple bruising) and AXILLARY MASS (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise). At the time of the report, SWELLING (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise/This morning it started to swell), PAIN IN EXTREMITY (whole arm of the injection is hurting really bad/hurting so bad behind arm/The patient was under a lot of pain and it was hard to understand her when she spoke), CONTUSION (under armpit there's a big bruise that keeps growing and growing/purple bruising) and AXILLARY MASS (under her armpit there's a big bruise that keeps growing and growing and there are bumps under the bruise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Butterfly rash, Headache, Nausea, Pyrexia, Vaccination site swelling
Clinical narrative: butterfly rash on her cheeks and nose; nausea; vomiting; headache; fever; swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BUTTERFLY RASH, NAUSEA, VOMITING, HEADACHE, and PYREXIA in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN for an unknown indication.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced BUTTERFLY RASH, NAUSEA, VOMITING, HEADACHE, PYREXIA, and VACCINATION SITE SWELLING. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency. At the time of the report, BUTTERFLY RASH, NAUSEA, VOMITING, HEADACHE, PYREXIA, and VACCINATION SITE SWELLING had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Treatment included Ice.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: butterfly rash on her cheeks and nose; nausea; vomiting; headache; fever; swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BUTTERFLY RASH, NAUSEA, VOMITING, HEADACHE, and PYREXIA in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN for an unknown indication.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced BUTTERFLY RASH, NAUSEA, VOMITING, HEADACHE, PYREXIA, and VACCINATION SITE SWELLING. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency. At the time of the report, BUTTERFLY RASH, NAUSEA, VOMITING, HEADACHE, PYREXIA, and VACCINATION SITE SWELLING had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Treatment included Ice.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore right arm on same day after receiving vaccine.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MELOXICAM for an unknown indication.   On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced PAIN IN EXTREMITY (A sore right arm on same day after receiving vaccine.). At the time of the report, PAIN IN EXTREMITY (A sore right arm on same day after receiving vaccine.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. Patient took vaccination at vaccination facility, pharmacy.    This case was linked to MOD-2021-288132 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 35 days between first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 090A21A, 0J8(H or N)20X and 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Cholesterol.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose). On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose) had resolved.            Patient had cholesterol blood pressure issues that were managed by medication.  Patient was not immunocompromised. Treatment information was not provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 17 year old patient received the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient received the vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient received the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient received the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Thawed and refrozen vaccine was administered to patients; Poor quality vaccine administered; 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 STORAGE ERROR (Thawed and refrozen vaccine was administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Thawed and refrozen vaccine was administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On 06-Oct-2021, PRODUCT STORAGE ERROR (Thawed and refrozen vaccine was administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Feeling abnormal
Clinical narrative: woke up feeling really crappy; dry cough for several hours that subsided periodically; felt nauseous; had chills last night; she felt okay, but had some fatigue; low fever max 98.6; massive headache; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (woke up feeling really crappy), COUGH (dry cough for several hours that subsided periodically), NAUSEA (felt nauseous), CHILLS (had chills last night) and FATIGUE (she felt okay, but had some fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUPROPION and BUSPIRONE for an unknown indication.    On 05-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 06-Oct-2021, the patient experienced FEELING ABNORMAL (woke up feeling really crappy), COUGH (dry cough for several hours that subsided periodically), NAUSEA (felt nauseous), CHILLS (had chills last night), FATIGUE (she felt okay, but had some fatigue), PYREXIA (low fever max 98.6) and HEADACHE (massive headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (woke up feeling really crappy), NAUSEA (felt nauseous), CHILLS (had chills last night), FATIGUE (she felt okay, but had some fatigue) and PYREXIA (low fever max 98.6) outcome was unknown and COUGH (dry cough for several hours that subsided periodically), VACCINATION SITE PAIN (pain at injection site) and HEADACHE (massive headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.6 (High) 98.6.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: woke up feeling really crappy; dry cough for several hours that subsided periodically; felt nauseous; had chills last night; she felt okay, but had some fatigue; low fever max 98.6; massive headache; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (woke up feeling really crappy), COUGH (dry cough for several hours that subsided periodically), NAUSEA (felt nauseous), CHILLS (had chills last night) and FATIGUE (she felt okay, but had some fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUPROPION and BUSPIRONE for an unknown indication.    On 05-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 06-Oct-2021, the patient experienced FEELING ABNORMAL (woke up feeling really crappy), COUGH (dry cough for several hours that subsided periodically), NAUSEA (felt nauseous), CHILLS (had chills last night), FATIGUE (she felt okay, but had some fatigue), PYREXIA (low fever max 98.6) and HEADACHE (massive headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (woke up feeling really crappy), NAUSEA (felt nauseous), CHILLS (had chills last night), FATIGUE (she felt okay, but had some fatigue) and PYREXIA (low fever max 98.6) outcome was unknown and COUGH (dry cough for several hours that subsided periodically), VACCINATION SITE PAIN (pain at injection site) and HEADACHE (massive headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.6 (High) 98.6.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; 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 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 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered from a vial that was left 24 hours at room temperature after being punctured; Vial that was left 24 hours at room temperature after being punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was left 24 hours at room temperature after being punctured) and PRODUCT STORAGE ERROR (Vial that was left 24 hours at room temperature after being punctured) 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 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vial that was left 24 hours at room temperature after being punctured). On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was left 24 hours at room temperature after being punctured). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was left 24 hours at room temperature after being punctured) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vial that was left 24 hours at room temperature after being punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided. The vial was punctured on 05 Oct 2021 and was left by mistake overnight at room temperature.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness
Clinical narrative: Had flu like symptoms; Mild headache; Just felt run down; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Had flu like symptoms), HEADACHE (Mild headache) and FATIGUE (Just felt run down) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.   On 30-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 INFLUENZA LIKE ILLNESS (Had flu like symptoms), HEADACHE (Mild headache) and FATIGUE (Just felt run down). At the time of the report, INFLUENZA LIKE ILLNESS (Had flu like symptoms), HEADACHE (Mild headache) and FATIGUE (Just felt run down) had resolved.            Patient was taking medication for Crohn's disease. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Feeling hot, Malaise, Swelling
Clinical narrative: Had a great deal of swelling; Had a great deal of heat; Had a great deal of uncomfortableness; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Had a great deal of swelling), FEELING HOT (Had a great deal of heat), MALAISE (Had a great deal of uncomfortableness) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Had a great deal of swelling), FEELING HOT (Had a great deal of heat), MALAISE (Had a great deal of uncomfortableness) and EXTRA DOSE ADMINISTERED (Extra dose administered). At the time of the report, SWELLING (Had a great deal of swelling), FEELING HOT (Had a great deal of heat) and MALAISE (Had a great deal of uncomfortableness) outcome was unknown and EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved.            Concomitant product use was not provider by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-345024 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination complication
Clinical narrative: Patient felt a little ill after the first Moderna covid-19 vaccine; felt tired; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient felt a little ill after the first Moderna covid-19 vaccine), FATIGUE (felt tired) and MYALGIA (muscle ache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient felt a little ill after the first Moderna covid-19 vaccine), FATIGUE (felt tired) and MYALGIA (muscle ache). At the time of the report, VACCINATION COMPLICATION (Patient felt a little ill after the first Moderna covid-19 vaccine), FATIGUE (felt tired) and MYALGIA (muscle ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported No treatment medications were reported.