chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: receive vaccine after temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (receive vaccine after temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (receive vaccine after temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (receive vaccine after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reports stated that every 12 hours there is a spike in the temperature where they store the vaccines reach a highest of 14.8 degrees Celsius, excursion does not last longer than 5 minutes. This also occurs when they are re-stalking the vaccines from the freezer to the fridge. He was unable to provide the lot numbers or patient information for those who had received the vaccines after these excursions.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling a bit under the weather (feeling unwell); This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling a bit under the weather (feeling unwell)) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN) for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension since 30-Jun-2005. Concomitant products included WARFARIN SODIUM for Pulmonary arterial hypertension, AMBRISENTAN and TADALAFIL for an unknown indication.   On 30-Jun-2005, the patient started TREPROSTINIL SODIUM (REMODULIN) (Intravenous) 1 dosage form continously. In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MALAISE (Feeling a bit under the weather (feeling unwell)). At the time of the report, MALAISE (Feeling a bit under the weather (feeling unwell)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling below the injection site; Itching below the injection site; Redness below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling below the injection site), VACCINATION SITE PRURITUS (Itching below the injection site) and VACCINATION SITE ERYTHEMA (Redness below the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swelling below the injection site), VACCINATION SITE PRURITUS (Itching below the injection site) and VACCINATION SITE ERYTHEMA (Redness below the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling below the injection site), VACCINATION SITE PRURITUS (Itching below the injection site) and VACCINATION SITE ERYTHEMA (Redness below the injection site) outcome was unknown.            No Concomitant Medications were provided. No Treatment history was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Non significant follow up appended.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on the left side of her neck and jaw; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the left side of her neck and jaw) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced RASH (Rash on the left side of her neck and jaw). At the time of the report, RASH (Rash on the left side of her neck and jaw) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Lot of fatigue; temperature for a day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Lot of fatigue) and PYREXIA (temperature for a day) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 23-Feb-2021, the patient experienced FATIGUE (Lot of fatigue) and PYREXIA (temperature for a day). On 24-Feb-2021, PYREXIA (temperature for a day) outcome was unknown. At the time of the report, FATIGUE (Lot of fatigue) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not applicable.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was provided.  This report refers to a case of Product storage error and expired product administered for mRNA-1273, lot # 003B21A, with no associated AEs.   This case was linked to MOD21-068620 (E2B Linked Report).; Sender's Comments: This report refers to a case of Product storage error and expired product administered for mRNA-1273, lot # 003B21A, with no associated AEs. MOD21-068620:crosslinked
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Vaccination site pain
Clinical narrative: Pain; Swollen knot; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain), INJECTION SITE SWELLING (Swollen knot) and INJECTION SITE ERYTHEMA (Redness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 000B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain), INJECTION SITE SWELLING (Swollen knot) and INJECTION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE PAIN (Pain), INJECTION SITE SWELLING (Swollen knot) and INJECTION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of OUT OF SPECIFICATION PRODUCT USE (Vaccine administered after temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced OUT OF SPECIFICATION PRODUCT USE (Vaccine administered after temperature excursion). On 02-Apr-2021, OUT OF SPECIFICATION PRODUCT USE (Vaccine administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Temperature dropped to : Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C.  No treatment information was provided.   This case was linked to MOD-2021-066725, MOD-2021-066824, MOD-2021-066807 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS, ALPRAZOLAM (XANAX) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 02-Mar-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) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) had not resolved. Not Provided          No treatment information was provided. The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the events was not applicable. The patient had constant diarrhea since vaccination and said that every time she put something in her mouth it just went right through.Patient also thought that it might be because of the Vitamin D supplement that she was taking. Patient said that she would stop taking her Vitamin D supplement for the meantime.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved. Not applicable      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 relevant concomitant medications were reported.   Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Numbness on the Left side nose, face and lips; Numbness on the Left side nose, face and lips; Tinkling in right side of lip; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on the Left side nose, face and lips), HYPOAESTHESIA ORAL (Numbness on the Left side nose, face and lips), PARAESTHESIA ORAL (Tinkling in right side of lip) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness on the Left side nose, face and lips), HYPOAESTHESIA ORAL (Numbness on the Left side nose, face and lips), PARAESTHESIA ORAL (Tinkling in right side of lip) and CHILLS (Chills). At the time of the report, HYPOAESTHESIA (Numbness on the Left side nose, face and lips), HYPOAESTHESIA ORAL (Numbness on the Left side nose, face and lips), PARAESTHESIA ORAL (Tinkling in right side of lip) and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication list was not provided. Treatment information was not provided.    This case was linked to MOD-2021-066587, MOD-2021-065932 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion). On 02-Apr-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) had resolved. Not Provided      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.   The  concomitant medications on use were not provided. No laboratory data was provided.  No treatment information was provided.  They had power outage on 01 Apr 2021 and vials were in freezer and refrigerator where temperature dropped to : Frozen vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses Lot no 027B21A 100 doses Lot no 030B21A 100 doses Lot No 02B21A 140 doses HCP said that 63 doses were administered and she also received the dose.
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Fatigue, Myalgia
Clinical narrative: in bed the whole day; pain all over her body; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of BED REST (in bed the whole day), MYALGIA (pain all over her body) and FATIGUE (flet tired) 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 No adverse event.    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 BED REST (in bed the whole day), MYALGIA (pain all over her body) and FATIGUE (flet tired). At the time of the report, BED REST (in bed the whole day), MYALGIA (pain all over her body) and FATIGUE (flet tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Dizzy; Feeling weak; Chills; Slight fever; Headache; Body ache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Feeling weak), CHILLS (Chills), PYREXIA (Slight fever) and HEADACHE (Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PROBIOTIC 10, LOSARTAN, POTASSIUM, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), CAPTOPRIL, HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE + CAPTOPRIL), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM PLUS VITAMIN D3), ATORVASTATIN, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Feeling weak), CHILLS (Chills), PYREXIA (Slight fever), HEADACHE (Headache), MYALGIA (Body ache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Feeling weak), CHILLS (Chills), PYREXIA (Slight fever), HEADACHE (Headache), MYALGIA (Body ache) and NAUSEA (Nausea) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.    This case was linked to MOD-2021-033460 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Dizzy; Feeling weak; Chills; Slight fever; Headache; Body ache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Feeling weak), CHILLS (Chills), PYREXIA (Slight fever) and HEADACHE (Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PROBIOTIC 10, LOSARTAN, POTASSIUM, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), CAPTOPRIL, HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE + CAPTOPRIL), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM PLUS VITAMIN D3), ATORVASTATIN, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Feeling weak), CHILLS (Chills), PYREXIA (Slight fever), HEADACHE (Headache), MYALGIA (Body ache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Feeling weak), CHILLS (Chills), PYREXIA (Slight fever), HEADACHE (Headache), MYALGIA (Body ache) and NAUSEA (Nausea) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.    This case was linked to MOD-2021-033460 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: entire arm is red; bumpy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (entire arm is red) and PERIPHERAL SWELLING (bumpy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 021B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS and FUROSEMIDE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ERYTHEMA (entire arm is red) and PERIPHERAL SWELLING (bumpy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (entire arm is red) and PERIPHERAL SWELLING (bumpy) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C). On 02-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; This case was received via an unknown source (no reference has been entered for a Regulatory authority or license partner) on 04-Apr-2021 and was forwarded to Moderna on 04-Apr-2021.    This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site warmth
Clinical narrative: little red and hot to touch; sore arm; little red and hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH, PAIN IN EXTREMITY, and VACCINATION SITE ERYTHEMA in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included VITAMINS, LIPITOR, and LEXAPRO for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced VACCINATION SITE WARMTH, PAIN IN EXTREMITY, and VACCINATION SITE ERYTHEMA. The patient was treated with TYLENOL at a dose of UNK dosage form. At the time of the report, VACCINATION SITE WARMTH, PAIN IN EXTREMITY, and VACCINATION SITE ERYTHEMA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient wants to know if these symptoms are normal after two weeks of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Dyspnoea, Malaise, Off label use
Clinical narrative: prescribed 10-20 breaths, four times a day (QID) of Tyvaso; Not feeling well; losing chucks of hair every time she showers; shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Not feeling well), ALOPECIA (losing chucks of hair every time she showers), DYSPNOEA (shortness of breath ) and OFF LABEL USE (prescribed 10-20 breaths, four times a day (QID) of Tyvaso) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL SODIUM inhalation gas for Pulmonary arterial hypertension and RIOCIGUAT (ADEMPAS) for an unknown indication.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included AMLODIPINE BESILATE for an unknown indication.   On 09-Apr-2018, the patient TREPROSTINIL SODIUM (unknown route) dosage was changed to un k. On 20-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TREPROSTINIL SODIUM (unknown route) at an unspecified dose four times per day On an unknown date, TREPROSTINIL SODIUM (unknown route) dosage was changed to at an unspecified dose four times per day. and RIOCIGUAT (ADEMPAS) (unknown route) unk,unk,unk. In March 2021, the patient experienced MALAISE (Not feeling well), ALOPECIA (losing chucks of hair every time she showers) and DYSPNOEA (shortness of breath ). On an unknown date, the patient experienced OFF LABEL USE (prescribed 10-20 breaths, four times a day (QID) of Tyvaso). At the time of the report, MALAISE (Not feeling well), ALOPECIA (losing chucks of hair every time she showers) and OFF LABEL USE (prescribed 10-20 breaths, four times a day (QID) of Tyvaso) outcome was unknown and DYSPNOEA (shortness of breath ) had not resolved. The reporter did not provide causality for the events of malaise      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and the events, malaise, dyspnea, alopecia, and off label use, the events were assessed as Not Related to Covid-19 vaccination.  The patient's underlying history of pulmonary hypertension is a contributory factor. It was also reported that hair loss started three to four months after starting treatment for pulmonary hypertension.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain, Radiculitis brachial
Clinical narrative: Brachial neuritis; Severe pain; Oral route of drug administration; This spontaneous case was reported by a consumer and describes the occurrence of RADICULITIS BRACHIAL (Brachial neuritis), PAIN (Severe pain) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Oral route of drug administration) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Oral) 1 dosage form. On an unknown date, the patient experienced RADICULITIS BRACHIAL (Brachial neuritis), PAIN (Severe pain) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Oral route of drug administration). At the time of the report, RADICULITIS BRACHIAL (Brachial neuritis), PAIN (Severe pain) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Oral route of drug administration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Oral) was unknown.       The concomitant medications were not provided. The treatment information was not provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after temperature excursion/vials were in freezer and refrigerator where temperature dropped to frozen vaccine -13.79 C, refrigerator 12 C; Vaccine administered after temperature excursion/vials were in freezer and refrigerator where temperature dropped to frozen vaccine -13.79 C, refrigerator 12 C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/vials were in freezer and refrigerator where temperature dropped to frozen vaccine -13.79 C, refrigerator 12 C) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/vials were in freezer and refrigerator where temperature dropped to frozen vaccine -13.79 C, refrigerator 12 C) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/vials were in freezer and refrigerator where temperature dropped to frozen vaccine -13.79 C, refrigerator 12 C) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/vials were in freezer and refrigerator where temperature dropped to frozen vaccine -13.79 C, refrigerator 12 C). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/vials were in freezer and refrigerator where temperature dropped to frozen vaccine -13.79 C, refrigerator 12 C) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion/vials were in freezer and refrigerator where temperature dropped to frozen vaccine -13.79 C, refrigerator 12 C) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided.   This case was linked to MOD21-068620 (E2B Linked Report).; Sender's Comments:  MOD21-068620:crosslinked
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Insomnia, Musculoskeletal stiffness, Myalgia
Clinical narrative: Could not sleep well; Chills; Body is achy; Felt tired; Stiff arms, legs, and neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff arms, legs, and neck), INSOMNIA (Could not sleep well), FATIGUE (Felt tired), CHILLS (Chills) and MYALGIA (Body is achy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included VITAMINS NOS and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff arms, legs, and neck), FATIGUE (Felt tired) and MYALGIA (Body is achy). On 02-Apr-2021, the patient experienced INSOMNIA (Could not sleep well) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Apr-2021, FATIGUE (Felt tired) had resolved. On 02-Apr-2021, INSOMNIA (Could not sleep well) and CHILLS (Chills) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff arms, legs, and neck) and MYALGIA (Body is achy) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-049696 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: tinnitus; sore arm; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (tinnitus) and PAIN IN EXTREMITY (sore arm) in a 121-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 09-Feb-2021, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included acetaminophen (Tylenol).  No relevant concomitant medications were reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Intentional product use issue, Wound
Clinical narrative: got the second dose on 42nd day on 15 april 2021; due to get 2nd dose on 01Apr2021, but vaccine provider refused to administer, because of serious cut injury on her hand and she received a tetanus injection, got the second dose on the 42nd day on 15april2021; serious cut injury; This spontaneous case was reported by an other and describes the occurrence of WOUND (serious cut injury), INTENTIONAL PRODUCT USE ISSUE (due to get 2nd dose on 01Apr2021, but vaccine provider refused to administer, because of serious cut injury on her hand and she received a tetanus injection, got the second dose on the 42nd day on 15april2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose on 42nd day on 15 april 2021) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and lot#019B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included TETANUS VACCINE for Cut wound.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced WOUND (serious cut injury). On 01-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (due to get 2nd dose on 01Apr2021, but vaccine provider refused to administer, because of serious cut injury on her hand and she received a tetanus injection, got the second dose on the 42nd day on 15april2021). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose on 42nd day on 15 april 2021). On 27-Mar-2021, WOUND (serious cut injury) had resolved. On 01-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (due to get 2nd dose on 01Apr2021, but vaccine provider refused to administer, because of serious cut injury on her hand and she received a tetanus injection, got the second dose on the 42nd day on 15april2021) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose on 42nd day on 15 april 2021) outcome was unknown.            Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Contact details, second dose details and events were updated
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Feeling abnormal, Feeling hot, Flushing
Clinical narrative: Swollen fingers; Mild headache; Site of injection started itching; Feeling lethargic; Joint pain in hips; Joint pain in her neck; Joint pain in finger; Feeling run down; Coughing; Tonsil area was hard like a rock; Restlessness; sore arm; Hot episodes; Flush episodes; Wakes up in the pool of sweat; Internally she is on fire; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Restlessness), TONSILLAR DISORDER (Tonsil area was hard like a rock), LETHARGY (Feeling lethargic), ARTHRALGIA (Joint pain in hips) and ARTHRALGIA (Joint pain in her neck) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced RESTLESSNESS (Restlessness), FEELING HOT (Hot episodes), FLUSHING (Flush episodes), HYPERHIDROSIS (Wakes up in the pool of sweat), FEELING HOT (Internally she is on fire) and VACCINATION SITE PAIN (sore arm). On 27-Mar-2021, the patient experienced TONSILLAR DISORDER (Tonsil area was hard like a rock). On 28-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling run down) and COUGH (Coughing). On 01-Apr-2021, the patient experienced LETHARGY (Feeling lethargic), ARTHRALGIA (Joint pain in hips), ARTHRALGIA (Joint pain in her neck), ARTHRALGIA (Joint pain in finger) and INJECTION SITE PRURITUS (Site of injection started itching). On 03-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen fingers) and HEADACHE (Mild headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, RESTLESSNESS (Restlessness) and VACCINATION SITE PAIN (sore arm) had resolved and TONSILLAR DISORDER (Tonsil area was hard like a rock), LETHARGY (Feeling lethargic), ARTHRALGIA (Joint pain in hips), ARTHRALGIA (Joint pain in her neck), ARTHRALGIA (Joint pain in finger), PERIPHERAL SWELLING (Swollen fingers), FEELING HOT (Hot episodes), FLUSHING (Flush episodes), HYPERHIDROSIS (Wakes up in the pool of sweat), FEELING HOT (Internally she is on fire), FEELING ABNORMAL (Feeling run down), COUGH (Coughing), INJECTION SITE PRURITUS (Site of injection started itching) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included paracetamol and unspecified cough medicine.  Concomitant medications details were not reported by the reporter. The patient reported taking an antihistamine for her seasonal allergies as well.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Injection site pruritus, Lethargy, Peripheral swelling
Clinical narrative: Swollen fingers; Mild headache; Site of injection started itching; Feeling lethargic; Joint pain in hips; Joint pain in her neck; Joint pain in finger; Feeling run down; Coughing; Tonsil area was hard like a rock; Restlessness; sore arm; Hot episodes; Flush episodes; Wakes up in the pool of sweat; Internally she is on fire; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Restlessness), TONSILLAR DISORDER (Tonsil area was hard like a rock), LETHARGY (Feeling lethargic), ARTHRALGIA (Joint pain in hips) and ARTHRALGIA (Joint pain in her neck) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced RESTLESSNESS (Restlessness), FEELING HOT (Hot episodes), FLUSHING (Flush episodes), HYPERHIDROSIS (Wakes up in the pool of sweat), FEELING HOT (Internally she is on fire) and VACCINATION SITE PAIN (sore arm). On 27-Mar-2021, the patient experienced TONSILLAR DISORDER (Tonsil area was hard like a rock). On 28-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling run down) and COUGH (Coughing). On 01-Apr-2021, the patient experienced LETHARGY (Feeling lethargic), ARTHRALGIA (Joint pain in hips), ARTHRALGIA (Joint pain in her neck), ARTHRALGIA (Joint pain in finger) and INJECTION SITE PRURITUS (Site of injection started itching). On 03-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen fingers) and HEADACHE (Mild headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, RESTLESSNESS (Restlessness) and VACCINATION SITE PAIN (sore arm) had resolved and TONSILLAR DISORDER (Tonsil area was hard like a rock), LETHARGY (Feeling lethargic), ARTHRALGIA (Joint pain in hips), ARTHRALGIA (Joint pain in her neck), ARTHRALGIA (Joint pain in finger), PERIPHERAL SWELLING (Swollen fingers), FEELING HOT (Hot episodes), FLUSHING (Flush episodes), HYPERHIDROSIS (Wakes up in the pool of sweat), FEELING HOT (Internally she is on fire), FEELING ABNORMAL (Feeling run down), COUGH (Coughing), INJECTION SITE PRURITUS (Site of injection started itching) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included paracetamol and unspecified cough medicine.  Concomitant medications details were not reported by the reporter. The patient reported taking an antihistamine for her seasonal allergies as well.