chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numb arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numb arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numb arm). At the time of the report, HYPOAESTHESIA (Numb arm) 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.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Is a sore throat one of the side effects of the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Is a sore throat one of the side effects of the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Is a sore throat one of the side effects of the 2nd dose). At the time of the report, OROPHARYNGEAL PAIN (Is a sore throat one of the side effects of the 2nd dose) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Getting COVID After the Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Getting COVID After the Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Getting COVID After the Vaccine). At the time of the report, COVID-19 (Getting COVID After the Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: terrible aches/everything on me aches; fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (terrible aches/everything on me aches) and PYREXIA (fever of 101) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (terrible aches/everything on me aches) and PYREXIA (fever of 101). At the time of the report, PAIN (terrible aches/everything on me aches) and PYREXIA (fever of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever.         The concomitant medication was not reported.The treatment history was  not reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypoaesthesia, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes on my neck it is sweeling up/lymph nodes in the left side of her neck are swollen; The lymph nodes in the left side of her neck are swollen and it is very painful; Bad dizziness/she felt dizzy/dizzy for 3 about days; Weakness/ weak for 3 about days; One hour after the shot both arms and legs very numb and rigid; One hour after the shot both arms and legs very numb and rigid, this lasted for about 2 days; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Bad dizziness/she felt dizzy/dizzy for 3 about days), ASTHENIA (Weakness/ weak for 3 about days), HYPOAESTHESIA (One hour after the shot both arms and legs very numb and rigid), MUSCLE RIGIDITY (One hour after the shot both arms and legs very numb and rigid, this lasted for about 2 days) and LYMPHADENOPATHY (Swollen lymph nodes on my neck it is sweeling up/lymph nodes in the left side of her neck are swollen) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced DIZZINESS (Bad dizziness/she felt dizzy/dizzy for 3 about days), ASTHENIA (Weakness/ weak for 3 about days), HYPOAESTHESIA (One hour after the shot both arms and legs very numb and rigid) and MUSCLE RIGIDITY (One hour after the shot both arms and legs very numb and rigid, this lasted for about 2 days). On 19-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on my neck it is sweeling up/lymph nodes in the left side of her neck are swollen) and LYMPH NODE PAIN (The lymph nodes in the left side of her neck are swollen and it is very painful). At the time of the report, DIZZINESS (Bad dizziness/she felt dizzy/dizzy for 3 about days), ASTHENIA (Weakness/ weak for 3 about days), HYPOAESTHESIA (One hour after the shot both arms and legs very numb and rigid) and MUSCLE RIGIDITY (One hour after the shot both arms and legs very numb and rigid, this lasted for about 2 days) had resolved and LYMPHADENOPATHY (Swollen lymph nodes on my neck it is sweeling up/lymph nodes in the left side of her neck are swollen) and LYMPH NODE PAIN (The lymph nodes in the left side of her neck are swollen and it is very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow up document received on 19 Aug 2021 included reporter address, patient details and new events were added. Dose details and events onset date were  updated.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle rigidity
Clinical narrative: Swollen lymph nodes on my neck it is sweeling up/lymph nodes in the left side of her neck are swollen; The lymph nodes in the left side of her neck are swollen and it is very painful; Bad dizziness/she felt dizzy/dizzy for 3 about days; Weakness/ weak for 3 about days; One hour after the shot both arms and legs very numb and rigid; One hour after the shot both arms and legs very numb and rigid, this lasted for about 2 days; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Bad dizziness/she felt dizzy/dizzy for 3 about days), ASTHENIA (Weakness/ weak for 3 about days), HYPOAESTHESIA (One hour after the shot both arms and legs very numb and rigid), MUSCLE RIGIDITY (One hour after the shot both arms and legs very numb and rigid, this lasted for about 2 days) and LYMPHADENOPATHY (Swollen lymph nodes on my neck it is sweeling up/lymph nodes in the left side of her neck are swollen) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced DIZZINESS (Bad dizziness/she felt dizzy/dizzy for 3 about days), ASTHENIA (Weakness/ weak for 3 about days), HYPOAESTHESIA (One hour after the shot both arms and legs very numb and rigid) and MUSCLE RIGIDITY (One hour after the shot both arms and legs very numb and rigid, this lasted for about 2 days). On 19-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on my neck it is sweeling up/lymph nodes in the left side of her neck are swollen) and LYMPH NODE PAIN (The lymph nodes in the left side of her neck are swollen and it is very painful). At the time of the report, DIZZINESS (Bad dizziness/she felt dizzy/dizzy for 3 about days), ASTHENIA (Weakness/ weak for 3 about days), HYPOAESTHESIA (One hour after the shot both arms and legs very numb and rigid) and MUSCLE RIGIDITY (One hour after the shot both arms and legs very numb and rigid, this lasted for about 2 days) had resolved and LYMPHADENOPATHY (Swollen lymph nodes on my neck it is sweeling up/lymph nodes in the left side of her neck are swollen) and LYMPH NODE PAIN (The lymph nodes in the left side of her neck are swollen and it is very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow up document received on 19 Aug 2021 included reporter address, patient details and new events were added. Dose details and events onset date were  updated.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Inflammation, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: 2 or 3 days after the vaccine, my left foot became inflamed in a gout like condition; Swollen from toe to bottom of calf; Missed 3 nights sleep; Had to walk with a cane for two weeks.; Swollen from toe to bottom of calf. Very painful; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (2 or 3 days after the vaccine, my left foot became inflamed in a gout like condition), PERIPHERAL SWELLING (Swollen from toe to bottom of calf), INSOMNIA (Missed 3 nights sleep), GAIT DISTURBANCE (Had to walk with a cane for two weeks.) and PAIN IN EXTREMITY (Swollen from toe to bottom of calf. Very painful) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 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 INFLAMMATION (2 or 3 days after the vaccine, my left foot became inflamed in a gout like condition), PERIPHERAL SWELLING (Swollen from toe to bottom of calf), INSOMNIA (Missed 3 nights sleep), GAIT DISTURBANCE (Had to walk with a cane for two weeks.) and PAIN IN EXTREMITY (Swollen from toe to bottom of calf. Very painful). At the time of the report, INFLAMMATION (2 or 3 days after the vaccine, my left foot became inflamed in a gout like condition), PERIPHERAL SWELLING (Swollen from toe to bottom of calf), INSOMNIA (Missed 3 nights sleep), GAIT DISTURBANCE (Had to walk with a cane for two weeks.) and PAIN IN EXTREMITY (Swollen from toe to bottom of calf. Very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Pretty bad looking rash on both of my legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Pretty bad looking rash on both of my legs) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     The patient's past medical history included Angioedema (angioedema/anaphylaxis when patient took a sulfa medication.).    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced RASH (Pretty bad looking rash on both of my legs). In August 2021, RASH (Pretty bad looking rash on both of my legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medications were not reported.  It was stated that the patient experienced the same rash when patient took INH in the 70s for a positive PPD.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Headache, Injury
Clinical narrative: falling in the bathroom and hurt herself as a result of the fall; Hurt herself as a result of fall; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FALL (falling in the bathroom and hurt herself as a result of the fall), INJURY (Hurt herself as a result of fall) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus and Primary progressive multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    In February 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 FALL (falling in the bathroom and hurt herself as a result of the fall), INJURY (Hurt herself as a result of fall) and HEADACHE (Headache). At the time of the report, FALL (falling in the bathroom and hurt herself as a result of the fall), INJURY (Hurt herself as a result of fall) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-291913 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (had her 1st dose on 3/30/21 and never went back for the 2nd) 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (had her 1st dose on 3/30/21 and never went back for the 2nd). At the time of the report, PRODUCT DOSE OMISSION ISSUE (had her 1st dose on 3/30/21 and never went back for the 2nd) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment Medications were provided. Pharmacist wanted to know What happens when they wait more than 42 days to get their 2nd dose.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: sore arm; under 18 years old; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment medication was not reported. The concomitant medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: arm soreness; under 18 years old; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.  After receiving the vaccine patient experienced arm soreness, but had no other symptoms. Exercised to make the arm pain go away.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Malaise, Peripheral swelling, Rash
Clinical narrative: arm swell; arm was hot; Moderna rash / rash on her arm; did not feel good; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel good), PERIPHERAL SWELLING (arm swell), FEELING HOT (arm was hot) and RASH (Moderna rash / rash on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C11A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MALAISE (did not feel good). On an unknown date, the patient experienced PERIPHERAL SWELLING (arm swell), FEELING HOT (arm was hot) and RASH (Moderna rash / rash on her arm). At the time of the report, MALAISE (did not feel good) was resolving and PERIPHERAL SWELLING (arm swell), FEELING HOT (arm was hot) and RASH (Moderna rash / rash on her arm) outcome was unknown.            No concomitant medications provided. No treatment medications provided. After the second shot patient did not feel good for 3 days, then started to feel better.   This case was linked to MOD-2021-073004 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal
Clinical narrative: felt bad; had bad chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad) and CHILLS (had bad chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad) and CHILLS (had bad chills). At the time of the report, FEELING ABNORMAL (felt bad) and CHILLS (had bad chills) had resolved.            No concomitant medications was provided.  No treatment medications was provided.  The patient have not yet had the booster but qualified and the patient was considering it.   Reporter did not allow further contact
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received Pfizer vaccine (1st dose)/ Patient received Moderna vaccine (2nd dose); This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer vaccine (1st dose)/ Patient received Moderna vaccine (2nd dose)) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer vaccine (1st dose)/ Patient received Moderna vaccine (2nd dose)). On 03-Jul-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer vaccine (1st dose)/ Patient received Moderna vaccine (2nd dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided. No Treatment Medications were provided. Patient received Pfizer vaccine on 03JUL2021.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Vomiting nonstop, can't keep anything down, not even water; Nauseousness; Headache; Fever all day; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting nonstop, can't keep anything down, not even water), NAUSEA (Nauseousness), HEADACHE (Headache) and PYREXIA (Fever all day) 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 17-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced VOMITING (Vomiting nonstop, can't keep anything down, not even water), NAUSEA (Nauseousness), HEADACHE (Headache) and PYREXIA (Fever all day). On 19-Aug-2021, PYREXIA (Fever all day) had resolved. At the time of the report, VOMITING (Vomiting nonstop, can't keep anything down, not even water), NAUSEA (Nauseousness) and HEADACHE (Headache) outcome was unknown.            Concomitant medication was not provided by the reporter.  Treatment information were not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: Got her third dose; Fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after second dose) and EXTRA DOSE ADMINISTERED (Got her third dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 012M20A and 017E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PYREXIA (Fever after second dose). On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Got her third dose). On 19-Aug-2021, EXTRA DOSE ADMINISTERED (Got her third dose) had resolved. At the time of the report, PYREXIA (Fever after second dose) outcome was unknown.            No concomitant medications were provided.  Treatment medication was not provided.     Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Rash, Rash pruritic, Vaccination site induration, Vaccination site rash
Clinical narrative: forehead and cheeks are itchy; Eyes itchy; rash on her face that came and went/ rash on forehead and cheeks; injection site was hard; injection site had a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (forehead and cheeks are itchy), EYE PRURITUS (Eyes itchy), RASH (rash on her face that came and went/ rash on forehead and cheeks), VACCINATION SITE INDURATION (injection site was hard) and VACCINATION SITE RASH (injection site had a rash) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RASH PRURITIC (forehead and cheeks are itchy), EYE PRURITUS (Eyes itchy), RASH (rash on her face that came and went/ rash on forehead and cheeks), VACCINATION SITE INDURATION (injection site was hard) and VACCINATION SITE RASH (injection site had a rash). At the time of the report, RASH PRURITIC (forehead and cheeks are itchy), EYE PRURITUS (Eyes itchy) and RASH (rash on her face that came and went/ rash on forehead and cheeks) outcome was unknown and VACCINATION SITE INDURATION (injection site was hard) and VACCINATION SITE RASH (injection site had a rash) had resolved.            Relevant concomitant medications were not provided by the reporter. The patient's rash came and went. Sometimes it lasted a few days and sometimes just part of the day.  Mostly the rash was on her forehead, cheeks and eyes were itchy. The injection site was hard and a rash lasted for 3-4 days before it went away. Treatment medication was  not reported.   This case was linked to (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pyrexia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fevers) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fevers). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fevers) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: normal (normal) normal. 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. Within 24 hours of receiving the vaccine, the patient started to have daily fevers. This situation was ongoing for more than 2 weeks currently. The healthcare professional (HCP) ran laboratory and conducted studies, but everything looked normal. Patient took Tylenol and Ibuprofen to treat this, but not regularly. Patient had an 'IDU'.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided. No concomitant medication was reported.   This case was linked to MOD-2021-292013 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant when vaccinated; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant when vaccinated) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast feeding (nursing baby).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant when vaccinated). The delivery occurred  and was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. On 05-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant when vaccinated) had resolved.            Relevant concomitant medications were not reported.  It was reported that patient  was pregnant when she had both of her Moderna vaccine and at the time of reporting she was a nursing mom.  The treatment information was  not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a Moderna vaccine from a vial that should have been discarded; 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 EXPIRED PRODUCT ADMINISTERED (received a Moderna vaccine from a vial that should have been discarded) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021 at 11:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021 at 11:17 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a Moderna vaccine from a vial that should have been discarded). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a Moderna vaccine from a vial that should have been discarded) had resolved.            The patient received a Moderna vaccine from the vial that should have been discarded at 2:00 AM. She had received the vaccine 9 hours after the expiration date.  No concomitant product information was provided.  Treatment information was not provided.   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Insomnia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), INTENTIONAL DOSE OMISSION (Second dose to be given more than 36 days/She did not get the second dose due to the fear of experiencing side effects), INSOMNIA (Unable to sleep), ARTHRALGIA (Extreme joint pain) and HEADACHE (Headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizziness), INSOMNIA (Unable to sleep), ARTHRALGIA (Extreme joint pain), HEADACHE (Headache), VACCINATION SITE PAIN (Excruciating pain on left arm), FATIGUE (Exhaustion) and NAUSEA (Nausea). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Second dose to be given more than 36 days/She did not get the second dose due to the fear of experiencing side effects). On 23-Mar-2021, DIZZINESS (Dizziness), INSOMNIA (Unable to sleep), ARTHRALGIA (Extreme joint pain), HEADACHE (Headache), VACCINATION SITE PAIN (Excruciating pain on left arm), FATIGUE (Exhaustion) and NAUSEA (Nausea) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (Second dose to be given more than 36 days/She did not get the second dose due to the fear of experiencing side effects) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concurrent ad treatment medication was reported by patient.  All the event lasted for 5 days.   She was planning to get the second dose anytime as it was required by her office to do so.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission, Nausea, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), INTENTIONAL DOSE OMISSION (Second dose to be given more than 36 days/She did not get the second dose due to the fear of experiencing side effects), INSOMNIA (Unable to sleep), ARTHRALGIA (Extreme joint pain) and HEADACHE (Headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizziness), INSOMNIA (Unable to sleep), ARTHRALGIA (Extreme joint pain), HEADACHE (Headache), VACCINATION SITE PAIN (Excruciating pain on left arm), FATIGUE (Exhaustion) and NAUSEA (Nausea). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Second dose to be given more than 36 days/She did not get the second dose due to the fear of experiencing side effects). On 23-Mar-2021, DIZZINESS (Dizziness), INSOMNIA (Unable to sleep), ARTHRALGIA (Extreme joint pain), HEADACHE (Headache), VACCINATION SITE PAIN (Excruciating pain on left arm), FATIGUE (Exhaustion) and NAUSEA (Nausea) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (Second dose to be given more than 36 days/She did not get the second dose due to the fear of experiencing side effects) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concurrent ad treatment medication was reported by patient.  All the event lasted for 5 days.   She was planning to get the second dose anytime as it was required by her office to do so.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pain on arm of injection; Fever; Nausea; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on arm of injection), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Slight headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes, MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced PAIN IN EXTREMITY (Pain on arm of injection), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Slight headache). At the time of the report, PAIN IN EXTREMITY (Pain on arm of injection), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included Diabetes Medications. Treatment information was not reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hot flush, Peripheral swelling, Post-acute COVID-19 syndrome, Pruritus
Clinical narrative: She is referring it as a covid arm.; A week later, her left arm was very itchy; It was red; It was hot to touch; It was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A week later, her left arm was very itchy), ERYTHEMA (It was red), HOT FLUSH (It was hot to touch), PERIPHERAL SWELLING (It was swollen) and POST-ACUTE COVID-19 SYNDROME (She is referring it as a covid arm.) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PRURITUS (A week later, her left arm was very itchy), ERYTHEMA (It was red), HOT FLUSH (It was hot to touch) and PERIPHERAL SWELLING (It was swollen). On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (She is referring it as a covid arm.). At the time of the report, PRURITUS (A week later, her left arm was very itchy), ERYTHEMA (It was red), HOT FLUSH (It was hot to touch), PERIPHERAL SWELLING (It was swollen) and POST-ACUTE COVID-19 SYNDROME (She is referring it as a covid arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Anti-histamine was used for treatment.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Product dose omission issue, Pyrexia
Clinical narrative: Was in bed for one and half days; he has received 1 dose of the vaccine and never got the 2nd dose as advised by his HCP; Had slight fever; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Was in bed for one and half days), PRODUCT DOSE OMISSION ISSUE (he has received 1 dose of the vaccine and never got the 2nd dose as advised by his HCP) and PYREXIA (Had slight fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 BEDRIDDEN (Was in bed for one and half days), PRODUCT DOSE OMISSION ISSUE (he has received 1 dose of the vaccine and never got the 2nd dose as advised by his HCP) and PYREXIA (Had slight fever). At the time of the report, BEDRIDDEN (Was in bed for one and half days), PRODUCT DOSE OMISSION ISSUE (he has received 1 dose of the vaccine and never got the 2nd dose as advised by his HCP) and PYREXIA (Had slight fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Mobility decreased, Pyrexia, Somnolence
Clinical narrative: sleepiness; was in bed for about 2 days; loss of appetite, no appetite; no urge to eat; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness), MOBILITY DECREASED (was in bed for about 2 days), DECREASED APPETITE (loss of appetite, no appetite; no urge to eat), CHILLS (chills) and PYREXIA (fever) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepiness), MOBILITY DECREASED (was in bed for about 2 days), DECREASED APPETITE (loss of appetite, no appetite; no urge to eat), CHILLS (chills) and PYREXIA (fever). At the time of the report, SOMNOLENCE (sleepiness), MOBILITY DECREASED (was in bed for about 2 days), DECREASED APPETITE (loss of appetite, no appetite; no urge to eat), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Slight chest pain she has never had on her right side; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Slight chest pain she has never had on her right side) 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 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced CHEST PAIN (Slight chest pain she has never had on her right side). At the time of the report, CHEST PAIN (Slight chest pain she has never had on her right side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Having pain in the lower back; 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 BACK PAIN (Having pain in the lower back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Having pain in the lower back). At the time of the report, BACK PAIN (Having pain in the lower back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Lip swelling, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), LIP SWELLING (Lip swelling), SWELLING (Swelling around eyes) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced LIP SWELLING (Lip swelling). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), SWELLING (Swelling around eyes) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), SWELLING (Swelling around eyes) and HEADACHE (Headache) outcome was unknown and LIP SWELLING (Lip swelling) had resolved. No concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2021-29218.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Vaccination site pain
Clinical narrative: Felt achy; Back was achy; Left arm was achy like when you get a flu shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy), BACK PAIN (Back was achy) and PAIN IN EXTREMITY (Left arm was achy like when you get a flu shot) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21N) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Felt achy), BACK PAIN (Back was achy) and PAIN IN EXTREMITY (Left arm was achy like when you get a flu shot). At the time of the report, PAIN (Felt achy), BACK PAIN (Back was achy) and PAIN IN EXTREMITY (Left arm was achy like when you get a flu shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.  Patient stated that she did not feel sick or bad just achy.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Facial pain, Gait disturbance, Herpes zoster
Clinical narrative: arm swelled up/almost like a baseball/It was humongous; arm was red; arm was inflamed; arm was hot; couldn't get up and walk; when she got up, she got dizzy; had sores on her face; her eye was almost shut because of the swelling; shingles in the left side of her face and left eye and it hurt; whole body started aching; More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up/almost like a baseball/It was humongous), ERYTHEMA (arm was red), INFLAMMATION (arm was inflamed), SKIN WARM (arm was hot) and GAIT DISTURBANCE (couldn't get up and walk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker. Concomitant products included IBUPROFEN and FEXOFENADINE HYDROCHLORIDE (CHILDREN'S ALLEGRA ALLERGY) for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swelled up/almost like a baseball/It was humongous), ERYTHEMA (arm was red), INFLAMMATION (arm was inflamed), SKIN WARM (arm was hot), GAIT DISTURBANCE (couldn't get up and walk), DIZZINESS (when she got up, she got dizzy), FACIAL PAIN (had sores on her face), SWELLING OF EYELID (her eye was almost shut because of the swelling), HERPES ZOSTER (shingles in the left side of her face and left eye and it hurt), MYALGIA (whole body started aching) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, PERIPHERAL SWELLING (arm swelled up/almost like a baseball/It was humongous), ERYTHEMA (arm was red), INFLAMMATION (arm was inflamed), SKIN WARM (arm was hot), GAIT DISTURBANCE (couldn't get up and walk), DIZZINESS (when she got up, she got dizzy), FACIAL PAIN (had sores on her face), SWELLING OF EYELID (her eye was almost shut because of the swelling) and MYALGIA (whole body started aching) outcome was unknown and HERPES ZOSTER (shingles in the left side of her face and left eye and it hurt) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Inhaler..