chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Immunoglobulins, Light chain analysis abnormal
Clinical narrative: kappa/lambda ratio was .09 which is way out; This spontaneous case was reported by a consumer and describes the occurrence of LIGHT CHAIN ANALYSIS ABNORMAL (kappa/lambda ratio was .09 which is way out) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and D11A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced LIGHT CHAIN ANALYSIS ABNORMAL (kappa/lambda ratio was .09 which is way out). At the time of the report, LIGHT CHAIN ANALYSIS ABNORMAL (kappa/lambda ratio was .09 which is way out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Immunoglobulins: .09 (abnormal) Patient had a blood work 5 months after the second dose of the vaccine (in August 2021) and in it his kappa/lambda ratio was .09 which is way out..         No concomitant medications reported by reporter No treatment medications provided by the reporter.  They went through scenarios and the only thing he can think of is maybe the vaccine did it. He's looking to do a booster and wants to be sure he won't have trouble and if the vaccine could interfere like this.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling of body temperature change, Hyperhidrosis, Vaccination complication
Clinical narrative: She has been having a lot of sweating; A lot of heat then a lot of cold; Having very strong effects/All the symptoms that you told me/All that you read me is what I had; In the lower part of her back she has a horrible pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (She has been having a lot of sweating), FEELING OF BODY TEMPERATURE CHANGE (A lot of heat then a lot of cold), VACCINATION COMPLICATION (Having very strong effects/All the symptoms that you told me/All that you read me is what I had) and BACK PAIN (In the lower part of her back she has a horrible pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HYPERHIDROSIS (She has been having a lot of sweating), FEELING OF BODY TEMPERATURE CHANGE (A lot of heat then a lot of cold), VACCINATION COMPLICATION (Having very strong effects/All the symptoms that you told me/All that you read me is what I had) and BACK PAIN (In the lower part of her back she has a horrible pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (She has been having a lot of sweating) and FEELING OF BODY TEMPERATURE CHANGE (A lot of heat then a lot of cold) had not resolved and VACCINATION COMPLICATION (Having very strong effects/All the symptoms that you told me/All that you read me is what I had) and BACK PAIN (In the lower part of her back she has a horrible pain) outcome was unknown.            No concomitant medications were mentioned. It was stated that taking ibuprofen helped her.    This case was linked to MOD-2021-404712, MOD-2021-404716 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: arm was very painful; fatigue; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very painful), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A or 0BM20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] and BETA VULGARIS, FOLIC ACID, MALUS SPP. VINEGAR EXTRACT, PUNICA GRANATUM, VITAMIN B12 NOS (GOLI APPLE CIDER VINEGAR) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was very painful), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headaches). At the time of the report, PAIN IN EXTREMITY (arm was very painful), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headaches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported. No medical history was provided by the reporter.   This case was linked to MOD-2021-404309, MOD-2021-404413 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Feeling abnormal, Gait disturbance, Influenza like illness
Clinical narrative: aches in legs; I walk and it is painful; Patient is sitting and her back just hurts/back (lower backache).; like having the flu; irritable; it is painful/Patient said that everything hurts; Cranky; ached all over; aches in hips; This spontaneous case was reported by a non-health professional and describes the occurrence of ARTHRALGIA (aches in hips), PAIN IN EXTREMITY (aches in legs), GAIT DISTURBANCE (I walk and it is painful), BACK PAIN (Patient is sitting and her back just hurts/back (lower backache).) and INFLUENZA LIKE ILLNESS (like having the flu) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included MONTELUKAST, HYDROXYZINE, DEXLANSOPRAZOLE (DEXILANT) and ATORVASTATIN for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ARTHRALGIA (aches in hips), GAIT DISTURBANCE (I walk and it is painful), BACK PAIN (Patient is sitting and her back just hurts/back (lower backache).), INFLUENZA LIKE ILLNESS (like having the flu), IRRITABILITY (irritable), PAIN (it is painful/Patient said that everything hurts), FEELING ABNORMAL (Cranky) and MYALGIA (ached all over). On an unknown date, the patient experienced PAIN IN EXTREMITY (aches in legs). At the time of the report, ARTHRALGIA (aches in hips), PAIN IN EXTREMITY (aches in legs), GAIT DISTURBANCE (I walk and it is painful), BACK PAIN (Patient is sitting and her back just hurts/back (lower backache).), INFLUENZA LIKE ILLNESS (like having the flu), IRRITABILITY (irritable), PAIN (it is painful/Patient said that everything hurts), FEELING ABNORMAL (Cranky) and MYALGIA (ached all over) outcome was unknown.            No treatment details were reported.   This case was linked to MOD-2021-404332 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Myalgia, Pain, Pain in extremity
Clinical narrative: aches in legs; I walk and it is painful; Patient is sitting and her back just hurts/back (lower backache).; like having the flu; irritable; it is painful/Patient said that everything hurts; Cranky; ached all over; aches in hips; This spontaneous case was reported by a non-health professional and describes the occurrence of ARTHRALGIA (aches in hips), PAIN IN EXTREMITY (aches in legs), GAIT DISTURBANCE (I walk and it is painful), BACK PAIN (Patient is sitting and her back just hurts/back (lower backache).) and INFLUENZA LIKE ILLNESS (like having the flu) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included MONTELUKAST, HYDROXYZINE, DEXLANSOPRAZOLE (DEXILANT) and ATORVASTATIN for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ARTHRALGIA (aches in hips), GAIT DISTURBANCE (I walk and it is painful), BACK PAIN (Patient is sitting and her back just hurts/back (lower backache).), INFLUENZA LIKE ILLNESS (like having the flu), IRRITABILITY (irritable), PAIN (it is painful/Patient said that everything hurts), FEELING ABNORMAL (Cranky) and MYALGIA (ached all over). On an unknown date, the patient experienced PAIN IN EXTREMITY (aches in legs). At the time of the report, ARTHRALGIA (aches in hips), PAIN IN EXTREMITY (aches in legs), GAIT DISTURBANCE (I walk and it is painful), BACK PAIN (Patient is sitting and her back just hurts/back (lower backache).), INFLUENZA LIKE ILLNESS (like having the flu), IRRITABILITY (irritable), PAIN (it is painful/Patient said that everything hurts), FEELING ABNORMAL (Cranky) and MYALGIA (ached all over) outcome was unknown.            No treatment details were reported.   This case was linked to MOD-2021-404332 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Illness, Influenza, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of illness (started getting really sick/feeling sick), influenza (flu-like), pain in extremity (left foot still hurts), peripheral swelling (left leg swelled up) and decreased appetite (appetite is off) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 051F21A) for COVID-19 vaccination. The occurrence of additional events detailed below. The patient's past medical history included blood clot. Concurrent medical conditions included type 2 diabetes mellitus. On Nov 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 20, 2021, patient had pain in extremity (left foot still hurts), peripheral swelling (left leg swelled up) and pain in extremity (left arm was sore for 3 days). On Nov 28, 2021, patient experienced illness (started getting really sick/feeling sick), influenza (flu-like), decreased appetite (appetite is off), dizziness (dizzy) and vomiting (throwing up for 3 days). Patient treated with acetylsalicylic acid (baby aspirin) for swelling of legs, at an unspecified dose and frequency. On Nov 22, 2021, pain in extremity (left arm was sore for 3 days) resolved. On Dec 1, 2021, vomiting (throwing up for 3 days) resolved. At the time of the report, illness (started getting really sick/feeling sick), pain in extremity (left foot still hurts) and dizziness (dizzy): not resolved. Influenza (flu-like) and decreased appetite (appetite is off) outcome unknown. Peripheral swelling (left leg swelled up): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of illness (started getting really sick/feeling sick), influenza (flu-like), pain in extremity (left foot still hurts), peripheral swelling (left leg swelled up) and decreased appetite (appetite is off) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 051F21A) for COVID-19 vaccination. The occurrence of additional events detailed below. The patient's past medical history included blood clot. Concurrent medical conditions included type 2 diabetes mellitus. On Nov 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 20, 2021, patient had pain in extremity (left foot still hurts), peripheral swelling (left leg swelled up) and pain in extremity (left arm was sore for 3 days). On Nov 28, 2021, patient experienced illness (started getting really sick/feeling sick), influenza (flu-like), decreased appetite (appetite is off), dizziness (dizzy) and vomiting (throwing up for 3 days). Patient treated with acetylsalicylic acid (baby aspirin) for swelling of legs, at an unspecified dose and frequency. On Nov 22, 2021, pain in extremity (left arm was sore for 3 days) resolved. On Dec 1, 2021, vomiting (throwing up for 3 days) resolved. At the time of the report, illness (started getting really sick/feeling sick), pain in extremity (left foot still hurts) and dizziness (dizzy): not resolved. Influenza (flu-like) and decreased appetite (appetite is off) outcome unknown. Peripheral swelling (left leg swelled up): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site vesicles, Myalgia, Pyrexia, Vaccination site erythema
Clinical narrative: Multiple blisters; Injection site is itchy; slight fever at 100 deg F; Injection site is red; Injection site is swollen; Injection site is hard; horrible body ache; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE VESICLES (Multiple blisters), VACCINATION SITE PRURITUS (Injection site is itchy), PYREXIA (slight fever at 100 deg F), VACCINATION SITE ERYTHEMA (Injection site is red) and INJECTION SITE SWELLING (Injection site is swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE VESICLES (Multiple blisters), VACCINATION SITE PRURITUS (Injection site is itchy), PYREXIA (slight fever at 100 deg F), VACCINATION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE INDURATION (Injection site is hard) and MYALGIA (horrible body ache). At the time of the report, INJECTION SITE VESICLES (Multiple blisters), VACCINATION SITE PRURITUS (Injection site is itchy), PYREXIA (slight fever at 100 deg F), VACCINATION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE INDURATION (Injection site is hard) and MYALGIA (horrible body ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant informations were reported.  No treatment informations were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus
Clinical narrative: Multiple blisters; Injection site is itchy; slight fever at 100 deg F; Injection site is red; Injection site is swollen; Injection site is hard; horrible body ache; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE VESICLES (Multiple blisters), VACCINATION SITE PRURITUS (Injection site is itchy), PYREXIA (slight fever at 100 deg F), VACCINATION SITE ERYTHEMA (Injection site is red) and INJECTION SITE SWELLING (Injection site is swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE VESICLES (Multiple blisters), VACCINATION SITE PRURITUS (Injection site is itchy), PYREXIA (slight fever at 100 deg F), VACCINATION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE INDURATION (Injection site is hard) and MYALGIA (horrible body ache). At the time of the report, INJECTION SITE VESICLES (Multiple blisters), VACCINATION SITE PRURITUS (Injection site is itchy), PYREXIA (slight fever at 100 deg F), VACCINATION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE INDURATION (Injection site is hard) and MYALGIA (horrible body ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant informations were reported.  No treatment informations were reported.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Productive cough, Rash, Urticaria
Clinical narrative: Phlegm in throat; Thought he was not going to be able to breath; similar rash; Hives all over/welt that looked like a spider bite; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Phlegm in throat), DYSPNOEA (Thought he was not going to be able to breath), URTICARIA (Hives all over/welt that looked like a spider bite) and RASH (similar rash) 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.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced URTICARIA (Hives all over/welt that looked like a spider bite). On an unknown date, the patient experienced PRODUCTIVE COUGH (Phlegm in throat), DYSPNOEA (Thought he was not going to be able to breath) and RASH (similar rash). At the time of the report, PRODUCTIVE COUGH (Phlegm in throat), DYSPNOEA (Thought he was not going to be able to breath), URTICARIA (Hives all over/welt that looked like a spider bite) and RASH (similar rash) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 2.5mL dose for their booster dose/2.5mL dose administered as booster doses for 2 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2.5 milliliter. On 03-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 2.5mL dose for their booster dose/2.5mL dose administered as booster doses for 2 patients). On 03-Dec-2021, ACCIDENTAL OVERDOSE (Received 2.5mL dose for their booster dose/2.5mL dose administered as booster doses for 2 patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patients received 2.5mL dose for their respective booster doses. Concomitant and treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Nasal congestion
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of NASAL CONGESTION (Nasal stuffiness) and COUGH (Mild cough) 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 NASAL CONGESTION (Nasal stuffiness) and COUGH (Mild cough). At the time of the report, NASAL CONGESTION (Nasal stuffiness) and COUGH (Mild cough) 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 medication were reported. No treatment information was provided by the reporter.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore time to time) and VACCINATION SITE SWELLING (a hard bump and swollen left arm,) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029f21a, 038r21a and 046a21a) for COVID-19 vaccination. No Medical History information was reported.On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore time to time). On 05-Dec-2021, the patient experienced VACCINATION SITE SWELLING (a hard bump and swollen left arm,). At the time of the report, VACCINATION SITE PAIN (sore time to time) and VACCINATION SITE SWELLING (a hard bump and swollen left arm,) outcome was unknown.Concomitant medication was not provided. Treatment information was not provided. Patient stated side effects experienced after getting the Moderna covid19 Booster was normal and wasn't like a blood clot.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) 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) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant product information was not provided.Treatment information was not provided. Facility had a 20 minute excursion in the freezer where the Moderna vials were stored.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of RHINORRHOEA (Runny nose), COUGH (Experiencing dry cough) and PYREXIA (Fever of 100.1F) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), AMLODIPINE BESILATE (NORVASC) and POTASSIUM CHLORIDE for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose), COUGH (Experiencing dry cough) and PYREXIA (Fever of 100.1F). At the time of the report, RHINORRHOEA (Runny nose), COUGH (Experiencing dry cough) and PYREXIA (Fever of 100.1F) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (High) fever of 100.1F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses given after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) 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) (Intramuscular) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dysphagia, Feeding disorder, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty swallowing, difficulty drinking), CHEST DISCOMFORT (Tightness in chest when he swallows), PRODUCTIVE COUGH (Phlegm building up in his mouth, phlegm created from his mouth over night), FEEDING DISORDER (Difficulty eating) and RASH PRURITIC (Wherever he itches it would turn into a rash) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064421A, 040B21A and 005221A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced DYSPHAGIA (Difficulty swallowing, difficulty drinking), CHEST DISCOMFORT (Tightness in chest when he swallows), PRODUCTIVE COUGH (Phlegm building up in his mouth, phlegm created from his mouth over night), FEEDING DISORDER (Difficulty eating), PYREXIA (Fever, overheating) and CHILLS (Chills). On 24-Nov-2021, the patient experienced RASH PRURITIC (Wherever he itches it would turn into a rash), URTICARIA (Hives around his body, wherever he itches it would turn into a hive), MYALGIA (Aching muscles) and HEADACHE (He also had a pretty bad headache). At the time of the report, DYSPHAGIA (Difficulty swallowing, difficulty drinking), CHEST DISCOMFORT (Tightness in chest when he swallows), PRODUCTIVE COUGH (Phlegm building up in his mouth, phlegm created from his mouth over night), FEEDING DISORDER (Difficulty eating), RASH PRURITIC (Wherever he itches it would turn into a rash), URTICARIA (Hives around his body, wherever he itches it would turn into a hive), PYREXIA (Fever, overheating), CHILLS (Chills), MYALGIA (Aching muscles) and HEADACHE (He also had a pretty bad headache) outcome was unknown. Treatment information was not provided.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Productive cough, Pyrexia, Rash pruritic, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty swallowing, difficulty drinking), CHEST DISCOMFORT (Tightness in chest when he swallows), PRODUCTIVE COUGH (Phlegm building up in his mouth, phlegm created from his mouth over night), FEEDING DISORDER (Difficulty eating) and RASH PRURITIC (Wherever he itches it would turn into a rash) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064421A, 040B21A and 005221A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced DYSPHAGIA (Difficulty swallowing, difficulty drinking), CHEST DISCOMFORT (Tightness in chest when he swallows), PRODUCTIVE COUGH (Phlegm building up in his mouth, phlegm created from his mouth over night), FEEDING DISORDER (Difficulty eating), PYREXIA (Fever, overheating) and CHILLS (Chills). On 24-Nov-2021, the patient experienced RASH PRURITIC (Wherever he itches it would turn into a rash), URTICARIA (Hives around his body, wherever he itches it would turn into a hive), MYALGIA (Aching muscles) and HEADACHE (He also had a pretty bad headache). At the time of the report, DYSPHAGIA (Difficulty swallowing, difficulty drinking), CHEST DISCOMFORT (Tightness in chest when he swallows), PRODUCTIVE COUGH (Phlegm building up in his mouth, phlegm created from his mouth over night), FEEDING DISORDER (Difficulty eating), RASH PRURITIC (Wherever he itches it would turn into a rash), URTICARIA (Hives around his body, wherever he itches it would turn into a hive), PYREXIA (Fever, overheating), CHILLS (Chills), MYALGIA (Aching muscles) and HEADACHE (He also had a pretty bad headache) outcome was unknown. Treatment information was not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Doses given after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Had a 20 min excursion in the freezer) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) 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) (Intramuscular) 1 dosage form. On 28-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Had a 20 min excursion in the freezer). On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Doses given after temperature excursion). On 28-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Had a 20 min excursion in the freezer) had resolved. At the time of the report, PRODUCT ADMINISTRATION ERROR (Doses given after temperature excursion) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant information was not provided.The dose was administered from 29-Nov-2021 to 01-Dec-2021.Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes:On 03-Dec-2021: Follow up received contain patient demographics and dose details.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Welts; It's very itchy; Rash all over his body/started on his arms/Then it was on his stomach; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts), RASH PRURITIC (It's very itchy) and RASH (Rash all over his body/started on his arms/Then it was on his stomach) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Welts), RASH PRURITIC (It's very itchy) and RASH (Rash all over his body/started on his arms/Then it was on his stomach). At the time of the report, URTICARIA (Welts), RASH PRURITIC (It's very itchy) and RASH (Rash all over his body/started on his arms/Then it was on his stomach) outcome was unknown. Concomitant product use was not provider by the reporter.Treatment information was not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Hypoaesthesia, Nausea
Clinical narrative: Hives after one hour, numbness in arm of injection site, pins and needle in hands and feet, dizziness, blurry vision, chills, fever (100.2), fatigue, nausea, scratchy throat
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Throat irritation, Urticaria, Vision blurred
Clinical narrative: Hives after one hour, numbness in arm of injection site, pins and needle in hands and feet, dizziness, blurry vision, chills, fever (100.2), fatigue, nausea, scratchy throat
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Product storage error
Clinical narrative: Patient was given a Moderna booster dose on 11/29/21, from a vial that had 1st been opened on 11/26/21. It was stored in the refrigerator between uses. Confirmed with Moderna that the biggest concern would be risk of infection rather than decrease in efficacy.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Speech disorder, Syncope, Tinnitus
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Severe, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: pt with syncopal episode following vaccine but initially unable to speak so epi pen was given.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Severe, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: pt with syncopal episode following vaccine but initially unable to speak so epi pen was given.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Headache
Clinical narrative: Mild headache and fatigue started approx 1 day after shot. Have had mild to moderate headache and fatigue since then and continuing now.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site inflammation, Pain, Pain in extremity, Wrong technique in product usage process
Clinical narrative: I was offered and got the flu shot at my annual gynecological exam. It went fine and I had the expected sore arm, but that night I noticed my shoulder seemed more sore than usual - more in the joint that the muscle than I normally see. We were at my fiancé's daughter's house and she's a pharmacist so I mentioned this so she looked at my arm and immediately noticed that they gave the injection too high in my shoulder. She said it could lead to some complications so keep an eye on it and have it checked out if the pain didn't go away after a week or two. It continued to be sore and even getting painful. On November 17th I finally sent a message to my doctor , telling her that it hurt every time I moved my arm and even without movement, there was a constant ache with pain shooting into my arm. I found out she was out of the office due to a family emergency and continued trying to treat it with ice, heat,  and Tylenol (I can't take ibuprofen), but it got so bad that on Friday, November 19th I finally went to urgent care. They examined me and felt it was due to the incorrect placement of the flu shot injection and resulting inflammation and prescribed me prednisone and told me to try to keep moving my arm to help the inflammation go away.  The prednisone helped while I was on it, although it didn't completely take the pain away, but as soon as I was off of the meds, the pain came right back. As urgent care told me to update Dr  if I still had pain after I was done with the prednisone, I did that. On November 29th, she prescribed another short taper of prednisone, which I just finished. This short taper slightly helped, but I still had significant pain during it, and now that I'm done with it, the pain is back at extreme levels.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Additional Details: Dizziness and patient fell.  pharmacy call 911.  Pt requested parametic.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Headache, Hypoxia
Clinical narrative: Patient is a 53 y.o. female with COPD, DM2, morbid obesity, CAD and hydradenitis suppurativa on Humira who presented to the ED due to shortness of breath, fever, cough, nausea/vomiting and headache that began 11/29.  She was seen by her PCP and treated with Levaquin and prednisone but did not have any improvement.  In the ED on 12/5, she tested positive for COVID-19.  She is fully vaccinated (vaccinated prior to starting Humira) and is not aware of any definite COVID exposures although recently discovered that her grandson was exposed at school and his test has not resulted.  In the ED, she was found to be hypoxemic to 87% on room air.  Admission was requested for further management.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Patient is a 53 y.o. female with COPD, DM2, morbid obesity, CAD and hydradenitis suppurativa on Humira who presented to the ED due to shortness of breath, fever, cough, nausea/vomiting and headache that began 11/29.  She was seen by her PCP and treated with Levaquin and prednisone but did not have any improvement.  In the ED on 12/5, she tested positive for COVID-19.  She is fully vaccinated (vaccinated prior to starting Humira) and is not aware of any definite COVID exposures although recently discovered that her grandson was exposed at school and his test has not resulted.  In the ED, she was found to be hypoxemic to 87% on room air.  Admission was requested for further management.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Peripheral swelling
Clinical narrative: Major swelling under left arm  Minor back pain
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: FULL BODY ACHES AND PAINS,  FOR 3 DAYS      ACETAMINOPHEN
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Bronchitis, Bronchospasm, COVID-19
Clinical narrative: Pt is a 69 y.o. female with past medical history of lupus, mixed connective tissue disorder, chronic immunosuppression on Plaquenil, methotrexate, and Rituxan, interstitial fibrosis likely secondary to autoimmune disease, prior smoking history, who presents to the ER with complaints of shortness of breath, cough, and loss of taste and smell.   Patient reports that she has felt ill with bronchitis-like symptoms since October. She reports that she has not had any resolution in her symptoms since that time despite seeing multiple nurse practitioners outpatient and treatment for bronchitis. She states that 3 days prior to admission she began to lose her taste and smell. She reports fever as high as 102. Oxygen saturation as low as 87% on room air upon presentation in the ER tonight. She tested positive for COVID-19 on 12/2/2021.   Reports occasional dry heaving associated with coughing. Reports worsening shortness of breath prompting her visit to the ER tonight. She reports significant bronchospasm after coughing episodes despite antitussives at home. Reports chills. Denies any nausea but does report decreased appetite. No diarrhea. Husband also tested positive over the past few days.   Patient is fully vaccinated and boosted for COVID-19.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Dyspnoea, Malaise
Clinical narrative: Pt is a 69 y.o. female with past medical history of lupus, mixed connective tissue disorder, chronic immunosuppression on Plaquenil, methotrexate, and Rituxan, interstitial fibrosis likely secondary to autoimmune disease, prior smoking history, who presents to the ER with complaints of shortness of breath, cough, and loss of taste and smell.   Patient reports that she has felt ill with bronchitis-like symptoms since October. She reports that she has not had any resolution in her symptoms since that time despite seeing multiple nurse practitioners outpatient and treatment for bronchitis. She states that 3 days prior to admission she began to lose her taste and smell. She reports fever as high as 102. Oxygen saturation as low as 87% on room air upon presentation in the ER tonight. She tested positive for COVID-19 on 12/2/2021.   Reports occasional dry heaving associated with coughing. Reports worsening shortness of breath prompting her visit to the ER tonight. She reports significant bronchospasm after coughing episodes despite antitussives at home. Reports chills. Denies any nausea but does report decreased appetite. No diarrhea. Husband also tested positive over the past few days.   Patient is fully vaccinated and boosted for COVID-19.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pyrexia, Retching, SARS-CoV-2 test positive
Clinical narrative: Pt is a 69 y.o. female with past medical history of lupus, mixed connective tissue disorder, chronic immunosuppression on Plaquenil, methotrexate, and Rituxan, interstitial fibrosis likely secondary to autoimmune disease, prior smoking history, who presents to the ER with complaints of shortness of breath, cough, and loss of taste and smell.   Patient reports that she has felt ill with bronchitis-like symptoms since October. She reports that she has not had any resolution in her symptoms since that time despite seeing multiple nurse practitioners outpatient and treatment for bronchitis. She states that 3 days prior to admission she began to lose her taste and smell. She reports fever as high as 102. Oxygen saturation as low as 87% on room air upon presentation in the ER tonight. She tested positive for COVID-19 on 12/2/2021.   Reports occasional dry heaving associated with coughing. Reports worsening shortness of breath prompting her visit to the ER tonight. She reports significant bronchospasm after coughing episodes despite antitussives at home. Reports chills. Denies any nausea but does report decreased appetite. No diarrhea. Husband also tested positive over the past few days.   Patient is fully vaccinated and boosted for COVID-19.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Pallor
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Additional Details: Patient was pale and felt dizziness a few minutes after getting her Pfizer pediatric vaccine. We checked blood pressure 65/46 HR 53. She felt better after 5 minutes. Mom was counseled to call the pharmacy this evening if needed.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Medium, Additional Details: Patient had seizure shortly after vaccine, seizure lasted for approximately 30 seconds, paramedics were called and took patient to the hospital.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Headache, Lymphadenopathy, Pain
Clinical narrative: VERY swollen lymph node under left arm, chills, body pain, sharp pains in head, hair follicles hurt
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (101.3 fever), MYALGIA (Body ache), CHILLS (some chills) and FATIGUE (general fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (101.3 fever), MYALGIA (Body ache), CHILLS (some chills) and FATIGUE (general fatigue). At the time of the report, PYREXIA (101.3 fever), MYALGIA (Body ache), CHILLS (some chills) and FATIGUE (general fatigue) had not resolved. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Body temperature: 101.3 (abnormal) 101.3 degree Fahrenheit. No concomitant medications were reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Hyperhidrosis, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating like a pig) and PYREXIA (Fever of 103) 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 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 HYPERHIDROSIS (Sweating like a pig) and PYREXIA (Fever of 103). At the time of the report, HYPERHIDROSIS (Sweating like a pig) and PYREXIA (Fever of 103) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Body temperature: 103 (High) 103 degree. Symptoms: It was reported that the patient had received second dose of Moderna COVID-19 vaccine six months before.No concomitant medications were reported. No treatment medications were reported.