chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vaccination site pain
Clinical narrative: Sore left injection site arm; Was very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was very sick) and VACCINATION SITE PAIN (Sore left injection site arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis since 01-Mar-2014. Concomitant products included CELECOXIB (CELEBREX) from March 2020 to an unknown date and GABAPENTIN from March 2020 to an unknown date for Arthritis, ALENDRONATE SODIUM (ALENDRONATE) from March 2020 to an unknown date for Brittle bone disease and Osteoporosis, METHOCARBAMOL from March 2020 to an unknown date for Muscle relaxation.    On 05-Aug-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced ILLNESS (Was very sick). On 05-Aug-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). On 06-Aug-2021, VACCINATION SITE PAIN (Sore left injection site arm) had resolved. At the time of the report, ILLNESS (Was very sick) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  The patient's left arm was sore for a day.   This case was linked to MOD-2021-335248 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Follow-up received: Patient's demography, relevant medical history, batch/lot number and concomitant medication was updated.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Stopped needing a cane to walk/ Knee 80% better; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Stopped needing a cane to walk/ Knee 80% better) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Knee arthroplasty (He had multiple problems ever since.) in 2020.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Stopped needing a cane to walk/ Knee 80% better). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Stopped needing a cane to walk/ Knee 80% better) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.  The day after his 2nd dose he stopped needing a cane to walk and his knee was 80% better.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna Covid-19 vaccine administered 13 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered 13 hours after first puncture) in a 28-year-old male patient who received mRNA-1273 (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 28-Sep-2021,  after starting mRNA-1273, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered 13 hours after first puncture). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered 13 hours after first puncture) had resolved.        For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided. Patient had not experienced any adverse reactions after vaccination.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Nausea, Vaccination complication, Vomiting
Clinical narrative: Little bit sick; Trouble walking; Nausea; Vomiting; Little bit fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Little bit sick), GAIT DISTURBANCE (Trouble walking), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Little bit fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091021A) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concurrent medical conditions included Cancer (Diagnosed cancer in spring.). Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for Chemotherapy, LEVOTHYROXINE and AXITINIB (INLYTA) for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced VACCINATION COMPLICATION (Little bit sick), GAIT DISTURBANCE (Trouble walking), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Little bit fatigue). At the time of the report, VACCINATION COMPLICATION (Little bit sick), GAIT DISTURBANCE (Trouble walking), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Little bit fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was stated that the patient has only one kidney.  Treatment information was not provided.   This case was linked to MOD-2021-335657 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Rebound effect, Somnolence
Clinical narrative: slept for 2 days; rebound effect; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of SOMNOLENCE (slept for 2 days), REBOUND EFFECT (rebound effect) and FATIGUE (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 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 SOMNOLENCE (slept for 2 days), REBOUND EFFECT (rebound effect) and FATIGUE (fatigue). At the time of the report, SOMNOLENCE (slept for 2 days), REBOUND EFFECT (rebound effect) and FATIGUE (fatigue) 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 relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: pain in his lower back; pain in his knee is "killing him"; fever of 103° F; if he gets up, he has extreme neck pain: "It's killing me"; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (if he gets up, he has extreme neck pain: "It's killing me"), PAIN IN EXTREMITY (pain in the arm), BACK PAIN (pain in his lower back), ARTHRALGIA (pain in his knee is "killing him") and PYREXIA (fever of 103° F) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 052E21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2021 and Pneumonia in March 2021.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced NECK PAIN (if he gets up, he has extreme neck pain: "It's killing me"), PAIN IN EXTREMITY (pain in the arm), ARTHRALGIA (pain in his knee is "killing him") and PYREXIA (fever of 103° F). On an unknown date, the patient experienced BACK PAIN (pain in his lower back). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (if he gets up, he has extreme neck pain: "It's killing me"), PAIN IN EXTREMITY (pain in the arm), BACK PAIN (pain in his lower back), ARTHRALGIA (pain in his knee is "killing him") and PYREXIA (fever of 103° F) outcome was unknown.            No Concomitant informations were reported.   This case was linked to MOD-2021-335720 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Hypersensitivity
Clinical narrative: a severe allergic reaction after eating grapes; body over reacted; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (a severe allergic reaction after eating grapes) and ALLERGY TO VACCINE (body over reacted) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HYPERSENSITIVITY (a severe allergic reaction after eating grapes) and ALLERGY TO VACCINE (body over reacted). At the time of the report, HYPERSENSITIVITY (a severe allergic reaction after eating grapes) and ALLERGY TO VACCINE (body over reacted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided To whom it may concern-  I am not sure if this is beneficial to forward this information to the appropriate channels.  Patient received the Maderna vaccine in March. I have never had any type of food alergy. I have always eaten grapes. The other day I ate two small bundles of grapes with seeds in them and had a severe allergic reaction where I had to go to the ER and treated for the event. I feel there is a connection with how my immune system reacted having the vaccine and this event months later. Where my body over reacted this way. I feel this is is something to start following in future research and keep statistics on soon as these concerns and improving the issues that rollout.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Swelling, Thrombosis, Ultrasound scan
Clinical narrative: blood clot in left leg/by the size of the clot it had probably been building for a while; Swelling; Severe Pain; second dose given >35 days from first dose; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (blood clot in left leg/by the size of the clot it had probably been building for a while) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient experienced THROMBOSIS (blood clot in left leg/by the size of the clot it had probably been building for a while) (seriousness criterion medically significant), SWELLING (Swelling), PAIN (Severe Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given >35 days from first dose). The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. In September 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given >35 days from first dose) had resolved. At the time of the report, THROMBOSIS (blood clot in left leg/by the size of the clot it had probably been building for a while), SWELLING (Swelling) and PAIN (Severe Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: diagnosed blood clot (abnormal) diagnosed blood clot via an ultrasound of left leg.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: This is a case of Inappropriate schedule of product administration in a 75-year-old male patient with no relevant medical history, who experienced the unexpected event Thrombosis. The event occurred approximately 6 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This is a case of Inappropriate schedule of product administration in a 75-year-old male patient with no relevant medical history, who experienced the unexpected event Thrombosis. The event occurred approximately 6 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bedridden, Body temperature, Head discomfort, Headache
Clinical narrative: felt pressure in the head; nodules between throat and clavicle; Pain in the legs; Pain in the lower back; I was in bed; Lot of headaches; Fever between 38.7 and 38.8 C; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (felt pressure in the head), NODULE (nodules between throat and clavicle), PAIN IN EXTREMITY (Pain in the legs), BACK PAIN (Pain in the lower back) and BEDRIDDEN (I was in bed) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (felt pressure in the head), NODULE (nodules between throat and clavicle), PAIN IN EXTREMITY (Pain in the legs), BACK PAIN (Pain in the lower back), BEDRIDDEN (I was in bed), HEADACHE (Lot of headaches) and PYREXIA (Fever between 38.7 and 38.8 C). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of every 6-8 hours. At the time of the report, HEAD DISCOMFORT (felt pressure in the head), NODULE (nodules between throat and clavicle), PAIN IN EXTREMITY (Pain in the legs), BACK PAIN (Pain in the lower back), HEADACHE (Lot of headaches) and PYREXIA (Fever between 38.7 and 38.8 C) outcome was unknown and BEDRIDDEN (I was in bed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) between 38.7 and 38.8 degree Celsius.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient received second dose on 26 SEP 2021.   This case was linked to MOD-2021-336063 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain in extremity, Pyrexia
Clinical narrative: felt pressure in the head; nodules between throat and clavicle; Pain in the legs; Pain in the lower back; I was in bed; Lot of headaches; Fever between 38.7 and 38.8 C; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (felt pressure in the head), NODULE (nodules between throat and clavicle), PAIN IN EXTREMITY (Pain in the legs), BACK PAIN (Pain in the lower back) and BEDRIDDEN (I was in bed) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (felt pressure in the head), NODULE (nodules between throat and clavicle), PAIN IN EXTREMITY (Pain in the legs), BACK PAIN (Pain in the lower back), BEDRIDDEN (I was in bed), HEADACHE (Lot of headaches) and PYREXIA (Fever between 38.7 and 38.8 C). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of every 6-8 hours. At the time of the report, HEAD DISCOMFORT (felt pressure in the head), NODULE (nodules between throat and clavicle), PAIN IN EXTREMITY (Pain in the legs), BACK PAIN (Pain in the lower back), HEADACHE (Lot of headaches) and PYREXIA (Fever between 38.7 and 38.8 C) outcome was unknown and BEDRIDDEN (I was in bed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) between 38.7 and 38.8 degree Celsius.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient received second dose on 26 SEP 2021.   This case was linked to MOD-2021-336063 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Bedridden, Dyspnoea, Fatigue
Clinical narrative: Made sounds like she had shortness of breath at some point; Stomach ache; Very tired; Knees hurt a lot, particularly the left knee which is very painful; Stayed for 2 days in bed; Nodule on the left side next to the clavicle; Rash in the right arm and under the breasts, where it is very itchy; Lot of pressure in the head; Strong flu; Sore throat; Difficulty to walk; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Stayed for 2 days in bed), NODULE (Nodule on the left side next to the clavicle), DYSPNOEA (Made sounds like she had shortness of breath at some point), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy) and HEAD DISCOMFORT (Lot of pressure in the head) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced BEDRIDDEN (Stayed for 2 days in bed), NODULE (Nodule on the left side next to the clavicle), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy), HEAD DISCOMFORT (Lot of pressure in the head), INFLUENZA (Strong flu), OROPHARYNGEAL PAIN (Sore throat), GAIT DISTURBANCE (Difficulty to walk) and ARTHRALGIA (Knees hurt a lot, particularly the left knee which is very painful). On 29-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Made sounds like she had shortness of breath at some point), ABDOMINAL PAIN UPPER (Stomach ache) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at a dose of Every 6-8 hours. At the time of the report, BEDRIDDEN (Stayed for 2 days in bed) had not resolved and NODULE (Nodule on the left side next to the clavicle), DYSPNOEA (Made sounds like she had shortness of breath at some point), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy), HEAD DISCOMFORT (Lot of pressure in the head), INFLUENZA (Strong flu), OROPHARYNGEAL PAIN (Sore throat), GAIT DISTURBANCE (Difficulty to walk), ABDOMINAL PAIN UPPER (Stomach ache), FATIGUE (Very tired) and ARTHRALGIA (Knees hurt a lot, particularly the left knee which is very painful) outcome was unknown.            It was reported that the patient didn't go to work.   This case was linked to MOD-2021-336022 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Head discomfort, Influenza, Nodule, Oropharyngeal pain
Clinical narrative: Made sounds like she had shortness of breath at some point; Stomach ache; Very tired; Knees hurt a lot, particularly the left knee which is very painful; Stayed for 2 days in bed; Nodule on the left side next to the clavicle; Rash in the right arm and under the breasts, where it is very itchy; Lot of pressure in the head; Strong flu; Sore throat; Difficulty to walk; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Stayed for 2 days in bed), NODULE (Nodule on the left side next to the clavicle), DYSPNOEA (Made sounds like she had shortness of breath at some point), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy) and HEAD DISCOMFORT (Lot of pressure in the head) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced BEDRIDDEN (Stayed for 2 days in bed), NODULE (Nodule on the left side next to the clavicle), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy), HEAD DISCOMFORT (Lot of pressure in the head), INFLUENZA (Strong flu), OROPHARYNGEAL PAIN (Sore throat), GAIT DISTURBANCE (Difficulty to walk) and ARTHRALGIA (Knees hurt a lot, particularly the left knee which is very painful). On 29-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Made sounds like she had shortness of breath at some point), ABDOMINAL PAIN UPPER (Stomach ache) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at a dose of Every 6-8 hours. At the time of the report, BEDRIDDEN (Stayed for 2 days in bed) had not resolved and NODULE (Nodule on the left side next to the clavicle), DYSPNOEA (Made sounds like she had shortness of breath at some point), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy), HEAD DISCOMFORT (Lot of pressure in the head), INFLUENZA (Strong flu), OROPHARYNGEAL PAIN (Sore throat), GAIT DISTURBANCE (Difficulty to walk), ABDOMINAL PAIN UPPER (Stomach ache), FATIGUE (Very tired) and ARTHRALGIA (Knees hurt a lot, particularly the left knee which is very painful) outcome was unknown.            It was reported that the patient didn't go to work.   This case was linked to MOD-2021-336022 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Made sounds like she had shortness of breath at some point; Stomach ache; Very tired; Knees hurt a lot, particularly the left knee which is very painful; Stayed for 2 days in bed; Nodule on the left side next to the clavicle; Rash in the right arm and under the breasts, where it is very itchy; Lot of pressure in the head; Strong flu; Sore throat; Difficulty to walk; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Stayed for 2 days in bed), NODULE (Nodule on the left side next to the clavicle), DYSPNOEA (Made sounds like she had shortness of breath at some point), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy) and HEAD DISCOMFORT (Lot of pressure in the head) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced BEDRIDDEN (Stayed for 2 days in bed), NODULE (Nodule on the left side next to the clavicle), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy), HEAD DISCOMFORT (Lot of pressure in the head), INFLUENZA (Strong flu), OROPHARYNGEAL PAIN (Sore throat), GAIT DISTURBANCE (Difficulty to walk) and ARTHRALGIA (Knees hurt a lot, particularly the left knee which is very painful). On 29-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Made sounds like she had shortness of breath at some point), ABDOMINAL PAIN UPPER (Stomach ache) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at a dose of Every 6-8 hours. At the time of the report, BEDRIDDEN (Stayed for 2 days in bed) had not resolved and NODULE (Nodule on the left side next to the clavicle), DYSPNOEA (Made sounds like she had shortness of breath at some point), RASH PRURITIC (Rash in the right arm and under the breasts, where it is very itchy), HEAD DISCOMFORT (Lot of pressure in the head), INFLUENZA (Strong flu), OROPHARYNGEAL PAIN (Sore throat), GAIT DISTURBANCE (Difficulty to walk), ABDOMINAL PAIN UPPER (Stomach ache), FATIGUE (Very tired) and ARTHRALGIA (Knees hurt a lot, particularly the left knee which is very painful) outcome was unknown.            It was reported that the patient didn't go to work.   This case was linked to MOD-2021-336022 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Felt like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Felt like I had the flu) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INFLUENZA (Felt like I had the flu). At the time of the report, INFLUENZA (Felt like I had the flu) had resolved.            No concomitant medications were provided. No treatment medications were reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue, Surgery, Weight decreased
Clinical narrative: did not get her second shot; lost weight since the surgery; she had surgery; had arm pain; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (she had surgery), PAIN IN EXTREMITY (had arm pain), WEIGHT DECREASED (lost weight since the surgery) and PRODUCT DOSE OMISSION ISSUE (did not get her second shot) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced PAIN IN EXTREMITY (had arm pain). On 07-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SURGERY (she had surgery) and WEIGHT DECREASED (lost weight since the surgery). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get her second shot). The patient was treated with AZITHROMYCIN (ZITHROMAX) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, SURGERY (she had surgery), PAIN IN EXTREMITY (had arm pain), WEIGHT DECREASED (lost weight since the surgery) and PRODUCT DOSE OMISSION ISSUE (did not get her second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was unknown.  Company comment: This is a case of product dose omission issue for this 44-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of pain in extremity, surgery and weight decreased. The event pain in extremity occurred on the same day after administration of the first dose of the Moderna COVID-19 Vaccine; the events surgery and weight decreased occurred 26 days after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This is a case of product dose omission issue for this 44-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of pain in extremity, surgery and weight decreased. The event pain in extremity occurred on the same day after administration of the first dose of the Moderna COVID-19 Vaccine; the events surgery and weight decreased occurred 26 days after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Was administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: my arm hurt; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm hurt), HEADACHE (headache) and MYALGIA (body ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included OXYBUTYNIN, MAGNESIUM, ZINC, VITAMIN C [ASCORBIC ACID], TOCOPHEROL (VITAMIN E [TOCOPHEROL]), CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]), KRILL OIL, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN (LUTEIN [TOCOPHERYL ACETATE;XANTOFYL;ZEAXANTHIN]), FAMOTIDINE, PROGESTERONE and ESTRADIOL for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm hurt), HEADACHE (headache) and MYALGIA (body ache). At the time of the report, PAIN IN EXTREMITY (my arm hurt), HEADACHE (headache) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were provided.  The patient had a bit of a headache and body ache but nothing severe   This case was linked to MOD-2021-336727, MOD-2021-336728 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Rash, Urticaria
Clinical narrative: Her left hand start itching/right arm, then feet/itching moved all over her body, 18inch by 18inch patch on back, butt, legs.; Felt like they were on fire; Hives on steroids; Broke out in a whole body rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Her left hand start itching/right arm, then feet/itching moved all over her body, 18inch by 18inch patch on back, butt, legs.), FEELING ABNORMAL (Felt like they were on fire), URTICARIA (Hives on steroids) and RASH (Broke out in a whole body rash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 025B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-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 PRURITUS (Her left hand start itching/right arm, then feet/itching moved all over her body, 18inch by 18inch patch on back, butt, legs.), FEELING ABNORMAL (Felt like they were on fire), URTICARIA (Hives on steroids) and RASH (Broke out in a whole body rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; CORTISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and Manual therapy (Tried using an ice pack) for Rash. At the time of the report, PRURITUS (Her left hand start itching/right arm, then feet/itching moved all over her body, 18inch by 18inch patch on back, butt, legs.), FEELING ABNORMAL (Felt like they were on fire), URTICARIA (Hives on steroids) and RASH (Broke out in a whole body rash) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient started experiencing the adverse events in mid-August.   Patient went to the doctor and she told her to take Benadryl which she took and she reports it helped her get to sleep. The ice pack used by the patient worked the best but the cortisone cream  did not work. Benadryl helped the patient to get sleep.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headache; sore arm; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (headache) and MYALGIA (sore arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's disease and Thyroidectomy. Concurrent medical conditions included Rheumatoid arthritis.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and MYALGIA (sore arm). The patient was treated with HYDROCORTISONE at a dose of UNK dosage form; ADALIMUMAB (HUMIRA) at a dose of UNK dosage form; ETANERCEPT (ENBREL) at a dose of UNK dosage form and HYDROCODONE at a dose of UNK dosage form. At the time of the report, HEADACHE (headache) and MYALGIA (sore arm) 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.   Concomitant medication was not provided. Other treatment medication included oral steroids.   This case was linked to MOD-2021-336827, MOD-2021-336828 (Patient Link).; Sender's Comments: This case concerns a 47 year-old female patient with medical history of Hashimoto's disease, who experienced the unexpected serious events of headache and myalgia. The events occurred on an unknown date after the first dose of mRNA 1273 vaccine. The rechallenge is not applicable in this case as no additional dosing will be given. The medical history of Hashimoto's disease, remains a confounder. The benefit-risk relationship of the vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Cold sweat, Freezing phenomenon, Nausea
Clinical narrative: bone pain; pain like bones were freezing; cold sweat; Patient was began to shake; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain), FREEZING PHENOMENON (pain like bones were freezing), COLD SWEAT (cold sweat), TREMOR (Patient was began to shake) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included OXYBUTYNIN, MAGNESIUM, ZINC, VITAMIN C [ASCORBIC ACID], VITAMIN E [VITAMIN E NOS], CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]), KRILL OIL, LUTEIN [XANTOFYL], FAMOTIDINE (FAMOTIDINE AMEL), PROGESTERONE and ESTRADIOL for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced BONE PAIN (bone pain), FREEZING PHENOMENON (pain like bones were freezing), COLD SWEAT (cold sweat), TREMOR (Patient was began to shake), CHILLS (chills) and NAUSEA (nausea). At the time of the report, BONE PAIN (bone pain), FREEZING PHENOMENON (pain like bones were freezing), COLD SWEAT (cold sweat), TREMOR (Patient was began to shake), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-336576, MOD-2021-336728 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: bone pain; pain like bones were freezing; cold sweat; Patient was began to shake; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain), FREEZING PHENOMENON (pain like bones were freezing), COLD SWEAT (cold sweat), TREMOR (Patient was began to shake) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included OXYBUTYNIN, MAGNESIUM, ZINC, VITAMIN C [ASCORBIC ACID], VITAMIN E [VITAMIN E NOS], CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]), KRILL OIL, LUTEIN [XANTOFYL], FAMOTIDINE (FAMOTIDINE AMEL), PROGESTERONE and ESTRADIOL for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced BONE PAIN (bone pain), FREEZING PHENOMENON (pain like bones were freezing), COLD SWEAT (cold sweat), TREMOR (Patient was began to shake), CHILLS (chills) and NAUSEA (nausea). At the time of the report, BONE PAIN (bone pain), FREEZING PHENOMENON (pain like bones were freezing), COLD SWEAT (cold sweat), TREMOR (Patient was began to shake), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-336576, MOD-2021-336728 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 patients got expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: lump in neck on side of injection ( most concerning) lymphadenopathy fever, chills, extreme arm pain
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Tremor, Urticaria
Clinical narrative: Hives, shaking, sweating
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Felt tired; had a sore injection site arm; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Felt tired) and VACCINATION SITE PAIN (had a sore injection site arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 016B21A and 050C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 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. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (Felt tired) and VACCINATION SITE PAIN (had a sore injection site arm). At the time of the report, FATIGUE (Felt tired) and VACCINATION SITE PAIN (had a sore injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-336849, MOD-2021-336855 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling on arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on 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 14-Feb-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 an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling on arm). At the time of the report, PERIPHERAL SWELLING (Swelling on arm) outcome was unknown.      No concomitant medications were reported.   No treatment information was provided.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle fatigue, Muscle spasms
Clinical narrative: Within few days of having 2nd dose, he started with muscle cramping all over the body./Cramping gets worst when he does physical activity./The muscles are extremely fatigued, cramping and locking; The muscles are extremely fatigued; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021.    This spontaneous case was reported by a nurse and describes the occurrence of MUSCLE SPASMS (Within few days of having 2nd dose, he started with muscle cramping all over the body./Cramping gets worst when he does physical activity./The muscles are extremely fatigued, cramping and locking) and MUSCLE FATIGUE (The muscles are extremely fatigued) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939893 and 017E21A) for COVID-19 vaccination.     Concomitant products included CREATINE for an unknown indication.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MUSCLE SPASMS (Within few days of having 2nd dose, he started with muscle cramping all over the body./Cramping gets worst when he does physical activity./The muscles are extremely fatigued, cramping and locking) and MUSCLE FATIGUE (The muscles are extremely fatigued). At the time of the report, MUSCLE SPASMS (Within few days of having 2nd dose, he started with muscle cramping all over the body./Cramping gets worst when he does physical activity./The muscles are extremely fatigued, cramping and locking) and MUSCLE FATIGUE (The muscles are extremely fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, White blood cell count: elevated (High) Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product included supplements. Treatment medications were given as none.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received on 05Oct 2021 contain no new information