chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Herpes zoster
Clinical narrative: Shingles; blister on thigh and groin area; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and BLISTER (blister on thigh and groin area) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     no medical information reported.  The patient's past medical history included Shingles (20 years ago and was supposed to receive the vaccine but was never vaccinated). Concomitant products included AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR), ATORVASTATIN, ALLOPURINOL, DILTIAZEM and PLANTAGO OVATA SEED HUSK (PSYLLIUM HUSKS) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021 at 9:00 AM, the patient experienced HERPES ZOSTER (Shingles). In April 2021, the patient experienced BLISTER (blister on thigh and groin area). At the time of the report, HERPES ZOSTER (Shingles) had resolved and BLISTER (blister on thigh and groin area) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Treatment medication information was not provided.  It was reported that patient Developed SHINGLES ( second time , had 25 years ago) typical symptoms , small blisters on and across upper thigh and goin area, MOST PAINFULL no none treatment , had to take It course, lasted 3 months and finally healed and pain went away, the blisters did leave a scared area. I have since had the SHINGLES shot ( one of two) . Patient is not looking to go through that again    Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: significant follow up received on 01-sep-2021,including concomitant medication and patient height and weight, race and ethnic information and batch/lot no.of both doses
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: she didn't get her second dose one month after her 1st dose because her husband; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she didn't get her second dose one month after her 1st dose because her husband) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she didn't get her second dose one month after her 1st dose because her husband). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she didn't get her second dose one month after her 1st dose because her husband) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information were not provided. No Concomitant drugs were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: The Followup received in which dosage information is mentioned.(The patient chose to receive her second vaccine even though it was past the recommended time frame).Changed the patient gender male to female as per follow up document.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Has not received the 2nd dose yet passed 40 day period; Positive for covid after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd dose yet passed 40 day period) and SUSPECTED COVID-19 (Positive for covid after the 1st dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd dose yet passed 40 day period) and SUSPECTED COVID-19 (Positive for covid after the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd dose yet passed 40 day period) and SUSPECTED COVID-19 (Positive for covid after the 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, SARS-CoV-2 test: (Positive) Positive for covid after the 1st dose.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: TCR attached- outcome and Second dose information added.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Medicine taste in her throat; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Medicine taste in her throat) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced TASTE DISORDER (Medicine taste in her throat). At the time of the report, TASTE DISORDER (Medicine taste in her throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had reported that his adverse event is currently fine and got resolved by itself.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Added event outcome and narrative was updated accordingly.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Headache
Clinical narrative: numb; tingling; hasn't slept; feeling light headed; whole body feeling cold; being sore; nausea; headache; feel like she has to vomit; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numb), PARAESTHESIA (tingling), INSOMNIA (hasn't slept), DIZZINESS (feeling light headed) and FEELING COLD (whole body feeling cold) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced HYPOAESTHESIA (numb), PARAESTHESIA (tingling), INSOMNIA (hasn't slept), DIZZINESS (feeling light headed), FEELING COLD (whole body feeling cold), MYALGIA (being sore), NAUSEA (nausea), HEADACHE (headache), NAUSEA (feel like she has to vomit), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PEPPERMINT [MENTHA X PIPERITA] at an unspecified dose and frequency. On 15-Jul-2021, PARAESTHESIA (tingling) had resolved. At the time of the report, HYPOAESTHESIA (numb) had not resolved and INSOMNIA (hasn't slept), DIZZINESS (feeling light headed), FEELING COLD (whole body feeling cold), MYALGIA (being sore), NAUSEA (nausea), HEADACHE (headache), NAUSEA (feel like she has to vomit), CHILLS (chills) and FATIGUE (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.   Patient also experienced being sore. No concomitant medication was provided by reporter. Patient also had water to stay hydrated and advised to take rest at home after vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow-up received and does not contain any new information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Myalgia, Nausea, Paraesthesia
Clinical narrative: numb; tingling; hasn't slept; feeling light headed; whole body feeling cold; being sore; nausea; headache; feel like she has to vomit; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numb), PARAESTHESIA (tingling), INSOMNIA (hasn't slept), DIZZINESS (feeling light headed) and FEELING COLD (whole body feeling cold) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced HYPOAESTHESIA (numb), PARAESTHESIA (tingling), INSOMNIA (hasn't slept), DIZZINESS (feeling light headed), FEELING COLD (whole body feeling cold), MYALGIA (being sore), NAUSEA (nausea), HEADACHE (headache), NAUSEA (feel like she has to vomit), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PEPPERMINT [MENTHA X PIPERITA] at an unspecified dose and frequency. On 15-Jul-2021, PARAESTHESIA (tingling) had resolved. At the time of the report, HYPOAESTHESIA (numb) had not resolved and INSOMNIA (hasn't slept), DIZZINESS (feeling light headed), FEELING COLD (whole body feeling cold), MYALGIA (being sore), NAUSEA (nausea), HEADACHE (headache), NAUSEA (feel like she has to vomit), CHILLS (chills) and FATIGUE (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.   Patient also experienced being sore. No concomitant medication was provided by reporter. Patient also had water to stay hydrated and advised to take rest at home after vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow-up received and does not contain any new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm with her first injection of Moderna vaccine in her right arm but it did spread to her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm with her first injection of Moderna vaccine in her right arm but it did spread to her left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On 06-Jun-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 VACCINATION SITE PAIN (Sore arm with her first injection of Moderna vaccine in her right arm but it did spread to her left arm). At the time of the report, VACCINATION SITE PAIN (Sore arm with her first injection of Moderna vaccine in her right arm but it did spread to her left arm) outcome was unknown.            Concomitant product use was not provided. Treatment information was unknown.   This case was linked to MOD-2021-262572 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: TCR received on 10 Sep 2021,contains Non Significant Information.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Muscle spasms, Pain in extremity
Clinical narrative: severe pain in the feet/"aching"/ "pain is crazy"; cramping; "bone hurts"; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-122190) on 21-Jul-2021 and was forwarded to Moderna on 21-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in the feet/"aching"/ "pain is crazy"), MUSCLE SPASMS (cramping) and BONE PAIN ("bone hurts") in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced PAIN IN EXTREMITY (severe pain in the feet/"aching"/ "pain is crazy"), MUSCLE SPASMS (cramping) and BONE PAIN ("bone hurts"). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (severe pain in the feet/"aching"/ "pain is crazy"), MUSCLE SPASMS (cramping) and BONE PAIN ("bone hurts") 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 included cholesterol medication.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Non-significant follow-up: Follow up document contain no new information
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Greater than 35 days between doses of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of Moderna Covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of Moderna Covid-19 vaccine) had resolved.            Concomitant medication list was not provided. Treatment information was not provided.  Patient received her second dose of Moderna Covid-19 Vaccine sometime during the week of 13 July 2021.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received and contains no new information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site was Itchy after 1st dose; Injection site was red after 1st dose; Injection site was painful after 1st dose; Arm was swollen at injection site after 1st dose; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was Itchy after 1st dose), VACCINATION SITE ERYTHEMA (Injection site was red after 1st dose), VACCINATION SITE PAIN (Injection site was painful after 1st dose) and VACCINATION SITE SWELLING (Arm was swollen at injection site after 1st dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was Itchy after 1st dose), VACCINATION SITE ERYTHEMA (Injection site was red after 1st dose), VACCINATION SITE PAIN (Injection site was painful after 1st dose) and VACCINATION SITE SWELLING (Arm was swollen at injection site after 1st dose). At the time of the report, VACCINATION SITE PRURITUS (Injection site was Itchy after 1st dose), VACCINATION SITE ERYTHEMA (Injection site was red after 1st dose), VACCINATION SITE PAIN (Injection site was painful after 1st dose) and VACCINATION SITE SWELLING (Arm was swollen at injection site after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was provided.   This case was linked to MOD-2021-262880 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Form attached included no new information.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received the first dose of the Moderna vaccine on 28Apr2021 and has not gotten the second dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna vaccine on 28Apr2021 and has not gotten the second dose yet) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna vaccine on 28Apr2021 and has not gotten the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna vaccine on 28Apr2021 and has not gotten the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter. Patient want their second dose now but HCP wanted to know what the recommendation is since its been 84 days since the first dose.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up received, contain no new information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Chest X-ray, Chest pain, Electrocardiogram
Clinical narrative: chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack; little red trail in her vision right after she looks outside; were in pain or anxiety; headache is very severe; numbness; tingling around the rightankle", " needles and pins; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00183340 and 058A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), TEMAZEPAM and SUMATRIPTAN for an unknown indication.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack) (seriousness criterion hospitalization), ERYTHROPSIA (little red trail in her vision right after she looks outside), ANXIETY (were in pain or anxiety) and HEADACHE (headache is very severe). At the time of the report, CHEST PAIN (chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack), ERYTHROPSIA (little red trail in her vision right after she looks outside) and ANXIETY (were in pain or anxiety) outcome was unknown and HEADACHE (headache is very severe) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Chest X-ray: normal (normal) Normal. On an unknown date, Electrocardiogram: normal (normal) Normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Took migraine medicine for headache (medicine name is unknown)   This case was linked to MOD-2021-308647 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up received included concomitant medication, second dose details, laboratory data and new events was added and action taken was updated.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythropsia, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack; little red trail in her vision right after she looks outside; were in pain or anxiety; headache is very severe; numbness; tingling around the rightankle", " needles and pins; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00183340 and 058A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), TEMAZEPAM and SUMATRIPTAN for an unknown indication.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack) (seriousness criterion hospitalization), ERYTHROPSIA (little red trail in her vision right after she looks outside), ANXIETY (were in pain or anxiety) and HEADACHE (headache is very severe). At the time of the report, CHEST PAIN (chest pain pretty bad/muscles around chest hurting/thought they were getting a heart attack), ERYTHROPSIA (little red trail in her vision right after she looks outside) and ANXIETY (were in pain or anxiety) outcome was unknown and HEADACHE (headache is very severe) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Chest X-ray: normal (normal) Normal. On an unknown date, Electrocardiogram: normal (normal) Normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Took migraine medicine for headache (medicine name is unknown)   This case was linked to MOD-2021-308647 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up received included concomitant medication, second dose details, laboratory data and new events was added and action taken was updated.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Intentional overdose
Clinical narrative: Got her 3  rd dose of the Moderna COVID-19 Vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL OVERDOSE (Got her 3  rd dose of the Moderna COVID-19 Vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 048A21A and 011D21A) for COVID-19 vaccination.     The patient's past medical history included Lung transplant.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced INTENTIONAL OVERDOSE (Got her 3  rd dose of the Moderna COVID-19 Vaccine). At the time of the report, INTENTIONAL OVERDOSE (Got her 3  rd dose of the Moderna COVID-19 Vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Antibody test: negative (Negative) Negative and negative (Negative) Negative. On an unknown date, Antibody test: negative (Negative) Negative.         Concomitant product included several unspecified medications.  Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: regulatory authority FU- No new information
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: mild soreness in the arm; Fatigue after the second; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), PAIN IN EXTREMITY (mild soreness in the arm) and FATIGUE (Fatigue after the second) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 037A21B) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ASCORBIC ACID (VIT C), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and PROBIOTICS NOS for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was in November 2020 and the estimated date of delivery was 10-Aug-2021. On 17-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (mild soreness in the arm) and FATIGUE (Fatigue after the second). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 17-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (mild soreness in the arm) and FATIGUE (Fatigue after the second) 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 considered MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) to be possibly related. No further causality assessments were provided for PAIN IN EXTREMITY (mild soreness in the arm) and FATIGUE (Fatigue after the second).    No treatment medications were reported.  Last menstrual period was reported as beginning of November  This is a case of vaccine exposure during pregnancy with associated AEs for PT fatigue and pain in extremity for this female.   This case was linked to MOD-2021-278047 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received and updated contact information. Changes from the initial document included addition of event and change in PT term for another event; Sender's Comments: This is a case of vaccine exposure during pregnancy with associated AEs for PT fatigue and pain in extremity for this female.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count increased
Clinical narrative: issue with her platelet/platelet count had gone up to more than 1 million; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT INCREASED (issue with her platelet/platelet count had gone up to more than 1 million) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 PLATELET COUNT INCREASED (issue with her platelet/platelet count had gone up to more than 1 million). At the time of the report, PLATELET COUNT INCREASED (issue with her platelet/platelet count had gone up to more than 1 million) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 1 million (High) gone up to more than 1 million.         No concomitant medications reported.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: The follow-up information received contain significant information- event outcome updated to not recovered/ not resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Inappropriate schedule of product administration
Clinical narrative: Poison ivy; Received my first dose of the vaccine on 11MAR2021 and did not get the second dose / Doses too far apart; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Poison ivy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received my first dose of the vaccine on 11MAR2021 and did not get the second dose / Doses too far apart) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received my first dose of the vaccine on 11MAR2021 and did not get the second dose / Doses too far apart). On an unknown date, the patient experienced DERMATITIS CONTACT (Poison ivy). On 10-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received my first dose of the vaccine on 11MAR2021 and did not get the second dose / Doses too far apart) had resolved. At the time of the report, DERMATITIS CONTACT (Poison ivy) outcome was unknown.            Treatment information was not provided by the reporter.  Patient did not experienced  any event after second dose administered.  Patient did not take any oral medication to combat the itching.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up receive on 9-AUG-2021 Event poison ivy updated On 08-Sep-2021: Follow up received. Second dose added, event inappropriate schedule of drug administered added and action taken changed to not applicable
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: dizziness; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea) and VOMITING (vomiting) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088B21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and NORETHISTERONE (NORLYDA) for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced DIZZINESS (dizziness), NAUSEA (nausea) and VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), NAUSEA (nausea) and VOMITING (vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Heart rate, Palpitations, Paraesthesia
Clinical narrative: Anxiety prior to scheduled appointment for 2nd shot; Dizziness; vision seems off; tightness in throat; head feels tingly; Heart pumping fast; Anxiety after first shot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VISUAL IMPAIRMENT (vision seems off), THROAT TIGHTNESS (tightness in throat), PARAESTHESIA (head feels tingly) and PALPITATIONS (Heart pumping fast) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced DIZZINESS (Dizziness), VISUAL IMPAIRMENT (vision seems off), THROAT TIGHTNESS (tightness in throat), PARAESTHESIA (head feels tingly), PALPITATIONS (Heart pumping fast) and VACCINATION COMPLICATION (Anxiety after first shot). On 03-Sep-2021, the patient experienced ANXIETY (Anxiety prior to scheduled appointment for 2nd shot). On 07-Aug-2021, VACCINATION COMPLICATION (Anxiety after first shot) had resolved. At the time of the report, DIZZINESS (Dizziness), VISUAL IMPAIRMENT (vision seems off), THROAT TIGHTNESS (tightness in throat), PARAESTHESIA (head feels tingly), PALPITATIONS (Heart pumping fast) and ANXIETY (Anxiety prior to scheduled appointment for 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Aug-2021, Heart rate: high (High) Heart pumping fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Significant Follow-up include event of Anxiety .
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Vaccination complication, Visual impairment
Clinical narrative: Anxiety prior to scheduled appointment for 2nd shot; Dizziness; vision seems off; tightness in throat; head feels tingly; Heart pumping fast; Anxiety after first shot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VISUAL IMPAIRMENT (vision seems off), THROAT TIGHTNESS (tightness in throat), PARAESTHESIA (head feels tingly) and PALPITATIONS (Heart pumping fast) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced DIZZINESS (Dizziness), VISUAL IMPAIRMENT (vision seems off), THROAT TIGHTNESS (tightness in throat), PARAESTHESIA (head feels tingly), PALPITATIONS (Heart pumping fast) and VACCINATION COMPLICATION (Anxiety after first shot). On 03-Sep-2021, the patient experienced ANXIETY (Anxiety prior to scheduled appointment for 2nd shot). On 07-Aug-2021, VACCINATION COMPLICATION (Anxiety after first shot) had resolved. At the time of the report, DIZZINESS (Dizziness), VISUAL IMPAIRMENT (vision seems off), THROAT TIGHTNESS (tightness in throat), PARAESTHESIA (head feels tingly), PALPITATIONS (Heart pumping fast) and ANXIETY (Anxiety prior to scheduled appointment for 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Aug-2021, Heart rate: high (High) Heart pumping fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Significant Follow-up include event of Anxiety .
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received 2.5 months after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 2.5 months after the first dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 2.5 months after the first dose). On 05-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 2.5 months after the first dose) had resolved.            No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. The patient denied of experiencing any adverse reactions after 1st or 2nd dose of the vaccine and had already spoken to the physician regarding the effectiveness of the dose.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received contains updated phone number of reporter and updated narrative
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Influenza like illness, Malaise
Clinical narrative: Felt like the flu; Shooting pain in the left arm /achy; Malaise; Nausea; Little headache; Possible mild fever; Tiny chill; Intense chest pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), CHEST PAIN (Intense chest pain), INFLUENZA LIKE ILLNESS (Felt like the flu), PAIN IN EXTREMITY (Shooting pain in the left arm /achy) and PYREXIA (Possible mild fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced CHEST PAIN (Intense chest pain). On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Possible mild fever) and CHILLS (Tiny chill). On an unknown date, the patient experienced MALAISE (Malaise), INFLUENZA LIKE ILLNESS (Felt like the flu), PAIN IN EXTREMITY (Shooting pain in the left arm /achy), NAUSEA (Nausea) and HEADACHE (Little headache). At the time of the report, MALAISE (Malaise), CHEST PAIN (Intense chest pain), INFLUENZA LIKE ILLNESS (Felt like the flu), PAIN IN EXTREMITY (Shooting pain in the left arm /achy), PYREXIA (Possible mild fever), CHILLS (Tiny chill), NAUSEA (Nausea) and HEADACHE (Little headache) outcome was unknown.         No concomitant medications details were provided. No treatment medications details were provided.   This case was linked to MOD-2021-280640 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Non-Significant Follow up- Reporter email address and contact details updated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Felt like the flu; Shooting pain in the left arm /achy; Malaise; Nausea; Little headache; Possible mild fever; Tiny chill; Intense chest pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), CHEST PAIN (Intense chest pain), INFLUENZA LIKE ILLNESS (Felt like the flu), PAIN IN EXTREMITY (Shooting pain in the left arm /achy) and PYREXIA (Possible mild fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced CHEST PAIN (Intense chest pain). On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Possible mild fever) and CHILLS (Tiny chill). On an unknown date, the patient experienced MALAISE (Malaise), INFLUENZA LIKE ILLNESS (Felt like the flu), PAIN IN EXTREMITY (Shooting pain in the left arm /achy), NAUSEA (Nausea) and HEADACHE (Little headache). At the time of the report, MALAISE (Malaise), CHEST PAIN (Intense chest pain), INFLUENZA LIKE ILLNESS (Felt like the flu), PAIN IN EXTREMITY (Shooting pain in the left arm /achy), PYREXIA (Possible mild fever), CHILLS (Tiny chill), NAUSEA (Nausea) and HEADACHE (Little headache) outcome was unknown.         No concomitant medications details were provided. No treatment medications details were provided.   This case was linked to MOD-2021-280640 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Non-Significant Follow up- Reporter email address and contact details updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Insomnia, Nerve compression, Pain in extremity
Clinical narrative: Cannot sleep; Sudden pain in either forearm or hand Pain; Pinched nerve; Numbness in rt arm from shoulder to finger tiips; wake up not feeling right; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in rt arm from shoulder to finger tiips), INSOMNIA (Cannot sleep), PAIN IN EXTREMITY (Sudden pain in either forearm or hand Pain), FEELING ABNORMAL (wake up not feeling right) and NERVE COMPRESSION (Pinched nerve) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine), Drug allergy (Dilaudid), Allergy to antibiotic (Doxicycline), Age-related macular degeneration, Hyperlipidemia since 21-Dec-2015, Hypertension since 21-Dec-2015, Impaired fasting glucose since 15-Jun-2017 and Sleep apnea since 06-Jun-2016. Concomitant products included ATORVASTATIN from 21-Dec-2015 to an unknown date for Cholesterol, DILTIAZEM HYDROCHLORIDE (DILTIAZEM AN) from 21-Dec-2015 to an unknown date for Hypertension, HYDROCHLOROTHIAZIDE from 21-Dec-2015 to an unknown date, SPIRULINA [SPIRULINA SPP.] from 17-Oct-2019 to an unknown date and CALCIUM CARBONATE from 09-Jul-2019 to an unknown date for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced FEELING ABNORMAL (wake up not feeling right). On 15-May-2021, the patient experienced HYPOAESTHESIA (Numbness in rt arm from shoulder to finger tiips). On an unknown date, the patient experienced INSOMNIA (Cannot sleep), PAIN IN EXTREMITY (Sudden pain in either forearm or hand Pain) and NERVE COMPRESSION (Pinched nerve). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in rt arm from shoulder to finger tiips) had not resolved, INSOMNIA (Cannot sleep), PAIN IN EXTREMITY (Sudden pain in either forearm or hand Pain) and FEELING ABNORMAL (wake up not feeling right) outcome was unknown and NERVE COMPRESSION (Pinched nerve) was resolving.            Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow-up 2 information included no new information. On 06-Sep-2021: Follow-up information included patient demographics, medical history, concomitant and treatment information, dose 1 outcome, dose 2 info, and new events.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first Moderna injection in May/2021 and did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first Moderna injection in May/2021 and did not get the second dose) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first Moderna injection in May/2021 and did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first Moderna injection in May/2021 and did not get the second dose) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received on 08-Sep-2021 contains significant information, added dose two details.