chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Giving the full dose instead of the half dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Giving the full dose instead of the half dose) 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 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. In October 2021, the patient experienced ACCIDENTAL OVERDOSE (Giving the full dose instead of the half dose). In October 2021, ACCIDENTAL OVERDOSE (Giving the full dose instead of the half dose) had resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient received full dose of booster dose instead of the half dose.   This case was linked to MOD-2021-366267, MOD-2021-366289, MOD-2021-365955, MOD-2021-365960 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm, the size of a softball; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm, the size of a softball) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm, the size of a softball). At the time of the report, PERIPHERAL SWELLING (Swollen arm, the size of a softball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medications were reported.   This case was linked to MOD-2021-366140 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Tinnitus, Vaccination site pain
Clinical narrative: Ringing Ear; Headache; Chills; Nausea; Left sore arm; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Ringing Ear), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Left sore arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic and Prediabetes. Concomitant products included METFORMIN for an unknown indication.    On 24-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing Ear), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Left sore arm). At the time of the report, TINNITUS (Ringing Ear) had not resolved and HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE PAIN (Left sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: arm was swollen; arm was a rashy red color; arm was itchy (like a bee sting); arm was a rashy red color; arm begun to hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm begun to hurt), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE RASH (arm was a rashy red color), VACCINATION SITE PRURITUS (arm was itchy (like a bee sting)) and VACCINATION SITE ERYTHEMA (arm was a rashy red color) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced VACCINATION SITE PAIN (arm begun to hurt). On 26-Oct-2021, the patient experienced VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE RASH (arm was a rashy red color), VACCINATION SITE PRURITUS (arm was itchy (like a bee sting)) and VACCINATION SITE ERYTHEMA (arm was a rashy red color). At the time of the report, VACCINATION SITE PAIN (arm begun to hurt), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE RASH (arm was a rashy red color), VACCINATION SITE PRURITUS (arm was itchy (like a bee sting)) and VACCINATION SITE ERYTHEMA (arm was a rashy red color) outcome was unknown.            Concomitant medications was not provided by the reporter.  Treatment information was not provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: was in bed for 2 days; fever; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (was in bed for 2 days) and PYREXIA (fever) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced MOBILITY DECREASED (was in bed for 2 days) and PYREXIA (fever). On 17-Apr-2021, MOBILITY DECREASED (was in bed for 2 days) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-365654 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow up received and contains The Email address updated.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: achy; tired; chills; pounding head ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), FATIGUE (tired), CHILLS (chills) and HEADACHE (pounding head ache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy), FATIGUE (tired), CHILLS (chills) and HEADACHE (pounding head ache). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, PAIN (achy) and FATIGUE (tired) outcome was unknown and CHILLS (chills) and HEADACHE (pounding head ache) had resolved.            No concomitant medications were reported   This case was linked to MOD-2021-366207 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to patient after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use By Date) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use By Date). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.   This case was linked to MOD-2021-366127 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient given 0.5 mL as a booster dose instead of the recommended 0.25 mL; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient given 0.5 mL as a booster dose instead of the recommended 0.25 mL) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 016B21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Renal cancer.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient given 0.5 mL as a booster dose instead of the recommended 0.25 mL). On 26-Oct-2021, EXTRA DOSE ADMINISTERED (Patient given 0.5 mL as a booster dose instead of the recommended 0.25 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood oestrogen, Confusional state, Dysgeusia, Fear of disease, Progesterone
Clinical narrative: She also had vaginal spotting just one time/ Later she stated streaks of vaginal blood for a few days; She kept changing her story; scared that she might have uterine cancer; sour taste in her mouth and metallic taste in the mouth; This spontaneous case was reported by a nurse and describes the occurrence of DYSGEUSIA (sour taste in her mouth and metallic taste in the mouth), CONFUSIONAL STATE (She kept changing her story), FEAR OF DISEASE (scared that she might have uterine cancer) and VAGINAL HAEMORRHAGE (She also had vaginal spotting just one time/ Later she stated streaks of vaginal blood for a few days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040021A and 048F21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Patient had the same taste( sour taste and metallic taste) in her mouth during her pregnancy when she had high estrogen and low progesterone) and Dysgeusia (Sour taste/ Metallic taste).   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (sour taste in her mouth and metallic taste in the mouth). On 27-Oct-2021, the patient experienced CONFUSIONAL STATE (She kept changing her story) and FEAR OF DISEASE (scared that she might have uterine cancer). On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (She also had vaginal spotting just one time/ Later she stated streaks of vaginal blood for a few days). At the time of the report, DYSGEUSIA (sour taste in her mouth and metallic taste in the mouth), CONFUSIONAL STATE (She kept changing her story) and FEAR OF DISEASE (scared that she might have uterine cancer) outcome was unknown and VAGINAL HAEMORRHAGE (She also had vaginal spotting just one time/ Later she stated streaks of vaginal blood for a few days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2021, Blood oestrogen: 287 (High) she had high estrogen. On 20-Oct-2021, Progesterone: 0.5 (Low) low progesterone. On an unknown date, Blood oestrogen: high (High) During her pregnancy  she had high estrogen. On an unknown date, Progesterone: low (Low) During her pregnancy she had low progesterone.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-365563 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: She also had vaginal spotting just one time/ Later she stated streaks of vaginal blood for a few days; She kept changing her story; scared that she might have uterine cancer; sour taste in her mouth and metallic taste in the mouth; This spontaneous case was reported by a nurse and describes the occurrence of DYSGEUSIA (sour taste in her mouth and metallic taste in the mouth), CONFUSIONAL STATE (She kept changing her story), FEAR OF DISEASE (scared that she might have uterine cancer) and VAGINAL HAEMORRHAGE (She also had vaginal spotting just one time/ Later she stated streaks of vaginal blood for a few days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040021A and 048F21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Patient had the same taste( sour taste and metallic taste) in her mouth during her pregnancy when she had high estrogen and low progesterone) and Dysgeusia (Sour taste/ Metallic taste).   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (sour taste in her mouth and metallic taste in the mouth). On 27-Oct-2021, the patient experienced CONFUSIONAL STATE (She kept changing her story) and FEAR OF DISEASE (scared that she might have uterine cancer). On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (She also had vaginal spotting just one time/ Later she stated streaks of vaginal blood for a few days). At the time of the report, DYSGEUSIA (sour taste in her mouth and metallic taste in the mouth), CONFUSIONAL STATE (She kept changing her story) and FEAR OF DISEASE (scared that she might have uterine cancer) outcome was unknown and VAGINAL HAEMORRHAGE (She also had vaginal spotting just one time/ Later she stated streaks of vaginal blood for a few days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2021, Blood oestrogen: 287 (High) she had high estrogen. On 20-Oct-2021, Progesterone: 0.5 (Low) low progesterone. On an unknown date, Blood oestrogen: high (High) During her pregnancy  she had high estrogen. On an unknown date, Progesterone: low (Low) During her pregnancy she had low progesterone.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-365563 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache
Clinical narrative: Headache; Dizzy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), CHILLS (Chills) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 959904/939904, 022M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced DIZZINESS (Dizzy) and CHILLS (Chills). On 27-Oct-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) on 26-Oct-2021 for Chills, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizzy) was resolving and CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Patient was taking other unspecified medications. After vaccination, patient experienced chills and took Tylenol. She was also dizzy. Patient stated that she was having a little trouble with dizziness and it was getting better. She experienced a headache during the night and was awake for some time.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Dehydration, Malaise
Clinical narrative: went down; she was dehydrated; ended up giving the full dose instead of the half dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (went down), DEHYDRATION (she was dehydrated) and ACCIDENTAL OVERDOSE (ended up giving the full dose instead of the half dose) 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 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (ended up giving the full dose instead of the half dose). On an unknown date, the patient experienced MALAISE (went down) and DEHYDRATION (she was dehydrated). On 22-Oct-2021, ACCIDENTAL OVERDOSE (ended up giving the full dose instead of the half dose) had resolved. At the time of the report, MALAISE (went down) and DEHYDRATION (she was dehydrated) outcome was unknown.            No concomitant medication was reported.  No treatment drug was reported.   This case was linked to MOD-2021-366021 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia
Clinical narrative: passed away from Covid-19 Pneumonia 24OCT2021; Caught Covid-19 20OCT2021/Mom developed a cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (passed away from Covid-19 Pneumonia 24OCT2021) and COVID-19 (Caught Covid-19 20OCT2021/Mom developed a cough) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Caught Covid-19 20OCT2021/Mom developed a cough) (seriousness criterion hospitalization). On 24-Oct-2021, the patient experienced COVID-19 PNEUMONIA (passed away from Covid-19 Pneumonia 24OCT2021) (seriousness criteria death, hospitalization and medically significant). The patient died on 24-Oct-2021. The reported cause of death was COVID-19 pneumonia. It is unknown if an autopsy was performed. At the time of death, COVID-19 (Caught Covid-19 20OCT2021/Mom developed a cough) outcome was unknown.            No Concomitant medication were provided by the reporter  No treatment medications were provided by the reporter  This case concerns a 58-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of COVID-19 Pneumonia and COVID-19. The events occurred 6 months and 28 days after the second dose of mRNA-1273 had a fatal outcome, with death occurring the following day. No autopsy report was disclosed. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 in not affected by this report.   This case was linked to MOD-2021-365577 (Patient Link).; Sender's Comments: This case concerns a 58-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of COVID-19 Pneumonia and COVID-19. The events occurred 6 months and 28 days after the second dose of mRNA-1273 had a fatal outcome, with death occurring the following day. No autopsy report was disclosed. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 in not affected by this report.; Reported Cause(s) of Death: COVID-19 pneumonia
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-365967, MOD-2021-365701 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Heart rate
Clinical narrative: Chest pressure; Feels like I was hit in the chest with a Softball / pain in the chest; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Feels like I was hit in the chest with a Softball / pain in the chest), DIZZINESS (Dizziness) and CHEST DISCOMFORT (Chest pressure) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04C21A, 046821A and 018821A) for COVID-19 vaccination.     Concurrent medical conditions included Congestive heart failure.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced CHEST PAIN (Feels like I was hit in the chest with a Softball / pain in the chest) and DIZZINESS (Dizziness). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest pressure). At the time of the report, CHEST PAIN (Feels like I was hit in the chest with a Softball / pain in the chest) and DIZZINESS (Dizziness) had not resolved and CHEST DISCOMFORT (Chest pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, Heart rate: rapid (High) rapid.         Patient had no history of COVID-19 infection.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Headache, Myalgia, Pain
Clinical narrative: It's starting to bruise underneath; severe joint pain; severe muscle pain; headache; it was extremely painful / it was sharp; she had bleeding on the injection site for +15 hs / there was lots of fresh bleeding; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (it was extremely painful / it was sharp), VACCINATION SITE HAEMORRHAGE (she had bleeding on the injection site for +15 hs / there was lots of fresh bleeding), CONTUSION (It's starting to bruise underneath), ARTHRALGIA (severe joint pain) and MYALGIA (severe muscle pain) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 030L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, ACETYLSALICYLIC ACID for Clotting disorder, ETHINYLESTRADIOL, NORGESTIMATE (TRINESSA), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ESCITALOPRAM OXALATE (LEXAPRO), LEVOTHYROXINE SODIUM (SYNTHROID) and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced PAIN (it was extremely painful / it was sharp) and VACCINATION SITE HAEMORRHAGE (she had bleeding on the injection site for +15 hs / there was lots of fresh bleeding). On an unknown date, the patient experienced CONTUSION (It's starting to bruise underneath), ARTHRALGIA (severe joint pain), MYALGIA (severe muscle pain) and HEADACHE (headache). On 27-Oct-2021, PAIN (it was extremely painful / it was sharp) and VACCINATION SITE HAEMORRHAGE (she had bleeding on the injection site for +15 hs / there was lots of fresh bleeding) had resolved. At the time of the report, CONTUSION (It's starting to bruise underneath), ARTHRALGIA (severe joint pain), MYALGIA (severe muscle pain) and HEADACHE (headache) outcome was unknown.            No treatment were reported.   This case was linked to MOD-2021-366431, MOD-2021-366435 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: It's starting to bruise underneath; severe joint pain; severe muscle pain; headache; it was extremely painful / it was sharp; she had bleeding on the injection site for +15 hs / there was lots of fresh bleeding; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (it was extremely painful / it was sharp), VACCINATION SITE HAEMORRHAGE (she had bleeding on the injection site for +15 hs / there was lots of fresh bleeding), CONTUSION (It's starting to bruise underneath), ARTHRALGIA (severe joint pain) and MYALGIA (severe muscle pain) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 030L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, ACETYLSALICYLIC ACID for Clotting disorder, ETHINYLESTRADIOL, NORGESTIMATE (TRINESSA), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ESCITALOPRAM OXALATE (LEXAPRO), LEVOTHYROXINE SODIUM (SYNTHROID) and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced PAIN (it was extremely painful / it was sharp) and VACCINATION SITE HAEMORRHAGE (she had bleeding on the injection site for +15 hs / there was lots of fresh bleeding). On an unknown date, the patient experienced CONTUSION (It's starting to bruise underneath), ARTHRALGIA (severe joint pain), MYALGIA (severe muscle pain) and HEADACHE (headache). On 27-Oct-2021, PAIN (it was extremely painful / it was sharp) and VACCINATION SITE HAEMORRHAGE (she had bleeding on the injection site for +15 hs / there was lots of fresh bleeding) had resolved. At the time of the report, CONTUSION (It's starting to bruise underneath), ARTHRALGIA (severe joint pain), MYALGIA (severe muscle pain) and HEADACHE (headache) outcome was unknown.            No treatment were reported.   This case was linked to MOD-2021-366431, MOD-2021-366435 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm hurt/ hardly any pain/arm didn't hurt that much/pretty much gone; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt/ hardly any pain/arm didn't hurt that much/pretty much gone) and FATIGUE (feeling tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) 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) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt/ hardly any pain/arm didn't hurt that much/pretty much gone) and FATIGUE (feeling tired). On 03-Mar-2021, PAIN IN EXTREMITY (arm hurt/ hardly any pain/arm didn't hurt that much/pretty much gone) and FATIGUE (feeling tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-366456, MOD-2021-366464 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow-up received on 01-Nov-2021, anatomical site added. Narrative updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Discomfort, Illness, Influenza
Clinical narrative: couldn't move at all, was very sick; felt terrible; felt like a terrible flu in her body; CVS record reports she recieved the 0.5 ml dose rather than the .25ml booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (couldn't move at all, was very sick), DISCOMFORT (felt terrible), INFLUENZA (felt like a terrible flu in her body) and ACCIDENTAL OVERDOSE (CVS record reports she recieved the 0.5 ml dose rather than the .25ml booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (CVS record reports she recieved the 0.5 ml dose rather than the .25ml booster dose). On an unknown date, the patient experienced ILLNESS (couldn't move at all, was very sick), DISCOMFORT (felt terrible) and INFLUENZA (felt like a terrible flu in her body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Oct-2021, ACCIDENTAL OVERDOSE (CVS record reports she recieved the 0.5 ml dose rather than the .25ml booster dose) had resolved. At the time of the report, ILLNESS (couldn't move at all, was very sick), DISCOMFORT (felt terrible) and INFLUENZA (felt like a terrible flu in her body) was resolving.            No Concomitant medication details were provided.   Reporter did not allow further contact
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Therapeutic response unexpected
Clinical narrative: Psoriasis on his elbows actually improved for a few days; Fatigue; Total body soreness; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Psoriasis on his elbows actually improved for a few days), FATIGUE (Fatigue) and MYALGIA (Total body soreness) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Autoimmune disorder.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 05-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Psoriasis on his elbows actually improved for a few days), FATIGUE (Fatigue) and MYALGIA (Total body soreness). On 08-Apr-2021, THERAPEUTIC RESPONSE UNEXPECTED (Psoriasis on his elbows actually improved for a few days), FATIGUE (Fatigue) and MYALGIA (Total body soreness) had resolved.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-366494, MOD-2021-366526 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 expired doses were given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 expired doses were given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A/006C21A/043B21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 expired doses were given). In October 2021, EXPIRED PRODUCT ADMINISTERED (5 expired doses were given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that, first it was said these lot numbers had been granted an extension for expiration date, but then HCP  received a notice from the health department with a list of lot numbers that were truly expired, and all three were on the list.  5 expired doses of vials were administered to 5 patients (two doses administered in the current week and three doses on the last week).  The vial was initially stored in the refrigerator right before the doses were given, on the same day.  No concomitant medication details were reported. No treatment medication details were reported.  The vials with lot numbers of 040B21A, 006C21A, 043B21A have expiry dates of 02-Oct-2021, 03-Oct-2021 and 10-Oct-2021 respectively. The vials did not undergo any temperature excursions.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contains non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: mild aches and pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (mild aches and pains) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PAIN (mild aches and pains). At the time of the report, PAIN (mild aches and pains) had not resolved.            No concomitant medications were reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth, Hypersomnia, Illness
Clinical narrative: "Was sick"; "slept all day Tuesday"; Teeth sensitivity/can barley eat or drink due to the teeth sensitivity; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH (Teeth sensitivity/can barley eat or drink due to the teeth sensitivity), ILLNESS ("Was sick") and HYPERSOMNIA ("slept all day Tuesday") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399W and 036AZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced HYPERAESTHESIA TEETH (Teeth sensitivity/can barley eat or drink due to the teeth sensitivity) and HYPERSOMNIA ("slept all day Tuesday"). On an unknown date, the patient experienced ILLNESS ("Was sick"). The patient was treated with SODIUM FLUORIDE (SENSODYNE [SODIUM FLUORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERAESTHESIA TEETH (Teeth sensitivity/can barley eat or drink due to the teeth sensitivity), ILLNESS ("Was sick") and HYPERSOMNIA ("slept all day Tuesday") outcome was unknown.      No concomitant medications were mentioned. Batch number of 2nd dose "028A 2 or Z IA". This case concerns a 65-year-old, male patient with no medical history disclosed, who experienced the unexpected non-serious adverse event of special interest of hypersomnia with other non serious unexpected events. The event of hypersomnia occurred approximately 2 days after the third dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred after the third dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 65-year-old, male patient with no medical history disclosed, who experienced the unexpected non-serious adverse event of special interest of hypersomnia with other non serious unexpected events. The event of hypersomnia occurred approximately 2 days after the third dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred after the third dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Arthralgia, Heart rate, Vaccination site pain
Clinical narrative: Booster dose of 0.5 ml; pain that persisted into her back left shoulder/ Her pain in her left shoulder has persisted; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain that persisted into her back left shoulder/ Her pain in her left shoulder has persisted), VACCINATION SITE PAIN (injection site pain) and ACCIDENTAL OVERDOSE (Booster dose of 0.5 ml) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Right bundle branch block (Mild Right bundle branch block). Previously administered products included for Flu: Flu vaccine (unknown manufacturer and unknown injection site) on 17-Oct-2021. Concurrent medical conditions included Hashimoto's thyroiditis and Early menopause. Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for Hormone replacement therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In October 2021, the patient experienced ARTHRALGIA (pain that persisted into her back left shoulder/ Her pain in her left shoulder has persisted) and VACCINATION SITE PAIN (injection site pain). On 23-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Booster dose of 0.5 ml). On 23-Oct-2021, ACCIDENTAL OVERDOSE (Booster dose of 0.5 ml) had resolved. On 27-Oct-2021, VACCINATION SITE PAIN (injection site pain) had resolved. At the time of the report, ARTHRALGIA (pain that persisted into her back left shoulder/ Her pain in her left shoulder has persisted) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Heart rate: 39 (Low) 39 beats per minute for 10 minutes during her sleep.         Treatment information was not provided. Other concomitant medications included many over the counter vitamins.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster dose received less than 28 days after 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose received less than 28 days after 2nd dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose received less than 28 days after 2nd dose). On 26-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose received less than 28 days after 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inhibitory drug interaction
Clinical narrative: Botox not working for the patient; This spontaneous case was reported by a non-health professional and describes the occurrence of INHIBITORY DRUG INTERACTION (Botox not working for the patient) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product BOTOX injection for Migraine.    Has Alzheimer's. (mhb).  Concurrent medical conditions included Alzheimer's disease, Migraine and Cognitive impairment.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-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 started BOTOX (unknown route) at an unspecified dose. On an unknown date, the patient experienced INHIBITORY DRUG INTERACTION (Botox not working for the patient). At the time of the report, INHIBITORY DRUG INTERACTION (Botox not working for the patient) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 330 patients Received expired dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (330 patients Received expired dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (330 patients Received expired dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (330 patients Received expired dose of the vaccine) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: arm started to hurt; shoulder started to hurt, It's hurting a lot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm started to hurt) and ARTHRALGIA (shoulder started to hurt, It's hurting a lot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm started to hurt) and ARTHRALGIA (shoulder started to hurt, It's hurting a lot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm started to hurt) outcome was unknown and ARTHRALGIA (shoulder started to hurt, It's hurting a lot) had not resolved.            The patient had 3 Moderna shots, but after the second one her shoulder started hurting, she had it in the same arm as the second. To this day her shoulder is still hurting her, she even is going to get an MRI. She was having minor issues with her shoulder before the shot and now she's having major issues. It was hurting a lot. She did not have any of this problems before the vaccine.  First dose was in January, second vaccine in February, third vaccine in August in a different arm. The patient Has a condition on the red blood cells, Parkinson's and myofibrosis.  She had antibody tesst to see how powerful Moderna was in her body.  Fist time was after having the two doses and antibodies read like 1 69.  Second time after the third dose, antibodies shooted to 1000 049.  Third time about a month after taking the third dose, on September, went down to 7 30.  NO concomitant medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow-up received on 27-Oct-2021. Patient demographics updated, historical condition updated, vaccine details updated.