chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Presyncope
Clinical narrative: afraid of getting her second dose; Severe joint pain; Nausea; Pain in back and shoulder balde; Dizziness; Felt of fainting; Tingling in the back and shoulderblades; Tightness in the back and shoulderblades; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PRESYNCOPE (Felt of fainting), PARAESTHESIA (Tingling in the back and shoulderblades), MUSCLE TIGHTNESS (Tightness in the back and shoulderblades) and FEAR OF INJECTION (afraid of getting her second dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided by the reporter.     On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DIZZINESS (Dizziness), PRESYNCOPE (Felt of fainting), PARAESTHESIA (Tingling in the back and shoulderblades), MUSCLE TIGHTNESS (Tightness in the back and shoulderblades), NAUSEA (Nausea) and MYALGIA (Pain in back and shoulder balde). On 14-Apr-2021, the patient experienced ARTHRALGIA (Severe joint pain). On an unknown date, the patient experienced FEAR OF INJECTION (afraid of getting her second dose). On 15-Apr-2021, DIZZINESS (Dizziness), PRESYNCOPE (Felt of fainting) and NAUSEA (Nausea) had resolved. On 20-Apr-2021, PARAESTHESIA (Tingling in the back and shoulderblades), MUSCLE TIGHTNESS (Tightness in the back and shoulderblades) and MYALGIA (Pain in back and shoulder balde) had resolved. At the time of the report, FEAR OF INJECTION (afraid of getting her second dose) and ARTHRALGIA (Severe joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash is more evident now; Skin rash on face; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Skin rash on face) and RASH (Rash is more evident now) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included GABAPENTIN, METFORMIN, LISINOPRIL, OMEPRAZOLE, THYROID (ARMOUR THYROID) and AMLODIPINE for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced RASH (Skin rash on face). On an unknown date, the patient experienced RASH (Rash is more evident now). At the time of the report, RASH (Skin rash on face) and RASH (Rash is more evident now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Non-significant follow up was received on 29-MAY-2021.Contact Information was updated
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Gait inability
Clinical narrative: Inability to walk for a week; limping for 30-days; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Inability to walk for a week) and GAIT DISTURBANCE (limping for 30-days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced GAIT INABILITY (Inability to walk for a week) and GAIT DISTURBANCE (limping for 30-days). On 26-Mar-2021, GAIT DISTURBANCE (limping for 30-days) had resolved. At the time of the report, GAIT INABILITY (Inability to walk for a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-031733 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-031733:Reporter's case
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Chills, Heart rate, Heart rate increased
Clinical narrative: Blood sugar was elevated; Chills after 2nd dose; Fast heartbeat after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heartbeat after 2nd dose), BLOOD GLUCOSE INCREASED (Blood sugar was elevated) and CHILLS (Chills after 2nd dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B218 and 17B218) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN ASPART (NOVOLOG) for Diabetes mellitus, INSULIN GLARGINE (LANTUS) for Type 1 diabetes mellitus, GABAPENTIN, LISINOPRIL and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HEART RATE INCREASED (Fast heartbeat after 2nd dose) and CHILLS (Chills after 2nd dose). On 29-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar was elevated). On 29-Apr-2021, HEART RATE INCREASED (Fast heartbeat after 2nd dose) and CHILLS (Chills after 2nd dose) had resolved. At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar was elevated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood glucose: elevated (High) Elevated. On 28-Apr-2021, Heart rate: fast heartbeat (High) increased.         Treatment for the events included paracetamol  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-098766 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose; a leftover marble-sized knot on the injection site; noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose; 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 VACCINATION SITE WARMTH (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose), VACCINATION SITE MASS (a leftover marble-sized knot on the injection site) and VACCINATION SITE SWELLING (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose), VACCINATION SITE MASS (a leftover marble-sized knot on the injection site) and VACCINATION SITE SWELLING (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose). At the time of the report, VACCINATION SITE WARMTH (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose), VACCINATION SITE MASS (a leftover marble-sized knot on the injection site) and VACCINATION SITE SWELLING (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose) outcome was unknown. Not Provided          No Relevant concomitant medications was reported. Treatment information was not provided.  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-098889 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills; tired; light headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (tired) and HEADACHE (light headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included lung. Concurrent medical conditions included Drug allergy (Nitrofurantonin), Drug allergy (Macbid), Drug allergy (Metronidazole), Drug allergy (Liptor), Drug allergy (Niacin) and Asthma. Concomitant products included FAMOTIDINE for Acid reflux (oesophageal), CETIRIZINE and MONTELUKAST for Allergy, FLUTICASONE PROPIONATE (FLOVENT) for Asthma, PRAVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FISH OIL and CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021 at 11:31 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced CHILLS (Chills) and HEADACHE (light headache). 27-Feb-2021, the patient experienced FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, CHILLS (Chills), FATIGUE (tired) and HEADACHE (light headache) had resolved.            This case was linked to MOD-2021-098562 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up document attached on 3-JUN-2021 :  Race ,Allergies, medical history updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID after first dose; Second dose administered almost 90 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered almost 90 days after first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered almost 90 days after first dose). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered almost 90 days after first dose) outcome was unknown. Not Provided          No Concomitant medications were provided No Treatment information provided    This case was linked to MOD-2021-099029 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: all over super soreness; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (all over super soreness) and PYREXIA (fever) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-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 28-Apr-2021, the patient experienced PAIN (all over super soreness) and PYREXIA (fever). At the time of the report, PAIN (all over super soreness) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Sex: U
Vaccine: COVID19
Symptoms: Neuralgia, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: nerve pain that travels to the left elbow; hot left bicep muscle that improved somewhat, but worsened when they got their second dose; leftover marble-sized knot on the injection site; noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerve pain that travels to the left elbow), VACCINATION SITE WARMTH (hot left bicep muscle that improved somewhat, but worsened when they got their second dose), VACCINATION SITE MASS (leftover marble-sized knot on the injection site) and VACCINATION SITE SWELLING (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (nerve pain that travels to the left elbow), VACCINATION SITE WARMTH (hot left bicep muscle that improved somewhat, but worsened when they got their second dose), VACCINATION SITE MASS (leftover marble-sized knot on the injection site) and VACCINATION SITE SWELLING (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose). At the time of the report, NEURALGIA (nerve pain that travels to the left elbow) and VACCINATION SITE SWELLING (noted a swollen, hot left bicep muscle that improved somewhat, but worsened when they got their second dose) had not resolved and VACCINATION SITE WARMTH (hot left bicep muscle that improved somewhat, but worsened when they got their second dose) and VACCINATION SITE MASS (leftover marble-sized knot on the injection site) outcome was unknown.            Treatment information not provided   This case was linked to MOD-2021-098836 (Patient Link).   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Product dose omission issue, Vaccination site pain
Clinical narrative: pain went from arm to the neck-severe, ongoing and worse at night; Second dose of Moderna COVID-19 vaccine not received 37 days after the first dose; arm sore; severe pain in the arm where vaccine was administered/ the pain went up a notch/ sore arm/ the worst pain they had after a vaccination but not incapacitated/ The repain in the arm getting better in the last 3 days, but they still feel a little sore l; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (severe pain in the arm where vaccine was administered/ the pain went up a notch/ sore arm/ the worst pain they had after a vaccination but not incapacitated/ The repain in the arm getting better in the last 3 days, but they still feel a little sore l), NECK PAIN (pain went from arm to the neck-severe, ongoing and worse at night), PRODUCT DOSE OMISSION ISSUE (Second dose of Moderna COVID-19 vaccine not received 37 days after the first dose) and PAIN IN EXTREMITY (arm sore) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and LISINOPRIL for Blood pressure, TRAZODONE for Sleep disorder, OMEPRAZOLE for Stomach pain, ALPRAZOLAM (XANAX) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (severe pain in the arm where vaccine was administered/ the pain went up a notch/ sore arm/ the worst pain they had after a vaccination but not incapacitated/ The repain in the arm getting better in the last 3 days, but they still feel a little sore l). On an unknown date, the patient experienced NECK PAIN (pain went from arm to the neck-severe, ongoing and worse at night), PRODUCT DOSE OMISSION ISSUE (Second dose of Moderna COVID-19 vaccine not received 37 days after the first dose) and PAIN IN EXTREMITY (arm sore). At the time of the report, VACCINATION SITE PAIN (severe pain in the arm where vaccine was administered/ the pain went up a notch/ sore arm/ the worst pain they had after a vaccination but not incapacitated/ The repain in the arm getting better in the last 3 days, but they still feel a little sore l), NECK PAIN (pain went from arm to the neck-severe, ongoing and worse at night), PRODUCT DOSE OMISSION ISSUE (Second dose of Moderna COVID-19 vaccine not received 37 days after the first dose) and PAIN IN EXTREMITY (arm sore) outcome was unknown. Not Provided      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.   The patient took Tylenol as treatment medication   This case was linked to MOD-2021-098669.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Positive) on 28-May-2020 and Hypercholesteremia.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, SARS-CoV-2 antibody test: unknown (Positive) COVID-19 Positive. On an unknown date, Blood cholesterol: unknown (High) high cholesterol.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Statin are the concomitant medication reported by reporter. No treatment medications provided by the reporter.   Patient states that he is slightly overweight.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: maternal exposure during pregnancy; sore arm; fatigue; chills; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and CHILLS (chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A.) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-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 on 13-Nov-2020 and the estimated date of delivery was 17-Sep-2021. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and CHILLS (chills). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  On 04-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was Allergy pill. Treatment information was not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dizziness, Dyspnoea, Palpitations
Clinical narrative: Shortness of breath; Itchy; loss of taste; loss of  smell; Palpitation; Dizzy; Big red bump started with a size of dime on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PRURITUS (Itchy), AGEUSIA (loss of taste), ANOSMIA (loss of  smell) and PALPITATIONS (Palpitation) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Positive) on 05-Jan-2021.   On 30-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 28-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red bump started with a size of dime on the injection site). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), PRURITUS (Itchy), AGEUSIA (loss of taste), ANOSMIA (loss of  smell), PALPITATIONS (Palpitation) and DIZZINESS (Dizzy). At the time of the report, DYSPNOEA (Shortness of breath), AGEUSIA (loss of taste), PALPITATIONS (Palpitation), DIZZINESS (Dizzy) and VACCINATION SITE ERYTHEMA (Big red bump started with a size of dime on the injection site) had not resolved and PRURITUS (Itchy) and ANOSMIA (loss of  smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 antibody test: unknown (Positive) positive for COVID-19.         Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.      This case was linked to MOD-2021-098918 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 antibody test, Vaccination site erythema
Clinical narrative: Shortness of breath; Itchy; loss of taste; loss of  smell; Palpitation; Dizzy; Big red bump started with a size of dime on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PRURITUS (Itchy), AGEUSIA (loss of taste), ANOSMIA (loss of  smell) and PALPITATIONS (Palpitation) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Positive) on 05-Jan-2021.   On 30-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 28-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red bump started with a size of dime on the injection site). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), PRURITUS (Itchy), AGEUSIA (loss of taste), ANOSMIA (loss of  smell), PALPITATIONS (Palpitation) and DIZZINESS (Dizzy). At the time of the report, DYSPNOEA (Shortness of breath), AGEUSIA (loss of taste), PALPITATIONS (Palpitation), DIZZINESS (Dizzy) and VACCINATION SITE ERYTHEMA (Big red bump started with a size of dime on the injection site) had not resolved and PRURITUS (Itchy) and ANOSMIA (loss of  smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 antibody test: unknown (Positive) positive for COVID-19.         Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.      This case was linked to MOD-2021-098918 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of a rash (arm, neck and chest) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 024M20A and 001B21A) for COVID-19 immunization. No medical history reported. On Mar 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient developed a rash (arm, neck and chest). At the time of the report, rash (arm, neck and chest) outcome: unknown. Patient treated with Zyrtec (cetirizine dihydrochloride) cream. This case linked to MOD-2021-021889 (patient link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling cold, Headache
Clinical narrative: was very Cold; Difficult to get up this morning; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (was very Cold), ASTHENIA (Difficult to get up this morning) and HEADACHE (Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced FEELING COLD (was very Cold), ASTHENIA (Difficult to get up this morning) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING COLD (was very Cold), ASTHENIA (Difficult to get up this morning) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.   This case was linked to MOD-2021-099009 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 17-year old patient received both doses of the vaccine.; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 17-year old patient received both doses of the vaccine.) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 17-year old patient received both doses of the vaccine.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 17-year old patient received both doses of the vaccine.) had resolved.        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. No  concomitant medications reported
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dysgeusia, Headache, Limb discomfort, Rash
Clinical narrative: metallic taste; taste became intense,taste had worsen,tasted like nickels in mouth; unusual rash on chest traveling up to neck; injection site soreness; could not raise arm for 5 days; headache; sick to stomach; odd reaction; pervasive metallic taste in mouth; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (odd reaction), TASTE DISORDER (pervasive metallic taste in mouth), DYSGEUSIA (metallic taste), ABDOMINAL DISCOMFORT (sick to stomach) and TASTE DISORDER (taste became intense,taste had worsen,tasted like nickels in mouth) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was not provided by reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION COMPLICATION (odd reaction), TASTE DISORDER (pervasive metallic taste in mouth) and ABDOMINAL DISCOMFORT (sick to stomach). On an unknown date, the patient experienced DYSGEUSIA (metallic taste), TASTE DISORDER (taste became intense,taste had worsen,tasted like nickels in mouth), VACCINATION SITE PAIN (injection site soreness), LIMB DISCOMFORT (could not raise arm for 5 days), HEADACHE (headache) and RASH (unusual rash on chest traveling up to neck). At the time of the report, VACCINATION COMPLICATION (odd reaction), TASTE DISORDER (pervasive metallic taste in mouth), TASTE DISORDER (taste became intense,taste had worsen,tasted like nickels in mouth), VACCINATION SITE PAIN (injection site soreness), LIMB DISCOMFORT (could not raise arm for 5 days), HEADACHE (headache) and RASH (unusual rash on chest traveling up to neck) 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.   Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Vaccination complication, Vaccination site pain
Clinical narrative: metallic taste; taste became intense,taste had worsen,tasted like nickels in mouth; unusual rash on chest traveling up to neck; injection site soreness; could not raise arm for 5 days; headache; sick to stomach; odd reaction; pervasive metallic taste in mouth; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (odd reaction), TASTE DISORDER (pervasive metallic taste in mouth), DYSGEUSIA (metallic taste), ABDOMINAL DISCOMFORT (sick to stomach) and TASTE DISORDER (taste became intense,taste had worsen,tasted like nickels in mouth) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was not provided by reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION COMPLICATION (odd reaction), TASTE DISORDER (pervasive metallic taste in mouth) and ABDOMINAL DISCOMFORT (sick to stomach). On an unknown date, the patient experienced DYSGEUSIA (metallic taste), TASTE DISORDER (taste became intense,taste had worsen,tasted like nickels in mouth), VACCINATION SITE PAIN (injection site soreness), LIMB DISCOMFORT (could not raise arm for 5 days), HEADACHE (headache) and RASH (unusual rash on chest traveling up to neck). At the time of the report, VACCINATION COMPLICATION (odd reaction), TASTE DISORDER (pervasive metallic taste in mouth), TASTE DISORDER (taste became intense,taste had worsen,tasted like nickels in mouth), VACCINATION SITE PAIN (injection site soreness), LIMB DISCOMFORT (could not raise arm for 5 days), HEADACHE (headache) and RASH (unusual rash on chest traveling up to neck) 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.   Treatment information was not provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Headache, Nasopharyngitis
Clinical narrative: difficult to get up; very cold; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (difficult to get up), NASOPHARYNGITIS (very cold) and HEADACHE (headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced NASOPHARYNGITIS (very cold) and HEADACHE (headache). On 29-Apr-2021, the patient experienced DYSSTASIA (difficult to get up). At the time of the report, DYSSTASIA (difficult to get up), NASOPHARYNGITIS (very cold) and HEADACHE (headache) outcome was unknown.            This case was linked to MOD-2021-098979 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: 17-year old patient received both doses of the vaccine. Second dose was administered; This spontaneous case was reported by a nurse and describes the occurrence of OFF LABEL USE (17-year old patient received both doses of the vaccine. Second dose was administered) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced OFF LABEL USE (17-year old patient received both doses of the vaccine. Second dose was administered). At the time of the report, OFF LABEL USE (17-year old patient received both doses of the vaccine. Second dose was administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Headache, Illness, Nausea
Clinical narrative: She did not got the second shot; arm was sore; became really sick; hasn't gotten out of bed; could hardly walk; dry heaving and vomiting; headache; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She did not got the second shot), PAIN IN EXTREMITY (arm was sore), ILLNESS (became really sick), ASTHENIA (hasn't gotten out of bed) and GAIT DISTURBANCE (could hardly walk) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Positive) on 28-May-2020. Concurrent medical conditions included Asthma.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), ILLNESS (became really sick), ASTHENIA (hasn't gotten out of bed), GAIT DISTURBANCE (could hardly walk), VOMITING (dry heaving and vomiting), HEADACHE (headache), PYREXIA (fever) and NAUSEA (nausea). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She did not got the second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (She did not got the second shot) had resolved and PAIN IN EXTREMITY (arm was sore), ILLNESS (became really sick), ASTHENIA (hasn't gotten out of bed), GAIT DISTURBANCE (could hardly walk), VOMITING (dry heaving and vomiting), HEADACHE (headache), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2020, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information reported were blood pressure medications. Hydration and water is the treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: New Event added.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue, Pyrexia, SARS-CoV-2 antibody test, Vomiting
Clinical narrative: She did not got the second shot; arm was sore; became really sick; hasn't gotten out of bed; could hardly walk; dry heaving and vomiting; headache; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She did not got the second shot), PAIN IN EXTREMITY (arm was sore), ILLNESS (became really sick), ASTHENIA (hasn't gotten out of bed) and GAIT DISTURBANCE (could hardly walk) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Positive) on 28-May-2020. Concurrent medical conditions included Asthma.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), ILLNESS (became really sick), ASTHENIA (hasn't gotten out of bed), GAIT DISTURBANCE (could hardly walk), VOMITING (dry heaving and vomiting), HEADACHE (headache), PYREXIA (fever) and NAUSEA (nausea). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She did not got the second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (She did not got the second shot) had resolved and PAIN IN EXTREMITY (arm was sore), ILLNESS (became really sick), ASTHENIA (hasn't gotten out of bed), GAIT DISTURBANCE (could hardly walk), VOMITING (dry heaving and vomiting), HEADACHE (headache), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2020, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information reported were blood pressure medications. Hydration and water is the treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: New Event added.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID after first dose; Second dose administered almost 90 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Second dose administered almost 90 days after first dose) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced OFF LABEL USE (Second dose administered almost 90 days after first dose). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first dose). At the time of the report, OFF LABEL USE (Second dose administered almost 90 days after first dose) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first dose) outcome was unknown. Not Provided          No Concomitant medications were provided No Treatment information provided    This case was linked to MOD-2021-098874 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pyrexia
Clinical narrative: lump in lymph nodes; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lump in lymph nodes), PYREXIA (fever) and CHILLS (chills) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (lump in lymph nodes), PYREXIA (fever) and CHILLS (chills). At the time of the report, LYMPHADENOPATHY (lump in lymph nodes), PYREXIA (fever) and CHILLS (chills) was resolving.            No concomitant medications were reported.  Patient recovered from 1st dose side effects. Patient said she is recovered but not 100%.   This case was linked to MOD-2021-030632 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: sore arm from the elbow to the shoulder (almost going up to the neck); injection site was itchy; injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm from the elbow to the shoulder (almost going up to the neck)), VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was red) in a 47-year-old female patient 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 PAIN IN EXTREMITY (sore arm from the elbow to the shoulder (almost going up to the neck)), VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was red). At the time of the report, PAIN IN EXTREMITY (sore arm from the elbow to the shoulder (almost going up to the neck)), VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported No treatment medication was reported   This case was linked to MOD-2021-031699, MOD-2021-099111, MOD-2021-099111 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore muscle near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore muscle near injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0448A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore muscle near injection site). On 27-Mar-2021, VACCINATION SITE PAIN (sore muscle near injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided .No treatment details were provided.   This case was linked to MOD-2021-099079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow up received on 29MAY2021, Updated patient height, race, vaccine facility information
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation delayed, Pyrexia
Clinical narrative: Delayed onset of menses by 7 days; low grade fever; small headache/small headache in the morning and by the afternoon went away; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Delayed onset of menses by 7 days), PYREXIA (low grade fever) and HEADACHE (small headache/small headache in the morning and by the afternoon went away) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 0448A21A) for COVID-19 vaccination.     The patient's past medical history included Constipation. Concurrent medical conditions included Thyroid disorder NOS.   On 25-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PYREXIA (low grade fever) and HEADACHE (small headache/small headache in the morning and by the afternoon went away). On an unknown date, the patient experienced MENSTRUATION DELAYED (Delayed onset of menses by 7 days). On 25-Apr-2021, HEADACHE (small headache/small headache in the morning and by the afternoon went away) had resolved. At the time of the report, MENSTRUATION DELAYED (Delayed onset of menses by 7 days) and PYREXIA (low grade fever) outcome was unknown.            Patient reported headache was intense on 23-Apr-2021 which turned to small headache on 24-Apr-2021 and subsequently went away on 25-Apr-2021 Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   This case was linked to MOD-2021-099054 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Added patient demographic, added medical history.