chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Musculoskeletal stiffness, Overweight, Pain
Clinical narrative: Soreness in her arm; pain; Feeling abnormal; Joint pain; overweight; stiffness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), PAIN (pain), FEELING ABNORMAL (Feeling abnormal), ARTHRALGIA (Joint pain) and OVERWEIGHT (overweight) in a 51-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.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included COVID-19 in October 2020 and Knee replacement.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (unknown route) 15 milligram. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in her arm), PAIN (pain), FEELING ABNORMAL (Feeling abnormal), ARTHRALGIA (Joint pain), OVERWEIGHT (overweight) and MUSCULOSKELETAL STIFFNESS (stiffness). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), FEELING ABNORMAL (Feeling abnormal) and OVERWEIGHT (overweight) had not resolved, PAIN (pain) had resolved, ARTHRALGIA (Joint pain) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiffness) was resolving.        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.   Concomitant and Treatment medications were not provided by reporter.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in her arm; pain; Feeling abnormal; Joint pain; overweight; stiffness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), PAIN (pain), FEELING ABNORMAL (Feeling abnormal), ARTHRALGIA (Joint pain) and OVERWEIGHT (overweight) in a 51-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.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included COVID-19 in October 2020 and Knee replacement.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (unknown route) 15 milligram. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in her arm), PAIN (pain), FEELING ABNORMAL (Feeling abnormal), ARTHRALGIA (Joint pain), OVERWEIGHT (overweight) and MUSCULOSKELETAL STIFFNESS (stiffness). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), FEELING ABNORMAL (Feeling abnormal) and OVERWEIGHT (overweight) had not resolved, PAIN (pain) had resolved, ARTHRALGIA (Joint pain) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiffness) was resolving.        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.   Concomitant and Treatment medications were not provided by reporter.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: Second dose which is scheduled on 07Apr2021; Sore arm at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose which is scheduled on 07Apr2021) and INJECTION SITE PAIN (Sore arm at the site of injection) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose which is scheduled on 07Apr2021) and INJECTION SITE PAIN (Sore arm at the site of injection). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose which is scheduled on 07Apr2021) and INJECTION SITE PAIN (Sore arm at the site of injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       no concomitants and treatments medications was reported   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Follow-up information received on 17 Jul 2021 contains significant information. updated event outcomes to recovered.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Eczema, Urticaria
Clinical narrative: spongiotic dermatitis; Hives; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives) and ECZEMA (spongiotic dermatitis) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 immunization.     No Medical History information was reported.    On 04-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced ECZEMA (spongiotic dermatitis). The patient was treated with PREDNISONE at a dose of 2 courses of prednisone and TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) at a dose of daily for 2 months. At the time of the report, URTICARIA (Hives) and ECZEMA (spongiotic dermatitis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: revealed spongiotic dermatitis. Revealed spongiotic dermatitis..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Action taken with mRNA1273 is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis
Clinical narrative: hearing organ music/when she takes her hearing aids out/its the same organ song; This spontaneous case was reported by a patient and describes the occurrence of HYPERACUSIS (hearing organ music/when she takes her hearing aids out/its the same organ song) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A. and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced HYPERACUSIS (hearing organ music/when she takes her hearing aids out/its the same organ song). At the time of the report, HYPERACUSIS (hearing organ music/when she takes her hearing aids out/its the same organ song) outcome was unknown. Not Provided          Concomitant medication included unspecified high blood pressure medication and cholesterol medication.  Treatment information was not provided.  Action taken with mRNA-1273 was not applicable
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Myalgia, Nausea, Pain in extremity
Clinical narrative: Two loose bowel movements/diarrhea; Nausea; large area of redness; aches; itching/terrible itching; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching/terrible itching), PAIN IN EXTREMITY (sore arm), DIARRHOEA (Two loose bowel movements/diarrhea), ERYTHEMA (large area of redness) and MYALGIA (aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010921A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Animal bite (Bitten by rabbit at the age of 6). Previously administered products included for an unreported indication: RABIES (states that she was bitten by a rabbit skunk that had rabies when she was 6 years old).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (itching/terrible itching), PAIN IN EXTREMITY (sore arm) and MYALGIA (aches). On 01-Apr-2021, the patient experienced ERYTHEMA (large area of redness). On 02-Apr-2021, the patient experienced NAUSEA (Nausea). On 03-Apr-2021, the patient experienced DIARRHOEA (Two loose bowel movements/diarrhea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1/3 of a benadryl pill. At the time of the report, PRURITUS (itching/terrible itching), PAIN IN EXTREMITY (sore arm), DIARRHOEA (Two loose bowel movements/diarrhea), ERYTHEMA (large area of redness), MYALGIA (aches) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No new information was provided in follow-up.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-Jun-2021 contains no new information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Two loose bowel movements/diarrhea; Nausea; large area of redness; aches; itching/terrible itching; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching/terrible itching), PAIN IN EXTREMITY (sore arm), DIARRHOEA (Two loose bowel movements/diarrhea), ERYTHEMA (large area of redness) and MYALGIA (aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010921A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Animal bite (Bitten by rabbit at the age of 6). Previously administered products included for an unreported indication: RABIES (states that she was bitten by a rabbit skunk that had rabies when she was 6 years old).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (itching/terrible itching), PAIN IN EXTREMITY (sore arm) and MYALGIA (aches). On 01-Apr-2021, the patient experienced ERYTHEMA (large area of redness). On 02-Apr-2021, the patient experienced NAUSEA (Nausea). On 03-Apr-2021, the patient experienced DIARRHOEA (Two loose bowel movements/diarrhea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1/3 of a benadryl pill. At the time of the report, PRURITUS (itching/terrible itching), PAIN IN EXTREMITY (sore arm), DIARRHOEA (Two loose bowel movements/diarrhea), ERYTHEMA (large area of redness), MYALGIA (aches) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No new information was provided in follow-up.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-Jun-2021 contains no new information.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: having a patient who is about seventeen and one-half years of age receive as their first dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (having a patient who is about seventeen and one-half years of age receive as their first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical adverse events reported.).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (having a patient who is about seventeen and one-half years of age receive as their first dose). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (having a patient who is about seventeen and one-half years of age receive as their first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 008B21-2A) with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling face
Clinical narrative: facial swelling; facial numbness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling) and HYPOAESTHESIA (facial numbness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced SWELLING FACE (facial swelling) and HYPOAESTHESIA (facial numbness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE at a dose of 0.1 percent. At the time of the report, SWELLING FACE (facial swelling) and HYPOAESTHESIA (facial numbness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: warmness at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warmness at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced INJECTION SITE WARMTH (warmness at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site). At the time of the report, INJECTION SITE WARMTH (warmness at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Cough, Headache, Sinus disorder
Clinical narrative: shoulder felt sore; severe headache; cough; thinks it might be COVID; sinus problems; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), COVID-19 (thinks it might be COVID), SINUS DISORDER (sinus problems), ARTHRALGIA (shoulder felt sore) and HEADACHE (severe headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure increased.    On 29-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 COUGH (cough), COVID-19 (thinks it might be COVID) and SINUS DISORDER (sinus problems). On an unknown date, the patient experienced ARTHRALGIA (shoulder felt sore) and HEADACHE (severe headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (cough), COVID-19 (thinks it might be COVID), SINUS DISORDER (sinus problems), ARTHRALGIA (shoulder felt sore) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd Dose, more than 36 days have past since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose, more than 36 days have past since first dose) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose, more than 36 days have past since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose, more than 36 days have past since first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No treatment information was provided
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Insomnia, Myalgia
Clinical narrative: felt "like I was hit by a truck"; loss of appetite; injection site became hard; injection site became hot; injection site became itchy/ severe red with constant itching; injection site became swollen; injection site red/gigantic red patch/large red patch approximately 3" tall and 5-7"wide; tired; nausea; body aches; arm pain; didn't sleep well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), INSOMNIA (didn't sleep well), FEELING ABNORMAL (felt "like I was hit by a truck"), DECREASED APPETITE (loss of appetite) and VACCINATION SITE INDURATION (injection site became hard) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tylenol), Glaucoma since November 2015, Drug allergy (Aspirin), Pollen allergy and Drug allergy. Concomitant products included DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (COSOPT PF) and LATANOPROST for Glaucoma, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and INSOMNIA (didn't sleep well). On 03-Apr-2021, the patient experienced FEELING ABNORMAL (felt "like I was hit by a truck"), DECREASED APPETITE (loss of appetite), VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE WARMTH (injection site became hot), VACCINATION SITE PRURITUS (injection site became itchy/ severe red with constant itching), VACCINATION SITE SWELLING (injection site became swollen), VACCINATION SITE ERYTHEMA (injection site red/gigantic red patch/large red patch approximately 3" tall and 5-7"wide), FATIGUE (tired), NAUSEA (nausea) and MYALGIA (body aches). On 03-Apr-2021, PAIN IN EXTREMITY (arm pain) and INSOMNIA (didn't sleep well) had resolved. On 04-Apr-2021, FEELING ABNORMAL (felt "like I was hit by a truck"), DECREASED APPETITE (loss of appetite), FATIGUE (tired), NAUSEA (nausea) and MYALGIA (body aches) had resolved. On 15-Apr-2021, VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE WARMTH (injection site became hot), VACCINATION SITE PRURITUS (injection site became itchy/ severe red with constant itching), VACCINATION SITE SWELLING (injection site became swollen) and VACCINATION SITE ERYTHEMA (injection site red/gigantic red patch/large red patch approximately 3" tall and 5-7"wide) had resolved.            As treatment the patient was prescribed a topical steroid.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Medical history updated and concomitant medications added. Event recovery date provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: felt "like I was hit by a truck"; loss of appetite; injection site became hard; injection site became hot; injection site became itchy/ severe red with constant itching; injection site became swollen; injection site red/gigantic red patch/large red patch approximately 3" tall and 5-7"wide; tired; nausea; body aches; arm pain; didn't sleep well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), INSOMNIA (didn't sleep well), FEELING ABNORMAL (felt "like I was hit by a truck"), DECREASED APPETITE (loss of appetite) and VACCINATION SITE INDURATION (injection site became hard) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tylenol), Glaucoma since November 2015, Drug allergy (Aspirin), Pollen allergy and Drug allergy. Concomitant products included DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (COSOPT PF) and LATANOPROST for Glaucoma, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and INSOMNIA (didn't sleep well). On 03-Apr-2021, the patient experienced FEELING ABNORMAL (felt "like I was hit by a truck"), DECREASED APPETITE (loss of appetite), VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE WARMTH (injection site became hot), VACCINATION SITE PRURITUS (injection site became itchy/ severe red with constant itching), VACCINATION SITE SWELLING (injection site became swollen), VACCINATION SITE ERYTHEMA (injection site red/gigantic red patch/large red patch approximately 3" tall and 5-7"wide), FATIGUE (tired), NAUSEA (nausea) and MYALGIA (body aches). On 03-Apr-2021, PAIN IN EXTREMITY (arm pain) and INSOMNIA (didn't sleep well) had resolved. On 04-Apr-2021, FEELING ABNORMAL (felt "like I was hit by a truck"), DECREASED APPETITE (loss of appetite), FATIGUE (tired), NAUSEA (nausea) and MYALGIA (body aches) had resolved. On 15-Apr-2021, VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE WARMTH (injection site became hot), VACCINATION SITE PRURITUS (injection site became itchy/ severe red with constant itching), VACCINATION SITE SWELLING (injection site became swollen) and VACCINATION SITE ERYTHEMA (injection site red/gigantic red patch/large red patch approximately 3" tall and 5-7"wide) had resolved.            As treatment the patient was prescribed a topical steroid.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Medical history updated and concomitant medications added. Event recovery date provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: felt "like I was hit by a truck"; loss of appetite; injection site became hard; injection site became hot; injection site became itchy/ severe red with constant itching; injection site became swollen; injection site red/gigantic red patch/large red patch approximately 3" tall and 5-7"wide; tired; nausea; body aches; arm pain; didn't sleep well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), INSOMNIA (didn't sleep well), FEELING ABNORMAL (felt "like I was hit by a truck"), DECREASED APPETITE (loss of appetite) and VACCINATION SITE INDURATION (injection site became hard) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tylenol), Glaucoma since November 2015, Drug allergy (Aspirin), Pollen allergy and Drug allergy. Concomitant products included DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (COSOPT PF) and LATANOPROST for Glaucoma, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and INSOMNIA (didn't sleep well). On 03-Apr-2021, the patient experienced FEELING ABNORMAL (felt "like I was hit by a truck"), DECREASED APPETITE (loss of appetite), VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE WARMTH (injection site became hot), VACCINATION SITE PRURITUS (injection site became itchy/ severe red with constant itching), VACCINATION SITE SWELLING (injection site became swollen), VACCINATION SITE ERYTHEMA (injection site red/gigantic red patch/large red patch approximately 3" tall and 5-7"wide), FATIGUE (tired), NAUSEA (nausea) and MYALGIA (body aches). On 03-Apr-2021, PAIN IN EXTREMITY (arm pain) and INSOMNIA (didn't sleep well) had resolved. On 04-Apr-2021, FEELING ABNORMAL (felt "like I was hit by a truck"), DECREASED APPETITE (loss of appetite), FATIGUE (tired), NAUSEA (nausea) and MYALGIA (body aches) had resolved. On 15-Apr-2021, VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE WARMTH (injection site became hot), VACCINATION SITE PRURITUS (injection site became itchy/ severe red with constant itching), VACCINATION SITE SWELLING (injection site became swollen) and VACCINATION SITE ERYTHEMA (injection site red/gigantic red patch/large red patch approximately 3" tall and 5-7"wide) had resolved.            As treatment the patient was prescribed a topical steroid.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Medical history updated and concomitant medications added. Event recovery date provided.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: sciatic back pain; 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 BACK PAIN (sciatic back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sciatica.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced BACK PAIN (sciatic back pain). At the time of the report, BACK PAIN (sciatic back pain) outcome was unknown. Not Provided          Concomitant product use was not provided. Action taken in response to mRNA-1273 in the event was not applicable. Patient was asking Is it okay  to take prednisone.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm only hurt a little; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (arm only hurt a little) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm only hurt a little). At the time of the report, PAIN IN EXTREMITY (arm only hurt a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: moderna arm: entire upper arm 12long x 3wide inch; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (moderna arm: entire upper arm 12long x 3wide inch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE REACTION (moderna arm: entire upper arm 12long x 3wide inch). The patient was treated with CORTISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (moderna arm: entire upper arm 12long x 3wide inch) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was also taking  "statin" as concomitant medication  Action taken with mRNA-1273 was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-067651 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067651:Crosslinked with dose 1
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills persisted for 03 weeks (occurs during the evening); fever (temperature was a little over a degree over normal); This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills persisted for 03 weeks (occurs during the evening)) and PYREXIA (fever (temperature was a little over a degree over normal)) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (fever (temperature was a little over a degree over normal)). On 14-Mar-2021, the patient experienced CHILLS (Chills persisted for 03 weeks (occurs during the evening)). On 15-Mar-2021, PYREXIA (fever (temperature was a little over a degree over normal)) had resolved. At the time of the report, CHILLS (Chills persisted for 03 weeks (occurs during the evening)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported Treatment information not provided
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Pyrexia, SARS-CoV-2 test, Vaccination complication
Clinical narrative: COVID-19; Weakness; became sick; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ASTHENIA (Weakness), VACCINATION COMPLICATION (became sick) and PYREXIA (fever) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ASTHENIA (Weakness), VACCINATION COMPLICATION (became sick) and PYREXIA (fever). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), ASTHENIA (Weakness), VACCINATION COMPLICATION (became sick) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: positive (Positive) nasal test Rapid antigen. On 30-Mar-2021, SARS-CoV-2 test: positive (Positive) Oropharyngeal RT-PCR.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported.  The patient was diagnosed with COVID-19 on 29MAR2021.  It is unknown whether the patient received the 2nd planned dose scheduled for 07APR2021.  The reporter denied any treatment.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Results of COVID-19 tests provided, symptom of fever and loss of taste for 1 day were reported
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Felt sick for a week after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt sick for a week after vaccination) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN for Diabetic.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Felt sick for a week after vaccination). At the time of the report, VACCINATION COMPLICATION (Felt sick for a week after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported   This case was linked to MOD-2021-067693 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Discomfort, Paraesthesia
Clinical narrative: left side sometimes still feels heavy; side of my face got tingly from eyes to cheek, still tingly; eyelids got heavy; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (left side sometimes still feels heavy), PARAESTHESIA (side of my face got tingly from eyes to cheek, still tingly) and ASTHENOPIA (eyelids got heavy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included POTASSIUM, FUROSEMIDE, ATORVASTATIN, LEVOTHYROXINE and ESCITALOPRAM for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DISCOMFORT (left side sometimes still feels heavy), PARAESTHESIA (side of my face got tingly from eyes to cheek, still tingly) and ASTHENOPIA (eyelids got heavy). At the time of the report, DISCOMFORT (left side sometimes still feels heavy) and PARAESTHESIA (side of my face got tingly from eyes to cheek, still tingly) had not resolved and ASTHENOPIA (eyelids got heavy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous case reported by an other healthcare professional (subsequently medically confirmed), describes the occurrence of hypoesthesia (numbness of upper extremities) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included Crohn's disease since November 2018. Concomitant products included Stelara (ustekinumab) for Crohn's disease. On Feb 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. February 2021, patient experienced hypoesthesia (numbness of upper extremities). At the time of the report, hypoesthesia (numbness of upper extremities): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Tinnitus
Clinical narrative: tinnitus and ringing in the ears after first dose; Has not received her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus and ringing in the ears after first dose) and PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced TINNITUS (tinnitus and ringing in the ears after first dose) and PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose). At the time of the report, TINNITUS (tinnitus and ringing in the ears after first dose) and PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications not provided. Treatment information not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy, Product dose omission issue
Clinical narrative: got pregnant after first dose; did not get second dose; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PREGNANCY (got pregnant after first dose) and PRODUCT DOSE OMISSION ISSUE (did not get second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant Medical History reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Oct-2021. On an unknown date, the patient experienced PREGNANCY (got pregnant after first dose) and PRODUCT DOSE OMISSION ISSUE (did not get second dose). At the time of the report, PREGNANCY (got pregnant after first dose) and PRODUCT DOSE OMISSION ISSUE (did not get second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This is a case of a pregnancy which occurred after the first dose of vaccine. No associated AEs were reported for this 35-year-old female patient. In addition, the patient did not complete vaccination course (2nd dose not given). Patient will continue for further monitoring during the pregnancy
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose fluctuation, Dyschromatopsia, Headache, Myalgia
Clinical narrative: no energy; Sick for 4/5 days after 2nd dose; House appeared yellowish green in color; Fluctuations in blood sugar level; headache; Pain in one part of body and then in other; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (no energy), VACCINATION COMPLICATION (Sick for 4/5 days after 2nd dose), DYSCHROMATOPSIA (House appeared yellowish green in color), BLOOD GLUCOSE FLUCTUATION (Fluctuations in blood sugar level) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 10-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 experienced ASTHENIA (no energy), VACCINATION COMPLICATION (Sick for 4/5 days after 2nd dose), DYSCHROMATOPSIA (House appeared yellowish green in color), BLOOD GLUCOSE FLUCTUATION (Fluctuations in blood sugar level), HEADACHE (headache) and MYALGIA (Pain in one part of body and then in other). At the time of the report, ASTHENIA (no energy), VACCINATION COMPLICATION (Sick for 4/5 days after 2nd dose), DYSCHROMATOPSIA (House appeared yellowish green in color), BLOOD GLUCOSE FLUCTUATION (Fluctuations in blood sugar level), HEADACHE (headache) and MYALGIA (Pain in one part of body and then in other) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medication provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.     This case was linked to MOD-2021-067681 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: no energy; Sick for 4/5 days after 2nd dose; House appeared yellowish green in color; Fluctuations in blood sugar level; headache; Pain in one part of body and then in other; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (no energy), VACCINATION COMPLICATION (Sick for 4/5 days after 2nd dose), DYSCHROMATOPSIA (House appeared yellowish green in color), BLOOD GLUCOSE FLUCTUATION (Fluctuations in blood sugar level) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 10-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 experienced ASTHENIA (no energy), VACCINATION COMPLICATION (Sick for 4/5 days after 2nd dose), DYSCHROMATOPSIA (House appeared yellowish green in color), BLOOD GLUCOSE FLUCTUATION (Fluctuations in blood sugar level), HEADACHE (headache) and MYALGIA (Pain in one part of body and then in other). At the time of the report, ASTHENIA (no energy), VACCINATION COMPLICATION (Sick for 4/5 days after 2nd dose), DYSCHROMATOPSIA (House appeared yellowish green in color), BLOOD GLUCOSE FLUCTUATION (Fluctuations in blood sugar level), HEADACHE (headache) and MYALGIA (Pain in one part of body and then in other) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medication provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.     This case was linked to MOD-2021-067681 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pruritus
Clinical narrative: injection site tiching; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PRURITUS (injection site tiching) 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 UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE PRURITUS (injection site tiching). At the time of the report, INJECTION SITE PRURITUS (injection site tiching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: Tested positive with COVID-19; felt rotten; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive with COVID-19) and FEELING ABNORMAL (felt rotten) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Asthma.    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 COVID-19 (Tested positive with COVID-19) and FEELING ABNORMAL (felt rotten). At the time of the report, COVID-19 (Tested positive with COVID-19) and FEELING ABNORMAL (felt rotten) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, Before vaccination and positive (Positive) Positive, after vaccination.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.   This case was linked to MOD21-069665 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non-Significant follow up appended to AER: contact information On 29-Jul-2021: Significant Follow up received and age of the patient, and one event updated.; Sender's Comments:  MOD21-069665:Patient case