chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: itching; red blotches on my arm; hot at the injection site; became uncomfortable; uncomfortable sleeping on that side; The injection site was itchy; The injection site was red; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), RASH MACULAR (red blotches on my arm), VACCINATION SITE WARMTH (hot at the injection site), ANXIETY (became uncomfortable) and INSOMNIA (uncomfortable sleeping on that side) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriasis.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PRURITUS (itching), RASH MACULAR (red blotches on my arm), VACCINATION SITE WARMTH (hot at the injection site), ANXIETY (became uncomfortable), INSOMNIA (uncomfortable sleeping on that side), VACCINATION SITE PRURITUS (The injection site was itchy), VACCINATION SITE ERYTHEMA (The injection site was red) and VACCINATION SITE PAIN (injection site soreness). At the time of the report, PRURITUS (itching), RASH MACULAR (red blotches on my arm), VACCINATION SITE WARMTH (hot at the injection site), ANXIETY (became uncomfortable), INSOMNIA (uncomfortable sleeping on that side), VACCINATION SITE PRURITUS (The injection site was itchy), VACCINATION SITE ERYTHEMA (The injection site was red) and VACCINATION SITE PAIN (injection site soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details include antihistamine for itching, red blotches on my arm and became uncomfortable and rubbed it with some steroid cream for red blotches had come together and made a big red spot.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Additional information received on 12-May-2021 as contact information updated.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: intermittent watery diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (intermittent watery diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DIARRHOEA (intermittent watery diarrhea). At the time of the report, DIARRHOEA (intermittent watery diarrhea) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable. Action taken with mRNA-1273 in response to the events was not reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Second dose of vaccine to be administered past day 36; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Second dose of vaccine to be administered past day 36) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Second dose of vaccine to be administered past day 36). At the time of the report, OFF LABEL USE (Second dose of vaccine to be administered past day 36) 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 and concomitant medicines were not reported  Action taken with mRNA-1273 in response to the event was unknown
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Tinnitus
Clinical narrative: when he woke up he didn't feel well.; woke up and ears were ringing; woke up with a bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (when he woke up he didn't feel well.), TINNITUS (woke up and ears were ringing) and HEADACHE (woke up with a bad headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MALAISE (when he woke up he didn't feel well.), TINNITUS (woke up and ears were ringing) and HEADACHE (woke up with a bad headache). On 05-Mar-2021, MALAISE (when he woke up he didn't feel well.) and HEADACHE (woke up with a bad headache) had resolved. At the time of the report, TINNITUS (woke up and ears were ringing) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included prednisone. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Headache, Pain in extremity, Rash
Clinical narrative: Sore arm; Rashes to both armpits; Chills; Headache; Black and blue line that went from her left armpit to breast line, which was about 4 inches long; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Black and blue line that went from her left armpit to breast line, which was about 4 inches long), PAIN IN EXTREMITY (Sore arm), RASH (Rashes to both armpits), CHILLS (Chills) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CONTUSION (Black and blue line that went from her left armpit to breast line, which was about 4 inches long), RASH (Rashes to both armpits), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). On 06-Mar-2021, CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, CONTUSION (Black and blue line that went from her left armpit to breast line, which was about 4 inches long), PAIN IN EXTREMITY (Sore arm) and RASH (Rashes to both armpits) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included diphenhydramine. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Pruritus, Urticaria
Clinical narrative: hives-forearms, stomach-left side only-not itchy, Hives on left side of stomach, Hives on face, couldn't see them but felt them; both forearms-itchy; face skin in extremely dry; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives-forearms, stomach-left side only-not itchy, Hives on left side of stomach, Hives on face, couldn't see them but felt them), PRURITUS (both forearms-itchy) and DRY SKIN (face skin in extremely dry) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced URTICARIA (hives-forearms, stomach-left side only-not itchy, Hives on left side of stomach, Hives on face, couldn't see them but felt them), PRURITUS (both forearms-itchy) and DRY SKIN (face skin in extremely dry). At the time of the report, URTICARIA (hives-forearms, stomach-left side only-not itchy, Hives on left side of stomach, Hives on face, couldn't see them but felt them), PRURITUS (both forearms-itchy) and DRY SKIN (face skin in extremely dry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information included lotion.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on face, hands, and genital region; Rash on face, hands, and genital region; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of RASH (Rash on face, hands, and genital region) and the second episode of RASH (Rash on face, hands, and genital region) in a male 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. Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA) and FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced the first episode of RASH (Rash on face, hands, and genital region) and the second episode of RASH (Rash on face, hands, and genital region). At the time of the report, last episode of RASH (Rash on face, hands, and genital region) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Prednisone for 10 days.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Furuncle, Injection site erythema, Pruritus, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: big red bump, like a big giant hive; itchy at the injection site; swollen at the injection site; red at the injection site; arm was itchy in my sleep; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (arm was itchy in my sleep) and FURUNCLE (big red bump, like a big giant hive) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart failure. Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE), METOPROLOL and DIGOXIN for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PRURITUS (arm was itchy in my sleep). On 29-Mar-2021, the patient experienced FURUNCLE (big red bump, like a big giant hive). At the time of the report, PRURITUS (arm was itchy in my sleep) outcome was unknown and FURUNCLE (big red bump, like a big giant hive) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included an unspecified medication for heart failure.  No treatment was received for the events.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal oedema, Oropharyngeal pain
Clinical narrative: nose became swollen on the sides; throat felt sore on the right side; This spontaneous case was reported by a consumer and describes the occurrence of NASAL OEDEMA (nose became swollen on the sides) and OROPHARYNGEAL PAIN (throat felt sore on the right side) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced NASAL OEDEMA (nose became swollen on the sides) and OROPHARYNGEAL PAIN (throat felt sore on the right side). At the time of the report, NASAL OEDEMA (nose became swollen on the sides) and OROPHARYNGEAL PAIN (throat felt sore on the right side) had resolved.            No concomitant medications provided. No treatment information provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Updated Event outcomes of Nasal Edema and Oropharyngeal pain from unknown to Recovered. Updated Rechallenge to Negative Rechallenge on 21-Apr-2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site rash
Clinical narrative: Rash at the site of the injection; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE RASH (Rash at the site of the injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 27-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash at the site of the injection). On 22-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, VACCINATION SITE RASH (Rash at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details include naproxen. Consented for follow-up from safety.Preferred method of contact phone
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Myalgia, Wheezing
Clinical narrative: shortness of breath; wheezing in breast; fatigue; muscle aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), WHEEZING (wheezing in breast), FATIGUE (fatigue) and MYALGIA (muscle aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, LOSARTAN and SIMVASTATIN for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), WHEEZING (wheezing in breast), FATIGUE (fatigue) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), WHEEZING (wheezing in breast), FATIGUE (fatigue) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore; achy; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore), PAIN (achy), FATIGUE (fatigue) and PYREXIA (fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for an unknown indication.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore) and PAIN (achy). On 07-Mar-2021, FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (sore) and PAIN (achy) outcome was unknown. Not Provided          treatment: Tylenol   This case was linked to US-MODERNATX, INC.-MOD-2021-060667 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060667:dose 1(husband case)
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Received the first dose from Pfizer's COVID-19 vaccine and the second dose from Moderna; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received the first dose from Pfizer's COVID-19 vaccine and the second dose from Moderna) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Received the first dose from Pfizer's COVID-19 vaccine and the second dose from Moderna). At the time of the report, WRONG PRODUCT ADMINISTERED (Received the first dose from Pfizer's COVID-19 vaccine and the second dose from Moderna) had resolved.     This case was linked to MOD21-064472, US-MODERNATX, INC.-MOD-2021-060574 (E2B Linked Report).; Reporter's Comments: This report refers to a case of wrong dose administered for mRNA-1273 with no associated AEs.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060574:Same reporter (MOD21-064472)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced HEART RATE INCREASED (rapid heart beat). At the time of the report, HEART RATE INCREASED (rapid heart beat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling, soreness, redness and warmness in the injection site; Swelling, soreness, redness and warmness in the injection site; Swelling, soreness, redness and warmness in the injection site; Swelling, soreness, redness and warmness in the injection site; Soreness of her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of her arm), VACCINATION SITE WARMTH (Swelling, soreness, redness and warmness in the injection site), VACCINATION SITE SWELLING (Swelling, soreness, redness and warmness in the injection site), VACCINATION SITE ERYTHEMA (Swelling, soreness, redness and warmness in the injection site) and VACCINATION SITE PAIN (Swelling, soreness, redness and warmness in the injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of her arm). On 28-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Swelling, soreness, redness and warmness in the injection site), VACCINATION SITE SWELLING (Swelling, soreness, redness and warmness in the injection site), VACCINATION SITE ERYTHEMA (Swelling, soreness, redness and warmness in the injection site) and VACCINATION SITE PAIN (Swelling, soreness, redness and warmness in the injection site). On 26-Mar-2021, PAIN IN EXTREMITY (Soreness of her arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (Swelling, soreness, redness and warmness in the injection site), VACCINATION SITE SWELLING (Swelling, soreness, redness and warmness in the injection site), VACCINATION SITE ERYTHEMA (Swelling, soreness, redness and warmness in the injection site) and VACCINATION SITE PAIN (Swelling, soreness, redness and warmness in the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-060735 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-060735:Son's Case
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Dizziness, Fatigue, Feeling jittery, Hypoaesthesia
Clinical narrative: seeing double; blurred vision; numbness in nose and cheek areas on both side; felt jittery; dizzy; continued to be tired; slept all day; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day), DIPLOPIA (seeing double), VISION BLURRED (blurred vision), HYPOAESTHESIA (numbness in nose and cheek areas on both side) and FEELING JITTERY (felt jittery) in a 59-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 No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced SOMNOLENCE (slept all day). On 28-Mar-2021, the patient experienced FATIGUE (continued to be tired). On 29-Mar-2021, the patient experienced FEELING JITTERY (felt jittery) and DIZZINESS (dizzy). On an unknown date, the patient experienced DIPLOPIA (seeing double), VISION BLURRED (blurred vision) and HYPOAESTHESIA (numbness in nose and cheek areas on both side). At the time of the report, SOMNOLENCE (slept all day), DIPLOPIA (seeing double), VISION BLURRED (blurred vision), HYPOAESTHESIA (numbness in nose and cheek areas on both side), FEELING JITTERY (felt jittery), DIZZINESS (dizzy) and FATIGUE (continued to be tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vision blurred
Clinical narrative: seeing double; blurred vision; numbness in nose and cheek areas on both side; felt jittery; dizzy; continued to be tired; slept all day; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day), DIPLOPIA (seeing double), VISION BLURRED (blurred vision), HYPOAESTHESIA (numbness in nose and cheek areas on both side) and FEELING JITTERY (felt jittery) in a 59-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 No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced SOMNOLENCE (slept all day). On 28-Mar-2021, the patient experienced FATIGUE (continued to be tired). On 29-Mar-2021, the patient experienced FEELING JITTERY (felt jittery) and DIZZINESS (dizzy). On an unknown date, the patient experienced DIPLOPIA (seeing double), VISION BLURRED (blurred vision) and HYPOAESTHESIA (numbness in nose and cheek areas on both side). At the time of the report, SOMNOLENCE (slept all day), DIPLOPIA (seeing double), VISION BLURRED (blurred vision), HYPOAESTHESIA (numbness in nose and cheek areas on both side), FEELING JITTERY (felt jittery), DIZZINESS (dizzy) and FATIGUE (continued to be tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Discomfort, Hyperhidrosis, Injection site erythema
Clinical narrative: redness around injection site; fever; felt like I'd been run over; severe chills; Palpitations; Felt shity; weak; poor sleep; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Palpitations), DISCOMFORT (Felt shity), ASTHENIA (weak), POOR QUALITY SLEEP (poor sleep) and HYPERHIDROSIS (felt like I'd been run over) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PALPITATIONS (Palpitations), DISCOMFORT (Felt shity), ASTHENIA (weak), POOR QUALITY SLEEP (poor sleep) and CHILLS (severe chills). On 26-Mar-2021, the patient experienced HYPERHIDROSIS (felt like I'd been run over) and PYREXIA (fever). On 29-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness around injection site). At the time of the report, PALPITATIONS (Palpitations), DISCOMFORT (Felt shity), ASTHENIA (weak), POOR QUALITY SLEEP (poor sleep), HYPERHIDROSIS (felt like I'd been run over), CHILLS (severe chills), PYREXIA (fever) and INJECTION SITE ERYTHEMA (redness around injection site) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Poor quality sleep, Pyrexia
Clinical narrative: redness around injection site; fever; felt like I'd been run over; severe chills; Palpitations; Felt shity; weak; poor sleep; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Palpitations), DISCOMFORT (Felt shity), ASTHENIA (weak), POOR QUALITY SLEEP (poor sleep) and HYPERHIDROSIS (felt like I'd been run over) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PALPITATIONS (Palpitations), DISCOMFORT (Felt shity), ASTHENIA (weak), POOR QUALITY SLEEP (poor sleep) and CHILLS (severe chills). On 26-Mar-2021, the patient experienced HYPERHIDROSIS (felt like I'd been run over) and PYREXIA (fever). On 29-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness around injection site). At the time of the report, PALPITATIONS (Palpitations), DISCOMFORT (Felt shity), ASTHENIA (weak), POOR QUALITY SLEEP (poor sleep), HYPERHIDROSIS (felt like I'd been run over), CHILLS (severe chills), PYREXIA (fever) and INJECTION SITE ERYTHEMA (redness around injection site) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Vaccination site pain
Clinical narrative: sick; Headache.; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache.) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced ILLNESS (sick) and HEADACHE (Headache.). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache.) outcome was unknown.            No concomitant medication details were provided. Treatment information included Tylenol.   This case was linked to MOD-2021-060870 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: AE updated in TCR form.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peroneal nerve palsy, Spinal stenosis, Vaccination site pain
Clinical narrative: drop foot; spinal stenosis; hands and legs ache; pain at injection left; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection left), PAIN IN EXTREMITY (hands and legs ache), PERONEAL NERVE PALSY (drop foot) and SPINAL STENOSIS (spinal stenosis) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and CLOPIDOGREL for an unknown indication.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection left), PAIN IN EXTREMITY (hands and legs ache), PERONEAL NERVE PALSY (drop foot) and SPINAL STENOSIS (spinal stenosis). At the time of the report, VACCINATION SITE PAIN (pain at injection left), PAIN IN EXTREMITY (hands and legs ache), PERONEAL NERVE PALSY (drop foot) and SPINAL STENOSIS (spinal stenosis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Poor quality product administered, SARS-CoV-2 test
Clinical narrative: Diagnosed with COVID/Allergy like symptoms/A little tired/Nasal congestion/runny nose; Maybe a concern vaccine lot might have been bad/not good; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID/Allergy like symptoms/A little tired/Nasal congestion/runny nose) and DRUG INEFFECTIVE (Lack of drug effect) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 immunisation.     Concurrent medical conditions included Penicillin allergy (possible amoxicillin) and Allergy to intravenous contrast media (IVP dye).   On 12-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Diagnosed with COVID/Allergy like symptoms/A little tired/Nasal congestion/runny nose) and DRUG INEFFECTIVE (Lack of drug effect). On 16-Mar-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (Diagnosed with COVID/Allergy like symptoms/A little tired/Nasal congestion/runny nose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.         The patient reported taking no concomitant medications.  The patient stated that she had no reaction to the vaccine. She had a rapid COVID-19 antigen test on 16-Mar-2021 when she was fully vaccinated, and tested positive. The only reason the patient got tested was due to her non-vaccinated husband and son testing positive. She only experienced allergy-like symptoms (reported as nasal congestion and runny nose) for about 4-5 days and was a little tired. The patient also reported maybe a concern the vaccine lot might have been bad/not good. The patient had no treatment. This is a case of lack of efficacy of the vaccine. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.   This case was linked to MOD-2021-185476 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Upon internal review on 11-AUG-2021, an event lack of effect was added to the case. On 27-May-2021: Completed VAERs form. Event of poor quality vaccine administered added. Event of COVID-19 updated. Event of nasopharyngitis removed (considered symptom of COVID-19).; Sender's Comments: This is a case of lack of efficacy of the vaccine. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: missed second dosage; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed second dosage) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed second dosage). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed second dosage) outcome was unknown. Not Provided          No concomitant medications  information was reported.  No Treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Followup received on 15-jun-2021 and 2nd dose updated, no AE
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose of vaccine to be administered past day 36; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose of vaccine to be administered past day 36) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose of vaccine to be administered past day 36). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose of vaccine to be administered past day 36) 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.   No concomitant medication included.  No treatment medication included.  No side effects reported by the patient after the first dose.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: She experienced dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She experienced dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (She experienced dizziness). At the time of the report, DIZZINESS (She experienced dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Feeling abnormal, Hyperhidrosis
Clinical narrative: red circle around the injection site; sweated through my sheets; temperature was 103°F; weak; severe chills; heart palpitations; felt shitty; had poor sleep; My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), FEELING ABNORMAL (felt shitty), SLEEP DISORDER (had poor sleep), HYPERHIDROSIS (sweated through my sheets) and BODY TEMPERATURE INCREASED (temperature was 103°F) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    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 VACCINATION SITE PAIN (My arm was sore at the injection site). On 25-Mar-2021, the patient experienced PALPITATIONS (heart palpitations), FEELING ABNORMAL (felt shitty), SLEEP DISORDER (had poor sleep), ASTHENIA (weak) and CHILLS (severe chills). On 26-Mar-2021, the patient experienced HYPERHIDROSIS (sweated through my sheets) and BODY TEMPERATURE INCREASED (temperature was 103°F). On 29-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle around the injection site). At the time of the report, PALPITATIONS (heart palpitations), FEELING ABNORMAL (felt shitty), SLEEP DISORDER (had poor sleep), HYPERHIDROSIS (sweated through my sheets), BODY TEMPERATURE INCREASED (temperature was 103°F), ASTHENIA (weak), CHILLS (severe chills), VACCINATION SITE PAIN (My arm was sore at the injection site) and VACCINATION SITE ERYTHEMA (red circle around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Sleep disorder, Vaccination site erythema, Vaccination site pain
Clinical narrative: red circle around the injection site; sweated through my sheets; temperature was 103°F; weak; severe chills; heart palpitations; felt shitty; had poor sleep; My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), FEELING ABNORMAL (felt shitty), SLEEP DISORDER (had poor sleep), HYPERHIDROSIS (sweated through my sheets) and BODY TEMPERATURE INCREASED (temperature was 103°F) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    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 VACCINATION SITE PAIN (My arm was sore at the injection site). On 25-Mar-2021, the patient experienced PALPITATIONS (heart palpitations), FEELING ABNORMAL (felt shitty), SLEEP DISORDER (had poor sleep), ASTHENIA (weak) and CHILLS (severe chills). On 26-Mar-2021, the patient experienced HYPERHIDROSIS (sweated through my sheets) and BODY TEMPERATURE INCREASED (temperature was 103°F). On 29-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle around the injection site). At the time of the report, PALPITATIONS (heart palpitations), FEELING ABNORMAL (felt shitty), SLEEP DISORDER (had poor sleep), HYPERHIDROSIS (sweated through my sheets), BODY TEMPERATURE INCREASED (temperature was 103°F), ASTHENIA (weak), CHILLS (severe chills), VACCINATION SITE PAIN (My arm was sore at the injection site) and VACCINATION SITE ERYTHEMA (red circle around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-074957 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074957:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: vomiting; Chills; Nausea; headache; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (vomiting), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 27-Mar-2021, the patient experienced VOMITING (vomiting), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (headache). On 27-Mar-2021, DIARRHOEA (Diarrhea), VOMITING (vomiting), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details not provided
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash, Vaccination site erythema, Vaccination site warmth
Clinical narrative: injection site slightly warm; a liitle rash; red spots at the injection site; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site slightly warm), RASH (a liitle rash), VACCINATION SITE ERYTHEMA (red spots at the injection site) and MYALGIA (soreness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history was not reported.).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site slightly warm), RASH (a liitle rash), VACCINATION SITE ERYTHEMA (red spots at the injection site) and MYALGIA (soreness). At the time of the report, VACCINATION SITE WARMTH (injection site slightly warm), RASH (a liitle rash), VACCINATION SITE ERYTHEMA (red spots at the injection site) and MYALGIA (soreness) outcome was unknown. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information was not reported
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: fatigue; fever of 101 degrees F; hurting all over; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever of 101 degrees F) and PAIN (hurting all over) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (hurting all over). On 07-Mar-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever of 101 degrees F). On 07-Mar-2021, FATIGUE (fatigue), PYREXIA (fever of 101 degrees F) and PAIN (hurting all over) had resolved. Not Provided          No concomitant medication is provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-060651 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060651:dose 2(husband case)