chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity, Pregnancy test, Ultrasound foetal, Ultrasound scan
Clinical narrative: Received the first shot of the Moderna vaccine while pregnant; Sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received the first shot of the Moderna vaccine while pregnant) and PAIN IN EXTREMITY (Sore arm) in a 35-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (4 drinks/week, Stopped on 12Aug2020) on 12-Aug-2020. Concurrent medical conditions included Penicillin allergy. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 25-Feb-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 12-Jul-2020 and the estimated date of delivery was 20-Apr-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received the first shot of the Moderna vaccine while pregnant) and PAIN IN EXTREMITY (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy. The vaginal delivery occurred in April 2021, which was reported as Full-term. For neonate 1, the birth weight was 3620 grams (7lbs 16oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Unknown. Head circumference 34. On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received the first shot of the Moderna vaccine while pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2020, Pregnancy test: positive (Positive) Positive. On 25-Nov-2020, Ultrasound scan: (normal) Anatomy Scan. On an unknown date, Ultrasound foetal: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided   This case was linked to MOD-2021-201600 (Parent-Child Link).   See case MOD-2021-201600 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up appended to AER on 2-jun-2021: Patient Race ,Ethnicity, Medical history ,Allergies , LMP ,lab test, Delivery Date , and Infant details updated.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: felt dizzy/so dizzy that a man sitting next to her had to grab her to steady her.; This spontaneous case was reported by a consumer and describes the occurrence of   in an 81-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 (past medical history not provided).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Myalgia
Clinical narrative: Felt like the sensation after chemo; Felt extremely tired; Body was aching; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like the sensation after chemo), FATIGUE (Felt extremely tired) and MYALGIA (Body was aching) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (12 years ago,received chemo).    On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (Felt like the sensation after chemo), FATIGUE (Felt extremely tired) and MYALGIA (Body was aching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Feb-2021, FEELING ABNORMAL (Felt like the sensation after chemo), FATIGUE (Felt extremely tired) and MYALGIA (Body was aching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information as not reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Dyspnoea, Headache
Clinical narrative: no sense of taste; no sense of smell; felt like a head cold; throat felt like it was swollen; hard to breath; dry cough; throat felt like it was tingly; throat felt as if something was in it; pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), NASOPHARYNGITIS (felt like a head cold), PHARYNGEAL SWELLING (throat felt like it was swollen) and DYSPNOEA (hard to breath) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes mellitus (from past 49 years) since an unknown date.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), NASOPHARYNGITIS (felt like a head cold), PHARYNGEAL SWELLING (throat felt like it was swollen), DYSPNOEA (hard to breath), COUGH (dry cough), THROAT IRRITATION (throat felt like it was tingly), OROPHARYNGEAL DISCOMFORT (throat felt as if something was in it) and HEADACHE (pounding headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), NASOPHARYNGITIS (felt like a head cold), PHARYNGEAL SWELLING (throat felt like it was swollen), DYSPNOEA (hard to breath), COUGH (dry cough), OROPHARYNGEAL DISCOMFORT (throat felt as if something was in it) and HEADACHE (pounding headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal discomfort, Pharyngeal swelling, Throat irritation
Clinical narrative: no sense of taste; no sense of smell; felt like a head cold; throat felt like it was swollen; hard to breath; dry cough; throat felt like it was tingly; throat felt as if something was in it; pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), NASOPHARYNGITIS (felt like a head cold), PHARYNGEAL SWELLING (throat felt like it was swollen) and DYSPNOEA (hard to breath) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes mellitus (from past 49 years) since an unknown date.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), NASOPHARYNGITIS (felt like a head cold), PHARYNGEAL SWELLING (throat felt like it was swollen), DYSPNOEA (hard to breath), COUGH (dry cough), THROAT IRRITATION (throat felt like it was tingly), OROPHARYNGEAL DISCOMFORT (throat felt as if something was in it) and HEADACHE (pounding headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), NASOPHARYNGITIS (felt like a head cold), PHARYNGEAL SWELLING (throat felt like it was swollen), DYSPNOEA (hard to breath), COUGH (dry cough), OROPHARYNGEAL DISCOMFORT (throat felt as if something was in it) and HEADACHE (pounding headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Nasal congestion
Clinical narrative: Weak; Tired; Chills; Low grade fever 101; Aches; Like my nose was stuffy; Arm very painful; like a truck had run over me/was a mess yesterday; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aches), ASTHENIA (Weak), NASAL CONGESTION (Like my nose was stuffy), PAIN IN EXTREMITY (Arm very painful) and FEELING ABNORMAL (like a truck had run over me/was a mess yesterday) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Aches), NASAL CONGESTION (Like my nose was stuffy), PAIN IN EXTREMITY (Arm very painful), FEELING ABNORMAL (like a truck had run over me/was a mess yesterday), CHILLS (Chills) and PYREXIA (Low grade fever 101). On 26-Feb-2021, the patient experienced FATIGUE (Tired). On an unknown date, the patient experienced ASTHENIA (Weak). At the time of the report, PAIN IN EXTREMITY (Aches), ASTHENIA (Weak), NASAL CONGESTION (Like my nose was stuffy), PAIN IN EXTREMITY (Arm very painful), FEELING ABNORMAL (like a truck had run over me/was a mess yesterday), FATIGUE (Tired), CHILLS (Chills) and PYREXIA (Low grade fever 101) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Weak; Tired; Chills; Low grade fever 101; Aches; Like my nose was stuffy; Arm very painful; like a truck had run over me/was a mess yesterday; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aches), ASTHENIA (Weak), NASAL CONGESTION (Like my nose was stuffy), PAIN IN EXTREMITY (Arm very painful) and FEELING ABNORMAL (like a truck had run over me/was a mess yesterday) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Aches), NASAL CONGESTION (Like my nose was stuffy), PAIN IN EXTREMITY (Arm very painful), FEELING ABNORMAL (like a truck had run over me/was a mess yesterday), CHILLS (Chills) and PYREXIA (Low grade fever 101). On 26-Feb-2021, the patient experienced FATIGUE (Tired). On an unknown date, the patient experienced ASTHENIA (Weak). At the time of the report, PAIN IN EXTREMITY (Aches), ASTHENIA (Weak), NASAL CONGESTION (Like my nose was stuffy), PAIN IN EXTREMITY (Arm very painful), FEELING ABNORMAL (like a truck had run over me/was a mess yesterday), FATIGUE (Tired), CHILLS (Chills) and PYREXIA (Low grade fever 101) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Body aches; Injection site swelling; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and PAIN (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) 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) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and PAIN (Body aches). At the time of the report, INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and PAIN (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Lymphadenopathy, Pain in extremity, Vaccination site swelling
Clinical narrative: Chills; swollen lymph node in armpit; still painfull; Vaccination site swelling; Vaccination site redness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    A spontaneous report  was received from a health care professional concerning a 68-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed serious chills and a swollen lymph node in the armpit Redness and swelling at the vaccination site..       The patient's medical history was reported  that she is cancer survivor and had undergone mastectomy 2.5 years ago.. Products known to have been used by the patient, within two weeks prior to the event, was not reported.     On 18 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 19 Jan 2021, the patient developed vaccination site redness and swelling .  Treatment for the event was not reported. On 16 Jan 2021 ,the patient developed severe chills, swollen lymph node in the armpit and pain .Treatment for event was not reported.     Action taken with mRNA-1273 in response to the event was not reported.      The outcome of the event, vaccination site redness and swelling, severe chills, swollen lymph node in the armpit  , was considered recovering/resolving.  The outcome of the event, Pain, not recovered.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: A little pain; Low grade fever 100.1 f; Mild Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little pain), PYREXIA (Low grade fever 100.1 f) and HEADACHE (Mild Headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (A little pain), PYREXIA (Low grade fever 100.1 f) and HEADACHE (Mild Headache). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (A little pain), PYREXIA (Low grade fever 100.1 f) and HEADACHE (Mild Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 degree Celsius (High) 100.1 degree Celsius.     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 medication details not provided by the reporter.    This case was linked to MOD-2021-027745 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Myalgia, Nausea
Clinical narrative: flu like side effects; Achy; Tired; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like side effects), MYALGIA (Achy), FATIGUE (Tired) and NAUSEA (nauseated) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like side effects), MYALGIA (Achy), FATIGUE (Tired) and NAUSEA (nauseated). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like side effects), MYALGIA (Achy), FATIGUE (Tired) and NAUSEA (nauseated) had resolved.            She mentioned the first one didn't bother her at all.  Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: headache; body ache; temperature 99; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN (body ache) and PYREXIA (temperature 99) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 HEADACHE (headache), PAIN (body ache) and PYREXIA (temperature 99). At the time of the report, HEADACHE (headache), PAIN (body ache) and PYREXIA (temperature 99) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: patient who is having a delayed reaction from the first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (patient who is having a delayed reaction from the first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (patient who is having a delayed reaction from the first shot). At the time of the report, VACCINATION SITE REACTION (patient who is having a delayed reaction from the first shot) outcome was unknown. Not Provided      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  information was  provided. No Treatment information was  provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Photophobia, Pyrexia
Clinical narrative: sensitive to light; fever of 102.9 F; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (sensitive to light), PYREXIA (fever of 102.9 F) and HEADACHE (bad headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-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 PHOTOPHOBIA (sensitive to light), PYREXIA (fever of 102.9 F) and HEADACHE (bad headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, q6h and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK, q6h. At the time of the report, PHOTOPHOBIA (sensitive to light), PYREXIA (fever of 102.9 F) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (Inconclusive) 100.1.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received Motrin and Tylenol every six hour but it did not help.   This case was linked to MOD-2021-027714 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscles get so sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscles get so sore) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscles get so sore). At the time of the report, MYALGIA (Muscles get so sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant concomitant medications reported.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Illness, Nausea, Pain in extremity
Clinical narrative: stomach problems and feeling bad; feel sick; arm little sore; Nauseous, very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach problems and feeling bad), ILLNESS (feel sick), PAIN IN EXTREMITY (arm little sore) and NAUSEA (Nauseous, very uncomfortable) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 043L20A) for COVID-19 vaccination.     Concomitant products included ONDANSETRON for Product used for unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach problems and feeling bad), ILLNESS (feel sick), PAIN IN EXTREMITY (arm little sore) and NAUSEA (Nauseous, very uncomfortable). At the time of the report, ABDOMINAL DISCOMFORT (stomach problems and feeling bad), ILLNESS (feel sick), PAIN IN EXTREMITY (arm little sore) and NAUSEA (Nauseous, very uncomfortable) outcome was unknown.            Reporter did not allow further contact
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Pruritus
Clinical narrative: Hot; Itchiness around injection site; Red; worse when touched; A spontaneous report was received from a nurse concerning a 87-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Injection site warmth, Pruritus, erythema and Pruritus aggravated.  The patient's medical history, as provided by the reporter, included breast cancer. Concomitant medications reported included levothyroxine 50mcg, gabapentin 300mg, tylenol 500mg TID, osteo bi-flex, lidocaine cream 4%, Magnesium 250mg BID, multivitamin, prolia Q6M, fresh optic BID, Vitc + Vit. D3.  On 12 Feb 2021, approximately eight days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection. Patient cannot get vaccination on her right arm due to the medical history of breast cancer.  On 19 Feb 2021, prior to receiving mRNA-1273, the patient felt itchiness,heat on and around the injection site. Also patient still has itchiness and got worsened when touched. Treatment taken for the event itchiness was included as Cortisone Cream. Action taken with mRNA-1273 in response to the events was not reported.   No laboratory report was provided.  All the events were considered as unresolved.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of hyperhidrosis (sweated), headache, myalgia (body aches) and chills in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 015M20A) for COVID-19 immunization. No medical history reported. On Feb 25, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Feb 25, 2021, patient experienced hyperhidrosis (sweated). On Feb 25, 2021, at 5:30 pm, patient experienced chills. On Feb 26, 2021, patient experienced headache and myalgia (body aches). At the time of the report, hyperhidrosis (sweated), headache, myalgia (body aches) outcome: unknown; and chills: resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia, Taste disorder, Tremor
Clinical narrative: Shaking; The taste in her mouth was different; Pain all over body; Fever; Vomiting; Pain injection site; A spontaneous report was received from a consumer concerning a 43 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had a fever 102f, vomiting, shaking, the taste in her mouth was different. and she had pain all over the body.  The patient's medical history was COVID-19 provided by the reporter. Concomitant medication was not reported.  On 23 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031M20A) via intramuscular route in her right arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the events had a fever 102f, vomiting, shaking, the taste in her mouth was different. and she had pain all over the body. Treatment included advil and Tylenol were provided by the reporter.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, had a fever 102f, vomiting, shaking, the taste in her mouth was different. and she had pain all over the body were unknown at the time of this report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Shaking; The taste in her mouth was different; Pain all over body; Fever; Vomiting; Pain injection site; A spontaneous report was received from a consumer concerning a 43 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had a fever 102f, vomiting, shaking, the taste in her mouth was different. and she had pain all over the body.  The patient's medical history was COVID-19 provided by the reporter. Concomitant medication was not reported.  On 23 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031M20A) via intramuscular route in her right arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the events had a fever 102f, vomiting, shaking, the taste in her mouth was different. and she had pain all over the body. Treatment included advil and Tylenol were provided by the reporter.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, had a fever 102f, vomiting, shaking, the taste in her mouth was different. and she had pain all over the body were unknown at the time of this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Injection site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of injection site pain (sore at the injection site) and COVID-19 (she tested positive for COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 2, 2021, patient experienced injection site pain (sore at the injection site). On Feb 13, 2021, patient experienced COVID-19 (she tested positive for COVID-19). At the time of the report, injection site pain (sore at the injection site) and COVID-19 (she tested positive for COVID-19) outcome: unknown. Diagnostic results: On Feb 13, 2021, COVID-19: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: side effects after second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects after second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Past medical history not provided).    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 ADVERSE DRUG REACTION (side effects after second dose). At the time of the report, ADVERSE DRUG REACTION (side effects after second dose) outcome was unknown.            Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing; Running nose; Flu like symptom; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), RHINORRHOEA (Running nose) and INFLUENZA LIKE ILLNESS (Flu like symptom) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M208) 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 25-Feb-2021, the patient experienced SNEEZING (Sneezing), RHINORRHOEA (Running nose) and INFLUENZA LIKE ILLNESS (Flu like symptom). At the time of the report, SNEEZING (Sneezing), RHINORRHOEA (Running nose) and INFLUENZA LIKE ILLNESS (Flu like symptom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Anorexia; Headache; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Anorexia), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DECREASED APPETITE (Anorexia), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, DECREASED APPETITE (Anorexia), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red spot on the arm a little bigger than a quarter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot on the arm a little bigger than a quarter) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 VACCINATION SITE ERYTHEMA (Red spot on the arm a little bigger than a quarter). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot on the arm a little bigger than a quarter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: On 5/28/2021 I went to the emergency room after experiencing chest and jaw pain that radiated down the back of my arms. I was diagnosed with a heart attack and admitted for a cardiac cath. I did not receive a stent as they did not initially find any blockages however, upon further review a small blockage was found but it did not require a stent. After follow up I was diagnosed with a myocardial infarction, coronary artery disease with angina. After the cardiac MRI I was diagnosed with myopericarditis as well.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchiness; Reddish color; A spontaneous report was received from a consumer concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events reddish color/vaccination site erythema and itchiness/pruritus.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A)via unknown route for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient developed reddish color and itchiness.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown   The outcome of events- reddish color and  itchiness -was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling jittery, Limb discomfort, Lip swelling
Clinical narrative: Jittery; Dizzy; Swollen upper lip; Pain from elbow down to hand; This spontaneous case was reported by a consumer and describes the occurrence of FEELING JITTERY (Jittery), DIZZINESS (Dizzy), LIP SWELLING (Swollen upper lip) and LIMB DISCOMFORT (Pain from elbow down to hand) in a patient of an unknown age and gender 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 26-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 FEELING JITTERY (Jittery), DIZZINESS (Dizzy), LIP SWELLING (Swollen upper lip) and LIMB DISCOMFORT (Pain from elbow down to hand). At the time of the report, FEELING JITTERY (Jittery), DIZZINESS (Dizzy), LIP SWELLING (Swollen upper lip) and LIMB DISCOMFORT (Pain from elbow down to hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Did not feel so great; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and FEELING ABNORMAL (Did not feel so great) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder since an unknown date. Concomitant products included TOFACITINIB CITRATE (XELJANZ) for Autoimmune disorder, HYDROCHLOROTHIAZIDE and RAMIPRIL for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 22-Jan-2021, the patient experienced FEELING ABNORMAL (Did not feel so great). On 23-Jan-2021, PAIN IN EXTREMITY (Pain in arm) and FEELING ABNORMAL (Did not feel so great) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information included Haif a Benadryl, Methylprednisolone and inhaler.    This case was linked to MOD-2021-027856 (E2B Linked Report).; Sender's Comments:  MOD-2021-027856:Same patient, 2nd dose
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test, Vaccination site movement impairment
Clinical narrative: limitation of movement on the left arm where the vaccine was administered; body aches; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (limitation of movement on the left arm where the vaccine was administered), PAIN (body aches), PYREXIA (fever) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (body aches), PYREXIA (fever) and CHILLS (chills). On 28-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (limitation of movement on the left arm where the vaccine was administered). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 29-Jan-2021, PAIN (body aches), PYREXIA (fever) and CHILLS (chills) had resolved. On 30-Jan-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (limitation of movement on the left arm where the vaccine was administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.    This case was linked to MOD-2021-027839 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Ear infection, Oropharyngeal pain
Clinical narrative: sore throat; ear infection; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and EAR INFECTION (ear infection) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and EAR INFECTION (ear infection). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and EAR INFECTION (ear infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Nasopharyngitis, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Cold; COVID arm (red and swollen on the vaccination arm); COVID arm (red and swollen on the vaccination arm); Lymph node on neck; Felt achy; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), MYALGIA (Felt achy), VACCINATION SITE ERYTHEMA (COVID arm (red and swollen on the vaccination arm)), VACCINATION SITE SWELLING (COVID arm (red and swollen on the vaccination arm)) and LYMPHADENOPATHY (Lymph node on neck) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (Felt achy). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), VACCINATION SITE ERYTHEMA (COVID arm (red and swollen on the vaccination arm)), VACCINATION SITE SWELLING (COVID arm (red and swollen on the vaccination arm)) and LYMPHADENOPATHY (Lymph node on neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold) and LYMPHADENOPATHY (Lymph node on neck) outcome was unknown, MYALGIA (Felt achy) and VACCINATION SITE ERYTHEMA (COVID arm (red and swollen on the vaccination arm)) had resolved and VACCINATION SITE SWELLING (COVID arm (red and swollen on the vaccination arm)) 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 considered NASOPHARYNGITIS (Cold) to be not related. No further causality assessments were provided for MYALGIA (Felt achy), VACCINATION SITE ERYTHEMA (COVID arm (red and swollen on the vaccination arm)), VACCINATION SITE SWELLING (COVID arm (red and swollen on the vaccination arm)) and LYMPHADENOPATHY (Lymph node on neck).    No concomitant medication reported
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: temperature of 102 F and felt achy and feverish.; flu like symptoms; 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 INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (temperature of 102 F and felt achy and feverish.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-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 INFLUENZA LIKE ILLNESS (flu like symptoms). On an unknown date, the patient experienced PYREXIA (temperature of 102 F and felt achy and feverish.). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and PYREXIA (temperature of 102 F and felt achy and feverish.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: racing heart (130 beats per minute, resting); could not stand up because the body pain was so intense; fever (T-104.4F); chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (racing heart (130 beats per minute, resting)), MYALGIA (could not stand up because the body pain was so intense), PYREXIA (fever (T-104.4 F)) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) 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) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced HEART RATE INCREASED (racing heart (130 beats per minute, resting)), MYALGIA (could not stand up because the body pain was so intense), PYREXIA (fever (T-104.4F)) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (racing heart (130 beats per minute, resting)), MYALGIA (could not stand up because the body pain was so intense), PYREXIA (fever (T-104.4F)) and CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: negative (Inconclusive) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-027834 (Patient Link).