chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Burning sensation, Chills, Fatigue, Myalgia
Clinical narrative: Fatigue; Chills; Muscle aches and pains,/other pain; I experienced an allergic reaction to the first injection; The injection site was real sore, and it came into the inside part of my arm; All swollen; My arm was of two different colors; Warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (I experienced an allergic reaction to the first injection), VACCINATION SITE PAIN (The injection site was real sore, and it came into the inside part of my arm), SWELLING (All swollen), SKIN DISCOLOURATION (My arm was of two different colors) and BURNING SENSATION (Warm to the touch) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced ALLERGY TO VACCINE (I experienced an allergic reaction to the first injection), VACCINATION SITE PAIN (The injection site was real sore, and it came into the inside part of my arm), SWELLING (All swollen), SKIN DISCOLOURATION (My arm was of two different colors) and BURNING SENSATION (Warm to the touch). On an unknown date, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Muscle aches and pains,/other pain). On 20-May-2021, ALLERGY TO VACCINE (I experienced an allergic reaction to the first injection), VACCINATION SITE PAIN (The injection site was real sore, and it came into the inside part of my arm), SWELLING (All swollen), SKIN DISCOLOURATION (My arm was of two different colors) and BURNING SENSATION (Warm to the touch) had resolved. At the time of the report, FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Muscle aches and pains,/other pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported concomitant medication for blood pressure.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Swelling, Vaccination site pain
Clinical narrative: Fatigue; Chills; Muscle aches and pains,/other pain; I experienced an allergic reaction to the first injection; The injection site was real sore, and it came into the inside part of my arm; All swollen; My arm was of two different colors; Warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (I experienced an allergic reaction to the first injection), VACCINATION SITE PAIN (The injection site was real sore, and it came into the inside part of my arm), SWELLING (All swollen), SKIN DISCOLOURATION (My arm was of two different colors) and BURNING SENSATION (Warm to the touch) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced ALLERGY TO VACCINE (I experienced an allergic reaction to the first injection), VACCINATION SITE PAIN (The injection site was real sore, and it came into the inside part of my arm), SWELLING (All swollen), SKIN DISCOLOURATION (My arm was of two different colors) and BURNING SENSATION (Warm to the touch). On an unknown date, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Muscle aches and pains,/other pain). On 20-May-2021, ALLERGY TO VACCINE (I experienced an allergic reaction to the first injection), VACCINATION SITE PAIN (The injection site was real sore, and it came into the inside part of my arm), SWELLING (All swollen), SKIN DISCOLOURATION (My arm was of two different colors) and BURNING SENSATION (Warm to the touch) had resolved. At the time of the report, FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Muscle aches and pains,/other pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported concomitant medication for blood pressure.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia, Somnolence
Clinical narrative: very sleepy; and then was asleep; wake up with fever of 101.2 to 102; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (very sleepy), INSOMNIA (and then was asleep) and PYREXIA (wake up with fever of 101.2 to 102) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Alcohol allergy, Allergy to chemicals and Allergy to chemicals. Concomitant products included BISOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCT), LEVOTHYROXINE SODIUM (SYNTHYROID), AMITRIPTYLINE and METHOCARBAMOL (ROBAXIN) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (very sleepy), INSOMNIA (and then was asleep) and PYREXIA (wake up with fever of 101.2 to 102). At the time of the report, SOMNOLENCE (very sleepy), INSOMNIA (and then was asleep) and PYREXIA (wake up with fever of 101.2 to 102) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-009280 (Patient Link).   Reporter did not allow further contact
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Syringe broke and vaccine splashed over patient's arm/ Received lower than recommended dose during the 2nd  dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Syringe broke and vaccine splashed over patient's arm/ Received lower than recommended dose during the 2nd  dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced UNDERDOSE (Syringe broke and vaccine splashed over patient's arm/ Received lower than recommended dose during the 2nd  dose). At the time of the report, UNDERDOSE (Syringe broke and vaccine splashed over patient's arm/ Received lower than recommended dose during the 2nd  dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  While administering 2nd dose of vaccine the syringe exploded and vaccine splashed out and needle got stuck in the patient's arm. The vaccine leaked into patient's arm and splashed into the pharmacist face.  No treatment details were provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Nausea, Pain, Vomiting
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of ageusia (loss of taste), pain (general body aches), nausea and vomiting in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 3, 2021, patient experienced ageusia (loss of taste), pain (general body aches), nausea and vomiting. At the time of the report, ageusia (loss of taste), pain (general body aches), nausea) and vomiting outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Genital herpes, Musculoskeletal discomfort
Clinical narrative: Genital herpes (first episode ever); Discomfort at top of both thighs / hip area; No appetite; "I felt like I had been hit by a truck"; Tired; Chills; Feverish; This spontaneous case was reported by a physician and describes the occurrence of DECREASED APPETITE (No appetite), MUSCULOSKELETAL DISCOMFORT (Discomfort at top of both thighs / hip area), GENITAL HERPES (Genital herpes (first episode ever)), FATIGUE (Tired) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Genital herpes since 2005.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (Chills) and PYREXIA (Feverish). On 10-Feb-2021, the patient experienced DECREASED APPETITE (No appetite), FATIGUE (Tired) and MYALGIA ("I felt like I had been hit by a truck"). On 11-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Discomfort at top of both thighs / hip area). On 03-Mar-2021, the patient experienced GENITAL HERPES (Genital herpes (first episode ever)). On 10-Feb-2021, DECREASED APPETITE (No appetite), FATIGUE (Tired), CHILLS (Chills), PYREXIA (Feverish) and MYALGIA ("I felt like I had been hit by a truck") had resolved. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Discomfort at top of both thighs / hip area) had not resolved and GENITAL HERPES (Genital herpes (first episode ever)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-041091 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: FU is NNI
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Genital herpes (first episode ever); Discomfort at top of both thighs / hip area; No appetite; "I felt like I had been hit by a truck"; Tired; Chills; Feverish; This spontaneous case was reported by a physician and describes the occurrence of DECREASED APPETITE (No appetite), MUSCULOSKELETAL DISCOMFORT (Discomfort at top of both thighs / hip area), GENITAL HERPES (Genital herpes (first episode ever)), FATIGUE (Tired) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Genital herpes since 2005.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (Chills) and PYREXIA (Feverish). On 10-Feb-2021, the patient experienced DECREASED APPETITE (No appetite), FATIGUE (Tired) and MYALGIA ("I felt like I had been hit by a truck"). On 11-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Discomfort at top of both thighs / hip area). On 03-Mar-2021, the patient experienced GENITAL HERPES (Genital herpes (first episode ever)). On 10-Feb-2021, DECREASED APPETITE (No appetite), FATIGUE (Tired), CHILLS (Chills), PYREXIA (Feverish) and MYALGIA ("I felt like I had been hit by a truck") had resolved. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Discomfort at top of both thighs / hip area) had not resolved and GENITAL HERPES (Genital herpes (first episode ever)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-041091 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: FU is NNI
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Pruritus, Pyrexia
Clinical narrative: Itching; Redness; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Redness), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PRURITUS (Itching), ERYTHEMA (Redness), PYREXIA (Fever) and CHILLS (Chills) had resolved.            Concomitant and treatment medications were not provided.   This case was linked to MOD-2021-008602.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant FU - Updated outcome of the events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Really tired; A little bit of temperature; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Really tired) and PYREXIA (A little bit of temperature) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Really tired) and PYREXIA (A little bit of temperature). At the time of the report, FATIGUE (Really tired) and PYREXIA (A little bit of temperature) 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.   Concomitant medication were not provided. Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Influenza like illness, Syringe issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (The syringe exploded and vaccine splashed out in to the pharmacist face), ACCIDENTAL EXPOSURE TO PRODUCT (The syringe exploded and vaccine splashed out in to the pharmacist face) and INFLUENZA LIKE ILLNESS (Flu like symptom) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history provided by reporter.  On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced SYRINGE ISSUE (The syringe exploded and vaccine splashed out in to the pharmacist face), ACCIDENTAL EXPOSURE TO PRODUCT (The syringe exploded and vaccine splashed out in to the pharmacist face) and INFLUENZA LIKE ILLNESS (Flu like symptom). On 03-Feb-2021, SYRINGE ISSUE (The syringe exploded and vaccine splashed out in to the pharmacist face) and ACCIDENTAL EXPOSURE TO PRODUCT (The syringe exploded and vaccine splashed out in to the pharmacist face) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptom) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patients concomitant medication include birth control pills. No treatment medication provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product
Clinical narrative: the syringe exploded and vaccine splashed in to the pharmacist face; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (the syringe exploded and vaccine splashed in to the pharmacist face) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (the syringe exploded and vaccine splashed in to the pharmacist face). On 03-Jun-2021, ACCIDENTAL EXPOSURE TO PRODUCT (the syringe exploded and vaccine splashed in to the pharmacist face) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported.  Treatment medications was not provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Throwing up; High fever; Sore body; 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 VOMITING (Throwing up), PYREXIA (High fever) and MYALGIA (Sore body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Throwing up), PYREXIA (High fever) and MYALGIA (Sore body). At the time of the report, VOMITING (Throwing up), PYREXIA (High fever) and MYALGIA (Sore body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. Treatment information was not provided.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Feeling cold, Headache, Pyrexia
Clinical narrative: Feeling cold; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cold), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VITAMINS NOS for an unknown indication.    The patient's past medical history included Pacemaker insertion (cardiac) (They stated that she has pacemaker/stent and that she doesn't have a spleen.). Concurrent medical conditions included Hypertension. Concomitant products included LATANOPROST, OMEPRAZOLE, LISINOPRIL and ALIROCUMAB (PRALUENT) for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started VITAMINS NOS (unknown route) 2000 milligram. On 03-Jun-2021, the patient experienced FEELING COLD (Feeling cold). 03-Jun-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING COLD (Feeling cold), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with the product mRNA-1273 was not applicable.   This case was linked to MOD-2021-247127 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received and contains no new information.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling hot
Clinical narrative: stomach pain after 3 week's of hot first dose; hot first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    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 ABDOMINAL PAIN UPPER (stomach pain after 3 week's of hot first dose) and FEELING HOT (hot first dose) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain after 3 week's of hot first dose) and FEELING HOT (hot first dose). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain after 3 week's of hot first dose) and FEELING HOT (hot first dose) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Med Info Agent: AE submitted via virtual assistant I have stomach pain after 3 week's of hot first dose.   Reporter did not allow further contact
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Computerised tomogram, Endoscopy, Laryngeal mass, Laryngeal neoplasm
Clinical narrative: laryngeal mass; speech disorder; vocal cord neoplasm; Loss of voice; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Loss of voice), LARYNGEAL MASS (laryngeal mass), SPEECH DISORDER (speech disorder) and LARYNGEAL NEOPLASM (vocal cord neoplasm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0ZZMZ0A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Head injury in December 2020 and Fall on 24-Dec-2020. Concomitant products included PREDNISONE for Rheumatoid arthritis.   In 2001, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg once a week. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced APHONIA (Loss of voice), SPEECH DISORDER (speech disorder) and LARYNGEAL NEOPLASM (vocal cord neoplasm). In April 2021, the patient experienced LARYNGEAL MASS (laryngeal mass). The patient was treated with Surgery (Tumour removal) for Laryngeal mass and Surgery (Tumor removal) for Laryngeal neoplasm. In April 2021, APHONIA (Loss of voice), LARYNGEAL MASS (laryngeal mass), SPEECH DISORDER (speech disorder) and LARYNGEAL NEOPLASM (vocal cord neoplasm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2020, Computerised tomogram: unknown (Inconclusive) Inconclusive. In March 2021, Endoscopy: abnormal (abnormal) Lump on vocal cord.      Action taken with mRNA-1273 in response to events was not applicable.  Patient had 2 Outpatient surgery and removed everything out. Tumor was non-cancerous.; Sender's Comments: Based on reporter's causality (laryngeal mass was the etiology that must developed all symptoms, resolved after surgical treatment) the event is assessed as unlikely related to mRNA-1273
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: laryngeal mass; speech disorder; vocal cord neoplasm; Loss of voice; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Loss of voice), LARYNGEAL MASS (laryngeal mass), SPEECH DISORDER (speech disorder) and LARYNGEAL NEOPLASM (vocal cord neoplasm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0ZZMZ0A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Head injury in December 2020 and Fall on 24-Dec-2020. Concomitant products included PREDNISONE for Rheumatoid arthritis.   In 2001, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg once a week. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced APHONIA (Loss of voice), SPEECH DISORDER (speech disorder) and LARYNGEAL NEOPLASM (vocal cord neoplasm). In April 2021, the patient experienced LARYNGEAL MASS (laryngeal mass). The patient was treated with Surgery (Tumour removal) for Laryngeal mass and Surgery (Tumor removal) for Laryngeal neoplasm. In April 2021, APHONIA (Loss of voice), LARYNGEAL MASS (laryngeal mass), SPEECH DISORDER (speech disorder) and LARYNGEAL NEOPLASM (vocal cord neoplasm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2020, Computerised tomogram: unknown (Inconclusive) Inconclusive. In March 2021, Endoscopy: abnormal (abnormal) Lump on vocal cord.      Action taken with mRNA-1273 in response to events was not applicable.  Patient had 2 Outpatient surgery and removed everything out. Tumor was non-cancerous.; Sender's Comments: Based on reporter's causality (laryngeal mass was the etiology that must developed all symptoms, resolved after surgical treatment) the event is assessed as unlikely related to mRNA-1273
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchy; tiny little bumps on different areas of my body; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (itchy) and RASH (tiny little bumps on different areas of my body) 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 30-May-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 PRURITUS (itchy) and RASH (tiny little bumps on different areas of my body). At the time of the report, PRURITUS (itchy) and RASH (tiny little bumps on different areas of my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Unevaluable event; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (Unevaluable event). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 22 patients vaccinated using old vial from 03/12/21; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 03/12/21) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     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 09-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 03/12/21). On 09-Mar-2021, EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 03/12/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-207548, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258689, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258704, MOD-2021-258706, MOD-2021-258660.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up received, updated patient identifiers and demographics. On 01-Jul-2021: Follow up received added contact details. Added HCP  requested for followup and querying about revaccination procedure. On 01-Jul-2021: Follow-up received, no new information was updated.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. Concurrent medical conditions included Multiple sclerosis and Gait disturbance. Concomitant products included DALFAMPRIDINE for Gait disturbance, TERIFLUNOMIDE (AUBAGIO) from 22-Mar-2017 to an unknown date for Multiple sclerosis. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient did not use any treatment medication for the symptom.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and RASH (rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032LZ0A) for COVID-19 vaccination. The patient's past medical history included Crohns disease aggravated. Previously administered products included for an unreported indication: STELARA (Manufacturer janssen Biotech). Concomitant products included USTEKINUMAB (STELARA) for Crohns disease aggravated, PROBIOTICS NOS, MULTIVITAMIN [VITAMINS NOS], CALTRATE + D PLUS and MILK THISTLE [SILYBUM MARIANUM] for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Jan-2021, the patient experienced PRURITUS (itching) and RASH (rash). The patient was treated with HYDROCORTISONE (topical) for Symptomatic treatment, at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) (oral) for Symptomatic treatment, at an unspecified dose and frequency. On 12-Jan-2021, PRURITUS (itching) and RASH (rash) had resolved. This case was linked to MOD-2021-007588.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: sore arm/aches and pains; diarrhea; tired/extremely tired; chills; fever 101; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm/aches and pains), DIARRHOEA (diarrhea), FATIGUE (tired/extremely tired), CHILLS (chills) and PYREXIA (fever 101) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm/aches and pains), DIARRHOEA (diarrhea), FATIGUE (tired/extremely tired), CHILLS (chills) and PYREXIA (fever 101). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm/aches and pains), DIARRHOEA (diarrhea), FATIGUE (tired/extremely tired), CHILLS (chills) and PYREXIA (fever 101) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) 101.         No concomitant medication included.   This case was linked to MOD-2021-182959 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-jun-2021 , event outcome and treatment were updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sore arm/aches and pains; diarrhea; tired/extremely tired; chills; fever 101; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm/aches and pains), DIARRHOEA (diarrhea), FATIGUE (tired/extremely tired), CHILLS (chills) and PYREXIA (fever 101) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm/aches and pains), DIARRHOEA (diarrhea), FATIGUE (tired/extremely tired), CHILLS (chills) and PYREXIA (fever 101). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm/aches and pains), DIARRHOEA (diarrhea), FATIGUE (tired/extremely tired), CHILLS (chills) and PYREXIA (fever 101) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) 101.         No concomitant medication included.   This case was linked to MOD-2021-182959 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-jun-2021 , event outcome and treatment were updated.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: accidently touched him on the arm and it was sore; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (accidently touched him on the arm and it was sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (accidently touched him on the arm and it was sore). On 25-Mar-2021, PAIN IN EXTREMITY (accidently touched him on the arm and it was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications not provided.   Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Is totally miserable; High fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Is totally miserable), PYREXIA (High fever) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced FEELING ABNORMAL (Is totally miserable), PYREXIA (High fever) and MYALGIA (Body aches). At the time of the report, FEELING ABNORMAL (Is totally miserable), PYREXIA (High fever) and MYALGIA (Body aches) outcome was unknown.            No concomitant medications reported.  Treatment medications was not provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: side effect; 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 REACTION (side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history information was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (side effect). At the time of the report, ADVERSE REACTION (side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information about concomitants was provided.  No information about treatment medication was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Colour blindness, Fatigue, Vision blurred
Clinical narrative: vision blurr; Tired; colour blindness; This spontaneous case was reported by a nurse and describes the occurrence of VISION BLURRED (vision blurr), COLOUR BLINDNESS (colour blindness) and FATIGUE (Tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020 and Fever (Patient had high fever.). Concurrent medical conditions included Multiple sclerosis.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced COLOUR BLINDNESS (colour blindness). On an unknown date, the patient experienced VISION BLURRED (vision blurr) and FATIGUE (Tired). At the time of the report, VISION BLURRED (vision blurr), COLOUR BLINDNESS (colour blindness) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.     This case was linked to MOD-2021-003907 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; 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 DIZZINESS (Dizziness) 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 Stroke.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medications was not provided.  Treatment medications was not provided.  ER gave her Cat-scan, Blood work and cardiogram. No sign of stroke.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: I have had doarrhea since getting the vaccine 7 days ago; 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 DIARRHOEA (I have had doarrhea since getting the vaccine 7 days ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (I have had doarrhea since getting the vaccine 7 days ago). At the time of the report, DIARRHOEA (I have had doarrhea since getting the vaccine 7 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication were not provided.  The treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling sensation; Numbness/numbness of left hand going up to left forearm; 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 PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness/numbness of left hand going up to left forearm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness/numbness of left hand going up to left forearm). At the time of the report, PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness/numbness of left hand going up to left forearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash lasted approximately 3 weeks with each shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash lasted approximately 3 weeks with each shot) in a 69-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 RASH (rash lasted approximately 3 weeks with each shot). At the time of the report, RASH (rash lasted approximately 3 weeks with each shot) had resolved.            No concomitants were reported  No treatment was reported.   This case was linked to MOD-2021-005655  (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Fibrin D dimer, Heart rate, Heart rate increased
Clinical narrative: Pulse rate increasing eventually 122-136-145-156; Blood pressure was 176 over 110; Had fever on second day 102 Temp; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Pulse rate increasing eventually 122-136-145-156), HYPERTENSION (Blood pressure was 176 over 110) and PYREXIA (Had fever on second day 102 Temp) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 HEART RATE INCREASED (Pulse rate increasing eventually 122-136-145-156), HYPERTENSION (Blood pressure was 176 over 110) and PYREXIA (Had fever on second day 102 Temp). At the time of the report, HEART RATE INCREASED (Pulse rate increasing eventually 122-136-145-156), HYPERTENSION (Blood pressure was 176 over 110) and PYREXIA (Had fever on second day 102 Temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 176/110 (High) High. In 2021, Body temperature: 102 (High) High. In 2021, Fibrin D dimer: high (High) elevated. In 2021, Heart rate: 122 (High) Increasing 122-136-145-156..         Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-006816 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.