chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: After the first one, two weeks later, patient was awakened by severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (After the first one, two weeks later, patient was awakened by severe joint pain) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (After the first one, two weeks later, patient was awakened by severe joint pain). The patient was treated with LORATADINE (LORATAB) for Joint pain, at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) for Joint pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (After the first one, two weeks later, patient was awakened by severe joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter.    This case was linked to MOD-2021-309996 (Patient Link).   Reporter did not allow further contact
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Hyperhidrosis, Inappropriate schedule of product administration
Clinical narrative: woke up in a puddle of sweat; dizziness; weakness; Fever; nausea; vomiting; fatigue; less than 25 days for administration of the second dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), HYPERHIDROSIS (woke up in a puddle of sweat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 25 days for administration of the second dose) and PYREXIA (Fever) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, ISOSORBIDE, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN 1000) and ATORVASTATIN for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 25 days for administration of the second dose). On 06-Sep-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), PYREXIA (Fever), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue). On an unknown date, the patient experienced HYPERHIDROSIS (woke up in a puddle of sweat). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 06-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), HYPERHIDROSIS (woke up in a puddle of sweat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 25 days for administration of the second dose), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, Pyrexia: high (High) High (fever of 102 F).         Patient also take Water pill as a concomitant medication.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: woke up in a puddle of sweat; dizziness; weakness; Fever; nausea; vomiting; fatigue; less than 25 days for administration of the second dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), HYPERHIDROSIS (woke up in a puddle of sweat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 25 days for administration of the second dose) and PYREXIA (Fever) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, ISOSORBIDE, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN 1000) and ATORVASTATIN for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 25 days for administration of the second dose). On 06-Sep-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), PYREXIA (Fever), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue). On an unknown date, the patient experienced HYPERHIDROSIS (woke up in a puddle of sweat). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 06-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), HYPERHIDROSIS (woke up in a puddle of sweat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 25 days for administration of the second dose), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, Pyrexia: high (High) High (fever of 102 F).         Patient also take Water pill as a concomitant medication.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Malaise, Myalgia
Clinical narrative: Her husband started to feel ill 2SEP2021; Fever on and off; Positive covid-19 test; Whole body aches like with the flu; Her husband started to feel ill 2SEP2021 with weakness/Low energy; Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Her husband started to feel ill 2SEP2021 with weakness/Low energy), COUGH ( Dry cough), COVID-19 (Positive covid-19 test), MALAISE (Her husband started to feel ill 2SEP2021) and PYREXIA (Fever on and off) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced ASTHENIA (Her husband started to feel ill 2SEP2021 with weakness/Low energy), COUGH ( Dry cough) and MYALGIA (Whole body aches like with the flu). On 06-Sep-2021, the patient experienced COVID-19 (Positive covid-19 test) and PYREXIA (Fever on and off). On an unknown date, the patient experienced MALAISE (Her husband started to feel ill 2SEP2021). The patient was treated with IBUPROFEN at an unspecified dose and frequency; MULTIVITAMINS [VITAMINS NOS] at an unspecified dose and frequency; ZINC at an unspecified dose and frequency and VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency. At the time of the report, ASTHENIA (Her husband started to feel ill 2SEP2021 with weakness/Low energy), COUGH ( Dry cough), COVID-19 (Positive covid-19 test), MALAISE (Her husband started to feel ill 2SEP2021), PYREXIA (Fever on and off) and MYALGIA (Whole body aches like with the flu) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was reported by reporter.  Their son came from school on 31 august 2021 and had tested positive for COVID-19 infection
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Her husband started to feel ill 2SEP2021; Fever on and off; Positive covid-19 test; Whole body aches like with the flu; Her husband started to feel ill 2SEP2021 with weakness/Low energy; Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Her husband started to feel ill 2SEP2021 with weakness/Low energy), COUGH ( Dry cough), COVID-19 (Positive covid-19 test), MALAISE (Her husband started to feel ill 2SEP2021) and PYREXIA (Fever on and off) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced ASTHENIA (Her husband started to feel ill 2SEP2021 with weakness/Low energy), COUGH ( Dry cough) and MYALGIA (Whole body aches like with the flu). On 06-Sep-2021, the patient experienced COVID-19 (Positive covid-19 test) and PYREXIA (Fever on and off). On an unknown date, the patient experienced MALAISE (Her husband started to feel ill 2SEP2021). The patient was treated with IBUPROFEN at an unspecified dose and frequency; MULTIVITAMINS [VITAMINS NOS] at an unspecified dose and frequency; ZINC at an unspecified dose and frequency and VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency. At the time of the report, ASTHENIA (Her husband started to feel ill 2SEP2021 with weakness/Low energy), COUGH ( Dry cough), COVID-19 (Positive covid-19 test), MALAISE (Her husband started to feel ill 2SEP2021), PYREXIA (Fever on and off) and MYALGIA (Whole body aches like with the flu) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was reported by reporter.  Their son came from school on 31 august 2021 and had tested positive for COVID-19 infection
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Fibromyalgia, Gastrointestinal disorder, Joint dislocation
Clinical narrative: her elbows came out; felt tired/ experienced chronic fatigue; achy all over; Fibromyalgia; More problems breathing; Problems with her intestines; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Fibromyalgia), DYSPNOEA (More problems breathing), GASTROINTESTINAL DISORDER (Problems with her intestines), FATIGUE (felt tired/ experienced chronic fatigue) and MYALGIA (achy all over) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Asthma (, she had problems with her lungs (sister has asthma but after second dose experienced more problems breathing).   Sister also had problems with her intestines.  ).   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. In January 2021, the patient experienced FIBROMYALGIA (Fibromyalgia), DYSPNOEA (More problems breathing) and GASTROINTESTINAL DISORDER (Problems with her intestines). On an unknown date, the patient experienced FATIGUE (felt tired/ experienced chronic fatigue), MYALGIA (achy all over) and JOINT DISLOCATION (her elbows came out). At the time of the report, FIBROMYALGIA (Fibromyalgia), DYSPNOEA (More problems breathing), GASTROINTESTINAL DISORDER (Problems with her intestines), FATIGUE (felt tired/ experienced chronic fatigue), MYALGIA (achy all over) and JOINT DISLOCATION (her elbows came out) outcome was unknown.            Sister was concerned about receiving full third dose and not half, as Moderna submitted FDA approval for 50 mcg dose now. she was worried that whether this dose will create any problem or not Concomitant medication use was unknown Treatment information was unknown   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: her elbows came out; felt tired/ experienced chronic fatigue; achy all over; Fibromyalgia; More problems breathing; Problems with her intestines; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Fibromyalgia), DYSPNOEA (More problems breathing), GASTROINTESTINAL DISORDER (Problems with her intestines), FATIGUE (felt tired/ experienced chronic fatigue) and MYALGIA (achy all over) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Asthma (, she had problems with her lungs (sister has asthma but after second dose experienced more problems breathing).   Sister also had problems with her intestines.  ).   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. In January 2021, the patient experienced FIBROMYALGIA (Fibromyalgia), DYSPNOEA (More problems breathing) and GASTROINTESTINAL DISORDER (Problems with her intestines). On an unknown date, the patient experienced FATIGUE (felt tired/ experienced chronic fatigue), MYALGIA (achy all over) and JOINT DISLOCATION (her elbows came out). At the time of the report, FIBROMYALGIA (Fibromyalgia), DYSPNOEA (More problems breathing), GASTROINTESTINAL DISORDER (Problems with her intestines), FATIGUE (felt tired/ experienced chronic fatigue), MYALGIA (achy all over) and JOINT DISLOCATION (her elbows came out) outcome was unknown.            Sister was concerned about receiving full third dose and not half, as Moderna submitted FDA approval for 50 mcg dose now. she was worried that whether this dose will create any problem or not Concomitant medication use was unknown Treatment information was unknown   Reporter did not allow further contact
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave Moderna COVID 19 vaccine to a 17-year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave Moderna COVID 19 vaccine to a 17-year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave Moderna COVID 19 vaccine to a 17-year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave Moderna COVID 19 vaccine to a 17-year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter doesn't know if patient received the 2nd dose. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: arm is really hurting / complaining continuously about the pain in his arm; extreme sharp pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is really hurting / complaining continuously about the pain in his arm) and VACCINATION SITE PAIN (extreme sharp pain at the injection site) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013A21A) for COVID-19 vaccination.     Concomitant products included CYANOCOBALAMIN (VITAMIN B12 AAA), VITAMIN-D (VITAMIN D AND ANALOGUES), DORZOLAMIDE, APIXABAN (ELIQUIS), HYDROCHLOROTHIAZIDE, INSULIN GLARGINE (LANTUS), METFORMIN, LEVOTHYROXINE, LOSARTAN, CELECOXIB (CELEBREX) and LEUPRORELIN ACETATE (LUPRON) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm is really hurting / complaining continuously about the pain in his arm) and VACCINATION SITE PAIN (extreme sharp pain at the injection site). At the time of the report, PAIN IN EXTREMITY (arm is really hurting / complaining continuously about the pain in his arm) and VACCINATION SITE PAIN (extreme sharp pain at the injection site) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow up received-regulatory authority
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weaknness feeling) and DIZZINESS (Suffering Dizzines) in a male patient of an unknown age 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 ASTHENIA (Weaknness feeling) and DIZZINESS (Suffering Dizzines). At the time of the report, ASTHENIA (Weaknness feeling) and DIZZINESS (Suffering Dizzines) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication was reported No treatment Drug was reported Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 2 patients got COVID19 10 days following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (2 patients got COVID19 10 days following vaccination) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (2 patients got COVID19 10 days following vaccination). At the time of the report, COVID-19 (2 patients got COVID19 10 days following vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: got the first dose on 23Jun2021 and has not got second dose yet.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got the first dose on 23Jun2021 and has not got second dose yet.) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-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 PRODUCT DOSE OMISSION ISSUE (got the first dose on 23Jun2021 and has not got second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the first dose on 23Jun2021 and has not got second dose yet.) outcome was unknown.            patient reported Moderna vaccine first dose on 23Jun2021 and has not gotten the second dose yet. Caller inquires if they should start over the series or get the second dose now, Caller inquires where they could get the Moderna vaccine near their home.  No Medical History Reported. No Concomitant medication Reported
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, SARS-CoV-2 test, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect/still having the side effect as of today), INFLUENZA (flu) and VACCINATION COMPLICATION (tight symptoms/severe) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced VACCINATION COMPLICATION (side effect/still having the side effect as of today). On 07-Sep-2021, the patient experienced VACCINATION COMPLICATION (tight symptoms/severe). On an unknown date, the patient experienced INFLUENZA (flu). At the time of the report, VACCINATION COMPLICATION (side effect/still having the side effect as of today), INFLUENZA (flu) and VACCINATION COMPLICATION (tight symptoms/severe) had not resolved.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. No relevant concomitant medications were reported. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Difficulty of breathing; Chest pain; sore in the arm; Headache; Chills; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty of breathing), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (sore in the arm), HEADACHE (Headache) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore in the arm), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigued). On 05-Sep-2021, the patient experienced DYSPNOEA (Difficulty of breathing) and CHEST PAIN (Chest pain). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty of breathing) had not resolved and CHEST PAIN (Chest pain), PAIN IN EXTREMITY (sore in the arm), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive. On 06-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was provided.  Patient did lab tests on the heart, lungs, took blood pressure, took blood, and everything was normal.  Additional information about patient's past COVID-19 infection include that she did not have any fever but a light headache for only one day. Patient did not  feel difficulty of breathing, just a little chill, lost smell and ached for 1 day. Patient just stayed at home for 14 days.   Patient doesn't have a history of heart problems, myocarditis/pericarditis.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Difficulty of breathing; Chest pain; sore in the arm; Headache; Chills; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty of breathing), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (sore in the arm), HEADACHE (Headache) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore in the arm), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigued). On 05-Sep-2021, the patient experienced DYSPNOEA (Difficulty of breathing) and CHEST PAIN (Chest pain). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty of breathing) had not resolved and CHEST PAIN (Chest pain), PAIN IN EXTREMITY (sore in the arm), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive. On 06-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was provided.  Patient did lab tests on the heart, lungs, took blood pressure, took blood, and everything was normal.  Additional information about patient's past COVID-19 infection include that she did not have any fever but a light headache for only one day. Patient did not  feel difficulty of breathing, just a little chill, lost smell and ached for 1 day. Patient just stayed at home for 14 days.   Patient doesn't have a history of heart problems, myocarditis/pericarditis.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Arm is still real tender; Hurting all over; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is still real tender) and MYALGIA (Hurting all over) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced MYALGIA (Hurting all over). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is still real tender). On 07-Sep-2021, MYALGIA (Hurting all over) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm is still real tender) had not resolved.       Concomitant medication were not reported Treatment medication were not reported
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pruritus, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: arm has fever; itching/ itchiness; arm is hard; arm was still red; arm was still sore; arm is swollen; maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm has fever), PRURITUS (itching/ itchiness), VACCINATION SITE INDURATION (arm is hard), VACCINATION SITE ERYTHEMA (arm was still red) and VACCINATION SITE PAIN (arm was still sore) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm has fever), PRURITUS (itching/ itchiness), VACCINATION SITE INDURATION (arm is hard), VACCINATION SITE ERYTHEMA (arm was still red), VACCINATION SITE PAIN (arm was still sore), VACCINATION SITE SWELLING (arm is swollen) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (oral) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (arm has fever), PRURITUS (itching/ itchiness), VACCINATION SITE INDURATION (arm is hard), VACCINATION SITE ERYTHEMA (arm was still red), VACCINATION SITE PAIN (arm was still sore) and VACCINATION SITE SWELLING (arm is swollen) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included Benadryl cream.    Reporter did not allow further contact; Sender's Comments: This report is a case of a 25 year old female with a history of maternal  exposure to mRNA 1273 vaccine during pregnancy who developed non-serious adverse reaction, 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 patient will be followed up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm has fever; itching/ itchiness; arm is hard; arm was still red; arm was still sore; arm is swollen; maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm has fever), PRURITUS (itching/ itchiness), VACCINATION SITE INDURATION (arm is hard), VACCINATION SITE ERYTHEMA (arm was still red) and VACCINATION SITE PAIN (arm was still sore) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm has fever), PRURITUS (itching/ itchiness), VACCINATION SITE INDURATION (arm is hard), VACCINATION SITE ERYTHEMA (arm was still red), VACCINATION SITE PAIN (arm was still sore), VACCINATION SITE SWELLING (arm is swollen) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (oral) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (arm has fever), PRURITUS (itching/ itchiness), VACCINATION SITE INDURATION (arm is hard), VACCINATION SITE ERYTHEMA (arm was still red), VACCINATION SITE PAIN (arm was still sore) and VACCINATION SITE SWELLING (arm is swollen) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included Benadryl cream.    Reporter did not allow further contact; Sender's Comments: This report is a case of a 25 year old female with a history of maternal  exposure to mRNA 1273 vaccine during pregnancy who developed non-serious adverse reaction, 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 patient will be followed up.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination complication
Clinical narrative: I thought was dying; never got sick i took that shot it gave me the PII(32; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I thought was dying) and VACCINATION COMPLICATION (never got sick i took that shot it gave me the PII(32) 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 FEELING ABNORMAL (I thought was dying) and VACCINATION COMPLICATION (never got sick i took that shot it gave me the PII(32). At the time of the report, FEELING ABNORMAL (I thought was dying) and VACCINATION COMPLICATION (never got sick i took that shot it gave me the PII(32) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Nausea, Pruritus, Vaccination site erythema
Clinical narrative: armpit it's itching; pain in my collar bone armpit; red at the injection site; feeling tired; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (armpit it's itching), AXILLARY PAIN (pain in my collar bone armpit), VACCINATION SITE ERYTHEMA (red at the injection site), FATIGUE (feeling tired) and NAUSEA (nauseous) 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 PRURITUS (armpit it's itching), AXILLARY PAIN (pain in my collar bone armpit), VACCINATION SITE ERYTHEMA (red at the injection site), FATIGUE (feeling tired) and NAUSEA (nauseous). At the time of the report, PRURITUS (armpit it's itching), AXILLARY PAIN (pain in my collar bone armpit), VACCINATION SITE ERYTHEMA (red at the injection site), FATIGUE (feeling tired) and NAUSEA (nauseous) 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: SARS-CoV-2 test, Vaccination complication
Clinical narrative: After first dose I started having symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After first dose I started having symptoms) 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 12-Aug-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 COMPLICATION (After first dose I started having symptoms). At the time of the report, VACCINATION COMPLICATION (After first dose I started having symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.  Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: two side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (two side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (two side effects). At the time of the report, VACCINATION COMPLICATION (two side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. Treatment information was not provided.   This case was linked to MOD-2021-311020 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.  The patient had no symptoms after administration. No temperature excursion episodes, vial was stored correctly.   This case was linked to MOD-2021-311017 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: After first dose felt extremely fatigued with slight headache; After first dose felt extremely fatigued with slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (After first dose felt extremely fatigued with slight headache) and HEADACHE (After first dose felt extremely fatigued with slight headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 26-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 FATIGUE (After first dose felt extremely fatigued with slight headache) and HEADACHE (After first dose felt extremely fatigued with slight headache). At the time of the report, FATIGUE (After first dose felt extremely fatigued with slight headache) and HEADACHE (After first dose felt extremely fatigued with slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment medication was not reported.   This case was linked to MOD-2021-311070 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore left injection site arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included ADENOSINE from 03-Sep-2021 to an unknown date for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (sore left injection site arm). At the time of the report, MYALGIA (sore left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: high (High) Heart rate elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's consent to follow-up was affirmative.  Treatment product information was not provided.   This case was linked to MOD-2021-311047, MOD-2021-311053 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received no new information.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypersomnia, Myalgia
Clinical narrative: no energy; slept 20 hours one day; body aches; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue), ASTHENIA (no energy), HYPERSOMNIA (slept 20 hours one day) and MYALGIA (body aches) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-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 FATIGUE (extreme fatigue), ASTHENIA (no energy), HYPERSOMNIA (slept 20 hours one day) and MYALGIA (body aches). At the time of the report, FATIGUE (extreme fatigue), ASTHENIA (no energy), HYPERSOMNIA (slept 20 hours one day) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Impaired work ability, Pain in extremity, Paraesthesia
Clinical narrative: Numbness in my legs and arms; Tingling glass; Bleeding a lot; pain is terrible in my legs; her skin felt tough like leather; impaired work ability; A little bit more tired/ drained; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Numbness in my legs and arms) and PARAESTHESIA (Tingling glass) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 HYPOAESTHESIA (Numbness in my legs and arms) (seriousness criterion medically significant). an unknown date, the patient experienced PARAESTHESIA (Tingling glass) (seriousness criterion medically significant), VACCINATION SITE HAEMORRHAGE (Bleeding a lot), PAIN IN EXTREMITY (pain is terrible in my legs), SKIN DISORDER (her skin felt tough like leather), IMPAIRED WORK ABILITY (impaired work ability), FATIGUE (A little bit more tired/ drained) and PYREXIA (Fever). At the time of the report, HYPOAESTHESIA (Numbness in my legs and arms), PARAESTHESIA (Tingling glass), VACCINATION SITE HAEMORRHAGE (Bleeding a lot), PAIN IN EXTREMITY (pain is terrible in my legs), SKIN DISORDER (her skin felt tough like leather) and IMPAIRED WORK ABILITY (impaired work ability) outcome was unknown and FATIGUE (A little bit more tired/ drained) and PYREXIA (Fever) was resolving.            No concomitant drug information provided. The patient used pads and unspecified creams for treatment. Company Comment : 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.  Further information has been requests.   This case was linked to MOD-2021-311170 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received includes no new information.; 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.  Further information has been requests.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin disorder, Vaccination site haemorrhage
Clinical narrative: Numbness in my legs and arms; Tingling glass; Bleeding a lot; pain is terrible in my legs; her skin felt tough like leather; impaired work ability; A little bit more tired/ drained; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Numbness in my legs and arms) and PARAESTHESIA (Tingling glass) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 HYPOAESTHESIA (Numbness in my legs and arms) (seriousness criterion medically significant). an unknown date, the patient experienced PARAESTHESIA (Tingling glass) (seriousness criterion medically significant), VACCINATION SITE HAEMORRHAGE (Bleeding a lot), PAIN IN EXTREMITY (pain is terrible in my legs), SKIN DISORDER (her skin felt tough like leather), IMPAIRED WORK ABILITY (impaired work ability), FATIGUE (A little bit more tired/ drained) and PYREXIA (Fever). At the time of the report, HYPOAESTHESIA (Numbness in my legs and arms), PARAESTHESIA (Tingling glass), VACCINATION SITE HAEMORRHAGE (Bleeding a lot), PAIN IN EXTREMITY (pain is terrible in my legs), SKIN DISORDER (her skin felt tough like leather) and IMPAIRED WORK ABILITY (impaired work ability) outcome was unknown and FATIGUE (A little bit more tired/ drained) and PYREXIA (Fever) was resolving.            No concomitant drug information provided. The patient used pads and unspecified creams for treatment. Company Comment : 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.  Further information has been requests.   This case was linked to MOD-2021-311170 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received includes no new information.; 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.  Further information has been requests.