chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Vaccination site erythema, Vaccination site rash
Clinical narrative: Vaccine exposure during pregnancy; injection site reaction rash and redness; injection site reaction rash and redness; A spontaneous report (United states) was received from pharmacist concerning herself 40 years old, pregnant, female patient  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and vaccination site reaction.  The patient's medical history was not provided. Concomitant medications were not listed.  on 4 Jan 2021 patient received their first of two planned doses mRNA-1273(Lot number: 026L20A) for prophylaxis of COVID-19 infection.  On 02 Nov 2020 the patient received a positive pregnancy test. Her last menstrual period was on 07 Oct 2021 and conception date was unknown. The patient's estimated due date is 14 Jul 2021.  On 01 Feb 2021,the pregnant patient exposed to their second of two planned doses of mRNA-1273 (Lot number:028L20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection and experienced sore arm and injection site reaction. She was enrolled in the pregnancy registry. No treatment information provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, exposure during pregnancy was considered resolved on 01 Feb 2021, other events sore arm and injection site reaction was recovered/ resolved on 05 Feb 2021.; Sender's Comments: This case concerns a 40-Year-old female who received mRNA-1273 while pregnant (vaccine exposure during pregnancy) and experienced vaccination site rash and redness.  Positive pregnancy test was 02 Nov 2020, last menstrual period was 07 Oct 2021, and estimated due date is 14 Jul 2021.  The other events are consistent with product profile and temporarily associated with use and causal relationship cannot be excluded. Vaccine exposure during pregnancy is not applicable.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Arm itched like crazy; Their doctor told that the shot was lower than where it is normally; Arm was a little sore in the injection site; arm become red; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Their doctor told that the shot was lower than where it is normally), VACCINATION SITE PAIN (Arm was a little sore in the injection site), VACCINATION SITE ERYTHEMA (arm become red) and VACCINATION SITE PRURITUS (Arm itched like crazy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011ZLOA) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation and Cholesterol. Concomitant products included METOPROLOL and APIXABAN (ELIQUIS) for Atrial fibrillation, SIMVASTATIN for Cholesterol, VITAMINS NOS (ICAPS PLUS [VITAMINS NOS]) for Eye disorder NOS, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, LUBIPROSTONE (AMITIZA), VITAMIN D NOS and CALCIUM for an unknown indication.   On 09-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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Their doctor told that the shot was lower than where it is normally), VACCINATION SITE PAIN (Arm was a little sore in the injection site) and VACCINATION SITE ERYTHEMA (arm become red). On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Arm itched like crazy). On 09-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Their doctor told that the shot was lower than where it is normally) had resolved. On 18-Feb-2021, VACCINATION SITE PAIN (Arm was a little sore in the injection site), VACCINATION SITE ERYTHEMA (arm become red) and VACCINATION SITE PRURITUS (Arm itched like crazy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable The doctor told that the shot was lower than where it is normally given, and the caller think it was subcutaneous.   This case was linked to MOD-2021-015972 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Non-significant follow up appended
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Ocular discomfort, Paraesthesia oral
Clinical narrative: sensation in eye; tingling lips; numbness in chin; numbness in face; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (tingling lips), HYPOAESTHESIA (numbness in chin), HYPOAESTHESIA (numbness in face) and OCULAR DISCOMFORT (sensation in eye) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included PARACETAMOL (TYLENOL).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PARAESTHESIA ORAL (tingling lips), HYPOAESTHESIA (numbness in chin) and HYPOAESTHESIA (numbness in face). On 29-Jan-2021, the patient experienced OCULAR DISCOMFORT (sensation in eye). At the time of the report, PARAESTHESIA ORAL (tingling lips), HYPOAESTHESIA (numbness in chin), HYPOAESTHESIA (numbness in face) and OCULAR DISCOMFORT (sensation in eye) outcome was unknown. 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.   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Swelling face
Clinical narrative: Swollen face left side; Headache left side; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Swollen face left side) and HEADACHE (Headache left side) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 04-Feb-2021, the patient experienced SWELLING FACE (Swollen face left side) and HEADACHE (Headache left side). On 04-Feb-2021, HEADACHE (Headache left side) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and SWELLING FACE (Swollen face left side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case concerns a 77-year-old female who experienced NS unexpected events of sore throat and face swelling and NS expected event of headache.  Sore throat onset the same day as the first dose of mRNA-1273, with headache and face swelling 8 days after mRNA-1273. Headache resolved. Other event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Follow-up received included no new information. On 20-Apr-2021: Follow-up received included no new information.; Reporter's Comments: This case concerns a 77-year-old female who experienced NS unexpected events of sore throat and face swelling and NS expected event of headache.  Sore throat onset the same day as the first dose of mRNA-1273, with headache and face swelling 8 days after mRNA-1273. Headache resolved. Other event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness
Clinical narrative: felt dizzy; diarrhea; A spontaneous report was received from a consumer concerning, a 39 years old Female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced dizziness and had diarrhea.  The patient's medical history was not provided.  On 27-Jan-2021, Prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 27-Jan-2021 the patient experienced dizziness and had diarrhea.  Concomitant product use was not provided by the reporter.   No Laboratory details was provided.  No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the event was unknown
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Warmth at injection site; vaccination site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth at injection site) and VACCINATION SITE ERYTHEMA (vaccination site redness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmth at injection site) and VACCINATION SITE ERYTHEMA (vaccination site redness). At the time of the report, VACCINATION SITE WARMTH (Warmth at injection site) and VACCINATION SITE ERYTHEMA (vaccination site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain in extremity, Pyrexia, Vaccination site urticaria
Clinical narrative: Arm soreness; Temperature of 99 degrees; Mild chills; Severe hives; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), PYREXIA (Temperature of 99 degrees), CHILLS (Mild chills) and VACCINATION SITE URTICARIA (Severe hives) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness), PYREXIA (Temperature of 99 degrees), CHILLS (Mild chills) and VACCINATION SITE URTICARIA (Severe hives). At the time of the report, PAIN IN EXTREMITY (Arm soreness), PYREXIA (Temperature of 99 degrees), CHILLS (Mild chills) and VACCINATION SITE URTICARIA (Severe hives) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 degree Celsius High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Malaise
Clinical narrative: tingling her left side of her abdomen; arm pain; myalgia; fever; malaise; HA; chills; fatigue; sweating; trouble lifting her arm; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling her left side of her abdomen), PAIN IN EXTREMITY (arm pain), MYALGIA (myalgia), PYREXIA (fever) and MALAISE (malaise) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling her left side of her abdomen), PAIN IN EXTREMITY (arm pain), MYALGIA (myalgia), PYREXIA (fever), MALAISE (malaise), HEADACHE (HA), CHILLS (chills), FATIGUE (fatigue), HYPERHIDROSIS (sweating), MOBILITY DECREASED (trouble lifting her arm) and NAUSEA (nausea). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]) for Shingles, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling her left side of her abdomen), PAIN IN EXTREMITY (arm pain), PYREXIA (fever), MALAISE (malaise), CHILLS (chills), FATIGUE (fatigue), HYPERHIDROSIS (sweating), MOBILITY DECREASED (trouble lifting her arm) and NAUSEA (nausea) had resolved and MYALGIA (myalgia) and HEADACHE (HA) outcome was unknown.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: New events and their respective outcomes added.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: tingling her left side of her abdomen; arm pain; myalgia; fever; malaise; HA; chills; fatigue; sweating; trouble lifting her arm; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling her left side of her abdomen), PAIN IN EXTREMITY (arm pain), MYALGIA (myalgia), PYREXIA (fever) and MALAISE (malaise) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling her left side of her abdomen), PAIN IN EXTREMITY (arm pain), MYALGIA (myalgia), PYREXIA (fever), MALAISE (malaise), HEADACHE (HA), CHILLS (chills), FATIGUE (fatigue), HYPERHIDROSIS (sweating), MOBILITY DECREASED (trouble lifting her arm) and NAUSEA (nausea). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]) for Shingles, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling her left side of her abdomen), PAIN IN EXTREMITY (arm pain), PYREXIA (fever), MALAISE (malaise), CHILLS (chills), FATIGUE (fatigue), HYPERHIDROSIS (sweating), MOBILITY DECREASED (trouble lifting her arm) and NAUSEA (nausea) had resolved and MYALGIA (myalgia) and HEADACHE (HA) outcome was unknown.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: New events and their respective outcomes added.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: tingling her left side of her abdomen; arm pain; myalgia; fever; malaise; HA; chills; fatigue; sweating; trouble lifting her arm; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling her left side of her abdomen), PAIN IN EXTREMITY (arm pain), MYALGIA (myalgia), PYREXIA (fever) and MALAISE (malaise) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling her left side of her abdomen), PAIN IN EXTREMITY (arm pain), MYALGIA (myalgia), PYREXIA (fever), MALAISE (malaise), HEADACHE (HA), CHILLS (chills), FATIGUE (fatigue), HYPERHIDROSIS (sweating), MOBILITY DECREASED (trouble lifting her arm) and NAUSEA (nausea). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]) for Shingles, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling her left side of her abdomen), PAIN IN EXTREMITY (arm pain), PYREXIA (fever), MALAISE (malaise), CHILLS (chills), FATIGUE (fatigue), HYPERHIDROSIS (sweating), MOBILITY DECREASED (trouble lifting her arm) and NAUSEA (nausea) had resolved and MYALGIA (myalgia) and HEADACHE (HA) outcome was unknown.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: New events and their respective outcomes added.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: being warmer (estimates body temperature above 99-99.2 F); This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (being warmer (estimates body temperature above 99-99.2 F)) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (being warmer (estimates body temperature above 99-99.2 F)). At the time of the report, PYREXIA (being warmer (estimates body temperature above 99-99.2 F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature: 99-99.2 f (High) Patient experienced being warmer (estimates body temperature above 99-99.2 F).     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 product use was not provided by the reporter. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (hard time trying to elevate her arm), INJECTION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMIN D3 from 2000 to an unknown date for Bone density decreased, MONASCUS PURPUREUS (RED YEAST RICE) for Cholesterol, FISH OIL (OMEGA 3 FISH OIL [FISH OIL]) from 2000 to an unknown date for Dry eye, MAGNESIUM GLUCONATE for Muscle cramps, PARACETAMOL (TYLENOL) and VITAMIN C [ASCORBIC ACID] from 2000 to an unknown date for an unknown indication. On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (hard time trying to elevate her arm). On 23-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever), NAUSEA (Nausea), HEADACHE (severe headache) and FATIGUE (A little fatigue). On 24-Jan-2021, INJECTION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever), NAUSEA (Nausea) and HEADACHE (severe headache) had resolved. On 25-Jan-2021, FATIGUE (A little fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (hard time trying to elevate her arm) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Follow-up received on 24-April-2021. Added concomitant medications, patient demographics
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (hard time trying to elevate her arm), INJECTION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMIN D3 from 2000 to an unknown date for Bone density decreased, MONASCUS PURPUREUS (RED YEAST RICE) for Cholesterol, FISH OIL (OMEGA 3 FISH OIL [FISH OIL]) from 2000 to an unknown date for Dry eye, MAGNESIUM GLUCONATE for Muscle cramps, PARACETAMOL (TYLENOL) and VITAMIN C [ASCORBIC ACID] from 2000 to an unknown date for an unknown indication. On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (hard time trying to elevate her arm). On 23-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever), NAUSEA (Nausea), HEADACHE (severe headache) and FATIGUE (A little fatigue). On 24-Jan-2021, INJECTION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever), NAUSEA (Nausea) and HEADACHE (severe headache) had resolved. On 25-Jan-2021, FATIGUE (A little fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (hard time trying to elevate her arm) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Follow-up received on 24-April-2021. Added concomitant medications, patient demographics
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: swollen arm; red spot; chills; headache; threw up; diarrhea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache) and VOMITING (threw up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache), VOMITING (threw up), DIARRHOEA (diarrhea) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache), VOMITING (threw up) and DIARRHOEA (diarrhea) had resolved and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021 and was forwarded to Moderna on 27-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache) and VOMITING (threw up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache), VOMITING (threw up), DIARRHOEA (diarrhea) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache), VOMITING (threw up) and DIARRHOEA (diarrhea) had resolved and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vomiting
Clinical narrative: swollen arm; red spot; chills; headache; threw up; diarrhea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache) and VOMITING (threw up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache), VOMITING (threw up), DIARRHOEA (diarrhea) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache), VOMITING (threw up) and DIARRHOEA (diarrhea) had resolved and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021 and was forwarded to Moderna on 27-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache) and VOMITING (threw up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache), VOMITING (threw up), DIARRHOEA (diarrhea) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (red spot), CHILLS (chills), HEADACHE (headache), VOMITING (threw up) and DIARRHOEA (diarrhea) had resolved and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pruritus, Pyrexia, Rhinorrhoea
Clinical narrative: upper respiratory symptom like running nose; tremendously itching all over her body; headache; fever; body ache; This spontaneous case was reported by a health care professional and describes the occurrence of RHINORRHOEA (upper respiratory symptom like running nose), PRURITUS (tremendously itching all over her body), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body ache) in a 35-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (upper respiratory symptom like running nose), PRURITUS (tremendously itching all over her body), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body ache). At the time of the report, RHINORRHOEA (upper respiratory symptom like running nose), PRURITUS (tremendously itching all over her body), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body ache) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021 and was forwarded to Moderna on 26-Jan-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of RHINORRHOEA (upper respiratory symptom like running nose), PRURITUS (tremendously itching all over her body), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body ache) in a 35-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (upper respiratory symptom like running nose), PRURITUS (tremendously itching all over her body), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body ache). At the time of the report, RHINORRHOEA (upper respiratory symptom like running nose), PRURITUS (tremendously itching all over her body), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body ache) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: her arm bothered her for a week after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (her arm bothered her for a week after the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 LIMB DISCOMFORT (her arm bothered her for a week after the 1st dose). At the time of the report, LIMB DISCOMFORT (her arm bothered her for a week after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: 4x4 slightly raised red area; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (4x4 slightly raised red area) and VACCINATION SITE ERYTHEMA (red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE SWELLING (4x4 slightly raised red area) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE SWELLING (4x4 slightly raised red area) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Stomach Issues; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach Issues) and DIARRHOEA (Diarrhea) 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach Issues) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (Stomach Issues) and DIARRHOEA (Diarrhea) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Oral pain
Clinical narrative: Soreness in mouth 1 hour after vaccination; Funny taste in mouth 1 hour after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Soreness in mouth 1 hour after vaccination) and DYSGEUSIA (Funny taste in mouth 1 hour after vaccination) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Throat cancer (Throat cancer diagnosed 15 years ago) since an unknown date.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced ORAL PAIN (Soreness in mouth 1 hour after vaccination) and DYSGEUSIA (Funny taste in mouth 1 hour after vaccination). At the time of the report, ORAL PAIN (Soreness in mouth 1 hour after vaccination) and DYSGEUSIA (Funny taste in mouth 1 hour after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very bad pain in his arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pain in extremity, Vaccination site movement impairment
Clinical narrative: Can't lift the arm; Hurts so bad; Hard injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Can't lift the arm), ARTHRALGIA (Hurts so bad) and INJECTION SITE PAIN (Hard injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 19-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't lift the arm), ARTHRALGIA (Hurts so bad) and INJECTION SITE PAIN (Hard injection site). The patient was treated with OXYCODONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Can't lift the arm), ARTHRALGIA (Hurts so bad) and INJECTION SITE PAIN (Hard injection site) 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain in extremity
Clinical narrative: Only had a sore arm; her heart rate was a little faster; A spontaneous report was received from a consumer concerning a 71-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in extremity, and her heart rate was a little faster/heart rate increased.  The patient's medical history was not provided. Concomitant medication included baby aspirin everyday for heart beat.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:unknown)in the right arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021,the patient received their second of two planned doses of mRNA-1273 vaccine for prophylaxis of COVID-19 infection.   After the first dose of vaccination , the patient only had a sore arm. Also, her heart rate was a little faster.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events were not applicable.  The outcome of events, sore arm and heart rate was little faster, were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site irritation, Vaccination site pruritus
Clinical narrative: raised reddish patch the size of a tennis ball which was "irritating"; raised reddish patch the size of a tennis ball which was "irritating"; itchiness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (raised reddish patch the size of a tennis ball which was "irritating"), VACCINATION SITE PRURITUS (itchiness on the injection site) and VACCINATION SITE ERYTHEMA (raised reddish patch the size of a tennis ball which was "irritating") 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness on the injection site). On 30-Jan-2021, the patient experienced VACCINATION SITE IRRITATION (raised reddish patch the size of a tennis ball which was "irritating") and VACCINATION SITE ERYTHEMA (raised reddish patch the size of a tennis ball which was "irritating"). At the time of the report, VACCINATION SITE IRRITATION (raised reddish patch the size of a tennis ball which was "irritating"), VACCINATION SITE PRURITUS (itchiness on the injection site) and VACCINATION SITE ERYTHEMA (raised reddish patch the size of a tennis ball which was "irritating") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Tongue discomfort
Clinical narrative: Burning tongue; Tingly lips; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (Burning tongue) and ORAL DISCOMFORT (Tingly lips) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VALSARTAN (DIOVAN).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TONGUE DISCOMFORT (Burning tongue) and ORAL DISCOMFORT (Tingly lips). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available informAation and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: experiencing headache, nausea, and fatigue after receiving vaccination.; experiencing headache, nausea, and fatigue after receiving vaccination.; experiencing headache, nausea, and fatigue after receiving vaccination.; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (experiencing headache, nausea, and fatigue after receiving vaccination.), NAUSEA (experiencing headache, nausea, and fatigue after receiving vaccination.) and FATIGUE (experiencing headache, nausea, and fatigue after receiving vaccination.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (experiencing headache, nausea, and fatigue after receiving vaccination.), NAUSEA (experiencing headache, nausea, and fatigue after receiving vaccination.) and FATIGUE (experiencing headache, nausea, and fatigue after receiving vaccination.). At the time of the report, HEADACHE (experiencing headache, nausea, and fatigue after receiving vaccination.), NAUSEA (experiencing headache, nausea, and fatigue after receiving vaccination.) and FATIGUE (experiencing headache, nausea, and fatigue after receiving vaccination.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-022474, US-MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018092) US-MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018092)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy about 5 mins; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy about 5 mins) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Medications unknown). Concomitant products included LETROZOLE 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 03-Feb-2021, the patient experienced DIZZINESS (dizzy about 5 mins). On 03-Feb-2021, DIZZINESS (dizzy about 5 mins) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; A spontaneous report was received from a consumer concerning a unknown age female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 12 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced the events sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 14 Jan 2021 the outcome of events sore arm was resolved.; Reporter's Comments: This case concerns a female of unknown age who experienced a NS unexpected event of Pain in extremity.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.