chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Peripheral coldness
Clinical narrative: Violent case of diarrhea; Cold hands feet; Mild Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mild Soreness), DIARRHOEA (Violent case of diarrhea) and PERIPHERAL COLDNESS (Cold hands feet) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN (Mild Soreness). On 31-Jan-2021, the patient experienced DIARRHOEA (Violent case of diarrhea) and PERIPHERAL COLDNESS (Cold hands feet). At the time of the report, PAIN (Mild Soreness) and PERIPHERAL COLDNESS (Cold hands feet) outcome was unknown and DIARRHOEA (Violent case of diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: hand is still restricted, can not use the arm; Pain that did not go away/pain in her arm; shoulder injury related to vaccine administration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (hand is still restricted, can not use the arm), SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (shoulder injury related to vaccine administration) and PAIN IN EXTREMITY (Pain that did not go away/pain in her arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (shoulder injury related to vaccine administration). On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain that did not go away/pain in her arm). On an unknown date, the patient experienced HYPOKINESIA (hand is still restricted, can not use the arm). At the time of the report, HYPOKINESIA (hand is still restricted, can not use the arm), SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (shoulder injury related to vaccine administration) and PAIN IN EXTREMITY (Pain that did not go away/pain in her arm) outcome was unknown.            Concomitant medications were not provided. The patient's doctor did prescribe methylprednisolone, but she was not able to finish it as it upset her stomach. She had seen several doctors. She had all types of tests including an MRI.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Date of birth, events updated.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Sore shot arms; TIRED; achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore shot arms), FATIGUE (TIRED) and MYALGIA (achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PAIN IN EXTREMITY (Sore shot arms), FATIGUE (TIRED) and MYALGIA (achy). At the time of the report, PAIN IN EXTREMITY (Sore shot arms), FATIGUE (TIRED) and MYALGIA (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-043696 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: A spontaneous report was received from a Consumer concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red, painful, and itchy rash. The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient experienced the event  red, painful, and itchy rash. Treatment details included Antibiotics, Prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event red, painful, and itchy rash was unknown..
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Vaccination site pain
Clinical narrative: Shortness of breath; Little soreness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Little soreness around injection site) and DYSPNOEA (Shortness of breath) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0291_20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE PAIN (Little soreness around injection site). On 22-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath). On 21-Jan-2021, INJECTION SITE PAIN (Little soreness around injection site) had resolved. At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Vomiting
Clinical narrative: Dizziness room spinning; Vomiting; Low grade  fever; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness room spinning, vomiting, low grade fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Dizziness room spinning, Vomiting, Low grade fever.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), dizziness room spinning, vomiting, low grade fever was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Erythema, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Difficulty in swallowing; face red; Arm of injection hardly to move; Arm of injection hardly to move; A spontaneous report  was received from a 63 years old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events difficulty in swallowing, face red, pain, arm of injection hardly to move.  The patient's past medical history included anaphylactic reaction and the patient was allergic to codeine flu shot and shellfish. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029LA0A) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  On 28 Jan 2021, after the first dose of vaccination, the patient could not swallow water, face turned to be red and her arm of the shot was sore till the point that she hardly cannot use it. On the same day the patient went to Emergency Room, they gave her a medicine (unspecified medication) to relax.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event's difficulty in swallowing, face red and arm of injection hardly to move was unknown.; Reporter'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.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema
Clinical narrative: its very tender around it; a red splotch around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (its very tender around it) and VACCINATION SITE ERYTHEMA (a red splotch around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (a red splotch around the injection site). On an unknown date, the patient experienced TENDERNESS (its very tender around it). At the time of the report, TENDERNESS (its very tender around it) and VACCINATION SITE ERYTHEMA (a red splotch around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported .  No treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Non significant followup - Contact Information updated
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Malaise, Vaccination site pain
Clinical narrative: Malaise; Loss of appetite; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), DECREASED APPETITE (Loss of appetite) and VACCINATION SITE PAIN (Pain at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Pyothorax in 2005 and Tooth infection.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and VACCINATION SITE PAIN (Pain at injection site). On 21-Jan-2021, the patient experienced MALAISE (Malaise). The patient was treated with IBUPROFEN at a dose of 400 mg once a day. On 20-Jan-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. On 26-Jan-2021, MALAISE (Malaise) had resolved. At the time of the report, DECREASED APPETITE (Loss of appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; 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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Red sploge of the size of my hand; Arm is slightly swollen; Red sploge is extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red sploge of the size of my hand), PERIPHERAL SWELLING (Arm is slightly swollen) and PRURITUS (Red sploge is extremely itchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) 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 28-Jan-2021, the patient experienced ERYTHEMA (Red sploge of the size of my hand), PERIPHERAL SWELLING (Arm is slightly swollen) and PRURITUS (Red sploge is extremely itchy). At the time of the report, ERYTHEMA (Red sploge of the size of my hand), PERIPHERAL SWELLING (Arm is slightly swollen) and PRURITUS (Red sploge is extremely itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; 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.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Chills; Headache; Soreness at the injection site; Pain in the left hip; Fever of 101 Degrees F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101 Degrees F), CHILLS (Chills), HEADACHE (Headache), INJECTION SITE PAIN (Soreness at the injection site) and ARTHRALGIA (Pain in the left hip) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 101 Degrees F), CHILLS (Chills), HEADACHE (Headache), INJECTION SITE PAIN (Soreness at the injection site) and ARTHRALGIA (Pain in the left hip). At the time of the report, PYREXIA (Fever of 101 Degrees F), CHILLS (Chills), HEADACHE (Headache), INJECTION SITE PAIN (Soreness at the injection site) and ARTHRALGIA (Pain in the left hip) outcome was unknown. Not Provided          Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore arm; Exhaustion; A spontaneous report was received from a consumer concerning a 73-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, exhaustion.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the event(s) sore arm, exhaustion.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, exhaustion was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: injection site started itching; injection site got red; arm hurt at the injection site; A spontaneous report was received from a consumer concerning a 66-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm hurt at the injection site, injection site started itching, injection site got red. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient experienced the event arm hurt at the injection site . On 27 Jan 2021, the patient experienced the events injection site started itching and injection site got red. Treatment details included For the symptoms: none., Other: medicine for her blood pressure, cholesterol and breast cancer., FM 28Jan2021 Action taken with mRNA-1273 in response to the events was unknown.  the outcome of event arm hurt at the injection site was considered resolved on 22 Jan 2021. The outcome of events, injection site started itching and injection site got red were unknown..
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Heart rate increased, Pruritus
Clinical narrative: itchy red rash on face and ears; Fatigue; fast heart rate; dizziness; out of breath; itchy in ears and face; arm soreness; A spontaneous report was received from a consumer concerning a 41-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm soreness, fast heart beat (resting heart rate of 100 bpm and above), fatigue, out of breath, dizziness, rash in face, itchy in ears, red in ears, rash in ears, red in face, itchy in face.  The patient's medical history was not provided. Concomitant medications reported were Methimazole for hyperthyroidism for drug use for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) arm soreness. On 14 Feb 2021, the patient experienced the event(s) fast heart beat (resting heart rate of 100 bpm and above), fatigue, out of breath, dizziness, rash in face, itchy in ears, red in ears, rash in ears, red in face, itchy in face.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 15 Feb 2021 the outcome of event(s), rash in face, itchy in ears, red in ears, rash in ears, red in face, itchy in face was resolved. The outcome of event(s), arm soreness, fast heart beat (resting heart rate of 100 bpm and above), fatigue, out of breath, dizziness was unknown.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pain
Clinical narrative: itchy red rash on face and ears; Fatigue; fast heart rate; dizziness; out of breath; itchy in ears and face; arm soreness; A spontaneous report was received from a consumer concerning a 41-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm soreness, fast heart beat (resting heart rate of 100 bpm and above), fatigue, out of breath, dizziness, rash in face, itchy in ears, red in ears, rash in ears, red in face, itchy in face.  The patient's medical history was not provided. Concomitant medications reported were Methimazole for hyperthyroidism for drug use for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) arm soreness. On 14 Feb 2021, the patient experienced the event(s) fast heart beat (resting heart rate of 100 bpm and above), fatigue, out of breath, dizziness, rash in face, itchy in ears, red in ears, rash in ears, red in face, itchy in face.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 15 Feb 2021 the outcome of event(s), rash in face, itchy in ears, red in ears, rash in ears, red in face, itchy in face was resolved. The outcome of event(s), arm soreness, fast heart beat (resting heart rate of 100 bpm and above), fatigue, out of breath, dizziness was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Flu like symptoms; rash was very hot; rash is swollen; broke out in a rash at injection site; A spontaneous report  was received from a consumer for a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu like symptoms (influenza like illness), broke out in a rash at injection site 8 days later (vaccination site rash), rash was swollen (vaccination site swelling) and rash was very hot (vaccination site warmth).  The patient's medical history was not provided. No concomitant product use was reported.  On 06 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in right arm for prophylaxis of COVID-19 infection. On an unknown date, after receiving the vaccines, patient experienced flu like symptoms. On 14 Feb 2021, 8 days later, she broke out in a rash at injection site. The rash was swollen, and rash was very hot.  The treatment medication was not reported.  Action taken with mRNA-1273 with respect to the events was unknown.  The outcome of the events was not reported.  The reporter did not provide the causality assessment for the events.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Fatigue, Headache, Insomnia
Clinical narrative: Not able to sleep last night; Not able to get up; fatigue; Headache; Nausea; High fever,  Fever of 107°F,  Fever of 100.2°F; Muscle pain; Chills; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high fever,  fever of 107°f,  fever of 100.2°f/pyrexia, muscle pain/myalgia, chills, fatigue, headache, nausea, not able to get up/bedridden, not able to sleep last night/insomnia.  The patient's medical history included arthrosis, arthritis, and osteoporosis. Concomitant medications reported were blood thinners, etanercept, Osteoporosis medications.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) on 20 Feb 2021 in the right arm for prophylaxis of COVID-19 infection.   On 20 Feb 2021 8 hours after receiving the vaccine the patient had high fever, muscle pain, chills. No one told her that she could have side effects. In the morning had extreme fatigue, headache, nausea, and is not able to get up. She wanted to know what should take to treat the symptoms because she is an old woman and is not able to go to hospital. On Sunday she had fever of 107°F. Caller took Tylenol to treat the symptoms because no one give her any advice on side effects and what to do. For the rest of the day, caller had fever of 100.2°F. She was not able to sleep last night and stated she felt like having the virus again. Treatment for the events include Paracetamol.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The event experienced high fever, fever of 107°f, fever of 100.2°f was resolved on 22 Feb 2021. The outcome of the events muscle pain, chills, fatigue, headache, nausea, not able to get up, not able to sleep last night was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Not able to sleep last night; Not able to get up; fatigue; Headache; Nausea; High fever,  Fever of 107°F,  Fever of 100.2°F; Muscle pain; Chills; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high fever,  fever of 107°f,  fever of 100.2°f/pyrexia, muscle pain/myalgia, chills, fatigue, headache, nausea, not able to get up/bedridden, not able to sleep last night/insomnia.  The patient's medical history included arthrosis, arthritis, and osteoporosis. Concomitant medications reported were blood thinners, etanercept, Osteoporosis medications.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) on 20 Feb 2021 in the right arm for prophylaxis of COVID-19 infection.   On 20 Feb 2021 8 hours after receiving the vaccine the patient had high fever, muscle pain, chills. No one told her that she could have side effects. In the morning had extreme fatigue, headache, nausea, and is not able to get up. She wanted to know what should take to treat the symptoms because she is an old woman and is not able to go to hospital. On Sunday she had fever of 107°F. Caller took Tylenol to treat the symptoms because no one give her any advice on side effects and what to do. For the rest of the day, caller had fever of 100.2°F. She was not able to sleep last night and stated she felt like having the virus again. Treatment for the events include Paracetamol.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The event experienced high fever, fever of 107°f, fever of 100.2°f was resolved on 22 Feb 2021. The outcome of the events muscle pain, chills, fatigue, headache, nausea, not able to get up, not able to sleep last night was not resolved.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Malaise, Nausea, Pain in extremity
Clinical narrative: Malaise; left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday; Itchy; nausea, could not eat; Fever; Nausea, could not eat; Headache; left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), PAIN IN EXTREMITY (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday), PRURITUS (Itchy), DECREASED APPETITE (nausea, could not eat) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00UM20A and 013C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic lymphocytic leukemia. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MALAISE (Malaise), PAIN IN EXTREMITY (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday), PRURITUS (Itchy), PYREXIA (Fever), NAUSEA (Nausea, could not eat), HEADACHE (Headache) and VACCINATION SITE SWELLING (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday). 16-Feb-2021, the patient experienced DECREASED APPETITE (nausea, could not eat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, PYREXIA (Fever) had resolved. On 21-Feb-2021, MALAISE (Malaise), DECREASED APPETITE (nausea, could not eat) and NAUSEA (Nausea, could not eat) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday) and PRURITUS (Itchy) had resolved and HEADACHE (Headache) and VACCINATION SITE SWELLING (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient is on medication centromine.  patient has received Tylenol and advil after both doses.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Vaccination site swelling
Clinical narrative: Malaise; left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday; Itchy; nausea, could not eat; Fever; Nausea, could not eat; Headache; left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), PAIN IN EXTREMITY (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday), PRURITUS (Itchy), DECREASED APPETITE (nausea, could not eat) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00UM20A and 013C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic lymphocytic leukemia. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MALAISE (Malaise), PAIN IN EXTREMITY (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday), PRURITUS (Itchy), PYREXIA (Fever), NAUSEA (Nausea, could not eat), HEADACHE (Headache) and VACCINATION SITE SWELLING (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday). 16-Feb-2021, the patient experienced DECREASED APPETITE (nausea, could not eat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, PYREXIA (Fever) had resolved. On 21-Feb-2021, MALAISE (Malaise), DECREASED APPETITE (nausea, could not eat) and NAUSEA (Nausea, could not eat) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday) and PRURITUS (Itchy) had resolved and HEADACHE (Headache) and VACCINATION SITE SWELLING (left arm is swollen from shoulder to elbow, very painful, it is getting worse everyday) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient is on medication centromine.  patient has received Tylenol and advil after both doses.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: very fatigued; severe chills; headache; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (very fatigued), CHILLS (severe chills) and HEADACHE (headache) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Heart failure and Thyroid disorder. Concomitant products included OXYGEN for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (very fatigued), CHILLS (severe chills) and HEADACHE (headache). On 23-Jan-2021, FATIGUE (very fatigued) and CHILLS (severe chills) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included 5 blood pressure medications, heart failure medication and thyroid medicine.  Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 32L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was 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 was not applicable.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site discomfort, Vaccination site pain, Vaccination site pruritus
Clinical narrative: arm is tender, sore, just got worse, on underside of arm; Forearm itches; Injection site is irritated; arm is itching; Injection site is swollen; tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness at injection site), TENDERNESS (arm is tender), PAIN IN EXTREMITY (arm is sore), PRURITUS (arm is itching) and PRURITUS (got worse) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (tenderness at injection site). On 27-Jan-2021, the patient experienced TENDERNESS (arm is tender), PAIN IN EXTREMITY (arm is sore), PRURITUS (arm is itching), PRURITUS (got worse), VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE DISCOMFORT (Injection site is irritated) and PRURITUS (Forearm itches). On an unknown date, the patient experienced PAIN IN EXTREMITY (was on underside of arm). At the time of the report, VACCINATION SITE PAIN (tenderness at injection site), TENDERNESS (arm is tender), PAIN IN EXTREMITY (arm is sore), PRURITUS (arm is itching), PRURITUS (got worse), VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE DISCOMFORT (Injection site is irritated) and PRURITUS (Forearm itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medication Treatment for the events, included benadryl
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: arm is tender, sore, just got worse, on underside of arm; Forearm itches; Injection site is irritated; arm is itching; Injection site is swollen; tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness at injection site), TENDERNESS (arm is tender), PAIN IN EXTREMITY (arm is sore), PRURITUS (arm is itching) and PRURITUS (got worse) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (tenderness at injection site). On 27-Jan-2021, the patient experienced TENDERNESS (arm is tender), PAIN IN EXTREMITY (arm is sore), PRURITUS (arm is itching), PRURITUS (got worse), VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE DISCOMFORT (Injection site is irritated) and PRURITUS (Forearm itches). On an unknown date, the patient experienced PAIN IN EXTREMITY (was on underside of arm). At the time of the report, VACCINATION SITE PAIN (tenderness at injection site), TENDERNESS (arm is tender), PAIN IN EXTREMITY (arm is sore), PRURITUS (arm is itching), PRURITUS (got worse), VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE DISCOMFORT (Injection site is irritated) and PRURITUS (Forearm itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medication Treatment for the events, included benadryl
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus
Clinical narrative: rash; arm was itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and VACCINATION SITE PRURITUS (arm was itchy) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (arm was itchy). On 12-Feb-2021, the patient experienced RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. At the time of the report, RASH (rash) and VACCINATION SITE PRURITUS (arm was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction after second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction after second dose). At the time of the report, ADVERSE REACTION (Adverse reaction after second dose) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Pyrexia, Rash macular
Clinical narrative: Arm of the injection has red spots/blotchy red, not just one dot; 100.2° F; Over 100° F; 99.1° F; No appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), RASH MACULAR (Arm of the injection has red spots/blotchy red, not just one dot) and PYREXIA (100.2° F; Over 100° F; 99.1° F) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for an unknown indication.     The patient's past medical history included Autoimmune thyroid disorder (may be related to COVID), Premature atrial contraction and COVID-19 in March 2020. Concurrent medical conditions included Drug allergy (some antibiotics). Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DECREASED APPETITE (No appetite) and PYREXIA (100.2° F; Over 100° F; 99.1° F). On 29-Jan-2021, the patient experienced RASH MACULAR (Arm of the injection has red spots/blotchy red, not just one dot). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 28-Jan-2021, DECREASED APPETITE (No appetite) and PYREXIA (100.2° F; Over 100° F; 99.1° F) had resolved. At the time of the report, RASH MACULAR (Arm of the injection has red spots/blotchy red, not just one dot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysgeusia, Feeling abnormal, Headache
Clinical narrative: Soreness; Muscle aches; Chills; Headache; Metallic taste; Severe dizziness/lightheaded; Numbness; Weird; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), DIZZINESS (Severe dizziness/lightheaded), HYPOAESTHESIA (Numbness), FEELING ABNORMAL (Weird) and PAIN (Soreness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced DYSGEUSIA (Metallic taste), DIZZINESS (Severe dizziness/lightheaded), HYPOAESTHESIA (Numbness), FEELING ABNORMAL (Weird) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN (Soreness), MYALGIA (Muscle aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (Metallic taste), DIZZINESS (Severe dizziness/lightheaded), HYPOAESTHESIA (Numbness), FEELING ABNORMAL (Weird), PAIN (Soreness), HEADACHE (Headache), MYALGIA (Muscle aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Pain
Clinical narrative: Soreness; Muscle aches; Chills; Headache; Metallic taste; Severe dizziness/lightheaded; Numbness; Weird; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), DIZZINESS (Severe dizziness/lightheaded), HYPOAESTHESIA (Numbness), FEELING ABNORMAL (Weird) and PAIN (Soreness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced DYSGEUSIA (Metallic taste), DIZZINESS (Severe dizziness/lightheaded), HYPOAESTHESIA (Numbness), FEELING ABNORMAL (Weird) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN (Soreness), MYALGIA (Muscle aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (Metallic taste), DIZZINESS (Severe dizziness/lightheaded), HYPOAESTHESIA (Numbness), FEELING ABNORMAL (Weird), PAIN (Soreness), HEADACHE (Headache), MYALGIA (Muscle aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is very sore), PYREXIA (low grade fever) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011N20A) for COVID-19 vaccination. Concomitant products included INSULIN GLARGINE (LANTUS), DULAGLUTIDE (TRULICITY), METFORMIN, LANSOPRAZOLE, ESCITALOPRAM OXALATE (LEXAPRO), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BUPROPION and ATORVASTATIN 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 PAIN IN EXTREMITY (arm is very sore), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm is very sore), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Adverse event after 2nd dose; Fatigue; Headache; Nausea; Chills; Not feeling well; Fever; Some soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) in a 77-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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Some soreness in injection arm). On 29-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Not feeling well), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse event after 2nd dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MALAISE (Not feeling well), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills), VACCINATION SITE PAIN (Some soreness in injection arm) and PYREXIA (Fever) had resolved and FATIGUE (Fatigue) had not resolved.            Concomitant product use was not provided by the reporter. The patient claimed that she did not experience any side effects from the first vaccination. The action taken for the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non significant follow up On 12-Jul-2021: Non-significant follow-up case booked in; 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.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication, Vaccination site pain
Clinical narrative: Adverse event after 2nd dose; Fatigue; Headache; Nausea; Chills; Not feeling well; Fever; Some soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) in a 77-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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Some soreness in injection arm). On 29-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Not feeling well), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse event after 2nd dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MALAISE (Not feeling well), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Chills), VACCINATION SITE PAIN (Some soreness in injection arm) and PYREXIA (Fever) had resolved and FATIGUE (Fatigue) had not resolved.            Concomitant product use was not provided by the reporter. The patient claimed that she did not experience any side effects from the first vaccination. The action taken for the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non significant follow up On 12-Jul-2021: Non-significant follow-up case booked in; 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.