chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: Respiratory tract congestion; Taste loss; Smell loss; Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid), RESPIRATORY TRACT CONGESTION (Respiratory tract congestion), AGEUSIA (Taste loss) and ANOSMIA (Smell loss) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced COVID-19 (Tested positive for covid). On an unknown date, the patient experienced RESPIRATORY TRACT CONGESTION (Respiratory tract congestion), AGEUSIA (Taste loss) and ANOSMIA (Smell loss). At the time of the report, COVID-19 (Tested positive for covid), RESPIRATORY TRACT CONGESTION (Respiratory tract congestion), AGEUSIA (Taste loss) and ANOSMIA (Smell loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: NNI
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Headache, Pyrexia
Clinical narrative: feeling dizzy; wasn't steady on his feet; slight headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzy), GAIT DISTURBANCE (wasn't steady on his feet), HEADACHE (slight headache) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Defibrillator/pacemaker insertion and Heart disease, unspecified (He is a heart disease patient , has a pace maker and defibrillator.).    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (feeling dizzy), GAIT DISTURBANCE (wasn't steady on his feet), HEADACHE (slight headache) and PYREXIA (fever). At the time of the report, DIZZINESS (feeling dizzy), GAIT DISTURBANCE (wasn't steady on his feet), HEADACHE (slight headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not provided. Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Tremor
Clinical narrative: fever; chills; headache; shaking; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), HEADACHE (headache), TREMOR (shaking) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PYREXIA (fever), CHILLS (chills), HEADACHE (headache), TREMOR (shaking) and FATIGUE (fatigue). At the time of the report, PYREXIA (fever), CHILLS (chills), HEADACHE (headache), TREMOR (shaking) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient was diagnosed with COVID-19 after vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient was diagnosed with COVID-19 after vaccination) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient was diagnosed with COVID-19 after vaccination). At the time of the report, COVID-19 (Patient was diagnosed with COVID-19 after vaccination) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment details included Monoclonal Antibodies.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: followup received on 25-jun-21 with NNI
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema
Clinical narrative: Redness at the injection site; slight itching; A spontaneous report was received from a 83-years-old  female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events slight itching and redness at the injection site.  The patient's medical history was not provided. Concomitant medications reported were losartin, eliquis for drug use for unknown indication.  On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route of administration and unknown anatomical location for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event slight itching.  On 5 Feb 2021, the patient experienced the event redness at the injection site.  Treatment details included Tylenol for itching.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, slight itching  was unknown and redness at the injection site was considered recovering.; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dyspnoea, Muscle spasms, Pain in extremity
Clinical narrative: very severe pain in her extremities; Pain in back; cramps; loos her breath; she was shivering; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very severe pain in her extremities), BACK PAIN (Pain in back), MUSCLE SPASMS (cramps), DYSPNOEA (loos her breath) and CHILLS (she was shivering) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (very severe pain in her extremities), BACK PAIN (Pain in back), MUSCLE SPASMS (cramps), DYSPNOEA (loos her breath) and CHILLS (she was shivering). At the time of the report, PAIN IN EXTREMITY (very severe pain in her extremities), BACK PAIN (Pain in back), MUSCLE SPASMS (cramps), DYSPNOEA (loos her breath) and CHILLS (she was shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; A spontaneous report was received from a consumer for a 42 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an urinary tract infection (UTI).  The patient's medical included diabetes. No concomitant product use was reported.  On 13-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 10-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 06-Feb-2021,  the patient experienced symptoms consistent with an urinary tract infection. Treatment for the UTI  included Levofloxacin and Fluconazole.  There was no change planned to the dosing schedule of mRNA-1273 in response to the event  The outcome of the event, urinary tract infection was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Patient declined further contact. No further follow-up information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis flare; This spontaneous case was reported by a health care professional and describes the occurrence of PSORIASIS (psoriasis flare) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA AC) for Psoriasis.    No Medical History information was reported.   In August 2018, the patient started ADALIMUMAB (HUMIRA AC) (unknown route) 40 milligram. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PSORIASIS (psoriasis flare). At the time of the report, PSORIASIS (psoriasis flare) had not 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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: itching; painful; red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), VACCINATION SITE PAIN (painful) and VACCINATION SITE ERYTHEMA (red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) 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 VACCINATION SITE PAIN (painful) and VACCINATION SITE ERYTHEMA (red). On 27-Jan-2021, the patient experienced PRURITUS (itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 29-Jan-2021, VACCINATION SITE PAIN (painful) and VACCINATION SITE ERYTHEMA (red) had resolved. At the time of the report, PRURITUS (itching) had not 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.   Concomitant medications details also included multivitamins.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Genital swelling
Clinical narrative: his penis is swelling up; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL SWELLING (his penis is swelling up) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Edema legs.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GENITAL SWELLING (his penis is swelling up). At the time of the report, GENITAL SWELLING (his penis is swelling up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: No specific follow-up information recorded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Eructation, Fatigue
Clinical narrative: burping gas; Can breath deeply now, but has to do it more often; muscles are sore like when you do exercise; sharp pain in the chest; kind of muscle spasm; could not breath; Could not get up without her husband lifting her; Fever; muscle pain; chills; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not get up without her husband lifting her), CHEST PAIN (sharp pain in the chest), MUSCLE SPASMS (kind of muscle spasm), DYSPNOEA (could not breath) and ERUCTATION (burping gas) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer, Hypertension and High cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced MOBILITY DECREASED (Could not get up without her husband lifting her), PYREXIA (Fever), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (extreme fatigue). On 09-Feb-2021, the patient experienced CHEST PAIN (sharp pain in the chest), MUSCLE SPASMS (kind of muscle spasm) and DYSPNOEA (could not breath). On 12-Feb-2021, the patient experienced ERUCTATION (burping gas), DYSPNOEA (Can breath deeply now, but has to do it more often) and MYALGIA (muscles are sore like when you do exercise). On 04-Feb-2021, MOBILITY DECREASED (Could not get up without her husband lifting her), PYREXIA (Fever), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (extreme fatigue) had resolved. On 12-Feb-2021, CHEST PAIN (sharp pain in the chest), MUSCLE SPASMS (kind of muscle spasm) and DYSPNOEA (could not breath) had resolved. At the time of the report, ERUCTATION (burping gas), DYSPNOEA (Can breath deeply now, but has to do it more often) and MYALGIA (muscles are sore like when you do exercise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were Kitruda Autoimmune medication for Cancer, Vitamins, High blood pressure pill, Stevia and beat root rice pills High cholesterol. Treatment details were not reported by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: burping gas; Can breath deeply now, but has to do it more often; muscles are sore like when you do exercise; sharp pain in the chest; kind of muscle spasm; could not breath; Could not get up without her husband lifting her; Fever; muscle pain; chills; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not get up without her husband lifting her), CHEST PAIN (sharp pain in the chest), MUSCLE SPASMS (kind of muscle spasm), DYSPNOEA (could not breath) and ERUCTATION (burping gas) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer, Hypertension and High cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced MOBILITY DECREASED (Could not get up without her husband lifting her), PYREXIA (Fever), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (extreme fatigue). On 09-Feb-2021, the patient experienced CHEST PAIN (sharp pain in the chest), MUSCLE SPASMS (kind of muscle spasm) and DYSPNOEA (could not breath). On 12-Feb-2021, the patient experienced ERUCTATION (burping gas), DYSPNOEA (Can breath deeply now, but has to do it more often) and MYALGIA (muscles are sore like when you do exercise). On 04-Feb-2021, MOBILITY DECREASED (Could not get up without her husband lifting her), PYREXIA (Fever), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (extreme fatigue) had resolved. On 12-Feb-2021, CHEST PAIN (sharp pain in the chest), MUSCLE SPASMS (kind of muscle spasm) and DYSPNOEA (could not breath) had resolved. At the time of the report, ERUCTATION (burping gas), DYSPNOEA (Can breath deeply now, but has to do it more often) and MYALGIA (muscles are sore like when you do exercise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were Kitruda Autoimmune medication for Cancer, Vitamins, High blood pressure pill, Stevia and beat root rice pills High cholesterol. Treatment details were not reported by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: SCIATIC NERVE ACTING UP; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (SCIATIC NERVE ACTING UP) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced SCIATICA (SCIATIC NERVE ACTING UP). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SCIATICA (SCIATIC NERVE ACTING UP) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headache; their sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and VACCINATION SITE PAIN (their sore arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included RIZATRIPTAN for Migraine headache.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (headache) and VACCINATION SITE PAIN (their sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) and VACCINATION SITE PAIN (their sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Illness, Vomiting
Clinical narrative: both are sick; Diarrhea; very hard weakness; Throw up a lot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (both are sick), DIARRHOEA (Diarrhea), ASTHENIA (very hard weakness) and VOMITING (Throw up a lot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ILLNESS (both are sick), DIARRHOEA (Diarrhea), ASTHENIA (very hard weakness) and VOMITING (Throw up a lot). The patient was treated with TRAZODONE for Pain, at a dose of 1 dosage form. At the time of the report, ILLNESS (both are sick), DIARRHOEA (Diarrhea), ASTHENIA (very hard weakness) and VOMITING (Throw up a lot) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   This case was linked to MOD-2021-033897, MOD-2021-033897 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Pruritus, Rash, Vaccination site rash
Clinical narrative: Mother fell the other day and needs surgery; Rash on injection site arm; Very itching; Rash on opposite arm of injection from elbow up; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Mother fell the other day and needs surgery), PRURITUS (Very itching), RASH (Rash on opposite arm of injection from elbow up) and VACCINATION SITE RASH (Rash on injection site arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (Very itching) and RASH (Rash on opposite arm of injection from elbow up). On 23-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (Rash on injection site arm). On 10-Feb-2021, the patient experienced FALL (Mother fell the other day and needs surgery). At the time of the report, FALL (Mother fell the other day and needs surgery), PRURITUS (Very itching), RASH (Rash on opposite arm of injection from elbow up) and VACCINATION SITE RASH (Rash on injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. On 18-Jan-2021, the reporter stated that her mother had a rash on the opposite arm from elbow to upper arm and the rash was very itchy. About five days later rash was on injection site of the arm. On 10-Feb-2021, her mother Fell (feel) the and needed surgery. Treatment was the unspecified surgery.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling on her ja right below her ear; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling on her ja right below her ear) in a female 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 (No medical history reported).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Swelling on her ja right below her ear). At the time of the report, SWELLING FACE (Swelling on her ja right below her ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on my arm underneath the site of injection, big 5-6 inches; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my arm underneath the site of injection, big 5-6 inches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LEVOTHYROXINE and CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash on my arm underneath the site of injection, big 5-6 inches). At the time of the report, RASH (rash on my arm underneath the site of injection, big 5-6 inches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Topical cream.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling almost the size of a golf ball now; Painful left arm; hot to the touch; itching; swelling; redness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling almost the size of a golf ball now), PAIN IN EXTREMITY (Painful left arm), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swelling) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included LISINOPRIL for Blood pressure, ATORVASTATIN for Cholesterol, PANTOPRAZOLE for Gastrooesophageal reflux disease, ACETYLSALICYLIC ACID (ASPIRIN 81) for Heart disease, unspecified, MAGNESIUM and BIOTIN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced SWELLING (swelling almost the size of a golf ball now), PAIN IN EXTREMITY (Painful left arm), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness). On 20-Feb-2021, SWELLING (swelling almost the size of a golf ball now), PAIN IN EXTREMITY (Painful left arm), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE PRURITUS (itching) 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.   This case was linked to MOD-2021-034040, MODERNATX, INC.-MOD-2021-034040 (E2B Linked Report). This case was linked to MOD-2021-100039, MOD-2021-100039 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Agency form; Sender's Comments:  MOD-2021-034040:Crosslinked, Husband case US-MODERNATX, INC.-MOD-2021-034040:Wife's case
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: swelling almost the size of a golf ball now; Painful left arm; hot to the touch; itching; swelling; redness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling almost the size of a golf ball now), PAIN IN EXTREMITY (Painful left arm), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swelling) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included LISINOPRIL for Blood pressure, ATORVASTATIN for Cholesterol, PANTOPRAZOLE for Gastrooesophageal reflux disease, ACETYLSALICYLIC ACID (ASPIRIN 81) for Heart disease, unspecified, MAGNESIUM and BIOTIN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced SWELLING (swelling almost the size of a golf ball now), PAIN IN EXTREMITY (Painful left arm), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness). On 20-Feb-2021, SWELLING (swelling almost the size of a golf ball now), PAIN IN EXTREMITY (Painful left arm), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE PRURITUS (itching) 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.   This case was linked to MOD-2021-034040, MODERNATX, INC.-MOD-2021-034040 (E2B Linked Report). This case was linked to MOD-2021-100039, MOD-2021-100039 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Agency form; Sender's Comments:  MOD-2021-034040:Crosslinked, Husband case US-MODERNATX, INC.-MOD-2021-034040:Wife's case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pruritus
Clinical narrative: Red Rash; Injection site itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itch) and RASH ERYTHEMATOUS (Red Rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itch). On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash). At the time of the report, VACCINATION SITE PRURITUS (Injection site itch) and RASH ERYTHEMATOUS (Red Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache
Clinical narrative: Back Ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Ache) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BACK PAIN (Back Ache) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back Ache) and HEADACHE (Headache) 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 relevant concomitant medications were reported.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight tenderness at the injection site) in a 90-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 22-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 PAIN (slight tenderness at the injection site). At the time of the report, VACCINATION SITE PAIN (slight tenderness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness at the injection; swelling at the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection) and VACCINATION SITE SWELLING (swelling at the injection) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection) and VACCINATION SITE SWELLING (swelling at the injection). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection) and VACCINATION SITE SWELLING (swelling at the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash) and RASH PRURITIC (itchy (rash)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history provided by Reporter.  Concomitant products included ADALIMUMAB (HUMIRA), METHOTREXATE and PREDNISONE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced RASH ERYTHEMATOUS (red rash) and RASH PRURITIC (itchy (rash)). At the time of the report, RASH ERYTHEMATOUS (red rash) and RASH PRURITIC (itchy (rash)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR received contains no new information
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Hyperhidrosis, Pain
Clinical narrative: sweating; exhausted; Arm really sore; crappy with aches; fever; joints killing me; headache; This spontaneous case was reported by an other health professional and describes the occurrence of PAIN IN EXTREMITY (Arm really sore), PAIN (crappy with aches), HYPERHIDROSIS (sweating), PYREXIA (fever) and ARTHRALGIA (joints killing me) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm really sore), PAIN (crappy with aches), PYREXIA (fever), ARTHRALGIA (joints killing me) and HEADACHE (headache). On 06-Feb-2021, the patient experienced HYPERHIDROSIS (sweating) and FATIGUE (exhausted). At the time of the report, PAIN IN EXTREMITY (Arm really sore), PAIN (crappy with aches), HYPERHIDROSIS (sweating), PYREXIA (fever), ARTHRALGIA (joints killing me), HEADACHE (headache) and FATIGUE (exhausted) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. No Treatment for the event was provided.   This case was linked to MOD-2020-001482 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sweating; exhausted; Arm really sore; crappy with aches; fever; joints killing me; headache; This spontaneous case was reported by an other health professional and describes the occurrence of PAIN IN EXTREMITY (Arm really sore), PAIN (crappy with aches), HYPERHIDROSIS (sweating), PYREXIA (fever) and ARTHRALGIA (joints killing me) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm really sore), PAIN (crappy with aches), PYREXIA (fever), ARTHRALGIA (joints killing me) and HEADACHE (headache). On 06-Feb-2021, the patient experienced HYPERHIDROSIS (sweating) and FATIGUE (exhausted). At the time of the report, PAIN IN EXTREMITY (Arm really sore), PAIN (crappy with aches), HYPERHIDROSIS (sweating), PYREXIA (fever), ARTHRALGIA (joints killing me), HEADACHE (headache) and FATIGUE (exhausted) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. No Treatment for the event was provided.   This case was linked to MOD-2020-001482 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: a week later after getting vaccine, she got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (a week later after getting vaccine, she got COVID) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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 an unknown date, the patient experienced COVID-19 (a week later after getting vaccine, she got COVID). At the time of the report, COVID-19 (a week later after getting vaccine, she got COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness
Clinical narrative: was tested positive for Covid; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (was tested positive for Covid) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Blood pressure.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 24-Jan-2021, the patient experienced COVID-19 (was tested positive for Covid). At the time of the report, COVID-19 (was tested positive for Covid) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure medication, thyroid medication. Treatment details included Infusion  for Covid on 26Jan2021. it lasted 2 hours.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash in the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE RASH (rash in the injection site) in a 75-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash in the injection site). At the time of the report, VACCINATION SITE RASH (rash in the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment for the event includes Clobetasol.    This case was linked to US-MODERNATX, INC.-MOD-2021-034723 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-034723:Case for patent 1
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: four to six drops of the vaccine came out with the needle; A spontaneous report was received from a  Consumer concerning his father a male patient of unspecified age  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced four to six drops of the vaccine came out with the needle/under dose.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  for prophylaxis of COVID-19 infection.  On an unknown date, it was reported that the patient received four to six drops less of the vaccine that came out with the needle.   Treatment details not provided..   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event four to six drops of the vaccine came out with the needle was considered resolved.; Reporter's Comments: This report refers to a case of possible underdose for mRNA-1273 with no associated AEs.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: slightly itchy; extremely bright red/ rash is also slightly itchy/ huge red rim around it; huge rash/ went from shoulder to elbow in the arm I got the injection in; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (slightly itchy), RASH ERYTHEMATOUS (extremely bright red/ rash is also slightly itchy/ huge red rim around it) and RASH (huge rash/ went from shoulder to elbow in the arm I got the injection in) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by Reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, METOPROLOL, ANASTROZOLE, GABAPENTIN and POTASSIUM 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 05-Feb-2021, the patient experienced PRURITUS (slightly itchy), RASH ERYTHEMATOUS (extremely bright red/ rash is also slightly itchy/ huge red rim around it) and RASH (huge rash/ went from shoulder to elbow in the arm I got the injection in). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form. At the time of the report, PRURITUS (slightly itchy), RASH ERYTHEMATOUS (extremely bright red/ rash is also slightly itchy/ huge red rim around it) and RASH (huge rash/ went from shoulder to elbow in the arm I got the injection in) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Hydrocortisone cream.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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 05-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid arm). At the time of the report, VACCINATION SITE REACTION (Covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling at the Injection Site; Redness at near the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the Injection Site) and VACCINATION SITE ERYTHEMA (Redness at near the Injection Site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blind.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the Injection Site) and VACCINATION SITE ERYTHEMA (Redness at near the Injection Site). At the time of the report, VACCINATION SITE SWELLING (Swelling at the Injection Site) and VACCINATION SITE ERYTHEMA (Redness at near the Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was 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.