chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Mild sore arm; fatigue; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced a mild sore arm and fatigue.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 07-Jan-2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient's husband reported that she received her Moderna vaccine on 07-Jan-2021 at 0830.  On 08-Jan-2021, he reported that she experienced a mild sore arm and fatigue.  He stated that both of those symptoms resolved later that same day.     Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, a mild sore arm and fatigue, was not provided.   The events, a mild sore arm and fatigue, were considered recovered/resolved on 08-Jan-2021.; 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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Fatigue, Feeling abnormal, Mass
Clinical narrative: found "a knot under my bicep"; bright red; itchy; didnt feel right; itchy; Arm swelling; Arm pain-feels someone kicked me on the arm; Arm hot to touch; rash around the shot area about 3 inches wide. The rash kept spreading and spreading,; really tired; exhausted; slept the whole day; slightly raised temp (3 degrees highter than normal); nausea; diarrhea; Normal vaccination soreness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Arm pain-feels someone kicked me on the arm), VACCINATION SITE WARMTH (Arm hot to touch), DIARRHOEA (diarrhea) and MASS (found "a knot under my bicep") in a 36-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 31-Dec-2020, the patient experienced DIARRHOEA (diarrhea), VACCINATION SITE PAIN (Normal vaccination soreness ) and NAUSEA (nausea). On 09-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Arm pain-feels someone kicked me on the arm), VACCINATION SITE WARMTH (Arm hot to touch), ERYTHEMA (bright red), PRURITUS (itchy), FEELING ABNORMAL (didnt feel right), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE RASH (rash around the shot area about 3 inches wide. The rash kept spreading and spreading,), FATIGUE (really tired; exhausted; slept the whole day) and PYREXIA (slightly raised temp (3 degrees highter than normal)). On 11-Jan-2021, the patient experienced MASS (found "a knot under my bicep"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 11-Jan-2021 at an unspecified dose and frequency. On 03-Jan-2021, DIARRHOEA (diarrhea) and NAUSEA (nausea) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Arm pain-feels someone kicked me on the arm), VACCINATION SITE WARMTH (Arm hot to touch), PRURITUS (itchy), FEELING ABNORMAL (didnt feel right) and VACCINATION SITE RASH (rash around the shot area about 3 inches wide. The rash kept spreading and spreading,) had not resolved and MASS (found "a knot under my bicep"), ERYTHEMA (bright red), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (Normal vaccination soreness ), FATIGUE (really tired; exhausted; slept the whole day) and PYREXIA (slightly raised temp (3 degrees highter than normal)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: found "a knot under my bicep"; bright red; itchy; didnt feel right; itchy; Arm swelling; Arm pain-feels someone kicked me on the arm; Arm hot to touch; rash around the shot area about 3 inches wide. The rash kept spreading and spreading,; really tired; exhausted; slept the whole day; slightly raised temp (3 degrees highter than normal); nausea; diarrhea; Normal vaccination soreness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Arm pain-feels someone kicked me on the arm), VACCINATION SITE WARMTH (Arm hot to touch), DIARRHOEA (diarrhea) and MASS (found "a knot under my bicep") in a 36-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 31-Dec-2020, the patient experienced DIARRHOEA (diarrhea), VACCINATION SITE PAIN (Normal vaccination soreness ) and NAUSEA (nausea). On 09-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Arm pain-feels someone kicked me on the arm), VACCINATION SITE WARMTH (Arm hot to touch), ERYTHEMA (bright red), PRURITUS (itchy), FEELING ABNORMAL (didnt feel right), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE RASH (rash around the shot area about 3 inches wide. The rash kept spreading and spreading,), FATIGUE (really tired; exhausted; slept the whole day) and PYREXIA (slightly raised temp (3 degrees highter than normal)). On 11-Jan-2021, the patient experienced MASS (found "a knot under my bicep"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 11-Jan-2021 at an unspecified dose and frequency. On 03-Jan-2021, DIARRHOEA (diarrhea) and NAUSEA (nausea) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Arm pain-feels someone kicked me on the arm), VACCINATION SITE WARMTH (Arm hot to touch), PRURITUS (itchy), FEELING ABNORMAL (didnt feel right) and VACCINATION SITE RASH (rash around the shot area about 3 inches wide. The rash kept spreading and spreading,) had not resolved and MASS (found "a knot under my bicep"), ERYTHEMA (bright red), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (Normal vaccination soreness ), FATIGUE (really tired; exhausted; slept the whole day) and PYREXIA (slightly raised temp (3 degrees highter than normal)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Vertigo
Clinical narrative: Lost balance; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and BALANCE DISORDER (Lost balance) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.  No medical history was provided by the reporter.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VERTIGO (Vertigo). On 08-Jan-2021, the patient experienced BALANCE DISORDER (Lost balance). At the time of the report, VERTIGO (Vertigo) and BALANCE DISORDER (Lost balance) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: warm to touch; her arm started to get swollen; A spontaneous report was received from a consumer (United States) concerning a 61-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced her arm started to get swollen and was warm to touch.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28-Dec-2020, approximately ten days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Patient's husband reported that she received her Moderna vaccine on 28-Dec-2020.  He stated that on day 10, 07-Jan-2021, her arm started to swell and was warm to the touch. He wished to know if that was normal.    There was no treatment for the event per report.  Action taken with mRNA-1273 in response to the events, her arm started to get swollen and was warm to touch, was not provided.   The outcome of the events, her arm started to get swollen and was warm to touch, was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Throat irritation
Clinical narrative: Itchy throat; Face started to swell; A spontaneous report was received from a consumer concerning her daughter, a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy throat/ throat irritation and face started to swell/ swelling face.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unspecified date, prior to the onset of the events, the patient received their dose of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced itchy throat and face started to swell.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event itchy throat and face started to swell was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Critical details such as the dosing date, onset date of the event, patient's age/ gender and medical history are lacking. Further information has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Heavy menstrual bleeding, Paraesthesia
Clinical narrative: tingling sensation of the hands; Regular to Heavy menstrual flow; Feeling cold; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling sensation of the hands), HEAVY MENSTRUAL BLEEDING (Regular to Heavy menstrual flow) and FEELING COLD (Feeling cold) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Irregular periods (as reported by patient (she is irregular)) since an unknown date. Concomitant products included EMERGEN C for Prophylaxis.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PARAESTHESIA (tingling sensation of the hands), HEAVY MENSTRUAL BLEEDING (Regular to Heavy menstrual flow) and FEELING COLD (Feeling cold). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing from 31-Dec-2020 for Adverse event following immunisation, at a dose of UNK dosage form, bid. At the time of the report, PARAESTHESIA (tingling sensation of the hands) and FEELING COLD (Feeling cold) had not resolved and HEAVY MENSTRUAL BLEEDING (Regular to Heavy menstrual flow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: cough; nasal drainage; Loss of taste; Loss of smell; This spontaneous case was reported by a physician and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), COUGH (cough) and RHINORRHOEA (nasal drainage) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: HEPATITIS B VACCINE (1 of 3 series) on 27-Nov-2020.    On 29-Dec-2020 at 2:33 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). On an unknown date, the patient experienced COUGH (cough) and RHINORRHOEA (nasal drainage). On 14-Jan-2021, AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), COUGH (cough) and RHINORRHOEA (nasal drainage) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient denied any treatment measures.      Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Events (cough, nasal drainage and loss in sense of smell to seasonal allergies) updated. The outcome of events updated and information regarding patient's Hepatitis B vaccine updated. On 02-Jun-2021: Follow-up information contains non-significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded for the event,  Loss of taste and Loss of smell.  Very limited information regarding the event, positive test,  has been provided at this time.  Further information has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: felt tingling in my hands; dizzy for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy for 4 days) and PARAESTHESIA (felt tingling in my hands) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0112204) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy for 4 days) and PARAESTHESIA (felt tingling in my hands). At the time of the report, DIZZINESS (dizzy for 4 days) had resolved and PARAESTHESIA (felt tingling in my hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment provided for the event was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Reporter first and last name updated for spelling, email added, and new event of tingling in hands 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 event, a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; MIld fatigue; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (MIld fatigue) and HEADACHE (Mild headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided). Concomitant products included VITAMIN D NOS for Immunization.    On 07-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (MIld fatigue) and HEADACHE (Mild headache). On 08-Jan-2021, PAIN IN EXTREMITY (Sore arm), FATIGUE (MIld fatigue) and HEADACHE (Mild headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available 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: Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Burning sensation; Itchy sensation; The area of injection was hot; The area of injection was red; A spontaneous report was received from a consumer, concerning herself, a 68-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced burning sensation, itchy sensation, the area of injection site was hot and red.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 09-JAN-2021, after the first dose of vaccine she started having a burning and Itchy sensation. When she rolled up her sleeves the area of injection was noticed to be red and hot. Patient was treated with paracetamol 1000mg and diphenhydramine 25 mg, but it was not working, and she was still having the same symptoms.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, burning sensation, itchy sensation, the area of inject site was hot and red were considered not resolved at the time of this report.; 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.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Hyperhidrosis
Clinical narrative: Deep sweat; Dizzy; Sore Shoulders; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), HYPERHIDROSIS (Deep sweat) and ARTHRALGIA (Sore Shoulders) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect (No Medical  History provided). Concomitant products included CANAGLIFLOZIN, METFORMIN HYDROCHLORIDE (INVOKAMET), OMEPRAZOLE, LISINOPRIL, HYDROCODONE and AMLODIPINE for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced ARTHRALGIA (Sore Shoulders). On 08-Jan-2021, the patient experienced DIZZINESS (Dizzy). On 09-Jan-2021, the patient experienced HYPERHIDROSIS (Deep sweat). At the time of the report, DIZZINESS (Dizzy), HYPERHIDROSIS (Deep sweat) and ARTHRALGIA (Sore Shoulders) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature (low-Unknown): 93.5 (Low) degrees Fahrenheit and 95.2 (Low) degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; 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: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: redness and heat at the injection site or a quarter inch away; itchy; redness and heat at the injection site or a quarter inch away; A spontaneous report was received from a consumer concerning a 94-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced itchy, redness and heat at the injection site.   The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on 30 Dec 2020 in the left arm for prophylaxis of COVID-19 infection.   A consumer who is the patient called to report she received the Moderna COVID-19 vaccine on 30 Dec 2020. On 08 Jan 2021, she reported her arm was itchy, saw redness and felt heat at the injection site or a quarter inch away from the injection site.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The events, itchy, redness and heat at the injection site, were considered unknown.   The reporter did not provide an assessment of the events, itchy, redness and heat at the injection site.; Reporter's Comments: Based on the established safety profile and a temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded.  Injection site pruritus and injection site redness are consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: diarrhea; red hard bump the size of a dime on teh side of her arm at the injection site; red hard bump the size of a dime on the side of her arm at the injection site; soreness at the injection site; A spontaneous report was received from a 66 year old female consumer who was participating in the mRNA-1273 Emergency Use Program and experienced soreness at the injection site and later a red hard bump the size of a dime on the side of her arm at the injection site.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 29 Dec 2020, after receiving the vaccine, the patient experienced soreness at the injection site. On 08 Jan 2021, the patient developed a red hard bump the size of a dime on the side of her arm at the injection site. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, experienced soreness at the injection site and later a red hard bump the size of a dime on the side of her arm at the injection site, were considered 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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Musculoskeletal discomfort, Musculoskeletal stiffness, Nausea
Clinical narrative: Feels like the head is swelling; Couldn't sleep on her left side; Feeling nauseated; Headache; Pain/pulling on the left side of my neck, giving me discomfort; Left arm stiff ,seems to be spreading to the right side; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Pain/pulling on the left side of my neck, giving me discomfort), MUSCULOSKELETAL STIFFNESS (Left arm stiff ,seems to be spreading to the right side), HEAD DISCOMFORT (Feels like the head is swelling), SLEEP DISORDER (Couldn't sleep on her left side) and NAUSEA (Feeling nauseated) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Stomach discomfort. Concomitant products included LOSARTAN and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Left arm stiff ,seems to be spreading to the right side). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Pain/pulling on the left side of my neck, giving me discomfort), HEAD DISCOMFORT (Feels like the head is swelling), SLEEP DISORDER (Couldn't sleep on her left side), NAUSEA (Feeling nauseated) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Physical therapy (Heating pad) for Musculoskeletal stiffness. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Pain/pulling on the left side of my neck, giving me discomfort), MUSCULOSKELETAL STIFFNESS (Left arm stiff ,seems to be spreading to the right side), HEAD DISCOMFORT (Feels like the head is swelling), SLEEP DISORDER (Couldn't sleep on her left side), NAUSEA (Feeling nauseated) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: This case concerns a 75-year-old female with a non-serious unexpected events of musculoskeletal discomfort, musculoskeletal stiffness, head discomfort, sleep disorder and non-serious unexpected nausea and headache. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Feels like the head is swelling; Couldn't sleep on her left side; Feeling nauseated; Headache; Pain/pulling on the left side of my neck, giving me discomfort; Left arm stiff ,seems to be spreading to the right side; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Pain/pulling on the left side of my neck, giving me discomfort), MUSCULOSKELETAL STIFFNESS (Left arm stiff ,seems to be spreading to the right side), HEAD DISCOMFORT (Feels like the head is swelling), SLEEP DISORDER (Couldn't sleep on her left side) and NAUSEA (Feeling nauseated) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Stomach discomfort. Concomitant products included LOSARTAN and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Left arm stiff ,seems to be spreading to the right side). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Pain/pulling on the left side of my neck, giving me discomfort), HEAD DISCOMFORT (Feels like the head is swelling), SLEEP DISORDER (Couldn't sleep on her left side), NAUSEA (Feeling nauseated) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Physical therapy (Heating pad) for Musculoskeletal stiffness. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Pain/pulling on the left side of my neck, giving me discomfort), MUSCULOSKELETAL STIFFNESS (Left arm stiff ,seems to be spreading to the right side), HEAD DISCOMFORT (Feels like the head is swelling), SLEEP DISORDER (Couldn't sleep on her left side), NAUSEA (Feeling nauseated) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: This case concerns a 75-year-old female with a non-serious unexpected events of musculoskeletal discomfort, musculoskeletal stiffness, head discomfort, sleep disorder and non-serious unexpected nausea and headache. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-002362 (E2B Linked Report).; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-002362:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Gastritis
Clinical narrative: Bout of gastritis; Sick to my stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to my stomach) and GASTRITIS (Bout of gastritis) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Gastritis.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to my stomach). On an unknown date, the patient experienced GASTRITIS (Bout of gastritis). At the time of the report, ABDOMINAL DISCOMFORT (Sick to my stomach) and GASTRITIS (Bout of gastritis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: new event has been updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the medical history of gastritis could be a contributory factor.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Diarrhoea, Vaccination site erythema, Vaccination site pain
Clinical narrative: Stomach still bloated, Stomach still gassy; Abdominal pain on her right side; diarrhea; Arm soreness; Redness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN (Abdominal pain on her right side), DIARRHOEA (diarrhea), ABDOMINAL DISTENSION (Stomach still bloated, Stomach still gassy), VACCINATION SITE PAIN (Arm soreness) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), AMLODIPINE, TURMERIC [CURCUMA LONGA RHIZOME] and MULTIVITAMIN [VITAMINS NOS].    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced DIARRHOEA (diarrhea), VACCINATION SITE PAIN (Arm soreness) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 10-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain on her right side). On 11-Jan-2021, the patient experienced ABDOMINAL DISTENSION (Stomach still bloated, Stomach still gassy). On 09-Jan-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, ABDOMINAL PAIN (Abdominal pain on her right side), ABDOMINAL DISTENSION (Stomach still bloated, Stomach still gassy), VACCINATION SITE PAIN (Arm soreness) and VACCINATION SITE ERYTHEMA (Redness at the injection site) 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.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: No specific follow-up information recorded.; 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: M
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: pain and tenderness in arm; Could not sleep; A spontaneous report was received from a consumer who was also a 71-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain, tenderness, it was hard to put on a pair of pants and shirt, and he could not sleep because of it.   The patient's medical history included arthritis. Products known to have been used by the patient were Lisinopril 5mg, Glipizide 10mg, Rosuvastatin 40mg, Carvedilol 25mg, Aspirin OTC, Tylenol for arthritis.   On 07 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 025J20A) for prophylaxis of COVID-19 infection.    On 07 Jan 2021, approximately a couple hours after the mRNA-1273 vaccine was given, the patient reported that he felt pain, tenderness, and it was hard to put a pair of pants and a shirt on, and he could not sleep because of it.   On 08 Jan 2021, he reports that the events didn't go away, but does feel a little bit better.   Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, experienced pain, tenderness, it was hard to put on a pair of pants and shirt, and he could not sleep because of it was not provided.; 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: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain in extremity
Clinical narrative: pain feels like it is "going down my right leg; lower right back pain/bcak pain is very mild nowbut still there, lower right back; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain feels like it is "going down my right leg), BACK PAIN (lower right back pain/bcak pain is very mild nowbut still there, lower right back) and FATIGUE (Fatigue) in a 59-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 (No reported medical history.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain feels like it is "going down my right leg) and BACK PAIN (lower right back pain/bcak pain is very mild nowbut still there, lower right back). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 500 mg twice a day. On 09-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (pain feels like it is "going down my right leg) and BACK PAIN (lower right back pain/bcak pain is very mild nowbut still there, lower right back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment includes muscle relaxer and he is doing a lot of stretching and using an inversion table which usually helps but didn't this time.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Erythematous area at the injection site; A spontaneous report was received from a physician, who is a 47-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red erythematous area at the injection site.  The patient's medical history was not provided. Concomitant medications were not reported.  On 05 JAN 2021, the patient received their first dose of mRNA-1273 (Batch number: 011J20A) intramuscularly in her left arm for the prophylaxis of COVID-19 infection.   On 13 JAN 2021, the patient experienced red erythematous area at the injection site. Treatment for the event included cetirizine and hydrocortisone.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, red erythematous area at the injection site was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia, Rhinorrhoea, Vaccination complication
Clinical narrative: Fever; Congestion; Runny nose; Didnt feel good , felt like dragging; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Didnt feel good , felt like dragging), NASAL CONGESTION (Congestion), RHINORRHOEA (Runny nose) and PYREXIA (Fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011120A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION COMPLICATION (Didnt feel good , felt like dragging). On 10-Jan-2021, the patient experienced NASAL CONGESTION (Congestion) and RHINORRHOEA (Runny nose). On 11-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, VACCINATION COMPLICATION (Didnt feel good , felt like dragging), NASAL CONGESTION (Congestion), RHINORRHOEA (Runny nose) and PYREXIA (Fever) 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.   Treatment information was not provided.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tenderness on the left arm where she got the injection; A spontaneous report was received from a consumer concerning a 78-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tenderness on the left arm where she got the injection.   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 (Lot number : Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 08-Jan-2021, the patient called to report that about a week ago she received the vaccine and experienced tenderness on the left arm where she got the injection. She stated her arm is better now. Treatment for the event included exercise and a hot compress.   Action taken with mRNA-1273 in response to the events was not reported.   The event, tenderness on the left arm where she got the injection, was reported as resolved on 08-Jan-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Developed a hive (exactly a week after); Itching rash around the area (exactly a week after); A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine, and who developed a hive or itching rash around the area.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 07-Jan-2021, approximately a week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 I(Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 07-Jan-2021, patient developed a hive or itching rash around the area. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.    The outcome of the events developed a hive or itching rash around the area was considered unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious expected events of injection site urticaria and injection site pruritus. Event onset occurred 8 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; Fever; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine, and who experienced chills and fever.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On 08-Jan-2021, patient experienced chills and fever. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events experienced chills and fever were considered unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious expected events of pyrexia and chills.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Photosensitivity reaction
Clinical narrative: Skin was red; Hot pink look on skin/photo sensitivity to sun; A spontaneous report was received from a 64-year-old female patient concerning herself who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced photosensitivity to sun/ Photosensitivity reaction with hot pink look on the skin and skin was red/ Erythema.   The patient's medical history was not provided. Concomitant medications included 2 Ibuprofens and 2 Motrin prior to vaccine administration  On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J202A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021 after receiving the vaccine, the patient was sitting out in the sun and had complaints of photosensitivity to sun with a hot pink look on the skin. She tested this again on 09 Jan 2021 and noticed her skin was red. Patient states she can normally sit out in the sun without burning. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, experienced photosensitivity to sun with hot pink look on the skin and skin was red, were considered resolved on 10 Jan 2021.; 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.