chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: red raised itchy rash at the injection site, 4cm across and defined; red raised itchy rash at the injection site, 4cm across and defined; red raised itchy rash at the injection site, 4cm across and defined; soreness at injection site; injection site swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect (No reported medical history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported event sand the product use cannot be excluded.  Injection site erythema, Injection site rash, injection site pain and injection site pruritus are consistent with the known safety profile of the vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Limb discomfort, Vaccination site pain
Clinical narrative: difficulty lifting arm; Severe headache; Fatigue; Sore joints; Sore arm at the injection; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (difficulty lifting arm), VACCINATION SITE PAIN (Sore arm at the injection), HEADACHE (Severe headache), FATIGUE (Fatigue) and ARTHRALGIA (Sore joints) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021 at 3:00 PM, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection). On 06-Jan-2021, the patient experienced LIMB DISCOMFORT (difficulty lifting arm), HEADACHE (Severe headache), FATIGUE (Fatigue) and ARTHRALGIA (Sore joints). At the time of the report, LIMB DISCOMFORT (difficulty lifting arm), VACCINATION SITE PAIN (Sore arm at the injection), HEADACHE (Severe headache), FATIGUE (Fatigue) and ARTHRALGIA (Sore joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medication included Paracetamol.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Nausea
Clinical narrative: Back ache; Body aches; Nauseous; High fever; Chills; Felt tired; Headache; A spontaneous report was received from a pharmacist concerning, a 49-year old, female patient, who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced fever, chills, feeling tired, headache, nausea, body aches and back ache.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.    On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273(Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient began to experience high fever, chills, felt tired, and a headache. On 08 Jan 2021, the patient reports a worsened headache, nausea, body aches and back ache. Treatment for the event included paracetamol and ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome events, fever, chills, and feeling tired, were considered unknown.   The outcome events, headache, nausea, body aches and back ache, were 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Back ache; Body aches; Nauseous; High fever; Chills; Felt tired; Headache; A spontaneous report was received from a pharmacist concerning, a 49-year old, female patient, who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced fever, chills, feeling tired, headache, nausea, body aches and back ache.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.    On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273(Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient began to experience high fever, chills, felt tired, and a headache. On 08 Jan 2021, the patient reports a worsened headache, nausea, body aches and back ache. Treatment for the event included paracetamol and ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome events, fever, chills, and feeling tired, were considered unknown.   The outcome events, headache, nausea, body aches and back ache, were 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Diarrhoea, Ear pain
Clinical narrative: Flu Like Symptoms; Injection site inflammed; Not been able to sleeplast 2 nights; pain in the ears and shoulders; Lymph nodes swollen; pain in the shoulders; arm  was super red and it was inflamed.; Left side was in pain; Pain near rib cage; Arm was sore; Diarrhea; Very weak; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN UPPER (Left side was in pain), MUSCULOSKELETAL CHEST PAIN (Pain near rib cage), PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea) and ASTHENIA (Very weak) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011520A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), MULTIVITAMIN & MINERAL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced ABDOMINAL PAIN UPPER (Left side was in pain), MUSCULOSKELETAL CHEST PAIN (Pain near rib cage), PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea) and ASTHENIA (Very weak). On 01-Jan-2021, the patient experienced EAR PAIN (pain in the ears and shoulders), LYMPHADENOPATHY (Lymph nodes swollen), ARTHRALGIA (pain in the shoulders) and VACCINATION SITE ERYTHEMA (arm  was super red and it was inflamed.). On 05-Jan-2021, the patient experienced INSOMNIA (Not been able to sleeplast 2 nights). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (Injection site inflammed) and INFLUENZA LIKE ILLNESS (Flu Like Symptoms). At the time of the report, ABDOMINAL PAIN UPPER (Left side was in pain), MUSCULOSKELETAL CHEST PAIN (Pain near rib cage), PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea), ASTHENIA (Very weak), VACCINATION SITE INFLAMMATION (Injection site inflammed), INSOMNIA (Not been able to sleeplast 2 nights), EAR PAIN (pain in the ears and shoulders), LYMPHADENOPATHY (Lymph nodes swollen), ARTHRALGIA (pain in the shoulders) and VACCINATION SITE ERYTHEMA (arm  was super red and it was inflamed.) had not resolved and INFLUENZA LIKE ILLNESS (Flu Like Symptoms) 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.   Treatment information includes ice and heat alternation in the arm.y  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: Influenza like illness, Insomnia, Lymphadenopathy, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Flu Like Symptoms; Injection site inflammed; Not been able to sleeplast 2 nights; pain in the ears and shoulders; Lymph nodes swollen; pain in the shoulders; arm  was super red and it was inflamed.; Left side was in pain; Pain near rib cage; Arm was sore; Diarrhea; Very weak; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN UPPER (Left side was in pain), MUSCULOSKELETAL CHEST PAIN (Pain near rib cage), PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea) and ASTHENIA (Very weak) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011520A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), MULTIVITAMIN & MINERAL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced ABDOMINAL PAIN UPPER (Left side was in pain), MUSCULOSKELETAL CHEST PAIN (Pain near rib cage), PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea) and ASTHENIA (Very weak). On 01-Jan-2021, the patient experienced EAR PAIN (pain in the ears and shoulders), LYMPHADENOPATHY (Lymph nodes swollen), ARTHRALGIA (pain in the shoulders) and VACCINATION SITE ERYTHEMA (arm  was super red and it was inflamed.). On 05-Jan-2021, the patient experienced INSOMNIA (Not been able to sleeplast 2 nights). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (Injection site inflammed) and INFLUENZA LIKE ILLNESS (Flu Like Symptoms). At the time of the report, ABDOMINAL PAIN UPPER (Left side was in pain), MUSCULOSKELETAL CHEST PAIN (Pain near rib cage), PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea), ASTHENIA (Very weak), VACCINATION SITE INFLAMMATION (Injection site inflammed), INSOMNIA (Not been able to sleeplast 2 nights), EAR PAIN (pain in the ears and shoulders), LYMPHADENOPATHY (Lymph nodes swollen), ARTHRALGIA (pain in the shoulders) and VACCINATION SITE ERYTHEMA (arm  was super red and it was inflamed.) had not resolved and INFLUENZA LIKE ILLNESS (Flu Like Symptoms) 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.   Treatment information includes ice and heat alternation in the arm.y  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: Vaccination site erythema, Vaccination site inflammation
Clinical narrative: Flu Like Symptoms; Injection site inflammed; Not been able to sleeplast 2 nights; pain in the ears and shoulders; Lymph nodes swollen; pain in the shoulders; arm  was super red and it was inflamed.; Left side was in pain; Pain near rib cage; Arm was sore; Diarrhea; Very weak; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN UPPER (Left side was in pain), MUSCULOSKELETAL CHEST PAIN (Pain near rib cage), PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea) and ASTHENIA (Very weak) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011520A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), MULTIVITAMIN & MINERAL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced ABDOMINAL PAIN UPPER (Left side was in pain), MUSCULOSKELETAL CHEST PAIN (Pain near rib cage), PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea) and ASTHENIA (Very weak). On 01-Jan-2021, the patient experienced EAR PAIN (pain in the ears and shoulders), LYMPHADENOPATHY (Lymph nodes swollen), ARTHRALGIA (pain in the shoulders) and VACCINATION SITE ERYTHEMA (arm  was super red and it was inflamed.). On 05-Jan-2021, the patient experienced INSOMNIA (Not been able to sleeplast 2 nights). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (Injection site inflammed) and INFLUENZA LIKE ILLNESS (Flu Like Symptoms). At the time of the report, ABDOMINAL PAIN UPPER (Left side was in pain), MUSCULOSKELETAL CHEST PAIN (Pain near rib cage), PAIN IN EXTREMITY (Arm was sore), DIARRHOEA (Diarrhea), ASTHENIA (Very weak), VACCINATION SITE INFLAMMATION (Injection site inflammed), INSOMNIA (Not been able to sleeplast 2 nights), EAR PAIN (pain in the ears and shoulders), LYMPHADENOPATHY (Lymph nodes swollen), ARTHRALGIA (pain in the shoulders) and VACCINATION SITE ERYTHEMA (arm  was super red and it was inflamed.) had not resolved and INFLUENZA LIKE ILLNESS (Flu Like Symptoms) 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.   Treatment information includes ice and heat alternation in the arm.y  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Red oval on arm; Arm hurting; A spontaneous report was received from other health care professional concerning a 50-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm hurting/ pain in extremity and red oval on arm/ erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 31 Dec 2020, prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch Number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced arm hurting and noticed big red spot nine days later, on 9 Jan 2021. On 09 Jan 2021, the patient noticed red oval on arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, arm hurting and red oval on arm was not reported.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events,  and excluding any other etiology, a causal relationship with the event cannot be excluded
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Arm felt warm touch; Soreness at the injection site; Redness at the injection site; A spontaneous report was received from a consumer concerning a 70-years-old, female patient who received Moderna's COVID-19 Vaccine and experienced soreness at the site of injection, redness at the site of injection and arm felt warm touch.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 Dec 2020, approximately 10 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection.   On 08 Jan 2021, patient experienced soreness at the site of injection, redness at the site of injection and arm felt warm touch.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events soreness at the site of injection, redness at the site of injection and arm felt warm touch was not resolved.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Movement disorder, Pain
Clinical narrative: Breaking out in sweats; Couldn't get out of bed; all I did was sleep; whole body had aches all over her joint; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Breaking out in sweats), MOVEMENT DISORDER (Couldn't get out of bed), PAIN (whole body had aches all over her joint), CHILLS (Chills) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE 1A PHARMA), LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN 81).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN (whole body had aches all over her joint), CHILLS (Chills) and HEADACHE (Headache). On 06-Jan-2021, the patient experienced MOVEMENT DISORDER (Couldn't get out of bed) and SOMNOLENCE (all I did was sleep). On 07-Jan-2021, the patient experienced HYPERHIDROSIS (Breaking out in sweats). At the time of the report, HYPERHIDROSIS (Breaking out in sweats), MOVEMENT DISORDER (Couldn't get out of bed), PAIN (whole body had aches all over her joint), CHILLS (Chills), HEADACHE (Headache) and SOMNOLENCE (all I did was sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Ibuprofen.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: Somnolence
Clinical narrative: Breaking out in sweats; Couldn't get out of bed; all I did was sleep; whole body had aches all over her joint; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Breaking out in sweats), MOVEMENT DISORDER (Couldn't get out of bed), PAIN (whole body had aches all over her joint), CHILLS (Chills) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE 1A PHARMA), LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN 81).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN (whole body had aches all over her joint), CHILLS (Chills) and HEADACHE (Headache). On 06-Jan-2021, the patient experienced MOVEMENT DISORDER (Couldn't get out of bed) and SOMNOLENCE (all I did was sleep). On 07-Jan-2021, the patient experienced HYPERHIDROSIS (Breaking out in sweats). At the time of the report, HYPERHIDROSIS (Breaking out in sweats), MOVEMENT DISORDER (Couldn't get out of bed), PAIN (whole body had aches all over her joint), CHILLS (Chills), HEADACHE (Headache) and SOMNOLENCE (all I did was sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Ibuprofen.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination complication
Clinical narrative: COVID-19; Side effects; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and VACCINATION COMPLICATION (Side effects) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 14-Jan-2021, the patient experienced COVID-19 (COVID-19). In January 2021, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, COVID-19 (COVID-19) and VACCINATION COMPLICATION (Side effects) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: (Positive) Test result positive was on 14 Jan 2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant product use was not provided by the reporter.  Treatment for the event included none.; Sender's Comments: Based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 is assessed as unlikely related to mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the event Vaccination complication, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Headache, Malaise
Clinical narrative: felt sicker with the Vaccine than with the Covid; felt nausea; vomiting; chills; headaches; back ache; was debilitating; This spontaneous case was reported by a nurse and describes the occurrence of BACK PAIN (back ache), ASTHENIA (was debilitating), MALAISE (felt sicker with the Vaccine than with the Covid), CHILLS (chills) and HEADACHE (headaches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L210A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (she was  tested positive for Covid on 27Apr2020) on 27-Apr-2020, Hysterectomy and Surgery (lap band surgery, carpal tunnel surgery, and left shoulder surgery 2 times.). Concurrent medical conditions included Drug allergy (Allergies to Sulfas). Concomitant products included LEVOTHYROXINE, LOSARTAN POTASSIUM (LOSARTIN) and DICLOFENAC for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced BACK PAIN (back ache), ASTHENIA (was debilitating), CHILLS (chills) and HEADACHE (headaches). On 06-Jan-2021, the patient experienced MALAISE (felt sicker with the Vaccine than with the Covid), NAUSEA (felt nausea) and VOMITING (vomiting). At the time of the report, BACK PAIN (back ache), ASTHENIA (was debilitating), MALAISE (felt sicker with the Vaccine than with the Covid), CHILLS (chills), HEADACHE (headaches), NAUSEA (felt nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2020, SARS-CoV-2 antibody test positive: positive (Positive) she was  tested positive for Covid on 27Apr2020.     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 of the events was reported as none.  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.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 antibody test positive, Vomiting
Clinical narrative: felt sicker with the Vaccine than with the Covid; felt nausea; vomiting; chills; headaches; back ache; was debilitating; This spontaneous case was reported by a nurse and describes the occurrence of BACK PAIN (back ache), ASTHENIA (was debilitating), MALAISE (felt sicker with the Vaccine than with the Covid), CHILLS (chills) and HEADACHE (headaches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L210A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (she was  tested positive for Covid on 27Apr2020) on 27-Apr-2020, Hysterectomy and Surgery (lap band surgery, carpal tunnel surgery, and left shoulder surgery 2 times.). Concurrent medical conditions included Drug allergy (Allergies to Sulfas). Concomitant products included LEVOTHYROXINE, LOSARTAN POTASSIUM (LOSARTIN) and DICLOFENAC for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced BACK PAIN (back ache), ASTHENIA (was debilitating), CHILLS (chills) and HEADACHE (headaches). On 06-Jan-2021, the patient experienced MALAISE (felt sicker with the Vaccine than with the Covid), NAUSEA (felt nausea) and VOMITING (vomiting). At the time of the report, BACK PAIN (back ache), ASTHENIA (was debilitating), MALAISE (felt sicker with the Vaccine than with the Covid), CHILLS (chills), HEADACHE (headaches), NAUSEA (felt nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2020, SARS-CoV-2 antibody test positive: positive (Positive) she was  tested positive for Covid on 27Apr2020.     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 of the events was reported as none.  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.; 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 lymphadenopathy, Vaccination site rash, Vaccination site swelling
Clinical narrative: armpit is swollen a little more; rash at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE LYMPHADENOPATHY (armpit is swollen a little more) 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 reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). 06-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site). On 09-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (armpit is swollen a little more). At the time of the report, VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE LYMPHADENOPATHY (armpit is swollen a little more) 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.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cytogenetic abnormality, Maternal exposure during pregnancy, Pregnancy test, Ultrasound abdomen
Clinical narrative: Pregnant (received vaccine); This spontaneous prospective pregnancy case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (received vaccine)) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use from 2008 to 08-Aug-2020. Previously administered products included for Pregnancy: Folic acid from June 2020 to August 2020. Concurrent medical conditions included Seasonal allergy since 1998 and Constipation since December 2020. Concomitant products included MACROGOL 3350 (MIRALAX) for Constipation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, CETIRIZINE for Seasonal allergy.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 28-Jul-2020 and the estimated date of delivery was 04-May-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (received vaccine)). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 11-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (received vaccine)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2020, Pregnancy test: positive (Positive) positive. On 06-Oct-2020, Ultrasound abdomen: normal (normal) normal. On 15-Dec-2020, Ultrasound abdomen: normal (normal) normal. On an unknown date, Cytogenetic abnormality: normal (normal) Negative (normal).     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.   Treatment medications were not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Congenital adrenal hyperplasia. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), FOLIC ACID, LEVOTHYROXINE, PROGESTERONE and ESTRADIOL (ESTROGEN).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Aug-2020 and the estimated date of delivery was 21-Jul-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There were three previous pregnancies of the patient. On 6-AUG-2018, patient was pregnant and the outcome was live full time birth and Second pregnancy was on 10-Feb-2020 which was a miscarriage and the outcome resulted in spontaneous abortion. The current pregnancy details included her date of menstrual period (25-Aug-2020) and date of positive pregnancy test was on 12-Nov-2020. The estimation date for the conception was on 02-Nov-2020 and estimated due date for the pregnancy of the patient  was on 21-Jul-2020. Additional information concerning this pregnancy was included IVF- identical twin boys.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: Corrected Dose number to 1, Para to 1, Number of Fetus to 2 (identical twin boys), Removed Delivery Date; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: swelling in his left calf; swelling in his left ankle; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in his left calf) and JOINT SWELLING (swelling in his left ankle) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical History Information was reported.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling in his left calf) and JOINT SWELLING (swelling in his left ankle). At the time of the report, PERIPHERAL SWELLING (swelling in his left calf) and JOINT SWELLING (swelling in his left ankle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 16-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in his left calf) and JOINT SWELLING (swelling in his left ankle) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical History Information was reported.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling in his left calf) and JOINT SWELLING (swelling in his left ankle). At the time of the report, PERIPHERAL SWELLING (swelling in his left calf) and JOINT SWELLING (swelling in his left ankle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant and received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant and received the vaccine) in a 32-year-old female 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 effect (No adverse event reported.). Concurrent medical conditions included Pregnant.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Jul-2020 and the estimated date of delivery was 01-May-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant and received the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant and received the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site hypoaesthesia, Injection site paraesthesia, Malaise
Clinical narrative: Rough night; Feeling terrible; Fever; Chills; Headache; Tinging in the arm of injection; loss of sensation in the arm of injection; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE PARAESTHESIA (Tinging in the arm of injection), INJECTION SITE HYPOAESTHESIA (loss of sensation in the arm of injection), SLEEP DISORDER (Rough night), MALAISE (Feeling terrible) and PYREXIA (Fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Jan-2021, the patient experienced INJECTION SITE PARAESTHESIA (Tinging in the arm of injection) and INJECTION SITE HYPOAESTHESIA (loss of sensation in the arm of injection).   On an unknown date, the patient experienced SLEEP DISORDER (Rough night), MALAISE (Feeling terrible), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency.   At the time of the report, INJECTION SITE PARAESTHESIA (Tinging in the arm of injection) and INJECTION SITE HYPOAESTHESIA (loss of sensation in the arm of injection) had resolved and SLEEP DISORDER (Rough night), MALAISE (Feeling terrible), PYREXIA (Fever), CHILLS (Chills) 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.   Concomitant product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: Patient's information 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 events, a causal relationship cannot be excluded
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Rough night; Feeling terrible; Fever; Chills; Headache; Tinging in the arm of injection; loss of sensation in the arm of injection; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE PARAESTHESIA (Tinging in the arm of injection), INJECTION SITE HYPOAESTHESIA (loss of sensation in the arm of injection), SLEEP DISORDER (Rough night), MALAISE (Feeling terrible) and PYREXIA (Fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Jan-2021, the patient experienced INJECTION SITE PARAESTHESIA (Tinging in the arm of injection) and INJECTION SITE HYPOAESTHESIA (loss of sensation in the arm of injection).   On an unknown date, the patient experienced SLEEP DISORDER (Rough night), MALAISE (Feeling terrible), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency.   At the time of the report, INJECTION SITE PARAESTHESIA (Tinging in the arm of injection) and INJECTION SITE HYPOAESTHESIA (loss of sensation in the arm of injection) had resolved and SLEEP DISORDER (Rough night), MALAISE (Feeling terrible), PYREXIA (Fever), CHILLS (Chills) 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.   Concomitant product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: Patient's information 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 events, a causal relationship cannot be excluded
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: round circle around injection site; hives at the site of injection; injection site itchy; soreness of arm; redness at the site of injection; A spontaneous report was received from a consumer concerning a 36-year old, female patient who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced injection site redness, soreness of the arm, injection site hives, injection site itching, and a round circle around the injection site.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient had a sore arm and redness at the site of injection. These side effects resolved after a few days. On 06 Jan 2021, the patient noticed she had hives at the site of injection that was itchy and had a round circle around it. Treatment information for the event was not included.   Action taken with mRNA-1273 in response to the events was not reported.   The events, injection site redness and soreness of the arm, were considered recovered/resolved on an unknown date.   The events, injection site hives, injection site itching, and a round circle around the injection site, were unknown/not reported.; 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. Further information has been requested
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Malaise, Pain in extremity
Clinical narrative: Doesn't feel well; Fatigued; Didn't sleep well; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Pneumonectomy on 17-Sep-2019. Concurrent medical conditions included Lung cancer (In remission. Dates not provided.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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.   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.; 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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: Flu like symptoms; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache) in a 32-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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency.   At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) 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.   Concomitant product use was not provided by the reporter.; 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.