chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Blood test, Inflammation, Pain in extremity
Clinical narrative: having an auto immune reaction / auto immune symptoms started roughly around 6 weeks; Pain all 4 extremities / complains of hands; Inflammation all 4 extremities / wrists Inflammed; Rheumatoid factor positive; hands including wrists painful and inflammed; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of AUTOIMMUNE DISORDER (having an auto immune reaction / auto immune symptoms started roughly around 6 weeks) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid factor. Concomitant products included METOPROLOL for Hypertension, PANTOPRAZOLE and VITAMINS NOS for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced AUTOIMMUNE DISORDER (having an auto immune reaction / auto immune symptoms started roughly around 6 weeks) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain all 4 extremities / complains of hands), INFLAMMATION (Inflammation all 4 extremities / wrists Inflammed), RHEUMATOID FACTOR POSITIVE (Rheumatoid factor positive) and ARTHRALGIA (hands including wrists painful and inflammed). The patient was treated with NAPROXEN SODIUM (ALEVE) for Antiinflammatory therapy, at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE DISORDER (having an auto immune reaction / auto immune symptoms started roughly around 6 weeks), PAIN IN EXTREMITY (Pain all 4 extremities / complains of hands), INFLAMMATION (Inflammation all 4 extremities / wrists Inflammed), RHEUMATOID FACTOR POSITIVE (Rheumatoid factor positive) and ARTHRALGIA (hands including wrists painful and inflammed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood test: abnormal (abnormal) auto immune reaction; with a positive CCP antibody and Rheumatoid Factor. On 01-Apr-2021, X-ray: normal (normal) Normal.         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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid factor positive, X-ray
Clinical narrative: having an auto immune reaction / auto immune symptoms started roughly around 6 weeks; Pain all 4 extremities / complains of hands; Inflammation all 4 extremities / wrists Inflammed; Rheumatoid factor positive; hands including wrists painful and inflammed; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of AUTOIMMUNE DISORDER (having an auto immune reaction / auto immune symptoms started roughly around 6 weeks) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid factor. Concomitant products included METOPROLOL for Hypertension, PANTOPRAZOLE and VITAMINS NOS for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced AUTOIMMUNE DISORDER (having an auto immune reaction / auto immune symptoms started roughly around 6 weeks) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain all 4 extremities / complains of hands), INFLAMMATION (Inflammation all 4 extremities / wrists Inflammed), RHEUMATOID FACTOR POSITIVE (Rheumatoid factor positive) and ARTHRALGIA (hands including wrists painful and inflammed). The patient was treated with NAPROXEN SODIUM (ALEVE) for Antiinflammatory therapy, at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE DISORDER (having an auto immune reaction / auto immune symptoms started roughly around 6 weeks), PAIN IN EXTREMITY (Pain all 4 extremities / complains of hands), INFLAMMATION (Inflammation all 4 extremities / wrists Inflammed), RHEUMATOID FACTOR POSITIVE (Rheumatoid factor positive) and ARTHRALGIA (hands including wrists painful and inflammed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood test: abnormal (abnormal) auto immune reaction; with a positive CCP antibody and Rheumatoid Factor. On 01-Apr-2021, X-ray: normal (normal) Normal.         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.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Respiratory tract infection, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Respiratory infection; Got sick there; Tested again 5/17 this time Positive; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY TRACT INFECTION (Respiratory infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested again 5/17 this time Positive). On an unknown date, the patient experienced RESPIRATORY TRACT INFECTION (Respiratory infection) (seriousness criterion medically significant) and ILLNESS (Got sick there). At the time of the report, RESPIRATORY TRACT INFECTION (Respiratory infection), ILLNESS (Got sick there) and SARS-COV-2 TEST POSITIVE (Tested again 5/17 this time Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 17-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided/ unknown. Text:  AE submitted via social media: "I received 2 Moderna vaccines, 2/14 and 3/14. I traveled to another country 5/5 and got sick there (respiratory infection). Got Covid tested there 5/15, which was negative. (Antigen test). Tested again 5/17, this time Positive! Received Re" "Seems that my body did not produce enough antibodies to prevent infection. C I get re-vaccinated or would that even help?"   Treatment information was provided/ unknown.  Company Comment: Limited information regarding the reported sick / respiratory infection has been provided at this time and a causal relationship cannot be excluded.  The positive test for Covid-19 is unlikely related to the previous administration Moderna vaccine.; Sender's Comments: Limited information regarding the reported sick / respiratory infection has been provided at this time and a causal relationship cannot be excluded.  The positive test for Covid-19 is unlikely related to the previous administration Moderna vaccine
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye swelling, Lymphadenopathy, Meningitis, Micturition urgency
Clinical narrative: Swelling of eyes; Using bathroom alot; Nausea; Breathing problems; Swollen lymph nodes; Meningitis; Dizzy; Pain all over body; This spontaneous case was reported by a consumer and describes the occurrence of MENINGITIS (Meningitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Common variable immunodeficiency.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced MENINGITIS (Meningitis) (seriousness criterion medically significant), DIZZINESS (Dizzy) and MYALGIA (Pain all over body). On 03-May-2021, the patient experienced RESPIRATION ABNORMAL (Breathing problems), EYE SWELLING (Swelling of eyes), MICTURITION URGENCY (Using bathroom alot), NAUSEA (Nausea) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, MENINGITIS (Meningitis), RESPIRATION ABNORMAL (Breathing problems), DIZZINESS (Dizzy), EYE SWELLING (Swelling of eyes), MICTURITION URGENCY (Using bathroom alot), NAUSEA (Nausea), MYALGIA (Pain all over body) and LYMPHADENOPATHY (Swollen lymph nodes) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Patient was put on a steroid and also put on a Nebulizer for breathing problems.  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.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Respiration abnormal
Clinical narrative: Swelling of eyes; Using bathroom alot; Nausea; Breathing problems; Swollen lymph nodes; Meningitis; Dizzy; Pain all over body; This spontaneous case was reported by a consumer and describes the occurrence of MENINGITIS (Meningitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Common variable immunodeficiency.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced MENINGITIS (Meningitis) (seriousness criterion medically significant), DIZZINESS (Dizzy) and MYALGIA (Pain all over body). On 03-May-2021, the patient experienced RESPIRATION ABNORMAL (Breathing problems), EYE SWELLING (Swelling of eyes), MICTURITION URGENCY (Using bathroom alot), NAUSEA (Nausea) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, MENINGITIS (Meningitis), RESPIRATION ABNORMAL (Breathing problems), DIZZINESS (Dizzy), EYE SWELLING (Swelling of eyes), MICTURITION URGENCY (Using bathroom alot), NAUSEA (Nausea), MYALGIA (Pain all over body) and LYMPHADENOPATHY (Swollen lymph nodes) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Patient was put on a steroid and also put on a Nebulizer for breathing problems.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Surgery
Clinical narrative: Surgery; The patient did not receive the second shot in time; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SURGERY (Surgery) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced SURGERY (Surgery) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient did not receive the second shot in time). The patient was hospitalized from 28-Mar-2021 to 02-Apr-2021 due to SURGERY. The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) for Surgery, at a dose of UNK dosage form and METOPROLOL for Surgery, at a dose of UNK dosage form. At the time of the report, SURGERY (Surgery) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (The patient did not receive the second shot in time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Description: The patient had surgery on 28 Mar 2021, the type of surgery was not specified and was hospitalized for six days. Due to this event patient did not receive the second shot in time.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Scan, Thrombosis
Clinical narrative: pain in calf; Deep vein thrombosis; Blood Clot; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) and THROMBOSIS (Blood Clot) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Deep vein thrombosis.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion medically significant) and THROMBOSIS (Blood Clot) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in calf). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at a dose of 1 dosage form. At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis), THROMBOSIS (Blood Clot) and PAIN IN EXTREMITY (pain in calf) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Scan: blood clot (abnormal) blood clot.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included unspecified anti-coagulant and  antibiotic.  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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Dyspnoea, Loss of consciousness, Pyrexia
Clinical narrative: Passing out feeling when trying to stand up; Severe abdominal pain; Problem to breath in air all the way because of  abdominal pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out feeling when trying to stand up) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ARIPIPRAZOLE (ABILIFY) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passing out feeling when trying to stand up) (seriousness criterion medically significant), ABDOMINAL PAIN (Severe abdominal pain), DYSPNOEA (Problem to breath in air all the way because of  abdominal pain), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, LOSS OF CONSCIOUSNESS (Passing out feeling when trying to stand up), DYSPNOEA (Problem to breath in air all the way because of  abdominal pain), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and ABDOMINAL PAIN (Severe abdominal pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Since 20 May 2021, roughly since 9:00pm onwards, patient started the symptoms like fever, chills and passing out feeling when trying to stand up and severe abdominal pain and having problem to breath in air all the way because of abdominal pain. Patient took Ibuprofen two tablets for the symptoms developed and the abdominal pain still not better, according to the patient. Patient did not take the regular medication Abilify, today (on day of report) which patient used to take daily, because of abdominal pain.  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.   This case was linked to MOD-2021-162196 (Patient Link).; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Headache, Lymphadenopathy, Nausea
Clinical narrative: Abnormal clusters of lymph nodes in left of my brain and neck region; I could not not keep down water and medication; Extreme nausea; Headache; Neck pain; Extremely dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck pain), DIZZINESS (Extremely dizzy), LYMPHADENOPATHY (Abnormal clusters of lymph nodes in left of my brain and neck region), NAUSEA (Extreme nausea), HEADACHE (Headache) and VOMITING (I could not not keep down water and medication) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 006B21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion hospitalization), DIZZINESS (Extremely dizzy) (seriousness criterion hospitalization), NAUSEA (Extreme nausea) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). On 14-May-2021, the patient experienced LYMPHADENOPATHY (Abnormal clusters of lymph nodes in left of my brain and neck region) (seriousness criterion hospitalization) and VOMITING (I could not not keep down water and medication) (seriousness criterion hospitalization). The patient was hospitalized on 14-May-2021 due to HEADACHE, LYMPHADENOPATHY, NAUSEA and VOMITING. The patient was treated with BUTALBITAL ongoing since an unknown date for Headache, at an unspecified dose and frequency and ONDANSETRON ongoing since an unknown date for Nausea, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck pain), DIZZINESS (Extremely dizzy), LYMPHADENOPATHY (Abnormal clusters of lymph nodes in left of my brain and neck region), NAUSEA (Extreme nausea), HEADACHE (Headache) and VOMITING (I could not not keep down water and medication) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Computerised tomogram: (abnormal) Abnormal clusters of lymph nodes in left of my brain and neck region..         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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vomiting
Clinical narrative: Abnormal clusters of lymph nodes in left of my brain and neck region; I could not not keep down water and medication; Extreme nausea; Headache; Neck pain; Extremely dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck pain), DIZZINESS (Extremely dizzy), LYMPHADENOPATHY (Abnormal clusters of lymph nodes in left of my brain and neck region), NAUSEA (Extreme nausea), HEADACHE (Headache) and VOMITING (I could not not keep down water and medication) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 006B21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion hospitalization), DIZZINESS (Extremely dizzy) (seriousness criterion hospitalization), NAUSEA (Extreme nausea) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). On 14-May-2021, the patient experienced LYMPHADENOPATHY (Abnormal clusters of lymph nodes in left of my brain and neck region) (seriousness criterion hospitalization) and VOMITING (I could not not keep down water and medication) (seriousness criterion hospitalization). The patient was hospitalized on 14-May-2021 due to HEADACHE, LYMPHADENOPATHY, NAUSEA and VOMITING. The patient was treated with BUTALBITAL ongoing since an unknown date for Headache, at an unspecified dose and frequency and ONDANSETRON ongoing since an unknown date for Nausea, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck pain), DIZZINESS (Extremely dizzy), LYMPHADENOPATHY (Abnormal clusters of lymph nodes in left of my brain and neck region), NAUSEA (Extreme nausea), HEADACHE (Headache) and VOMITING (I could not not keep down water and medication) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Computerised tomogram: (abnormal) Abnormal clusters of lymph nodes in left of my brain and neck region..         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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fall, Foot fracture, Loss of consciousness, Myalgia
Clinical narrative: Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom; Left foot was broken; Had fallen on her foot, fell; Mild aches; Bed was soaked with diarrhea after second dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (Bed was soaked with diarrhea after second dose). 02-Apr-2021, the patient experienced MYALGIA (Mild aches). On 19-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom) (seriousness criterion medically significant) and FOOT FRACTURE (Left foot was broken). 19-Apr-2021, the patient experienced FALL (Had fallen on her foot, fell). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Ache, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom), FOOT FRACTURE (Left foot was broken), DIARRHOEA (Bed was soaked with diarrhea after second dose), FALL (Had fallen on her foot, fell) and MYALGIA (Mild aches) outcome was unknown.            Concomitant product use was unknown. The patient reported that the day after her second shot, she woke up and her bed was soaked with diarrhea. She has no memory of this, but on 19Apr2021, she woke up on the floor in the bathroom. She stated that she had fallen on her foot, and her left foot was broken. She also reported she had mild aches on 02Apr2021. Treatment information was not provided.  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.   This case was linked to MOD-2021-162182 (Patient Link).; 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: Limb discomfort, Musculoskeletal discomfort, Product dose omission issue, Pulmonary congestion, Tendon disorder
Clinical narrative: My tendons are loose; Tendon issues/ arch in her right foot has dropped; Congestion; Can I still get the 2nd dose; Pain at the injection site; Redness at the injection site; The bones in my right foot started popping; The bones in my neck started popping /  It would pop with movement; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Congestion) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Charcot-Marie-Tooth disease (The patient's left foot has a brace on it) and Neuropathy since an unknown date. Concurrent medical conditions included Diabetes and Smoker.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (The bones in my right foot started popping), MUSCULOSKELETAL DISCOMFORT (The bones in my neck started popping /  It would pop with movement), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 06-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Can I still get the 2nd dose). On 21-May-2021, the patient experienced PULMONARY CONGESTION (Congestion) (seriousness criterion medically significant), TENDON LAXITY (My tendons are loose) and TENDON DISORDER (Tendon issues/ arch in her right foot has dropped). On 06-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Can I still get the 2nd dose) had resolved. At the time of the report, PULMONARY CONGESTION (Congestion), TENDON LAXITY (My tendons are loose), TENDON DISORDER (Tendon issues/ arch in her right foot has dropped), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown and LIMB DISCOMFORT (The bones in my right foot started popping) and MUSCULOSKELETAL DISCOMFORT (The bones in my neck started popping /  It would pop with movement) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported/ unknown.  Treatment included Vancomycin and Cortisone epidural.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-162325 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-162325:Crosslink
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon laxity, Vaccination site erythema, Vaccination site pain
Clinical narrative: My tendons are loose; Tendon issues/ arch in her right foot has dropped; Congestion; Can I still get the 2nd dose; Pain at the injection site; Redness at the injection site; The bones in my right foot started popping; The bones in my neck started popping /  It would pop with movement; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Congestion) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Charcot-Marie-Tooth disease (The patient's left foot has a brace on it) and Neuropathy since an unknown date. Concurrent medical conditions included Diabetes and Smoker.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced LIMB DISCOMFORT (The bones in my right foot started popping), MUSCULOSKELETAL DISCOMFORT (The bones in my neck started popping /  It would pop with movement), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 06-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Can I still get the 2nd dose). On 21-May-2021, the patient experienced PULMONARY CONGESTION (Congestion) (seriousness criterion medically significant), TENDON LAXITY (My tendons are loose) and TENDON DISORDER (Tendon issues/ arch in her right foot has dropped). On 06-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Can I still get the 2nd dose) had resolved. At the time of the report, PULMONARY CONGESTION (Congestion), TENDON LAXITY (My tendons are loose), TENDON DISORDER (Tendon issues/ arch in her right foot has dropped), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown and LIMB DISCOMFORT (The bones in my right foot started popping) and MUSCULOSKELETAL DISCOMFORT (The bones in my neck started popping /  It would pop with movement) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported/ unknown.  Treatment included Vancomycin and Cortisone epidural.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-162325 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-162325:Crosslink
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Illness, Impaired driving ability, Loss of personal independence in daily activities
Clinical narrative: Meniere's disease; not able to do anything; throwing up; Dizzy/ Light headed; sick; Cannot drive; Ear stuffed up; Ringing in Ear; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (Meniere's disease) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History reported.  Concomitant products included LISINOPRIL, LEVOTHYROXINE and SIMVASTATIN for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced TINNITUS (Ringing in Ear). On 11-Mar-2021, the patient experienced EAR DISCOMFORT (Ear stuffed up). On 14-Mar-2021, the patient experienced DIZZINESS (Dizzy/ Light headed), ILLNESS (sick), IMPAIRED DRIVING ABILITY (Cannot drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to do anything) and VOMITING (throwing up). On 21-Apr-2021, the patient experienced MENIERE'S DISEASE (Meniere's disease) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Ear discomfort, at an unspecified dose and frequency. At the time of the report, MENIERE'S DISEASE (Meniere's disease), EAR DISCOMFORT (Ear stuffed up), DIZZINESS (Dizzy/ Light headed), ILLNESS (sick), IMPAIRED DRIVING ABILITY (Cannot drive), TINNITUS (Ringing in Ear), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to do anything) and VOMITING (throwing up) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was also provided treatment with a low salt diet and an unspecified diuretic.  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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Meniere's disease, Tinnitus, Vomiting
Clinical narrative: Meniere's disease; not able to do anything; throwing up; Dizzy/ Light headed; sick; Cannot drive; Ear stuffed up; Ringing in Ear; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (Meniere's disease) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History reported.  Concomitant products included LISINOPRIL, LEVOTHYROXINE and SIMVASTATIN for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced TINNITUS (Ringing in Ear). On 11-Mar-2021, the patient experienced EAR DISCOMFORT (Ear stuffed up). On 14-Mar-2021, the patient experienced DIZZINESS (Dizzy/ Light headed), ILLNESS (sick), IMPAIRED DRIVING ABILITY (Cannot drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to do anything) and VOMITING (throwing up). On 21-Apr-2021, the patient experienced MENIERE'S DISEASE (Meniere's disease) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Ear discomfort, at an unspecified dose and frequency. At the time of the report, MENIERE'S DISEASE (Meniere's disease), EAR DISCOMFORT (Ear stuffed up), DIZZINESS (Dizzy/ Light headed), ILLNESS (sick), IMPAIRED DRIVING ABILITY (Cannot drive), TINNITUS (Ringing in Ear), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to do anything) and VOMITING (throwing up) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was also provided treatment with a low salt diet and an unspecified diuretic.  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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness postural, Fatigue, Headache, Loss of consciousness, Myalgia
Clinical narrative: Dizziness on standing; Muscle pain; Fatigue; Nausea; Headache; Fever; Blacked out; Hives; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACRIVASTINE (BENADRYL ALLERGY RELIEF), PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 16-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizziness on standing), MYALGIA (Muscle pain), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out), URTICARIA (Hives), DIZZINESS POSTURAL (Dizziness on standing), MYALGIA (Muscle pain), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Urticaria
Clinical narrative: Dizziness on standing; Muscle pain; Fatigue; Nausea; Headache; Fever; Blacked out; Hives; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACRIVASTINE (BENADRYL ALLERGY RELIEF), PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 16-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizziness on standing), MYALGIA (Muscle pain), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out), URTICARIA (Hives), DIZZINESS POSTURAL (Dizziness on standing), MYALGIA (Muscle pain), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Arthralgia, Dysphagia, Feeling abnormal, Immunosuppression
Clinical narrative: feeling miserable; did not take the second dose; feeling unwell; Vaccine attacked the ankles; Vaccine attacked immune system; Throat was falling short; Anaphylactic shock; Vaccine attack on ankle; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) and IMMUNOSUPPRESSION (Vaccine attacked immune system) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 CALCIUM and FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant) and DYSPHAGIA (Throat was falling short). 14-Jan-2021, the patient experienced JOINT INSTABILITY (Vaccine attack on ankle). On an unknown date, the patient experienced IMMUNOSUPPRESSION (Vaccine attacked immune system) (seriousness criterion medically significant), FEELING ABNORMAL (feeling miserable), PRODUCT DOSE OMISSION ISSUE (did not take the second dose), MALAISE (feeling unwell) and ARTHRALGIA (Vaccine attacked the ankles). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), IMMUNOSUPPRESSION (Vaccine attacked immune system), DYSPHAGIA (Throat was falling short), FEELING ABNORMAL (feeling miserable), MALAISE (feeling unwell), ARTHRALGIA (Vaccine attacked the ankles) and JOINT INSTABILITY (Vaccine attack on ankle) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not take the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       15 minutes after vaccination patient had anaphylactic shock with allergies and chronic hives. The patient was taken to emergency room for 6 hours. The patient was treated with unspecified intravenous medication.  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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Joint instability, Malaise, Product dose omission issue
Clinical narrative: feeling miserable; did not take the second dose; feeling unwell; Vaccine attacked the ankles; Vaccine attacked immune system; Throat was falling short; Anaphylactic shock; Vaccine attack on ankle; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) and IMMUNOSUPPRESSION (Vaccine attacked immune system) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 CALCIUM and FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant) and DYSPHAGIA (Throat was falling short). 14-Jan-2021, the patient experienced JOINT INSTABILITY (Vaccine attack on ankle). On an unknown date, the patient experienced IMMUNOSUPPRESSION (Vaccine attacked immune system) (seriousness criterion medically significant), FEELING ABNORMAL (feeling miserable), PRODUCT DOSE OMISSION ISSUE (did not take the second dose), MALAISE (feeling unwell) and ARTHRALGIA (Vaccine attacked the ankles). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), IMMUNOSUPPRESSION (Vaccine attacked immune system), DYSPHAGIA (Throat was falling short), FEELING ABNORMAL (feeling miserable), MALAISE (feeling unwell), ARTHRALGIA (Vaccine attacked the ankles) and JOINT INSTABILITY (Vaccine attack on ankle) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not take the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       15 minutes after vaccination patient had anaphylactic shock with allergies and chronic hives. The patient was taken to emergency room for 6 hours. The patient was treated with unspecified intravenous medication.  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: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Still's disease
Clinical narrative: Flare up of his Still's disease; This spontaneous case was reported by a consumer and describes the occurrence of STILL'S DISEASE (Flare up of his Still's disease) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Still's disease.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced STILL'S DISEASE (Flare up of his Still's disease) (seriousness criterion medically significant). At the time of the report, STILL'S DISEASE (Flare up of his Still's disease) outcome was unknown.            No concomitant medication provided.  Treatment information was included steroids.  Patient hasn't had a flare up since August of 2018.  Action taken with mRNA-1273 in response to the event was not applicable.  Company comment: 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.A; 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.A