chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Haemorrhage, Head injury
Clinical narrative: there was blood; felt on the kitchen and bang it's head; felt on the kitchen and bang it's head; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (there was blood) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HAEMORRHAGE (there was blood) (seriousness criterion medically significant), HEAD INJURY (felt on the kitchen and bang it's head) and FALL (felt on the kitchen and bang it's head). At the time of the report, HAEMORRHAGE (there was blood), HEAD INJURY (felt on the kitchen and bang it's head) and FALL (felt on the kitchen and bang it's head) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test
Clinical narrative: bad headaches; Positive test result for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive test result for COVID-19) 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.     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 06-Feb-2021, the patient experienced COVID-19 (Positive test result for COVID-19) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (bad headaches). At the time of the report, COVID-19 (Positive test result for COVID-19) and HEADACHE (bad headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information was not provided. The patient wanted to know whether she can take her second dose of vaccine as planned.  Company comment This case concerns an adult female with a serious unexpected event of COVID-19 and nonserious expected headache. Latency unknown after first dose mRNA-1273. . Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an adult female with a serious unexpected event of COVID-19 and nonserious expected headache. Latency unknown after first dose mRNA-1273. . Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lyme disease
Clinical narrative: Diagnosed with lime disease 2 weeks after the first dose; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of LYME DISEASE (diagnosed with lime disease 2 weeks after the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced LYME DISEASE (diagnosed with lime disease 2 weeks after the first dose) (seriousness criterion medically significant). At the time of the report, LYME DISEASE (diagnosed with lime disease 2 weeks after the first dose) 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 medications were not reported.  Treatment medications reported included unspecified antibiotics.  Company Comment: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.   This case was linked to MOD21-067706, MOD21-027050, MOD21-085516 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Added route of administration for suspect product.Onset date of event provided.Contact details updated On 03-May-2021: NNI; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely. MOD21-067706:Crosslink MOD21-027050:Crosslink MOD21-085516:Crosslink
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Face injury, Fall, Feeling abnormal, Radius fracture
Clinical narrative: left radial fractures; hit left side of face - vein to eye; fell; felt terrible; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RADIUS FRACTURE (left radial fractures) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history reported.  Concomitant products included OMEPRAZOLE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced FEELING ABNORMAL (felt terrible). On 06-Mar-2021, the patient experienced RADIUS FRACTURE (left radial fractures) (seriousness criterion hospitalization), FACE INJURY (hit left side of face - vein to eye) and FALL (fell). On 06-Mar-2021, FACE INJURY (hit left side of face - vein to eye) and FALL (fell) had resolved. On 07-Mar-2021, FEELING ABNORMAL (felt terrible) had resolved. At the time of the report, RADIUS FRACTURE (left radial fractures) outcome was unknown. Not Provided          No treatment details were reported. Was seen in ER x 2 visits , 8-Mar-2021   This case was linked to MOD-2021-137773 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Pain in extremity, Vaccination site pain
Clinical narrative: it's like I have arthritis in this arm. It's not just a general arm pain, it's a little more than that; Pain on her right arm still ongoing; Pain while vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (it's like I have arthritis in this arm. It's not just a general arm pain, it's a little more than that) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced ARTHRITIS (it's like I have arthritis in this arm. It's not just a general arm pain, it's a little more than that) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain on her right arm still ongoing) and VACCINATION SITE PAIN (Pain while vaccine administration). At the time of the report, ARTHRITIS (it's like I have arthritis in this arm. It's not just a general arm pain, it's a little more than that) and PAIN IN EXTREMITY (Pain on her right arm still ongoing) had not resolved and VACCINATION SITE PAIN (Pain while vaccine administration) outcome was unknown.            Patient reports no concomitant medications. No treatment medications were reported. Patient's physician stated an MRI is necessary if patient's pain continues.  Action taken with mRNA-1273 in response to the events 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 events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: New event: Pain while vaccine administration was added; 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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Blood test, C-reactive protein, COVID-19, Coagulation factor
Clinical narrative: mild Covid-19 infection; Loss of smell one after other; Sore throat; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (mild Covid-19 infection) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced COVID-19 (mild Covid-19 infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANOSMIA (Loss of smell one after other), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever). At the time of the report, COVID-19 (mild Covid-19 infection), ANOSMIA (Loss of smell one after other), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Blood test: inceased protein (High) blood work showed highly elevated clotting indicator, and increased levels of protein. But the levels are improving.. On 24-Apr-2021, C-reactive protein: increased (High) increased. On 24-Apr-2021, Coagulation factor: increased (High) increased. On 24-Apr-2021, Computerised tomogram normal: unknown (Inconclusive) unknown results. On 24-Apr-2021, SARS-CoV-2 test: positive (Positive) He did the PCR test twice, both showing positive results..         No concomitant medicines were reported. Patient was treated with blood thinners & other medicines.  Action taken with the drug in response to events was not applicable.  Caller is returning a call from safety. Caller provided additional information. Patient provided HCP details and wanted to know next steps safety will take. Wants to share blood test details via email. Denied consent to follow up with HCP, wants to follow up with HCP first and provide more info later.  Based on the current available information and lack of temporal  association between the use of the product and the start date of the events, a causal relationship  is assessed as unlikely related to mRNA-1273.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: New events were added, lab result, hospitalization; Sender's Comments: Based on the current available information and lack of temporal  association between the use of the product and the start date of the events, a causal relationship  is assessed as unlikely related to mRNA-1273.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: mild Covid-19 infection; Loss of smell one after other; Sore throat; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (mild Covid-19 infection) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced COVID-19 (mild Covid-19 infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANOSMIA (Loss of smell one after other), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever). At the time of the report, COVID-19 (mild Covid-19 infection), ANOSMIA (Loss of smell one after other), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Blood test: inceased protein (High) blood work showed highly elevated clotting indicator, and increased levels of protein. But the levels are improving.. On 24-Apr-2021, C-reactive protein: increased (High) increased. On 24-Apr-2021, Coagulation factor: increased (High) increased. On 24-Apr-2021, Computerised tomogram normal: unknown (Inconclusive) unknown results. On 24-Apr-2021, SARS-CoV-2 test: positive (Positive) He did the PCR test twice, both showing positive results..         No concomitant medicines were reported. Patient was treated with blood thinners & other medicines.  Action taken with the drug in response to events was not applicable.  Caller is returning a call from safety. Caller provided additional information. Patient provided HCP details and wanted to know next steps safety will take. Wants to share blood test details via email. Denied consent to follow up with HCP, wants to follow up with HCP first and provide more info later.  Based on the current available information and lack of temporal  association between the use of the product and the start date of the events, a causal relationship  is assessed as unlikely related to mRNA-1273.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: New events were added, lab result, hospitalization; Sender's Comments: Based on the current available information and lack of temporal  association between the use of the product and the start date of the events, a causal relationship  is assessed as unlikely related to mRNA-1273.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Vaccination site bruising, Vaccination site pain, Vaccination site urticaria
Clinical narrative: Yellowish bruise towards the back of her left arm; Blistery rash; Cannot move left arm/Restricted to do normal activities; Terrible pain on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Cannot move left arm/Restricted to do normal activities), VACCINATION SITE BRUISING (Yellowish bruise towards the back of her left arm), VACCINATION SITE PAIN (Terrible pain on her left arm) and VACCINATION SITE URTICARIA (Blistery rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced MOBILITY DECREASED (Cannot move left arm/Restricted to do normal activities) (seriousness criterion disability) and VACCINATION SITE PAIN (Terrible pain on her left arm) (seriousness criterion disability). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Yellowish bruise towards the back of her left arm) (seriousness criterion disability) and VACCINATION SITE URTICARIA (Blistery rash) (seriousness criterion disability). On 05-Apr-2021, VACCINATION SITE BRUISING (Yellowish bruise towards the back of her left arm) had resolved. On 06-Apr-2021, VACCINATION SITE URTICARIA (Blistery rash) had resolved. On 27-Apr-2021, MOBILITY DECREASED (Cannot move left arm/Restricted to do normal activities) and VACCINATION SITE PAIN (Terrible pain on her left arm) had resolved.            Treatment information included ibuprofen, paracetamol and also applied ice and heat for the event "terrible pain on her left arm". No concomitant medication 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.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Non-significant follow up was accepted on 20-May-2021, address of reporter and last name of reporter were 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: May possibly have allergy; Tested positive for COVID/had trouble breathing/Developed pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Tested positive for COVID/had trouble breathing/Developed pneumonia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced COVID-19 PNEUMONIA (Tested positive for COVID/had trouble breathing/Developed pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERSENSITIVITY (May possibly have allergy). At the time of the report, COVID-19 PNEUMONIA (Tested positive for COVID/had trouble breathing/Developed pneumonia) and HYPERSENSITIVITY (May possibly have allergy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, SARS-CoV-2 test: positive (Positive) developed pneumonia.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.   Treatment for the event included: Amoxicillin.  Company comment: Very limited information regarding this event of Hypersensivitiy has been provided at this time. Further information has been requested. Based on biological implausibility the event of COVID-19 infection causality is assessed as not applicable in related to mRNA-1273.; Sender's Comments: Very limited information regarding this event of Hypersensivitiy has been provided at this time. Further information has been requested. Based on biological implausibility the event of COVID-19 infection causality is assessed as not applicable in related to mRNA-1273.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary thrombosis, Thrombosis, Vaccination site pain
Clinical narrative: blood clots in both lungs; blood clots in left leg; shortness of breath; after the administration her arm hurt really bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY THROMBOSIS (blood clots in both lungs) and THROMBOSIS (blood clots in left leg) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (after the administration her arm hurt really bad). On 15-Apr-2021, the patient experienced PULMONARY THROMBOSIS (blood clots in both lungs) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (blood clots in left leg) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (shortness of breath). The patient was hospitalized from 15-Apr-2021 to 18-Apr-2021 due to PULMONARY THROMBOSIS and THROMBOSIS. On 01-Apr-2021, VACCINATION SITE PAIN (after the administration her arm hurt really bad) had resolved. At the time of the report, PULMONARY THROMBOSIS (blood clots in both lungs), THROMBOSIS (blood clots in left leg) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient received Apixaban as a treatment medication for blood clots.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.; 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.  Further information has been requested.  .
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Colitis ulcerative, Headache, Hypersensitivity, Nausea
Clinical narrative: Ulcerative colitis relapse; Allergy; Sinus disorder; Headache; Nausea; This spontaneous case was reported by a physician and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis relapse) in a 43-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.     Concurrent medical conditions included Ulcerative colitis since 21-Jul-2020, Anxious mood (Felt anxious, scarred) since 21-Jan-2021, Feeling sad (Felt sad/blue), Fatigue (Fatigue returning) since 21-Jan-2021, Diarrhea (DIARRHEA/4-5 DIARRHEA EPISODES, Daily semi formed stools) since 21-Jan-2021, Constipation, Rectal bleeding, Stomach pain (PAIN IN THE STOMACH/ABDOMEN), Decreased appetite (NOT FEELING HUNGRY), Joint pain, Difficulty sleeping, Pain and Social problem (NOT ABLE TO KEEP UP WITH FRIENDS/PEERS). Concomitant products included ADALIMUMAB (HUMIRA) from 21-Jul-2020 to an unknown date for Ulcerative colitis.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis relapse) (seriousness criterion medically significant), HYPERSENSITIVITY (Allergy), SINUS DISORDER (Sinus disorder), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis relapse), HYPERSENSITIVITY (Allergy), SINUS DISORDER (Sinus disorder), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) No antibodies for Humira found. On an unknown date, Weight: lost few pounds (Inconclusive) Lost few pounds.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's allergy and sinus events were treated with Fexofenadine (ALLEGRA). Treatment of other events were not reported.  Company Comment  This case concerns a 43-year-old female with a serious unexpected event of colitis ulcerative and nonserious unexpected hypersensitivity, sinus disorder, and expected headache, nausea. Latency 3 days after second mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 43-year-old female with a serious unexpected event of colitis ulcerative and nonserious unexpected hypersensitivity, sinus disorder, and expected headache, nausea. Latency 3 days after second mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder, Weight
Clinical narrative: Ulcerative colitis relapse; Allergy; Sinus disorder; Headache; Nausea; This spontaneous case was reported by a physician and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis relapse) in a 43-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.     Concurrent medical conditions included Ulcerative colitis since 21-Jul-2020, Anxious mood (Felt anxious, scarred) since 21-Jan-2021, Feeling sad (Felt sad/blue), Fatigue (Fatigue returning) since 21-Jan-2021, Diarrhea (DIARRHEA/4-5 DIARRHEA EPISODES, Daily semi formed stools) since 21-Jan-2021, Constipation, Rectal bleeding, Stomach pain (PAIN IN THE STOMACH/ABDOMEN), Decreased appetite (NOT FEELING HUNGRY), Joint pain, Difficulty sleeping, Pain and Social problem (NOT ABLE TO KEEP UP WITH FRIENDS/PEERS). Concomitant products included ADALIMUMAB (HUMIRA) from 21-Jul-2020 to an unknown date for Ulcerative colitis.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis relapse) (seriousness criterion medically significant), HYPERSENSITIVITY (Allergy), SINUS DISORDER (Sinus disorder), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis relapse), HYPERSENSITIVITY (Allergy), SINUS DISORDER (Sinus disorder), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) No antibodies for Humira found. On an unknown date, Weight: lost few pounds (Inconclusive) Lost few pounds.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's allergy and sinus events were treated with Fexofenadine (ALLEGRA). Treatment of other events were not reported.  Company Comment  This case concerns a 43-year-old female with a serious unexpected event of colitis ulcerative and nonserious unexpected hypersensitivity, sinus disorder, and expected headache, nausea. Latency 3 days after second mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 43-year-old female with a serious unexpected event of colitis ulcerative and nonserious unexpected hypersensitivity, sinus disorder, and expected headache, nausea. Latency 3 days after second mRNA-1273 dose. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Heart rate, Heart rate variability decreased, Palpitations, Respiratory rate increased
Clinical narrative: heart rate variability below my personal range; elevated troponin; Tachycardia; Breathing rate above my personal range; Heart Palpitations while sitting at my desk in a video meeting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY RATE INCREASED (Breathing rate above my personal range), PALPITATIONS (Heart Palpitations while sitting at my desk in a video meeting), TACHYCARDIA (Tachycardia), HEART RATE VARIABILITY DECREASED (heart rate variability below my personal range) and TROPONIN INCREASED (elevated troponin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021 at 7:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced RESPIRATORY RATE INCREASED (Breathing rate above my personal range) (seriousness criterion hospitalization) and HEART RATE VARIABILITY DECREASED (heart rate variability below my personal range) (seriousness criterion hospitalization). On 29-Apr-2021, the patient experienced PALPITATIONS (Heart Palpitations while sitting at my desk in a video meeting) (seriousness criterion hospitalization), TACHYCARDIA (Tachycardia) (seriousness criterion hospitalization) and TROPONIN INCREASED (elevated troponin) (seriousness criterion hospitalization). The patient was hospitalized from 29-Apr-2021 to 30-Apr-2021 due to PALPITATIONS, RESPIRATORY RATE INCREASED, TACHYCARDIA and TROPONIN INCREASED. At the time of the report, RESPIRATORY RATE INCREASED (Breathing rate above my personal range), PALPITATIONS (Heart Palpitations while sitting at my desk in a video meeting), TACHYCARDIA (Tachycardia), HEART RATE VARIABILITY DECREASED (heart rate variability below my personal range) and TROPONIN INCREASED (elevated troponin) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Heart rate: 202 (Inconclusive) 202 beats per minute. On 29-Apr-2021, Troponin: increased (High) Elevated Troponin. On 30-Apr-2021, Echocardiogram: normal (normal) Negative for Heart Attack.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       I got an allergy shot in both my left and right arms on 26 Apr 2021 at 4:00 PM. On 20 Apr 2021  I went to the ER at 2:00 PM , elevated Troponin was detected and I was admitted at 4:00 PM for an evaluation for a heart attack.  On 4/30/21,  I was discharged from the hospital because the Echocardiogram and Stress test were negative for a heart attack.  No concomitant medications or treatment information were provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Troponin, Troponin increased
Clinical narrative: heart rate variability below my personal range; elevated troponin; Tachycardia; Breathing rate above my personal range; Heart Palpitations while sitting at my desk in a video meeting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY RATE INCREASED (Breathing rate above my personal range), PALPITATIONS (Heart Palpitations while sitting at my desk in a video meeting), TACHYCARDIA (Tachycardia), HEART RATE VARIABILITY DECREASED (heart rate variability below my personal range) and TROPONIN INCREASED (elevated troponin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021 at 7:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced RESPIRATORY RATE INCREASED (Breathing rate above my personal range) (seriousness criterion hospitalization) and HEART RATE VARIABILITY DECREASED (heart rate variability below my personal range) (seriousness criterion hospitalization). On 29-Apr-2021, the patient experienced PALPITATIONS (Heart Palpitations while sitting at my desk in a video meeting) (seriousness criterion hospitalization), TACHYCARDIA (Tachycardia) (seriousness criterion hospitalization) and TROPONIN INCREASED (elevated troponin) (seriousness criterion hospitalization). The patient was hospitalized from 29-Apr-2021 to 30-Apr-2021 due to PALPITATIONS, RESPIRATORY RATE INCREASED, TACHYCARDIA and TROPONIN INCREASED. At the time of the report, RESPIRATORY RATE INCREASED (Breathing rate above my personal range), PALPITATIONS (Heart Palpitations while sitting at my desk in a video meeting), TACHYCARDIA (Tachycardia), HEART RATE VARIABILITY DECREASED (heart rate variability below my personal range) and TROPONIN INCREASED (elevated troponin) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Heart rate: 202 (Inconclusive) 202 beats per minute. On 29-Apr-2021, Troponin: increased (High) Elevated Troponin. On 30-Apr-2021, Echocardiogram: normal (normal) Negative for Heart Attack.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       I got an allergy shot in both my left and right arms on 26 Apr 2021 at 4:00 PM. On 20 Apr 2021  I went to the ER at 2:00 PM , elevated Troponin was detected and I was admitted at 4:00 PM for an evaluation for a heart attack.  On 4/30/21,  I was discharged from the hospital because the Echocardiogram and Stress test were negative for a heart attack.  No concomitant medications or treatment information were provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Haematuria, Haemorrhage urinary tract, Thirst
Clinical narrative: Blood clot in urine (black in color) (described it as mucous like and black in color).; Blood in urine (Red in color)(described it as mucous like and black in color).; Aways thirsty; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (Blood clot in urine (black in color) (described it as mucous like and black in color).) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced HAEMORRHAGE URINARY TRACT (Blood clot in urine (black in color) (described it as mucous like and black in color).) (seriousness criterion medically significant), HAEMATURIA (Blood in urine (Red in color)(described it as mucous like and black in color).) and THIRST (Aways thirsty). At the time of the report, HAEMORRHAGE URINARY TRACT (Blood clot in urine (black in color) (described it as mucous like and black in color).), HAEMATURIA (Blood in urine (Red in color)(described it as mucous like and black in color).) and THIRST (Aways thirsty) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.. No allergy reported. No treatment done. Patient did not inform health care provider yet.  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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Product dose omission issue
Clinical narrative: Fell and ended up in the hospital; it is more than 42 days after receiving 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Fell and ended up in the hospital) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced FALL (Fell and ended up in the hospital) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (it is more than 42 days after receiving 1st dose). At the time of the report, FALL (Fell and ended up in the hospital) and PRODUCT DOSE OMISSION ISSUE (it is more than 42 days after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient fell down and ended up in the hospital on the way to get their 2nd dose. Now it has been more than 42 days since receiving their first dose.  Company Comment: This case concerns a 78-year-old female patient who did not receive second dose due to a fall on the way to receiving second dose  and yet to receive the 2nd dose after more than 42 days from receiving 1st dose (missed dose).   There is not enough information to assess the relatedness of fall to product use  The event of missed dose is assessed as not applicable.; Sender's Comments: This case concerns a 78-year-old female patient who did not receive second dose due to a fall on the way to receiving second dose  and yet to receive the 2nd dose after more than 42 days from receiving 1st dose (missed dose).   There is not enough information to assess the relatedness of fall to product use  The event of missed dose is assessed as not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Thrombosis
Clinical narrative: suspected blood clot; When walking experiences traumatic pain in legs; her legs went numb while at store; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (suspected blood clot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (When walking experiences traumatic pain in legs) and HYPOAESTHESIA (her legs went numb while at store). On an unknown date, the patient experienced THROMBOSIS (suspected blood clot) (seriousness criterion medically significant). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at a dose of unknown. On 16-Apr-2021, HYPOAESTHESIA (her legs went numb while at store) had resolved. At the time of the report, THROMBOSIS (suspected blood clot) outcome was unknown and PAIN IN EXTREMITY (When walking experiences traumatic pain in legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Nausea, Ocular hypertension, Pain in extremity
Clinical narrative: Panic; Very dizzy; Very nauseous; Felt a lot of pressure in eyes; Left arm went numb, left leg went numb; Light sensitivity; Right arm pain; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERTENSION (Felt a lot of pressure in eyes) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Right arm pain). On 16-Apr-2021, the patient experienced OCULAR HYPERTENSION (Felt a lot of pressure in eyes) (seriousness criterion medically significant), HYPOAESTHESIA (Left arm went numb, left leg went numb), PHOTOPHOBIA (Light sensitivity), DIZZINESS (Very dizzy) and NAUSEA (Very nauseous). On an unknown date, the patient experienced PANIC REACTION (Panic). At the time of the report, OCULAR HYPERTENSION (Felt a lot of pressure in eyes), PAIN IN EXTREMITY (Right arm pain), HYPOAESTHESIA (Left arm went numb, left leg went numb), PHOTOPHOBIA (Light sensitivity), PANIC REACTION (Panic), DIZZINESS (Very dizzy) and NAUSEA (Very nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment details were provided.  Company Comment: Very limited information regarding these events has been provided at this time. The events may be related to the preexisting anxiety the patient has. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events may be related to the preexisting anxiety the patient has. Further information has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Panic reaction, Photophobia
Clinical narrative: Panic; Very dizzy; Very nauseous; Felt a lot of pressure in eyes; Left arm went numb, left leg went numb; Light sensitivity; Right arm pain; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERTENSION (Felt a lot of pressure in eyes) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Right arm pain). On 16-Apr-2021, the patient experienced OCULAR HYPERTENSION (Felt a lot of pressure in eyes) (seriousness criterion medically significant), HYPOAESTHESIA (Left arm went numb, left leg went numb), PHOTOPHOBIA (Light sensitivity), DIZZINESS (Very dizzy) and NAUSEA (Very nauseous). On an unknown date, the patient experienced PANIC REACTION (Panic). At the time of the report, OCULAR HYPERTENSION (Felt a lot of pressure in eyes), PAIN IN EXTREMITY (Right arm pain), HYPOAESTHESIA (Left arm went numb, left leg went numb), PHOTOPHOBIA (Light sensitivity), PANIC REACTION (Panic), DIZZINESS (Very dizzy) and NAUSEA (Very nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment details were provided.  Company Comment: Very limited information regarding these events has been provided at this time. The events may be related to the preexisting anxiety the patient has. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events may be related to the preexisting anxiety the patient has. Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Eye pain, Head discomfort, Headache, Ocular discomfort
Clinical narrative: light that can be seen in the right side of the eye; eye pain; little dots and floaters in vision; pressure in eye; pressure in head; pain on roof of head; slight fever; headache; vitreous degeneration; blurred dark circles in vision which were darkest on outside; noticeably different vision; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS DEGENERATION (vitreous degeneration) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (acetaminophen with codein). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and MULTIVITAMINS;MINERALS for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced VISUAL IMPAIRMENT (noticeably different vision). On 25-Apr-2021, the patient experienced VITREOUS DEGENERATION (vitreous degeneration) (seriousness criterion medically significant), VISION BLURRED (blurred dark circles in vision which were darkest on outside), EYE DISORDER (light that can be seen in the right side of the eye), EYE PAIN (eye pain), VITREOUS FLOATERS (little dots and floaters in vision), OCULAR DISCOMFORT (pressure in eye), HEAD DISCOMFORT (pressure in head), PAIN (pain on roof of head), PYREXIA (slight fever) and HEADACHE (headache). At the time of the report, VITREOUS DEGENERATION (vitreous degeneration), VISION BLURRED (blurred dark circles in vision which were darkest on outside), VISUAL IMPAIRMENT (noticeably different vision), EYE DISORDER (light that can be seen in the right side of the eye), EYE PAIN (eye pain), VITREOUS FLOATERS (little dots and floaters in vision), OCULAR DISCOMFORT (pressure in eye), HEAD DISCOMFORT (pressure in head), PAIN (pain on roof of head), PYREXIA (slight fever) and HEADACHE (headache) 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.