chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dehydration, Diarrhoea, Headache, Hospitalisation
Clinical narrative: she was hospitalized after the first vaccine; 2 bags of IV medication for being dehydrated; diarrhea; headache; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (she was hospitalized after the first vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE and CETIRIZINE HYDROCHLORIDE (CETRIZINE) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIARRHOEA (diarrhea), HEADACHE (headache) and VOMITING (vomiting). On an unknown date, the patient experienced HOSPITALISATION (she was hospitalized after the first vaccine) (seriousness criterion hospitalization prolonged) and DEHYDRATION (2 bags of IV medication for being dehydrated). On 22-Jan-2021, DIARRHOEA (diarrhea), HEADACHE (headache) and VOMITING (vomiting) had resolved. At the time of the report, HOSPITALISATION (she was hospitalized after the first vaccine) and DEHYDRATION (2 bags of IV medication for being dehydrated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: negative tested negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Nausea medication, 2 bags of IV medication for being dehydrated.  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-2021-085893 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Additional information received; 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: Vomiting
Clinical narrative: she was hospitalized after the first vaccine; 2 bags of IV medication for being dehydrated; diarrhea; headache; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (she was hospitalized after the first vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE and CETIRIZINE HYDROCHLORIDE (CETRIZINE) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIARRHOEA (diarrhea), HEADACHE (headache) and VOMITING (vomiting). On an unknown date, the patient experienced HOSPITALISATION (she was hospitalized after the first vaccine) (seriousness criterion hospitalization prolonged) and DEHYDRATION (2 bags of IV medication for being dehydrated). On 22-Jan-2021, DIARRHOEA (diarrhea), HEADACHE (headache) and VOMITING (vomiting) had resolved. At the time of the report, HOSPITALISATION (she was hospitalized after the first vaccine) and DEHYDRATION (2 bags of IV medication for being dehydrated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: negative tested negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Nausea medication, 2 bags of IV medication for being dehydrated.  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-2021-085893 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Additional information received; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Nausea, Swelling, Systemic lupus erythematosus, Vaccination site pain
Clinical narrative: Lupus flare up; Lupus flare up.; Nauseous; Pain on the right arm / muscular pain and it could be for the injection site; Swelling; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus-like syndrome. Concomitant products included RANITIDINE HYDROCHLORIDE (ZANTAC).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced SWELLING (Swelling) and VACCINATION SITE PAIN (Pain on the right arm / muscular pain and it could be for the injection site). On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) (seriousness criterion medically significant), CONDITION AGGRAVATED (Lupus flare up.) and NAUSEA (Nauseous). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up), CONDITION AGGRAVATED (Lupus flare up.), SWELLING (Swelling), NAUSEA (Nauseous) and VACCINATION SITE PAIN (Pain on the right arm / muscular pain and it could be for the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Serious Event 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: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Confusional state, Cough, Myalgia
Clinical narrative: COVID-19; confusion; weakness; cough; fever; body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization prolonged), ASTHENIA (weakness) (seriousness criterion hospitalization prolonged), COUGH (cough) (seriousness criterion hospitalization prolonged), PYREXIA (fever) (seriousness criterion hospitalization prolonged) and MYALGIA (body aches) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 14-Mar-2021 due to ASTHENIA, CONFUSIONAL STATE, COUGH, COVID-19, MYALGIA and PYREXIA. At the time of the report, COVID-19 (COVID-19), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.  Patient was hospitalized due to worsening condition.  Company Comment: This case concerns a 97-year-old female hospitalized with serious unexpected events of COVID-19 with confusional state, asthenia, cough, pyrexia and myalgia. Latency 6 days after first dose mRNA-1273. 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: This case concerns a 97-year-old female hospitalized with serious unexpected events of COVID-19 with confusional state, asthenia, cough, pyrexia and myalgia. Latency 6 days after first dose mRNA-1273. 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: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19; confusion; weakness; cough; fever; body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization prolonged), ASTHENIA (weakness) (seriousness criterion hospitalization prolonged), COUGH (cough) (seriousness criterion hospitalization prolonged), PYREXIA (fever) (seriousness criterion hospitalization prolonged) and MYALGIA (body aches) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 14-Mar-2021 due to ASTHENIA, CONFUSIONAL STATE, COUGH, COVID-19, MYALGIA and PYREXIA. At the time of the report, COVID-19 (COVID-19), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.  Patient was hospitalized due to worsening condition.  Company Comment: This case concerns a 97-year-old female hospitalized with serious unexpected events of COVID-19 with confusional state, asthenia, cough, pyrexia and myalgia. Latency 6 days after first dose mRNA-1273. 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: This case concerns a 97-year-old female hospitalized with serious unexpected events of COVID-19 with confusional state, asthenia, cough, pyrexia and myalgia. Latency 6 days after first dose mRNA-1273. 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: Coordination abnormal, Crepitations, Diarrhoea, Dizziness, Ear pain
Clinical narrative: audio and visual hallucinations; diarrhea; low blood pressure; earache; mental fog; coordination problems; head rushes; crackling; Eyes not following finger test; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATIONS, MIXED (audio and visual hallucinations) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) 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 SIMETICONE (GAS X), PARACETAMOL (TYLENOL) and VITAMINS NOS for an unknown indication.   On 03-Mar-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 03-Mar-2021, the patient experienced HALLUCINATIONS, MIXED (audio and visual hallucinations) (seriousness criterion medically significant), DIARRHOEA (diarrhea), HYPOTENSION (low blood pressure), EAR PAIN (earache), FEELING ABNORMAL (mental fog), COORDINATION ABNORMAL (coordination problems), ORTHOSTATIC HYPOTENSION (head rushes), CREPITATIONS (crackling), EYE MOVEMENT DISORDER (Eyes not following finger test) and DIZZINESS (Dizziness). At the time of the report, HALLUCINATIONS, MIXED (audio and visual hallucinations) and DIARRHOEA (diarrhea) had resolved, HYPOTENSION (low blood pressure), EAR PAIN (earache), FEELING ABNORMAL (mental fog), COORDINATION ABNORMAL (coordination problems), ORTHOSTATIC HYPOTENSION (head rushes), CREPITATIONS (crackling) and EYE MOVEMENT DISORDER (Eyes not following finger test) had not resolved and DIZZINESS (Dizziness) outcome was unknown.            The arm that the patient received each dose was not confirmed.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Feeling abnormal, Hallucinations, mixed, Hypotension, Orthostatic hypotension
Clinical narrative: audio and visual hallucinations; diarrhea; low blood pressure; earache; mental fog; coordination problems; head rushes; crackling; Eyes not following finger test; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATIONS, MIXED (audio and visual hallucinations) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) 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 SIMETICONE (GAS X), PARACETAMOL (TYLENOL) and VITAMINS NOS for an unknown indication.   On 03-Mar-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 03-Mar-2021, the patient experienced HALLUCINATIONS, MIXED (audio and visual hallucinations) (seriousness criterion medically significant), DIARRHOEA (diarrhea), HYPOTENSION (low blood pressure), EAR PAIN (earache), FEELING ABNORMAL (mental fog), COORDINATION ABNORMAL (coordination problems), ORTHOSTATIC HYPOTENSION (head rushes), CREPITATIONS (crackling), EYE MOVEMENT DISORDER (Eyes not following finger test) and DIZZINESS (Dizziness). At the time of the report, HALLUCINATIONS, MIXED (audio and visual hallucinations) and DIARRHOEA (diarrhea) had resolved, HYPOTENSION (low blood pressure), EAR PAIN (earache), FEELING ABNORMAL (mental fog), COORDINATION ABNORMAL (coordination problems), ORTHOSTATIC HYPOTENSION (head rushes), CREPITATIONS (crackling) and EYE MOVEMENT DISORDER (Eyes not following finger test) had not resolved and DIZZINESS (Dizziness) outcome was unknown.            The arm that the patient received each dose was not confirmed.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Chills
Clinical narrative: Stroke with fine motor skills not working; Severe shaking chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke with fine motor skills not working) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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 NINTEDANIB ESILATE (OFEV), EZETIMIBE, SIMVASTATIN (VYTORIN) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced CHILLS (Severe shaking chills). On 05-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke with fine motor skills not working) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke with fine motor skills not working) and CHILLS (Severe shaking chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is taking clopidogrel (Plavix) 75mg and aspirin 81mg as advised by health care professional to try to alleviate the symptoms.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthma, Cough, Electrocardiogram, Mobility decreased, Musculoskeletal chest pain
Clinical narrative: Mobility decreased; rib pain; drug induced asthma; coughing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MOBILITY DECREASED (Mobility decreased), MUSCULOSKELETAL CHEST PAIN (rib pain), ASTHMA (drug induced asthma) and COUGH (coughing) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 008B212A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Asthma, Rheumatoid arthritis and Blood pressure high. Concomitant products included LOSARTAN for Blood pressure management, VITAMIN D NOS, CALCIUM, ASCORBIC ACID (VITAMIN C ACID) and IRON for Supplementation therapy.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 07-Mar-2021, the patient experienced MOBILITY DECREASED (Mobility decreased) (seriousness criterion medically significant), MUSCULOSKELETAL CHEST PAIN (rib pain) (seriousness criterion medically significant), ASTHMA (drug induced asthma) (seriousness criterion medically significant) and COUGH (coughing) (seriousness criterion medically significant). At the time of the report, MOBILITY DECREASED (Mobility decreased), MUSCULOSKELETAL CHEST PAIN (rib pain), ASTHMA (drug induced asthma) and COUGH (coughing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Electrocardiogram: normal (normal) No complications. On 07-Mar-2021, SARS-CoV-2 test: negative for covid 19 infection (Negative) Negative for Covid 19 Infection.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 07 Mar 2021, the patient presented to the emergency room and was unspecified antibiotics and medications for asthma, cough, and pain.  Treatment medication included naproxen, albuterol, tessalon perle, codeine, guaifenesin, buspar, magnesium sulphate and prednisone.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test
Clinical narrative: Mobility decreased; rib pain; drug induced asthma; coughing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MOBILITY DECREASED (Mobility decreased), MUSCULOSKELETAL CHEST PAIN (rib pain), ASTHMA (drug induced asthma) and COUGH (coughing) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 008B212A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Asthma, Rheumatoid arthritis and Blood pressure high. Concomitant products included LOSARTAN for Blood pressure management, VITAMIN D NOS, CALCIUM, ASCORBIC ACID (VITAMIN C ACID) and IRON for Supplementation therapy.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 07-Mar-2021, the patient experienced MOBILITY DECREASED (Mobility decreased) (seriousness criterion medically significant), MUSCULOSKELETAL CHEST PAIN (rib pain) (seriousness criterion medically significant), ASTHMA (drug induced asthma) (seriousness criterion medically significant) and COUGH (coughing) (seriousness criterion medically significant). At the time of the report, MOBILITY DECREASED (Mobility decreased), MUSCULOSKELETAL CHEST PAIN (rib pain), ASTHMA (drug induced asthma) and COUGH (coughing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Electrocardiogram: normal (normal) No complications. On 07-Mar-2021, SARS-CoV-2 test: negative for covid 19 infection (Negative) Negative for Covid 19 Infection.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 07 Mar 2021, the patient presented to the emergency room and was unspecified antibiotics and medications for asthma, cough, and pain.  Treatment medication included naproxen, albuterol, tessalon perle, codeine, guaifenesin, buspar, magnesium sulphate and prednisone.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Erythema, Hypersensitivity, Speech disorder, Throat tightness
Clinical narrative: throat closed up; she could not talk; severe allergic reaction; left ear was on fire; knees were red; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (throat closed up) and SPEECH DISORDER (she could not talk) in a 67-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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced THROAT TIGHTNESS (throat closed up) (seriousness criterion medically significant), SPEECH DISORDER (she could not talk) (seriousness criterion medically significant), HYPERSENSITIVITY (severe allergic reaction), EAR DISCOMFORT (left ear was on fire) and ERYTHEMA (knees were red). On 19-Feb-2021, THROAT TIGHTNESS (throat closed up), SPEECH DISORDER (she could not talk), HYPERSENSITIVITY (severe allergic reaction), EAR DISCOMFORT (left ear was on fire) and ERYTHEMA (knees were red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Tasted bitterness in mouth about 1 minutes after injection, back of throat and tongue started to tingle and feel numb about 5 mins after injection, slightly lightheaded and tingles when down shoulders to hands after 10 minutes. Entirety lasted for 30-45 minutes or so.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Diagnosed with Bells Palsy
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Headache, Herpes zoster, Pain, Rash
Clinical narrative: Painful Rash followed by Shingles diagnosis.  7 days headache, body aches, mostly bedridden.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Hypoaesthesia oral, Paraesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: Tasted bitterness in mouth about 1 minutes after injection, back of throat and tongue started to tingle and feel numb about 5 mins after injection, slightly lightheaded. Entirety lasted for 30 minutes or so.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia
Clinical narrative: Tasted bitterness in mouth about 1 minutes after injection, back of throat and tongue started to tingle and feel numb about 5 mins after injection, slightly lightheaded. Entirety lasted for 30 minutes or so.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Developed tinnitus and still present almost 3 months later. Going to take prednisone to try to relieve
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Paraesthesia oral
Clinical narrative: 20 min. after receiving her second moderna dose this client with a previous h/o severe allergic rxn c/o shortness of breath and her upper lip tingly, the client agreed to be checked by EMS, BP elevated at 160/100, O2 sat 96% P 108. EMS called approx 5 min. in to my assessment pBP still high 152/86, LSCTA per EMS, they offered to take her to be observed if she wanted but told the  client her lung were clear and that lip and tongue tingling could be anxiety. The client agreed to go home and take her inhaler and some benadryl and see if that helps her sx and if not she would seek emergent care prn. The client went back to work 50 min. after injection and planned to have co workers assist her if needed. Client signed refusal of transport for the medics.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased activity, General physical health deterioration, Infection, Inflammation, Muscle spasticity
Clinical narrative: Declining health condition; Hand swollen; Cannot lift the arm; Physical activity significantly decreased; Infection; Inflammation; Arm pain/pain got worsened; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (Declining health condition) in an 85-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.     The patient's past medical history included Stent placement (stent placed before receiving the vaccine.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Declining health condition) (seriousness criterion medically significant), PERIPHERAL SWELLING (Hand swollen), MUSCLE SPASTICITY (Cannot lift the arm), DECREASED ACTIVITY (Physical activity significantly decreased), INFECTION (Infection), INFLAMMATION (Inflammation) and PAIN IN EXTREMITY (Arm pain/pain got worsened). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (Declining health condition), PERIPHERAL SWELLING (Hand swollen), MUSCLE SPASTICITY (Cannot lift the arm), DECREASED ACTIVITY (Physical activity significantly decreased), INFECTION (Infection), INFLAMMATION (Inflammation) and PAIN IN EXTREMITY (Arm pain/pain got worsened) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       The patient developed arm pain for his father couple of months back next day after receiving the first dose. The pain got worsened from then making the hand swollen and physical activity significantly decreased. The reporter contacted 3 doctors to address the concern and none could figure the reason. The reporter was concerned about his father's declining health condition and mentioned that he cannot his arm. The physician recommended not to have the second dose. First Health care provider considered as Arthritis, Second now considered as Gait and third doctor diagnosed as Infection and Inflammation.  Treatment medication include Prednisone.  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.