chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Cold sweat, Erythema, Malaise, Retching
Clinical narrative: At 12:05 am client came to the staff office treatment facility stating he feels sick and has been throwing up. He stated he had the Johnson & Johnson vaccine Tuesday 4/6/21 in the morning and around 6 pm on Tuesday he started to feel sick.  The staff took his temperature and it was 100.9 degrees.  The client was dry heaving and red in the face and having cold sweats.  Staff monitored him while 911 was called and paramedics showed up within 10 minutes.  The Program Manager was notified and the client was given instructions for when going to the hospital.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: At 12:05 am client came to the staff office treatment facility stating he feels sick and has been throwing up. He stated he had the Johnson & Johnson vaccine Tuesday 4/6/21 in the morning and around 6 pm on Tuesday he started to feel sick.  The staff took his temperature and it was 100.9 degrees.  The client was dry heaving and red in the face and having cold sweats.  Staff monitored him while 911 was called and paramedics showed up within 10 minutes.  The Program Manager was notified and the client was given instructions for when going to the hospital.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Throat irritation
Clinical narrative: Pt recieved the vaccine and minutes later developed itching in her throat and ears. Pt recieved benadryl en route. At the hospital pt was also given Prednisone 40mg. Patient significantly improved and was discharged home.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient was light headed after 10 minutes of getting Moderna Vaccine. Patient became stable after 15 minutes and was under pharmacist observation for 30 minutes.
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Dyspnoea, Fatigue, Feeling abnormal, Haemorrhage
Clinical narrative: Blood leakage; Trouble breathing; Shot when right through her body like a wave; Black and blue bruise mark on her arm; Heartburn; Feeling sick; Felt so tired; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Blood leakage) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 36A21A) 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 historical condition reported.). Concomitant products included LEVOTHYROXINE, METOPROLOL, LOSARTAN and ROSUVASTATIN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HAEMORRHAGE (Blood leakage) (seriousness criterion medically significant), DYSPNOEA (Trouble breathing), FEELING ABNORMAL (Shot when right through her body like a wave), VACCINATION SITE DISCOLOURATION (Black and blue bruise mark on her arm), DYSPEPSIA (Heartburn), MALAISE (Feeling sick) and FATIGUE (Felt so tired). At the time of the report, HAEMORRHAGE (Blood leakage), DYSPNOEA (Trouble breathing), FEELING ABNORMAL (Shot when right through her body like a wave), VACCINATION SITE DISCOLOURATION (Black and blue bruise mark on her arm), DYSPEPSIA (Heartburn), MALAISE (Feeling sick) and FATIGUE (Felt so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with Vicks and paracetamol. Reporter's causality was not reported.   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. Very limited information regarding the has been provided at this time for the event (hemorrhage). 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. Very limited information regarding the has been provided at this time for the event (hemorrhage). Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site discolouration
Clinical narrative: Blood leakage; Trouble breathing; Shot when right through her body like a wave; Black and blue bruise mark on her arm; Heartburn; Feeling sick; Felt so tired; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Blood leakage) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 36A21A) 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 historical condition reported.). Concomitant products included LEVOTHYROXINE, METOPROLOL, LOSARTAN and ROSUVASTATIN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HAEMORRHAGE (Blood leakage) (seriousness criterion medically significant), DYSPNOEA (Trouble breathing), FEELING ABNORMAL (Shot when right through her body like a wave), VACCINATION SITE DISCOLOURATION (Black and blue bruise mark on her arm), DYSPEPSIA (Heartburn), MALAISE (Feeling sick) and FATIGUE (Felt so tired). At the time of the report, HAEMORRHAGE (Blood leakage), DYSPNOEA (Trouble breathing), FEELING ABNORMAL (Shot when right through her body like a wave), VACCINATION SITE DISCOLOURATION (Black and blue bruise mark on her arm), DYSPEPSIA (Heartburn), MALAISE (Feeling sick) and FATIGUE (Felt so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with Vicks and paracetamol. Reporter's causality was not reported.   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. Very limited information regarding the has been provided at this time for the event (hemorrhage). 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. Very limited information regarding the has been provided at this time for the event (hemorrhage). Further information has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Cheilitis, Lip blister, Lip erythema, Lip pain
Clinical narrative: Blisters (4) and slight swelling / redness on upper lip. Slight irritation and burning pain. Possible blister(1)  on inside of mouth on lower lip.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Blisters (4) and slight swelling / redness on upper lip. Slight irritation and burning pain. Possible blister(1)  on inside of mouth on lower lip.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Fatigue, Headache, Pain
Clinical narrative: Arm red, swollen,  warm to touch and painful. Achy body down to the bones, fatigued, headache, SOB,  symptoms improving, but not gone
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm red, swollen,  warm to touch and painful. Achy body down to the bones, fatigued, headache, SOB,  symptoms improving, but not gone
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: My arm is very sore, it is hard to move it around at all. Thought this would stop but it has continued
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pruritus, Injection site reaction, Myalgia
Clinical narrative: I got my COVID-19 shot on March 30th, 2021 and had some fatigue, joint pain and muscle pain. On 04/05/2021 I started running a low grade temperature 100.9. This morning 04/07/2021 my arm was itching and I reached up to scratch my arm and where the vaccine was given is a 2x3 whelp and it itches.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: I got my COVID-19 shot on March 30th, 2021 and had some fatigue, joint pain and muscle pain. On 04/05/2021 I started running a low grade temperature 100.9. This morning 04/07/2021 my arm was itching and I reached up to scratch my arm and where the vaccine was given is a 2x3 whelp and it itches.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Eye movement disorder, Fall, Snoring, Syncope
Clinical narrative: Vasovagal syncope - occurred about 3-5 minutes after administration.  Patient slouched in chair, eyes rolled back slightly and patient was snoring. Patient was guided to the floor by pharmacist and significant other and regained consciousness after just a few moments.  Patient was unaware of what happened. Patient was given water and remained lying on the floor for a few minutes and then was able to sit up and recover.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Palpitations, Pyrexia
Clinical narrative: Low grade fever and chills started 10 hours. Body aches , low grade 101 fever for 48 hours after. Most concerned with heart palpitations that were happening at least 30 times an hour for the first week. It lessened to a few an hour the 2nd week. This is the 3rd week and they are not as frequent but still occurring.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: Heart fluttering. Blood pressure 155/98.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Ear infection, Facial paralysis, Herpes zoster, Oropharyngeal pain
Clinical narrative: Shingles; Sore throat; Swelling of the left side of his face; Ear infection; Rash on the side of his face, inside his ear, and on his scalp; Loss of hearing; Drooping of his left lip; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Loss of hearing) and FACIAL PARALYSIS (Drooping of his left lip) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) 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 recorded medical history). Concomitant products included AMOXICILLIN SODIUM (AMOXYCILLIN [AMOXICILLIN SODIUM]) for Laceration.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DEAFNESS (Loss of hearing) (seriousness criterion medically significant), FACIAL PARALYSIS (Drooping of his left lip) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Swelling of the left side of his face), EAR INFECTION (Ear infection) and RASH (Rash on the side of his face, inside his ear, and on his scalp). On 27-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, DEAFNESS (Loss of hearing), FACIAL PARALYSIS (Drooping of his left lip), HERPES ZOSTER (Shingles), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Swelling of the left side of his face), EAR INFECTION (Ear infection) and RASH (Rash on the side of his face, inside his ear, and on his scalp) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient went to urgent care center for the events experienced. Treatment for the events included ciprofloxacin 0.3%, dexamethasone 0.1% suspension and cefdinir. Treatment for shingles included valacyclovir 1mg, gabapentin 300mg, and prednisolone 4mg.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Significant follow up appended.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Shingles; Sore throat; Swelling of the left side of his face; Ear infection; Rash on the side of his face, inside his ear, and on his scalp; Loss of hearing; Drooping of his left lip; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Loss of hearing) and FACIAL PARALYSIS (Drooping of his left lip) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) 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 recorded medical history). Concomitant products included AMOXICILLIN SODIUM (AMOXYCILLIN [AMOXICILLIN SODIUM]) for Laceration.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DEAFNESS (Loss of hearing) (seriousness criterion medically significant), FACIAL PARALYSIS (Drooping of his left lip) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Swelling of the left side of his face), EAR INFECTION (Ear infection) and RASH (Rash on the side of his face, inside his ear, and on his scalp). On 27-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, DEAFNESS (Loss of hearing), FACIAL PARALYSIS (Drooping of his left lip), HERPES ZOSTER (Shingles), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Swelling of the left side of his face), EAR INFECTION (Ear infection) and RASH (Rash on the side of his face, inside his ear, and on his scalp) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient went to urgent care center for the events experienced. Treatment for the events included ciprofloxacin 0.3%, dexamethasone 0.1% suspension and cefdinir. Treatment for shingles included valacyclovir 1mg, gabapentin 300mg, and prednisolone 4mg.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Significant follow up appended.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Mitral valve incompetence
Clinical narrative: Mitral valve leaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MITRAL VALVE INCOMPETENCE (Mitral valve leaking) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Aortic valve disease.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced MITRAL VALVE INCOMPETENCE (Mitral valve leaking) (seriousness criterion hospitalization). The patient was hospitalized on 16-Mar-2021 due to MITRAL VALVE INCOMPETENCE. At the time of the report, MITRAL VALVE INCOMPETENCE (Mitral valve leaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was provided. Treatment information was not included.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Diagnosed with cellulitus; Itchy at injection site; Hard at injection site; Red at injection site; Swelling at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Diagnosed with cellulitus) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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 LORAZEPAM for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced CELLULITIS (Diagnosed with cellulitus) (seriousness criterion medically significant), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, CELLULITIS (Diagnosed with cellulitus), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included lorazepam and unspecified blood pressure medication.  This case concerns a 74-year-old female with a serious unexpected event of cellulitis, and nonserious unexpected vaccination site pruritus, vaccination site induration, vaccination site erythema, vaccination site swelling. Event onset 9 days after mRNA-1273. Event resolving. 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 74-year-old female with a serious unexpected event of cellulitis, and nonserious unexpected vaccination site pruritus, vaccination site induration, vaccination site erythema, vaccination site swelling. Event onset 9 days after mRNA-1273. Event resolving. 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: Arthralgia, Balance disorder, Bruxism, Chills, Decreased appetite
Clinical narrative: Don't have interest in eating or drinking; TMJ; Groggy; I can't balance; Face is pouring sweating; Maybe I'm dehydrated; Pain when my cheek hit the floor; Dislocated my finger; Head full fog; Vertigo; Bad joint pain; Fatigue; Faint; Neck spasms; Shaking; Jaw clenching; Spasms / Neck spasms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) 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.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced TREMOR (Shaking), BRUXISM (Jaw clenching), MUSCLE SPASMS (Spasms / Neck spasms) and CHILLS (Chills). On an unknown date, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant), DECREASED APPETITE (Don't have interest in eating or drinking), TEMPOROMANDIBULAR JOINT SYNDROME (TMJ), SOMNOLENCE (Groggy), BALANCE DISORDER (I can't balance), HYPERHIDROSIS (Face is pouring sweating), DEHYDRATION (Maybe I'm dehydrated), FACIAL PAIN (Pain when my cheek hit the floor), JOINT DISLOCATION (Dislocated my finger), FEELING ABNORMAL (Head full fog), VERTIGO (Vertigo), ARTHRALGIA (Bad joint pain), FATIGUE (Fatigue) and MUSCLE SPASMS (Neck spasms). At the time of the report, SYNCOPE (Faint) had resolved and TREMOR (Shaking), BRUXISM (Jaw clenching), MUSCLE SPASMS (Spasms / Neck spasms), DECREASED APPETITE (Don't have interest in eating or drinking), TEMPOROMANDIBULAR JOINT SYNDROME (TMJ), SOMNOLENCE (Groggy), BALANCE DISORDER (I can't balance), HYPERHIDROSIS (Face is pouring sweating), DEHYDRATION (Maybe I'm dehydrated), FACIAL PAIN (Pain when my cheek hit the floor), JOINT DISLOCATION (Dislocated my finger), FEELING ABNORMAL (Head full fog), VERTIGO (Vertigo), ARTHRALGIA (Bad joint pain), FATIGUE (Fatigue), CHILLS (Chills) and MUSCLE SPASMS (Neck spasms) outcome was unknown.            Treatment information was not reported.   This case was linked to MOD-2021-056711 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the eventS, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Facial pain, Fatigue, Feeling abnormal, Hyperhidrosis
Clinical narrative: Don't have interest in eating or drinking; TMJ; Groggy; I can't balance; Face is pouring sweating; Maybe I'm dehydrated; Pain when my cheek hit the floor; Dislocated my finger; Head full fog; Vertigo; Bad joint pain; Fatigue; Faint; Neck spasms; Shaking; Jaw clenching; Spasms / Neck spasms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) 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.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced TREMOR (Shaking), BRUXISM (Jaw clenching), MUSCLE SPASMS (Spasms / Neck spasms) and CHILLS (Chills). On an unknown date, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant), DECREASED APPETITE (Don't have interest in eating or drinking), TEMPOROMANDIBULAR JOINT SYNDROME (TMJ), SOMNOLENCE (Groggy), BALANCE DISORDER (I can't balance), HYPERHIDROSIS (Face is pouring sweating), DEHYDRATION (Maybe I'm dehydrated), FACIAL PAIN (Pain when my cheek hit the floor), JOINT DISLOCATION (Dislocated my finger), FEELING ABNORMAL (Head full fog), VERTIGO (Vertigo), ARTHRALGIA (Bad joint pain), FATIGUE (Fatigue) and MUSCLE SPASMS (Neck spasms). At the time of the report, SYNCOPE (Faint) had resolved and TREMOR (Shaking), BRUXISM (Jaw clenching), MUSCLE SPASMS (Spasms / Neck spasms), DECREASED APPETITE (Don't have interest in eating or drinking), TEMPOROMANDIBULAR JOINT SYNDROME (TMJ), SOMNOLENCE (Groggy), BALANCE DISORDER (I can't balance), HYPERHIDROSIS (Face is pouring sweating), DEHYDRATION (Maybe I'm dehydrated), FACIAL PAIN (Pain when my cheek hit the floor), JOINT DISLOCATION (Dislocated my finger), FEELING ABNORMAL (Head full fog), VERTIGO (Vertigo), ARTHRALGIA (Bad joint pain), FATIGUE (Fatigue), CHILLS (Chills) and MUSCLE SPASMS (Neck spasms) outcome was unknown.            Treatment information was not reported.   This case was linked to MOD-2021-056711 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the eventS, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Joint dislocation, Muscle spasms, Somnolence, Syncope, Temporomandibular joint syndrome
Clinical narrative: Don't have interest in eating or drinking; TMJ; Groggy; I can't balance; Face is pouring sweating; Maybe I'm dehydrated; Pain when my cheek hit the floor; Dislocated my finger; Head full fog; Vertigo; Bad joint pain; Fatigue; Faint; Neck spasms; Shaking; Jaw clenching; Spasms / Neck spasms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) 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.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced TREMOR (Shaking), BRUXISM (Jaw clenching), MUSCLE SPASMS (Spasms / Neck spasms) and CHILLS (Chills). On an unknown date, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant), DECREASED APPETITE (Don't have interest in eating or drinking), TEMPOROMANDIBULAR JOINT SYNDROME (TMJ), SOMNOLENCE (Groggy), BALANCE DISORDER (I can't balance), HYPERHIDROSIS (Face is pouring sweating), DEHYDRATION (Maybe I'm dehydrated), FACIAL PAIN (Pain when my cheek hit the floor), JOINT DISLOCATION (Dislocated my finger), FEELING ABNORMAL (Head full fog), VERTIGO (Vertigo), ARTHRALGIA (Bad joint pain), FATIGUE (Fatigue) and MUSCLE SPASMS (Neck spasms). At the time of the report, SYNCOPE (Faint) had resolved and TREMOR (Shaking), BRUXISM (Jaw clenching), MUSCLE SPASMS (Spasms / Neck spasms), DECREASED APPETITE (Don't have interest in eating or drinking), TEMPOROMANDIBULAR JOINT SYNDROME (TMJ), SOMNOLENCE (Groggy), BALANCE DISORDER (I can't balance), HYPERHIDROSIS (Face is pouring sweating), DEHYDRATION (Maybe I'm dehydrated), FACIAL PAIN (Pain when my cheek hit the floor), JOINT DISLOCATION (Dislocated my finger), FEELING ABNORMAL (Head full fog), VERTIGO (Vertigo), ARTHRALGIA (Bad joint pain), FATIGUE (Fatigue), CHILLS (Chills) and MUSCLE SPASMS (Neck spasms) outcome was unknown.            Treatment information was not reported.   This case was linked to MOD-2021-056711 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the eventS, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vertigo
Clinical narrative: Don't have interest in eating or drinking; TMJ; Groggy; I can't balance; Face is pouring sweating; Maybe I'm dehydrated; Pain when my cheek hit the floor; Dislocated my finger; Head full fog; Vertigo; Bad joint pain; Fatigue; Faint; Neck spasms; Shaking; Jaw clenching; Spasms / Neck spasms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) 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.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced TREMOR (Shaking), BRUXISM (Jaw clenching), MUSCLE SPASMS (Spasms / Neck spasms) and CHILLS (Chills). On an unknown date, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant), DECREASED APPETITE (Don't have interest in eating or drinking), TEMPOROMANDIBULAR JOINT SYNDROME (TMJ), SOMNOLENCE (Groggy), BALANCE DISORDER (I can't balance), HYPERHIDROSIS (Face is pouring sweating), DEHYDRATION (Maybe I'm dehydrated), FACIAL PAIN (Pain when my cheek hit the floor), JOINT DISLOCATION (Dislocated my finger), FEELING ABNORMAL (Head full fog), VERTIGO (Vertigo), ARTHRALGIA (Bad joint pain), FATIGUE (Fatigue) and MUSCLE SPASMS (Neck spasms). At the time of the report, SYNCOPE (Faint) had resolved and TREMOR (Shaking), BRUXISM (Jaw clenching), MUSCLE SPASMS (Spasms / Neck spasms), DECREASED APPETITE (Don't have interest in eating or drinking), TEMPOROMANDIBULAR JOINT SYNDROME (TMJ), SOMNOLENCE (Groggy), BALANCE DISORDER (I can't balance), HYPERHIDROSIS (Face is pouring sweating), DEHYDRATION (Maybe I'm dehydrated), FACIAL PAIN (Pain when my cheek hit the floor), JOINT DISLOCATION (Dislocated my finger), FEELING ABNORMAL (Head full fog), VERTIGO (Vertigo), ARTHRALGIA (Bad joint pain), FATIGUE (Fatigue), CHILLS (Chills) and MUSCLE SPASMS (Neck spasms) outcome was unknown.            Treatment information was not reported.   This case was linked to MOD-2021-056711 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the eventS, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: First dose "knocked her out"; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (First dose "knocked her out") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (First dose "knocked her out") (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (First dose "knocked her out") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Insomnia, Pain, Pain in extremity
Clinical narrative: Swelling of groin and testicles; Swelling of groin and testicles; Pain on hands and feet; Weakness; Chills; Generalized pain; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized pain), SWELLING (Swelling of groin and testicles) and TESTICULAR SWELLING (Swelling of groin and testicles) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INSOMNIA (Insomnia). On 26-Mar-2021, the patient experienced PAIN (Generalized pain) (seriousness criterion medically significant), ASTHENIA (Weakness) and CHILLS (Chills). On 27-Mar-2021, the patient experienced SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant), TESTICULAR SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain on hands and feet). At the time of the report, PAIN (Generalized pain), INSOMNIA (Insomnia), ASTHENIA (Weakness) and CHILLS (Chills) was resolving and SWELLING (Swelling of groin and testicles), TESTICULAR SWELLING (Swelling of groin and testicles) and PAIN IN EXTREMITY (Pain on hands and feet) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Testicular swelling
Clinical narrative: Swelling of groin and testicles; Swelling of groin and testicles; Pain on hands and feet; Weakness; Chills; Generalized pain; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized pain), SWELLING (Swelling of groin and testicles) and TESTICULAR SWELLING (Swelling of groin and testicles) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INSOMNIA (Insomnia). On 26-Mar-2021, the patient experienced PAIN (Generalized pain) (seriousness criterion medically significant), ASTHENIA (Weakness) and CHILLS (Chills). On 27-Mar-2021, the patient experienced SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant), TESTICULAR SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain on hands and feet). At the time of the report, PAIN (Generalized pain), INSOMNIA (Insomnia), ASTHENIA (Weakness) and CHILLS (Chills) was resolving and SWELLING (Swelling of groin and testicles), TESTICULAR SWELLING (Swelling of groin and testicles) and PAIN IN EXTREMITY (Pain on hands and feet) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ugly allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (ugly allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    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 HYPERSENSITIVITY (ugly allergic reaction) (seriousness criterion hospitalization). At the time of the report, HYPERSENSITIVITY (ugly allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Reporter did not allow further contact.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Joint swelling, Liver injury, Muscle strain, Vaccination site bruising
Clinical narrative: liver level was up 1000 times what it normally is; pain in arm; a little bruising on that arm; pulled a muscle in the back of my thigh; calves and ankles are all swollen; hardly walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIVER INJURY (liver level was up 1000 times what it normally is) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in arm) and VACCINATION SITE BRUISING (a little bruising on that arm). On an unknown date, the patient experienced LIVER INJURY (liver level was up 1000 times what it normally is) (seriousness criterion medically significant), MUSCLE STRAIN (pulled a muscle in the back of my thigh), JOINT SWELLING (calves and ankles are all swollen) and GAIT INABILITY (hardly walk). At the time of the report, LIVER INJURY (liver level was up 1000 times what it normally is), VACCINATION SITE PAIN (pain in arm), VACCINATION SITE BRUISING (a little bruising on that arm), MUSCLE STRAIN (pulled a muscle in the back of my thigh), JOINT SWELLING (calves and ankles are all swollen) and GAIT INABILITY (hardly walk) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included one dose of acetaminophen 500mg and heating pad.  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: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: liver level was up 1000 times what it normally is; pain in arm; a little bruising on that arm; pulled a muscle in the back of my thigh; calves and ankles are all swollen; hardly walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIVER INJURY (liver level was up 1000 times what it normally is) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in arm) and VACCINATION SITE BRUISING (a little bruising on that arm). On an unknown date, the patient experienced LIVER INJURY (liver level was up 1000 times what it normally is) (seriousness criterion medically significant), MUSCLE STRAIN (pulled a muscle in the back of my thigh), JOINT SWELLING (calves and ankles are all swollen) and GAIT INABILITY (hardly walk). At the time of the report, LIVER INJURY (liver level was up 1000 times what it normally is), VACCINATION SITE PAIN (pain in arm), VACCINATION SITE BRUISING (a little bruising on that arm), MUSCLE STRAIN (pulled a muscle in the back of my thigh), JOINT SWELLING (calves and ankles are all swollen) and GAIT INABILITY (hardly walk) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included one dose of acetaminophen 500mg and heating pad.  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: Abortion of ectopic pregnancy, Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABORTION OF ECTOPIC PREGNANCY (Miscarriage) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypospadias on 15-Jun-2019 and Pregnancy (one). Concurrent medical conditions included Subfertility (Treated since 2018).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Jan-2021 and the estimated date of delivery was 29-Oct-2021. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). On 05-Mar-2021, the patient experienced ABORTION OF ECTOPIC PREGNANCY (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Ectopic pregnancy. On 04-Mar-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, ABORTION OF ECTOPIC PREGNANCY (Miscarriage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion.; Sender's Comments: This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Asthenopia, Hypoaesthesia, Myalgia, Nasal congestion
Clinical narrative: Little out of it in her head, very quick surge of pain on her left leg which is repeating; Left nose congestion; Left side of the face being numb; Eyebrows were kind of very heavy; Muscle aches; Temperature little high, heat was radiating to back of her head; A spontaneous report was received from a consumer concerning a 71-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced left nose congestion/ nose congestion, left side of the face being numb/ Hypoesthesia, eyebrows were kind of very heavy/asthenopia , little out of it in her head/adverse reaction, muscle aches/ myalgia, temperature little high,heat was radiating to back of her head/ pyrexia.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.  On 25 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:016B21A ) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On unknown date, prior to receiving mRNA-1273, the patient felt left nose congestion, left side of the face being numb, eyebrows were kind of very heavy, little out of it in her head, heat was radiating to back of her head, muscle aches, temperature little high. Treatment for events included diphenhydramine HCl, acetylsalicylic acid.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, left nose congestion, left side of the face being numb, eyebrows were kind of very heavy, little out of it in her head, heat was radiating to back of her head, muscle aches, temperature little high were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Little out of it in her head, very quick surge of pain on her left leg which is repeating; Left nose congestion; Left side of the face being numb; Eyebrows were kind of very heavy; Muscle aches; Temperature little high, heat was radiating to back of her head; A spontaneous report was received from a consumer concerning a 71-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced left nose congestion/ nose congestion, left side of the face being numb/ Hypoesthesia, eyebrows were kind of very heavy/asthenopia , little out of it in her head/adverse reaction, muscle aches/ myalgia, temperature little high,heat was radiating to back of her head/ pyrexia.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.  On 25 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:016B21A ) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On unknown date, prior to receiving mRNA-1273, the patient felt left nose congestion, left side of the face being numb, eyebrows were kind of very heavy, little out of it in her head, heat was radiating to back of her head, muscle aches, temperature little high. Treatment for events included diphenhydramine HCl, acetylsalicylic acid.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, left nose congestion, left side of the face being numb, eyebrows were kind of very heavy, little out of it in her head, heat was radiating to back of her head, muscle aches, temperature little high were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Atrial flutter, Cardiac pacemaker insertion, Dizziness
Clinical narrative: procedure in which his heart was cut from top to bottom/pacemaker dependent; fast heart rate; afib; red dots on both of his arms; rash on both arms; dizzy; sick; very weak/no energy; hard time walking; cannot do the simplest of tasks; flutter; A spontaneous report was received from a Consumer concerning herself, a 57-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, fast heart rate, cardiac pacemaker dependent, atrial fibrillation, red dots on both of his arms, rash on both arms, dizziness, sick, Atrial flutter, very weak and no energy, hard time walking, and cannot do the simplest of tasks.  The patient's medical history included atrial fibrillation and had a pacemaker placed about 8-9 months ago.  Products known to have been used by the patient, within two weeks prior to the event were blood pressure medication, antiarrhythmics.  On 01 Mar 2021, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: 030m20a) via unknown route for prophylaxis of COVID-19 infection.  On 01 Mar 2021, after vaccination, the patient developed red dots on both of his arms. For next two days, the patient had rash on both arms, was dizzy, felt sick, developed fast heart rate; went to hospital twice for heart rate either 07 Mar 2021 or 13 Mar 2021.During first visit to hospital, fast rate was brought under control, while in the second visit, the patient had a procedure in which his heart was cut from top to bottom and was made pacemaker dependent. The atrial fibrillation could not be controlled for 26 hours and had a flutter which was not identified and could not be controlled. Flutter returned after stopping amlodipine and hence patient was restarted on amlodipine. The patient now feels very weak, has a hard time walking, has no energy, cannot do the simplest of tasks, still experiences fast heart rate and flutter every now and then.   No Laboratory investigations were provided. The Treatment information included pacemaker, amlodipine.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, fast heart rate, cardiac pacemaker dependent, atrial fibrillation, red dots on both of his arms, rash on both arms, dizziness, sick, atrial flutter, very weak and no energy, hard time walking, cannot do the simplest of tasks were unknown.