chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: sore arm; burning sensation at injection site (felt like bee sting); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PAIN (burning sensation at injection site (felt like bee sting)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PAIN (burning sensation at injection site (felt like bee sting)). On 11-Apr-2021, VACCINATION SITE PAIN (burning sensation at injection site (felt like bee sting)) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: severe arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe arm pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe arm pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 15-Mar-2021, PAIN IN EXTREMITY (severe arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicine information is provided by the reporter   This case was linked to MOD-2021-073934 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up document is received on 17-JUN-2021 and it doesn't have any new information
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: red itchy bump on the right arm  after second shot of vaccination; red itchy bump on the right arm  after second shot of vaccination; red itchy bump on the right arm  after second shot of vaccination; feeling tired after the second vaccine; light-headed after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light-headed after the second vaccine), VACCINATION SITE MASS (red itchy bump on the right arm  after second shot of vaccination), VACCINATION SITE PRURITUS (red itchy bump on the right arm  after second shot of vaccination), VACCINATION SITE ERYTHEMA (red itchy bump on the right arm  after second shot of vaccination) and FATIGUE (feeling tired after the second vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019821A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (light-headed after the second vaccine) and FATIGUE (feeling tired after the second vaccine). On 10-Apr-2021, the patient experienced VACCINATION SITE MASS (red itchy bump on the right arm  after second shot of vaccination), VACCINATION SITE PRURITUS (red itchy bump on the right arm  after second shot of vaccination) and VACCINATION SITE ERYTHEMA (red itchy bump on the right arm  after second shot of vaccination). At the time of the report, DIZZINESS (light-headed after the second vaccine), VACCINATION SITE MASS (red itchy bump on the right arm  after second shot of vaccination), VACCINATION SITE PRURITUS (red itchy bump on the right arm  after second shot of vaccination), VACCINATION SITE ERYTHEMA (red itchy bump on the right arm  after second shot of vaccination) and FATIGUE (feeling tired after the second vaccine) had not resolved. Not Provided           Patient also reported that will be having a HIDA scan to check her liver and other parts on Thursday 15Apr2021 if doesn't affect her vaccine. Relevant concomitant product usage were not reported by the reporter. No treatment details were added. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Initial insomnia
Clinical narrative: trouble falling asleep; This spontaneous case was reported by a consumer and describes the occurrence of INITIAL INSOMNIA (trouble falling asleep) 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced INITIAL INSOMNIA (trouble falling asleep). On 09-Apr-2021, INITIAL INSOMNIA (trouble falling asleep) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-127517 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Headache, Nasal congestion
Clinical narrative: vomiting; diarrhea.; still congested; shaking chills; coughing; nose running; low-grade fever; feverish; chills; headache; aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish), CHILLS (chills), VOMITING (vomiting), DIARRHEA (diarrhea.) and NASAL CONGESTION (still congested) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (feverish), CHILLS (chills), HEADACHE (headache) and PAIN (aches). On 09-Apr-2021, the patient experienced COUGH (coughing), RHINORRHOEA (nose running) and PYREXIA (low-grade fever). On 10-Apr-2021, the patient experienced CHILLS (shaking chills). On 12-Apr-2021, the patient experienced VOMITING (vomiting), DIARRHEA (diarrhea.) and NASAL CONGESTION (still congested). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (feverish), CHILLS (chills), VOMITING (vomiting), DIARRHEA (diarrhea.), NASAL CONGESTION (still congested), COUGH (coughing), HEADACHE (headache), PAIN (aches), RHINORRHOEA (nose running), PYREXIA (low-grade fever) and CHILLS (shaking chills) outcome was unknown. Not Provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: vomiting; diarrhea.; still congested; shaking chills; coughing; nose running; low-grade fever; feverish; chills; headache; aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish), CHILLS (chills), VOMITING (vomiting), DIARRHEA (diarrhea.) and NASAL CONGESTION (still congested) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (feverish), CHILLS (chills), HEADACHE (headache) and PAIN (aches). On 09-Apr-2021, the patient experienced COUGH (coughing), RHINORRHOEA (nose running) and PYREXIA (low-grade fever). On 10-Apr-2021, the patient experienced CHILLS (shaking chills). On 12-Apr-2021, the patient experienced VOMITING (vomiting), DIARRHEA (diarrhea.) and NASAL CONGESTION (still congested). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (feverish), CHILLS (chills), VOMITING (vomiting), DIARRHEA (diarrhea.), NASAL CONGESTION (still congested), COUGH (coughing), HEADACHE (headache), PAIN (aches), RHINORRHOEA (nose running), PYREXIA (low-grade fever) and CHILLS (shaking chills) outcome was unknown. Not Provided
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Pyrexia, Vaccination site lymphadenopathy
Clinical narrative: Feverish; chills; pain; felt really weak; painful swollen lymphnode in under arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feverish), CHILLS (chills), PAIN (pain), ASTHENIA (felt really weak) and VACCINATION SITE LYMPHADENOPATHY (painful swollen lymphnode in under arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (Feverish), CHILLS (chills), PAIN (pain), ASTHENIA (felt really weak) and VACCINATION SITE LYMPHADENOPATHY (painful swollen lymphnode in under arm). At the time of the report, PYREXIA (Feverish), CHILLS (chills), PAIN (pain), ASTHENIA (felt really weak) and VACCINATION SITE LYMPHADENOPATHY (painful swollen lymphnode in under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided by reporter.    Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received and contains updated AE Contact information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site mass
Clinical narrative: lump below injection site; redness below injection site; head ache; This spontaneous case was reported by an audiologist and describes the occurrence of VACCINATION SITE MASS (lump below injection site), VACCINATION SITE ERYTHEMA (redness below injection site) and HEADACHE (head ache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concomitant products included LETROZOLE (FEMARA) and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced HEADACHE (head ache). On 12-Apr-2021, the patient experienced VACCINATION SITE MASS (lump below injection site) and VACCINATION SITE ERYTHEMA (redness below injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Apr-2021, HEADACHE (head ache) had resolved. At the time of the report, VACCINATION SITE MASS (lump below injection site) and VACCINATION SITE ERYTHEMA (redness below injection site) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that patient took second dose did great and not even sore arm was reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up included outcome of events were updated and second dose information added On 16-Jul-2021: Follow up included no new significant information
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Cold sweat, Diarrhoea, Dizziness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy) and FEELING ABNORMAL (going to die) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), PREDNISONE, METHYLPHENIDATE HYDROCHLORIDE (RITALIN), PIMOZIDE, POTASSIUM and BUMETANIDE (BUMEX) for an unknown indication. On 18-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 DYSPNEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy), HEART RATE INCREASED (elevated heartbeat), PAIN (pain across chest and shoulders), SWELLING FACE (face swelling), JOINT SWELLING (ankle swelling), DIZZINESS (Dizziness) and DIARRHOEA (horrible diarrhea). On 19-Mar-2021, the patient experienced AGEUSIA (loss of taste), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme tiredness). On 11-Apr-2021, the patient experienced SWELLING (toe become swollen). On an unknown date, the patient experienced FEELING ABNORMAL (going to die). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy), FEELING ABNORMAL (going to die), HEART RATE INCREASED (elevated heartbeat), PAIN (pain across chest and shoulders), SWELLING FACE (face swelling), JOINT SWELLING (ankle swelling), DIZZINESS (Dizziness), DIARRHOEA (horrible diarrhea), SWELLING (toe become swollen), AGEUSIA (loss of taste), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme tiredness) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dyspnoea, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy) and FEELING ABNORMAL (going to die) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), PREDNISONE, METHYLPHENIDATE HYDROCHLORIDE (RITALIN), PIMOZIDE, POTASSIUM and BUMETANIDE (BUMEX) for an unknown indication. On 18-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 DYSPNEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy), HEART RATE INCREASED (elevated heartbeat), PAIN (pain across chest and shoulders), SWELLING FACE (face swelling), JOINT SWELLING (ankle swelling), DIZZINESS (Dizziness) and DIARRHOEA (horrible diarrhea). On 19-Mar-2021, the patient experienced AGEUSIA (loss of taste), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme tiredness). On 11-Apr-2021, the patient experienced SWELLING (toe become swollen). On an unknown date, the patient experienced FEELING ABNORMAL (going to die). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy), FEELING ABNORMAL (going to die), HEART RATE INCREASED (elevated heartbeat), PAIN (pain across chest and shoulders), SWELLING FACE (face swelling), JOINT SWELLING (ankle swelling), DIZZINESS (Dizziness), DIARRHOEA (horrible diarrhea), SWELLING (toe become swollen), AGEUSIA (loss of taste), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme tiredness) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Joint swelling, Pain, Pyrexia, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy) and FEELING ABNORMAL (going to die) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), PREDNISONE, METHYLPHENIDATE HYDROCHLORIDE (RITALIN), PIMOZIDE, POTASSIUM and BUMETANIDE (BUMEX) for an unknown indication. On 18-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 DYSPNEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy), HEART RATE INCREASED (elevated heartbeat), PAIN (pain across chest and shoulders), SWELLING FACE (face swelling), JOINT SWELLING (ankle swelling), DIZZINESS (Dizziness) and DIARRHOEA (horrible diarrhea). On 19-Mar-2021, the patient experienced AGEUSIA (loss of taste), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme tiredness). On 11-Apr-2021, the patient experienced SWELLING (toe become swollen). On an unknown date, the patient experienced FEELING ABNORMAL (going to die). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy), FEELING ABNORMAL (going to die), HEART RATE INCREASED (elevated heartbeat), PAIN (pain across chest and shoulders), SWELLING FACE (face swelling), JOINT SWELLING (ankle swelling), DIZZINESS (Dizziness), DIARRHOEA (horrible diarrhea), SWELLING (toe become swollen), AGEUSIA (loss of taste), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme tiredness) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy) and FEELING ABNORMAL (going to die) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), PREDNISONE, METHYLPHENIDATE HYDROCHLORIDE (RITALIN), PIMOZIDE, POTASSIUM and BUMETANIDE (BUMEX) for an unknown indication. On 18-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 DYSPNEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy), HEART RATE INCREASED (elevated heartbeat), PAIN (pain across chest and shoulders), SWELLING FACE (face swelling), JOINT SWELLING (ankle swelling), DIZZINESS (Dizziness) and DIARRHOEA (horrible diarrhea). On 19-Mar-2021, the patient experienced AGEUSIA (loss of taste), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme tiredness). On 11-Apr-2021, the patient experienced SWELLING (toe become swollen). On an unknown date, the patient experienced FEELING ABNORMAL (going to die). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy), FEELING ABNORMAL (going to die), HEART RATE INCREASED (elevated heartbeat), PAIN (pain across chest and shoulders), SWELLING FACE (face swelling), JOINT SWELLING (ankle swelling), DIZZINESS (Dizziness), DIARRHOEA (horrible diarrhea), SWELLING (toe become swollen), AGEUSIA (loss of taste), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme tiredness) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling, Ultrasound scan
Clinical narrative: Lump developed on the clavicle (left); Inflammed lymph node; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Lump developed on the clavicle (left)) and LYMPHADENOPATHY (Inflammed lymph node) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 03sa21a) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Lump developed on the clavicle (left)) and LYMPHADENOPATHY (Inflammed lymph node). At the time of the report, SWELLING (Lump developed on the clavicle (left)) and LYMPHADENOPATHY (Inflammed lymph node) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: enflamed lymph node (abnormal) enflamed lymph node.         No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-073706 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 25-MAY-2021.Added events outcome from (unknown to not recovered/not resolved)  till date.; Sender's Comments:  MOD-2021-073706:First dose case
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: inadvertently administered with 1.0 ml of the vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine). On 10-Apr-2021, ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site dysaesthesia, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site rash
Clinical narrative: left arm is still quit sensitive; left arm turned real red, hot, inflamed and a burning sensation; left arm turned real red, hot, inflamed and a burning sensation; left arm turned real red, hot, inflamed and a burning sensation; localized rash then started spreading from shoulder to the elbow area; left arm turned real red, hot, inflamed and a burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (left arm is still quit sensitive), VACCINATION SITE WARMTH (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE INFLAMMATION (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE ERYTHEMA (left arm turned real red, hot, inflamed and a burning sensation) and VACCINATION SITE RASH (localized rash then started spreading from shoulder to the elbow area) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, METFORMIN and tresiba insulin injection for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (left arm is still quit sensitive), VACCINATION SITE WARMTH (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE INFLAMMATION (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE ERYTHEMA (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE RASH (localized rash then started spreading from shoulder to the elbow area) and VACCINATION SITE PAIN (left arm turned real red, hot, inflamed and a burning sensation). At the time of the report, VACCINATION SITE DYSAESTHESIA (left arm is still quit sensitive), VACCINATION SITE WARMTH (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE INFLAMMATION (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE ERYTHEMA (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE RASH (localized rash then started spreading from shoulder to the elbow area) and VACCINATION SITE PAIN (left arm turned real red, hot, inflamed and a burning sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes Neosporin, hydrocortisone cream, Ice and antibiotics.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: left arm is still quit sensitive; left arm turned real red, hot, inflamed and a burning sensation; left arm turned real red, hot, inflamed and a burning sensation; left arm turned real red, hot, inflamed and a burning sensation; localized rash then started spreading from shoulder to the elbow area; left arm turned real red, hot, inflamed and a burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (left arm is still quit sensitive), VACCINATION SITE WARMTH (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE INFLAMMATION (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE ERYTHEMA (left arm turned real red, hot, inflamed and a burning sensation) and VACCINATION SITE RASH (localized rash then started spreading from shoulder to the elbow area) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, METFORMIN and tresiba insulin injection for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (left arm is still quit sensitive), VACCINATION SITE WARMTH (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE INFLAMMATION (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE ERYTHEMA (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE RASH (localized rash then started spreading from shoulder to the elbow area) and VACCINATION SITE PAIN (left arm turned real red, hot, inflamed and a burning sensation). At the time of the report, VACCINATION SITE DYSAESTHESIA (left arm is still quit sensitive), VACCINATION SITE WARMTH (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE INFLAMMATION (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE ERYTHEMA (left arm turned real red, hot, inflamed and a burning sensation), VACCINATION SITE RASH (localized rash then started spreading from shoulder to the elbow area) and VACCINATION SITE PAIN (left arm turned real red, hot, inflamed and a burning sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes Neosporin, hydrocortisone cream, Ice and antibiotics.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Hypokinesia, Lymph node pain, Pain in extremity
Clinical narrative: Chest is very sore and painful; Cant lift things with left arm; Left breast is very sore and painful; Lymph nodes underneath left arm is very sore and painful; Very sore and painful radiating down my left arm; After first dose, in same arm of injection and same arm she had lymph nodes removed due to breast cancer, she is very sore in left arm; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Chest is very sore and painful), HYPOKINESIA (Cant lift things with left arm), BREAST PAIN (Left breast is very sore and painful), LYMPH NODE PAIN (Lymph nodes underneath left arm is very sore and painful) and PAIN IN EXTREMITY (Very sore and painful radiating down my left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (History of breast cancer.) and Surgical procedure (History of breast cancer surgery.). Concurrent medical conditions included Dyspepsia and Cholesterol. Concomitant products included LETROZOLE for Breast cancer, ATORVASTATIN for Cholesterol, OMEPRAZOLE for Digestion impaired, VITAMIN D3, CALCIUM and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced CHEST PAIN (Chest is very sore and painful), HYPOKINESIA (Cant lift things with left arm), BREAST PAIN (Left breast is very sore and painful), LYMPH NODE PAIN (Lymph nodes underneath left arm is very sore and painful), PAIN IN EXTREMITY (Very sore and painful radiating down my left arm) and VACCINATION SITE PAIN (After first dose, in same arm of injection and same arm she had lymph nodes removed due to breast cancer, she is very sore in left arm). The patient was treated with IBUPROFEN at a dose of 800 mg and HYDROCORTISONE ACETATE (HYDROCORTISONE ACE) at a dose of 250 mg. At the time of the report, CHEST PAIN (Chest is very sore and painful), HYPOKINESIA (Cant lift things with left arm), BREAST PAIN (Left breast is very sore and painful), LYMPH NODE PAIN (Lymph nodes underneath left arm is very sore and painful), PAIN IN EXTREMITY (Very sore and painful radiating down my left arm) and VACCINATION SITE PAIN (After first dose, in same arm of injection and same arm she had lymph nodes removed due to breast cancer, she is very sore in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chest is very sore and painful; Cant lift things with left arm; Left breast is very sore and painful; Lymph nodes underneath left arm is very sore and painful; Very sore and painful radiating down my left arm; After first dose, in same arm of injection and same arm she had lymph nodes removed due to breast cancer, she is very sore in left arm; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Chest is very sore and painful), HYPOKINESIA (Cant lift things with left arm), BREAST PAIN (Left breast is very sore and painful), LYMPH NODE PAIN (Lymph nodes underneath left arm is very sore and painful) and PAIN IN EXTREMITY (Very sore and painful radiating down my left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (History of breast cancer.) and Surgical procedure (History of breast cancer surgery.). Concurrent medical conditions included Dyspepsia and Cholesterol. Concomitant products included LETROZOLE for Breast cancer, ATORVASTATIN for Cholesterol, OMEPRAZOLE for Digestion impaired, VITAMIN D3, CALCIUM and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced CHEST PAIN (Chest is very sore and painful), HYPOKINESIA (Cant lift things with left arm), BREAST PAIN (Left breast is very sore and painful), LYMPH NODE PAIN (Lymph nodes underneath left arm is very sore and painful), PAIN IN EXTREMITY (Very sore and painful radiating down my left arm) and VACCINATION SITE PAIN (After first dose, in same arm of injection and same arm she had lymph nodes removed due to breast cancer, she is very sore in left arm). The patient was treated with IBUPROFEN at a dose of 800 mg and HYDROCORTISONE ACETATE (HYDROCORTISONE ACE) at a dose of 250 mg. At the time of the report, CHEST PAIN (Chest is very sore and painful), HYPOKINESIA (Cant lift things with left arm), BREAST PAIN (Left breast is very sore and painful), LYMPH NODE PAIN (Lymph nodes underneath left arm is very sore and painful), PAIN IN EXTREMITY (Very sore and painful radiating down my left arm) and VACCINATION SITE PAIN (After first dose, in same arm of injection and same arm she had lymph nodes removed due to breast cancer, she is very sore in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears/ringing sound like white noise; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears/ringing sound like white noise) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced TINNITUS (Ringing in ears/ringing sound like white noise). At the time of the report, TINNITUS (Ringing in ears/ringing sound like white noise) had not resolved. Not Provided          Patient experienced a ringing sound like white noise in his ears that doesn't seem to be going away. He has not taken any treatments for his symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Significant followup
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Blood pressure increased, Bowel movement irregularity, Depression, Gait disturbance
Clinical narrative: very depressed; can not walk properly; Blood pressure increased; Sinus tachycardia; Vertigo; Arthritis; Left foot swells; Hypertension; Heart racing; Vision problem; Ringing bells in his ears; Cant drive by himself; Physical therapy for bowel moments; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (Arthritis), PERIPHERAL SWELLING (Left foot swells), HYPERTENSION (Hypertension), PALPITATIONS (Heart racing) and VISUAL IMPAIRMENT (Vision problem) in a 59-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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced ARTHRITIS (Arthritis), PERIPHERAL SWELLING (Left foot swells), HYPERTENSION (Hypertension), PALPITATIONS (Heart racing), VISUAL IMPAIRMENT (Vision problem), TINNITUS (Ringing bells in his ears), IMPAIRED DRIVING ABILITY (Cant drive by himself) and BOWEL MOVEMENT IRREGULARITY (Physical therapy for bowel moments). On 20-Jan-2021, the patient experienced SINUS TACHYCARDIA (Sinus tachycardia) and VERTIGO (Vertigo). On 21-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased). On an unknown date, the patient experienced DEPRESSION (very depressed) and GAIT DISTURBANCE (can not walk properly). The patient was treated with LISINOPRIL on 21-Jan-2021 for Hypertension, at a dose of 20 milligram; METOPROLOL on 12-Feb-2021 for Palpitation, at a dose of 25 milligram and Physical therapy for Bowel movement irregularity. At the time of the report, ARTHRITIS (Arthritis), PERIPHERAL SWELLING (Left foot swells), HYPERTENSION (Hypertension), PALPITATIONS (Heart racing), VISUAL IMPAIRMENT (Vision problem), TINNITUS (Ringing bells in his ears), IMPAIRED DRIVING ABILITY (Cant drive by himself), BOWEL MOVEMENT IRREGULARITY (Physical therapy for bowel moments), DEPRESSION (very depressed), GAIT DISTURBANCE (can not walk properly), SINUS TACHYCARDIA (Sinus tachycardia), VERTIGO (Vertigo) and BLOOD PRESSURE INCREASED (Blood pressure increased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 20 Jan 2021 CT scan of brain was done with unknown results and patient was sent home. On 12 Feb 2021 Blood pressure was 157/78 , Heart rate 99 , respiration rate 18 was found. No concomitant medications were reported. The patient had seen multiple doctors for his symptoms   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: significant follow up received and new events ( Vertigo, sinus tachycardia and blood pressure increased) were added.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Impaired driving ability, Palpitations, Peripheral swelling, Sinus tachycardia
Clinical narrative: very depressed; can not walk properly; Blood pressure increased; Sinus tachycardia; Vertigo; Arthritis; Left foot swells; Hypertension; Heart racing; Vision problem; Ringing bells in his ears; Cant drive by himself; Physical therapy for bowel moments; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (Arthritis), PERIPHERAL SWELLING (Left foot swells), HYPERTENSION (Hypertension), PALPITATIONS (Heart racing) and VISUAL IMPAIRMENT (Vision problem) in a 59-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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced ARTHRITIS (Arthritis), PERIPHERAL SWELLING (Left foot swells), HYPERTENSION (Hypertension), PALPITATIONS (Heart racing), VISUAL IMPAIRMENT (Vision problem), TINNITUS (Ringing bells in his ears), IMPAIRED DRIVING ABILITY (Cant drive by himself) and BOWEL MOVEMENT IRREGULARITY (Physical therapy for bowel moments). On 20-Jan-2021, the patient experienced SINUS TACHYCARDIA (Sinus tachycardia) and VERTIGO (Vertigo). On 21-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased). On an unknown date, the patient experienced DEPRESSION (very depressed) and GAIT DISTURBANCE (can not walk properly). The patient was treated with LISINOPRIL on 21-Jan-2021 for Hypertension, at a dose of 20 milligram; METOPROLOL on 12-Feb-2021 for Palpitation, at a dose of 25 milligram and Physical therapy for Bowel movement irregularity. At the time of the report, ARTHRITIS (Arthritis), PERIPHERAL SWELLING (Left foot swells), HYPERTENSION (Hypertension), PALPITATIONS (Heart racing), VISUAL IMPAIRMENT (Vision problem), TINNITUS (Ringing bells in his ears), IMPAIRED DRIVING ABILITY (Cant drive by himself), BOWEL MOVEMENT IRREGULARITY (Physical therapy for bowel moments), DEPRESSION (very depressed), GAIT DISTURBANCE (can not walk properly), SINUS TACHYCARDIA (Sinus tachycardia), VERTIGO (Vertigo) and BLOOD PRESSURE INCREASED (Blood pressure increased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 20 Jan 2021 CT scan of brain was done with unknown results and patient was sent home. On 12 Feb 2021 Blood pressure was 157/78 , Heart rate 99 , respiration rate 18 was found. No concomitant medications were reported. The patient had seen multiple doctors for his symptoms   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: significant follow up received and new events ( Vertigo, sinus tachycardia and blood pressure increased) were added.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo, Visual impairment
Clinical narrative: very depressed; can not walk properly; Blood pressure increased; Sinus tachycardia; Vertigo; Arthritis; Left foot swells; Hypertension; Heart racing; Vision problem; Ringing bells in his ears; Cant drive by himself; Physical therapy for bowel moments; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (Arthritis), PERIPHERAL SWELLING (Left foot swells), HYPERTENSION (Hypertension), PALPITATIONS (Heart racing) and VISUAL IMPAIRMENT (Vision problem) in a 59-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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced ARTHRITIS (Arthritis), PERIPHERAL SWELLING (Left foot swells), HYPERTENSION (Hypertension), PALPITATIONS (Heart racing), VISUAL IMPAIRMENT (Vision problem), TINNITUS (Ringing bells in his ears), IMPAIRED DRIVING ABILITY (Cant drive by himself) and BOWEL MOVEMENT IRREGULARITY (Physical therapy for bowel moments). On 20-Jan-2021, the patient experienced SINUS TACHYCARDIA (Sinus tachycardia) and VERTIGO (Vertigo). On 21-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased). On an unknown date, the patient experienced DEPRESSION (very depressed) and GAIT DISTURBANCE (can not walk properly). The patient was treated with LISINOPRIL on 21-Jan-2021 for Hypertension, at a dose of 20 milligram; METOPROLOL on 12-Feb-2021 for Palpitation, at a dose of 25 milligram and Physical therapy for Bowel movement irregularity. At the time of the report, ARTHRITIS (Arthritis), PERIPHERAL SWELLING (Left foot swells), HYPERTENSION (Hypertension), PALPITATIONS (Heart racing), VISUAL IMPAIRMENT (Vision problem), TINNITUS (Ringing bells in his ears), IMPAIRED DRIVING ABILITY (Cant drive by himself), BOWEL MOVEMENT IRREGULARITY (Physical therapy for bowel moments), DEPRESSION (very depressed), GAIT DISTURBANCE (can not walk properly), SINUS TACHYCARDIA (Sinus tachycardia), VERTIGO (Vertigo) and BLOOD PRESSURE INCREASED (Blood pressure increased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 20 Jan 2021 CT scan of brain was done with unknown results and patient was sent home. On 12 Feb 2021 Blood pressure was 157/78 , Heart rate 99 , respiration rate 18 was found. No concomitant medications were reported. The patient had seen multiple doctors for his symptoms   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: significant follow up received and new events ( Vertigo, sinus tachycardia and blood pressure increased) were added.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain, Paraesthesia, Vaccination complication
Clinical narrative: Started feeling bad/as sick as he was he could not get the second dose; Pain in the body; Could not sleep at night; hands "fell asleep"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Started feeling bad/as sick as he was he could not get the second dose), PAIN (Pain in the body), INSOMNIA (Could not sleep at night) and PARAESTHESIA (hands "fell asleep") in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 17-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 VACCINATION COMPLICATION (Started feeling bad/as sick as he was he could not get the second dose), PAIN (Pain in the body), INSOMNIA (Could not sleep at night) and PARAESTHESIA (hands "fell asleep"). At the time of the report, VACCINATION COMPLICATION (Started feeling bad/as sick as he was he could not get the second dose), PAIN (Pain in the body), INSOMNIA (Could not sleep at night) and PARAESTHESIA (hands "fell asleep") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  On 20 Mar 2021, the patient started felling bad and was having pain in the body.  He went to the emergency room as he could not sleep at night and also his hands "fell asleep."  The patient was treated with meloxicam and referred to a specialist.  The patient said these symptoms were ongoing and getting worse over time.  Per the patient, his doctor said "as sick as he was he could not get the second dose".  The patient then asked if he could get the second dose.  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.