chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Renal pain
Clinical narrative: Kidney pain; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Kidney pain) and PAIN IN EXTREMITY (Arm pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sickness (Patient was severely sick in January and got ride herself) in January 2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RENAL PAIN (Kidney pain) and PAIN IN EXTREMITY (Arm pain). At the time of the report, RENAL PAIN (Kidney pain) and PAIN IN EXTREMITY (Arm pain) 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.   No concomitant medications  were provided. No Treatment information was  provided. Reporter confirmed that patient never had COVID-19 also never tested positive for antibodies.   This case was linked to MOD-2021-332607 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right injection site arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore right injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-333374 (Patient Link).
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Pain in extremity, Rhinorrhoea
Clinical narrative: Full blown cold; Sniffles; Dry cough; Arm soreness; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Dry cough), PAIN IN EXTREMITY (Arm soreness), RHINORRHOEA (Sniffles) and NASOPHARYNGITIS (Full blown cold) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 031M20A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included Mouth cancer, Tongue neoplasm NOS, Knee replacement (Total right knee replacement surgery) and Radiation therapy. Concurrent medical conditions included Type 2 diabetes mellitus and Loss of taste.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm soreness). On 23-Sep-2021, the patient experienced COUGH (Dry cough). On 24-Sep-2021, the patient experienced RHINORRHOEA (Sniffles). On 27-Sep-2021, the patient experienced NASOPHARYNGITIS (Full blown cold). In September 2021, PAIN IN EXTREMITY (Arm soreness) and RHINORRHOEA (Sniffles) had resolved. On 24-Sep-2021, COUGH (Dry cough) had resolved. At the time of the report, NASOPHARYNGITIS (Full blown cold) had not resolved.            No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-042571 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Inappropriate schedule of product administration, Vertigo
Clinical narrative: Received second dose on day 38; episodes of dizziness; episodes of vertigo; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose on day 38), DIZZINESS (episodes of dizziness) and VERTIGO (episodes of vertigo) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose on day 38), DIZZINESS (episodes of dizziness) and VERTIGO (episodes of vertigo). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose on day 38) had resolved and DIZZINESS (episodes of dizziness) and VERTIGO (episodes of vertigo) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: diagnosed with shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (diagnosed with shingles) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 149C21A) for COVID-19 vaccination.     Concurrent medical conditions included Stomach pain since April 2021.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, 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 HERPES ZOSTER (diagnosed with shingles). At the time of the report, HERPES ZOSTER (diagnosed with shingles) outcome was unknown.        No relevant concomitant medications were reported. No treatment information was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Myalgia
Clinical narrative: Muscle soreness like flu shot; I could not get warm/I was cold; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING COLD (I could not get warm/I was cold) and MYALGIA (Muscle soreness like flu shot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN HCTZ), MONTELUKAST SODIUM (SINGULAIR), NIACIN and POTASSIUM for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (I could not get warm/I was cold). On an unknown date, the patient experienced MYALGIA (Muscle soreness like flu shot). The patient was treated with PARACETAMOL (TYLENOL) for Prophylactic, at an unspecified dose and frequency. At the time of the report, FEELING COLD (I could not get warm/I was cold) had resolved and MYALGIA (Muscle soreness like flu shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-333379 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dysgeusia
Clinical narrative: Metallic taste in her mouth; loss of sense of taste; loss of sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in her mouth), AGEUSIA (loss of sense of taste) and ANOSMIA (loss of sense of smell) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included GABAPENTIN, DULOXETINE, FUROSEMIDE, OMEPRAZOLE, IBUPROFEN and ELETRIPTAN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth), AGEUSIA (loss of sense of taste) and ANOSMIA (loss of sense of smell). On 09-Jan-2021, DYSGEUSIA (Metallic taste in her mouth) had resolved. On 04-Feb-2021, AGEUSIA (loss of sense of taste) and ANOSMIA (loss of sense of smell) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.    This case was linked to MOD-2021-333537 (Patient Link).; Sender's Comments: This spontaneous case concerns a 51-year-old female patient with no relevant medical history reported who experienced non serous unexpected events of dysgeusia, ageusia and anosmia. The events occurred within 24 hours from the first dose of Spikevax. Rechallenge was unknown since there is no information regarding the second dose and reoccurrence of the events. The benefit-risk relationship of drug is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Received Pfizer COVID-19 Vaccine as 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received Pfizer COVID-19 Vaccine as 3rd dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Received Pfizer COVID-19 Vaccine as 3rd dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Received Pfizer COVID-19 Vaccine as 3rd dose) 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.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Blood test, Loss of consciousness, Malaise
Clinical narrative: Blacked out; Stomach started to mumble; Stomach started to hurt; Feeling sick; Wanted to throw up; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out) in a 19-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.     Concurrent medical conditions included Asthma.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (Stomach started to mumble), ABDOMINAL PAIN UPPER (Stomach started to hurt), MALAISE (Feeling sick) and NAUSEA (Wanted to throw up). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out), ABDOMINAL DISCOMFORT (Stomach started to mumble), ABDOMINAL PAIN UPPER (Stomach started to hurt), MALAISE (Feeling sick) and NAUSEA (Wanted to throw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Blood test: normal (normal) everything was fine.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient got the first dose of the Moderna vaccine and minutes after, patient's stomach started to mumble and hurt and felt sick, like wanted to throw up and then blacked out.  When patient woke up, run over to the pharmacist and told what happened and they told to sit down and called an ambulance and when patient got into the hospital it was so busy that patient was sitting in the ER with the ambulance bed for a long time.  The hospital did a blood test and told that everything was fine, so patient went home. One of the doctors told that reaction to the second dose would be worse, so patient decided not to get it.  Concomitant medications were not provided.Treatment information was not provided.  This case concerns a 19-year-old, male subject with a history of asthma, who experienced the unexpected events of loss of consciousness, abdominal discomfort, abdominal pain upper malaise and nausea. The event occurred the same day the first dose of the Moderna Covid-19 vaccine was given. The rechallenge is not applicable in this case. The reporter's assessment  is not provided. The benefit-risk relationship of the vaccine is not affected by this report; Sender's Comments: This case concerns a 19-year-old, male subject with a history of asthma, who experienced the unexpected events of loss of consciousness, abdominal discomfort, abdominal pain upper malaise and nausea. The event occurred the same day the first dose of the Moderna Covid-19 vaccine was given. The rechallenge is not applicable in this case. The reporter's assessment  is not provided. The benefit-risk relationship of the vaccine is not affected by this report
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Blacked out; Stomach started to mumble; Stomach started to hurt; Feeling sick; Wanted to throw up; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out) in a 19-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.     Concurrent medical conditions included Asthma.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (Stomach started to mumble), ABDOMINAL PAIN UPPER (Stomach started to hurt), MALAISE (Feeling sick) and NAUSEA (Wanted to throw up). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out), ABDOMINAL DISCOMFORT (Stomach started to mumble), ABDOMINAL PAIN UPPER (Stomach started to hurt), MALAISE (Feeling sick) and NAUSEA (Wanted to throw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Blood test: normal (normal) everything was fine.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient got the first dose of the Moderna vaccine and minutes after, patient's stomach started to mumble and hurt and felt sick, like wanted to throw up and then blacked out.  When patient woke up, run over to the pharmacist and told what happened and they told to sit down and called an ambulance and when patient got into the hospital it was so busy that patient was sitting in the ER with the ambulance bed for a long time.  The hospital did a blood test and told that everything was fine, so patient went home. One of the doctors told that reaction to the second dose would be worse, so patient decided not to get it.  Concomitant medications were not provided.Treatment information was not provided.  This case concerns a 19-year-old, male subject with a history of asthma, who experienced the unexpected events of loss of consciousness, abdominal discomfort, abdominal pain upper malaise and nausea. The event occurred the same day the first dose of the Moderna Covid-19 vaccine was given. The rechallenge is not applicable in this case. The reporter's assessment  is not provided. The benefit-risk relationship of the vaccine is not affected by this report; Sender's Comments: This case concerns a 19-year-old, male subject with a history of asthma, who experienced the unexpected events of loss of consciousness, abdominal discomfort, abdominal pain upper malaise and nausea. The event occurred the same day the first dose of the Moderna Covid-19 vaccine was given. The rechallenge is not applicable in this case. The reporter's assessment  is not provided. The benefit-risk relationship of the vaccine is not affected by this report
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Dyspnoea, Headache, Heart rate
Clinical narrative: difficulty breathing; feeling dizzy; feeling ball in throat; cold sweet; feeling blackout; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), DIZZINESS (feeling dizzy), OROPHARYNGEAL DISCOMFORT (feeling ball in throat), COLD SWEAT (cold sweet) and DIZZINESS (feeling blackout) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced DYSPNOEA (difficulty breathing), DIZZINESS (feeling dizzy), OROPHARYNGEAL DISCOMFORT (feeling ball in throat), COLD SWEAT (cold sweet), DIZZINESS (feeling blackout) and HEADACHE (headache). At the time of the report, DYSPNOEA (difficulty breathing) had not resolved and DIZZINESS (feeling dizzy), OROPHARYNGEAL DISCOMFORT (feeling ball in throat), COLD SWEAT (cold sweet), DIZZINESS (feeling blackout) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported. Patient states that the adverse event fast heartbeat is still unresolved.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: difficulty breathing; feeling dizzy; feeling ball in throat; cold sweet; feeling blackout; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), DIZZINESS (feeling dizzy), OROPHARYNGEAL DISCOMFORT (feeling ball in throat), COLD SWEAT (cold sweet) and DIZZINESS (feeling blackout) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced DYSPNOEA (difficulty breathing), DIZZINESS (feeling dizzy), OROPHARYNGEAL DISCOMFORT (feeling ball in throat), COLD SWEAT (cold sweet), DIZZINESS (feeling blackout) and HEADACHE (headache). At the time of the report, DYSPNOEA (difficulty breathing) had not resolved and DIZZINESS (feeling dizzy), OROPHARYNGEAL DISCOMFORT (feeling ball in throat), COLD SWEAT (cold sweet), DIZZINESS (feeling blackout) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported. Patient states that the adverse event fast heartbeat is still unresolved.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Fatigue, Myalgia, Nausea
Clinical narrative: she had injection site reaction/same thing happened; Dizziness; Mild nausea/Nothing horrible but the nausea is annoying.; Tiredness; Muscle ache in her trunk area/Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (she had injection site reaction/same thing happened), DIZZINESS (Dizziness), NAUSEA (Mild nausea/Nothing horrible but the nausea is annoying.), FATIGUE (Tiredness) and MYALGIA (Muscle ache in her trunk area/Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 031A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (she had injection site reaction/same thing happened), DIZZINESS (Dizziness), NAUSEA (Mild nausea/Nothing horrible but the nausea is annoying.), FATIGUE (Tiredness) and MYALGIA (Muscle ache in her trunk area/Sore arm). At the time of the report, VACCINATION SITE REACTION (she had injection site reaction/same thing happened), DIZZINESS (Dizziness), NAUSEA (Mild nausea/Nothing horrible but the nausea is annoying.), FATIGUE (Tiredness) and MYALGIA (Muscle ache in her trunk area/Sore arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: clean (normal) clean. On an unknown date, Urine analysis: clean (normal) clean.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.   No treatment medication were provided   This case was linked to MOD-2021-333515, MOD-2021-333533 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vaccination site reaction
Clinical narrative: she had injection site reaction/same thing happened; Dizziness; Mild nausea/Nothing horrible but the nausea is annoying.; Tiredness; Muscle ache in her trunk area/Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (she had injection site reaction/same thing happened), DIZZINESS (Dizziness), NAUSEA (Mild nausea/Nothing horrible but the nausea is annoying.), FATIGUE (Tiredness) and MYALGIA (Muscle ache in her trunk area/Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 031A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (she had injection site reaction/same thing happened), DIZZINESS (Dizziness), NAUSEA (Mild nausea/Nothing horrible but the nausea is annoying.), FATIGUE (Tiredness) and MYALGIA (Muscle ache in her trunk area/Sore arm). At the time of the report, VACCINATION SITE REACTION (she had injection site reaction/same thing happened), DIZZINESS (Dizziness), NAUSEA (Mild nausea/Nothing horrible but the nausea is annoying.), FATIGUE (Tiredness) and MYALGIA (Muscle ache in her trunk area/Sore arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: clean (normal) clean. On an unknown date, Urine analysis: clean (normal) clean.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.   No treatment medication were provided   This case was linked to MOD-2021-333515, MOD-2021-333533 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Breakthrough COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakthrough COVID-19 infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced COVID-19 (Breakthrough COVID-19 infection) (seriousness criteria hospitalization and medically significant). At the time of the report, COVID-19 (Breakthrough COVID-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications were not reported.  Treatment included monoclonal antibodies.  Patient received first two Moderna COVID-19 vaccinations and had caught breakthrough COVID-19 case. Patient was in Emergency Room and admitted to hospital as a result of COVID-19 infection.  Company comment: This case concerns a patient of unknown age and gender who experienced the unlisted, serious event of COVID-19 infection (hospitalization). The reporter/patient reports both doses of mRNA-1273 given but there is no information on timing so re-challenge in unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender who experienced the unlisted, serious event of COVID-19 infection (hospitalization). The reporter/patient reports both doses of mRNA-1273 given but there is no information on timing so re-challenge in unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Taste disorder, Vaccination site pain
Clinical narrative: After both doses, I lost my ability to taste seasoned foods, but can taste sweets just fine.; The pain at the injection site was more severe than the others; I had mild soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (After both doses, I lost my ability to taste seasoned foods, but can taste sweets just fine.), INJECTION SITE PAIN (The pain at the injection site was more severe than the others) and VACCINATION SITE PAIN (I had mild soreness at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 058E21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (oesophageal). Concomitant products included FAMOTIDINE for Acid reflux (oesophageal).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (I had mild soreness at the injection site). On 25-Sep-2021, the patient experienced INJECTION SITE PAIN (The pain at the injection site was more severe than the others). On 27-Sep-2021, the patient experienced TASTE DISORDER (After both doses, I lost my ability to taste seasoned foods, but can taste sweets just fine.). At the time of the report, TASTE DISORDER (After both doses, I lost my ability to taste seasoned foods, but can taste sweets just fine.), INJECTION SITE PAIN (The pain at the injection site was more severe than the others) and VACCINATION SITE PAIN (I had mild soreness at the injection site) outcome was unknown.            No Treatment medications were reported. Events included: (1) The tips of all my fingers on both hands, except my thumbs, are real white on top, like they don't have any circulation  (2) As I move them around, it seems like the blood starts circulating again.   This case was linked to MOD-2021-333396 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B2A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site pain
Clinical narrative: The tips of all my fingers on both hands, except my thumbs, are real white on top, like they don't have any circulation. As I move them around, it seems like the blood starts circulating again; The pain at the injection site was more severe than the others; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (The tips of all my fingers on both hands, except my thumbs, are real white on top, like they don't have any circulation. As I move them around, it seems like the blood starts circulating again) and VACCINATION SITE PAIN (The pain at the injection site was more severe than the others) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 026A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (oesophageal).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, the patient experienced SKIN DISCOLOURATION (The tips of all my fingers on both hands, except my thumbs, are real white on top, like they don't have any circulation. As I move them around, it seems like the blood starts circulating again) and VACCINATION SITE PAIN (The pain at the injection site was more severe than the others). The patient was treated with PARACETAMOL (TYLENOL) for Injection site pain, at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (The tips of all my fingers on both hands, except my thumbs, are real white on top, like they don't have any circulation. As I move them around, it seems like the blood starts circulating again) and VACCINATION SITE PAIN (The pain at the injection site was more severe than the others) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-333396 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Jaundice, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of jaundice (eyes and face looked jaundice), gait disturbance (could not walk), pain in extremity (pain in lower and upper extremities/drags feet) and feeling abnormal (brain fog) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included autoimmune disorder (NOS). In May 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced jaundice (eyes and face looked jaundice), gait disturbance (could not walk), pain in extremity (pain in lower and upper extremities/drags feet) and feeling abnormal (brain fog). Patient treated with Tylenol (paracetamol) ongoing since an unknown date at an unspecified dose and frequency; amitriptyline hydrochloride ongoing since an unknown date at an unspecified dose and frequency; and nifedipine ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, jaundice (eyes and face looked jaundice), gait disturbance (could not walk), pain in extremity (pain in lower and upper extremities/drags feet) and feeling abnormal (brain fog) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications not provided. Reporter mentioned patient has not received second dose. Doctor does not recommended her getting the second dose but employer is push pushing to get the second dose.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Dizziness, Eye swelling, Feeling abnormal
Clinical narrative: Blood sugar has been higher; Dizziness; Right Eye swelling; brain fog; Watery eyes; headache; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar has been higher), DIZZINESS (Dizziness), EYE SWELLING (Right Eye swelling), FEELING ABNORMAL (brain fog) and LACRIMATION INCREASED (Watery eyes) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar has been higher), DIZZINESS (Dizziness), EYE SWELLING (Right Eye swelling), FEELING ABNORMAL (brain fog), LACRIMATION INCREASED (Watery eyes), HEADACHE (headache) and PYREXIA (low grade fever). The patient was treated with SEMAGLUTIDE (OZEMPIC) for Blood sugar increased, at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar has been higher), DIZZINESS (Dizziness), EYE SWELLING (Right Eye swelling), FEELING ABNORMAL (brain fog), LACRIMATION INCREASED (Watery eyes), HEADACHE (headache) and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: higher (High) higher.   No concomitant medication information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lacrimation increased, Pyrexia
Clinical narrative: Blood sugar has been higher; Dizziness; Right Eye swelling; brain fog; Watery eyes; headache; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar has been higher), DIZZINESS (Dizziness), EYE SWELLING (Right Eye swelling), FEELING ABNORMAL (brain fog) and LACRIMATION INCREASED (Watery eyes) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar has been higher), DIZZINESS (Dizziness), EYE SWELLING (Right Eye swelling), FEELING ABNORMAL (brain fog), LACRIMATION INCREASED (Watery eyes), HEADACHE (headache) and PYREXIA (low grade fever). The patient was treated with SEMAGLUTIDE (OZEMPIC) for Blood sugar increased, at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar has been higher), DIZZINESS (Dizziness), EYE SWELLING (Right Eye swelling), FEELING ABNORMAL (brain fog), LACRIMATION INCREASED (Watery eyes), HEADACHE (headache) and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: higher (High) higher.   No concomitant medication information was provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Gait disturbance, Gait inability, Headache
Clinical narrative: Memory got all confused; Not walking right; Horrible headache; Got sick; Could not walk; Very weak/extremely weak; Could not lift himself up; Could barely move; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), GAIT INABILITY (Could not walk), ASTHENIA (Very weak/extremely weak), LIMB DISCOMFORT (Could not lift himself up) and HYPOKINESIA (Could barely move) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Diabetes, Blood pressure high and Heart disease, unspecified.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced ILLNESS (Got sick), GAIT INABILITY (Could not walk), ASTHENIA (Very weak/extremely weak), LIMB DISCOMFORT (Could not lift himself up) and HYPOKINESIA (Could barely move). On 25-Sep-2021, the patient experienced HEADACHE (Horrible headache). On 26-Sep-2021, the patient experienced GAIT DISTURBANCE (Not walking right). On 27-Sep-2021, the patient experienced CONFUSIONAL STATE (Memory got all confused). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, 2 Tylenols. At the time of the report, ILLNESS (Got sick), GAIT INABILITY (Could not walk), ASTHENIA (Very weak/extremely weak), LIMB DISCOMFORT (Could not lift himself up), HYPOKINESIA (Could barely move), GAIT DISTURBANCE (Not walking right), CONFUSIONAL STATE (Memory got all confused) and HEADACHE (Horrible headache) outcome was unknown.      Reporter stated that the patient takes medication for a heart condition, diabetes and high blood pressure and stated that they are not sure whether the patient is immunocompromised.   This case was linked to MOD-2021-333558 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Illness, Limb discomfort
Clinical narrative: Memory got all confused; Not walking right; Horrible headache; Got sick; Could not walk; Very weak/extremely weak; Could not lift himself up; Could barely move; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), GAIT INABILITY (Could not walk), ASTHENIA (Very weak/extremely weak), LIMB DISCOMFORT (Could not lift himself up) and HYPOKINESIA (Could barely move) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Diabetes, Blood pressure high and Heart disease, unspecified.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced ILLNESS (Got sick), GAIT INABILITY (Could not walk), ASTHENIA (Very weak/extremely weak), LIMB DISCOMFORT (Could not lift himself up) and HYPOKINESIA (Could barely move). On 25-Sep-2021, the patient experienced HEADACHE (Horrible headache). On 26-Sep-2021, the patient experienced GAIT DISTURBANCE (Not walking right). On 27-Sep-2021, the patient experienced CONFUSIONAL STATE (Memory got all confused). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, 2 Tylenols. At the time of the report, ILLNESS (Got sick), GAIT INABILITY (Could not walk), ASTHENIA (Very weak/extremely weak), LIMB DISCOMFORT (Could not lift himself up), HYPOKINESIA (Could barely move), GAIT DISTURBANCE (Not walking right), CONFUSIONAL STATE (Memory got all confused) and HEADACHE (Horrible headache) outcome was unknown.      Reporter stated that the patient takes medication for a heart condition, diabetes and high blood pressure and stated that they are not sure whether the patient is immunocompromised.   This case was linked to MOD-2021-333558 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site reaction
Clinical narrative: Injection site reaction such as sore arm; Injection site reaction such as sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction such as sore arm) and PAIN IN EXTREMITY (Injection site reaction such as sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Injection site reaction such as sore arm) and PAIN IN EXTREMITY (Injection site reaction such as sore arm). At the time of the report, VACCINATION SITE REACTION (Injection site reaction such as sore arm) and PAIN IN EXTREMITY (Injection site reaction such as sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information were reported.   This case was linked to MOD-2021-333451, MOD-2021-333533 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (felt crummy after his first Moderna COVID-19 vaccination) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. In April 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient felt abnormal (feeling crummy after his first Moderna COVID-19 vaccination). At the time of the report, feeling abnormal (felt crummy after his first Moderna COVID-19 vaccination) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: thyroid trouble; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THYROID DISORDER (thyroid trouble) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THYROID DISORDER (thyroid trouble). At the time of the report, THYROID DISORDER (thyroid trouble) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant informations were reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Vaccination site induration, Vaccination site warmth
Clinical narrative: injection site gets warm to the touch/ injection site especially gets hot with sun exposure; There is a kind of hardness in his arm at the injection site; also experienced fever; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site gets warm to the touch/ injection site especially gets hot with sun exposure), VACCINATION SITE INDURATION (There is a kind of hardness in his arm at the injection site), PYREXIA (also experienced fever), CHILLS (chills) and NAUSEA (nausea) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management (Blood pressure) and Blood cholesterol abnormal (Cholesterol).    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced PYREXIA (also experienced fever), CHILLS (chills) and NAUSEA (nausea). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site gets warm to the touch/ injection site especially gets hot with sun exposure) and VACCINATION SITE INDURATION (There is a kind of hardness in his arm at the injection site). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 20-Sep-2021, PYREXIA (also experienced fever), CHILLS (chills) and NAUSEA (nausea) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site gets warm to the touch/ injection site especially gets hot with sun exposure) and VACCINATION SITE INDURATION (There is a kind of hardness in his arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported for indication Blood Pressure and Cholesterol with unknown medications   This case was linked to MOD-2021-333268 (Patient Link).