chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications are reported   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm hurt; Area where I received the shot is very hard like a big knot; Area where I received the shot is very hard like a big knot; Its always extra warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Its always extra warm), VACCINATION SITE PAIN (Arm hurt), VACCINATION SITE INDURATION (Area where I received the shot is very hard like a big knot) and VACCINATION SITE SWELLING (Area where I received the shot is very hard like a big knot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Its always extra warm), VACCINATION SITE PAIN (Arm hurt), VACCINATION SITE INDURATION (Area where I received the shot is very hard like a big knot) and VACCINATION SITE SWELLING (Area where I received the shot is very hard like a big knot). At the time of the report, FEELING HOT (Its always extra warm) outcome was unknown and VACCINATION SITE PAIN (Arm hurt), VACCINATION SITE INDURATION (Area where I received the shot is very hard like a big knot) and VACCINATION SITE SWELLING (Area where I received the shot is very hard like a big knot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. The area where the patient received the shot was very hard like a big knot  and its always extra warm . Treatment medication were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Sick to my stomic; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to my stomic) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Sick to my stomic). At the time of the report, ABDOMINAL DISCOMFORT (Sick to my stomic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction to the second; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to the second) 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 VACCINATION COMPLICATION (Reaction to the second). At the time of the report, VACCINATION COMPLICATION (Reaction to the second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication were not reported.  Patient did run a reaction to the a reaction to the second.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Sever headach; Body hurts all over; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Sever headach) and MYALGIA (Body hurts all over) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection.    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 HEADACHE (Sever headach) and MYALGIA (Body hurts all over). At the time of the report, HEADACHE (Sever headach) and MYALGIA (Body hurts all over) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided. On an unknown date, Body temperature: 98.2 (normal) Temperature 98.2. Reportedly, this was patient's 3rd shot.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: I had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had a sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (I had a sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 19-Feb-2021 for Myalgia, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (I had a sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.    Concomitant product use was not provided by the reporter.  Patient took her second dose on 18-FEB-2021 on left arm, lot number was 013M20A.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested   This case was linked to MOD-2021-288260 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Tinnitus
Clinical narrative: Tinnitus, mostly white noise but sometimes ringing; flu feeling for one day; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus, mostly white noise but sometimes ringing) and INFLUENZA (flu feeling for one day) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus, mostly white noise but sometimes ringing) and INFLUENZA (flu feeling for one day). At the time of the report, TINNITUS (Tinnitus, mostly white noise but sometimes ringing) and INFLUENZA (flu feeling for one day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received the booster at the same time as the DTap; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received the booster at the same time as the DTap) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) from 16-Aug-2021 to an unknown date for Diphtheria immunisation.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (received the booster at the same time as the DTap). On 16-Aug-2021, EXTRA DOSE ADMINISTERED (received the booster at the same time as the DTap) had resolved.        No Information on concomitant medications were reported.  No treatment details were reported.  Company Comment: This is a case of Extra Dose Administered (lot #052E21A) to an immunocompromised patient with no AEs reported. Further information has been requested.; Sender's Comments: This is a case of Extra Dose Administered (lot #052E21A) to an immunocompromised patient with no AEs reported. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Symptoms from virus; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Symptoms from virus) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Symptoms from virus). At the time of the report, VACCINATION COMPLICATION (Symptoms from virus) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Visual impairment
Clinical narrative: Kinda dysfunctional; My vision is worse; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Kinda dysfunctional) and VISUAL IMPAIRMENT (My vision is worse) 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 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 ASTHENIA (Kinda dysfunctional) and VISUAL IMPAIRMENT (My vision is worse). At the time of the report, ASTHENIA (Kinda dysfunctional) and VISUAL IMPAIRMENT (My vision is worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Slight stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Slight stroke) 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.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Slight stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Slight stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment: Very limited information regarding this event/s has been provided at this time.  No further information is to be expected.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  No further information is to be expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ""rare" side effects"; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (""rare" side effects") in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (""rare" side effects") (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (""rare" side effects") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was admitted I ICU.  No concomitant drugs were reported. No treatment information was reported.  Very limited information regarding this event has been provided at this time. Further information is not expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information is not expected.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Prison setting has administered Moderna vaccine to residents but that the vials are 1-2 days expired.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Prison setting has administered Moderna vaccine to residents but that the vials are 1-2 days expired.) 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 EXPIRED PRODUCT ADMINISTERED (Prison setting has administered Moderna vaccine to residents but that the vials are 1-2 days expired.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Prison setting has administered Moderna vaccine to residents but that the vials are 1-2 days expired.) 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 medications were provided.  No treatment medications were provided by the reporter.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation, Unevaluable event, Vaccination complication
Clinical narrative: Caller also mentions that she was hospitalized recently, and when asked she answered that for nothing related to COVID.; experienced normal side effects; lessergy for 1 or 2 days; This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (Caller also mentions that she was hospitalized recently, and when asked she answered that for nothing related to COVID.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, VITAMIN 15, CALCIUM, COLECALCIFEROL (CALCIUM + VITAMIN D3), RUBUS IDAEUS (BERRY ACTIVE RASPBERRY KETONES) and CENTRUM JR [ASCORBIC ACID;BIOTIN;CALCIUM;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COPPER;CYANOCOBALAMIN;ERGOCALCIFEROL;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;MOLYBDENUM;NICOTINAMIDE;PHOSPHORUS;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;TH for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Caller also mentions that she was hospitalized recently, and when asked she answered that for nothing related to COVID.) (seriousness criterion hospitalization), VACCINATION COMPLICATION (experienced normal side effects) and UNEVALUABLE EVENT (lessergy for 1 or 2 days). At the time of the report, HOSPITALISATION (Caller also mentions that she was hospitalized recently, and when asked she answered that for nothing related to COVID.), VACCINATION COMPLICATION (experienced normal side effects) and UNEVALUABLE EVENT (lessergy for 1 or 2 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reportedly consumed lots of fluids as treatment.  It was recommended to her that she drink Gatorade.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: whole body hurts; aching; fever; her head is killing her; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole body hurts), MYALGIA (aching), PYREXIA (fever) and HEADACHE (her head is killing her) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (whole body hurts), MYALGIA (aching), PYREXIA (fever) and HEADACHE (her head is killing her). At the time of the report, PAIN (whole body hurts), MYALGIA (aching), PYREXIA (fever) and HEADACHE (her head is killing her) outcome was unknown.            No concomitant medications were reported by the reporter.  The events reported occurred after the second dose.   No Treatment information was provided by the reporter.   This case was linked to MOD-2021-268418 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Hypersensitivity, Lip swelling, Staphylococcal infection, Urticaria
Clinical narrative: A staph infection; An allergic reaction (hives and swollen lips); Hives; swollen lips; Cellulitis; This spontaneous case was reported by a pharmacist and describes the occurrence of CELLULITIS (Cellulitis), STAPHYLOCOCCAL INFECTION (A staph infection), HYPERSENSITIVITY (An allergic reaction (hives and swollen lips)), URTICARIA (Hives) and LIP SWELLING (swollen lips) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criteria hospitalization and medically significant), STAPHYLOCOCCAL INFECTION (A staph infection) (seriousness criteria hospitalization and medically significant), HYPERSENSITIVITY (An allergic reaction (hives and swollen lips)) (seriousness criterion hospitalization), URTICARIA (Hives) (seriousness criterion hospitalization) and LIP SWELLING (swollen lips) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to CELLULITIS, HYPERSENSITIVITY, LIP SWELLING and URTICARIA. At the time of the report, CELLULITIS (Cellulitis), STAPHYLOCOCCAL INFECTION (A staph infection), HYPERSENSITIVITY (An allergic reaction (hives and swollen lips)), URTICARIA (Hives) and LIP SWELLING (swollen lips) 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 by the reporter. No treatment information was provided by the reporter.  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.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: paralysis side effects; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (paralysis side effects) 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 PARALYSIS (paralysis side effects) (seriousness criterion medically significant). At the time of the report, PARALYSIS (paralysis side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had paralysis side effects after the vaccine . Concomitant and treatment medications were not reported.  Company comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: rapid arrhythmia; Couldn't breath, short of breath; pulse was 240; atrial fibrillation; palpitations during walking, heart started racing; This spontaneous case was reported by an other health care professional and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation), ARRHYTHMIA (rapid arrhythmia), PALPITATIONS (palpitations during walking, heart started racing), DYSPNOEA (Couldn't breath, short of breath) and HEART RATE INCREASED (pulse was 240) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031l20a and 012l20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included TRIAMTERENE for Blood pressure high.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PALPITATIONS (palpitations during walking, heart started racing) (seriousness criterion hospitalization). In June 2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria hospitalization and medically significant). On 16-Jul-2021, the patient experienced ARRHYTHMIA (rapid arrhythmia) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Couldn't breath, short of breath) (seriousness criterion hospitalization) and HEART RATE INCREASED (pulse was 240) (seriousness criterion hospitalization). The patient was treated with METOPROLOL on 16-Jun-2021 at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), ARRHYTHMIA (rapid arrhythmia), DYSPNOEA (Couldn't breath, short of breath) and HEART RATE INCREASED (pulse was 240) outcome was unknown and PALPITATIONS (palpitations during walking, heart started racing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Heart rate: 240 (High) pulse was of 240.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stayed 3 days in ICU and discharged 3 days later.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blood count, Thrombocytopenia
Clinical narrative: Recently diagnosed with thrombocytopenia; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (Recently diagnosed with thrombocytopenia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thrombocytosis (he had a history of elevated platelets).   On 01-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (Recently diagnosed with thrombocytopenia) (seriousness criterion medically significant). The patient was treated with HYDROXYUREA ongoing since an unknown date for Thrombocytopenia, at an unspecified dose and frequency. At the time of the report, THROMBOCYTOPENIA (Recently diagnosed with thrombocytopenia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: normal (normal) blood counts are all normal.         Patient was recently diagnosed with thrombocytopenia, which he stated is not related to the vaccine because he had a history of elevated platelets. his physician had been advising him to go see a hematologist for about a year.  Concomitant medications were not provided by the reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient was recently diagnosed with thrombocytopenia which he stated is not related to the vaccine because he had a history of elevated platelets. Myelosuppression is a common side effects of the drug "HYDROXYUREA"  Further information is expected..; 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. Patient was recently diagnosed with thrombocytopenia which he stated is not related to the vaccine because he had a history of elevated platelets.Myelosuppression is a common side effects of the drug "HYDROXYUREA"  Further information is expected..
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Pyrexia, Scratch, Skin striae, Vaccination complication
Clinical narrative: emergency room and they gave me antibiotics in case I had cellulitis; Covid Arm; fever; burning; scratch; stretch mark; area hot to the touch; injection site  swollen and red arm; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (scratch), SKIN STRIAE (stretch mark), VACCINATION SITE WARMTH (area hot to the touch), VACCINATION SITE ERYTHEMA (injection site  swollen and red arm) and CELLULITIS (emergency room and they gave me antibiotics in case I had cellulitis) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced SCRATCH (scratch) (seriousness criterion medically significant), SKIN STRIAE (stretch mark) (seriousness criterion medically significant), VACCINATION SITE WARMTH (area hot to the touch) (seriousness criterion medically significant), VACCINATION SITE ERYTHEMA (injection site  swollen and red arm) (seriousness criterion medically significant), VACCINATION COMPLICATION (Covid Arm), PYREXIA (fever) and VACCINATION SITE PAIN (burning). On an unknown date, the patient experienced CELLULITIS (emergency room and they gave me antibiotics in case I had cellulitis) (seriousness criterion medically significant). At the time of the report, SCRATCH (scratch), SKIN STRIAE (stretch mark), VACCINATION SITE WARMTH (area hot to the touch), VACCINATION SITE ERYTHEMA (injection site  swollen and red arm), CELLULITIS (emergency room and they gave me antibiotics in case I had cellulitis), VACCINATION COMPLICATION (Covid Arm), PYREXIA (fever) and VACCINATION SITE PAIN (burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Patient visited to the emergency room and prescribed  antibiotics in case patient had cellulitis. The Emergency Room  told  to the patient about Corvid Arm. and also prescribed steroids.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-289518 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: emergency room and they gave me antibiotics in case I had cellulitis; Covid Arm; fever; burning; scratch; stretch mark; area hot to the touch; injection site  swollen and red arm; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (scratch), SKIN STRIAE (stretch mark), VACCINATION SITE WARMTH (area hot to the touch), VACCINATION SITE ERYTHEMA (injection site  swollen and red arm) and CELLULITIS (emergency room and they gave me antibiotics in case I had cellulitis) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced SCRATCH (scratch) (seriousness criterion medically significant), SKIN STRIAE (stretch mark) (seriousness criterion medically significant), VACCINATION SITE WARMTH (area hot to the touch) (seriousness criterion medically significant), VACCINATION SITE ERYTHEMA (injection site  swollen and red arm) (seriousness criterion medically significant), VACCINATION COMPLICATION (Covid Arm), PYREXIA (fever) and VACCINATION SITE PAIN (burning). On an unknown date, the patient experienced CELLULITIS (emergency room and they gave me antibiotics in case I had cellulitis) (seriousness criterion medically significant). At the time of the report, SCRATCH (scratch), SKIN STRIAE (stretch mark), VACCINATION SITE WARMTH (area hot to the touch), VACCINATION SITE ERYTHEMA (injection site  swollen and red arm), CELLULITIS (emergency room and they gave me antibiotics in case I had cellulitis), VACCINATION COMPLICATION (Covid Arm), PYREXIA (fever) and VACCINATION SITE PAIN (burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Patient visited to the emergency room and prescribed  antibiotics in case patient had cellulitis. The Emergency Room  told  to the patient about Corvid Arm. and also prescribed steroids.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-289518 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had a sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (I had a sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (I had a sore arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (I had a sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded   This case was linked to MOD-2021-289014 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: after a week but returned in full fource after a rigorous uphill hike (prickers throughout my body); The "pricker" sensation in my calves was extremely painful,feelings of "prickers" throughout my body; had feelings of "prickers" throughout my body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The "pricker" sensation in my calves was extremely painful,feelings of "prickers" throughout my body), PARAESTHESIA (had feelings of "prickers" throughout my body) and PARAESTHESIA (after a week but returned in full fource after a rigorous uphill hike (prickers throughout my body)) 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 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced PAIN IN EXTREMITY (The "pricker" sensation in my calves was extremely painful,feelings of "prickers" throughout my body) (seriousness criterion medically significant) and PARAESTHESIA (had feelings of "prickers" throughout my body) (seriousness criterion medically significant). On 14-Aug-2021, the patient experienced PARAESTHESIA (after a week but returned in full fource after a rigorous uphill hike (prickers throughout my body)) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (The "pricker" sensation in my calves was extremely painful,feelings of "prickers" throughout my body) and PARAESTHESIA (after a week but returned in full fource after a rigorous uphill hike (prickers throughout my body)) outcome was unknown and PARAESTHESIA (had feelings of "prickers" throughout my body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Two hours after patient had feelings of prickers throughout the body. It subsided after a week but returned in full force on 8/14 after a rigorous uphill hike. The pricker sensation in calves was extremely painful.       Company Comment   Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Pain in extremity, Sudden hearing loss, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: My hearing is distorted; I had sudden hearing loss in my right ear/repeated episodes of hearing loss; My injection site arm was hot; My injection site arm itched like crazy; my injection site arm was red; My injection site arm was swollen; I had a sore arm; This spontaneous case was reported by a physician and describes the occurrence of SUDDEN HEARING LOSS (I had sudden hearing loss in my right ear/repeated episodes of hearing loss) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (I had a sore arm). On 23-Jan-2021, the patient experienced SUDDEN HEARING LOSS (I had sudden hearing loss in my right ear/repeated episodes of hearing loss) (seriousness criterion medically significant), VACCINATION SITE WARMTH (My injection site arm was hot), VACCINATION SITE PRURITUS (My injection site arm itched like crazy), VACCINATION SITE ERYTHEMA (my injection site arm was red) and VACCINATION SITE SWELLING (My injection site arm was swollen). On 17-Aug-2021, the patient experienced HYPOACUSIS (My hearing is distorted). At the time of the report, SUDDEN HEARING LOSS (I had sudden hearing loss in my right ear/repeated episodes of hearing loss), HYPOACUSIS (My hearing is distorted), PAIN IN EXTREMITY (I had a sore arm), VACCINATION SITE WARMTH (My injection site arm was hot), VACCINATION SITE PRURITUS (My injection site arm itched like crazy), VACCINATION SITE ERYTHEMA (my injection site arm was red) and VACCINATION SITE SWELLING (My injection site arm was swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-289003 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: My hearing is distorted; I had sudden hearing loss in my right ear/repeated episodes of hearing loss; My injection site arm was hot; My injection site arm itched like crazy; my injection site arm was red; My injection site arm was swollen; I had a sore arm; This spontaneous case was reported by a physician and describes the occurrence of SUDDEN HEARING LOSS (I had sudden hearing loss in my right ear/repeated episodes of hearing loss) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (I had a sore arm). On 23-Jan-2021, the patient experienced SUDDEN HEARING LOSS (I had sudden hearing loss in my right ear/repeated episodes of hearing loss) (seriousness criterion medically significant), VACCINATION SITE WARMTH (My injection site arm was hot), VACCINATION SITE PRURITUS (My injection site arm itched like crazy), VACCINATION SITE ERYTHEMA (my injection site arm was red) and VACCINATION SITE SWELLING (My injection site arm was swollen). On 17-Aug-2021, the patient experienced HYPOACUSIS (My hearing is distorted). At the time of the report, SUDDEN HEARING LOSS (I had sudden hearing loss in my right ear/repeated episodes of hearing loss), HYPOACUSIS (My hearing is distorted), PAIN IN EXTREMITY (I had a sore arm), VACCINATION SITE WARMTH (My injection site arm was hot), VACCINATION SITE PRURITUS (My injection site arm itched like crazy), VACCINATION SITE ERYTHEMA (my injection site arm was red) and VACCINATION SITE SWELLING (My injection site arm was swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-289003 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Sore arm; Systemically she felt bad but not significant; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Systemically she felt bad but not significant) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included Inflammatory bowel disease, Small fiber neuropathy, Diastolic heart failure and Chemotherapy from 2003 to 2004. Concurrent medical conditions included Osteoporosis. Concomitant products included VEDOLIZUMAB (ENTYVIO) and PYRIDOSTIGMINE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-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 PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Systemically she felt bad but not significant). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Systemically she felt bad but not significant) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-289133 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: Diverticulitis inflammation months after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis inflammation months after second vaccine) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer (He has been taking Xtandi for prostate Cancer for more than a year.). Concomitant products included ENZALUTAMIDE (XTANDI) for Prostate cancer.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced DIVERTICULITIS (Diverticulitis inflammation months after second vaccine) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 15-Aug-2021 to 16-Aug-2021 due to DIVERTICULITIS. The patient was treated with CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE (CIPRO [CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE]) for Adverse event, at an unspecified dose and frequency and METRONIDAZOLE BENZOATE (FLAGYL [METRONIDAZOLE BENZOATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIVERTICULITIS (Diverticulitis inflammation months after second vaccine) outcome was unknown.            Action taken with suspect drug was not applicable.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, this patient's advanced age and diet (Eat too many seeds) remains a contributory factor.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, this patient's advanced age and diet (Eat too many seeds) remains a contributory factor.