chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: On again off again rash under his injection arm and chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (On again off again rash under his injection arm and chest) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023m20A and 0121m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-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 RASH (On again off again rash under his injection arm and chest). At the time of the report, RASH (On again off again rash under his injection arm and chest) had not resolved.            No concomitant product use was provided by the reporter.   No treatment medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Contusion, Joint stiffness, Lethargy
Clinical narrative: pain; joint stiffness; Heat rash; rash on chest; On and off chills; aches; fever; Pain at injection site; Skin feeling warm; Bottom of his feet started feeling bruised; slept most of the day and through the night; lethargic; No energy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Skin feeling warm), CONTUSION (Bottom of his feet started feeling bruised), SOMNOLENCE (slept most of the day and through the night), PAIN (pain) and JOINT STIFFNESS (joint stiffness) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced SKIN WARM (Skin feeling warm), CONTUSION (Bottom of his feet started feeling bruised), SOMNOLENCE (slept most of the day and through the night), LETHARGY (lethargic), ASTHENIA (No energy) and VACCINATION SITE PAIN (Pain at injection site). On 23-Jul-2021, the patient experienced PYREXIA (fever) and MYALGIA (aches). On 24-Jul-2021, the patient experienced PAIN (pain), JOINT STIFFNESS (joint stiffness), MILIARIA (Heat rash), RASH (rash on chest) and CHILLS (On and off chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 23-Jul-2021, SOMNOLENCE (slept most of the day and through the night) had resolved. On 10-Aug-2021, PAIN (pain), JOINT STIFFNESS (joint stiffness), MILIARIA (Heat rash), LETHARGY (lethargic), RASH (rash on chest), PYREXIA (fever), CHILLS (On and off chills) and MYALGIA (aches) had resolved. At the time of the report, SKIN WARM (Skin feeling warm), ASTHENIA (No energy) and VACCINATION SITE PAIN (Pain at injection site) had not resolved and CONTUSION (Bottom of his feet started feeling bruised) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Aug-2021: Follow up received on 21-AUG-2021 contains Patient Demographic details, Vaccine Facility Information and Added events and Events outcome.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Miliaria, Myalgia, Pain, Pyrexia, Rash
Clinical narrative: pain; joint stiffness; Heat rash; rash on chest; On and off chills; aches; fever; Pain at injection site; Skin feeling warm; Bottom of his feet started feeling bruised; slept most of the day and through the night; lethargic; No energy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Skin feeling warm), CONTUSION (Bottom of his feet started feeling bruised), SOMNOLENCE (slept most of the day and through the night), PAIN (pain) and JOINT STIFFNESS (joint stiffness) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced SKIN WARM (Skin feeling warm), CONTUSION (Bottom of his feet started feeling bruised), SOMNOLENCE (slept most of the day and through the night), LETHARGY (lethargic), ASTHENIA (No energy) and VACCINATION SITE PAIN (Pain at injection site). On 23-Jul-2021, the patient experienced PYREXIA (fever) and MYALGIA (aches). On 24-Jul-2021, the patient experienced PAIN (pain), JOINT STIFFNESS (joint stiffness), MILIARIA (Heat rash), RASH (rash on chest) and CHILLS (On and off chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 23-Jul-2021, SOMNOLENCE (slept most of the day and through the night) had resolved. On 10-Aug-2021, PAIN (pain), JOINT STIFFNESS (joint stiffness), MILIARIA (Heat rash), LETHARGY (lethargic), RASH (rash on chest), PYREXIA (fever), CHILLS (On and off chills) and MYALGIA (aches) had resolved. At the time of the report, SKIN WARM (Skin feeling warm), ASTHENIA (No energy) and VACCINATION SITE PAIN (Pain at injection site) had not resolved and CONTUSION (Bottom of his feet started feeling bruised) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Aug-2021: Follow up received on 21-AUG-2021 contains Patient Demographic details, Vaccine Facility Information and Added events and Events outcome.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Skin warm, Somnolence, Vaccination site pain
Clinical narrative: pain; joint stiffness; Heat rash; rash on chest; On and off chills; aches; fever; Pain at injection site; Skin feeling warm; Bottom of his feet started feeling bruised; slept most of the day and through the night; lethargic; No energy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Skin feeling warm), CONTUSION (Bottom of his feet started feeling bruised), SOMNOLENCE (slept most of the day and through the night), PAIN (pain) and JOINT STIFFNESS (joint stiffness) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced SKIN WARM (Skin feeling warm), CONTUSION (Bottom of his feet started feeling bruised), SOMNOLENCE (slept most of the day and through the night), LETHARGY (lethargic), ASTHENIA (No energy) and VACCINATION SITE PAIN (Pain at injection site). On 23-Jul-2021, the patient experienced PYREXIA (fever) and MYALGIA (aches). On 24-Jul-2021, the patient experienced PAIN (pain), JOINT STIFFNESS (joint stiffness), MILIARIA (Heat rash), RASH (rash on chest) and CHILLS (On and off chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 23-Jul-2021, SOMNOLENCE (slept most of the day and through the night) had resolved. On 10-Aug-2021, PAIN (pain), JOINT STIFFNESS (joint stiffness), MILIARIA (Heat rash), LETHARGY (lethargic), RASH (rash on chest), PYREXIA (fever), CHILLS (On and off chills) and MYALGIA (aches) had resolved. At the time of the report, SKIN WARM (Skin feeling warm), ASTHENIA (No energy) and VACCINATION SITE PAIN (Pain at injection site) had not resolved and CONTUSION (Bottom of his feet started feeling bruised) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Aug-2021: Follow up received on 21-AUG-2021 contains Patient Demographic details, Vaccine Facility Information and Added events and Events outcome.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Had a first dose of Moderna but that was several months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Had a first dose of Moderna but that was several months ago) 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 PRODUCT DOSE OMISSION ISSUE (Had a first dose of Moderna but that was several months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Had a first dose of Moderna but that was several months ago) had resolved.            No concomitant medications were provided. Treatment information was not provided.  The patient queried whether it was necessary to receive the second dose and where could the second dose be available in the patient's area.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Hyperhidrosis, Limb discomfort, Nausea
Clinical narrative: Left armpit started bothering her after first dose; Weakness; Sweating; Stomach cramps; Her side effects made her nervous about the second shot; Left arm injection site was sore; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Left armpit started bothering her after first dose), ASTHENIA (Weakness), HYPERHIDROSIS (Sweating), ABDOMINAL PAIN UPPER (Stomach cramps) and NERVOUSNESS (Her side effects made her nervous about the second shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced LIMB DISCOMFORT (Left armpit started bothering her after first dose), ASTHENIA (Weakness), HYPERHIDROSIS (Sweating), ABDOMINAL PAIN UPPER (Stomach cramps), NERVOUSNESS (Her side effects made her nervous about the second shot), VACCINATION SITE PAIN (Left arm injection site was sore), VOMITING (Vomiting) and NAUSEA (Nausea). At the time of the report, LIMB DISCOMFORT (Left armpit started bothering her after first dose), ASTHENIA (Weakness), HYPERHIDROSIS (Sweating), ABDOMINAL PAIN UPPER (Stomach cramps), NERVOUSNESS (Her side effects made her nervous about the second shot), VACCINATION SITE PAIN (Left arm injection site was sore), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment information was not provided.  The patient thought that may be she was having severe side effects because she already had antibodies.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Vaccination site pain, Vomiting
Clinical narrative: Left armpit started bothering her after first dose; Weakness; Sweating; Stomach cramps; Her side effects made her nervous about the second shot; Left arm injection site was sore; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Left armpit started bothering her after first dose), ASTHENIA (Weakness), HYPERHIDROSIS (Sweating), ABDOMINAL PAIN UPPER (Stomach cramps) and NERVOUSNESS (Her side effects made her nervous about the second shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced LIMB DISCOMFORT (Left armpit started bothering her after first dose), ASTHENIA (Weakness), HYPERHIDROSIS (Sweating), ABDOMINAL PAIN UPPER (Stomach cramps), NERVOUSNESS (Her side effects made her nervous about the second shot), VACCINATION SITE PAIN (Left arm injection site was sore), VOMITING (Vomiting) and NAUSEA (Nausea). At the time of the report, LIMB DISCOMFORT (Left armpit started bothering her after first dose), ASTHENIA (Weakness), HYPERHIDROSIS (Sweating), ABDOMINAL PAIN UPPER (Stomach cramps), NERVOUSNESS (Her side effects made her nervous about the second shot), VACCINATION SITE PAIN (Left arm injection site was sore), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment information was not provided.  The patient thought that may be she was having severe side effects because she already had antibodies.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: Minimally sore / Midly sore; Felt tired / Felt tired but nothing out of ordinary; Felt chilled; Noticed the left super clavicular lymph node was slightly enlarged/Felt a pea size enlargement/It is still enlarged; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Minimally sore / Midly sore), FATIGUE (Felt tired / Felt tired but nothing out of ordinary), CHILLS (Felt chilled) and LYMPHADENOPATHY (Noticed the left super clavicular lymph node was slightly enlarged/Felt a pea size enlargement/It is still enlarged) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, VALSARTAN, HYDROCHLOROTHIAZIDE and ROSUVASTATIN CALCIUM for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced LYMPHADENOPATHY (Noticed the left super clavicular lymph node was slightly enlarged/Felt a pea size enlargement/It is still enlarged). On an unknown date, the patient experienced PAIN IN EXTREMITY (Minimally sore / Midly sore), FATIGUE (Felt tired / Felt tired but nothing out of ordinary) and CHILLS (Felt chilled). At the time of the report, PAIN IN EXTREMITY (Minimally sore / Midly sore), FATIGUE (Felt tired / Felt tired but nothing out of ordinary), CHILLS (Felt chilled) and LYMPHADENOPATHY (Noticed the left super clavicular lymph node was slightly enlarged/Felt a pea size enlargement/It is still enlarged) outcome was unknown.            No treatment information was mentioned. The patient's shot was given inch and a half higher than the first shot, it was given high in deltoid muscle and he felt it go in. He felt tired, chilled, did not take temp because it was not bad. Then around two months later, beginning of July-2021 around the 4th 5th or 6th, he noticed the left super clavicular lymph node was slightly enlarged. The patient stated he went on computer to research and googled, it showed where all the lymph nodes were in head and neck. The patient started to check on himself after reading about the lymphatic system and started to feel around the left super clavicular lymph node. He stated that he felt a pea size enlargement and when he felt it, It has been 2 months ago since he got vaccine and stated that it is still enlarged. The patient stated that the area was getting smaller slowly.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to a patient) 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 (expired dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: 5 doses were administered out of vial that was punctured 15 days ago; Vials are out of range for temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses were administered out of vial that was punctured 15 days ago) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vials are out of range for temperature) 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 30-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses were administered out of vial that was punctured 15 days ago) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vials are out of range for temperature). On 30-Jul-2021, EXPIRED PRODUCT ADMINISTERED (5 doses were administered out of vial that was punctured 15 days ago) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vials are out of range for temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   5 doses were administered out of vial that was punctured on 16 Aug 2021 and temperature was also recorded out of range. No concomitant medications were reported No treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: severe numbness; tingling; pain in hands, feet, arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (severe numbness), PARAESTHESIA (tingling) and PAIN IN EXTREMITY (pain in hands, feet, arms and legs) 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 06-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 HYPOAESTHESIA (severe numbness), PARAESTHESIA (tingling) and PAIN IN EXTREMITY (pain in hands, feet, arms and legs). At the time of the report, HYPOAESTHESIA (severe numbness), PARAESTHESIA (tingling) and PAIN IN EXTREMITY (pain in hands, feet, arms and legs) outcome was unknown.            No concomitant medication was provided. No treatment medication information was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: covid arm; Itches; The patiIt got bigger, raised area, and now has another red spot; Raised area; Red spot all the way around the vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm), VACCINATION SITE PRURITUS (Itches), VACCINATION SITE RASH (The patiIt got bigger, raised area, and now has another red spot), VACCINATION SITE SWELLING (Raised area) and VACCINATION SITE ERYTHEMA (Red spot all the way around the vaccine site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concurrent medical conditions included Allergic reaction to drug, Blood pressure high, Cholesterol, Hot flashes, Drug allergy (Advil - Hives), Drug allergy (Aleve- Hives), Drug allergy (Birth control pill - Pulmonary Embolism) and Drug allergy (Estrogen cream - High blood pressure). Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for Blood pressure high, ATORVASTATIN for Cholesterol, VENLAFAXINE for Hot flashes, VITAMIN D3 for an unknown indication.  On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot all the way around the vaccine site). On an unknown date, the patient experienced VACCINATION COMPLICATION (covid arm), VACCINATION SITE PRURITUS (Itches), VACCINATION SITE RASH (The patiIt got bigger, raised area, and now has another red spot) and VACCINATION SITE SWELLING (Raised area). On 05-Aug-2021, VACCINATION SITE ERYTHEMA (Red spot all the way around the vaccine site) had resolved. At the time of the report, VACCINATION COMPLICATION (covid arm), VACCINATION SITE PRURITUS (Itches), VACCINATION SITE RASH (The patiIt got bigger, raised area, and now has another red spot) and VACCINATION SITE SWELLING (Raised area) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Patient's concomitant medication also included water pill.   Patient did not took any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow-up received contains updated patient demographic details(race, height, weight), added concomitant drug (Hydrochlorothiazide), and updated other drug dose details, updated event outcomes.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Pain, Renal pain, Weight, Weight decreased
Clinical narrative: Pain in her kidney; So painful that she couldn't stand or get out of bed/ Still takes her half an hour to get out of bed; Losing weight and being "skin and bones"; So much pain that she screamed; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Pain in her kidney), BEDRIDDEN (So painful that she couldn't stand or get out of bed/ Still takes her half an hour to get out of bed), WEIGHT DECREASED (Losing weight and being "skin and bones") and PAIN (So much pain that she screamed) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     The patient's past medical history included Leg amputation (Right leg). Concurrent medical conditions included Cholesterol (takes cholesterol pill), Arterial disorder (Has tiny arteries which causes blood to flow slower) and Wheelchair user (patient is wheelchair user). Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced RENAL PAIN (Pain in her kidney), BEDRIDDEN (So painful that she couldn't stand or get out of bed/ Still takes her half an hour to get out of bed), WEIGHT DECREASED (Losing weight and being "skin and bones") and PAIN (So much pain that she screamed). On 01-Aug-2021, RENAL PAIN (Pain in her kidney) had resolved. On 04-Aug-2021, BEDRIDDEN (So painful that she couldn't stand or get out of bed/ Still takes her half an hour to get out of bed), WEIGHT DECREASED (Losing weight and being "skin and bones") and PAIN (So much pain that she screamed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Weight: 78 pounds (Low) 80 pounds before taking vaccine , now 78 pounds.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Additional concomitant medication includes cholesterol medication (one pill at night). Treatment information was not provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine Used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On 24-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was provided.  No Treatment medication information was provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Cough, Erythema, Fatigue, Feeling abnormal
Clinical narrative: he was sweating all day; itching all the time on his back/Generalised itching; His spine was inflamed; He had a burning sensation on his spine; He had one red dot on the right side of his spine; I have a bad cold; Cough; Runny nose; Flushing; Feeling hot; felt a little bit tired the morning of his vaccine; felt a little bit strange the morning of his vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a little bit strange the morning of his vaccine), HYPERHIDROSIS (he was sweating all day), PRURITUS (itching all the time on his back/Generalised itching), INFLAMMATION (His spine was inflamed) and BURNING SENSATION (He had a burning sensation on his spine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cold in 2017. Concurrent medical conditions included Allergy to antibiotic (Amoxicillin), Drug allergy (Duloxetine), Niacin supplementation and Drug allergy (Niaspan).  On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced FEELING ABNORMAL (felt a little bit strange the morning of his vaccine) and FATIGUE (felt a little bit tired the morning of his vaccine). On 01-Aug-2021, the patient experienced NASOPHARYNGITIS (I have a bad cold), COUGH (Cough), RHINORRHOEA (Runny nose), FLUSHING (Flushing) and FEELING HOT (Feeling hot). On 02-Aug-2021, the patient experienced HYPERHIDROSIS (he was sweating all day), PRURITUS (itching all the time on his back/Generalised itching), INFLAMMATION (His spine was inflamed), BURNING SENSATION (He had a burning sensation on his spine) and ERYTHEMA (He had one red dot on the right side of his spine). At the time of the report, FEELING ABNORMAL (felt a little bit strange the morning of his vaccine), HYPERHIDROSIS (he was sweating all day), PRURITUS (itching all the time on his back/Generalised itching), ERYTHEMA (He had one red dot on the right side of his spine), NASOPHARYNGITIS (I have a bad cold), COUGH (Cough), RHINORRHOEA (Runny nose), FLUSHING (Flushing), FEELING HOT (Feeling hot) and FATIGUE (felt a little bit tired the morning of his vaccine) had not resolved and INFLAMMATION (His spine was inflamed) and BURNING SENSATION (He had a burning sensation on his spine) 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 medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow-up received , patient demographics , relevant history ( allergy , historical condition) and new events are updated.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Hyperhidrosis, Inflammation, Nasopharyngitis
Clinical narrative: he was sweating all day; itching all the time on his back/Generalised itching; His spine was inflamed; He had a burning sensation on his spine; He had one red dot on the right side of his spine; I have a bad cold; Cough; Runny nose; Flushing; Feeling hot; felt a little bit tired the morning of his vaccine; felt a little bit strange the morning of his vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a little bit strange the morning of his vaccine), HYPERHIDROSIS (he was sweating all day), PRURITUS (itching all the time on his back/Generalised itching), INFLAMMATION (His spine was inflamed) and BURNING SENSATION (He had a burning sensation on his spine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cold in 2017. Concurrent medical conditions included Allergy to antibiotic (Amoxicillin), Drug allergy (Duloxetine), Niacin supplementation and Drug allergy (Niaspan).  On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced FEELING ABNORMAL (felt a little bit strange the morning of his vaccine) and FATIGUE (felt a little bit tired the morning of his vaccine). On 01-Aug-2021, the patient experienced NASOPHARYNGITIS (I have a bad cold), COUGH (Cough), RHINORRHOEA (Runny nose), FLUSHING (Flushing) and FEELING HOT (Feeling hot). On 02-Aug-2021, the patient experienced HYPERHIDROSIS (he was sweating all day), PRURITUS (itching all the time on his back/Generalised itching), INFLAMMATION (His spine was inflamed), BURNING SENSATION (He had a burning sensation on his spine) and ERYTHEMA (He had one red dot on the right side of his spine). At the time of the report, FEELING ABNORMAL (felt a little bit strange the morning of his vaccine), HYPERHIDROSIS (he was sweating all day), PRURITUS (itching all the time on his back/Generalised itching), ERYTHEMA (He had one red dot on the right side of his spine), NASOPHARYNGITIS (I have a bad cold), COUGH (Cough), RHINORRHOEA (Runny nose), FLUSHING (Flushing), FEELING HOT (Feeling hot) and FATIGUE (felt a little bit tired the morning of his vaccine) had not resolved and INFLAMMATION (His spine was inflamed) and BURNING SENSATION (He had a burning sensation on his spine) 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 medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow-up received , patient demographics , relevant history ( allergy , historical condition) and new events are updated.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rhinorrhoea
Clinical narrative: he was sweating all day; itching all the time on his back/Generalised itching; His spine was inflamed; He had a burning sensation on his spine; He had one red dot on the right side of his spine; I have a bad cold; Cough; Runny nose; Flushing; Feeling hot; felt a little bit tired the morning of his vaccine; felt a little bit strange the morning of his vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a little bit strange the morning of his vaccine), HYPERHIDROSIS (he was sweating all day), PRURITUS (itching all the time on his back/Generalised itching), INFLAMMATION (His spine was inflamed) and BURNING SENSATION (He had a burning sensation on his spine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cold in 2017. Concurrent medical conditions included Allergy to antibiotic (Amoxicillin), Drug allergy (Duloxetine), Niacin supplementation and Drug allergy (Niaspan).  On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced FEELING ABNORMAL (felt a little bit strange the morning of his vaccine) and FATIGUE (felt a little bit tired the morning of his vaccine). On 01-Aug-2021, the patient experienced NASOPHARYNGITIS (I have a bad cold), COUGH (Cough), RHINORRHOEA (Runny nose), FLUSHING (Flushing) and FEELING HOT (Feeling hot). On 02-Aug-2021, the patient experienced HYPERHIDROSIS (he was sweating all day), PRURITUS (itching all the time on his back/Generalised itching), INFLAMMATION (His spine was inflamed), BURNING SENSATION (He had a burning sensation on his spine) and ERYTHEMA (He had one red dot on the right side of his spine). At the time of the report, FEELING ABNORMAL (felt a little bit strange the morning of his vaccine), HYPERHIDROSIS (he was sweating all day), PRURITUS (itching all the time on his back/Generalised itching), ERYTHEMA (He had one red dot on the right side of his spine), NASOPHARYNGITIS (I have a bad cold), COUGH (Cough), RHINORRHOEA (Runny nose), FLUSHING (Flushing), FEELING HOT (Feeling hot) and FATIGUE (felt a little bit tired the morning of his vaccine) had not resolved and INFLAMMATION (His spine was inflamed) and BURNING SENSATION (He had a burning sensation on his spine) 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 medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow-up received , patient demographics , relevant history ( allergy , historical condition) and new events are updated.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Hyperhidrosis, Pruritus
Clinical narrative: When running short distance felt like out of breath; Itching on both arms/Generalised itching; Arms becoming reddish; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on both arms/Generalised itching), ERYTHEMA (Arms becoming reddish), HYPERHIDROSIS (Sweating) and DYSPNOEA (When running short distance felt like out of breath) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced PRURITUS (Itching on both arms/Generalised itching), ERYTHEMA (Arms becoming reddish) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced DYSPNOEA (When running short distance felt like out of breath). At the time of the report, PRURITUS (Itching on both arms/Generalised itching), ERYTHEMA (Arms becoming reddish) and DYSPNOEA (When running short distance felt like out of breath) had not resolved and HYPERHIDROSIS (Sweating) 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.   The concomitant medications were not reported. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Added new event, event onset date, outcome  and updated patient details and reporter information.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hot flush, Hyperhidrosis
Clinical narrative: Shortness of breath; Hot flush; Wife has been sweating for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Wife has been sweating for 4 days), DYSPNOEA (Shortness of breath) and HOT FLUSH (Hot flush) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0780214) 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) (Intramuscular) 1 dosage form. On 01-Aug-2021 at 10:30 AM, the patient experienced HYPERHIDROSIS (Wife has been sweating for 4 days). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and HOT FLUSH (Hot flush). At the time of the report, HYPERHIDROSIS (Wife has been sweating for 4 days) had not resolved and DYSPNOEA (Shortness of breath) and HOT FLUSH (Hot flush) 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 reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Added patient details and new events and event outcomes were added
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Hypoaesthesia, Pain in jaw, Sinus pain
Clinical narrative: Jaw Hurt; Sinus hurt; Face numbness that went away within 24 hours, left side of her face and neck numbed up; Facial pain for a few days; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Face numbness that went away within 24 hours, left side of her face and neck numbed up), FACIAL PAIN (Facial pain for a few days), PAIN IN JAW (Jaw Hurt) and SINUS PAIN (Sinus hurt) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced HYPOAESTHESIA (Face numbness that went away within 24 hours, left side of her face and neck numbed up) and FACIAL PAIN (Facial pain for a few days). On 04-Aug-2021, the patient experienced PAIN IN JAW (Jaw Hurt) and SINUS PAIN (Sinus hurt). On 04-Aug-2021, HYPOAESTHESIA (Face numbness that went away within 24 hours, left side of her face and neck numbed up) and FACIAL PAIN (Facial pain for a few days) had resolved. At the time of the report, PAIN IN JAW (Jaw Hurt) and SINUS PAIN (Sinus hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was provided by the reporter.  No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow-up received contains updated drug start date, anatomical location and events of pain in jaw, sinus pain updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Arthralgia, Bedridden, Cough, Headache
Clinical narrative: Felt like the flu; Dry cough; Loss of voice; Bed ridden; couldn't lift her arm/couldn't move her arm; arm was killing her; arm was sore; Muscles aches; Joint ache; Head throbs; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like the flu), COUGH (Dry cough), APHONIA (Loss of voice), BEDRIDDEN (Bed ridden) and MOBILITY DECREASED (couldn't lift her arm/couldn't move her arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (a year ago).   On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like the flu), COUGH (Dry cough), APHONIA (Loss of voice), BEDRIDDEN (Bed ridden), MOBILITY DECREASED (couldn't lift her arm/couldn't move her arm), LIMB DISCOMFORT (arm was killing her), PAIN IN EXTREMITY (arm was sore), MYALGIA (Muscles aches), ARTHRALGIA (Joint ache) and HEADACHE (Head throbs). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like the flu), COUGH (Dry cough), APHONIA (Loss of voice), BEDRIDDEN (Bed ridden), MOBILITY DECREASED (couldn't lift her arm/couldn't move her arm), LIMB DISCOMFORT (arm was killing her), PAIN IN EXTREMITY (arm was sore), MYALGIA (Muscles aches), ARTHRALGIA (Joint ache) and HEADACHE (Head throbs) outcome was unknown.            Concomitant medications were not provided. No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow Up information was received on 24-Aug-2021 and contains new events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Limb discomfort, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Felt like the flu; Dry cough; Loss of voice; Bed ridden; couldn't lift her arm/couldn't move her arm; arm was killing her; arm was sore; Muscles aches; Joint ache; Head throbs; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like the flu), COUGH (Dry cough), APHONIA (Loss of voice), BEDRIDDEN (Bed ridden) and MOBILITY DECREASED (couldn't lift her arm/couldn't move her arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (a year ago).   On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like the flu), COUGH (Dry cough), APHONIA (Loss of voice), BEDRIDDEN (Bed ridden), MOBILITY DECREASED (couldn't lift her arm/couldn't move her arm), LIMB DISCOMFORT (arm was killing her), PAIN IN EXTREMITY (arm was sore), MYALGIA (Muscles aches), ARTHRALGIA (Joint ache) and HEADACHE (Head throbs). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like the flu), COUGH (Dry cough), APHONIA (Loss of voice), BEDRIDDEN (Bed ridden), MOBILITY DECREASED (couldn't lift her arm/couldn't move her arm), LIMB DISCOMFORT (arm was killing her), PAIN IN EXTREMITY (arm was sore), MYALGIA (Muscles aches), ARTHRALGIA (Joint ache) and HEADACHE (Head throbs) outcome was unknown.            Concomitant medications were not provided. No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow Up information was received on 24-Aug-2021 and contains new events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Dysgeusia, Head discomfort, Hypoaesthesia, Musculoskeletal discomfort
Clinical narrative: metallic taste in mouth; feels like she is having stroke; neck still hurts; side of her face was numb; arm stiff; eyes were stiff; pressure behind head; pressure behind neck; pressure behind eyes; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in mouth), HEAD DISCOMFORT (pressure behind head), MUSCULOSKELETAL DISCOMFORT (pressure behind neck), OCULAR DISCOMFORT (pressure behind eyes) and CARDIAC DISCOMFORT (feels like she is having stroke) in a 43-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.     The patient's past medical history included Infection, Surgery (multiple surgeries) and Biliary stent placement.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced HEAD DISCOMFORT (pressure behind head) and MUSCULOSKELETAL DISCOMFORT (pressure behind neck). 30-Jul-2021, the patient experienced OCULAR DISCOMFORT (pressure behind eyes). On an unknown date, the patient experienced DYSGEUSIA (metallic taste in mouth), CARDIAC DISCOMFORT (feels like she is having stroke), NECK PAIN (neck still hurts), HYPOAESTHESIA (side of her face was numb), MUSCULOSKELETAL STIFFNESS (arm stiff) and OCULAR DISCOMFORT (eyes were stiff). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of She took it for 4-5 days and then stopped and PARACETAMOL (TYLENOL) for Adverse event, at a dose of She took it for 4-5 days and then stopped. At the time of the report, DYSGEUSIA (metallic taste in mouth), HEAD DISCOMFORT (pressure behind head), MUSCULOSKELETAL DISCOMFORT (pressure behind neck), OCULAR DISCOMFORT (pressure behind eyes), CARDIAC DISCOMFORT (feels like she is having stroke), NECK PAIN (neck still hurts), HYPOAESTHESIA (side of her face was numb), MUSCULOSKELETAL STIFFNESS (arm stiff) and OCULAR DISCOMFORT (eyes were stiff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  The pressure behind neck and head started within 10 minutes of getting the vaccine and got worse overnight. The adverse events were fast and differently at each time.