chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy at rash area; Full body rash; hematoma is underneath; She states that the vaccine activated her psoriasis; both of her forearms were just itching like crazy; She looked at her elbows and it looks like a blister is underneath; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA INFECTION (hematoma is underneath), PSORIASIS (She states that the vaccine activated her psoriasis), PRURITUS (both of her forearms were just itching like crazy), BLISTER (She looked at her elbows and it looks like a blister is underneath) and RASH PRURITIC (itchy at rash area) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder and Psoriasis. Concomitant products included AMITRIPTYLINE for Sleep problem, LORATADINE, FUROSEMIDE, SPIRONOLACTONE, VITAMINS NOS, COLLAGEN, MAGNESIUM, BIOTIN, POTASSIUM, VITAMIN D3, ZINC, VIBURNUM OPULUS BARK (CRAMP BARK) and MELATONIN for an unknown indication.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced HAEMATOMA INFECTION (hematoma is underneath), PSORIASIS (She states that the vaccine activated her psoriasis), PRURITUS (both of her forearms were just itching like crazy) and BLISTER (She looked at her elbows and it looks like a blister is underneath). On an unknown date, the patient experienced RASH PRURITIC (itchy at rash area) and RASH (Full body rash). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, HAEMATOMA INFECTION (hematoma is underneath), PSORIASIS (She states that the vaccine activated her psoriasis), PRURITUS (both of her forearms were just itching like crazy), BLISTER (She looked at her elbows and it looks like a blister is underneath), RASH PRURITIC (itchy at rash area) and RASH (Full body rash) outcome was unknown.            Patient weight provided as 175, with no unit.  Patient was treated with two doses of prednisone, Antihistamine and Listerine.  Patient was given antihistamines, but symptoms just keeps getting worse and the rash was spreading all over. Patient had autoimmune disorder and psoriasis at baseline and did not take any medications for these conditions.   This case was linked to MOD-2021-242099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received that included added events, concomitant medications, patent weight, treatment information
Sex: U
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: So I just got my 2 nd dose and now I am experiencing left ear pain.; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (So I just got my 2 nd dose and now I am experiencing left ear pain.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported ).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (So I just got my 2 nd dose and now I am experiencing left ear pain.). At the time of the report, EAR PAIN (So I just got my 2 nd dose and now I am experiencing left ear pain.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Small Lump at the Injection Site months after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Small Lump at the Injection Site months after the injection) 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. In 2021, the patient experienced VACCINATION SITE MASS (Small Lump at the Injection Site months after the injection). At the time of the report, VACCINATION SITE MASS (Small Lump at the Injection Site months after the injection) 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.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle aches are so intense that I can't stand for long; fever doesn't stop.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches are so intense that I can't stand for long) and PYREXIA (fever doesn't stop.) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle aches are so intense that I can't stand for long) and PYREXIA (fever doesn't stop.). At the time of the report, MYALGIA (Muscle aches are so intense that I can't stand for long) and PYREXIA (fever doesn't stop.) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 38 days apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (38 days apart) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (38 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (38 days apart) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis viral, Product dose omission issue
Clinical narrative: Patient missed the time frame between the both doses of Moderna COVID-19 vaccine; Stomach flu; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed the time frame between the both doses of Moderna COVID-19 vaccine) and GASTROENTERITIS VIRAL (Stomach flu) 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-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed the time frame between the both doses of Moderna COVID-19 vaccine) and GASTROENTERITIS VIRAL (Stomach flu). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed the time frame between the both doses of Moderna COVID-19 vaccine) and GASTROENTERITIS VIRAL (Stomach flu) 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.   Concomitant product information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: added patient demographics, updated first dose details, added adverse event, updated adverse event detail
Sex: U
Vaccine: COVID19
Symptoms: Pain, Rash pruritic
Clinical narrative: Pain; Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and RASH PRURITIC (Itchy rash) 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 26-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 PAIN (Pain) and RASH PRURITIC (Itchy rash). At the time of the report, PAIN (Pain) and RASH PRURITIC (Itchy rash) outcome was unknown.            No concomitant medications were provided by the reporter.   No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow-up received on 31-Jul-2021, indicated reporter's address, no other new information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Nausea
Clinical narrative: Was very sick for a day; Really bad diarrhea for 12 hours; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was very sick for a day), DIARRHOEA (Really bad diarrhea for 12 hours) and NAUSEA (Nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included TIZANIDINE for Migraine, TRAZODONE for Sleep disorder, OXYBUTYNIN CHLORIDE, TOPIRAMATE, MONTELUKAST SODIUM, ALPRAZOLAM, PANTOPRAZOLE SODIUM, ARIPIPRAZOLE, DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ), ESTRADIOL, VALPROATE SEMISODIUM (DIVALPROEX), GABAPENTIN, TRAMADOL and PRAZOSIN for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced ILLNESS (Was very sick for a day), DIARRHOEA (Really bad diarrhea for 12 hours) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (Was very sick for a day), DIARRHOEA (Really bad diarrhea for 12 hours) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-242179 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed 2nd dose and it's been 4 months; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed 2nd dose and it's been 4 months) 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 PRODUCT DOSE OMISSION ISSUE (missed 2nd dose and it's been 4 months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed 2nd dose and it's been 4 months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Impaired work ability, Inappropriate schedule of product administration, Panic attack
Clinical narrative: Panic attack; Impaired work ability; Anxiety; She did not receive the 2nd dose between day 25-35 of getting the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), PANIC ATTACK (Panic attack), IMPAIRED WORK ABILITY (Impaired work ability) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did not receive the 2nd dose between day 25-35 of getting the 1st dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did not receive the 2nd dose between day 25-35 of getting the 1st dose). In May 2021, the patient experienced ANXIETY (Anxiety). On an unknown date, the patient experienced PANIC ATTACK (Panic attack) and IMPAIRED WORK ABILITY (Impaired work ability). The patient was treated with SERTRALINE HYDROCHLORIDE (ZOLOFT) at an unspecified dose and frequency and LORAZEPAM at an unspecified dose and frequency. On 28-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did not receive the 2nd dose between day 25-35 of getting the 1st dose) had resolved. At the time of the report, ANXIETY (Anxiety) had not resolved and PANIC ATTACK (Panic attack) and IMPAIRED WORK ABILITY (Impaired work ability) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANXIETY (Anxiety), PANIC ATTACK (Panic attack) and IMPAIRED WORK ABILITY (Impaired work ability) to be possibly related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did not receive the 2nd dose between day 25-35 of getting the 1st dose).    Concomitant product use was not provided. Treatment information was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events anxiety, panic attack and impaired work ability, a causal relationship cannot be excluded. This report, also, refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 021B21A..; 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 anxiety, panic attack and impaired work ability, a causal relationship cannot be excluded. This report, also, refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 021B21A.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Flatulence
Clinical narrative: Intestinal distress; Gas; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Intestinal distress), FLATULENCE (Gas) and DIARRHOEA (Diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EPINEPHRINE (EPIPEN) for Bee sting.   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 an unknown date, the patient experienced ABDOMINAL PAIN (Intestinal distress), FLATULENCE (Gas) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN (Intestinal distress), FLATULENCE (Gas) and DIARRHOEA (Diarrhea) outcome was unknown.            No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. He had experienced similar side effects as the 1st dose after the 2nd dose.   This case was linked to MOD-2021-006269 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received the Moderna Covid-19 vaccine more than 12 hours after the vial was punctured; 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 (received the Moderna Covid-19 vaccine more than 12 hours after the vial was punctured) 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 24-Jun-2021 at 8:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021 at 8:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the Moderna Covid-19 vaccine more than 12 hours after the vial was punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the Moderna Covid-19 vaccine more than 12 hours after the vial was punctured) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   This case concerns 4 patients.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Headache, Rhinorrhoea, Vaccination site rash
Clinical narrative: Runny nose; A rash 2 inches below the injection site; Very hot; Red; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Very hot), ERYTHEMA (Red), RHINORRHOEA (Runny nose), VACCINATION SITE RASH (A rash 2 inches below the injection site) and HEADACHE (Bad headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 208C21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported ). Concomitant products included TRAZODONE, TIZANIDINE, OXYBUTYNIN CHLORIDE, TOPIRAMATE, MONTELUKAST SODIUM, ALPRAZOLAM, PANTOPRAZOLE SODIUM, ARIPIPRAZOLE, DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ), ESTRADIOL, VALPROATE SEMISODIUM (DIVALPROEX), GABAPENTIN, TRAMADOL and PRAZOSIN for an unknown indication.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced HEADACHE (Bad headache). On 29-Jun-2021, the patient experienced FEELING HOT (Very hot), ERYTHEMA (Red) and VACCINATION SITE RASH (A rash 2 inches below the injection site). On an unknown date, the patient experienced RHINORRHOEA (Runny nose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and CORTISONE at a dose of Cream. At the time of the report, FEELING HOT (Very hot), ERYTHEMA (Red), RHINORRHOEA (Runny nose), VACCINATION SITE RASH (A rash 2 inches below the injection site) and HEADACHE (Bad headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: pain, and soreness in the injection site arm; fatigue; chills; Soreness in the Injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain, and soreness in the injection site arm), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (Soreness in the Injection site arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, the patient experienced MYALGIA (pain, and soreness in the injection site arm), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (Soreness in the Injection site arm). On 02-Jun-2021, MYALGIA (pain, and soreness in the injection site arm), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (Soreness in the Injection site arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-242276 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: feeling symptomatic after my second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (feeling symptomatic after my second dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (feeling symptomatic after my second dose). At the time of the report, VACCINATION COMPLICATION (feeling symptomatic after my second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Respiratory symptom
Clinical narrative: Are people experiencing respiratory issues weeks after getting the vaccine?; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYMPTOM (Are people experiencing respiratory issues weeks after getting the vaccine?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 RESPIRATORY SYMPTOM (Are people experiencing respiratory issues weeks after getting the vaccine?). At the time of the report, RESPIRATORY SYMPTOM (Are people experiencing respiratory issues weeks after getting the vaccine?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's information were not provided.  Concomitant medications were not provided.  Treatment medications was not given.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia
Clinical narrative: arm went numb down to the tips of my fingers/Felt like circulation in my forearm down to my fingers had been cut off/As soon as he injected me with the vaccine, my arm went numb; experienced something very strange/very strange feeling/every now and then I get the weird sensation that it's getting numb again; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm went numb down to the tips of my fingers/Felt like circulation in my forearm down to my fingers had been cut off/As soon as he injected me with the vaccine, my arm went numb) and FEELING ABNORMAL (experienced something very strange/very strange feeling/every now and then I get the weird sensation that it's getting numb again) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 30-Jun-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced HYPOAESTHESIA (arm went numb down to the tips of my fingers/Felt like circulation in my forearm down to my fingers had been cut off/As soon as he injected me with the vaccine, my arm went numb) and FEELING ABNORMAL (experienced something very strange/very strange feeling/every now and then I get the weird sensation that it's getting numb again). At the time of the report, HYPOAESTHESIA (arm went numb down to the tips of my fingers/Felt like circulation in my forearm down to my fingers had been cut off/As soon as he injected me with the vaccine, my arm went numb) and FEELING ABNORMAL (experienced something very strange/very strange feeling/every now and then I get the weird sensation that it's getting numb again) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information, if any, was not provided   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Addition information included primary reporter address, patient details, Added suspect dose batch number, date and route of administration, Added concomitant medicine, Added event dates and outcome.
Sex: U
Vaccine: COVID19
Symptoms: Eye pain
Clinical narrative: Eye pain after the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Eye pain after the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 EYE PAIN (Eye pain after the shot). At the time of the report, EYE PAIN (Eye pain after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 15 year old patient received the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient received the moderna vaccine) in a 15-year-old female patient 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) dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient received the moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient received the moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.   Reporter did not allow further contact.
Sex: M
Vaccine: COVID19
Symptoms: White blood cell disorder
Clinical narrative: wondering if I should get my Vaccine again, because my white blood cell; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL DISORDER (wondering if I should get my Vaccine again, because my white blood cell) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Stem cell transplant. Concurrent medical conditions included Cancer.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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 WHITE BLOOD CELL DISORDER (wondering if I should get my Vaccine again, because my white blood cell). At the time of the report, WHITE BLOOD CELL DISORDER (wondering if I should get my Vaccine again, because my white blood cell) outcome was unknown.            Concomitant medication was not provided by reporter. No treatment information was provided by the reporter aside from massive chemotherapy last year. Action taken in response to mRNA-1273 was not applicable
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Facial numbness) 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 HYPOAESTHESIA (Facial numbness). At the time of the report, HYPOAESTHESIA (Facial numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided  No treatment information was reported
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Heart rate, Nausea, Vaccination site pain
Clinical narrative: Injection site arm hot/feeling like I am burning up inside; Aanxiety; Nauseous; Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Injection site arm hot/feeling like I am burning up inside), ANXIETY (Aanxiety), NAUSEA (Nauseous) and VACCINATION SITE PAIN (Sore injection site arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced FEELING HOT (Injection site arm hot/feeling like I am burning up inside), ANXIETY (Aanxiety), NAUSEA (Nauseous) and VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, FEELING HOT (Injection site arm hot/feeling like I am burning up inside), ANXIETY (Aanxiety), NAUSEA (Nauseous) and VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, Heart rate: increased (High) heart is racing.         Concomitant medication list was not provided. Treatment information was not provided. It was reported that the patient's arm was very sore and hot for which she needed to ice her arm.   This case was linked to MOD-2021-242206 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (Headache). At the time of the report, CHILLS (chills) and HEADACHE (Headache) outcome was unknown.            No treatment details were reported.  No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: lot of arm soreness for the first 3 days; first day it was hard to lift the arm up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (lot of arm soreness for the first 3 days) and MOBILITY DECREASED (first day it was hard to lift the arm up) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CORTISONE for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PAIN IN EXTREMITY (lot of arm soreness for the first 3 days) and MOBILITY DECREASED (first day it was hard to lift the arm up). On 02-Jun-2021, MOBILITY DECREASED (first day it was hard to lift the arm up) had resolved. On 05-Jun-2021, PAIN IN EXTREMITY (lot of arm soreness for the first 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Product dose omission issue, Rash
Clinical narrative: The patient has not received the second dose; severe rash/rash  4 inches by 4 inches in size; joint pain; headache; itchy rash; red rash; hives; extreme dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness), RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash), URTICARIA (hives) and PRODUCT DOSE OMISSION ISSUE (The patient has not received the second dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic and Drug allergy (epinephrine).    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (extreme dizziness). On 20-Apr-2021, the patient experienced RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash), URTICARIA (hives), RASH (severe rash/rash  4 inches by 4 inches in size), ARTHRALGIA (joint pain) and HEADACHE (headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient has not received the second dose). At the time of the report, DIZZINESS (extreme dizziness), RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash), URTICARIA (hives), PRODUCT DOSE OMISSION ISSUE (The patient has not received the second dose), RASH (severe rash/rash  4 inches by 4 inches in size), ARTHRALGIA (joint pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were  reported  for mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessment.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: The patient has not received the second dose; severe rash/rash  4 inches by 4 inches in size; joint pain; headache; itchy rash; red rash; hives; extreme dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness), RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash), URTICARIA (hives) and PRODUCT DOSE OMISSION ISSUE (The patient has not received the second dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic and Drug allergy (epinephrine).    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (extreme dizziness). On 20-Apr-2021, the patient experienced RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash), URTICARIA (hives), RASH (severe rash/rash  4 inches by 4 inches in size), ARTHRALGIA (joint pain) and HEADACHE (headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient has not received the second dose). At the time of the report, DIZZINESS (extreme dizziness), RASH PRURITIC (itchy rash), RASH ERYTHEMATOUS (red rash), URTICARIA (hives), PRODUCT DOSE OMISSION ISSUE (The patient has not received the second dose), RASH (severe rash/rash  4 inches by 4 inches in size), ARTHRALGIA (joint pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were  reported  for mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessment.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia
Clinical narrative: weakness in arm; Whole arm was affected,including shoulder and elbow soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in arm) and MYALGIA (Whole arm was affected,including shoulder and elbow soreness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced MUSCULAR WEAKNESS (weakness in arm) and MYALGIA (Whole arm was affected,including shoulder and elbow soreness). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, MUSCULAR WEAKNESS (weakness in arm) and MYALGIA (Whole arm was affected,including shoulder and elbow soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant products were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Vaccination site pain
Clinical narrative: weakness; light headiness; super super sore injection arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (light headiness), VACCINATION SITE PAIN (super super sore injection arm) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), DIZZINESS (light headiness), VACCINATION SITE PAIN (super super sore injection arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ASTHENIA (weakness), DIZZINESS (light headiness), VACCINATION SITE PAIN (super super sore injection arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant products were reported.   This case was linked to MOD-2021-242373 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Eye irritation
Clinical narrative: Eye irritation; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eye irritation) 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 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE IRRITATION (Eye irritation). At the time of the report, EYE IRRITATION (Eye irritation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: I felt tingling in my fingers; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (I felt tingling in my fingers) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included LOSARTAN for Blood pressure, LOVASTATIN for Cholesterol.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PARAESTHESIA (I felt tingling in my fingers). At the time of the report, PARAESTHESIA (I felt tingling in my fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.   This case was linked to MOD-2021-242471 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Myalgia
Clinical narrative: felt fuzzy; She reports that after the first shot she had a sore arm; little tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt fuzzy), MYALGIA (She reports that after the first shot she had a sore arm) and FATIGUE (little tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Arterial disorder, MACROGOL 3350 (MIRALAX) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FEELING ABNORMAL (felt fuzzy), MYALGIA (She reports that after the first shot she had a sore arm) and FATIGUE (little tired). At the time of the report, FEELING ABNORMAL (felt fuzzy), MYALGIA (She reports that after the first shot she had a sore arm) and FATIGUE (little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were provided.   This case was linked to MOD-2021-242413 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received and patient contact information updated.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: "caught covid"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ("caught covid") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 ("caught covid"). At the time of the report, COVID-19 ("caught covid") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Vaccination site pain
Clinical narrative: weakness; light headiness; super super sore injection arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (light headiness), VACCINATION SITE PAIN (super super sore injection arm) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), DIZZINESS (light headiness), VACCINATION SITE PAIN (super super sore injection arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ASTHENIA (weakness), DIZZINESS (light headiness), VACCINATION SITE PAIN (super super sore injection arm) and HEADACHE (headache) outcome was unknown.            Concomitant medication included anti-depressant in which the product used for unknown indication.    This case was linked to MOD-2021-242327 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: i had a cough for a week now at times i cough up mucous; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (i had a cough for a week now at times i cough up mucous) 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 PRODUCTIVE COUGH (i had a cough for a week now at times i cough up mucous).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant product use was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a patient received an expired vaccine; 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 (a patient received an expired vaccine) 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 EXPIRED PRODUCT ADMINISTERED (a patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  Pharmacist stated that a patient received an expired vaccine, and wanted to know if he could repeat the dose. No associated adverse events were reported.  No treatment medication was reported.