chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRY VISION; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and high blood pressure, and other pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blurry vision was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED JANSSEN COVID-19 VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 04-OCT-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced expired janssen covid-19 vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired janssen covid-19 vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: RINGING IN EARS INTERMITTENTLY WHICH TURNED INTO CONSTANT HIGH PITCHED INSANE RINGING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced ringing in ears intermittently which turned into constant high pitched insane ringing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ears intermittently which turned into constant high pitched insane ringing. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced elevated blood pressure. On SEP-2021, the patient experienced swollen lymph nodes in neck/swollen lymph nodes in groin. On SEP-2021, the patient experienced spiked fever. Laboratory data included: Blood pressure (NR: not provided) elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spiked fever, elevated blood pressure and swollen lymph nodes in neck/swollen lymph nodes in groin was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 02-OCT-2021) dose was not reported, administered on 03-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-OCT-2021, the patient experienced expired product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fall, Weight increased
Clinical narrative: FALL; WEIGHT GAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: depression, chipped bone thumb, gall stone, gall bladder removed, anxiety, shaking, urinary urgency, and pain, and concurrent conditions included: multiple sclerosis. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, clonazepam, cyanocobalamin, ergocalciferol, escitalopram, fish oil, naproxen sodium, ocrelizumab, and oxybutynin. On an unspecified date, the patient experienced fall, and weight gain. The action taken with covid-19 vaccine was not applicable. The outcome of the fall and weight gain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF VACCINE PAST EXPIRATION DATE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-OCT-2021, the patient experienced administration of vaccine past expiration date. The action taken with covid-19 vaccine was not applicable. The outcome of administration of vaccine past expiration date was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PASSES FROM LIFE TO DEATH; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, as per the reporter "my mom passes from life to death from your vaccine". Patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211006389-covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Lacrimation increased, Nasopharyngitis, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: HEAD CONGESTION; CHEST CONGESTION; WATERY EYES; COUGH; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 01-OCT-2021, the patient experienced head congestion. On 01-OCT-2021, the patient experienced chest congestion. On 01-OCT-2021, the patient experienced watery eyes. On 01-OCT-2021, the patient experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the head congestion, chest congestion, watery eyes and cough was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 41 year old female. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 201A21A and expiry: 21-SEP-2021) dose was not reported, frequency 1 total, administered on 22-JUL-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 19-SEP-2021, the patient started experiencing covid-19 infection symptoms (confirmed clinical vaccination failure). On 26-SEP-2021, polymerase chain reaction (PCR) test was performed and on 01-OCT-2021, the test result was positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number 90000195846.; Sender's Comments: V0: 20211006398-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A31A, expiry: 21-SEP-2021) dose was not reported, administered on 01-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Hyperhidrosis, Nasopharyngitis, Pyrexia
Clinical narrative: COLD; WARM; SWEATING VERY BAD; KICKED IN REALLY HEAVY; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced cold, warm, sweating very bad, kicked in really heavy, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 39 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the kicked in really heavy, fever, cold, warm and sweating very bad, was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: COLD; WARM; SWEATING VERY BAD; KICKED IN REALLY HEAVY; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced cold, warm, sweating very bad, kicked in really heavy, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 39 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the kicked in really heavy, fever, cold, warm and sweating very bad, was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED AN EXPIRED DOSE OF VACCINE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 02-OCT-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-OCT-2021, the patient experienced administered an expired dose of vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administered an expired dose of vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: CHEST PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-OCT-2021, the patient experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient didn't experience any adverse event after the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: A LITTLE SORENESS IN THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced a little soreness in the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little soreness in the injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Menstrual disorder
Clinical narrative: MORNING HEAT SIMILAR TO HOT FLASHES; ALTERATIONS IN MENSTRUAL CYCLE (MENSTRUATING EVERY 18 DAYS); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced morning heat similar to hot flashes, and alterations in menstrual cycle (menstruating every 18 days). The action taken with covid-19 vaccine  was not applicable. The outcome of the morning heat similar to hot flashes and alterations in menstrual cycle (menstruating every 18 days) was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Pain in extremity
Clinical narrative: SLIGHT SORENESS IN THE RIGHT ARM; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no relevant medical history and No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, Laboratory data included: Pain scale (NR: not provided) 0.5-1/10. On 04-MAY-2021, the patient experienced slight soreness in the right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight soreness in the right arm on MAY-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Musculoskeletal pain
Clinical narrative: CHEST PAIN EVERYDAY; VERY TIRED; TERRIBLE MUSCLE AND JOINT PAIN EVERY SINGLE DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 03-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included acetylsalicylic acid. On an unspecified date, the patient experienced chest pain everyday, very tired, and terrible muscle and joint pain every single day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very tired, chest pain everyday and terrible muscle and joint pain every single day was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Oral disorder, Oral mucosal blistering
Clinical narrative: PAINLESS BUMPS INSIDE THE MOUTH ALONG THE UPPER AND LOWER LIPS; PAINLESS BLISTERS INSIDE THE MOUTH ALONG THE UPPER AND LOWER LIPS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: neck injury, neck fusion surgery, sinus issue, and shortness of breath. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced painless bumps inside the mouth along the upper and lower lips, and painless blisters inside the mouth along the upper and lower lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painless bumps inside the mouth along the upper and lower lips, and painless blisters inside the mouth along the upper and lower lips. This report was non-serious.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dermatitis contact, Laboratory test, Pyrexia
Clinical narrative: Chills; Fever; Very itchy rash on right fore arm/ Allergic contact dermatitis/ Rash from elbow down arm which looks like poison ivy/ Itching like crazy; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Very itchy rash on right fore arm/ Allergic contact dermatitis/ Rash from elbow down arm which looks like poison ivy/ Itching like crazy), CHILLS (Chills) and PYREXIA (Fever) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 010M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included SIMVASTATIN and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DERMATITIS CONTACT (Very itchy rash on right fore arm/ Allergic contact dermatitis/ Rash from elbow down arm which looks like poison ivy/ Itching like crazy). On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with TRIAMCINOLONE ACETONIDE (TRIAMCINOLON [TRIAMCINOLONE ACETONIDE]) on 05-Apr-2021 for Allergic contact dermatitis, at a dose of 1 dosage form once a day and CETIRIZINE HCL for Adverse event, at a dose of 10 milligram. At the time of the report, DERMATITIS CONTACT (Very itchy rash on right fore arm/ Allergic contact dermatitis/ Rash from elbow down arm which looks like poison ivy/ Itching like crazy) was resolving and CHILLS (Chills) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: negative (Negative) Possible shingles was tested negative.         On 25-Mar-2021, after second vaccination, the patient noticed a very itchy rash on right forearm. Initially the patient thought of it as poison ivy. It started to spread to more of forearm.  On 05-Apr-2021, the patient visited a dermatologist and the rash was diagnosed as allergic contact dermatitis. The patient was prescribed with triamcinolone acetonide to be used daily.  On 19-Apr-2021, during follow-up exam, the rash had mostly gone away.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow-up received: lab data, concomitant, treatment medication and event verbatim and coding of rash were updated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: loose stool/watery diarrhea; arm was sore; She felt a little tired that night (23/Jul/2021) and the next day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (loose stool/watery diarrhea), PAIN IN EXTREMITY (arm was sore) and FATIGUE (She felt a little tired that night (23/Jul/2021) and the next day) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced PAIN IN EXTREMITY (arm was sore) and FATIGUE (She felt a little tired that night (23/Jul/2021) and the next day). On 24-Jul-2021, the patient experienced DIARRHOEA (loose stool/watery diarrhea). On 25-Jul-2021, PAIN IN EXTREMITY (arm was sore) had resolved. At the time of the report, DIARRHOEA (loose stool/watery diarrhea) and FATIGUE (She felt a little tired that night (23/Jul/2021) and the next day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient did not take  any medication as a corrective treatment.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up information include event myalgia recoded with pain in extremity.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm hurt a little after first dose; Little lump after first dose; A bit swollen after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm hurt a little after first dose/arm hurt a  little after second dose), VACCINATION SITE INDURATION (little lump after first dose/little lump after second dose) and VACCINATION SITE SWELLING (a bit swollen after second dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder and Immunoglobulins abnormal. Concomitant products included HYDROCORTISONE, PREDNISOLONE, FLUDROCORTISONE, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR HFA), LORAZEPAM (ATIVAN), POTASSIUM CHLORIDE, OXYTOCIN and CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm hurt a little after first dose/arm hurt a  little after second dose), VACCINATION SITE INDURATION (little lump after first dose/little lump after second dose) and VACCINATION SITE SWELLING (a bit swollen after second dose). At the time of the report, VACCINATION SITE PAIN (arm hurt a little after first dose/arm hurt a  little after second dose), VACCINATION SITE INDURATION (little lump after first dose/little lump after second dose) and VACCINATION SITE SWELLING (a bit swollen after second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included thyroid medication112mcg/daily,vitamins every day, over the counter,asthma medication as needed, migraine medication as needed, itchy skin medication as needed, IBS stomach medication as needed nausea as needed. No Treatment was provided. Symptoms lasted for a couple of days. Lab data was not provided.   This case was linked to MOD-2021-272102 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up received on 20-SEP-2021 contain updated reporter information. Antibody test and concomitant information updated from the initial version.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast pain, Erythema, Lymphoedema, Rash
Clinical narrative: bright red; tightness in the breast; lymphoedema; thought it was a rash from a fungus/  it was no fungus / rash is still present but it's so much better; Sharp pain in breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Sharp pain in breast), ERYTHEMA (bright red), BREAST DISCOMFORT (tightness in the breast), LYMPHOEDEMA (lymphoedema) and RASH (thought it was a rash from a fungus/  it was no fungus / rash is still present but it's so much better) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Surgery (lymph nodes removed on the left side 11 years ago). Concomitant products included ROSUVASTATIN for Blood cholesterol abnormal, CALCIUM and VALACICLOVIR for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced BREAST PAIN (Sharp pain in breast) and RASH (thought it was a rash from a fungus/  it was no fungus / rash is still present but it's so much better). On an unknown date, the patient experienced ERYTHEMA (bright red), BREAST DISCOMFORT (tightness in the breast) and LYMPHOEDEMA (lymphoedema). The patient was treated with DOXYCYCLINE for Infection, at a dose of for 4 to 5 weeks; CEFADROXIL for Infection, at a dose of for 4 to 5 weeks and CORTISONE at a dose of for 4 to 5 weeks. At the time of the report, BREAST PAIN (Sharp pain in breast), ERYTHEMA (bright red) and BREAST DISCOMFORT (tightness in the breast) outcome was unknown and LYMPHOEDEMA (lymphoedema) and RASH (thought it was a rash from a fungus/  it was no fungus / rash is still present but it's so much better) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data includes biopsy which was fine and sonic gram and a mammogram with unknown results.  Treatment included topical steroid cream from 05-MAY-2021 to 06-APR-2021   This case was linked to MOD-2021-274985.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up received contains significant information: Added event and treatment
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Therapeutic response unexpected
Clinical narrative: lot of agony; first shot  removed the pain/soreness she was having from flu shot in Nov2020; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (first shot  removed the pain/soreness she was having from flu shot in Nov2020) and PAIN (lot of agony) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) 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) (Intramuscular) 1 dosage form. In November 2020, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (first shot  removed the pain/soreness she was having from flu shot in Nov2020). On an unknown date, the patient experienced PAIN (lot of agony). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (first shot  removed the pain/soreness she was having from flu shot in Nov2020) had resolved and PAIN (lot of agony) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment information was not provided.   This case was linked to MOD-2021-276741 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received included event addition and patient initials was updated..
Sex: F
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Electrolyte imbalance, Feeling hot, Hypoaesthesia, Pain in extremity
Clinical narrative: Both arms feel a little hot; Electrolyte imbalance; Carpal tunnel syndrome; The pain on her lower arms would still occur once in a while and she says that they feel a little hot.; Tingling on her fingers - the right pinky, 4th and maybe even the 3rd; Weird numbness on her fingers; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on her fingers - the right pinky, 4th and maybe even the 3rd), HYPOAESTHESIA (Weird numbness on her fingers), FEELING HOT (Both arms feel a little hot), ELECTROLYTE IMBALANCE (Electrolyte imbalance) and PAIN IN EXTREMITY (The pain on her lower arms would still occur once in a while and she says that they feel a little hot.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced PARAESTHESIA (Tingling on her fingers - the right pinky, 4th and maybe even the 3rd), HYPOAESTHESIA (Weird numbness on her fingers) and PAIN IN EXTREMITY (The pain on her lower arms would still occur once in a while and she says that they feel a little hot.). On an unknown date, the patient experienced FEELING HOT (Both arms feel a little hot), ELECTROLYTE IMBALANCE (Electrolyte imbalance) and CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome). At the time of the report, PARAESTHESIA (Tingling on her fingers - the right pinky, 4th and maybe even the 3rd), HYPOAESTHESIA (Weird numbness on her fingers), FEELING HOT (Both arms feel a little hot), ELECTROLYTE IMBALANCE (Electrolyte imbalance) and PAIN IN EXTREMITY (The pain on her lower arms would still occur once in a while and she says that they feel a little hot.) had not resolved and CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome) outcome was unknown.            No concomitant medications information was not reported No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Significant follow-up, gender of patient and event was added.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Both arms feel a little hot; Electrolyte imbalance; Carpal tunnel syndrome; The pain on her lower arms would still occur once in a while and she says that they feel a little hot.; Tingling on her fingers - the right pinky, 4th and maybe even the 3rd; Weird numbness on her fingers; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on her fingers - the right pinky, 4th and maybe even the 3rd), HYPOAESTHESIA (Weird numbness on her fingers), FEELING HOT (Both arms feel a little hot), ELECTROLYTE IMBALANCE (Electrolyte imbalance) and PAIN IN EXTREMITY (The pain on her lower arms would still occur once in a while and she says that they feel a little hot.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced PARAESTHESIA (Tingling on her fingers - the right pinky, 4th and maybe even the 3rd), HYPOAESTHESIA (Weird numbness on her fingers) and PAIN IN EXTREMITY (The pain on her lower arms would still occur once in a while and she says that they feel a little hot.). On an unknown date, the patient experienced FEELING HOT (Both arms feel a little hot), ELECTROLYTE IMBALANCE (Electrolyte imbalance) and CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome). At the time of the report, PARAESTHESIA (Tingling on her fingers - the right pinky, 4th and maybe even the 3rd), HYPOAESTHESIA (Weird numbness on her fingers), FEELING HOT (Both arms feel a little hot), ELECTROLYTE IMBALANCE (Electrolyte imbalance) and PAIN IN EXTREMITY (The pain on her lower arms would still occur once in a while and she says that they feel a little hot.) had not resolved and CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome) outcome was unknown.            No concomitant medications information was not reported No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Significant follow-up, gender of patient and event was added.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Improper storage of product in use; Called to provide patient information (Administered improperly stored vaccine); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Called to provide patient information (Administered improperly stored vaccine)) and PRODUCT STORAGE ERROR (Improper storage of product in use) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Called to provide patient information (Administered improperly stored vaccine)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Improper storage of product in use). On 08-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Called to provide patient information (Administered improperly stored vaccine)) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Improper storage of product in use) 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 was provided by the reporter. The vial was moved from the freezer to the refrigerator on 09-Jul-2021. The vials were first punctured on 11-Jul-2021. The vial was left in the refrigerator and on 08-Aug-2021 patient was given doses from the expired vial.  No treatment was provided by the reporter.   This case was linked to MOD21-128181, MOD21-128210 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up information include an extra event was added as per MSA comment On 09-Aug-2021: Follow-up information include no new information
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: He felt like he had something he needed to cough up but couldn't.; Lack of efficacy; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), FEELING ABNORMAL (He felt like he had something he needed to cough up but couldn't.) and DRUG INEFFECTIVE (Lack of efficacy) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). On an unknown date, the patient experienced FEELING ABNORMAL (He felt like he had something he needed to cough up but couldn't.). At the time of the report, COVID-19 (Tested positive for COVID-19), FEELING ABNORMAL (He felt like he had something he needed to cough up but couldn't.) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient was treated with unspecified antibodies on 08-Aug-2021.   This case was linked to MOD-2021-125093, MOD-2021-128278, MOD-2021-128330 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Upon internal review on 30-Sep-2021, events of tested positive for COVID-19 and lack of drug effect were added.; Sender's Comments: This case concerns an 82-year-old, male patient with no disclosed medical history, who experienced the unexpected events of Covid-19 and feeling abnormal; Drug ineffective was considered as an additional event. The events occurred approximately 5 months after second dose of Moderna vaccine. The patient's old age may have increased his risk of getting infected with Covid-19. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeding disorder, Feeling cold, Headache, Insomnia
Clinical narrative: freezing cold; arm hurt; covid arm; couldn't eat; couldn't sleep; fatigue; massive headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freezing cold), PAIN IN EXTREMITY (arm hurt), VACCINATION COMPLICATION (covid arm), FEEDING DISORDER (couldn't eat) and INSOMNIA (couldn't sleep) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (freezing cold), PAIN IN EXTREMITY (arm hurt), VACCINATION COMPLICATION (covid arm), FEEDING DISORDER (couldn't eat), INSOMNIA (couldn't sleep), FATIGUE (fatigue) and HEADACHE (massive headache). At the time of the report, FEELING COLD (freezing cold), PAIN IN EXTREMITY (arm hurt), VACCINATION COMPLICATION (covid arm), FEEDING DISORDER (couldn't eat), INSOMNIA (couldn't sleep), FATIGUE (fatigue) and HEADACHE (massive headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-283924 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: freezing cold; arm hurt; covid arm; couldn't eat; couldn't sleep; fatigue; massive headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freezing cold), PAIN IN EXTREMITY (arm hurt), VACCINATION COMPLICATION (covid arm), FEEDING DISORDER (couldn't eat) and INSOMNIA (couldn't sleep) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (freezing cold), PAIN IN EXTREMITY (arm hurt), VACCINATION COMPLICATION (covid arm), FEEDING DISORDER (couldn't eat), INSOMNIA (couldn't sleep), FATIGUE (fatigue) and HEADACHE (massive headache). At the time of the report, FEELING COLD (freezing cold), PAIN IN EXTREMITY (arm hurt), VACCINATION COMPLICATION (covid arm), FEEDING DISORDER (couldn't eat), INSOMNIA (couldn't sleep), FATIGUE (fatigue) and HEADACHE (massive headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-283924 (Patient Link).
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Greater than 12 hours after initial vial puncture; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial puncture) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling cold
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back is hurting), FEELING COLD (cold with chills) and CHILLS (chills this morning) 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 BACK PAIN (back is hurting), FEELING COLD (cold with chills) and CHILLS (chills this morning). At the time of the report, BACK PAIN (back is hurting), FEELING COLD (cold with chills) and CHILLS (chills this morning) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact.