chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin increased, Hormone level abnormal, Insulin resistance, Laboratory test, Reproductive tract disorder
Clinical narrative: WEIGHT GAIN AROUND MIDDLE; ANXIETY BECAME WORSE; INSULIN RESISTANCE OVERNIGHT; BRAIN FOG BECAME WORSE; DEPRESSION BECAME WORSE; FEMALE ISSUES WORSENED; HIGH A1C; NEGATIVELY IMPACTED HORMONES, FEMALE MOSTLY; MADDENING; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hormone replacement therapy, anxiety, brain fog, and depression, and other pre-existing medical conditions included: She never had a high A1C, and already follow a lower carb diet. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-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 weight gain around middle, anxiety became worse, insulin resistance overnight, brain fog became worse, depression became worse, female issues worsened, high a1c, negatively impacted hormones, female mostly, and maddening. Laboratory data (dates unspecified) included: HbA1C (NR: not provided) high, and Lab test (NR: not provided) negatively impacted hormones. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from negatively impacted hormones, female mostly, weight gain around middle, anxiety became worse, insulin resistance overnight, brain fog became worse, depression became worse, female issues worsened, high a1c, and maddening. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: WEIGHT GAIN AROUND MIDDLE; ANXIETY BECAME WORSE; INSULIN RESISTANCE OVERNIGHT; BRAIN FOG BECAME WORSE; DEPRESSION BECAME WORSE; FEMALE ISSUES WORSENED; HIGH A1C; NEGATIVELY IMPACTED HORMONES, FEMALE MOSTLY; MADDENING; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hormone replacement therapy, anxiety, brain fog, and depression, and other pre-existing medical conditions included: She never had a high A1C, and already follow a lower carb diet. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-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 weight gain around middle, anxiety became worse, insulin resistance overnight, brain fog became worse, depression became worse, female issues worsened, high a1c, negatively impacted hormones, female mostly, and maddening. Laboratory data (dates unspecified) included: HbA1C (NR: not provided) high, and Lab test (NR: not provided) negatively impacted hormones. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from negatively impacted hormones, female mostly, weight gain around middle, anxiety became worse, insulin resistance overnight, brain fog became worse, depression became worse, female issues worsened, high a1c, and maddening. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement
Clinical narrative: BLOOD PRESSURE WENT CRAZY; 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. The patient's pre-existing medical conditions included: The patient blood pressure numbers were better than they had been for years just 3 months before taking the shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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, the patient experienced blood pressure went crazy. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood pressure went crazy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: DEATH; BLOOD CLOT; This spontaneous report received from a consumer via social media through 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, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date 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, following the vaccination developed blood clots and died six months later. On an unspecified date, the patient died from unknown cause of death. It was unspecified whether an autopsy was performed. The reporter reported that, "I heard today they completely pulled J and J off the market. I don't know for sure though. I was also told that a nurse was forced so she would not lose her job. She developed blood clots and died about 6 months later." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: 20220236855-COVID-19 VACCINE AD26.COV2.S-Death,Blood clots. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS AFTER BLOWING NOSE; This spontaneous report received from a patient concerned a 67 year old white and non hispanic or latino patient of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, non-smoker, and non alcohol consumer, and other pre-existing medical conditions included: the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the patient experienced blood clots after blowing nose. About 4 out of 7 times, when the patient blew the nose, the patient got a lot of blood clot. It always happened in the morning and the patient had not a runny nose at those times. There were also no nosebleeds. The patient discussed it with rheumatologist, but they did not say much about it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots after blowing nose. This report was serious (Other Medically Important Condition). Sender's Comments: V0.20220236868- covid-19 vaccine ad26.cov2.s - Blood clots after blowing nose. 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).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: SHINGLES; FELLING MISERABLE; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, 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. No concomitant medications were reported. On an unspecified date, the patient experienced shingles, and felling miserable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shingles and felling miserable was not reported. This report was non-serious. This case, from the same reporter is linked to 20220236609.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (fully vaccination consumer, tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced COVID-19 (fully vaccination consumer, tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (fully vaccination consumer, tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. Company comment: This case concerns an 88-year-old male patient, who developed the unexpected event of COVID-19, about 5 months after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report. Sender's Comments: This case concerns an 88-year-old male patient, who developed the unexpected event of COVID-19, about 5 months after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired gastric emptying
Clinical narrative: Gastroparesis; This spontaneous case was reported by a physician and describes the occurrence of IMPAIRED GASTRIC EMPTYING (Gastroparesis) in a 36-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 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 IMPAIRED GASTRIC EMPTYING (Gastroparesis) (seriousness criterion medically significant). At the time of the report, IMPAIRED GASTRIC EMPTYING (Gastroparesis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  It was reported that patient had symptoms after receiving two doses of Moderna vaccine.  Treatment medication was not given.  Company Comment: This spontaneous case concerns a 36-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of impaired gastric emptying (LLT: gastroparesis). The event occurred on an unspecified date after administration of the second dose of the Moderna mRNA-1273 vaccine on an unspecified date. Treatment information and outcome of the event were unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 36-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of impaired gastric emptying (LLT: gastroparesis). The event occurred on an unspecified date after administration of the second dose of the Moderna mRNA-1273 vaccine on an unspecified date. Treatment information and outcome of the event were unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body Aches returned about 4 months after 2nd shot; Body aches after 2nd shot/Diagnosed with "vaccine related body aches" after 2nd shot; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (Body aches after 2nd shot/Diagnosed with "vaccine related body aches" after 2nd shot) and MYALGIA (Body Aches returned about 4 months after 2nd shot) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced MYALGIA (Body aches after 2nd shot/Diagnosed with "vaccine related body aches" after 2nd shot) (seriousness criterion hospitalization). On 01-Feb-2022, the patient experienced MYALGIA (Body Aches returned about 4 months after 2nd shot) (seriousness criterion hospitalization). At the time of the report, MYALGIA (Body aches after 2nd shot/Diagnosed with "vaccine related body aches" after 2nd shot) had resolved and MYALGIA (Body Aches returned about 4 months after 2nd shot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, Pt took 2 doses of Moderna COVID-19 vaccine. First dose: 5 months ago (Lot# and Exp. Date: Unknown) and 2nd shot 4 months ago (Lot# and Exp. Date: Unknown). After the second dose(4 months ago), Pt had body aches. He went to the hospital and was told that it is vaccine related. About 10 days ago, the body aches returned. Pt was healthy prior to vaccination and not had medical history of any type of disease.  Concomitant medication was not provided Treatment information was not reported.  Company comment:This case concerns  a 24-year-old male patient  with no medical history, who experienced the serious events of Myalgia (2 episodes). The first episode occurred in the same month the patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The second episode of Myalgia occurred approximately 4 months after his second dose. The patient was hospitalized and was told it was vaccine related.).The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender's Comments: This case concerns  a 24-year-old male patient  with no medical history, who experienced the serious events of Myalgia (2 episodes). The first episode occurred in the same month the patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The second episode of Myalgia occurred approximately 4 months after his second dose. The patient was hospitalized and was told it was vaccine related.).The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacist call because they gave a expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist call because they gave a expired vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist call because they gave a expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist call because they gave a expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication included Prostate medication No Treatment medications reported.   This case was linked to MOD-2022-482662 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist call because they gave a expired vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2022 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist call because they gave a expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist call because they gave a expired vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient height was reported as 5 feet 9 inches. Patient had no allergies related to medications, food and other products. There was no concomitant list provided by the reporter. Patient did not received other vaccines within 1 month prior to Moderna COVID-19 vaccine. It was unknown whether AE cause patient to seek medical care. It was unknown whether patient experienced a similar event in the past and the symptoms were improved or worsened. It was unknown whether patient ever had COVID positive test or diagnosis. No treatment information was provided. It was reported that vials were never stored in the refrigerator and were kept at -12 degree Fahrenheit. When vial was took out of the freezer was left for 2 hours at room temperature. This case was linked to MOD-2022-482624 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Systemic lupus erythematosus
Clinical narrative: Lupus; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (From COVID, patient could not breath, went to the hospital, got a chest x-ray) in March 2020.   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) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus) (seriousness criterion medically significant). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: result not reported (Inconclusive) Result not reported. On an unknown date, Blood test: result not reported (Inconclusive) Result not reported.         Patient was on no concomitant medication.  On an unknown date in Oct-2021, the patient started to experience a skin rash. Patient had pretty severe skin rash. Patient was seeing a dermatologist specialist and everything. They have no idea what it was. They have done biopsies, given patient a topical steroid cream, prednisone, and blood tests. The doctors were saying that patient had an autoimmune deficiency, and diagnosed with Lupus.  Company Comment: This spontaneous case concerns a 56-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Systemic lupus erythematosus. The patient developed a severe skin rash after the vaccination for which biopsy and blood tests were performed and the dermatologist prescribed topical steroid cream and prednisone; it was further diagnosed as Lupus. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Systemic lupus erythematosus. The patient developed a severe skin rash after the vaccination for which biopsy and blood tests were performed and the dermatologist prescribed topical steroid cream and prednisone; it was further diagnosed as Lupus. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Limb discomfort, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (from  his elbow to his finger tips, he lost a lot of mobility/but can't use his left arm like he use to), LIMB DISCOMFORT (some days can use arm really well/other days seem like is not alot of muscle there/can't carry anything more 50 pounds), PAIN IN EXTREMITY (had symptoms/the first three days suck/his left arm hurt) and FEELING ABNORMAL (It is like a felling like the body telling him like a disconfirm felling, not a pain or ache) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2022, the patient experienced MOBILITY DECREASED (from  his elbow to his finger tips, he lost a lot  of mobility/but can't use his left arm like he use to) and PAIN IN EXTREMITY (had symptoms/the first three days suck/his left arm hurt). On an unknown date, the patient experienced LIMB DISCOMFORT (some days can use arm really well/other days seem like is not alot of muscle there/can't carry anything  more 50 pounds) and FEELING ABNORMAL (It is like a felling like the body telling him like a disconfirm felling, not a pain or ache). At the time of the report, MOBILITY DECREASED (from  his elbow to his finger tips, he lost a lot  of mobility/but can't use his left arm like he use to) and LIMB DISCOMFORT (some days can use arm really well/other days seem like is not alot of muscle there/can't carry anything  more 50 pounds) had not resolved and PAIN IN EXTREMITY (had symptoms/the first three days suck/his left arm hurt) and FEELING ABNORMAL (It is like a felling like the body telling him like a disconfirm felling, not a pain or ache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was provided by the reporter. Patient reported that symptoms was not got worse or better, but remains the same. No treatment was provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Pruritus, Vaccination site erythema, Vaccination site mass
Clinical narrative: skin was rough to the touch; injection site hot; redness and itchiness spread almost to elbowand to chest; redness and itchiness spread almost to elbowand to chest; injection site itching; rounded lump around injection site; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (skin was rough to the touch), VACCINATION SITE WARMTH (injection site hot), PRURITUS (redness and itchiness spread almost to elbowand to chest), ERYTHEMA (redness and itchiness spread almost to elbowand to chest) and VACCINATION SITE PRURITUS (injection site itching) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (injection site hot), PRURITUS (redness and itchiness spread almost to elbowand to chest), ERYTHEMA (redness and itchiness spread almost to elbowand to chest), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE MASS (rounded lump around injection site) and VACCINATION SITE ERYTHEMA (injection site red). On an unknown date, the patient experienced DRY SKIN (skin was rough to the touch). At the time of the report, DRY SKIN (skin was rough to the touch) outcome was unknown and VACCINATION SITE WARMTH (injection site hot), PRURITUS (redness and itchiness spread almost to elbowand to chest), ERYTHEMA (redness and itchiness spread almost to elbowand to chest), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE MASS (rounded lump around injection site) and VACCINATION SITE ERYTHEMA (injection site red) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  3 to 4 days after receiving her first dose of the Moderna COVID 19 vaccine she experienced itching and a rounded red hot lump around her injection site. This redness and itchiness spread almost to her elbow and to her chest. Patient called her dermatologist who recommended antihistamines which did not help very much but she slowly started to heal after about 1 month. The symptoms were alarming to her and she was concerned about anaphylaxis. She consulted an allergist who encouraged her to get a second dose. Patient has never previously been diagnosed with COVID 19.   This case was linked to MOD-2022-483265, MOD-2022-481671 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: skin was rough to the touch; injection site hot; redness and itchiness spread almost to elbowand to chest; redness and itchiness spread almost to elbowand to chest; injection site itching; rounded lump around injection site; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (skin was rough to the touch), VACCINATION SITE WARMTH (injection site hot), PRURITUS (redness and itchiness spread almost to elbowand to chest), ERYTHEMA (redness and itchiness spread almost to elbowand to chest) and VACCINATION SITE PRURITUS (injection site itching) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (injection site hot), PRURITUS (redness and itchiness spread almost to elbowand to chest), ERYTHEMA (redness and itchiness spread almost to elbowand to chest), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE MASS (rounded lump around injection site) and VACCINATION SITE ERYTHEMA (injection site red). On an unknown date, the patient experienced DRY SKIN (skin was rough to the touch). At the time of the report, DRY SKIN (skin was rough to the touch) outcome was unknown and VACCINATION SITE WARMTH (injection site hot), PRURITUS (redness and itchiness spread almost to elbowand to chest), ERYTHEMA (redness and itchiness spread almost to elbowand to chest), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE MASS (rounded lump around injection site) and VACCINATION SITE ERYTHEMA (injection site red) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  3 to 4 days after receiving her first dose of the Moderna COVID 19 vaccine she experienced itching and a rounded red hot lump around her injection site. This redness and itchiness spread almost to her elbow and to her chest. Patient called her dermatologist who recommended antihistamines which did not help very much but she slowly started to heal after about 1 month. The symptoms were alarming to her and she was concerned about anaphylaxis. She consulted an allergist who encouraged her to get a second dose. Patient has never previously been diagnosed with COVID 19.   This case was linked to MOD-2022-483265, MOD-2022-481671 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Rash
Clinical narrative: Rash; Headache; Fatigue; General aches for a few days; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (General aches for a few days) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RASH (Rash), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (General aches for a few days). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in 2021 for Rash, Headache, Fatigue and Myalgia, at an unspecified dose and frequency. In 2021, HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (General aches for a few days) had resolved. At the time of the report, RASH (Rash) was resolving.            No concomitant medications were reported. It was reported that her rash had not resolved at the time of the second dose but had improved significantly and she had not experienced any symptoms for the months between her rash resolving and the booster dose of the vaccine. It was reported that there was no product complaint associated. Treatment medication information: she may have taken a Tylenol once or twice for her symptoms.   This case was linked to MOD-2022-483243, MOD-2022-481671 (Patient Link).
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First full doses of the Covid Moderna vaccine in March and May of 2021, Moderna booster shot on September 29, 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First full doses of the Covid Moderna vaccine in March and May of 2021, Moderna booster shot on September 29, 2021) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First full doses of the Covid Moderna vaccine in March and May of 2021, Moderna booster shot on September 29, 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First full doses of the Covid Moderna vaccine in March and May of 2021, Moderna booster shot on September 29, 2021) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after vial being punctured and left at room temperature for almost 23 hours) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after vial being punctured and left at room temperature for almost 23 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered after vial being punctured and left at room temperature for almost 23 hours) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter. It was reported that the vial was initially stored in refrigerator on 28-Jan-2022 and the vial was first punctured on 13-Feb-2022 at 11:11 AM. The vial was punctured and then left at room temperature range (8 Degree Celsius to 25 Degree Celsius) for about 23 hours. Patient was administered with the vaccine on 14-Feb-2022. The vial did not undergo any temperature excursions. Reporter stated that they gave the patient two doses at their facility but was not sure if this is their booster or second dose.  No treatment medication was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: an immunocompromised patient received a booster dose of the Moderna Covid-19 Vaccine in the past instead of a 3rd full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (an immunocompromised patient received a booster dose of the Moderna Covid-19 Vaccine in the past instead of a 3rd full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (an immunocompromised patient received a booster dose of the Moderna Covid-19 Vaccine in the past instead of a 3rd full dose). At the time of the report, ACCIDENTAL UNDERDOSE (an immunocompromised patient received a booster dose of the Moderna Covid-19 Vaccine in the past instead of a 3rd full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No any concomitant medications were reported. No any treatment medications were reported.  Reporter stated that an immunocompromised patient received a booster dose of the Moderna Covid-19 Vaccine in the past instead of a 3rd full dose. The patient received Moderna for their 1st two doses.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: down for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (down for 3 days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Has not gotten since. Bad reaction and stayed home for days and wasn't feeling well.) in 2005. Past adverse reactions to the above products included Sickness with Flu shot. Concurrent medical conditions included Diabetes, Hypertension, Hypercholesterolaemia, Drug allergy (Cannot use hydrocodone and depo - had reaction many years ago.) and Food allergy (Food and other products). Concomitant products included ATORVASTATIN for Hypercholesterolaemia, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOORTHIAZIDE) for Hypertension.    On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2022, the patient experienced DEPRESSED MOOD (down for 3 days). The patient was treated with MELATONIN at a dose of 5 milligram, softgel before bedtime. In January 2022, DEPRESSED MOOD (down for 3 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication include GARDANCE 10mg once a day for diabetes.   This case was linked to MOD-2022-483426 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 003J21/2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Brand: Flu Fluarix Lot #: D7AE5 Route: Intramuscular Dose: 0.5ml) on 18-Jan-2022. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose). On 05-Feb-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Follow up received contains non-significant information.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 003J21/2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu Fluarix (Lot-D7AE5, route-Intramuscular and dose- 0.5ml.) on 18-Jan-2022. Past adverse reactions to the above products included No adverse event with Flu Fluarix.   On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 05-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the Second Moderna Covid-19 dose 18 days after the Moderna Covid-19 First Dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported. The patients did not  experienced any symptoms and did not seek for medical care.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Non-significant follow-up, reporter fax number added.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Variability of menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Variability of menstrual cycle) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced MENSTRUAL DISORDER (Variability of menstrual cycle). At the time of the report, MENSTRUAL DISORDER (Variability of menstrual cycle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experiencing ongoing variability in menstrual cycle to the point where it was unacceptable. Had followed up with OBGYN to do ultrasounds looking for cause. No attributable cause.She reported to V-safe. It had been stated that wanted to report to AE hotline feels "it needs to be taken more seriously by Moderna" States she was frustrated because she bled all of January said just started period again today after only 2 weeks.  No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-483763 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Limb discomfort, Pulmonary calcification, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke into hives every day, in arms, hand, everywhere), HYPERTENSION (blood pressure was outrageous/high), LIMB DISCOMFORT (blockage in both legs) and PULMONARY CALCIFICATION (calcified spot in left lung) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 02-Jan-2022. Concurrent medical conditions included Allergy to antibiotic (Amoxicillin allergy) and Penicillin allergy (penicillin Allergy). In February 2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (broke into hives every day, in arms, hand, everywhere), HYPERTENSION (blood pressure was outrageous/high), LIMB DISCOMFORT (blockage in both legs) and PULMONARY CALCIFICATION (calcified spot in left lung). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, URTICARIA (broke into hives every day, in arms, hand, everywhere), HYPERTENSION (blood pressure was outrageous/high), LIMB DISCOMFORT (blockage in both legs) and PULMONARY CALCIFICATION (calcified spot in left lung) had not resolved. Concomitant medications nerve blockers were provided. Patient went emergency room (ER) three times because of the hives, and went to the doctors numbers of times, and got steroid shots and pills. Additional treatment steroids were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 Expired moderna covid-19 dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Expired moderna covid-19 dose administered) 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 14-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Expired moderna covid-19 dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Expired moderna covid-19 dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccine was supposed to expire on 12-FEB-2022 (30 BUD) and was administered on 14-FEB-2022;  Concomitant medication information was not reported Treatment information was not reported
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: 0.25mL given for 2nd dose; dose interval greater than 35 days; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (0.25mL given for 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose interval greater than 35 days) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 084J21A) for COVID-19 vaccination.     The patient's past medical history included Neutropenia and COVID-19 (First diagnosed in November 30, 2020) on 30-Nov-2020. Concurrent medical conditions included Diabetes and Penicillin allergy. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 02-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (0.25mL given for 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose interval greater than 35 days). At the time of the report, ACCIDENTAL UNDERDOSE (0.25mL given for 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose interval greater than 35 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient medical history includes other mental health issues.  It was reported inmate received a 0.25 mL for a 2nd dose of Moderna instead of 0.5 mL. Asked if he should gave another 0.25 mL to make a full dose.  No treatment information details were reported.