chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.  Pharmacist received vaccine on 28-MAY-2021 and used on  27-JUN-2021 after refrigeration. She never used the lot until the vial was used on twenty patients.Pharmacist quarantined them as unusable.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received on 6-JUL-2021 contains no significant information. On 07-Jul-2021: Follow-up details were received and does not contains any significant information: patient details were updated.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: real achy; had a little bit of fever one day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (real achy) and PYREXIA (had a little bit of fever one day) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (real achy) and PYREXIA (had a little bit of fever one day). At the time of the report, MYALGIA (real achy) and PYREXIA (had a little bit of fever one day) was resolving.            Patient takes concomitant medications but denied providing them. No Treatment information was provided.    This case was linked to MOD-2021-020886 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Product storage error, Vaccination site pain
Clinical narrative: Vaccine was sitting out at room temperature/ Pharmacist did not do a good job administering/Due to heat; Reaction; Pain in arm at injection site / Chronic pain in left arm from injectionsite to just above elbow joint; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was sitting out at room temperature/ Pharmacist did not do a good job administering/Due to heat), VACCINATION SITE PAIN (Pain in arm at injection site / Chronic pain in left arm from injectionsite to just above elbow joint) and HYPERSENSITIVITY (Reaction) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Anxiety. Concomitant products included VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Anxiety.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm at injection site / Chronic pain in left arm from injectionsite to just above elbow joint). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was sitting out at room temperature/ Pharmacist did not do a good job administering/Due to heat) and HYPERSENSITIVITY (Reaction). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PRODUCT STORAGE ERROR (Vaccine was sitting out at room temperature/ Pharmacist did not do a good job administering/Due to heat) had resolved, VACCINATION SITE PAIN (Pain in arm at injection site / Chronic pain in left arm from injectionsite to just above elbow joint) had not resolved and HYPERSENSITIVITY (Reaction) 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.   This case was linked to MOD-2021-249108, MOD-2021-271057 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received on 28-JUL-2021. No New Information was received.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications was reported.  Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccines were sitting out at room temperature in the heat as it was a warm day; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (The vaccines were sitting out at room temperature in the heat as it was a warm day) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccines were sitting out at room temperature in the heat as it was a warm day). At the time of the report, PRODUCT STORAGE ERROR (The vaccines were sitting out at room temperature in the heat as it was a warm day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's concomitant medications were not reported.   No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Triggered mild/moderate symptoms; This spontaneous case was reported by an other and describes the occurrence of MALAISE (Triggered mild/moderate symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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. In March 2021, the patient experienced MALAISE (Triggered mild/moderate symptoms). At the time of the report, MALAISE (Triggered mild/moderate symptoms) outcome was unknown.            No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased
Clinical narrative: TSH  level was higher 12.92 and 15.8; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD THYROID STIMULATING HORMONE INCREASED (TSH  level was higher 12.92 and 15.8) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLOOD THYROID STIMULATING HORMONE INCREASED (TSH  level was higher 12.92 and 15.8). At the time of the report, BLOOD THYROID STIMULATING HORMONE INCREASED (TSH  level was higher 12.92 and 15.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Blood thyroid stimulating hormone: 12.92 (High) High TSH. On 28-Jun-2021, Blood thyroid stimulating hormone: 15.8 (High) High TSH.         Patient had upcoming appointment with his doctor to discuss the findings. Concomitant medication was statin. No treatment information were provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccines that were expired past the 30 days and given to 24 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccines that were expired past the 30 days and given to 24 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011d21a exp11-27-2021.) 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 EXPIRED PRODUCT ADMINISTERED (Moderna vaccines that were expired past the 30 days and given to 24 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccines that were expired past the 30 days and given to 24 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given Expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 EXPIRED PRODUCT ADMINISTERED (Given Expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given Expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. In June 2021, the patient experienced VACCINATION SITE PAIN (arm pain). At the time of the report, VACCINATION SITE PAIN (arm pain) had not resolved. No concomitant medications were provided by the reporter. No treatment was provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discolouration, Breast swelling, Feeling hot, Rash erythematous, Skin discolouration
Clinical narrative: right side of rib cage  suffered discoloration; right side of breast  suffered discoloration; right side of rib cage swelling; right side of rib cage and right breast suffered heat.; that  right breast suffered swelling; swelling of lymph nodes under right arm; radiation recall; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (radiation recall), SKIN DISCOLOURATION (right side of rib cage  suffered discoloration), BREAST DISCOLOURATION (right side of breast  suffered discoloration), SWELLING (right side of rib cage swelling) and FEELING HOT (right side of rib cage and right breast suffered heat.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032A21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (Patient is a breast cancer survivor and said that followed all protocols and waited 8 weeks after getting cancer treatment to get Moderna vaccine.).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced RASH ERYTHEMATOUS (radiation recall) and SWELLING (swelling of lymph nodes under right arm). On 21-Apr-2021, the patient experienced SKIN DISCOLOURATION (right side of rib cage  suffered discoloration), BREAST DISCOLOURATION (right side of breast  suffered discoloration), SWELLING (right side of rib cage swelling), FEELING HOT (right side of rib cage and right breast suffered heat.) and BREAST SWELLING (that  right breast suffered swelling). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) from 30-Apr-2021 to 19-May-2021 at a dose of 750 milligram three times a day; CEFADROXIL ongoing since an unknown date at a dose of UNK, bid; CEFTRIAXONE SODIUM (MEDIZONE [CEFTRIAXONE SODIUM]) (topical) ongoing since an unknown date at a dose of 0.1 % and PUROMYCIN at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (radiation recall), SKIN DISCOLOURATION (right side of rib cage  suffered discoloration), BREAST DISCOLOURATION (right side of breast  suffered discoloration), SWELLING (right side of rib cage swelling), FEELING HOT (right side of rib cage and right breast suffered heat.), BREAST SWELLING (that  right breast suffered swelling) and SWELLING (swelling of lymph nodes under right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: right side of rib cage  suffered discoloration; right side of breast  suffered discoloration; right side of rib cage swelling; right side of rib cage and right breast suffered heat.; that  right breast suffered swelling; swelling of lymph nodes under right arm; radiation recall; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (radiation recall), SKIN DISCOLOURATION (right side of rib cage  suffered discoloration), BREAST DISCOLOURATION (right side of breast  suffered discoloration), SWELLING (right side of rib cage swelling) and FEELING HOT (right side of rib cage and right breast suffered heat.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032A21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (Patient is a breast cancer survivor and said that followed all protocols and waited 8 weeks after getting cancer treatment to get Moderna vaccine.).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced RASH ERYTHEMATOUS (radiation recall) and SWELLING (swelling of lymph nodes under right arm). On 21-Apr-2021, the patient experienced SKIN DISCOLOURATION (right side of rib cage  suffered discoloration), BREAST DISCOLOURATION (right side of breast  suffered discoloration), SWELLING (right side of rib cage swelling), FEELING HOT (right side of rib cage and right breast suffered heat.) and BREAST SWELLING (that  right breast suffered swelling). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) from 30-Apr-2021 to 19-May-2021 at a dose of 750 milligram three times a day; CEFADROXIL ongoing since an unknown date at a dose of UNK, bid; CEFTRIAXONE SODIUM (MEDIZONE [CEFTRIAXONE SODIUM]) (topical) ongoing since an unknown date at a dose of 0.1 % and PUROMYCIN at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (radiation recall), SKIN DISCOLOURATION (right side of rib cage  suffered discoloration), BREAST DISCOLOURATION (right side of breast  suffered discoloration), SWELLING (right side of rib cage swelling), FEELING HOT (right side of rib cage and right breast suffered heat.), BREAST SWELLING (that  right breast suffered swelling) and SWELLING (swelling of lymph nodes under right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) 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.
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Full blown flu; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA (Full blown flu) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Full blown flu). At the time of the report, INFLUENZA (Full blown flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (barely move my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (barely move my arm). At the time of the report, LIMB DISCOMFORT (barely move my arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported by the reporter. No treatment medication reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (looked like alien) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (looked like alien). At the time of the report, UNEVALUABLE EVENT (looked like alien) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No information about concomitant and treatment was provided by reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site erythema, Vaccination site pain
Clinical narrative: red and sore; tenderness; horrible rash and it itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (horrible rash and it itches), VACCINATION SITE ERYTHEMA (red and sore) and VACCINATION SITE PAIN (tenderness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced RASH PRURITIC (horrible rash and it itches). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red and sore) and VACCINATION SITE PAIN (tenderness). At the time of the report, RASH PRURITIC (horrible rash and it itches) had not resolved, VACCINATION SITE ERYTHEMA (red and sore) outcome was unknown and VACCINATION SITE PAIN (tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided by reporter.  No treatment information provided by reporter.   Reporter did not allow further contact
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: Weak immune Response; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (Weak immune Response) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included METHOTREXATE and ETANERCEPT (ENBREL) for Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (Weak immune Response). At the time of the report, IMMUNE SYSTEM DISORDER (Weak immune Response) outcome was unknown.            Treatment information was not provided.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: Vaccination adverse reaction; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Having a localized reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (Having a localized reaction) in a 56-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 VACCINATION SITE REACTION (Having a localized reaction). At the time of the report, VACCINATION SITE REACTION (Having a localized reaction) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   This case was linked to MOD-2021-023329 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 patients from secondary clinic were given vaccine on 2july2021 that was punctured 6june2021.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients from secondary clinic were given vaccine on 2july2021 that was punctured 6june2021.) 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 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients from secondary clinic were given vaccine on 2july2021 that was punctured 6june2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients from secondary clinic were given vaccine on 2july2021 that was punctured 6june2021.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pyrexia, Urine analysis, X-ray
Clinical narrative: Fever, from about 30' to 60' after receiving dose/First 39.3, 39.4. After that improved, then came back again, now 38.5; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever, from about 30' to 60' after receiving dose/First 39.3, 39.4. After that improved, then came back again, now 38.5) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3004222) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PYREXIA (Fever, from about 30' to 60' after receiving dose/First 39.3, 39.4. After that improved, then came back again, now 38.5). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever, from about 30' to 60' after receiving dose/First 39.3, 39.4. After that improved, then came back again, now 38.5) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) negative. On an unknown date, Urine analysis: negative (Negative) negative. On an unknown date, X-ray: 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 medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: I have migraine its been 24 hours since my 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (I have migraine its been 24 hours since my 2nd vaccine) 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 Migraine.    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 MIGRAINE (I have migraine its been 24 hours since my 2nd vaccine). At the time of the report, MIGRAINE (I have migraine its been 24 hours since my 2nd vaccine) 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: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received second dose at day 21; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose at day 21) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jul-2021 at 8:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose at day 21). On 06-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose at day 21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-250093 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: He started with ringing in the ear; He came down with a severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (He came down with a severe headache) and TINNITUS (He started with ringing in the ear) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   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 14-Mar-2021, the patient experienced HEADACHE (He came down with a severe headache). On 15-Mar-2021, the patient experienced TINNITUS (He started with ringing in the ear). At the time of the report, HEADACHE (He came down with a severe headache) and TINNITUS (He started with ringing in the ear) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported. Action taken with mRNA-1273 in response to the event was not applicable
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Flatulence, Insomnia, Palpitations
Clinical narrative: Heart palpitations/ Heart was racing; Shortness of breath; Had gas but could not burp it up; Could not sleep; This spontaneous case was reported by a pharmacist and describes the occurrence of PALPITATIONS (Heart palpitations/ Heart was racing), DYSPNOEA (Shortness of breath), FLATULENCE (Had gas but could not burp it up) and INSOMNIA (Could not sleep) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-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 PALPITATIONS (Heart palpitations/ Heart was racing), DYSPNOEA (Shortness of breath), FLATULENCE (Had gas but could not burp it up) and INSOMNIA (Could not sleep). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart palpitations/ Heart was racing), DYSPNOEA (Shortness of breath), FLATULENCE (Had gas but could not burp it up) and INSOMNIA (Could not sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2021, Blood pressure measurement: 185/132 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The pharmacist declined to give the patient the second dose and told him to go to an urgent care or emergency department.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint pain in-hips, knees, elbows, shoulders, hands; muscle aches/everything hurts; This case was received via an unknown source (no reference has been entered for a health authority or partner) on 07-Jul-2021 and was forwarded to Moderna on 07-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in-hips, knees, elbows, shoulders, hands) and MYALGIA (muscle aches/everything hurts) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOMEFLOXACIN HYDROCHLORIDE (LOMAX [LOMEFLOXACIN HYDROCHLORIDE]), APIXABAN (ELIQUIS), METOPROLOL, ALPRAZOLAM and ATORVASTATIN for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain in-hips, knees, elbows, shoulders, hands) and MYALGIA (muscle aches/everything hurts). At the time of the report, ARTHRALGIA (Joint pain in-hips, knees, elbows, shoulders, hands) and MYALGIA (muscle aches/everything hurts) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: TCR form received and it contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS (arm has a red rash) and PRURITUS (arm is itching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (arm has a red rash) and PRURITUS (arm is itching). At the time of the report, RASH ERYTHEMATOUS (arm has a red rash) and PRURITUS (arm is itching) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Extra dose administered, Pyrexia
Clinical narrative: back aches for a few hours; little bit of fewer; vaccinated on December-2020, and January-2021, then Jun-2021 and JUL-2021; vaccinated on December-2020, and January-2021, then Jun-2021 and; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (vaccinated on December-2020, and January-2021, then Jun-2021 and), EXTRA DOSE ADMINISTERED (vaccinated on December-2020, and January-2021, then Jun-2021 and JUL-2021), BACK PAIN (back aches for a few hours) and PYREXIA (little bit of fewer) 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.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced EXTRA DOSE ADMINISTERED (vaccinated on December-2020, and January-2021, then Jun-2021 and). In July 2021, the patient experienced EXTRA DOSE ADMINISTERED (vaccinated on December-2020, and January-2021, then Jun-2021 and JUL-2021). On an unknown date, the patient experienced BACK PAIN (back aches for a few hours) and PYREXIA (little bit of fewer). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In June 2021, EXTRA DOSE ADMINISTERED (vaccinated on December-2020, and January-2021, then Jun-2021 and) had resolved. In July 2021, EXTRA DOSE ADMINISTERED (vaccinated on December-2020, and January-2021, then Jun-2021 and JUL-2021) had resolved. At the time of the report, BACK PAIN (back aches for a few hours) and PYREXIA (little bit of fewer) had resolved.            No concomitant medication was reported. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: a lot of joint pain; joints are just "killing her"; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (a lot of joint pain; joints are just "killing her") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), INDAPAMIDE, ATORVASTATIN, EZETIMIBE, ASPIRIN [ACETYLSALICYLIC ACID] and ROSUVASTATIN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (a lot of joint pain; joints are just "killing her"). The patient was treated with MELOXICAM ongoing since an unknown date for Physical therapy, at a dose of 7.5 mg once a day and Physical therapy for Arthralgia. At the time of the report, ARTHRALGIA (a lot of joint pain; joints are just "killing her") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got the blood work done and went to the chiropractor. Patient reported  that the doctor took out Atorvastatin and put the patient on rosuvastatin 5 mg twice a week.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow up received :- Updated patient demographic detail and concomitant medication is added.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: had the vaccine and felt bad and went to bed and the next day was fine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (had the vaccine and felt bad and went to bed and the next day was fine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (had the vaccine and felt bad and went to bed and the next day was fine). At the time of the report, FEELING ABNORMAL (had the vaccine and felt bad and went to bed and the next day was fine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter. for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: wife had both doses in her 2nd trimester; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (wife had both doses in her 2nd trimester) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 30-Sep-2020 and the estimated date of delivery was 08-Jul-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (wife had both doses in her 2nd trimester). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 05-Feb-2021, EXPOSURE DURING PREGNANCY (wife had both doses in her 2nd trimester) had resolved.            No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling weird,body feels a little different; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feeling weird,body feels a little different) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     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 07-Jul-2021, the patient experienced FEELING ABNORMAL (Feeling weird,body feels a little different). At the time of the report, FEELING ABNORMAL (Feeling weird,body feels a little different) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received second dose  at day 21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose  at day 21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose  at day 21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose  at day 21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to MOD-2021-249914 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose 3/23/2021 and failed to follow up with the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jul-2021 and was forwarded to Moderna on 07-Jul-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose 3/23/2021 and failed to follow up with the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-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 PRODUCT DOSE OMISSION ISSUE (first dose 3/23/2021 and failed to follow up with the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose 3/23/2021 and failed to follow up with the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received on 26-Jun-2021 and contains no new information.