chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Feeling hot, Lymphadenopathy, Mass
Clinical narrative: swollen gland around ear drum; Fever and fatigue; Fever and fatigue; Really itchy and hot; From elbow up to left side of body, inside of arm, front of chest to collar bone to shoulder/neck and back have red splotches; Really sharp ear pain; Have red splotchy rash/welts over left side of body; Really itchy and hot; After second dose had bump on left collar bone, all symptoms on left side looks like bug bite; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Really itchy and hot), MASS (After second dose had bump on left collar bone, all symptoms on left side looks like bug bite), RASH ERYTHEMATOUS (From elbow up to left side of body, inside of arm, front of chest to collar bone to shoulder/neck and back have red splotches), EAR PAIN (Really sharp ear pain) and RASH ERYTHEMATOUS (Have red splotchy rash/welts over left side of body) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced MASS (After second dose had bump on left collar bone, all symptoms on left side looks like bug bite). On 30-Oct-2021, the patient experienced PRURITUS (Really itchy and hot), RASH ERYTHEMATOUS (From elbow up to left side of body, inside of arm, front of chest to collar bone to shoulder/neck and back have red splotches), EAR PAIN (Really sharp ear pain), RASH ERYTHEMATOUS (Have red splotchy rash/welts over left side of body), FEELING HOT (Really itchy and hot), FATIGUE (Fever and fatigue) and PYREXIA (Fever and fatigue). On an unknown date, the patient experienced LYMPHADENOPATHY (swollen gland around ear drum). At the time of the report, PRURITUS (Really itchy and hot), MASS (After second dose had bump on left collar bone, all symptoms on left side looks like bug bite), RASH ERYTHEMATOUS (From elbow up to left side of body, inside of arm, front of chest to collar bone to shoulder/neck and back have red splotches), EAR PAIN (Really sharp ear pain), RASH ERYTHEMATOUS (Have red splotchy rash/welts over left side of body), FEELING HOT (Really itchy and hot), LYMPHADENOPATHY (swollen gland around ear drum), FATIGUE (Fever and fatigue) and PYREXIA (Fever and fatigue) had not resolved.            Concomitant medication details were not provided. Treatment medication included Vitamin C.   This case was linked to MOD-2021-376911 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash erythematous
Clinical narrative: swollen gland around ear drum; Fever and fatigue; Fever and fatigue; Really itchy and hot; From elbow up to left side of body, inside of arm, front of chest to collar bone to shoulder/neck and back have red splotches; Really sharp ear pain; Have red splotchy rash/welts over left side of body; Really itchy and hot; After second dose had bump on left collar bone, all symptoms on left side looks like bug bite; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Really itchy and hot), MASS (After second dose had bump on left collar bone, all symptoms on left side looks like bug bite), RASH ERYTHEMATOUS (From elbow up to left side of body, inside of arm, front of chest to collar bone to shoulder/neck and back have red splotches), EAR PAIN (Really sharp ear pain) and RASH ERYTHEMATOUS (Have red splotchy rash/welts over left side of body) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced MASS (After second dose had bump on left collar bone, all symptoms on left side looks like bug bite). On 30-Oct-2021, the patient experienced PRURITUS (Really itchy and hot), RASH ERYTHEMATOUS (From elbow up to left side of body, inside of arm, front of chest to collar bone to shoulder/neck and back have red splotches), EAR PAIN (Really sharp ear pain), RASH ERYTHEMATOUS (Have red splotchy rash/welts over left side of body), FEELING HOT (Really itchy and hot), FATIGUE (Fever and fatigue) and PYREXIA (Fever and fatigue). On an unknown date, the patient experienced LYMPHADENOPATHY (swollen gland around ear drum). At the time of the report, PRURITUS (Really itchy and hot), MASS (After second dose had bump on left collar bone, all symptoms on left side looks like bug bite), RASH ERYTHEMATOUS (From elbow up to left side of body, inside of arm, front of chest to collar bone to shoulder/neck and back have red splotches), EAR PAIN (Really sharp ear pain), RASH ERYTHEMATOUS (Have red splotchy rash/welts over left side of body), FEELING HOT (Really itchy and hot), LYMPHADENOPATHY (swollen gland around ear drum), FATIGUE (Fever and fatigue) and PYREXIA (Fever and fatigue) had not resolved.            Concomitant medication details were not provided. Treatment medication included Vitamin C.   This case was linked to MOD-2021-376911 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.        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.  Patient stated that tinnitus got worse, It was so loud and was like having crickets, like when you step outside in the summer in her head 24/7. She states when there was other noise like the TV playing or her CPAP machine noise it wasn't as noticeable, but when she sits down to read it was really bothersome.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Urticaria, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hive on the left arm; left arm became hot; fever; left arm became big; achy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hive on the left arm), VACCINATION SITE WARMTH (left arm became hot), PYREXIA (fever), VACCINATION SITE SWELLING (left arm became big) and MYALGIA (achy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive tape allergy (band-aid adhesives), Drug allergy (prednisone injections) and COPD.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced URTICARIA (hive on the left arm), VACCINATION SITE WARMTH (left arm became hot), PYREXIA (fever), VACCINATION SITE SWELLING (left arm became big) and MYALGIA (achy). At the time of the report, URTICARIA (hive on the left arm), VACCINATION SITE WARMTH (left arm became hot), PYREXIA (fever), VACCINATION SITE SWELLING (left arm became big) and MYALGIA (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Patient stated that on an unknown date she had COPD Inhaler (Trelegy) and she had her flu shot on 13-Oct-2021. Patient also stated that she is on lot of medications and have been on them for many years but did not list the medication names.   This case was linked to MOD-2021-376966, MOD-2021-376967 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site urticaria, Pyrexia, Vaccination site swelling
Clinical narrative: hive on the left arm; left arm became hot; fever; left arm became big; achy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hive on the left arm), VACCINATION SITE WARMTH (left arm became hot), PYREXIA (fever), VACCINATION SITE SWELLING (left arm became big) and MYALGIA (achy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive tape allergy (band-aid adhesives), Drug allergy (prednisone injections) and COPD.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced URTICARIA (hive on the left arm), VACCINATION SITE WARMTH (left arm became hot), PYREXIA (fever), VACCINATION SITE SWELLING (left arm became big) and MYALGIA (achy). At the time of the report, URTICARIA (hive on the left arm), VACCINATION SITE WARMTH (left arm became hot), PYREXIA (fever), VACCINATION SITE SWELLING (left arm became big) and MYALGIA (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Patient stated that on an unknown date she had COPD Inhaler (Trelegy) and she had her flu shot on 13-Oct-2021. Patient also stated that she is on lot of medications and have been on them for many years but did not list the medication names.   This case was linked to MOD-2021-376966, MOD-2021-376967 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Urticaria, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Felt wiped out/ Hit her hard; Left arm swelled up; Had a fever for 2 days; Big hive at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt wiped out/ Hit her hard), VACCINATION SITE SWELLING (Left arm swelled up), PYREXIA (Had a fever for 2 days) and INJECTION SITE URTICARIA (Big hive at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 012A21A and 004M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Flu shot) on 13-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Adhesive tape allergy (Adhesives including band-aid adhesives) and Drug allergy (Prednisone injections). Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) for COPD.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced FATIGUE (Felt wiped out/ Hit her hard), VACCINATION SITE SWELLING (Left arm swelled up), PYREXIA (Had a fever for 2 days) and INJECTION SITE URTICARIA (Big hive at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 30-Oct-2021, PYREXIA (Had a fever for 2 days) had resolved. At the time of the report, FATIGUE (Felt wiped out/ Hit her hard), VACCINATION SITE SWELLING (Left arm swelled up) and INJECTION SITE URTICARIA (Big hive at injection site) was resolving.            After receiving the booster dose, left arm swelled up to elbow from the injection site and had a fever for 2 days. The patient had a big hive at injection site down to elbow. The patient reported the booster dose was so much worse than the second Moderna shot and felt "wiped out" until present day. The patient stated it "hit her hard, nailed her". The patient was using Benadryl cream as treatment medication.  On 05-Nov-2021, the patient was a little better.   This case was linked to MOD-2021-376966, MOD-2021-376927 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site urticaria, Pyrexia, Vaccination site swelling
Clinical narrative: Felt wiped out/ Hit her hard; Left arm swelled up; Had a fever for 2 days; Big hive at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt wiped out/ Hit her hard), VACCINATION SITE SWELLING (Left arm swelled up), PYREXIA (Had a fever for 2 days) and INJECTION SITE URTICARIA (Big hive at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 012A21A and 004M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Flu shot) on 13-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Adhesive tape allergy (Adhesives including band-aid adhesives) and Drug allergy (Prednisone injections). Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) for COPD.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced FATIGUE (Felt wiped out/ Hit her hard), VACCINATION SITE SWELLING (Left arm swelled up), PYREXIA (Had a fever for 2 days) and INJECTION SITE URTICARIA (Big hive at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 30-Oct-2021, PYREXIA (Had a fever for 2 days) had resolved. At the time of the report, FATIGUE (Felt wiped out/ Hit her hard), VACCINATION SITE SWELLING (Left arm swelled up) and INJECTION SITE URTICARIA (Big hive at injection site) was resolving.            After receiving the booster dose, left arm swelled up to elbow from the injection site and had a fever for 2 days. The patient had a big hive at injection site down to elbow. The patient reported the booster dose was so much worse than the second Moderna shot and felt "wiped out" until present day. The patient stated it "hit her hard, nailed her". The patient was using Benadryl cream as treatment medication.  On 05-Nov-2021, the patient was a little better.   This case was linked to MOD-2021-376966, MOD-2021-376927 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; High fever; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PYREXIA (High fever) and ARTHRALGIA (Joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PYREXIA (High fever) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 2. At the time of the report, PAIN IN EXTREMITY (Arm pain), PYREXIA (High fever) and ARTHRALGIA (Joint pain) outcome was unknown.            Concomitant information was not provided.  Treatment information was not provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: After second dose not feeling welll for about 4-5 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After second dose not feeling welll for about 4-5 days) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (After second dose not feeling welll for about 4-5 days). At the time of the report, VACCINATION COMPLICATION (After second dose not feeling welll for about 4-5 days) had resolved.            No concomitant medications were reported. No treatment medications were provided.   This case was linked to MOD-2021-376941 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site lymphadenopathy, Vaccination site pruritus
Clinical narrative: It is very red/ 4 inches long/ 3 inches wide/ It is big; Swelled up/ raised up, big knot under it; Itching really bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (It is very red/ 4 inches long/ 3 inches wide/ It is big), VACCINATION SITE LYMPHADENOPATHY (Swelled up/ raised up, big knot under it) and VACCINATION SITE PRURITUS (Itching really bad) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. A39904, 010A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (It is very red/ 4 inches long/ 3 inches wide/ It is big), VACCINATION SITE LYMPHADENOPATHY (Swelled up/ raised up, big knot under it) and VACCINATION SITE PRURITUS (Itching really bad). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (It is very red/ 4 inches long/ 3 inches wide/ It is big), VACCINATION SITE LYMPHADENOPATHY (Swelled up/ raised up, big knot under it) and VACCINATION SITE PRURITUS (Itching really bad) outcome was unknown.      Following to vaccination, patient had side effects. The patient stated that 2 inches below the injection site, it was very red, 4 inches long, 3 inches wide- was big, red, swelled up, raised up, big knot under it, and stated that it is itching really bad. The patient stated that she took Tylenol for these discomfort and stated "no" for concomitant medications. No relevant concomitant medications was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema of eyelid, Oral mucosal eruption, Oral mucosal erythema, Product dose omission issue, Pruritus
Clinical narrative: missed dose; rash around the eyes and the mouth; it is itchy; At first it was just red above the eyelid; At first it was just red around the mouth; rash around the eyes; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL ERUPTION (rash around the eyes and the mouth), PRURITUS (it is itchy), ERYTHEMA OF EYELID (At first it was just red above the eyelid), ORAL MUCOSAL ERYTHEMA (At first it was just red around the mouth) and RASH (rash around the eyes) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS.    On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, the patient experienced ORAL MUCOSAL ERUPTION (rash around the eyes and the mouth), PRURITUS (it is itchy), ERYTHEMA OF EYELID (At first it was just red above the eyelid), ORAL MUCOSAL ERYTHEMA (At first it was just red around the mouth) and RASH (rash around the eyes). On 02-Nov-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) on 02-Nov-2021 for Adverse reaction, at an unspecified dose and frequency. On 02-Nov-2021, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved. At the time of the report, ORAL MUCOSAL ERUPTION (rash around the eyes and the mouth), PRURITUS (it is itchy), ERYTHEMA OF EYELID (At first it was just red above the eyelid), ORAL MUCOSAL ERYTHEMA (At first it was just red around the mouth) and RASH (rash around the eyes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication included supplements.  Rash was not painful. At first it was just red, not even itchy (above the eyelid and around the mouth). Then it started to feel itchy. This morning it became worse because yesterday patient didn't take antihistamine. Second shot was scheduled for the 02Nov2021. Pharmacist said that they could not give patient the shot because she had an allergy.  Treatment medication was not provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: missed dose; rash around the eyes and the mouth; it is itchy; At first it was just red above the eyelid; At first it was just red around the mouth; rash around the eyes; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL ERUPTION (rash around the eyes and the mouth), PRURITUS (it is itchy), ERYTHEMA OF EYELID (At first it was just red above the eyelid), ORAL MUCOSAL ERYTHEMA (At first it was just red around the mouth) and RASH (rash around the eyes) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS.    On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, the patient experienced ORAL MUCOSAL ERUPTION (rash around the eyes and the mouth), PRURITUS (it is itchy), ERYTHEMA OF EYELID (At first it was just red above the eyelid), ORAL MUCOSAL ERYTHEMA (At first it was just red around the mouth) and RASH (rash around the eyes). On 02-Nov-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) on 02-Nov-2021 for Adverse reaction, at an unspecified dose and frequency. On 02-Nov-2021, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved. At the time of the report, ORAL MUCOSAL ERUPTION (rash around the eyes and the mouth), PRURITUS (it is itchy), ERYTHEMA OF EYELID (At first it was just red above the eyelid), ORAL MUCOSAL ERYTHEMA (At first it was just red around the mouth) and RASH (rash around the eyes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication included supplements.  Rash was not painful. At first it was just red, not even itchy (above the eyelid and around the mouth). Then it started to feel itchy. This morning it became worse because yesterday patient didn't take antihistamine. Second shot was scheduled for the 02Nov2021. Pharmacist said that they could not give patient the shot because she had an allergy.  Treatment medication was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Occupational exposure to product
Clinical narrative: some of the vaccine liquid got into her eye; This spontaneous case was reported by a pharmacist and describes the occurrence of OCCUPATIONAL EXPOSURE TO PRODUCT in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced OCCUPATIONAL EXPOSURE TO PRODUCT. At the time of the report, OCCUPATIONAL EXPOSURE TO PRODUCT outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Incoherent, Vaccination complication
Clinical narrative: [after second dose] incoherent; [after second dose] no strength, no nothing; severe reaction to second dose/"off the wall" reaction; This spontaneous case was reported by a consumer and describes the occurrence of INCOHERENT ([after second dose] incoherent), ASTHENIA ([after second dose] no strength, no nothing) and VACCINATION COMPLICATION (severe reaction to second dose/"off the wall" reaction) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Irritable bowel syndrome, Hypertension, Coronary artery disease, GERD and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, CLOPIDOGREL for Coronary artery disease, METFORMIN HYDROCHLORIDE (METFORMIN ER) and EMPAGLIFLOZIN (JARDIANCE) for Diabetes, PANTOPRAZOLE for GERD, LOSARTAN and HCTZ for Hypertension, CHOLESTYRAMINE and NORTRIPTYLINE for Irritable bowel syndrome, METOPROLOL for an unknown indication.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCOHERENT ([after second dose] incoherent), ASTHENIA ([after second dose] no strength, no nothing) and VACCINATION COMPLICATION (severe reaction to second dose/"off the wall" reaction). At the time of the report, INCOHERENT ([after second dose] incoherent), ASTHENIA ([after second dose] no strength, no nothing) and VACCINATION COMPLICATION (severe reaction to second dose/"off the wall" reaction) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. The patient was almost incoherent, no strength, no nothing for 24 hours gradually it faded.   This case was linked to MOD-2021-377774, MOD-2021-370410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Non-Significant follow-up appended On 05-Nov-2021: Upon follow-up receipt: Additional reporter added HCP added, patient demographic details added, medical history added, concomitants added, events start/stop added, events outcome updated. On 08-Nov-2021: Upon follow-up receipt: Non significant follow up
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Very serious nasal drip and was diagnosed with sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Very serious nasal drip and was diagnosed with sinus infection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061F21A, 013M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic sinusitis, unspecified (Patient's sinus problem has been on and off for years, something chronic, but over the past months it had turned into an infection).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-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 SINUSITIS (Very serious nasal drip and was diagnosed with sinus infection). The patient was treated with AMOXICILLIN on 03-Nov-2021 for Sinus infection, at a dose of 500 mg. At the time of the report, SINUSITIS (Very serious nasal drip and was diagnosed with sinus infection) outcome was unknown.            Concomitant medication was not provided by the reporter.  Patient went to the doctor, who prescribed Amoxicillin and Steroids (the latter never took).  Patient received the COVID booster dose on 03-Nov-2021 and on the same day patient started taking Amoxicillin. Patient had sinus problem which turned into an infection over the past months. Patient never stopped taking the antibiotic.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Pain at the injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), MONTELUKAST SODIUM (SINGULAIR) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Fatigue). In March 2021, VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were provided.  With the first dose, patient experienced pain at the injection site and fatigue. But, it went away in 2 to 5 days.   This case was linked to MOD-2021-376981 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Liver disorder, Pain, Renal disorder
Clinical narrative: From the ribs to the hips if it iss inside your body it hurts; Found sits in my liver and kidney; Found sits in my liver and kidney; This spontaneous case was reported by a consumer and describes the occurrence of PAIN, LIVER DISORDER, and RENAL DISORDER in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN, LIVER DISORDER, and RENAL DISORDER. At the time of the report, PAIN, LIVER DISORDER, and RENAL DISORDER outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.  The patient said that has kind of internal problems, that started overlapping with the Moderna vaccine, started in December, January, and then in the middle of the summer got significantly worst after the second dose of the vaccine. From the ribs to the hips if it was inside your body, it hurts. Found sits in liver and kidney and they do not know if it was going to a mayor disease or cancer. Patient had trouble with steroids in the past. This case concerns a 74-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious events of pain, liver disorder, and renal disorder following administration of the second dose of the Moderna COVID-19 Vaccine on 05Mar2021. The start dates of the events were not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Infection
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of illness (she got sick) and infection in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness (she got sick) and infection. At the time of the report, illness (she got sick) and infection outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Patient got sick at the time the second vaccine was supposed to be administered, so she never got it. She had some type of infection and was on antibiotics. Her physician recommended she not take the vaccine at that time.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia
Clinical narrative: every joint in my body was super painful; light fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (every joint in my body was super painful) and PYREXIA (light fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ARTHRALGIA (every joint in my body was super painful) and PYREXIA (light fever). At the time of the report, ARTHRALGIA (every joint in my body was super painful) and PYREXIA (light fever) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-377003, MOD-2021-377031 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: hard area around injection site; Chills; Fatigue; Muscle pain; Headache; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard area around injection site), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068F21A, 047B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced VACCINATION SITE INDURATION (hard area around injection site), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, VACCINATION SITE INDURATION (hard area around injection site), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site induration
Clinical narrative: hard area around injection site; Chills; Fatigue; Muscle pain; Headache; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard area around injection site), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068F21A, 047B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced VACCINATION SITE INDURATION (hard area around injection site), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, VACCINATION SITE INDURATION (hard area around injection site), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID despite having both doses; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 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 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 COVID-19 (COVID despite having both doses). At the time of the report, COVID-19 (COVID despite having both doses) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown. This case concerns a male patient of unknown age, with no medical history provided, who experienced the non-serious unexpected AESI of COVID 19. The event occurred on an unknown date after receiving the second dose of the Moderna COVID 19 vaccine. The rechallenge is not applicable considering the nature of the event. The benefit-risk relationship of the Moderna COVID 19 vaccine is not affected by this report. Case processed with very limited information and no consent for follow up has been granted so no further information is expected. Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received doses administered more than 12 hours post puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses administered more than 12 hours post puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017e21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses administered more than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses administered more than 12 hours post puncture) had resolved.        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 reported. This is a case of expired product administered for this patient of unknown age and unknown gender with no relevant medical history, with no associated events reported after administration of an unspecified dose of the Moderna COVID-19 Vaccine. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This is a case of expired product administered for this patient of unknown age and unknown gender with no relevant medical history, with no associated events reported after administration of an unspecified dose of the Moderna COVID-19 Vaccine. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: 9 days after the booster shot she had hives all over the body.; she had noticed itchy patches; 9 days after the booster shot she had rash all over the body. night she had a in her arms and back. The next day it was over her stomach, inner thighs, scalp, knees, feet and ankles; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (9 days after the booster shot she had hives all over the body.), PRURITUS (she had noticed itchy patches) and RASH (9 days after the booster shot she had rash all over the body. night she had a in her arms and back. The next day it was over her stomach, inner thighs, scalp, knees, feet and ankles) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039021A, 012A21A and 012M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PERTUSSIS VACCINE (Patient had bad reaction after this shot when a child.). Concurrent medical conditions included Drug allergy (Allergic to many medications.). Concomitant products included GABAPENTIN, PROBIOTICS NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced URTICARIA (9 days after the booster shot she had hives all over the body.), PRURITUS (she had noticed itchy patches) and RASH (9 days after the booster shot she had rash all over the body. night she had a in her arms and back. The next day it was over her stomach, inner thighs, scalp, knees, feet and ankles). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and HYDROXYZINE for Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (9 days after the booster shot she had hives all over the body.), PRURITUS (she had noticed itchy patches) and RASH (9 days after the booster shot she had rash all over the body. night she had a in her arms and back. The next day it was over her stomach, inner thighs, scalp, knees, feet and ankles) outcome was unknown.            Concomitant medication also include allergy pills and prednisone for 10 days . She said that on 01 NOV 21 at night she had a in her arms and back. The next day it was over her stomach and inner thighs; then, the next day in face and scalp, and last night to the side of the knees and now at the top of feet and ankles. She went to the ER on Wednesday 03 NOV 21 at 1am.   This case was linked to MOD-2021-377126 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 012A21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Fever, at a dose of 1 dosage form. At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Body temperature: 99 - 102 (High) fever at 99 in the morning, but the fever is now at 102..         Treatment information was not reported.