chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Renal cell carcinoma (lost a kidney, due to renal cell carcinoma) and Blood pressure high.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.            Concomitant medications included was non-specified blood pressure medicine. She saw a cardiologist a week, or so, after the emergency room visit. He changed her blood pressure medicine. Her Dr changed her blood pressure medicine back to the original one.  Treatment medication was not provided by the reporter.  This case concerns an 88 year-old female patient with no reported relevant medical history who experienced the unexpected serious event of vaccination site pain. The event occurred approximately 1 day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per reporter, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.   This case was linked to MOD-2021-370170 (Patient Link). Sender's Comments: This case concerns an 88 year-old female patient with no reported relevant medical history who experienced the unexpected serious event of vaccination site pain. The event occurred approximately 1 day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per reporter, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: booster took me out unlike 1 & 2; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (booster took me out unlike 1 & 2) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (booster took me out unlike 1 & 2) (seriousness criterion medically significant). At the time of the report, VACCINATION COMPLICATION (booster took me out unlike 1 & 2) outcome was unknown.            Relevant concomitant medications were not reported by the reporter. Treatment information was not provided by the reporter.  This is a spontaneous  case concerning a patient  of unknown age and gender, with no relevant medical history reported ,  who experienced the non serious  unexpected event   of  vaccination complication after receiving a third dose (booster) of Moderna COVID-19 vaccine. Time to onset is unknown. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Additional information has been requested.; Sender's Comments: This is a spontaneous  case concerning a patient  of unknown age and gender, with no relevant medical history reported ,  who experienced the non serious  unexpected event   of  vaccination complication after receiving a third dose (booster) of Moderna COVID-19 vaccine. Time to onset is unknown. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Additional information has been requested
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Triple negative breast cancer
Clinical narrative: Triple negative breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of TRIPLE NEGATIVE BREAST CANCER (Triple negative breast cancer) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced TRIPLE NEGATIVE BREAST CANCER (Triple negative breast cancer) (seriousness criterion medically significant). At the time of the report, TRIPLE NEGATIVE BREAST CANCER (Triple negative breast cancer) was resolving.            Concomitant medications were not reported . Treatment information was reported as Chemotherapy and Radiation therapy.  Patient received significant testing including a lumpectomy then started chemotherapy on 8JUL2021. Patient continued to take chemotherapy every weekday up until 16SEP2021. Patient had also started radiation from 19OCT2021 which is scheduled to continue until 16NOV2021. patient was feeling much better now after the conclusion of her chemotherapy. Patient mentioned that her count was really low during her treatments.  This case concerns a 69 year-old female patient with no reported medical history, who experienced the unexpected serious event of triple negative breast cancer. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 69 year-old female patient with no reported medical history, who experienced the unexpected serious event of triple negative breast cancer. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: all the aches and pains that you're supposed to have; headache; muscle pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (all the aches and pains that you're supposed to have), HEADACHE (headache) and MYALGIA (muscle pains) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (all the aches and pains that you're supposed to have), HEADACHE (headache) and MYALGIA (muscle pains). At the time of the report, PAIN (all the aches and pains that you're supposed to have), HEADACHE (headache) and MYALGIA (muscle pains) outcome was unknown.            No Concomitant Medications were provided by the reporter.  No Treatment Information were provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Arm is very sore from the injection; Has terrible chills; Headache; Muscle pains; A lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore from the injection), CHILLS (Has terrible chills), HEADACHE (Headache), MYALGIA (Muscle pains) and FATIGUE (A lot of fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm is very sore from the injection), CHILLS (Has terrible chills), HEADACHE (Headache), MYALGIA (Muscle pains) and FATIGUE (A lot of fatigue). At the time of the report, PAIN IN EXTREMITY (Arm is very sore from the injection), CHILLS (Has terrible chills), HEADACHE (Headache), MYALGIA (Muscle pains) and FATIGUE (A lot of fatigue) outcome was unknown.            No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Product administration error
Clinical narrative: Product administration error; accidental underdose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Product administration error) and ACCIDENTAL UNDERDOSE (accidental underdose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error) and ACCIDENTAL UNDERDOSE (accidental underdose). On 01-Nov-2021, PRODUCT ADMINISTRATION ERROR (Product administration error) and ACCIDENTAL UNDERDOSE (accidental underdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications were used no treatment information was provided
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old was administered the first dose of the Moderna Covid19 Vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old was administered the first dose of the Moderna Covid19 Vaccine.) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE and HYDROXYZINE for an unknown indication.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old was administered the first dose of the Moderna Covid19 Vaccine.). On 16-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old was administered the first dose of the Moderna Covid19 Vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was reported. This is a case of Product administered to patient of inappropriate age for this 12-year-old male patient with no relevant medical history reported. The patient received the first dose of mRNA-1273  vaccine on 16-Sep-2021. No adverse events were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a case of Product administered to patient of inappropriate age for this 12-year-old male patient with no relevant medical history reported. The patient received the first dose of mRNA-1273  vaccine on 16-Sep-2021. No adverse events were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 3rd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Erythema, Paraesthesia
Clinical narrative: "red all over"; numbness, burning and tingling for the last 3 months; Burning in hands; numbness, burning and tingling for the last 3 months; shoulder pain for 3 months; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA ("red all over"), the first episode of PARAESTHESIA (numbness, burning and tingling for the last 3 months), BURNING SENSATION (Burning in hands), the second episode of PARAESTHESIA (numbness, burning and tingling for the last 3 months) and ARTHRALGIA (shoulder pain for 3 months) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) 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) (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 at an unspecified dose. On an unknown date, the patient experienced ERYTHEMA ("red all over"), the first episode of PARAESTHESIA (numbness, burning and tingling for the last 3 months), BURNING SENSATION (Burning in hands), the second episode of PARAESTHESIA (numbness, burning and tingling for the last 3 months) and ARTHRALGIA (shoulder pain for 3 months). The patient was treated with GABAPENTIN for Adverse event, at a dose of 1 dosage form. At the time of the report, ERYTHEMA ("red all over"), BURNING SENSATION (Burning in hands), the last episode of PARAESTHESIA (numbness, burning and tingling for the last 3 months) and ARTHRALGIA (shoulder pain for 3 months) outcome was unknown.            Treatment:  Muscle relaxant are used. Concomitant medication was not provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia
Clinical narrative: Shortness of breath and hypoxia within 24 hours of COVID vaccine.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in arm that received shot still
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: cold sweats; sore arm; Soaking Wet; cold chills; felt real tired for 2 days and a half; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (Soaking Wet), CHILLS (cold chills) and FATIGUE (felt real tired for 2 days and a half) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLD SWEAT (cold sweats), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (Soaking Wet), CHILLS (cold chills), FATIGUE (felt real tired for 2 days and a half) and MYALGIA (myalgia). At the time of the report, COLD SWEAT (cold sweats), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (Soaking Wet), CHILLS (cold chills) and MYALGIA (myalgia) outcome was unknown and FATIGUE (felt real tired for 2 days and a half) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received on 04-NOV-2021 and contains no new information. Updated event soaking wet and outcome of an event fatigue from unknown to recovered/resolved from initial document.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: cold sweats; sore arm; Soaking Wet; cold chills; felt real tired for 2 days and a half; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (Soaking Wet), CHILLS (cold chills) and FATIGUE (felt real tired for 2 days and a half) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLD SWEAT (cold sweats), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (Soaking Wet), CHILLS (cold chills), FATIGUE (felt real tired for 2 days and a half) and MYALGIA (myalgia). At the time of the report, COLD SWEAT (cold sweats), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (Soaking Wet), CHILLS (cold chills) and MYALGIA (myalgia) outcome was unknown and FATIGUE (felt real tired for 2 days and a half) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received on 04-NOV-2021 and contains no new information. Updated event soaking wet and outcome of an event fatigue from unknown to recovered/resolved from initial document.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Neuralgia
Clinical narrative: nerve pain from prior accident became much worse; Blisters all over my body after the second Moderna Covid-19 vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerve pain from prior accident became much worse) and BLISTER (Blisters all over my body after the second Moderna Covid-19 vaccination.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Nerve damage (she has severe nerve damage from an accident falling down a water fall 21 years ago).   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (nerve pain from prior accident became much worse) and BLISTER (Blisters all over my body after the second Moderna Covid-19 vaccination.). At the time of the report, NEURALGIA (nerve pain from prior accident became much worse) and BLISTER (Blisters all over my body after the second Moderna Covid-19 vaccination.) outcome was unknown.            No Treatment information was provided. No concomitant medication was provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Aches and pains; Slight fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches and pains), PYREXIA (Slight fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Subcutaneous nodule.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MYALGIA (Aches and pains), PYREXIA (Slight fever), HEADACHE (Headache) and NAUSEA (Nausea). On 22-Mar-2021, MYALGIA (Aches and pains), PYREXIA (Slight fever), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-372093, MOD-2021-372417 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm after 2nd shot; Very low fever after 2nd shot; Headache after 2nd shot; Fatigue after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after 2nd shot), PYREXIA (Very low fever after 2nd shot), HEADACHE (Headache after 2nd shot) and FATIGUE (Fatigue after 2nd shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after 2nd shot), PYREXIA (Very low fever after 2nd shot), HEADACHE (Headache after 2nd shot) and FATIGUE (Fatigue after 2nd shot). On 15-Mar-2021, PAIN IN EXTREMITY (Sore arm after 2nd shot), PYREXIA (Very low fever after 2nd shot), HEADACHE (Headache after 2nd shot) and FATIGUE (Fatigue after 2nd shot) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-372307, MOD-2021-372413 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 3 patient died; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (3 patient died) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            It was reported that an oncologist informed to the reporter that few of her patient died out of 100-200 fully vaccinated probably caught COVID. And 3 patient died. They ran unspecified test on them had no protection from vaccine. No antibody found. No concomitant medications were reported. No treatment medications were reported.  Company comment: This spontaneous case report concerns a subject of unknown age and gender that experienced the serious unexpected AESI event of Death after an unknown period of Moderna COVID-19 vaccine administration. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report; Sender's Comments: This spontaneous case report concerns a subject of unknown age and gender that experienced the serious unexpected AESI event of Death after an unknown period of Moderna COVID-19 vaccine administration. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report; Reported Cause(s) of Death: Unknown cause of death
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site reaction
Clinical narrative: Covid arm on the arm of the injection; Little nauseous; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm on the arm of the injection), NAUSEA (Little nauseous) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU (for 3 days) in 2020. Past adverse reactions to the above products included Arm discomfort with FLU. Concomitant products included LISINOPRIL, PANTOPRAZOLE, FAMOTIDINE, FISH OIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced NAUSEA (Little nauseous). In February 2021, the patient experienced FATIGUE (Tired). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm on the arm of the injection). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 10-Feb-2021, NAUSEA (Little nauseous) had resolved. In February 2021, FATIGUE (Tired) had resolved. At the time of the report, VACCINATION SITE REACTION (Covid arm on the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-372356 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Followup was received and included no new information.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Malaise
Clinical narrative: unable to work or leave bed; Felt very sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very sick) and IMPAIRED WORK ABILITY (unable to work or leave bed) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts (Peanuts).    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt very sick) and IMPAIRED WORK ABILITY (unable to work or leave bed). On 30-Oct-2021, MALAISE (Felt very sick) and IMPAIRED WORK ABILITY (unable to work or leave bed) had resolved. Not Provided          No concomitant medication was reported.  No treatment information was provided.   This case was linked to MOD-2021-372550, MOD-2021-372550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up received, added relevant history, patient details and event details
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 2nd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: They gave a full dose to a patient,instead of giving a booster shot.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (They gave a full dose to a patient,instead of giving a booster shot.) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (They gave a full dose to a patient,instead of giving a booster shot.). At the time of the report, ACCIDENTAL OVERDOSE (They gave a full dose to a patient,instead of giving a booster shot.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Feeling abnormal, Gait disturbance, Pain
Clinical narrative: could hardly walk; feel this is killing them; pains and it was bothering; knee was bothering them too; something started bothering them terribly/m lot of pain/really bothering them/so much pain on their back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (something started bothering them terribly/m lot of pain/really bothering them/so much pain on their back), GAIT DISTURBANCE (could hardly walk), FEELING ABNORMAL (feel this is killing them), PAIN (pains and it was bothering) and ARTHRALGIA (knee was bothering them too) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Oct-2021 at 12:30 PM, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced BACK PAIN (something started bothering them terribly/m lot of pain/really bothering them/so much pain on their back). On 02-Nov-2021, the patient experienced GAIT DISTURBANCE (could hardly walk), FEELING ABNORMAL (feel this is killing them), PAIN (pains and it was bothering) and ARTHRALGIA (knee was bothering them too). At the time of the report, BACK PAIN (something started bothering them terribly/m lot of pain/really bothering them/so much pain on their back), GAIT DISTURBANCE (could hardly walk), FEELING ABNORMAL (feel this is killing them), PAIN (pains and it was bothering) and ARTHRALGIA (knee was bothering them too) had not resolved.            No Concomitant medications were provided by the reporter. No Treatment information was reported. They tried to put ice on it but it did not helped There. Patient recalled that after the second Moderna vaccine they were going through therapy for an injection on the knee, and for 3 days they had pains and it was bothering them too, so much they had to skip therapy for a few days.   This case was linked to MOD-2021-373473 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Headache, Myalgia
Clinical narrative: headache; chills; body aches; Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (headache), CHILLS (chills), MYALGIA (body aches) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced HEADACHE (headache), CHILLS (chills), MYALGIA (body aches) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved. At the time of the report, HEADACHE (headache), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Patient received the 1st dose of Pfizer vaccine 10-Mar-2021, the lot number was a EN6206.  The expiration was JUN-2021. Patient received the 2nd dose of Pfizer 07-APR-2021, the lot number was a EW0150.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: followup received on 2-Nov-2021 and non-serious events are added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site irritation
Clinical narrative: Injection site irritation after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (Injection site irritation after 1st dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE IRRITATION (Injection site irritation after 1st dose). At the time of the report, VACCINATION SITE IRRITATION (Injection site irritation after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It mentioned that the patient was receiving a newmedication since a week ago due to her blood pressure regulating problem.  No treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 2nd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment information was provided.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered dose past the manufacture expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided
Age: 68.0
Sex: U
Vaccine: FLUX
Symptoms: Anxiety, Pain, Polymyalgia rheumatica
Clinical narrative: diagnosed with Polymyalgia Rheumatica (PMR); Initial information received on 28-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a 68-year-old and unknown gender patient who experienced diagnosed with polymyalgia rheumatica (PMR) after receiving INFLUENZA VACCINE.  The patient's past vaccination(s) included COVID-19 VACCINE on 03-MAR-2021, HEPATITIS A on 17-DEC-2009, FLUZONE HIGH DOSE on 02-OCT-2018, FLUZONE HIGH DOSE on 05-SEP-2019 and FLUZONE HIGH DOSE QUADARIVALENT on 01-SEP-2021.  The patient's medical history, medical treatment(s), concomitant medications and family history were not provided.  On 01-Sep-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On a 28-Oct, the patient developed a serious diagnosed with polymyalgia rheumatica (PMR) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data not reported.  On an unknown date, the patient received PREDNISONE as corrective treatment for the event.  Patient symptoms for PMR were intensely painful. The patient have additional anxiety over COVID now knowing Prednisone is an immunosuppressant.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a 68-year-old patient (unknown gender) who had polymyalgia rheumatica after receiving INFLUENZA VACCINE (Unknown manufacturer). The time to onset is unknown. The patient's past vaccination(s) included COVID-19 VACCINE, HEPATITIS A, FLUZONE HIGH DOSE (first dose and second dose) and FLUZONE HIGH DOSE QUADARIVALENT. Furthermore information regarding medical history, medical treatment(s), concomitant medications, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cranial nerve disorder, Dizziness, Ear pain, Eye pain
Clinical narrative: Flair of Trigeminal Neuralgia, now getting ready to have to have surgery due to the inflammation on the cranial nerves from having the COVID-19 vaccines. Facial pain, Headaches, Ear Pain, Trouble Chewing, Trouble Sleeping, Fatigue, Eye Pain, Dizziness, Have been getting treated with medications, and can't get the pain and inflammation back under control. Have seen a neurosurgeon and was told it was now too complicated for the Gamma knife, I have to have open Brain surgery to get fixed, due to now having multi-cranial nerve involvement.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Fatigue, Headache, Inflammation, Insomnia
Clinical narrative: Flair of Trigeminal Neuralgia, now getting ready to have to have surgery due to the inflammation on the cranial nerves from having the COVID-19 vaccines. Facial pain, Headaches, Ear Pain, Trouble Chewing, Trouble Sleeping, Fatigue, Eye Pain, Dizziness, Have been getting treated with medications, and can't get the pain and inflammation back under control. Have seen a neurosurgeon and was told it was now too complicated for the Gamma knife, I have to have open Brain surgery to get fixed, due to now having multi-cranial nerve involvement.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Mastication disorder, Trigeminal neuralgia
Clinical narrative: Flair of Trigeminal Neuralgia, now getting ready to have to have surgery due to the inflammation on the cranial nerves from having the COVID-19 vaccines. Facial pain, Headaches, Ear Pain, Trouble Chewing, Trouble Sleeping, Fatigue, Eye Pain, Dizziness, Have been getting treated with medications, and can't get the pain and inflammation back under control. Have seen a neurosurgeon and was told it was now too complicated for the Gamma knife, I have to have open Brain surgery to get fixed, due to now having multi-cranial nerve involvement.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test normal, Chest pain, Computerised tomogram normal, Nausea
Clinical narrative: Heartbeat 128 beats per min Weakness nausea chest pain
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray normal
Clinical narrative: Heartbeat 128 beats per min Weakness nausea chest pain
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC was reported; she is above the recommended age of 45 for GARDASIL 9 and she received her first dose of GARDASIL 9 on 8/23/2021; This spontaneous report was received from a female patient of age above 45 years, who was referring to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-AUG-2021, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, anatomical location, route of administration, lot # and expiration date were not reported) (Inappropriate age at vaccine administration). Her second dose is scheduled for 19-OCT-2021. No additional adverse event was reported.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient receiving 3 doses; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 26th October 2020) and Shingrix (received second dose on 9th February 2021).   On 1st November 2021, the patient received the 3rd dose of Shingrix. On 1st November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient had received the third dose of Shingrix, which led to extra dose administered. The reporter consented to follow up. Consent was given for FU
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 26 year old white female of unknown ethnicity. The patient's height and weight were not reported. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2110210, expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 20-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-NOV-2021, patient reporter her first symptom of cough. Patient also reported being symptomatic with congestion and loss of taste. Patient also experienced confirmed covid-19 infection and confirmed clinical vaccination failure. On 07-NOV-2021, patient was tested positive for covid-19 with a home test kit. Patient later went in to a hospital place and got tested again and test results from the hospital were pending. She was exposed through her husband who showed the symptoms first. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition). This report was associated with regulatory authority.; Sender's Comments: V0: 20211119185-Covid-19 vaccine ad26.cov2.s- Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Aneurysm
Clinical narrative: ANEURYSM; This spontaneous report received from a consumer via social media concerned a 49 year old adult female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was in good health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced aneurysm. The consumer reported as "I know someone else that died after jab from aneurysm. She was only 49 and in good health". On an unspecified date, the patient died from aneurysm. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of from aneurysm on an unspecified date. This report was serious (Death).; Sender's Comments: V0: 20211119575-COVID-19 VACCINE AD26.COV2.S-Aneurysm. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: ANEURYSM