chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Oxygen saturation, Productive cough
Clinical narrative: wet cough; pain in her ribs; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (wet cough) and MUSCULOSKELETAL CHEST PAIN (pain in her ribs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. lot 037AUB and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid cancer (Patient had her thyroid taken out ten years ago.) and Drug allergy (slight sensitivity to glycerin). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROXINE) for an unknown indication.   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. In April 2021, the patient experienced PRODUCTIVE COUGH (wet cough) and MUSCULOSKELETAL CHEST PAIN (pain in her ribs). The patient was treated with PANTOPRAZOLE at a dose of 40 mg once a day; MONTELUKAST at a dose of 10 mg once a day; GABAPENTIN at a dose of 100 mg every twelve hours; LEVOCETIRIZINE at a dose of 5 mg once a day and PARACETAMOL (TYLENOL) for Rib pain, at an unspecified dose and frequency. At the time of the report, PRODUCTIVE COUGH (wet cough) had not resolved and MUSCULOSKELETAL CHEST PAIN (pain in her ribs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Oxygen saturation: low (Low) Low during the night.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She had a sleep test on 27-Sep-2021 which they were awaiting results of.  Every test had come back negative.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID 19 after receiving both doses; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19 after receiving both doses) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first 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 SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19 after receiving both doses). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19 after receiving both doses) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.; Sender's Comments: This report concerns a 89 year old female patient with no relevant medical history who tested positive for COVID-19 (non-serious and unexpected). The event occurred after an unknown duration following vaccination with second dose of mRNA-1273. The report states that the patient tested positive for COVID-19 after receiving two doses of mRNA-1273. Re-challenge was not applicable as the event happened after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273  is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling hot, Illness, Myalgia, Pyrexia
Clinical narrative: Body feels like a oven.; Sick like is dying; Bad coughing; Really bad body aches; A fever of 102F° or 103F°; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Body feels like a oven.), ILLNESS (Sick like is dying), COUGH (Bad coughing), MYALGIA (Really bad body aches) and PYREXIA (A fever of 102F° or 103F°) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076c21a and 037f21a) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Oct-2021, the patient experienced FEELING HOT (Body feels like a oven.), ILLNESS (Sick like is dying), COUGH (Bad coughing), MYALGIA (Really bad body aches) and PYREXIA (A fever of 102F° or 103F°). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING HOT (Body feels like a oven.), ILLNESS (Sick like is dying), COUGH (Bad coughing), MYALGIA (Really bad body aches) and PYREXIA (A fever of 102F° or 103F°) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2021, Body temperature: 102  or 103 (High) 102F° or 103F.         No concomitant information were reported by the reporter   This case was linked to MOD-2021-347166 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soar arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soar arm) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE, VITAMIN D [VITAMIN D NOS], FISH OIL, VITAMIN C [ASCORBIC ACID], WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]), QUERCETIN, VITAMIN B NOS and ONDANSETRON HYDROCHLORIDE (ONDANSETRAN) for an unknown indication.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced VACCINATION SITE PAIN (Soar arm). At the time of the report, VACCINATION SITE PAIN (Soar arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  The patient reported that post receiving their first dose of the Moderna COVID-19 vaccine immediately they got a sore arm and it was still on going.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pyrexia
Clinical narrative: Felt sick but was manageable; Body aches; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Oct-2021 and was forwarded to Moderna on 09-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick but was manageable), MYALGIA (Body aches) and PYREXIA (Fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced ILLNESS (Felt sick but was manageable), MYALGIA (Body aches) and PYREXIA (Fever). The patient was treated with IBUPROFEN in September 2021 for Adverse event, at an unspecified dose and frequency. On 10-Sep-2021, ILLNESS (Felt sick but was manageable), MYALGIA (Body aches) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported.  The reporter was calling on behalf of the patient who after five hours post getting their first dose of the Moderna COVID-19 vaccine experienced body aches, a fever and felt sick which was manageable.  Reportedly, the patient took ibuprofen and the symptoms went away on the 10-Sep-2021.   This case was linked to MOD-2021-347141 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival abscess
Clinical narrative: abscesses on her gums/abscess on her gums now; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL ABSCESS (abscesses on her gums/abscess on her gums now) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced GINGIVAL ABSCESS (abscesses on her gums/abscess on her gums now) (seriousness criterion medically significant). The patient was treated with Surgery (Root canal) for Gingival abscess. At the time of the report, GINGIVAL ABSCESS (abscesses on her gums/abscess on her gums now) had not 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.; Sender's Comments: This case concerns a 60-year-old, female patient with no relevant medical history, who experienced the unexpected event of gingival abscess. The event gingival abscess occurred approximately 3 months after the second dose of mRNA-1273 vaccine administration. The rechallenge was unknown as there's no information available about the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Depressed mood, Disturbance in attention, Fatigue, Inappropriate schedule of product administration
Clinical narrative: I received the second dose 21 days after the first dose; Feeling sad; I had memory loss, lack of focus and concentration, I could not concentrate on /I walk into a room and can't remember why I came there forgetting things forgetting people; lack of focus and concentration; Extremely tired, I was in tears at times; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Feeling sad), AMNESIA (I had memory loss, lack of focus and concentration, I could not concentrate on /I walk into a room and can't remember why I came there forgetting things forgetting people), DISTURBANCE IN ATTENTION (lack of focus and concentration), FATIGUE (Extremely tired, I was in tears at times) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received the second dose 21 days after the first dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DEPRESSED MOOD (Feeling sad), AMNESIA (I had memory loss, lack of focus and concentration, I could not concentrate on /I walk into a room and can't remember why I came there forgetting things forgetting people), DISTURBANCE IN ATTENTION (lack of focus and concentration) and FATIGUE (Extremely tired, I was in tears at times). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received the second dose 21 days after the first dose). At the time of the report, DEPRESSED MOOD (Feeling sad) outcome was unknown, AMNESIA (I had memory loss, lack of focus and concentration, I could not concentrate on /I walk into a room and can't remember why I came there forgetting things forgetting people), DISTURBANCE IN ATTENTION (lack of focus and concentration) and FATIGUE (Extremely tired, I was in tears at times) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received the second dose 21 days after the first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Weight: decreased (Low) Lost 12 pounds.         Patient reported that symptoms started after the second dose had difficulty in concentrating, had memory issues and extreme fatigue. The symptoms were gradually resolving. The patient also expressed disappointment at the lack of resources to help in dealing with those side effect.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: I received the second dose 21 days after the first dose; Feeling sad; I had memory loss, lack of focus and concentration, I could not concentrate on /I walk into a room and can't remember why I came there forgetting things forgetting people; lack of focus and concentration; Extremely tired, I was in tears at times; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Feeling sad), AMNESIA (I had memory loss, lack of focus and concentration, I could not concentrate on /I walk into a room and can't remember why I came there forgetting things forgetting people), DISTURBANCE IN ATTENTION (lack of focus and concentration), FATIGUE (Extremely tired, I was in tears at times) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received the second dose 21 days after the first dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DEPRESSED MOOD (Feeling sad), AMNESIA (I had memory loss, lack of focus and concentration, I could not concentrate on /I walk into a room and can't remember why I came there forgetting things forgetting people), DISTURBANCE IN ATTENTION (lack of focus and concentration) and FATIGUE (Extremely tired, I was in tears at times). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received the second dose 21 days after the first dose). At the time of the report, DEPRESSED MOOD (Feeling sad) outcome was unknown, AMNESIA (I had memory loss, lack of focus and concentration, I could not concentrate on /I walk into a room and can't remember why I came there forgetting things forgetting people), DISTURBANCE IN ATTENTION (lack of focus and concentration) and FATIGUE (Extremely tired, I was in tears at times) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received the second dose 21 days after the first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Weight: decreased (Low) Lost 12 pounds.         Patient reported that symptoms started after the second dose had difficulty in concentrating, had memory issues and extreme fatigue. The symptoms were gradually resolving. The patient also expressed disappointment at the lack of resources to help in dealing with those side effect.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 post puncture) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 post puncture). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient was administered with dose > 12 post puncture. Reportedly, it was patient's first dose.   This case was linked to MOD-2021-347329 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 60 days after the 1st one) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056D21A and 939911) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 60 days after the 1st one). On 27-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 60 days after the 1st one) had resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient received their second dose of the Moderna COVID-19 vaccine 60 days after the first dose. The patient received both the doses at the same vaccination facility.   Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2021: Significant follow up was received which contains the batch number for the second dose, dosage date for the second dose and event start date. Incorporated these information in the report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Ten patients were administered an expired dose of the Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Ten patients were administered an expired dose of the Moderna COVID-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Ten patients were administered an expired dose of the Moderna COVID-19 vaccine). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Ten patients were administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Musculoskeletal chest pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Chest was tender; Trouble catching his breath; Site of injection is swollen (like a ball); Site of injection is tender to touch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Oct-2021 and was forwarded to Moderna on 09-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Chest was tender), DYSPNOEA (Trouble catching his breath), VACCINATION SITE SWELLING (Site of injection is swollen (like a ball)) and VACCINATION SITE PAIN (Site of injection is tender to touch) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A or 05GE21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID (VITAMIN C ACID) and IBUPROFEN for an unknown indication.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Chest was tender), DYSPNOEA (Trouble catching his breath), VACCINATION SITE SWELLING (Site of injection is swollen (like a ball)) and VACCINATION SITE PAIN (Site of injection is tender to touch). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Chest was tender), DYSPNOEA (Trouble catching his breath), VACCINATION SITE SWELLING (Site of injection is swollen (like a ball)) and VACCINATION SITE PAIN (Site of injection is tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient reported that on 08-Oct-2021, the patient noticed that the site of injection was swollen (like a ball) and was tender to touch. The patient also had trouble catching their breath and their chest was tender on 08-OCT-2021 but felt better on the day of reporting. (09-Oct-2021).  stated that they do not drink a lot, no smoking or use of drugs.
Sex: U
Vaccine: COVID19
Symptoms: Aneurysm
Clinical narrative: he had an aneurysm; This spontaneous case was reported by a consumer and describes the occurrence of ANEURYSM (he had an aneurysm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (for aneurysm) on 25-Mar-2021.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ANEURYSM (he had an aneurysm). The patient was treated with Surgery for Aneurysm. At the time of the report, ANEURYSM (he had an aneurysm) outcome was unknown.            The patient started taking a blood thinner after the surgery. Concomitant medication were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-151149 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-151149:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses beyond the use-by date was administered; 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 (doses beyond the use-by date was administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses beyond the use-by date was administered). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses beyond the use-by date was administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Ten patients got those doses between 01Oct2021 and 03Oct2021. The date in which the vial initially stored the in the refrigerator was 30Aug2021.  No concomitant medications was provided by the reporter. No treatments medications was provided by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 post puncture) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 post puncture). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient was administered with dose >12 post puncture. Reportedly, it was patient's first dose.   This case was linked to MOD-2021-347184 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Product dose omission issue
Clinical narrative: shingles; delay second dose; shooting pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (shooting pain), HERPES ZOSTER (shingles) and PRODUCT DOSE OMISSION ISSUE (delay second dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (shooting pain). On an unknown date, the patient experienced HERPES ZOSTER (shingles) and PRODUCT DOSE OMISSION ISSUE (delay second dose). At the time of the report, PAIN (shooting pain) and HERPES ZOSTER (shingles) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (delay second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Gave Moderna COVID19 Vaccine to a patient who was supposed to get the flu shot.; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Gave Moderna COVID19 Vaccine to a patient who was supposed to get the flu shot.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (Vaccinated with DOSE-2 with Pfizer in APRIL 2021) in April 2021.    On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Gave Moderna COVID19 Vaccine to a patient who was supposed to get the flu shot.). On 09-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (Gave Moderna COVID19 Vaccine to a patient who was supposed to get the flu shot.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The reporter stated that on 09-Oct-2021, they gave a Moderna COVID-19 Vaccine to a patient who was supposed to get the flu shot. It was also reported that the patient received their second dose of Pfizer COVID-19 Vaccine in April 2021.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: arm really hurt; slight fever; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (arm really hurt) and PYREXIA (slight fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Colon cancer.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm really hurt) and PYREXIA (slight fever). At the time of the report, VACCINATION SITE PAIN (arm really hurt) and PYREXIA (slight fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient was running late for her chemo appointment. She was going into getting her colon operated on, so she wants to make sure she does not get COVID when she was in the hospital.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-347431 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: did not receive full dose (2nd dose); This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (did not receive full dose (2nd dose)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Colon cancer.    On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (did not receive full dose (2nd dose)). On 07-Oct-2021, ACCIDENTAL UNDERDOSE (did not receive full dose (2nd dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter  The patient was complaining that she feels she did not receive a full dose of the vaccine. The patient reports that during the second dose, the pharmacist had one syringe with 0.5 mL, and one syringe with less than that. The patient said she wanted the syringe with 0.5 mL in it, and the pharmacist apparently said that was for another patient who was bigger and larger, who needed a full dose. The patient asked the pharmacist to open up a new vial. She believes she received 0.3 mL of a vaccine, instead of 0.5 mL.  The patient said she was running late for her chemo appointment, and said she is dying of colon cancer. She also reports she has A plus blood type, and that she was told that is the blood type that coronavirus affects the most. She is going into getting her colon operated on, so she wants to make sure she does not get COVID when she is in the hospital.  The patient believes she did not receive a full dose for the second shot, and said she did not get any side effects from this dose.  Treatment information was not provided.   This case was linked to MOD-2021-347404 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: painful injection site arm; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE PAIN (painful injection site arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (painful injection site arm). At the time of the report, INJECTION SITE PAIN (painful injection site arm) 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.   No concomitant medications were reported. No treatment details were reported. It was reported that patient did not have lot number and expiration date of the dose, and also did not remember which arm the patient received the vaccination.   This case was linked to MOD-2021-348585 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA 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 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced PYREXIA. At the time of the report, PYREXIA had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  It was reported that the patient experienced fever post receiving the booster shot.  The patient received the booster shot on 08-Oct-2021 and was having a temperature on the day of reporting (09-Oct-2021).
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Iadvertently gave Pfizer as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Iadvertently gave Pfizer as a second dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 08-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Iadvertently gave Pfizer as a second dose). On 08-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (Iadvertently gave Pfizer as a second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.; Sender's Comments: This case concerns a 68 year-old, male with no relevant medical history reported, who experienced the event of INTERCHANGE OF VACCINE PRODUCTS with no other AE reported . The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: little bit sore and itched on the side for 1 or 2 days; little bit sore and itched on the side for 1 or 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little bit sore and itched on the side for 1 or 2 days) and PRURITUS (little bit sore and itched on the side for 1 or 2 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN (little bit sore and itched on the side for 1 or 2 days) and PRURITUS (little bit sore and itched on the side for 1 or 2 days). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (little bit sore and itched on the side for 1 or 2 days) and PRURITUS (little bit sore and itched on the side for 1 or 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Amnesia, Confusional state
Clinical narrative: Mental confusion; Memory loss/Symptoms like those of early Alzheimers, patients could not remember family members; 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 CONFUSIONAL STATE and AMNESIA 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 CONFUSIONAL STATE and AMNESIA. At the time of the report, CONFUSIONAL STATE and AMNESIA was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medications provided. No treatment medications provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lipoma, Pyrexia
Clinical narrative: lipoma on the left arm; got very sick; fever "and all that"; This spontaneous case was reported by a consumer and describes the occurrence of LIPOMA (lipoma on the left arm), ILLNESS (got very sick) and PYREXIA (fever "and all that") in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C2VT and 939902or9399oZ) for COVID-19 vaccination.     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 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIPOMA (lipoma on the left arm), ILLNESS (got very sick) and PYREXIA (fever "and all that"). The patient was treated with STEROIDS for Adverse event, at an unspecified dose and frequency; VALACICLOVIR HYDROCHLORIDE (VALTREX) for Rash, at an unspecified dose and frequency; GABAPENTIN for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, LIPOMA (lipoma on the left arm), ILLNESS (got very sick) and PYREXIA (fever "and all that") outcome was unknown.            Concomitant medications were not reported. On an unknown date, Patient had computerised tomogram: of head: No result reported.   This case was linked to MOD-2021-347551 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Headache, Herpes zoster, Illness, Loss of personal independence in daily activities
Clinical narrative: Got very sick; Has lost work; Severe pain; Rash; Fever "and all that"; Head pain; Severe case of shingles on the right side of their face affecting the mouth, going up their chin; Ear is extremely swollen; Lesions on their cheek bone/e lesions in their ear; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Got very sick), HERPES ZOSTER (Severe case of shingles on the right side of their face affecting the mouth, going up their chin), EAR SWELLING (Ear is extremely swollen), SKIN LESION (Lesions on their cheek bone/e lesions in their ear) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has lost work) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 054C2VT) 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 17-Sep-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 HERPES ZOSTER (Severe case of shingles on the right side of their face affecting the mouth, going up their chin), EAR SWELLING (Ear is extremely swollen) and SKIN LESION (Lesions on their cheek bone/e lesions in their ear). On an unknown date, the patient experienced ILLNESS (Got very sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has lost work), PAIN (Severe pain), RASH (Rash), PYREXIA (Fever "and all that") and HEADACHE (Head pain). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Rash, at an unspecified dose and frequency; GABAPENTIN for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, ILLNESS (Got very sick), HERPES ZOSTER (Severe case of shingles on the right side of their face affecting the mouth, going up their chin), EAR SWELLING (Ear is extremely swollen), SKIN LESION (Lesions on their cheek bone/e lesions in their ear), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has lost work), PAIN, RASH, PYREXIA and HEADACHE outcome was unknown.            Concomitant medication was not provided.  2 weeks after the second dose, the patient developed a severe case of shingles on the right side of their face, affecting the mouth, going up their chin, and developing lesions on their cheek bone and ear. The ear was extremely swollen.At one point they went to the ER where they took a CT scan of their head because they were having severe pain but no rash had presented yet for the shingles. Patient mentioned that they were normally healthy.   This case was linked to MOD-2021-347545 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, Skin lesion
Clinical narrative: Got very sick; Has lost work; Severe pain; Rash; Fever "and all that"; Head pain; Severe case of shingles on the right side of their face affecting the mouth, going up their chin; Ear is extremely swollen; Lesions on their cheek bone/e lesions in their ear; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Got very sick), HERPES ZOSTER (Severe case of shingles on the right side of their face affecting the mouth, going up their chin), EAR SWELLING (Ear is extremely swollen), SKIN LESION (Lesions on their cheek bone/e lesions in their ear) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has lost work) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 054C2VT) 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 17-Sep-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 HERPES ZOSTER (Severe case of shingles on the right side of their face affecting the mouth, going up their chin), EAR SWELLING (Ear is extremely swollen) and SKIN LESION (Lesions on their cheek bone/e lesions in their ear). On an unknown date, the patient experienced ILLNESS (Got very sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has lost work), PAIN (Severe pain), RASH (Rash), PYREXIA (Fever "and all that") and HEADACHE (Head pain). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Rash, at an unspecified dose and frequency; GABAPENTIN for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, ILLNESS (Got very sick), HERPES ZOSTER (Severe case of shingles on the right side of their face affecting the mouth, going up their chin), EAR SWELLING (Ear is extremely swollen), SKIN LESION (Lesions on their cheek bone/e lesions in their ear), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has lost work), PAIN, RASH, PYREXIA and HEADACHE outcome was unknown.            Concomitant medication was not provided.  2 weeks after the second dose, the patient developed a severe case of shingles on the right side of their face, affecting the mouth, going up their chin, and developing lesions on their cheek bone and ear. The ear was extremely swollen.At one point they went to the ER where they took a CT scan of their head because they were having severe pain but no rash had presented yet for the shingles. Patient mentioned that they were normally healthy.   This case was linked to MOD-2021-347545 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination site erythema, Vaccination site pain
Clinical narrative: COVID-19 infection (diagnosis date not asked/Hospitalization due to COVID-19 (dates not asked).; Left arm was red; Left arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection (diagnosis date not asked/Hospitalization due to COVID-19 (dates not asked).) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Left arm was red) and VACCINATION SITE PAIN (Left arm was hurting). On an unknown date, the patient experienced COVID-19 (COVID-19 infection (diagnosis date not asked/Hospitalization due to COVID-19 (dates not asked).) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID-19 infection (diagnosis date not asked/Hospitalization due to COVID-19 (dates not asked).), VACCINATION SITE ERYTHEMA (Left arm was red) and VACCINATION SITE PAIN (Left arm was hurting) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.  Company Comment: This case concerns an 89-year-old, female patient with previous relevant medical history of cancer, who experienced the unexpected events of COVID-19. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-346692 (Patient Link).; Sender's Comments: This case concerns an 89-year-old, female patient with previous relevant medical history of cancer, who experienced the unexpected events of COVID-19. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: got a half dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (got a half dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (got a half dose). At the time of the report, ACCIDENTAL UNDERDOSE (got a half dose) had resolved.            No concomitant medications were not reported. No treatment medications were not provided. Patient got a half dose and that it was because she was above 65 years of age.