chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: experience itchy arms; experience sore arm; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (experience itchy arms) and PAIN IN EXTREMITY (experience sore arm) in a 62-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57143B) for COVID-19 vaccination.     The patient was never tested positive for COVID-19.  The patient did not receive any other vaccine given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy and Meningitis (had the condition for 15 years) since 2007.    On 07-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Sep-2022, the patient experienced PRURITUS (experience itchy arms) and PAIN IN EXTREMITY (experience sore arm). At the time of the report, PRURITUS (experience itchy arms) and PAIN IN EXTREMITY (experience sore arm) had not resolved.            No concomitant medications were reported.   The patient received Moderna vaccine dose 1 on 27-Jan-2021 (Batch lot no. 007M20A), dose 2 on 24-Feb-2021 (Batch lot no. 002A2) and dose 3 (1st booster dose) on 18-Nov-2021 (Batch lot no. 048F21A).  It was reported that, the patient experienced sore and itchy arm after getting the booster dose. The patient did not seek medical help yet for side effects. The patient did not experience similar events in the past.  No treatment details were reported.   This case was linked to MOD-2022-644010 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event; Pediatric Booster dose was administered instead of Booster Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.   On 30-Oct-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Sep-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Sep-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent).    No concomitant medications were reported. It was reported that pediatric booster dose was administered to  patient instead of the bivalent booster dose. Unfortunately, the Moderna Pediatric vaccine vial was mixed with the Bivalent Booster vials.  The goal was to administer the Booster Bivalent dose, but the Pediatric vial was administered instead.  There was no information primary doses. The adverse event did not cause patient to seek medical care. The patient did not experienced a similar event in the past. No treatment medications were reported.   This case was linked to MOD-2022-644030 (Patient Link).
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was administered booster shot with the pediatric formulation of 0.5 ml; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient was administered booster shot with the pediatric formulation of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Patient was administered booster shot with the pediatric formulation of 0.5 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient was administered booster shot with the pediatric formulation of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient was administered booster shot with the pediatric formulation of 0.5 ml).    Concomitant medications was not provided. It was stated that 4 patients received the pediatric formulation of 0.5 mL as their booster doses instead of the Moderna COVID-19 vaccine, bivalent.Pharmacist asked what needs to be done for these patients. They should administered the bivalent vaccine now or wait and if they required to wait ,how long. Patients had not reported any adverse reactions at the time of reporting. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-644021, US-MODERNATX, INC.-MOD-2022-644022, US-MODERNATX, INC.-MOD-2022-644023 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644021:(same reporter) US-MODERNATX, INC.-MOD-2022-644022:(same reporter) US-MODERNATX, INC.-MOD-2022-644023:(same reporter)
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: 4 patients received the pediatric formulation of 0.5 mL as their booster doses (Lot #064A22A, Expiration date: 25SEP2022), instead of the Moderna COVID-19 vaccine, bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (4 patients received the pediatric formulation of 0.5 mL as their booster doses (Lot #064A22A, Expiration date: 25SEP2022), instead of the Moderna COVID-19 vaccine, bivalent) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (4 patients received the pediatric formulation of 0.5 mL as their booster doses (Lot #064A22A, Expiration date: 25SEP2022), instead of the Moderna COVID-19 vaccine, bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (4 patients received the pediatric formulation of 0.5 mL as their booster doses (Lot #064A22A, Expiration date: 25SEP2022), instead of the Moderna COVID-19 vaccine, bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (4 patients received the pediatric formulation of 0.5 mL as their booster doses (Lot #064A22A, Expiration date: 25SEP2022), instead of the Moderna COVID-19 vaccine, bivalent).    No concomitant information provided. Patients have not reported any adverse reactions at this time. HCP  was  looking for recommendations/guidance for these patients. No treatment information provided   This case was linked to US-MODERNATX, INC.-MOD-2022-644023, US-MODERNATX, INC.-MOD-2022-644018 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644023:same reporter US-MODERNATX, INC.-MOD-2022-644018:(same reporter)
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 4 patients adult patients were administered booster shots with the pediatric formulation; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (4 patients adult patients were administered booster shots with the pediatric formulation) and NO ADVERSE EVENT (No adverse event) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (4 patients adult patients were administered booster shots with the pediatric formulation) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (4 patients adult patients were administered booster shots with the pediatric formulation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (4 patients adult patients were administered booster shots with the pediatric formulation).    No concomitant medication were provided.  Patient was expecting to get the bivalent booster (dose 5).  It was reported that the patient received the pediatric formulation of 0.5 mL as their booster doses (Lot 064A22A, Expiration date: 25SEP2022), instead of the Moderna COVID-19 vaccine, bivalent.   Patient have not reported any adverse reactions at this time.  No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2022-644023 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644023:same reporter
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult patient was administered booster shot with the pediatric formulation instead of the bivalent booster dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient was administered booster shot with the pediatric formulation instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient was administered booster shot with the pediatric formulation instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient was administered booster shot with the pediatric formulation instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient was administered booster shot with the pediatric formulation instead of the bivalent booster dose).    No concomitant medications were provided.  Patient was expecting to get the bivalent booster dose (dose 5).  It was reported that the patient received the pediatric formulation dose of 0.5 mL as the third booster dose instead of the bivalent booster dose of Moderna COVID-19 vaccine.  Patient had not reported any adverse reactions at this time. The reporter was looking for recommendations/guidance for the next steps to be taken in regards to the patient's dose.  No treatment details was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-644021, US-MODERNATX, INC.-MOD-2022-644022, US-MODERNATX, INC.-MOD-2022-644018 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644021:same reporter US-MODERNATX, INC.-MOD-2022-644022:same reporter US-MODERNATX, INC.-MOD-2022-644018:same reporter
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, Joint stiffness, Mass, Musculoskeletal stiffness, Oropharyngeal discomfort
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck was stiff on one side/ Mine went up my neck and was kind of below my ear), OROPHARYNGEAL DISCOMFORT (I could feel one side of my throat like my jaw is stiff or something), JOINT STIFFNESS (I could feel one side of my throat like my jaw is stiff or something), MASS (The middle of the night I had a lump there below my ear, and above my lower jaw/ When I laugh stuff I feel it in my jaw) and EXTRA DOSE ADMINISTERED (Patient had 5 shots of the Moderna vaccine at this time) in a 70-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. No Medical History information was reported. On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck was stiff on one side/ Mine went up my neck and was kind of below my ear), OROPHARYNGEAL DISCOMFORT (I could feel one side of my throat like my jaw is stiff or something), JOINT STIFFNESS (I could feel one side of my throat like my jaw is stiff or something) and MASS (The middle of the night I had a lump there below my ear, and above my lower jaw/ When I laugh stuff I feel it in my jaw). On 09-Sep-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient had 5 shots of the Moderna vaccine at this time). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Neck was stiff on one side/ Mine went up my neck and was kind of below my ear), OROPHARYNGEAL DISCOMFORT (I could feel one side of my throat like my jaw is stiff or something), JOINT STIFFNESS (I could feel one side of my throat like my jaw is stiff or something), MASS (The middle of the night I had a lump there below my ear, and above my lower jaw/ When I laugh stuff I feel it in my jaw) and EXTRA DOSE ADMINISTERED (Patient had 5 shots of the Moderna vaccine at this time) outcome was unknown. No concomitant medications were provided. On an unknown date, patient had received 5 shots of the Moderna vaccine. Patient reported that she experienced neck stiff on one side. It went up her neck and was kind of below her ear. Patient felt one side of her throat like her jaw was stiff or something. Patient took Tylenol last night. The middle of the night patient had a lump there below her ear, and above her lower jaw. At 4:00 AM took another Tylenol. When patient laugh and stuff patient felt it in her jaw. 70 years old. No difficulty breathing. This case was linked to MODERNATX, INC. (E2B Linked Report). Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC :Husband case.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: the needle was not properly sealed with the syringe and the vaccine leaked; no adverse event; patient was administered approximately 0.1 mL instead of 0.5 mL of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (the needle was not properly sealed with the syringe and the vaccine leaked), UNDERDOSE (patient was administered approximately 0.1 mL instead of 0.5 mL of the vaccine) and NO ADVERSE EVENT (no adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced UNDERDOSE (patient was administered approximately 0.1 mL instead of 0.5 mL of the vaccine). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (the needle was not properly sealed with the syringe and the vaccine leaked) and NO ADVERSE EVENT (no adverse event). At the time of the report, DEVICE CONNECTION ISSUE (the needle was not properly sealed with the syringe and the vaccine leaked), UNDERDOSE (patient was administered approximately 0.1 mL instead of 0.5 mL of the vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (the needle was not properly sealed with the syringe and the vaccine leaked) and UNDERDOSE (patient was administered approximately 0.1 mL instead of 0.5 mL of the vaccine).    It was unknown if patient was under any concomitant or regular medication.  On an unknown date in 2021, patient received first dose of COVID-19 Vaccine (unknown route, lot number unknown).   No treatment medication was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: with all the shots, I had something like fatigue; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (with all the shots, I had something like fatigue) in a female patient of an unknown age who received mRNA-1273 for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273  (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (with all the shots, I had something like fatigue). At the time of the report, FATIGUE (with all the shots, I had something like fatigue) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  Patient had 2 full shots and 2 booster shots of the Moderna, and with all shots she had experienced things like fatigue.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event; Pediatric Booster dose was administered instead of Booster Bivalent.; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent.) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Oct-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Sep-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Sep-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Pediatric Booster dose was administered instead of Booster Bivalent.).    No concomitant medication were reported.  It was reported that pediatric booster dose was administered to the patient instead of the bivalent booster dose.   Unfortunately, the Moderna Pediatric vaccine vial was mixed with the Bivalent Booster vials. The goal was to administer the Booster Bivalent dose, but instead the Pediatric vial was administered. The AE did not cause patient to seek medical care. The patient did not experienced a similar event in the past no information on Primary Doses.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: with all the other shots, I had something like fatigue; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (with all the other shots, I had something like fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 FATIGUE (with all the other shots, I had something like fatigue). At the time of the report, FATIGUE (with all the other shots, I had something like fatigue) outcome was unknown.            Concomitant medication list was not provided.  Patient had 2 full shots and 2 booster shots of the Moderna previously. It was reported that with all shots patient had experienced things like fatigue.  Treatment information was not provided.   This case was linked to MOD-2022-644029, MOD-2022-644032 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient wanted to check the lot number of the booster dose patient received to make sure that patient had in fact received the Moderna COVID-19 vaccine, bivalent. Patient not had any reaction with that vaccine and patient was not sure why. Patient had 2 full shots and 2 booster shots of the Moderna previously. Patient was expecting to be in bed, sick after receiving the 3rd booster shot. Patient went to a different pharmacy than usual and patient was curious whether patient received the bivalent booster or not.  No treatment information was reported.   This case was linked to MOD-2022-644031, MOD-2022-644029 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I tested positive for COVID-19 on Fri (09Sep2022); This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I tested positive for COVID-19 on Fri (09Sep2022)) in a male patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced COVID-19 (I tested positive for COVID-19 on Fri (09Sep2022)). At the time of the report, COVID-19 (I tested positive for COVID-19 on Fri (09Sep2022)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2022, SARS-CoV-2 test: (Positive) Tested positive for Covid-19.     The action taken with mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Company comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the non-serious unexpected event of COVID-19, the next following day after receiving booster dose with mRNA-1273.222 BIVALENT vaccine.  SARS-CoV-2 test was performed with positive result. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  No concomitant medications was reported. No treatment drug details was reported. Sender's Comments: Company comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the non-serious unexpected event of COVID-19, the next following day after receiving booster dose with mRNA-1273.222 BIVALENT vaccine.  SARS-CoV-2 test was performed with positive result. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Lip blister, Taste disorder
Clinical narrative: Patient taste was not lost but most things did not taste right; Blisters on his lower lip line that extent from one side to other side and a small blister in his upper lip line as well; This spontaneous case was reported by a patient and describes the occurrence of LIP BLISTER (Blisters on his lower lip line that extent from one side to other side and a small blister in his upper lip line as well) and TASTE DISORDER (Patient taste was not lost but most things did not taste right) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ENZALUTAMIDE for an unknown indication.    No Medical History information was reported.   On 22-May-2020, the patient started ENZALUTAMIDE (Oral) 160 milligram once a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2020, the patient experienced LIP BLISTER (Blisters on his lower lip line that extent from one side to other side and a small blister in his upper lip line as well). On 22-Mar-2021, the patient experienced TASTE DISORDER (Patient taste was not lost but most things did not taste right). The last dose administered for ENZALUTAMIDE (ENZALUTAMIDE) was on 01-Sep-2022. At the time of the report, LIP BLISTER (Blisters on his lower lip line that extent from one side to other side and a small blister in his upper lip line as well) outcome was unknown and TASTE DISORDER (Patient taste was not lost but most things did not taste right) had not resolved.  No concomitant medication information was provided. On 01-Sep-2022 the patient had been advised by the doctor to hold Enzalutamide for 3 months due to unknown reason. No treatment medication were provided.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). At the time of the report, VACCINATION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to MOD-2022-644138, MOD-2022-644145 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). At the time of the report, VACCINATION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to MOD-2022-644138, MOD-2022-644145 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). At the time of the report, VACCINATION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to MOD-2022-644138, MOD-2022-644145 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm itched; red left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (left arm itched) and VACCINATION SITE ERYTHEMA (red left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   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, the patient experienced VACCINATION SITE PRURITUS (left arm itched) and VACCINATION SITE ERYTHEMA (red left arm). At the time of the report, VACCINATION SITE PRURITUS (left arm itched) and VACCINATION SITE ERYTHEMA (red left arm) outcome was unknown.            No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-644061 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: left arm itched; red left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (left arm itched) and VACCINATION SITE ERYTHEMA (red left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   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, the patient experienced VACCINATION SITE PRURITUS (left arm itched) and VACCINATION SITE ERYTHEMA (red left arm). At the time of the report, VACCINATION SITE PRURITUS (left arm itched) and VACCINATION SITE ERYTHEMA (red left arm) outcome was unknown.            No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-644061 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: left arm itched; red left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (left arm itched) and VACCINATION SITE ERYTHEMA (red left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   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, the patient experienced VACCINATION SITE PRURITUS (left arm itched) and VACCINATION SITE ERYTHEMA (red left arm). At the time of the report, VACCINATION SITE PRURITUS (left arm itched) and VACCINATION SITE ERYTHEMA (red left arm) outcome was unknown.            No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-644061 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Itching; A red sore arm; A red sore arm; A lot of swelling in her left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (A red sore arm), VACCINATION SITE ERYTHEMA (A red sore arm) and VACCINATION SITE SWELLING (A lot of swelling in her left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A and 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   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-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient experienced VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (A red sore arm). 12-Apr-2022, the patient experienced VACCINATION SITE PAIN (A red sore arm). 12-Apr-2022, the patient experienced VACCINATION SITE SWELLING (A lot of swelling in her left arm). At the time of the report, VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (A red sore arm), VACCINATION SITE ERYTHEMA (A red sore arm) and VACCINATION SITE SWELLING (A lot of swelling in her left arm) outcome was unknown.            No concomitant medication information was provided. It was reported that patient received second booster of Moderna Covid-19 vaccine. No treatment medication were provided.   This case was linked to MOD-2022-644061, MOD-2022-644138 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching; A red sore arm; A red sore arm; A lot of swelling in her left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (A red sore arm), VACCINATION SITE ERYTHEMA (A red sore arm) and VACCINATION SITE SWELLING (A lot of swelling in her left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A and 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   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-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient experienced VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (A red sore arm). 12-Apr-2022, the patient experienced VACCINATION SITE PAIN (A red sore arm). 12-Apr-2022, the patient experienced VACCINATION SITE SWELLING (A lot of swelling in her left arm). At the time of the report, VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (A red sore arm), VACCINATION SITE ERYTHEMA (A red sore arm) and VACCINATION SITE SWELLING (A lot of swelling in her left arm) outcome was unknown.            No concomitant medication information was provided. It was reported that patient received second booster of Moderna Covid-19 vaccine. No treatment medication were provided.   This case was linked to MOD-2022-644061, MOD-2022-644138 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching; A red sore arm; A red sore arm; A lot of swelling in her left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (A red sore arm), VACCINATION SITE ERYTHEMA (A red sore arm) and VACCINATION SITE SWELLING (A lot of swelling in her left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A and 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   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-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient experienced VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (A red sore arm). 12-Apr-2022, the patient experienced VACCINATION SITE PAIN (A red sore arm). 12-Apr-2022, the patient experienced VACCINATION SITE SWELLING (A lot of swelling in her left arm). At the time of the report, VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (A red sore arm), VACCINATION SITE ERYTHEMA (A red sore arm) and VACCINATION SITE SWELLING (A lot of swelling in her left arm) outcome was unknown.            No concomitant medication information was provided. It was reported that patient received second booster of Moderna Covid-19 vaccine. No treatment medication were provided.   This case was linked to MOD-2022-644061, MOD-2022-644138 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID Disease 2 months after 2nd booster; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID Disease 2 months after 2nd booster) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 032L20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (COVID Disease 2 months after 2nd booster). At the time of the report, COVID-19 (COVID Disease 2 months after 2nd booster) had resolved.            No Concomitant medication was reported. No treatment information was provided.  Company comment: This spontaneous case concerns a 73-year-old male patient with no medical history reported, who experienced the adverse event of special interest of COVID-19 2 months after the fourth dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73-year-old male patient with no medical history reported, who experienced the adverse event of special interest of COVID-19 2 months after the fourth dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Bivalent vaccine applied as a Second Primary Series dose; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Bivalent vaccine applied as a Second Primary Series dose) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. Unknown) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Bivalent vaccine applied as a Second Primary Series dose) and NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Bivalent vaccine applied as a Second Primary Series dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Bivalent vaccine applied as a Second Primary Series dose).    No Concomitant medication were reported.  It was reported that Patient had an appointment to receive Moderna's second dose from primary series but instead patient received Moderna's newBivalent Booster dose.   No treatment drug were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Extra dose administered, No adverse event
Clinical narrative: No adverse event; Vaccine leaked out of the syringe where the needle was attached while being vaccinated.A lot of liquid came out; They repeated the bivalent booster on him; This spontaneous case was reported by a patient and describes the occurrence of DEVICE CONNECTION ISSUE (Vaccine leaked out of the syringe where the needle was attached while being vaccinated.A lot of liquid came out), EXTRA DOSE ADMINISTERED (They repeated the bivalent booster on him) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced DEVICE CONNECTION ISSUE (Vaccine leaked out of the syringe where the needle was attached while being vaccinated.A lot of liquid came out) and EXTRA DOSE ADMINISTERED (They repeated the bivalent booster on him). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (Vaccine leaked out of the syringe where the needle was attached while being vaccinated.A lot of liquid came out), EXTRA DOSE ADMINISTERED (They repeated the bivalent booster on him) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication were reported.  It was reported that patient took first dose of Moderna on unknown date, Lot number and Expiry date were also unknown.Second shot was given on unknown date, Lot number and Expiry date were also unknown.First Original Booster dose was given on 27-NOV-2021 Lot number and Expiry date were unknown.  It was reported that the person administering the vaccine asked the Pharmacy manager. They repeated the bivalent booster on him.  No treatment medication were reported.   Reporter did not allow further contact