chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; lower than authorized dose of Moderna bivalent vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients).    No concomitant medications were provided. It was reported that 18 elderly patients received 0.25 mL dose instead of 0.5 mL dose. The patients have not reported any adverse reactions at that time.  No treatment medication was provided. This case contains information for the 4th of 18 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666280, US-MODERNATX, INC.-MOD-2022-666278, US-MODERNATX, INC.-MOD-2022-666286, US-MODERNATX, INC.-MOD-2022-666290, US-MODERNATX, INC.-MOD-2022-666063 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666277: US-MODERNATX, INC.-MOD-2022-666278: US-MODERNATX, INC.-MOD-2022-666286: US-MODERNATX, INC.-MOD-2022-666284: US-MODERNATX, INC.-MOD-2022-666290: US-MODERNATX, INC.-MOD-2022-666280: US-MODERNATX, INC.-MOD-2022-666063:
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: Feeling sore; Dizzy; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Feeling sore) and DIZZINESS (Dizzy) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Feeling sore) and DIZZINESS (Dizzy). At the time of the report, PAIN (Feeling sore) and DIZZINESS (Dizzy) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Ear infection, Somnolence
Clinical narrative: after which he experienced a lot of ear infections; sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (after which he experienced a lot of ear infections) and SOMNOLENCE (sleepiness) in a 1-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced EAR INFECTION (after which he experienced a lot of ear infections) and SOMNOLENCE (sleepiness). At the time of the report, EAR INFECTION (after which he experienced a lot of ear infections) and SOMNOLENCE (sleepiness) outcome was unknown. Not Provided          No concomitant medication was provided by the reporter.  It was reported that the patient had received 1st dose of the Moderna COVID-19 vaccine, after which patient experienced a lot of ear infections due to which they had to delay 2nd dose of the Moderna. After the first dose, patient only experienced excessive sleepiness. There were not other symptoms.  No treatment medication was provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Lethargy, Myalgia, Vaccination site erythema, Vaccination site inflammation
Clinical narrative: Felt lethargic for a day and a half; Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.; Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.; Right arm ached; Whole body ached; Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (Felt lethargic for a day and a half), FLUSHING (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.), VACCINATION SITE INFLAMMATION (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.), VACCINATION SITE PAIN (Right arm ached) and MYALGIA (Whole body ached) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced LETHARGY (Felt lethargic for a day and a half), FLUSHING (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.), VACCINATION SITE INFLAMMATION (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.), VACCINATION SITE PAIN (Right arm ached), MYALGIA (Whole body ached) and VACCINATION SITE ERYTHEMA (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.). In January 2021, LETHARGY (Felt lethargic for a day and a half), VACCINATION SITE PAIN (Right arm ached) and MYALGIA (Whole body ached) had resolved. At the time of the report, FLUSHING (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.), VACCINATION SITE INFLAMMATION (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.) and VACCINATION SITE ERYTHEMA (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.) 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 patient received first Moderna Covid 19 vaccine primary series on 26-Jan-2021, expiration date was not known in right arm of administration. Patient was reported the adverse reactions. The treatment medication was not reported by reporter.   This case was linked to MOD-2022-666297, MOD-2022-666289, MOD-2022-666332 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Felt lethargic for a day and a half; Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.; Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.; Right arm ached; Whole body ached; Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (Felt lethargic for a day and a half), FLUSHING (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.), VACCINATION SITE INFLAMMATION (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.), VACCINATION SITE PAIN (Right arm ached) and MYALGIA (Whole body ached) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced LETHARGY (Felt lethargic for a day and a half), FLUSHING (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.), VACCINATION SITE INFLAMMATION (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.), VACCINATION SITE PAIN (Right arm ached), MYALGIA (Whole body ached) and VACCINATION SITE ERYTHEMA (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.). In January 2021, LETHARGY (Felt lethargic for a day and a half), VACCINATION SITE PAIN (Right arm ached) and MYALGIA (Whole body ached) had resolved. At the time of the report, FLUSHING (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.), VACCINATION SITE INFLAMMATION (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.) and VACCINATION SITE ERYTHEMA (Right arm had an inflamed red circle flush against her skin but like a circumference of an Orange.) 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 patient received first Moderna Covid 19 vaccine primary series on 26-Jan-2021, expiration date was not known in right arm of administration. Patient was reported the adverse reactions. The treatment medication was not reported by reporter.   This case was linked to MOD-2022-666297, MOD-2022-666289, MOD-2022-666332 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: She fell while walking in the street; This spontaneous case was reported by a patient and describes the occurrence of FALL (She fell while walking in the street) 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 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (She fell while walking in the street). At the time of the report, FALL (She fell while walking in the street) outcome was unknown.            No concomitant medications were reported.  The dose patient received on 11-Nov-2022 was booster dose.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received 0.25 mL dose instead of 0.5 mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 mL dose instead of 0.5 mL dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 mL dose instead of 0.5 mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 mL dose instead of 0.5 mL dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 ACCIDENTAL UNDERDOSE (Patient received 0.25 mL dose instead of 0.5 mL dose).    Concomitant product use was not provided by the reporter.  Lower than authorized dose of Moderna bivalent vaccine administered to patient.  The patient received 0.25 mL dose instead of 0.5 mL dose.  The patient have not reported any adverse reactions at this time.   Treatment information was not provided.  This case contains information for the 10th of 18 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666280, US-MODERNATX, INC.-MOD-2022-666278, US-MODERNATX, INC.-MOD-2022-666063, US-MODERNATX, INC.-MOD-2022-666248, US-MODERNATX, INC.-MOD-2022-666249, US-MODERNATX, INC.-MOD-2022-666250, US-MODERNATX, INC.-MOD-2022-666295, US-MODERNATX, INC.-MOD-2022-666290, US-MODERNATX, INC.-MOD-2022-666282, US-MODERNATX, INC.-MOD-2022-666281 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666284:Patient 9 US-MODERNATX, INC.-MOD-2022-666277:Patient 7 US-MODERNATX, INC.-MOD-2022-666278:Patient 14 US-MODERNATX, INC.-MOD-2022-666280:Patient 16 US-MODERNATX, INC.-MOD-2022-666063:Patient 1 US-MODERNATX, INC.-MOD-2022-666248:Patient 2 US-MODERNATX, INC.-MOD-2022-666249:Patient 3 US-MODERNATX, INC.-MOD-2022-666250:Patient 4 US-MODERNATX, INC.-MOD-2022-666295:Patient 12 US-MODERNATX, INC.-MOD-2022-666290:Patient 11 US-MODERNATX, INC.-MOD-2022-666282:Patient 18 US-MODERNATX, INC.-MOD-2022-666281:Patient 17
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Myalgia, Vaccination site pain
Clinical narrative: lethargic; sore right arm; tired; entire body ached; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargic), VACCINATION SITE PAIN (sore right arm), FATIGUE (tired) and MYALGIA (entire body ached) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced LETHARGY (lethargic), VACCINATION SITE PAIN (sore right arm), FATIGUE (tired) and MYALGIA (entire body ached). At the time of the report, LETHARGY (lethargic), VACCINATION SITE PAIN (sore right arm), FATIGUE (tired) and MYALGIA (entire body ached) outcome was unknown.      Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-666268, MOD-2022-666297, MOD-2022-666332 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; lower than authorized dose of Moderna bivalent vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients).    Concomitant product use was not provided by the reporter.  Patient received 0.25 mL dose instead of 0.5 mL dose. The patient had not reported any adverse reactions at this time.   Treatment information was not provided.  This case contains information for the 11th of 18 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666280, US-MODERNATX, INC.-MOD-2022-666286, US-MODERNATX, INC.-MOD-2022-666063, US-MODERNATX, INC.-MOD-2022-666248, US-MODERNATX, INC.-MOD-2022-666249, US-MODERNATX, INC.-MOD-2022-666250, US-MODERNATX, INC.-MOD-2022-666295, US-MODERNATX, INC.-MOD-2022-666278, US-MODERNATX, INC.-MOD-2022-666252, US-MODERNATX, INC.-MOD-2022-666255 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666284:Patient 9 US-MODERNATX, INC.-MOD-2022-666280:Patient 16 US-MODERNATX, INC.-MOD-2022-666277:Patient 11 US-MODERNATX, INC.-MOD-2022-666286:Patient 10 US-MODERNATX, INC.-MOD-2022-666063:Patient 1 US-MODERNATX, INC.-MOD-2022-666248:Patient 2 US-MODERNATX, INC.-MOD-2022-666249:Patient 3 US-MODERNATX, INC.-MOD-2022-666250:Patient 4 US-MODERNATX, INC.-MOD-2022-666295:Patient 12 US-MODERNATX, INC.-MOD-2022-666278:Patient 14 US-MODERNATX, INC.-MOD-2022-666252:Patient 6 US-MODERNATX, INC.-MOD-2022-666255:Patient 13
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Sore right arm; Achy body; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore right arm), MYALGIA (Achy body) and FATIGUE (Tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 056M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE PAIN (Sore right arm), MYALGIA (Achy body) and FATIGUE (Tiredness). In November 2021, VACCINATION SITE PAIN (Sore right arm), MYALGIA (Achy body) and FATIGUE (Tiredness) had resolved.            No concomitant medications were provided.  On 05-Nov-2021, the patient had sore right arm, achy body and tiredness for a day and a half.  The patient received second Moderna COVID-19 vaccine booster dose on 20-May-2022 (batch no. 056M21A, vaccination site: right arm).  On 20-May-2022, the patient had sore right arm, achy body and tiredness for a day and a half.  No treatment medication was provided.   This case was linked to MOD-2022-666268, MOD-2022-666332, MOD-2022-666289 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient received first Moderna Covid 19 bivalent vaccine booster dose, Patient reports adverse reactions; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient received first Moderna Covid 19 bivalent vaccine booster dose, Patient reports adverse reactions) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient received first Moderna Covid 19 bivalent vaccine booster dose, Patient reports adverse reactions). At the time of the report, IMMUNISATION REACTION (Patient received first Moderna Covid 19 bivalent vaccine booster dose, Patient reports adverse reactions) outcome was unknown.            Patient's height was reported as 5"2"  Concomitant medications were not provided.  Treatment medications were not provided.   This case was linked to MOD-2022-666268, MOD-2022-666297, MOD-2022-666289 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (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 dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 ACCIDENTAL UNDERDOSE (Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL).    No concomitant product was reported.  No treatment information was reported.  This case contains information for the 3rd of 9 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL to our adult patients.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL to our adult patients.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (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 dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL to our adult patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL to our adult patients.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 ACCIDENTAL UNDERDOSE (Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL to our adult patients.).    Concomitant medications were not provided. Treatment medications were not provided.  This case was for second patient of 9 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660845, US-MODERNATX, INC.-MOD-2022-666770, US-MODERNATX, INC.-MOD-2022-666771, US-MODERNATX, INC.-MOD-2022-666772, US-MODERNATX, INC.-MOD-2022-666773, US-MODERNATX, INC.-MOD-2022-666774 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660845:Patient 1 US-MODERNATX, INC.-MOD-2022-666770:Patient 7 US-MODERNATX, INC.-MOD-2022-666771:Patient 4 US-MODERNATX, INC.-MOD-2022-666772:Patient 5 US-MODERNATX, INC.-MOD-2022-666773:Patient 6 US-MODERNATX, INC.-MOD-2022-666774:Patient 8
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (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 dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 ACCIDENTAL UNDERDOSE (Administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL).    No concomitant medication information provided.   No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (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 dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (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 ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case was for seventh patient of 9 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660845, US-MODERNATX, INC.-MOD-2022-666768, US-MODERNATX, INC.-MOD-2022-666748, US-MODERNATX, INC.-MOD-2022-666773, US-MODERNATX, INC.-MOD-2022-666772, US-MODERNATX, INC.-MOD-2022-666774 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660845:Patient 1 US-MODERNATX, INC.-MOD-2022-666748:Patient 3 US-MODERNATX, INC.-MOD-2022-666768:Patient 2 US-MODERNATX, INC.-MOD-2022-666773:Patient 6 US-MODERNATX, INC.-MOD-2022-666772:Patient 5 US-MODERNATX, INC.-MOD-2022-666774:Patient 8
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (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 dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients).    No concomitants product information reported.  It was reported that they had administered patient the Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL to adult patient.  No treatment product information reported.  This case was for patient 4 of 9 patients reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Administration error/Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL to adult patient.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration error/Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL to adult patient.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (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 dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Administration error/Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL to adult patient.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administration error/Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL to adult patient.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 ACCIDENTAL UNDERDOSE (Administration error/Administered Moderna COVID-19 Bivalent 0.25mL, instead of 0.5mL to adult patient.).    No concomitant product use was reported.   No treatment information was provided.  This case contains information for the 05th patient out of 09 patients as described by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (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 dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (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 ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients).    No concomitants product information reported.  Health care professional stated she had called for an administration error in which they administered patient the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL to adult patient.  No treatment product information reported.  This case was for patient 6 of 9 patients reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (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 dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (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 ACCIDENTAL UNDERDOSE (administered patients the Moderna Covid 19 Bivalent 0.25mL, instead of 0.5mL).    Concomitant medication list was not provided. Treatment information was not provided. This case contains information for the 8th of 9 adult patients described by the reporter.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5, on 09Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation; BNT162b2, on 05Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; COVID-19 vaccine, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 25 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: NSAIDs" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Dose Number: 1:Pfizer / Dose Number: 1:Janssen; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose 2 (booster), single (Lot number: PE3590) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 30Mar2021 as dose 1, single (Lot number: 1805018), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Neutropenia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 1:Pfizer / Dose Number: 1:Janssen"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID again; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: After getting both doses, he clarified he had COVID Dec2021; After getting both doses, he clarified he had COVID Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "After getting both doses, he clarified he had COVID Dec2021". Clinical course: Clinical course:  Reporter want to know new variant it's included in the Pfizer booster and what was the age group allowed to take the shot by the FDA. Patient had both of the Pfizer COVID-19 Vaccines, the primary doses. he did not get the booster yet because he had the COVID virus. It's been 6-8 months since it's passed. He was inquiring about the new Bivalent Vaccine, but he was not gotten that yet due to having COVID in the past. After transfer reporter confirmed he was received both doses of the COVID-19 Vaccine. After getting both doses, he clarified he had COVID Dec2021. During interaction he mentioned he was filling out forms and in the process of getting the booster now. Patient got COVID the day was supposed to get the booster". While attempting to capture details he stated he was trying to fill forms out and requested someone call him back later. Informed Pfizer may follow-up and usually by mail.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An 84-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9261), on 17Feb2021 as dose 2, single (Lot number: EN6200) and on 25Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 83 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Oct2022 as dose 5 (booster), single (Lot number: 055F22B), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 08May2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "HLD" (unspecified if ongoing), notes: HLD; "fatty liver" (unspecified if ongoing); "Cataract" (unspecified if ongoing); "Hyperglycemia" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing); "Rhinitis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Sulfa (hives)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nexium, reaction(s): "Known allergies: Nexium (hives)". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08May2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Oct2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive; (13Oct2022) Negative, notes: Home test on 13Oct negative; (18Oct2022) Positive, notes: positive home COVID test on 18Oct2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that the patient may have had COVID rebound after Paxlovid treatment. Upper respiratory symptoms, congestion, fatigue, sore throat started 07Oct2022. Home antigen COVID test positive 08Oct2022. Prescribed Paxlovid on 08Oct2022. No symptoms on 13Oct2022 after completing Paxlovid. Home test on 13Oct2022 negative.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events interchange of vaccine products, vaccination failure and covid-19 and BNT162B2.
Sex: F
Vaccine: PNC13
Symptoms: Fear, Immediate post-injection reaction, Peripheral swelling
Clinical narrative: severe swelling of her left arm; This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient.  An elderly female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: COVID-19 VACCINE taken for covid-19 immunisation as dose number unknown, single. The following information was reported: PERIPHERAL SWELLING (medically significant) with onset 2021, outcome "unknown", described as "severe swelling of her left arm". Therapeutic measures were taken as a result of peripheral swelling.  Clinical course: Pfizer employee stated, "So, the doctor told me that the almost immediately started to swell up in left arm and she went to provider who administered her a steroid (Treatment) to reduce the swelling and then a year and half ago. And it was not that bad, so because of that she looked like to take her shingle shot. she was eligible for her single shot (Further clarification unknown, hence captured as unspecified shingle shot), so it created a level of fear in her, she did take her COVID shot (Manufacturer name not clarified hence left unchecked in tab) and the shingle shot, she was due for but she said I haven't done it again, you know because she got very bad experience and little scared." It was reported that No, it was administered a year and half ago. No, we do not have the Lot#." She did take her COVID shot and shingle shot, she was due for but she said I haven't done it again, because she got very bad experience and little scared. Patient had no known allergies. She shared that when she was over 65, so she got her Prevnar 13, she had an unusual reaction immediately, mean it is listed in the packaging insert, she had a very severe swelling of her left arm, after almost immediately, after getting you know the Prevnar 13.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events and The suspected drug cannot be ruled out.