chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: staff member reconstituted the Shingrix antigen with diluent from a Sanofi meningoccal vaccine and administered it; reconstituted the Shingrix antigen with diluent from a Sanofi meningoccal vaccine and administered it; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 39-year-old male patient who received Herpes zoster (Shingrix) (batch number CSM4M, expiry date 30-SEP-2025) for prophylaxis.   Concurrent medical conditions included hiv infection and immunocompromised.   On 04-JAN-2024, the patient received the 2nd dose of Shingrix. On 04-JAN-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: staff member reconstituted the Shingrix antigen with diluent from a Sanofi meningoccal vaccine and administered it) and inappropriate dose of vaccine administered (Verbatim: reconstituted the Shingrix antigen with diluent from a Sanofi meningoccal vaccine and administered it). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-JAN-2024 The licensed practical nurse (LPN) stated a staff member reconstituted the Shingrix antigen with diluent from a Sanofi Meningococcal vaccine and administered it to an immunocompromised patient under the age of 50, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 8.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: they administered Kinrix to an 8 year old; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 09-JAN-2024, the patient received Kinrix. On 09-JAN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: they administered Kinrix to an 8 year old). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-JAN-2024 The pediatrician reported that yesterday (day before reporting) they administered Kinrix to an 8 year old patient, which led to inappropriate age at vaccine administration. As per package insert Kinrix is FDA (Food and Drug Administration) approved for children age 4 through 6. The vaccine administration facility was the same as primary reporter. Since the report was sent to the representative via email, GSK not had the opportunity to ask for consent from the reporter for GSK safety to follow up.
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: pregnant patient received a dose of Arexvy; 32 years old patient received Arexvy vaccine; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9TB72, expiry date 03-JUL-2025) for prophylaxis.   On 08-JAN-2024, the patient received Arexvy. On 08-JAN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 32 years old patient received Arexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received a dose of Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 10-Jan-2024 The reporter reported that the pregnant patient received Arexvy vaccine. The vaccine administration facility was the same as primary reporter. The patient received Arexvy who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Herpes zoster, Incomplete course of vaccination, Muscle spasms, Pain in extremity
Clinical narrative: Shingles; Hives; Red spots; pain in her left arm; Muscle spasms; Chest pain; Dr.recommended that she not get the 2nd dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm) and did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles), hives (Verbatim: Hives), red spotty rash (Verbatim: Red spots), pain in arm (Verbatim: pain in her left arm), muscle spasms (Verbatim: Muscle spasms), chest pain (Verbatim: Chest pain) and incomplete course of vaccination (Verbatim: Dr.recommended that she not get the 2nd dose of Shingrix). The outcome of the shingles, hives, red spotty rash, pain in arm, muscle spasms, chest pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, hives, red spotty rash, pain in arm, muscle spasms and chest pain to be related to Shingrix.     It was unknown if the company considered the shingles, hives, red spotty rash, pain in arm, muscle spasms and chest pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JAN-2024 On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, less than a week after receiving Shingrix, the patient experienced hives, red spotty rash and chest pain. The patient reported that received her 1st dose of Shingrix a year ago and had pain in her left arm the same day as the vaccine.  The patient also reported that the same week as the vaccine, she experienced chest pain, red spots, and hives on her left side.  The patient had called her doctor for an appointment and was told it sounded like she was having a heart attack, and her doctor sent her to the Emergency Room.  The patient was in the emergency room (ER) a couple of hours and not overnight. In the ER she was told she was having muscle spasms, no heart attack or shingles, and sent home.  The next day after going to the ER the patient went to her primary care physician and was told she had shingles.  The patient reported that her doctor had recommended that she not get the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient did not have a date of administration or lot and expiry information. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Urticaria
Clinical narrative: Shingles; Hives; Red spots; pain in her left arm; Muscle spasms; Chest pain; Dr.recommended that she not get the 2nd dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm) and did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles), hives (Verbatim: Hives), red spotty rash (Verbatim: Red spots), pain in arm (Verbatim: pain in her left arm), muscle spasms (Verbatim: Muscle spasms), chest pain (Verbatim: Chest pain) and incomplete course of vaccination (Verbatim: Dr.recommended that she not get the 2nd dose of Shingrix). The outcome of the shingles, hives, red spotty rash, pain in arm, muscle spasms, chest pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, hives, red spotty rash, pain in arm, muscle spasms and chest pain to be related to Shingrix.     It was unknown if the company considered the shingles, hives, red spotty rash, pain in arm, muscle spasms and chest pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JAN-2024 On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, less than a week after receiving Shingrix, the patient experienced hives, red spotty rash and chest pain. The patient reported that received her 1st dose of Shingrix a year ago and had pain in her left arm the same day as the vaccine.  The patient also reported that the same week as the vaccine, she experienced chest pain, red spots, and hives on her left side.  The patient had called her doctor for an appointment and was told it sounded like she was having a heart attack, and her doctor sent her to the Emergency Room.  The patient was in the emergency room (ER) a couple of hours and not overnight. In the ER she was told she was having muscle spasms, no heart attack or shingles, and sent home.  The next day after going to the ER the patient went to her primary care physician and was told she had shingles.  The patient reported that her doctor had recommended that she not get the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient did not have a date of administration or lot and expiry information. The reporter consented to follow-up.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient was inadvertently administered an expired Hiberix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received Hib (Hiberix) (batch number 74YN7, expiry date 30-DEC-2023) for prophylaxis.   On 11-JAN-2024, the patient received Hiberix (lt. vastus lateralis). On 11-JAN-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: patient was inadvertently administered an expired Hiberix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 11-Jan-2024 The reporter was a medical assistant. The reporter reported that the patient inadvertently administered an expired Hiberix vaccine, which led to expired vaccine used. The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: Maladministration of Arexvy reconstituted with sterile water; Maladministration of Arexvy reconstituted with sterile water; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 11-JAN-2024, the patient received Arexvy. On 11-JAN-2024, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: Maladministration of Arexvy reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Maladministration of Arexvy reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-Jan-2024 The reporter was lookin for a guidance on a patient who received Arexvy vaccine reconstituted with sterile water. No further information was available at the moment of the call such as lot number injected or patient's details. Arexvy reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: potential case of shingles after series vaccination; shingles after series vaccination; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: potential case of shingles after series vaccination) (serious criteria GSK medically significant) and shingles (Verbatim: shingles after series vaccination). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 11-JAN-2024 The reporter reported via sales representative via customer relationship management. Reporter reported the case of shingles after series vaccination. The vaccine administration facility was the same as primary reporter. Submitted via sales representative on MD behalf. No adverse event details were available. The reporter consented to follow-up. This case was considered as suspected vaccination failure as details regarding completion of time to onset and laboratory details were unknown at a time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: Due to COVID customer did not go back to get second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (on 1st October 2021 received 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: Due to COVID customer did not go back to get second dose). The outcome of the social problem was unknown.   Additional Information: GSK Receipt date: 12-JAN-2024 A pharmacist reported that due to Covid patient did not go back to get second dose. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. Patient was forced by his company to have Johnson's Vaccine and now it caused him blood clots. Patient did not want to provide any information instead he told that he would just contact his lawyer (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:Thrombosis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Myalgia, Pain, Sleep disorder, Tenderness
Clinical narrative: huge swelling on injection site; painful to touch; Painful to sleep on that side, taking of sweaters hurt; extreme muscle sorness for 2 weeks still; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 29-DEC-2023, the patient received Arexvy. On 29-DEC-2023, less than a day after receiving Arexvy, the patient experienced muscle soreness (Verbatim: extreme muscle sorness for 2 weeks still). On an unknown date, the patient experienced injection site swelling (Verbatim: huge swelling on injection site), tenderness (Verbatim: painful to touch) and pain (Verbatim: Painful to sleep on that side, taking of sweaters hurt). The outcome of the injection site swelling and muscle soreness were not resolved and the outcome of the tenderness and pain were not reported.   It was unknown if the reporter considered the injection site swelling, muscle soreness, tenderness and pain to be related to Arexvy.     It was unknown if the company considered the injection site swelling, muscle soreness, tenderness and pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-JAN-2024 The patient was self-reported. The patient got Arexvy and she had been in her upper left arm ever since.  Patient had huge swelling on injection site, extreme muscle soreness for 2 weeks still. The patient also reported that painful to sleep on that side, taking of sweaters hurt, painful to touch.  The seriousness for huge swelling on injection site, extreme muscle soreness for 2 weeks still was intervention required. The reporter was requesting to follow up.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: they don't feel good; other than having sore arm that goes away in a couple of days; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (they don't feel good) and PAIN IN EXTREMITY (other than having sore arm that goes away in a couple of days ) in a 66-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised, Kidney disorder and Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol, CLONIDINE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), CALCIUM, COLECALCIFEROL (VITAMIN D3 CALCIUM), VITAMIN C [ASCORBIC ACID] and VITAMIN B12 NOS for an unknown indication.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (they don't feel good) and PAIN IN EXTREMITY (other than having sore arm that goes away in a couple of days ). At the time of the report, FEELING ABNORMAL (they don't feel good) and PAIN IN EXTREMITY (other than having sore arm that goes away in a couple of days ) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The treatment medication was not reported by reporter.   This case was linked to MOD-2024-756449 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Injection site erythema, Injection site mass
Clinical narrative: they don't feel good; other than having sore arm that goes away in a couple of days; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (they don't feel good) and PAIN IN EXTREMITY (other than having sore arm that goes away in a couple of days ) in a 66-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised, Kidney disorder and Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol, CLONIDINE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), CALCIUM, COLECALCIFEROL (VITAMIN D3 CALCIUM), VITAMIN C [ASCORBIC ACID] and VITAMIN B12 NOS for an unknown indication.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (they don't feel good) and PAIN IN EXTREMITY (other than having sore arm that goes away in a couple of days ). At the time of the report, FEELING ABNORMAL (they don't feel good) and PAIN IN EXTREMITY (other than having sore arm that goes away in a couple of days ) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The treatment medication was not reported by reporter.   This case was linked to MOD-2024-756449 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pollakiuria, Pyrexia
Clinical narrative: they don't feel good; other than having sore arm that goes away in a couple of days; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (they don't feel good) and PAIN IN EXTREMITY (other than having sore arm that goes away in a couple of days ) in a 66-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised, Kidney disorder and Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol, CLONIDINE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), CALCIUM, COLECALCIFEROL (VITAMIN D3 CALCIUM), VITAMIN C [ASCORBIC ACID] and VITAMIN B12 NOS for an unknown indication.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (they don't feel good) and PAIN IN EXTREMITY (other than having sore arm that goes away in a couple of days ). At the time of the report, FEELING ABNORMAL (they don't feel good) and PAIN IN EXTREMITY (other than having sore arm that goes away in a couple of days ) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The treatment medication was not reported by reporter.   This case was linked to MOD-2024-756449 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: lots of trips to the bathroom; stomach cramping; achy; hard visible knot on arm; injection site is red and still have a knot there.; Fever/normal temp is 96.5 and last night it spiked to 101.6; chills; This spontaneous case was reported by a patient and describes the occurrence of POLLAKIURIA (lots of trips to the bathroom), ABDOMINAL PAIN UPPER (stomach cramping), PAIN (achy), INJECTION SITE MASS (hard visible knot on arm) and INJECTION SITE ERYTHEMA (injection site is red and still have a knot there.) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised, Kidney disorder and Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol, CLONIDINE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), CALCIUM, ERGOCALCIFEROL (VITAMIN D2 + CALCIUM [CALCIUM;ERGOCALCIFEROL]), VITAMIN C [ASCORBIC ACID] and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 08-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Jan-2024, the patient experienced PYREXIA (Fever/normal temp is 96.5 and last night it spiked to 101.6) and CHILLS (chills). On an unknown date, the patient experienced POLLAKIURIA (lots of trips to the bathroom), ABDOMINAL PAIN UPPER (stomach cramping), PAIN (achy), INJECTION SITE MASS (hard visible knot on arm) and INJECTION SITE ERYTHEMA (injection site is red and still have a knot there.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, POLLAKIURIA (lots of trips to the bathroom), ABDOMINAL PAIN UPPER (stomach cramping), PAIN (achy), INJECTION SITE MASS (hard visible knot on arm), INJECTION SITE ERYTHEMA (injection site is red and still have a knot there.), PYREXIA (Fever/normal temp is 96.5 and last night it spiked to 101.6) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: normal temp is 96.5 and last night it spiked to 101.6..     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient also received other medications that are as needed and rare. It was also reported patient did not have known allergies. Caller felt somewhat better today, somewhat, feels like they had the flu.   This case was linked to MOD-2024-756481 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Injection site erythema, Injection site mass
Clinical narrative: lots of trips to the bathroom; stomach cramping; achy; hard visible knot on arm; injection site is red and still have a knot there.; Fever/normal temp is 96.5 and last night it spiked to 101.6; chills; This spontaneous case was reported by a patient and describes the occurrence of POLLAKIURIA (lots of trips to the bathroom), ABDOMINAL PAIN UPPER (stomach cramping), PAIN (achy), INJECTION SITE MASS (hard visible knot on arm) and INJECTION SITE ERYTHEMA (injection site is red and still have a knot there.) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised, Kidney disorder and Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol, CLONIDINE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), CALCIUM, ERGOCALCIFEROL (VITAMIN D2 + CALCIUM [CALCIUM;ERGOCALCIFEROL]), VITAMIN C [ASCORBIC ACID] and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 08-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Jan-2024, the patient experienced PYREXIA (Fever/normal temp is 96.5 and last night it spiked to 101.6) and CHILLS (chills). On an unknown date, the patient experienced POLLAKIURIA (lots of trips to the bathroom), ABDOMINAL PAIN UPPER (stomach cramping), PAIN (achy), INJECTION SITE MASS (hard visible knot on arm) and INJECTION SITE ERYTHEMA (injection site is red and still have a knot there.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, POLLAKIURIA (lots of trips to the bathroom), ABDOMINAL PAIN UPPER (stomach cramping), PAIN (achy), INJECTION SITE MASS (hard visible knot on arm), INJECTION SITE ERYTHEMA (injection site is red and still have a knot there.), PYREXIA (Fever/normal temp is 96.5 and last night it spiked to 101.6) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: normal temp is 96.5 and last night it spiked to 101.6..     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient also received other medications that are as needed and rare. It was also reported patient did not have known allergies. Caller felt somewhat better today, somewhat, feels like they had the flu.   This case was linked to MOD-2024-756481 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pollakiuria, Pyrexia
Clinical narrative: lots of trips to the bathroom; stomach cramping; achy; hard visible knot on arm; injection site is red and still have a knot there.; Fever/normal temp is 96.5 and last night it spiked to 101.6; chills; This spontaneous case was reported by a patient and describes the occurrence of POLLAKIURIA (lots of trips to the bathroom), ABDOMINAL PAIN UPPER (stomach cramping), PAIN (achy), INJECTION SITE MASS (hard visible knot on arm) and INJECTION SITE ERYTHEMA (injection site is red and still have a knot there.) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised, Kidney disorder and Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol, CLONIDINE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), CALCIUM, ERGOCALCIFEROL (VITAMIN D2 + CALCIUM [CALCIUM;ERGOCALCIFEROL]), VITAMIN C [ASCORBIC ACID] and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 08-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Jan-2024, the patient experienced PYREXIA (Fever/normal temp is 96.5 and last night it spiked to 101.6) and CHILLS (chills). On an unknown date, the patient experienced POLLAKIURIA (lots of trips to the bathroom), ABDOMINAL PAIN UPPER (stomach cramping), PAIN (achy), INJECTION SITE MASS (hard visible knot on arm) and INJECTION SITE ERYTHEMA (injection site is red and still have a knot there.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, POLLAKIURIA (lots of trips to the bathroom), ABDOMINAL PAIN UPPER (stomach cramping), PAIN (achy), INJECTION SITE MASS (hard visible knot on arm), INJECTION SITE ERYTHEMA (injection site is red and still have a knot there.), PYREXIA (Fever/normal temp is 96.5 and last night it spiked to 101.6) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: normal temp is 96.5 and last night it spiked to 101.6..     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient also received other medications that are as needed and rare. It was also reported patient did not have known allergies. Caller felt somewhat better today, somewhat, feels like they had the flu.   This case was linked to MOD-2024-756481 (Patient Link).
Age: 2.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Accidental overdose, Vaccination site pain
Clinical narrative: achy shot site; Was given 0.5 ml when they should had 0.25 ml/The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial; This spontaneous case was reported by a medical assistant and describes the occurrence of VACCINATION SITE PAIN (achy shot site) and ACCIDENTAL OVERDOSE (Was given 0.5 ml when they should had 0.25 ml/The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial) in a 24-month-old female patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5558B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) for an unknown indication.    The patient's past medical history included COVID-19 on 12-Jan-2022. Concurrent medical conditions included Allergy to animal (Cat).   On 27-Oct-2023, the patient received first dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .5 milliliter and first dose of INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) (Intramuscular use) 1 dosage form. On 27-Oct-2023, the patient experienced ACCIDENTAL OVERDOSE (Was given 0.5 ml when they should had 0.25 ml/The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial). On an unknown date, the patient experienced VACCINATION SITE PAIN (achy shot site). At the time of the report, VACCINATION SITE PAIN (achy shot site) and ACCIDENTAL OVERDOSE (Was given 0.5 ml when they should had 0.25 ml/The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter considered ACCIDENTAL OVERDOSE (Was given 0.5 ml when they should had 0.25 ml/The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial) to be not related. No further causality assessment was provided for VACCINATION SITE PAIN (achy shot site).    This case belongs to patient No. 29 out of 29. Patient had no acute or chronic long-standing health conditions at the time of vaccination. No relevant concomitant medications were reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747540 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747540:Patient 1 (Master case)
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 9 days beyond use date on product.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: none. pt did not exhibit any adverse effects.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid-19 vaccine 9 days beyond use date on product.
Age: 7.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product prescribing issue
Clinical narrative: Pediarix was ordered by the provider, rather than Td or Tdap, for a patient who had no immunization history and was following the "catch up schedule". Provider ordered Pediarix which is not licensed for children over the age of 6. Patient does NOT need to be re-immunized for Td/Tdap (2nd dose) but does need dose three 6 months from 2nd dose. Provider notified to follow up with patient. GSK contacted and spoke with Representative case ID 01908851 and is awaiting written response via email re: confirming other vaccines (Hep B and IPV) are still valid.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Covid vaccine 9 days beyond use date on product.
Sex: U
Vaccine: RSV
Symptoms: Device physical property issue
Clinical narrative: I was mixing it (Abrysvo) that's when it fell apart; This is a spontaneous report received from a Pharmacist.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9863, Expiration Date: Apr2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE PHYSICAL PROPERTY ISSUE (non-serious), described as "I was mixing it (Abrysvo) that's when it fell apart".  Additional information: The pharmacist reporter stated that they were using an Abrysvo shot in the kit (later clarified that it was not administered to any patient) and it kind of fall apart so they were wondering if they could send this back and get reimbursed for the product.  Causality for "i was mixing it (abrysvo) that's when it fell apart" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to the device constituent
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a Consumer or other non HCP. A 51-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19".  Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: treatment includes Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a consumer. A 50-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (lot number unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "allergies sulfa" (unspecified if ongoing); "allergies shellfish, peanuts" (unspecified if ongoing); "IgG immune deficiency" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Phenergan, reaction: "allergies"; Compazine, reaction: "allergies"; Reglan, reaction: "allergies"; Cipro, reaction: "allergies". Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3 (booster), manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 4 (booster), manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure and covid-19 which included Paxlovid taken from 28Dec2023 to 02Jan2024.  Additional Information: The patient took other medication in two weeks.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Headache, Nausea, Paranasal sinus discomfort, Perfume sensitivity
Clinical narrative: On Sunday 1/14/2024 I woke to extreme vertigo (~58-60hrs after injection). This caused extreme nausea and retching for 8 hours. I was able to eat miso soup (3/4 water) about 12 hours later. The symptoms were worse with any movement of my head. I also experienced a heightened sensitivity to all smells that also increased vertigo and retching. Today, I have what feels like sinus pressure and creating a dull headache/slight vertigo and brain fog.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Retching, Vertigo, Vertigo positional
Clinical narrative: On Sunday 1/14/2024 I woke to extreme vertigo (~58-60hrs after injection). This caused extreme nausea and retching for 8 hours. I was able to eat miso soup (3/4 water) about 12 hours later. The symptoms were worse with any movement of my head. I also experienced a heightened sensitivity to all smells that also increased vertigo and retching. Today, I have what feels like sinus pressure and creating a dull headache/slight vertigo and brain fog.
Age: 1.33
Sex: M
Vaccine: DTAP, MMR
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Swelling of thigh, pink rash covering entire thigh and down past knee
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Abdominal pain, Arthralgia, Asthenia, Axillary pain, Blood pressure increased
Clinical narrative: Immediately after receiving the vaccine around noon on 11/16/2023, I started feeling dizzy.  I found out I was not given the standard flu shot I have always received, but instead I was given Flubrok Quad, which I have never had before.  I was shocked that I was given this newer vaccine without my knowledge, especially since I have autoimmune issues.  That afternoon and evening, I experienced extreme fatigue, tiredness and weakness.   I awoke that night with and increase heart rate and increased BP, abdominal pain, and extreme thirst.  I took Benadryl and my symptoms decreased.  Over the next few days, I experienced numbness in my fingers, hands, and lower left leg.  My heart rate continued to exceed 100 and I was weak, dizzy, and felt faint at times.  On 11/19/2023, the lower part of my fingers on my left hand swelled temporarily and I experienced pain in my knuckles.  I had pain in my armpits off and on.   On 11/22/2023, I experienced pain on the inside of my arm and pain in my knuckles again.  On 11/23/2023,  my heart rate shot up to 122.  I continued to experience extreme fatigue and I felt very cold all the time.  On 11/27/2023, I awoke with numbness in my upper left arm near the injection site.  On 12/22/2023 pain in the injection site returned again.  I experienced extreme fatigue for over a month.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Fatigue, Feeling cold, Heart rate increased, Hypoaesthesia
Clinical narrative: Immediately after receiving the vaccine around noon on 11/16/2023, I started feeling dizzy.  I found out I was not given the standard flu shot I have always received, but instead I was given Flubrok Quad, which I have never had before.  I was shocked that I was given this newer vaccine without my knowledge, especially since I have autoimmune issues.  That afternoon and evening, I experienced extreme fatigue, tiredness and weakness.   I awoke that night with and increase heart rate and increased BP, abdominal pain, and extreme thirst.  I took Benadryl and my symptoms decreased.  Over the next few days, I experienced numbness in my fingers, hands, and lower left leg.  My heart rate continued to exceed 100 and I was weak, dizzy, and felt faint at times.  On 11/19/2023, the lower part of my fingers on my left hand swelled temporarily and I experienced pain in my knuckles.  I had pain in my armpits off and on.   On 11/22/2023, I experienced pain on the inside of my arm and pain in my knuckles again.  On 11/23/2023,  my heart rate shot up to 122.  I continued to experience extreme fatigue and I felt very cold all the time.  On 11/27/2023, I awoke with numbness in my upper left arm near the injection site.  On 12/22/2023 pain in the injection site returned again.  I experienced extreme fatigue for over a month.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Immediate post-injection reaction, Injection site hypoaesthesia, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Immediately after receiving the vaccine around noon on 11/16/2023, I started feeling dizzy.  I found out I was not given the standard flu shot I have always received, but instead I was given Flubrok Quad, which I have never had before.  I was shocked that I was given this newer vaccine without my knowledge, especially since I have autoimmune issues.  That afternoon and evening, I experienced extreme fatigue, tiredness and weakness.   I awoke that night with and increase heart rate and increased BP, abdominal pain, and extreme thirst.  I took Benadryl and my symptoms decreased.  Over the next few days, I experienced numbness in my fingers, hands, and lower left leg.  My heart rate continued to exceed 100 and I was weak, dizzy, and felt faint at times.  On 11/19/2023, the lower part of my fingers on my left hand swelled temporarily and I experienced pain in my knuckles.  I had pain in my armpits off and on.   On 11/22/2023, I experienced pain on the inside of my arm and pain in my knuckles again.  On 11/23/2023,  my heart rate shot up to 122.  I continued to experience extreme fatigue and I felt very cold all the time.  On 11/27/2023, I awoke with numbness in my upper left arm near the injection site.  On 12/22/2023 pain in the injection site returned again.  I experienced extreme fatigue for over a month.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Sleep disorder, Thirst
Clinical narrative: Immediately after receiving the vaccine around noon on 11/16/2023, I started feeling dizzy.  I found out I was not given the standard flu shot I have always received, but instead I was given Flubrok Quad, which I have never had before.  I was shocked that I was given this newer vaccine without my knowledge, especially since I have autoimmune issues.  That afternoon and evening, I experienced extreme fatigue, tiredness and weakness.   I awoke that night with and increase heart rate and increased BP, abdominal pain, and extreme thirst.  I took Benadryl and my symptoms decreased.  Over the next few days, I experienced numbness in my fingers, hands, and lower left leg.  My heart rate continued to exceed 100 and I was weak, dizzy, and felt faint at times.  On 11/19/2023, the lower part of my fingers on my left hand swelled temporarily and I experienced pain in my knuckles.  I had pain in my armpits off and on.   On 11/22/2023, I experienced pain on the inside of my arm and pain in my knuckles again.  On 11/23/2023,  my heart rate shot up to 122.  I continued to experience extreme fatigue and I felt very cold all the time.  On 11/27/2023, I awoke with numbness in my upper left arm near the injection site.  On 12/22/2023 pain in the injection site returned again.  I experienced extreme fatigue for over a month.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Vaccination administration error. Patient received the flu vaccine (Fluad) in error instead of the RSV vaccine. She previously got the flu vaccine at her doctor's office making it two doses of Fluad.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Swelling (hard to the touch), inflammation, redness, pain, and itchiness first emerged around the injection site on the deltoid a few hours after injection. This then spread down arm to the above the elbow over the next 2 days. These symptoms persisted even with administration of benadryl and ibuprofen. Spread has seemed slow and symptoms slightly improved; patient is otherwise stable.