chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received the first dose of Jynneos intramuscularly instead of subcutaneously; Case reference number US-BN-2024-002544 is a spontaneous case initially received from a pharmacist via Communications (reference number: USBAV24-2503) on 24-Sep-2024 and concerns a 27-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 20-Sep-2024, the patient was vaccinated with the first dose of Jynneos (batch number: 96867, expiry date: 20-Apr-2026) at a dose reported as one, administered intramuscularly in left deltoid for indication reported as vaccination (explicitly coded as 'inappropriate route of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Jynneos.  No further information was provided.; Reporter's Comments: A 27-year-old male patient was vaccinated with the first dose of Jynneos, administered intramuscularly in left deltoid for indication reported as vaccination, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse events due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect product, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 27-year-old male patient was vaccinated with the first dose of Jynneos, administered intramuscularly in left deltoid for indication reported as vaccination, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse events due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect product, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the Jynneos vaccine at age of 17; Case reference number US-BN-2024-002543 is a spontaneous case initially received from a nurse via Communications (reference number: USBAV24-2486) on 24-Sep-2024 and concerns a 17-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 30-Aug-2024, the patient was vaccinated with the first dose of Jynneos (batch number: unknown) at an unknown dose, subcutaneously in unknown site of administration for unknown indication (explicitly coded as 'product administered to patient of inappropriate age').  As reported, the patient did not experience any adverse events due to Jynneos.  No further information was provided.; Reporter's Comments: A 17-year-old male patient was vaccinated with the first dose of Jynneos for unknown indication, which is considered as product administered to patient of inappropriate age. The patient did not experience any adverse events due to Jynneos. Product administered to patient of inappropriate age is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered to patient of inappropriate age is not related to the suspect product, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 17-year-old male patient was vaccinated with the first dose of Jynneos for unknown indication, which is considered as product administered to patient of inappropriate age. The patient did not experience any adverse events due to Jynneos. Product administered to patient of inappropriate age is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered to patient of inappropriate age is not related to the suspect product, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient was vaccinated with the second dose of Jynneos two years after the first dose; Case reference number US-BN-2024-002560 is a spontaneous case initially received from a pharmacist via Communications (reference number: USBAV24-2529) on 26-Sep-2024, and concerns an adult male patient reported as 25-30 years old.   The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as two years ago, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at an unknown dose, or site, administered intramuscularly, for vaccination.  On 23-Sep-2024, two years after the first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at an unknown dose, or site, administered intramuscularly (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination.  No further information was provided.; Reporter's Comments: An adult male patient reported as 25-30 years old was vaccinated with the second dose of Jynneos for vaccination, two years after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to the Jynneos vaccination. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult male patient reported as 25-30 years old was vaccinated with the second dose of Jynneos for vaccination, two years after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to the Jynneos vaccination. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received Jynneos intradermally instead of subcutaneously, at a dose of 0.5 mL; Patient received Jynneos intradermally instead of subcutaneously, at a dose of 0.5 mL; Case reference number US-BN-2024-002564 is a spontaneous case initially received from a physician via agency (reference number: USBAV24-2539) on 27-Sep-2024 and concerns a 28-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at a dose of 0.5 milliliter, intradermally, in unknown site of administration for unknown indication (explicitly coded as 'intradermal injection' and 'vaccine overdose'). As reported, patient was planned to receive the second dose subcutaneously.  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Jynneos.  No further information was provided.; Reporter's Comments: A 28-year-old male patient was vaccinated with the first dose of Jynneos at a dose of 0.5 milliliter, intradermally, for unknown indication, which is considered as intradermal injection and vaccine overdose. It was unknown if the patient experienced any adverse events due to Jynneos. Intradermal injection and overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and overdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 28-year-old male patient was vaccinated with the first dose of Jynneos at a dose of 0.5 milliliter, intradermally, for unknown indication, which is considered as intradermal injection and vaccine overdose. It was unknown if the patient experienced any adverse events due to Jynneos. Intradermal injection and overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and overdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received second dose of Jynneos intramuscularly; Case reference number US-BN-2024-002565 is a spontaneous case initially received from a consumer via Communications (reference number: USBAV24-2540) on 27-Sep-2024 and concerns a 32-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at unknown dose, subcutaneously, at unknown site of administration for prevention of smallpox and monkeypox disease.  On 27-Sep-2024, unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at a dose of 0.5 milliliter, intramuscularly at unknown site of administration (explicitly coded as 'inappropriate route of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Jynneos.  No further information was provided.; Reporter's Comments: A 32-year-old male patient was vaccinated with the second dose of Jynneos for prevention of smallpox and monkeypox disease, intramuscularly, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse events due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 32-year-old male patient was vaccinated with the second dose of Jynneos for prevention of smallpox and monkeypox disease, intramuscularly, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse events due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos was administered intramuscularly instead of subcutaneously to a patient; Case reference number US-BN-2024-002571 is a spontaneous case initially received from a pharmacist via Communications (reference number: USBAV24-2557) on 30-Sep-2024 and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (batch number: unknown), at an unknown dose, or site, administered intramuscularly, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination.  No further information was provided.; Reporter's Comments: A patient of unknown age and gender was vaccinated with a dose of Jynneos administered intramuscularly, for an unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to the Jynneos vaccination. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with a dose of Jynneos administered intramuscularly, for an unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to the Jynneos vaccination. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Patient received second dose of Jynneos vaccine two days after the eight weeks; Second dose of Jynneos administered two days after beyond use date; Case reference number US-BN-2024-002592 is a spontaneous case initially received from pharmacist via Communications (reference number: USBAV24-2617) on 04-Oct-2024 and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (batch number: unknown) at an unknown dose, route and site of administration for unknown indication.  On an unspecified date, reported as two days from eight weeks from the first dose, and two days after beyond use date, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00015, expiry date: 30-Sep-2024) at an unknown dose, route and site of administration (explicitly coded as 'inappropriate schedule of vaccine administered' and 'expired vaccine used').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Jynneos.  No further information was provided.; Reporter's Comments: A patient of unknown age and gender was vaccinated with the second dose of Jynneos for unknown indication, reported as two days from eight weeks from the first dose, and two days after the beyond use date, which is considered as inappropriate schedule of vaccine administered and expired vaccine used. It was unknown if the patient experienced any adverse events due to Jynneos. Inappropriate schedule of product administration and expired product administered are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and expired product administered are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with the second dose of Jynneos for unknown indication, reported as two days from eight weeks from the first dose, and two days after the beyond use date, which is considered as inappropriate schedule of vaccine administered and expired vaccine used. It was unknown if the patient experienced any adverse events due to Jynneos. Inappropriate schedule of product administration and expired product administered are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and expired product administered are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the first dose of Jynneos in Feb-2023 and the second dose in Oct-2024; Case reference number US-BN-2024-002610 is a spontaneous case initially received from a pharmacist via Communications (reference number: USBAV24-2622) on 07-Oct-2024 and concerns a male patient of unknown age.   The patient's medical history and concomitant medication details were not provided.  On unspecified day in Feb-2023, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at an unknown dose, route and site of administration for an unknown indication.  On unspecified day in Oct-2024, unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at an unknown dose, route and site of administration (explicitly coded as Inappropriate schedule of product administration').   At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos.  No further information was provided.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos for an unknown indication in Feb-2023 and with the second dose in Oct-2024, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos for an unknown indication in Feb-2023 and with the second dose in Oct-2024, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shingles vaccine and i have the shingles right now/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the shingles vaccine and i have the shingles right now/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-OCT-2024 This case was reported by a patient via interactive digital media. The reporter reported that he/she had the shingles vaccine and he/she had the shingles right now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule,time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Maladministration of expired dose (less tahn 30 days expired); 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 patient who received MMR (Priorix) (expiry date 01-AUG-2024) for prophylaxis.   On 02-AUG-2024, the patient received Priorix. On 02-AUG-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Maladministration of expired dose (less tahn 30 days expired)). The outcome of the expired vaccine used was not applicable.   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: 19-SEP-2024 The other health professional (clinical coordinator) reported about the maladministration of expired dose in to a patient which led to expired vaccine used.  The vaccination date of patient was August second twenty-twenty four. No further detail about vaccine detail. This case was linked with US2024116644 and US2024116635, reported by same reporter.; Sender's Comments:  US-GSK-US2024116635:Same reporter/Diffrent patient US-GSK-US2024116644:Same reporter/Diffrent patient
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Induration, Injection site erythema, Injection site induration, Injection site irritation, Injection site pain
Clinical narrative: approximately three inch diameter red area at the injection site; approximately three inch diameter tenderness at the injection site/site injections very tender to the touch; increased swelling in the injection site; injection site irritation 3 inches in diameter; induration; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis.   On 01-OCT-2024, the patient received Bexsero (left deltoid) .5 ml. In OCT-2024, 2 hrs after receiving Bexsero, the patient experienced injection site erythema (Verbatim: approximately three inch diameter red area at the injection site), injection site tenderness (Verbatim: approximately three inch diameter tenderness at the injection site/site injections very tender to the touch), injection site swelling (Verbatim: increased swelling in the injection site), injection site irritation (Verbatim: injection site irritation 3 inches in diameter) and induration (Verbatim: induration). In OCT-2024, the outcome of the injection site erythema and injection site tenderness were resolved. The outcome of the injection site swelling, injection site irritation and induration were not reported.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site swelling, injection site irritation and induration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site erythema, injection site tenderness, injection site swelling, injection site irritation and induration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 07-OCT-2024 The nurse practitioner who was working at a school reported that a student (patient) received suspect vaccine Bexsero and 2 hours later came back to nurse office with an approximately three inch diameter red area and tenderness at the injection site. The GSK response center agent mentioned redness, induration and tenderness. The reporter stated, within 2 days of vaccination that they had increased swelling in the injection site, pain, more than the normal site reaction post vaccination. The nurse practitioner prescribed Benadryl and also a steroid in case of a more severe site reaction. When she spoke with a physician they mentioned that they also saw slightly unusual symptoms for kid back to back, similar injection site irritation 3 inches in diameter, both site injections were very erythematous and very tender to the touch. This case had been link with US2024123289, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123289:same reporter/different patient
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling
Clinical narrative: approximately three inch diameter red area at the injection site; approximately three inch diameter tenderness at the injection site/site injections very tender to the touch; increased swelling in the injection site; injection site irritation 3 inches in diameter; induration; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis.   On 01-OCT-2024, the patient received Bexsero (left deltoid) .5 ml. In OCT-2024, 2 hrs after receiving Bexsero, the patient experienced injection site erythema (Verbatim: approximately three inch diameter red area at the injection site), injection site tenderness (Verbatim: approximately three inch diameter tenderness at the injection site/site injections very tender to the touch), injection site swelling (Verbatim: increased swelling in the injection site), injection site irritation (Verbatim: injection site irritation 3 inches in diameter) and induration (Verbatim: induration). In OCT-2024, the outcome of the injection site erythema and injection site tenderness were resolved. The outcome of the injection site swelling, injection site irritation and induration were not reported.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site swelling, injection site irritation and induration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site erythema, injection site tenderness, injection site swelling, injection site irritation and induration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 07-OCT-2024 The nurse practitioner who was working at a school reported that a student (patient) received suspect vaccine Bexsero and 2 hours later came back to nurse office with an approximately three inch diameter red area and tenderness at the injection site. The GSK response center agent mentioned redness, induration and tenderness. The reporter stated, within 2 days of vaccination that they had increased swelling in the injection site, pain, more than the normal site reaction post vaccination. The nurse practitioner prescribed Benadryl and also a steroid in case of a more severe site reaction. When she spoke with a physician they mentioned that they also saw slightly unusual symptoms for kid back to back, similar injection site irritation 3 inches in diameter, both site injections were very erythematous and very tender to the touch. This case had been link with US2024123289, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123289:same reporter/different patient
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure increased, Fatigue, Flushing, Headache
Clinical narrative: flushing of the face and chest; Rash; Extreme weakness; Fast heart beat; Blood pressure 180/80; Severe headache; Pelvic pain; Tired/fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 73-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number A555J, expiry date 10-JUN-2025) for prophylaxis.   On 28-SEP-2024 17:00, the patient received FluLaval 2024-2025 season. On 29-SEP-2024, 1 days after receiving FluLaval 2024-2025 season, the patient experienced headache (Verbatim: Severe headache), pelvic pain (Verbatim: Pelvic pain) and tiredness (Verbatim: Tired/fatigue). On 02-OCT-2024, the patient experienced flushing (Verbatim: flushing of the face and chest), rash (Verbatim: Rash), weakness (Verbatim: Extreme weakness) and heartbeats increased (Verbatim: Fast heart beat). In OCT-2024, the patient experienced increased blood pressure (Verbatim: Blood pressure 180/80). On 07-OCT-2024, the outcome of the headache, pelvic pain and tiredness were resolved (duration 8 days) and the outcome of the flushing, rash, weakness and heartbeats increased were resolved (duration 5 days). The outcome of the increased blood pressure was resolved.   It was unknown if the reporter considered the headache, pelvic pain, tiredness, flushing, rash, weakness, heartbeats increased and increased blood pressure to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the headache, pelvic pain, tiredness, flushing, rash, weakness, heartbeats increased and increased blood pressure to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.   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: 07-OCT-2024 The reporter was the patient.  The patient received a dose of FluLaval vaccine on Saturday. The next two days (Sunday and Monday) the patient experienced a severe headache, pelvic pain, and fatigue. On Tuesday 01-OCT-2024, the patient felt better but was just tired. On Wednesday afternoon (02-OCT-2024), the patient had a sudden onset of extreme weakness, rash and flushing of the face and chest, and a fast heart beat.  The patient went to urgent care for treatment. While at urgent care, her urine was tested and was negative, and she was tested for COVID which was also negative. The patient's temperature was normal and pulse rate was 80 (her pulse was usually 55-60). Her blood pressure was 180/80. Her heart and lungs were clear. Time to onset of flushing, rash, weakness, heartbeats increased was 4 days and increased blood pressure was less than 2 weeks with FluLaval vaccine. The doctor believed what she was experiencing was from the vaccine. On Thursday 03-OCT-2024, the patient felt better but was tired. The patient was about 98 percent better on Sunday 06-OCT-2024 and was filling fine at the time of the reporting.
Sex: F
Vaccine: MEN, MENB
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: fainted immediately after administration of Bexsero; This serious case was reported by a other health professional via sales rep and described the occurrence of fainting in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On an unknown date, the patient received Bexsero and Menquadfi. On an unknown date, immediately after receiving Bexsero, the patient experienced fainting (Verbatim: fainted immediately after administration of Bexsero) (serious criteria GSK medically significant). The outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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-OCT-2024 The healthcare professional called to report an adverse reaction to Bexsero.  The HCP reported that 3 to 4 patients fainted immediately after administration of Bexsero.  Two of them being females, 2 of them were concomitantly given Menquadfi (Sanofi).  On an unknown date, immediately after receiving Menquadfi, the patient experienced fainting. It was unknown if the reporter considered the fainting to be related to Menquadfi. This was 1 of the 3 linked cases, reported by the same reporter; Sender's Comments: Syncope is a listed event which is considered related to GSK vaccine  Bexsero and Bexsero Pre-Filled Syringe Device. US-GSK-US2024125592:Same reporter/Different patient US-GSK-US2024125590:Same reporter/Different patient
Sex: F
Vaccine: MEN, MENB
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: fainted immediately after administration of Bexsero; This serious case was reported by a other health professional via sales rep and described the occurrence of fainting in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On an unknown date, the patient received Bexsero and Menquadfi. On an unknown date, immediately after receiving Bexsero, the patient experienced fainting (Verbatim: fainted immediately after administration of Bexsero) (serious criteria GSK medically significant). The outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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-OCT-2024 The healthcare professional called to report an adverse reaction to Bexsero.  The HCP reported that 3 to 4 patients fainted immediately after administration of Bexsero.  Two of them being females, 2 of them were concomitantly given Menquadfi (Sanofi).  On an unknown date, immediately after receiving Menquadfi, the patient experienced fainting. It was unknown if the reporter considered the fainting to be related to Menquadfi. This was 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments: Syncope is a listed event which is considered related to GSK  vaccine Bexsero and Meningococcal B vaccine PRE-FILLED SYRINGE DEVICE. US-GSK-US2024125590:Same reporter/Different patient US-GSK-US2024125596:Same reporter/Different patient
Sex: U
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: fainted immediately after administration of bexsero; This serious case was reported by a other health professional via sales rep and described the occurrence of fainting in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, immediately after receiving Bexsero, the patient experienced fainting (Verbatim: fainted immediately after administration of bexsero) (serious criteria GSK medically significant). The outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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-OCT-2024 The healthcare professional called to report an adverse reaction to Bexsero.  The HCP reported that 3 to 4 patients fainted immediately after administration of Bexsero.  This was 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments: Syncope is a listed event which is considered related to GSK  vaccine Bexsero and Meningococcal B vaccine PRE-FILLED SYRINGE DEVICE. US-GSK-US2024125592:Same reporter/Different patient US-GSK-US2024125596:Same reporter/Different patient
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I developed a surface blood clot in my leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (I developed a surface blood clot in my leg) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Shingles: Shingles zoster shot (Shingles zoster shot, don't know if this vaccine had anything that was in that Shingles shot and since she was allergic to that one). Past adverse reactions to the above products included Allergic reaction with Shingles zoster shot.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (I developed a surface blood clot in my leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (I developed a surface blood clot in my leg) had resolved.            Concomitant product use was not provided by the reporter.  Patient have had COVID vaccines since the beginning of the pandemic. She had the Moderna shot at least five times; the last time she had she developed a surface blood clot in her leg. Her doctor advised to not get the Moderna or Pfizer again. Her pharmacist told her about the Novavax but she did not know a lot about it. It was also reported that, she was very fortunate that she never got COVID but know people who were vaccinated and got it. She clarified her blood clot was not anything major, she had to put heat on it, and it went away. She said she looked but did not find anything about blood clots.  Treatment information was not provided.  Company Comment: The benefit -risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-774859 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774859:Case for Unspecified number of patients
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ear really, really bad and it's just getting worse; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Ringing in the ear really, really bad and it's just getting worse) in a 62-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. U66K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In March 2022, the patient experienced TINNITUS (Ringing in the ear really, really bad and it's just getting worse). At the time of the report, TINNITUS (Ringing in the ear really, really bad and it's just getting worse) had not resolved.            Patient reported receiving many Moderna Covid-19 series doses and her symptoms worsened.  Concomitant medication information was not provided.  It was reported that a while back around in 2022 patient got the ringing in the ear really, really bad and it just got worse. It was just a little bit like right after it was done in the spring of 2022 around March and then as the summer went on, it just got worse and worse and then this year it was even worse when she went into the urgent care. Patient wanted to say it was around 2022 or 2023. She did not think it was anything, but it's just gotten worse. Patient got it in March and then started experiencing it like not really dizziness but it's the ringing which made her kind of dizzy, and it made her lose train of thought because it was so loud. She did not know if there was anything associated with those shots that could cause tinnitus.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Head injury, Loss of consciousness
Clinical narrative: The patient stated that she heard about other people, another friend who got the vaccine and passed out and hit their head; The patient stated that she heard about other people, another friend who got the vaccine and passed out and hit their head; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (The patient stated that she heard about other people, another friend who got the vaccine and passed out and hit their head) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 LOSS OF CONSCIOUSNESS (The patient stated that she heard about other people, another friend who got the vaccine and passed out and hit their head) (seriousness criterion medically significant) and HEAD INJURY (The patient stated that she heard about other people, another friend who got the vaccine and passed out and hit their head). At the time of the report, LOSS OF CONSCIOUSNESS (The patient stated that she heard about other people, another friend who got the vaccine and passed out and hit their head) and HEAD INJURY (The patient stated that she heard about other people, another friend who got the vaccine and passed out and hit their head) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The reporter stated that she heard about other people, another friend who got the vaccine and passed out and hit their head. So, she did not know what they put on this vaccine.  No treatment information was provided. Company comment: The benefit-risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-774810 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2024: Live Follow up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774810:Invalid for another friend
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: She also confirmed she and her husband are the ones interested in taking the vaccine as she got he COVID-19 infection on 17AUG2024; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She also confirmed she and her husband are the ones interested in taking the vaccine as she got he COVID-19 infection on 17AUG2024) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 17-Aug-2024, the patient experienced COVID-19 (She also confirmed she and her husband are the ones interested in taking the vaccine as she got he COVID-19 infection on 17AUG2024). At the time of the report, COVID-19 (She also confirmed she and her husband are the ones interested in taking the vaccine as she got he COVID-19 infection on 17AUG2024) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Patient got the COVID-19 infection on 17-AUG-2024 and got very, very sick. It was reported that patient had steroids.   This case was linked to US-MODERNATX, INC.-MOD-2024-775034 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775034:Husband case
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis chronic
Clinical narrative: chronic bronchitis; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS CHRONIC (chronic bronchitis) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic bronchitis.    On 10-Jul-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS CHRONIC (chronic bronchitis). The patient was treated with PREDNISONE for Chronic bronchitis, at an unspecified dose and frequency. At the time of the report, BRONCHITIS CHRONIC (chronic bronchitis) outcome was unknown.        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.   The concomitant medication was not reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Palpitations
Clinical narrative: palpitations; heart condition; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (palpitations) and CARDIAC DISORDER (heart condition) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (palpitations) and CARDIAC DISORDER (heart condition). At the time of the report, PALPITATIONS (palpitations) and CARDIAC DISORDER (heart condition) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: high fever; extreme fatigue; headaches; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (high fever) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. as7143c) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 PYREXIA (high fever) (seriousness criterion medically significant), FATIGUE (extreme fatigue) and HEADACHE (headaches). At the time of the report, PYREXIA (high fever), FATIGUE (extreme fatigue) and HEADACHE (headaches) had resolved.            The concomitant medication was not reported by reporter.   She took 6 doses of the Spikevax COVID-19 vaccine but experienced side effects like high fever, extreme fatigue, and headaches lasting 2-4 days after each dose.  The treatment medication was not reported by reporter. Company comment: The benefit-risk relationship of product is not affected by this report   This case was linked to MOD-2024-775047 (Patient Link).