chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Pain in extremity
Clinical narrative: Patient received 3 vaccines on 10/16/16; Spikevax, RSV, and High Dose Flu.  The Spikevax and RSV werer given on the left arm.  Patient reported extreme soreness in the left arm and having to go to physical therapy for it.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna formulation for 12+years old. Child is 10 years old.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Headache, Injection site pain, Lethargy, Musculoskeletal stiffness
Clinical narrative: Symptoms of swelling, warmth, redness, lethargy, headache, arm stiffness, and injection site arm hurting to the touch started on 11/12/2023. The patient was seen by her cardiologist on 11/14/23 who recommended to follow up with primary care nurse practitioner 11/15/2023 who diagnosed patient cellulitis as a result of administration site error (too low in the deltoid). Provider prescribed doxycycline hyc 100 mg capsules twice daily to patient. First dose of antibiotic was taken on 11/15/2023 and resolution of symptoms began on 11/16/2023, but did not completely resolve. As of 11/16/2023, patient reports the injection site not as raised, not as bright red, has not gotten any bigger, and did not grow outside lines of demarcation. Patient reports lethargy, headache, arm stiffness, and injection site hurts to the touch.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Product administered at inappropriate site, Skin warm, Swelling, Tenderness
Clinical narrative: Symptoms of swelling, warmth, redness, lethargy, headache, arm stiffness, and injection site arm hurting to the touch started on 11/12/2023. The patient was seen by her cardiologist on 11/14/23 who recommended to follow up with primary care nurse practitioner 11/15/2023 who diagnosed patient cellulitis as a result of administration site error (too low in the deltoid). Provider prescribed doxycycline hyc 100 mg capsules twice daily to patient. First dose of antibiotic was taken on 11/15/2023 and resolution of symptoms began on 11/16/2023, but did not completely resolve. As of 11/16/2023, patient reports the injection site not as raised, not as bright red, has not gotten any bigger, and did not grow outside lines of demarcation. Patient reports lethargy, headache, arm stiffness, and injection site hurts to the touch.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: HPI: Got swelling in both shoulders, started day of the vaccines, now 2 days after the vaccines. Right worse than left. Red and warm. No vomiting. No diarrhea. No trouble breathing or swallowing.   Exam: Significant warmth, erythema, and swelling over entire right deltoid. No crepitus, no fluctuance. Left deltoid also with warmth and erythema; swelling limited to 2 cm. No crepitus, no fluctuance.   Assessment: Strong localized reaction but no systemic signs. He received Tdap and MCV, the stronger irritation was from the MCV. Given no prior primer, I suspect that this was more an irritant reaction than an IgE mediated. Treating with anti-histamine.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AE reported. No PQC.; Inbound call from nurse who reports expired ROTATEQ was administered to a patient.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not reported.   On 16-OCT-2023, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid vial, 2 mL (lot #W002562, expiration date: 12-OCT-2023) administered orally as prophylaxis. The vaccine had not experienced any temperature excursion through the date of administration. No additional adverse events (AE) reported. No PQC.    This is a non-valid case due to lack of patient's identifiers.  Follow-up information was received from a nurse on 13-NOV-2023.   Upon receipt of follow-up information, it was determined that this case is now valid because patient's identifier was received.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A HBP was transferred onto the line by a Merck account representative to report a temperature excursion.; no additional adverse events were reported; This spontaneous report has been received from a healthcare business professional, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # W039294 with expiration date: 11-DEC-2024; route, dose and strength were unknown) for prophylaxis (product storage error). The reporter was unable to provide a date of administration. The reporter said no additional adverse events were reported.   Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion below17.4 Fahrenheit degrees (F) for 2 hours 0 minutes 0 seconds. No previous temperature excursions reported.
Age: 0.17
Sex: M
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; Consumer transferred from CRT. Caller wanted to report a misuse AE on VAQTA. Caller stated that on 10/19/2023, her 2 month old son received VAQTA accidentally. The caller stated that her son was supposed to be getting his 2 month vaccines, but that t; Informed the caller that VAQTA is only approved in children 12 months and older as per the PI; This spontaneous report was received from a consumer and refers to a 2-month-old male patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 19-OCT-2023 the patient was vaccinated by accident with first dose of hepatitis a vaccine, inactivated (VAQTA) lot # 1971534 and expiration date 06-OCT-2023, intramuscularly in the right thigh for prophylaxis (exact dose was not provided).  Other suspect therapies included influenza a(h1n1) pdm09 vaccine (INFLUENZA A(H1N1) PDM09 VACCINE) (wrong product administered, product administered to patient of inappropriate age and no adverse event).
Sex: U
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received RECOMBIVAX HB on 24-OCT-2023 and again on accident on 27-OCT-2023; This spontaneous report has been received from a registered nurse concerning a 19-year-old patient of unknown gender.  The patient's concurrent conditions, medical history, concomitant therapies, and allergy/drug reactions were not reported.  On 24-OCT-2023, the patient was vaccinated with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (dose/route/frequency of administration, lot number, and expiration date not reported) for prophylaxis. On 27-OCT-2023, the patient was accidentally vaccinated again with hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) (lot number W036194 with expiry date 29-SEP-2025) dose: 1 dose (route/frequency of administration not reported) as prophylaxis (inappropriate schedule of product administration). The patient did not experience adverse events (no adverse event). The operator of the device was the health care professional.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Caller is a medical assistant transferred from Specialist requesting information on expired dose of PNEUMOVAX 23 (pfs) that was administered to a patient. Product expired 10/20/2023 and was administered to the patient 11/6/2023. Product had not exper; Caller is a medical assistant transferred from Specialist requesting information on expired dose of PNEUMOVAX 23 (pfs) that was administered to a patient. Product expired 10/20/2023 and was administered to the patient 11/6/2023. Product had not exper; This spontaneous report was received from other health care professional and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 06-NOV-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 ml, (lot number W007035 has been confirmed to be valid for polyvalent (23-valent) (PNEUMOVAX23), expiration date reported as 20-OCT-2023) (strength, route of administration, and indication were not provided).  A specialist requesting information on expired dose of polyvalent (23-valent) (PNEUMOVAX23) that was administered to a patient the product expired on 20-OCT-2023 and was administered to the patient 06-NOV-2023. At the time of reporting, the outcome of the event was not unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AEs or PQC reported.; Caller reported expired dose of VARIVAX administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a physician and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot number U029496 has been confirmed to be valid for varicella virus vaccine live (oka/merck) (VARIVAX)) expiration date reported as 21-SEP-2023) the expired vaccine was administered to the patient (Expired product administered) (strength, route of administration, and indication were not provided). At the time of reporting, the outcome of the event was not unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD (x019553   1/19/2025) Temperature and Time frame: -9.; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD (x019553   1/19/2025) Temperature and Time frame: -9.; This spontaneous report was received from other health care professional and refers to a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot number x019553, expiration date: 19-JAN-2025), administered as prophylaxis (strength, vaccination scheme and route and anatomical site of administration were not provided). The nurse was reporting that a patient received improperly stored vaccine (Improper storage of product in use). No additional adverse events were reported.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP Calling to report PROQUAD administration to 13 Y/O.  No additional AE.  No PQC.; HCP Calling to report PROQUAD administration to 13 Y/O.  No additional AE.  No PQC.; This spontaneous report was received from Other Health Professional and refers to a 13-year-old. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot number X018570, expiration date: 05-JAN-2025), administered as prophylaxis (strength, vaccination scheme and route and anatomical site of administration were not provided) (Inappropriate age at vaccine administration). No additional adverse events were reported.
Sex: F
Vaccine: HEPA
Symptoms: Intercepted medication error, No adverse event
Clinical narrative: No additional AE; Caller stated that the medical assistant mixed up the vaccines that were meant to be given to her 2-year-old daughter and instead gave them to her 2-month-old. The 2 year old daughter dd not receive any incorrect vaccines as the mistake was caught be; This spontaneous report was received from a consumer and refers to a 2-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 19-OCT-2023, caller stated that the medical assistant mixed up the vaccines that were meant to be given to her 2-year-old daughter and instead gave them to her 2-month-old. The 2-year-old daughter did not receive any incorrect vaccines that included hepatitis a vaccine, inactivated (VAQTA) lot # 1971534 and expiration date 06-OCT-2024, for prophylaxis (exact dose and dose number were not reported) and influenza a(h1n1) pdm09 vaccine (INFLUENZA A(H1N1) PDM09 VACCINE), as the mistake was caught before that (intercepted medication error and no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No adverse event; HCP calling to report expired dose of PNEUMOVAX 23 was administered post expiry. Per memo product was supported post expiry. Permission to contact HCP was granted. No additional information provided. No AE/PQC reported.; This spontaneous report was received from Pharmacist and refers to a patient of an unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (lot number W015900 has been confirmed to be valid for polyvalent (23-valent) (PNEUMOVAX23) expiration date reported as 20-OCT-2023) (strength, route of administration, and indication were not provided).  The reported calling to report that the expired dose of PNEUMOVAX 23 was administered post expiry (Expired vaccine used) and no additional information was provided.
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reactions noted; HBP calling to report AE for patient that received both PROQUAD and VARIVAX.  No adverse reactions noted.  Associated AE's: 02507181//02507181 No PQC.; This spontaneous report was received from an administrator and refers to a 4-year-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose, lot #X010526, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided); and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, single dose, lot #X018730, expiration date: 06-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (overdose). No additional adverse evenet was reported.; Sender's Comments:  US-009507513-2311USA004612:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: No adverse reactions noted; HBP calling to report AE for patient that received both PROQUAD and VARIVAX.  No adverse reactions noted.  Associated AE's: 02507181//02507145 No PQC.; This spontaneous report has been received from an administrator, regarding a neonate patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 19-OCT-2023, the patient was vaccinated with a single dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number: X010526, which was determined to be valid, with an expiration date on 11-APR-2025), in combination with a single dose of (PROQUAD) injection (lot number: X018730, which was determined to be valid, with an expiration date on 06-JAN-2025), both as prophylaxis (overdose).  No adverse reactions were noted.   This case is one of 3 reports from the same reporter.; Sender's Comments:  US-009507513-2311USA004439: US-009507513-2311USA004323:
Sex: U
Vaccine: PNC15
Symptoms: Product administered to patient of inappropriate age, Vaccination site reaction
Clinical narrative: injection site reactions um um after administration; Adult product administered to child; This spontaneous report was received from a company representative refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age).  On an unknown date, the patient experienced vaccination site reaction. The outcome of vaccination site reaction was unknown.  The causality assessment was not provided. ; Sender's Comments:  US-009507513-2311USA005497:
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: syncope; This serious case was reported by a nurse via sales rep and described the occurrence of syncope in a patient who received Men B NVS (Bexsero) for prophylaxis.   In OCT-2023, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced syncope (Verbatim: syncope) (serious criteria GSK medically significant). The outcome of the syncope was not reported.   It was unknown if the reporter considered the syncope to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the syncope 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: 09-NOV-2023 The nurse did not provide patient information but said she's had 2 patients experienced syncope after receiving Bexsero injection in the last month. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Erythema
Clinical narrative: erythema/Redness; discomfort; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced erythema (Verbatim: erythema/Redness) and discomfort (Verbatim: discomfort). The outcome of the erythema and discomfort were resolved.   It was unknown if the reporter considered the erythema and discomfort to be related to Shingrix.     It was unknown if the company considered the erythema and discomfort to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-NOV-2023 The physician reported that one of his patients experienced erythema and discomfort, 3 days after first dose of Shingrix vaccine administration.  The physician reported that he was unaware of the patient's injection site location. Redness and discomfort were resolved without intervention in both cases. This case had been linked with US2023AMR154557, reported by the same reporter for himself. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR154557:Same Reporter
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the first dose of Twinrix in May 2023 and yesterday received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in May 2023).   On 05-NOV-2023, the patient received the 2nd dose of Twinrix. On 05-NOV-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received the first dose of Twinrix in May 2023 and yesterday received the second dose). The outcome of the drug dose administration interval too long 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: 06-NOV-2023 The HCP asked if the series needed to be re started and if not what is the recommended interval between the second and third. An health care professional (HCP) reported that a patient received the 1st dose of Twinrix in May 2023 and yesterday (day before reporting) received the 2nd dose, which led to drug dose administration interval too long. During the call permission to follow up was not requested.
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Device temperature issue, No adverse event, Product storage error
Clinical narrative: vaccines administered after temperature excursion that occurred on 8/1/2023.  Vaccines were administered to unknown patients on unknown dates. No additional AEs; vaccines administered after temperature excursion that occurred on 8/1/2023.  Vaccines were administered to unknown patients on unknown dates. No additional AEs; This spontaneous report was received from a registered nurse referring to an unspecified number of unknown patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, an unspecified number of unknown patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot#W030849, expiry date: 26-MAR-2024 and lot#; X004371, expiry date: 07-AUG-2024 (recombinant Human albumin (rHA)) and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot#W018829, expiry date: 14-JUN-2024 as prophylaxis (dose and route of administration for both vaccines were not provided) that were exposed to temperature excursion of -11.8 Celsius degree, for 29 minutes that occurred on 01-AUG-2023. There were no previous temperature excursions. No additional Adverse events reported.  This is a non-valid case due to lack of patient's identifiers.  Follow-up information was received from the registered nurse regarding the 10-week-old female patient.  The patient historical vaccines included varicella virus vaccine live (VARIVAX). The patient had no known drug allergies (NKDA). Concomitant therapies were not provided.   On 15-AUG-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (administered subcutaneously in the right upper arm, lot number W030849, expiration date 26-MAR-2024) and with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) (administered intramuscularly at the left deltoid, lot number U7908AB, expiration date 03-OCT-2025). Both vaccines experienced a previous temperature excursion.    Furthermore, the nurse reported that there were ongoing issues with the freezer and auto-defrost. On 01-AUG-2023, the temperatures on state supplied data blogger reached -11.8 degree Celsius for 29 minutes.  She was unaware of temperature excursion until temporarily moving the vaccines to another office for temporary storage to manually defrost and had unit serviced on 16-AUG-2023.  The patient received immunization impacted by excursion prior to notification.  There were no known adverse events.   This case was previously considered non-valid, but upon receipt of follow-up patient identifiers were received and it was determined that the case is now valid.  This is one of three cases from the same reporter (2309USA002333 and 2311USA005371).
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Engerix-B /Late second dose; Case US2023154477 was identified as follow-up to case US2023154472 . Case US2023154477 was deleted due to being created in error. All future correspondence will be submitted to case US2023154472 .
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: patient was administered a dose of Shingrix on 07Nov2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 5NC4N, expiry date 08-OCT-2023) for prophylaxis.   On 07-NOV-2023, the patient received Shingrix. On 07-NOV-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: patient was administered a dose of Shingrix on 07Nov2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date- 08-NOV-2023 The Pharmacist reported that the patient received dose of Shingrix which was already expired, which led to expired vaccine used.  At the time of reporting, repeat dose has not been administered. This was 1 of the 2 cases, reported by the same reporter for different patient. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023154980:Same reporter,2nd patient
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not have his second dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first Shingrix vaccination in 2018 or 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not have his second dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-NOV-2023 The patient self-reported this case. The patient declined to provide any demographics.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter denied to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Cardiac operation
Clinical narrative: heart surgery; This serious case was reported by a pharmacist via call center representative and described the occurrence of cardiac operation in a male patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced cardiac operation (Verbatim: heart surgery) (serious criteria clinically significant/intervention required). The outcome of the cardiac operation was unknown.   It was unknown if the reporter considered the cardiac operation to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the cardiac operation to be related to Twinrix and Twinrix 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: 8-Nov-2023 Pharmacist reported that a patient received 2 doses of Twinrix and had heart surgery sometime after that. Reporting out of obligation, most likely not related, the reporter had to get off phone and could not give any details when agent tried to collect them, mailing address of Pharmacy in health care professional's details.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet had the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in April 2023).   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 incomplete course of vaccination (Verbatim: not yet had the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date- 08-NOV-2023 The patient not yet had the 2nd dose.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: The reporter believes the shingles involved the eyes; developed shingles approximately 1 week after receiving the SHINGRIX vaccine; This serious case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: The reporter believes the shingles involved the eyes) (serious criteria GSK medically significant) and shingles (Verbatim: developed shingles approximately 1 week after receiving the SHINGRIX vaccine). The outcome of the ophthalmic herpes zoster was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingrix.     It was unknown if the company considered the ophthalmic herpes zoster and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-NOV-2023 The reporter was an acquaintance of the patient.   The reporter stated that the patient developed shingles approximately 1 week after receiving the Shingrix vaccine.   The reporter believed the shingles involved the eyes. The reporter did not consent to follow-up. The case is linked with US2023155531, by same reporter.; Sender's Comments:  US-GSK-US2023155531:2 of 2 report
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Endocarditis, Heart valve calcification, Palpitations, Suspected COVID-19
Clinical narrative: INFECTIVE HEART VALVE; CALCIFIED HEART VALVE; HEART WAS POUNDING; SUSPECTED COVID-19 INFECTION; VESSELS SWELLED UP ALL OVER BODY; LOT OF PAIN IN HER ARM AND IT WAS BURNING AS SOON AS SHE RECEIVED IT; This spontaneous report received from a patient concerned a 71 year old female. Initial information was processed along with the additional information received on 14-NOV-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis, unspecified drug allergy, latex allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had not done any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 06-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 71 years old. Concomitant medications included metoprolol. On 06-MAY-2021, the patient experienced lot of pain in her arm and it was burning as soon as she received it, patient had a very bad reaction. On an unspecified date, the patient experienced infective heart valve, heart was pounding, vessels swelled up all over body, calcified heart valve, and suspected covid-19 infection. It was reported that patient got sick after getting it and felt weaker. On unspecified date AUG-2022, the patient received open heart surgery. She probably will need to get 2 more valves replaced. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart was pounding, calcified heart valve, infective heart valve, suspected covid-19 infection, lot of pain in her arm and it was burning as soon as she received it and vessels swelled up all over body was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000303556. The suspected product quality complaint has been confirmed to be the reported event was not associated with a product defect or product performance issue. this customer preference case has been assessed and did not represent a product quality complaint based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20231135023- Infective heart valve, Calcified heart valve. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: INFECTIVE HEART VALVE; CALCIFIED HEART VALVE; HEART WAS POUNDING; SUSPECTED COVID-19 INFECTION; VESSELS SWELLED UP ALL OVER BODY; LOT OF PAIN IN HER ARM AND IT WAS BURNING AS SOON AS SHE RECEIVED IT; This spontaneous report received from a patient concerned a 71 year old female. Initial information was processed along with the additional information received on 14-NOV-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis, unspecified drug allergy, latex allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had not done any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 06-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 71 years old. Concomitant medications included metoprolol. On 06-MAY-2021, the patient experienced lot of pain in her arm and it was burning as soon as she received it, patient had a very bad reaction. On an unspecified date, the patient experienced infective heart valve, heart was pounding, vessels swelled up all over body, calcified heart valve, and suspected covid-19 infection. It was reported that patient got sick after getting it and felt weaker. On unspecified date AUG-2022, the patient received open heart surgery. She probably will need to get 2 more valves replaced. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart was pounding, calcified heart valve, infective heart valve, suspected covid-19 infection, lot of pain in her arm and it was burning as soon as she received it and vessels swelled up all over body was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000303556. The suspected product quality complaint has been confirmed to be the reported event was not associated with a product defect or product performance issue. this customer preference case has been assessed and did not represent a product quality complaint based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20231135023- Infective heart valve, Calcified heart valve. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: received about 35% of the vaccine; prefilled syringes got stuck in the middle during administration; No adverse event; This spontaneous case was reported by a non-health professional and describes the occurrence of UNDERDOSE (received about 35% of the vaccine), SYRINGE ISSUE (prefilled syringes got stuck in the middle during administration) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced UNDERDOSE (received about 35% of the vaccine), SYRINGE ISSUE (prefilled syringes got stuck in the middle during administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (received about 35% of the vaccine), SYRINGE ISSUE (prefilled syringes got stuck in the middle during administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No relevant concomitant medications were reported.  The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem. Malfunction type was reported as CIRM.  The reporter stated, one of the prefilled syringes got stuck in the middle during administration. There was no way it was going out or in and the patient did not receive the full 0.3ml. Doesn't know if the patient got any at all or how much they received. The patient received about 35% of the vaccine.   No treatment information was reported.
Age: 92.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Rectal haemorrhage
Clinical narrative: This morning she went to the toilet (went 2) and saw blood in the toilet bowl. She states it was bright red. She is bleeding rectally.; This spontaneous case was reported by a patient and describes the occurrence of RECTAL HAEMORRHAGE (This morning she went to the toilet (went 2) and saw blood in the toilet bowl. She states it was bright red. She is bleeding rectally.) in a 92-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Patient had no allergies, COVID-19 diagnosis provided as none.  Concurrent medical conditions included Difficulty in walking (She has a problem walking), Walking aid user (She uses a cane) and Blood pressure high. Concomitant products included VALSARTAN for Blood pressure high.   On 12-Nov-2023, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 13-Nov-2023, the patient experienced RECTAL HAEMORRHAGE (This morning she went to the toilet (went 2) and saw blood in the toilet bowl. She states it was bright red. She is bleeding rectally.) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (This morning she went to the toilet (went 2) and saw blood in the toilet bowl. She states it was bright red. She is bleeding rectally.) outcome was unknown.            Reported that this was her second Moderna COVID-19 vaccination. She did not have a reaction to the first one. On 12-Nov-2023 she received SPIKEVAX. In the morning of 13-Nov-2023 she went to the toilet (went 2) and saw blood in the toilet bowl. She states it was bright red. She was bleeding rectally. This happened a half an hour ago of the reporting so she has not gone to the toilet again since to see if it was still happening. She did not go to the doctor right away because she doesn't have a car or anyone around her to take her. They give her an influenza vaccine at the same time in her other arm. She has no history of rectal bleeding.  No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 92-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Rectal haemorrhage, which occurred 1 day after SPIKEVAX 2023-2024, administered as second dose within COVID-19 vaccination schedule. Co-suspect product included Influenza vaccine. As reported, the patient went to the toilet and saw blood in the toilet bowl. She stated it was bright red. She was bleeding rectally. She did not go to the doctor right away because she didn´t have a car or anyone around her to take her. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to MOD-2021-067305, MOD-2022-551335.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: little bit of soreness at the injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 026A21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Chronic lung disease and Polyneuropathy.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (Fatigue). At the time of the report, INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient had taken 6 doses of the Moderna COVID-19 vaccine. Tolerated all shots well and not gotten sick, the patient had a little bit of soreness at the injection site and fatigue with all of the doses. This was similar compared to his experience with any other shots. Lasted 1.5 days before resolving with each dose. The patient was very thankful for the Moderna COVID-19 vaccines.  Other doses included-Dose 3: 09-Nov-2021, lot number 004F21N; Dose 4: 03-Jun-2022, lot number 05A22A; Dose 5: 28-Nov-2022, lot number 016H22A and Last dose unknown date or lot number but received it from a pharmacy.   This case was linked to MOD-2023-749422 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Injection site pain
Clinical narrative: little bit of soreness at the injection site; fatigue; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic lung disease and Polyneuropathy.    On 28-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue). At the time of the report, INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue) had resolved.            Concomitant medication was not reported.  Patient had taken six doses of the Moderna COVID-19 vaccine. Tolerated all shots well and had not gotten sick. Patient had a little bit of soreness at the injection site and fatigue with all of the doses. This is similar compared to his experience with any other shots. Lasted 1.5 days before resolving with each dose.  Doses were given as follows: 24 Feb2021, lot number 006M20A 26MAR2021, lot number 026A21A 9NOV2021, lot number 004F21N 3JUN2022, lot number 05A22A 28NOV2022, lot number 016H22A Last dose unknown date or lot number.  treatment information was not reported.   This case was linked to MOD-2023-749422 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: little bit of soreness at the injection site; fatigue; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. 004F21N and 05A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Chronic lung disease and Polyneuropathy.   On 09-Nov-2021, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 03-Jun-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue). At the time of the report, INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. Patient tolerated all shots well and has not gotten sick. Patient had a little bit of soreness at the injection site and fatigue with all of the doses. Events lasted about 1.5 days before resolving with each dose. Patient had taken another 4 doses of the Moderna COVID-19 vaccine as on 24FEB2021 with lot number 006M20A, 26MAR2021with lot number 026A21A, 28NOV2022 with lot number 016H22A and Last dose of unknown date or lot number.   This case was linked to MOD-2023-749422 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation reaction
Clinical narrative: Having a bad reaction; worst headache; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Having a bad reaction) and HEADACHE (worst headache) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Having a bad reaction) and HEADACHE (worst headache). At the time of the report, IMMUNISATION REACTION (Having a bad reaction) outcome was unknown and HEADACHE (worst headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient has received 2 Vaccines and 3 boosters. She received a Moderna vaccine yesterday and was having the worst headache. Having a bad reaction. was this usual.   No treatment information was reported.