chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported; a patient was administered PNEUMOVAX 23 that expired on 01JUL2021.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies, and concomitant therapies was provided.  On 13-AUG-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in prefilled syringe, lot #S034299, expiration date: 01-JUL-2021, 0.5 milliliter (injection site and route of administration were not provided) for prophylaxis (expired vaccine used). No additional adverse events were reported.
Age: 5.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs reported; a 5 year old patient was administered GARDASIL 9; This spontaneous report was received from a pharmacist and refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-AUG-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection in prefilled syringe, lot # T036812 (lot number was confirmed to be valid), expiration date: 28-APR-2023, 0.5 milliliter (injection site and route of administration were not provided) for prophylaxis (Inappropriate age at vaccine administration). No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T036812; expirationdate: 28-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: had additional small raised dots covering a 4 inch diameter circle around the injection site.; the injection site was warm; swollen like an egg; it hurting; This spontaneous report was received from a consumer concerning her daughter, a 9.5-year-old female patient. No concurrent condition, medical history, or concomitant therapy was reported.  On 14-AUG-2021 (Saturday), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, route, lot# and expiration date unknown) for prophylaxis.         On 16-AUG-2021 (Monday), the injection site was warm to the touch (vaccination site warmth), swollen like an egg (vaccination site swelling) and had additional small raised dots covering a 4 inch diameter circle around the injection site (vaccination site mass). She also complained of it hurting (vaccination site pain). The patient was not recovered from all events. The causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: herpes zoster; other zoster related injuries; This spontaneous report was received from a patient of unknown age and gender regarding a case in litigation on 18-AUG-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or about February 2016, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for the long-term prevention of shingles and zoster related conditions. Subsequently, the patient was treated by a physician for the following injuries herpes zoster and other zoster related injuries. At the reporting time, the outcome of herpes zoster and zoster related conditions was not provided. The reporter considered the event herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details provided; Improperly stored Proquad administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy, and concomitant medication was not provided.  On 16-AUG-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot #T029103 was confirmed to be valid, expiration date 23-FEB-2022; dose, route of administration, and anatomical location were not reported) for prophylaxis. The storage temperature was 9.6 Celsius degrees for 80 minutes. There was no previous temperature excursion. No additional adverse event details provided (no adverse event).  This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2108USA006155: US-009507513-2108USA006146: US-009507513-2108USA006125: US-009507513-2108USA005918: US-009507513-2108USA006030:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details provided; Improperly stored administered PROQUAD 9.6 C for 80 min; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 28-JUN-2021, the patient was vaccinated with an expired measles, mumps, rubella, and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) lot #T021301, expiration date 19-DEC-2021 (formulation, strength, exact dose, anatomical location, and route of administration were not reported) for prophylaxis (product storage error). The temperature excursion was reported as 9.6 degrees Celsius (C) for 80 minutes. There was no previous temperature excursion. It was unknown if a digital data logger was involved in capturing the temperature. No additional adverse event details provided (no adverse event). The outcome of the event was unknown.  This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-108USA006155.
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE/PQC reported; caller reports vaqta administered after a temperature excursion; This spontaneous report was received from an medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not reported.  On 17-AUG-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot #T023913, expiration date 31-MAR-2022 for prophylaxis (dose #, exact dose, route, and anatomical location were not reported). A vaccine undergo temperature excursion in temperature 9 Celsius degrees for 5 min. It was unknown if a digital data logger was involved. No additional adverse events was reported. Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details provided; Improperly stored administered VARIVAX 9.6 C for 80 mins; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-AUG-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot #S032356, expiration date 14-OCT-2021 (formulation, strength, exact dose, anatomical location, and route of administration were not reported) for prophylaxis (product storage error). The temperature excursion was reported as 9.6 degrees Celsius for 80 minutes. There was no previous temperature excursion reported. It was unknown if a data logger was used to capture the temperature. No additional adverse event details provided no adverse event. The outcome of the event was unknown.  This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-108USA006155.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Improperly stored VARIVAX administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy, and concomitant medication was not provided.  On 09-AUG-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S032356 was confirmed to be valid, expiration date 14-OCT-2021; dose, route of administration and anatomical location were not reported) for prophylaxis. The storage temperature was 9.6 Celsius degrees for 80 minutes. There was no previous temperature excursion. No additional adverse event details provided (no adverse event).  This is one of several reports received from the same reporter. Sender's Comments US-009507513-2108USA006030, US-009507513-2108USA005918, US-009507513-2108USA006125, US-009507513-2108USA006006, and  US-009507513-2108USA006146.
Sex: U
Vaccine: MMR, UNK
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No additional AE reported; administered expired diluent with MMRlI that was not expired; administered expired diluent with MMRlI that was not expired; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 17-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) 0.5 ml injection, lot #T016197 was confirmed to be valid, expiration date 11-MAY-2022 (route of administration and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with expired sterile diluent 0.5 ml, lot# S008565 was confirmed to be valid, expiration date 09-AUG-2021. No additional adverse event provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; A temperature excursion for ROTATEQ was reported. The product has been administered to one patient on 15AUG2021; This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 15-AUG-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent with one improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot number 1741235, which was verified to be a valid lot number, expiration date reported, and upon internal validation established as 09-MAR-2022), as prophylaxis (frequency, route of administration, anatomical location, and vaccination scheme were not reported) (product storage error). The administered vaccine underwent a temperature excursion of 10 degree Celsius (C), 9.4C, and 9.5C during a time frame of 27 minutes, 43 minutes and 17 minutes respectively. There was no previous temperature excursion. No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported. No other AE or PQC reported; Pharmacist called to report a temperature excursion / M-M-R-II was given on 18/AUG/2021; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy, and concomitant medication was not provided.  On 18-AUG-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella virus vaccine, live (rHA) (M-M-R II) 1 time dose (lot #T012806 was confirmed to be valid, expiration date 14-APR-2022; route of administration and anatomical location were not reported) for prophylaxis. The storage temperature was 10, 9.4, and 9.5 (on 13-AUG-2021, 14-AUG-2021, and 15-AUG-2021) Celsius degrees for 1 hour and 27 minutes. There was no previous temperature excursion. No additional adverse event details provided (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Caller stated the vaccine was administered after expiration.; This spontaneous report has been received from a pharmacist referring to patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On 24-AUG-2021, the patient was vaccinated with a 0.5 milliliters (mL) expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (lot number S025608, was verified to be a valid lot number with an expiration date reported and established as 18-AUG-2021) (dose number, vaccination scheme frequency, route, and anatomical site of administration were not provided) (expired product administered). It was reported that the vaccine did not had a temperature excursion. No additional adverse event (AE) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 10-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 05-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes (product storage error). There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 19-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes (product storage error). There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported. No other AE or PQC reported.; Improperly stored administered vaccine (7.52 F); This spontaneous report was received from a healthcare professional and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 09-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # T027304 was confirmed to be valid, for prophylaxis (dose, route and site of administration were not reported). The administered dose was exposed to the temperature of 7.52 degrees Fahrenheit for 6 hours and 4 minutes. There was nor previous temperature excursion. No additional adverse event was reported.; Sender's Comments:  US-009507513-2108USA006759:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported. No other AE or PQC reported.; Improperly stored administered vaccine (7.52 F); This spontaneous report was received from a healthcare professional and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot #T027304 was confirmed to be valid, for prophylaxis (dose, route and site of administration were not reported). The administered dose was exposed to the temperature of 7.52 degrees Fahrenheit for 6 hours and 4 minutes. There was nor previous temperature excursion. No additional adverse event was reported. Sender's Comments: US-009507513-2108USA006754.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE reported. No PQC. No additional AEs reported; A patient was administered expired PROQUAD.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 24-AUG-2021, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter, lot #T005406 was confirmed to be valid, expiration date 12-AUG-2021, for prophylaxis (route and site of administration were not reported). No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported. No PQC reported.; Inadvertently administered post expiry date.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 24-AUG-2021, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin) (M-M-R II) lot # S025158 was confirmed to be valid, expiration date 13-AUG-2021, for prophylaxis (dose, route and site of administration were not reported). No additional adverse event was reported.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No further information is available; The patient second dose of VAQTA was 0.5ml when the patient was 19 years old; This spontaneous report was received from the administrator in the physician's office, concerning a 19-years-old female patient. The patient's concomitant medications, concurrent conditions, historical conditions, and drug allergies were not reported.   On 22-JUN-2020 (at the age of 17-years-old), the patient was vaccinated with first dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe at the dose of 0.5 milliliter (ml); lot number S037574 has been validated to be a valid lot number, expiration date reported and validated as 10-APR-2021 (strength, route of administration, and anatomical location were not reported).   On 16-AUG-2021 (at the of 19-years-old), she received the second dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe at the dose of 0.5 milliliter (ml); lot number T035721 has been verified to be a valid lot number, expiration date reported and validated as 15-APR-2022 (strength, route of administration, and anatomical location were not reported) (incorrect dose administered). No adverse event reported, nor product quality complain involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient has not experienced any side effects/ No additional AE information provided; Pharmacist reports patient received their first dose of VAQTA in 2017/ did not receive their second dose/ has returned on 8/25/2021 to receive their second dose; Patient Date of Birth: 3/23/2017/ Pharmacist reports patient received their first dose of VAQTA in 2017; This spontaneous report has been received from a pharmacist referring to a 4-year-old patient (at reporting time) whose gender was not reported. The pharmacist did not provide information on the patient's pertinent medical history.  The pharmacist reported that the patient received the first dose of hepatitis a vaccine, inactivated (VAQTA) in 2017 as prophylaxis (formulation, administered dose, vaccination scheme frequency, route of administration, anatomical location of vaccination, lot number, and expiration date were not reported) (product administered to patient of inappropriate age).   The patient had returned on 25-AUG-2021 to receive the second dose of hepatitis a vaccine, inactivated (VAQTA) (0.5 milliliters (ml)) (formulation, route of administration, anatomical location of vaccination, lot number, and expiration date were not reported) (inappropriate schedule of product administration).  The patient had not experienced any side effects; no additional adverse event (AE) information was provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; One patient was inadvertently administered a expired dose of MMR II; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 20-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella virus vaccine, live (M-M-R II) 1 time dose, for prophylaxis (lot number S022754 has been determined a valid lot number for measles, mumps, and rubella virus vaccine, live; expiration date reported and establish as 22-JUL-2021) (strength, route of administration and anatomical location were not provided).         No adverse event reported.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; a patient was administered ROTATEQ that had undergone a temperature excursion; This spontaneous report was received from a nurse, referring to 10-weeka-old female patient. The patients' historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 17-AUG-2021, the patients was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot# 1742470, expiration date 16-MAR-2022, for prophylaxis (strength, dose, frequencywere not reported). No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA007324: US-009507513-2108USA007014:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other side effects; a patient was given an expired MMR II on 8/12/2021; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.      On 12-AUG-2021 the patient was vaccinated with an expired of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # S023656, expiration date 30-JUL-2021; dose and route were not reported) for prophylaxis (expired product administered). No other side effects were reported at time of call.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-DEC-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, on or about the same date, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the inoculation, the patient was treated for herpes zoster and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles and ill-defined disorder were not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: requesting information on a 14 year old administered PROQUAD; No additional AE details or PQC; This spontaneous report was received from a nurse, referring to a 14-year-old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella, and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). No additional adverse events details.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; ROTATEQ underwent a temperature excursion and was administered to patients; This spontaneous report was received from an administraror, referring to a patient of unknown age, and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies, and concurrent conditions were not reported.   On 19-AUG-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot# T033634 and expiration date 16-MAR-2022, for prophylaxis (strength, dose, frequency were not reported).  The temperature excursion was of 32.4 Fahrenheit degrees (°F) for 1 hours 24 minutes. A previous temperature excursion was not reported. No adverse effects were reported.  This is one of two reports received from the same reporter. Sender's Comments:  US-009507513-2108USA007733.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; ROTATEQ underwent a temperature excursion and was administered to patients; This spontaneous report was received from an administraror, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 19-AUG-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) orally, lot# T033634 and expiration date 16-MAR-2022, for prophylaxis (strength, dose, frequency were not reported).  The temperature excursion was of 32.4 Fahrenheit degrees (°F) for 1 hours 24 minutes. A previous temperature excursion was not reported. No adverse effects were reported.  This is one of two reports received from the same reporter. Sender's Comments: US-009507513-2108USA007723.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Te patient reported no additional AE.; nurse practitioner inadvertently administered a dose of MMRII to a patient intramuscularly rather than the recommended subcutaneous route; This spontaneous report was received from a nurse practitioner (described also as a nurse prescriber) and refers to a 25-year-old female patient. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On 26-AUG-2021, the patient was inadvertently administered a dose of measles, mumps, and rubella virus vaccine, live (M-M-R II) 0.5 ml intramuscularly (anatomical location, lot #, and expiration date were not provided) for prophylaxis. The recommended route of administration for the vaccine was subcutaneous route. The nurse stated the patient reported no adverse event.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; 2-dose series of GARDAIL-9. The first dose was administered 4/12/2021 and the second dose was administered 8/27/2021; This spontaneous report was received from a nurse and refers to a 11-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-APR-2021, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # T025369, expiration date 01-DEC-2022 (route of administration and anatomical location were not provided). On 27-AUG-2021, they received the second dose in 2-dose series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # T025369, expiration date 01-DEC-2022 (route of administration and anatomical location were not provided) (inappropriate schedule of vaccine administered). Both doses were administered for prophylaxis. There was no additional adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025369; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other issues or concerns at time of call.; patient who received an expired dose of MMR II; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 27-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella virus vaccine, live recombinant human albumin (rHA) (M-M-R II) lot #S020962, 07-JUL-2021 exact dose, route of administration, and anatomical location were not provided for prophylaxis. There was no additional adverse event reported.
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Pneumonia
Clinical narrative: she had pneumonia 6 weeks ago; This spontaneous report was received from a consumer refers to a 91-year-old female patient with chronic obstructive pulmonary disease. The patient did not experience drug reactions or allergies.   The patient's medical history included pneumonia in 2015 and hospitalization, on the same year; it was reported that she was in the hospital during that time for maybe 5-7 days and she could not remember the dates. Concomitant medications include unspecified antibiotics.   In 2016, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the arm for prophylaxis (dose, route of administration, lot number and expiration date were not reported).         The patient was asking in wanting to know if she should wait to get another pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), because she had pneumonia 6 weeks ago, on 19-JUL-2021 and she was hospitalized for 4 or 5 days. It was stated that she did received antibiotics during her stay. The patient did not know the names of the medication she took but she stopped taking the medication about 4 or 5 weeks ago. The patient stated she also received breathing treatments and had a nebulizer. Moreover, she stated she recently got her lungs checked, on an unspecified date in 2021 and they were completely clear now. However, it was reported that the patient did not perform laboratory test.  The outcome of pneumonia was reported as recovered, on an unspecified date in 2021.        Upon internal review the event of pneumonia was considered to be medically significant.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Extra dose administered, Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: Shingles; A year or so later I took 2 more; I got the first shot/ I took 2 more; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 6 years ago) and pain.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine and Shingles vaccine, the patient experienced shingles, drug dose administration interval too long and extra dose administered. On an unknown date, the outcome of the shingles, drug dose administration interval too long and extra dose administered were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had 1st dose 6 years ago and right side of the head was very painful. No pain medication helped. The reporter stated that, received 1st dose but it did not worked. A year or so later, the patient received 2nd dose of Shingrix late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter stated that, received 2 shingles vaccine, which led to extra dose administered. The reporter stated that, a year or so took 2 doses more, it finally helped.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: because of covid pandemic didn´t received second dose. 1st dose on sept 2020; This case was reported by a consumer and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on September 2020).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, 2nd dose was not received due to covid pandemic, which led to social problem. The patient did not remember if received 2nd dose of Shingrix. The reporter asked if get dose now even if it might be third.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to patient age 2 yr; Kinrix (3rd dose Dtap/IPV) given to child 2yr; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 2-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Dtap (received in 10th July 2019) and IPV (received in 16th September 2019).   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as the patient previously received Dtap and IVP vaccine. The 2 year 5 months patient was mistakenly administered Kinrix, which led to inappropriate age at vaccine administration, and inappropriate schedule of vaccine administered. The reporter enquired would this hurt the patient and if there was need to repeat the doses with non Kinrix or just give Kinrix again at age 4 years.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: body aches; sore arm; fatigue; headache; This case was reported by a consumer and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included COVID vaccine with an associated reaction of pain (2nd dose received on an unknown date and experienced headache, really sore arm, fatigue).   In August 2021, the patient received the 2nd dose of Shingles vaccine. In August 2021, less than 2 weeks after receiving Shingles vaccine, the patient experienced general body pain, pain in arm, fatigue and headache. On an unknown date, the outcome of the general body pain, pain in arm, fatigue and headache were unknown.   It was unknown if the reporter considered the general body pain, pain in arm, fatigue and headache to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received shingles vaccine last week and experienced body aches, headache, really sore arm, fatigue. The patient stated that it was crazy. The patient had an almost identical reaction to that as patient did to her/his second COVID vaccine. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: sick; hurts your arm; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccine with an associated reaction of pain in extremity (dose received on an unknown date).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced sickness and pain in arm. On an unknown date, the outcome of the sickness and pain in arm were unknown.   It was unknown if the reporter considered the sickness and pain in arm to be related to Shingles vaccine.  Additional details were provided as the patient self reported the case. The patient received Shingles shot and his/her arm hurts more than Covid shot and patient was sick the next day. The patient stated that debated the second, but it's still a month away patient will get it. The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR178217, reported by the same reporter. Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178217, comment response case.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Vaccine positive rechallenge
Clinical narrative: 2 series shot is a doozy; This case was reported by a consumer and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date refer case US2021AMR178133).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. After received shingle shot patient was doozy, but so much better than contracting shingles. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178133:same reporter, same patient, 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: I had flu like symptoms; This case was reported by a consumer via interactive and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received the1st of 2 shots on the arm and experienced flu like symptoms. The patient added that, the place where they administered the shot to the patient was awful.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurt like hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received Shingles vaccine and felt it hurt like hell. The reporter reported that better to get it than get shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles after 1st dose; This case was reported by a consumer via interactive digital media SHINGRIX and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In August 2021, between 3 and 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, had received one of the two part Shingrix shot in 2021, it's been about three months since first dose. At the time of reporting, the patient have shingles.  The patient asked when or if should he/she take second shot.