chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: PATIENT STARTED TO FEEL DIFFERENT AFTER 4 HOURS OF ADMINISTRATION, THE INJECTION SITE 4 INCHES BELOW STARTED TO GET SORE, WARM, HOT AND THROBBING, ITCHY BURNING PAIN. ON 9/14/20 AROUND 4PM PATIENT STATED SHE LOST HER TOTAL STRENGTH ON LEFT HAND AND UNABLE TO PICK OR HOLD ANYTHING. PATIENT STATED LAST NIGHT (9/15/2020) THE AREA GOT REALLY HOT AND HURTING. PATIENT PUT ICE PACK FOR 2 HOURS, GOT FELT BETTER AND ABLE TO SLEEP.
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: Patient complained of pain in left shoulder following shot. Swelling and redness morning. He put ice and was told to continue treatment with Ibuprofen on 9-8-20. Swelling subsided in 3 days, but pain continued. As of 9-16-20 patient said only limited range of motion in left shoulder pain only when sleeps on left side.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Acute kidney injury, Blood urine present, Eczema, Gait disturbance, IgA nephropathy
Clinical narrative: First sign peeing blood after vaccine acute kidney failure diagnosed with IGA and chronic exzema so bad could barely walk; First sign peeing blood after vaccine acute kidney failure diagnosed with IGA and chronic exzema so bad could barely walk; First sign peeing blood after vaccine acute kidney failure diagnosed with IGA and chronic exzema so bad could barely walk; could barely walk; This spontaneous information has been received from a physician via Health Agency, concerning a 19-years-old non-pregnant female patient. The patient had no prescriptions, over the counter medications, dietary supplements, or herbal remedies being taken at the time of the vaccination. Patient was allergic to sulfa and her concurrent conditions were not provided.  On 05-JUL-2008, the patient was vaccinated with her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in her right arm as prophylaxis (strength, route of administration, lot number and expiration date were not provided).   On 02-AUG-2009, the patient was peeing blood after the vaccine, and acute kidney failure was diagnosed with igA nephropathy and chronic eczema, which was so bad that she could barely walk (acute kidney injury, iga nephropathy, eczema and gait disturbance). It was reported that the patient went to the emergency room and was hospitalized 6 days. At the time of this report, the patient had not recovered from the aforementioned adverse events.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the aforementioned adverse events was not provided.  Upon internal review, acute kidney injury and iga nephropathy were determined to be medically significant events.  This is an amended report. The events acute kidney failure, igA nephropathy, eczema and gait disturbance were considered as disabling and life threatening events. Additionally, the acute kidney failure and iga nephropathy were not considered as medically significant events.  As of 15-SEP-2020, all telephone attempts trying to obtain additional information has been unsuccessful. 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Hypersensitivity, Hypersomnia, Malaise, Pain
Clinical narrative: consumer was calling to report experiencing an allergic reaction following the PNEUMOVAX 23 vaccination./Caller reported their HCP cannot control the allergic reaction and reported having rashes, swelling, and being sick all year after receiving the; excessive sleeping the first 3 months after the vaccination and is still having difficulty staying alert.; experiencing random pains throughout the body, but cannot state where the pain was coming from because the pain was constantly moving around the body; being sick all year; This spontaneous report was received from a consumer referring to herself as a non-pregnant 32-year-old female patient. The patient had no pertinent medical history, and concomitant medications. It was reported that the patient was allergic to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23).  On 28-AUG-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injected in the arm to prevent pneumonia (dose, frequency, route of administration, lot number and expiration date were not provided).  On the same date, following the vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) the patient experienced an allergic reaction (allergy to vaccine). It was reported that her health care provider (HCP) couldn't control the allergic reaction and stated had rashes, swelling and to be sick all year after vaccination (malaise). Also, she was excessive sleeping the first three months after the vaccination and was still having difficulty staying alert (somnolence). Additionally, she reported experiencing random pains throughout the body, but cannot stated where the pain was coming from because the pain was constantly moving around the body (pain). The patient went to the emergency room (ER) for the allergic reactions from the vaccine but did not stay overnight in the hospital. As part of her treatment the patient received omalizumab (XOLAIR) injections every three weeks to help her control the allergic reactions. Additionally, she was prescribed an epinephrine hydrochloride (EPIPEN) and hydroxychloroquine followed the allergic reactions. Also, as part of the treatment the patient received diphenhydramine hydrochloride (BENADRYL). It was reported that no laboratory diagnostics or studies were performed. At the reporting time the patient had not recovered from allergy to vaccine, malaise, somnolence and pain.   The action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was reported as discontinued.  The causal relationship between malaise, somnolence and pain and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not provided. The reporter considered allergy to vaccine to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23).
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Somnolence, Swelling
Clinical narrative: consumer was calling to report experiencing an allergic reaction following the PNEUMOVAX 23 vaccination./Caller reported their HCP cannot control the allergic reaction and reported having rashes, swelling, and being sick all year after receiving the; excessive sleeping the first 3 months after the vaccination and is still having difficulty staying alert.; experiencing random pains throughout the body, but cannot state where the pain was coming from because the pain was constantly moving around the body; being sick all year; This spontaneous report was received from a consumer referring to herself as a non-pregnant 32-year-old female patient. The patient had no pertinent medical history, and concomitant medications. It was reported that the patient was allergic to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23).  On 28-AUG-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injected in the arm to prevent pneumonia (dose, frequency, route of administration, lot number and expiration date were not provided).  On the same date, following the vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) the patient experienced an allergic reaction (allergy to vaccine). It was reported that her health care provider (HCP) couldn't control the allergic reaction and stated had rashes, swelling and to be sick all year after vaccination (malaise). Also, she was excessive sleeping the first three months after the vaccination and was still having difficulty staying alert (somnolence). Additionally, she reported experiencing random pains throughout the body, but cannot stated where the pain was coming from because the pain was constantly moving around the body (pain). The patient went to the emergency room (ER) for the allergic reactions from the vaccine but did not stay overnight in the hospital. As part of her treatment the patient received omalizumab (XOLAIR) injections every three weeks to help her control the allergic reactions. Additionally, she was prescribed an epinephrine hydrochloride (EPIPEN) and hydroxychloroquine followed the allergic reactions. Also, as part of the treatment the patient received diphenhydramine hydrochloride (BENADRYL). It was reported that no laboratory diagnostics or studies were performed. At the reporting time the patient had not recovered from allergy to vaccine, malaise, somnolence and pain.   The action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was reported as discontinued.  The causal relationship between malaise, somnolence and pain and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not provided. The reporter considered allergy to vaccine to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23).
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; diagnosed with shingles/ Suspected vaccination failure; diagnosed with shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected  vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. In May 2019, the patient received the 2nd dose of Shingrix. On 9th September 2020, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received two doses of Shingrix, one in February and one in May of 2019. On 9th September 2020, she was diagnosed with shingles. The patient  had a sore arm with both doses, and these resolved with in few days. The reporter consented to follow up. This case was considered as suspected vaccination failure as details laboratory confirmation was unknown at the time of reporting. This case is linked with case US2020AMR182489, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR182489:same reporter
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: sore arm; diagnosed with shingles/ Suspected vaccination failure; diagnosed with shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected  vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. In May 2019, the patient received the 2nd dose of Shingrix. On 9th September 2020, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received two doses of Shingrix, one in February and one in May of 2019. On 9th September 2020, she was diagnosed with shingles. The patient  had a sore arm with both doses, and these resolved with in few days. The reporter consented to follow up. This case was considered as suspected vaccination failure as details laboratory confirmation was unknown at the time of reporting. This case is linked with case US2020AMR182489, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR182489:same reporter
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Dry skin, Eczema, Erythema, Pruritus
Clinical narrative: Eczema, red and dry patches appear on neck and around eyes. And dry above the lips. Patches also itch. Itchy and red packets on arms (opposite side of elbow, where arms bend)
Age: 1.33
Sex: F
Vaccine: MMRV
Symptoms: Crying, Erythema, Mass, Pyrexia, Rash
Clinical narrative: High fever, crying, screaming, pink at entry point like bug bite, spots/rash all over body, lumps behind ears on skull, rash on trunk left side
Age: 1.33
Sex: F
Vaccine: MMRV
Symptoms: Screaming
Clinical narrative: High fever, crying, screaming, pink at entry point like bug bite, spots/rash all over body, lumps behind ears on skull, rash on trunk left side
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pruritus, Eye pruritus, Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Severe prutirus of entire body [including eyes, inner ear canals and vagina/rectum]; syncope; all-over skin redness; large pruritic gives on face, neck and jaw; numbness and tingling in extremities; pruritus more pronounced over all pulse points
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Vulvovaginal pruritus
Clinical narrative: Severe prutirus of entire body [including eyes, inner ear canals and vagina/rectum]; syncope; all-over skin redness; large pruritic gives on face, neck and jaw; numbness and tingling in extremities; pruritus more pronounced over all pulse points
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 15 year-old patient was administered PROQUAD.; This spontaneous report was received from a physician referring to a 15 years old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reaction or allergy and concomitant therapy was provided.   On 14-AUG-2020, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (1 dosage form, lot # S035110, expiration date 03-MAY-2021, strength and route were not provided) for prophylaxis (inappropriate age at vaccine administration).
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report was received from a nurse referring to an 18-year-old female patient. Information regarding the patient's pertinent medical history and drug reactions/allergies was not provided.  On 26-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not reported; lot # T002848 and expiration date 23-JAN-2022) for prophylaxis (product storage error). The administered vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S008566 and expiration date 16-NOV-2021).   The administered dose of the vaccine experienced multiple excursions in temperature range -14 Celsius degree to -10 Celsius degree (-12.1 Celsius degree) for 3 hours, and -9 Celsius degree to 8 Celsius degree (-7.5 Celsius degree) for 8 hours and 30 minutes recorded by a data logger. There was no previous temperature excursion.  This is one of multiple cases sent by the same reporter.; Sender's Comments:  US-009507513-2008USA014014: US-009507513-2008USA014069: US-009507513-2008USA014076: US-009507513-2008USA014108: US-009507513-2008USA014134: US-009507513-2008USA014180: US-009507513-2008USA014182: US-009507513-2008USA014186: US-009507513-2008USA014577: US-009507513-2008USA014634: US-009507513-2008USA014648: US-009507513-2009USA004106:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: RN that was calling to report temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving PROQUAD states that there have been administered doses.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  Since 28-JUL-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) had intermittent temperature excursion between a temperature of -14 degrees Celsius (C) to -10C (max -9.5C) for 38 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion.  On 11-AUG-2020, the patient was administered an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (0.5 milliliter (ml), lot # T009929, expiration date 16-SEP-2021, strength and route were not provided) for prophylaxis (product storage error).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: RN that was calling to report temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving PROQUAD states that there have been administered doses.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  Since 28-JUL-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) had intermittent temperature excursion between a temperature of -14 degrees Celsius (C) to -10C (max -9.5C) for 38 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion.  On 17-AUG-2020, the patient was administered an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (0.5 milliliter (ml), lot # T009929, expiration date 16-SEP-2021, strength and route were not provided) for prophylaxis (product storage error).
Sex: U
Vaccine: HEP, HEPA, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; Incorrect product storage; This spontaneous non-valid report was received from a healthcare worker regarding an unspecified number of patients of unknown age or gender. The patients' pertinent medical history, concurrent condition, concomitant medications, drug reactions and allergies were not reported.   On unspecified dates since July 2020, the patients were vaccinated with an unspecified amount of improperly stored doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # R021372 was verified to be valid, expiration date reported as 25-MAY-2021), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R020948 was verified to be valid, expiration date reported as 04-MAY-2021), hepatitis a vaccine, inactivated (VAQTA) (lot # S005723 was verified to be valid, expiration date reported as 10-JUL-2020) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1676332 was determined to be not valid, expiration date reported as 04-MAY-2021); (vaccination regimen, route of administration, and anatomical location were not reported for all the vaccines) all administered as prophylaxis (product storage error).   The vaccine was stored in temperature above 47 degrees Fahrenheit (F) (71°F) for a time frame of 596 hours and 35 minutes. There was no previous temperature excursion. The call was due to a data-logger. No adverse effect reported.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Pain, Peripheral swelling
Clinical narrative: Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Chills; Fatigue; Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Long grade fever; This spontaneous report was received from a Registered Nurse and refers to a 64-year-old female patient. Information about the patient's medical history, concurrent conditions, or concomitant medications was not provided.   On an unspecified date, the patient had received an initial dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 23 for prophylaxis (dose, route of administration, lot number, and expiration date were not reported).   On 21-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at 0.5 mL dose, intramuscularly, which had a lot # T009744 with expiration date on 28-JAN-2022 (anatomical location of administration was not reported) for the prevention of pneumococcal disease.   After vaccination, the patient contacted the registered nurse to report that, on approximately 21-AUG-2020, her arm was red, hot, and swollen from elbow to collarbone.  was painful to touch and to move.  The patient also reported having a low-grade fever, chills, and fatigue.  It was mentioned that all the symptoms lasted "48 hours after vaccine".  The patient did not seek medical attention or receive any treatment for the aforementioned symptoms.   At the time of the report, the patient was recovered.  The reporter did not provide the causality between the aforementioned events and vaccination with  Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2009USA002598:
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm, Tenderness
Clinical narrative: Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Chills; Fatigue; Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Arm is red, hot and swollen from elbow to collarbone. Painful to touch and to move; Long grade fever; This spontaneous report was received from a Registered Nurse and refers to a 64-year-old female patient. Information about the patient's medical history, concurrent conditions, or concomitant medications was not provided.   On an unspecified date, the patient had received an initial dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 23 for prophylaxis (dose, route of administration, lot number, and expiration date were not reported).   On 21-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) at 0.5 mL dose, intramuscularly, which had a lot # T009744 with expiration date on 28-JAN-2022 (anatomical location of administration was not reported) for the prevention of pneumococcal disease.   After vaccination, the patient contacted the registered nurse to report that, on approximately 21-AUG-2020, her arm was red, hot, and swollen from elbow to collarbone.  was painful to touch and to move.  The patient also reported having a low-grade fever, chills, and fatigue.  It was mentioned that all the symptoms lasted "48 hours after vaccine".  The patient did not seek medical attention or receive any treatment for the aforementioned symptoms.   At the time of the report, the patient was recovered.  The reporter did not provide the causality between the aforementioned events and vaccination with  Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2009USA002598:
Age: 24.0
Sex: U
Vaccine: HPV9, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; improperly stored vaccine administered to patient; This spontaneous report was received from a Licensed Practical Nurse, referring to a 24 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies or reactions was not provided.      On 18-AUG-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter (ml) as prophylaxis (dosage regimen, route of administration, and anatomical location were not reported; and lot number S008151 and expiration date 20-NOV-2021, which have been verified to be valid) and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml as prophylaxis (dosage regimen, route of administration, and anatomical location were not reported; and lot number T009744 and expiration date 28-JAN-2022, which have been verified to be valid) (product storage error). No additional adverse event details available.      The temperature excursion reported was 48.39 degrees fahrenheit (F), with a time frame of 1 hour and 45 minutes. No previous temperature excursion. A data logger was used.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On or about 16-JAN-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a pharmacist. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for herpes zoster. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt has and would continue to suffer 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 would continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Immune system disorder, Inflammation
Clinical narrative: zoster related immune inflammatory disease; zoster related immune inflammatory disease; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On or about 11-DEC-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a pharmacist. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for zoster related immune inflammatory disease. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt has and would continue to suffer 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 would continue to suffer such losses, and damages in the future. The outcome of the events was unknown. The causality was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer an adult patient of unknown gender regarding a case in litigation. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 28-MAR-2011, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, route and lot # were not provided) at a medical center for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unknown date, the patient was treated by a provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX): herpes zoster. At the time of the report, the patient's outcome was unknown.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HPV9
Symptoms: Syringe issue, Underdose
Clinical narrative: the syringe was leaking during administration of vaccine; the syringe was leaking during administration of vaccine / nurse requests information on revaccination; This spontaneous report was received from a nurse referring to a 13-year-old patient (gender not reported). The patient's concurrent conditions, pertinent medical history, drug reactions/allergies or concomitant therapies were not reported.  On 08-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1637651, expiration date 09-JUN-2022, 0.5 milliliter as prophylaxis (dose number, route of administration, anatomical vaccination site, and frequency were not reported). On that same day, while administrating the vaccine, the syringe was leaking (incorrect dose administered); it appeared to be leaking from the tip of the syringe, where the needle was attached, but the needle was securely fastened to the syringe (syringe issue). The nurse requested information on revaccination due to this situation. It was reported that needle was securely attached to the syringe, and the leakage was noticed while the plunger was being pushed forward during the administration. The syringe was discarded after its use.  The outcome of syringe issue and incorrect dose administered was unknown. 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry: ; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: He never went back to get the other two doses; He stated that there was no complications/No further adverse events or product complaints reported; This spontaneous report was received from a consumer regarding his son, a 21-year-old male patient. The patient's pertinent medical history, concurrent condition, concomitant medications, drug reactions and allergies were not reported.   On 02-JUN-2016, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis.  The reporter had a question regarding the vaccine dosing schedule and stated that his son never went back to get the other two doses (inappropriate schedule of product administration). There were no complications and no further adverse events, or product complaints reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant regarding a 12-month old patient of unknown gender. The patient's pertinent medical history, concurrent condition, concomitant medications, drug reactions and allergies were not reported.   On 17-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (vaccination regimen, route of administration, and anatomical location were not reported; lot # S012037 was verified to be valid, expiration date reported as 17-APR-2021) as prophylaxis (product storage error).   It was reported that the vaccine was stored in temperature of 5 degrees Celsius (reported as 5c) for a time frame of 12 hours.  The previous temperature excursion was at 8.4 degrees Fahrenheit (8.4°F) for a time frame of 60 hours. The call was due to a data-logger.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant concerning a 5-year-old male patient. The patient's past drug and pertinent medical history, as well as his concomitant medications and drug reaction or allergies, were not provided.  On 18-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHA), via subcutaneous as prophylaxis (reported as "well check") (concentration, frequency of vaccination scheme, and anatomical location of vaccination were not reported; lot number T005406 has been verified to be a valid lot number, expiration date reported and validated as 12-AUG-2021 (product storage error).The diluent used for reconstitution was properly stored.   The vaccine underwent a temperature excursion from -9 to 8 degrees Celsius (-6.1 degrees Celsius) for 13 hours, and between -14 to -10 degrees Celsius for 116 hours, as recorded by the data logger. There were no other temperature excursions previously.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Additional adverse reaction; Varivax and proquad the same day; This spontaneous report as received from a pharmacist refers to a 1 year old patient of unknow gender. Medical history, concurrent conditionss, and concomitant medication were not reported.  On 10-SEP-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis (Route, anatomical location, dose, lot number, and expiration date were not provided.)  The patient  did not excperienced additional adverse reaction.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No further AE/PQC reported.; received a dose of GARDASIL 9 too soon. Caller reports that the patient received the first dose of GARDASIL 9 on 27 Aug 2020 and the secood dose 10 Sep 2020; This spontaneous report as received from an office manager refers to a 24-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 27-AUG-2020, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, intramuscularly (lot number and expiration date were not provided); on 10-SEP-2020 (also reported as too soon), she received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, intramuscularly (lot number and expiration date were not provided), both as prophylaxis. No adverse effect was reported.
Age: 1.17
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine was administered to a consumer; This spontaneous report has been received from a nurse concerning a 14-month-old patient of unknown gender and ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On 14-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) (lot # S005249 with expiration date on 20-FEB-2020; dosage regimen and route of administration not reported) for prophylaxis; that had been exposed to a temperature excursion above 47 degree farenheit (F): 48.38F for 55 minutes and 54.32F for 7 hours and 14 minutes (no previous temperature excursions). Excursion was called by a digital data logger.
Sex: U
Vaccine: DTAP, DTAP
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Inappropriate schedule of product administration, Pharyngeal swelling
Clinical narrative: anaphylactic reaction; coughing; sneezing; swollen throat; couldn't breath; first dose of DTap (Infanrix) in 2013, the second dose in 2016 and the third dose in 2017; first dose of DTap (Infanrix) in 2013, the second dose in 2016 and the third dose in 2017; This case was reported by a physician via other manufacturer and described the occurrence of anaphylactic reaction in a patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   Previously administered products included Infanrix (received 1st dose in 2013).   On an unknown date, the patient received the 2nd dose of Infanrix and the 3rd dose of Infanrix. On an unknown date, not applicable after receiving Infanrix and unknown after receiving Infanrix, the patient experienced anaphylactic reaction (serious criteria hospitalization and GSK medically significant), cough (serious criteria hospitalization), sneezing (serious criteria hospitalization), throat swelling (serious criteria hospitalization), difficulty breathing (serious criteria hospitalization), drug dose administration interval too long and drug dose administration interval too long. On an unknown date, the outcome of the anaphylactic reaction, cough, sneezing, throat swelling, difficulty breathing, drug dose administration interval too long and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the anaphylactic reaction, cough, sneezing, throat swelling and difficulty breathing to be related to Infanrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose in 2016, which led to lengthening of vaccination schedule. The patient received 3rd dose in 2017, which led to lengthening of vaccination schedule.  The patient experienced anaphylactic reaction. The patient went to urgent care by ambulance to the hospital. The patient experienced coughing and sneezing and swollen throat and could not breath. No additional information was reported.
Sex: U
Vaccine: DTAP, DTAP
Symptoms: Sneezing
Clinical narrative: anaphylactic reaction; coughing; sneezing; swollen throat; couldn't breath; first dose of DTap (Infanrix) in 2013, the second dose in 2016 and the third dose in 2017; first dose of DTap (Infanrix) in 2013, the second dose in 2016 and the third dose in 2017; This case was reported by a physician via other manufacturer and described the occurrence of anaphylactic reaction in a patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   Previously administered products included Infanrix (received 1st dose in 2013).   On an unknown date, the patient received the 2nd dose of Infanrix and the 3rd dose of Infanrix. On an unknown date, not applicable after receiving Infanrix and unknown after receiving Infanrix, the patient experienced anaphylactic reaction (serious criteria hospitalization and GSK medically significant), cough (serious criteria hospitalization), sneezing (serious criteria hospitalization), throat swelling (serious criteria hospitalization), difficulty breathing (serious criteria hospitalization), drug dose administration interval too long and drug dose administration interval too long. On an unknown date, the outcome of the anaphylactic reaction, cough, sneezing, throat swelling, difficulty breathing, drug dose administration interval too long and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the anaphylactic reaction, cough, sneezing, throat swelling and difficulty breathing to be related to Infanrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose in 2016, which led to lengthening of vaccination schedule. The patient received 3rd dose in 2017, which led to lengthening of vaccination schedule.  The patient experienced anaphylactic reaction. The patient went to urgent care by ambulance to the hospital. The patient experienced coughing and sneezing and swollen throat and could not breath. No additional information was reported.
Age: 70.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: hives all over the body; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number B4527, expiry date 2nd May 2022) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   On 2nd September 2020, the patient received Shingrix and PNEUMOVAX. On 2nd September 2020, less than a day after receiving Shingrix, the patient experienced hives and rash. On an unknown date, the outcome of the hives and rash were not recovered/not resolved.   It was unknown if the reporter considered the hives and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and Neumovax both on same day and experienced hives all over the body and rash, not recovered at the moment they reported it. The reporter consented to follow up. It was unknown if the reporter considered the hives and rash to be related to PNEUMOVAX.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: arm swelling; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccine was not reported. The patient experienced arm swelling. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Condition aggravated, Diabetes mellitus, Injection site rash, Rash pruritic
Clinical narrative: itchy rash below the injection site; increase in her previously stable blood glucose levels; This case was reported by a consumer via call center representative and described the occurrence of diabetes mellitus aggravated in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RF5J, expiry date 25th April 2022) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 8th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2020, 24 hrs after receiving Shingrix, the patient experienced diabetes mellitus aggravated (serious criteria GSK medically significant) and injection site rash. In September 2020, the outcome of the diabetes mellitus aggravated was recovered/resolved. On an unknown date, the outcome of the injection site rash was recovering/resolving.   It was unknown if the reporter considered the diabetes mellitus aggravated and injection site rash to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's spouse. The patient had type 1 diabetes and experienced an increase in her previously stable blood glucose levels 24 hours after receiving the vaccine, blood sugar over 400, and this lasted for approximately 12 hours and resolved. The patient developed an itchy rash below the injection site after 24 hours, and this rash had improved but was still ongoing. The reporter consented to follow up. The batch number was updated from 4RFSJ to 4RF5J as per sales data sheet.