chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; lhe patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, and allergies were not provided.  On 19-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, vaccination scheme, anatomical location of injection and route of administration were not reported; lot number S035100, which has been verified to be valid, expiration date reported and validated as 31-MAY-2021) as prophylaxis (product storage error). According to the reporter, the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored. The vaccine underwent a temperature excursion of 6 degrees Fahrenheit (F) to 14F for 20 minutes; and another temperature excursion of 15F to 46F (38.8F) for 30 minutes. It was reported that no previous temperature excursion was suffered, and the digital data logger was involved. No additional adverse effects information provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; one patient received one dose of improperly stored VARIVAX; This spontaneous report was received from a medical assisstant referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drug, concurrent conditions and drug reactions or allergies were not reported.     On 09-MAR-2020, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, subcutaneously administered (strength, dose, vaccination scheme and anatomical location were not provided), lot number S022756, which has been verified to be valid, expiration date reported and validated as 22-JUL-2021, as prophylaxis (product storage error); which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT).  The vaccine was exposed to a temperature of 5.7 degrees Fahrenheit (F) for a timeframe of 18 minutes. There was two previous temperature excursion, one of minus 13.3 degrees Celcius (C) and the other one of minus 13.2 degrees C, both for 18 minutes. Digital data logger was involved. No additional adverse effects were reported.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Flatulence, Haematochezia, Insomnia, Lethargy
Clinical narrative: her daughter began to experience "bloody stool".; her daughter began to experience "extreme lethargy"; her daughter began to experience "bad gas"; the patient "would not sleep on end"; her daughter began to experience "bad diarrhea"; This spontaneous report was received from a consumer (who was also the patient's parent), referring to a two-months-old female patient.   No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 26-AUG-2017, the patient received a first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (dose, lot number and expiration date were unknown by the reporter) as prophylaxis.  On 26-AUG-2017, within hours of the vaccination, the patient began to experienced extreme lethargy, bad diarrhea, bad gas (flatulence) and bloody stool (hematochezia); also, it was also reported that for about two weeks, the patient "would not sleep on end" (insomnia). The consumer reported that medical attention was sought; however, no treatment was given for the adverse events and no laboratory or studies were performed.  It was reported that two to three weeks after vaccination, the patient started to improve her symptoms, however, in approximately October 2017, the patient had a full recovery from lethargy, diarrhea, flatulence, insomnia and haematochezia. The reporter confirmed that the patient did not receive any more doses from the vaccine, after this first dose.   The causal relationship between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the aforementioned events, was not provided.   Upon internal review, hematochezia was determined to be medically significant.
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administered PROQUAD/concurrently with VARIVAX; No adverse effects; pediatric patient was inadvertently administered PROQUAD instead of M-M-R II concurrently with VARIVAX; This spontaneous report was received from a registered nurse and refers to a 15 month old male patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 20-MAY-2020, the patient was inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot S031495 and expiration date 07-OCT-2021, lot # confirmed to be non valid) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) concurrently with varicella virus vaccine live (oka/merck)(VARIVAX) (lot S012533 and expiration date 20-OCT-2020, lot# confirmed to be non valid). The suspect vaccines were administered for prophylaxis, dose, strength, and route of administration were not reported. The vaccines were reconstituted with properly stored sterile diluent.  No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; improperly stored VARIVAX was administered to patient on 5/5/2020; 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, drug reactions, and allergies were not provided.  On 05-MAY-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (vaccination scheme, anatomical location of injection and route of admininistration were not reported; lot number S012036, which has been verified to be valid, expiration date reported and validated as 17-APR-2021) as prophylaxis (product storage error). The vaccine underwent a temperature excursion of 48.2 degrees (scale not specified) for 4 hours. There was no previous temperature excursion, and a digital data logger was involved. No adverse effects reported.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Product storage error
Clinical narrative: Nurse reported the patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S032055 and expiration date 09-NOV-2020) as prophylaxis.    According to the reporter, the temperature excursion was 12.1 degrees Celsius for a time frame of 16 hours and 11 minutes on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032055; expirationdate: 09-NOV-2020; 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 meet the criteria for Reportability
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a registered nurse referring to a patient of unknown demographics. The patient's concurrent conditions and medical history was not repoted. There was no concomitant medication reported.   On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1660704, expiration date: 20-MAR-2021) oral for prophylaxis. It was reported that the vaccine had a temperature excursion of 12.1 celcius degrees for a time frame of 16 hours and 11 minutes. There was no previous temperature excursions. The call was because of a digital data logger.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; Nurse reported the patient was administered an improperly stored dose of VAQTA on 5/26/2020; Information has been received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA)  injection, for prophylaxis (lot number S020241 with expiration date in 23-AUG-2020 (strength, route of administration and anatomical location not reported).  The hepatitis a vaccine, inactivated (VAQTA) was stored at a temperature range of 12.1 degrees Celsius (°C) for the time frame of 16 hours and 11 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; 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
Sex: U
Vaccine: HEPA, UNK
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapies, drug allergies and concurrent condition were not provided.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S020241, expiration date 23-AUG-2020; dose detail, strength and route were not provided) for prophylaxis (product storage error). The temperature excursion included 12.1 Celsius degree for 16 hours and 11 minutes. There was no preciously temperature excursion. There was a data logger involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S020241; expirationdate: 23-AUG-2020; 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 meet the criteria for Reportability
Sex: U
Vaccine: HEPA, UNK
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapies, drug allergies and concurrent condition were not provided.  On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S032055, expiration date 09-NOV-2020; dose detail, strength and route were not provided) for prophylaxis (product storage error). The temperature excursion included 12.1 Celsius degree for 16 hours and 11 minutes. There was no preciously temperature excursion. There was a data logger involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity:  ; manufacturerstate: ; manufacturercountry:  devicelotnumber: S032055; expirationdate: 09-NOV-2020; 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 meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapies, drug allergies and concurrent condition were not provided.  On 22-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S020241, expiration date 23-AUG-2020; dose detail, strength and route were not provided) for prophylaxis (product storage error). The temperature excursion included 12.1 Celsius degree for 16 hours and 11 minutes. There was no preciously temperature excursion. There was a data logger involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020241; expirationdate: 23-AUG-2020; 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 meet the criteria for Reportability
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of Rotateq; This spontaneous report was received from a nurse and refers to 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 19-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) ( lot # S013890, expiry date: 14-FEB-2021; dose, dose number, route of administration were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes. There were no previous excursions related. Data logger was involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; the patient was administered an improperly stored dose of ROTATEQ on 5/22/2020; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 22-MAY-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, lot # S013890, expiration date 14-FEB-2021 (exact dose, strength, frequency, route of administration and indication were not reported). The vaccine was stored at the temperature of 12.1 (C) for 16 hours 11 minutes which was registered by the data logger. There was no previous temperature excursion occurred. No additional adverse event information was provided.
Age: 1.42
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additonal adverse event; The patient was inadvertently administered a dose of PROQUAD that was expired; This spontaneous report was received from the office manager concerning to a 17 months old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 20-MAY-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # R030804, expiration date 22-APR-2020 (dose, frequency and route were not provided) for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: The patient was administered an improperly stored dose of ROTATEQ; This spontaneous report as received from a registered nurse, and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  On 19-MAY-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1660941 expiration date 12-FEB-2021, oral for prophylaxis.  The rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was exposed to a temperature excursion of 12.1°C during 16 hours 11 minutes called by data logger. There was not previous temperature excursions
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: one patien was administered improperly stored VARIVAX; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug reactions or allergies were not reported.  On unknown date in May 2020, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (lot # S024369 has been verified to be a valid lot number, expiration date reported and validated as 16-AUG-2022 or lot # S032356 has been verified to be a valid lot number, expiration date reported and validated as 14-OCT-2021) (concentration, dose, frequency of vaccination scheme and route of administration, were not reported), that was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot #S016837 and expiration date 01-FEB-2022; los # S032591 and expiration date 16-AUG-2022; lot # T000495 and expiration date 03-JUN-2022). The reporter did not have the actual lot # used for either varicella virus vaccine live (Oka/Merck) (VARIVAX) or sterile diluent, so all lot # were included.  The vaccines underwent a temperature excursion in the range of -9 to -8 degrees Celsius (-7.18 degrees Celsius) for 30 hours as recorded by a data logger. There was a previous temperature excursion in the range of -14 to -10 degrees Celsius for 2 hours; -50 to -14.79 degrees Celsius for 1 hours.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot # S020241 with expiration date on 23-AUG-2020 (strength, dose, anatomical location or route of administration were not provided), for prophylaxis. The storage temperature of the vaccine was reported as 12.1 degrees Celsius (°C) for a time frame of 16 hours and 11 minutes. There was no previous temperature excursion. No product quality complaint (PQC) was involved. Digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; 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 meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Malaise, Myalgia
Clinical narrative: severe chills; HEADACHE; muscle aches; felt crappy for 2 days; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unspecified date, for tolerance see  case US2020AMR088575).   On 17th May 2020, the patient received the 2nd dose of Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced chills, headache, myalgia and malaise. On an unknown date, the outcome of the chills, headache, myalgia and malaise were unknown.   It was unknown if the reporter considered the chills, headache, myalgia and malaise to be related to Shingrix.  Additional details were provided as follows: The patient age group was not reported, however captured as adult as per vaccine indication. After receiving Shingrix, the patient had severe chills, headache and muscle ache. The patient was asked all these were also some of the symptoms as Covid-19, so how long do the side effects normally last. The patient felt crappy for 2 days, then felt better for about a day and a half, but an over the last 24 hours from the time of reporting, side effects had come back but much worse. The patient was hoping to get a Covid-19 test early next week of the reporting day, as the patient was not sure why he/she felt this way, Shingrix or Covid 19.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: mild headache; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In May 2020, unknown after receiving Shingrix, the patient experienced headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient age group was not reported, however captured as adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st booster dose of Shingrix. After receiving Shingrix, the patient experienced mild headache. The patient received 2nd dose on 17th May 2020 and experienced severe chills, headache and muscle ache and felt crappy for tolerance see case US2020AMR088575. The patient was hoping to get a Covid-19 test early next week, as the patient was not sure why he/she felt this way, Shingrix or Covid .
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Injury associated with device, Occupational exposure to product, Product complaint, Syringe issue
Clinical narrative: luer lock device was loose; Pharmaceutical product complaint; Needle stick with a contaminated needle; Occupational exposure while administering product; Exposure via skin contact; This case was reported by a nurse via call center representative and described the occurrence of accidental needle stick in a 44-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 459GT, expiry date 7th June 2020) for an unknown indication. This case was associated with a product complaint.   On 6th September 2019 10:00, the patient received the 1st dose of FluLaval Tetra 2019-2020 season .5 ml. On 6th September 2019, immediately after receiving FluLaval Tetra 2019-2020 season, the patient experienced accidental needle stick, occupational exposure while administering product and exposure via skin contact. On an unknown date, the patient experienced syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the accidental needle stick, occupational exposure while administering product, exposure via skin contact, syringe issue and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The reporter stated that, the nurse was preparing syringe for administration and noticed the luer lock device was loose so she tightened the luer lock. The luer lock was again loose and she tightened it again and then administered the vaccine to a customer and as she was going to release the needle for disposal, the needle landed on her wrist, which led to accidental needle stick, occupational exposure while administering product and exposure via skin contact, syringe issue and pharmaceutical product complaint. As per the description, the luer lock device was screwed on before screwing on the needle and also after screwing the needle on because the nurse realized that the luer lock was not tight.   The product with the needle was discarded and not available for retrieval. On the 6th September 2019, the second incident happen. the nurse was preparing the injection for administration and noticed the luer lock device was loose and she screwed it back on and then tip cup with the luer lock device detached off. There was no exposure with this incident. The tip cup was not taken off. The reporter stated that the product might be available for retrieval, the nurse was not sure. The reporter consented to follow up.   Follow up information received from QA department on 25th September 2019: The conclusion of the QA statement was received as follows: GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.   Upon error correction received the correction done on 29th May 2020: The classification exclude from pader was removed from the case. It was unknown if the reporter considered the accidental needle stick to be related to FluLaval Tetra 2019-2020 season.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Pyrexia
Clinical narrative: become cold; temperature which was recorded at 99.9 F / increased to 100.; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2020, the patient received the 2nd dose of Shingrix. In May 2020, 9 hrs after receiving Shingrix, the patient experienced feeling cold and fever. The patient was treated with analgesic, nos (Pain Reliever (Drug Name Unknown)). On an unknown date, the outcome of the feeling cold was unknown and the outcome of the fever was recovering/resolving.   It was unknown if the reporter considered the feeling cold and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix around 3 pm in right arm from a local pharmacy. At midnight, the patient started to become cold and grabbing a blanket. At that time, she also checked her temperature which was recorded at 99.9 Farhenite.  On 22nd May 2020, morning after waking, fever increased to 100.6, and the patient suspected this might be due to sleeping with the additional blanket.  The patient reported fever reduced back down to 99.9 F and had taken extra strength pain reliever for fever relief.  The patient made a doctor's appointment and due to symptoms office wants to see her to rule out Covid-19.  The patient mentioned not having a physician but had made an appointment due to fever. She might consent for follow up to be sent to physician she would see on the day of reporting.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: mild flu like symptoms; muscle aches; headache; bone pain; fever; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st February 2020, the patient received the 1st dose of Shingrix. On 22nd February 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, myalgia, headache, bone pain and fever. On 26th February 2020, the outcome of the influenza-like symptoms, myalgia, headache, bone pain and fever were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, myalgia, headache, bone pain and fever to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient started having mild flu like symptoms. He experienced muscle aches, headache, bone pain and fever.  On the second day, the symptoms became worse and lessened on third day. The symptoms resolved on the fourth day. The reporter did not consented to follow up.
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Cardiac failure congestive, Chills, Cough, Decreased appetite
Clinical narrative: NAUSEA; DIARRHEA; GENERALIZED WEAKNESS; DECREASED APPETITE; URINARY URGENCY; PAIN DURING URINATION; ELEVATED LIVER FUNCTION TESTS; COUGH; SLIGHT DYSPNEA ON EXERTION WHILE AMBULATING; CONGESTIVE HEART FAILURE; FEVER; CHILLS; BCG VACCINE INFECTION; POSSIBLE SEPSIS; URINARY TRACT INFECTION; PYELONEPHRITIS; Information has been downloaded from Agency (US-SP-2005-02386).  This spontaneous report was received from a health professional referring to a 68-year-old male patient. The patient's medical history included prostate transurethral resection. The patient's concomitant medication was not reported. The patient's concurrent conditions included bladder cancer, benign prostatic hypertrophy, ulcerative colitis, deep vein thrombosis and hypercholesterolemia.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # was reported as 'LOT UNK' (strength, formulation, anatomical location, expiration date and indication were not reported).   On 26-OCT-2005, the patient administered bcg vaccine (THERACYS) (intravesical route for bladder cancer, batch/lot # was C2180A) (intravesical route for bladder cancer, batch/lot# was C2180A) (formulation, strength, anatomical location and expiration date were not reported).   On 29-OCT-2005, the patient experienced fever (pyrexia), chills, possible sepsis (sepsis), bcg vaccine infection (disseminated bacillus calmette-guerin infection), pyelonephritis and urinary tract infection and on an unknown date, the patient was hospitalized due to the events.   On an unknown date, the patient experienced nausea, congestive heart failure, slight dyspnea on exertion while ambulating (dyspnoea exertional), cough, elevated liver function tests (hepatic enzyme increased), pain during urination (dysuria), urinary urgency (micturition urgency), decreased appetite, generalized weakness (asthenia) and diarrhea and the patient hospitalized due the events. The action taken with suspect therapies was not reported.  On an unknown date, the patient was recovered from pyrexia. The outcome of chills, dyspnoea exertional, cough, hepatic enzyme increased, sepsis, dysuria, micturition urgency, decreased appetite, generalized weakness, pyelonephritis, urinary tract infection and nausea was reported as unknown. At time of report, the patient was not recovered from the events diarrhoea, congestive heart failure and disseminated bacillus calmette-guerin infection.  The relatedness between all the events and the suspect therapies was not provided.  The Agency considered all the events to be medically significant.; Sender's Comments:  2005-02399:
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Disseminated Bacillus Calmette-Guerin infection, Dyspnoea exertional, Dysuria, Liver function test increased
Clinical narrative: NAUSEA; DIARRHEA; GENERALIZED WEAKNESS; DECREASED APPETITE; URINARY URGENCY; PAIN DURING URINATION; ELEVATED LIVER FUNCTION TESTS; COUGH; SLIGHT DYSPNEA ON EXERTION WHILE AMBULATING; CONGESTIVE HEART FAILURE; FEVER; CHILLS; BCG VACCINE INFECTION; POSSIBLE SEPSIS; URINARY TRACT INFECTION; PYELONEPHRITIS; Information has been downloaded from Agency (US-SP-2005-02386).  This spontaneous report was received from a health professional referring to a 68-year-old male patient. The patient's medical history included prostate transurethral resection. The patient's concomitant medication was not reported. The patient's concurrent conditions included bladder cancer, benign prostatic hypertrophy, ulcerative colitis, deep vein thrombosis and hypercholesterolemia.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # was reported as 'LOT UNK' (strength, formulation, anatomical location, expiration date and indication were not reported).   On 26-OCT-2005, the patient administered bcg vaccine (THERACYS) (intravesical route for bladder cancer, batch/lot # was C2180A) (intravesical route for bladder cancer, batch/lot# was C2180A) (formulation, strength, anatomical location and expiration date were not reported).   On 29-OCT-2005, the patient experienced fever (pyrexia), chills, possible sepsis (sepsis), bcg vaccine infection (disseminated bacillus calmette-guerin infection), pyelonephritis and urinary tract infection and on an unknown date, the patient was hospitalized due to the events.   On an unknown date, the patient experienced nausea, congestive heart failure, slight dyspnea on exertion while ambulating (dyspnoea exertional), cough, elevated liver function tests (hepatic enzyme increased), pain during urination (dysuria), urinary urgency (micturition urgency), decreased appetite, generalized weakness (asthenia) and diarrhea and the patient hospitalized due the events. The action taken with suspect therapies was not reported.  On an unknown date, the patient was recovered from pyrexia. The outcome of chills, dyspnoea exertional, cough, hepatic enzyme increased, sepsis, dysuria, micturition urgency, decreased appetite, generalized weakness, pyelonephritis, urinary tract infection and nausea was reported as unknown. At time of report, the patient was not recovered from the events diarrhoea, congestive heart failure and disseminated bacillus calmette-guerin infection.  The relatedness between all the events and the suspect therapies was not provided.  The Agency considered all the events to be medically significant.; Sender's Comments:  2005-02399:
Sex: M
Vaccine: PPV
Symptoms: Micturition urgency, Nausea, Pyelonephritis, Pyrexia, Urinary tract infection
Clinical narrative: NAUSEA; DIARRHEA; GENERALIZED WEAKNESS; DECREASED APPETITE; URINARY URGENCY; PAIN DURING URINATION; ELEVATED LIVER FUNCTION TESTS; COUGH; SLIGHT DYSPNEA ON EXERTION WHILE AMBULATING; CONGESTIVE HEART FAILURE; FEVER; CHILLS; BCG VACCINE INFECTION; POSSIBLE SEPSIS; URINARY TRACT INFECTION; PYELONEPHRITIS; Information has been downloaded from Agency (US-SP-2005-02386).  This spontaneous report was received from a health professional referring to a 68-year-old male patient. The patient's medical history included prostate transurethral resection. The patient's concomitant medication was not reported. The patient's concurrent conditions included bladder cancer, benign prostatic hypertrophy, ulcerative colitis, deep vein thrombosis and hypercholesterolemia.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # was reported as 'LOT UNK' (strength, formulation, anatomical location, expiration date and indication were not reported).   On 26-OCT-2005, the patient administered bcg vaccine (THERACYS) (intravesical route for bladder cancer, batch/lot # was C2180A) (intravesical route for bladder cancer, batch/lot# was C2180A) (formulation, strength, anatomical location and expiration date were not reported).   On 29-OCT-2005, the patient experienced fever (pyrexia), chills, possible sepsis (sepsis), bcg vaccine infection (disseminated bacillus calmette-guerin infection), pyelonephritis and urinary tract infection and on an unknown date, the patient was hospitalized due to the events.   On an unknown date, the patient experienced nausea, congestive heart failure, slight dyspnea on exertion while ambulating (dyspnoea exertional), cough, elevated liver function tests (hepatic enzyme increased), pain during urination (dysuria), urinary urgency (micturition urgency), decreased appetite, generalized weakness (asthenia) and diarrhea and the patient hospitalized due the events. The action taken with suspect therapies was not reported.  On an unknown date, the patient was recovered from pyrexia. The outcome of chills, dyspnoea exertional, cough, hepatic enzyme increased, sepsis, dysuria, micturition urgency, decreased appetite, generalized weakness, pyelonephritis, urinary tract infection and nausea was reported as unknown. At time of report, the patient was not recovered from the events diarrhoea, congestive heart failure and disseminated bacillus calmette-guerin infection.  The relatedness between all the events and the suspect therapies was not provided.  The Agency considered all the events to be medically significant.; Sender's Comments:  2005-02399:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Flu like systems. Chills, fever, aches, headache, tired
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Flu like systems. Chills, fever, aches, headache, tired
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: ... blood pressure has been 130/90 with weight at 140lbs even taking 10mg amlodipine... lost weight, down to 112lbs and BP must have been going down that a month ago, got dizzy, noticed BP was 90/60 so cut amlodipine down to 5mg and for a month BP stabilized at 100-100/70-75... until the flu vaccine -- that same night, felt dizzy - thought BP was low, turns out it was 140/100 and continued that until today... thought maybe it was from the BIOGESIC (antipyretic, antihistamine) taken 3 tablets as a prophylaxis... but even after biogesic was stopped BP will high - took benadryl tablet (not allergic since it's 1st generation anti-histamine), drops down to 120/80 but goes back up again afterwards
Age: 75.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to have received a regular tetanus vaccine, we use Tenivac, but the MA gave the patient the Kinrix vaccine instead. No adverse reaction just wrong vaccine received.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; a 19 year old received a pediatric dose of VAQTA; This spontaneous report was received from a nurse prescriber via a company representative referring to a 19 year old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug allergies/reactions were not reported. On 24-SEP-2019, the patient received a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (strength, dose details, lot #, expiration date, route and anatomical location were not provided) for prophylaxis (product administered to patient of inappropriate age). No known adverse effects (no adverse event) were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: fever as high as 101.; I feel like a truck ran over me; felt like a truck was ran over; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st May 2020, the patient received Shingles vaccine. On 22nd May 2020, 1 days after receiving Shingles vaccine, the patient experienced fever, general body pain and feeling abnormal. On an unknown date, the outcome of the fever, general body pain and feeling abnormal were unknown.   It was unknown if the reporter considered the fever, general body pain and feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. On 22nd May 2020, the patient felt like a truck was ran over the patient.  The patient's body temperature was recorded as 101 degree F and 99 degree F. the patient was asked was this unusual after vaccine nation.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Blood test, Chills, Computerised tomogram
Clinical narrative: pain has moved to abdominal area; Diarrhea; Upper back pain; Chills; Nausea; Vomiting; Fatigue; Sweats; This case was reported by a consumer via call center representative and described the occurrence of chills in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in November of 2019, experienced tiredness, refer case US2020AMR087932).   On 1st March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st March 2020, immediately after receiving Shingrix, the patient experienced chills, nausea, vomiting, fatigue and sweating. On 6th March 2020, the patient experienced upper back pain. On an unknown date, the patient experienced abdominal pain and diarrhea. On an unknown date, the outcome of the chills, nausea, vomiting, upper back pain, abdominal pain, diarrhea, fatigue and sweating were unknown.   It was unknown if the reporter considered the chills, nausea, vomiting, upper back pain, abdominal pain, diarrhea, fatigue and sweating to be related to Shingrix.  Additional details were provided as follows: Immediately after getting the vaccine on right arm the patient experienced chills, nausea, vomiting, fatigue and sweats for 24 hours.  About 5 to 6 days after he developed pain in the upper portion of his back.  The patient went to see his physician for the upper back pain.  The back pain had moved to abdominal area.  The patient was also vomiting and had nausea at least once a week.  The patient was also experiencing diarrhea.  All of the side effects keep coming and going except the fatigue and pain the abdominal or back area which were constant.  No other details were provided.  Caller reporting adverse event for herself and her husband.  The reporter consented to follow up.  This case is 1 out of 4 cases reported by the same reporter.      Lab Comments: The patient had cat scan of chest and stomach.  The patient also had blood panel work to rule out fibroid, and any other effects on liver, kidneys and pancreas.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Hyperhidrosis, Immediate post-injection reaction, Injection site pain
Clinical narrative: pain has moved to abdominal area; Diarrhea; Upper back pain; Chills; Nausea; Vomiting; Fatigue; Sweats; This case was reported by a consumer via call center representative and described the occurrence of chills in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in November of 2019, experienced tiredness, refer case US2020AMR087932).   On 1st March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st March 2020, immediately after receiving Shingrix, the patient experienced chills, nausea, vomiting, fatigue and sweating. On 6th March 2020, the patient experienced upper back pain. On an unknown date, the patient experienced abdominal pain and diarrhea. On an unknown date, the outcome of the chills, nausea, vomiting, upper back pain, abdominal pain, diarrhea, fatigue and sweating were unknown.   It was unknown if the reporter considered the chills, nausea, vomiting, upper back pain, abdominal pain, diarrhea, fatigue and sweating to be related to Shingrix.  Additional details were provided as follows: Immediately after getting the vaccine on right arm the patient experienced chills, nausea, vomiting, fatigue and sweats for 24 hours.  About 5 to 6 days after he developed pain in the upper portion of his back.  The patient went to see his physician for the upper back pain.  The back pain had moved to abdominal area.  The patient was also vomiting and had nausea at least once a week.  The patient was also experiencing diarrhea.  All of the side effects keep coming and going except the fatigue and pain the abdominal or back area which were constant.  No other details were provided.  Caller reporting adverse event for herself and her husband.  The reporter consented to follow up.  This case is 1 out of 4 cases reported by the same reporter.      Lab Comments: The patient had cat scan of chest and stomach.  The patient also had blood panel work to rule out fibroid, and any other effects on liver, kidneys and pancreas.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: pain has moved to abdominal area; Diarrhea; Upper back pain; Chills; Nausea; Vomiting; Fatigue; Sweats; This case was reported by a consumer via call center representative and described the occurrence of chills in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in November of 2019, experienced tiredness, refer case US2020AMR087932).   On 1st March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st March 2020, immediately after receiving Shingrix, the patient experienced chills, nausea, vomiting, fatigue and sweating. On 6th March 2020, the patient experienced upper back pain. On an unknown date, the patient experienced abdominal pain and diarrhea. On an unknown date, the outcome of the chills, nausea, vomiting, upper back pain, abdominal pain, diarrhea, fatigue and sweating were unknown.   It was unknown if the reporter considered the chills, nausea, vomiting, upper back pain, abdominal pain, diarrhea, fatigue and sweating to be related to Shingrix.  Additional details were provided as follows: Immediately after getting the vaccine on right arm the patient experienced chills, nausea, vomiting, fatigue and sweats for 24 hours.  About 5 to 6 days after he developed pain in the upper portion of his back.  The patient went to see his physician for the upper back pain.  The back pain had moved to abdominal area.  The patient was also vomiting and had nausea at least once a week.  The patient was also experiencing diarrhea.  All of the side effects keep coming and going except the fatigue and pain the abdominal or back area which were constant.  No other details were provided.  Caller reporting adverse event for herself and her husband.  The reporter consented to follow up.  This case is 1 out of 4 cases reported by the same reporter.      Lab Comments: The patient had cat scan of chest and stomach.  The patient also had blood panel work to rule out fibroid, and any other effects on liver, kidneys and pancreas.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: soreness at injection site; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, between 5 and 7 months after receiving Shingrix, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were unknown.   It was unknown if the reporter considered the injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient experienced soreness at injection site and tiredness that lasted for couple days. Did not consent to follow-up. No other details were provided.  Caller reporting adverse event for herself and her husband.  This case is 1 out of 3 cases reported by the same reporter.