chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Balance disorder, Chills, Diplopia, Headache, Injection site erythema
Clinical narrative: nephropathy; imbalance issue; atraumatic acute optic nerve palsy; double vision; malaise; headache; fever; sore arm; sore at injection site; cough; sputum; This case was reported by a consumer via call center representative and described the occurrence of optic nerve injury in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2020, the patient received the 2nd dose of Shingrix. On 2nd February 2020, 1 days after receiving Shingrix, the patient experienced malaise, headache, fever, pain in arm and injection site pain. On 14th February 2020, the patient experienced optic nerve injury (serious criteria GSK medically significant) and double vision. On 15th February 2020, the patient experienced nephropathy and balance disorder. In February 2020, the patient experienced cough and sputum. On an unknown date, the outcome of the optic nerve injury, pain in arm, double vision and balance disorder were recovering/resolving and the outcome of the nephropathy was unknown and the outcome of the malaise, headache, fever, cough and sputum were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the optic nerve injury, nephropathy, malaise, headache, fever, pain in arm, double vision, balance disorder, cough, sputum and injection site pain to be related to Shingrix.  Additional details were provide as follows: This case was reported by the patient for herself. The patient received a dose of Shingrix on the left arm. A day after vaccination, the patient experienced general side effects of malaise, headache, fever and sore arm. That day was the worst and the reactions lasted a few days before resolving, but the left arm was still sore at injection site. On 14th February 2020, the patient presented with double vision and on 15th February 2020, the patient had imbalance issues. On 18th February 2020, the patient was seen by an ophthalmologist and diagnosed with atraumatic acute optic nerve palsy on 3 and 6 in the right eye only. On 19th February 2020, the patient was seen by her neurologist and stroke, MS and myasthenia were ruled out. A test revealed that the imbalance was due to a nephropathy. During that same week that she was seen by her ophthalmologist  and neurologist, she developed a cough and sputum and was prescribed prednisone and a z-pack. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Laboratory test, Magnetic resonance imaging normal, Malaise
Clinical narrative: nephropathy; imbalance issue; atraumatic acute optic nerve palsy; double vision; malaise; headache; fever; sore arm; sore at injection site; cough; sputum; This case was reported by a consumer via call center representative and described the occurrence of optic nerve injury in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2020, the patient received the 2nd dose of Shingrix. On 2nd February 2020, 1 days after receiving Shingrix, the patient experienced malaise, headache, fever, pain in arm and injection site pain. On 14th February 2020, the patient experienced optic nerve injury (serious criteria GSK medically significant) and double vision. On 15th February 2020, the patient experienced nephropathy and balance disorder. In February 2020, the patient experienced cough and sputum. On an unknown date, the outcome of the optic nerve injury, pain in arm, double vision and balance disorder were recovering/resolving and the outcome of the nephropathy was unknown and the outcome of the malaise, headache, fever, cough and sputum were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the optic nerve injury, nephropathy, malaise, headache, fever, pain in arm, double vision, balance disorder, cough, sputum and injection site pain to be related to Shingrix.  Additional details were provide as follows: This case was reported by the patient for herself. The patient received a dose of Shingrix on the left arm. A day after vaccination, the patient experienced general side effects of malaise, headache, fever and sore arm. That day was the worst and the reactions lasted a few days before resolving, but the left arm was still sore at injection site. On 14th February 2020, the patient presented with double vision and on 15th February 2020, the patient had imbalance issues. On 18th February 2020, the patient was seen by an ophthalmologist and diagnosed with atraumatic acute optic nerve palsy on 3 and 6 in the right eye only. On 19th February 2020, the patient was seen by her neurologist and stroke, MS and myasthenia were ruled out. A test revealed that the imbalance was due to a nephropathy. During that same week that she was seen by her ophthalmologist  and neurologist, she developed a cough and sputum and was prescribed prednisone and a z-pack. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: nephropathy; imbalance issue; atraumatic acute optic nerve palsy; double vision; malaise; headache; fever; sore arm; sore at injection site; cough; sputum; This case was reported by a consumer via call center representative and described the occurrence of optic nerve injury in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2020, the patient received the 2nd dose of Shingrix. On 2nd February 2020, 1 days after receiving Shingrix, the patient experienced malaise, headache, fever, pain in arm and injection site pain. On 14th February 2020, the patient experienced optic nerve injury (serious criteria GSK medically significant) and double vision. On 15th February 2020, the patient experienced nephropathy and balance disorder. In February 2020, the patient experienced cough and sputum. On an unknown date, the outcome of the optic nerve injury, pain in arm, double vision and balance disorder were recovering/resolving and the outcome of the nephropathy was unknown and the outcome of the malaise, headache, fever, cough and sputum were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the optic nerve injury, nephropathy, malaise, headache, fever, pain in arm, double vision, balance disorder, cough, sputum and injection site pain to be related to Shingrix.  Additional details were provide as follows: This case was reported by the patient for herself. The patient received a dose of Shingrix on the left arm. A day after vaccination, the patient experienced general side effects of malaise, headache, fever and sore arm. That day was the worst and the reactions lasted a few days before resolving, but the left arm was still sore at injection site. On 14th February 2020, the patient presented with double vision and on 15th February 2020, the patient had imbalance issues. On 18th February 2020, the patient was seen by an ophthalmologist and diagnosed with atraumatic acute optic nerve palsy on 3 and 6 in the right eye only. On 19th February 2020, the patient was seen by her neurologist and stroke, MS and myasthenia were ruled out. A test revealed that the imbalance was due to a nephropathy. During that same week that she was seen by her ophthalmologist  and neurologist, she developed a cough and sputum and was prescribed prednisone and a z-pack. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Headache; Cold; Exhausted; This case was reported by a consumer via call center representative and described the occurrence of headache in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix, the patient experienced headache, cold and exhaustion. On an unknown date, the outcome of the headache, cold and exhaustion were recovering/resolving.   It was unknown if the reporter considered the headache, cold and exhaustion to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of the Shingrix vaccine on 25th February 2020 at 2:00 PM and next morning he had a headache, felt cold, and was feeling exhausted. The patient could not went into work today. The follow up consent was granted
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling cold, Headache
Clinical narrative: Headache; Cold; Exhausted; This case was reported by a consumer via call center representative and described the occurrence of headache in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix, the patient experienced headache, cold and exhaustion. On an unknown date, the outcome of the headache, cold and exhaustion were recovering/resolving.   It was unknown if the reporter considered the headache, cold and exhaustion to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of the Shingrix vaccine on 25th February 2020 at 2:00 PM and next morning he had a headache, felt cold, and was feeling exhausted. The patient could not went into work today. The follow up consent was granted
Age: 0.08
Sex: U
Vaccine: HPV9, HPV9, UNK, HPV9
Symptoms: Crying, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: No additional adverse effect reported; a patient less than 9 years of age (as indicated per PI) was administered a dose of GARDASIL 9; This spontaneous report was received from a nurse referring to a 4-week-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On 12-MAR-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1621931 with expiration date 26-JAN-2022; dose detail and frequency were not reported) intramuscularly in the left vastus lateralis for prophylaxis (product administered to patient of inappropriate age). No additional adverse effect was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-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 meet the criteria for Reportability
Age: 0.08
Sex: U
Vaccine: HPV9, HPV9, UNK, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effect reported; a patient less than 9 years of age (as indicated per PI) was administered a dose of GARDASIL 9; This spontaneous report was received from a nurse referring to a 4-week-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On 12-MAR-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1621931 with expiration date 26-JAN-2022; dose detail and frequency were not reported) intramuscularly in the left vastus lateralis for prophylaxis (product administered to patient of inappropriate age). No additional adverse effect was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-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 meet the criteria for Reportability
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 13-SEP-2019, the patients were inadvertently administered improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R026541 with expiration date 11-JUL-2020 and lot # R029814 with expiration date 05-JUN-2020 (exact dose, injection site and route of administration were not reported) both for prophylaxis. Administered doses of vaccine experienced the temperature excursion of 51.62 degrees Fahrenheit for 10 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  The case is non-valid due to lack of patients' identifiers.  Upon receipt of follow-up information from medical assistant on 24-MAR-2020, the case now becomes valid as distinct patient identifiers were provided.   This case is regarding a 5-month-old female patient. On an unknown date in June 2019, the patient was vaccinated with a first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route, anatomical location, lot/batch # and expiry date were not reported). The patient's second dose was scheduled in August 2019 but the patient was vaccinated late with second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route, anatomical location were not reported) (lot # R026541 with expiry date: 11-JUL-2020) on 13-SEP-2019. On 17-OCT-2019, the patient was vaccinated with another dose (captured as third dose) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541).  This is one of the several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a registered nurse concerning to patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 23-DEC-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (dose, frequency, lot # and expiration date were not provided) for prophylaxis. On 24-FEB-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose (unspecified), orally (frequency not provided; lot # 1660112, expiration date 18-OCT-2020), for prophylaxis. The temperature excursion was called by the digital data logger. There were multiple temperature excursions below 2 degrees Celsius (1.28 degrees Celsius) for a time frame of 2 hours and 30 minutes (reported as hours). No previous temperature excursions were reported. No additional adverse effects were reported.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2003USA005892: US-009507513-2003USA005842: US-009507513-2003USA005917:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; the patient received one improperly stored dose of V ARIV AX; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information regarding patient's medical history, concomitant medications and concurrent conditions was provided. On 03-MAR-2020, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S028920, expiration date 19-SEP-2021 for prophylaxis (route of administration, dose and frequency were not reported). The vaccine was reconstituted with a properly stored sterile diluent. Digital Data logger was involved. The vaccine was stored at the temperature reported as from 6 to 14 degrees of Fahrenheit (F) (5.69 degrees of F), the time frame as 1 second. There was a previous temperature excursion: reported as from 6 to 14 degrees of F (5.81 degrees of F) for 28 minutes.  No adverse effect reported. This is one of two reports received from the same reporter and concerning the same suspect therapy and the same event.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: one patient was administered improperly stored PROQUAD; No adverse event; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 18-MAR-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) injection, lot number: S022913, expiration date: 19-JAN-2021 for prophylaxis (exact dose and route of administration were not provided) reconstituted with properly stored sterile diluent. No additional adverse effects were reported.   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) experienced temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit and 12 degree Fahrenheit for 3 hours and 59 minutes. The previous temperature excursion was 6 degree Fahrenheit to 14 degree Fahrenheit and 9 degree Fahrenheit for 8 hours and 51 minutes. The digital data logger was involved.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 60 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In March 2007, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for prophylaxis. In 2007, the patient suffered shingles, including any and all of its sequelae and had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of the event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: PPV
Symptoms: Aortic valve incompetence, Aortic valve replacement, Cardiac murmur, Diabetes mellitus, Knee arthroplasty
Clinical narrative: diagnosis of diabetes.; having a heart murmur; right knee replacement; aortic valve stopped working, the valve was replaced with a bovine valve; having stents put in in 2000; This spontaneous report was received from a currently 91 years old female patient referring to herself. The patient's pertinent medical history included rheumatic fever as a child. The patient's concomitant medication and drug reactions/allergies was not reported.     On an unknown date (reported as long ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia vaccine) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.         On an unknown date, the patient was having a heart murmur, having stents put in in 2000, as well as right knee replacement, during which her aortic valve stopped working, the valve was replaced with a bovine valve; diagnosed of diabetes. The outcome of the events was unknown. The causality assessment was not reported.     Upon internal review, diabetes was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Stent placement
Clinical narrative: diagnosis of diabetes.; having a heart murmur; right knee replacement; aortic valve stopped working, the valve was replaced with a bovine valve; having stents put in in 2000; This spontaneous report was received from a currently 91 years old female patient referring to herself. The patient's pertinent medical history included rheumatic fever as a child. The patient's concomitant medication and drug reactions/allergies was not reported.     On an unknown date (reported as long ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia vaccine) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.         On an unknown date, the patient was having a heart murmur, having stents put in in 2000, as well as right knee replacement, during which her aortic valve stopped working, the valve was replaced with a bovine valve; diagnosed of diabetes. The outcome of the events was unknown. The causality assessment was not reported.     Upon internal review, diabetes was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; an improperly stored PROQUAD was administered to a patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 23-MAR-2020, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (strength, dose detail and route were unknown; lot # S023652 and expiration date 26-JAN-2021) for prophylaxis. The vaccine was exposed to temperature excursion at minus 12.15 degrees Celsius for 3 hours (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effects were reported.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 6-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 17-SEP-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 4-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 17-SEP-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 4-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 19-SEP-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 6-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 23-SEP-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 4-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 25-SEP-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 2-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 30-SEP-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.67
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to an 8-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 03-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 2-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 04-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 6-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 08-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 2-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 09-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 6-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 15-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 6-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 17-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R029814 with expiration date 05-JUN-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 5-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 17-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R029814 with expiration date 05-JUN-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 2-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 17-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R029814 with expiration date 05-JUN-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 4-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 21-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R029814 with expiration date 05-JUN-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper
Clinical narrative: Severe stomach cramping; This case was reported by a consumer via call center representative and described the occurrence of stomach cramps in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th February 2020, the patient received the 1st dose of Shingrix. On 3rd March 2020, 3 days after receiving Shingrix, the patient experienced stomach cramps. On 5th March 2020, the outcome of the stomach cramps was recovered/resolved.   It was unknown if the reporter considered the stomach cramps to be related to Shingrix.  Additional information was provided as follows: The patient received first Shingrix vaccine on saturday and had some severe stomach cramping on tuesday and wednesday.  The patient felt fine at the time of reporting so far and was wondering if these symptoms could be related to the vaccine
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Pain, Rash, Vaccination failure
Clinical narrative: shingles rash on the right side near the backbone; shingles rash on the right side near the backbone; she has been taking acetaminophen for the pain; she has been taking acetaminophen for the pain; she received the first dose of the Shingrix and received second dose of the Shingrix vaccine in her left arm on 03/12/2019; This case was reported by a consumer and described the occurrence of vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (herpes near her nose and using the acyclovir topical formulation prescribed to treat that shingles.).   On 22nd June 2018, the patient received the 1st dose of Shingrix. On 12th March 2019, the patient received the 2nd dose of Shingrix. In March 2020, not applicable after receiving Shingrix, unknown after receiving Shingrix and an unknown time after starting Zovirax and Acetaminophen, the patient experienced drug dose administration interval too long. On 17th March 2020, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. The patient was treated with acyclovir (Zovirax) and paracetamol (Acetaminophen). On an unknown date, the outcome of the vaccination failure, shingles, rash, pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient received the 2nd dose of the Shingrix vaccine on 12th March 2019 and 1st vaccine on 22nd June 2018, later than the recommended schedule, which led to lengthening of the vaccination schedule. The patient experienced shingles rash on the right side near the backbone on 17th March, two days before date of reporting. She had been applying acyclovir topically and taking acetaminophen for the pain.  She had not been seen her doctor yet and as she was hesitant to go and see her doctor because of the Covid-19 incidences in her area.  She had shingles with no blister but just a rash with severe pain. The reporter contented to follow up with HCP. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: pale red blotchy; poking at the injection site; the site turned red; the injection site became hot to touch; half moon shape swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shoulder arthritis.   On 21st February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site warmth and swelling. On 21st February 2020, the patient experienced injection site erythema. On 29th February 2020, the patient experienced injection site reaction. On 1st March 2020, the patient experienced injection site rash. On 1st March 2020, the outcome of the injection site reaction was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site rash were recovering/resolving and the outcome of the swelling was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, swelling, injection site reaction and injection site rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received vaccine in her left arm and that same day the site turned red, a two to three inches perfectly round red area. The reaction got worse for the next seven days, the injection site became hot to touch, and developed a half moon shape swelling half inch belowthe red area. On 28 and 29th February 2020, the reaction was at its worse. On 29th February 2020, 8 days after vaccination, the patient also started feeling something poking inside and out at the injection site, it occurred like a wave, intermittently throughout the night but resolved the next day. On 1st March 2020, 9 days after vaccination, the site was pale red blotchy looking, and the half-moon swelling has resolved. The patient received steroid injections on left shoulder. The reporter consented to follow up. Provided caller with side effects information from PI. Referred caller to her physician regarding taking over the counter medication before taking her second Shingrix injections.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash macular
Clinical narrative: pale red blotchy; poking at the injection site; the site turned red; the injection site became hot to touch; half moon shape swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shoulder arthritis.   On 21st February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site warmth and swelling. On 21st February 2020, the patient experienced injection site erythema. On 29th February 2020, the patient experienced injection site reaction. On 1st March 2020, the patient experienced injection site rash. On 1st March 2020, the outcome of the injection site reaction was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site rash were recovering/resolving and the outcome of the swelling was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, swelling, injection site reaction and injection site rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received vaccine in her left arm and that same day the site turned red, a two to three inches perfectly round red area. The reaction got worse for the next seven days, the injection site became hot to touch, and developed a half moon shape swelling half inch belowthe red area. On 28 and 29th February 2020, the reaction was at its worse. On 29th February 2020, 8 days after vaccination, the patient also started feeling something poking inside and out at the injection site, it occurred like a wave, intermittently throughout the night but resolved the next day. On 1st March 2020, 9 days after vaccination, the site was pale red blotchy looking, and the half-moon swelling has resolved. The patient received steroid injections on left shoulder. The reporter consented to follow up. Provided caller with side effects information from PI. Referred caller to her physician regarding taking over the counter medication before taking her second Shingrix injections.