chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: None of the patients reported symptoms. No Additional AE's/PQC's were reported.; Improperly stored PEDVAXHIB has been administered to patients; This spontaneous report was received from a staff from an outpatient care, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  From 24-MAY-2021 to 25-MAY-2021, a temperature excursion occurred as haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T026067 has been verified to be a valid lot number, expiration date was reported as 01-APR-2023) was stored under 54.3 Fahrenheit (F) for 1 hour and 20 minutes, 55.0 F for 7 hours and 10 minutes and 56.8 F for 2 hours and 35 minutes. The temperature excursion was recorded by digital data logger. There was no previous temperature excursion. On 23-JUN-2021, the patient was vaccinated with the improperly stored vaccine (strength and route were not reported) 1 (unit not provided) for prophylaxis. The patient did not report symptoms. No additional adverse events (AE) or product quality complaints (PQC) were reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: None of the patients reported symptoms. No Additional AE's/PQC's were reported.; Improperly stored PEDVAXHIB has been administered to patients; This spontaneous report was received from a staff from an outpatient care, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  From 24-MAY-2021 to 25-MAY-2021, a temperature excursion occurred as haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T026067 has been verified to be a valid lot number, expiration date was reported as 01-APR-2023) was stored under 54.3 Fahrenheit (F) for 1 hour and 20 minutes, 55.0 F for 7 hours and 10 minutes and 56.8 F for 2 hours and 35 minutes. The temperature excursion was recorded by digital data logger. There was no previous temperature excursion. On 24-JUN-2021, the patient was vaccinated with the improperly stored vaccine (strength and route were not reported) 1 (unit not provided) for prophylaxis. The patient did not report symptoms. No additional adverse events (AE) or product quality complaints (PQC) were reported.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: not immune to RUBELLA; This spontaneous report was received from a female patient of unknown age referring to herself. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis.  The patient wanted to know if she could get just the rubella vaccine. She refused to answer any questions regarding why just the rubella vaccine was needed. She stated that she was immune to the mumps and measles but not rubella (onset date was not provided) so needing a booster vaccine. The outcome of the event was unknown. The causality assessment between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Product storage error
Clinical narrative: Product storage error; redness and swelling at the site of the injections; redness and swelling at the site of the injections; This spontaneous report was received from a physician, concerning  a 4 year old patient of unknown gender.The patient's pertinent medical history included 4 previous vaccinations with DIPHTHERIA VACCINE TOXOID (+) PERTUSSIS VACCINE ACELLULAR (+) TETANUS VACCINE TOXOID (TDAP) and 4 previous vaccinations with polio vaccine. The patient's concurrent conditions were not provided. The patient did not have any prior events with vaccinations and did not have any known allergies or drug reactions.  The patient's concomitant medications included an unspecified multivitamin.   On 29-JUN-2021, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis in the left arm lot #T024284 expiration date 15-JUL-2021 (strength, dose, frequency and route of administration were not provided). That day the patient also was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  also administered for prophylaxis in the right arm, lot #T006167 and expiration date 19-FEB-2022 (strength, dose, frequency and route of administration were not provided) and finally with the first dose diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) also administered in the left arm, lot #C5851AA and expiration date 25-MAR-2023 (strength, dose, frequency, indication and route of administration were not provided).  There was no illness at the time of vaccination and no vaccines were administered within 4 weeks.   The physician reported that the freezer was out of range for a two weeks period and the vaccine was administered on day 5 of a two weeks excursion which was equal to 120 hours that the vaccine was in the excursion.   The temperature excursion was at 24.9 F, no previous temperature excursion was reported.   The physician additionally informed that the temperature excursion resulted due to a malfunctioning of the data logger that was monitoring temperature but was not alerting the temperature excursion.   On an unspecified date, the patient experienced redness and swelling at the  site of the injections, the patient's mother informed the physician who told her that this was an usual post-vaccination reaction.   At the time of reporting the patient recovered from redness and swelling at the site of the injection.   The causal relationship between the vaccination with varicella virus vaccine live (oka/merck)(VARIVAX), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) and the adverse events was not provided by the reporting physician.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; PNEUMOVAX 23 that underwent a temperature excursion was administered; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 12-JUL-2021 the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) prefilled syringe (lot number T036820, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 01-JUL-2022) (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported), as prophylaxis (product storage error). The administered vaccine experienced a temperature excursion above 9°C (22.0C) for 44 hours 0 minutes and 0 seconds, as recorded by data logger. There was not a previous temperature excursion. No additional adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T036820; expirationdate: 01-JUL-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: no additional AE; an expired PNEUMOVAX23 was administered; Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 14-JUL-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot# S024808, expiry date 02-JUN-2021; route of administration were not reported) for prophylaxis. The product had not experienced any temperature excursions. No additional adverse event involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received their first dose of GARDASIL 9 at age 14 years; This spontaneous report has been received from a pharmacy technician referring to a 17-year-old female patient. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not provided.   On an unspecified date in 2017, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, vaccination scheme, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis.  The patient wanted to know about the recommendations for the vaccine dose scheme (inappropriate schedule of product administration).
Sex: U
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: It hurts way more than I thought it would, it's like getting the Gardasil shot; This spontaneous report was received from a patient of unknown age and gender concerning to itself. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, lot #, expiration date, route of administration, anatomical location not provided) for prophylaxis. During the administration of another unspecified medication, the reporter stated that hurt way more that it thought, stated that "it was like getting the quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) shot". The outcome of the pain associated to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) shot was unknown.  Causality assessment between pain and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, in 2017, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the vaccination, the patient was treated for shingles and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles and ill-defined disorder was not recovered. The reporter considered shingles and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus
Clinical narrative: itchy, painful blisters and was diagnosed with Herpes Zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not reported. On or around 21-FEB-2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered itchy, painful blisters and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), her symptoms resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was considered to be not recovered. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered to be disabling.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Nurse called to report a temperature excursion PROQUAD was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 20-JUL-2021 the patient was vaccinated with an improerly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 1 time dose, lot number T027294, expiration date 08-FEB-2022 (route of administration was not reported) for prophylaxis. No adverse event was reported.  The temperature excursion was of -12.6 degrees Celsius (°C) for 15 minutes. The vaccine has previous temperature excursions on unknown dates from -10°C to 8°C with an average of 3.3°Crs and 45 minutes and between -50°C and -15°C with an average of -15.1°C for 15 minutes. The call was due to digital data logger.
Sex: M
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: No additional AE details or PQC; second dose given in March 2019; 70 year old male patient who started GARDASIL 9; This spontaneous report as received from a pharmacy intern concerning a 70 year old male patient.    There was no information about the patient's medical history, concurrent conditions or concomitant medication.        In  November 2018,  the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported) and the second dose  of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No additional AE details or PQC.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered / temperature -0.03 C; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 14-JUL-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1621931, expiration date 26-JAN-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in a temperature of -0.03 degree Celsius (C) for 21 hours 30 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was reported.  This is one of several reports from the same reporter. 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: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered / temperature -0.03 C; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 29-JUN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1621931, expiration date 26-JAN-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in a temperature of -0.03 degree Celsius (C) for 21 hours 30 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was reported.  This is one of several reports from the same reporter. 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: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered / temperature -0.03 C; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 08-JUL-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1687290, expiration date 06-SEP-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in a temperature of -0.03 degree Celsius (C) for 21 hours 30 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was reported.  This is one of several reports from the same reporter. 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: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered / temperature -0.03 C; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 09-JUL-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1621931, expiration date 26-JAN-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in a temperature of -0.03 degree Celsius (C) for 21 hours 30 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was reported.  This is one of several reports from the same reporter. 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: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: patient was administered the vaccine in his left arm, and that was the arm he was complaining of pain and "warmness"; patient was administered the vaccine in his left arm, and that was the arm he was complaining of pain and "warmness"; This spontaneous report has been received from a medical assistant and refers to a 58-year-old male patient. The patient was allergic to penicillin, ipratropium, and dicloxacillin. The patient's medical history was not provided.   On 21-JUL-2021 in the morning, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T036820, expiration date of 01-JUL-2022, 0.5 milliliter, intramuscularly in the left arm for prophylaxis (routine immunization).  On the same date in the afternoon, he started complaining of left arm pain and "warmness". The patient went to the emergency room and was "advised if the pain and warmness got worse to come back". It was stated that the patient was administered the vaccine in his left arm, and that was the arm he was complaining of pain and "warmness". The patient received an unspecified treatment.   The outcome of the events was unknown. The causality was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T036820; expirationdate: 01-JUL-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; 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: VARZOS
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: Fatigue; Fever-like aches; knocked be out for about 24 hours each time with fatigue and fever-like aches. But I was better the next day; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced fatigue, pain and feeling unwell. On an unknown date, the outcome of the fatigue, pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fatigue, pain and feeling unwell to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination not reported. The patient got shingles vaccine this year. The patient reported it knocked the patient out for about 24 hours with fatigue and fever-like aches. But, the patient was better the next day. The patient further stated it was so much better than getting shingles and the patient was super grateful for the vaccine. For tolerance of 2nd dose of shingles vaccine, refer case US2021AMR156340.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156340:Same reporter,1 dose
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back disorder, Back pain, Clostridium difficile infection, Coccydynia
Clinical narrative: contracted c-diff; my female organs were shutting down; my heart was palpitating; my back gave out; had no feelings in my legs / my right foot still has no feelings; ears kept going in and out as in hearing; had nosebleeds never had a nosebleed in my life; my tailbone is killing me; feel like the back of my neck is broken; shoulders are very sore; shoulders are / in a lot of discomfort; the temples of my head hurt; This case was reported by a consumer via interactive digital media and described the occurrence of clostridioides difficile infection in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced clostridioides difficile infection (serious criteria hospitalization and GSK medically significant), vaginal discomfort (serious criteria hospitalization), palpitation (serious criteria hospitalization), back pain (serious criteria hospitalization), loss of sensation (serious criteria hospitalization), ear discomfort (serious criteria hospitalization), epistaxis (serious criteria hospitalization), coccydynia (serious criteria hospitalization), neck discomfort (serious criteria hospitalization), shoulder soreness (serious criteria hospitalization), shoulder discomfort (serious criteria hospitalization) and temporal headache (serious criteria hospitalization). On an unknown date, the outcome of the clostridioides difficile infection, vaginal discomfort, palpitation, back pain, loss of sensation, ear discomfort, epistaxis, coccydynia, neck discomfort, shoulder soreness, shoulder discomfort and temporal headache were unknown.   It was unknown if the reporter considered the clostridioides difficile infection, vaginal discomfort, palpitation, back pain, loss of sensation, ear discomfort, epistaxis, coccydynia, neck discomfort, shoulder soreness, shoulder discomfort and temporal headache to be related to Shingles vaccine.  Additional details were provided as follows: The report was the patient. The age at vaccination was not reported. The reporter stated that, within an hour after receiving Shingles vaccine her female organs were shutting down. Her heart was palpitating, her back gave out, the patient had no feelings in her legs, her right foot still had no feelings which the patient was getting it checked out in a couple days. The patient had an appointment, her ears kept going in and out as in hearing she had nosebleeds never had a nosebleed in her life. The patient's tailbone was killing her. The patient felt like the back of her neck was broken, her shoulders were very sore and in a lot of discomfort, the temples of the patient's head hurt. The patient had been hospitalized three times since the shot and also had contracted c-diff. The reporter stated that, the covid shots were nothing compared to this.
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Epistaxis, Female reproductive tract disorder, Headache, Hypoacusis
Clinical narrative: contracted c-diff; my female organs were shutting down; my heart was palpitating; my back gave out; had no feelings in my legs / my right foot still has no feelings; ears kept going in and out as in hearing; had nosebleeds never had a nosebleed in my life; my tailbone is killing me; feel like the back of my neck is broken; shoulders are very sore; shoulders are / in a lot of discomfort; the temples of my head hurt; This case was reported by a consumer via interactive digital media and described the occurrence of clostridioides difficile infection in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced clostridioides difficile infection (serious criteria hospitalization and GSK medically significant), vaginal discomfort (serious criteria hospitalization), palpitation (serious criteria hospitalization), back pain (serious criteria hospitalization), loss of sensation (serious criteria hospitalization), ear discomfort (serious criteria hospitalization), epistaxis (serious criteria hospitalization), coccydynia (serious criteria hospitalization), neck discomfort (serious criteria hospitalization), shoulder soreness (serious criteria hospitalization), shoulder discomfort (serious criteria hospitalization) and temporal headache (serious criteria hospitalization). On an unknown date, the outcome of the clostridioides difficile infection, vaginal discomfort, palpitation, back pain, loss of sensation, ear discomfort, epistaxis, coccydynia, neck discomfort, shoulder soreness, shoulder discomfort and temporal headache were unknown.   It was unknown if the reporter considered the clostridioides difficile infection, vaginal discomfort, palpitation, back pain, loss of sensation, ear discomfort, epistaxis, coccydynia, neck discomfort, shoulder soreness, shoulder discomfort and temporal headache to be related to Shingles vaccine.  Additional details were provided as follows: The report was the patient. The age at vaccination was not reported. The reporter stated that, within an hour after receiving Shingles vaccine her female organs were shutting down. Her heart was palpitating, her back gave out, the patient had no feelings in her legs, her right foot still had no feelings which the patient was getting it checked out in a couple days. The patient had an appointment, her ears kept going in and out as in hearing she had nosebleeds never had a nosebleed in her life. The patient's tailbone was killing her. The patient felt like the back of her neck was broken, her shoulders were very sore and in a lot of discomfort, the temples of the patient's head hurt. The patient had been hospitalized three times since the shot and also had contracted c-diff. The reporter stated that, the covid shots were nothing compared to this.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Musculoskeletal discomfort, Palpitations, Sensory loss, Vulvovaginal discomfort
Clinical narrative: contracted c-diff; my female organs were shutting down; my heart was palpitating; my back gave out; had no feelings in my legs / my right foot still has no feelings; ears kept going in and out as in hearing; had nosebleeds never had a nosebleed in my life; my tailbone is killing me; feel like the back of my neck is broken; shoulders are very sore; shoulders are / in a lot of discomfort; the temples of my head hurt; This case was reported by a consumer via interactive digital media and described the occurrence of clostridioides difficile infection in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced clostridioides difficile infection (serious criteria hospitalization and GSK medically significant), vaginal discomfort (serious criteria hospitalization), palpitation (serious criteria hospitalization), back pain (serious criteria hospitalization), loss of sensation (serious criteria hospitalization), ear discomfort (serious criteria hospitalization), epistaxis (serious criteria hospitalization), coccydynia (serious criteria hospitalization), neck discomfort (serious criteria hospitalization), shoulder soreness (serious criteria hospitalization), shoulder discomfort (serious criteria hospitalization) and temporal headache (serious criteria hospitalization). On an unknown date, the outcome of the clostridioides difficile infection, vaginal discomfort, palpitation, back pain, loss of sensation, ear discomfort, epistaxis, coccydynia, neck discomfort, shoulder soreness, shoulder discomfort and temporal headache were unknown.   It was unknown if the reporter considered the clostridioides difficile infection, vaginal discomfort, palpitation, back pain, loss of sensation, ear discomfort, epistaxis, coccydynia, neck discomfort, shoulder soreness, shoulder discomfort and temporal headache to be related to Shingles vaccine.  Additional details were provided as follows: The report was the patient. The age at vaccination was not reported. The reporter stated that, within an hour after receiving Shingles vaccine her female organs were shutting down. Her heart was palpitating, her back gave out, the patient had no feelings in her legs, her right foot still had no feelings which the patient was getting it checked out in a couple days. The patient had an appointment, her ears kept going in and out as in hearing she had nosebleeds never had a nosebleed in her life. The patient's tailbone was killing her. The patient felt like the back of her neck was broken, her shoulders were very sore and in a lot of discomfort, the temples of the patient's head hurt. The patient had been hospitalized three times since the shot and also had contracted c-diff. The reporter stated that, the covid shots were nothing compared to this.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Incomplete course of vaccination
Clinical narrative: allergic reaction; dr.said don't take second shot / won't get anywhere near it; This case was reported by a consumer via media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced allergic reaction and incomplete course of vaccination. On an unknown date, the outcome of the allergic reaction and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received the first dose of Shingrix a couple of years ago. The patient had developed allergic reaction. The doctor asked the patient to not take the second shot and the patient reported that he/ she won't get anywhere near it. Till the time of reporting, the patient had not received the second dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have two vacs and still got them again/Suspected Vaccination failure; got them again; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received two doses of shingles vaccine and still got shingles again. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received / first dose / in 2020 / 7 months later in 2021 / received /second dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. In 2021, 7 months after 1st dose, the patient received 2nd dose, late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up. This case was linked with case US2021158164, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021158164:same reporter - reporter´s husband case
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / more than 6 months / not received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose, 0.5 ml received in 2020, more than 6 months from  the date of reporting, by intramuscular route).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient' wife The age at vaccination was not applicable for this report. Till the time of reporting, it had been more than 6 months and  the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021158161, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021158161:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose /in 2018 & 2nd dose not given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional did not report patient's demographic details neither lot number nor expiration date of the 1st dose of Shingrix. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: They've been vaccinated with the first dose more than 6 months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than 6 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The pharmacist called to report that the patients were coming into her pharmacy to get the second dose of Shingrix and did not receive yet, which led to incomplete course of vaccination. The reporter wanted to know how to proceed.  At the time of the call the reporter did not had any patient demographics or vaccination information, because was just calling to know how to proceed in those cases. No further details were provided at the time of the call. The reporter did not consent to follow up. The HCP did not consent nor declined follow up, because was just searching for the Medical Information answer to enquiry.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Infanrix /administered to an 11YO; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 4L9E4, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd July 2021, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 22nd July 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: A dose of Infanrix was accidentally administered to an 11 Years old patient which led to inappropriate age at vaccine administration. The patient received Infanrix in right deltoid. At the time of the report the patient had not reported any issues. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on 2019/ second dose today (July 2021).; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in unknown date in 2019).   In July 2021, the patient received the 2nd dose of Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional case details were reported as follows: Pharmacist reported that a patient came back to the facility to receive the 2nd dose on the day of reporting (July 2021) that was later than recommended schedule which led to lengthening of vaccination schedule. As per conservative approach as the patient come back the facility for 2nd dose of vaccination she must had received. Lot number and expiration date was not available. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: administered 2 liquid conjugate vaccine components; administered 2 liquid conjugate vaccine components; This case was reported by a nurse via call center representative and described the occurrence of wrong technique in drug usage process in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMX417A, expiry date 31st August 2022) for prophylaxis.   On 19th July 2021, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 19th July 2021, unknown after receiving Menveo, the patient experienced wrong technique in drug usage process and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong technique in drug usage process and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Age at vaccination was not reported. Nurse reported that they administered 2 liquid conjugate vaccine components of Menveo to a patient, which led to wrong technique in drug usage process and inappropriate dose of vaccine administered. Nurse mentioned that the patient had no reactions after vaccination. HCP had no patient data. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.