chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Generalised erythema, Pruritus generalised, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized erythema in a 79-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included paraproteinemia and breast cancer. Concurrent medical conditions included monoclonal gammopathy. On 4th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th May 2018, 16 days after receiving SHINGRIX, the patient experienced generalized erythema, generalized urticaria and generalized pruritus. On an unknown date, the outcome of the generalized erythema, generalized urticaria and generalized pruritus were unchanged. It was unknown if the reporter considered the generalized erythema, generalized urticaria and generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient started experiencing redness, itching and welts all over the body. It started with itching and when she puts pressure on the area it became red. The areas mostly affected were trunk of the body, underneath the bra, arms, and legs. The itching was on and off. She had an autoimmune disease: monoclonal gammopathy (MGUF), and monoclonal Paraproteinemia. On 22nd June 2018 and on 11th July 2018, the patient had been visited to her primary care doctor. The patient had followed up appointment with her oncologist in 2 to 3 weeks (from the date of reporting).
Age: 0.17
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HEP, IPV, PNC13, RVX
Symptoms: Extra dose administered, No adverse event, Wrong technique in product usage process
Clinical narrative: Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 9 weeks old male patient who was inadvertently injected with the liquid DTaP and IPV portions of PENTACEL, followed by the complete PENTACEL dose in the same visit. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included a dose of Hepatitis B Vaccine for Immunisation and a dose of PREVNAR 13 for Immunisation; and a dose of Rotavirus Vaccine for Immunisation on 06-August-2018. On 06-Aug-2018, the patient received liquid DTaP and IPV portions of PENTACEL, followed by the complete PENTACEL dose 0.5 ml (lot number not reported via intramuscular route in the left thigh). This is the case of actual medication error, due to wrong technique in product usage process and extra dose administered. Caller reported no sign of adverse reaction had been observed to date. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: M
Vaccine: IPV, TD, VARCEL
Symptoms: Expired product administered, Wrong product administered
Clinical narrative: Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a seven years old male patient who was administered expired TENIVAC and administered expired TENIVAC to make up for his 5th missed dose of DTaP series. This is actual medication error case due to expired vaccine used and wrong vaccine administered. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included a dose of Varicella Vaccine for Immunisation; and a dose of IPOL for Immunisation. On 07-Aug-2018, the patient received a dose of suspect 0.5 ml TENIVAC lot U5280AA, exp date: 16-March-2018 via intramuscular route in the left thigh to make up for his 5th missed dose of DTaP series. It was not reported if the patient experienced any adverse event. Lab data, corrective treatment: not applicable. Outcome: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 09-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 days old female patient who received DAPTACEL instead of HEPATITIS B VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. It was a case of actual medication error due to Wrong vaccine administered. Adverse event was unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 21 years old male patient who was vaccinated with an 0.5 ml expired dose of MENACTRA (Batch number: U5523BA and expiry date: 08-Apr-2018) in the left deltoid (dose in series and route of administration were not reported) on 10-Aug-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used because the vaccine was expired on 08-Apr-2018. It was also reported that the patient was kept for 20 minutes after the vaccination to watch for side effects. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: Initial information received on 10-Aug-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age adult male patient who experienced severe malaise, severe pain, redness and swelling at injection site and fever over 102 Fahrenheit (38.8 degree Celsius), while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect ADACEL lot number not reported. On an unknown date, patient developed a non-serious severe malaise (malaise), severe pain, redness and swelling at injection site (vaccination site inflammation) and fever over 102 Fahrenheit (38.8 degree Celsius) (pyrexia) following the administration of ADACEL. Relevant lab tests include fever over 102 Fahrenheit. Final diagnosis was fever over 102 Fahrenheit (38.8 degree Celsius), severe pain, redness and swelling at injection site and severe malaise. It was not reported if the patient received a corrective treatment. The patient outcome was reported as recovered for severe malaise (lasting for seven days) and fever (lasting for 4 days) and unknown for severe pain, redness and swelling at injection site and fever.
Sex: M
Vaccine: FLU4
Symptoms: Eye pain, Laboratory test normal, Optic neuritis, Visual field defect
Clinical narrative: Initial information received on 10-Aug-2018 regarding an unsolicited valid serious case received from a Consumer (physician). This case involves Adult male patient (age unknown) who experienced optic neuritis, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On 01-Dec-2017, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5934NA, expiry date 30 Jun 2018 via intramuscular route in the left deltoid. On an unspecified date (reported as 11-Dec-2017 or 12-Dec-2017), the patient developed a serious optic neuritis with 12 or 13 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. On an unspecified date (reported as 11-Dec-2017 or 12-Dec-2017), the patient developed a serious pain with eye movement with 12 or 13 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. On an unspecified date (reported as 11-Dec-2017 or 12-Dec-2017), the patient developed a serious scotoma in the central field of his left eye with 12 or 13 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. Other relevant tests included - On an unknown date, all tests for Multiple sclerosis were negative. Final diagnosis was optic neuritis. The patient was treated with 1000 mg of SOLU-MEDROL IV for 3 days, then 100 mg Prednisone for 11 days, 50 mg prednisone for 1 day and 25 mg prednisone for 2 days. The patient outcome is reported as Recovered / Resolved on an unknown date for optic neuritis, as Recovered/Resolved on an unknown date for pain with eye movement and as Recovered/Resolved on an unknown date for scotoma in the central field of his left eye. Took 5-6 weeks for his symptoms to resolve. List of documents held by sender - none. Sender's Comments: This case concerns an adult patient who developed optic neuritis after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible. All tests for Multiple sclerosis were negative. The patient's medical condition at the time of vaccination, and past history were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: This spontaneous report was received from an unspecified reporter via a company representative and refers to a 10 or 11-year old patient of unknown gender. The patient did not have any pertinent medical history, concomitant medications and drug reactions or allergies. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (exact dose, route, site of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient reported "having a severe headache" for a few days. There was no treatment given for the event. No laboratory diagnostics were performed. Product quality complaint was not involved. The patient no longer had a headache. The outcome of severe headache was reported as recovered on an unspecified date. The relatedness between GARDASIL 9 and the event was not provided.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager referring to a 10 week old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 27-MAR-2018, the patient was vaccinated with an improperly stored ROTATEQ, lot # N013884, expiration date on 05-DEC-2018 (anatomical location and administration route were not reported) for prophylaxis (Incorrect product storage). Concomitant medications included properly stored Sterile Diluent. No adverse effects were reported. The vaccine was stored at 47 degrees Fahrenheit to 77degrees F (61.7 degrees F) for 2 hours 30 minutes and 32 degrees F to 35 degrees F (33F) for 6 hours 51 minutes. The  previous temperature excursion was reported as 47 degrees F to 77 degrees F (52F) for 1 hour 30 minutes. The call was due to digital data logger. This is one of several reports received from same reporter. Sender's Comments: US-009507513-1803USA010116; US-009507513-1808USA007352; US-009507513-1808USA007355; US-009507513-1808USA007354; US-009507513-1808USA007353.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager referring to a 10 week old patient of unknown gender. The patients' medical history and concurrent conditions were not reported. On 26-MAR-2018, the patient was vaccinated with an improperly stored ROTATEQ lot # N013884, expiration date on 05-DEC-2018 (anatomical location and administration route were not reported) for prophylaxis. Concomitant medications included properly stored sterile diluent. No adverse effects were reported. The vaccine was stored at 47°Fahrenheit to 77°F (61.7°F) for 2 hours 30 minutes and 32°F to 35°F (33F) for 6 hours 51 minutes. The previous temperature excursion was reported as 47°F to 77°F (52F) for 1 hour 30 minutes. The call was due to digital data logger. This is one of several reports received from same reporter. Sender's Comments: US-009507513-1803USA010116: US-009507513-1808USA007355: US-009507513-1808USA007354: US-009507513-1808USA007353: US-009507513-1808USA007351.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a 12 month old patient of unknown gender. The patients' medical history and concurrent conditions were not reported. On 30-MAR-2018, the patient was vaccinated with an improperly stored M-M-R II lot # N001532, expiration date 13-JAN-2019 (anatomical location and administration route were not reported) for prophylaxis. Concomitant medications included properly stored sterile diluent. No adverse effects were reported. The vaccine was stored at 47 degree Fahrenheit to 77 degree F (61.7 degree F) for 2 hours 30 minutes and 32 degree F to 35 degree F (33F) for 6 hours 51 minutes. The previous temperature excursion was reported as 47 degree F to 77 degree F (52F) for 1 hour 30 minutes. The call was due to digital data logger. This is one of several reports received from same reporter. Sender's Comments: US-009507513-1803USA010116: US-009507513-1808USA007354: US-009507513-1808USA007353: US-009507513-1808USA007351: US-009507513-1808USA007352.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a currently 2 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA, (which had a lot # of N020686 and an expiration date of 22-OCT-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA007361: US-009507513-1808USA007362: US-009507513-1808USA007363: US-009507513-1808USA007364: US-009507513-1808USA007365: US-009507513-1808USA007366: US-009507513-1808USA007367: US-009507513-1808USA007368: US-009507513-1808USA007369: US-009507513-1808USA007370: US-009507513-1808USA007371: US-009507513-1808USA007372: US-009507513-1808USA007373: US-009507513-1808USA007374: US-009507513-1808USA007375: US-009507513-1808USA007376: US-009507513-1808USA006354.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a currently 2 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA, (which had a lot # of N020686 and an expiration date of 22-OCT-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assitant, refers to a currently 16 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9),  (which had a lot # of N022728 and an expiration date of 31-MAY-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA006354:
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a currently 18 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9, (which had a lot # of N022728 and an expiration date of 31-MAY-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a currently 8 month old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ per oral, (which had a lot # of N030366 and an expiration date of 13-MAR-2019; however, dosage number was not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a currently 6 months old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ per oral, (which had a lot # of N030366 and an expiration date of 13-MAR-2019; however, dosage number was not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a currently 1 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored M-M-R II, (which had a lot # of N014486 and an expiration date of 10-MAY-2019; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354:
Age: 66.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Initial Report Received: 07-Aug-2018 and 08-Aug-2018. Patient is a 67-year-old man (race not provided) who was administered with HEPLISAV-B for hepatitis B immunization. The patient reported that he tested negative for hepatitis B surface antibodies after completing the HEPLISAV-B series. Relevant medical history included remission for mantle cell lymphoma. Concomitant medications included ASA, citalopram, flecainide, and CRESTOR. The patient received the first injection of HEPLISAV-B (Lot # 1033384, expiration 06-Apr-2019) on 18-Apr-2018. The patient received the second injection of HEPLISAV-B (same lot #/expiration as first dose) on 18-May-2018. Rituximab and bendamustine, administered for mantle cell lymphoma, were both stopped in Mar-2018. On 25-Jul-2018, 99 days after the first administration of HEPLISAV-B and 69 days after the second administration of HEPLISAV-B, the patient tested negative for hepatitis B surface antibodies. No other information was provided. At the time of the report, the outcome of the event was unknown. The reporter did not provide a seriousness assessment for the events. Company comment:  The company assessed the event of Hepatitis B surface antibody negative as non-serious. The event of Hepatitis B surface antibody negative is listed per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of Hepatitis B surface antibody negative as non-serious. The event of Hepatitis B surface antibody negative is listed per HEPLISAV-B USPI.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Injection site swelling in a 62-year-old adult female patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The healthcare professional reported that the patient received a dose of SHINGRIX subcutaneously, which led to incorrect route of vaccine administration. This case has been linked with US2018126944, reported by same reporter. Follow up information was received from a pharmacist on 8th August 2018: The patient's demographic details was updated. On 11th July 2018, the patient received 1st dose of 0.5 ml SHINGRIX. The error occurred during administration. It was administered subcutaneously where it meant to be injected intramuscularly. The patient reported days later that the injection site became swollen or red and painful. The reporter stated that they followed through with the patient and the patient stated the symptoms went away in a week. The patient was advised to return for a second dose in 2 to 6 months. The VAERS details were updated. This was medication error associated with adverse events.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX. On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fatigue and headache. On an unknown date, the patient experienced fever, injection site warmth, injection site induration, injection site swelling and injection site erythema. The patient was treated with naproxen. On 2nd August 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the chills, fatigue and fever were recovered/resolved and the outcome of the injection site warmth, injection site induration, injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the chills, fatigue, fever, injection site warmth, injection site induration, injection site swelling, headache and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The health care professional called from home and did not have SHINGRIX batch number and expiry date. The patient received SHINGRIX and the next day on 1st August 2018 began to experience severe chills (at 2:30) which subsided within 2 and a half hours. She additionally experienced a severe headache which lasted almost 2 full days and was not relieved by naproxen. The patient also experienced fatigue and light fever. The injection site area was slightly swollen, warm, and extremely hard.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX. On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fatigue and headache. On an unknown date, the patient experienced fever, injection site warmth, injection site induration, injection site swelling and injection site erythema. The patient was treated with naproxen. On 2nd August 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the chills, fatigue and fever were recovered/resolved and the outcome of the injection site warmth, injection site induration, injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the chills, fatigue, fever, injection site warmth, injection site induration, injection site swelling, headache and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The health care professional called from home and did not have SHINGRIX batch number and expiry date. The patient received SHINGRIX and the next day on 1st August 2018 began to experience severe chills (at 2:30) which subsided within 2 and a half hours. She additionally experienced a severe headache which lasted almost 2 full days and was not relieved by naproxen. The patient also experienced fatigue and light fever. The injection site area was slightly swollen, warm, and extremely hard.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Dysgeusia, Exposure via skin contact, Product quality issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of taste peculiar in a 30-year-old female patient who was reconstituting SHINGRIX (batch number M77B4, expiry date 8th February 2021) and (batch number 97H72, expiry date 8th February 2021) to the patient for prophylaxis. On 7th August 2018, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced taste peculiar, inadvertent exposure to vaccine, exposure via skin contact and product complaint. On an unknown date, the outcome of the taste peculiar, inadvertent exposure to vaccine, exposure via skin contact and product complaint were unknown. It was unknown if the reporter considered the taste peculiar to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that when she was attempting to withdraw SHINGRIX on the date of reporting, it was pretty pressurized and adjuvant from the vial, the liquid squirted out of the vial onto her face and flew into her mouth, which led to inadvertent exposure to vaccine, exposure via skin contact. The pharmacist may have got into her mouth since she had a funny taste in her mouth afterwards. She was not sure if she swallowed any. The pharmacist believes it was due to the vial being very pressurized. The pharmacist was unsure how much adjuvant was left in the affected vial. The pharmacist used a 3 ml BD syringe with a 25 gauge 1 inch safety needle. The stopper was pierced in the circular area dedicated to perforation and the vial was being held upside down when the adjuvant was being withdrawn. The liquid came out of the puncture in the stopper. The vial rubber stopper or metallic skirt did not detach or become loose at any time. The pharmacist only removed the plastic flip-off from the vial before handling and did not inject air from the syringe into the vial. The stopper was pierced once. The vaccine was stored in the refrigerator on the middle shelf. The average temperature of the refrigerator was 40 degree F and there were no temperature excursions after receipt and storage. Defect was observed after handling and there was no evidence of leakage in the package or carton. The pharmacist was an experienced user of the product and has not had this issue with previous SHINGRIX vials. There were no pictures available of the defect. In QA notes batch number of SHINGRIX and diluent were reported. The pharmacist was requested credit for (1) dose of SHINGRIX for replacement. The pharmacy would return vial in question to GlaxoSmithKline and filled related adverse event.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Influenza like illness, Loss of personal independence in daily activities, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 64-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza like illness, back pain and muscle pain. On an unknown date, the outcome of the influenza like illness and muscle pain were unknown and the outcome of the back pain was not recovered/not resolved. It was unknown if the reporter considered the influenza like illness, back pain and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX about 2 months ago. Afterwards the patient felt like she had the flu. It took her out for a least a week and a half with bad muscle aches. The patient's back ached so much that she was unable to care for her grandson. The patient's back still aches 2 months later in the muscles down each side of the spine.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 6th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms and chills. On an unknown date, the outcome of the fever, influenza-like symptoms and chills were recovered/resolved. It was unknown if the reporter considered the fever, influenza-like symptoms and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 69 or 70 years old. The patient experienced fever, chills and flu like symptoms. The date of onset was unknown but all the events are resolved by the time of reporting. The patient wondered if he should receive the 2nd shot based on his reaction to the 1st dose. The caller was transferred to Medical Information for additional assistance.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site mass, Injection site pain, Injection site reaction, Mass, Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 17-year-old female patient who received BEXSERO) (batch number 16G101, expiry date 31st May 2019) for prophylaxis. On 15th June 2018, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, several days after receiving BEXSERO, the patient experienced injection site lump, injection site pain, erythematous rash and mass. On an unknown date, the outcome of the injection site lump, injection site pain, erythematous rash and mass were recovered/resolved. It was unknown if the reporter considered the injection site lump, injection site pain, erythematous rash and mass to be related to BEXSERO. Additional information was reported as follows: The patient developed a apple sized lump at the injection site. The injection site lump lasted for two weeks, however it was painful for four weeks. The patient also stated that she had red rash on her left shoulder and neck. She also developed three lumps in the area between the shoulder and her neck. All the symptoms started a couple of days after the injection.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site lump in a 17-year-old female patient who received BEXSERO) (batch number 16G101, expiry date 31st May 2019) for prophylaxis. On 15th June 2018, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, several days after receiving BEXSERO, the patient experienced injection site lump, injection site pain, erythematous rash and mass. On an unknown date, the outcome of the injection site lump, injection site pain, erythematous rash and mass were recovered/resolved. It was unknown if the reporter considered the injection site lump, injection site pain, erythematous rash and mass to be related to BEXSERO. Additional information was reported as follows: The patient developed a apple sized lump at the injection site. The injection site lump lasted for two weeks, however it was painful for four weeks. The patient also stated that she had red rash on her left shoulder and neck. She also developed three lumps in the area between the shoulder and her neck. All the symptoms started a couple of days after the injection.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Varicella
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of chickenpox in a 55-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chickenpox, extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the chickenpox, extensive swelling of vaccinated limb and injection site erythema were recovering/resolving. It was unknown if the reporter considered the chickenpox, extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional details were as follows: The physician reported that the patient experienced chicken pox breakout all over the body. Along with redness and swelling at the injection site with an area of 5 to 10 inches in diameter. This case was linked with US2018143087, reported by the same reporter for the patient related to the patient in present case.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site blisters and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site blisters and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site blisters and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on an unknown deltoid and called back pharmacy on 8th August 2018 to report that the injection site was sore, red, and warm to touch. There was also reportedly a fluid-filled sack at the injection site which, according to the patient, moved around and changed sites on her arm each day. The reporter was uncertain of time of onset and progression of symptoms, but reported that the patient said her symptoms were still there.The pharmacist provided lot number M77B4 and expiration date of 8th August 2021, but he stated that he did not believe that was the lot number administered. He did not have access to the lot number which was administered. He had not seen the patient's arm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Dry mouth, Feeling hot, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 6th August 2018 19:30, the patient received the 1st dose of SHINGRIX. On 7th August 2018, 1 days after receiving SHINGRIX, the patient experienced chills, tremor, injection site swelling, muscle pain, headache, fever, sweating, injection site muscle pain, sleepiness and performance status decreased. In August 2018, the patient experienced nausea, dry mouth and dizziness. The patient was treated with non-drug therapy (Cold Compresses). On an unknown date, the outcome of the nausea, dry mouth, chills, injection site swelling, muscle pain, headache, fever, sweating, injection site muscle pain, dizziness and sleepiness were recovering/resolving and the outcome of the tremor was recovered/resolved and the outcome of the performance status decreased was unknown. It was unknown if the reporter considered the nausea, dry mouth, chills, tremor, injection site swelling, muscle pain, headache, fever, sweating, injection site muscle pain, dizziness, sleepiness and performance status decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had no chronic illness. The patient received the vaccination at 7:30 PM on left deltoid. The next morning about 8 AM, she felt nauseated, dizzy and had a dry mouth. The patient also had chills, and was shaking and trembling uncontrollably. The patient could not stay awake and slept for 10 to 12 hours. The patient could not function and her large muscles were aching. The patient still had a dry mouth but was no longer shaking. The patient never had an experience like this before. It was reported 10 hours in (unspecified), she woke up with a terrible headache. The patient had barely eaten some toast and ginger ale and was afraid to take Ibuprofen right away. Around 12 hours in (unspecified), she had a fever and was hot. The patient applied cold compresses and the fever broke and she began sweating and it seemed to relieve her symptoms. The patient had a mild local injection site muscle ache and a tiny amount of swelling.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Injection site swelling, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 6th August 2018 19:30, the patient received the 1st dose of SHINGRIX. On 7th August 2018, 1 days after receiving SHINGRIX, the patient experienced chills, tremor, injection site swelling, muscle pain, headache, fever, sweating, injection site muscle pain, sleepiness and performance status decreased. In August 2018, the patient experienced nausea, dry mouth and dizziness. The patient was treated with non-drug therapy (Cold Compresses). On an unknown date, the outcome of the nausea, dry mouth, chills, injection site swelling, muscle pain, headache, fever, sweating, injection site muscle pain, dizziness and sleepiness were recovering/resolving and the outcome of the tremor was recovered/resolved and the outcome of the performance status decreased was unknown. It was unknown if the reporter considered the nausea, dry mouth, chills, tremor, injection site swelling, muscle pain, headache, fever, sweating, injection site muscle pain, dizziness, sleepiness and performance status decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had no chronic illness. The patient received the vaccination at 7:30 PM on left deltoid. The next morning about 8 AM, she felt nauseated, dizzy and had a dry mouth. The patient also had chills, and was shaking and trembling uncontrollably. The patient could not stay awake and slept for 10 to 12 hours. The patient could not function and her large muscles were aching. The patient still had a dry mouth but was no longer shaking. The patient never had an experience like this before. It was reported 10 hours in (unspecified), she woke up with a terrible headache. The patient had barely eaten some toast and ginger ale and was afraid to take Ibuprofen right away. Around 12 hours in (unspecified), she had a fever and was hot. The patient applied cold compresses and the fever broke and she began sweating and it seemed to relieve her symptoms. The patient had a mild local injection site muscle ache and a tiny amount of swelling.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Performance status decreased, Pyrexia, Somnolence, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 6th August 2018 19:30, the patient received the 1st dose of SHINGRIX. On 7th August 2018, 1 days after receiving SHINGRIX, the patient experienced chills, tremor, injection site swelling, muscle pain, headache, fever, sweating, injection site muscle pain, sleepiness and performance status decreased. In August 2018, the patient experienced nausea, dry mouth and dizziness. The patient was treated with non-drug therapy (Cold Compresses). On an unknown date, the outcome of the nausea, dry mouth, chills, injection site swelling, muscle pain, headache, fever, sweating, injection site muscle pain, dizziness and sleepiness were recovering/resolving and the outcome of the tremor was recovered/resolved and the outcome of the performance status decreased was unknown. It was unknown if the reporter considered the nausea, dry mouth, chills, tremor, injection site swelling, muscle pain, headache, fever, sweating, injection site muscle pain, dizziness, sleepiness and performance status decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had no chronic illness. The patient received the vaccination at 7:30 PM on left deltoid. The next morning about 8 AM, she felt nauseated, dizzy and had a dry mouth. The patient also had chills, and was shaking and trembling uncontrollably. The patient could not stay awake and slept for 10 to 12 hours. The patient could not function and her large muscles were aching. The patient still had a dry mouth but was no longer shaking. The patient never had an experience like this before. It was reported 10 hours in (unspecified), she woke up with a terrible headache. The patient had barely eaten some toast and ginger ale and was afraid to take Ibuprofen right away. Around 12 hours in (unspecified), she had a fever and was hot. The patient applied cold compresses and the fever broke and she began sweating and it seemed to relieve her symptoms. The patient had a mild local injection site muscle ache and a tiny amount of swelling.