chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Product prescribing issue
Clinical narrative: PRESCRIBED ONE VIVOTIF CAPSULE TWICE A WEEK; This spontaneous case (PVX2019-931) was received from a pharmacist on 19-Apr-2019. It describes a 19-year-old male consumer who was "prescribed Vivotif 1 dose twice a week". The consumer was receiving Vivotif capsule (lot number: 3003242) for an unknown indication.  Case report: The consumer was prescribed one Vivotif capsule twice a week.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "prescribed Vivotif 1 dose twice a week" was unknown.  Company's Comment: The causality of the event "prescribed Vivotif 1 dose twice a week" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "prescribed Vivotif 1 dose twice a week" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED TO TAKE SECOND DOSE; This spontaneous case (PVX2019-945) was received from a nurse on 22-Apr-2019. It describes a male consumer who "missed to take second dose", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 19-Apr-2019 and missed to take the second dose, which was due on 21-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed to take second dose" was unknown.  Company's Comment: The causality of the event "missed to take second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take second dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND DOSE LATE; This spontaneous case (PVX2019-967) was received from a nurse on 23-Apr-2019. It describes a female consumer who "took second dose late". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 17-Apr-2019 and forgot to take second dose. She took the second dose on 21-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took second dose late" was unknown.  Company's Comment: The causality of the event "took second dose late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose late" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK LAST DOSE 2 WEEKS LATER THAN THE SCHEDULED TIME; This spontaneous case (PVX2019-970) was received from a pharmacist on 23-Apr-2019. It describes a male consumer who "took last dose 2 weeks later than the scheduled time", while being on Vivotif for an unknown indication.  Case report: The consumer took the first three doses of Vivotif and forgot to take the last dose for 2 weeks. He took the doses on 3-Apr-2019, 5-Apr-2019, 7-Apr-2019, and 21-Apr-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took last dose 2 weeks later than the scheduled time" was unknown.  Company's Comment: The causality of the event "took last dose 2 weeks later than the scheduled time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose 2 weeks later than the scheduled time" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THREE DOSES OF VIVOTIF EVERY DAY; This spontaneous case (PVX2019-1091) was received from a pharmacist on 02-May-2019. It describes a female consumer who "took three doses of Vivotif every day". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first three doses of Vivotif every day instead of every other day. She believed that the third dose was taken on 01-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took three doses of Vivotif every day" was unknown.  Company's Comment: The causality of the event "took three doses of Vivotif every day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses of Vivotif every day" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: STARTED VIVOTIF LESS THAN 2 WEEKS PRIOR TO TRAVEL; This spontaneous case (PVX2019-1099) was received from a consumer on 03-May-2019. It describes a 36-year-old female consumer who "started Vivotif less than 2 weeks prior to travel". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003275) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 02-May-2019. She had a planned travel to an endemic area on 06-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "started Vivotif less than 2 weeks prior to travel" was unknown.  Company's Comment: The causality of the event "started Vivotif less than 2 weeks prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "started Vivotif less than 2 weeks prior to travel" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: FORGOT TO TAKE THIRD AND FOURTH DOSE OF VIVOTIF ON TIME; A spontaneous case report was received from a pharmacist on 17-May-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201905-000389 (PVX2019-1238; wife) and PVX201905-000390 (PVX2019-1239, husband) were created and cross-linked in the database.  This case describes a male consumer who "forgot to take third and fourth dose of Vivotif on time". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took two doses of Vivotif on 10-May-2019 and 12-May-2019, respectively. Then, he forgot to take the remaining doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "forgot to take third and fourth dose of Vivotif on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take third and fourth dose of Vivotif on time" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000389:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND DOSE OF VIVOTIF ON DAY 2 INSTEAD OF DAY 3/ DID NOT COMPLETE VIVOTIF ONE WEEK BEFORE TRAVEL; This spontaneous case (PVX2019-1242) was received from a consumer on 17-May-2019. It describes a female consumer who "took second dose of Vivotif on day 2 instead of day 3 / did not complete Vivotif one week before travel", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took first two doses of Vivotif in a row. The two doses were taken on 16-May-2019 and 17-May-2019, respectively. Also, she had a planned trip to an endemic area next week on Saturday.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took second dose of Vivotif on day 2 instead of day 3 / did not complete Vivotif one week before travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose of Vivotif on day 2 instead of day 3 / did not complete Vivotif one week before travel" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK ALL FOUR DOSES OF VIVOTIF BUT DID NOT REFRIGERATE IT; A spontaneous case report was received from a caregiver on 20-May-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201905-000394 (PVX2019-1250; younger daughter) and PVX201905-000395 (PVX2019-1251, elder daughter) were created and cross-linked in the database.  This case describes a 14-year-old adolescent female consumer who "took all four doses of Vivotif but did not refrigerate it". The consumer was receiving oral Vivotif (one capsules every other day; lot no: 3003253) for typhoid prophylaxis.  Case report: The consumer took all the four doses of Vivotif but forgot to refrigerate it. The doses were taken on 12-May-2019, 14-May-2019, 16-May-2019, and 18-May-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took all four doses of Vivotif but did not refrigerate it" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took all four doses of Vivotif but did not refrigerate it" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000395:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-1265) was received from a pharmacist on 20-May-2019. It describes a female consumer who "took two doses in a row". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took the first and the second dose of Vivotif on consecutive days.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK VIVOTIF WITH FOOD; This spontaneous case (PVX2019-1298) was received from a consumer on 22-May-2019. It describes an 18-year-old female consumer who "took Vivotif with food". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took a dose of Vivotif with food on 19-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Underdose
Clinical narrative: TOOK ONLY ONE DOSE; This spontaneous case (PVX2019-1304) was received from a pharmacist on 22-May-2019. It describes a male consumer who "took only one dose". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif couple of weeks ago (almost 2 weeks). He did not take the remaining doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took only one dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK FOURTH DOSE ON DAY 8; This spontaneous case (PVX2019-1439) was received from a pharmacist on 04-Jun-2019. It describes a 16-year-old adolescent male consumer who "took fourth dose on day 8". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took the fourth dose of Vivotif on day 8. The first dose was taken on 27-May-2019 and the last dose on 03-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took fourth dose on day 8" was unknown.  Company's Comment: The causality of the event "took fourth dose on day 8" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took fourth dose on day 8" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED A DOSE; This spontaneous case (PVX2019-1440) was received from a pharmacist on 04-Jun-2019. It describes a male consumer who "missed a dose", while being on Vivotif for an unknown indication.  Case report: The consumer missed a dose of Vivotif that was due on 03-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "missed a dose" was unknown.  Company's Comment: The causality of the event "missed a dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed a dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case (PVX2019-1473) was received from a consumer on 07-Jun-2019. It describes a female consumer who "took one dose of unrefrigerated Vivotif". The consumer was receiving oral Vivotif (one dose every other day) (lot no: 3003272) for typhoid fever prophylaxis.  Case report: The consumer took the first unrefrigerated dose of Vivotif on 06-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND DOSE OF VIVOTIF ONE DAY LATE; This spontaneous case report (PVX2019-2969) was received from a nurse on 03-Dec-2019. It described a 35-year-old female consumer who "took second dose of Vivotif one day late" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever.  Case report: The consumer took the first dose of Vivotif on 25-Nov-2019 and the second dose of Vivotif on 28-Nov-2019, which was one day late according to the schedule. It was reported that she took the remaining doses of Vivotif according to schedule.  The action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of reported event was unknown.  Company Comment: A consumer took second dose of Vivotif one day late (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took second dose of Vivotif one day late (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient presented with shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix at a local pharmacy 2 weeks earlier than reporting date and experienced shingles. The patient did not think the shingles was related to the vaccine. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: feel a bit itchy.; red bumps appearing on her legs/spread to her arms, body and back/look like a latent case of chicken pox; red bumps; red; This case was reported by a consumer via sales rep and described the occurrence of itchy rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox at the age of 5 years). Previously administered products included Shingrix (did not have this reaction with the first dose of shingrix).   On 29th January 2020, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced itchy rash, varicella-like rash, papular rash and red rash. On an unknown date, the outcome of the itchy rash, varicella-like rash, papular rash and red rash were unknown.   It was unknown if the reporter considered the itchy rash, varicella-like rash, papular rash and red rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by the relative of the patient. Couple of weeks later the patient noticed red bumps appearing on her legs. Assuming it might be insect bites she tried to ignore them.  It started to spread to her arms, body and back. The red bumps she said look like a latent case of chicken pox even though she had chicken pox at the age of 5 years. The bumps do not hurt or itch except the ones that are drying feel a bit itchy.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: I experienced uncomfortable flu like side effects for 2-3 days.; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient had the first of two Shingrix vaccine injections.  The patient experienced uncomfortable flu like side effects for 2-3 days. The patient originally planned to get the second injection soon after March 24.  However, the reporter was concerned that the vaccine side effects symptoms could mask any onset of corona virus (which he/she do not now have). The reporter wanted to know what happens if he/she skip the second injection.  Do still have partial benefit from having received the first injection.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hot flush, Injection site pain, Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: My arm wasn't just sore; The nerve pain down my arm and into my neck within a few hours was so severe / extreme nerve pain; still have pain in the shoulder muscle; Shoulder pain; the pain in my arm and no sleep the night before; left work 4 hours early from headache; left work 4 hours early from headache; the itching inside started; my hot flashes are back; leg cramps; extreme muscle weakness; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included surgery.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm, nerve pain, muscle pain, shoulder pain, sleep disturbance, headache, activities of daily living impaired, pruritus, hot flashes, leg cramps and muscle weakness. On an unknown date, the outcome of the pain in arm, nerve pain, sleep disturbance, headache, activities of daily living impaired, pruritus, hot flashes, leg cramps and muscle weakness were unknown and the outcome of the muscle pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, nerve pain, muscle pain, shoulder pain, sleep disturbance, headache, activities of daily living impaired, pruritus, hot flashes, leg cramps and muscle weakness to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient reported to the physician that her arm was not just sore. The nerve pain down her arm and into her neck within a few hours was so severe she was taking pain meds leftover from her surgery.  The next day she left work 4 hours early from headache, the pain in her arm and no sleep the night before.  When she got home she crawled into bed and that's when the itching inside started. She never slept that afternoon or the next night. Since then her hot flashes were back and leg cramps with extreme muscle weakness and nerve pain. The patient was still having pain in the shoulder muscle where the doctor put the needle over a month ago in 2020. The patient don't think getting a second vaccine would be a good idea.
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Musculoskeletal pain, Myalgia, Neck pain, Neuralgia
Clinical narrative: My arm wasn't just sore; The nerve pain down my arm and into my neck within a few hours was so severe / extreme nerve pain; still have pain in the shoulder muscle; Shoulder pain; the pain in my arm and no sleep the night before; left work 4 hours early from headache; left work 4 hours early from headache; the itching inside started; my hot flashes are back; leg cramps; extreme muscle weakness; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included surgery.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm, nerve pain, muscle pain, shoulder pain, sleep disturbance, headache, activities of daily living impaired, pruritus, hot flashes, leg cramps and muscle weakness. On an unknown date, the outcome of the pain in arm, nerve pain, sleep disturbance, headache, activities of daily living impaired, pruritus, hot flashes, leg cramps and muscle weakness were unknown and the outcome of the muscle pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, nerve pain, muscle pain, shoulder pain, sleep disturbance, headache, activities of daily living impaired, pruritus, hot flashes, leg cramps and muscle weakness to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient reported to the physician that her arm was not just sore. The nerve pain down her arm and into her neck within a few hours was so severe she was taking pain meds leftover from her surgery.  The next day she left work 4 hours early from headache, the pain in her arm and no sleep the night before.  When she got home she crawled into bed and that's when the itching inside started. She never slept that afternoon or the next night. Since then her hot flashes were back and leg cramps with extreme muscle weakness and nerve pain. The patient was still having pain in the shoulder muscle where the doctor put the needle over a month ago in 2020. The patient don't think getting a second vaccine would be a good idea.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Sleep disorder
Clinical narrative: My arm wasn't just sore; The nerve pain down my arm and into my neck within a few hours was so severe / extreme nerve pain; still have pain in the shoulder muscle; Shoulder pain; the pain in my arm and no sleep the night before; left work 4 hours early from headache; left work 4 hours early from headache; the itching inside started; my hot flashes are back; leg cramps; extreme muscle weakness; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included surgery.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm, nerve pain, muscle pain, shoulder pain, sleep disturbance, headache, activities of daily living impaired, pruritus, hot flashes, leg cramps and muscle weakness. On an unknown date, the outcome of the pain in arm, nerve pain, sleep disturbance, headache, activities of daily living impaired, pruritus, hot flashes, leg cramps and muscle weakness were unknown and the outcome of the muscle pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, nerve pain, muscle pain, shoulder pain, sleep disturbance, headache, activities of daily living impaired, pruritus, hot flashes, leg cramps and muscle weakness to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient reported to the physician that her arm was not just sore. The nerve pain down her arm and into her neck within a few hours was so severe she was taking pain meds leftover from her surgery.  The next day she left work 4 hours early from headache, the pain in her arm and no sleep the night before.  When she got home she crawled into bed and that's when the itching inside started. She never slept that afternoon or the next night. Since then her hot flashes were back and leg cramps with extreme muscle weakness and nerve pain. The patient was still having pain in the shoulder muscle where the doctor put the needle over a month ago in 2020. The patient don't think getting a second vaccine would be a good idea.
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: does shingrix cause insomina; This case was reported by a consumer via interactive digital media and described the occurrence of insomnia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced insomnia. On an unknown date, the outcome of the insomnia was unknown.   It was unknown if the reporter considered the insomnia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Flushing, Heart rate increased, Hypertension, Injection site pain
Clinical narrative: soreness of arm; he got flushed; rapid heart beat; high blood pressure; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included myasthenia gravis (since Dec 2014 treated with plasmapheresis) and erectile dysfunction. Concomitant products included nitric oxide, Rockstar Energy Drink, prednisone and azathioprine.   On 26th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th February 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, flushing, heartbeats increased and blood pressure high. On 26th February 2020, the outcome of the flushing and heartbeats increased were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the blood pressure high was recovered/resolved.   It was unknown if the reporter considered the injection site pain, flushing, heartbeats increased and blood pressure high to be related to Shingrix.  Additional details were provided as follows: The patient experienced a little soreness of his arm (at injection site). At the time of reporting it was still a little sore but it was resolving. The patient had used those products before without side effects however when he used them day before reporting and then proceeded with his (sexual) activity he got flushed and had to sit down and stop. The patient was having a rapid heartbeat and high blood pressure.  The patient states that his blood pressure was usually around 100 by 55 and it was about 140 by 80. The patient states that his heart rate was normally 60 to 65 and it was 80.   The heart rate took longer to go down but it was below 80 today.  It was states that he has never had an episode like this before. He was not sure if it was related to the Shingrix or not but it was the only thing different that he can think of. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient's age could be 57 years or 58 years old. The patient reported that she received the first dose of Shingrix about 2 months ago. Afterwards she had a sore arm, which resolved. Consented to follow up. This case is linked to the case US2020AMR060549, reported by the same patient for the 2nd dose.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Ophthalmic herpes zoster
Clinical narrative: developed a case of Shingles in the eye after the 1st dose; was 3 months late for the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and drug dose administration interval too long. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the ophthalmic herpes zoster and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provide as follows: The age at vaccination was not reported. After 1st dose of Shingrix, the patient experienced Shingles in the eye. The patient was 3 months late for the second dose, which led to lengthening of the vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional adverse events reported; one patient received V ARIVAX reconstituted with sterile water for injection; This spontaneous non-valid report as received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions,  pertinent medical history, drug reactions and allergies and concomitant medications were unknown.  On 08-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), reconstituted with sterile water for injection. No additional adverse events were reported.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: developed soreness at the injection site following the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included arm operation. Previously administered products included Shingrix with an associated reaction of chills, Shingrix with an associated reaction of pyrexia, Shingrix with an associated reaction of malaise and Shingrix with an associated reaction of paraesthesia (For the tolerability of 1st dose, refer case US2020060018 reported for same patient.).   On 1st November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient developed soreness at the injection site. Consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: pain in her arm where she received the injection; The pain extends from her arm up into her neck; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2020, the patient received Shingrix (intramuscular) .5 ml. On 21st March 2020, 1 days after receiving Shingrix, the patient experienced pain in arm and neck pain. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the neck pain was unknown.   It was unknown if the reporter considered the pain in arm and neck pain to be related to Shingrix.  Additional details were provided as follows: The patient started that she experienced pain in her arm where she received the injection the next. The pain continued to get worse and is still very painful. The pain extends from her arm up into her neck.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Paraesthesia, Pyrexia
Clinical narrative: tingling sensation that starts behind his ear and goes down his neck to the top of his shoulder; he developed chills / shivers; fever; felt ill; This case was reported by a consumer via call center representative and described the occurrence of chills in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included arm operation.   On 1st July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced chills, fever, feeling unwell and tingling sensation. On an unknown date, the outcome of the chills, fever and feeling unwell were recovered/resolved and the outcome of the tingling sensation was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, feeling unwell and tingling sensation to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine in right arm and developed chills, fever, and shivers after receiving the vaccine. The patient states that he also felt ill after receiving the 1st dose. Patient states that these symptoms lasted for approximately 24 hours. The patient states that some time between the 1st and 2nd dose, he developed a tingling sensation that starts behind his ear and goes down his neck to the top of his shoulder. The patient states that the sensation comes and goes.  Consented to follow up. For the tolerability of 2nd dose, refer case US2020AMR060590 reported for same patient.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Started with intermittent fever 6 - 8 days after vaccination.  Then on 4/3/2020 had persistent high fever.   Fever broke 4/5/2020 and then widespread rash started as fever broke.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Breath sounds abnormal, Diarrhoea, Irritability, Peripheral swelling
Clinical narrative: This was my son's two month old shots-  Very fussy from the time it started throughout the night, diarrhea,  loud breathing sounds, and legs were swollen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blood immunoglobulin A, Full blood count, Henoch-Schonlein purpura, Impetigo, Metabolic function test
Clinical narrative: Patient was seen in PCP office for a rash on 3/2/2020.  Parent reported the rash onset 2/29/2020. At 3/2/2020 visit, patient was prescribed Bactroban and Bactrim for the treatment of impetigo.  Parent then took patient to dermatologist on 3/9/2020, where dermatologist diagnosed the rash as Henoch Schonlein Purpura.  Parent requested PCP to report this as a possible adverse reaction to MMR  vaccine given on 2/3/2020.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Patient was seen in PCP office for a rash on 3/2/2020.  Parent reported the rash onset 2/29/2020. At 3/2/2020 visit, patient was prescribed Bactroban and Bactrim for the treatment of impetigo.  Parent then took patient to dermatologist on 3/9/2020, where dermatologist diagnosed the rash as Henoch Schonlein Purpura.  Parent requested PCP to report this as a possible adverse reaction to MMR  vaccine given on 2/3/2020.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's medical history, concomitant therapy and concurrent condition were not provided.  In 2013 the patient was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated for shingles. The outcome of event was unknown.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's medical history, concomitant therapy and concurrent condition were not provided.  In 2014 the patient was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated for shingles. The outcome of event was unknown.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: fever; headache; neck stiffness; This case was reported by a physician via sales rep and described the occurrence of fever in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose and MENACTRA at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced fever, headache and stiff neck. On an unknown date, the outcome of the fever, headache and stiff neck were unknown.   It was unknown if the reporter considered the fever, headache and stiff neck to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient experienced fever, headache and stiff neck after vaccination. The patient was not sure if this was attributed to the vaccine.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass, Vaccine positive rechallenge
Clinical narrative: Large, red bulge near the injection site; Large, red bulge near the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site mass in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of injection site mass (received 1st dose on unknown date and developed  large, red bulge near the injection site, about 2 inches).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site mass and injection site erythema. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the injection site mass and injection site erythema were unknown.   It was unknown if the reporter considered the injection site mass and injection site erythema to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed a large, red bulge near the injection site, about 2 inches after administration of 2nd dose of vaccine. The reporter consented to follow up. This case has been linked with US2020039257, reported by same reporter.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: shivering; I am very ill today; fever; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2020, the patient received Shingrix. On 11th March 2020, 1 days after receiving Shingrix, the patient experienced shivering, feeling unwell and fever. On an unknown date, the outcome of the shivering, feeling unwell and fever were unknown.   It was unknown if the reporter considered the shivering, feeling unwell and fever to be related to Shingrix.  Additional details were provided as folows: The patient stated that after vaccination felt ill, shivering and fever. The patient asked, when should saw the physician.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Headache; Chills; sore arm; felt very fatigued; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 1st April 2020, the patient received the 2nd dose of Shingrix. On 1st April 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and fatigue. On 2nd April 2020, the patient experienced chills. On 4th April 2020, the patient experienced headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and chills were recovered/resolved and the outcome of the fatigue and headache were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fatigue, chills and headache to be related to Shingrix.  Additional details were provided as follows: On 1st April 2020, the patient experienced a sore arm again, but that evening also felt very fatigued. On Thursday, 2nd April 2020, she had some chills as well, but felt fine on Friday, 3rd April 2020. On Saturday, 4th April 2020, she experienced chills again along with a slight headache. She felt fine on Sunday, 5th April 2020, but this morning, 6th April 2020, she woke up with fatigue and a headache again. For the tolerability of 2nd dose, refer case US2020059964 reported for same patient.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Lethargy, Pain, Tension headache
Clinical narrative: Headache; Chills; sore arm; felt very fatigued; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 1st April 2020, the patient received the 2nd dose of Shingrix. On 1st April 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and fatigue. On 2nd April 2020, the patient experienced chills. On 4th April 2020, the patient experienced headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and chills were recovered/resolved and the outcome of the fatigue and headache were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fatigue, chills and headache to be related to Shingrix.  Additional details were provided as follows: On 1st April 2020, the patient experienced a sore arm again, but that evening also felt very fatigued. On Thursday, 2nd April 2020, she had some chills as well, but felt fine on Friday, 3rd April 2020. On Saturday, 4th April 2020, she experienced chills again along with a slight headache. She felt fine on Sunday, 5th April 2020, but this morning, 6th April 2020, she woke up with fatigue and a headache again. For the tolerability of 2nd dose, refer case US2020059964 reported for same patient.