chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: Pain at injection site; Inappropriate schedule of vaccine , patient choice; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose greater than 6 months before the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix somewhere else. The patient experienced pain at injection site after receiving Shingrix. The patient received 2nd dose of Shingrix late than the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Cold sores; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 3R774, expiry date 8th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced cold sores. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site warmth
Clinical narrative: warm; swelling; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, 1 week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the patient experienced injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patientr received dose of Shingrix in the left arm  in the beginning of December 2019. A week later the injection site area started to swell, 3 to 4 weeks ago the swelling started to progress and was now present down her arm to the crease. Less than 2 months after vaccination, the patient experienced injection site warmth. The reporter stated that, recently  has also become warm to the touch. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Blood iron decreased, Fatigue, Herpes zoster, Malaise
Clinical narrative: chronic fatigue; Her WBC's  went up; RCB were up; iron was very low; her B12 was low; noted she could not get out of bed; had shingles in her mouth, nostrils and throat; sick; as high as 104; sore throat; couldn't lift her head from the pillow; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lyme disease (noted that was not an issue when she received the Shingrix). Previously administered products included Zostavax (in 2009).   On 14th January 2019, the patient received the 1st dose of Shingrix. On 15th January 2019, 1 days after receiving Shingrix and an unknown time after starting Zovirax, the patient experienced shingles, malaise, fever, sore throat, muscle weakness and bedridden. In January 2020, the patient experienced white blood cell count increased, red blood cell count increased, iron decreased and vitamin b12 decreased. On an unknown date, the patient experienced chronic fatigue. The patient was treated with acyclovir (Zovirax), prednisone and iron. On 1st February 2019, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the malaise, sore throat, muscle weakness, white blood cell count increased, red blood cell count increased and bedridden were unknown and the outcome of the fever, chronic fatigue, iron decreased and vitamin b12 decreased were not recovered/not resolved.   It was unknown if the reporter considered the shingles, malaise, fever, sore throat, muscle weakness, chronic fatigue, white blood cell count increased, red blood cell count increased, iron decreased, vitamin b12 decreased and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and the day after the vaccine, that morning, she arose and had shingles in her mouth, nostrils and throat. She noted she was sick, couldn't lift her head from the pillow, sore throat and fever that started the following day that started low but got to as high as 104. She noted she could not get out of bed. She was seen by her private physician on Monday and prescribed Zovirax. She states she got sicker. She saw her private doctor prednisone shot and dose pack were prescribed. She noted she still has low grade fever off and on a year later along with chronic fatigue. She also noted her bloodwork was out of whack. Her WBC went up, her RCB were up, her iron was very low, and her B12 was low. She was placed on shots for the low iron, which it did come up but then has gone back down low and she was back on shots. The caller noted she had a history of Lyme disease, but noted that was not an issue when she received the Shingrix.  The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Oropharyngeal pain, Pyrexia, Red blood cell count increased, Vitamin B12 decreased
Clinical narrative: chronic fatigue; Her WBC's  went up; RCB were up; iron was very low; her B12 was low; noted she could not get out of bed; had shingles in her mouth, nostrils and throat; sick; as high as 104; sore throat; couldn't lift her head from the pillow; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lyme disease (noted that was not an issue when she received the Shingrix). Previously administered products included Zostavax (in 2009).   On 14th January 2019, the patient received the 1st dose of Shingrix. On 15th January 2019, 1 days after receiving Shingrix and an unknown time after starting Zovirax, the patient experienced shingles, malaise, fever, sore throat, muscle weakness and bedridden. In January 2020, the patient experienced white blood cell count increased, red blood cell count increased, iron decreased and vitamin b12 decreased. On an unknown date, the patient experienced chronic fatigue. The patient was treated with acyclovir (Zovirax), prednisone and iron. On 1st February 2019, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the malaise, sore throat, muscle weakness, white blood cell count increased, red blood cell count increased and bedridden were unknown and the outcome of the fever, chronic fatigue, iron decreased and vitamin b12 decreased were not recovered/not resolved.   It was unknown if the reporter considered the shingles, malaise, fever, sore throat, muscle weakness, chronic fatigue, white blood cell count increased, red blood cell count increased, iron decreased, vitamin b12 decreased and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and the day after the vaccine, that morning, she arose and had shingles in her mouth, nostrils and throat. She noted she was sick, couldn't lift her head from the pillow, sore throat and fever that started the following day that started low but got to as high as 104. She noted she could not get out of bed. She was seen by her private physician on Monday and prescribed Zovirax. She states she got sicker. She saw her private doctor prednisone shot and dose pack were prescribed. She noted she still has low grade fever off and on a year later along with chronic fatigue. She also noted her bloodwork was out of whack. Her WBC went up, her RCB were up, her iron was very low, and her B12 was low. She was placed on shots for the low iron, which it did come up but then has gone back down low and she was back on shots. The caller noted she had a history of Lyme disease, but noted that was not an issue when she received the Shingrix.  The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: chronic fatigue; Her WBC's  went up; RCB were up; iron was very low; her B12 was low; noted she could not get out of bed; had shingles in her mouth, nostrils and throat; sick; as high as 104; sore throat; couldn't lift her head from the pillow; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lyme disease (noted that was not an issue when she received the Shingrix). Previously administered products included Zostavax (in 2009).   On 14th January 2019, the patient received the 1st dose of Shingrix. On 15th January 2019, 1 days after receiving Shingrix and an unknown time after starting Zovirax, the patient experienced shingles, malaise, fever, sore throat, muscle weakness and bedridden. In January 2020, the patient experienced white blood cell count increased, red blood cell count increased, iron decreased and vitamin b12 decreased. On an unknown date, the patient experienced chronic fatigue. The patient was treated with acyclovir (Zovirax), prednisone and iron. On 1st February 2019, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the malaise, sore throat, muscle weakness, white blood cell count increased, red blood cell count increased and bedridden were unknown and the outcome of the fever, chronic fatigue, iron decreased and vitamin b12 decreased were not recovered/not resolved.   It was unknown if the reporter considered the shingles, malaise, fever, sore throat, muscle weakness, chronic fatigue, white blood cell count increased, red blood cell count increased, iron decreased, vitamin b12 decreased and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and the day after the vaccine, that morning, she arose and had shingles in her mouth, nostrils and throat. She noted she was sick, couldn't lift her head from the pillow, sore throat and fever that started the following day that started low but got to as high as 104. She noted she could not get out of bed. She was seen by her private physician on Monday and prescribed Zovirax. She states she got sicker. She saw her private doctor prednisone shot and dose pack were prescribed. She noted she still has low grade fever off and on a year later along with chronic fatigue. She also noted her bloodwork was out of whack. Her WBC went up, her RCB were up, her iron was very low, and her B12 was low. She was placed on shots for the low iron, which it did come up but then has gone back down low and she was back on shots. The caller noted she had a history of Lyme disease, but noted that was not an issue when she received the Shingrix.  The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Myalgia, Peripheral swelling
Clinical narrative: Redness in the arm; Swollen; Muscle pain; This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and muscle pain. On an unknown date, the outcome of the erythema of extremities, swelling arm and muscle pain were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The patient received Shingrix and developed redness in the arm, swollen and muscle pain. The reporter consented to follow up. All patient identifiers were given.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Redness in the arm; Swollen; Muscle pain; This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and muscle pain. On an unknown date, the outcome of the erythema of extremities, swelling arm and muscle pain were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The patient received Shingrix and developed redness in the arm, swollen and muscle pain. The reporter consented to follow up. All patient identifiers were given.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypertension, Injection site pain, Insomnia, Pain, Pyrexia
Clinical narrative: pain at the injection site; fever; aches; high blood pressure; trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles, sinus congestion and headache.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On 2nd October 2019, 10 hrs after receiving Shingrix, the patient experienced injection site pain, fever and pain. In October 2019, the patient experienced blood pressure high and difficulty sleeping. On an unknown date, the outcome of the injection site pain, fever and pain were recovered/resolved and the outcome of the blood pressure high and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, pain, blood pressure high and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows:  The reporter stated that within 10 hours of vaccination he developed pain at the injection site, fever, and aches.  The events resolved within a few days. The patient stated he also had developed high blood pressure and trouble sleeping, which was unresolved till the time of reporting. The reporter consented to follow up. Time to onset was considered as 10 hours as per source document. This case is linked to case US2020007427 reported by the same patient by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced urinary tract infection. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the urinary tract infection was not recovered/not resolved.   It was unknown if the reporter considered the urinary tract infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated she was currently on an antibiotic for Urinary tract infection.   The patient was asking if she could get second dose of Shingrix. No other information was provided.  The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain, Muscular weakness
Clinical narrative: Tenderness at the injection site; Redness at the injection site; irritation; physical weakness; Fatigue/when exerting himself like going shopping; Low fever; muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bone marrow transplant (from 2016). Previously administered products included Immunosupressive drugs (were stopped a couple of years prior to getting the Shingrix vaccine).   On 1st October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 10th October 2019, 9 days after receiving Shingrix, the patient experienced fatigue. On an unknown date, the patient experienced injection site tenderness, injection site erythema, low grade fever, muscle weakness, skin irritation and weakness. On an unknown date, the outcome of the injection site tenderness, injection site erythema, low grade fever and muscle weakness were recovered/resolved and the outcome of the skin irritation, fatigue and weakness were unknown.   It was unknown if the reporter considered the injection site tenderness, injection site erythema, low grade fever, muscle weakness, skin irritation, fatigue and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix intramuscularly and experienced a low fever and then the symptom resolved. The fatigue started and dissipated. Muscle weakness started to occur two weeks. The muscle weakness lasted for about two months and basically put him on the couch because of the physical, muscular weakness and fatigue when exerting himself like going shopping. He experienced tenderness and redness at the injection site. The patient was a bone morrow transplant survivor. He also had a series of transplant vaccinations after his transplant and the Shingrix was the last vaccination on the schedule. All other vaccinations were completed 6 months prior to getting the Shingrix vaccine. The patient refused to provide his DOB.  The reporter consented to follow up. For tolerance to 2nd dose, refer case US2020AMR009634.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Skin irritation
Clinical narrative: Tenderness at the injection site; Redness at the injection site; irritation; physical weakness; Fatigue/when exerting himself like going shopping; Low fever; muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bone marrow transplant (from 2016). Previously administered products included Immunosupressive drugs (were stopped a couple of years prior to getting the Shingrix vaccine).   On 1st October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 10th October 2019, 9 days after receiving Shingrix, the patient experienced fatigue. On an unknown date, the patient experienced injection site tenderness, injection site erythema, low grade fever, muscle weakness, skin irritation and weakness. On an unknown date, the outcome of the injection site tenderness, injection site erythema, low grade fever and muscle weakness were recovered/resolved and the outcome of the skin irritation, fatigue and weakness were unknown.   It was unknown if the reporter considered the injection site tenderness, injection site erythema, low grade fever, muscle weakness, skin irritation, fatigue and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix intramuscularly and experienced a low fever and then the symptom resolved. The fatigue started and dissipated. Muscle weakness started to occur two weeks. The muscle weakness lasted for about two months and basically put him on the couch because of the physical, muscular weakness and fatigue when exerting himself like going shopping. He experienced tenderness and redness at the injection site. The patient was a bone morrow transplant survivor. He also had a series of transplant vaccinations after his transplant and the Shingrix was the last vaccination on the schedule. All other vaccinations were completed 6 months prior to getting the Shingrix vaccine. The patient refused to provide his DOB.  The reporter consented to follow up. For tolerance to 2nd dose, refer case US2020AMR009634.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: Shingles after Shingrix; lesions; pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles, skin lesion and pain. On an unknown date, the outcome of the shingles, skin lesion and pain were unknown.   It was unknown if the reporter considered the shingles, skin lesion and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced Shingles, lesion and pain after receiving Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise
Clinical narrative: felt very sick; he couldn't function well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced feeling unwell and activities of daily living impaired. On an unknown date, the outcome of the feeling unwell and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and activities of daily living impaired to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported but it could be 50 to 51 years. The patient experienced very sick, after receiving 1st dose of Shingrix. For about 3 days he could not function well. The reporter consented to follow up. For tolerance with 2nd dose refer linked case.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash erythematous, Scab
Clinical narrative: Shingles rash; blisters appeared on the left side of the back and left under arm; red spots to darker spots; Irritation by her bra; Red spots; blisters are present but they are starting to crust over; pain all over the place where the rash was present; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 9th January 2020, 9 days after receiving Shingrix, the patient experienced pain. On an unknown date, the patient experienced shingles, blister, skin discoloration, skin irritation, red spotty rash and crust. On an unknown date, the outcome of the shingles, blister, skin discoloration, skin irritation, pain, red spotty rash and crust were unknown.   It was unknown if the reporter considered the shingles, blister, skin discoloration, skin irritation, pain, red spotty rash and crust to be related to Shingrix.  Additional details were provided as follows: Patient received Shingrix about a week later she started experiencing irritation by her bra rubbing underneath the arm. Next day blisters appeared on the left side of the back and left under arm. It got worse and worse and it wrapped around the left breast. It went from red spots to darker spots. It wrapped from middle of the spine, to the back, under the arm and over the breast.  All of this occurred on left side of the body. Patient stated that her back looked like was someone had whipped her and then it started to go away.  The blisters are present but they are starting to crust over on some of them.  On 8th January 2020 she visited her doctor, and she was confirmed to have Shingles. On 9th January 2020 she experienced pain all over the place where the rash was present, especially her breast area. Reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Skin irritation
Clinical narrative: Shingles rash; blisters appeared on the left side of the back and left under arm; red spots to darker spots; Irritation by her bra; Red spots; blisters are present but they are starting to crust over; pain all over the place where the rash was present; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 9th January 2020, 9 days after receiving Shingrix, the patient experienced pain. On an unknown date, the patient experienced shingles, blister, skin discoloration, skin irritation, red spotty rash and crust. On an unknown date, the outcome of the shingles, blister, skin discoloration, skin irritation, pain, red spotty rash and crust were unknown.   It was unknown if the reporter considered the shingles, blister, skin discoloration, skin irritation, pain, red spotty rash and crust to be related to Shingrix.  Additional details were provided as follows: Patient received Shingrix about a week later she started experiencing irritation by her bra rubbing underneath the arm. Next day blisters appeared on the left side of the back and left under arm. It got worse and worse and it wrapped around the left breast. It went from red spots to darker spots. It wrapped from middle of the spine, to the back, under the arm and over the breast.  All of this occurred on left side of the body. Patient stated that her back looked like was someone had whipped her and then it started to go away.  The blisters are present but they are starting to crust over on some of them.  On 8th January 2020 she visited her doctor, and she was confirmed to have Shingles. On 9th January 2020 she experienced pain all over the place where the rash was present, especially her breast area. Reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fall, Pyrexia, Syncope
Clinical narrative: fever; chills; fainted; fell on the floor; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fainting (not after vaccines but during medical procedures). The patient had a Family History of fainting (she comes from a family of fainters).   On 30th July 2019 12:45, the patient received the 1st dose of Shingrix. In July 2019, 13 hrs 15 min after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant) and fall. On 30th July 2019 22:00, the patient experienced fever and chills. On an unknown date, the outcome of the fainting, fall, fever and chills were recovered/resolved.   It was unknown if the reporter considered the fainting, fall, fever and chills to be related to Shingrix.  Additional details were provided as follows: At night 9 hours and 15 minutes after vaccination, the patient presented with symptoms of fever and chills. Early the next morning at approximately 2 or 3 am, the patient got up to go to the bathroom and fainted and fell on the floor and recovered after some time. The other symptoms resolved the next day. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: fainted; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient's friend. The age at vaccination was not reported. The patient fainted when she got up to go the bathroom during the night after receiving the vaccine that day.  The reporter did not consent to follow-up. The reporter declined to provide any additional details. This case has been linked with case US2020009790, reported by same reporter.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Expired product administered
Clinical narrative: Infanrix was given to pt. as part of her routine vaccinations. The dose was expired, and pt. had to return to clinic to be re vaccinated.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Myalgia
Clinical narrative: headache, muscle ache overall. dizziness
Age: 1.5
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Crying, Dysstasia, Gait disturbance, Insomnia, Pain
Clinical narrative: My son took a 3 hour nap after his appointment and as soon as he woke up he cried/screamed for the next 12 hours. This has not happened after any other vaccine appointments. He is so sore he will not walk or stand. My son has never not been able to sleep for 2-3 hour stretches, but did nothing but cry out last night.
Age: 1.5
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Screaming
Clinical narrative: My son took a 3 hour nap after his appointment and as soon as he woke up he cried/screamed for the next 12 hours. This has not happened after any other vaccine appointments. He is so sore he will not walk or stand. My son has never not been able to sleep for 2-3 hour stretches, but did nothing but cry out last night.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave adult dose instead of Pediatric dose.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Patient received the first dose of Shingrix in her left deltoid. The next day she began experiencing muscle pain and was unable to raise her arm above shoulder level. Upon doctor visit it was discovered that vaccine had entered the bursa and caused joint lock. Doctor believes vaccine was administered to high.  Patient has since made a full recovery and has regained full range of motion in her left arm. Patient just received the second dose of the Shingrix to complete the series in her left arm and has had no reactions at this time.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Influenza like illness, Local reaction, Nausea
Clinical narrative: Was vaccinated at approx 4pm on 1/16/20.  Woke up at 2am on 1/17/20 with headache.  Went to work but developed nausea and a sore arm. Symptoms became worse by mid-day with flu like symptoms and she left work early and went to bed. 1/17-1/20 stayed in bed, took motrin and slept. 1/21 Went back to work, arm continued to hurt with pain shooting up into her shoulder, neck and ear. Also, noted skin was blotchy.  Went to clinic who refered to PCP.  PCP gave Keflex for possible cellulitis and questioned injection site. (rash often seen above and below the injection site). PCP said she should still get #2. 1/23/20 followed up with patient and symptoms were improving. Systemic symptoms had resolved and local reaction was getting a little bit better each day.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Rash macular
Clinical narrative: Was vaccinated at approx 4pm on 1/16/20.  Woke up at 2am on 1/17/20 with headache.  Went to work but developed nausea and a sore arm. Symptoms became worse by mid-day with flu like symptoms and she left work early and went to bed. 1/17-1/20 stayed in bed, took motrin and slept. 1/21 Went back to work, arm continued to hurt with pain shooting up into her shoulder, neck and ear. Also, noted skin was blotchy.  Went to clinic who refered to PCP.  PCP gave Keflex for possible cellulitis and questioned injection site. (rash often seen above and below the injection site). PCP said she should still get #2. 1/23/20 followed up with patient and symptoms were improving. Systemic symptoms had resolved and local reaction was getting a little bit better each day.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site vesicles
Clinical narrative: On 1/22/20, mother of patient reports patient has a red, painful arm where his varicella vaccine was given 13 days ago. She stated he had only just brought it to her attention. He does not complain of itching, only pain. She says he has a low grade fever, but she thinks that's from an illness his sister has had. He does not have a rash. Phone call on 1/23/2020, Mom says hard lump is less today, but still red and rashy at vaccine site. Otherwise, no fever, feels well, active. No new symptoms. Mother of patient brought patient into Health Office on 1/24/2020. Swelling has decreased significantly, although there are now 5 vesicles noted around vaccine injection site. No fever. Patient reports they are starting to itch.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Mass, Pyrexia, Swelling, Vaccination site rash
Clinical narrative: On 1/22/20, mother of patient reports patient has a red, painful arm where his varicella vaccine was given 13 days ago. She stated he had only just brought it to her attention. He does not complain of itching, only pain. She says he has a low grade fever, but she thinks that's from an illness his sister has had. He does not have a rash. Phone call on 1/23/2020, Mom says hard lump is less today, but still red and rashy at vaccine site. Otherwise, no fever, feels well, active. No new symptoms. Mother of patient brought patient into Health Office on 1/24/2020. Swelling has decreased significantly, although there are now 5 vesicles noted around vaccine injection site. No fever. Patient reports they are starting to itch.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle disorder, Skin indentation, X-ray normal
Clinical narrative: Small, half dollar sized area on arm is indented, looks like muscle death
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV
Symptoms: Rash erythematous, Rash pruritic, Varicella post vaccine
Clinical narrative: pt seen in office today for itchy red spotty rash examined by NP dx with varicella
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling abnormal, Influenza like illness, Injection site erythema
Clinical narrative: Was vaccinated at approx 4pm on 1/16/20.  1/17/20 Went to work but felt a little "off". Symptoms became worse by mid-day and she visited the SNT, no fever. She left work early and went to bed. She started with fever, 102.3 and overnight she started with flu like symptoms, shivering, muscle aches and nausea. She described the symptoms as "AWFUL".  1/18 she remained in bed and arm became sore, by 1/19 her arm was hot to touch with a red circle around injection site and around the whole arm.  1/20 arm remained painful. 1/21 Went back to work and saw the SNT who refered to PCP.  PCP gave Keflex for possible cellulitis and questioned injection site. (rash often seen above and below the injection site). PCP said she should still get #2. 1/22/20 followed up with patient and symptoms were improving. Systemic symptoms had resolved and local reaction was much better with the Keflex .
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Was vaccinated at approx 4pm on 1/16/20.  1/17/20 Went to work but felt a little "off". Symptoms became worse by mid-day and she visited the SNT, no fever. She left work early and went to bed. She started with fever, 102.3 and overnight she started with flu like symptoms, shivering, muscle aches and nausea. She described the symptoms as "AWFUL".  1/18 she remained in bed and arm became sore, by 1/19 her arm was hot to touch with a red circle around injection site and around the whole arm.  1/20 arm remained painful. 1/21 Went back to work and saw the SNT who refered to PCP.  PCP gave Keflex for possible cellulitis and questioned injection site. (rash often seen above and below the injection site). PCP said she should still get #2. 1/22/20 followed up with patient and symptoms were improving. Systemic symptoms had resolved and local reaction was much better with the Keflex .
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Was vaccinated at approx 4pm on 1/16/20.  1/17/20 Went to work but felt a little "off". Symptoms became worse by mid-day and she visited the SNT, no fever. She left work early and went to bed. She started with fever, 102.3 and overnight she started with flu like symptoms, shivering, muscle aches and nausea. She described the symptoms as "AWFUL".  1/18 she remained in bed and arm became sore, by 1/19 her arm was hot to touch with a red circle around injection site and around the whole arm.  1/20 arm remained painful. 1/21 Went back to work and saw the SNT who refered to PCP.  PCP gave Keflex for possible cellulitis and questioned injection site. (rash often seen above and below the injection site). PCP said she should still get #2. 1/22/20 followed up with patient and symptoms were improving. Systemic symptoms had resolved and local reaction was much better with the Keflex .
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Facial pain, Fatigue, Head injury, Headache, Loss of consciousness
Clinical narrative: Patient went to waiting room to wait 15 min following vaccines. She got up during this wait time and went to the restroom. While standing at sink after using the toilet she fainted and hit her L forehead/L eye brow on the floor. Mom called from the bathroom for help and Dr and I both went to help. I found her on the floor on her left side, unconscious, I rolled her over to her back and she opened her eyes. Mom sat her up. Patient did not communicate verbally (normal for her) but would nod yes/no. I asked where she had pain and she pointed to her forehead/L eyebrow. Dr and Mom carried patient to an exam room and we had her lay down on exam table. She looked quite pale and tired, initial BP was low 78/60, HR 45. Patient denied feeling nauseated but admitted to feeling tired. We sat her up, gave her applesauce and some water. Mom reported she had not eaten anything yet today. I had her lay down to rest. 10 min later we rechecked BP which was 100/76, HR 60-70s, color in face much improved. Patient ready to sit up. Sat for 5 minutes w/o any recurrence of symptoms so helped her stand. She left office in stable condition, exam normal except for a bruise to L forehead/eyebrow. Instructed Mom to keep her home today and be sure to feed her prior to her booster dose of HPV in 6 months.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Patient went to waiting room to wait 15 min following vaccines. She got up during this wait time and went to the restroom. While standing at sink after using the toilet she fainted and hit her L forehead/L eye brow on the floor. Mom called from the bathroom for help and Dr and I both went to help. I found her on the floor on her left side, unconscious, I rolled her over to her back and she opened her eyes. Mom sat her up. Patient did not communicate verbally (normal for her) but would nod yes/no. I asked where she had pain and she pointed to her forehead/L eyebrow. Dr and Mom carried patient to an exam room and we had her lay down on exam table. She looked quite pale and tired, initial BP was low 78/60, HR 45. Patient denied feeling nauseated but admitted to feeling tired. We sat her up, gave her applesauce and some water. Mom reported she had not eaten anything yet today. I had her lay down to rest. 10 min later we rechecked BP which was 100/76, HR 60-70s, color in face much improved. Patient ready to sit up. Sat for 5 minutes w/o any recurrence of symptoms so helped her stand. She left office in stable condition, exam normal except for a bruise to L forehead/eyebrow. Instructed Mom to keep her home today and be sure to feed her prior to her booster dose of HPV in 6 months.
Age: 18.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Impaired driving ability, Loss of consciousness, Vision blurred
Clinical narrative: Client presented to clinic for 3rd injection today and reported that she experienced an episode of loss of consciousness 2 hours post vaccination after second dose of Rabies vaccine, while at school. Client stated that she did not have anything to eat prior to appointment and that she had to call her boyfriend to pick her up because she could not drive. 911 was not contacted.  She stated that she continued to feel light headed and experienced blurry vison for approximately 1 hour after incident.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, Measles antibody positive, No adverse event
Clinical narrative: Dose administered was 0.5 ml from a vial of expired MMR. Expiration date was 12/4/2019. Patient was observed for 30 minutes plus and no adverse reactions were noted or reported by patient. Discharged at 4 pm in stable condition with instructions to return to Student Health or go to nearest Emergency Room if any adverse events occur as noted on Vis dated 8/15/19. I contact Merck - spoke with RN - reported incident. He confirmed that Merck internal data supported the potency of the vaccine under the conditions I explained to him & vaccine storage recorded. Merck Case # 01465644 was created by RN. I contacted regional director of Dept. of Health & reported the incident. As of this report, the patient has not returned to report any adverse effects. MMR Vaccine has been pulled & discarded from vaccine supplies. Procedure reviewed in house & additional staff training implemented. Patients IgG titer confirmed measles immunity from 1st dose administered in 1999. No further MMR vaccination recommended.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Symptoms: SkinRash & Rash
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Narrative: Pt treated skin rash with diphenhydramine 25mg prn and prednisone tapering dose.  Symptoms: UrticariaPruritus
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Started getting red/ swollen the evening of vaccine. next morning it was size of half dollar and hard.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Chills, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Pt had returned to clinic 1/23/2020 post injection - Pt reports 1 day post-injection, pt had localized swelling, redness and warmth at site of injection. Associated symptoms of fever, chills, nausea, abdominal bloating and fatigue. Fever and chills resolved in 1 day. Pt states took Advil every 8h x 3 days during onset of symptoms. Per pt, symptoms overall resolving but still has fatigue, nausea, abd bloating, mild erythema and warmth to injection site. Pt instructed to apply cold compress and take acetaminophen PRN for localized reaction and pain, respectively. Also advised on BRAT diet. Planning for pt to F/U in 4 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Local reaction, Nausea, Pain, Pyrexia
Clinical narrative: Pt had returned to clinic 1/23/2020 post injection - Pt reports 1 day post-injection, pt had localized swelling, redness and warmth at site of injection. Associated symptoms of fever, chills, nausea, abdominal bloating and fatigue. Fever and chills resolved in 1 day. Pt states took Advil every 8h x 3 days during onset of symptoms. Per pt, symptoms overall resolving but still has fatigue, nausea, abd bloating, mild erythema and warmth to injection site. Pt instructed to apply cold compress and take acetaminophen PRN for localized reaction and pain, respectively. Also advised on BRAT diet. Planning for pt to F/U in 4 days.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain
Clinical narrative: patient came in the morning after vaccine was given complaining of pain at the injection site. he said his upper arm felt hard but there was no redness or sign of cellulitis. He was advised to apply ice and take ibuprofen for any swelling and if it does not get better to contact his prescriber.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Cyanosis, Ear infection, Encephalitis, Febrile convulsion, Laboratory test
Clinical narrative: Daughter suddenly stopped breathing, turned blue,  eyes open & fully dilated,  and making a terrible sound. Called 911, rushed to ER by ambulance, ER mis-diagnosed her with laryngospasms, sent us to Pediatrician for follow up. Pediatrician concurred with ER, sent us to ENT specialist for follow up. ENT specialist did scope of larynx--said everything looked fine. Went back to pediatrician, asked about the possibility of febrile seizures after second episode occurred. She agreed that it could be, sent a referral to Neurologist for follow up. After waiting weeks to get scheduled with a neurologist and several more months to get in we held off.  Shortly after, another episode occurred at the Dr's office , right on the doctor's table while we were there for ear infection treatment. The doctor we saw that day finally diagnosed her with febrile seizures after witnessing the  seizures first hand. Eventually found a different practice where the new Doctor diagnosed Encephalitis, and liver damage due to metal toxicity in liver from the 12 month vaccine series.