chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Swollen, sore arm at injection site. Fever, chills, and intense stomach pain. Symptoms did not subside after a few days.
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Injection site reaction, Pain in extremity, Pyrexia
Clinical narrative: Pt had Td vax and abx due to chemical burn on foot. Presents 2 d later to ER with 103 fever, arm pain, injection site reaction. Given ibuprofen and return precautions. Stated in narrative as Td with no pertussis component (given at physician office), unknown details.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Abdominal pain upper, Pruritus, Swelling
Clinical narrative: Swelling over 3 inches, itching, stomach ache.
Age: 0.83
Sex: F
Vaccine: DTAP
Symptoms: Depressed level of consciousness, Eye movement disorder, Hypophagia, Inability to crawl, Pyrexia
Clinical narrative: Within two hours had decreased level of consciousness and fever, then got a rash. Eyes glazed over and rolled back in head. Would not eat, sit up, crawl or focus with eyes for 7 days. Regressed back to infant stage. Would only drink some milk. Not interested in playing.
Age: 0.83
Sex: F
Vaccine: DTAP
Symptoms: Rash, Regressive behaviour, Staring, Vision blurred
Clinical narrative: Within two hours had decreased level of consciousness and fever, then got a rash. Eyes glazed over and rolled back in head. Would not eat, sit up, crawl or focus with eyes for 7 days. Regressed back to infant stage. Would only drink some milk. Not interested in playing.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Dizziness, Eye pain
Clinical narrative: Right arm pain and weakness at vaccine site at 4:30pm, weird dizzy feeling and chills and fuzzy feeling in head at 5:15pm, took temp, 100 degrees at 6pm, sharp headache on right side of head at 8pm, bad headache and right eyeball ache at 9pm, and 100.2 degree fever, all on 8/14/18, on day of vaccine. Next day, 8/15/2018, 100.3 degree fever, right arm ache at vaccine site, chills and sweats alternating, nauseous, stomach ache, intense headache and eyeball ache on right side, exhausted and weak feeling, alternating chills and sweats.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Feeling of body temperature change, Headache, Hyperhidrosis
Clinical narrative: Right arm pain and weakness at vaccine site at 4:30pm, weird dizzy feeling and chills and fuzzy feeling in head at 5:15pm, took temp, 100 degrees at 6pm, sharp headache on right side of head at 8pm, bad headache and right eyeball ache at 9pm, and 100.2 degree fever, all on 8/14/18, on day of vaccine. Next day, 8/15/2018, 100.3 degree fever, right arm ache at vaccine site, chills and sweats alternating, nauseous, stomach ache, intense headache and eyeball ache on right side, exhausted and weak feeling, alternating chills and sweats.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Right arm pain and weakness at vaccine site at 4:30pm, weird dizzy feeling and chills and fuzzy feeling in head at 5:15pm, took temp, 100 degrees at 6pm, sharp headache on right side of head at 8pm, bad headache and right eyeball ache at 9pm, and 100.2 degree fever, all on 8/14/18, on day of vaccine. Next day, 8/15/2018, 100.3 degree fever, right arm ache at vaccine site, chills and sweats alternating, nauseous, stomach ache, intense headache and eyeball ache on right side, exhausted and weak feeling, alternating chills and sweats.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chest pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient reports heat and swelling at injection site, followed by fever which started around 8 am on 8/15. Pt complaints of "heavy chest feeling that hurts to take deep breaths". Patient states that she has been "hurting from head to tow and has stayed in bed all day". Patient called pharmacy to report these symptoms at approximately 6:30 pm on 8/15/18.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Painful respiration, Pyrexia
Clinical narrative: Patient reports heat and swelling at injection site, followed by fever which started around 8 am on 8/15. Pt complaints of "heavy chest feeling that hurts to take deep breaths". Patient states that she has been "hurting from head to tow and has stayed in bed all day". Patient called pharmacy to report these symptoms at approximately 6:30 pm on 8/15/18.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Agitation, Anger, Crying, Dysarthria, Dyskinesia
Clinical narrative: 8/3/18 Patient received 2 vaccines in the office. Mom called 1/2 hr. later noted pt. had some abnormal movements of left side of his face for about a minute and slurred speech 10-15 mins. She mentioned that he had similar episodes a year ago; concerned if this episode was vaccine reaction. Returned to clinic acting normal, responding. Addendum: 08/04/2018 01:54 AM Mom called on phone about 1/2 hr. later that they noted pt. had some abnormal movements of left side of his face and had slurred speech for about 10-15 min. She mentioned that he had similar episode a year ago, concerned if this episode was a vaccine reaction, by the time she called pt. was acting normal self, seemed to have some droop of left side of mouth, did not have any other abnormal body movements. Patient was quite upset, agitated and crying with vaccine administration. Asked mom to RTC for evaluation. On return mom reported that a year ago he had a similar episode, was taken to ER and was admitted to the hospital, he had full workup for seizure and was told as possible febrile seizure and was later had F/U with pedi. neurologist, was advised watchful monitoring. On evaluation when pt. returned to clinic today, about an hour later he was acting his normal self, active, responding and interacting very well. Speech was normal, eye exam normal, with EOMI, PERLA, face symmetrical, normal neuro exam. Discussed in detail with mom about the etiology of the episode - possible focal seizure, cause of it could be from agitation and crying, but not adverse reaction to vaccine as child is clinically well at this time reassured mom, advised watchful monitoring and advised on seizure precautions, F/U with neurologist ASAP. Mom expressed understanding and agrees with the plan, she felt very assured after the exam and advice. 08/04/2018 01:56 AM, Assessment: possible seizure. 08/04/2018 02:25 AM, abnormal movement of left side of face lasted for about 1 min per mom, report.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Facial paralysis, Neurological examination normal
Clinical narrative: 8/3/18 Patient received 2 vaccines in the office. Mom called 1/2 hr. later noted pt. had some abnormal movements of left side of his face for about a minute and slurred speech 10-15 mins. She mentioned that he had similar episodes a year ago; concerned if this episode was vaccine reaction. Returned to clinic acting normal, responding. Addendum: 08/04/2018 01:54 AM Mom called on phone about 1/2 hr. later that they noted pt. had some abnormal movements of left side of his face and had slurred speech for about 10-15 min. She mentioned that he had similar episode a year ago, concerned if this episode was a vaccine reaction, by the time she called pt. was acting normal self, seemed to have some droop of left side of mouth, did not have any other abnormal body movements. Patient was quite upset, agitated and crying with vaccine administration. Asked mom to RTC for evaluation. On return mom reported that a year ago he had a similar episode, was taken to ER and was admitted to the hospital, he had full workup for seizure and was told as possible febrile seizure and was later had F/U with pedi. neurologist, was advised watchful monitoring. On evaluation when pt. returned to clinic today, about an hour later he was acting his normal self, active, responding and interacting very well. Speech was normal, eye exam normal, with EOMI, PERLA, face symmetrical, normal neuro exam. Discussed in detail with mom about the etiology of the episode - possible focal seizure, cause of it could be from agitation and crying, but not adverse reaction to vaccine as child is clinically well at this time reassured mom, advised watchful monitoring and advised on seizure precautions, F/U with neurologist ASAP. Mom expressed understanding and agrees with the plan, she felt very assured after the exam and advice. 08/04/2018 01:56 AM, Assessment: possible seizure. 08/04/2018 02:25 AM, abnormal movement of left side of face lasted for about 1 min per mom, report.
Age: 2.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at the injection site on (L) Lateral thigh. Area was also itchy and hot to the touch. Practitioner prescribed AUGMENTIN to treat a cellulitis infection of (L) thigh.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site swelling, Oropharyngeal pain, Pyrexia, Streptococcus test negative
Clinical narrative: Developed swelling in left arm, and fever. Went to urgent care and was diagnosed with cellulitis of left upper arm. Given prescription for cephalexin 250mg/5ml: take 5 ml by mouth 4 times a day for 10 days, total 200ml.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Erythemous rash approximately 12cm x 7cm on Right upper deltoid.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Pain, Rash, Rash erythematous
Clinical narrative: Pt came today (08-07-18) for 2nd SHINGRIX vacc. Linear rash noted under (R) eye. Pt says she broke out in a red raised rash the day after receiving 1st SHINGRIX (05-31-18) c/o rash and pain on (R) side of ace only and generalized achiness. No fever. Symptoms lasted for couple months. 2nd vaccine not given today.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness, Ultrasound scan
Clinical narrative: Red, swollen, tender from shoulder to elbow, no fever less than 24 hrs.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Constipation, Fatigue, Flatulence, Gastrointestinal pain
Clinical narrative: Bloating, constipation, gassy/gastrointestinal pains, tiredness/fatigue, malaise, irritable.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Irritability, Malaise
Clinical narrative: Bloating, constipation, gassy/gastrointestinal pains, tiredness/fatigue, malaise, irritable.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration, erythema at injection site.
Age: 72.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Cerebrovascular accident, Incomplete course of vaccination
Clinical narrative: My pharmacy manager spoke with the patient over the phone to remind the patient that he is due for his second dose of SHINGRIX. He stated he will not be receiving the second dose due to an adverse event. He stated he went to the hospital the next day from a possible stroke. His primary care physician suspected the vaccine may have been the reason for the stroke as it could have possibly hit a nerve. The patient nor the doctor's office contacted us in regards to the possible side effect of the vaccine.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Malaise Sat and Sun. Felt better.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Nausea, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 1st August 2018, the patient experienced shingles, nausea, fever and headache. On 2nd August 2018, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valaciclovir). On an unknown date, the outcome of the shingles, injection site pain, nausea, rash, fever and headache were unknown. It was unknown if the reporter considered the shingles, injection site pain, nausea, rash, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The patient had also reported the adverse events via VAERS. The patient received SHINGRIX vaccine in the left deltoid. The SHINGRIX vaccine hurted when going into the patient's top left shoulder. The patient developed a rash on her right forearm on the top and it had progressed toward the back and on her hand and wrist. The patient provided contact details of the physician. The patient stated that she was the second person to have a shingles outbreak after getting a SHINGRIX vaccination. Clarification had been requested for this patient. This case was linked with US2018GSK148796, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Injection site pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 1st August 2018, the patient experienced shingles, nausea, fever and headache. On 2nd August 2018, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valaciclovir). On an unknown date, the outcome of the shingles, injection site pain, nausea, rash, fever and headache were unknown. It was unknown if the reporter considered the shingles, injection site pain, nausea, rash, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The patient had also reported the adverse events via VAERS. The patient received SHINGRIX vaccine in the left deltoid. The SHINGRIX vaccine hurted when going into the patient's top left shoulder. The patient developed a rash on her right forearm on the top and it had progressed toward the back and on her hand and wrist. The patient provided contact details of the physician. The patient stated that she was the second person to have a shingles outbreak after getting a SHINGRIX vaccination. Clarification had been requested for this patient. This case was linked with US2018GSK148796, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 1st August 2018, the patient experienced shingles, nausea, fever and headache. On 2nd August 2018, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valaciclovir). On an unknown date, the outcome of the shingles, injection site pain, nausea, rash, fever and headache were unknown. It was unknown if the reporter considered the shingles, injection site pain, nausea, rash, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The patient had also reported the adverse events via VAERS. The patient received SHINGRIX vaccine in the left deltoid. The SHINGRIX vaccine hurted when going into the patient's top left shoulder. The patient developed a rash on her right forearm on the top and it had progressed toward the back and on her hand and wrist. The patient provided contact details of the physician. The patient stated that she was the second person to have a shingles outbreak after getting a SHINGRIX vaccination. Clarification had been requested for this patient. This case was linked with US2018GSK148796, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 1st August 2018, the patient experienced shingles, nausea, fever and headache. On 2nd August 2018, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valaciclovir). On an unknown date, the outcome of the shingles, injection site pain, nausea, rash, fever and headache were unknown. It was unknown if the reporter considered the shingles, injection site pain, nausea, rash, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The patient had also reported the adverse events via VAERS. The patient received SHINGRIX vaccine in the left deltoid. The SHINGRIX vaccine hurted when going into the patient's top left shoulder. The patient developed a rash on her right forearm on the top and it had progressed toward the back and on her hand and wrist. The patient provided contact details of the physician. The patient stated that she was the second person to have a shingles outbreak after getting a SHINGRIX vaccination. Clarification had been requested for this patient. This case was linked with US2018GSK148796, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Nausea, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced 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 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. The patient had a shingles outbreak after getting a SHINGRIX vaccination. This case was linked with US2018141927, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Injection site pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced 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 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. The patient had a shingles outbreak after getting a SHINGRIX vaccination. This case was linked with US2018141927, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced 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 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. The patient had a shingles outbreak after getting a SHINGRIX vaccination. This case was linked with US2018141927, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced 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 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. The patient had a shingles outbreak after getting a SHINGRIX vaccination. This case was linked with US2018141927, reported by the same reporter.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS, PPV
Symptoms: Infection
Clinical narrative: After having the shot at 3:30 PM in my left arm I had some soreness at the sight which gradually worsened later that night. By 11 PM the burning pain increased in my left arm, shoulder and neck. I went to another room so not to disturb my bed mate and took some OTC pain reliever and rubbed on some topical pain cream around 11:30 PM. The extreme burning pain worsened even more. I was unable to sleep or lie down. I paced around the room all night. At 7AM, my significant other took me to the emergency room at Hospital. At 8:50 AM, ER doctors and nurses treated me with intravenous injections for pain and antibiotics for infection. They noticed the injection was made high on arm. See attached copies of hospital - emergency report for treatment and diagnosis
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS, PPV
Symptoms: Abscess, C-reactive protein abnormal, Infection, Injection site pain, Insomnia
Clinical narrative: After having the shot at 3:30 PM in my left arm I had some soreness at the sight which gradually worsened later that night. By 11 PM the burning pain increased in my left arm, shoulder and neck. I went to another room so not to disturb my bed mate and took some OTC pain reliever and rubbed on some topical pain cream around 11:30 PM. The extreme burning pain worsened even more. I was unable to sleep or lie down. I paced around the room all night. At 7AM, my significant other took me to the emergency room at Hospital. At 8:50 AM, ER doctors and nurses treated me with intravenous injections for pain and antibiotics for infection. They noticed the injection was made high on arm. See attached copies of hospital - emergency report for treatment and diagnosis
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS, PPV
Symptoms: Metabolic function test, Nuclear magnetic resonance imaging abnormal, Pain, Product administered at inappropriate site, White blood cell count increased
Clinical narrative: After having the shot at 3:30 PM in my left arm I had some soreness at the sight which gradually worsened later that night. By 11 PM the burning pain increased in my left arm, shoulder and neck. I went to another room so not to disturb my bed mate and took some OTC pain reliever and rubbed on some topical pain cream around 11:30 PM. The extreme burning pain worsened even more. I was unable to sleep or lie down. I paced around the room all night. At 7AM, my significant other took me to the emergency room at Hospital. At 8:50 AM, ER doctors and nurses treated me with intravenous injections for pain and antibiotics for infection. They noticed the injection was made high on arm. See attached copies of hospital - emergency report for treatment and diagnosis
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX. On 29th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, muscle damage and activities of daily living impaired. The patient was treated with Nsaids (Unknown), steroids NOS and VICODIN. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the muscle damage and activities of daily living impaired were unknown. It was unknown if the reporter considered the injection site pain, muscle damage and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The patient reported his arm was sore in evening of day of vaccination. The next day, the patient had pain in the deltoid muscle of his left arm. Two weeks after the SHINGRIX injection, the patient consulted his physician who prescribed a course of steroid that provided some relief.  After the steroids were discontinued, the pain returned. The patient was given another round of unspecified stronger steroid. Again, some relief was obtained, but when the course of steroids was stopped, the pain returned. The patient was also prescribed VICODIN, at bedtime, to help him sleep and ease the arm pain. Even taking NSAIDs the pain was there at rest and pretty bad every time that he had to flex the deltoid. After two months of this pain, the patient went to his general physician (GP) and was put on a two week regimen of steroids. This greatly diminished the pain, but not totally. After the two weeks, when the steroids ran out, the pain came back. The GP's next step was to put the patient on a stronger steroid. At the time of reporting, the second shot of SHINGRIX was coming due, and the patient was not looking forward to it. Both the patient and the GP believed that SHINGRIX vaccine did some sort of permanent damage to the deltoid muscle. The patient could not be on steroids forever and wanted was for the pain to stop. It was greatly interfering with his daily life and should not be happening. The patient asked for suggestions. The patient had provided contact details of their physician.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Muscle injury
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX. On 29th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, muscle damage and activities of daily living impaired. The patient was treated with Nsaids (Unknown), steroids NOS and VICODIN. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the muscle damage and activities of daily living impaired were unknown. It was unknown if the reporter considered the injection site pain, muscle damage and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The patient reported his arm was sore in evening of day of vaccination. The next day, the patient had pain in the deltoid muscle of his left arm. Two weeks after the SHINGRIX injection, the patient consulted his physician who prescribed a course of steroid that provided some relief.  After the steroids were discontinued, the pain returned. The patient was given another round of unspecified stronger steroid. Again, some relief was obtained, but when the course of steroids was stopped, the pain returned. The patient was also prescribed VICODIN, at bedtime, to help him sleep and ease the arm pain. Even taking NSAIDs the pain was there at rest and pretty bad every time that he had to flex the deltoid. After two months of this pain, the patient went to his general physician (GP) and was put on a two week regimen of steroids. This greatly diminished the pain, but not totally. After the two weeks, when the steroids ran out, the pain came back. The GP's next step was to put the patient on a stronger steroid. At the time of reporting, the second shot of SHINGRIX was coming due, and the patient was not looking forward to it. Both the patient and the GP believed that SHINGRIX vaccine did some sort of permanent damage to the deltoid muscle. The patient could not be on steroids forever and wanted was for the pain to stop. It was greatly interfering with his daily life and should not be happening. The patient asked for suggestions. The patient had provided contact details of their physician.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Patient was ok for about 7 hours after vaccine, then developed fatigue and headache. Went to bed. Woke up with severe headache, aches all over body, and frightening tachycardia. She also had a low grade fever. I went away slowly in the morning. She is fine now.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Heart rate increased, Nausea, Pain in jaw, Pyrexia
Clinical narrative: Patient was ok for about 7 hours after vaccine, then developed fatigue and headache. Went to bed. Woke up with severe headache, aches all over body, and frightening tachycardia. She also had a low grade fever. I went away slowly in the morning. She is fine now.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia, Tachycardia
Clinical narrative: Patient was ok for about 7 hours after vaccine, then developed fatigue and headache. Went to bed. Woke up with severe headache, aches all over body, and frightening tachycardia. She also had a low grade fever. I went away slowly in the morning. She is fine now.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Influenza, Myalgia
Clinical narrative: I had my second SHINGRIX shot on July 31. On August 5, I awoke unable to roll over to position myself to get out of bed. The pain in my legs was fairly severe. I was unable to lower myself onto the toilet when I finally made it to the bathroom. Once that was accomplished I had great difficulty rising from the toilet. I was unable to stand in the kitchen even long enough to make myself a piece of toast. I was suffering awful chills even though it was hot enough for the air conditioner to run. I retrieved my heating pad from the bathroom closet and went back to bed. I was exhausted. My daughter came and took me to an emergency clinic to see a doctor. He did not believe this was an adverse reaction to the shingle shot because he had 2 and suffered no adverse reactions. The rest of the day was spent in bed for the most part. It is now August 8, and I am just now starting to feel comfortable walking without the support of my cane. I called GSK and was told this could go on for up to 7 days. I read this in the prescribing information off the internet, but I don't recall receiving anything from the pharmacy with the injection that would have prepared me for this. It was scary.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test normal, Chills, Fatigue, Gait disturbance, Myalgia
Clinical narrative: I had my second SHINGRIX shot on July 31. On August 5, I awoke unable to roll over to position myself to get out of bed. The pain in my legs was fairly severe. I was unable to lower myself onto the toilet when I finally made it to the bathroom. Once that was accomplished I had great difficulty rising from the toilet. I was unable to stand in the kitchen even long enough to make myself a piece of toast. I was suffering awful chills even though it was hot enough for the air conditioner to run. I retrieved my heating pad from the bathroom closet and went back to bed. I was exhausted. My daughter came and took me to an emergency clinic to see a doctor. He did not believe this was an adverse reaction to the shingle shot because he had 2 and suffered no adverse reactions. The rest of the day was spent in bed for the most part. It is now August 8, and I am just now starting to feel comfortable walking without the support of my cane. I called GSK and was told this could go on for up to 7 days. I read this in the prescribing information off the internet, but I don't recall receiving anything from the pharmacy with the injection that would have prepared me for this. It was scary.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, X-ray limb normal
Clinical narrative: I had my second SHINGRIX shot on July 31. On August 5, I awoke unable to roll over to position myself to get out of bed. The pain in my legs was fairly severe. I was unable to lower myself onto the toilet when I finally made it to the bathroom. Once that was accomplished I had great difficulty rising from the toilet. I was unable to stand in the kitchen even long enough to make myself a piece of toast. I was suffering awful chills even though it was hot enough for the air conditioner to run. I retrieved my heating pad from the bathroom closet and went back to bed. I was exhausted. My daughter came and took me to an emergency clinic to see a doctor. He did not believe this was an adverse reaction to the shingle shot because he had 2 and suffered no adverse reactions. The rest of the day was spent in bed for the most part. It is now August 8, and I am just now starting to feel comfortable walking without the support of my cane. I called GSK and was told this could go on for up to 7 days. I read this in the prescribing information off the internet, but I don't recall receiving anything from the pharmacy with the injection that would have prepared me for this. It was scary.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Dysstasia, Fatigue, Mobility decreased, Pain in extremity
Clinical narrative: I had my second SHINGRIX shot on July 31. On August 5, I awoke unable to roll over to position myself to get out of bed. The pain in my legs was fairly severe. I was unable to lower myself onto the toilet when I finally made it to the bathroom. Once that was accomplished I had great difficulty rising from the toilet. I was unable to stand in the kitchen even long enough to make myself a piece of toast. I was suffering awful chills even though it was hot enough for the air conditioner to run. I retrieved my heating pad from the bathroom closet and went back to bed. I was exhausted. My daughter came and took me to an emergency clinic to see a doctor. He did not believe this was an adverse reaction to the shingle shot because he had 2 and suffered no adverse reactions. The rest of the day was spent in bed for the most part. It is now August 8, and I am just now starting to feel comfortable walking without the support of my cane. I called GSK and was told this could go on for up to 7 days. I read this in the prescribing information off the internet, but I don't recall receiving anything from the pharmacy with the injection that would have prepared me for this. It was scary.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Walking aid user, White blood cell count decreased
Clinical narrative: I had my second SHINGRIX shot on July 31. On August 5, I awoke unable to roll over to position myself to get out of bed. The pain in my legs was fairly severe. I was unable to lower myself onto the toilet when I finally made it to the bathroom. Once that was accomplished I had great difficulty rising from the toilet. I was unable to stand in the kitchen even long enough to make myself a piece of toast. I was suffering awful chills even though it was hot enough for the air conditioner to run. I retrieved my heating pad from the bathroom closet and went back to bed. I was exhausted. My daughter came and took me to an emergency clinic to see a doctor. He did not believe this was an adverse reaction to the shingle shot because he had 2 and suffered no adverse reactions. The rest of the day was spent in bed for the most part. It is now August 8, and I am just now starting to feel comfortable walking without the support of my cane. I called GSK and was told this could go on for up to 7 days. I read this in the prescribing information off the internet, but I don't recall receiving anything from the pharmacy with the injection that would have prepared me for this. It was scary.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea
Clinical narrative: Pt. had trouble breathing - called MD - advised to go to ER - pt. didn't go-laid down for a while and felt better.
Age: 1.92
Sex: F
Vaccine: DTAP, HEPAB, MMR
Symptoms: Allergy test, Allergy to vaccine, Condition aggravated, Cow's milk intolerance, Epilepsy
Clinical narrative: Swelling in the neck, face, lips with bumpy rashes on the face. Two hours later went back to doctor. Told highly likely allergic to the protien in vaccine. Epilepsy seizure and dairy allergy since vaccination.
Age: 1.92
Sex: F
Vaccine: DTAP, HEPAB, MMR
Symptoms: Lip swelling, Rash, Swelling, Swelling face
Clinical narrative: Swelling in the neck, face, lips with bumpy rashes on the face. Two hours later went back to doctor. Told highly likely allergic to the protien in vaccine. Epilepsy seizure and dairy allergy since vaccination.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Barium swallow, Laryngoscopy, Laryngospasm, Reflux laryngitis, Swallow study
Clinical narrative: I had 2 episodes of laryngospasms within two weeks of the vaccine. I was referred by my primary care physician to Dr., an ENT. It was determined that I had laryngopharyngeal reflux and am being treated with ranitidine 150 mcg by mouth twice per day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain
Clinical narrative: Severe shivering. Had to turn on heat in house (90 degrees outside). Wrapped up under bed coverers over 8 hours. Night time. Also had soreness in upper arm at shot site. Lasted approx. 3 days.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose increased, Injected limb mobility decreased, Injection site pain, Malaise, Peripheral swelling
Clinical narrative: Rt shoulder became completely immobile and extremely painful 10/10; lower arm and hand swelling. Could move lower arm. Blood sugars elevated x 48 hrs; feeling of malaise.
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder, Neurological symptom, Reaction to preservatives
Clinical narrative: Information has been received from a physician via company representative, who provided a letter written by an unspecified child's mother. Follow-up information was received on 10-AUG-2018 from an online news article (see case # 1808USA005972 for infant's case). The writer of the article noted that he wrote an article back in 2015 (title not specified) to warn the public and expose the facts that were absent from the corporate-sponsored "mainstream" media, clearly showing that the measles vaccine was far more dangerous than the measles itself, known historically as a non-fatal common childhood infection. The article also discussed a story in 2014, in which a senior Epidemiologist at the Centers for Disease Control (CDC) co-authored and published research on the measles, mumps, rubella (MMR) vaccine (manufacturer not specified) for the CDC in 2004, and his decision to become a whistleblower and reveal data that was concealed by the CDC linking the MMR vaccine to autism among boys. Causality assessment was considered related. No further information was reported. Upon internal review, autism was considered to be medially significant. This is one of two reports from the same reporter. Additional information is not expected.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a 19 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were no provided. On 01-AUG-2018, the patient was vaccinated with 2 pediatric doses of VAQTA (strength, dosage and frequency were no reported), intramuscularly, for prophylaxis, lot# R013859, expiration date on 14-JUN-2019, which were drawn into 1 syringe and administered. No adverse effects were reported.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(manufacturer unknown) (lot, expiry date, dose, frequency and route of administration were not reported) for prophylaxis, when he was child. The reporter stated that, recent titers showed that the patient did not have immunity(hepatitis b surface antibody negative). The physician noted that he will administer a booster dose to the patient. The outcome of hepatitis b surface antibody negative was unknown. The causality assessment was not provided by the reporter. No product quality complaint was filed.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 26-JUL-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The Oka-Merck PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381:Original Case : 1808USA001261 US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513-1808USA004376:Original Case : 1808USA001261 US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004363:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004391:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004393:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004396:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004397:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004400:Original Case : 1808USA001261 US-009507513-1808USA004401:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA00126.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 26-JUL-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The Oka-Merck PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381:Original Case : 1808USA001261 US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513-1808USA004376:Original Case : 1808USA001261 US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004363:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004391:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004393:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004395:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004397:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004400:Original Case : 1808USA001261 US-009507513-1808USA004401:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA00126.