chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13
Symptoms: Therapy non-responder
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable Other-HCP on behalf of physician reported similar events for 3 patients. This is the 2nd of 3 reports. A patient of unspecified age race/ethnicity and gender received four doses of PREVNAR 13, all on an unknown date, at single dose, for immunization. Lot number of the fourth dose was 563665; while lot numbers of the other doses were not reported. Relevant medical history and concomitant medications were unknown. It was reported that the four doses did not immunize the patient. Possible 5th dose will be required. Clinical outcome was unknown at time of this report. The information on the lot numbers has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018128826 same reporter/drug/event, different patients. US-PFIZER INC-2018129213 same reporter/drug/event, different patients.
Sex: U
Vaccine: PNC13
Symptoms: Therapy non-responder
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program "IBCC (Inbound Call Center for HCPs)". A contactable Health Care Professional on behalf of physician reported similar events for three patients. This is the first of three reports. A patient of an unspecified age, gender, race and ethnicity received four doses of PREVNAR 13, all on an unknown date, at single dose, for immunization. Lot number of the fourth dose was S62923; while lot numbers of the other doses were not reported. Relevant medical history and concomitant medications were unknown. It was reported that the four doses did not immunize the patient. Possible 5th dose will be required. Clinical outcome was unknown at time of this report. The information on the lot numbers has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018128826 Same reporter/drug/event, different patients; US-PFIZER INC-2018129036 Same reporter/drug/event, different patients.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Electroencephalogram normal, Endotracheal intubation, Generalised tonic-clonic seizure, Infantile apnoea, Intensive care
Clinical narrative: Patient presented to ER with Grand Mal seizure. Patient became apneic and was intubated. Pt was transferred to hospital ICU approx. 2:45 AM. Patient reported to have possible febrile reaction to routine vaccines. EEG was performed which was normal. Pt was extubated 3/29/18 10AM. Stable condition.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Left arm got a hard knot under the skin, about the size of a half baseball. The site became warm, and remained for four to five days. It is now eight days post injection with only a little of the hardness left at the injection site. I realize that this was not a dangerous reaction, but I am reporting as it might be for the next person. As a further point of clarification, I showed the result to a friend (Dr.), who advised ice if needed on the site. As he was not worried, it also made me less apprehensive.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out, incident lasted less than a minute recovered completely with rest no intervention needed.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Patient was given a Tdap, MCV4 and then the HPV9 vaccine. Upon injection of the HPV4, the child had a syncope episode and fell out of the chair. He was not out for more than a few seconds.
Age: 31.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Chills, Discomfort, Impaired work ability, Nausea
Clinical narrative: Took one VIVOTIF capsule at 9:30 pm, 2.5 hours after ingesting evening meal, at 5 am next day experienced strong abdominal cramps, nausea, fever, chills. Attempted to go to work but came home because of discomfort. Pain lasted 24 hours.
Age: 31.0
Sex: F
Vaccine: TYP
Symptoms: Pyrexia
Clinical narrative: Took one VIVOTIF capsule at 9:30 pm, 2.5 hours after ingesting evening meal, at 5 am next day experienced strong abdominal cramps, nausea, fever, chills. Attempted to go to work but came home because of discomfort. Pain lasted 24 hours.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Alanine aminotransferase, Albumin globulin ratio, Anion gap, Aspartate aminotransferase, Basophil count
Clinical narrative: The patient is a 22-year-old female who presents to the emergency department with complaints of generalized muscle twitching and concern about reaction to the GARDASIL. She states that approximately an hour and a half ago she received the GARDASIL vaccination after a colposcopy and cervical biopsy. She had tested positive for HPV several weeks ago. She states that shortly after receiving the injection she felt nauseated and her nose was running. She also felt somewhat lightheaded and dizzy. She subsequent has started to develop some twitching of her muscles which seemed to intensify and is become more generalized. She denies any associated headache, change in vision, numbness or weakness in her extremities. She does not have any known history of seizures. She states that the only other medication that she took recently was a caffeine pill to help with exercise earlier this morning. She states that she has been taking this for approximately a week. She is generally healthy otherwise. The patient presents with generalized muscle spasms and tics which started shortly after receiving the GARDASIL injection. The significance of this is unclear. An IV was established and she received ATIVAN 1 mg initially. She had some improvement after the ATIVAN. Labs were all unremarkable. She did receive 1 L bolus of normal saline as well as BENADRYL 25 mg IV. The movements almost appeared like dystonic movements or tics. She did have some more improvement after administration of BENADRYL however still continued to have intermittent twinges. The exact etiology of this remains unclear however is suspicious for an adverse medication reaction from the GARDASIL given its association of occurring shortly after receiving the injection. The patient was advised to rest and push fluids. She was given 2 doses of ATIVAN 1 mg every 4-6 hours as needed for tonight. She is advised return to the emergency room immediately if she develops any worsening or change in symptoms. She is advised to follow-up with Dr. tomorrow.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Basophil percentage, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood calcium
Clinical narrative: The patient is a 22-year-old female who presents to the emergency department with complaints of generalized muscle twitching and concern about reaction to the GARDASIL. She states that approximately an hour and a half ago she received the GARDASIL vaccination after a colposcopy and cervical biopsy. She had tested positive for HPV several weeks ago. She states that shortly after receiving the injection she felt nauseated and her nose was running. She also felt somewhat lightheaded and dizzy. She subsequent has started to develop some twitching of her muscles which seemed to intensify and is become more generalized. She denies any associated headache, change in vision, numbness or weakness in her extremities. She does not have any known history of seizures. She states that the only other medication that she took recently was a caffeine pill to help with exercise earlier this morning. She states that she has been taking this for approximately a week. She is generally healthy otherwise. The patient presents with generalized muscle spasms and tics which started shortly after receiving the GARDASIL injection. The significance of this is unclear. An IV was established and she received ATIVAN 1 mg initially. She had some improvement after the ATIVAN. Labs were all unremarkable. She did receive 1 L bolus of normal saline as well as BENADRYL 25 mg IV. The movements almost appeared like dystonic movements or tics. She did have some more improvement after administration of BENADRYL however still continued to have intermittent twinges. The exact etiology of this remains unclear however is suspicious for an adverse medication reaction from the GARDASIL given its association of occurring shortly after receiving the injection. The patient was advised to rest and push fluids. She was given 2 doses of ATIVAN 1 mg every 4-6 hours as needed for tonight. She is advised return to the emergency room immediately if she develops any worsening or change in symptoms. She is advised to follow-up with Dr. tomorrow.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Blood chloride, Blood creatine phosphokinase, Blood creatinine, Blood glucose, Blood magnesium
Clinical narrative: The patient is a 22-year-old female who presents to the emergency department with complaints of generalized muscle twitching and concern about reaction to the GARDASIL. She states that approximately an hour and a half ago she received the GARDASIL vaccination after a colposcopy and cervical biopsy. She had tested positive for HPV several weeks ago. She states that shortly after receiving the injection she felt nauseated and her nose was running. She also felt somewhat lightheaded and dizzy. She subsequent has started to develop some twitching of her muscles which seemed to intensify and is become more generalized. She denies any associated headache, change in vision, numbness or weakness in her extremities. She does not have any known history of seizures. She states that the only other medication that she took recently was a caffeine pill to help with exercise earlier this morning. She states that she has been taking this for approximately a week. She is generally healthy otherwise. The patient presents with generalized muscle spasms and tics which started shortly after receiving the GARDASIL injection. The significance of this is unclear. An IV was established and she received ATIVAN 1 mg initially. She had some improvement after the ATIVAN. Labs were all unremarkable. She did receive 1 L bolus of normal saline as well as BENADRYL 25 mg IV. The movements almost appeared like dystonic movements or tics. She did have some more improvement after administration of BENADRYL however still continued to have intermittent twinges. The exact etiology of this remains unclear however is suspicious for an adverse medication reaction from the GARDASIL given its association of occurring shortly after receiving the injection. The patient was advised to rest and push fluids. She was given 2 doses of ATIVAN 1 mg every 4-6 hours as needed for tonight. She is advised return to the emergency room immediately if she develops any worsening or change in symptoms. She is advised to follow-up with Dr. tomorrow.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Blood osmolarity, Blood potassium, Blood sodium, Blood thyroid stimulating hormone, Blood urea
Clinical narrative: The patient is a 22-year-old female who presents to the emergency department with complaints of generalized muscle twitching and concern about reaction to the GARDASIL. She states that approximately an hour and a half ago she received the GARDASIL vaccination after a colposcopy and cervical biopsy. She had tested positive for HPV several weeks ago. She states that shortly after receiving the injection she felt nauseated and her nose was running. She also felt somewhat lightheaded and dizzy. She subsequent has started to develop some twitching of her muscles which seemed to intensify and is become more generalized. She denies any associated headache, change in vision, numbness or weakness in her extremities. She does not have any known history of seizures. She states that the only other medication that she took recently was a caffeine pill to help with exercise earlier this morning. She states that she has been taking this for approximately a week. She is generally healthy otherwise. The patient presents with generalized muscle spasms and tics which started shortly after receiving the GARDASIL injection. The significance of this is unclear. An IV was established and she received ATIVAN 1 mg initially. She had some improvement after the ATIVAN. Labs were all unremarkable. She did receive 1 L bolus of normal saline as well as BENADRYL 25 mg IV. The movements almost appeared like dystonic movements or tics. She did have some more improvement after administration of BENADRYL however still continued to have intermittent twinges. The exact etiology of this remains unclear however is suspicious for an adverse medication reaction from the GARDASIL given its association of occurring shortly after receiving the injection. The patient was advised to rest and push fluids. She was given 2 doses of ATIVAN 1 mg every 4-6 hours as needed for tonight. She is advised return to the emergency room immediately if she develops any worsening or change in symptoms. She is advised to follow-up with Dr. tomorrow.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Blood urea nitrogen/creatinine ratio, C-reactive protein, Carbon dioxide, Dizziness, Dystonia
Clinical narrative: The patient is a 22-year-old female who presents to the emergency department with complaints of generalized muscle twitching and concern about reaction to the GARDASIL. She states that approximately an hour and a half ago she received the GARDASIL vaccination after a colposcopy and cervical biopsy. She had tested positive for HPV several weeks ago. She states that shortly after receiving the injection she felt nauseated and her nose was running. She also felt somewhat lightheaded and dizzy. She subsequent has started to develop some twitching of her muscles which seemed to intensify and is become more generalized. She denies any associated headache, change in vision, numbness or weakness in her extremities. She does not have any known history of seizures. She states that the only other medication that she took recently was a caffeine pill to help with exercise earlier this morning. She states that she has been taking this for approximately a week. She is generally healthy otherwise. The patient presents with generalized muscle spasms and tics which started shortly after receiving the GARDASIL injection. The significance of this is unclear. An IV was established and she received ATIVAN 1 mg initially. She had some improvement after the ATIVAN. Labs were all unremarkable. She did receive 1 L bolus of normal saline as well as BENADRYL 25 mg IV. The movements almost appeared like dystonic movements or tics. She did have some more improvement after administration of BENADRYL however still continued to have intermittent twinges. The exact etiology of this remains unclear however is suspicious for an adverse medication reaction from the GARDASIL given its association of occurring shortly after receiving the injection. The patient was advised to rest and push fluids. She was given 2 doses of ATIVAN 1 mg every 4-6 hours as needed for tonight. She is advised return to the emergency room immediately if she develops any worsening or change in symptoms. She is advised to follow-up with Dr. tomorrow.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Eosinophil count, Eosinophil percentage, Globulin, Glomerular filtration rate, Granulocyte percentage
Clinical narrative: The patient is a 22-year-old female who presents to the emergency department with complaints of generalized muscle twitching and concern about reaction to the GARDASIL. She states that approximately an hour and a half ago she received the GARDASIL vaccination after a colposcopy and cervical biopsy. She had tested positive for HPV several weeks ago. She states that shortly after receiving the injection she felt nauseated and her nose was running. She also felt somewhat lightheaded and dizzy. She subsequent has started to develop some twitching of her muscles which seemed to intensify and is become more generalized. She denies any associated headache, change in vision, numbness or weakness in her extremities. She does not have any known history of seizures. She states that the only other medication that she took recently was a caffeine pill to help with exercise earlier this morning. She states that she has been taking this for approximately a week. She is generally healthy otherwise. The patient presents with generalized muscle spasms and tics which started shortly after receiving the GARDASIL injection. The significance of this is unclear. An IV was established and she received ATIVAN 1 mg initially. She had some improvement after the ATIVAN. Labs were all unremarkable. She did receive 1 L bolus of normal saline as well as BENADRYL 25 mg IV. The movements almost appeared like dystonic movements or tics. She did have some more improvement after administration of BENADRYL however still continued to have intermittent twinges. The exact etiology of this remains unclear however is suspicious for an adverse medication reaction from the GARDASIL given its association of occurring shortly after receiving the injection. The patient was advised to rest and push fluids. She was given 2 doses of ATIVAN 1 mg every 4-6 hours as needed for tonight. She is advised return to the emergency room immediately if she develops any worsening or change in symptoms. She is advised to follow-up with Dr. tomorrow.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Haematocrit, Haemoglobin, Lymphocyte count, Lymphocyte percentage, Mean cell haemoglobin
Clinical narrative: The patient is a 22-year-old female who presents to the emergency department with complaints of generalized muscle twitching and concern about reaction to the GARDASIL. She states that approximately an hour and a half ago she received the GARDASIL vaccination after a colposcopy and cervical biopsy. She had tested positive for HPV several weeks ago. She states that shortly after receiving the injection she felt nauseated and her nose was running. She also felt somewhat lightheaded and dizzy. She subsequent has started to develop some twitching of her muscles which seemed to intensify and is become more generalized. She denies any associated headache, change in vision, numbness or weakness in her extremities. She does not have any known history of seizures. She states that the only other medication that she took recently was a caffeine pill to help with exercise earlier this morning. She states that she has been taking this for approximately a week. She is generally healthy otherwise. The patient presents with generalized muscle spasms and tics which started shortly after receiving the GARDASIL injection. The significance of this is unclear. An IV was established and she received ATIVAN 1 mg initially. She had some improvement after the ATIVAN. Labs were all unremarkable. She did receive 1 L bolus of normal saline as well as BENADRYL 25 mg IV. The movements almost appeared like dystonic movements or tics. She did have some more improvement after administration of BENADRYL however still continued to have intermittent twinges. The exact etiology of this remains unclear however is suspicious for an adverse medication reaction from the GARDASIL given its association of occurring shortly after receiving the injection. The patient was advised to rest and push fluids. She was given 2 doses of ATIVAN 1 mg every 4-6 hours as needed for tonight. She is advised return to the emergency room immediately if she develops any worsening or change in symptoms. She is advised to follow-up with Dr. tomorrow.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count, Monocyte percentage
Clinical narrative: The patient is a 22-year-old female who presents to the emergency department with complaints of generalized muscle twitching and concern about reaction to the GARDASIL. She states that approximately an hour and a half ago she received the GARDASIL vaccination after a colposcopy and cervical biopsy. She had tested positive for HPV several weeks ago. She states that shortly after receiving the injection she felt nauseated and her nose was running. She also felt somewhat lightheaded and dizzy. She subsequent has started to develop some twitching of her muscles which seemed to intensify and is become more generalized. She denies any associated headache, change in vision, numbness or weakness in her extremities. She does not have any known history of seizures. She states that the only other medication that she took recently was a caffeine pill to help with exercise earlier this morning. She states that she has been taking this for approximately a week. She is generally healthy otherwise. The patient presents with generalized muscle spasms and tics which started shortly after receiving the GARDASIL injection. The significance of this is unclear. An IV was established and she received ATIVAN 1 mg initially. She had some improvement after the ATIVAN. Labs were all unremarkable. She did receive 1 L bolus of normal saline as well as BENADRYL 25 mg IV. The movements almost appeared like dystonic movements or tics. She did have some more improvement after administration of BENADRYL however still continued to have intermittent twinges. The exact etiology of this remains unclear however is suspicious for an adverse medication reaction from the GARDASIL given its association of occurring shortly after receiving the injection. The patient was advised to rest and push fluids. She was given 2 doses of ATIVAN 1 mg every 4-6 hours as needed for tonight. She is advised return to the emergency room immediately if she develops any worsening or change in symptoms. She is advised to follow-up with Dr. tomorrow.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle twitching, Nausea, Neutrophil count, Neutrophil percentage, Platelet count
Clinical narrative: The patient is a 22-year-old female who presents to the emergency department with complaints of generalized muscle twitching and concern about reaction to the GARDASIL. She states that approximately an hour and a half ago she received the GARDASIL vaccination after a colposcopy and cervical biopsy. She had tested positive for HPV several weeks ago. She states that shortly after receiving the injection she felt nauseated and her nose was running. She also felt somewhat lightheaded and dizzy. She subsequent has started to develop some twitching of her muscles which seemed to intensify and is become more generalized. She denies any associated headache, change in vision, numbness or weakness in her extremities. She does not have any known history of seizures. She states that the only other medication that she took recently was a caffeine pill to help with exercise earlier this morning. She states that she has been taking this for approximately a week. She is generally healthy otherwise. The patient presents with generalized muscle spasms and tics which started shortly after receiving the GARDASIL injection. The significance of this is unclear. An IV was established and she received ATIVAN 1 mg initially. She had some improvement after the ATIVAN. Labs were all unremarkable. She did receive 1 L bolus of normal saline as well as BENADRYL 25 mg IV. The movements almost appeared like dystonic movements or tics. She did have some more improvement after administration of BENADRYL however still continued to have intermittent twinges. The exact etiology of this remains unclear however is suspicious for an adverse medication reaction from the GARDASIL given its association of occurring shortly after receiving the injection. The patient was advised to rest and push fluids. She was given 2 doses of ATIVAN 1 mg every 4-6 hours as needed for tonight. She is advised return to the emergency room immediately if she develops any worsening or change in symptoms. She is advised to follow-up with Dr. tomorrow.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Platelet morphology normal, Protein total, Red blood cell count, Red blood cell morphology normal, Red cell distribution width
Clinical narrative: The patient is a 22-year-old female who presents to the emergency department with complaints of generalized muscle twitching and concern about reaction to the GARDASIL. She states that approximately an hour and a half ago she received the GARDASIL vaccination after a colposcopy and cervical biopsy. She had tested positive for HPV several weeks ago. She states that shortly after receiving the injection she felt nauseated and her nose was running. She also felt somewhat lightheaded and dizzy. She subsequent has started to develop some twitching of her muscles which seemed to intensify and is become more generalized. She denies any associated headache, change in vision, numbness or weakness in her extremities. She does not have any known history of seizures. She states that the only other medication that she took recently was a caffeine pill to help with exercise earlier this morning. She states that she has been taking this for approximately a week. She is generally healthy otherwise. The patient presents with generalized muscle spasms and tics which started shortly after receiving the GARDASIL injection. The significance of this is unclear. An IV was established and she received ATIVAN 1 mg initially. She had some improvement after the ATIVAN. Labs were all unremarkable. She did receive 1 L bolus of normal saline as well as BENADRYL 25 mg IV. The movements almost appeared like dystonic movements or tics. She did have some more improvement after administration of BENADRYL however still continued to have intermittent twinges. The exact etiology of this remains unclear however is suspicious for an adverse medication reaction from the GARDASIL given its association of occurring shortly after receiving the injection. The patient was advised to rest and push fluids. She was given 2 doses of ATIVAN 1 mg every 4-6 hours as needed for tonight. She is advised return to the emergency room immediately if she develops any worsening or change in symptoms. She is advised to follow-up with Dr. tomorrow.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Rhinorrhoea, Tic, White blood cell count, White blood cell morphology normal
Clinical narrative: The patient is a 22-year-old female who presents to the emergency department with complaints of generalized muscle twitching and concern about reaction to the GARDASIL. She states that approximately an hour and a half ago she received the GARDASIL vaccination after a colposcopy and cervical biopsy. She had tested positive for HPV several weeks ago. She states that shortly after receiving the injection she felt nauseated and her nose was running. She also felt somewhat lightheaded and dizzy. She subsequent has started to develop some twitching of her muscles which seemed to intensify and is become more generalized. She denies any associated headache, change in vision, numbness or weakness in her extremities. She does not have any known history of seizures. She states that the only other medication that she took recently was a caffeine pill to help with exercise earlier this morning. She states that she has been taking this for approximately a week. She is generally healthy otherwise. The patient presents with generalized muscle spasms and tics which started shortly after receiving the GARDASIL injection. The significance of this is unclear. An IV was established and she received ATIVAN 1 mg initially. She had some improvement after the ATIVAN. Labs were all unremarkable. She did receive 1 L bolus of normal saline as well as BENADRYL 25 mg IV. The movements almost appeared like dystonic movements or tics. She did have some more improvement after administration of BENADRYL however still continued to have intermittent twinges. The exact etiology of this remains unclear however is suspicious for an adverse medication reaction from the GARDASIL given its association of occurring shortly after receiving the injection. The patient was advised to rest and push fluids. She was given 2 doses of ATIVAN 1 mg every 4-6 hours as needed for tonight. She is advised return to the emergency room immediately if she develops any worsening or change in symptoms. She is advised to follow-up with Dr. tomorrow.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Blister, Erythema, Feeling hot, Pruritus, Rash erythematous
Clinical narrative: 7:00 PM client C/O feeling "funny" - hot of itchy. Red rash/whelps noted on entire face--red/blotchy; blisters noted under each eye. Redness noted on head under hair. Ears and neck noted to be red. Whelps noted on each arm, chest, and legs. C/O itching. Denied SOB, or tongue swelling. Generic BENADRYL 2 tabs given approximately 7:10 PM. One hour later - redness had decreased. Sxs began at church approximately 7:00 PM 3/28/18. States he felt "hot and itchy". He was seen and evaluated by his mother, who is an RN and another RN, school nurse, at church. BENADRYL generic tabs was given by his mother at church (not at the clinic). He was in his mother's sight and care for the entire reaction. By 8:00 PM the redness was decreasing. Stopped itching at 8:30 PM. By 9:30 PM the redness and whelps were gone.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: 7:00 PM client C/O feeling "funny" - hot of itchy. Red rash/whelps noted on entire face--red/blotchy; blisters noted under each eye. Redness noted on head under hair. Ears and neck noted to be red. Whelps noted on each arm, chest, and legs. C/O itching. Denied SOB, or tongue swelling. Generic BENADRYL 2 tabs given approximately 7:10 PM. One hour later - redness had decreased. Sxs began at church approximately 7:00 PM 3/28/18. States he felt "hot and itchy". He was seen and evaluated by his mother, who is an RN and another RN, school nurse, at church. BENADRYL generic tabs was given by his mother at church (not at the clinic). He was in his mother's sight and care for the entire reaction. By 8:00 PM the redness was decreasing. Stopped itching at 8:30 PM. By 9:30 PM the redness and whelps were gone.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth, Peripheral swelling
Clinical narrative: Event occurred after second injection in series approximately 36 days after the first. Red, raised bump approximately 2" in diameter developed at site of injection on right arm mid-deltoid within 36 hours. Site was hot to the touch with minor swelling down right arm and fingers. Patient reported that swelling and tenderness was increasing instead of decreasing. She did not take any antihistamines for reaction. I encouraged her to seek medical attention if swelling or pain continued to increase.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diplegia, Mobility decreased, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of paralysis legs in a 69-year-old female patient who received SHINGRIX. On 16th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced paralysis legs (serious criteria GSK medically significant), chills, mobility decreased and fever. On an unknown date, the outcome of the paralysis legs, chills, mobility decreased and fever were recovered/resolved. The reporter considered the paralysis legs, chills, mobility decreased and fever to be related to SHINGRIX. Additional details were provided as follows: The reporter was friend of patient. The reporter called to report side effects for his wife as well as friend of them, who also had a side effect. The chills described as extreme. Six hours after chills, the patient could not move her limbs.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Pain in extremity, Vomiting
Clinical narrative: Headache, vomiting, sore arm.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Developed a large orange sized lump on the L deltoid area. Warm to the touch, circular, edematous and painful.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient received first SHINGRIX vaccine 2/26/18 and developed shingles symptoms 5 days after administration. Shingles diagnosed and confirmed by PCP 3/9/18. Rash located on right lower abdomen. Treatment: Acyclovir 800 mg other, acetaminophen 650 mg TID.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pruritus, Rash erythematous, Skin irritation
Clinical narrative: Right away was irritated had some itching started in sensitive areas of the body and has spread pretty much throughout most of her body red dots almost confluent itches a lot.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated, Influenza like illness, Pain, Pain in extremity
Clinical narrative: PT CALLED AND EXPLAINED SHE WAS FEELING PAIN IN THE ARMS AND BODY ACHES, ALSO FLU LIKE SYMPTONS THAT TRIGGERED HER ASTHMA.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus, Rash, Urticaria
Clinical narrative: 62 y/o, male, presents with (L) arm pain, redness, and chest wall redness/itchiness since he received recombinant zoster vaccine. Denies shortness of breath or throat swelling. No fever, chills. NO any new exposures. Rash and urticarial pruritus. Famotidine 1 tab BID, Diphenhydramine 1 tab QID, epinephrine 0.3 mg once.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Face injury, Fall, Injection site pain, Loss of control of legs
Clinical narrative: Patient took nap and around 7pm legs collapsed. Patient fell down on face, on legs lost feeling and had pain. Called clinic and went to ER and did some testing that day and also days later. That month had neck surgery in the same facility. Problems with legs still continued; legs very week, can't do leg lifts. Right deltoid feels like the needle broke off in there; pain wakes him up at night when he rolls over. Patient has gone to clinic on multiple occasions since then. Patients reports problems getting copies of records and appointments for about a year or so. Was referred to Physical Therapy and had about 7 sessions. Currently, takes ALEVE about 2 times a day. Feels condition not improving and it is actually getting worse-both on legs and shoulder. Loss feeling in your fingertips, arm pretty much paralyzed, pain in elbow is about an 8 and in shoulder is about a 9.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Middle insomnia, Mobility decreased, Monoplegia, Muscular weakness, Musculoskeletal pain
Clinical narrative: Patient took nap and around 7pm legs collapsed. Patient fell down on face, on legs lost feeling and had pain. Called clinic and went to ER and did some testing that day and also days later. That month had neck surgery in the same facility. Problems with legs still continued; legs very week, can't do leg lifts. Right deltoid feels like the needle broke off in there; pain wakes him up at night when he rolls over. Patient has gone to clinic on multiple occasions since then. Patients reports problems getting copies of records and appointments for about a year or so. Was referred to Physical Therapy and had about 7 sessions. Currently, takes ALEVE about 2 times a day. Feels condition not improving and it is actually getting worse-both on legs and shoulder. Loss feeling in your fingertips, arm pretty much paralyzed, pain in elbow is about an 8 and in shoulder is about a 9.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Neck surgery, Pain, Sensory loss
Clinical narrative: Patient took nap and around 7pm legs collapsed. Patient fell down on face, on legs lost feeling and had pain. Called clinic and went to ER and did some testing that day and also days later. That month had neck surgery in the same facility. Problems with legs still continued; legs very week, can't do leg lifts. Right deltoid feels like the needle broke off in there; pain wakes him up at night when he rolls over. Patient has gone to clinic on multiple occasions since then. Patients reports problems getting copies of records and appointments for about a year or so. Was referred to Physical Therapy and had about 7 sessions. Currently, takes ALEVE about 2 times a day. Feels condition not improving and it is actually getting worse-both on legs and shoulder. Loss feeling in your fingertips, arm pretty much paralyzed, pain in elbow is about an 8 and in shoulder is about a 9.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain at inj site. No fever, lump, streaking.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: My shoulder is painful, particularly when I put on my shirt, jacket or try to roll my shirt collar down. Particularly when I raise my arm. Ibuprofen doesn't seem to help. I am supposed to take 2nd injection soon, but I am reluctant to take it. Please advise.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 69-year-old male patient who received SHINGRIX. In November 2017, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain was recovered/resolved. The reporter considered the pain to be related to SHINGRIX. Additional information was received as follows: The patient had complained of severe pain for 3 days, after receiving SHINGRIX. The pharmacist did not have lot number or expiry date of SHINGRIX as it was given elsewhere. It was reported that the patient took Ibuprofen without relief for this pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 60-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). On 13th March 2018 09:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th March 2018, less than an hour after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovering/resolving and the outcome of the injection site warmth was unknown. The reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The reporter had a patient that received the SHINGRIX vaccine on right deltoid and experienced redness, swelling, and heat at the injection site within 30 minutes of the vaccination. The patient returned to the office on 15th March 2018 and described that the redness and swelling were resolving. The field representative was unable to provide additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than year after receiving SHINGRIX, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was the reported by pharmacist who herself received the SHINGRIX vaccine. The age at vaccination was not reported. The patient experienced a sore arm that she could not lift for 36 hours after the first injection of SHINGRIX. This case was linked to the case US2018GSK047404, reported for the same patient and also US2018GSK047403, reported by the same reporter for different patient.
Age: 75.0
Sex: F
Vaccine: PNC10, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2018). Concomitant products included pneumococcal vaccine. On 14th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site erythema to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and Pneumonia vaccination on the left arm on the same day, at the physician's office. The reporter reported that, the patient experienced a 7 cm approximately in diameter red spot on her left arm where she received the SHINGRIX. No details related to pneumonia vaccination injection were known. The call was transferred to the Medical Information to discuss questions related to medical treatment for the arm.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of numbness of upper extremities in a female patient who received SHINGRIX. 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 numbness of upper extremities and mobility decreased. On an unknown date, the outcome of the numbness of upper extremities and mobility decreased were recovered/resolved. It was unknown if the reporter considered the numbness of upper extremities and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. For 2 days the patient experienced arm numbness with limited arm movement, which has since resolved. The patient did not reported whether this affecting her quality of life.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Migraine
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of migraine in a female patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (for 1st dose refer case US2018GSK050304). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced migraine and stomach discomfort. On an unknown date, the outcome of the migraine and stomach discomfort were recovered/resolved. It was unknown if the reporter considered the migraine and stomach discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacist who herself received the SHINGRIX vaccine. The age at the vaccination was not reported. The patient experienced sickness to her stomach and consistent migraines. This case was linked to the case US2018GSK047403, reported by the same reporter for different patient.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. In March 2018, less than a year after receiving SHINGRIX, the patient experienced fever, shivers, nocturnal awakening, muscle pain, fatigability generalized, headache, injection site erythema and injection site pain. On an unknown date, the patient experienced general body pain. On an unknown date, the outcome of the fever, shivers, nocturnal awakening, muscle pain, fatigability generalized, headache, injection site erythema, injection site pain and general body pain were unknown. It was unknown if the reporter considered the fever, shivers, nocturnal awakening, muscle pain, fatigability generalized, headache, injection site erythema, injection site pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient, who was also a pharmacist experienced the same side effects as his wife, but much less severe. The patient's wife (case US2018GSK046332) experienced the fever fluctuating from normal to 101 and back, severe chills with intense shivering that awoke the patient several times during 3 nights, body and muscle aching, general fatigue and mild headache for 72 plus hours and redness, soreness and mild pain at injection site. The patient's wife commented that it was okay if she had develop immunity to shingles but that left her with two questions. One was what should she expect as side effects from the second dose and what counseling they should give to their patients. They did not want to alarm them but the reporter was a little frightened by her side effects. She further asked if they just warn them of the probable side effects and suggest mild acetaminophen dosing and what if any warnings should they make prior to the second dose especially for herself. The reporter also mentioned that if the first available shingle vaccine was any indication they, as pharmacist, would be giving a great many of these vaccines.
Sex: M
Vaccine: VARZOS
Symptoms: Middle insomnia, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. In March 2018, less than a year after receiving SHINGRIX, the patient experienced fever, shivers, nocturnal awakening, muscle pain, fatigability generalized, headache, injection site erythema and injection site pain. On an unknown date, the patient experienced general body pain. On an unknown date, the outcome of the fever, shivers, nocturnal awakening, muscle pain, fatigability generalized, headache, injection site erythema, injection site pain and general body pain were unknown. It was unknown if the reporter considered the fever, shivers, nocturnal awakening, muscle pain, fatigability generalized, headache, injection site erythema, injection site pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient, who was also a pharmacist experienced the same side effects as his wife, but much less severe. The patient's wife (case US2018GSK046332) experienced the fever fluctuating from normal to 101 and back, severe chills with intense shivering that awoke the patient several times during 3 nights, body and muscle aching, general fatigue and mild headache for 72 plus hours and redness, soreness and mild pain at injection site. The patient's wife commented that it was okay if she had develop immunity to shingles but that left her with two questions. One was what should she expect as side effects from the second dose and what counseling they should give to their patients. They did not want to alarm them but the reporter was a little frightened by her side effects. She further asked if they just warn them of the probable side effects and suggest mild acetaminophen dosing and what if any warnings should they make prior to the second dose especially for herself. The reporter also mentioned that if the first available shingle vaccine was any indication they, as pharmacist, would be giving a great many of these vaccines.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Diarrhea for 7 days, stomach felt awful but never vomited - 3 to 4 days of feeling awful and low grade fever - headache as well.