chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Pain
Clinical narrative: Pt. called and said has a rash size about 5 inches diameter at site of injection and sore to touch. She got PREVNAR inj. 4 days ago. (Initially body ache and pain on 1st day).
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Right arm became very hot and red. Swelling occurred tremendously. Redness and irritation carried down arm 6 inches. Swelling greater than 5 inches across. Extremely sore. Cannot move arm.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Skin irritation
Clinical narrative: Right arm became very hot and red. Swelling occurred tremendously. Redness and irritation carried down arm 6 inches. Swelling greater than 5 inches across. Extremely sore. Cannot move arm.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Skin warm
Clinical narrative: Right arm became very hot and red. Swelling occurred tremendously. Redness and irritation carried down arm 6 inches. Swelling greater than 5 inches across. Extremely sore. Cannot move arm.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Emotional distress, Headache, Hyperhidrosis, Immediate post-injection reaction, Irritability
Clinical narrative: Son screamed immediately after vaccination and did not calm down. Screamed when awake for at least 24 hours. High fever as well. Sweating and tremors. Grabbing head. Thermometer was broken, an estimated 103-104. Looking back, I should have taken child to ER but he fell back asleep after screaming and thrashing and I didn't want to wake him again- I did make contact/speak with an aunt (nurse practitioner) and she stated this reaction was seen with this vaccination. I called doctor's office and spoke with nurse about the reaction as well. She stated there wasn't much that could be done because I didn't have an accurate temp measurement, but it was very high. Son has been very fussy and sick off/on since receiving vaccine, a normally very healthy child.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Malaise, Pyrexia, Screaming, Tremor
Clinical narrative: Son screamed immediately after vaccination and did not calm down. Screamed when awake for at least 24 hours. High fever as well. Sweating and tremors. Grabbing head. Thermometer was broken, an estimated 103-104. Looking back, I should have taken child to ER but he fell back asleep after screaming and thrashing and I didn't want to wake him again- I did make contact/speak with an aunt (nurse practitioner) and she stated this reaction was seen with this vaccination. I called doctor's office and spoke with nurse about the reaction as well. She stated there wasn't much that could be done because I didn't have an accurate temp measurement, but it was very high. Son has been very fussy and sick off/on since receiving vaccine, a normally very healthy child.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Agitation, Mental status changes, Paranoia, Psychotic disorder, Suicidal ideation
Clinical narrative: Pt  had received the BEXSERO vaccine at approximately 3:14 PM on June 7, 2018. That evening pt began to show mental status changes specifically expressing suicidal ideations. Pt stated that he "wanted to go to sleep and not wake up". Pt  had been completely psychologically stable and had not expressed suicidal ideations since November 2016 when lithium carbonate was administered. The suicidal ideations, mental status changes and agitation continued the next day on June 8, 2018. Pt  was admitted to the acute psychiatric adolescent unit. During his admittance which is still happening at present date (July 4, 2018) he has degraded in his mental status. His mental status degraded on the weekend of June 16-17, 2018 that he was called "psychotic" and "paranoid" by staff. To attempt to stabilize pt. He was given clonazepam and Latuda daily addded to his current medication regime with little success. Pt is not stable psychologically. He attempted suicide / cutting his arms and legs on June 25, 2018.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Suicide attempt
Clinical narrative: Pt  had received the BEXSERO vaccine at approximately 3:14 PM on June 7, 2018. That evening pt began to show mental status changes specifically expressing suicidal ideations. Pt stated that he "wanted to go to sleep and not wake up". Pt  had been completely psychologically stable and had not expressed suicidal ideations since November 2016 when lithium carbonate was administered. The suicidal ideations, mental status changes and agitation continued the next day on June 8, 2018. Pt  was admitted to the acute psychiatric adolescent unit. During his admittance which is still happening at present date (July 4, 2018) he has degraded in his mental status. His mental status degraded on the weekend of June 16-17, 2018 that he was called "psychotic" and "paranoid" by staff. To attempt to stabilize pt. He was given clonazepam and Latuda daily addded to his current medication regime with little success. Pt is not stable psychologically. He attempted suicide / cutting his arms and legs on June 25, 2018.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Moderate muscle pain; 99.9 fever; aches; headache.
Age: 54.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Asthenia, Back pain, Chills, Dizziness, Dry mouth
Clinical narrative: First sign was throat swelling up. Went to drink water and wouldn't go down as normal. Backed up in throat and drained ever so slowly down my throat. Then fever hit hard at 104 degrees for 2 days, 103 for 2 days, 101 for 1 day........though fever would break a little and then go back up. Along with it....severe body aches especially along lower back, super parched mouth....so thirsty. Shivering. Nausea. Massive headache. Sweating through sheets for 5 days, dizziness. This is day 10 and only just starting to feel better though still a little difficult to swallow.
Age: 54.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Dysphagia, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: First sign was throat swelling up. Went to drink water and wouldn't go down as normal. Backed up in throat and drained ever so slowly down my throat. Then fever hit hard at 104 degrees for 2 days, 103 for 2 days, 101 for 1 day........though fever would break a little and then go back up. Along with it....severe body aches especially along lower back, super parched mouth....so thirsty. Shivering. Nausea. Massive headache. Sweating through sheets for 5 days, dizziness. This is day 10 and only just starting to feel better though still a little difficult to swallow.
Age: 54.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Pharyngeal oedema, Pyrexia, Thirst
Clinical narrative: First sign was throat swelling up. Went to drink water and wouldn't go down as normal. Backed up in throat and drained ever so slowly down my throat. Then fever hit hard at 104 degrees for 2 days, 103 for 2 days, 101 for 1 day........though fever would break a little and then go back up. Along with it....severe body aches especially along lower back, super parched mouth....so thirsty. Shivering. Nausea. Massive headache. Sweating through sheets for 5 days, dizziness. This is day 10 and only just starting to feel better though still a little difficult to swallow.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, CSF test, Delirium, Infection, Intensive care
Clinical narrative: Acute delirium that progressed to altered consciousness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nervous system disorder
Clinical narrative: Acute delirium that progressed to altered consciousness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Chills, Fatigue, Headache
Clinical narrative: Moderate pain at injection site and in arm pit, fever, chills, headache, muscle/joint aches, tiredness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Moderate pain at injection site and in arm pit, fever, chills, headache, muscle/joint aches, tiredness.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Shot itself was very painful, 3 days later my arm in area of injection site continues to be red, painful, swollen, deep ache, cannot sleep on that side. I will NOT be getting the 2nd shot. I'm not brave enough.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Blood urine present, Chills, Crying, Haematuria, Headache
Clinical narrative: Pt presented to the office in mild distress. Mom reported within 1-2 hours after vaccines, pt began having fever, chills, and h/a, and severe right upper arm pain at injection site of Meningococcal B. Mom gave MOTRIN to pt without improvement. H/a worsened to the point of crying so mom brought her to our after hours clinic. No bruising, swelling or redness noted to either injection site. Pt unable to tolerate h/a. Crying out loudly off and on in the office. She reported h/a 10 out of 0-10 on pain scale. C/o photophobia. Having rigors in office along with chills. Pt unable to lie flat without increasing headache. c/o nausea, no vomiting. Pt in so much pain, she began breathing too rapidly and EMS was called to transport her to ER.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Injection site pain, Laboratory test, Nausea, Photophobia, Pyrexia
Clinical narrative: Pt presented to the office in mild distress. Mom reported within 1-2 hours after vaccines, pt began having fever, chills, and h/a, and severe right upper arm pain at injection site of Meningococcal B. Mom gave MOTRIN to pt without improvement. H/a worsened to the point of crying so mom brought her to our after hours clinic. No bruising, swelling or redness noted to either injection site. Pt unable to tolerate h/a. Crying out loudly off and on in the office. She reported h/a 10 out of 0-10 on pain scale. C/o photophobia. Having rigors in office along with chills. Pt unable to lie flat without increasing headache. c/o nausea, no vomiting. Pt in so much pain, she began breathing too rapidly and EMS was called to transport her to ER.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Respiratory rate increased, Urinary tract infection
Clinical narrative: Pt presented to the office in mild distress. Mom reported within 1-2 hours after vaccines, pt began having fever, chills, and h/a, and severe right upper arm pain at injection site of Meningococcal B. Mom gave MOTRIN to pt without improvement. H/a worsened to the point of crying so mom brought her to our after hours clinic. No bruising, swelling or redness noted to either injection site. Pt unable to tolerate h/a. Crying out loudly off and on in the office. She reported h/a 10 out of 0-10 on pain scale. C/o photophobia. Having rigors in office along with chills. Pt unable to lie flat without increasing headache. c/o nausea, no vomiting. Pt in so much pain, she began breathing too rapidly and EMS was called to transport her to ER.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: At about 12 hours from injection I started to get the chills and then high fever. Took an aspirin to reduce it. Felt tired and run down for the next 36 hours. Soreness of arm for about 3 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: 9 PM that evening fever, chills, nausea, lightheaded, weak, headache, incoherent at times, very sore arm. Could not get out of bed til the 29th, several more days of fatigue.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Incoherent, Nausea, Pain in extremity, Pyrexia
Clinical narrative: 9 PM that evening fever, chills, nausea, lightheaded, weak, headache, incoherent at times, very sore arm. Could not get out of bed til the 29th, several more days of fatigue.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient has severe itching at site of adminstration. It was raised about 2 inches in diameter on day 4, looked red. Patient used warm compression, oral diphenhydramine, topical diphenhydramine and hydrocortisone. On day 6, the size of the raise was about 4 inches. Still itching.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Mouth swelling, Paraesthesia oral
Clinical narrative: Swelling and tingling of mouth- pat states he started getting blisters.
Age: 1.58
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Gait inability, Pyrexia, Urticaria, Varicella post vaccine
Clinical narrative: Same day hives. Continued for 2 days.... The following 3 days unable to walk. Fever. No eating. Now has chicken pox.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Ill-defined disorder
Clinical narrative: Patient said that an acute illness started the day after his shot and continued for 2 days. He had nausea, stomach pain, fatigue, headache, muscle pain, shivering, fever. He also had injection site reactions of swelling and itching. On 7-4-18 his left shoulder and deltoid had new skin tissue where it looked like scabs had been and new skin was forming. He stated that his left arm itched the most but his right arm also itched. Itchiness especially worse at night. We ruled out other causes of atopic dermatitis such as new soaps, exposure to plants that can cause a reaction, and foods. He stated that he had scratched the spots a lot so they scabbed up. The injection site had also been scratched. His doctor told him to take BENADRYL or ZYRTEC and he has used hydrocortisone cream along with various moisturizers. Since it looked like he was healing, I told him to continue hydrocortisone cream several times a day on the areas (he was using maybe once daily) and to take the BENADRYL when the itching was at its worst. I also told him if the itching didn't subside after a few more days to go to his dermatologist.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site scab, Injection site swelling, Myalgia, Nausea
Clinical narrative: Patient said that an acute illness started the day after his shot and continued for 2 days. He had nausea, stomach pain, fatigue, headache, muscle pain, shivering, fever. He also had injection site reactions of swelling and itching. On 7-4-18 his left shoulder and deltoid had new skin tissue where it looked like scabs had been and new skin was forming. He stated that his left arm itched the most but his right arm also itched. Itchiness especially worse at night. We ruled out other causes of atopic dermatitis such as new soaps, exposure to plants that can cause a reaction, and foods. He stated that he had scratched the spots a lot so they scabbed up. The injection site had also been scratched. His doctor told him to take BENADRYL or ZYRTEC and he has used hydrocortisone cream along with various moisturizers. Since it looked like he was healing, I told him to continue hydrocortisone cream several times a day on the areas (he was using maybe once daily) and to take the BENADRYL when the itching was at its worst. I also told him if the itching didn't subside after a few more days to go to his dermatologist.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Scab, Scratch
Clinical narrative: Patient said that an acute illness started the day after his shot and continued for 2 days. He had nausea, stomach pain, fatigue, headache, muscle pain, shivering, fever. He also had injection site reactions of swelling and itching. On 7-4-18 his left shoulder and deltoid had new skin tissue where it looked like scabs had been and new skin was forming. He stated that his left arm itched the most but his right arm also itched. Itchiness especially worse at night. We ruled out other causes of atopic dermatitis such as new soaps, exposure to plants that can cause a reaction, and foods. He stated that he had scratched the spots a lot so they scabbed up. The injection site had also been scratched. His doctor told him to take BENADRYL or ZYRTEC and he has used hydrocortisone cream along with various moisturizers. Since it looked like he was healing, I told him to continue hydrocortisone cream several times a day on the areas (he was using maybe once daily) and to take the BENADRYL when the itching was at its worst. I also told him if the itching didn't subside after a few more days to go to his dermatologist.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: Rash underarm and upper torso (little itchy).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity, Somnolence
Clinical narrative: I received the injection at 1:30 p.m. on July 2, 2018; by 6:30 p.m. the arm was hurting a lot. I put ice on it and it helped some. On the morning of July 3, 2018 I started experiencing headache and felt extremely tired and sleepy. This lasted until July 4, in the morning.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Pain
Clinical narrative: Patient called on 7/3 to report that a six inch diagonal rash developed on her left arm starting at the injection site. The rash started 2 days after immunization and radiates heat according to the patient. The patient also reported  body aches and pain. I recommended that the patient use a cold compress every 15 minutes as well as a non sedating antihistamine due to insomnia therapy.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Breast pain, Pain in extremity
Clinical narrative: Patient received 2nd dose of SHINGRIX vaccine on 7/3/18. Patient had reaction to 1st dose of SHINGRIX and went to her doctor to be seen after the 1 dose. When she came to pharmacy to get 2nd dose, she filled medications (VISTARIL and CLARITIN) which were prescribed by her doctor and she was told to take these when receiving her 2nd dose of SHINGRIX. Patient called on 7/4/18 to let us know that she is having a reaction to the 2nd dose of SHINGRIX. She is experiencing sore arm, pain from armpit to breast area. No visible swelling or redness. Told patient to call her doctor and let them know about reaction and to seek medical treatment if symptoms get worse. Told patient to follow up with us and we would call her.
Age: 50.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Facial paralysis
Clinical narrative: Pt came in approx 19 hours after vaccine was given with drooping of right side of face that was progressively getting worse which is typical in a Bell's palsy reaction. Sent pt to MD who referred to ER. ER gave pt prednisone and antiviral.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Nausea
Clinical narrative: Patient reported being light headed, stomach ache, and nausea.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Un-raised, inch-long red line at site of injection, warm to the touch.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Balance disorder, Chills, Decreased appetite, Dizziness
Clinical narrative: Woke up at 2:20 am the next morning with uncontrollable shivers. It took 45 minutes to stop shivering but I remained cold in the morning at wake up. I had headache and flu like muscle/joint pain. I was light headed and a bit off balance with no appetite. It is now over 12 hours since onset of events and I still have strong muscle/joint pain but no longer any shivers.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia
Clinical narrative: Woke up at 2:20 am the next morning with uncontrollable shivers. It took 45 minutes to stop shivering but I remained cold in the morning at wake up. I had headache and flu like muscle/joint pain. I was light headed and a bit off balance with no appetite. It is now over 12 hours since onset of events and I still have strong muscle/joint pain but no longer any shivers.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Vaccine was adminstered 7/3/18 at 10:45am, then @ 8pm patient noted rash on face and neck. Injection site on right deltoid doesnt have a rash rash.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Hypersomnia, Insomnia
Clinical narrative: After both of these shots my arm was exceptionally sore (more so than with the usual flu shot), I was tired, had chills, diarrhea, felt ill. With both doses, slept most of the next day, unable to do much of anything else. Difficult to sleep as even a sheet on my arm was painful. Day 2 after shot, feeling OK to do activities but arm is still very sore.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Tenderness
Clinical narrative: After both of these shots my arm was exceptionally sore (more so than with the usual flu shot), I was tired, had chills, diarrhea, felt ill. With both doses, slept most of the next day, unable to do much of anything else. Difficult to sleep as even a sheet on my arm was painful. Day 2 after shot, feeling OK to do activities but arm is still very sore.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: Headache, shivering, fever, chills, upset stomach, and diarrhea through out the day of July 4, 2018.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Hyperhidrosis, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Sweaty palm and tingling in hand on same side of injection. Severe pain radiating from my shoulder down to my hand, my shoulder up to my head and my shoulder over to my spine. Date of report is July 4th. Pain is still persisting.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia, Spinal pain
Clinical narrative: Sweaty palm and tingling in hand on same side of injection. Severe pain radiating from my shoulder down to my hand, my shoulder up to my head and my shoulder over to my spine. Date of report is July 4th. Pain is still persisting.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Vaccination complication
Clinical narrative: Patient called pharmacy on 7/2/2018 to report that she had a reaction to the SHINGRIX booster vaccine that she received on 6/29/2018. She stated that her arm had a very large red and raised area around the area where she received the injection almost immediately after receiving the vaccination. It was very sore to touch and was somewhat itchy. She described that it looked like someone punched her in the arm. She had no problems whatsoever with the first injection. She had already been taking a daily dose of CLARITIN for seasonal allergies. I advised her to take  BENADRYL to see if it would help with the reaction. I also told her that if the reaction got worse or did not improve in the next 24 hours to contact her physician.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Fever, muscle aches, pain, headache, fatigue, shaky.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Fever, muscle aches, pain, headache, fatigue, shaky.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Erythema, Injection site pain
Clinical narrative: Patient's complaints of severe pain at injection site, asthenia, redness, we recommend to visit primary physician for evaluation. Treatment prednisone 5mg, cetirizine 10 mg, sulindac, Azithromycin.
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: Antinuclear antibody negative, Blood creatinine increased, Blood urea increased, Condition aggravated, Glomerular filtration rate decreased
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid serious case received from a nurse. This case is linked with 2018SA175572, 2018SA175593 and 2018SA175612 (Same patient). This case involves a 43-year-old female patient (age not reported) who experienced lost 50 percent of her kidney function, anemic, low HGB, blood in urine while she received vaccine FLUBLOK QIV. Patients past medical history included yrs ago she took the flu vaccine which was a standard seasonal one but not sure which one. States that night she became hypertensive, tachy, panicky, short of breath, swollen face and was covered in hives. Her husband took her to the ER and they gave her a SOLUMEDROL dose pack. States she has an allergy to latex and they were wondering if the reaction may have been due to the stopper. States that was in hospital that is now part of clinic and they wanted her to be vaccinate again. States in late 2015 she was premedicated with 50 mg BENADRYL and her renal functions normal but on the low side. They had her wait an hour then gave her the FLUBLOK and a few months later she got a purple rash on her thigh and they thought she it could have been an immunological rash. States she was more tired that summer and her urine changed color and she was drinking a lot of tea and it was hot. In Nov 2016 she had a 2nd dose of FLUBLOK and became short of breath. In January her PCP did more of a cardiac workup, chest xray and her renal function had deteriorated so she went to a Nephrologist for the renal function. The patient received third dose of FLUBLOK QIV on 07 Nov 2017 (Batch number: QSAA1702, exp date: 23 March 2018, route and site of administration was not reported). On Dec-2017, the patient had renal biopsy and now she has scarring and lost 50 percent of her kidney function, anemic, low HGB, and blood in urine following the administration of third dose INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant. (Other relevant tests included No lab data). Final diagnosis was lost 50 percent of her kidney function. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for lost 50 percent of her kidney function, anemic, low HGB, blood in urine. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient who presented with impairment of renal function after vaccination with FLUBLOK QIV vaccine. The time to onset is not clearly defined and the patient has a history of deterioration and improvement of kidney function in the past with relation to previous vaccination. There is no information regarding patient's kidney function at time of first vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: HIV test negative, Hepatitis viral test negative, IgA nephropathy, Renal impairment, Tubulointerstitial nephritis
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid serious case received from a nurse. This case is linked with 2018SA175572, 2018SA175593 and 2018SA175612 (Same patient). This case involves a 43-year-old female patient (age not reported) who experienced lost 50 percent of her kidney function, anemic, low HGB, blood in urine while she received vaccine FLUBLOK QIV. Patients past medical history included yrs ago she took the flu vaccine which was a standard seasonal one but not sure which one. States that night she became hypertensive, tachy, panicky, short of breath, swollen face and was covered in hives. Her husband took her to the ER and they gave her a SOLUMEDROL dose pack. States she has an allergy to latex and they were wondering if the reaction may have been due to the stopper. States that was in hospital that is now part of clinic and they wanted her to be vaccinate again. States in late 2015 she was premedicated with 50 mg BENADRYL and her renal functions normal but on the low side. They had her wait an hour then gave her the FLUBLOK and a few months later she got a purple rash on her thigh and they thought she it could have been an immunological rash. States she was more tired that summer and her urine changed color and she was drinking a lot of tea and it was hot. In Nov 2016 she had a 2nd dose of FLUBLOK and became short of breath. In January her PCP did more of a cardiac workup, chest xray and her renal function had deteriorated so she went to a Nephrologist for the renal function. The patient received third dose of FLUBLOK QIV on 07 Nov 2017 (Batch number: QSAA1702, exp date: 23 March 2018, route and site of administration was not reported). On Dec-2017, the patient had renal biopsy and now she has scarring and lost 50 percent of her kidney function, anemic, low HGB, and blood in urine following the administration of third dose INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant. (Other relevant tests included No lab data). Final diagnosis was lost 50 percent of her kidney function. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for lost 50 percent of her kidney function, anemic, low HGB, blood in urine. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient who presented with impairment of renal function after vaccination with FLUBLOK QIV vaccine. The time to onset is not clearly defined and the patient has a history of deterioration and improvement of kidney function in the past with relation to previous vaccination. There is no information regarding patient's kidney function at time of first vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: Anaemia, Biopsy kidney, Blood urine present, Haemoglobin decreased, Renal function test
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid serious case received from a nurse. This case is linked with 2018SA175572, 2018SA175593 and 2018SA175612 (Same patient). This case involves a 43-year-old female patient (age not reported) who experienced lost 50 percent of her kidney function, anemic, low HGB, blood in urine while she received vaccine FLUBLOK QIV. Patients past medical history included yrs ago she took the flu vaccine which was a standard seasonal one but not sure which one. States that night she became hypertensive, tachy, panicky, short of breath, swollen face and was covered in hives. Her husband took her to the ER and they gave her a SOLUMEDROL dose pack. States she has an allergy to latex and they were wondering if the reaction may have been due to the stopper. States that was in hospital that is now part of clinic and they wanted her to be vaccinate again. States in late 2015 she was premedicated with 50 mg BENADRYL and her renal functions normal but on the low side. They had her wait an hour then gave her the FLUBLOK and a few months later she got a purple rash on her thigh and they thought she it could have been an immunological rash. States she was more tired that summer and her urine changed color and she was drinking a lot of tea and it was hot. In Nov 2016 she had a 2nd dose of FLUBLOK and became short of breath. In January her PCP did more of a cardiac workup, chest xray and her renal function had deteriorated so she went to a Nephrologist for the renal function. The patient received third dose of FLUBLOK QIV on 07 Nov 2017 (Batch number: QSAA1702, exp date: 23 March 2018, route and site of administration was not reported). On Dec-2017, the patient had renal biopsy and now she has scarring and lost 50 percent of her kidney function, anemic, low HGB, and blood in urine following the administration of third dose INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant. (Other relevant tests included No lab data). Final diagnosis was lost 50 percent of her kidney function. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for lost 50 percent of her kidney function, anemic, low HGB, blood in urine. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient who presented with impairment of renal function after vaccination with FLUBLOK QIV vaccine. The time to onset is not clearly defined and the patient has a history of deterioration and improvement of kidney function in the past with relation to previous vaccination. There is no information regarding patient's kidney function at time of first vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: Renal impairment, Scar
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid serious case received from a nurse. This case is linked with 2018SA175572, 2018SA175593 and 2018SA175612 (Same patient). This case involves a 43-year-old female patient (age not reported) who experienced lost 50 percent of her kidney function, anemic, low HGB, blood in urine while she received vaccine FLUBLOK QIV. Patients past medical history included yrs ago she took the flu vaccine which was a standard seasonal one but not sure which one. States that night she became hypertensive, tachy, panicky, short of breath, swollen face and was covered in hives. Her husband took her to the ER and they gave her a SOLUMEDROL dose pack. States she has an allergy to latex and they were wondering if the reaction may have been due to the stopper. States that was in hospital that is now part of clinic and they wanted her to be vaccinate again. States in late 2015 she was premedicated with 50 mg BENADRYL and her renal functions normal but on the low side. They had her wait an hour then gave her the FLUBLOK and a few months later she got a purple rash on her thigh and they thought she it could have been an immunological rash. States she was more tired that summer and her urine changed color and she was drinking a lot of tea and it was hot. In Nov 2016 she had a 2nd dose of FLUBLOK and became short of breath. In January her PCP did more of a cardiac workup, chest xray and her renal function had deteriorated so she went to a Nephrologist for the renal function. The patient received third dose of FLUBLOK QIV on 07 Nov 2017 (Batch number: QSAA1702, exp date: 23 March 2018, route and site of administration was not reported). On Dec-2017, the patient had renal biopsy and now she has scarring and lost 50 percent of her kidney function, anemic, low HGB, and blood in urine following the administration of third dose INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant. (Other relevant tests included No lab data). Final diagnosis was lost 50 percent of her kidney function. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for lost 50 percent of her kidney function, anemic, low HGB, blood in urine. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient who presented with impairment of renal function after vaccination with FLUBLOK QIV vaccine. The time to onset is not clearly defined and the patient has a history of deterioration and improvement of kidney function in the past with relation to previous vaccination. There is no information regarding patient's kidney function at time of first vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: Cardiac function test, Chest X-ray, Dyspnoea, Renal function test, Renal impairment
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid serious case received from a nurse. This case is linked with 2018SA175572, 2018SA175593 and 2018SA175612 (Same patient). This case involves a 43-year-old female patient (age not reported) who experienced lost 50 percent of her kidney function, anemic, low HGB, blood in urine while she received vaccine FLUBLOK QIV. Patients past medical history included yrs ago she took the flu vaccine which was a standard seasonal one but not sure which one. States that night she became hypertensive, tachy, panicky, short of breath, swollen face and was covered in hives. Her husband took her to the ER and they gave her a SOLUMEDROL dose pack. States she has an allergy to latex and they were wondering if the reaction may have been due to the stopper. States that was in hospital that is now part of clinic and they wanted her to be vaccinate again. States in late 2015 she was premedicated with 50 mg BENADRYL and her renal functions normal but on the low side. They had her wait an hour then gave her the FLUBLOK and a few months later she got a purple rash on her thigh and they thought she it could have been an immunological rash. States she was more tired that summer and her urine changed color and she was drinking a lot of tea and it was hot. In Nov 2016 she had a 2nd dose of FLUBLOK and became short of breath. In January her PCP did more of a cardiac workup, chest xray and her renal function had deteriorated so she went to a Nephrologist for the renal function. The patient received third dose of FLUBLOK QIV on 07 Nov 2017 (Batch number: QSAA1702, exp date: 23 March 2018, route and site of administration was not reported). On Dec-2017, the patient had renal biopsy and now she has scarring and lost 50 percent of her kidney function, anemic, low HGB, and blood in urine following the administration of third dose INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant. (Other relevant tests included No lab data). Final diagnosis was lost 50 percent of her kidney function. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for lost 50 percent of her kidney function, anemic, low HGB, blood in urine. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient who presented with impairment of renal function after vaccination with FLUBLOK QIV vaccine. The time to onset is not clearly defined and the patient has a history of deterioration and improvement of kidney function in the past with relation to previous vaccination. There is no information regarding patient's kidney function at time of first vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: Antinuclear antibody negative, Blood creatinine increased, Blood urea increased, Condition aggravated, Glomerular filtration rate decreased
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse (patient itself). This case is linked to cases 2018SA175572, 2018SA175593 and 2018SA164901 (same patient). This case involves Adult female patient who experienced renal function had deteriorated and short of breath, while she received vaccine FLUBLOK QIV. The patient's past vaccination included flu vaccine, and FLUBLOK. The patient's past medical history, medical treatment and family history were not provided. In Nov 2016, the patient received a second dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported in unknown administration site. The patient developed a serious renal function had deteriorated and short of breath unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event (renal impairment) was assessed as medically significant. In January her PCP did more of a cardiac workup, chest xray and her renal function had deteriorated so she went to a Nephrologist for the renal function. Final diagnosis was short of breath and renal function had deteriorated. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for renal function had deteriorated and as Unknown for short of breath. List of documents held by sender: none. Sender's Comments: Patient developed Renal impairment and dyspnoea after vaccination. Exact time to onset is unknown. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: HIV test negative, Hepatitis viral test negative, IgA nephropathy, Renal impairment, Tubulointerstitial nephritis
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse (patient itself). This case is linked to cases 2018SA175572, 2018SA175593 and 2018SA164901 (same patient). This case involves Adult female patient who experienced renal function had deteriorated and short of breath, while she received vaccine FLUBLOK QIV. The patient's past vaccination included flu vaccine, and FLUBLOK. The patient's past medical history, medical treatment and family history were not provided. In Nov 2016, the patient received a second dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported in unknown administration site. The patient developed a serious renal function had deteriorated and short of breath unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event (renal impairment) was assessed as medically significant. In January her PCP did more of a cardiac workup, chest xray and her renal function had deteriorated so she went to a Nephrologist for the renal function. Final diagnosis was short of breath and renal function had deteriorated. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for renal function had deteriorated and as Unknown for short of breath. List of documents held by sender: none. Sender's Comments: Patient developed Renal impairment and dyspnoea after vaccination. Exact time to onset is unknown. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: Anaemia, Biopsy kidney, Blood urine present, Haemoglobin decreased, Renal function test
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse (patient itself). This case is linked to cases 2018SA175572, 2018SA175593 and 2018SA164901 (same patient). This case involves Adult female patient who experienced renal function had deteriorated and short of breath, while she received vaccine FLUBLOK QIV. The patient's past vaccination included flu vaccine, and FLUBLOK. The patient's past medical history, medical treatment and family history were not provided. In Nov 2016, the patient received a second dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported in unknown administration site. The patient developed a serious renal function had deteriorated and short of breath unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event (renal impairment) was assessed as medically significant. In January her PCP did more of a cardiac workup, chest xray and her renal function had deteriorated so she went to a Nephrologist for the renal function. Final diagnosis was short of breath and renal function had deteriorated. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for renal function had deteriorated and as Unknown for short of breath. List of documents held by sender: none. Sender's Comments: Patient developed Renal impairment and dyspnoea after vaccination. Exact time to onset is unknown. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: Renal impairment, Scar
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse (patient itself). This case is linked to cases 2018SA175572, 2018SA175593 and 2018SA164901 (same patient). This case involves Adult female patient who experienced renal function had deteriorated and short of breath, while she received vaccine FLUBLOK QIV. The patient's past vaccination included flu vaccine, and FLUBLOK. The patient's past medical history, medical treatment and family history were not provided. In Nov 2016, the patient received a second dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported in unknown administration site. The patient developed a serious renal function had deteriorated and short of breath unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event (renal impairment) was assessed as medically significant. In January her PCP did more of a cardiac workup, chest xray and her renal function had deteriorated so she went to a Nephrologist for the renal function. Final diagnosis was short of breath and renal function had deteriorated. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for renal function had deteriorated and as Unknown for short of breath. List of documents held by sender: none. Sender's Comments: Patient developed Renal impairment and dyspnoea after vaccination. Exact time to onset is unknown. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLUR4, FLUR4, FLUR4
Symptoms: Cardiac function test, Chest X-ray, Dyspnoea, Renal function test, Renal impairment
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse (patient itself). This case is linked to cases 2018SA175572, 2018SA175593 and 2018SA164901 (same patient). This case involves Adult female patient who experienced renal function had deteriorated and short of breath, while she received vaccine FLUBLOK QIV. The patient's past vaccination included flu vaccine, and FLUBLOK. The patient's past medical history, medical treatment and family history were not provided. In Nov 2016, the patient received a second dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported in unknown administration site. The patient developed a serious renal function had deteriorated and short of breath unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event (renal impairment) was assessed as medically significant. In January her PCP did more of a cardiac workup, chest xray and her renal function had deteriorated so she went to a Nephrologist for the renal function. Final diagnosis was short of breath and renal function had deteriorated. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for renal function had deteriorated and as Unknown for short of breath. List of documents held by sender: none. Sender's Comments: Patient developed Renal impairment and dyspnoea after vaccination. Exact time to onset is unknown. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.