chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Neck pain, Night sweats, Pallor, Thyroid function test, Thyroxine
Clinical narrative: Fatigue, dizziness, migraine, weakness, muscle pain, falling down, lightheadedness, diarrhea, vomiting, loss of appetite, low concentration, chills, night sweats, decreased mobility, pale, increased heart rate, stomach pain, neck pain, ear pain.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Tri-iodothyronine free, Troponin, Urine analysis, Vomiting
Clinical narrative: Fatigue, dizziness, migraine, weakness, muscle pain, falling down, lightheadedness, diarrhea, vomiting, loss of appetite, low concentration, chills, night sweats, decreased mobility, pale, increased heart rate, stomach pain, neck pain, ear pain.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain
Clinical narrative: PATIENT DEVELOPED CHILLS OVERNIGHT AND REDNESS AND SORENESS/PAIN AROUND INJECTION SITE. TOOK TYLENOL TO HELP WITH CHILLS.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: About 16 hours after vaccine was administered, woke up with muscle aches and pains. Was able to get back to sleep after taking 2 Naproxen Sodium 220mg along with half a dose of Diphenhydramine Hcl. Aches continued the next day, along with soreness of left arm.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: By mistake patient was given pediatric dose instead of adult dose of ENGERIX-B. This was not realized until 2/9/2018 when I was looking at patients alert report and saw that the dose was invalid. I left a msg for the pt to return my call to let her know what happened and have her come in to get the correct dose.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Decreased appetite, Infrequent bowel movements, Injection site reaction, Macule, Pallor
Clinical narrative: He received the vaccines above in the morning and, later that evening, he developed a rash consisting of 1 mm blanching red macules over anterior and posterior trunk and proximal thighs.  He also breast fed less than usual and had less urine output and fewer bowel movements than usual.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rash, Urine output decreased
Clinical narrative: He received the vaccines above in the morning and, later that evening, he developed a rash consisting of 1 mm blanching red macules over anterior and posterior trunk and proximal thighs.  He also breast fed less than usual and had less urine output and fewer bowel movements than usual.
Age: 66.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient came in on 2/15/18 and said he received SHINGRIX and PREVNAR on 02/13/2018 and that same day his arm showed big red circle swollen with pain and fever. But on 02/15/18 his arm still red and slightly swollen but no fever. Will keep eye on it if redness and swelling still there he will consult dr.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Haematochezia, Rectal haemorrhage
Clinical narrative: Pt LP received SHINGRIX vaccine 2/14/18. Pt is extremely hard of hearing. His wife came in to the store on 2/15/18 and reported pt had blood coming from his rectum yesterday 8 hours after receiving SHINGRIX. He has had about 5 spouts of rectal bleeding, bright red - some with stools. Wife did not know if he has a history of hemorrhoids. He takes 81mg of ASA. I contacted his primary care doctor whom did not know if he had hemorrhoids. His nurse, did say he has refused colonoscopies d/t having a son that died from colon cancer. I called the manufacture they did not have any reports of blood spewing from the rectum, blood in stools, etc. Only GI - nausea, vomiting, diarrhea, and abdominal pain. Cannot determine if vaccine caused ADR or not. Pt has follow up with PCP on Monday.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Asthenia, Dizziness, Hypoaesthesia, Nausea
Clinical narrative: Within a few minutes felt dizzy, then felt as if had to go to bathroom but couldn't, felt weak all over, felt nausea.. Arm felt numb. Then felt severe abdominal pain like cramps but much worse than ever felt before, staff commented that her face looked like she was experiencing contractions, her throat felt pain but not like closing (like asthma) just felt tight/sore. Symptoms passed after about 25 minutes or so. Doctors commented they had never seen such a severe reaction. Patient fine rest of day. We are still in the same day. Patient had zero symptoms after first dose; in opposite arm previously.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Oropharyngeal pain, Throat tightness, Urinary retention, White blood cell count normal
Clinical narrative: Within a few minutes felt dizzy, then felt as if had to go to bathroom but couldn't, felt weak all over, felt nausea.. Arm felt numb. Then felt severe abdominal pain like cramps but much worse than ever felt before, staff commented that her face looked like she was experiencing contractions, her throat felt pain but not like closing (like asthma) just felt tight/sore. Symptoms passed after about 25 minutes or so. Doctors commented they had never seen such a severe reaction. Patient fine rest of day. We are still in the same day. Patient had zero symptoms after first dose; in opposite arm previously.
Age: 34.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Back pain, Chills, Dystonia, Hyperhidrosis, Pain
Clinical narrative: 5 minutes after the vaccine was administrated the patient complained of severe pain shooting down her arm, at a pain level of 9. She immediately started sweating and the pain traveled up to her jaw and down her back on the left side. She had difficulty talking because of the pain and then went into shaking and chills. This reaction occurred over a period of 30 minutes when her fiancé came in and took her to the ER. The doctor called the pharmacy and said it didn't look like an allergy but a dystonic reaction and treated her with Ativan and benadryl and the patient went home later that night.
Age: 34.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pain in extremity, Pain in jaw, Tremor
Clinical narrative: 5 minutes after the vaccine was administrated the patient complained of severe pain shooting down her arm, at a pain level of 9. She immediately started sweating and the pain traveled up to her jaw and down her back on the left side. She had difficulty talking because of the pain and then went into shaking and chills. This reaction occurred over a period of 30 minutes when her fiancé came in and took her to the ER. The doctor called the pharmacy and said it didn't look like an allergy but a dystonic reaction and treated her with Ativan and benadryl and the patient went home later that night.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: VOMITING RIGHT AFTER ADMINISTRATION.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Hyperhidrosis, Lymphadenopathy, Migraine
Clinical narrative: On Saturday, 2/10/18, huge swelling in armpit, lymph nodes, but I felt fine. I took pictures if you want them & my doctor has a set of them, too. On Sunday, 2/11/18, an intense migraine started and lasted for a few days, accompanied by vomiting, sweating, and freezing. I saw the doctor on 2/13/18, she told me what to watch for regarding the lymph nodes and to come back if any of them occurred. She said I should get the second dose, but move it further out in the 2 - 6 mo window. She gave me a script to help with migraine, if I get one on the second dose. I was able to keep down water & broth on 2/13/18 and solid food by 2/14/18. Today, I'm just exhausted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: On Saturday, 2/10/18, huge swelling in armpit, lymph nodes, but I felt fine. I took pictures if you want them & my doctor has a set of them, too. On Sunday, 2/11/18, an intense migraine started and lasted for a few days, accompanied by vomiting, sweating, and freezing. I saw the doctor on 2/13/18, she told me what to watch for regarding the lymph nodes and to come back if any of them occurred. She said I should get the second dose, but move it further out in the 2 - 6 mo window. She gave me a script to help with migraine, if I get one on the second dose. I was able to keep down water & broth on 2/13/18 and solid food by 2/14/18. Today, I'm just exhausted.
Age: 75.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Reduced mobility, pain, shoulder swelling, believe vaccination was given too high, happened at time vaccination was given.
Age: 75.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Mobility decreased, Pain, Product administered at inappropriate site, Swelling
Clinical narrative: Reduced mobility, pain, shoulder swelling, believe vaccination was given too high, happened at time vaccination was given.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: Pt started to get itchy about 2 days after her Tdap 2 wks ago (1-8-18). Continued to worsen through the week. Over this past weekend she noted that the area looked a bit red and the itching was worsening. Wants the site evaluated. Denies overt pain, or discomfort to touch.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Pallor, Skin discolouration
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of difficulty breathing in a 18-year-old female patient who received BEXSERO (batch number 16A401, expiry date January 2019). On 8th February 2018 09:00, the patient received the 1st dose of BEXSERO .5 ml. On 8th February 2018, 3 hrs after receiving BEXSERO, the patient experienced difficulty breathing, skin discoloration and pale. On an unknown date, the outcome of the difficulty breathing, skin discoloration and pale were unknown. It was unknown if the reporter considered the difficulty breathing, skin discoloration and pale to be related to BEXSERO. Additional details were provided as follows: The patient received the vaccine in the left deltoid. About 3 to 4 hours after the patient received dose of BEXSERO, the patient experienced trouble breathing, turned purple, and then pale. The patient was taken to the emergency department by an ambulance called from her mother. Health care professional did not think this was due to the BEXSERO, stated that patient was fine when she was leaving the office.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 62-year-old female patient who received SHINGRIX. On 11th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th January 2018, immediately after receiving SHINGRIX, the experienced decreased appetite and injection site pain. On 12th January 2018, the patient experienced fatigue, upset stomach, fever and headache. On an unknown date, the outcome of the fatigue, upset stomach, decreased appetite, injection site pain, fever, and headache were recovered/resolved. The reporter considered the fatigue, upset stomach, decreased appetite, injection site pain and fever to be related to SHINGRIX. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported an adverse event on SHINGRIX injection. The patient requested to remain anonymous and offered limited information pertaining to the adverse event. The patient stated she received a SHINRIX injection on 11th January 2018 at a local pharmacy. She stated immediately after the injection, she had localized pain at the injection site and decrease hunger. She stated the next day after the injection she had severe fatigue, headache, fever and upset stomach. The patient stated since the reaction happened in January, she was not sure how long it lasted. She did not have the lot number or expiration. The patient requested information about what adverse reactions to expect from the second shot in the series. The agent referred the caller to the SHINGRIX website and PI. The agent instructed the caller to contact her health care professional with medical issues. The patient denied receiving additional vaccines at the time of the SHINGRIX vaccine or within 4 weeks. The patient has denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 62-year-old female patient who received SHINGRIX. On 11th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th January 2018, immediately after receiving SHINGRIX, the experienced decreased appetite and injection site pain. On 12th January 2018, the patient experienced fatigue, upset stomach, fever and headache. On an unknown date, the outcome of the fatigue, upset stomach, decreased appetite, injection site pain, fever, and headache were recovered/resolved. The reporter considered the fatigue, upset stomach, decreased appetite, injection site pain and fever to be related to SHINGRIX. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported an adverse event on SHINGRIX injection. The patient requested to remain anonymous and offered limited information pertaining to the adverse event. The patient stated she received a SHINRIX injection on 11th January 2018 at a local pharmacy. She stated immediately after the injection, she had localized pain at the injection site and decrease hunger. She stated the next day after the injection she had severe fatigue, headache, fever and upset stomach. The patient stated since the reaction happened in January, she was not sure how long it lasted. She did not have the lot number or expiration. The patient requested information about what adverse reactions to expect from the second shot in the series. The agent referred the caller to the SHINGRIX website and PI. The agent instructed the caller to contact her health care professional with medical issues. The patient denied receiving additional vaccines at the time of the SHINGRIX vaccine or within 4 weeks. The patient has denied permission to contact their physician.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, swelling, and pain (R) arm. BANOPHEN and prednisolone given.
Age: 37.0
Sex: F
Vaccine: YF, YF
Symptoms: Erythema
Clinical narrative: Right back of arm 2 in x 1 in red area, non-raised, no complaints of itching, afebrile, no numbness or tingling of extremity. Full ROM present.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Seen for WCE in office 02/02/18. Rec'd. 1 yr. IMM. Fever began 2/09/18 PM; 102 degrees max. Seen in office 02/10/18 for S/S. No local site reactions noted. No head cold S/S. No eye drainage. To monitor and Tx with TYLENOL/MOTRIN PRN. To C/office if worsening.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Retching
Clinical narrative: Received the new SHINGRIX vaccination and had very bad side effect for 15 hours including shivering, sweats, nausea, wretching vomiting, and light headedness.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Received the new SHINGRIX vaccination and had very bad side effect for 15 hours including shivering, sweats, nausea, wretching vomiting, and light headedness.
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Back pain, Headache, Nephrolithiasis, Night sweats
Clinical narrative: Took third dose of VIVOTIF. Wrenching vomiting, pain all around abdomen and back, extreme headache. Have had 2 kidney stones in my past. I felt worse from this than the kidney stones. Called doctor who said to discontinue use. Feel much better today after sweating heavily most of the night.
Sex: M
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Took third dose of VIVOTIF. Wrenching vomiting, pain all around abdomen and back, extreme headache. Have had 2 kidney stones in my past. I felt worse from this than the kidney stones. Called doctor who said to discontinue use. Feel much better today after sweating heavily most of the night.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Got shingles vaccine Sunday about 5PM. Experiencing muscle and joint pain all over!
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Interchange of vaccine products, Musculoskeletal stiffness, Seizure, Syncope
Clinical narrative: My daughter received the second shot of GARDASIL, this second time it was GARDASIL 9. Immediately after receiving the shot she fainted and experience stiffness/seizure that lasted 3-5 minutes. She was taken to the ER by ambulance. After 3 hours of observation she was discharged and referred to a neurologist for further examination.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Hot flush, Nausea, Vomiting
Clinical narrative: My 15yr old daughter received her 2nd GARDASIL vaccine on Monday 2/15/18. On Wednesday 2/7/18 she started to become dizzy, nauseas, and developed a headache. The nausea and vomiting has continued for 5 days. She also has a headache. She had had hot flashes and periods of dizziness over the past 5 days.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: My one year old was vaccinated on 1/29/2018 with the varicella vaccination and on 2/7/2018 has a full case of chicken pox.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Blood gases abnormal, Blood lactic acid increased, Chest X-ray abnormal, Cough
Clinical narrative: Hospital Course: The patient is a 40-year-old female who presented on the 8th to the emergency room with complaint of influenza type symptoms hurting all over. The patient was febrile at the time of admission and family members had been positive for influenza. The patient had also been on antibiotic for urinary tract infection that was prescribed earlier in the week. The patient was experiencing body aches, fever, fatigue, diarrhea, congestion all consistent with influenza running through the family. The patient unfortunately had 15 or so loose stools during short period of time. The patient is exhibiting a rash to entire upper body, redness across her skin which broke out on earlier in the day. The patient was started on IV fluids, was pan cultured. The patient's blood cultures were negative. The patient's urine cultures, however, confirmed urinary tract infection of E. coli. During the rehydrating process, the patient was noted to have a nice improvement in her hemoglobins. White counts were normal to the majority of the hospital stay. The patient's exam, however, demonstrated some congestive cough that led to a follow-up chest x-ray and that chest x-ray showed a new left-sided pneumonia, which may have been present at the time of admission is not well demonstrated on x-ray. However, it was noted that the patient received a PNEUMOVAX 23 pneumonia vaccination the day prior to onset. Given the urinary tract infection culture results and the chest x-ray, it was felt that antibiotic was necessary given her significant allergies. She was placed on aztreonam. The patient's red skin symptoms continued to get worse despite no prior exposure to antibiotics at least aztreonam. The patient's aztreonam was held. Urine output was reported to be minimal and follow-up labs on the 15th demonstrated the patient to be acidotic elevated white count, elevated lactic acid, all concerning for sepsis. The patient case was discussed with Dr. who given the abrupt change in the patient's overall kidney function and the large bump in the white count will be better served in a tertiary center. The case was discussed with the intensive this at facility and the patient is being transferred to the ICU there. An ABG done earlier in the morning demonstrated again the patient to be acidotic. Oxygen was started just prior to that due to diminished pulse Ox level. The patient's labs and vitals were stable prior to admission. Oxygen sats were 91% on 40% Venti but she was afebrile pulse 93, respiratory rate of 25, blood pressure 115/64 on just 150 cc an hour IV fluids. The patient is a very difficult IV stick. She has had history of developing thromboses in the extremities due to this factor 5 condition that she has and as a result central lines have not been used since that period of time. The patient has had some of her follow up care specifically Cardiology at another location. Further records could be provided if needed. The patient was transferred in stable condition. We will follow post discharge.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Culture urine positive, Diarrhoea, Erythema, Escherichia infection, Fatigue
Clinical narrative: Hospital Course: The patient is a 40-year-old female who presented on the 8th to the emergency room with complaint of influenza type symptoms hurting all over. The patient was febrile at the time of admission and family members had been positive for influenza. The patient had also been on antibiotic for urinary tract infection that was prescribed earlier in the week. The patient was experiencing body aches, fever, fatigue, diarrhea, congestion all consistent with influenza running through the family. The patient unfortunately had 15 or so loose stools during short period of time. The patient is exhibiting a rash to entire upper body, redness across her skin which broke out on earlier in the day. The patient was started on IV fluids, was pan cultured. The patient's blood cultures were negative. The patient's urine cultures, however, confirmed urinary tract infection of E. coli. During the rehydrating process, the patient was noted to have a nice improvement in her hemoglobins. White counts were normal to the majority of the hospital stay. The patient's exam, however, demonstrated some congestive cough that led to a follow-up chest x-ray and that chest x-ray showed a new left-sided pneumonia, which may have been present at the time of admission is not well demonstrated on x-ray. However, it was noted that the patient received a PNEUMOVAX 23 pneumonia vaccination the day prior to onset. Given the urinary tract infection culture results and the chest x-ray, it was felt that antibiotic was necessary given her significant allergies. She was placed on aztreonam. The patient's red skin symptoms continued to get worse despite no prior exposure to antibiotics at least aztreonam. The patient's aztreonam was held. Urine output was reported to be minimal and follow-up labs on the 15th demonstrated the patient to be acidotic elevated white count, elevated lactic acid, all concerning for sepsis. The patient case was discussed with Dr. who given the abrupt change in the patient's overall kidney function and the large bump in the white count will be better served in a tertiary center. The case was discussed with the intensive this at facility and the patient is being transferred to the ICU there. An ABG done earlier in the morning demonstrated again the patient to be acidotic. Oxygen was started just prior to that due to diminished pulse Ox level. The patient's labs and vitals were stable prior to admission. Oxygen sats were 91% on 40% Venti but she was afebrile pulse 93, respiratory rate of 25, blood pressure 115/64 on just 150 cc an hour IV fluids. The patient is a very difficult IV stick. She has had history of developing thromboses in the extremities due to this factor 5 condition that she has and as a result central lines have not been used since that period of time. The patient has had some of her follow up care specifically Cardiology at another location. Further records could be provided if needed. The patient was transferred in stable condition. We will follow post discharge.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Intensive care, Nasal congestion, Oxygen saturation decreased, Pain
Clinical narrative: Hospital Course: The patient is a 40-year-old female who presented on the 8th to the emergency room with complaint of influenza type symptoms hurting all over. The patient was febrile at the time of admission and family members had been positive for influenza. The patient had also been on antibiotic for urinary tract infection that was prescribed earlier in the week. The patient was experiencing body aches, fever, fatigue, diarrhea, congestion all consistent with influenza running through the family. The patient unfortunately had 15 or so loose stools during short period of time. The patient is exhibiting a rash to entire upper body, redness across her skin which broke out on earlier in the day. The patient was started on IV fluids, was pan cultured. The patient's blood cultures were negative. The patient's urine cultures, however, confirmed urinary tract infection of E. coli. During the rehydrating process, the patient was noted to have a nice improvement in her hemoglobins. White counts were normal to the majority of the hospital stay. The patient's exam, however, demonstrated some congestive cough that led to a follow-up chest x-ray and that chest x-ray showed a new left-sided pneumonia, which may have been present at the time of admission is not well demonstrated on x-ray. However, it was noted that the patient received a PNEUMOVAX 23 pneumonia vaccination the day prior to onset. Given the urinary tract infection culture results and the chest x-ray, it was felt that antibiotic was necessary given her significant allergies. She was placed on aztreonam. The patient's red skin symptoms continued to get worse despite no prior exposure to antibiotics at least aztreonam. The patient's aztreonam was held. Urine output was reported to be minimal and follow-up labs on the 15th demonstrated the patient to be acidotic elevated white count, elevated lactic acid, all concerning for sepsis. The patient case was discussed with Dr. who given the abrupt change in the patient's overall kidney function and the large bump in the white count will be better served in a tertiary center. The case was discussed with the intensive this at facility and the patient is being transferred to the ICU there. An ABG done earlier in the morning demonstrated again the patient to be acidotic. Oxygen was started just prior to that due to diminished pulse Ox level. The patient's labs and vitals were stable prior to admission. Oxygen sats were 91% on 40% Venti but she was afebrile pulse 93, respiratory rate of 25, blood pressure 115/64 on just 150 cc an hour IV fluids. The patient is a very difficult IV stick. She has had history of developing thromboses in the extremities due to this factor 5 condition that she has and as a result central lines have not been used since that period of time. The patient has had some of her follow up care specifically Cardiology at another location. Further records could be provided if needed. The patient was transferred in stable condition. We will follow post discharge.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia, Pyrexia, Rash generalised, Respiratory tract congestion, White blood cell count increased
Clinical narrative: Hospital Course: The patient is a 40-year-old female who presented on the 8th to the emergency room with complaint of influenza type symptoms hurting all over. The patient was febrile at the time of admission and family members had been positive for influenza. The patient had also been on antibiotic for urinary tract infection that was prescribed earlier in the week. The patient was experiencing body aches, fever, fatigue, diarrhea, congestion all consistent with influenza running through the family. The patient unfortunately had 15 or so loose stools during short period of time. The patient is exhibiting a rash to entire upper body, redness across her skin which broke out on earlier in the day. The patient was started on IV fluids, was pan cultured. The patient's blood cultures were negative. The patient's urine cultures, however, confirmed urinary tract infection of E. coli. During the rehydrating process, the patient was noted to have a nice improvement in her hemoglobins. White counts were normal to the majority of the hospital stay. The patient's exam, however, demonstrated some congestive cough that led to a follow-up chest x-ray and that chest x-ray showed a new left-sided pneumonia, which may have been present at the time of admission is not well demonstrated on x-ray. However, it was noted that the patient received a PNEUMOVAX 23 pneumonia vaccination the day prior to onset. Given the urinary tract infection culture results and the chest x-ray, it was felt that antibiotic was necessary given her significant allergies. She was placed on aztreonam. The patient's red skin symptoms continued to get worse despite no prior exposure to antibiotics at least aztreonam. The patient's aztreonam was held. Urine output was reported to be minimal and follow-up labs on the 15th demonstrated the patient to be acidotic elevated white count, elevated lactic acid, all concerning for sepsis. The patient case was discussed with Dr. who given the abrupt change in the patient's overall kidney function and the large bump in the white count will be better served in a tertiary center. The case was discussed with the intensive this at facility and the patient is being transferred to the ICU there. An ABG done earlier in the morning demonstrated again the patient to be acidotic. Oxygen was started just prior to that due to diminished pulse Ox level. The patient's labs and vitals were stable prior to admission. Oxygen sats were 91% on 40% Venti but she was afebrile pulse 93, respiratory rate of 25, blood pressure 115/64 on just 150 cc an hour IV fluids. The patient is a very difficult IV stick. She has had history of developing thromboses in the extremities due to this factor 5 condition that she has and as a result central lines have not been used since that period of time. The patient has had some of her follow up care specifically Cardiology at another location. Further records could be provided if needed. The patient was transferred in stable condition. We will follow post discharge.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dizziness, Headache, Influenza virus test negative, Pyrexia
Clinical narrative: Had annual exam, all normal and bp 122/81 and got SHINGRIX vaccine first shot. 24 hrs later had high fever of 102 and severe headache and lightheaded. Went back to Dr right then thinking picked up the flu. Flu test negative but bp now 166/104. Dr had me take Ibuprofen and lie down for awhile. Bp down to about 144/90. Went home and back to Dr next day then another 3 days after that. Bp running in 140s/90s consistently. Been monitoring at home and always high, 140-160/90-105 or so. Never ever had high bp in my entire life. Do all my yearly visits, preventative care etc. Never had a single high reading before. 51 yr old woman with no family history of high bp, both parents alive in their 80s with no bp problems. High bp hit overnight and not coming down 2 wks later.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020) and (batch number FJ573 ?, expiry date 30th January 2020). On 22nd January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. The patient was treated with steroids and muscle relaxants. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: On 22nd January 2018 at 11:25 hours, the patient received SHINGRIX in left deltoid. The patient came into the pharmacy on the day of reporting and stated that her left arm was severely sore. The patient went to her physician and received steroids and a muscle relaxant but neither medication provided any relief. The reported lot number (batch number FJ573 ?) does not match any GSK lot number and clarification has been raised for the same.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site bruising, injection site erythema and intramuscular formulation administered by other route.  On an unknown date, the outcome of the injection site swelling, injection site bruising, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site swelling, injection site bruising and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient received SHINGRIX via subcutaneous instead of intramuscular route at a different office location, which led to which to inappropriate route of vaccination. The patient experienced raised, red, bruised and swollen at injection site.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Blood albumin, Blood glucose increased, Blood lactic acid normal, Crying, Electrocardiogram normal
Clinical narrative: This spontaneous report was received from pharmacy technician and refers to a 41 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular in the right deltoid, lot # N027624 and expiration date 11-MAY-2019 for prophylaxis (strength, dose and frequency were not reported). On 25-JAN-2018, the patient experienced severe pain, swelling and hives. It was reported that the patient was advised by the clinic to go to the emergency department. At the reporting time, the patient was recovering from the events swelling, urticaria and pain. The reporter did not assess the causal relationship between therapy with pneumococcal vaccine, polyvalent (23-valent) and the aforementioned events. This is one of several reports received from the same reporter.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Full blood count, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report was received from pharmacy technician and refers to a 41 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular in the right deltoid, lot # N027624 and expiration date 11-MAY-2019 for prophylaxis (strength, dose and frequency were not reported). On 25-JAN-2018, the patient experienced severe pain, swelling and hives. It was reported that the patient was advised by the clinic to go to the emergency department. At the reporting time, the patient was recovering from the events swelling, urticaria and pain. The reporter did not assess the causal relationship between therapy with pneumococcal vaccine, polyvalent (23-valent) and the aforementioned events. This is one of several reports received from the same reporter.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Injection site swelling, Lymphocyte count decreased, PCO2 normal, PO2 normal, Rash macular
Clinical narrative: This spontaneous report was received from pharmacy technician and refers to a 41 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular in the right deltoid, lot # N027624 and expiration date 11-MAY-2019 for prophylaxis (strength, dose and frequency were not reported). On 25-JAN-2018, the patient experienced severe pain, swelling and hives. It was reported that the patient was advised by the clinic to go to the emergency department. At the reporting time, the patient was recovering from the events swelling, urticaria and pain. The reporter did not assess the causal relationship between therapy with pneumococcal vaccine, polyvalent (23-valent) and the aforementioned events. This is one of several reports received from the same reporter.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Crying, Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report was received from pharmacy technician and refers to a 41 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular in the right deltoid, lot # N027624 and expiration date 11-MAY-2019 for prophylaxis (strength, dose and frequency were not reported). On 25-JAN-2018, the patient experienced severe pain, swelling and hives. It was reported that the patient was advised by the clinic to go to the emergency department. At the reporting time, the patient was recovering from the events swelling, urticaria and pain. The reporter did not assess the causal relationship between therapy with pneumococcal vaccine, polyvalent (23-valent) and the aforementioned events. This is one of several reports received from the same reporter.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV, PPV, PPV
Symptoms: Pain, Swelling, Urticaria
Clinical narrative: This spontaneous report was received from pharmacy technician and refers to a 41 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular in the right deltoid, lot # N027624 and expiration date 11-MAY-2019 for prophylaxis (strength, dose and frequency were not reported). On 25-JAN-2018, the patient experienced severe pain, swelling and hives. It was reported that the patient was advised by the clinic to go to the emergency department. At the reporting time, the patient was recovering from the events swelling, urticaria and pain. The reporter did not assess the causal relationship between therapy with pneumococcal vaccine, polyvalent (23-valent) and the aforementioned events. This is one of several reports received from the same reporter.
Age: 26.0
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: CD4 lymphocytes abnormal
Clinical narrative: This spontaneous report was received from a physician, and refers to a 26 year old patient with hiv infection. No information about the patient's medical history was provided. The patient had no drug reactions/allergies. On 05-JAN-2018, the patient was vaccinated with a dose VARIVAX injection, for vaccination (prophylaxis), (dose, frequency, route, lot number and expiration date were not provided). Concomitant therapies included cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate (GENVOYA) and azithromycin. On 23-JAN-2018, the patient had an enzyme linked immunosorbent assay (ELISA) test and was diagnosed with acquired immunodeficiency syndrome (AIDS). Additionally, on 24-JAN-2018, the patient had a cluster of differentiation 4 (CD4) with a count of 49 (units not provided). Moreover, on an unspecified date in 2018, the patient had a rash all over his body (rash generalized) and was prescribed with acyclovir since 07-FEB-2018 (details were not provided). No product quality complaint (PQC) was involved. At the time of reporting, the outcome of acquired immunodeficiency syndrome and rash generalized was unknown. The causal relationship between VARIVAX and the reported events was not provided. Upon internal review, the event acquired immunodeficiency syndrome  was determined to be medically significant.
Age: 26.0
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Fatigue, HIV test positive, Headache, Influenza like illness, Laboratory test
Clinical narrative: This spontaneous report was received from a physician, and refers to a 26 year old patient with hiv infection. No information about the patient's medical history was provided. The patient had no drug reactions/allergies. On 05-JAN-2018, the patient was vaccinated with a dose VARIVAX injection, for vaccination (prophylaxis), (dose, frequency, route, lot number and expiration date were not provided). Concomitant therapies included cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate (GENVOYA) and azithromycin. On 23-JAN-2018, the patient had an enzyme linked immunosorbent assay (ELISA) test and was diagnosed with acquired immunodeficiency syndrome (AIDS). Additionally, on 24-JAN-2018, the patient had a cluster of differentiation 4 (CD4) with a count of 49 (units not provided). Moreover, on an unspecified date in 2018, the patient had a rash all over his body (rash generalized) and was prescribed with acyclovir since 07-FEB-2018 (details were not provided). No product quality complaint (PQC) was involved. At the time of reporting, the outcome of acquired immunodeficiency syndrome and rash generalized was unknown. The causal relationship between VARIVAX and the reported events was not provided. Upon internal review, the event acquired immunodeficiency syndrome  was determined to be medically significant.
Age: 26.0
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Pain, Pyrexia, Rhinorrhoea, Urine analysis
Clinical narrative: This spontaneous report was received from a physician, and refers to a 26 year old patient with hiv infection. No information about the patient's medical history was provided. The patient had no drug reactions/allergies. On 05-JAN-2018, the patient was vaccinated with a dose VARIVAX injection, for vaccination (prophylaxis), (dose, frequency, route, lot number and expiration date were not provided). Concomitant therapies included cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate (GENVOYA) and azithromycin. On 23-JAN-2018, the patient had an enzyme linked immunosorbent assay (ELISA) test and was diagnosed with acquired immunodeficiency syndrome (AIDS). Additionally, on 24-JAN-2018, the patient had a cluster of differentiation 4 (CD4) with a count of 49 (units not provided). Moreover, on an unspecified date in 2018, the patient had a rash all over his body (rash generalized) and was prescribed with acyclovir since 07-FEB-2018 (details were not provided). No product quality complaint (PQC) was involved. At the time of reporting, the outcome of acquired immunodeficiency syndrome and rash generalized was unknown. The causal relationship between VARIVAX and the reported events was not provided. Upon internal review, the event acquired immunodeficiency syndrome  was determined to be medically significant.
Age: 26.0
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Acquired immunodeficiency syndrome, CD4 lymphocytes decreased, Immunology test, Immunology test abnormal, Rash generalised
Clinical narrative: This spontaneous report was received from a physician, and refers to a 26 year old patient with hiv infection. No information about the patient's medical history was provided. The patient had no drug reactions/allergies. On 05-JAN-2018, the patient was vaccinated with a dose VARIVAX injection, for vaccination (prophylaxis), (dose, frequency, route, lot number and expiration date were not provided). Concomitant therapies included cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate (GENVOYA) and azithromycin. On 23-JAN-2018, the patient had an enzyme linked immunosorbent assay (ELISA) test and was diagnosed with acquired immunodeficiency syndrome (AIDS). Additionally, on 24-JAN-2018, the patient had a cluster of differentiation 4 (CD4) with a count of 49 (units not provided). Moreover, on an unspecified date in 2018, the patient had a rash all over his body (rash generalized) and was prescribed with acyclovir since 07-FEB-2018 (details were not provided). No product quality complaint (PQC) was involved. At the time of reporting, the outcome of acquired immunodeficiency syndrome and rash generalized was unknown. The causal relationship between VARIVAX and the reported events was not provided. Upon internal review, the event acquired immunodeficiency syndrome  was determined to be medically significant.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPA, SMALL, TYP
Symptoms: Chest pain, Computerised tomogram thorax normal, Dizziness, Dyspnoea, Echocardiogram normal
Clinical narrative: Pt evaluated in ED on 20JAN2018 due to male presents to chest pain. States he woke up that morning and felt fine and then while standing felt a little lightheaded and had acute onset of severe 10 out of 10 chest pain. No similar symptoms in past. No stimulant or supplement use. No recent travel, trauma, or illness. Hx significant for smallpox vaccination along with a series of others on 10JAN2018. ED evaluation significant for rising troponin and elevate CPK-MB. He was transferred to another hospital for further eval. Records currently not available. Pt report that they completed multiple chest ultrasounds, EKG, and CT w/ contrast without any pathological findings. No recommendations for medication or f/u. He was discharged this morning. Reports hasn't had chest pain or dizziness since Sat/Sun. This is a 19yoM otherwise healthy presenting to office for f/u chest pain. Patient presented to the ER 20JAN with non-exertional midsternal chest pain associated with LUE weakness in the setting of recent smallpox vaccination 14d prior. Cardiac w/u was initiated at this time, notable for elevated troponins (1.870, and 90min later, 5.750) and CK-MB (28). The patient was then transferred to another hospital, where he was evaluated with CT Chest with contrast and Echocardiogram, both of which were unremarkable. With resolution of his chest pain (no documented troponins), the patient was discharged 2d later with instructions to follow-up in clinic. Records were not available at this clinic visit and the patient was unfortunately lost to f/u. Since the episode 20JAN, patient reports no further episodes of chest pain or difficulty breathing. He has been PT'ing at his own pace, which includes runs and light weightlifting. He reports no SOB, DOE, edema, or palpitations. Acute myocarditis, unspecified: This is a 19yoM otherwise healthy presenting with episode of chest pain and elevated troponins in the setting of recent smallpox vaccination. Submitted consult prior to appointment, deemed probable Post-smallpox-vaccine-associated myopericarditis. Initiated LIMDU (Patient to PT at own pace and to be non-travel x6mo); forms submitted and patient instructed to report to office at hospital. Will repeat cardiac enzymes (troponin/CK-MB). Obtain baseline ESR/CRP. Include patient in Smallpox Vaccine Myopericarditis Registry for long-term follow up. Submitted VAERS form for Smallpox allergy. Patient to receive temporary deferment for Anthrax, JEV, etc - Referring to Internal Medicine (as no Cardiology on island) for follow-up. Patient to be seen 03-17MAR, then again JUL2018 prior to RTFD. Will leave to Internal Medicine discretion whether patient needs local outpatient Cardiology referral or further risk stratification, like exercise stress testing. Will f/u consult; patient may need medevac to MC for Cardiology evaluation. Case management actively involved and will help coordination of care. RTC for f/u 6wks; patient will need close monitoring to ensure appropriate follow-up care and coordination.