chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Day after vaccines, fever/chills and muscle ache/pain, extreme pain in right arm at site of injection. Fever/chills gone following day but muscle ache/pain continued and intensified in both hands. Developed joint pain in week after injection. Still having roaming joint and muscle pain. Pain in the hands continues to be constant and undiminished. 5 on pain scale of 1-10 - not over the top but unrelenting.
Age: 58.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Pyrexia
Clinical narrative: Day after vaccines, fever/chills and muscle ache/pain, extreme pain in right arm at site of injection. Fever/chills gone following day but muscle ache/pain continued and intensified in both hands. Developed joint pain in week after injection. Still having roaming joint and muscle pain. Pain in the hands continues to be constant and undiminished. 5 on pain scale of 1-10 - not over the top but unrelenting.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Discomfort, Injection site erythema, Skin lesion, Swelling
Clinical narrative: 26 y/o male who reports this morning to clinic for assessment of redness around left shoulder and swelling in axillary area for last 4 days. Patient received smallpox vaccination on 11 May 2018. No concerns have been raised about progression of site reaction on left deltoid. Patient has been caring for lesion as instructed and has experienced no other rashes. He denies headache, chest pain, shortness of breath, fatigue, fever or chills. Patient does have some discomfort in left axilla when raising arm over head. He asks how soon he may return to his usual work in the gym. He has otherwise been able to go about his activities of daily living without difficulty.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Vomiting
Clinical narrative: Vomiting.
Sex: U
Vaccine: PNC13
Symptoms: Chills, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician received from Merck Research Laboratories (Case Number: 00834228). A pediatric patient of unspecified age and gender received PREVNAR 13, (batch/lot and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pediatric patient experienced fever and chills on an unspecified date. The outcome of the events was unknown. The information on the batch/lot number and expiration date has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 9cm area of tender erythematous induration surrounding injection site, flu like symptoms developed within 4 hours of injection.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Insomnia, Myalgia, Nausea, Pyrexia
Clinical narrative: Approximately 4 - 5 hours after taking the vaccine, fever, intense muscle pain, pain at the point of vaccination, joint pain, nausea and difficulty sleeping the first night.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: Approximately 4 - 5 hours after taking the vaccine, fever, intense muscle pain, pain at the point of vaccination, joint pain, nausea and difficulty sleeping the first night.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like sx: myalgia, fever, sweating, lasted about 2 days.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: My left upper arm became increasingly more painful and red over 2-3 days with a low grade temp, anorexia. The erythema was primarily in the anterior area of upper left arm and not at the injection site.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Patient developed shingles approximately 3 weeks after immunization. Shingles outbreak located on same arm and included injection site. On 5/24/18, patient saw his dermatologist who said the shingles outbreak was probably caused by trauma from the immunization. He prescribed Valacyclovir 1000mg three times daily for 7 days, Tramadol 50mg three times daily, and Betamethasone valerate 0.1% cream once daily as needed. Patient also went to the emergency room on 5/27/18 to treat nausea assocaited from Valacyclovir and Tramadol.
Age: 72.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Acute respiratory failure, Fungal infection, Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old female patient who received Influenza vaccine Quadrivalent. Co-suspect products included ADVAIR Diskus inhalation powder (batch number 7ZP4239, expiry date 31st December 2018) for chronic obstructive pulmonary disease. Concurrent medical conditions included drug allergy (allergy to drug aspirin, codeine or statins). Concomitant products included ipratropium bromide, PLAVIX and PROAIR. In November 2017, the patient received Influenza vaccine Quadrivalent. On an unknown date, the patient started ADVAIR Diskus (inhaled) 1 puff(s) twice daily (2 puff(s) daily). On 25th December 2017, less than a year after receiving Influenza vaccine Quadrivalent and not applicable after starting ADVAIR DISKUS, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On 30th December 2017, the patient experienced acute  respiratory failure (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced yeast infection. The patient was treated with CIPRO. ADVAIR  Diskus was continued with no change. On an unknown date, the outcome of the vaccination failure and yeast infection were unknown and the outcome of the acute respiratory failure and influenza were recovered/resolved. It was unknown if the reporter considered the vaccination failure, acute respiratory failure and influenza to be related to influenza vaccine Quadrivalent. The reporter considered the yeast infection to be possibly related to influenza vaccine Quadrivalent and ADVAIR Diskus. It was unknown if the reporter considered the acute respiratory failure and influenza to be related to ADVAIR Diskus. Additional details were provided as follows: Concomitant product included Beta blocker. The patient got a flu shot in November 2017 and developed the flu on Christmas day. The patient was on CIPRO and on the 5th day the patient developed acute lung failure and was hospitalized for 6 days. The patient then was placed in a nursing home for 3 weeks. When the patient took ADVAIR, (ADVAIR was started in 1999) she felt better. The patient never had pneumonia before, her dosage of ADVAIR had been increased to 500/50 started on the day of reporting. The patient rinsed her mouth with water and brushes her teeth, but she still had yeast infections. This case was considered as suspected vaccination failure, the confirmatory laboratory test and TTO (time to onset) was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blood HIV RNA increased, Fatigue, Impaired work ability, Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of HIV viral load increased in a adult patient who received SHINGRIX. Concurrent medical conditions included HIV infection. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced HIV viral load increased (serious criteria GSK medically significant), influenza-like symptoms and tiredness. On an unknown date, the outcome of the HIV viral load increased, influenza-like symptoms and tiredness were unknown. It was unknown if the reporter considered the HIV viral load increased, influenza-like symptoms and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient complained of flu-like symptoms, very tired and did not go to work for 1 week, and his viral count was increased. The pharmacist refused to provide additional details.
Age: 20.0
Sex: F
Vaccine: HEP, JEV1
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient became lightheaded and diaphoretic given water/juice.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Angiogram, Asthenia, Borrelia test, CSF test, Computerised tomogram
Clinical narrative: Pain started in (L) shoulder on 3-29-18, went into (L) neck for 4 days, very stiff neck. 4-7-18 had all over body aches and weakness, (L) side facial droop and dysphagia and dysarthria. Acyclovir, SOLU-MEDROL given, 4-12-18. (L) sided weakness in arm and legs and trouble breathing. Was in ICU for 4 days receiving plasmapheresis treatments x  5, SOLU-MEDROL. Inflammatory polyneuropathy. Discharge from hospital.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Dysarthria, Dysphagia, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Pain started in (L) shoulder on 3-29-18, went into (L) neck for 4 days, very stiff neck. 4-7-18 had all over body aches and weakness, (L) side facial droop and dysphagia and dysarthria. Acyclovir, SOLU-MEDROL given, 4-12-18. (L) sided weakness in arm and legs and trouble breathing. Was in ICU for 4 days receiving plasmapheresis treatments x  5, SOLU-MEDROL. Inflammatory polyneuropathy. Discharge from hospital.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Facial paralysis, Full blood count, Hemiparesis, Immunology test, Injection site pain
Clinical narrative: Pain started in (L) shoulder on 3-29-18, went into (L) neck for 4 days, very stiff neck. 4-7-18 had all over body aches and weakness, (L) side facial droop and dysphagia and dysarthria. Acyclovir, SOLU-MEDROL given, 4-12-18. (L) sided weakness in arm and legs and trouble breathing. Was in ICU for 4 days receiving plasmapheresis treatments x  5, SOLU-MEDROL. Inflammatory polyneuropathy. Discharge from hospital.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Intensive care, Metabolic function test, Musculoskeletal stiffness, Neck pain, Nerve conduction studies
Clinical narrative: Pain started in (L) shoulder on 3-29-18, went into (L) neck for 4 days, very stiff neck. 4-7-18 had all over body aches and weakness, (L) side facial droop and dysphagia and dysarthria. Acyclovir, SOLU-MEDROL given, 4-12-18. (L) sided weakness in arm and legs and trouble breathing. Was in ICU for 4 days receiving plasmapheresis treatments x  5, SOLU-MEDROL. Inflammatory polyneuropathy. Discharge from hospital.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Nuclear magnetic resonance imaging, Pain, Plasmapheresis, Polyneuropathy, Pulmonary function test
Clinical narrative: Pain started in (L) shoulder on 3-29-18, went into (L) neck for 4 days, very stiff neck. 4-7-18 had all over body aches and weakness, (L) side facial droop and dysphagia and dysarthria. Acyclovir, SOLU-MEDROL given, 4-12-18. (L) sided weakness in arm and legs and trouble breathing. Was in ICU for 4 days receiving plasmapheresis treatments x  5, SOLU-MEDROL. Inflammatory polyneuropathy. Discharge from hospital.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: Patient stated she still have soreness/tenderness in the shoulder area of the arm she received the vaccine. Sx started 1-2 days after injection. Sx in upper arm and joint area.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: 5/22 Patient claimed she was in a lot of pain. It started at the injection site and has traveled down her arm, behind her shoulder and near her arm pit. She also said her arm is becoming more red. I instructed her to take BENADRYL every 4-6 hrs and to seek care if it does not improve in a few days. Patient is also taking ADVIL which is helping the pain. Symptoms occurred several hours after shot was given. Pain has improved but not the redness. 5/25 - Pt says doing much better. Redness almost all gone.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, non tender mildly warm areas on bilateral deltoid (R) 8x7 cm (L) 10x9 cm.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal oedema, Swollen tongue, Urticaria
Clinical narrative: Pt. states at 7 pm she noticed she had hives, a couple minutes later her tongue and throat started to swell for the next 12hr. Pt. stated she took I tab of L-lysine which did not help.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Has redness and warm skin with prickly burning sensation at sight of injection and on trunk of body - beginning to subside.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Paraesthesia, Skin warm
Clinical narrative: Has redness and warm skin with prickly burning sensation at sight of injection and on trunk of body - beginning to subside.
Age: 56.0
Sex: M
Vaccine: MNQ
Symptoms: Pain, Pain in extremity, Pruritus, Rash erythematous, Swelling
Clinical narrative: Received MENVEO on 5/22/18 in (R) arm. Tuesday night-achy, 2 out of 10. Achiness down arm. Very itchy. 5/23/18-evening shower noticed red rash, swelling.
Age: 53.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Client received Tdap, MMR, and varicella vaccine on 5/21/18. Presented to clinic today, 5/24/18 with raised, red, warm to touch area approx 3 in in diameter. Painful to touch. No open areas drainage noted. Client was referred to PCP at clinic.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Gait disturbance, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Had PNEUMOVAX here on Wed, developed redness and pain around site, with fevers to 103, not feeling well, and leg swelling up, itching and redness spreading, so went to ER on Thursday, given IV steroid and put on BENADRYL. The site area developed bruising, but now is much improved. He wouldn't walk for a day or two, and now still walking on tiptoes, but fevers and redness are gone. Has always gotten fevers with vaccines, so initially mother wasn't too concerned, never reacted like this. Did not get any hives or redness other than the injection site area, but it spread down leg.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Had PNEUMOVAX here on Wed, developed redness and pain around site, with fevers to 103, not feeling well, and leg swelling up, itching and redness spreading, so went to ER on Thursday, given IV steroid and put on BENADRYL. The site area developed bruising, but now is much improved. He wouldn't walk for a day or two, and now still walking on tiptoes, but fevers and redness are gone. Has always gotten fevers with vaccines, so initially mother wasn't too concerned, never reacted like this. Did not get any hives or redness other than the injection site area, but it spread down leg.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Antinuclear antibody negative, Aspiration bone marrow normal, Blood immunoglobulin A normal, Blood immunoglobulin E normal, Blood immunoglobulin G normal
Clinical narrative: 05/03 EMAIL to PCP stating increase bruising for several weeks. 05/17 labs: plt count 78K. + neutropenia ANC=140. PCP on VAC. Covering MD orders chart review(CR) 5/21: CR done by Dr. MD requesting an emergent appt With 2 cell lines. Appt Friday 05/25. Plus additional labs to be done: MD recommends repeat CBC and obtaining a full chem 20 (including LDH, uric acid, phos and potassium). Mom notified and will get labs on Wed. 05/23 Repeat Labs done with CBC results= plt 14K ANC=240. Dr notified STAT. Consult appt changed to 05/23@ 1300 with Dr. Mom notified. Aware plt are lower. Rest labs WNL and fax. 05/23: seen OP by Dr: "Peripheral smear sent for pathology review, official report pending but no obvious blasts. However, does not rule out leukemia". Pt needs to have Bone marrow bx and aspiration to r/o Leukemia. Procedure scheduled for OP clinic on 05/24. Repeat Cbc w diff showing plt=14K. ANC=528. Copy of labs done as ordered by Dr faxed to Dr. 05/24 Repeat labs done: plt=7K ANC=795 prior to procedure. BOMA w bx done under sedation by Dr. Flow cytometry done to R/O malignancy. Pt sent home. 05/29 F/U appt with Dr: Flow cytometry on peripheral blood (5/23/18) and BMA (5/24/18) negative for abnormal clonal population or malignancy Assessment: Patient is an active, well-appearing 3 yr old male with increased bruising and severe neutropenia and thrombocytopenia noted on lab evaluation week of 5/23/18, with remote history of fevers and vomiting approximately 10 days prior to initial consultation and immunizations including live MMR vaccine approximately six weeks prior to evaluation consistent with diagnosis of newly diagnosed immune thrombocytopenia purpura (ITP) and severe neutropenia post-bone marrow aspirate/biopsy negative for malignancy. Plt=19K ANC=150 Hgb=11.8 Parvo IgG positive (1.22), IgM negative, consistent w/prior exposure/infection o IgGAME normalo CMV negativeo ANA negativeo DAT negativeo EBV profile PENDINGo LDH, Uric Acid, chemistries normal 5/23/18 (results above) Dx: 05/30 EBV profile negative. Pt's next appt 06/05 with Dr. Pt will be followed by counts recover.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Blood immunoglobulin M normal, Blood lactate dehydrogenase normal, Blood smear test, Blood uric acid normal, Contusion
Clinical narrative: 05/03 EMAIL to PCP stating increase bruising for several weeks. 05/17 labs: plt count 78K. + neutropenia ANC=140. PCP on VAC. Covering MD orders chart review(CR) 5/21: CR done by Dr. MD requesting an emergent appt With 2 cell lines. Appt Friday 05/25. Plus additional labs to be done: MD recommends repeat CBC and obtaining a full chem 20 (including LDH, uric acid, phos and potassium). Mom notified and will get labs on Wed. 05/23 Repeat Labs done with CBC results= plt 14K ANC=240. Dr notified STAT. Consult appt changed to 05/23@ 1300 with Dr. Mom notified. Aware plt are lower. Rest labs WNL and fax. 05/23: seen OP by Dr: "Peripheral smear sent for pathology review, official report pending but no obvious blasts. However, does not rule out leukemia". Pt needs to have Bone marrow bx and aspiration to r/o Leukemia. Procedure scheduled for OP clinic on 05/24. Repeat Cbc w diff showing plt=14K. ANC=528. Copy of labs done as ordered by Dr faxed to Dr. 05/24 Repeat labs done: plt=7K ANC=795 prior to procedure. BOMA w bx done under sedation by Dr. Flow cytometry done to R/O malignancy. Pt sent home. 05/29 F/U appt with Dr: Flow cytometry on peripheral blood (5/23/18) and BMA (5/24/18) negative for abnormal clonal population or malignancy Assessment: Patient is an active, well-appearing 3 yr old male with increased bruising and severe neutropenia and thrombocytopenia noted on lab evaluation week of 5/23/18, with remote history of fevers and vomiting approximately 10 days prior to initial consultation and immunizations including live MMR vaccine approximately six weeks prior to evaluation consistent with diagnosis of newly diagnosed immune thrombocytopenia purpura (ITP) and severe neutropenia post-bone marrow aspirate/biopsy negative for malignancy. Plt=19K ANC=150 Hgb=11.8 Parvo IgG positive (1.22), IgM negative, consistent w/prior exposure/infection o IgGAME normalo CMV negativeo ANA negativeo DAT negativeo EBV profile PENDINGo LDH, Uric Acid, chemistries normal 5/23/18 (results above) Dx: 05/30 EBV profile negative. Pt's next appt 06/05 with Dr. Pt will be followed by counts recover.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Cytomegalovirus test negative, Epstein-Barr virus test, Flow cytometry, Haemoglobin normal, Immune thrombocytopenic purpura
Clinical narrative: 05/03 EMAIL to PCP stating increase bruising for several weeks. 05/17 labs: plt count 78K. + neutropenia ANC=140. PCP on VAC. Covering MD orders chart review(CR) 5/21: CR done by Dr. MD requesting an emergent appt With 2 cell lines. Appt Friday 05/25. Plus additional labs to be done: MD recommends repeat CBC and obtaining a full chem 20 (including LDH, uric acid, phos and potassium). Mom notified and will get labs on Wed. 05/23 Repeat Labs done with CBC results= plt 14K ANC=240. Dr notified STAT. Consult appt changed to 05/23@ 1300 with Dr. Mom notified. Aware plt are lower. Rest labs WNL and fax. 05/23: seen OP by Dr: "Peripheral smear sent for pathology review, official report pending but no obvious blasts. However, does not rule out leukemia". Pt needs to have Bone marrow bx and aspiration to r/o Leukemia. Procedure scheduled for OP clinic on 05/24. Repeat Cbc w diff showing plt=14K. ANC=528. Copy of labs done as ordered by Dr faxed to Dr. 05/24 Repeat labs done: plt=7K ANC=795 prior to procedure. BOMA w bx done under sedation by Dr. Flow cytometry done to R/O malignancy. Pt sent home. 05/29 F/U appt with Dr: Flow cytometry on peripheral blood (5/23/18) and BMA (5/24/18) negative for abnormal clonal population or malignancy Assessment: Patient is an active, well-appearing 3 yr old male with increased bruising and severe neutropenia and thrombocytopenia noted on lab evaluation week of 5/23/18, with remote history of fevers and vomiting approximately 10 days prior to initial consultation and immunizations including live MMR vaccine approximately six weeks prior to evaluation consistent with diagnosis of newly diagnosed immune thrombocytopenia purpura (ITP) and severe neutropenia post-bone marrow aspirate/biopsy negative for malignancy. Plt=19K ANC=150 Hgb=11.8 Parvo IgG positive (1.22), IgM negative, consistent w/prior exposure/infection o IgGAME normalo CMV negativeo ANA negativeo DAT negativeo EBV profile PENDINGo LDH, Uric Acid, chemistries normal 5/23/18 (results above) Dx: 05/30 EBV profile negative. Pt's next appt 06/05 with Dr. Pt will be followed by counts recover.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Laboratory test normal, Neutropenia, Neutrophil count decreased, Parvovirus B19 test positive, Platelet count decreased
Clinical narrative: 05/03 EMAIL to PCP stating increase bruising for several weeks. 05/17 labs: plt count 78K. + neutropenia ANC=140. PCP on VAC. Covering MD orders chart review(CR) 5/21: CR done by Dr. MD requesting an emergent appt With 2 cell lines. Appt Friday 05/25. Plus additional labs to be done: MD recommends repeat CBC and obtaining a full chem 20 (including LDH, uric acid, phos and potassium). Mom notified and will get labs on Wed. 05/23 Repeat Labs done with CBC results= plt 14K ANC=240. Dr notified STAT. Consult appt changed to 05/23@ 1300 with Dr. Mom notified. Aware plt are lower. Rest labs WNL and fax. 05/23: seen OP by Dr: "Peripheral smear sent for pathology review, official report pending but no obvious blasts. However, does not rule out leukemia". Pt needs to have Bone marrow bx and aspiration to r/o Leukemia. Procedure scheduled for OP clinic on 05/24. Repeat Cbc w diff showing plt=14K. ANC=528. Copy of labs done as ordered by Dr faxed to Dr. 05/24 Repeat labs done: plt=7K ANC=795 prior to procedure. BOMA w bx done under sedation by Dr. Flow cytometry done to R/O malignancy. Pt sent home. 05/29 F/U appt with Dr: Flow cytometry on peripheral blood (5/23/18) and BMA (5/24/18) negative for abnormal clonal population or malignancy Assessment: Patient is an active, well-appearing 3 yr old male with increased bruising and severe neutropenia and thrombocytopenia noted on lab evaluation week of 5/23/18, with remote history of fevers and vomiting approximately 10 days prior to initial consultation and immunizations including live MMR vaccine approximately six weeks prior to evaluation consistent with diagnosis of newly diagnosed immune thrombocytopenia purpura (ITP) and severe neutropenia post-bone marrow aspirate/biopsy negative for malignancy. Plt=19K ANC=150 Hgb=11.8 Parvo IgG positive (1.22), IgM negative, consistent w/prior exposure/infection o IgGAME normalo CMV negativeo ANA negativeo DAT negativeo EBV profile PENDINGo LDH, Uric Acid, chemistries normal 5/23/18 (results above) Dx: 05/30 EBV profile negative. Pt's next appt 06/05 with Dr. Pt will be followed by counts recover.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Thrombocytopenia, Vomiting
Clinical narrative: 05/03 EMAIL to PCP stating increase bruising for several weeks. 05/17 labs: plt count 78K. + neutropenia ANC=140. PCP on VAC. Covering MD orders chart review(CR) 5/21: CR done by Dr. MD requesting an emergent appt With 2 cell lines. Appt Friday 05/25. Plus additional labs to be done: MD recommends repeat CBC and obtaining a full chem 20 (including LDH, uric acid, phos and potassium). Mom notified and will get labs on Wed. 05/23 Repeat Labs done with CBC results= plt 14K ANC=240. Dr notified STAT. Consult appt changed to 05/23@ 1300 with Dr. Mom notified. Aware plt are lower. Rest labs WNL and fax. 05/23: seen OP by Dr: "Peripheral smear sent for pathology review, official report pending but no obvious blasts. However, does not rule out leukemia". Pt needs to have Bone marrow bx and aspiration to r/o Leukemia. Procedure scheduled for OP clinic on 05/24. Repeat Cbc w diff showing plt=14K. ANC=528. Copy of labs done as ordered by Dr faxed to Dr. 05/24 Repeat labs done: plt=7K ANC=795 prior to procedure. BOMA w bx done under sedation by Dr. Flow cytometry done to R/O malignancy. Pt sent home. 05/29 F/U appt with Dr: Flow cytometry on peripheral blood (5/23/18) and BMA (5/24/18) negative for abnormal clonal population or malignancy Assessment: Patient is an active, well-appearing 3 yr old male with increased bruising and severe neutropenia and thrombocytopenia noted on lab evaluation week of 5/23/18, with remote history of fevers and vomiting approximately 10 days prior to initial consultation and immunizations including live MMR vaccine approximately six weeks prior to evaluation consistent with diagnosis of newly diagnosed immune thrombocytopenia purpura (ITP) and severe neutropenia post-bone marrow aspirate/biopsy negative for malignancy. Plt=19K ANC=150 Hgb=11.8 Parvo IgG positive (1.22), IgM negative, consistent w/prior exposure/infection o IgGAME normalo CMV negativeo ANA negativeo DAT negativeo EBV profile PENDINGo LDH, Uric Acid, chemistries normal 5/23/18 (results above) Dx: 05/30 EBV profile negative. Pt's next appt 06/05 with Dr. Pt will be followed by counts recover.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Inflammation, Injection site inflammation, Injection site rash, Injection site swelling
Clinical narrative: Temperature, swelling, rash, inflammation in arm and chest around injection site.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Swelling
Clinical narrative: Temperature, swelling, rash, inflammation in arm and chest around injection site.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse and refers to four children patients of unknown age and gender. It was stated that they were under 15 years of age. No information was provided regarding the patient's medical history, concurrent conditions, drug history, allergies or concomitant medications. On an unspecified date in May 2017, reported as "about a year ago", the patients were vaccinated with first dose of GARDASIL 9 injection, (lot number N009173 with expiration date on 20-OCT-2019 for HPV vaccination) (strength, route of administration and anatomical location were not reported. On an unknown date, the patients fainted (syncope). It was reported that the patients did not seek for medical attention and it was unknown if the patients received any treatment. The patients recovered from the event on an unknown date. The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the event. This is a corrected report. The correct initial aware date is 15-MAY-2018 and not 16-MAY-2018 as previously reported. Therefore, the safety report US-009507513-1805USA007240 is being deleted from our files and all the information is being captured in this new case US-009507513-1805USA008787.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: Patient states that after he left the PHD IZ Clinic, he kept a previously scheduled PCP appointment. At that appointment, he was told that his BP and HR were both elevated. He denies ever having issues with BP or HR in the past. He is feeling better this morning
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site swelling, Injection site warmth
Clinical narrative: Approx 3 hours after receiving injection began to feel tingling to left upper arm. By 8:00 pm - arm became severe painful. Upper arm - axillary and side of (L) breast involved - areas severe hot to touch, severe redden - maroon color to entire (L) upper arm - severe raised areas - with severe pain. Duration - Sunday 3/25/18 thru - following Saturday, having to go to urgent care for follow-up. Treatment - heating pad - elevation - and medications. Begin to feel some relief three weeks - past - after receiving injection. I also have pictures of the severe problem with my arm after injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Approx 3 hours after receiving injection began to feel tingling to left upper arm. By 8:00 pm - arm became severe painful. Upper arm - axillary and side of (L) breast involved - areas severe hot to touch, severe redden - maroon color to entire (L) upper arm - severe raised areas - with severe pain. Duration - Sunday 3/25/18 thru - following Saturday, having to go to urgent care for follow-up. Treatment - heating pad - elevation - and medications. Begin to feel some relief three weeks - past - after receiving injection. I also have pictures of the severe problem with my arm after injection.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Injection site reaction, Local reaction, Viral rash
Clinical narrative: Local reaction to PQ of L thigh: about 2 cm in diameter. Viral exanthem of the trunk.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Syncope, nausea, vomiting - one episode occurring around 8pm. Vaccine administered at 4:25 pm.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Malaise, Nausea
Clinical narrative: Sore arm: immediately and for 2 succeeding days. Fatigue, aching, headache, general malaise, nausea: onset on day 2; abated by day 3.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm: immediately and for 2 succeeding days. Fatigue, aching, headache, general malaise, nausea: onset on day 2; abated by day 3.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction, Rash erythematous
Clinical narrative: Local site reaction. Red rash, but not raised, painful or itchy.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Peripheral swelling
Clinical narrative: Headache soon after shot. Headache lasted two days. Swelling in arm for a week. Day 2, chills with flu like symptoms.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Adult patient received a pediatric dose of Hep B. Health Department notified. Patient notified and informed she needs to come back in to receive adult dose of Hep B per the health department. Patient voiced understanding and will make appointment for vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Erythema, Pain, Swelling
Clinical narrative: Large area of swelling, redness and pain. Chills, dizziness.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye disorder, Facial paralysis, Loss of personal independence in daily activities, Nuclear magnetic resonance imaging brain
Clinical narrative: Bells palsy facial droop and eye involvement. Patient has not been able to return to work due to symptoms. Seen in clinic 5/9/2018,  and emergency room 5/9/2018. Treated with Prednisone, Valacyclovir, MRI scan completed 5/10/2018 seen in clinic for again 5/11/2018 for continues symptoms prescribed eye drops REFRESH PM and REFRESH PLUS, continued inability to return to work.
Age: 20.0
Sex: F
Vaccine: DT
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: DT instead of Td given to 20 y.o.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Feeling abnormal, Generalised tonic-clonic seizure, Incomplete course of vaccination, Secretion discharge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of grand mal seizure in a 80-year-old male patient who received SHINGRIX. The patient's past medical history included grand mal seizure (3 years before the reporting date, after having a stroke) and stroke (had several times, 3 years before the reporting date). Concomitant products included buspirone hydrochloride, calcium unknown, clopidogrel, phenytoin, aripiprazole, Lisinopril and chlorthalidone. On 8th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th May 2018, 1 days after receiving SHINGRIX, the patient experienced grand mal seizure (serious criteria hospitalization and GSK medically significant), spaced out (serious criteria hospitalization), mucus discharge and fall. On an unknown date, the outcome of the grand mal seizure, spaced out, mucus discharge and fall were recovered/resolved. The reporter considered the grand mal seizure, spaced out, mucus discharge and fall to be probably related to SHINGRIX. Additional information was received as follows: This case was reported by the patient's wife. At 13:15, the patient received SHINGRIX on left arm. The patient had been doing very well over the past couple of years until this adverse event. The patient was at a meeting when he suddenly became out of it, put his head down with mucus running from his nose and mouth, and then fell out of the chair. In May 2018, the patient was taken to the hospital and stayed for 2 days. The patient's general physician had told him not to receive the 2nd dose of SHINGRIX.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of idiopathic thrombocytopenic purpura in a 83-year-old female patient who received SHINGRIX. On 13th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, 14 days after receiving SHINGRIX, the patient experienced idiopathic thrombocytopenic purpura (serious criteria hospitalization, GSK medically significant and other: As per reporter). SHINGRIX was discontinued. On an unknown date, the outcome of the idiopathic thrombocytopenic purpura was unknown. It was unknown if the reporter considered the idiopathic thrombocytopenic purpura to be related to SHINGRIX. Additional information were provided as follows: The nurse reported that the patient was hospitalized for acute ITP (idiopathic thrombocytopenic purpura). The patient's platelets count dropped to 4. The hematologist or oncologist consulted about the patient was insistent that this event caused due to SHINGRIX.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Hyperhidrosis, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 67-year-old female patient who received SHINGRIX. The patient's past medical history included chickenpox (had chicken pox at young age). Previously administered products included ZOSTAVAX with an associated reaction of pyrexia (received in winter 2 years ago and experienced low grade fever rash, chicken pox Dx by clinic, itching, front and back and soreness). Concurrent medical conditions included asthma and blood pressure. Concomitant products included LAMICTAL, ASMANEX, CLARITINE, clonazepam, FOCALIN, trazodone and ZOLOFT. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced sickness. On 23rd May 2018, the patient experienced seizure (serious criteria GSK medically significant), fever, muscle tension, muscle twitching, sleeplessness, sweating, upset stomach, injection site pain and injection site swelling. On 24th May 2018, the patient experienced general body pain and weakness. In May 2018, the outcome of the seizure, fever, muscle tension, muscle twitching, sleeplessness and sweating were recovered/resolved. On an unknown date, the outcome of the upset stomach, injection site pain, injection site swelling and sickness were unknown and the outcome of the general body pain and weakness were not recovered/not resolved. The reporter considered the seizure, fever, muscle tension, muscle twitching, sleeplessness, sweating, upset stomach, general body pain, weakness, injection site pain, injection site swelling and sickness to be related to SHINGRIX. Additional details were provided as follows: The patient stated it took her a while to agree to the product, because about 2 years ago she had ZOSTAVAX and experienced a rash that was identified as chicken pox or possibly a mild case of shingles. She stated it was itchy, looked like chicken pox and was on her front and back. The patient stated that she also had a case documented for chicken pox when she was younger. A few hours later receiving SHINGRIX, the patient was in bed with a high fever, her body would tense, twitch, freeze and release. She thought she could be possibly be having a seizure and she had difficulty sleeping, sweats during the night and upset stomach. The patient stated that she had very mild injection site soreness and swelling compared to the other issues she was experiencing. On 24th May 2018 in morning, 1 day after receiving SHINGRIX the patient was weak and her body was achy. In May 2018, less than a week after receiving SHINGRIX, the patient was sick. This case has been linked with case US2018093523, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Malaise, Muscle tightness, Muscle twitching, Night sweats
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 67-year-old female patient who received SHINGRIX. The patient's past medical history included chickenpox (had chicken pox at young age). Previously administered products included ZOSTAVAX with an associated reaction of pyrexia (received in winter 2 years ago and experienced low grade fever rash, chicken pox Dx by clinic, itching, front and back and soreness). Concurrent medical conditions included asthma and blood pressure. Concomitant products included LAMICTAL, ASMANEX, CLARITINE, clonazepam, FOCALIN, trazodone and ZOLOFT. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced sickness. On 23rd May 2018, the patient experienced seizure (serious criteria GSK medically significant), fever, muscle tension, muscle twitching, sleeplessness, sweating, upset stomach, injection site pain and injection site swelling. On 24th May 2018, the patient experienced general body pain and weakness. In May 2018, the outcome of the seizure, fever, muscle tension, muscle twitching, sleeplessness and sweating were recovered/resolved. On an unknown date, the outcome of the upset stomach, injection site pain, injection site swelling and sickness were unknown and the outcome of the general body pain and weakness were not recovered/not resolved. The reporter considered the seizure, fever, muscle tension, muscle twitching, sleeplessness, sweating, upset stomach, general body pain, weakness, injection site pain, injection site swelling and sickness to be related to SHINGRIX. Additional details were provided as follows: The patient stated it took her a while to agree to the product, because about 2 years ago she had ZOSTAVAX and experienced a rash that was identified as chicken pox or possibly a mild case of shingles. She stated it was itchy, looked like chicken pox and was on her front and back. The patient stated that she also had a case documented for chicken pox when she was younger. A few hours later receiving SHINGRIX, the patient was in bed with a high fever, her body would tense, twitch, freeze and release. She thought she could be possibly be having a seizure and she had difficulty sleeping, sweats during the night and upset stomach. The patient stated that she had very mild injection site soreness and swelling compared to the other issues she was experiencing. On 24th May 2018 in morning, 1 day after receiving SHINGRIX the patient was weak and her body was achy. In May 2018, less than a week after receiving SHINGRIX, the patient was sick. This case has been linked with case US2018093523, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Seizure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 67-year-old female patient who received SHINGRIX. The patient's past medical history included chickenpox (had chicken pox at young age). Previously administered products included ZOSTAVAX with an associated reaction of pyrexia (received in winter 2 years ago and experienced low grade fever rash, chicken pox Dx by clinic, itching, front and back and soreness). Concurrent medical conditions included asthma and blood pressure. Concomitant products included LAMICTAL, ASMANEX, CLARITINE, clonazepam, FOCALIN, trazodone and ZOLOFT. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced sickness. On 23rd May 2018, the patient experienced seizure (serious criteria GSK medically significant), fever, muscle tension, muscle twitching, sleeplessness, sweating, upset stomach, injection site pain and injection site swelling. On 24th May 2018, the patient experienced general body pain and weakness. In May 2018, the outcome of the seizure, fever, muscle tension, muscle twitching, sleeplessness and sweating were recovered/resolved. On an unknown date, the outcome of the upset stomach, injection site pain, injection site swelling and sickness were unknown and the outcome of the general body pain and weakness were not recovered/not resolved. The reporter considered the seizure, fever, muscle tension, muscle twitching, sleeplessness, sweating, upset stomach, general body pain, weakness, injection site pain, injection site swelling and sickness to be related to SHINGRIX. Additional details were provided as follows: The patient stated it took her a while to agree to the product, because about 2 years ago she had ZOSTAVAX and experienced a rash that was identified as chicken pox or possibly a mild case of shingles. She stated it was itchy, looked like chicken pox and was on her front and back. The patient stated that she also had a case documented for chicken pox when she was younger. A few hours later receiving SHINGRIX, the patient was in bed with a high fever, her body would tense, twitch, freeze and release. She thought she could be possibly be having a seizure and she had difficulty sleeping, sweats during the night and upset stomach. The patient stated that she had very mild injection site soreness and swelling compared to the other issues she was experiencing. On 24th May 2018 in morning, 1 day after receiving SHINGRIX the patient was weak and her body was achy. In May 2018, less than a week after receiving SHINGRIX, the patient was sick. This case has been linked with case US2018093523, reported by the same reporter.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Erythema, Headache, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 53-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 10th May 2018, several hours after receiving SHINGRIX, the patient experienced swelling (serious criteria disability), malaise (serious criteria disability), fever (serious criteria disability), headache (serious criteria disability), tingling (serious criteria disability), appetite lost (serious criteria disability), erythema (serious criteria disability) and dizziness (serious criteria disability). On 16th May 2018, the outcome of the swelling, malaise, fever, headache, tingling, appetite lost, erythema and dizziness were recovered/resolved. The reporter considered the swelling, malaise, fever, headache, tingling, appetite lost, erythema and dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The healthcare professional (HCP) reported that the patient experienced extreme swelling, redness, malaise, dizziness, headaches, loss of appetite and tingling in the face. The patient also got a fever of 103 degree F and stated that these side effects were started a few hours after receiving the vaccination and were severe for the next 2 days. It took a total of 6 days events to resolve. The HCP reported that this was disabling to the patient because the day the patient got the vaccine, she had to leave work early as well as take a day off from work. There were days where she could not get out of bed.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Paraesthesia, Pyrexia, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 53-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 10th May 2018, several hours after receiving SHINGRIX, the patient experienced swelling (serious criteria disability), malaise (serious criteria disability), fever (serious criteria disability), headache (serious criteria disability), tingling (serious criteria disability), appetite lost (serious criteria disability), erythema (serious criteria disability) and dizziness (serious criteria disability). On 16th May 2018, the outcome of the swelling, malaise, fever, headache, tingling, appetite lost, erythema and dizziness were recovered/resolved. The reporter considered the swelling, malaise, fever, headache, tingling, appetite lost, erythema and dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The healthcare professional (HCP) reported that the patient experienced extreme swelling, redness, malaise, dizziness, headaches, loss of appetite and tingling in the face. The patient also got a fever of 103 degree F and stated that these side effects were started a few hours after receiving the vaccination and were severe for the next 2 days. It took a total of 6 days events to resolve. The HCP reported that this was disabling to the patient because the day the patient got the vaccine, she had to leave work early as well as take a day off from work. There were days where she could not get out of bed.