chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On 18-JUN-2015, the patient were vaccinated with improperly stored doses of PROQUAD (lot number L005295 and expiry date 17-AUG-2016) (dosing, regimen, route were unknown). No concomitant medications were reported. No adverse effects were reported. There effects were reported. There was no product quality issue reported. Follow up information was received on 10-JUL-2015. It was reported that lot number L005295 with an expiry date of 17-AUG-2016 is a valid lot number for PROQUAD. On 03-AUG-2015, a phone call was made to the certified medical assistant. The phone call went directly to voice mail. A voice mail message was left requesting that the certified medical assistant return the phone call. Additionally, a request was made for patient identifiers, lot number, expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from the reporting Certified Medical Assistant (C.M.A) during a phone call on 05-AUG-2015. The C.M.A. reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 4-year-old patient of unknown gender. On22-JUN-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (albumin status HSA) lot # L005295. This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event information and narrative were updated.
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On 18-JUN-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot number L005295 and expiry date 17-AUG-2016) (dosing, regimen, route were unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information was received on 10-JUL-2015. It was reported that lot number L005295 with an expiry date of 17-AUG-2016 is a valid lot number for PROQUAD (Merck). On 03-AUG-2015, a phone call was made to the certified medical assistant. The phone call went directly to voice mail. A voice mail message was left requesting that the certified medical assistant return the phone call. Additionally, a request was made for patient identifiers, lot number, expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from the reporting Certified Medical Assistant (C.M.A.) during a phone call on 05-AUG-2015. The C.M.A. reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding an 8-year-old patient of unknown gender. On 06-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L005295. This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event information and narrative were updated.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Migraine, Nausea, Vomiting
Clinical narrative: Dizziness; nausea; migraine; Vomited then went to sleep and woke up at 11pm and felt fine.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: I am having very tight chest feelings and feel like I can't take a deep breath. This has gone on since about a half hour after the vaccine was forced on me. My employer forced me to get this vaccine against my will or I would face termination immediately even though I requested exemption and was told I had to be compliant. My questions were not answered and were avoided and ignored. I was not given any information about the batch number or ingredients of the vaccine.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Dizziness, Injection site erythema
Clinical narrative: Patient became dizzy and red spot at sight of injection. He went to the ER 11/5/2015 in the evening. The ER MD diagnosed patient with cellulitis, prescribed Keflex 500 mg po TID x 7 days. Follow up visit with MD 11/11/2015 resolved-no sequelae.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Chills, Muscle spasms, Pyrexia
Clinical narrative: Chest pains, Leg cramps, shivering, low grade fever (99.2-100.3).
Age: 19.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: At the injection site members left deltoid it turned red, half dollar in size, and there was a pea size area that was hard. Member was given 25 mg of Benadryl and PA-C also assessed the site. Member waited 15 minutes in the clinic after given Benadryl and there was not further reaction. The redness was the same and did not spread. The member reported she was feeling "fine".
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Dysphonia, Flushing, Headache, Local swelling
Clinical narrative: I received the flu vaccination in the am of 11/10/15.  By pm of that day I had a spotty rash (very itchy) to my chest area. Also had a headache. By Weds (11/11/15) Rash had thickened an I had body aches fever and runny nose.  Rash to progressively worsen the next couple of days. By Friday (11/13/2015) the rash had spread up onto my neck and up the left side of my face. My face and neck were swollen with the rash becoming very painful by this time (I had started taking Benadryl when the rash started also was taking Ibuprofen). By Saturday the rash took on a sunburn/chemical burn appearance, and had spread to both ac areas on my arms with the left side worse than the right.... .was extremely painful and itchy.... also had swelling in the throat and became hoarse.  (I work in the ER as RN so the ER doctor treated me as output with a IM injection of steroids (Kenalog and Decadron and also started me on a Medrol dose pack.  My face had sunburn type appearance by Sunday and felt very flushed.  Rash and symptoms are almost gone by today Tues (11/17/2015).  Still have some itching to the chest and a couple of areas that feel "burned". I reported all this to our employee health nurse and to my ER director.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pharyngeal oedema, Pruritus, Pyrexia, Rash pruritic
Clinical narrative: I received the flu vaccination in the am of 11/10/15.  By pm of that day I had a spotty rash (very itchy) to my chest area. Also had a headache. By Weds (11/11/15) Rash had thickened an I had body aches fever and runny nose.  Rash to progressively worsen the next couple of days. By Friday (11/13/2015) the rash had spread up onto my neck and up the left side of my face. My face and neck were swollen with the rash becoming very painful by this time (I had started taking Benadryl when the rash started also was taking Ibuprofen). By Saturday the rash took on a sunburn/chemical burn appearance, and had spread to both ac areas on my arms with the left side worse than the right.... .was extremely painful and itchy.... also had swelling in the throat and became hoarse.  (I work in the ER as RN so the ER doctor treated me as output with a IM injection of steroids (Kenalog and Decadron and also started me on a Medrol dose pack.  My face had sunburn type appearance by Sunday and felt very flushed.  Rash and symptoms are almost gone by today Tues (11/17/2015).  Still have some itching to the chest and a couple of areas that feel "burned". I reported all this to our employee health nurse and to my ER director.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea, Swelling face
Clinical narrative: I received the flu vaccination in the am of 11/10/15.  By pm of that day I had a spotty rash (very itchy) to my chest area. Also had a headache. By Weds (11/11/15) Rash had thickened an I had body aches fever and runny nose.  Rash to progressively worsen the next couple of days. By Friday (11/13/2015) the rash had spread up onto my neck and up the left side of my face. My face and neck were swollen with the rash becoming very painful by this time (I had started taking Benadryl when the rash started also was taking Ibuprofen). By Saturday the rash took on a sunburn/chemical burn appearance, and had spread to both ac areas on my arms with the left side worse than the right.... .was extremely painful and itchy.... also had swelling in the throat and became hoarse.  (I work in the ER as RN so the ER doctor treated me as output with a IM injection of steroids (Kenalog and Decadron and also started me on a Medrol dose pack.  My face had sunburn type appearance by Sunday and felt very flushed.  Rash and symptoms are almost gone by today Tues (11/17/2015).  Still have some itching to the chest and a couple of areas that feel "burned". I reported all this to our employee health nurse and to my ER director.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On 18-JUN-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot number L005295 and expiry date 17-AUG-2016) (dosing, regimen, route were unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information was received on 10-JUL-2015. It was reported that lot number L005295 with an expiry date of 17-AUG-2016 is a valid lot number for PROQUAD (Merck). On 03-AUG-2015, a phone call was made to the certified medical assistant. The phone call went directly to voice mail. A voice mail message was left requesting that the certified medical assistant return the phone call. Additionally, a request was made for patient identifiers, lot number, expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from the reporting Certified Medical Assistant (C.M.A.) during a phone call on 05-AUG-2015. The C.M.A. reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 4-year-old patient of unknown gender. On 22-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L005295. This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event information and narrative were updated.
Sex: U
Vaccine: PPV
Symptoms: Chromosome analysis abnormal, Vaccination failure
Clinical narrative: This literature marketed report as received from the authors of a public article. Introduction: Jacobsen's syndrome (JS) was a rare disorder (prevalence: 1: 100,000) associated with partial deletion of the long arm of chromosome 11. Clinical features included learning disorders, hearing, ocular, hepatic and renal dysfunction, and growth hormone deficiency. Low CD4+ T-Cells and humoral defects had been reported in three cases in the literature. The reporters presented three patients (pts) with a spectrum of immunodeficiency. Three patients with JS aged 3 to 9 years (median age: 6 years) presented for immune assessment. All had a history of recurrent infections: sinopulmonary infection (n=3) and cutaneous warts (n=2). All patients had chromosomal analysis consistent with JS. Two patients had hearing deficits, all three had skeletal abnormalities, one had short stature, and one had anatomical lung disease on Computerized Tomography (CT). Leukopenia was identified in a single patient but no other cytopenias were identified. B cell assessment documented low age-matched serum immunoglobulin levels (IgA, IgG, IgM) in two of three patients who concomitantly had absent or very low class switched memory B cell (CD19+27+IgM-IgD-) populations. Two had robust responses to polysaccharide and protein vaccination. One patient had a suboptimal response to PNEUMOVAX (< 60% serotype specific antibody production). T cell assessment was abnormal for a single patient with low CD3+ and CD3+4+ cell percentage and absolute cell numbers but normal in vitro proliferation to phytohemagglutinin A, Candida and tetanus. IgG supplementation was provided to the child with leukopenia, poor pneumococcal vaccine response and absent switched memory B cells and antibiotic prophylaxis for the patient with low IgG levels and low memory B cell studies. Both had improvement of their sinopulmonary infections. Conclusion: Two of three patients with JS and recurrent infections had immune abnormalities characterized by B cell dysfunction. The affected patients responded well to immune interventions including IgG supplementation and prophylactic antibiotics. This rare disorder was reported to impact 200 individuals and these 2 cases increased the number of reported JS patients with B cell dysfunction to 4%. The reporters recommended that patients with JS had complete immune evaluation of B and T cell function. As in other B cell disorders, IgG supplementation or antibiotic prophylaxis might improve quality of life for affected individuals. This case refers to the child of unknown gender who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (reported as "PNEUMOVAX", dose, route and lot # not reported). The patient had a suboptimal response to PNEUMOVAX 23 (< 60% serotype specific antibody production) (Vaccination failure). IgG supplementation was provided to the child. The patient had improvement of sinopulmonary infections. The outcome of "suboptimal response to the vaccine" was unknown. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Lymphadenopathy, Mobility decreased
Clinical narrative: Information has been received from a pharmacist referring to a 51 year old male patient with hypertension and unspecified cardiac problems. The patient's past medical history included lymphoma. Information about drug reactions or allergies was unspecified. On 07-NNOV-2015, the patient was vaccinated with ZOSTAVAX, 19400 PFU (lot number, dose and route were unknown) for shingles prevention. Concomitant medications were unspecified. On an unknown date in November 2015, the patient developed enlarged lymph nodes under the arm and he could not move his arm. The patient sought medical attention via contacting the pharmacist. The outcome of the events was reported as not recovered/not resolved. The causality between the events and ZOSTAVAX was unspecified. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Computerised tomogram, Injection site swelling, Lymph node pain
Clinical narrative: Information has been received from a pharmacist referring to a 51 year old male patient with hypertension and unspecified cardiac problems. The patient's past medical history included lymphoma. Information about drug reactions or allergies was unspecified. On 07-NNOV-2015, the patient was vaccinated with ZOSTAVAX, 19400 PFU (lot number, dose and route were unknown) for shingles prevention. Concomitant medications were unspecified. On an unknown date in November 2015, the patient developed enlarged lymph nodes under the arm and he could not move his arm. The patient sought medical attention via contacting the pharmacist. The outcome of the events was reported as not recovered/not resolved. The causality between the events and ZOSTAVAX was unspecified. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a pharmacist referring to an adult patient of unknown age and gender. There was no medical history or concurrent condition reported. On an unknown date the patient was vaccinated with an initial adult dose of VAQTA (1.0 ml, lot# and route were unknown). Then, on 27-OCT-2015, the patient inadvertently administered a pediatric dose of VAQTA (0.5 ml, lot# and route were unknown) (accidentally underdose). No concomitant medication was provided. No adverse effect was reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis, Cough, Dysphonia, Fatigue, Pain
Clinical narrative: Pain on arm started a few hours later. The pain was worst that night and lasted 24 hours decreased over 3 days 11/9 cough started. On 11/10 cough, sinus pain, sinus pressure body aches and fatigue. Fatigue and cough were the worse. Now voice is going. Took NYQUIL and cough drops  and did not help much. Started MUCINEX on 11/13. Went to urgent care and diagnosed with bronchitis. Was given amoxicillin. Has been sleeping for 12-17 hours per day. Has never received Flu vax before.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Paranasal sinus discomfort, Sinus headache
Clinical narrative: Pain on arm started a few hours later. The pain was worst that night and lasted 24 hours decreased over 3 days 11/9 cough started. On 11/10 cough, sinus pain, sinus pressure body aches and fatigue. Fatigue and cough were the worse. Now voice is going. Took NYQUIL and cough drops  and did not help much. Started MUCINEX on 11/13. Went to urgent care and diagnosed with bronchitis. Was given amoxicillin. Has been sleeping for 12-17 hours per day. Has never received Flu vax before.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Fine motor skill dysfunction, Rash, Rotator cuff syndrome, X-ray normal
Clinical narrative: Redness day of injection which gradually got worse. Rash broke out in arm as well. Dexterity of fingers decreased continues to today. Have to grab coffee up with 2 hands because afraid that he will drop it. On 11/11 went to Urgent Care and doctor specified there was an issue with rotator cuff and sent pt to orthopedist. Orthopedist took X-ray but nothing found. Given cortisone shot which did not help at all. Has no strength in arm. Told to wait and see if improves.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: C-reactive protein increased, Injection site rash
Clinical narrative: Information has been received from a pharmacist referring to a 61 year old female patient with no known allergies and none pertinent medical history. On 05-OCT-2015 the patient was vaccinated with ZOSTAVAX, lot # L020482, expiration date 02-SEP-2016, 0.65 ml, subcutaneous in the left arm. On the same day, the patient was also vaccinated with inactivated flu vaccine in the left arm ((lot#, dose and route not reported). The pharmacist stated the patient developed injection site rash, left arm, post vaccination with ZOSTAVAX (date unspecified). On 08-OCT-2015 ("3 days later"), the patient went for her regular general scheduled appointment at her health care provider office, and lab work showed she had C-reactive protein in the blood. Pharmacist stated he was not sure if this lab result was due to the rash or not. No treatment was given for the events. The pharmacist stated the rash was not shingles, and was just a slight reaction. The rash had resolved on an unspecified date in 2015. The outcome of "C-reactive protein in the blood" was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (lot# K002831, expiration date 15-JAN-2016, dose, dose# and route unknown). No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site scar, Injection site vesicles, Secretion discharge
Clinical narrative: Information has been received from a pharmacist and a pharmacy technician referring to the 46 year old female pharmacy technician. The patient was allergic to cephalosporins. The patient had no pertinent medical history. On 19-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K012785 with expiration date 28-NOV-2015, 0.65 ml, subcutaneous) to prevent against shingles, which was outside of the recommendations in the ZOSTAVAX prescribing information. Concomitant therapies included bupropion, cyclobenzaprine, metoprolol tartrate, quetiapine fumarate and fluoxetine. On 20-JAN-2015 the patient developed red weepy blisters around the injection site after receiving ZOSTAVAX. The patient did not seek medical attention. No treatment was given for the event and no lab diagnostics performed. The patient stated that the red weepy blisters recovered on an unknown date of February 2015 (reported as took about 2-3 weeks to heal). The patient currently still had a scar where the blisters were located at. Causality was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a male patient of unknown age referring to himself. There was no medical history or drug reaction/allergies reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (1 injection, route, lot# and expired date were unknown) in his upper right arm. No concomitant medication was reported. On unknown dates the patient experienced redness, swelling, itching, and warm to the touch at his injection site. The patient did not seek any medical attention. At the time of reporting, the outcome of the events was unknown. Additional information is not expected since there was no contact information provided.
Age: 74.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Blood creatinine, Full blood count, Metabolic function test, Myalgia
Clinical narrative: Severe diffuse myalgias.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot# L014458, expiration date 11-FEB-2017, dose, dose# and route unknown). No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. The patient was vaccinated with two doses of PNEUMOVAX 23 (dose, route and lot# were unknown) on 10-SEP-2015 and 29-OCT-2015, respectively, which was shorter than the recommended interval (inappropriate schedule of drug administration). No concomitant medication was provided. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with his first dose of GARDASIL (route of administration, dose, lot number and expiration date were not reported) or GARDASIL 9 (route of administration, dose, lot number and expiration date were not reported). The physician unknown which vaccine was administered. On an unknown date, the patient developed hives and a rash around the periphery of the injection site. The patient sought unspecified medical attention. The outcome of the events was unknown. The relatedness between the events and suspect therapies was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On unknown dates, the patients received unspecified doses of ROTATEQ (orally, dose not reported, lot # K013861 with expiration date: 18-MAY-2016) immunization series that were improperly stored. The patients received the vaccinations between 06-NOV-2015 and 10-NOV-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old, non pregnant female patient with drug allergies including penicillin, neomycin, sulfa and ZITHROMAX. The patient had no concurrent conditions and pertinent medical history. On 06-NOV-2015, the patient was vaccinated with ZOSTAVAX lot # L028281, expiration date 28-OCT-2016, 0.65 ml, subcutaneous. On 07-NOV-2015, the patient developed "itching, warmth, redness, pain extending into her armpit and firmness to the touch" at the injection site. No lab diagnostic studies were performed. No treatment was given due to events. On 09-NOV-2015, the patient returned to the pharmacy to inquire about the adverse effects. The outcome of events was reported as not recovered. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old, non pregnant female patient with drug allergies including penicillin, neomycin, sulfa and ZITHROMAX. The patient had no concurrent conditions and pertinent medical history. On 06-NOV-2015, the patient was vaccinated with ZOSTAVAX lot # L028281, expiration date 28-OCT-2016, 0.65 ml, subcutaneous. On 07-NOV-2015, the patient developed "itching, warmth, redness, pain extending into her armpit and firmness to the touch" at the injection site. No lab diagnostic studies were performed. No treatment was given due to events. On 09-NOV-2015, the patient returned to the pharmacy to inquire about the adverse effects. The outcome of events was reported as not recovered. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Influenza virus test
Clinical narrative: States arrived at hotel approximately 6pm, having chills with headache that continued to worsen without temperature going up but not checked. Ambulance was called and he was taken to Hosp evaluated and admitted.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 13-NOV-2015, the patient was vaccinated with an expired dose of GARDASIL lot # J003727 expiration date 07-NOV-2015. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of unspecified patients. On an unspecified date in 2015, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (lot # K026666, expiration date 22-OCT-2016). No adverse effects have been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a male patient of unknown age. Patient's historical conditions included recurring past cases of shingles. On an unknown date, the patient was vaccinated with ZOSTAVAX, lot number, expiration date, dose and anatomical location were not provided, subcutaneous injection. No concomitant medication were reported. On an unknown date, the reporter stated that the vaccine did not work (vaccination failure) and the patient developed shingles again. At the time of the report, the outcome shingles and vaccination failure was unknown. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On 18-JUN-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot number L005295 and expiry date 17-AUG-2016) (dosing, regimen, route were unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information was received on 10-JUL-2015. It was reported that lot number L005295 with an expiry date of 17-AUG-2016 is a valid lot number for PROQUAD (Merck). On 03-AUG-2015, a phone call was made to the certified medical assistant. The phone call went directly to voice mail. A voice mail message was left requesting that the certified medical assistant return the phone call. Additionally, a request was made for patient identifiers, lot number, expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from the reporting Certified Medical Assistant (C.M.A.) during a phone call on 05-AUG-2015. The C.M.A. reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 4-year-old patient of unknown gender. On 11-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L005295. This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event information and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional and a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2015, the patient was vaccinated with a first dose of improperly stored GARDASIL injection (intramuscular, lot # K007828, expiration date 02-MAR-2017, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On 18-JUN-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot number L005295 and expiry date 17-AUG-2016) (dosing, regimen, route were unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information was received on 10-JUL-2015. It was reported that lot number L005295 with an expiry date of 17-AUG-2016 is a valid lot number for PROQUAD (Merck). On 03-AUG-2015, a phone call was made to the certified medical assistant. The phone call went directly to voice mail. A voice mail message was left requesting that the certified medical assistant return the phone call. Additionally, a request was made for patient identifiers, lot number, expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from the reporting Certified Medical Assistant (C.M.A.) during a phone call on 05-AUG-2015. The C.M.A. reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 6-year-old patient of unknown gender. On 20-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L005295. This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event information and narrative were updated.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of unspecified patients. On an unspecified date in 2015, the patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # L013429, expiration date 21-JUL-2017). No adverse effects have been reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Fatigue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58-year-old female patient (the reporter's mother), smoker with type 2 diabetes mellitus, drug reactions or allergies to sulfur and penicillin. The patient's medical history included pneumonia. On 03-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported) due to previous history of pneumonia. Concomitant therapies included DEMEROL, NUCYNTA, metformin, trazodone hydrochloride (manufacturer unknown), diclofenac, atorvastatin, FLONASE and tizanidine hydrochloride. It was reported that on approximately 04-NOV-2015, 1 or 2 days after the vaccination the patient began experiencing fatigue and it has been every day since. There were no lab diagnostics studies performed. The patient did not seek medical attention. No treatment was given for the adverse event. The outcome of fatigue was reported as not recovered/not resolved. The reporter considered the event disabling since the patient was unable to do anything from housework to driving. The relatedness between PNEUMOVAX 23 and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (dose and route were not reported, lot # K023432 with expiration date: 18-JUN-2016). The patients received the vaccinations between 06-NOV-2015 and 10-NOV-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-AUG-2015, the patient received a dose of M-M-R II (lot#, expiration date, dose and route of administration were not reported) that was inadvertently reconstituted with improperly stored sterile diluent (dose one, lot# reported as L016272, expiration date 24-FEB-2018, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Swelling from shoulder to fingertips x 2 days, stiffness. Ibuprofen 200 mg prn.
Age: 26.0
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 26 year old patient of unknown gender GARDASIL 9 (dose, route and lot# were unknown. On 12-NOV-2015, the patient received the third dose in the HPV vaccine series with GARDASIL (dose, route and lot# were unknown) (interchange of vaccine products). No concomitant medication was provided. No adverse effects were reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Antimicrobial susceptibility test sensitive, B-lymphocyte count, Blood immunoglobulin A normal, Blood immunoglobulin G decreased
Clinical narrative: This report refers to a 72 year old female patient without history of severe infections. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot#, dose, route and dose number were unspecified). On an unknown date the patient with COP presented for immune deficiency evaluation. Symptoms of cough and dyspnea along with computerized tomogram (CT) chest findings of multiple bilateral opacities improved with a prolonged course of high-dose steroids. As a result, she developed significant adverse effects of chronic steroid use. Attempts to reduce untoward effects of steroids by decreasing prednisone dose to below 20mg/day resulted in recurrence of symptoms and lung consolidation. Laboratory evaluation (date unspecified) revealed mildly decreased immunoglobulin G (IgG) 630mg/dl with low IgG2 108mg/dl and IgG3 8.5mg/dl, normal IgA/IgM; protective titers to tetanus and diphtheria, with suboptimal response to PNEUMOVAX23; low CD3 390/micro-L, CD4 268/micro-L, and CD8 103/micro-L on oral steroids; normal B cells. It was unclear if the patient's immune profile was secondary to prolonged steroid use or if preceded development of COP. SCig with globulin, immune (HIZENTRA) at a dose of 150mg/kg/week was initiated. Concurrently, MMF was started by her pulmonologist. Over 4 years of follow-up, combined SCig and MMF therapy, notably without steroids, resulted in an maintained clinical and radiographic remission. The outcome of suboptimal response to PNEUMOVAX23 was not provided. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Blood immunoglobulin M normal, CD4 lymphocytes decreased, CD8 lymphocytes decreased, Computerised tomogram thorax abnormal, Cough
Clinical narrative: This report refers to a 72 year old female patient without history of severe infections. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot#, dose, route and dose number were unspecified). On an unknown date the patient with COP presented for immune deficiency evaluation. Symptoms of cough and dyspnea along with computerized tomogram (CT) chest findings of multiple bilateral opacities improved with a prolonged course of high-dose steroids. As a result, she developed significant adverse effects of chronic steroid use. Attempts to reduce untoward effects of steroids by decreasing prednisone dose to below 20mg/day resulted in recurrence of symptoms and lung consolidation. Laboratory evaluation (date unspecified) revealed mildly decreased immunoglobulin G (IgG) 630mg/dl with low IgG2 108mg/dl and IgG3 8.5mg/dl, normal IgA/IgM; protective titers to tetanus and diphtheria, with suboptimal response to PNEUMOVAX23; low CD3 390/micro-L, CD4 268/micro-L, and CD8 103/micro-L on oral steroids; normal B cells. It was unclear if the patient's immune profile was secondary to prolonged steroid use or if preceded development of COP. SCig with globulin, immune (HIZENTRA) at a dose of 150mg/kg/week was initiated. Concurrently, MMF was started by her pulmonologist. Over 4 years of follow-up, combined SCig and MMF therapy, notably without steroids, resulted in an maintained clinical and radiographic remission. The outcome of suboptimal response to PNEUMOVAX23 was not provided. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Lung consolidation, T-lymphocyte count decreased
Clinical narrative: This report refers to a 72 year old female patient without history of severe infections. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot#, dose, route and dose number were unspecified). On an unknown date the patient with COP presented for immune deficiency evaluation. Symptoms of cough and dyspnea along with computerized tomogram (CT) chest findings of multiple bilateral opacities improved with a prolonged course of high-dose steroids. As a result, she developed significant adverse effects of chronic steroid use. Attempts to reduce untoward effects of steroids by decreasing prednisone dose to below 20mg/day resulted in recurrence of symptoms and lung consolidation. Laboratory evaluation (date unspecified) revealed mildly decreased immunoglobulin G (IgG) 630mg/dl with low IgG2 108mg/dl and IgG3 8.5mg/dl, normal IgA/IgM; protective titers to tetanus and diphtheria, with suboptimal response to PNEUMOVAX23; low CD3 390/micro-L, CD4 268/micro-L, and CD8 103/micro-L on oral steroids; normal B cells. It was unclear if the patient's immune profile was secondary to prolonged steroid use or if preceded development of COP. SCig with globulin, immune (HIZENTRA) at a dose of 150mg/kg/week was initiated. Concurrently, MMF was started by her pulmonologist. Over 4 years of follow-up, combined SCig and MMF therapy, notably without steroids, resulted in an maintained clinical and radiographic remission. The outcome of suboptimal response to PNEUMOVAX23 was not provided. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (dose and route were not reported, lot # J015437 with expiration date: 09-OCT-2016). The patients received the vaccinations between 06-NOV-2015 and 10-NOV-2015. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood test normal, Chest X-ray normal, Drooling, Eye movement disorder
Clinical narrative: Tactile fever, decreased energy, Motrin given around 4:00 PM he slumped over, eyes rolled back in head, drooling lasting 5 minutes, no tonic-clonic activity taken to ER.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Pyrexia
Clinical narrative: Tactile fever, decreased energy, Motrin given around 4:00 PM he slumped over, eyes rolled back in head, drooling lasting 5 minutes, no tonic-clonic activity taken to ER.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient has reported persistent pain in the lateral right arm region since the time of the vaccine administration to the present.  She was evaluated by her personal MD.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia
Clinical narrative: Received influenza vaccine left deltoid on 11/11. New onset skin numbness left anterior knee noted 11/13. Since then have developed numbness left lower leg, today advancing across right knee and into left thigh. Reported to employee health nurse today. MD appointment pending.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional and a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2015, the patient was vaccinated with a first dose of improperly stored GARDASIL injection (intramuscularly, lot # K007828, expiration date 02-MAR-2017, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test, Rash, Rubella antibody test
Clinical narrative: She sts that the  rash now involves both arms, elbows and involves abdomen all the way to pelvic area. She reports that she has no rash on her back and minimal if only rash on lower extremities.
Age: 1.65
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMRV, PNC13
Symptoms: Crying, Erythema, Rash, Scratch
Clinical narrative: Immunizations given at about 4:20 pm on 11-16-15. (PENTACEL, PREVNAR, Hep A, PROQUAD and Flu). Child cried after receiving vaccines and grandmother and aunt held and consoled child. Child already had some redness and scratches to face. But about 5 min after receiving vaccines while she was still crying, child started getting small raised bumps to her face, few on abd and 1 on arm. BENADRYL 1.5ml given po, bump and redness gone by 4:53 pm.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old male patient. The patient had no drug reactions and no allergies. On 28-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65ml, subcutaneously, lot # L024999, expiration date: 06-OCT-2016. Concomitant medications were unspecified. On 03-NOV-2015 (also reported as "a few days after patient received ZOSTAVAX"), the injection site became red and raised and the area was hard to touch and also itchy, it was when the patient first noticed raised area on his arm, and when he woke up the next morning injection site was more irritated with a lot of itching. On 03-NOV-2015, the patient went to see his physician. Physician told patient that the injection site was infected and doxycycline was prescribed for the patient. The raised area around injection site was about 6 inches in length with 2 inches in diameter. There were no laboratory diagnostics studies performed. The outcome of the adverse events was reported as not recovered. The relatedness between the events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.