chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blood creatine phosphokinase MB, CSF cell count normal, CSF glucose normal, CSF oligoclonal band, CSF protein normal
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: CSF test, Chest X-ray, Computerised tomogram, Electrocardiogram normal, Eye pain
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Headache, Hypertension, Inflammation, International normalised ratio normal, Iritis
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Laboratory test, Lymphocyte percentage decreased, Maculopathy, Mean cell haemoglobin increased, Monocyte percentage
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neutrophil count normal, Neutrophil percentage increased, Nuclear magnetic resonance imaging normal, Optic neuritis, Papilloedema
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Photophobia, Protein total normal, Prothrombin time, Pterygium, Retinopathy
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Tumour marker test, Vision blurred, Visual impairment, Vitreous floaters
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lymphadenitis, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient with acetaminophen, PERCOCET and SEPTRA allergy. On 02-FEB-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous in the left arm (deltoid) for vaccination (lot # J008128 is an invalid lot number for ZOSTAVAX, expiry date and dose unknown). Concomitant therapies included LIPITOR, pantoprazole and SYNTHROID. The pharmacist reported that the patient reported red, inflamed, swollen lymph nodes in the injection site arm. The red, inflamed, swollen lymph nodes were described as moving (creeping) from the armpit to the elbow and hand. The patient contacted the pharmacist. The pharmacist reported that the patient took BENADRYL as treatment and the inflamed lymph nodes were getting better. The patient was recovering. No rash was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB dosing details unknown. On an unknown date the patient experienced ended up contracting chicken pox. The patient called to confirm a lot number. The outcome of the event is unknown. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Inflammation, Injection site induration
Clinical narrative: Localized inflammatory response 14cm x 18cm induration on the left deltoid.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. On 18-JAN-2014 the patient was vaccinated subcutaneous with 0.65 ml dose of ZOSTAVAX (lot # J011212, 29_AUG-2014). The pharmacist reported that the patient experienced a rash, described as redness, swelling, and about the size of the palm of a hand, at injection site, after receiving ZOSTAVAX. The patient saw pharmacist on 20-JAN-2014 and rash had begun to resolve. OTC BENADRYL or hydrocortisone cream was given for the event. The patient sought medical attention by seeing the pharmacist. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 07-FEB-2014, the patient was vaccinated with an expired dose of ZOSTAVAX, lot # H020000, expiry date 02-FEB-2014 (dose and route not reported) for vaccination. No adverse event was reported. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass
Clinical narrative: This spontaneous report was received from a pharmacist referring to approximately 63-year-old female patient. On 23-DEC-2013 the patient was vaccinated with ZOSTAVAX vial (lot # J004599, expiry date: 18-JUL-2014), single dose, subcutaneous, for vaccination. No other concomitant therapies reported. On 23-DEC-2013, the patient experienced hard lump at the injection site. The lump resolved within 1 hour without requiring medical treatment. There were no lab diagnostic tests performed. The action taken was reported as not applicable. The patient sought medical attention by visiting the pharmacy. There was no significant disability or inability. The event was not life threatening. There was no hospitalization, no overdose and no PQC was involved. The outcome of hard lump at the injection site was reported as recovered on 23-DEC-2013. The casualty of the event was unspecified. No further information provided. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin G decreased, Blood immunoglobulin M normal, Clostridium test negative, Corynebacterium test negative
Clinical narrative: Information has been received from a published literature article. Nephrotic syndrome (NS) comprises of several signs and symptoms that denote kidney damage, which include proteinuria, hypoalbuminemia, hyperlipidemia, and edema. In addition, immune abnormalities have been reported to be associated with NS. We present 3 patients with congenital NS who demonstrate unique patterns of immune deficiency and illustrate the importance of immune evaluation in this condition. Case Report: Three 4-year old patients (two males and one female) presented with chronic nasal congestion, recurrent otitis and a history of frequent relapsing idiopathic minimal change NS. Immune evaluation revealed normal lymphocyte subsets, IgA and IgM, as well as protective antibody titers for tetanus and diphtheria. However, they were found to have IgG 300-400 and non-protective pneumococcal antibodies despite vaccination. Variability was present in lymphocyte mitogen stimulation test with low pokeweed mitogen simulation response. This case report refer to a 4 year old female patient. Conclusion: Children with NS may have a high prevalence of impaired antibody response to pneumococci and pneumococcal polysaccharide vaccine, which may lead to susceptibility to bacterial infections, particularly pneumococci. Thus, immune evaluation is warranted in this condition regardless of remission state. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: Information has been received from a published literature article. Nephrotic syndrome (NS) comprises of several signs and symptoms that denote kidney damage, which include proteinuria, hypoalbuminemia, hyperlipidemia, and edema. In addition, immune abnormalities have been reported to be associated with NS. We present 3 patients with congenital NS who demonstrate unique patterns of immune deficiency and illustrate the importance of immune evaluation in this condition. Case Report: Three 4-year old patients (two males and one female) presented with chronic nasal congestion, recurrent otitis and a history of frequent relapsing idiopathic minimal change NS. Immune evaluation revealed normal lymphocyte subsets, IgA and IgM, as well as protective antibody titers for tetanus and diphtheria. However, they were found to have IgG 300-400 and non-protective pneumococcal antibodies despite vaccination. Variability was present in lymphocyte mitogen stimulation test with low pokeweed mitogen simulation response. This case report refer to a 4 year old female patient. Conclusion: Children with NS may have a high prevalence of impaired antibody response to pneumococci and pneumococcal polysaccharide vaccine, which may lead to susceptibility to bacterial infections, particularly pneumococci. Thus, immune evaluation is warranted in this condition regardless of remission state. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to multiple patients of unknown age and gender. Approximately on 11-FEB-2014 23 hours ago, the patients were vaccinated with ZOSTAVAX vial (strength, dose number, dose unit, lot# and expiry date, route unknown). Approximately on 11-FEB-2014 23 hours ago patients who have received ZOSTAVAX have developed shingles at a later, but the episodes of shingles post-vaccination were less severe than shingles usually was. VZV packet declined for the physician by the representative because the physician does not have a patient who is currently experiencing shingles after receiving ZOSTAVAX. The outcome of shingles is unknown. No additional information provided. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 62 year old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX vial (strength, dose number, dose unit, route, lot number and expiry date unknown). On an unknown date a week after the patient received ZOSTAVAX, patient came back into the office with a rash that looked like shingles on his left side. The outcome of rash that looked like shingles on his left side was unknown. No further information was provided. Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry eye, Photophobia
Clinical narrative: This spontaneous report as received from an 84 year old female consumer refers to herself. The patient' medical history included dry eyes, cataract surgery years ago. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous, injection, one single shot (dose unspecified). Concomitant medications were unspecified. On an unknown date, the patient was experiencing dry eye and can't be exposed to bright light. She went to an unspecified ophthalmologist who could not determine a problem but gave her three eye drops for her symptoms samples of REFRESH OPTIVE, ALREX, and SYSTANE BALANCE. However, the patient has not had too much of improvement with these treatments. No product quality compliance involved. The outcome of events was unknown. The reporters causality for the events with the ZOSTAVAX was unspecified. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from registered nurse refers to a 26 year old female patient. On 10-JUN-1997 as a child, the patient was vaccinated with RECOMBIVAX HB injection 2.5/0.5 (dose unit, route, lot number and expiry date unknown) first dose. Patient received second and third dose on 10-JUL-1997 and 10-AUG-1997 respectively. Nurse reported that after receiving 3 doses of RECOMBIVAX HB injection, now at the age of 26 years, patient showed negative titers to hepatitis B. Nurse reported the patient was due to start medical school and the school has requirement of immunity to hepatitis B by 01-MAR-2014. Patient visited office. Nurse stated that the patient received RECOMBIVAX HB on 31-JAN-2014 and she was trying to administer an accelerated dosing of RECOMBIVAX HB to the patient. The outcome of is showing negative titers to hepatitis B after receiving unspecified hepatitis B as a child, received an unspecified hepatitis B as a child on 06/10/1997, 07/10/1997 and 08/10/1997 and patient received RECOMBIVAX HB on 01/31/2014 was unknown. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown demography. It was reported that the nurse reported to determine the temperature stability of GARDASIL. The nurse reported that the GARDASIL (dose, route and frequency was not reported) which was exposed to temperature outside the prescribing information which was not supported may have vaccinated to an unspecified number of patients on an unknown date. No adverse events were reported. No further information was provided. This case is linked to the case 1402USA007859 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown demography. It was reported that the nurse reported to determine the temperature stability of VAQTA. The nurse reported that the VAQTA (dose, route and frequency was not reported) which was exposed to temperature outside the prescribing information which was not supported may have vaccinated to an unspecified number of patients on an unknown date. No adverse events were reported. No further information was provided. This case is linked to the case 1402USA004498 (same reporter link). Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Chest pain, Pruritus, Serum sickness, Swelling
Clinical narrative: This spontaneous report was received from a physician refers to a 30 year old female patient. The patient pertinent medical history included asthma and allergic rhinitis. The patient had drug reaction or allergic history of BETADINE by using BETADINE, the patient developed a rash from topical use and patient had unspecified food allergies. On 10-JAN-2014 the patient was vaccinated with second dose of VARIVAX (merck) lot # J003709 (Expiry: 27-MAR-2015) (dose, route and frequency was not reported). On 05-FEB-2014, the patient experienced generalized hives, itching and swelling as well as generalized joint pain and chest pain. The patient sought medical attention and visited the physician office. The Physician thinks the patient might have serum sickness. The patient was treated with prednisone, hydroxyzine and ibuprofen. It was also reported that on 28-MAR-1985, the patient had received the first dose of VARIVAX (merck) (dose, route, lot number, expiry and frequency was not reported). The outcome of the events generalized hives, itching and swelling as well as generalized joint pain, chest pain and serum sickness was reported as not recovered. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician refers to a 30 year old female patient. The patient pertinent medical history included asthma and allergic rhinitis. The patient had drug reaction or allergic history of BETADINE by using BETADINE, the patient developed a rash from topical use and patient had unspecified food allergies. On 10-JAN-2014 the patient was vaccinated with second dose of VARIVAX (merck) lot # J003709 (Expiry: 27-MAR-2015) (dose, route and frequency was not reported). On 05-FEB-2014, the patient experienced generalized hives, itching and swelling as well as generalized joint pain and chest pain. The patient sought medical attention and visited the physician office. The Physician thinks the patient might have serum sickness. The patient was treated with prednisone, hydroxyzine and ibuprofen. It was also reported that on 28-MAR-1985, the patient had received the first dose of VARIVAX (merck) (dose, route, lot number, expiry and frequency was not reported). The outcome of the events generalized hives, itching and swelling as well as generalized joint pain, chest pain and serum sickness was reported as not recovered. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Injection site nodule, Injection site warmth, Neck pain, Pain
Clinical narrative: Hard "knot" at injection site. Warm to touch. Pain radiating up to neck started in 24 hours after injection and lasted 3 days.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX given under age 4.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: C-reactive protein normal, Full blood count normal, Influenza A virus test negative, Influenza virus test negative, Pyrexia
Clinical narrative: Patient received 12 month vaccines of MMR, Varicella, Hep A, Pneumococcal at well child exam, mom called one week later stating patient started with fever that same evening of vaccines and has had a rash for about 5 days. Patient was brought in that day with fever and scarlatiniform rash. Lab work, RSV and influenza were done and all negative. Antibiotic was given.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Rash scarlatiniform, Respiratory syncytial virus test negative
Clinical narrative: Patient received 12 month vaccines of MMR, Varicella, Hep A, Pneumococcal at well child exam, mom called one week later stating patient started with fever that same evening of vaccines and has had a rash for about 5 days. Patient was brought in that day with fever and scarlatiniform rash. Lab work, RSV and influenza were done and all negative. Antibiotic was given.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Dizziness postural, Feeling cold, Headache, Impaired driving ability
Clinical narrative: Began feeling nauseated and had a severe headache.  After this, began to feel feverish, but was not able to take temperature.  Felt very cold, but skin was extremely hot to touch.  Muscle and joint aches all over body throughout the night.  Became very dizzy when trying to stand up. Unable to go to hospital because was not in condition to drive and it was the middle of the night. Headache continued through the next day.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia, Nausea, Pyrexia, Skin warm
Clinical narrative: Began feeling nauseated and had a severe headache.  After this, began to feel feverish, but was not able to take temperature.  Felt very cold, but skin was extremely hot to touch.  Muscle and joint aches all over body throughout the night.  Became very dizzy when trying to stand up. Unable to go to hospital because was not in condition to drive and it was the middle of the night. Headache continued through the next day.
Age: 0.18
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: Pt given Kenrix 0.5ml IM-Right thigh instead of giving age appropriate dose of Dtap and IPV. Manufacturer: Glaxo Smith Kline, Lot#AC220B235AA.
Age: 63.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Abasia, Blood test abnormal, Joint swelling, Mobility decreased, Pain
Clinical narrative: Left knee became so swollen that I couldn't see my kneecap; over a period of a few weeks, symptoms became worse, to the point that I couldn't walk and could not lift my arms, developed low grade fever.  Pain continues to this day.
Age: 63.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Pyrexia
Clinical narrative: Left knee became so swollen that I couldn't see my kneecap; over a period of a few weeks, symptoms became worse, to the point that I couldn't walk and could not lift my arms, developed low grade fever.  Pain continues to this day.
Age: 63.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Abasia, Joint swelling, Mobility decreased, Pain, Pyrexia
Clinical narrative: Left knee became so swollen that I couldn't see my kneecap; over a period of a few weeks, symptoms became worse, to the point that I couldn't walk and could not lift my arms, developed low grade fever.  Pain continues to this day.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site cellulitis, Local swelling, Pain, Pyrexia
Clinical narrative: Patient received influenza and Pneumovax vaccines both in right arm.  Developed body aches and low grade fever which resolved and then developed redness and swelling of upper arm.  Diagnosed as right upper arm cellulitis.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received influenza and Pneumovax vaccines both in right arm.  Developed body aches and low grade fever which resolved and then developed redness and swelling of upper arm.  Diagnosed as right upper arm cellulitis.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Itchy hives-like rash that itched for 9 days after onset.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose, route and frequency were not reported). The nurse reported that one of the facilities records the temperature of their freezer storing VARIVAX (Merck) only once or twice a week. The nurse stated that from 16-NOV-2013 to 29-JAN-2014, when the temperature was recorded, it was 6F. The nurse stated that it was not confirmed the overall average temperature of the freezer has been between -58F and 5F. On an unknown date, improperly stored VARIVAX (Merck) have been administered to patients. The nurse reported that he will provide the lot number and expiration dates of the doses and as well as dates of placement of the doses of product into the freezer and dates of administration of the doses to the patient. No adverse effect was unknown. This case is linked to the case 1402USA007996 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (dose, route and frequency were not reported). The nurse reported that one of the facilities records the temperature of their freezer storing PROQUAD (Merck) only once or twice a week. The nurse stated that from 16-NOV-2013 to 29-JAN-2014, when the temperature was recorded, it was 6F. The nurse stated that it was not confirmed the overall average temperature of the freezer has been between -58F and 5F. On an unknown date, improperly stored PROQUAD (Merck) have been administered to patients. The nurse reported that he will provide the lot number and expiration dates of the doses and as well as dates of placement of the doses of product into the freezer and dates of administration of the doses to the patient. No adverse effect was known. This case is linked to the case 1402USA002366 (same reporter link). Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cyanosis, Gaze palsy, Hypotonia, Posture abnormal, Respiratory arrest
Clinical narrative: Foster parent was feeding baby when half-way thru bottle the baby yelled out, went limp, turned very blue, stopped breathing and arched his head back and eyes rolled back in his head. This lasted 15 seconds and baby snapped out of it on his own. Foster parent says baby did not choke on the formula (Enfamil).
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ultrasound skull
Clinical narrative: Foster parent was feeding baby when half-way thru bottle the baby yelled out, went limp, turned very blue, stopped breathing and arched his head back and eyes rolled back in his head. This lasted 15 seconds and baby snapped out of it on his own. Foster parent says baby did not choke on the formula (Enfamil).
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dysphagia, Guillain-Barre syndrome, Muscular weakness, Paraesthesia
Clinical narrative: Tingling in fingers and toes. Weakness in hands, loss of balance eventually paralyzed from waist down (temporary). Inability to swallow.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Paralysis
Clinical narrative: Tingling in fingers and toes. Weakness in hands, loss of balance eventually paralyzed from waist down (temporary). Inability to swallow.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site discharge, Injection site pain, Injection site reaction, Muscle tightness
Clinical narrative: Employee states (R) deltoid became tight and throbbing with liquid discharge - reported by phone 1-10-14 at 2:50 pm - not able to come in for visit. Advised to follow up at Emer. Dept. 1-13-14 - followed up and symptoms gone on 1-11-14 per patient.
Age: 52.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Rash generalised, Varicella post vaccine
Clinical narrative: Approx 3 days after shot pox marks and rashes appeared. All over the body but concentrated in the armpits and inner thighs. Prescribed topical steroids.
Age: 52.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Rash generalised
Clinical narrative: Approx 3 days after shot pox marks and rashes appeared. All over the body but concentrated in the armpits and inner thighs. Prescribed topical steroids.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Pain in extremity, Rheumatoid factor negative, X-ray normal
Clinical narrative: Case number PHEH2014US002867 is an initial spontaneous report received from health care professional on 10 Feb 2014. This report refers to a 36-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309101) intramuscularly on 15 Jan 2014. On 16 Jan 2014, she woke up with pain in her arm and had trouble in lifting her arm. It was reported that her pain continued and it was examined by a doctor. She underwent rheumatoid panel and an X-ray exam and the doctor could not find anything wrong with her. She had an excruciating pain and unable to take her clothes off due to difficulty lifting her arm. The final outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site bruising, Neck pain, Oral herpes
Clinical narrative: Large bruise at injection site though he was gentle. It grew large and remained several days sudden onset of herpes in mouth, lips and face - though hadn't had such a severe case in past. Took my usual treatment of Lysine which usually works, but sores only got worse. When started got pain in back of neck - took ZOVIRAX - worked so didn't go to ER.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient had a rash (large area) post exposure of PNEUMOVAX admin. MD gave Rx for Doxycycline 100mg and patient will follow up with MD. Advised to contact us as well.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Red, swollen area around injection site that same night. Next day fever 103 --> went to ER. Got TAMIFLU. That night spiked 105 degrees went to ER next day Sat. Spent 2 days in hospital. Diagnosis cellulitis. Pt concerned of RPh sterilization technique.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, Myalgia, Pyrexia
Clinical narrative: Post flu shot fever - in AM - 99.6-99.8 in PM - 100.4-100.8, chills, muscle aches, "scratchy" throat, dry cough, fatigue. Treatment - rest. From Thurs Dec 12 to Tues. Dec 17 2013.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Post flu shot fever - in AM - 99.6-99.8 in PM - 100.4-100.8, chills, muscle aches, "scratchy" throat, dry cough, fatigue. Treatment - rest. From Thurs Dec 12 to Tues. Dec 17 2013.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Night sweats, Pyrexia, Tremor
Clinical narrative: Had uncontrollable shaking, cold. Fever 101.9. TYLENOL used - sweat through the night.
Age: 1.08
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Cough, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Developed suddenly rash neck, papular macular, cough and fever day 9 after vaccine, rash trunk upper extremity non blanching.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Skin ulcer
Clinical narrative: Extra as lot of pain to area and side of upper (left) body. Sore outbreak on neck had related pain to area of shot. Treatment extra rest next week and month, sores lower down of left side disappeared.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Fall, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Pls see progress note date 1/29/14. Itchiness x 2 days in (L) arm. C/O left upper arm sore, today red and swollen. Sweating, subj fever last night. No CP or SOB but throat feeling tight this AM, better after BENADRYL here. Felt dizzy, fell to ground yesterday but denies LOC. Similar episodes approximately 1x/week on average. Only happen when she's up, never when sitting. Usually when running after kids. Didn't take BP rx yet today.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Pruritus, Pyrexia, Throat tightness
Clinical narrative: Pls see progress note date 1/29/14. Itchiness x 2 days in (L) arm. C/O left upper arm sore, today red and swollen. Sweating, subj fever last night. No CP or SOB but throat feeling tight this AM, better after BENADRYL here. Felt dizzy, fell to ground yesterday but denies LOC. Similar episodes approximately 1x/week on average. Only happen when she's up, never when sitting. Usually when running after kids. Didn't take BP rx yet today.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Fatigue, Heart rate irregular, Influenza like illness, Loss of consciousness
Clinical narrative: Vaccine given - 8-21-13. Symptoms 8-27-13 - high fever. Pale, weakness, blackouts, irregular heartbeat, fatigue - flu like.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Pyrexia
Clinical narrative: Vaccine given - 8-21-13. Symptoms 8-27-13 - high fever. Pale, weakness, blackouts, irregular heartbeat, fatigue - flu like.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient (age and gender of patient unspecified). Patients medical history was unspecified. On 05-FEB-2014, the patient was vaccinated with expired dose of ZOSTAVAX subcutaneous injection, 0.65 ml, (Lot number unspecified, expiry date 20-OCT-2013. Concomitant medications were unspecified. No adverse effect reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning an 81 year old female patient with diabetes. On 19-OCT-2012 the patient was vaccinated with ZOSTAVAX (dose and route not provided) (Lot # reported as 03638AE; expiration date: 06-MAR-2013) to prevent shingles. Concomitant therapies included gabapentin (manufacturer unknown0. The patient went to the emergency room with pain along her ribcage that extended from her front to back (onset of the event was on 21-JAN-2014). Field employee stated the patient did not develop any lesions, but the physician mentioned she believed the patient had shingles. The patient was treated with FAMVIR. On an unspecified date, a CT scan and blood work were performed, the results were not provided. The patient's outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician, for VARIVAX (Merck) and GARDASIL, Pregnancy Registry products, concerning a 14 years old female patient. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not provided) and the second dose of GARDASIL (dose, route and lot number not provided) on 05-JUn-2012. The patient was also vaccinated with other suspect therapies including BOOSTRIX and MENACTRA on 05-JUN-2012. No concomitant medications were reported. Subsequently, the patient became pregnant. The Last Menstrual Period (LMP) or her gestational age and Estimated Date of Delivery were not known. Additional information has been requested. Update (10-FEB-2014): The patient's doctor was contacted in order to obtain follow-up regarding the patient's pregnancy outcome. However, the doctor informed that the doctor did not see the patient since the vaccination, and the doctor has no information on the pregnancy, delivery or OBGYN. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: 7 INCHES X 4 INCHES WARM AND SIGNIFICANT ERYTHEMA.
Age: 1.19
Sex: M
Vaccine: DTAP, FLUX, HIBV
Symptoms: Chills, Disorientation, Pyrexia
Clinical narrative: Fever: 104 degrees, disoriented, chills. Treatment: taken to Urgent Care and administered Tylenol and Motrin regimen, also cold compress and chilled bath.
Age: 0.86
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Body temperature increased, Convulsion, Haematocrit normal, Haemoglobin normal, Lethargy
Clinical narrative: 10 month old had felt warm in afternoon after his shots.  Mom had him in her bed and he started having a seizure, showed lethargy.  Brought into ER.  She did give him Motrin earlier in evening.  He was given O2 in ER along with IV fluids, Tylenol suppository and Motrin.  Rectal temp 104.6 upon arrival and decreased to 100 after fluids, suppository.  Was observed for few hours and released.
Age: 0.86
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Neutrophil percentage decreased, Platelet count decreased, Skin warm, White blood cell count normal
Clinical narrative: 10 month old had felt warm in afternoon after his shots.  Mom had him in her bed and he started having a seizure, showed lethargy.  Brought into ER.  She did give him Motrin earlier in evening.  He was given O2 in ER along with IV fluids, Tylenol suppository and Motrin.  Rectal temp 104.6 upon arrival and decreased to 100 after fluids, suppository.  Was observed for few hours and released.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Fall, Muscle rigidity, Presyncope
Clinical narrative: Patient received Menactra (booster) and Gardasil vaccines at ~10:00am.  He then had labs drawn via peripheral antecubital stick a few minutes after the vaccines.  During the lab draw, patient complained of "feeling dizzy" and fell back.  Patient was initially rigid, very transient.  MD thought it was a vasovagal reaction.  Patient also has history of seizures as a child.  Patient did not think it was a seizure because he "didn't feel the same as he did when he had seizures as a kid".  He was observed for additional 15 minutes. He was instructed to go to the local ER for follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling at injection site. Has grown continually worse. Swelling & redness now about 4 inch diameter. Informed Doctor's office, waiting for call back.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red, hard circle at site of injection. No pain or other symptoms per pt. Advised to call dr if worsens.
Age: 36.0
Sex: F
Vaccine: FLUR3
Symptoms: Urticaria
Clinical narrative: Pt. received vaccine 11/25/2013.  Hives noticed on trunk and L upper extremity on monrning of 11/26/2013.  Hives then became more diffuse and began to spread over next 3-4 days over entire body.  Pt took famotidine and Benadryl on 11/26/2013.  Pt say MD on 12/5/2013 after little to no relief.  MD prescribed Medrol dose pack x 2.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, White blood cell count normal
Clinical narrative: Redness, induration, heat swelling RUA.  Moist heat applied.  Treated with IV Doxycycline and showed improvement.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: NONE.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Administered Fluzone HD to under 65 yo.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Injection site pain, Insomnia, Myalgia, Nausea
Clinical narrative: Sore at injection site, increased to 8/10 by evening. Unable to sleep, unable to lie down w/out 8/10 pain. Used heat, ice, acetaminophen q 6 hrs, massage. Called ER Family practice resident on call, who could recommend nothing else. Could not work next day, pain too severe. By Friday, 2/14/2014, I regained functional use of arm by taking acetaminophen q 6 hrs. During the week I had a 1 degree fever, nausea, and muscle aches.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Sore at injection site, increased to 8/10 by evening. Unable to sleep, unable to lie down w/out 8/10 pain. Used heat, ice, acetaminophen q 6 hrs, massage. Called ER Family practice resident on call, who could recommend nothing else. Could not work next day, pain too severe. By Friday, 2/14/2014, I regained functional use of arm by taking acetaminophen q 6 hrs. During the week I had a 1 degree fever, nausea, and muscle aches.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eyelid oedema, Pharyngeal erythema, Pharyngeal oedema, Swelling face
Clinical narrative: THROAT AND FACE STARTED GETTING RED AND SWOLLEN.. BY SAT. MORNING ONE EYE WAS ALMOST SWOLLEN SHUT... STILL SAME ISSUE ON SUNDAY AND MONDAY MORNING. I STARTED TAKING BENADRYL ON SUNDAY.