chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Night sweats, Pyrexia, Retching
Clinical narrative: Pt's wife called and reported that pt had an adverse reaction following PNEUMOVAX on 8/20- she reported he had a fever, night sweats, dry heaves, and very sore injection site x4 days. She reports that s/s have resolved.
Age: 0.8
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 10 month old male infant. On an unknown date the patient was vaccinated with VAQTA (0.5 ml, frequency and lot# were not reported) intramuscularly, which was outside of prescribing information recommendations for age range, at an unspecified medical practice. No adverse effects to the infant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age with rheumatoid arthritis. In approximately February 2014 (reported as "about a year ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route were not reported). Subsequently, on an unknown date, the patient developed shingles. The patient "was working with the Centers for Disease Control (CDC)" about the event. The patient had sought unspecified medical attention. The outcome of shingles was not provided. Additional information is not expected because the reporter had no patient information available and did not want to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a consumer refers to her friends who were each over 26 years old patients of unspecified demographics. On an unspecified dates the patients (drug administered to patient of inappropriate age) were vaccinated with GARDASIL (dose and lot numbers were unspecified), intramuscularly for an unknown indication. No adverse effects were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. Since 17-FEB-2015, the patients were vaccinated with RECOMBIVAX HB (strength, dose, lot# were not reported) intramuscular which were stored improperly. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt reports redness, warmth and tenderness at injection site. No treatment indicated.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythematous rash in a 2-year-old female patient who received PEDIARIX (batch number 4233K, expiry date 5th September 2016). On 27th October 2014 09:30, the patient received the 2nd dose of PEDIARIX. On an unknown date, the dose was an unknown dose. On 29th October 2014, 2 days after receiving PEDIARIX, the patient experienced erythematous rash and pruritus. On an unknown date, the outcome of the erythematous rash and pruritus were recovered/resolved. It was unknown if the reporter considered the erythematous rash and pruritus to be related to PEDIARIX. Additional information: a 2 year old patient experienced a localized rash (itchy and red) following vaccination.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: No therapeutic response, Seroconversion test negative
Clinical narrative: This spontaneous report was received from a physician refers to his 27 year old female daughter. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX first dose (dose, strength and lot number were not provided). Co-suspect or concomitant therapies were not reported. On an unknown date, the patient received a second dose of (Oka/Merck) VARIVAX and was tested and did not seroconvert, after that the patient received either one or two more doses of (Oka/Merck) VARIVAX and she still did not seroconvert. Therefore, the reporting physician was figuring out whether to vaccinate her again. Patient sought medical attention through a healthcare provider visit and patient did not received treatment for the events. At the time of the report, the outcome of the events seroconversion test negative and no therapeutic response was not recovered. The causal relationship between the events and vaccination with (Oka/Merck) VARIVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an unspecified numbers of patients. On an unspecified date, the patients received a batch of improperly stored M-M-R II (dose, strength, route and lot# were not reported). No adverse effects reported. This case was one of the three reports received from the same reporter. (Other two products captured in case 1503USA003160 and case 1503USA003159). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an unspecified numbers of patients. On an unspecified date, the patients received a batch of improperly stored PEDVAXHIB (dose, strength, route and lot# were not reported). No adverse effects reported. This case was one of the three reports received from the same reporter. (Other two products were captured in case 1502USA005910 and case 1503USA003159). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. On 12-FEB-2015 the patient was vaccinated with ZOSTAVAX (dose, strength, route were not reported, lot # J011830, expiration date: 26-DEC-2014). No adverse events were 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 healthcare worker refers to unspecified number of patients of unknown age and gender who on an unknown dates were vaccinated with improperly stored doses of RECOMBIVAX HB 2.5 MCG/0.5, (dose, route, lot # and expiration date were not provided). No adverse effects reported. This is one of several reports received from the same reporter. 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 unspecified number of patients of unknown age and gender who on an unspecified dates were vaccinated with improperly stored doses of GARDASIL (dose, route, lot # and expiration date were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: DTP
Symptoms: Rash
Clinical narrative: Rash
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 05-FEB-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, dosage and route unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Erythema, Hypothermia, Vomiting, Wheezing
Clinical narrative: Diffuse erythema, vomiting, hypothermia, wheezing, anaphylaxis concerning.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Heart rate abnormal, Syncope
Clinical narrative: Well adolescent, received first GARDASIL vaccine. Within 2 minutes she complained of headache while sitting on exam table, then slumped over having fainted. Heart rate 40, returned to normal in 2 minutes. Fully alert after 2 minutes.
Age: 1.57
Sex: M
Vaccine: DTAPIPVHIB, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site scab
Clinical narrative: Noticed lesions 3/8/15 during  bath. On date of visit, 3/11/15 they were starting to dry up. Lesions on (R) lateral mid thigh with approx 1.5 x 3cm eryth indurated area. Within this area, there are 3 small scabbed vesicular lesions. Parent apply cortisone cream from OTC. painful to patient when touched.
Age: 1.57
Sex: M
Vaccine: DTAPIPVHIB, HEPA, VARCEL
Symptoms: Injection site vesicles, Skin lesion
Clinical narrative: Noticed lesions 3/8/15 during  bath. On date of visit, 3/11/15 they were starting to dry up. Lesions on (R) lateral mid thigh with approx 1.5 x 3cm eryth indurated area. Within this area, there are 3 small scabbed vesicular lesions. Parent apply cortisone cream from OTC. painful to patient when touched.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site rash, Rash
Clinical narrative: Minutes after being given the vaccines he had eruption of rashes on arms, body and face, no fever, no swelling of eyes and lips. But subsided after 30 mins.
Age: 72.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Underdose
Clinical narrative: Pt. was mistakenly given pediatric dose (5 mcg) of RECOMBIVAX HB for 1st and 2nd dose of series. Third dose was given at correct dose of 10 mcg. Manufacturer recommends repeating series. We will give a 10 mcg dose next month and in 6 months.
Age: 72.0
Sex: F
Vaccine: HEP, HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Pt. was mistakenly given pediatric dose (5 mcg) of RECOMBIVAX HB for 1st and 2nd dose of series. Third dose was given at correct dose of 10 mcg. Manufacturer recommends repeating series. We will give a 10 mcg dose next month and in 6 months.
Age: 5.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: ZOSTAVAX administered mistakenly in place of VARIVAX.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Pt experienced red, swollen, itchy reaction from injection site down to elbow 2 days after administration. Pt did not have oral fever, but reaction site stayed warm for 2 days. Pt reported prickling sensation around injection site. No pain, but uncomfortable x 5 days. No interruption in daily activities reported.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Paraesthesia
Clinical narrative: Pt experienced red, swollen, itchy reaction from injection site down to elbow 2 days after administration. Pt did not have oral fever, but reaction site stayed warm for 2 days. Pt reported prickling sensation around injection site. No pain, but uncomfortable x 5 days. No interruption in daily activities reported.
Age: 76.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: (L) arm (upper) red, swollen, itchy. Treated for possible cellulitis and possible allergic reaction.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Swelling, Urticaria
Clinical narrative: Hives and swelling. Antibiotics, steroids.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 20-JAN-2015, the patient was vaccinated with a first dose of VAQTA (route, dose, lot # and expiration date were not provided). Then, on 09-MAR-2015, 49 days after the first vaccination, the patient was vaccinated with a second dose of VAQTA (route, dose, lot # and expiration date were not provided) which was an inappropriate schedule of drug administration. No adverse effects were reported. Additional information has been requested.
Age: 0.48
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 6 cm x 6 cm erythema with swelling and heat.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test positive, Arthralgia, Asthenia, Blood immunoglobulin G increased, Cellulitis
Clinical narrative: Pt here for assessment of red rash, localized warmth and soreness on left upper arm just below inj. site that started about Monday or Tuesday a.m. pt reported fever/chills Tuesday and Wednesday, but none today. Pt seen and examined. Agree with nursing note. Tmax 103-temp this am at home was 99. Was having chills, feels weak, arm painful, red swollen. Also has had 4 tick bites a day or two prior to vaccine. No other symptoms. Likely cellulitis due to PNEUMOVAX but will start doxy and get tick titers to make sure.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Influenza like illness, Injection site pain, Injection site warmth
Clinical narrative: Pt here for assessment of red rash, localized warmth and soreness on left upper arm just below inj. site that started about Monday or Tuesday a.m. pt reported fever/chills Tuesday and Wednesday, but none today. Pt seen and examined. Agree with nursing note. Tmax 103-temp this am at home was 99. Was having chills, feels weak, arm painful, red swollen. Also has had 4 tick bites a day or two prior to vaccine. No other symptoms. Likely cellulitis due to PNEUMOVAX but will start doxy and get tick titers to make sure.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Pt here for assessment of red rash, localized warmth and soreness on left upper arm just below inj. site that started about Monday or Tuesday a.m. pt reported fever/chills Tuesday and Wednesday, but none today. Pt seen and examined. Agree with nursing note. Tmax 103-temp this am at home was 99. Was having chills, feels weak, arm painful, red swollen. Also has had 4 tick bites a day or two prior to vaccine. No other symptoms. Likely cellulitis due to PNEUMOVAX but will start doxy and get tick titers to make sure.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Pt here for assessment of red rash, localized warmth and soreness on left upper arm just below inj. site that started about Monday or Tuesday a.m. pt reported fever/chills Tuesday and Wednesday, but none today. Pt seen and examined. Agree with nursing note. Tmax 103-temp this am at home was 99. Was having chills, feels weak, arm painful, red swollen. Also has had 4 tick bites a day or two prior to vaccine. No other symptoms. Likely cellulitis due to PNEUMOVAX but will start doxy and get tick titers to make sure.
Age: 59.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Per note in patient chart: Pt experienced fatigue and fever and diarrhea and left upper arm red+warm+itching+painful+edema, all is resolving pt declines need for further medical care for reactions, advised pt to take BENADRYL if itching is bothersome, pt verbalized understanding. Sedation, rash, urticaria pruritus and diarrhea.
Age: 59.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Injection site pruritus, Injection site warmth, Pruritus, Pyrexia, Rash
Clinical narrative: Per note in patient chart: Pt experienced fatigue and fever and diarrhea and left upper arm red+warm+itching+painful+edema, all is resolving pt declines need for further medical care for reactions, advised pt to take BENADRYL if itching is bothersome, pt verbalized understanding. Sedation, rash, urticaria pruritus and diarrhea.
Age: 59.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Sedation, Urticaria
Clinical narrative: Per note in patient chart: Pt experienced fatigue and fever and diarrhea and left upper arm red+warm+itching+painful+edema, all is resolving pt declines need for further medical care for reactions, advised pt to take BENADRYL if itching is bothersome, pt verbalized understanding. Sedation, rash, urticaria pruritus and diarrhea.
Age: 36.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Injection site swelling, Peripheral swelling, Pyrexia, Skin tightness
Clinical narrative: This spontaneous report was received from a physician's assistant via company representative and refers to a 36 year old female patient. No medical history or concurrent conditions were reported. On 18-FEB-2015, the patient was vaccinated with PNEUMOVAX 23 through an unspecified route (dose and route were not reported). Other suspect product initiated on the same day included unspecified flu vaccine which was administered in the same arm as PNEUMOVAX 23. No concomitant medications were reported. On 19-FEB-2015, the patient experienced swelling around the injection site, vomiting and was unable to keep anything down, fever of 102 F, arm was swollen, tight and red. Hence the physician's assistant recommended the patient to visit an emergency room, (ER) on 20-FEB-2015. The patient sought medical attention with physician's assistant by texting back and forth via cellular phone. On an unknown date, the patient's white blood count was 1900. The outcome of the events was unknown. The reporter did not assess the events with pneumococcal vaccine, polyvalent (23-valent). No other information was available. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Vomiting, White blood cell count decreased
Clinical narrative: This spontaneous report was received from a physician's assistant via company representative and refers to a 36 year old female patient. No medical history or concurrent conditions were reported. On 18-FEB-2015, the patient was vaccinated with PNEUMOVAX 23 through an unspecified route (dose and route were not reported). Other suspect product initiated on the same day included unspecified flu vaccine which was administered in the same arm as PNEUMOVAX 23. No concomitant medications were reported. On 19-FEB-2015, the patient experienced swelling around the injection site, vomiting and was unable to keep anything down, fever of 102 F, arm was swollen, tight and red. Hence the physician's assistant recommended the patient to visit an emergency room, (ER) on 20-FEB-2015. The patient sought medical attention with physician's assistant by texting back and forth via cellular phone. On an unknown date, the patient's white blood count was 1900. The outcome of the events was unknown. The reporter did not assess the events with pneumococcal vaccine, polyvalent (23-valent). No other information was available. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (LVN) refers to a patient of unknown age and gender. No information on their medical history or concurrent conditions was provided. It was reported that on 12-FEB-2015, improperly stored PROQUAD (Merck) (lot # K020748, dose, route of administration and expiration date were not provided) have been administered to the patient. No adverse effects were reported. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.36
Sex: M
Vaccine: PNC13
Symptoms: Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Patient developed a tonic clonic seizures (2/17/15). Patient received PREVNAR 13 the day prior to the seizure episode. He had fever and there is history of febrile seizure.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. The patient received a dose of ZOSTAVAX on 18-APR-2011 (subcutaneously; dose, lot#, expiration date and anatomical location were not reported) and on 25-FEB-2015 (subcutaneously; dose, lot#, expiration date and anatomical location were not reported). No adverse effects were known at the time of the report. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to an unspecified amount of patients of unknown age and gender. The medical assistant reported that doses of VARIVAX (Merck) INJ (dose, route and lotnu mber not provided), which have been exposed to temperatures outside of the recommended range, have been administered to patients on unspecified dates since 17-FEB-2015. No adverse effect was reported. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Abasia, Injection site rash, Pain, Pyrexia
Clinical narrative: Patient developed rash on left thigh approx. 3 hours after vaccine. Painful, unable to walk the next morning. Gave Ibuprofen. Seen at 10:30 AM 3/12 - improved rash and able to walk. Also had fever 101.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Child developed redness and swelling about 24 hours after vaccine. Swelling and redness increased and became warm after 48 hours. Treated for cellulitis.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. On an unknown dates since 16-FEB-2015, the patients were vaccinated with an unspecified number of improperly stored doses of M-M-R II, subcutaneous (dose and lot number were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. On an unknown dates since 16-FEB-2015, the patients were vaccinated with an unspecified number of improperly stored doses of VAQTA intramuscularly (dose and lot number were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a male patient of unknown age. In April 2014 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route and lot# were not reported). The patient received his second dose of GARDASIL (dose, route and lot# were not reported) late on 27-FEB-2015. No adverse events were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a healthcare student referring to a male patient of unknown age. On an unspecified date in December 2014 the patient was vaccinated with ZOSTAVAX strength and lot# unspecified, 0.65 ml once, subcutaneous in the arm. On an unspecified date in December 2014 the patient experienced injection site pain after receiving ZOSTAVAX. The injection site pain resolved after 3 weeks on an unspecified date. Patient then developed new pain in this same arm in which he had received ZOSTAVAX which radiated down through the entire arm, and also developed numbness in the fingertips of this arm, all since an unspecified date. The patient called pharmacy to seek medical attention. The outcome of new pain and numbness in the fingertips was not recovered. Additional information is not expected because the reporter did not know physician information and did not wish to be contacted for follow up.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a healthcare worker refers to a patient of unknown age and gender. On 10-FEB-2015 the patient was vaccinated with an improperly stored dose of M-M-R II, lot # K002527, expiration date: 18-FEB-2016, dosage and route unspecified. 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: Information has been received from a physician and a healthcare worker referring to unspecified number of patients of unknown ages and gender. On unspecified dates since 05-FEB-2015 the patients were vaccinated with improperly stored doses of M-M-R II (lot #, strength, dosage and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. The patients medical histories were not reported. On an unknown date, the patients received improperly stored VAQTA, (lot #, dose, route and site of administration were not reported). No adverse events were reported. This is one of several reports from the same reporter. 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 nurse refers to an unspecified number of patients. The patient's medical histories were not reported. In February 2015 (reported as between 17-FEB-2015 and 25-FEB-2015), the patients received improperly stored doses of GARDASIL, 0.5 ml, intramuscularly (lot # and site of administration were not reported). No adverse events were reported. This is one of several reports from the same reporter. 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 nurse refers to an unspecified number of patients. The patient's medical histories were not reported. On an unknown date, the patients received improperly stored doses of RECOMBIVAX HB (dose, route, site of administration and lot # were not reported). No adverse events were reported. This one of several reports from the same reporter. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 2 months old male infant. On 06-AUG-2014 the patient was vaccinated with first dose RECOMBIVAX HB (lot number and expiry date unknown) (dosing regimen and route unknown). No concomitant medications were reported. On 06-AUG-2014 the patient was vaccinated with first dose of RECOMBIVAX HB and on 02-OCT-2014 received the second dose and on 05-DEC-2014 the patient received the third dose of RECOMBIVAX HB (inappropriate schedule of drug administration). No adverse events were reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. There was no product quality issue reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with MMR II injection (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. On an unknown date the patient had titers drawn (details unspecified) which revealed negative for measles. The action taken with therapy with MMR II was unknown. The outcome of the event was unknown. The relatedness of the events to the therapy with MMR II was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist and 57 year old female consumer refers to herself. Pertinent medical history included scleroderma, type B pulmonary hypertension, allergy to egg products, iodine products and Penicillin. On 11-FEB-2015, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location and lot number was unspecified by reporter). Concomitant therapies included LETAIRIS, TYVASO and unspecified blood pressure medication. On an unknown date in February 2015 the patient experienced itching, soreness, and swelling after receiving the ZOSTAVAX at the injection site. The reporter also stated that there was a lump or nodule, the size of a quarter, around injection site. The patient sought medical attention by making a call to pharmacist. No treatment was given for the events. The outcome of vaccination site nodule was reported as not recovered/not resolved. The outcome of itching, soreness, and swelling after receiving the ZOSTAVAX at the injection site was reported as recovering/resolving (reported as lasted for four to five days and then subsided). The causal relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 16-JAN-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, dosage and route unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 20-JAN-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, dosage and route unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 24-DEC-2014 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, dosage and route unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a physician via a literature article, concerning a pregnant female who on an unknown date was vaccinated with a first dose of GARDASIL 0.5 ml, (lot#, application site and route were not reported) (Vaccine exposure during pregnancy). The Last Menstrual Period and Estimated Date of Delivery were unknown. The outcome of the event vaccine exposure during pregnancy was outcome pending. The investigator considered the event vaccine exposure during pregnancy to be not related to GARDASIL. Follow-up information was received in a published literature on 02-MAR-2015. Study participants, ethics, study design and vaccine composition have previously been reported. Briefly, this trial was initiated in January 2007 and data for the Month 60 analysis were collected up to May 2012. Women stratified by age (18-26, 27-35 and 36-45 y) were randomized (1:1 ratio) to receive 0.5 mL of HPV-16/18 vaccine or HPV 6/11/16/18 vaccine according to their recommended 3-dose regimens (Months 0, 1 and 6 or Months 0, 2 and 6, respectively). In order to maintain the blind, women received one dose of placebo (aluminum hydroxide) at either Month 1 or 2, as appropriate. The subjects, investigator, study personnel, and sponsor remained blinded until database freeze of the study. Of note, all data presented in this end-of study analysis have been unblinded. Thirty centers participated in the Month 60 follow-up. Anti-HPV-16 and -18 antibody levels were measured in all available blood samples. Methods for the PBNA and ELISA assays used in this investigation have been described elsewhere. Safety assessments in this end-of-study analysis were as described previously, including SAEs, NOCDs, NOADs, MSCs, and pregnancy outcomes. A total of 172 pregnancies were reported up to Month 60, with similar outcomes between vaccine groups. There were 71.9% (n = 69) and 73.7% (n = 56) live infants, respectively, in the HPV-16/18 and HPV-6/11/16/18 vaccine groups, with no unanticipated anomalies or outcomes. Fifteen (15.6%) and 11 cases (14.5%) of spontaneous abortion with no apparent congenital anomaly were reported in the HPV-16/18 and HPV-6/11/16/18 vaccine groups, respectively. This report referred to the three pregnant females. The patients were lost to follow up. This is one of the several reports received from the same source. Additional information is not expected. Literature information, study information, reporter, patient, product and narrative were updated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. On an unknown dates since 16-FEB-2015, the patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB intramuscularly (dose and lot number 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: 27.0
Sex: M
Vaccine: TYP, TYP
Symptoms: Pruritus, Rash, Skin lesion
Clinical narrative: On 1/5/15 the patient received his first dose of oral typhoid in the morning before lunch. At 1600 after working in frigid temperatures he took a shower and then noted hives on his elbows and extreme pruritis. He denied dyspnea, palpitations, lightheadedness, dysplasia, angioedema, abdominal pain, N, V, or diarrhea. On 1/6/15 he noted hives on his fingers, thumbs, wrist and forehead which were itchy. The pruritis increased in the evening after he showered. On 1/7/15 the patient took dose #2 of the oral typhoid. He reported to the Immunization Clinic to question if he needed another vaccination and he reported his symptoms. Employee contacted our office and the patient was advised to be seen by his PCM. The patient was given ATARAX and SIQ'd for 48 hours. Later that evening the patient noted that the hives had extended to his face and ears. At his follow-up appointment on 1/8/15 hives were noted on bilateral wrists, left elbow, left temple, lower cervical region and left posterior auricular region. The patient was prescribed ZANTAC and ZYRTEC. The patient stated that the hives and itching were much improved on 1/9/15 and totally resolved by 1/11/15.
Age: 27.0
Sex: M
Vaccine: TYP, TYP
Symptoms: Allergy test negative, Pruritus, Urticaria
Clinical narrative: On 1/5/15 the patient received his first dose of oral typhoid in the morning before lunch. At 1600 after working in frigid temperatures he took a shower and then noted hives on his elbows and extreme pruritis. He denied dyspnea, palpitations, lightheadedness, dysplasia, angioedema, abdominal pain, N, V, or diarrhea. On 1/6/15 he noted hives on his fingers, thumbs, wrist and forehead which were itchy. The pruritis increased in the evening after he showered. On 1/7/15 the patient took dose #2 of the oral typhoid. He reported to the Immunization Clinic to question if he needed another vaccination and he reported his symptoms. Employee contacted our office and the patient was advised to be seen by his PCM. The patient was given ATARAX and SIQ'd for 48 hours. Later that evening the patient noted that the hives had extended to his face and ears. At his follow-up appointment on 1/8/15 hives were noted on bilateral wrists, left elbow, left temple, lower cervical region and left posterior auricular region. The patient was prescribed ZANTAC and ZYRTEC. The patient stated that the hives and itching were much improved on 1/9/15 and totally resolved by 1/11/15.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth in 10 cm diameter around anthrax injection site on L deltoid.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient states on 2/10/2015 arm started swelling by 2/11/15 large area of swelling and open red spot in middle.  Saw PCP who treated with icon on area 20 minutes 2-3 times per day, silvadene daily on wound and cover with bandaid, prednisone taper pack.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site pustule, Rash pustular
Clinical narrative: Less than 50 pustules on face, neck, trunk, arms, legs, no fever. ER visit 3/11/2015, no labs performed, dx. by ER Dr. made per S&S, mother used Caladryl lotion.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diet refusal, Injection site reaction, Irritability, Urticaria
Clinical narrative: Patient woke up from nap covered in welts.  Reaction started on right quadricept.  He was fussy and refused to eat.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Death, Generalised tonic-clonic seizure, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a consumer refers to her cousin, an approximately 3 years old male patient. On an unknown date, in early 1990's the patient was vaccinated with M-M-R II, (therapy type HSA, dose and Lot# were not reported). On an unknown date, immediately after vaccination, the patient experienced general grand mal seizures that continued to worsen throughout a one year period. On an unknown date, when the patient was having up to 40 seizures a day, he was admitted to a hospital. On an unknown date, reported as one year after vaccination with M-M-R II the patient died. The cause of death was reported as seizure. Relatedness between grand mal seizure and M-M-R II was not reported. Upon internal review general grand mal seizures were considered to be medically significant. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Condition aggravated, Developmental delay, Seizure
Clinical narrative: Pt and twin brother with neonatal seizure disorder, he was on phenobarbital with seizures controlled (no sz > 1 month prior to vaccines). Got PENTACEL and PREVNAR 11/22/13 and sz began 8 d later. Development has been delayed following increase in sz frequency at that point.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date, the patients may have received was vaccinated with M-M-R II, subcutaneous (dose and lot number were not reported). The vaccines were improperly exposed to 48.5F for 5 hours 49 minutes (on 01-FEB-2015), and to 48.5F for 9 hours 44 minutes (on 02-FEB-2015), and to room temperatures<77F for 31 minutes (on 24-FEB-2015) for 16 minutes (on 16-FEB-2015) for 15 minutes (on 09-FEB-2015) for 15 minutes (on 06-FEB-2015) for 24 minutes (on 30-JAN-2015) for 31 minutes (on 27-JAN-2015) for 40 minutes (on 15-JAN-2015) for 16 minutes (on 06-JAN-2015) and for 54 minutes (on 30-DEC-2014). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health worker (medical assistant) regarding patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patient. Since 31-DEC-2014, improperly stored ROTATEQ liquid (strength and dose were not reported) lot K008140, expiration date 30-MAR-2016 were administered to unspecified patients. No adverse effects were reported. The outcome of the events reported were unknown. This case is linked to the cases 1503USA006428, 1502USA000168 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, unspecified number of unspecified patients were administered an unspecified number of improperly stored doses of ROTATEQ (strength, dose and lot# were not reported) oral. No adverse effect reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt received a Varicella and Kinrix shot in her left thigh. One on Subcu and one IM. Pt's left thigh started to become red and itchy the day after. No fever, no pain. Pt was seen in clinic 2 dyas after and pts symptoms were not worse or better from the day before. Pt's leg was warm to the touch.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Sore neck and arm, neck pain relieved but arm pain worsened. Tried ice, heat, and ointments with no relief of sharp pains.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health worker (medical assistant) regarding patients of unknown age and gender. Since 31-DEC-2014, improperly stored ROTATEQ (strength and dose were not reported) lot K006456, expiration date 08-MAR-2016 were administered to unspecified patients. No adverse effects were reported. The outcome of the events reported were unknown. This case is linked to the cases 1503USA006429, 1502USA000168 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker refers to an the patient of unknown age. The healthcare worker reported an unspecified number of unspecified patients were administered an unspecified number of improperly stored doses of ROTATEQ (doses, route and lot# not reported). No adverse effect was reported. It was unknown if the patients sought medical attention. This is one of the several reports with the same reporter. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Decreased appetite, Rash, Rash erythematous, Rash generalised
Clinical narrative: Red spots started on face and have spread to rest of body.  Slightly elevated temperature.  Loss of appetite.  She still has all of these symptoms.  I have not been treating any of them.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injection site pain, Mobility decreased, Nuclear magnetic resonance imaging, Screaming
Clinical narrative: Prior to the injection, nurse commented that she would give the shot higher than I thought she would, then there was unusually intense pain at time of injection--I screamed. Over the next few to several weeks, pain worsened, mobility decreased, could barely move it. Four months later mobility is much better, but still have a lot of pain.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Body temperature increased, Diarrhoea, Influenza virus test negative, Nasal discharge discolouration, Pain in extremity
Clinical narrative: Patient had a temp of 99.9 that night. her temp went up to 100.9 the next day and she was complaining of leg pains, vomited and had diarrhea. She was brought to the doctors office on 3/2/15 (3 days after her immunization was given, and was diagnosed with possible Viral Gastroenteritis. She was brought to ER that night because her temperarature went up to 102 despite fever medications. She tested negative for RSV, Influenza and Strep in the ER. Mom called the Pmds office the next day because the patient is still running a fever and had developed some greenish nasal secretions Zithromax was prescribed over the phone. Her fever broke on 3/8/15. She was brought back to the Pmd's office and was diagnosed with an upper respiratory tract infection.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Respiratory syncytial virus test negative, Streptococcus test negative, Upper respiratory tract infection, Vomiting
Clinical narrative: Patient had a temp of 99.9 that night. her temp went up to 100.9 the next day and she was complaining of leg pains, vomited and had diarrhea. She was brought to the doctors office on 3/2/15 (3 days after her immunization was given, and was diagnosed with possible Viral Gastroenteritis. She was brought to ER that night because her temperarature went up to 102 despite fever medications. She tested negative for RSV, Influenza and Strep in the ER. Mom called the Pmds office the next day because the patient is still running a fever and had developed some greenish nasal secretions Zithromax was prescribed over the phone. Her fever broke on 3/8/15. She was brought back to the Pmd's office and was diagnosed with an upper respiratory tract infection.
Age: 59.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PT reports having pain at injection site since vacination was given. About 6 days later, he notice area was skin was red and hot to touch, still painful.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Extra dose administered, Hypertension, Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a 84-year-old patient who received FLUARIX. The patient's past medical history included influenza. Concurrent medical conditions included pain. Concomitant products included LOVAZA, Losartan, Vitamin B12, biotin, NASONEX, Calcium Carbonate + Vitamin D, clonidine, furosemide, levothyroxine, simvastatin and spironolactone. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, LOVAZA and Losartan, the patient experienced influenza (serious criteria hospitalization), blood pressure high (serious criteria hospitalization), aphasia (serious criteria hospitalization) and extra dose administered. On an unknown date, the outcome of the influenza, blood pressure high and aphasia were recovered/resolved and the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the influenza, blood pressure high and aphasia to be related to FLUARIX. Additional information: The patient only got one very mild case of the flu (since she started medication with LOVAZA). She used to get flu twice a year and would be in the hospital for weeks. One year she got a double dose of FLUARIX and ended up in the hospital with very high blood pressure and she couldn't talk. Please refer to case US2015028273 for tolerance to co-suspect drugs LOVAZA and Losartan.