chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a physician refers to a 18 year old male patient. The patient had penicillin allergy and allergy to a lot of other unspecified drugs. On unknown dates the patient was vaccinated with the first and second doses of M-M-R II (strength, route, lot number and expiry dates were not reported). There were no concomitant medications reported. It was reported that the patient had received the first dose of M-M-R II too early, when he was not even 4 months old (date unspecified). A lab test was carried out for titers for measles, mumps and rubella vaccine on an unknown date and the patient showed low titers for measles component. The patient did not receive any treatment for the event. The patient had sought medical attention by doctor visit. There was no product quality complaint involved. The outcome of low titers for measles component was reported as not recovered at the time of the report. The causality of the event low titers for measles component was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding patients (age and gender not reported). The nurse reported 2 doses of improperly stored VARIVAX (Merck) was inadvertently administered to patients. The dates of vaccination were not reported. (The number of patients was not reported. It is unclear if it was 2 patients or more than 2 patients.) No adverse effects reported. No additional information was reported. Additional information is expected.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Pneumonia
Clinical narrative: This spontaneous report as received from a register nurse refers to a 78 year old female patient. The patient's pertinent medical history included hypothyroidism, primary pulmonary hypertension, atrial fibrillation, benign essential hypertension, severe rheumatoid arthritis and osteoporosis. It was also reported that the patient had a history of allergy to amlodipine and AUGMENTIN. On an unspecified date in 2006, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not provided). The nurse reported that the patient took many unspecified medications. On an unspecified date, the patient developed pneumonia. The patient was diagnosed on 12-JAN-2015. The patient received ZITHROMAX as a treatment of adverse event and chest x-ray was performed. The patient sought medical attention. The outcome of the event was reported as recovering/resolving. The relatedness between the event and the PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a dentist concerning his wife who was 61 years of age. The dentist reported that his wife was vaccinated on 14DEC2014 with ZOSTAVAX, .65 ml, in the unspecified forearm. On 15DEC2014 the patient noticed redness at the injection site after she removed the Band-Aid. The patient did not seek medical attention. The outcome of injection site erythema was reported to be recovering/resolving. Additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Galactorrhoea
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 18 year old female patient. On 04-JUN-2014 the patient was vaccinated with GARDASIL dose 1. On 04-DEC-2014 the patient received her third dose and at that time told her physician that she lactates for 7 days after each dose. The outcome of patient lactates after each GARDASIL dose was reported as recovered/resolved. No treatment was given. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received on 12-DEC-2014 from market research (research hub project # 14-1133). On an unknown date a patient (age, gender not reported) was vaccinated with ZOSTAVAX. The reporter reported, "I had a patient that got shingles from the shingles vaccine." The outcome of shingles is unknown. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swollen, red, itchy x 3 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling from left shoulder to left elbow.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swollen at site.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 1-7-15 Mom calls. Gold ball sized red spot rt. leg. No pain. Able to walk. instructed to circle area and warm soaks, BENADRYL. Call if bigger. 1-8-15 Saw physician. Red swollen area rt thigh 8 cm x 4 cm. Put on KEFLEX 250 mg TID x 10 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling of vaccination site, left leg. (+) fever and abd. pain.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Decreased appetite, Diarrhoea, Injection site erythema, Injection site pain, Insomnia
Clinical narrative: Fever, trouble sleeping, lethargy, irritability loss of appetite, pain/redness at injection site vomiting, diarrhea. AU above for 1 week. Dr visit required. Dr said it was not flu or stomach virus.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Irritability, Lethargy, Pyrexia, Vomiting
Clinical narrative: Fever, trouble sleeping, lethargy, irritability loss of appetite, pain/redness at injection site vomiting, diarrhea. AU above for 1 week. Dr visit required. Dr said it was not flu or stomach virus.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Influenza virus test negative, Pyrexia, Tremor
Clinical narrative: Fever, shaking, headache beginning about 7 hrs after vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Discomfort, Grip strength decreased, Hypoaesthesia, Injection site discomfort
Clinical narrative: Mild discomfort and redness at site for 1st 4 days then on 1/6/15 whole arm hurting, upper back on left side, discomfort, dull pain, numbing, losing sensation in arm and having difficulty gripping/grasping items w/left hand.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Pain in extremity, Sensory loss
Clinical narrative: Mild discomfort and redness at site for 1st 4 days then on 1/6/15 whole arm hurting, upper back on left side, discomfort, dull pain, numbing, losing sensation in arm and having difficulty gripping/grasping items w/left hand.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction about 1" in radius.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Facial paresis, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Vaccine given on 12/23/14. On 12/24/14 sore, raised, red, hot area of injection site with flu-like sxs of fever, myalgias, chills. 1/2/15 (R) facial Bell's palsy with weakness of (R) face.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Myalgia, Pyrexia, VIIth nerve paralysis
Clinical narrative: Vaccine given on 12/23/14. On 12/24/14 sore, raised, red, hot area of injection site with flu-like sxs of fever, myalgias, chills. 1/2/15 (R) facial Bell's palsy with weakness of (R) face.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received on 17-DEC-2014 from a physician (also reported as a pharmacist) via a company representative. The physician reported that he experienced shingles after being vaccinated with ZOSTAVAX. The physician reported that he got a mild case of shingles after he received the vaccine. The outcome of shingles was not reported. The physician denied seeking medical attention and denied receiving treatment for shingles. No further adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from Pfizer (manufacturer control number 2014331640) on 12-DEC-2014. A nurse practitioner reported a patient (age, gender and ethnicity not reported) had an allergic reaction to PNEUMOVAX 23 last year (2013). The outcome of the allergic reaction was not reported. Additional information is expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information had been received from a nurse who reported that a patient received his third dose of GARDASIL "too early'". The nurse stated that the GARDASIL series was administered to the patent as followed: first dose on 21-JUL-2014, second dose on 26-SEP-2014, and third dose on 09-DEC-2014. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a non health care reporter refers to 10 patients of unknown age. On an unknown date, the 10 patients were administered with the PNEUMOVAX 23 with lot # K010466 and expiry date 23-MAR-2016 (strength, dose, route not reported) that were exposed to temperatures outside of the required temperature range on 24-NOV-2014. The efficacy of this product outside the temperature range has not been established. It was reported that the customer purchased on 10 pack of the vaccine, therefore, it has been administered to 10 patients. The outcome of the event was unknown. The ages and gender of the patients were unknown at the time of this report. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On unknown dates, the patient was vaccinated with the first, second and third doses of GARDASIL (route, lot # and expiration dates were not provided). The patient received three doses of GARDASIL on unspecified dates, with each dose having been administered one year apart. These doses of GARDASIL were administered years ago. The registered nurse did not think that the patient experienced any adverse effects. The nurse stated that it was just the way that the patient wanted it done. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II. On an unknown date the patient experienced titer showed he was not immune to mumps or rubella. The pharmacist reported that he had titers drawn on an unspecified date and the titers showed that he was not immune to mumps or rubella but had immunity to measles. The pharmacist stated that he received a dose of M-M-R II on an unspecified date after the titers were drawn. The pharmacist reported that he does not think he has ever received a dose of M-M-R II prior to have the titers drawn but he is unsure. The outcome of titer showed he was not immune to mumps or rubella is unknown. Action taken with M-M-R II was not provided. The reporter did not report if the adverse events were related to the therapy drug. No further information was provided.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Nausea, Pyrexia, Rash macular, Vomiting
Clinical narrative: This spontaneous report as received from a patient's father refers to a 14 year old male patient. The patient did not have pertinent medical history, history of drug reactions or allergies. On 02-JAN-2015 the patient was vaccinated with a second dose of GARDASIL, (dose, route, lot number and expiration date not reported). Concomitant therapies included influenza virus vaccine (manufacturer unknown). On 03-JAN-2015, the patient experienced headache, fever, vomiting, blotchy skin and nausea. No treatment was given for the adverse events. Labs were not performed. The outcome of the events was reported as not recovered. 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 medical assistant refers to 3 patients of unknown age and gender. On an unknown date 3 unspecified patients were vaccinated with VARIVAX (Merck) injection (lot number and expiry date unknown) (dosing regimen and frequency unknown) that was improperly stored. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VARIVAX (Merck) was unknown. No product quality issue was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On unspecified dates in 1994, the patient received 3 doses of an unspecified Hepatitis B vaccine (manufactuerr unknown) (dose, route and lot# unknown) (RECOMBIVAX could not be ruled out). The patient received the third dose 10 months after administration of the second dose. No adverse effect reported. This is one of the several reports from the same reporter (linked to 1501USA006830). Additional information has been reuqested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patient. The patient received 3 doses of an unspecified Hepatitis B vaccine ((manufacturer unknown, RECOMBIVAX could not be ruled out) dose, route and lot# not reported) in approximately 1995 (reported as "about 20 years ago"). It was reported that the patient was recently administered 3 more doses of an unspecified Hepatitis B vaccine (manufacturer unknown, RECOMBIVAX HB could not be ruled out) on unspecified dates. No adverse effect was reported for this patient. This is one of the several reports from the same reporter (linked to 1501USA001237). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a couple of nurses via company representative refers to an unspecified number of patients (age and gender not reported). On an unknown date the patients were vaccinated with GARDASIL (strength, dose, dose number, lot #, application site were not reported), intramuscularly for routine recommendation. On an unknown dates the patients experienced "hurt". The outcome of event was not reported. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse refers to a patient of unknown age and gender. Medical history and current condition of the patient was not reported. On 12-JAN-2015 the patient was inadvertently administered a dose of GARDASIL (lot#, expiry date unspecified), 0.5 ml, intramuscular, that had been improperly stored. No adverse effects reported. No product quality complaint (PQC) involved. Additional information is not expected as we are not permitted to contact the reporter.
Age: 71.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Discomfort, Feeling hot, Injection site reaction, Myalgia
Clinical narrative: This spontaneous report as received from a 71 year old female patient concerning herself. Patient's medical history included psoriasis. None drug reactions or allergies were reported. On 10-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration and lot # were not reported). Other suspect therapy included influenza virus vaccine (manufacturer unspecified) also reported as "FLU shot" (dose, frequency, route of administration, lot # and indication were not provided) administered on the same day. Concomitant therapies included LEXAPRO and SYNTHROID. On 08-JAN-2015, the patient developed injection site reaction and she experienced muscle and joint pain. The patient stated that she was uncomfortable, tingly (no further specified by the reporter) and hot (no further specified by the reporter). She had a fever as well. The patient sought medical attention during a scheduled office visit and received a treatment which included prednisone (manufacturer unspecified) and KEFLEX. Unspecified laboratory and diagnostics tests were performed on an unknown date. No product quality complaint (PQC) was involved. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the events and ZOSTAVAX was not assessed by the reporter. Additional information is not expected, as no contact details were provided by the reporter.
Age: 71.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: This spontaneous report as received from a 71 year old female patient concerning herself. Patient's medical history included psoriasis. None drug reactions or allergies were reported. On 10-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration and lot # were not reported). Other suspect therapy included influenza virus vaccine (manufacturer unspecified) also reported as "FLU shot" (dose, frequency, route of administration, lot # and indication were not provided) administered on the same day. Concomitant therapies included LEXAPRO and SYNTHROID. On 08-JAN-2015, the patient developed injection site reaction and she experienced muscle and joint pain. The patient stated that she was uncomfortable, tingly (no further specified by the reporter) and hot (no further specified by the reporter). She had a fever as well. The patient sought medical attention during a scheduled office visit and received a treatment which included prednisone (manufacturer unspecified) and KEFLEX. Unspecified laboratory and diagnostics tests were performed on an unknown date. No product quality complaint (PQC) was involved. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the events and ZOSTAVAX was not assessed by the reporter. Additional information is not expected, as no contact details were provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a female patient of unknown age who was reporting on herself. The patient's medical history and concurrent conditions were not reported. On 08-JAN-2015 the patient was vaccinated with 1 single shot of ZOSTAVAX (vial, route of administration, lot number and expiration date were not reported). On 08-JAN-2015, after receiving ZOSTAVAX the patient experienced a burning, stinging sensation and redness near the injection site. The outcome of the event was not reported. The relatedness between ZOSTAVAX and the event was not reported. Additional information is not expected because there is no patient's and physician's contact information.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker who refers to a group of six patients of unknown age and gender. Patients' medical histories were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (doses, frequencies, indications, routes of administrations and lot numbers were not provided). No concomitant medication and no adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Culture, Feeling abnormal, Headache, Lethargy
Clinical narrative: This spontaneous report as received from a 63 year old female patient with no drug reactions/allergies, refers to herself. On 26-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, dose was not reported (lot# and expiration date were not provided). The patient reported that after receiving ZOSTAVAX, on an unspecified date in December 2014 (reported as 'week before 25-DEC-2014'), she developed chicken pox. She stated, she has been "miserable" with itchy rash. The patient also reported an "intolerable itching in front part of body, and now it has started on the back of body." She has not been able to sleep good because of the itching. In weeks prior to developing rash the patient experienced headaches, chills, and felt lethargic. The patient sought medical attention by visiting the office. Skin culture was performed on an unknown date (results were not provided). For the treatment the patient was given LOTRIMIN lotion, cortisone cream and a drug reported as 'ACYLIV'. The outcome of chicken pox and 'she has not been able to sleep good' was reported as recovering/resolving. Relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep, Pruritus generalised, Rash pruritic, Varicella
Clinical narrative: This spontaneous report as received from a 63 year old female patient with no drug reactions/allergies, refers to herself. On 26-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, dose was not reported (lot# and expiration date were not provided). The patient reported that after receiving ZOSTAVAX, on an unspecified date in December 2014 (reported as 'week before 25-DEC-2014'), she developed chicken pox. She stated, she has been "miserable" with itchy rash. The patient also reported an "intolerable itching in front part of body, and now it has started on the back of body." She has not been able to sleep good because of the itching. In weeks prior to developing rash the patient experienced headaches, chills, and felt lethargic. The patient sought medical attention by visiting the office. Skin culture was performed on an unknown date (results were not provided). For the treatment the patient was given LOTRIMIN lotion, cortisone cream and a drug reported as 'ACYLIV'. The outcome of chicken pox and 'she has not been able to sleep good' was reported as recovering/resolving. Relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. The patient has no pertinent medical history or concurrent medications. Patient has no known drug reactions/allergies. On 06-JAN-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, Lot # K009874 expiration date on 19-MAR-2016, 0.5 ml, intramuscular. Co-suspect therapies or concomitant medications were not provided. It was reported that patient contacted pharmacist on 08-JAN-2015 stating that she was experiencing redness, soreness and itching at injection. The pharmacist advised patient to take TYLENOL for the soreness and at an unspecified time later, patient took BENADRYL. Pharmacist stated that patient was recovered on 10-JAN-2015 from adverse events. The relatedness between the events and suspect therpay was not provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. The patient has no pertinent medical history or concurrent medications. Patient has no known drug reactions/allergies. On 06-JAN-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, Lot # K009874 expiration date on 19-MAR-2016, 0.5 ml, intramuscular. Co-suspect therapies or concomitant medications were not provided. It was reported that patient contacted pharmacist on 08-JAN-2015 stating that she was experiencing redness, soreness and itching at injection. The pharmacist advised patient to take TYLENOL for the soreness and at an unspecified time later, patient took BENADRYL. Pharmacist stated that patient was recovered on 10-JAN-2015 from adverse events. The relatedness between the events and suspect therpay was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot number, dose and route were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, the patients received doses of improperly stored GARDASIL (lot#, dose and route not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, the patients received doses of improperly stored VAQTA (lot #, dose and route not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vision blurred, Visual impairment
Clinical narrative: Information has been received from a registered nurse on 12-JAN-2015 referring to a 14 year old female patient with BACTRIM allergy. The patient's pertinent medical history included left chalazion eye surgery on an unspecified date in 2013 and had right eyelid chalazion on 15-MAY-2013. The patient was vaccinated with her first dose and second dose of GARDASIL (first dose: lot#K006124, expire date: 02-FEB-2017; second dose: lot # K009482, expire date: 06-MAR-2017) 0.5 ml, intramuscular on 10-NOV-2014 and on 12-JAN-2015, respectively. There was no concomitant medication. "Within the first five to ten minutes" of receiving her second dose of GARDASIL, the patient developed lightheadedness and her vision felt "shaky". She felt like her eyes were "unable to stay focused". The patient had been in the office for "about two hours now" "resting" and her lightheadedness had gotten better and her vision had gotten a "tiny bit" better. No treatment was given for the events. No lab diagnostics studies were performed. The patient took vital signs test at 3:30pm (12-JAN-2015): pulse 61, temperature 98F, and blood pressure while siting was 118/62. A second set of patient's vital signs were taken at 5:20pm: pulse 68, temperature 98.4F, blood pressure while sitting was 120/60, and blood pressure while standing was 120/68. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of 0.5 ml RECOMBIVAX HB (lot # K004989, expiration date 14-NOV-2015), intramuscular which was exposed to 32.5F for 2 hours. This event was considered as incorrect product storage. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of PEDVAXHIB, (lot # was reported as K007258, expiration date 04-MAR-2017), (lot # K004540, expiration date 03-DEC-2016), (dose, route unspecified) which were exposed to 32.5F for 2 hours. This event was considered as incorrect product storage. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report has been received from a female nurse practitioner of unknown age via a field representative refers to herself. The patient's medical history included "repeated" sinusitis. The patient said her physician (unspecified by reporter) recommended that since she was younger than 65 years of age and had "repeated" sinusitis, she needed to get vaccinated with PNEUMOVAX 23. In October 2007 the patient was vaccinated with PNEUMOVAX 23 (dose, lot# and route not specified). After receiving PNEUMOVAX 23, the patient experienced injection site reactions on the same day that she got vaccinated. The patient had cellulitis and there was redness and tenderness at the injection site. The patient's arm was swollen from the "upper portion" to the elbow of that same arm. The patient did not seek medical attention, instead she gave herself ibuprofen, TYLENOL and a warm compress as treatment. The outcome of the events was not reported. The causality was not provided. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Brachial plexopathy, Immediate post-injection reaction, Muscular weakness, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a nurse refers to a 23 year old male patient. Patient medical history included Asperger's syndrome, attention deficit disorder (ADD), depression and basal metabolic index (BMI) of 36 and other concurrent conditions were not reported. On 01-OCT-2014 the patient was vaccinated with first dose of GARDASIL (lot # J013277 and expiry date 05-AUG-2015), dose 0.5 ml via intramuscular in the left arm. On 01-OCT-2014 the patient experienced brachial plexus neuropathy, pain, tingling and left arm weakness immediately after receiving the first dose of GARDASIL. Pain, tingling and left arm weakness resolved after one week and the patient was not seen at that time. On 10-DEC-2014, patient received the second dose of GARDASIL (Lot # K003520 and expiry date 20-NOV-2016) and approximately in 2014 (reported as again) experienced brachial plexus neuropathy, pain, tingling and left arm weakness which has continued. It was reported that the patient was seen by nurse practitioner on 07-JAN-2015. Cancer and overdose was not reported. The outcome of the events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 14-JAN-2015 the patient was vaccinated with VARIVAX (Merck) 0.5 ml, subcutaneously (lot # H020251, expiry date 08-NOV-2014) (dosing regimen and frequency unknown) for an unknown indication that had expired on 08-NOV-2014. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VARIVAX (Merck) was unknown. No product quality issue was reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 29 OCT 2013. A 59-year-old female patient who denied illness at the time of vaccination, not indicated on form/possible Chron's disease/IBS/steroids and concomitant medication were not reported, had received an intramuscular dose of FLUZONE (lot number: UH891AA, dose number were not reported) in the deltoid on 14 OCT 2013.  On 14 OCT 2013, the patient had experienced pain at injection site and radiated from neck to fingers in arm shot was administered. Patient claimed that it was happened almost immediately. Swelling and redness were with limited movement in fingers. Laboratory investigations were not reported and the patient had received OTC Benadryl, steroid shot and pain medication as correction medications. At the time of this report, the patient had not recovered from events. Documents held by send: None.  Additional informtion received from the reporter on 21 NOV 2013. Vaccine was given at pharmacy (vaccinated at field was added)
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Initial report received from a healthcare professional on 29 OCT 2013. A 59-year-old female patient who denied illness at the time of vaccination, not indicated on form/possible Chron's disease/IBS/steroids and concomitant medication were not reported, had received an intramuscular dose of FLUZONE (lot number: UH891AA, dose number were not reported) in the deltoid on 14 OCT 2013.  On 14 OCT 2013, the patient had experienced pain at injection site and radiated from neck to fingers in arm shot was administered. Patient claimed that it was happened almost immediately. Swelling and redness were with limited movement in fingers. Laboratory investigations were not reported and the patient had received OTC Benadryl, steroid shot and pain medication as correction medications. At the time of this report, the patient had not recovered from events. Documents held by send: None.  Additional informtion received from the reporter on 21 NOV 2013. Vaccine was given at pharmacy (vaccinated at field was added)
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Initial report received from a healthcare provider on 23 OCTOBER 2013. A 29 year old female patient whose medical history and concomitant medications were not reported, received dose one of FLUZONE on right deltoid (batch no: UH918AB) (route not reported) on 21 OCTOBER 2013. On 22 OCTOBER 2013, the patient had mump like rash and itching 24 hours following FLUZONE administration. Patient had a baby five days ago. Patient never had a reaction to FLUZONE before. Lab investigation and corrective treatment was not reported. At the time of this report, the outcome of event was unknown. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity, Poor quality sleep
Clinical narrative: Initial report received from a non-healthcare professional on 27 October 2013. A 57-year-old female patient with no relevant medical history and no concomitant medication received intramuscular first dose of FLUZONE intramuscularly in left arm batch number UH918AB, (dose not reported) on 10 October 2013. On 27 October 2013, the patient had, ongoing dull throbbing ache. The patient was unable to lift arm, cannot rotate arm. The patient was having pain in shoulder, down arm that wakes her up at night. Laboratory investigation and corrective treatment was not reported. At the time of this report, the patient was not recovered. Documents held by sender: none. Follow-up information received from a non-healthcare professional on 06 January 2014. The patient went to see physician and was unsure whether the reaction was from vaccine or a nerve issue. The patient was undergoing physical therapy.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial information regarding unsolicited case received from nurse on 25-OCT-2013: This case involves a 17-year-old female patient. The patient's past medical history included asthma, anxiety, no known drug allergies and ADHD. Concomitant medications were unknown. On 22-Oct-2013, the patient received FLUZONE TIV (Lot# UH96AE and expiration date unknown) in left arm. On 23-Oct-2013, the patient developed a red swollen, hot area at the injection site. last night was increasing in size from 3'x2" to 3.5 x 2.5 inches. The patient prescribed MOTRIN and ice packs. The outcome of the event was not recovered. No further information provided. List of documents held by sender: none.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Feeling of body temperature change, Headache, Nausea, Pyrexia
Clinical narrative: Initial report received from a consumer on 30 October 2013. A "92-years-old" female patient had received intramuscular dose of FLUZONE (batch number: UH891AA) in left deltoid on 22 October 2013. The patient had previously received many doses of FLUZONE (lot number, dose, route and site of vaccine administration was not reported) on unspecified date. The patient had no illness at time of vaccination and allergy to Sulfa drug. The patient's concomitant medications were not reported. On 28 October 2013, the patient experience with nausea and vomiting. She had a decreased appetite the next day. On 30 October 2013, the patient had a headache and then hot/cold and had a fever of 99.5F. Relevant diagnostic tests and laboratory data were not reported. As of 30 October 2013, the patient was not recovered from the events. As of 12 December 2013, the patient was recovered from the events. Documents held by sender: none.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Initial report received from a consumer on 30 October 2013. A "92-years-old" female patient had received intramuscular dose of FLUZONE (batch number: UH891AA) in left deltoid on 22 October 2013. The patient had previously received many doses of FLUZONE (lot number, dose, route and site of vaccine administration was not reported) on unspecified date. The patient had no illness at time of vaccination and allergy to Sulfa drug. The patient's concomitant medications were not reported. On 28 October 2013, the patient experience with nausea and vomiting. She had a decreased appetite the next day. On 30 October 2013, the patient had a headache and then hot/cold and had a fever of 99.5F. Relevant diagnostic tests and laboratory data were not reported. As of 30 October 2013, the patient was not recovered from the events. As of 12 December 2013, the patient was recovered from the events. Documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Acne, Burning sensation, Pain, Pain in extremity, Skin reaction
Clinical narrative: Initial report received from a reporter on 20 November 2013. A 64-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number UH906AB) via intramuscular route at left arm, on 08 October 2013. On 09 October 2013, after receiving vaccine the patient experienced arm pain, serious skin reaction, acne like lesions, burning and painful especially on left side. Corrective treatment was not reported. At the time of this report the outcome of adverse events were not resolved. Documents held by sender: none.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Dyspnoea, Pyrexia
Clinical narrative: Based on the follow-up information received on 16 May 2014, this case initially considered as serious was downgraded to non-serious. This case is associated with 2013SA112440. Initial report received from healthcare professional on 31 October 2013.  A 11 patients (age 6 months to 4 year and gender unknown) whose medical history and concomitant medications were not reported received FLUZONE (lot number UH907AC and expiration date unknown) (route, site and dose number not reported) since 19 October 2013. Within 24 hours, the patients developed shortness of breath (SOB), asthma attack, fevers 2-3 days. Laboratory investigation and corrective treatment were not reported. As of this report, events outcome was unknown. Documents held by sender: none. The initial of patient was updated and the 6-year-old male patient had received vaccine on 24 October 2013 and adverse event developed on 24 October 2013. On an unspecified date the patient was recovered from the event. The patient was vaccinated at private doctor's office/hospital. No further information was reported. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: ANTH, FLU3, SMALL
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: This case was received on 12 February 2014 via a third party query tool search on the VAERS database under reference number 513141. A 27 year-old female patient had received the following vaccines on 30 July 2013 (also reported as 10 August 2013) a left arm injection of ACAM2000 (lot number VV04003A) and intramuscular FLUZONE injection (SANOFI PASTEUR, batch and site not reported) and an intramuscular EMERGENT (batch number and site not reported). There may be a discrepancy between the vent date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. The patient received smallpox vaccine on 10 August 2013 and confirmed pregnancy on 15 November 2013. A pregnancy test was positive on 15 November 2013. No further details were available at the time of this report. The patient outcome was unknown. Upon internal review on 28 July 2014, it was noted that the vaccine FLUZONE had been incorrectly coded as INFLUENZA SPLIT TRITON THIOMERSAL FREE VACCINE. No additional new information has been added tot he case. Documents held by sender: None
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site atrophy, Injection site reaction, Muscle atrophy
Clinical narrative: Initial report received on 10 December 2013 from consumer. A female patients whose age, medical history and concomitant medications were unknown, received a dose of FLUZONE (route was intramuscular, lot #, expiration date unknown and site was not reported) on 14 October 2013. Patient reported that on 14 October 2013 developed an area approximately 2x2 cm of skin and muscle atrophy at site of injection. No muscle weakness, no redness or swelling, no abscess. Event was not recovered at the time of report. List of documents held by sender: none. Following information was received on 24 January 2014: Patient's birth date reported, suspect drug batch number reported as UH894AA and a site of administration as left deltoid. On 21 October 2013, the patient developed subcutaneous atrophy at site od injection at 3.50 pm. The patient received other medication with vitamin b12, folic acid, Haludronic acid 20 mg, vitamin C, Restasis Thera Tears. Patient had no pre-existing allergies with penicillin and sulfa. The patient did not experience this adverse event previously.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Initial report received from healthcare professional on 21 November 2013. A 59-year-old male patient whose medical history and concomitant medications were not reported, received FLUZONE (lot number UH894AA, expiration date 30-Jun-2014 and site of administration intramuscular) at left deltoid (dose number not reported) on 20 November 2013. On 21 November 2013, the patient woke up with the worst headache. Laboratory investigation was unknown and corrective treatment included ADVIL. As of this report, the patient had not recovered from the events. Documents held by sender: none.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ageusia, Dysgeusia, Salivary hypersecretion, Weight decreased
Clinical narrative: Initial report received from healthcare professional on 10 December 2013. A 49-year-old male patient whose medical history and concomitant medications were no reported received FLUZONE (lot number UH926AB and expiration date unknown) (site, route and dose number not reported) on 12 November 2013. On 12 November 2013, 1 hour after he had the vaccine the he ate Mexican food which had not taste the same as usual. The next morning her had loss of taste and hist mouth tasted like baking soda. A metallic taste is still present and he has increased saliva production from glands in the back of his throat. He has been back and forth to the doctor and has lost 10 pounds. He will be going to an ENT for a consult. Laboratory investigation and corrective treatment were not reported. As of this report, the patient had not recovered from the events. Documents held by sender: none. Follow up information received from non health care professional on 21 January 2014. No new information was provided.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ageusia, Dysgeusia
Clinical narrative: Initial report received from healthcare professional on 10 December 2013. A 49-year-old male patient whose medical history and concomitant medications were no reported received FLUZONE (lot number UH926AB and expiration date unknown) (site, route and dose number not reported) on 12 November 2013. On 12 November 2013, 1 hour after he had the vaccine the he ate Mexican food which had not taste the same as usual. The next morning her had loss of taste and hist mouth tasted like baking soda. A metallic taste is still present and he has increased saliva production from glands in the back of his throat. He has been back and forth to the doctor and has lost 10 pounds. He will be going to an ENT for a consult. Laboratory investigation and corrective treatment were not reported. As of this report, the patient had not recovered from the events. Documents held by sender: none. Follow up information received from non health care professional on 21 January 2014. No new information was provided.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ageusia, Dysgeusia, Salivary hypersecretion, Weight decreased
Clinical narrative: Initial report received from a healthcare professional on 16 January 2014. A male patient (born on 05 June 1964), had received a dose of FUZONE (batch number, dose number, route and site of administration not reported) on an unspecified date of November 2013. The patient's illness at the time of vaccination and pre-existing medical conditions were unknown. 2 months from the time of the vaccine, the patient complained of loss of sense of taste. The patient had no problem with sense of smell and had difficulty with salt. Metallic taste in mouth persisted. There was 50% improvement after discontinuing METOPROLOL.  Laboratory investigations and corrective treatments were not reported. Documents held by sender: none.  Follow-up information received from healthcare professional on 31 March 2014. Patient's age was updated as 49 year.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ageusia, Dysgeusia
Clinical narrative: Initial report received from a healthcare professional on 16 January 2014. A male patient (born on 05 June 1964), had received a dose of FUZONE (batch number, dose number, route and site of administration not reported) on an unspecified date of November 2013. The patient's illness at the time of vaccination and pre-existing medical conditions were unknown. 2 months from the time of the vaccine, the patient complained of loss of sense of taste. The patient had no problem with sense of smell and had difficulty with salt. Metallic taste in mouth persisted. There was 50% improvement after discontinuing METOPROLOL.  Laboratory investigations and corrective treatments were not reported. Documents held by sender: none.  Follow-up information received from healthcare professional on 31 March 2014. Patient's age was updated as 49 year.