chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a male patient of unknown age. The physician assistant reported that patient possibly received his second dose of GARDASIL late. The patient was vaccinated with a first dose of GARDASIL (Lot #, dose, route unspecified) on 26-OCT-2011, although the dose was ordered on that day, there was no documentation that was administered and the patient's mother said he did not received GARDASIL that day. A dose of GARDASIL (0.5ml, Lot#, route unspecified) was administered on 05-NOV-2012. This dose might be a second or first dose. No adverse effect reported. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot # unspecified) in October 2011 and the second dose (lot # unspecified) on 12-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a 3 years old patient with immunisation. The patient was vaccinated with, 1 DF GARDASIL. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced inappropriate schedule of vaccine administered. No treatment information was reported. The outcome of inappropriate schedule of vaccine administered is unknown. Inappropriate schedule of vaccine administered is not related to GARDASIL. No further information was provided.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a caller/consumer, whose daughter of an unknown age has not yet received her second GARDASIL dose after receiving the first dose 5-6 months ago. She inquired about the correct dosing. She was encouraged her to speak with her daughter's HCP. The patient was vaccinated with, 1 DF GARDASIL. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced inappropriate schedule of vaccine administered. No treatment information was reported. The outcome of inappropriate schedule of vaccine administered is unknown. Inappropriate schedule of vaccine administered is not related to GARDASIL. No further AE information was provided.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse who is the primary reporter, refers to a patient of unknown age. The nurse is reporting that a patient was vaccinated with GARDASIL in February 2011 and dose 2 of GARDASIL in August 2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced inappropriate schedule of vaccine administered. No treatment information was reported. Inappropriate schedule of vaccine administered is not related to GARDASIL. No further information is available.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccine given at 0824 on 11/15/12 in (R) deltoid at about 10 am pt started getting sore arm & redness at site at about 3pm pt presented back to clinic with painful, swollen (R) deltoid, limited ROM (90 degrees abduction). Treated with ice/TYLENOL good relief of pain still limited ROM VSS: 131/95 T-99.6 P 100. Sent home with ice pack, TYLENOL, MOTRIN.
Sex: U
Vaccine: HPV4
Symptoms: Injection site lymphadenopathy
Clinical narrative: This spontaneous report was received from a physician concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, patient developed lymph nodes near the site of injection after being administered GARDASIL. The outcome of the event was unknown at the time of the report. The relatedness for the event was unknown for GARDASIL. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: ADEN_4_7, IPV, MNQ, TDAP
Symptoms: Computerised tomogram, Convulsion, Dizziness, Headache, Lip swelling
Clinical narrative: Received usual vaccines with no problems. Next morning patient had a fainting spell, woke up, and fainted again. He reports was told he had convulsions. Was taken to ED, had spinal puncture and CT, observed, and discharged. That night (10pm) had lip swelling. The next AM had face swelling, hives all over (arms, legs, trunk) which were big red raised itchy splotches. Lips were swollen so he "looked like a duck". C/O throat tightness. Reports receiving EPI on ambulance back to hospital. Has had persistent head aches and "dizziness"/light headedness since then. Had uneventful breakfast at 0530 (french toast, blueberry, eggs, hashbrowns). Seen 04 Jun at clinic and given MOTRIN at 0900 for head ache. At 1200 hives recurred and also some throat tightening. No lip swelling today. Never had dyspnea, emesis, diarrhea, or abd cramping. No LH or presyncope today or with prior rash. Urticaria became chronic. No additional syncopal episodes.
Age: 27.0
Sex: M
Vaccine: ADEN_4_7, IPV, MNQ, TDAP
Symptoms: Lumbar puncture, Rash macular, Rash pruritic, Swelling face, Syncope
Clinical narrative: Received usual vaccines with no problems. Next morning patient had a fainting spell, woke up, and fainted again. He reports was told he had convulsions. Was taken to ED, had spinal puncture and CT, observed, and discharged. That night (10pm) had lip swelling. The next AM had face swelling, hives all over (arms, legs, trunk) which were big red raised itchy splotches. Lips were swollen so he "looked like a duck". C/O throat tightness. Reports receiving EPI on ambulance back to hospital. Has had persistent head aches and "dizziness"/light headedness since then. Had uneventful breakfast at 0530 (french toast, blueberry, eggs, hashbrowns). Seen 04 Jun at clinic and given MOTRIN at 0900 for head ache. At 1200 hives recurred and also some throat tightening. No lip swelling today. Never had dyspnea, emesis, diarrhea, or abd cramping. No LH or presyncope today or with prior rash. Urticaria became chronic. No additional syncopal episodes.
Age: 27.0
Sex: M
Vaccine: ADEN_4_7, IPV, MNQ, TDAP
Symptoms: Throat tightness, Urticaria, Urticaria chronic
Clinical narrative: Received usual vaccines with no problems. Next morning patient had a fainting spell, woke up, and fainted again. He reports was told he had convulsions. Was taken to ED, had spinal puncture and CT, observed, and discharged. That night (10pm) had lip swelling. The next AM had face swelling, hives all over (arms, legs, trunk) which were big red raised itchy splotches. Lips were swollen so he "looked like a duck". C/O throat tightness. Reports receiving EPI on ambulance back to hospital. Has had persistent head aches and "dizziness"/light headedness since then. Had uneventful breakfast at 0530 (french toast, blueberry, eggs, hashbrowns). Seen 04 Jun at clinic and given MOTRIN at 0900 for head ache. At 1200 hives recurred and also some throat tightening. No lip swelling today. Never had dyspnea, emesis, diarrhea, or abd cramping. No LH or presyncope today or with prior rash. Urticaria became chronic. No additional syncopal episodes.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Blood test normal, Mycoplasma test, Parvovirus B19 test negative, Pyrexia, Urticaria
Clinical narrative: Fever of 102 degrees F and urticarial rash 5 days after DTaP,HIB and PREVNAR vaccine.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: Pt. took 1st dose of oral typhoid on 11/14/12 and 5 hours later developed severe abdominal pain. She took ADVIL and rested for 3 hours and the pain resolved.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Rash
Clinical narrative: Mom noticed rash on thighs yesterday 11/14/12 2 days after shots were given. Also noticed rash under pt's neck.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Eyelid oedema, Pruritus, Urticaria
Clinical narrative: 30 minutes after receiving immunizations patient developed severe hives, puffy eyes, itching. Patient returned to clinic received BENADRYL, ORAPRED, monitoring of HR, BP and pulse ox. No respiratory involvement. ARNP also consulted & allergist. Patient monitored in clinic for 2 hours.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Balance disorder, Headache
Clinical narrative: Day following vax, she had sensation of things around her moving/disequilib. Later had headache that has persisted.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Polymerase chain reaction, Rash, Varicella virus test positive
Clinical narrative: 11/5/12 Rash developed on thigh/buttock (L) appeared to be in > 1 dermal zone. 11/9 mult. small vesicles spreading - Herpes PCR (-) varicella zoster results on (+) 11/14/12, started on acyclovir 11/14.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was inadvertently administered Tdap instead of her second hepatitis B injection. According to patient she had previously been administered a Tdap. *(The previous Tdap was not administered at our facility). According to patient - there were no adverse events.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site scab
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient with vaccination. The patient was vaccinated with, .65 ml ZOSTAVAX on 19-OCT-2012. No other co-suspects were reported. Concomitant medications included: VALTREX. The pharmacist called to report that a patient developed a rash 10 days after being vaccinated with ZOSTAVAX. The patient was treated with VALTREX. The outcome of rash is unknown. The relatedness for rash is unknown for ZOSTAVAX. No further AE information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient with vaccination. The patient was vaccinated with, .65 ml ZOSTAVAX on 19-OCT-2012. No other co-suspects were reported. Concomitant medications included: VALTREX. The pharmacist called to report that a patient developed a rash 10 days after being vaccinated with ZOSTAVAX. The patient was treated with VALTREX. The outcome of rash is unknown. The relatedness for rash is unknown for ZOSTAVAX. No further AE information is available.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 84 years old male patient with no drug reactions or allergies. The patient was vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (lot # H011052; exp date September 2013) on 11-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient developed a mild case of shingles on 12-OCT-2012. The patient told the pharmacist there was a rash that started in the area between his breasts and wrapped around to one side of his body towards his back (unspecified which side of the patient's body. The patient had symptoms for 2 weeks and then he recovered. The patient had a physician office visit and was given an unspecified cream as treatment for the event. The relatedness for the reported event was not provided for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Information was received from an insurance claims examiner regarding a female who on an unspecified date was vaccinated with ZOSTAVAX at a pharmacy. On 18-AUG-2012 she experienced an allergic reaction after receiving the vaccine. The outcome was unknown. Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: This spontaneous report was received from a nurse regarding a 76 years old male patient with penicillin allergy, sulfa allergy and streptomycin allergy. On 30-OCT-2012, the patient was vaccinated with dose of 0.5 ml PNEUMOVAX23 intramuscularly in the right arm (lot# reported as H13581, expiry: 15-MAR-2014). Concomitant medications included omeprazole(manufacturer unknown) and LIPITOR. On 30-OCT-2012, the patient developed erythema in his right arm where injection was given. Swelling was noticed in the area little bit lower than injection site and it was red, painful and little hot to touch. Swelling went down to the elbow but in the morning of 01-NOV-2012, the patient called the office again and stated that his lower part of arm was also swollen and noticed fluid in the area. No treatment was given. Patient will be coming into the office again today for examination. The outcome of the events was unknown. Patient sought medical attention(office visit). This is one of two reports received from the same reporter regarding patient #1. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Vaccination complication
Clinical narrative: Information was received from a claims examiner regarding a female who was placed on therapy with ZOSTAVAX. On 24-SEP-2012, the patient experienced an allergic reaction due to this vaccine. The outcome of the event was not reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Pruritus, Rash generalised, Skin lesion, Sleep disorder
Clinical narrative: This spontaneous report was received from a 71 years old male consumer reporting on himself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported) on 11-JUL-2012. No other co-suspects were reported. Concomitant medications included atenolol and LIPITOR. The consumer reported experiencing an itching sensation after receiving ZOSTAVAX was administered on 11-JUL-2012. Within a few days, a rash developed on the right side of his face. The rash then spread all over his body and formed "lesions". He also developed welts on his hands. The reporter mentioned that the rash was on both sides of his body. He had been seen by his physician, on 14-SEP-2012. During this visit he was prescribed triamcinolone 0.1% cream. The physician also referred him to a dermatologist, who he saw on 22-OCT-2012. During this visit he was told to stop using the triamcinolone 0.1% cream and was prescribed betamethasone dipropionate ointment. A skin biopsy was also done on the 22-OCT-2012 office visit to dermatologist (results not provided). The patient saw the dermatologist a second time on 31-OCT-2012. During this visit he was prescribed a one-week regimen of prednisone (manufacturer unknown) 20 mg, two tablets once daily. The patient stated that since he started taking the prednisone (manufacturer unknown) on 31-OCT-2012, the symptoms seemed to be slightly more tolerable. He also stated he had been taking BENADRYL (unspecified strength and amount) at night to help him sleep. The outcome of the events was reported as not recovered. The relatedness for itching sensation for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a 71 years old male consumer reporting on himself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported) on 11-JUL-2012. No other co-suspects were reported. Concomitant medications included atenolol and LIPITOR. The consumer reported experiencing an itching sensation after receiving ZOSTAVAX was administered on 11-JUL-2012. Within a few days, a rash developed on the right side of his face. The rash then spread all over his body and formed "lesions". He also developed welts on his hands. The reporter mentioned that the rash was on both sides of his body. He had been seen by his physician, on 14-SEP-2012. During this visit he was prescribed triamcinolone 0.1% cream. The physician also referred him to a dermatologist, who he saw on 22-OCT-2012. During this visit he was told to stop using the triamcinolone 0.1% cream and was prescribed betamethasone dipropionate ointment. A skin biopsy was also done on the 22-OCT-2012 office visit to dermatologist (results not provided). The patient saw the dermatologist a second time on 31-OCT-2012. During this visit he was prescribed a one-week regimen of prednisone (manufacturer unknown) 20 mg, two tablets once daily. The patient stated that since he started taking the prednisone (manufacturer unknown) on 31-OCT-2012, the symptoms seemed to be slightly more tolerable. He also stated he had been taking BENADRYL (unspecified strength and amount) at night to help him sleep. The outcome of the events was reported as not recovered. The relatedness for itching sensation for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pemphigoid, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a 71 years old male consumer reporting on himself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported) on 11-JUL-2012. No other co-suspects were reported. Concomitant medications included atenolol and LIPITOR. The consumer reported experiencing an itching sensation after receiving ZOSTAVAX was administered on 11-JUL-2012. Within a few days, a rash developed on the right side of his face. The rash then spread all over his body and formed "lesions". He also developed welts on his hands. The reporter mentioned that the rash was on both sides of his body. He had been seen by his physician, on 14-SEP-2012. During this visit he was prescribed triamcinolone 0.1% cream. The physician also referred him to a dermatologist, who he saw on 22-OCT-2012. During this visit he was told to stop using the triamcinolone 0.1% cream and was prescribed betamethasone dipropionate ointment. A skin biopsy was also done on the 22-OCT-2012 office visit to dermatologist (results not provided). The patient saw the dermatologist a second time on 31-OCT-2012. During this visit he was prescribed a one-week regimen of prednisone (manufacturer unknown) 20 mg, two tablets once daily. The patient stated that since he started taking the prednisone (manufacturer unknown) on 31-OCT-2012, the symptoms seemed to be slightly more tolerable. He also stated he had been taking BENADRYL (unspecified strength and amount) at night to help him sleep. The outcome of the events was reported as not recovered. The relatedness for itching sensation for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster, Herpes zoster ophthalmic
Clinical narrative: This spontaneous report as received from a consumer refers to a 69 years old female patient. The patient's medical history included back pain, 4 back surgeries and pulmonary issues. The patient was vaccinated with ZOSTAVAX on 08-APR-2005. Other suspect therapies included PNEUMOVAX23 at the same time as the ZOSTAVAX. Concomitant medications included NEURONTIN, NASACORT, pravastatin sodium, PULMICORT, albuterol and "Polasec 40 mlgms". On 2010 the patient experienced shingles on her head. In total she experienced four times shingles on her head and in October 2012 she experienced shingles on her left eye. She was treated with VALTREX. The outcome of shingles on her left eye and shingles on her head was unknown. The relatedness for shingles on her left eye and shingles on her head was not provided for PNEUMOVAX23 and ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender with no pertinent medical history. On 11-AUG-2011, the patient was vaccinated with dose 1 VAQTA (dose, route and lot # not provided). On 27-DEC-2011, the patient was vaccinated with dose 2 VAQTA (dose, route and lot # not provided). No concomitant medications were reported. The Medical Assistant reported that patient received two doses of VAQTA only about 4 months apart. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VAQTA (25 U) (dose, route and lot not reported) and approximately 4.5 months later the patient was vaccinated with the second dose of VAQTA (dose, route and lot not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 11 months old patient(gender unspecified). On an unknown date, the patient was vaccinated with a dose of VARIVAX (lot # and route not reported) at 11 months and 7 days of age. No concomitant medications were reported. No adverse effect was reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician regarding a 31 years old male patient. On an unknown date, the patient was vaccinated with a dose of VARIVAX (lot #, dose, route and expiration date not reported) as part of childhood vaccine. No concomitant medications were reported. On an unspecified dates, the patient experienced 4 episodes of shingles already. The patient had sought medical attention(office visit). No treatment was given. The outcome of shingles was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a company representative refers to a female patient of unknown age. The patient was vaccinated with, .65 ml ZOSTAVAX on 29-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 03-NOV-2012 the patient experienced shingles, 6 days after onset of therapy. No treatment information was reported. The outcome of shingles is unknown. The relatedness for shingles is unknown for ZOSTAVAX. Patient sought medical attention, went to an urgent care facility. Additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. The patient was vaccinated with PNEUMOVAX23 (lot # (670045/0211AA), expiration date 25-OCT-2012, dose and lot # were unknown). No other co-suspects were reported. No concomitant medications were reported. The patient received PNEUMOVAX23 on Friday 09-NOV-2012 that was expired. No adverse effects were reported. The outcome of event was unknown. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a pharmacist who reported on 06-OCT-2012 one unspecified patient received expired (Merck) ZOSTAVAX (lot #0618AA exp date 26-JUL-2012). The patient was not experiencing any known symptoms. The outcome was unknown at the time of report. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. On 08-NOV-2012, the patient was vaccinated with an expired dose of ZOSTAVAX lot # (671452/1124AA) (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a pharmacist who reported on 23-OCT-2012 one unspecified patient received expired ZOSTAVAX (Merck) (lot #0618AA exp date 26-JUL-2012). The patient was not experiencing any known symptoms. The outcome was unknown at the time of report. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a nurse who is the primary reporter. The nurse is reporting 2 patients who were inadvertently administered VARIVAX lot # (668455/1310Z), on 11/12/2012, 1 DF VARIVAX (merck) that had expired on 10/07/2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced expired drug administered. No treatment information was reported. The outcome of expired drug administered is unknown. Expired drug administered is not related to VARIVAX (Merck). No further information was provided. All drop-down fields apply to both patients.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX on 13-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. Pharmacist is not sure if the expiration date of 05-OCT-2012 is of the ZOSTAVAX or diluent used in the ZOSTAVAX. No adverse events reported. No treatment information was reported. The outcome of expired drug administered and no adverse event is unknown. Expired drug administered is not related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with expired PNEUMOVAX 23 (lot# 669379/0453AA). No adverse event was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Pharmacist refers to a patient of unknown age. The patient was vaccinated with M-M-R II on 09-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced expired vaccine used. No treatment information was reported. The outcome of expired vaccine used is unknown. Expired vaccine used is not related to M-M-R II. From lot 1481Z, which had expired on 11/03/2012. No adverse effect reported. No further information is available. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a claims management agency representing a pharmacy concerning a female patient, with an unknown medical history, who on an unspecified date, received a dose of PNEUMOVAX23. Subsequently on 02-OCT-2012 the patient experienced an adverse reaction after receiving the vaccine. No additional information has been provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was inadvertently vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot # 667916/1066Z) on 31-OCT-2012 that had expired on 03-MAR-2012. No adverse effects reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Nodule, Oedema peripheral
Clinical narrative: This pharmacist reports that a 60 year old male patient was given a "standard" dose of ZOSTAVAX on 24Oct2012. The patient's relevant medical history, relevant concomitant medications, and relevant past drug history were not reported. In Oct2012, he developed a knot on his arm, and swelling in his arm. It is unknown if there were labs. The events resolved in a couple of days in Oct2012. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Measles post vaccine, Rash generalised, Rash maculo-papular, Rash vesicular, Varicella post vaccine
Clinical narrative: Initial information was received from a medical assistant concerning an approximately 15 months old male patient without pertinent medical history or drug reactions/allergies, who on 01-NOV-2012, the patient was vaccinated with a dose of VARIVAX (merck) (lot H011913 exp date 14-JUN-2014) (dose, route and indication were not reported). Suspect vaccine included a dose of M-M-R II (lot 0644AE exp date 27-MAR-2014) (dose, route and indication were not reported), Hib conj vaccine (tet toxoid). Concomitant medications included HAVRIX and PREVNAR 13. PENTACEL (dose, route, indication and lot number were not reported) and FLUZONE (route, dose, indication and lot number were not reported, all of them on the same date. On 09-NOV-2012 the patient developed chicken pox and measles. The patient had two different types of rashes vesicular primarily on the arms but also all over the body and a maculopapular rash primarily on the face, but also all over the body. The patient was treated with TYLENOL. At the time of report, the patient was recovering from the events. No laboratory test was performed. It was reported that the patient sought medical attention by contacting the office. This is one of several reports form the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a nurse who is the primary reporter. The nurse is reporting 2 patients who were inadvertently administered VARIVAX lot # (668455/1310Z), on 11/12/2012, 1 DF VARIVAX (Merck) that had expired on 10/07/2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced expired drug administered. No treatment information was reported. The outcome of expired drug administered is unknown. Expired drug administered is not related to VARIVAX (Merck). No further information was provided. All drop-down fields apply to both patients.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a other refers to a female patient of unknown age. The patient was vaccinated with, 1 DF ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced hypersensitivity. No treatment information was reported. The outcome of hypersensitivity is unknown. The relatedness for hypersensitivity is unknown for ZOSTAVAX. No further information is available.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old female patient with asthma and allergy sulfas who on 13-NOV-2012 was vaccinated with a dose of PNEUMOVAX23 (lot number, dose, route and indication were not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient developed itching at the injection site of PNEUMOVAX23 vaccination. No treatment information was reported. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered from the adverse event. The relatedness for the adverse event was unknown for PNEUMOVAX 23. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with a unspecified history of allergies and drug reactions on October 2012 (above 1 month ago), the patient was vaccinated subcutaneously with ZOSTAVAX (dose and lot # not reported). No concomitant medications were reported. The pharmacist stated that patient, who was administered ZOSTAVAX 1 month ago, was recently diagnosed (approximately in 2012) with genital herpes simplex lesions after an evaluation with her unspecified physician. At the time of the report the patient's outcome of genital herpes simplex lesions was reported as not recovered/resolved. The relatedness for genital herpes simplex lesions was unknown for ZOSTAVAX. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Feeling cold, Middle insomnia, Pain
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 65 years old female patient with calexa allergies. On 09-NOV-2012, at 2:00 pm. the patient was vaccinated with one dose of PNEUMOVAX23 intramuscularly (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. On 10-NOV-2012, she was sleeping and at 2:00 am, the patient woke up because she experienced body aches and she felt cold. She had not fever. She was treated with TYLENOL and ibuprofen. The patient recovered 24 hours after onset of symptoms. There were not diagnostic tests performed. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Tremor
Clinical narrative: Information has been received from a claims administrator, concerning a patient who on 07MAY2012, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). The patient sustained an allergic reaction after receiving the vaccine. It was unknown if the patient sought medical attention. At the time of reporting, the outcome of the event was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a claims administrator, concerning a patient who on 07MAY2012, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). The patient sustained an allergic reaction after receiving the vaccine. It was unknown if the patient sought medical attention. At the time of reporting, the outcome of the event was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Information has been received from a consumer (claim number 30120917376-0001) concerning a her self (age unknown). On unknown date, the patient was vaccinated with ZOSTAVAX (dose and lot number not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced allergic reaction after receiving the vaccine. No treatment information was reported. The outcome of allergic reaction was unknown. The relatedness for allergic reaction was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a consumer (claim number 30120917376-0001) concerning a her self (age unknown). On unknown date, the patient was vaccinated with ZOSTAVAX (dose and lot number not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced allergic reaction after receiving the vaccine. No treatment information was reported. The outcome of allergic reaction was unknown. The relatedness for allergic reaction was unknown for ZOSTAVAX. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Oedema peripheral, Pain, Rash, Secretion discharge
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 63 years old male patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with ZOSTAVAX (lot # H012518 Exp 09-OCT-2012) (dose not reported) on 11-NOV-2012. No other co-suspects were reported. Concomitant medications included ULTRAM and AGGRENOX. The pharmacist reported that the patient developed painful, oozing blisters and itchy rash on mouth, face, hands, stomach, and legs after receiving a dose of ZOSTAVAX. He was diagnosed with chickenpox. The reporter stated that the patient was exposed to shingles prior to getting ZOSTAVAX. The patient saw the physician on an unspecified date. Treatment for the event included acyclovir, gabapentin and hydrocodone. The outcome of chickenpox was unknown. The relatedness for chickenpox was not provided for ZOSTAVAX. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Skin ulcer
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 63 years old male patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with ZOSTAVAX (lot # H012518 Exp 09-OCT-2012) (dose not reported) on 11-NOV-2012. No other co-suspects were reported. Concomitant medications included ULTRAM and AGGRENOX. The pharmacist reported that the patient developed painful, oozing blisters and itchy rash on mouth, face, hands, stomach, and legs after receiving a dose of ZOSTAVAX. He was diagnosed with chickenpox. The reporter stated that the patient was exposed to shingles prior to getting ZOSTAVAX. The patient saw the physician on an unspecified date. Treatment for the event included acyclovir, gabapentin and hydrocodone. The outcome of chickenpox was unknown. The relatedness for chickenpox was not provided for ZOSTAVAX. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Blister, Pain, Rash generalised, Secretion discharge, Varicella
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 63 years old male patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with ZOSTAVAX (lot # H012518 Exp 09-OCT-2012) (dose not reported) on 11-NOV-2012. No other co-suspects were reported. Concomitant medications included ULTRAM and AGGRENOX. The pharmacist reported that the patient developed painful, oozing blisters and itchy rash on mouth, face, hands, stomach, and legs after receiving a dose of ZOSTAVAX. He was diagnosed with chickenpox. The reporter stated that the patient was exposed to shingles prior to getting ZOSTAVAX. The patient saw the physician on an unspecified date. Treatment for the event included acyclovir, gabapentin and hydrocodone. The outcome of chickenpox was unknown. The relatedness for chickenpox was not provided for ZOSTAVAX. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased
Clinical narrative: Rapid heartbeat.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate irregular, Herpes zoster, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 80 years old male patient. The patient's medical history included colitis. The patient did not have any drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot # was unknown) 6 months ago (approximately in May 2012). No other co-suspects were reported. Concomitant medications included: ENTOCORT and Statins. The patient developed shingles after receiving ZOSTAVAX 10 days ago (approximately on 02-NOV-2012). The physician also reported that the patient had an irregular heart rate and collapsed at some unspecified time after receiving ZOSTAVAX and was admitted to hospital. The shingles was considered as Significant Disability or Incapacity. The outcome of events were reported as not recovered/not resolved. The treatment of VALTEX and topical steroids were given for adverse events. No lab diagnosis studies performed. The patient sought medical attention via contacting physician. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Dyspnoea, Rash generalised
Clinical narrative: This spontaneous report was received from a 64 years old female reporting on herself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 29-OCT-2012. No other co-suspects were reported. Concomitant medications included BENADRYL and prednisone (manufacturer unknown). The consumer stated that since 30-OCT-2012, she had experience a rash that covered different parts of her body at different times but had since spread all over her body. She stated that they would cover an entire portion of her body at a time then move to a different part of her body. She stated that since the rash had gone away, she had also experienced difficulty breathing starting on 04-NOV-2012. She stated that the effects caused her to stay home for about a week. Unspecified treatment was given for the events. The patient sought unspecified medical attention and no lab diagnostic tests were performed. The patient received unspecified treatment for the event. The outcome of difficulty breathing was reported as recovering. The relatedness for the reported events was not provided for ZOSTAVAX. The reporter considered the events to be disabling. Additional information is not expected.
Sex: F
Vaccine: FLU3
Symptoms: Lyme disease
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 06-Nov-2012) concerns a female patient. On an unknown date the patient received AFLURIA (batch number: P50508) injection at a pharmacy as 'shingles vaccine' (as reported). On 06-Nov-2012 the patient then had a scheduled doctor's appointment and was diagnosed with Lyme's disease at time of doctor's appointment.
Sex: M
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Optic neuritis
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 06-Nov-2012) concerns a male patient. On ??-Oct-2012 the patient received ZOSTAVAX. Concomitantly the patient also received flu vaccine (manufacturer, brand name and batch number were not provided). On ??-Oct-2012 the patient developed optic neuritis. Patient outcome is unknown.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain
Clinical narrative: Pain at injection site that moved into shoulder and neck area 4/10. Pain described as intermittent, sharp.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Headache, body & muscle aches beginning day after receiving flu vaccine, with symptoms ongoing two weeks later.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Rash, Staphylococcal infection
Clinical narrative: Woke up with a rash on legs, which spread throughout the day to arms, stomach, chest, neck, face, and ears.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash macular
Clinical narrative: Erythematous non-pruritic, non-burning macular rash located on abdomen (above the naval), chest and neck. Occurred that evening (received vaccine during the day), and is still there but resolving on 11/16/12. No treatments.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Itching and hives around vaccine site, lasting 3 days.
Age: 5.0
Sex: F
Vaccine: FLUN3, MMRV
Symptoms: Blister, Erythema, Herpes simplex serology negative, Pain, Skin warm
Clinical narrative: 1st night after vaccine redness & swelling, 2nd day started to get hot to the touch with redness & swelling still per mom, 3rd day Sunday 11/11/12 called Dr. on call and said that there were blisters, swelling, hot to the touch, redness, very painful. Dr. sent patient to ER to be seen.
Age: 5.0
Sex: F
Vaccine: FLUN3, MMRV
Symptoms: Swelling, Viral test negative
Clinical narrative: 1st night after vaccine redness & swelling, 2nd day started to get hot to the touch with redness & swelling still per mom, 3rd day Sunday 11/11/12 called Dr. on call and said that there were blisters, swelling, hot to the touch, redness, very painful. Dr. sent patient to ER to be seen.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Feeling hot, Pruritus, Pyrexia
Clinical narrative: Client reports cough, itching, SOB, heat on arm, fever and indention below site of injection.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Skin disorder
Clinical narrative: Client reports cough, itching, SOB, heat on arm, fever and indention below site of injection.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on scalp started in the morning. got worse through out the day with treatment of Benadryl, severe all over the body hives when I woke up in the morning on 11/16/12, went to ER, given treatment of prednosone, and Pepcid.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypoaesthesia, Lip swelling
Clinical narrative: Received shot around 3:20 PM. Dizziness was first symptom followed by shaking, tightness of chest, shortness of breath, swelling of lips, numbness in face. Symptoms appeared around 3:40-3:45 PM.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Tremor
Clinical narrative: Received shot around 3:20 PM. Dizziness was first symptom followed by shaking, tightness of chest, shortness of breath, swelling of lips, numbness in face. Symptoms appeared around 3:40-3:45 PM.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Discomfort, Erythema, Paraesthesia, Skin warm, Swelling
Clinical narrative: Client given Menveo vaccine in left deltoid on yesterday.  Today has Approx. 4inchX5inch Swollen, Red, Warm to touch, with discomfort 6 on scale 1-10. Left hand tingling.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Cellulitis, Oedema peripheral, Pyrexia
Clinical narrative: Fever, weakness; swelling Rt. UE. Cellulitis RUE. Tx - Vancomycin 1gm IV Q12 hours; ZOSYN 3.375gm IV Q6 hours.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: C-reactive protein, Chest X-ray, Full blood count, Influenza virus test, Irritability
Clinical narrative: Pt received vaccines on 9/28/12, later that evening pt was very irritable and had temp. of 102 degrees. Gave TYLENOL, pt had return of fever on 9/29/12. Went to ER, was admitted.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Lumbar puncture, Pyrexia, Urine analysis
Clinical narrative: Pt received vaccines on 9/28/12, later that evening pt was very irritable and had temp. of 102 degrees. Gave TYLENOL, pt had return of fever on 9/29/12. Went to ER, was admitted.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site inflammation, Pruritus, Pyrexia
Clinical narrative: 1st 24 hours-slight fever, itching, headache. Thereafter-red inflammed area at shot location x 48 hours.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Erythema, Eye infection, Oedema, Pruritus, Radioallergosorbent test positive
Clinical narrative: Pt is a 5 y/o with egg allergy. Received FLUMIST 10/18/11 with no reaction. Had FLUMIST 11/08/2012. Pt had reaction 45 min later with facial erythema, edema & conjunctival infection & pruritus, rx BENADRYL - lasted 24 hrs.