chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Case number PHHY2012US111275, is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number 466928) received on 04 Dec 2012 with a follow up report received from the Quality Assurance department (QA reference number: 210326) on 01 Apr 2014. This report refers to a 33-year-old female patient. Her medical history and concomitant medications were unknown. She was vaccinated with FLUVIRIN (batch number 1204201) intramuscularly in her left arm on 18 Sep 2012. On the same day, two hours after vaccination her arm was sore. By the following morning, arm was itchy, red, hot to the touch and swollen to the size of a coke can. The outcome of the events was reported as condition unchanged as of 29 Sep 2012. The seriousness and causality assessment of the events was not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch 1204201 was manufactured in accordance with the approved internal procedures and is in compliance with the cGMP requirements. Follow up report received from the Quality Assurance department (QA reference number: 210326) on 01 Apr 2014: The batch review report.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Drug label confusion, Flatulence, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's current conditions or medical history were not reported. On 27-MAR-2014, also reported as yesterday, the patient was vaccinated with a dose of PROQUAD (Merck) and VARIVAX (Merck) (at the same office visit, separate sites) (dose, route, lot numbers and expiration dates were not reported) instead of MMR II and VARIVAX (Merck). The nurse reported that the labels of the MMR II and PROQUAD (Merck) had similar coloration and MMR II appears first on the PROQUAD (Merck) label. However the nurse felt that the error was medication error rather than product confusion. No adverse effect reported. Additional information has been requested. This spontaneous report as received from a current 46 year old female patient reporting on herself with polycystic ovary syndrome, Human Papilloma Virus (HPV) and no drug reaction/allergies. On unknown dates, the patient was vaccinated with doses 1, 2 and 3 of GARDASIL (dose, route, lot numbers and expiration dates were not reported). The patient was not taking concomitant medications. On an unknown date, the patient reported, "I had stinging pain that runs through my body and I had experienced stomach pains after I received all 3 shots of GARDASIL". The patient then explained "I had HPV before receiving all 3 shots of GARDASIL and I wish I could get more shots because this helped me." The patient also reported that although I felt relief from the HPV running in my body after I received all 3 shots of GARDASIL, my stomach pain is so bad that I want to kill myself and after receiving my third dose of GARDASIL I had experienced tremendous gas." The patient also reported she experienced "throbbing in her left leg," however the throbbing has "gone down after receiving the third dose." The patient stated "the vaccine seems to be working, because toxins are being released from my body. Outcome of stinging body pain, stomach pain, wanted to kill herself and gas was unknown at the time of the report. Outcome of throbbing in left leg was recovering resolving at the time of the report. No lab diagnostics were performed. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Suicidal ideation, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's current conditions or medical history were not reported. On 27-MAR-2014, also reported as yesterday, the patient was vaccinated with a dose of PROQUAD (Merck) and VARIVAX (Merck) (at the same office visit, separate sites) (dose, route, lot numbers and expiration dates were not reported) instead of MMR II and VARIVAX (Merck). The nurse reported that the labels of the MMR II and PROQUAD (Merck) had similar coloration and MMR II appears first on the PROQUAD (Merck) label. However the nurse felt that the error was medication error rather than product confusion. No adverse effect reported. Additional information has been requested. This spontaneous report as received from a current 46 year old female patient reporting on herself with polycystic ovary syndrome, Human Papilloma Virus (HPV) and no drug reaction/allergies. On unknown dates, the patient was vaccinated with doses 1, 2 and 3 of GARDASIL (dose, route, lot numbers and expiration dates were not reported). The patient was not taking concomitant medications. On an unknown date, the patient reported, "I had stinging pain that runs through my body and I had experienced stomach pains after I received all 3 shots of GARDASIL". The patient then explained "I had HPV before receiving all 3 shots of GARDASIL and I wish I could get more shots because this helped me." The patient also reported that although I felt relief from the HPV running in my body after I received all 3 shots of GARDASIL, my stomach pain is so bad that I want to kill myself and after receiving my third dose of GARDASIL I had experienced tremendous gas." The patient also reported she experienced "throbbing in her left leg," however the throbbing has "gone down after receiving the third dose." The patient stated "the vaccine seems to be working, because toxins are being released from my body. Outcome of stinging body pain, stomach pain, wanted to kill herself and gas was unknown at the time of the report. Outcome of throbbing in left leg was recovering resolving at the time of the report. No lab diagnostics were performed. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Blood pressure increased, Flatulence, Headache, Pain
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's current conditions or medical history were not reported. On 27-MAR-2014, also reported as yesterday, the patient was vaccinated with a dose of PROQUAD (Merck) and VARIVAX (Merck) (at the same office visit, separate sites) (dose, route, lot numbers and expiration dates were not reported) instead of MMR II and VARIVAX (Merck). The nurse reported that the labels of the MMR II and PROQUAD (Merck) had similar coloration and MMR II appears first on the PROQUAD (Merck) label. However the nurse felt that the error was medication error rather than product confusion. No adverse effect reported. Additional information has been requested. This spontaneous report as received from a current 46 year old female patient reporting on herself with polycystic ovary syndrome, Human Papilloma Virus (HPV) and no drug reaction/allergies. On unknown dates, the patient was vaccinated with doses 1, 2 and 3 of GARDASIL (dose, route, lot numbers and expiration dates were not reported). The patient was not taking concomitant medications. On an unknown date, the patient reported, "I had stinging pain that runs through my body and I had experienced stomach pains after I received all 3 shots of GARDASIL". The patient then explained "I had HPV before receiving all 3 shots of GARDASIL and I wish I could get more shots because this helped me." The patient also reported that although I felt relief from the HPV running in my body after I received all 3 shots of GARDASIL, my stomach pain is so bad that I want to kill myself and after receiving my third dose of GARDASIL I had experienced tremendous gas." The patient also reported she experienced "throbbing in her left leg," however the throbbing has "gone down after receiving the third dose." The patient stated "the vaccine seems to be working, because toxins are being released from my body. Outcome of stinging body pain, stomach pain, wanted to kill herself and gas was unknown at the time of the report. Outcome of throbbing in left leg was recovering resolving at the time of the report. No lab diagnostics were performed. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Papilloma viral infection, Suicidal ideation
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's current conditions or medical history were not reported. On 27-MAR-2014, also reported as yesterday, the patient was vaccinated with a dose of PROQUAD (Merck) and VARIVAX (Merck) (at the same office visit, separate sites) (dose, route, lot numbers and expiration dates were not reported) instead of MMR II and VARIVAX (Merck). The nurse reported that the labels of the MMR II and PROQUAD (Merck) had similar coloration and MMR II appears first on the PROQUAD (Merck) label. However the nurse felt that the error was medication error rather than product confusion. No adverse effect reported. Additional information has been requested. This spontaneous report as received from a current 46 year old female patient reporting on herself with polycystic ovary syndrome, Human Papilloma Virus (HPV) and no drug reaction/allergies. On unknown dates, the patient was vaccinated with doses 1, 2 and 3 of GARDASIL (dose, route, lot numbers and expiration dates were not reported). The patient was not taking concomitant medications. On an unknown date, the patient reported, "I had stinging pain that runs through my body and I had experienced stomach pains after I received all 3 shots of GARDASIL". The patient then explained "I had HPV before receiving all 3 shots of GARDASIL and I wish I could get more shots because this helped me." The patient also reported that although I felt relief from the HPV running in my body after I received all 3 shots of GARDASIL, my stomach pain is so bad that I want to kill myself and after receiving my third dose of GARDASIL I had experienced tremendous gas." The patient also reported she experienced "throbbing in her left leg," however the throbbing has "gone down after receiving the third dose." The patient stated "the vaccine seems to be working, because toxins are being released from my body. Outcome of stinging body pain, stomach pain, wanted to kill herself and gas was unknown at the time of the report. Outcome of throbbing in left leg was recovering resolving at the time of the report. No lab diagnostics were performed. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Autoimmune disorder, Injection site pain, Musculoskeletal pain, Pruritus
Clinical narrative: Shingles from head to toe! Pain, swelling at site in arm. Pain began in rt. shoulder blade, then left, then back of head. Fierce itching w/pain. Traveled down back to hips, buttocks, entire back of both legs to ankles. Covered w/ugly rash over entire back of body, slowly moved to front!
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Local swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shingles from head to toe! Pain, swelling at site in arm. Pain began in rt. shoulder blade, then left, then back of head. Fierce itching w/pain. Traveled down back to hips, buttocks, entire back of both legs to ankles. Covered w/ugly rash over entire back of body, slowly moved to front!
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: Shingles from head to toe! Pain, swelling at site in arm. Pain began in rt. shoulder blade, then left, then back of head. Fierce itching w/pain. Traveled down back to hips, buttocks, entire back of both legs to ankles. Covered w/ugly rash over entire back of body, slowly moved to front!
Age: 0.88
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: 1/21/11 Hep A was ordered and given in error. No reported complications.
Age: 0.88
Sex: M
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Vaccination error
Clinical narrative: 1/21/11 Hep A was ordered and given in error. No reported complications.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Joint stiffness, Muscle tightness, Nausea, Pain
Clinical narrative: 2/19/14 Nausea approximately 8:30 pm, chills, muscle tightness, pain, hand and arm tightness, fever approximately 102.9 pm at 10 pm. Took Ibuprofen 400 mg at 10:30 pm and 12 pm. 2/20/14 chills, fever subsided, soreness slowly subsided. Took Ibuprofen 400 mg and BENADRYL 25 mg approximately 12:00 noon. Took additional 25 mg BENADRYL at bedtime.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: 2/19/14 Nausea approximately 8:30 pm, chills, muscle tightness, pain, hand and arm tightness, fever approximately 102.9 pm at 10 pm. Took Ibuprofen 400 mg at 10:30 pm and 12 pm. 2/20/14 chills, fever subsided, soreness slowly subsided. Took Ibuprofen 400 mg and BENADRYL 25 mg approximately 12:00 noon. Took additional 25 mg BENADRYL at bedtime.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Muscle tightness, Nausea, Pain, Pyrexia
Clinical narrative: 2/19/14 Nausea approximately 8:30 pm, chills, muscle tightness, pain, hand and arm tightness, fever approximately 102.9 pm at 10 pm. Took Ibuprofen 400 mg at 10:30 pm and 12 pm. 2/20/14 chills, fever subsided, soreness slowly subsided. Took Ibuprofen 400 mg and BENADRYL 25 mg approximately 12:00 noon. Took additional 25 mg BENADRYL at bedtime.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Injection site bruising
Clinical narrative: Bruise at injection site, joint pain in legs and arms.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal, Periarthritis
Clinical narrative: Immediate pain at injection site and unable to move left (ipsilateral) shoulder by next day. Frozen shoulder requiring surgical manipulation under anesthesia 4 months later.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Surgery
Clinical narrative: Immediate pain at injection site and unable to move left (ipsilateral) shoulder by next day. Frozen shoulder requiring surgical manipulation under anesthesia 4 months later.
Age: 42.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Asthenia, Body temperature increased, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: Temperature 104 degrees F, pain 8-10 out of 10, entire body weakness, dizzy, rapid heartbeat, swollen throat, harsh voice, trouble breathing, blur vision, yeast infection, nervousness, weight loss (rapid).
Age: 42.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Fungal infection, Heart rate increased, Nervousness, Pain, Pharyngeal oedema
Clinical narrative: Temperature 104 degrees F, pain 8-10 out of 10, entire body weakness, dizzy, rapid heartbeat, swollen throat, harsh voice, trouble breathing, blur vision, yeast infection, nervousness, weight loss (rapid).
Age: 42.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Vision blurred, Weight decreased
Clinical narrative: Temperature 104 degrees F, pain 8-10 out of 10, entire body weakness, dizzy, rapid heartbeat, swollen throat, harsh voice, trouble breathing, blur vision, yeast infection, nervousness, weight loss (rapid).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Lymphadenopathy, Tenderness
Clinical narrative: Rash at injection site, injection site swelling and tenderness, under arm tenderness, swollen lymph nodes in neck on side vaccine was given.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Eyelid oedema, Renal impairment, Renal injury
Clinical narrative: Went to ER because eyes swelled shut several hours after shot. Gave BENADRYL, checked BP - was very high. Patient reports kidney damage - now has 50% function.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Eyelid oedema, Headache, Influenza, Nausea
Clinical narrative: Went to ER because eyes swelled shut several hours after shot. Gave BENADRYL, checked BP - was very high. Patient reports kidney damage - now has 50% function.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Renal disorder, Sinus headache, Swelling, Swelling face
Clinical narrative: Went to ER because eyes swelled shut several hours after shot. Gave BENADRYL, checked BP - was very high. Patient reports kidney damage - now has 50% function.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vision blurred
Clinical narrative: Went to ER because eyes swelled shut several hours after shot. Gave BENADRYL, checked BP - was very high. Patient reports kidney damage - now has 50% function.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Laboratory test normal, Tremor
Clinical narrative: Patient received PNEUMOVAX and developed an adverse reaction to the vaccine 1 hour later. Pt complained of dizziness, shaking, chest tightness and elevated blood pressure. EMT was called and pt was hospitalized.
Age: 70.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a register nurse concerning a patient of unknown age and gender who on 02-APR-2014 the patient was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test normal, Chest X-ray normal, Chromosome analysis normal, Computerised tomogram head, Computerised tomogram normal
Clinical narrative: At 3 months of age (week of 12/23/13), I noticed eye rolling incidents when patient was lying in complete supine. I also noticed she did not make good/much direct eye contact and moved her body/extremities more than "normal."
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cytogenetic analysis normal, Decreased eye contact, Dyskinesia, Electroencephalogram normal, Eye movement disorder
Clinical narrative: At 3 months of age (week of 12/23/13), I noticed eye rolling incidents when patient was lying in complete supine. I also noticed she did not make good/much direct eye contact and moved her body/extremities more than "normal."
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging brain normal, Pyrexia, Ultrasound abdomen normal
Clinical narrative: At 3 months of age (week of 12/23/13), I noticed eye rolling incidents when patient was lying in complete supine. I also noticed she did not make good/much direct eye contact and moved her body/extremities more than "normal."
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in March 2014, the patients were vaccinated with RECOMBIVAX HB (thimerosal status was not reported) that on 14-MAR-2014 were exposed to 52F for 17 hours (dose, route and lot numbers were not reported). Concomitant medications were not reported. No adverse effects reported. This case is linked to cases 1403USA012181, 1404USA004082 and 1404USA004083 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in March 2014, the patients were vaccinated with ROTATEQ that on 14-MAR-2014 were exposed to 52F for 17 hours (dose, route and lot numbers were not reported). Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1403USA012181, 1404USA004081 and 1404USA004082 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in March 2014, the patients were vaccinated with GARDASIL that on 14-MAR-2014 were exposed to 52F for 17 hours (dose, route and lot numbers were not reported). Concomitant medications were not reported. No adverse effects reported. This case is linked to cases 1404USA004081, 1404USA004082 and 1404USA004083 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unspecified date in March 2014, the patients were vaccinated with VAQTA that on 14-MAR-2014 were exposed to 52F for 17 hours (dose, route and lot numbers were not reported). Concomitant medications were not reported. No adverse effects reported. This case is linked to cases 1403USA012181, 1404USA004081 and 1404USA004083 via same reporter link. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a register nurse concerning a patient of unknown age and gender who on 02-APR-2014 the patient was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Induration, Injection site pain, Injection site swelling
Clinical narrative: More than 12 hrs after immunization for 5 year well child visit, mother noted painful swelling on (L) posterior upper thigh; Ibuprofen given and warm compress applied; Initial 10 cm induration reduced to 5 cm and no longer painful.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Given 2-21-14 - Developed pain at injection site as expected then over next weeks - fever, chills, fatigue and weakness.
Age: 0.59
Sex: M
Vaccine: DTAP, FLU3, HIBV, MMR
Symptoms: Inflammation, Rash erythematous, Rash generalised, Rash pruritic, Streptococcus test negative
Clinical narrative: Rash all over described as erythematous, inflamed, and itchy. Spares palms of hands, soles of feet.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Erythema
Clinical narrative: Localized erythema to right quadriceps and left quadriceps.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area around injection site is swollen, warm, red approximately 3 inches in diameter.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache
Clinical narrative: Patient received Tdap and meningococcal vaccines and developed a frontal headache about 5 minutes after administration. She was observed for 20 minutes; no other reactions.
Sex: U
Vaccine: VARZOS
Symptoms: Liquid product physical issue, No adverse event, Product quality issue, Vaccination error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 23-MAR-2014, the pharmacist reported that due to a product quality issue with ZOSTAVAX the patient was stuck twice with the needle attempting injection of ZOSTAVAX vial 0.65 ml (route, lot number and expiration date were not reported). No adverse experiences noted. The pharmacist also reported appearance and viscosity issues with ZOSTAVAX. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling left deltoid - superior trapezius muscle decreased ROM.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from unspecified health professional via company representative refers to a unknown number of patients of unknown age and gender. Unspecified number of patients medical history and other drug allergic reactions were not reported. On an unknown date the unspecified number of patients were vaccinated with ZOSTAVAX vial (strength, dose number, dose, units, lot number and expiry date unknown). No concomitant medications were reported. Unspecified health professional reported that most of the patients receiving ZOSTAVAX have no injection site reactions but once in a while there was one on an unknown date. On an unknown date the unspecified number of patients experienced injection site reactions. The outcome of injection site reactions was unknown. The reporter did not provide causality of injection site reactions to ZOSTAVAX. No further information provided. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Local reaction, Paraesthesia
Clinical narrative: This spontaneous report as received from a nurse via field employee refers to herself who was a female patient of unknown age. Nurse reported that she was administered ZOSTAVAX (strength, lot #, dose, route were unspecified) on an unspecified date sometime this week in March 2014 for "age eligible". Nurse reported a local reaction "in the office" (where ZOSTAVAX was administered) at the injection site descried as a little knot, swollen and red. Nurse also reported that she experienced itching and tingling all over her body at an unspecified time "fairly soon" after being administered ZOSTAVAX. Nurse stated that she was still feeling some generalized itching and had a little redness around the injection site. Patient took a BENADRYL and a CLARITIN this morning (28-MAR-2014) as treatment. No lab diagnostics studies were performed. It was unspecified if patient had sought medical attention. The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report as received from a nurse via field employee refers to herself who was a female patient of unknown age. Nurse reported that she was administered ZOSTAVAX (strength, lot #, dose, route were unspecified) on an unspecified date sometime this week in March 2014 for "age eligible". Nurse reported a local reaction "in the office" (where ZOSTAVAX was administered) at the injection site descried as a little knot, swollen and red. Nurse also reported that she experienced itching and tingling all over her body at an unspecified time "fairly soon" after being administered ZOSTAVAX. Nurse stated that she was still feeling some generalized itching and had a little redness around the injection site. Patient took a BENADRYL and a CLARITIN this morning (28-MAR-2014) as treatment. No lab diagnostics studies were performed. It was unspecified if patient had sought medical attention. The outcome was unknown. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Viral titre decreased
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 47 year old female patient. On 22-NOV-2013 the patient received the first dose of VARIVAX (lot # J008229, expiry date: 15-MAR-2015 dose 0.5 ml, subcutaneously) for "school requirement". On 21-JAN-2014 the patient received the 2nd dose of VARIVAX (lot# J008229, expiry date: 12-JULY-2015, dose 0.5ml subcutaneously). The patient was seen in the office on 26-MAR-2014 and stated that, on unspecified date in 2014, had titers drawn at her community college which showed her to have borderline immunity. The titers were re-drawn on 26-MAR-2014 and results received on 28-MAR-2014 showed a value of less than 0.9 which was considered negative. The outcome of the events was unknown. The relationship of the events to VARIVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This spontaneous report as received from a registered nurse, via a company representative, refers to two patients of unknown age. On 18-MAR-2014 two patients were vaccinated with ZOSTAVAX, single dose, in the arm. The patients were also administered TDAO in the same arm on 18-MAR-2014. This case refers to patient one of two patients. In March 2014, the patient developed "localized reactions". The patient sought medical attention and visited the office. The outcome of localized reactions and causality assessment were not provided. This case is linked to case 1404USA004017 (patient two of two patients). Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Macule, Skin lesion
Clinical narrative: Pt seen on 3/21/14 - received PEDIARIX on 2/14/14 - small red mark at injection site, large bump noted there on 3/20/14 - not red or hot to touch but tender. Exam 3/21 showed 1.5 x 2.5 inch cystic lesion that transilluminated with 0.5 cm purple macule with punctate center.
Age: 0.46
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Abscess, Erythema, Staphylococcus test positive, Streptococcus test positive, Swelling
Clinical narrative: Pt seen for first time in our office 9/3/13. Had imms (L) thigh 7/12/13 - PEDIARIX and HIB. Swelling and redness noted MD August. KEFLEX given - no help. Seen here 9/3 -> for U/S - > showed small abscess -> I and D by Dr with resolution. Cx grew coag neg staph, strep viridans.
Age: 0.46
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Ultrasound scan
Clinical narrative: Pt seen for first time in our office 9/3/13. Had imms (L) thigh 7/12/13 - PEDIARIX and HIB. Swelling and redness noted MD August. KEFLEX given - no help. Seen here 9/3 -> for U/S - > showed small abscess -> I and D by Dr with resolution. Cx grew coag neg staph, strep viridans.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Joint swelling
Clinical narrative: Patient had swelling around injection site that persisted for 5 days. Erythematous 1.5" diameter and further swelling to the elbow (about 6" in diameter). Gave patient BENADRYL 50mg at day 3 and was okay.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Fall
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 17 year old female patient with no drug reactions or allergies and with no medical history. On 02-APR-2014 the patient was vaccinated intramuscularly with the first dose of GARDASIL (lot # J011960, expiration date 06-AUG-2015, dose not reported). Concomitant therapies included NUVARING. On 02-APR-2014 after receiving the first dose of GARDASIL the patient experienced seizure. The reporter stated that the patient fell out of the chair she was sitting in the office. The patient was taken to the hospital by the paramedics and was admitted. The outcome of seizure was unknown. The patient sought medical attention by being at the doctor's office. The relatedness between the therapy with GARDASIL and seizure was not reported. Upon internal review the event of seizure was determined to be medically significant. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dry skin, Erythema, Flushing, Nausea, Pruritus
Clinical narrative: 1 hr after immunization complained of nausea. Complained of itching on legs only, dry areas noted, hx of eczema, face flushed red. Denies SOB, chest pain, rash, hives, wheezing. BENADRYL given for itching, monitored for 30 minutes, sent home with mother with ER precautions.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Hypoaesthesia, Muscular weakness, Tremor
Clinical narrative: Patient tolerated vaccination well for approximately 20 minutes after admin. Upon returning to pharmacy area to pay and sign, became weak in legs (could not stand, had to be seated). Very shaky hands, numbness in cheeks/face. Given water and seated, called ambulance and stayed w/ pt until medics arrived.
Age: 1.02
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old patient (gender unspecified). On 18-MAR-2014, the patient was vaccinated with PROQUAD injection, dose 0.5 ml, subcutaneous that was stored (outside prescribing information) at 30 Fahrenheit (F) for 2.5 hours. Concomitant therapy was unspecified. No adverse effect was reported. No product quality complaint was involved. The outcome of received PROQUAD that was stored (outside prescribing information) at 30 F for 2.5 hours was unknown. No further information was provided. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: HEP, HEPA, RAB, TDAP
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Four days after receiving Tdap, RABAVERT #1, HAVRIX #2 and Hep B #3, patient developed a generalized rash (red, raised tiny bumps) on both arms and torso. Rash very itchy, no fever or angioedema.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pertussis
Clinical narrative: Pt has had 6 doses of pertussis vaccine with last dose (BOOSTRIX) 7-8-11 and still contracted pertussis.
Sex: U
Vaccine: HEPA, HIBV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, Hepatitis B surface antibody negative, Underdose
Clinical narrative: This spontaneous report as received from a physician refers to a currently 35 year old female patient. Medical history, drug reactions or allergies were not reported. On 13-MAR-2014, the patient was vaccinated with an expired dose of RECOMBIVAX HB 5/0.5mcg/ml, lot # 669599/0231AA, thimerosal free, expiration date: 14-OCT-2013 (also reported as 04-OCT-2013) (dose number not reported) because of a low titer (less than 5) after completion of three doses of Hepatitis B vaccine (manufacturer unknown, dates of administration unspecified, administrated previously at another unspecified facility). Concomitant medication was not reported. The patient received expired dose of RECOMBIVAX HB instead of receiving an adult dose of this vaccine due to medication error, no product confusion discovered. No adverse event reported other than low titer. The outcome of all events was unknown. The causality was not reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a licensed vocational nurse (LVN) concerning a patient of unknown age and gender who on an unknown date was vaccinated with a dose of PNEUMOVAX 23, (route, lot number and expiration was not provided). No suspect or concomitant medications were reported. The licensed vocational nurse reported that the patient experienced abnormal injection site swelling and redness after administration of PNEUMOVAX 23. At the time of the report, the patient's outcome was not provided. Additional information has been requested.
Age: 82.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles broke out on left side.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented at office 4-1-14 with left upper arm swelling below deltoid area 6 x 8 cm. Patient states the swelling started almost immediately after injection given 3/27/14. Area reddened and very itchy.
Age: 79.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Headache
Clinical narrative: The day after vaccines were administered, patient experienced intense "pulsing, grabbing pain" in head sporadically. Stated was not like a normal headache kind of sensation. This persisted for 2 days in a row, then ceased to occur since then.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a 30 year old female patient who is a registered nurse regarding herself. On an unknown date, the patient was vaccinated with 2 doses of MMR II when she was child. On an unknown date she had received a third dose of MMR II when she was 30 years of age because one or both of her doses of MMR II when administered as a child could not be verified. No adverse effect reported with the third dose of MMR II. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm warm to touch; reddened and raised at injection site; hard knot at injection site. Rash to upper and lower extremities.
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Left upper arm warm to touch; reddened and raised at injection site; hard knot at injection site. Rash to upper and lower extremities.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unkonwn age and unknown gender. On an unspecified date six years ago (assumed in 2008) the patient was vaccinated with the first dose GARDASIL, 0.5 ml, intramuscular. On 21-MAR-2014 the patient was vaccinated with the second dose GARDASIL 0.5 ml, intramuscular. No adverse effects were reported. No consent for follow up. Additional information is not expected.
Age: 1.13
Sex: M
Vaccine: MMRV
Symptoms: Asthenia, Crying, Discomfort, Hypersomnia, Malaise
Clinical narrative: 3-22 By evening was not feeling well, came down with a fever. Gave TYLENOL. 3-23 Had fever of 102 - 103 degrees all day. Had no energy, cried a lot, slept a lot, very runny nose, gave TYLENOL at different times. 3-24 was some better during the day. Still had a very runny nose. Didn't go to bed. Started golfing worked up and uncomfortable. From 9-10 pm had episodes of uncontrollable pain with short seizure like activity - lasting seconds at a time. Woke at midnight with similar episodes for 1/2 hour. 3-25 Alright during the day but very restless night and awake from 3-5:30 am. 3-27 follow-up with dr.
Age: 1.13
Sex: M
Vaccine: MMRV
Symptoms: Pain, Pyrexia, Restlessness, Rhinorrhoea, Seizure like phenomena
Clinical narrative: 3-22 By evening was not feeling well, came down with a fever. Gave TYLENOL. 3-23 Had fever of 102 - 103 degrees all day. Had no energy, cried a lot, slept a lot, very runny nose, gave TYLENOL at different times. 3-24 was some better during the day. Still had a very runny nose. Didn't go to bed. Started golfing worked up and uncomfortable. From 9-10 pm had episodes of uncontrollable pain with short seizure like activity - lasting seconds at a time. Woke at midnight with similar episodes for 1/2 hour. 3-25 Alright during the day but very restless night and awake from 3-5:30 am. 3-27 follow-up with dr.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Chest pain, Decreased appetite, Fatigue, Throat tightness
Clinical narrative: Throat tightening and chest pain for a few seconds every 1/2 hour all night, decreased appetite and very tired. Resolved by morning.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Vomiting projectile
Clinical narrative: Given PEDIARIX, Hib, PCV-13. Reaction 3-4 hrs after vaccine given had projectile vomiting and incessantly crying lasting x 3 hrs.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Influenza, Influenza A virus test negative, Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: Initial case received from a Health Care professional, who is also the patient, on 01 April 2014. A 49-year-old female patient, with a reported medical history of migraines and allergy to penicillin (reported as "allergy PCN") and no reported concomitant therapies, had received a dose of FLUZONE on the left deltoid on 30 September 2013 (batch number UH910AC, route of administration not reported). She had previously received several yearly flu shots. On 18 March 2014, the patient experienced flu-like symptoms. She was tested positive for both the A and B strains of influenza. Substrains were not identified. Results were negative for H1N1. Chest X-ray was normal. The patient took self-medication with ZITHROMAX for an unspecified productive cough. The patient recovered from the events. Documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Productive cough
Clinical narrative: Initial case received from a Health Care professional, who is also the patient, on 01 April 2014. A 49-year-old female patient, with a reported medical history of migraines and allergy to penicillin (reported as "allergy PCN") and no reported concomitant therapies, had received a dose of FLUZONE on the left deltoid on 30 September 2013 (batch number UH910AC, route of administration not reported). She had previously received several yearly flu shots. On 18 March 2014, the patient experienced flu-like symptoms. She was tested positive for both the A and B strains of influenza. Substrains were not identified. Results were negative for H1N1. Chest X-ray was normal. The patient took self-medication with ZITHROMAX for an unspecified productive cough. The patient recovered from the events. Documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: Patient returned to clinic @1410 showing signs of anaphylaxis. Epinephrine was administered @1415. Vitals signs were documented in health system. Patient was transferred by EMS to Medical Center.
Age: 69.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Site hard and red and swollen and warm and tender, oval area about size of 1/2 dollar. Later headache, neck/chest and cheeks have red blotches, arm ached to elbow and wrist.
Age: 69.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Pain in extremity, Rash macular
Clinical narrative: Site hard and red and swollen and warm and tender, oval area about size of 1/2 dollar. Later headache, neck/chest and cheeks have red blotches, arm ached to elbow and wrist.
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction, Local swelling
Clinical narrative: This spontaneous report as received from a registered nurse, via a company representative, refers to two patients of unknown age. On 18-MAR-2014 two patients were vaccinated with ZOSTAVAX, single dose, in the arm. The patients were also administered Tdap in the same arm on 18-MAR-2014. This case refers to patient two of two patients. In March 2014, the patient developed "localized reactions". This patient developed swelling that extended to the elbow. The patient sought medical attention and visited the office. The outcome of the events and causality assessment were not provided. This case is linked to case 1403USA010921 (patient one of two patients). Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: HEPATYP, TYP
Symptoms: Asthenia, Ear pain, Fatigue, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: Tiredness, sore ears, throat; weakness 9:00 PM. 6:00 AM, next day, fever, spikes to 103 F, then sweating and fever drops to 102 then to 99. by 8:00 a.m.
Age: 75.0
Sex: M
Vaccine: HEPATYP, TYP
Symptoms: Pyrexia
Clinical narrative: Tiredness, sore ears, throat; weakness 9:00 PM. 6:00 AM, next day, fever, spikes to 103 F, then sweating and fever drops to 102 then to 99. by 8:00 a.m.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site nodule
Clinical narrative: Knot noted in right leg when palpating it. No swelling noted. No redness noted.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Ear congestion, Meniere's disease, Tinnitus, Vertigo, Vomiting
Clinical narrative: Initially had fullness in right ear and tinnitus. Approximately 2 weeks after TDAP, I had vertigo with vomiting.
Age: 22.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Severe itching, redness, swelling, and mass at injection site. Continues to get worse.
Age: 37.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site coldness, Injection site pain, Neck pain, Pain
Clinical narrative: Patient reported pain at time of Twinrix injection to left deltoid, radiating to neck.  Pain has continued at left deltoid and at anterior shoulder.  Worsens with certain movements such as abduction and external rotation.  Describes "cold" sensation at deltoid since injection.  Phone call to patient today (4/7/2014).  Continues with pain to left deltoid.  Shoulder pain has resolved.  Still doing range of motion exercises.  To follow-up with primary care provider if pain continues.
Age: 10.0
Sex: F
Vaccine: TYP
Symptoms: Condition aggravated, Pruritus, Rash, Stomatitis
Clinical narrative: Rash that had been under arms got worse and spread to chest, back, face and ears; not so much on arms or legs.  Very itchy.  No fever, diarrhea, sores in mouth.  Lasted 3 weeks.
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus
Clinical narrative: Right arm itching.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Significant swelling and redness at injection site.
Age: 48.0
Sex: M
Vaccine: YF
Symptoms: Dyspnoea, Muscle spasms, Paraesthesia, Sensation of heaviness, Urticaria
Clinical narrative: Tingling in face and heaviness feet and calves; Client took Benadryl at 15:15.  By 15:15 was better.  Spoke with client on 4/7.  Stated he was having cramps in calves and shoulder.  Other complaints resolved.  Told to go to ER if notes difficulty breathing, hives.
Age: 0.22
Sex: F
Vaccine: DTAP, HIBV, PER, UNK
Symptoms: Decreased eye contact, Foaming at mouth, Gaze palsy, Glassy eyes, Irritability
Clinical narrative: Patient was sitting in her car seat and began bubbling from her mouth; her eyes crossed and body stiffened for approximately 1 minute.  Afterward, her left eye drifted in and seemed to lag.  Mother and father took her to be examined by pediatrician at 1:45 PM the same day.  Doctor noted no residual signs or eye abnormalities during examination; reflexes and eye movement appeared normal. Doctor referred patient to a neurologist.  Following the event, patient appeared glassy eyed and was irritable for 3-4 days with a tendency to startle, short hysterical crying spells, and a reduction in making eye-contact, smiling, and vocalization that she had previously been doing regularly.  By the 5th day, she appeared to have resumed her previous level of alertness and interactivity.
Age: 0.22
Sex: F
Vaccine: DTAP, HIBV, PER, UNK
Symptoms: Musculoskeletal stiffness, Strabismus
Clinical narrative: Patient was sitting in her car seat and began bubbling from her mouth; her eyes crossed and body stiffened for approximately 1 minute.  Afterward, her left eye drifted in and seemed to lag.  Mother and father took her to be examined by pediatrician at 1:45 PM the same day.  Doctor noted no residual signs or eye abnormalities during examination; reflexes and eye movement appeared normal. Doctor referred patient to a neurologist.  Following the event, patient appeared glassy eyed and was irritable for 3-4 days with a tendency to startle, short hysterical crying spells, and a reduction in making eye-contact, smiling, and vocalization that she had previously been doing regularly.  By the 5th day, she appeared to have resumed her previous level of alertness and interactivity.