chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin lesion
Clinical narrative: This spontaneous report as received from a register nurse and a VZV questionnaire, concerning a 72 year old female patient. The patient's medical history included shingles and breast cancer with metastasis, diagnosed three years ago (in approximately January 2011) and none allergies. On Friday 24-JAN-2014, afternoon (also reported as within the last 3 years) the patient was vaccinated with ZOSTAVAX lot # J011549 expiration date 19-DEC-2014, 0.65 ml, subcutaneous in the left arm per Oncology specialist request. Concomitant therapies included XGEVA, amlodipine besylate, letrozole, furosemide, metoprolol, LANTUS SOLOSTAR, NOVOLOG Flex pen, hydrochlorothiazide (manufacturer unknown) and levothyroxine. The register nurse reported that on 25-JAN-2014, 24 hours of receiving ZOSTAVAX the patient developed a "fist sized rash on her back that looks like shingles". The reporter explained that the patient was vaccinated in the afternoon on Friday 24-JAN-2014 and in the afternoon of Sunday 25-JAN-2014 she had a spot on her back (reported as center of back) that was itching and slightly burning. Also the patient's husband stated had noticed redden area size of a fist. The rash was described as raised red papules, number of lesions approximately 20 of 4 x 4 inches, herpes zoster dermatome. The reporter explained that the patient went to see her doctor on 27-JAN-2014 and it looked like shingles. A sample was obtain  on 27-JAN-2014 from the skin papule. The patient was treated with ZOVIRAX 200 mg once daily for 5 days. At the time of the report the outcome was reported as recovered (in January 2014). The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a currently 90 year old female consumer reporting on herself with high blood pressure and thyroid problems. The patient did not have drug reactions/allergies. In approximately 2004 (about ten years ago), the patient was vaccinated with ZOSTAVAX (Lot number, expiration date, dose and route were not reported. Concomitant medications were to many to name. In November-2013 (about two months ago), the patient experienced shingles after receiving the ZOSTAVAX vaccine. The patient felt pain in her side, red, soreness under her breast and itching. No product quality complaint (PQC) was reported. Her physician provided her an eight-day supply of medication to treat the shingles (name not specified) that helped the symptoms to subside. The patient sought medical attention in the office. The outcome of the event was reported as recovering. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4, MEN
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old male patient with none medical history. On an unspecified date in 2014 about 4-6 weeks ago the patient was vaccinated with dose 1 of GARDASIL (lot# was not reported). There was none concomitant medication. The patient began to vomit and became light headed and pale. The patient had been administered an unspecified meningococcal vaccine (manufacturer unknown) a few minutes before GARDASIL was administered. The patient sought medical attention in the office. No treatment was given for the adverse event. No lab diagnosis study was performed. The patient recovered the same day that GARDASIL was administered. The physician reported that the patient may not continue with the GARDASIL series. The physician reported that the patient had not consumed an adequate amount of fluids before receiving GARDASIL vaccination. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a male patient of unknown age. On unknown dates the patient was vaccinated with 2 doses of VARIVAX (merck) (dose, frequency, route and lot# not reported). The patient had a titer level of 91 after receiving this 2 doses of VARIVAX (merck). At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 0.48
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse via field representative refers to a 5 month old patient of unknown gender. The nurse reported that the patient received ROTATEQ (lot# and expiry date unknown) suspension, 2ml, oral on the following dates: 25-SEP-2013, 14-JAN-2014 and 31-JAN-2014. No symptoms reported. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A antibody negative
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a female patient of unknown age. On unknown dates the patient was vaccinated with an unspecified hepatitis A vaccine, inactivated (manufacture unknown) (dose, frequency, route and lot# not reported) series twice (vaccine administered 4 times total). On an unknown date the patient had negative titers. The patient sought unspecified medical attention via office visit. At the time of reporting, the patients outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients (unknown age and gender). In January 2014 (within the last week), the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX (merck) (lot number, dose and route of administration were not reported). No adverse event was reported. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. Patient with no pertinent medical history, drug reactions or allergies. On an unknown date in November 2013 the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. On an unknown date in approximately November 2013, 2 days after the injection, the patient experienced a red and irritated injection site reaction. Pharmacist also reported that as of yesterday (22-JAN-2014, also reported as 22-JAN-2013), the patient's skin surrounding the injection of ZOSTAVAX was still a light pink. Pharmacist was able to confirm that the reaction was not a rash. There was not treatment given for the events. There were no lab diagnostics studies performed. The patient's present status was reported as recovering. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: HEPAB
Symptoms: Aspartate aminotransferase increased, Asthenia, Blood bilirubin increased, Pain, Pyrexia
Clinical narrative: 01-14-12 Fever, body aches and weakness. Max temp 102 degrees.
Age: 63.0
Sex: M
Vaccine: HEPAB
Symptoms: Viral test
Clinical narrative: 01-14-12 Fever, body aches and weakness. Max temp 102 degrees.
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Myalgia
Clinical narrative: Muscular left arm pain (pain and aching sensation).
Age: 1.03
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Erythema, Macule, Rash generalised
Clinical narrative: Rash on entire body, erythema macules, no pustules, no vesicles.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site induration
Clinical narrative: Red area, few days later large red egg shaped area on back of arm. Itchy, hard injection site.
Age: 16.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Mom called states received vaccines 1-14-14. 2 days after vaccination he developed rash to bilateral legs. (+) itching (+) redness. Rash covers legs completely. Decreased itching now but increased rash.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Blood sodium decreased, CSF protein increased, Dyspnoea
Clinical narrative: 11-9-13 back and leg pain over all weakness. Tingling and 7AM numbness feet and hands shortness of breath 11-19-13 admitted low sodium and facial weakness 6 PM 12 -19-13 admitted after spinal tap 5 PM with Guillain Barre Syndrome, given 5 days of IVIG 12-24-13 Inpat. Rehab 5 PM sent home 12-31-13 noon to continue w/ therapy.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Facial paresis, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: 11-9-13 back and leg pain over all weakness. Tingling and 7AM numbness feet and hands shortness of breath 11-19-13 admitted low sodium and facial weakness 6 PM 12 -19-13 admitted after spinal tap 5 PM with Guillain Barre Syndrome, given 5 days of IVIG 12-24-13 Inpat. Rehab 5 PM sent home 12-31-13 noon to continue w/ therapy.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: 11-9-13 back and leg pain over all weakness. Tingling and 7AM numbness feet and hands shortness of breath 11-19-13 admitted low sodium and facial weakness 6 PM 12 -19-13 admitted after spinal tap 5 PM with Guillain Barre Syndrome, given 5 days of IVIG 12-24-13 Inpat. Rehab 5 PM sent home 12-31-13 noon to continue w/ therapy.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dyspnoea, Erythema, Influenza, Mouth haemorrhage
Clinical narrative: 10 Jan 14 1 P Shingles vaccination. 11 9 A Stiffness, weakness, flu symptoms. 12 9 A Red blotches on chest and back, pain, bloody discharge from mouth. 11 A Pharmacist: Take 'BENADRYL' for 3 days. 12 Jan 9 am: Enlarged red areas, brown spots, swelling, pain. 14 Jan 9 am: Blisters, stabbing and burning pain, 'sick as a dog'. 15 Jan 9 am: Worsening condition, difficulty breathing, shaking. 4 PM: Physician: "You have the shingles, 'the whole thing!' Shingles = Weeks of misery! I can see the value of taking the vaccination to prevent or reduce the possibility of getting the shingles - However, had I known that I would have the shingles the next day I would not have taken the shot.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Pain, Rash macular, Skin discolouration, Swelling
Clinical narrative: 10 Jan 14 1 P Shingles vaccination. 11 9 A Stiffness, weakness, flu symptoms. 12 9 A Red blotches on chest and back, pain, bloody discharge from mouth. 11 A Pharmacist: Take 'BENADRYL' for 3 days. 12 Jan 9 am: Enlarged red areas, brown spots, swelling, pain. 14 Jan 9 am: Blisters, stabbing and burning pain, 'sick as a dog'. 15 Jan 9 am: Worsening condition, difficulty breathing, shaking. 4 PM: Physician: "You have the shingles, 'the whole thing!' Shingles = Weeks of misery! I can see the value of taking the vaccination to prevent or reduce the possibility of getting the shingles - However, had I known that I would have the shingles the next day I would not have taken the shot.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: 10 Jan 14 1 P Shingles vaccination. 11 9 A Stiffness, weakness, flu symptoms. 12 9 A Red blotches on chest and back, pain, bloody discharge from mouth. 11 A Pharmacist: Take 'BENADRYL' for 3 days. 12 Jan 9 am: Enlarged red areas, brown spots, swelling, pain. 14 Jan 9 am: Blisters, stabbing and burning pain, 'sick as a dog'. 15 Jan 9 am: Worsening condition, difficulty breathing, shaking. 4 PM: Physician: "You have the shingles, 'the whole thing!' Shingles = Weeks of misery! I can see the value of taking the vaccination to prevent or reduce the possibility of getting the shingles - However, had I known that I would have the shingles the next day I would not have taken the shot.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: 10 Jan 14 1 P Shingles vaccination. 11 9 A Stiffness, weakness, flu symptoms. 12 9 A Red blotches on chest and back, pain, bloody discharge from mouth. 11 A Pharmacist: Take 'BENADRYL' for 3 days. 12 Jan 9 am: Enlarged red areas, brown spots, swelling, pain. 14 Jan 9 am: Blisters, stabbing and burning pain, 'sick as a dog'. 15 Jan 9 am: Worsening condition, difficulty breathing, shaking. 4 PM: Physician: "You have the shingles, 'the whole thing!' Shingles = Weeks of misery! I can see the value of taking the vaccination to prevent or reduce the possibility of getting the shingles - However, had I known that I would have the shingles the next day I would not have taken the shot.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test positive, Herpes zoster, Hypersensitivity, Musculoskeletal pain, Rash
Clinical narrative: In discussing the zoster vaccine with my doctor, I asked about side effects. She indicated that she had given many of these vaccines and had not had any patients who experienced side effects. I had the vaccine on 12/2/13. Within a day or so, I developed extreme sensitivity on the right side of my body both in my hip/top of right thigh area and also near my back left shoulder area including very sharp, intense shooting pains. I then developed an outbreak/rash on the back of my upper right thigh. I went back to Dr. on 12/18. While she was surprised at my symptoms and the rash, she was in agreement that the rash did appear to be a shingles rash. So, it appears I developed a mild case of shingles directly after receiving the vaccine. Please note: I do not remember having chicken pox as a child and my mother said I never did even though my siblings did have chicken pox. However, a titer test done by Dr. indicated I had antibodies to chicken pox.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: In discussing the zoster vaccine with my doctor, I asked about side effects. She indicated that she had given many of these vaccines and had not had any patients who experienced side effects. I had the vaccine on 12/2/13. Within a day or so, I developed extreme sensitivity on the right side of my body both in my hip/top of right thigh area and also near my back left shoulder area including very sharp, intense shooting pains. I then developed an outbreak/rash on the back of my upper right thigh. I went back to Dr. on 12/18. While she was surprised at my symptoms and the rash, she was in agreement that the rash did appear to be a shingles rash. So, it appears I developed a mild case of shingles directly after receiving the vaccine. Please note: I do not remember having chicken pox as a child and my mother said I never did even though my siblings did have chicken pox. However, a titer test done by Dr. indicated I had antibodies to chicken pox.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Diarrhoea
Clinical narrative: Shortly after receiving vaccines pt began with several bouts of diarrhea.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP, TDAP
Symptoms: Aspiration bursa normal, Injection site pain, Musculoskeletal disorder, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient started to experience pain in left shoulder approximately 20 min. after vaccination. Pain continued and as well as losing ability to the arm. Sought treatment from doctor after 19 days he ordered MRI, patient started on meds. MRI "appeared" "septic" though aspiration showed no puss of bacteria. Doc feels it was possibly injected into bursa. Meds given were MEDROL and Gabapentin.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP, TDAP
Symptoms: Bursitis, Injection site oedema, Injection site pain, Injection site reaction, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient started to experience pain in left shoulder approximately 20 min. after vaccination. Pain continued and as well as losing ability to the arm. Sought treatment from doctor after 19 days he ordered MRI, patient started on meds. MRI "appeared" "septic" though aspiration showed no puss of bacteria. Doc feels it was possibly injected into bursa. Meds given were MEDROL and Gabapentin.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Within 30 min. after rec'ing Hep B vaccine, dev'd hive-like rash over upper body. + Pruritus. No resp. distress. Tx'd with Benadryl 50 mg. Started to improve w/in 30 min. Within 3-4 hrs. sx's resolved.
Age: 0.99
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure decreased, Ear discomfort, Feeling abnormal, Pallor, Respiration abnormal
Clinical narrative: Not sure exact time vaccine given. Approx 4-5 min after injection my daughter expressed "funny" feeling in head, next felt like she had water in ears - color drained from face - breathing appeared to change - more deliberate. Verbalized not being able to see - RN sought MD to come to room - pt lied down - began to feel better after sev. min - BP dropped but recovered. Everything happened very quickly. Only received GARDASIL vaccine 1st dose.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Visual acuity reduced
Clinical narrative: Not sure exact time vaccine given. Approx 4-5 min after injection my daughter expressed "funny" feeling in head, next felt like she had water in ears - color drained from face - breathing appeared to change - more deliberate. Verbalized not being able to see - RN sought MD to come to room - pt lied down - began to feel better after sev. min - BP dropped but recovered. Everything happened very quickly. Only received GARDASIL vaccine 1st dose.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure decreased, Dizziness, Dyspnoea, Ear discomfort, Head discomfort
Clinical narrative: Not sure exact time vaccine given. Approx 4-5 min after injection my daughter expressed "funny" feeling in head, next felt like she had water in ears - color drained from face - breathing appeared to change - more deliberate. Verbalized not being able to see - RN sought MD to come to room - pt lied down - began to feel better after sev. min - BP dropped but recovered. Everything happened very quickly. Only received GARDASIL vaccine 1st dose.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Not sure exact time vaccine given. Approx 4-5 min after injection my daughter expressed "funny" feeling in head, next felt like she had water in ears - color drained from face - breathing appeared to change - more deliberate. Verbalized not being able to see - RN sought MD to come to room - pt lied down - began to feel better after sev. min - BP dropped but recovered. Everything happened very quickly. Only received GARDASIL vaccine 1st dose.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Blood pressure abnormal, Blood test, Dizziness
Clinical narrative: Skipping heart, sweating, weakness, paleness, dizzy, tinnitus, (everything went off - B.P. - heart - tinnitus very loud) unbalanced, too sick to see the doctor. Several weeks and still pulse rate not right.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Extrasystoles, Hyperhidrosis, Pallor, Tinnitus
Clinical narrative: Skipping heart, sweating, weakness, paleness, dizzy, tinnitus, (everything went off - B.P. - heart - tinnitus very loud) unbalanced, too sick to see the doctor. Several weeks and still pulse rate not right.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Sore arm for 2 weeks, from PNEUMOVAX 23 - unrelieved by over the counter analgesics.
Age: 0.59
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 0.62
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Severe swelling, redness, heat at vaccination site approx 8-12 hrs after receiving shot. Seen at outside urgent care, treated with clindamycin and diphenhydramine -> worse overnight, referred to med ctr, rx IV abs and diphenhydramine.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given #3 Hep A injections. No side effects or reaction.
Age: 1.04
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site macule, Macule, Pruritus
Clinical narrative: Rash started 2/5 and became more diffuse thru night and AM 2/6; intense erythematous macules without confluency on face, trunk, arms, legs, palms and soles; no oral lesions noted; (+) itching; afebrile; mild UAC; (-) conjunctivitis.
Age: 1.04
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Rash generalised, Upper respiratory tract congestion
Clinical narrative: Rash started 2/5 and became more diffuse thru night and AM 2/6; intense erythematous macules without confluency on face, trunk, arms, legs, palms and soles; no oral lesions noted; (+) itching; afebrile; mild UAC; (-) conjunctivitis.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Dysphagia, Urticaria
Clinical narrative: Urticaria/Mild dysphagia.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as receiving from a consumer referring on her husband refers to a male patient of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot and expiration date were not reported). Co suspect or concomitant therapies were not reported. The reporter stated that the patient experienced itchiness at the injection site after receiving ZOSTAVAX. The outcome for itchiness was unknown at the time of the report. This is one of two reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a 62 year old female consumer reporting on herself, with a drug allergy/reaction to morphine. The patient's medical history was not reported. On 17-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml (reported as standard dose) (route, lot and expiration dates were not reported). Concomitant therapies included an unspecified flu vaccine (manufacturer unknown) 3 months before and regular regimen of unspecified medications. Approximately on 24-DEC-2013, reported as 1 to 2.5 weeks after vaccination, the patient stated that after receiving ZOSTAVAX she noticed that she began having very small eruptions of tiny bumps along her abdomen and left side. The patient stated that the bumps are very small. Around the size of the head of a pin and are itchy. Also explained that the bumps are intermittent and often appear one at a time before drying up. The patient stated that at this time she notices about six of these bumps that are currently dried up and may indicate the end of the occurrences all together. At the time of the report the patient was recovering from the events. The patient did not sought for medical attention or received any treatment. No lab diagnostics were performed. This is one of the two reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner and a nurse concerning a 12 year old female patient with no pertinent medical history or drug reactions/allergies who on 27-JAN-2014 was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. No concomitant medications were reported. It was reported that on 28-JAN-2014, the patient experienced 3 syncopal episodes. The patient was evaluated at a local emergency room but no details of the evaluation were provided. The patient experienced another syncopal episode on 29-JAN-2014 (reported as today). The patient had not received any treatment for the event; at the time of the report, the patient had not recovered from the event. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Joint range of motion decreased, Joint stiffness, Musculoskeletal stiffness, Pain
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 36 year old female patient. The patient's current conditions or medical history were not reported. Approximately in January-2007, reported as six years earlier, the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route, indication, lot and expiration date were not reported), administered concurrently with a dose of influenza (manufacturer unknown) (dose and lot number was not reported) in the same arm. On 14-OCT-2013, the patient received a second dose of PNEUMOVAX23 intramuscular (also reported as intermuscular) in the right deltoid (dose, lot and expiration date were not reported). On 14-OCT-2013, within two hours post vaccination, the patient experienced body aches, injection site swelling, fever, and stiffening of the arm. Within 6 to 8 hours, her joints stiffened further, limiting range of motion. The symptoms continued until range of motion returned, approximately seven days post vaccination. The patient recovered after stopping therapy and it was not reintroduced. It was also reported that no adverse reaction was reported with the first dose of PNEUMOVAX23. The patient sought medical attention. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 36 year old female patient. The patient's current conditions or medical history were not reported. Approximately in January-2007, reported as six years earlier, the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route, indication, lot and expiration date were not reported), administered concurrently with a dose of influenza (manufacturer unknown) (dose and lot number was not reported) in the same arm. On 14-OCT-2013, the patient received a second dose of PNEUMOVAX23 intramuscular (also reported as intermuscular) in the right deltoid (dose, lot and expiration date were not reported). On 14-OCT-2013, within two hours post vaccination, the patient experienced body aches, injection site swelling, fever, and stiffening of the arm. Within 6 to 8 hours, her joints stiffened further, limiting range of motion. The symptoms continued until range of motion returned, approximately seven days post vaccination. The patient recovered after stopping therapy and it was not reintroduced. It was also reported that no adverse reaction was reported with the first dose of PNEUMOVAX23. The patient sought medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown demographics. The patient's current conditions or medical history were not reported. On 07-DEC-2013, the patient was vaccinated with a single dose of ZOSTAVAX vial (dose, route, lot and expiration date were not reported) for prevention of shingles. On an unknown date, it was reported that the patient experienced an unspecified rash at the injection site. The patient was recovered at the time of the report, the event improved after stopping therapy and the therapy was not reintroduced. This is one of several reports from the same source. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old female patient. The patient's current conditions or medical history were not reported. On 19-AUG-2013, the patient was vaccinated with a dose of VAQTA (dose, route, indication, lot and expiration date were not provided). No adverse effect reported. At the time of the report the outcome was unknown. 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 registered nurse refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 27-AUG-2013, the patient was vaccinated with the first dose of VAQTA 25/0.5 U/ml (route, dose, lot and expiration date were not reported). On 26-JAN-2013, less than six months later, the patient was vaccinated with the second dose of VAQTA 25/0.5 U/ml (route, dose, lot and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse practitioner refers to unknown number of unspecified patients. On an unknown date, the patients were vaccinated with RECOMBIVAX HB, intramuscular on an accelerated schedule of 4 doses administered on day 0, day 7, day 21, and a booster dose at 12 months after the first dose. No adverse effects reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown demographics. The patient's current conditions or medical history were not reported. On 07-DEC-2013, the patient was vaccinated with a single dose of ZOSTAVAX vial (dose, route, lot and expiration date were not reported) for prevention of shingles. On an unknown date, it was reported that the patient experienced an unspecified rash at the injection site. The patient was recovered at the time of the report, the event improved after stopping therapy and the therapy was not reintroduced. This is one of several reports from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Patient states within 30 minutes of vaccine, she began itching around her neck. She then noticed a red "bumpy" rash on her waist, chest, neck and face. She did not go to the dr or ER. She used ALLEGRA and cortisone cream. No fever. States the rash is fading 2/6/14.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 27-JAN-2014 the patient was vaccinated with one dose of ZOSTAVAX 19400 PFU in each arm (dose, indication, lot #, expiration date not reported), one of the doses was administered intramuscularly instead of subcutaneously. No adverse effects were reported. No PQC. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unspecified date in July 2013 the patient was vaccinated with GARDASIL dose 1 (lot number and expiry date unknown) (dosing regimen and frequency unknown), a second dose of GARDASIL on an unspecified date in December 2013. On 29-NOV-2013 the patient was vaccinated with GARDASIL dose 3. No adverse events were reported. No product quality issue was reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Atrioventricular block, Hypoaesthesia, Injection site swelling, Local swelling, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 26 year old female patient with heartburn, smoker, naproxen (reported as naproxyn) allergy and acetaminophen, EXCEDRIN allergy. The patient was a post-partum patient, after delivering an infant on 29-JAN-2014. On 31-JAN-2014 the patient was vaccinated with PNEUMOVAX 23 (Lot # J013345; Expiration date: 11-JAN-2015), 0.5 ml, intramuscular in the left deltoid for prevention of pneumonia. Concomitant therapies included acetaminophen, NORCO. On 31-JAN-2014, the patient experienced fever 100.4, sharp pain shooting down to hand, numbness, and swelling from the injection site to the hand and mildly elevated white blood count after receiving PNEUMOVAX 23. The patient was treated with BENADRYL and ice pack to arm. The patient was discharged to home on 31-JAN-2014. The patient's outcome was unknown. Pharmacist requested lot check. This is one of several reports from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 26 year old female patient with heartburn, smoker, naproxen (reported as naproxyn) allergy and acetaminophen, EXCEDRIN allergy. The patient was a post-partum patient, after delivering an infant on 29-JAN-2014. On 31-JAN-2014 the patient was vaccinated with PNEUMOVAX 23 (Lot # J013345; Expiration date: 11-JAN-2015), 0.5 ml, intramuscular in the left deltoid for prevention of pneumonia. Concomitant therapies included acetaminophen, NORCO. On 31-JAN-2014, the patient experienced fever 100.4, sharp pain shooting down to hand, numbness, and swelling from the injection site to the hand and mildly elevated white blood count after receiving PNEUMOVAX 23. The patient was treated with BENADRYL and ice pack to arm. The patient was discharged to home on 31-JAN-2014. The patient's outcome was unknown. Pharmacist requested lot check. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, PNC, UNK
Symptoms: Injection site abscess, Injection site nodule, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) via sales representative and described the occurrence of injection site abscess in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included PREVNAR (non-gsk); non-GSK manufacturer; unknown; right thigh given on an unspecified date; unspecified vaccine; manufacturer unspecified; unknown; right thigh given on an unspecified date. On an unspecified date the subject received 2nd dose of PEDIARIX (unknown, left thigh) as the 4-months series vaccination for PEDIARIX. At an unspecified time within months of 2nd vaccination with PEDIARIX, the subject experienced injection site abscess and nodule injection site. The infant subject received the full 2, 4 and 6 months series of PEDIARIX; the specific age of the baby was not provided. After each injection of PEDIARIX on unknown dates, the baby had nodules from on the leg. All three doses of PEDIARIX had been injected in the left thigh. All of the nodules formed on the same thigh and were localized to the exact same area where the PEDIARIX was injected. Other vaccines, included PREVNAR, had been administered on the right thigh with no nodules. The infant subject was scheduled to have surgery to have pus taken out/ drained of the little abscesses that have formed. The reporting nurse practitioner was not certain that this was even related to PEDIARIX. This case was assessed as medically serious by GSK. The immunization series with PEDIARIX was not discontinued. At the time of reporting the injection site abscess and nodule at injection site were unresolved. Please see cases A1059527A and A1059527C for the subject's experience with previous and subsequent doses of PEDIARIX.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Pt received MMR vaccine 1-6-14 for college entry. LMP at that time 12/21/13. Pt discovered she was pregnant on 2/3/14 - confirmed in our office.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report overheard from a company representative from 2 nurses refers to a child patient of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot and expiration date were not reported) instead of VARIVAX (Merck). No adverse event was mentioned. Additional information is not expected.
Sex: U
Vaccine: DTAPHEPBIP, PNC, UNK
Symptoms: Injection site abscess, Injection site nodule, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) via sales representative and described the occurrence of injection site abscess in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included PREVNAR (non-gsk); non-GSK manufacturer; unknown; right thigh given on an unspecified date; unspecified vaccine; manufacturer unspecified; unknown; right thigh given on an unspecified date. On an unspecified date the subject received 3rd dose of PEDIARIX (unknown, left thigh) as the 6-months series vaccination for PEDIARIX. At an unspecified time within months of 3rd vaccination with PEDIARIX, the subject experienced injection site abscess and nodule injection site. The infant subject received the full 2, 4 and 6 months series of PEDIARIX; the specific age of the baby was not provided. After each injection of PEDIARIX on unknown dates, the baby had nodules from on the leg. All three doses of PEDIARIX had been injected in the left thigh. All of the nodules formed on the same thigh and were localized to the exact same area where the PEDIARIX was injected. Other vaccines, included PREVNAR, had been administered on the right thigh with no nodules. The infant subject was scheduled to have surgery to have pus taken out/ drained of the little abscesses that have formed. The reporting nurse practitioner was not certain that this was even related to PEDIARIX. This case was assessed as medically serious by GSK. The immunization series with PEDIARIX was not discontinued. At the time of reporting the injection site abscess and nodule at injection site were unresolved. Please see cases A1059527B and A1059527C for the subject's experience with previous doses of PEDIARIX.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Injection site abscess, Injection site nodule, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) via sales representative and described the occurrence of injection site abscess in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included PREVNAR (non-gsk); non-GSK manufacturer; unknown; right thigh given on an unspecified date; unspecified vaccine; manufacturer unspecified; unknown; right thigh given on an unspecified date. On an unspecified date the subject received 3rd dose of PEDIARIX (unknown, left thigh) as the 2-months series vaccination for PEDIARIX. At an unspecified time within months of 1st vaccination with PEDIARIX, the subject experienced injection site abscess and nodule injection site. The infant subject received the full 2, 4 and 6 months series of PEDIARIX; the specific age of the baby was not provided. After each injection of PEDIARIX on unknown dates, the baby had nodules from on the leg. All three doses of PEDIARIX had been injected in the left thigh. All of the nodules formed on the same thigh and were localized to the exact same area where the PEDIARIX was injected. Other vaccines, included PREVNAR, had been administered on the right thigh with no nodules. The infant subject was scheduled to have surgery to have pus taken out/ drained of the little abscesses that have formed. The reporting nurse practitioner was not certain that this was even related to PEDIARIX. This case was assessed as medically serious by GSK. The immunization series with PEDIARIX was not discontinued. At the time of reporting the injection site abscess and nodule at injection site were unresolved. Please see cases A1059527A and A1059527B for the subject's experience with subsequent doses of PEDIARIX.
Age: 43.0
Sex: M
Vaccine: DTP
Symptoms: Bordetella test positive, Bronchospasm, Chest X-ray normal, Chlamydia test, Computerised tomogram normal
Clinical narrative: This case was reported in a literature article and described the occurrence of pertussis in a 43-year-old male subject who was vaccinated with DTP (manufacturer unspecified), DTPa ((with small D + P), manufacturer unspecified). The subject was healthy. There was an outbreak of pertussis less than 20 miles away from subject's place. On unspecified dates, the subject received primary course of DTP (unknown route, injection site and batch number), booster dose of DTPa (with small D + P) (unknown route, injection site and batch number). At an unspecified time after vaccination with DTP, 1 year after vaccination with booster dose of DTPa (with small D + P), the subject presented to the emergency department with continued shortness of breath and a two week history of low grade fever and non-productive cough without whoop. He had previously been seen twice in his primary care provider's office with complaints of and an initial sore throat. After his first visit, he was thought to have a viral upper respiratory tract infection and was given supportive care. After 7 days, he was placed on prednisone and Albuterol for putative bronchospastic complications manifesting as occasional wheezing. The symptoms failed to improve requiring hospitalization for further management. The subject complained of dyspnea at rest and on exertion but denied hemoptysis or chest pain. An exam was notable for hypoxia (85% on room air) with dry rales and end-expiratory wheezing, without respiratory distress. Routine laboratory tests were unremarkable. The chest radiograph and computerized tomography scan did not demonstrate signs of infection. Because of the lack of specific findings, prolonged symptoms and significant hypoxia, atypical infections were considered. Serology for mycoplasma, chlamydia and Bordetella were sent. Bordetella IgM and IgG titers were significantly elevated. The subject was diagnosed with pertussis which was considered as a vaccination failure. At the time of reporting the outcome of the events were resolved. Author's comment: despite advancements in vaccination, cases of pertussis are still seen sporadically in the adult population. In this case, despite a recent well-publicized outbreak less than 20 miles away, providers did not consider a vaccination failure due to this assumption, resulting in significant morbidity requiring hospitalization. Therefore, although rare, pertussis vaccination failure does occur, and should be considered in the workup for a coughing illness lasting more than 5 days, even without the classic whoop.
Age: 43.0
Sex: M
Vaccine: DTP
Symptoms: Cough, Dyspnoea, Dyspnoea exertional, Hypoxia, Laboratory test normal
Clinical narrative: This case was reported in a literature article and described the occurrence of pertussis in a 43-year-old male subject who was vaccinated with DTP (manufacturer unspecified), DTPa ((with small D + P), manufacturer unspecified). The subject was healthy. There was an outbreak of pertussis less than 20 miles away from subject's place. On unspecified dates, the subject received primary course of DTP (unknown route, injection site and batch number), booster dose of DTPa (with small D + P) (unknown route, injection site and batch number). At an unspecified time after vaccination with DTP, 1 year after vaccination with booster dose of DTPa (with small D + P), the subject presented to the emergency department with continued shortness of breath and a two week history of low grade fever and non-productive cough without whoop. He had previously been seen twice in his primary care provider's office with complaints of and an initial sore throat. After his first visit, he was thought to have a viral upper respiratory tract infection and was given supportive care. After 7 days, he was placed on prednisone and Albuterol for putative bronchospastic complications manifesting as occasional wheezing. The symptoms failed to improve requiring hospitalization for further management. The subject complained of dyspnea at rest and on exertion but denied hemoptysis or chest pain. An exam was notable for hypoxia (85% on room air) with dry rales and end-expiratory wheezing, without respiratory distress. Routine laboratory tests were unremarkable. The chest radiograph and computerized tomography scan did not demonstrate signs of infection. Because of the lack of specific findings, prolonged symptoms and significant hypoxia, atypical infections were considered. Serology for mycoplasma, chlamydia and Bordetella were sent. Bordetella IgM and IgG titers were significantly elevated. The subject was diagnosed with pertussis which was considered as a vaccination failure. At the time of reporting the outcome of the events were resolved. Author's comment: despite advancements in vaccination, cases of pertussis are still seen sporadically in the adult population. In this case, despite a recent well-publicized outbreak less than 20 miles away, providers did not consider a vaccination failure due to this assumption, resulting in significant morbidity requiring hospitalization. Therefore, although rare, pertussis vaccination failure does occur, and should be considered in the workup for a coughing illness lasting more than 5 days, even without the classic whoop.