chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Full blood count normal, Metabolic function test, Myopericarditis, Nausea, Presyncope
Clinical narrative: 19 y/o male received primary Smallpox Vaccine (SPV), Anthrax (AVA#1), Typhoid VICPs o 06JUN11 in preparation for deployment in SEP 2011. He experienced a syncopal episode & nausea during PT on 21JUN2011 (Day #15 s/p receipt SPV). SM reports presyncopal episode & nausea the next day (22JUN11) while doing inventory at work- on feet, bending, lifting, etc. Went to ED for evaluation. Treated for "Possible Heat Exhaustion" with IV 2L NS IV fluids and ZOFRAN. No cardiac enzymes, ESR or CRP drawn. CBC and CMP WNL. EKG obtained in ED interpreted as "normal" NSR, normal p axis, V-rate 50-99, " consider left atrial abnormality- wide or notched P waves, PR 120 with baseline wander in Lead V4. SM experienced a recurrent sensation of presyncope & nausea after participating in 4-mile run on 01JUL11. SM also reports a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes w/o radiation to jaw, throat, neck or left arm, accompanied by SOB and sensation of heart "skipping a beat". Cardiac Panel (08JUL11) with + CK of 524 U/L (55-170); CKMB of 5.0 U/L WNL (2-16); CRP 0.1 WNL (Ref. 1.0 mg/dl) and ESR was 6 WNL (0-15 mm/hr). SM initially denied positional worsening of CP/SOB in supine position, but reported  a recurrent episode of similar CP on SAT 09JUL11 when lying down on bed in barracks, which last 5-10 minutes. Cardiology Consult to r/o underlying cardiac dysfunction, valvular dz, or dysrhythmias. Clinical presentation of SM's CP does not seen c/w Vaccinia Myopericarditis, but this must be considered in Differential Dx, as SM's sx occurred w/in a 30-day window of primary SPV immunization & other vaccines mentioned. Therefore, could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the SPV. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of SPV, but by presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Red blood cell sedimentation rate normal, Syncope, Vaccinia virus infection
Clinical narrative: 19 y/o male received primary Smallpox Vaccine (SPV), Anthrax (AVA#1), Typhoid VICPs o 06JUN11 in preparation for deployment in SEP 2011. He experienced a syncopal episode & nausea during PT on 21JUN2011 (Day #15 s/p receipt SPV). SM reports presyncopal episode & nausea the next day (22JUN11) while doing inventory at work- on feet, bending, lifting, etc. Went to ED for evaluation. Treated for "Possible Heat Exhaustion" with IV 2L NS IV fluids and ZOFRAN. No cardiac enzymes, ESR or CRP drawn. CBC and CMP WNL. EKG obtained in ED interpreted as "normal" NSR, normal p axis, V-rate 50-99, " consider left atrial abnormality- wide or notched P waves, PR 120 with baseline wander in Lead V4. SM experienced a recurrent sensation of presyncope & nausea after participating in 4-mile run on 01JUL11. SM also reports a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes w/o radiation to jaw, throat, neck or left arm, accompanied by SOB and sensation of heart "skipping a beat". Cardiac Panel (08JUL11) with + CK of 524 U/L (55-170); CKMB of 5.0 U/L WNL (2-16); CRP 0.1 WNL (Ref. 1.0 mg/dl) and ESR was 6 WNL (0-15 mm/hr). SM initially denied positional worsening of CP/SOB in supine position, but reported  a recurrent episode of similar CP on SAT 09JUL11 when lying down on bed in barracks, which last 5-10 minutes. Cardiology Consult to r/o underlying cardiac dysfunction, valvular dz, or dysrhythmias. Clinical presentation of SM's CP does not seen c/w Vaccinia Myopericarditis, but this must be considered in Differential Dx, as SM's sx occurred w/in a 30-day window of primary SPV immunization & other vaccines mentioned. Therefore, could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the SPV. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of SPV, but by presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram.
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Abdominal pain upper, Body temperature increased, Chills, Injection site pustule, Nausea
Clinical narrative: 18 y/o M went to Clinic this morning & Provider contacted clinic for eval of SM's (2) new pustular lesions forming below and medial to central SPV Jennerian Pustule on left upper arm. SM received his primary SPV (LUE) on 18JUL11. He also received AVA #1, TYPHIM Vi and Hep B #1 (all in RUE) at the same time. No hives, facial edema, lip swelling, eye swelling, breathing difficulty or swallowing difficulty during 1st 15 minutes s/p receipt of vaccines mentioned or in first 3 hours s/p vaccination. No unusual symptoms until 26JUL11 (Day #8 s/p imm), when the SM noticed another small pustule had appeared beneath the central Jennerian Pustule on his LUE. SM reports feelings chills (T 99.6F), nausea, stomach ache and general body ache. He did not take any OTC Ibuprofen or TYLENOL for symptom relief. He noticed a second pustule forming medially next to his central Jennerian Pustule the next day (27JUL11). He continues to feel some generalized body ache, but no longer feels nauseous. He denies any chest pain or SOB, no pain radiating from chest to neck, throat, or left arm. He has been using an occlusive square bandage over his SPV site, not permitting air circulation. (2) "Satellite lesions" -> from vaccinia drainage on bandage.
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP
Symptoms: Pain
Clinical narrative: 18 y/o M went to Clinic this morning & Provider contacted clinic for eval of SM's (2) new pustular lesions forming below and medial to central SPV Jennerian Pustule on left upper arm. SM received his primary SPV (LUE) on 18JUL11. He also received AVA #1, TYPHIM Vi and Hep B #1 (all in RUE) at the same time. No hives, facial edema, lip swelling, eye swelling, breathing difficulty or swallowing difficulty during 1st 15 minutes s/p receipt of vaccines mentioned or in first 3 hours s/p vaccination. No unusual symptoms until 26JUL11 (Day #8 s/p imm), when the SM noticed another small pustule had appeared beneath the central Jennerian Pustule on his LUE. SM reports feelings chills (T 99.6F), nausea, stomach ache and general body ache. He did not take any OTC Ibuprofen or TYLENOL for symptom relief. He noticed a second pustule forming medially next to his central Jennerian Pustule the next day (27JUL11). He continues to feel some generalized body ache, but no longer feels nauseous. He denies any chest pain or SOB, no pain radiating from chest to neck, throat, or left arm. He has been using an occlusive square bandage over his SPV site, not permitting air circulation. (2) "Satellite lesions" -> from vaccinia drainage on bandage.
Age: 1.28
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Immunization (Varicella).
Age: 18.0
Sex: M
Vaccine: HEP, HEPA, MNQ
Symptoms: Anxiety, Body temperature increased, Influenza like illness, Injection site pain, Irritability
Clinical narrative: 8/4/11 8:30 A parent reports client with elevated temp <101 degrees F and increased anxiety. Stated also has soreness at site and general flu-like symptoms ("crabby"). 8/4/11 3:15 pm: spoke with client who reports no further issues/resolved.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever T max 102.6, redness and swelling at injection site. Pt given BACTRIM 200-4-5 1tsp PO BID x 10 days, Rifampin susp. 75/5 1 tsp PO BID x 10 days.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Syncope, Urine output increased
Clinical narrative: "Lightheaded", pale, diphoretic, faint. Laid pt. down for 15-20 minutes - ambulatory when left clinic.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Pt rec'd immunizations 8/3/11. Mom called 8/4/11 - states very dizzy & arms very sore.
Age: 1.03
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt developed chicken pox lesions (20-30) diffusely over entire body approx 10 days after VARIVAX. No fever, no vomiting. Well appearing child.
Age: 7.0
Sex: F
Vaccine: IPV, PNC13
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 3 cm red/raised circular patch, warm to touch around vaccine site.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Immediate post-injection reaction, Nausea, Syncope
Clinical narrative: Became nauseous "stomach hurt" immediately & she fainted. Placed from sitting position on pt. table to lying flat. Layed, & was dizzy - remained laying down for approx 10 minutes then sitting then went home ambulatory.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles
Clinical narrative: Swollen erythematous about 10cm area (R) posterior upper arm with induration & vesicles/blisters centrally.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever to 101.7 axillary; vomiting; no treatment.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Bed rest, Fatigue, Injection site pain, Injection site warmth, Pain
Clinical narrative: Extreme fatigue, pt. hurt all over, required bed rest x24 hrs; injection site warm & tender, pt did not come to clinic.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt developed an urticarial rash over his entire body area including scalp, face, back, trunk, buttocks, genitalia, extremities approximately 18 hours after administration of Hepatitis A, MMR, and Varicella vaccines. Received one dose of diphenhydramine in clinic, prescribed hydroxyzine, rash improving.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 12 cm x 11 cm area; warm, red, indurated to (RT) arm at injection site. Non-tender; full ROM. Tx: cool compresses; PRN BENADRYL. Return to office or call if: severe pain, fever; increased redness after 48-72 hours.
Age: 3.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 60 x 50 mm of red, swollen, and hot to touch area in upper (R) arm in deltoid area, parents of child instructed by pediatric nurse practitioner to use cold compress in site of injection and give BENADRYL Children Rx.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Photosensitivity reaction, Pruritus, Rash, Rash macular
Clinical narrative: Onset of photosensitivity rash on forearms, cheeks, ankles 2 weeks after receiving ZOSTAVAX. Mild pruritus. No treatment received so far. Macular erythema, no vesicles.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pyrexia, Urticaria
Clinical narrative: Localized welt, fever, arthralgias <24 hrs after injection. No diffuse rash or oral edema.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local rxn - erythema & swelling at injection site ((L) arm). Both resolved about 15 mins after 12.5mg of BENADRYL PO given.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Onset urticaria 5 days after receiving Hep B # 3.
Age: 7.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: No adverse event
Clinical narrative: Patient is a 7 yr female who received KINRIX on 7/29/11, had no adverse events or symptoms.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Dizziness, Hypoaesthesia, Muscle twitching, Pallor
Clinical narrative: Mom stated pt started to twitch (non-seizure) pale, dizzy, clammy. C/o numbness to leg. Tx patient was put in room. Elevated (B) legs. Ambulance called.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Cough, Crying, Erythema, Listless, Pallor
Clinical narrative: The patient began crying/coughing and red in the face while receiving the rotavirus drink. I sat the pt. up immediately - he continued coughing/crying. Mom picked him up - he became quiet, unresponsive, pale, listless w/in 5-10 seconds. The doctor was notified immediately and gave back blows. He cried w/in 10 seconds and remained stable.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: The patient began crying/coughing and red in the face while receiving the rotavirus drink. I sat the pt. up immediately - he continued coughing/crying. Mom picked him up - he became quiet, unresponsive, pale, listless w/in 5-10 seconds. The doctor was notified immediately and gave back blows. He cried w/in 10 seconds and remained stable.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema
Clinical narrative: Information has been received from a nurse concerning a 72 year old female who on 28-SEP-2010 was vaccinated with PNEUMOVAX 23 (lot # 664608/1312Y) given as one shot for "prevention of invasive pneumococcal disease". Subsequently the patient experienced a 22 sonometer redness from the injection site past the elbow to the forearm. The patient has sought medical attention and was given prednisone for the event. At the time of reporting, outcome of the event was not reported. The reporting nurse considered the event to be serious as an other important medical event. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated the second 0.5ml dose with PNEUMOVAX 23 (lot# not reported). A couple years ago, the patient developed a reaction to PNEUMOVAX 23 and was admitted to an unspecified hospital for an unspecified length of time. The nurse did not specify what the reaction was. At the time of this report, the patient's outcome was not reported. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose, lot number, date of event, recovery status and hospital name. This is a corrected report. The AE coding "vaccination adverse reaction" has been changed to "adverse event". Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Local reaction, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 70 year old female patient who on an unspecified date was vaccinated with the second dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date on 04-JUL-2011). The physician reported that the patient developed fever of 39 degrees C that lasted for 2 days and cellulitis within 12 hours of receiving the vaccine. The patient may have been treated with antibiotics. The physician did not provide any information on the duration of cellulitis. The physician reported that she had never seen so many adverse reactions with this vaccine and had stopped using this lot number. The physician requested an investigation of the specific lot. At the time of the report, the outcome of the patient was not reported. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (665904/0866Z) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the physician concerning the 70 year old female patient with hypertension (HTN), noninsulin dependent diabetes mellitus (NIDDM), obesity, hyperlipidemia, depression and no illness at time of vaccination who was vaccinated the first dose of PNEUMOVAX 23 (Lot # unknown) in November 2005, and the second dose of PNEUMOVAX 23 (Lot # 665904/0866Z) IM into her right deltoid on 10-SEP-2010. On 11-SEP-2010, 7:00 AM, the patient developed high fever up to 102 and severe local reaction consistent with cellulitis. The patient was treated with OTC nonsteroidal anti-inflammatory drug (NSAIDS). No antibiotic. On 16-SEP-2010, the patient's events recovered. The patient's high fever up to 102 and severe local reaction consistent with cellulitis were considered to be other important medical events by the physician. No further information is available.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 47 year old female patient who on an unspecified date was vaccinated with the second dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date on 04-JUL-2011). The physician reported that on an unspecified date, the patient developed severe cellulitis within 12 hours of vaccination. The patient might have been treated with antibiotics. The physician did not provide any information on the duration of cellulitis. At the time of the report, the outcome of the patient was not reported. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (665904/0866Z) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from a physician concerning a 47 year old female with asthma, depression and obesity and no illness at time of vaccination who in 2002, was vaccinated with the first dose of PNEUMOVAX 23 and on 17-SEP-2010, was vaccinated with the second dose of PNEUMOVAX 23 intramuscularly in her right deltoid. On 18-SEP-2010, the patient developed significant cellulitis reaction and low grade fever. At the time of the report, the outcomes were unknown. Significant cellulitis with fever was considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Local reaction, Pyrexia, Swelling
Clinical narrative: Information has been received from a physician concerning a 66 year old male patient who on an unspecified date was vaccinated with the first dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date on 04-JUL-2011). The physician reported that the patient developed fever of 38.5C and severe cellulitis within 12 hours of receiving the vaccination. The patient may have been treated with antibiotics. The physician did not provide any information on the duration of cellulitis and fever. The physician reported that she had never seen so many adverse reactions with this vaccine and had stopped using this lot number. The physician requested an investigation of the specific lot. At the time of the report, the outcome of the patient was not reported. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (665904/0866Z) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from the physician who reported that the 66 year old male patient with neither illness at time of vaccination nor pre-existing allergies, birth defects/medical conditions who on 13-SEP-2010 was received intramuscularly at right deltoid with the first dose of PNEUMOVAX 23. On 14-SEP-2010 the patient developed high fever up to 103 F and swell local reaction- cellulitis for 6 days. The patient was treated with doxycycline and nonsteroidal antiinflammatory drugs (NSAIDS). The physician considered the patient's fever and cellulitis to be other important medical events. No further information is available.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site mass, Injection site rash, Rash erythematous, Skin reaction
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of 0.5ml of PNEUMOVAX 23 (Lot# 665925/0932Z) (Exp 07/18/2011), IM right arm. The medical assistant stated that on unspecified date the patient developed a lump and a big red spot at the injection site that traveled down the whole right arm 24 hours post vaccination. All drop down boxes apply to all five patients. At the time of the report the patient outcome was unknown, there were no diagnostics studies performed. The patient sought unspecified medical attention. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the medical assistant concerning the 74 year old female retired patient with no illness at time of vaccination and no adverse events following prior vaccination and with hypothyroidism, hypertension, dyslipidemia, atrial fibrillation and pulmonary hypertension who on 13-OCT-2010 at morning was vaccinated intramuscular in the left upper extremity with the first dose of PNEUMOVAX 23 (Lot# 665925/0932Z). Concomitantly on the same day, the patient received intramuscularly in the right upper extremity a first dose of FLUARIX (Lot# AFLLA616AA). On 14-OCT-2010, a large erythematous rash was noted on lateral aspect of left arm from mid deltoid recessed to elbow. No fever or infection. There were no laboratory tests or diagnostic studies performed. On 22-OCT-2010, the patient had recovered. The reporter considered the large erythematous rash to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # 664653/1337Y). Subsequently the patient experienced high fever. At the time of this report, the patient's outcome was unknown. Follow-up information has been received from a pharmacist who reported that the 34 year old male patient with quadriplegia and allergic to ZITHROMAX on 16-OCT-2010 was vaccinated into the left deltoid with a dose of PNEUMOVAX 23. The patient had received a dose of influenza virus split virion 3v vaccine inactivated (manufacturer unknown) on 12-OCT-2010. The pharmacist also reported that on 17-OCT-2010, the temperature of patient was 103.8 degrees, he had redness and swelling at the injection site (left deltoid); the patient was hospitalized (details not known by pharmacist). On an unspecified date the patient recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664653/1337Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information was received from a health care professional which reported that the 34 year old male patient with gastrooesophageal reflux disease (GERD), spasms, quadriplegia and urinary tract infection at the time of vaccination, who on 16-OCT-2010, was vaccinated in the left deltoid with the first dose of PNEUMOVAX 23 (Lot# 664653/1337Y). On 17-OCT-2010 at 13:00, the patient had elevated temperature, redness and swollen to the left deltoid. The patient was sent out to the emergency room. At the time of the report, the patient recovered (date unspecified). This is one of several reports received from the same source. No further information is available.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Injection site rash, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 vaccine (Lot # 664653/1337Y). Subsequently the patient experienced rash. At the time of this report, the patient's outcome was unknown. Follow-up information has been received from a pharmacist who reported that the 90 year old female patient with Coronary artery disease (CAD), depression, dementia, and no known allergies on 16-OCT-2010 was vaccinated into the right deltoid with a dose of PNEUMOVAX 23 vaccine. The patient had received a dose of influenza virus split virion 3v vaccine inactivated (manufacturer unknown) on 12-OCT-2010. The pharmacist also reported that on 17-OCT-2010, the patient had a rash on arm to elbow, afebrile. On an unspecified date the patient recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664653/1337Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the agency and was released. This is one of several reports received from the same source. Follow-up information has been received concerning a 90 year old female patient with Coronary artery disease (CAD), Alzheimer, depression and dementia who on 16-OCT-2010 was vaccinated into the right deltoid with the first dose of PNEUMOVAX 23 vaccine (Lot # 664653/1337Y). Not known illness at time of vaccination. It was reported that on 17-OCT-2010, the patient experienced a localized reaction to right deltoid swollen and warm to touch (previously reported had a rash on arm to elbow, afebrile). A complete blood count (CBC) was performed on an unspecified date (results not reported). On an unspecified date the patient recovered. Right deltoid swollen and warm to touch was considered an other important medical event by the reporter due to required medical/surgical intervention to prevent one of the outcomes listed. No further information is available.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 vaccine (Lot # 664653/1337Y). Subsequently the patient experienced rash. At the time of this report, the patient's outcome was unknown. Follow-up information has been received from a pharmacist who reported that the 90 year old female patient with Coronary artery disease (CAD), depression, dementia, and no known allergies on 16-OCT-2010 was vaccinated into the right deltoid with a dose of PNEUMOVAX 23 vaccine. The patient had received a dose of influenza virus split virion 3v vaccine inactivated (manufacturer unknown) on 12-OCT-2010. The pharmacist also reported that on 17-OCT-2010, the patient had a rash on arm to elbow, afebrile. On an unspecified date the patient recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664653/1337Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the agency and was released. This is one of several reports received from the same source. Follow-up information has been received concerning a 90 year old female patient with Coronary artery disease (CAD), Alzheimer, depression and dementia who on 16-OCT-2010 was vaccinated into the right deltoid with the first dose of PNEUMOVAX 23 vaccine (Lot # 664653/1337Y). Not known illness at time of vaccination. It was reported that on 17-OCT-2010, the patient experienced a localized reaction to right deltoid swollen and warm to touch (previously reported had a rash on arm to elbow, afebrile). A complete blood count (CBC) was performed on an unspecified date (results not reported). On an unspecified date the patient recovered. Right deltoid swollen and warm to touch was considered an other important medical event by the reporter due to required medical/surgical intervention to prevent one of the outcomes listed. No further information is available.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 60 year old female patient with asthma, gastrooesophageal reflux disease, hypertension, arthritis, cardiac failure congestive, pulmonary embolism and rhinitis allergic and no drug reactions/allergies, who on 26-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z Exp 18-JUL-2011). Concomitant therapy included warfarin, SINGULAIR, SYMBICORT, PREVACID, prednisone, potassium (unspecified), NASONEX, NAPROSYN, lisinopril, DARVOCET-N, calcium (unspecified), ALLEGRA-D, albuterol sulfate and albuterol sulfate. On 26-OCT-2010, at night, the patient began to develop redness, swelling, and heat at the injection site. She also had a fever. She was diagnosed with cellulitis. She received CIPRO. She recovered on 04-NOV-2010. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665925/0932Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information was received from a medical assistant who stated that the patient with no illness at time of vaccination "healthy", on 26-OCT-2010, was vaccinated IM in the right arm with a dose of PNEUMOVAX 23 (Lot# 665925/0932Z) at 14:30. It was reported also that on 26-OCT-2010 (also reported as 28-OCT-2010) at 12:45, the patient complaint of redness, pain, swelling at injection site, within 8-10 hours. The patient was seen in the office on 28-OCT-2010 for the same reason. Patient was given Ciprofloxacine 750 mg for 7 days. And on 01-NOV-2010 (previously reported as 04-NOV-2010), the condition resolved and patient recovered. The reporting physician considered cellulitis an other important medical event. No further information is available.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Medical Assistant concerning a 54 year old male patient with gastrooesophageal reflux disease, diabetes, hypertension, hyperlipidaemia and allergic rhinitis and no drug reactions/allergies, who on 01-NOV-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # 665925/0932Z). Concomitant therapy included PRILOSEC, metformin, glipizide, aspirin, CRESTOR, COREG and ASTEPRO. The same night of vaccination, the patient developed redness, swelling and heat at injection site. He also had a fever. The patient was diagnosed with cellulitis. The patient was treated with BACTRIM. At the time of the report, the patient was recovering. No laboratory diagnostics studies were performed. This is one of several reports from the same source. The reported is requesting a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Research Center and was released. Follow-up information has been received from a certified medical assistant who stated that the patient who on 01-NOV-2010, was vaccinated IM in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665925/0932Z). Approximately 8 hours later the patient experienced redness, stiffness, heat, swelling and pain at injection site. The patient returned to the physician's office on 03-NOV-2010 and was evaluated and treated for cellulitis with BACTRIM DS. It was also reported that on 19-NOV-2010 (also reported duration 5 days) the patient recovered. Cellulitis was reported to be an other important medical event. No further information is available.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: Information has been received from a Medical Assistant concerning a 54 year old male patient with gastrooesophageal reflux disease, diabetes, hypertension, hyperlipidaemia and allergic rhinitis and no drug reactions/allergies, who on 01-NOV-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # 665925/0932Z). Concomitant therapy included PRILOSEC, metformin, glipizide, aspirin, CRESTOR, COREG and ASTEPRO. The same night of vaccination, the patient developed redness, swelling and heat at injection site. He also had a fever. The patient was diagnosed with cellulitis. The patient was treated with BACTRIM. At the time of the report, the patient was recovering. No laboratory diagnostics studies were performed. This is one of several reports from the same source. The reported is requesting a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Research Center and was released. Follow-up information has been received from a certified medical assistant who stated that the patient who on 01-NOV-2010, was vaccinated IM in the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665925/0932Z). Approximately 8 hours later the patient experienced redness, stiffness, heat, swelling and pain at injection site. The patient returned to the physician's office on 03-NOV-2010 and was evaluated and treated for cellulitis with BACTRIM DS. It was also reported that on 19-NOV-2010 (also reported duration 5 days) the patient recovered. Cellulitis was reported to be an other important medical event. No further information is available.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 48 year old female patient with insomnia, anxiety, hyperlipidaemia and hypertension and no drug reactions or allergies who on 03-NOV-2010 was vaccinated intramuscular with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z, expiration date: 18-JUL-2011). Concomitant therapy included AMBIEN, XANAX, simvastatin (manufacturer unknown), estrogens, PREMARIN, NORVASC and aspirin. The medical assistant reported that the night of 03-NOV-2010, the patient began to develop soreness at the injection site. On 05-NOV-2010, she developed redness, swelling and heat at the injection site. She also had a fever. She was diagnosed with cellulitis. She received LEVAQUIN. No lab diagnostics studies were performed. At the time of the report the patient was recovering. The office requested a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Research Center and was released. Follow up information was received from a medical assistant who indicated that the patient on 03-NOV-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 in his left arm. Eight to ten hours later, the patient noticed redness, heat, pain and swelling in the area of injection. The patient returned to the physician's office on 05-NOV-2010 and was treated with LEVAQUIN 750 mg for seven days. At the time of the report, the condition had resolved. The medical assistant considered cellulitis to be an other important medical event. This is one of several reports received from the same source. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 48 year old female patient with insomnia, anxiety, hyperlipidaemia and hypertension and no drug reactions or allergies who on 03-NOV-2010 was vaccinated intramuscular with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z, expiration date: 18-JUL-2011). Concomitant therapy included AMBIEN, XANAX, simvastatin (manufacturer unknown), estrogens, PREMARIN, NORVASC and aspirin. The medical assistant reported that the night of 03-NOV-2010, the patient began to develop soreness at the injection site. On 05-NOV-2010, she developed redness, swelling and heat at the injection site. She also had a fever. She was diagnosed with cellulitis. She received LEVAQUIN. No lab diagnostics studies were performed. At the time of the report the patient was recovering. The office requested a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Research Center and was released. Follow up information was received from a medical assistant who indicated that the patient on 03-NOV-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 in his left arm. Eight to ten hours later, the patient noticed redness, heat, pain and swelling in the area of injection. The patient returned to the physician's office on 05-NOV-2010 and was treated with LEVAQUIN 750 mg for seven days. At the time of the report, the condition had resolved. The medical assistant considered cellulitis to be an other important medical event. This is one of several reports received from the same source. Additional information is not expected.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a registered pharmacist concerning a 34 year old male smoker patient, with penicillin allergy, diabetes, intractable gastric reflux, Touretts disorder, hematuria and headaches, who on 10-NOV-2010, while in the hospital recovering from "lapfundoplasty" surgery for intractable GERD, was vaccinated with a dose of PNEUMOVAX 23 (lot #, expire date and route not reported), 0.5 ml. Concomitant therapy included NEXIUM, GOLYTELY, nystatin, morphine, famotidine (MSD), TYLOX, LORTAB and doxycycline. On 10-NOV-2010 the patient was discharged from hospital and returned the next day (on 11-NOV-2010) with a 3 cm erythemic area at the injection site. The patient was sent home. On 12-NOV-2010 the patient returned to the hospital because the injection site reaction had grown to 6 to 7 cm and became indurated and on 12-NOV-2010 the patient was admitted to the hospital for observation. Injection site reaction had not yet been treated. At the time of the report, the patient had not recovered. Additional information has been requested. This is an amended report. Upon review of the file, the code medication error-inappropriate schedule of drug administered had been removed.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a male who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot# 667995/1150Z, expiration date on 4-MAR-2012). Subsequently the patient experienced cellulitis and fever after administration of PNEUMOVAX 23 and may have been hospitalized for two days (name of hospital was unknown). The patient was treated with antibiotics. She did not have the patient's chart so she could not provide patient specific information. She was requesting a lot check. A lot check has been initiated. The health care professional contacted during telephone follow up could not supply the following information: patient name, date of birth, date of vaccination, date of event, recovery status, and hospital name. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Headache, Nausea, Neck pain
Clinical narrative: Information has been received from a health care worker concerning a 54 years old female patient with arthritis and allergy to Ibuprofen, who on 07-MAR-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot # 667915/1111Z, Exp 02-MAR-2012) 0.5 ml, intramuscularly. Concomitant therapy included simvastatin (manufacturer unknown), ACIPHEX, SOMA, HALCION, NEURONTIN, PERCOCET and alendronate sodium. On 08-MAR-2011, the patient developed severe joint pain all over her body including neck, after receiving PNEUMOVAX 23 (lot # 667915/1111Z, Exp 02-MAR-2012). The patient also had headaches and nausea. It was reported that the patient received TYLENOL for the treatment of the Adverse events. The patient sought unspecified medical attention. No Lab diagnostics studies were performed. At the time of the report the patient's outcome was not recovered. The reporter requested a lot check due to the patient's adverse experiences. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the physician concerning the 54 year old female patient with IBP allergy and no illness at time of vaccination, who on 07-MAR-2011 at 9:00 am was vaccinated into the left arm with the second dose PNEUMOVAX 23 (lot # 667915/1111Z). The physician reported that on 08-MAR-2011 the patient developed diffuse arthralgias which required emergency room/doctor visit and resulted in persistent or significant disability/incapacity (weeks). At the time of the report, the patient had improved and diffuse arthralgias were better. Diffuse arthralgias were considered to be disabling by the reporting physician. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Electrocardiogram, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a health care worker concerning a 51 year old female patient with Chronic Obstructive Pulmonary Disease (COPD), Osteoarthritis and Reflex Sympathetic Dystrophy syndrome, and with no drug reactions or allergies reported, who on 11-MAR-2011 was vaccinated with a dose of 0.5 ml subcutaneous, PNEUMOVAX 23 (Lot #: 667416/0956Z exp: 17-DEC-2011). Concomitant therapy included ALLEGRA, PRAVACHOL, ZOLOFT, atenolol, hydrochlorothiazide (manufacturer unknown), alendronate sodium and KLONOPIN. The health care worker reported that on 11-MAR-2011 the patient developed an injection site reaction including soreness and pain with fever of 99.8 degrees F after receiving PNEUMOVAX 23 (Lot #: 667416/0956Z), and that the patient had been traveling toward her neck. The patient was admitted into the hospital on an unknown date and released the next day. An EKG and a blood work were performed (results not provided). The patient was given TYLENOL and nonsteroidal anti-inflammatory drug (NSAID) for the treatment of the AE. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 (Lot # unknown). The pharmacist reported that a colleague administered PNEUMOVAX 23 to the patient who had received it one year prior (date unknown). After the administration, the patient developed redness and swelling at the injection site. It is unknown if the patient sought medical attention. Follow up information has been received from the pharmacist concerning the 72 year old female patient with multiple myeloma, stage I who on 19-JUL-2010 at 17:15 was vaccinated with the second dose of PNEUMOVAX 23 SC. Patient's arm became swollen and red the day after administration. On 20-JUL-2010 at 08:00 the patient developed cellulitis. She had last PNEUMOVAX 23 one year previous and had reaction "now". The patient felt better after 2 doses of KEFLEX 500 mg (take one three times daily). On unspecified date, the patient recovered from cellulitis. The cellulitis, swollen and red in arms was considered to be an other important medical event by the reporter. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: Information has been received from a medical technologist concerning a 70 year old female patient with high cholesterol, osteoporosis and "EMY" allergy who on 26-AUG-2010 was vaccinated IM with the second 0.5 ml dose of PNEUMOVAX 23 (lot number 667136/0499Z, exp date 25-NOV-2011). The patient was vaccinated with the first dose of PNEUMOVAX 23 in 2005 with no adverse event reported. Concomitant therapies included: simvastatin, alendronate sodium and NASONEX. Her family called the office on 30-AUG-2010 to report the patient was in the hospital and receiving IV intravenous, antibiotics for a possible injection site reaction. No additional information is available at this time. Doctor was concerned about others having similar reactions with this lot of PNEUMOVAX 23 and was requesting a lot check. Intravenous antibiotics was considered to be an other important medical event by the reporter. Additional information has been received from a medical technologist reported that she was uncertain if the patient was still in the hospital. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a pharmacist concerning an 85 year old female patient with sulfonamide allergy who on 07-SEP-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665708/0651Z). The pharmacist reported that the patient in a long-term care facility received the PNEUMOVAX 23, and subsequently, on 09-SEP-2010 the patient developed an unspecified cellulitis surrounding the injection site that required treatment with unspecified antibiotics. It was unknown whether this was the patient's first dose of PNEUMOVAX 23. At the time of the report, the patient had not recovered. The patient's unspecified cellulitis surrounding the injection site was considered to be an other important medical event by the pharmacist. This is one of several reports from the same source. The pharmacist requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.