chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site oedema, Pain, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 34 year old male patient with no known drug allergies who on Jan 10, 2003, in the pm, was vaccinated IM in the left deltoid with a first dose of pneumococcal vaccine 23 polyvalent (lot #644104/0873M). It was noted that the patient had a upper respiratory infection at the time of vaccination. Subsequently the patient experienced a red, big, swollen arm that was warm to the touch. It as noted that he had a fever of 103 degrees F and his vaccinated arm was the size of a grapefruit at the injection site. The patient sought medical attention at the physician's office, but the nurse did not know what interventions were recommended by the doctor. The reporter would like a lot check. Follow up information indicated that on Jan 11, 2003, and Jan 12, 2003 in the am, the patient developed a fever of 103 F, was achy, fatigued, and had a red, swollen ,and hard left deltoid. It was noted that the patient recovered on Jan 15, 2003. It was noted that the patient did not seek medical attention as previously reported. No further information is available.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: Information has been received concerning a female patient, with no allergies who on 01/11/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M).  Subsequently the patient developed swelling "up under the arm, not at the injection site."  Unspecified medical attention was sought.  Follow up information was received from a physician concerning a 82 year old male patient (previously reported as female) who on 01/09/2003 (previously reported as 01/11/2003 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M) into the left arm.  Concomitant medication includes rofecoxib (MSD).  Subsequently, on 01/10/2003, the patient developed erythema on the side of the arm opposite of the injection site, 3 inches by 3 inches.  It was noted that the patient required a doctor visit.  It was reported that the patient recovered.  It was noted that a female (previously reported as  male) patient from the same source had a similar experience (WAES # 0301USA00989).  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered pharmacist concerning a 25 year old female nurse who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # not reported).  Following the vaccination the nurse experienced "severe local pain" at the injection site.  It was noted that it was unknown if this was the first injection of the vaccine.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Laboratory test abnormal, Pain, Pruritus
Clinical narrative: Information has been received from a medical assistant concerning a 33 year old female who on 01/08/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  On 01/10/2003 the patient returned to the physician's office with cellulitis, body aches and chills.  It was reported that on 01/08/2003 the patient's white blood cell count was 6.1.  On 01/10/2003 the patient's white blood cell count had increased to 18.9.  On 01/13/2003 the patient contacted the office and reported that her condition had improved but she still had some itching in the area of the cellulitis.  Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician concerning a 36 year old Caucasian male with asthma and a history of gun shot wound to the chest, with prolonged time on a ventilator in 1992, and subsequent ARDS.  On 01/15/2003 in the PM the patient was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M), SC (also reported as IM) in the right arm.  There was no illness at the time of vaccination.  Concomitant therapy included fluticasone propionate (+) salmetrol xinafoate (Advair Diskus 150), which reportedly on 01/15/2003, "he has been having a worse time breathing.  Initially he did well.  It was only in recent months he has had a problem."  Upon physical examination the patient's blood pressure was reported to be 120/70 and pulse 80, with respirations 20.  The patient was reportedly afebrile.  The patient had diffuse wheezing in his chest.  He had fairly good air exchange, with slightly prolonged expiratory phase.  There was "no severe distress at this time."  The patient's heart had a regular rate and rhythm.  There was no peripheral edema in the extremities or cyanosis or clubbing.  The patient's asthma was classified as "moderate".  Subsequently, 5 minutes after vaccination at 2:00PM, the patient was standing at the check out counter, he had a severe onset of throbbing sensation in his back, followed by back pain, back spasms in the lumbar area.  His legs became weak and they sat him down in a wheel chair and brought him back into the room.  He was having severe pain in his legs and were described as stiff.  It was reported that "when we gried to bend them they caused severe back pain."  He was not nauseated or diaphoretic.  The physician ruled out vasovagal reaction (BP 120/80 and pulse was 90 and regular).  His skin was pink and he was fully awake.  After about three to four minutes, he was sitting in the chair, it reportedly began easing up and within five minutes, he was standing back up on his feet and back to normal.  It was reported that "etiology of his problem remains (?) unknown."  The patient's severe low back pain with bilateral leg numbness lasted 5 minutes and then resolved, "it passed and the patient felt fine."  The patient was observed for another ten minutes and "he did well, and was released."  The patient sought unspecified medical attention.  It was noted that the patient did not have any adverse reactions following prior vaccinations.  It was also noted that the patient had a flu shot "back in October".  There were no relevant diagnostic tests or laboratory data.  No further information is expected.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site induration
Clinical narrative: Information has been received from a physician concerning a 55 year old Caucasian female with an allergy to penicillin who on 11/05/2002 in the AM was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 641116/1160L, Lot # 643251/0445M was also reported), subcutaneously.  There was not illness at the time of vaccination.  On 11/08/2002, the patient developed cellulitis of arm with induration.  There was no fever or other systemic effects reported.  It was noted that the patient did not have any adverse reactions following prior vaccinations.  It was also reported that the patient improved.  The patient sought unspecified medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 66 year old white female who on 01/10/2003 at 14:00 hours was vaccinated in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 644217/1026M). Concomitant therapy included acetaminophen (+) dextromethorphan hydrobromide (+) doxylamine succinate (+) pseudoepherine HCl (NYQUIL), aspring (A.S.A.), lansoprazole (PREVACID) and atorvastatin calcium (LIPITOR).  Illness at the time of vaccination included an upper respiratory infection (URI).  The LPN reported that on the evening of 01/11/2003, the patient developed erythema at the injection area.  The LPN also reported that the 17cm x 9 cm injection area was raised and hot to the touch.  Unspecified medical attention was sought.  On 01/20/2003, the patient's events resolved.  It was also reported that another patient developed injection site swelling, erythema, and warmth after being vaccinated with pneumococcal vaccine 23 polyvalent.  (WAES # 0303USA00340).  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Oedema, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a male patient who on 01/14/2003 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 641532/1353L).  There were no concomitant medications.  On 01/14/2003 at 14:00 hours the patient's arm was red at the injection site.  The patient was seen on 01/16/2003 and the patient's arm was red, swollen and hot to the touch.  The patient experienced pain from the injection site to the "mid" of his forearm.  He was sent to urgent care for follow up.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a male patient, who was well at the time of vaccination and with no history of allergies who was vaccinated on an unspecified date with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M).  Subsequently the patient developed a large red area at the site of the injection and a very sore arm.  Unspecified medical attention was sought.  On 01/21/2003 it was noted that the patient had recovered.  The physician would like an investigation into this particular lot.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The physician also reported that a female patient was vaccination with pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M) and had a sore, red arm (WAES # 0301USA01505).  Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Oedema
Clinical narrative: Information has been received from a medical assistant concerning a 78 year old retired, white male patient with no known drug allergies, relevant medical history or illnesses at time of vaccination who on 12/12/2002 at 08:00 was vaccinated IM in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644218/1027M).  Concomitant therapy was unspecified.  On 12/14/2002 the patient developed swelling and redness at the injection site 24-48 hours after vaccination.  The patient developed some swelling in the left upper arm down to mid forearm 48 hours after injection.  It was noted that the patient was afebrile with no fash or hives.  Subsequently, the patient recovered.  The reporter expressed concern with the lot.  The medical assistant reported on another male patient (WAES # 0212USA01466).  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  No further information is requested.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema, Pain, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning an 81 year old white female with allergies to penicillin and phenobarbital who on 10/30/2002 was vaccinated in the left arm with a second dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Concomitant vaccination on 10/30/2002 given IM in the right arm included a dose of influenza virus vaccine (FLUVIRIN)(Lot # E32852GA).  It was reported that the patient had several previous doses of the latter vaccine.  The patient had gallstones at the time of vaccination.  On 10/30/2002 the patient developed cellulitis of the left arm.  The patient had pain, redness, itching and swelling in the injected arm.  She was given cephalexin (KEFLEX) 500mg one four times daily.  The symptoms subsided in a few days.  It was reported that the patient recovered on 11/02/2002.  It was also reported that one other patient received the same vaccine and developed a cellulitis-type reaction (WAES # 0301USA02553).  No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site warmth, Petechiae
Clinical narrative: Information has been received from a registered nurse concerning a female nursing home resident with no known drug allergies who was vaccinated on an unspecified date with a second dose of pneumococcal vaccine 23 polyvalent (Lot # not reported).  It is unknown when she received the first dose.  Subsequently the patient experienced an injection site reaction.  The patient's arm was swollen from the shoulder to the elbow, petechiae formed over the entire arm and the area was hot to the touch.  The patient had no fever.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site warmth, Oedema, Rash erythematous
Clinical narrative: Information has been received from a woman in a physician's office concerning a female who was vaccinated with the second dose of pneumococcal vaccine 23 polyvalent (Lot # 644106/0819M).  the woman reported that the patient had an injection site reaction as her upper inner arm became red, hot, raised and swollen.  A diagnosis of cellulitis was subsequently made.  The patient sought unspecified medical and was treated with cephalexin (KEFLEX).  At the time of this report the outcome was unknown.  The woman also reported that another patient also developed cellulitis after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES # 0302USA00944).  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Feeling hot, Oedema, Tenderness
Clinical narrative: Information has been received from a physician's assistant concerning a 62 year old female with allergies to sulfa, amoxicillin/clavulanate potassium (Augmentin), nitrofurantoin macrocrytals (Macrobid), and cephalexin monohydrate (Keflex) who on Dec 5, 2002 was vaccinated in the left deltoid with a first dose of pneumococcal vaccine 23 polyvalent (lot#644106/0819M). There was no illness at the time of vaccination. On Dec 05, 2002 the patient experienced "left arm red, hot, swollen, tender, chills." Medical attention was sought at the doctor's office and antibiotics were given. The patient recovered on Dec 09, 2002. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema, Pain
Clinical narrative: Information has been received from a woman in a medical office concerning a female patient with a "non contributory" medical history who on Dec 5, 2002 was vaccinated in the left deltoid with a first dose of pneumococcal vaccine 23 polyvalent  (lot#644106/0819). Concomitant therapy included lansprazole (Prevacid), estrogens,conjugated (Premarin) and verapamil HCl (Verelan). There was no illness at the time of vaccination. On Dec 5,2002 the patient experienced a "red, hot, swollen, painful lef tupper arm." Medical attention was sought at the doctor's office antibiotics were given. The patient recovered on Dec 09, 2002. No further information is expected.
Age: 9.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 9 year old female patient with a diagnosis of nephrotic syndrome and no known drug allergies who on Feb 3, 2003 was vaccinated in the left arm with a first dose of pneumococcal vaccine 23 polyvalent (lot# 644107/0955M). Concomitant vaccinations the same day included influenza virus vaccine (Flushield) in the right arm. Other concomitant medication included prednisone. There was no illness at the time of vaccination. In the am of Feb 4, 2003 the patient experienced intermittent numbness and tingling of both feet for one day. Unspecified medical attention was sought. It was unknown if intervention was required. Follow up information from the physician indicated that no treatment or evaluation was necessary and that spontaneous resolution occurred. There were no diagnostic tests or laboratory results. The patient recovered on Feb 4, 2003. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a woman in a physician's office concerning a female who was vaccinated with the second dose of pneumococcal vaccine 23 polyvalent (Lot# 644106/0819M). The woman reported that the patient had an injection site reaction as her elbow became red and hot to the touch. A diagnosis of cellulitis was subsequently made. Unspecified medical attention was sought and the patient was treated with cephalexin (Keflex). At the time of this report, the outcome was unknown. The woman also reported that another patient had also developed cellulitus after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES0301USA03064). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Oedema
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose pneumococcal vaccine 23 polyvalent. The reporter indicated that the patient was revaccinated in less than two years time and experienced a "very significant swollen arm reaction." The reporter was unable to provide any additional specific patient information. The reporter also mentioned multiple patients who were vaccinated with a dose of pneumococcal vaccine 23 polyvalent and subsequently developed "sever reactions that were temporarily rebilitating including tingling in the arm and fingers that lasted five or more days" (WAES0302USA02407). Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: Information has been received from a physician concerning a 56 year old female,also reported at 57 years old, who on Oct 18, 2002, reported as Oct 18, 2003, was vaccinated in the left thigh with a first dose of pneumococcal vaccine 23 polyvalent (Lot# 643251/0445M). On Oct 18, 2002 in the PM, reported as Oct 18, 2003,on the night of vaccination, the patient developed local swelling, redness, and itching at the injection site, which was 5 inches by 4 inches in size. The reporter indicated that the patient recovered. Unspecified medical attention was sought. The reporter indicated that five or six patients experienced a sever injection site reaction after vaccination (WAES0303USA01861: WAES0303USA01727: WAES0303USA01728: WAES0303USA01730). No further information is expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Pain
Clinical narrative: Information has been received from a consumer concerning his 64 year old wife with no past medical history and allergies to diphenhydramine hydrochloride (Benadryl) and naproxen who in Oct 2002, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included alprazolam (Xanax), doxepin, acetaminophen/hydrocodone bitartrate (Vicodin Tablets) and alendronate sodium.  In Oct 2002, immediately after the  patient received the vaccination, she stated that"she felt something that felt like a silver dollar in her arm". Later that day, the patient's arm began to swell between her elbow and her shoulder. The reporter indicated that the patient still has pain at the injection site, and "it feels like there is a ball in her arm at the spot". It was also noted that she is also experiencing pain in that shoulder where she received a cortisone acetate (Corticone) injection. Unspecified medical attention was sought. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a 73 year old male who was vaccinated with pneumococcal vaccine 23polyvalent. The physician reported that the patient developed left upper extremity cellulitus. Unspecified medical attention was sought. Subsequently, the patient recovered from left upper extremity cellulitis. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Joint range of motion decreased, Oedema, Pain, Rash
Clinical narrative: Information has been received from a consumer concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot# 644218/1027M). Subsequently the patient developed a rash. The reporter had no other information to provide. Unspecified medical attention was sought. Follow up information from the physician indicated that the patient developed pain and swelling in the deltoid and shoulder area following vaccination. The reporter indicated that the patient could not lie down on that side and could not lift the arm because of pain. The patient went to the ER and was treated with an anti-inflammatory because"they thought it was cellulitis".  The reporter indicated that two other patients developed a rash after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot#644218/1027M) (WAES0302USA02959 and WAES0303USA01561). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Oedema, Pain
Clinical narrative: Information has been received from a consumer concerning a female physician who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot#644218/1027M). Subsequently the physician developed a rash. The reporter has no other information to provide. Unspecified medical attention was sought. Follow up information from the patient indicated that following vaccination the physician developed pain and swelling in her deltoid and shoulder area. She reported that she could not lie down on that side and that she could not lift her arm because of the pain. The physician stated that it was not cellulitis, and she was treated with an anti inflammatory and ice packs. Two other patients developed a rash after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot# 644218/1027M) (WAES0302USA02882 and WAES0303USA01561). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Laboratory test abnormal
Clinical narrative: Info has been received from a physician's assistant concerning a female who was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, 4 weeks later, the pt's titers were checked and the pt's response was "minimal." The pt sought unspecified medical attention. Additional info has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Malaise, Pain
Clinical narrative: Info has been received from a 64 year old male in sales with no medical history and no allergies who on 02/25/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #643249/0358M). There was no illness at the time of vaccination. There were no concomitant medications. On the afternoon of 02/25/2003, the pt developed general malaise with aches and pains, a site reaction that included left upper arm redness, swelling, pain and being "very hot". The redness and swelling spread into the axilla and down the left arm to 2+ inches below the elbow. The pt had a high temperature of 103 degrees for one day. Medical attention was sought and he was treated with ibuprophen 600 mg every 4 hours. Improvement was noted in a temperature decline and aches and pains within 2 days. The redness, heat and swelling continued for approx one week and were replaced by itching. It was reported that the pt's return to "normal" took approx 2 weeks. Subsequently, the pt recovered. It was also noted that the pt had an abnormal sedimentation rate and CRP which will be repeated in 3 months. Additional info has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Info has been received from a 64 year old male in sales with no medical history and no allergies who on 02/25/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #643249/0358M). There was no illness at the time of vaccination. There were no concomitant medications. On the afternoon of 02/25/2003, the pt developed general malaise with aches and pains, a site reaction that included left upper arm redness, swelling, pain and being "very hot". The redness and swelling spread into the axilla and down the left arm to 2+ inches below the elbow. The pt had a high temperature of 103 degrees for one day. Medical attention was sought and he was treated with ibuprophen 600 mg every 4 hours. Improvement was noted in a temperature decline and aches and pains within 2 days. The redness, heat and swelling continued for approx one week and were replaced by itching. It was reported that the pt's return to "normal" took approx 2 weeks. Subsequently, the pt recovered. It was also noted that the pt had an abnormal sedimentation rate and CRP which will be repeated in 3 months. Additional info has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Skin burning sensation
Clinical narrative: Info has been received from a consumer concerning a male pt who on 02/26/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #643249/0358M). The reporter indicated that the pt had a reaction at the injection site which was described as a burning and itching sensation. Unspecified medical attention was sought. Follow up information indicated that it is unknown if the patient recovered. Additional info has been requested.
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Influenza like illness, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a woman concerning a male who on 02/28/2003 was vaccinatd with pneumococcal vaccine 23 polyvalent.  The woman reported that in March 2003, her husband developed a sore throat, fatigue and flu-like symptoms.  The reporter felt that the sore throat, fatigue and flu-like symptoms were related to the pneumococcal vaccine 23 polyvalent vaccine.  At the time of this report, the outcome was unknown and the patient had not sought medical attention.  The woman also reported that her daughter also developed a sore throat, fatigue and flu-like symptoms after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES # 0303USA00342).  No further information is available.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a LPN concerning a 60 year old white retired male with penicillin allergy who on 01/06/2003 at 14:30, was vaccinated in the right deltoid with pneumococcal vaccine 23 polyvalent (Lot #644217/1026M).  Illness at the time of vaccination included conjuctivitis and upper respiratory infection.  The LPN reported that on 01/07/2003, the patient developed erythema at the injection area.  The area was also hot to the touch and a 17cm x 9cm section around the injection area was raised.  On 01/16/2003, the patient recovered from his events.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  It was also reported that another patient developed erythema and peripheral swelling after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES # 0303USA00340).  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Influenza like illness, Pharyngolaryngeal pain
Clinical narrative: Info has been received from a woman concerning a female who on 02/28/2003 was vaccinated with pneumococcal vaccine 23 polyvalent. The woman reported that in March 2003, her daughter developed a sore throat, fatigue and flu-like symptoms. The woman felt that sore throat, fatigue and flu-like symptoms were related to the pneumococcal vaccine 23 polyvalent vaccine. At the time of this report, the outcome was unknown and the pt had not sought medical attention. The woman also reported that her husband also developed a sore throat, fatigue and flu-like symptoms after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES #0030USA00155). No further info is available.
Sex: U
Vaccine: PPV
Symptoms: Dizziness, Injection site oedema, Rash, Vomiting
Clinical narrative: Info has been received from a surgical supply company concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641116/1160L). Subsequently the pt developed swelling, dizziness, vomiting and a rash. Unspecified medical attention was sought. "Dr. requests a lot check". The reporter also mentioned 2 other pts (WAES #0303USA00570 and 0303USA00571). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema
Clinical narrative: Info has been received from a female consumer with allergies to penicillin and bee stings, and no past medical history who in Dec 2000 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included estrogen. It was reported that over the next 2 days, her arm swelled up and then it went down. Unspecified medical attention was sought. Additional info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Info has been received from a surgical supply company concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #64116/1160L). Subsequently the pt developed a 3" red spot on the right bicep which lasted "for a long time". Unspecified medical attention was sought. "Dr. requests a lot check".  The reporter also mentioned 2 other pts (WAES #0303USA00409 and 0303USA00571).  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: Info has been received from a surgical supply company concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641116/1160L). Subsequently the pt developed a 4 cm red spot (still red after a week), chills after the 3rd day and a fever. Unspecified medical treatment was sought. "Dr. requests a lot check". The reporter also mentioned 2 other pts (WAES #0303USA00409 and 0303USA00570). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Injection site mass
Clinical narrative: Info has been received from a registered pharmacist concerning a female pt in her late 50's who on 03/10/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On 03/11/2003 the pt developed a severe headache, lightheadedness and a "huge knot-like swelling at injection site". Unspecified medical attention was sought. Additional info has been requested.
Age: 2.7
Sex: M
Vaccine: PPV
Symptoms: Rash pustular
Clinical narrative: Info has been received from a physician concerning a 31 month old male pt with a past medical history of otitis media, asthma, impetigo and mild eczema who on 02/14/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #644220/1119M), in the left leg. On 02/14/2003 the pt was reported to be "well at the time of the visit." The child had been prescribed an albuterol nebulizer treatment PRN, however it was noted that "he has not had to use the nebulizer." On 02/20/2003 the mother of the pt called into the office to report that the child had a rash with pus filled blisters in the left thigh at site of the injection. The child had a follow-up visit on 02/24/2003 and it was documented that the rash and pus filled blisters were resolving and were drying at the time of the visit. The pt was treated with cephalexin and polymyxin B sulfate, neomycin sulfate (Neosporin). The pt was diagnosed with possible impetigo, "unsure if vaccine related." Follow-up reported that the pt had "impetigo-like areas". It was also reported that the pt's brother had adverse symptoms following vaccination with pneumococcal vaccine 23 polyvalent (WAES #0302USA02744). Additional info has been requested.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Info has been received from a registered nurse concerning an 84-year-old male who on 03/11/2003 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (Lot #644219/1079M). The reporter indicated that the pt developed swelling around the upper arm, and the area became red and hard. It was noted that this has not yet resolved, and the pt has not yet been seen. Unspecified medical attention was sought. The reporter indicates that 2 other pts developed reactions after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #644219/1079M) (WAES #0303USA01441 and 0303USA)1442). The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Info has been received from a nurse practitioner concerning an adult female employee who approximately 2 weeks ago was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M). The reporter stated that now the pt had developed a macular, papular, itchy, generalized body rash on the neck, trunk, legs and feet, with feet being the worst. There was no fever. Unspecified medical attention was sought. Follow-up info was received which indicated that the reporter was unable to remember the pt's name. It was indicated that the pt recovered. No further info is expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: Info has been received from a woman in a medical office concerning a 65-year-old male with coronary artery disease and hypertension who on 11/21/2002 was vaccinated with pneumococcal vaccine 23 polyvalent (lot #643890/0679M-diluent vial), in the left deltoid. There was no illness at the time of vaccination. On 11/22/2002 the pt had left arm swelling and hot, achiness, fever and nausea. Subsequently, the pt recovered on 11/25/2002. Follow-up info reported that the pt "did not follow-up with clinic after reactions." No further info is expected.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Info has been received from a registered nurse concerning a 74-year-old male who on 02/26/2003 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (Lot #644219/1079M). It was reported that the pt developed swelling and redness. The pt has not been seen, and the reporter is not sure if the reaction has resolved. Unspecified medical attention was sought. The reporter indicated that 2 other pts developed reactions after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #644219/1079M) (WAES #0303USA01236 and 0303USA01442). The reporter expressed concern regarding the lot number. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research was released. Additional info has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Info has been received from a registered nurse concerning a 72-year-old male who on 03/11/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #644219/1079M). The reporter indicated that the pt developed swelling and redness. The pt is due to be seen. Unspecified medical attention was sought. The reporter indicated that 2 other pts developed reactions after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #644219/1079M) (WAES #0303USA01236 and 0303USA01441). The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain, Rash, Swelling
Clinical narrative: Info has been received from a consumer concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #644218/1027M). Subsequently the pt developed a rash. The reporter had no other info to provide. Unspecified medical attention was sought. Follow up info from the physician indicated that the pt developed pain and swelling in the deltoid and shoulder area following vaccination. The reporter noted that the pt could not lie down on that side and could not lift the arm because of the pain. The reporter indicated that 2 other pts developed a rash after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #644218/1027M) (WAES #0302USA02959 and 0302USA02882). Additional info has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Info has been received from a physician concerning a 75 year old female who on 10/30/2002 was vaccinated intramuscularly in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (Lot #643504/0735M). On 10/30/2002 concomitant therapy included an intramuscular dose of influenza virus vaccine (FLUZONE) (lot number U0920AA) in the right deltoid. On 10/30/2002 in the PM, the pt developed a local reaction at site of the pneumococcal vaccine 23 polyvalent with redness and itching, that was reported on 11/01/2002. Subsequently, the pt recovered. The physician also reported on 4 other pts (WAES #0302USA02179, 0303USA01861, 0303USA01728 and 0303USA01730). No further info is expected.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a physician concerning a 42 year old female pt who on 11/20/2002 was vaccinated with an intramuscular dose of pneumococcal vaccine 23 polyvalent (Lot #643504/0735M) in the left deltoid. On 11/21/2002 the pt developed a local reaction on left arm with swelling, redness and pain. It was unknown if the pt had recovered. Follow-up info revealed that the pt recovered. The physician also reported on 4 other pts (WAES #0302USA02179, 0303USA01861, 0303USA01727 and 0303USA01730). No further info is expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Info has been received from a physician concerning a 68 year old female pt who on 02/18/2003 was vaccinated intramuscularly in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot #644220/1119M). On 02/18/2002 the pt developed local swelling and redness at left arm. It was unknown if the pt had recovered. Follow-up info revealed that the pt recovered and had no discomfort on 03/27/2003. The physician also reported on 4 other pts with vaccine site reactions (WAES #0303USA01861, 0302USA02179, 0303USA01727 and 0303USA01728). No further info is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a nurse practitioner concerning an adult female with no drug allergies or illness at the time of vaccination who at 13:00 on 10/11/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #641116/1160L) IM in the right deltoid. On 10/11/2002, the pt subsequently developed redness, soreness and swelling. The pt was seen and was treated with warm compresses, acetaminophen (TYLENOL), and diphenhydramine (BENADRYL). The pt was told to elevate her arm. On 10/12/2002, the pt recovered. The nurse indicated that she would like a lot check performed on lot 641116/1160L. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No additional info is expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a nurse practitioner concerning a 72 year old female with gastroesophageal reflux, fibromyalgia, lumbar stenosis and allergies to penicillin, sulfa, diazepam (VALIUM), cephalexin (KEFLEX), iodine, azithromycin (ZITHROMAX), levofloxacin (LEVAQUIN), rofecoxib (MSD) (see WAES #0303USA02245), and an unspecified therapy, and no illness at the time of vaccination who at 10:00 on 10/24/2002 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 641116/1160L). Concomitant therapy included omeprazole (PRILOSEC). On 10/24/2002, the pt developed a red, swollen, painful arm and went to the ER. She was treated with warm compress to arm and elevation, acetaminophen (TYLENOL), and diphenhydramine (BENADRYL). The pt was given a prescription for unspecified steroids which she did not fill. The pt was seen by the nurse on day 2. On 10/28/2002, the pt recovered. The nurse indicted that she would like a lot check performed on lot 641116/1160L. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No additional info is expected.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pain, Pyrexia
Clinical narrative: Info has been received from a health professional concerning a 77 year retired male with gastro-esophageal reflux disease, hypertension, and angina who on the morning of 12/30/2002 was vaccinated in the right deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot #644104/0873M). There was no illness at the time of vaccination. On the afternoon of 12/30/2002, the pt called the physician's office and said he was "terribly sick" with pain in the right arm which was very red with edema on the upper arm and a fever. It was also reported that the arm was warm to the touch. Unspecified medical attention was sought. It was reported that on 01/02/2003 the pt recovered. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that 4 other pts had similar reactions after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #644104/0873M) (WAES 0303USA00947, 0301USA01143 and 0303USA01427). Additional info is not expected.
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site mass, Pain
Clinical narrative: Info has been received from a female pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). Subsequently, the pt developed a knot the size of a golf ball, warmth and tenderness at the injection site for 3 to 4 days. Medical attention was not sought. Additional info has been requested.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site warmth, Oedema
Clinical narrative: Information has been received from a health professional concerning an 82 year old white male who on 04/09/2003 was vaccinated with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (Lot # 644218/1027M).  On approximately 04/09/2003 the patient developed a fever, swelling, a sore area hot to the touch that was hard with bruising and a big lump.  On approximately 04/11/2003, "a couple days later", the patient recovered after being treated with unspecified antibiotics.  It was also noted that a 60 year old female patient was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644218/1027M) and developed the same symptoms (WAES # 0304USA01253).  No further information is expected.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a health professional concerning an 82 year old white male who on 04/09/2003 was vaccinated with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (Lot # 644218/1027M).  On approximately 04/09/2003 the patient developed a fever, swelling, a sore area hot to the touch that was hard with bruising and a big lump.  On approximately 04/11/2003, "a couple days later", the patient recovered after being treated with unspecified antibiotics.  It was also noted that a 60 year old female patient was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644218/1027M) and developed the same symptoms (WAES # 0304USA01253).  No further information is expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Information has been received from a MA concerning a 69 year old white female who on 03/18/2003 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645255/1212M).  There was no illness at the time of vaccination.  On 03/19/2003 the patient developed pain and severe erythema.  Medical attention was sought and the patient required prednisone.  Subsequently, the patient recovered.  It was also noted that a number of other patients were vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645255/1212M) and also developed swelling and pain (WAES # 0303USA02187).  No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a RN concerning a female patient who in 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  Subsequently in 2002, the patient had a "reaction to the pneumonia vaccine".  Five days post vaccination, the patient reported that by day 5 all of her signs and symptoms has resolved.  The reporter mentioned that other patients also had experiences following vaccination with pneumococcal vaccine 23 polyvalent (WAES # 0211USA02459, 0301USA00465, 0301USA00466, 0304USA01150).  Additional information has been requested.