chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Similar reaction on previous exposure to drug
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of swelling at injection site in a 31-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), TETANUS vaccine (Unknown manufacturer). A physician or other health care professional has not verified this report. The subject's medical history included seizure disorder. Concurrent medical conditions included high blood pressure. Concurrent medications included Blood pressure medication. On an unknown date in January 1998, approximately 1988 and 1984 the subject received unspecified doses of TETANUS vaccine (details unknown). On 19 November 2007 at 14:00 the subject received a dose of BOOSTRIX (unknown route, right arm). One hour after vaccination with BOOSTRIX, the subject experienced swelling at injection site that was approximately 1.5 inches tall and 3 inches round. The injection site reaction remained for approximately 4 weeks. One week after vaccination with BOOSTRIX, the subject experienced joint stiffness in every joint of his body, pain in all joints, muscular fatigue and muscle aches. The swelling at injection site resolved in December 2007. The joint stiffness, joint pain, muscular fatigue and muscle pain were unresolved at the time of reporting. The consumer reported that all blood work remains negative and no diagnosis has been made. The consumer also reported that he had experienced similar reactions after previous tetanus vaccinations in 1984, 1988 and January 1998, but that this reaction has been the most severe. He stated that he was hospitalized after previous tetanus vaccinations due to these symptoms. The consumer reported that he now has daily scheduled appointments with his doctor but has not been hospitalized.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: (L) injection (MMR & DTaP) 8/3/09 24 hrs later parent noted redness 48 later child c/o pain at injection site w/noted spreading erythema no assoc fevers.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse event, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Adverse effect fever 100.8, myalgias, redness @ injection site after administered.  6x8 cm area.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 10cm x 6cm area of induration, warmth, erythema at the (R) deltoid area, Non-tender to touch. Treatment prescribed: ATARAX 10mg tid x 4 days Orapred 30 mg once a day for 3 days.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Became pale 5 min after injection. Legs elevated. Fainted in chair. Eased down to floor by staff x 2. Easily aroused, oriented. BP 107/62. Skin warm, dry. CRT < 3 sec. Rested on floor x 5 min. Rested in chair x 10 min. Given juice/crackers. No injury sustained. Left with mother in stable medical condition.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever began a few hours after immunizations- reached 104. 1.
Age: 39.0
Sex: M
Vaccine: HIBV, MNQ, PPV
Symptoms: Back pain, Electrocardiogram, Full blood count, Headache, Injection site erythema
Clinical narrative: Headache, (leg, neck, and back pain) fever 103, tachycardic, Redness and Swelling in Right upper arm around injection site.
Age: 39.0
Sex: M
Vaccine: HIBV, MNQ, PPV
Symptoms: Injection site swelling, Neck pain, Pain in extremity, Pyrexia, Tachycardia
Clinical narrative: Headache, (leg, neck, and back pain) fever 103, tachycardic, Redness and Swelling in Right upper arm around injection site.
Age: 39.0
Sex: M
Vaccine: HIBV, MNQ, PPV
Symptoms: Urine analysis
Clinical narrative: Headache, (leg, neck, and back pain) fever 103, tachycardic, Redness and Swelling in Right upper arm around injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Erythema, Pain, Rash
Clinical narrative: Patient received vaccines- KINRIX, MMR, Varicella. On 7/28/09 morning: Developed red rash on the left cheek same day in the afternoon (approx. 1:00pm) non pruritic, did not progress, disappeared, lose in afternoon; feels "achy".
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Nasal congestion, Rhinorrhoea, Swelling face, Wheezing
Clinical narrative: Pt. c/o wheezing & swelling of face within one hour of receiving vaccination.  C/o nasal congestion and rhinorrhea, pt. has remote h/o asthma- and was out in field with hay- not sure if Rx was caused by vaccination or environmental allergies.  Temp outside was very warm & pt. was in car while dad came back into office to get shot record.  Pt. was given Breathing treatment of A/b/PULMICORT in office.  Dad called next day.  Pt. doing fine.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Loss of consciousness, Repetitive speech, Tremor
Clinical narrative: About 4 pm, pt was at a restaurant, felt lightheaded, and was trembling. She stood and passed out. Upon awakening pt kept repeating herself over and over. Has hx of absence sz , cut off DEPAKOTE x 3-4 years. Says she feels like she had a sz.  9/29/09 PCP medical records received DOS 8/5/2009. Assessment: Syncope. Call from patient's mother. Patient felt light headed, stood and fainted. Kept repeating herself.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme minor
Age: 0.9
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Rash
Clinical narrative: Diffuse rash to face, torso, buttocks.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Lt arm swollen, hot touch. Onset Aug 4th 2009. Tx-apply ice prn.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Rash macular, Skin warm
Clinical narrative: Right leg with 12cm macule, warm to touch
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Received DTAP shot (5th shot) on 8-3-09. On 8-4-09, arm was very swollen about 4 inches long with red and white in the middle. No drainage, tender to the touch. On 8-5-09, she had blisters around the injection site - small 1mm lesions. Seen in office on 8-5-09.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Computerised tomogram abnormal, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Day after vaccination Pt. experienced redness and swelling at site of injection, the following day the redness extended to her right elbow with swelling which spread below her elbow.  She also began to experience epigastric pain three to four hours after vaccination.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood creatine phosphokinase, Blood electrolytes, Blood glucose, Blood urea, Dizziness
Clinical narrative: Presented to urgent care clinic with shortness of breath, pale, lightheadedness, labs drawn, IV normal saline 500ml.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Full blood count, Pallor
Clinical narrative: Presented to urgent care clinic with shortness of breath, pale, lightheadedness, labs drawn, IV normal saline 500ml.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 76 year old female patient with food allergy to mango and no other medical history who was vaccinated with a 0.5 ml IM dose of PNEUMOVAX 23 greater than 5 years ago (lot # 658555/0964U). About 24 hours after receiving PNEUMOVAX 23 the patient experienced cellulitis of the arm at the injection site characterized by a very swollen, red and tender arm. No lab diagnostics studies were performed. At the time of this report, the adverse event was ongoing. The patient sought medical attention via office visit. Cellulitis of the arm at the injection site was considered to be disabling. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Impaired driving ability, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 66 year old female with no pertinent medical history and no known drug allergies who on 13-OCT-2008 was vaccinated with the first dose of PNEUMOVAX 23 (Lot#659199/1541U) IM right arm. After administration the patient experienced severe muscle pain in her right arm, "She would not let any touch her arm." She developed erythema of right arm with central induration at the injection site. The skin was warm to touch. The nurse considered these events to be disabling because the patient "is not able to drive". On the same day the patient also received influenza virus vaccine (manufacturer unspecified), but in the left arm. The patient sought medical attention and at the time of report on 16-OCT-2008, patient was not recovered. This is one of several reports received from the same source. Additional information has been requested. A standard lot check investigation was performed. 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.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Myalgia
Clinical narrative: Information has been received from a nurse concerning a 66 year old female with no pertinent medical history and no known drug allergies who on 13-OCT-2008 was vaccinated with the first dose of PNEUMOVAX 23 (Lot#659199/1541U) IM right arm. After administration the patient experienced severe muscle pain in her right arm, "She would not let any touch her arm." She developed erythema of right arm with central induration at the injection site. The skin was warm to touch. The nurse considered these events to be disabling because the patient "is not able to drive". On the same day the patient also received influenza virus vaccine (manufacturer unspecified), but in the left arm. The patient sought medical attention and at the time of report on 16-OCT-2008, patient was not recovered. This is one of several reports received from the same source. Additional information has been requested. A standard lot check investigation was performed. 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.
Age: 97.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 97 year old female patient with no pertinent medical history who was vaccinated with a 0.5 ml IM dose of PNEUMOVAX greater than 5 years ago (lot # 658555/0964U).  Concomitant therapy included influenza virus vaccine (unspecified).  About 24 hours after receiving PNEUMOVAX the patient experienced cellulitis of the arm at the injection site characterized by a very swollen, red and tender arm.  No lab diagnostics studies were performed.  At time of reporting, the adverse event is ongoing.  The patient sought medical attention via office visit.  Cellulitis of the arm at the injection site was considered to be disabling.  This is one of the several reports from the same source.  Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 19 year old male patient with rheumatoid arthritis who on 17-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot# 657525/0554U). Concomitant therapy included ENBREL and NAPROSYN. On 17-OCT-2008 the patient experienced cellulitis and fever. The patient is currently hospitalized. The physician requested that a lot check. This is one of several reports from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Epicondylitis, Influenza like illness, Nuclear magnetic resonance imaging abnormal, Oedema peripheral
Clinical narrative: Information has been received from a 49 year old male a ph. D. with an allergy to clindamycin and penicillin and asthma who on 10-OCT-2008 was vaccinated IM in the upper deltoid with PNEUMOVAX 23 (lot # not reported). Concomitant therapy included ADVAIR and pravastatin Na. The ph. D. reported he experienced some adverse effects after getting PNEUMOVAX 23. Around the weekend of 10-OCT-2008 the patient had swelling of the right arm, warmth, soreness and flu-like symptoms without fever. He was seen on 13-OCT-2008 because he was still having problems with arm. He was diagnosed with tendonitis and was put in a sling. On 17-OCT-2008 the pain got worse and he took MOTRIN, aspirin, or VICODIN. On Monday 20-OCT-2008 the patient could move his arm and the arm symptom was downgraded to a tennis elbow. The patient was recovering by the time of this report. Follow up information was received from the ph. D. who reported that he has not been able to play hockey for 2 months now (disabling) because his elbow still hurts. He had an MRI on his elbow which showed inflammation. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Skin warm, Tendonitis
Clinical narrative: Information has been received from a 49 year old male a ph. D. with an allergy to clindamycin and penicillin and asthma who on 10-OCT-2008 was vaccinated IM in the upper deltoid with PNEUMOVAX 23 (lot # not reported). Concomitant therapy included ADVAIR and pravastatin Na. The ph. D. reported he experienced some adverse effects after getting PNEUMOVAX 23. Around the weekend of 10-OCT-2008 the patient had swelling of the right arm, warmth, soreness and flu-like symptoms without fever. He was seen on 13-OCT-2008 because he was still having problems with arm. He was diagnosed with tendonitis and was put in a sling. On 17-OCT-2008 the pain got worse and he took MOTRIN, aspirin, or VICODIN. On Monday 20-OCT-2008 the patient could move his arm and the arm symptom was downgraded to a tennis elbow. The patient was recovering by the time of this report. Follow up information was received from the ph. D. who reported that he has not been able to play hockey for 2 months now (disabling) because his elbow still hurts. He had an MRI on his elbow which showed inflammation. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a first dose of PNEUMOVAX 0.5 mL.  Concomitant vaccination included a dose of influenza virus vaccine (unspecified) at the same visit.  The patient experienced an anaphylactic reaction after receiving PNEUMOVAX and the dose of influenza virus vaccine (unspecified).  The patient was seen at the emergency room and was treated with EPINEPHRINE.  At time of reporting, the patient had recovered.  The physician considered the anaphylactic reaction to be life threatening and other important medical event.  Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Full blood count, Oedema peripheral, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning an 81 year old female inpatient (acute ischemic MI) with diabetes, hypertension and hypothyroidism; history of ischemic stroke (admitted to hospital on 26-SEP-2008) and allergy to latex, codeine and PERCOCET who on 01-OCT-2008 was vaccinated with one dose of PNEUMOVAX 23 (lot #658493/0991U) IM in the left arm. Concomitant therapy included LEXAPRO, unspecified multivitamin, KEPPRA, ACTOS, CLARITIN, SENOKOT, NEXIUM, metformin, SYNTHROID, CORGARD, GLUCOTROL, LOVENOX and LIPITOR. On 02-OCT-2008 the patient developed cellulitis on the left arm. It was swollen, red and tender to the touch. The cellulitis prolonged the hospitalization. The patient was treated with KEFLEX. Complete blood cell count was performed. Subsequently, she recovered from the cellulitis. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Chills, Erythema, Injection site erythema
Clinical narrative: Information has been received from a certified medical assistant concerning a 61 year old male patient with coronary artery disease, hypertension, depression and hyperlipidaemia, with no known drug reactions/allergies, who on 07-OCT-2008 was vaccinated with PNEUMOVAX 23 (Lot No #660718/0551X), 0.5 ml, intramuscularly. Concomitant therapy included bupropion HCl, losartan potassium, KLONOPIN, CRESTOR, nefazodone HCl and aspirin. On 08-OCT-2008 the patient developed pain, swelling, and redness at injection site. The patient had fever and chills. On 10-OCT-2008, the patient had a persistent fever of 103.6 F, erythema and pain at the right shoulder. The patient was prescribed KEFLEX. On 11-OCT-2008, the patient went to the ER and was admitted for further treatment. The patient was given ROCEPHIN GR and BACTRIM DS. The certified medical assistant reported that the redness got progressively worse. According to the patient's office chart, the patient didn't have fever but the ER notes documented a temperature of 101 F with chills. The patient was released on 13-OCT-2008. On 17-OCT-2008, the certified medical assistant reported that it was noted in the office chart that the patient was treated for right arm cellulitis. The patient was given vancomycin. The certified medical assistant reported that further notes on that day said "skin: right arm, lateral, mildly red, minimally swollen, no temp. The diagnosis was "cellulitis". Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal pain, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 61 year old male patient with coronary artery disease, hypertension, depression and hyperlipidaemia, with no known drug reactions/allergies, who on 07-OCT-2008 was vaccinated with PNEUMOVAX 23 (Lot No #660718/0551X), 0.5 ml, intramuscularly. Concomitant therapy included bupropion HCl, losartan potassium, KLONOPIN, CRESTOR, nefazodone HCl and aspirin. On 08-OCT-2008 the patient developed pain, swelling, and redness at injection site. The patient had fever and chills. On 10-OCT-2008, the patient had a persistent fever of 103.6 F, erythema and pain at the right shoulder. The patient was prescribed KEFLEX. On 11-OCT-2008, the patient went to the ER and was admitted for further treatment. The patient was given ROCEPHIN GR and BACTRIM DS. The certified medical assistant reported that the redness got progressively worse. According to the patient's office chart, the patient didn't have fever but the ER notes documented a temperature of 101 F with chills. The patient was released on 13-OCT-2008. On 17-OCT-2008, the certified medical assistant reported that it was noted in the office chart that the patient was treated for right arm cellulitis. The patient was given vancomycin. The certified medical assistant reported that further notes on that day said "skin: right arm, lateral, mildly red, minimally swollen, no temp. The diagnosis was "cellulitis". Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Blood urine present, Erythema, Injection site cellulitis, Pain in extremity, Urinary tract infection
Clinical narrative: Initial and follow up information has been receiving from a healthcare worker concerning a 27 year old female patient with a hypothyroid and a history of ovarian cyst and gastroenteritis, who on 01-NOV-2008 at 12:45 was vaccinated with a dose of PNEUMOVAX (lot # 660685/0619X). Concomitant vaccination included influenza virus vaccine (unspecified) (manufacturer unknown). On 04-NOV-2008 the patient developed cellulitis of the arm, at the injection site, after receiving the vaccine, and was placed on CEFTRIAXONE SODIUM (manufacturer unknown), 1gr, intramuscularly. On 05-NOV-2008 the patient sought medical attention, through an office visit and complained of arm pain, at that time therapy with BACTRIM was continued. Telephone memo information received on 11-NOV-2008 contained the following information: on 03-NOV-2008, the patient was seen by the physician. The patient complained that she thought that she had a possible allergic reaction to PNEUMOVAX vaccine. On 03-NOV-2008 the patient was diagnosed with a urinary tract infection (UTI) and was placed on BACTRIM, twice a day. The health care worker stated the patient's urine was positive for blood and leukocytes. On 04-NOV-2008, the patient returned to the physician's office and complained that her arm pain was worse. The patient was diagnosed with cellulitis. The patient was treated with ROCEPHIN, 1gm, IM and therapy with BACTRIM continued. On 05-NOV-2008 the health care worker stated the patient was seen again at the physician's office and still complained of arm pain and BACTRIM continued. The patient had not been in the physician's office since 05-Nov-2008. On follow up information received on 12-DEC-2008 was stated that the patient was vaccinated in the right deltoid and developed erythema (18cm X 18cm). The patient recovered after about 2 weeks. The cellulitis of the arm, at the injection site was considered to be disabling. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. This is one of two reports from the same source. No further information is available.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Urine analysis abnormal, White blood cells urine positive
Clinical narrative: Initial and follow up information has been receiving from a healthcare worker concerning a 27 year old female patient with a hypothyroid and a history of ovarian cyst and gastroenteritis, who on 01-NOV-2008 at 12:45 was vaccinated with a dose of PNEUMOVAX (lot # 660685/0619X). Concomitant vaccination included influenza virus vaccine (unspecified) (manufacturer unknown). On 04-NOV-2008 the patient developed cellulitis of the arm, at the injection site, after receiving the vaccine, and was placed on CEFTRIAXONE SODIUM (manufacturer unknown), 1gr, intramuscularly. On 05-NOV-2008 the patient sought medical attention, through an office visit and complained of arm pain, at that time therapy with BACTRIM was continued. Telephone memo information received on 11-NOV-2008 contained the following information: on 03-NOV-2008, the patient was seen by the physician. The patient complained that she thought that she had a possible allergic reaction to PNEUMOVAX vaccine. On 03-NOV-2008 the patient was diagnosed with a urinary tract infection (UTI) and was placed on BACTRIM, twice a day. The health care worker stated the patient's urine was positive for blood and leukocytes. On 04-NOV-2008, the patient returned to the physician's office and complained that her arm pain was worse. The patient was diagnosed with cellulitis. The patient was treated with ROCEPHIN, 1gm, IM and therapy with BACTRIM continued. On 05-NOV-2008 the health care worker stated the patient was seen again at the physician's office and still complained of arm pain and BACTRIM continued. The patient had not been in the physician's office since 05-Nov-2008. On follow up information received on 12-DEC-2008 was stated that the patient was vaccinated in the right deltoid and developed erythema (18cm X 18cm). The patient recovered after about 2 weeks. The cellulitis of the arm, at the injection site was considered to be disabling. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. This is one of two reports from the same source. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a healthcare worker concerning a patient (gender not specified) who on an unspecified date was vaccinated with PNEUMOVAX 23, Lot number 660685/0619X. It was reported that the patient developed cellulitis from PNEUMOVAX 23. The patient was hospitalized overnight. At the time of the report, it was reported that the patient had not recovered. Follow up information has been received from the medical assistant, who requested a lot check. No additional information was provided. A standard lot check was performed. All in process quality checks for the lot number 660685/0619 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 and was released. This is one of several reports concerning the same source. This is an amended report. On the AE screen for the event of cellulitis, the criteria hospitalization prolonged was changed from yes to unknown. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 79 year old female who on 03-NOV-2008 was vaccinated with PNEUMOVAX, Lot number 662687/0983X. Concomitant therapy included flu vaccine (manufacturer not reported) in the same arm. It was reported that the patient on 04-NOV-2008 had a red and swollen arm at the injection site where the PNEUMOVAX was given. The patient was hospitalized and given IV steroids. At the time of the report the patient was recovering. The patient sought medical attention, contacted physician. This is one of several reports concerning the same source. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an 85 year old male who on 04-NOV-2008 was vaccinated with PNEUMOVAX Lot no. 661577/1161X). The pharmacist reported that the patient was given influenza virus vaccine (unspecified) few days earlier in the opposite arm. On 05-NOV-2008 the patient had a large red swollen area at injection site were the PNEUMOVAX was given. The patient was admitted to the hospital and diagnosed with cellulitis. It was reported that the patient was treated with intravenous steroids. This is one of 3 reports from the same source. Additional information has been requested. This is an amended report. The patient received influenza virus vaccine (unspecified) in approximately November 2008.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Dermatitis allergic, Erythema, Induration, Injection site cellulitis, Myalgia
Clinical narrative: Initial and follow up information has been received from a healthcare worker concerning a 36 year old female patient who on 30-OCT-2008 at 09:55 was vaccinated with a dose of PNEUMOVAX 23 (lot # 660685/0619x). Concomitant vaccination included influenza virus vaccine (unspecified) (manufacturer unknown). On an unspecified date the patient developed cellulitis of the arm, at the injection site, after receiving the vaccine; on 03-NOV-2008 the patient was diagnosed with "allergic dermatitis with myalgia due to the pneumonia vaccine". The patient sought medical attention, through an office visit. On follow up information received on 12-DEC-2008 the patient developed erythema and induration in the right deltoid. The patient recovered about 1 week later. The cellulitis of the arm, at the injection site was considered to be disabling. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. This is one of two reports from the same source. No further information is available.
Age: 18.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from an office manager concerning a female who on 26-NOV-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot #656439/0577U). On an unspecified date the patient developed cellulitis and was hospitalized. At the time of this report, it was unknown if the patient was still hospitalized or her present status. A standard lot check investigation was performed. 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 and was released. Follow-up information was received from the office manager via medical records which reported that on 26-NOV-2008 the 18 year old female patient was vaccinated with a dose of PNEUMOVAX 23 (lot #656439/0577U) in the left arm. On the same day, the patient also received a dose of FLUZONE (lot # U2853AB) in the left arm. Thereafter, on approximately 28-NOV-2008, the patient developed fever, headache, left arm pain and was seen in the doctor's office where they noted her to have an elevated white count of 33000. On 28-NOV-2008, the patient was sent to the hospital for further evaluation. Upon admission, the child was afebrile. The left upper arm was red, indurated and tender all around the entire injection site. The rest of the physical exam was normal. Upon admission the white count in the hospital was 25.4. During the hospital stay, there was a repeat white count the day after admission where the white count had gone down to 17000. The child continued on TORADOL and MOTRIN for pain. There was an infectious disease consult which another physician thought that it might have either been a local reaction to the vaccination of PNEUMOVAX 23 versus a cellulitis of the area. During the hospital course the child was treated with UNASYN IV. She defervesced and her redness and swelling of her arm gradually improved. She was discharged home on 02-DEC-2008 to continue P.O. AUGMENTIN XR, 1 tablet, twice a day for 1 week. It was reported that the patient had fully recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from an office manager concerning a female who on 26-NOV-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot #656439/0577U). On an unspecified date the patient developed cellulitis and was hospitalized. At the time of this report, it was unknown if the patient was still hospitalized or her present status. A standard lot check investigation was performed. 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 and was released. Follow-up information was received from the office manager via medical records which reported that on 26-NOV-2008 the 18 year old female patient was vaccinated with a dose of PNEUMOVAX 23 (lot #656439/0577U) in the left arm. On the same day, the patient also received a dose of FLUZONE (lot # U2853AB) in the left arm. Thereafter, on approximately 28-NOV-2008, the patient developed fever, headache, left arm pain and was seen in the doctor's office where they noted her to have an elevated white count of 33000. On 28-NOV-2008, the patient was sent to the hospital for further evaluation. Upon admission, the child was afebrile. The left upper arm was red, indurated and tender all around the entire injection site. The rest of the physical exam was normal. Upon admission the white count in the hospital was 25.4. During the hospital stay, there was a repeat white count the day after admission where the white count had gone down to 17000. The child continued on TORADOL and MOTRIN for pain. There was an infectious disease consult which another physician thought that it might have either been a local reaction to the vaccination of PNEUMOVAX 23 versus a cellulitis of the area. During the hospital course the child was treated with UNASYN IV. She defervesced and her redness and swelling of her arm gradually improved. She was discharged home on 02-DEC-2008 to continue P.O. AUGMENTIN XR, 1 tablet, twice a day for 1 week. It was reported that the patient had fully recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician and a licensed practical nurse (L.P.N.) concerning a 71 year old male with hypertension, diabetes and a history of right cataract extraction and no drug allergies who on 02-JAN-2009 was vaccinated IM into the left deltoid with a 0.5ml dose of PNEUMOVAX 23 (lot # 663012/1163X). Concomitant therapy included "9 (unspecified) medications". It was reported that the patient received PNEUMOVAX 23 in the past with no problems. On 02-JAN-2009 the patient experienced the injection site being red, swollen and painful. The patient sought medical attention at physician's office. The physician believed the patient had cellulitis and had a white blood cell count of 18000. The patient was hospitalized, and still in hospital at the time of reporting. Unspecified lab work was performed in hospital. The adverse events were considered to be immediately life-threatening, the patient was on vancomycin I.V. and clindamycin I.V. 900mg every 8 hours. As of 05-JAN-2009, the patient was recovering. The reporter considered the adverse experiences to be other important medical events. This is one of several reports received from the same source. A standard lot check investigation was performed. 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 and was released.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a physician and a licensed practical nurse (L.P.N.) concerning a 71 year old male with hypertension, diabetes and a history of right cataract extraction and no drug allergies who on 02-JAN-2009 was vaccinated IM into the left deltoid with a 0.5ml dose of PNEUMOVAX 23 (lot # 663012/1163X). Concomitant therapy included "9 (unspecified) medications". It was reported that the patient received PNEUMOVAX 23 in the past with no problems. On 02-JAN-2009 the patient experienced the injection site being red, swollen and painful. The patient sought medical attention at physician's office. The physician believed the patient had cellulitis and had a white blood cell count of 18000. The patient was hospitalized, and still in hospital at the time of reporting. Unspecified lab work was performed in hospital. The adverse events were considered to be immediately life-threatening, the patient was on vancomycin I.V. and clindamycin I.V. 900mg every 8 hours. As of 05-JAN-2009, the patient was recovering. The reporter considered the adverse experiences to be other important medical events. This is one of several reports received from the same source. A standard lot check investigation was performed. 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 and was released.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Drug administered at inappropriate site
Clinical narrative: Information has been received from a pharmacist concerning a 41 year old female with breast cancer and morphine allergy who on 30-JAN-2009 was vaccinated with a dose of PNEUMOVAX 23 in the left gluteus, and then presented with cellulitis on 02-FEB-2009. The patient was hospitalized for the cellulitis. Follow up information received on 13-APR-2009 stated that there was no other information available. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a consumer concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 (lot #662018/1332X). Subsequently the patient experienced an unknown reaction that resulted in the patient being hospitalized for an unknown length of time (location unspecified). At the time of reporting, the outcome was unknown. The patient sought medical attention via visiting physician going to hospital. No further information is available.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a registered pharmacist concerning a 46 year old male with penicillin allergy. On 07-MAR-2009 the patient was hospitalized for an unknown reason. While hospitalized on 08-MAR-2009 the patient was vaccinated with a dose of PNEUMOVAX 23 and a dose of FLUZONE and discharged. On 10-MAR-2009 the patient was readmitted to the hospital for cellulitis reaction to PNEUMOVAX 23. The patient experienced fever of 103F. He had redness and pain at the PNEUMOVAX 23 injection site. The patient was treated with vancomycin. The lot number of the PNEUMOVAX 23 could not be identified and no lot check required. White blood cell count (WBC) was performed with result 20.1x1000. At the time of this report, the patient was recovered. Follow-up information was received from the registered pharmacist. The pharmacist refused to give the patient's name. The patient was admitted to the hospital on 07-MAR-2009 for back surgery (type not reported). The patient was discharged from the hospital on 09-MAR-2009. The patient was diagnosed with cellulitis and readmitted to the hospital on 10-MAR-2009. The patient was discharged from the hospital on 13-MAR-2009. The pharmacist stated that she did not have the PNEUMOVAX 23 lot number. This is one of several reports from the same source. No further information is available.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a registered pharmacist concerning a 46 year old male with penicillin allergy. On 07-MAR-2009 the patient was hospitalized for an unknown reason. While hospitalized on 08-MAR-2009 the patient was vaccinated with a dose of PNEUMOVAX 23 and a dose of FLUZONE and discharged. On 10-MAR-2009 the patient was readmitted to the hospital for cellulitis reaction to PNEUMOVAX 23. The patient experienced fever of 103F. He had redness and pain at the PNEUMOVAX 23 injection site. The patient was treated with vancomycin. The lot number of the PNEUMOVAX 23 could not be identified and no lot check required. White blood cell count (WBC) was performed with result 20.1x1000. At the time of this report, the patient was recovered. Follow-up information was received from the registered pharmacist. The pharmacist refused to give the patient's name. The patient was admitted to the hospital on 07-MAR-2009 for back surgery (type not reported). The patient was discharged from the hospital on 09-MAR-2009. The patient was diagnosed with cellulitis and readmitted to the hospital on 10-MAR-2009. The patient was discharged from the hospital on 13-MAR-2009. The pharmacist stated that she did not have the PNEUMOVAX 23 lot number. This is one of several reports from the same source. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female who on 24-JUL-2008 was vaccinated with a dose of PNEUMOVAX 23 (unspecified which dose, lot # not reported). On 24-JUL-2008 the patient experienced cellulitis. The patient had redness and swelling at the injection area. The patient sought an unspecified medical attention. She was treated with LEVAQUIN. It did not resolve and was further treated with AUGMENTIN. She was already in the hospital for another cause and this may have prolonged the stay. The patient recovered on an unspecified date. Follow-up information was received on 09-APR-2009 from pharmacist who reported that the patient was admitted to the hospital on 23-JUL-2008 for alcohol withdrawal. It was reported that the patient was discharged from the hospital on 26-JUL-2008. This is one of several reports from the same source. No further information is available.
Age: 1.1
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 1 year old male patient, who on 15-FEB-2008 at 11:00 was vaccinated IM in the left thigh with a 0.5mL second dose of PNEUMOVAX 23 (Lot# 658449/0989U) instead of PREVNAR. Concomitant suspect vaccination included a second dose of PEDVAXHIB (Lot# "UF208AB") administered IM in the left thigh. Concomitant vaccination included a second dose of DAPTACEL (Lot# C2797AA) administered IM in the right thigh. The patient had no adverse reactions. It was reported that this was a medication error because the staff was not careful in checking the vials before administration of the vaccine. One staff member removed the vaccine from the storage area and the second staff member administered the vaccine. It was indicated that the person administering the vaccine should have checked that the correct vaccine was removed from the storage area. The patient did not seek medical attention. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a physician and a licensed practical nurse concerning a 68 year old female patient with drug hypersensitivity to codeine and no medical history reported, who on 28-MAY-2008 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 658074/0803U). Concomitant therapy included LESCOL, DIOVAN, calcium (unspecified), omeprazole, glucosamine, XALATAN eyedrops, LEVOTHROID and LACTAID CAPLETS. On 29-MAY-2008 the patient developed a fever of 100.6 Fahrenheit, body aches, chills, and a local reaction at the injection site on the left arm. On 30-MAY-2008 the patient sought medical attention during an office visit. The fever was gone, but she was still achy and felt bad. The left arm was red and swollen. Her throat and chest were clear. Her neck was supple with no masses. Respirations were not compromised. The patient was treated with TYLENOL. She did not know if this was her first dose of PNEUMOVAX 23. Subsequently, the patient recovered. No product quality complaint was involved. No further information is available.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Urine analysis
Clinical narrative: Initial and follow up information has been received from a physician and a licensed practical nurse concerning a 68 year old female patient with drug hypersensitivity to codeine and no medical history reported, who on 28-MAY-2008 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 658074/0803U). Concomitant therapy included LESCOL, DIOVAN, calcium (unspecified), omeprazole, glucosamine, XALATAN eyedrops, LEVOTHROID and LACTAID CAPLETS. On 29-MAY-2008 the patient developed a fever of 100.6 Fahrenheit, body aches, chills, and a local reaction at the injection site on the left arm. On 30-MAY-2008 the patient sought medical attention during an office visit. The fever was gone, but she was still achy and felt bad. The left arm was red and swollen. Her throat and chest were clear. Her neck was supple with no masses. Respirations were not compromised. The patient was treated with TYLENOL. She did not know if this was her first dose of PNEUMOVAX 23. Subsequently, the patient recovered. No product quality complaint was involved. No further information is available.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old male with adverse drug reaction/allergy to ADVIL, who was hospitalised for an unrelated condition, and who on 03-JUN-2008 was vaccinated with PNEUMOVAX 23, subcutaneously to the right arm.  Within 24 hours, 04-JUN-2008, the patient developed swelling at injection site 9 x 7 centimeters, erythema and induration at injection site. It was reported that the patient had not recovered, but the reaction did not prolong his hospitalisation. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received concerning a patient who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot# not provided). Subsequently on an unspecified date the patient experienced redness at injection site. No further information was available. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Local reaction
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 70 to 80 year old male patient who on 11-JUN-2008, was vaccinated IM with a 0.5ml dose of PNUEMOVAX 23 (Lot# 657145/1226U). On 11-JUN-2008 within 12 hours of the vaccination, the patient experienced an injection site reaction. The reaction was a red, raised area of 3 to 6 cm at the injection site, also described as a localized reaction. It was being treated with ice. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of three reports from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a nurse concerning a "70 - 80 year old" female who is a patient in a rehabilitation hospital, who on 11-JUN-2008 was vaccinated intramuscularly with PNEUMOVAX 23 (Lot # 657145/1226U; site not reported). It was unknown whether this was the patient's first vaccination with PNEUMOVAX 23. On 11-JUN-2008 the patient developed a "localized" injection site reaction. The reaction was a red, raised area of 3 - 6 cm at the injection site. The patient sought medical treatment by seeing the nurse and the injection site reaction was being treated with ice to the area. AT the time of reporting, the patient was recovering. No additional information was provided. This is one of three reports from the same reporter. No additional information is available.