chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.3
Sex: F
Vaccine: PNC
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: Info regarding Prevnar vaccine was received from a healthcare professional regarding a 15 month old female pt who experienced injection site cellulitis. The pt received the fourth dose in 5/2005. The pt's concurrent illnesses include dermatitis atopic and urinary tract infection. Indication for Prevnar was immunization. Product was administered in 5/2005. Dose regimen was 1 dose, IM. Concomitant medications were not provided. Event Details: The pt experienced injection site cellulitis on 5/11/05. Site of administration was the left thigh. The pt recovered (May-2005). No additional info was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Crying, Injection site hypersensitivity, Injection site pain
Clinical narrative: Info regarding Prevnar vaccine was received from a healthcare professional regarding an unconfirmed number of babies who have screamed as though they were in more pain/stinging sensation than when they were administered other vaccines. The babies received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. Event Details: While being administered the Prevnar vaccine, an unconfirmed number of babies have screamed as though they were in more pain/stinging sensation than they were administered other vaccines. No additional info was available at the time of this report. Mfr's comment: The reporter was unable to specify the number of patients who experienced these events. Additional reports will be generated when identifying info is provided.
Sex: U
Vaccine: PNC, UNK
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Info regarding Prevnar vaccine was received from a healthcare professional regarding a pt who experienced injection site swelling and injection site knot. The pt received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day, IM. Concomitant therapy included unspecified vaccines. EVENT DETAILS: The reporter stated that one or two pts developed knotted swelling at the injection site and injection site induration. This is one of two reports from this facility where a pt developed knotted swelling following receipt of Prevnar. No additional info was available at the time of this report.
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Info regarding Prevnar vaccine was received from a healthcare professional regarding a 12 month old female pt who experienced injection site swelling immediate. The pt received the fourth dose in Feb/2006. The pt also received a dose of Varivax in Feb/2006. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered in Feb/2006. Dose regimen was 1 dose 1 time per day, IM. Concomitant therapy included Varivax vaccine. EVENT DETAILS: The pt experienced injection site swelling immediately post/vax at the administration site. The pt remained in the physician's office for 30 minutes for observation. No treatment medications were given. The date of recovery was not provided. No additional info was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Info regarding Prevnar vaccine was received from a healthcare professional regarding a 2 year old male pt who experienced injection site swelling and injection site knot. The pt received a dose on an unspecified date. Relevant medical history was not provided.  Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 Dosage Form 1 time per day, IM. Patient was not taking concomitant therapy. EVENT DETAILS: This is one of two pts from this facility who developed the same reaction following receipt of Prevnar. No additional info was available at the time of this report.
Age: 0.1
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Info regarding Prevnar vaccine was received from a healthcare professional regarding a 2 month old male pt who experienced injection site redness and injection site lump. At 2 months of age, the pt received a dose on 7/20/05. Pt had no relevant medical history. Indication for Prevnar was immunization. Product was administered on 7/20/05. Dose regimen was 1 dose, IM. Pt was not taking concomitant therapy. EVENT DETAILS: On 7/20/05, the pt received 1 dose of Prevnar. The very next day, pt experienced a red lump at the injection site. Pt was treated with ice, diphenhydramine and Tylenol for the discomfort. No further info was provided. Added note: Caller stated that 2 pts experienced the same event.
Age: 0.33
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from healthcare professional regarding a 4 month old female pt who experienced injection site redness and injection site lump. At 4 months of age, the pt received a dose on 24Aug05. Pt had no relevant medical history. Indication for Prevnar was immunization. Product was administered on 24Aug05. Dose regimen was 1 dose (IM). Concomitant medications were not reported. On 24Aug05, the pt received one dose of Prevnar. The very next day pt experienced a red lump at the injection site. Pt was treated with antibiotics and has since recovered.
Age: 0.22
Sex: M
Vaccine: PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 2 month old male pt who experienced fever as high as 103 degrees F and became irritable. At 2 months of age, the pt received the first dose on 01Nov04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 01Nov04. Dose regimen was 1 dose (IM). Concomitant medications were not reported. A mother reported that her son developed fever as high as 103 degrees F (pyrexia) and became irritable on 01Nov04 after his Prevnar injection. The child recovered within a couple days. See related case(s): HQWYE997313OCT05 (adverse event, non expedited) and HQWYE997413OCT05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Info regarding Prevnar vaccine was received from a healthcare professional regarding a 2 year old pt who experienced injection site reaction with swelling, induration, redness and pain. The child was also fussy. At 2 years of age, he received the 4th dose on 7/13/05. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 7/13/05. Dose regimen was 1 dose 1 time per day, IM. Concomitant therapy included Vaqta. No other medications were prescribed. EVENT DETAILS: The pt experienced an injection site reaction described as a 9-12cm area of swelling with hardness, redness and pain in the right thigh on 7/14/05. The day he was seen by the pediatrician. He was able to walk but was very fussy. He was treated with oral Benadryl and warm compresses. No additional info was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a pt who experienced hives. The pt received vaccine. The pts concurrent illness includes an allergy to eggs. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The pt experienced hives (urticaria). No additional information was available at the time of this report.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Crying, Injection site oedema, Pyrexia, Screaming
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a physician regarding a 7 month old female pt who experienced fever of 99F, swelling at the injection site and was crying and inconsolable. At 2 months of age, the pt received a dose on 25Apr05. The pt also received a dose of Pediarix (diphtheria/tetanus/acellular pertussis/hep B vaccine/polio virus inactivated) on 25Apr05. Pt had no relevant medical history. Indication for Prevnar was immunization. Product was administered on 25Apr05. Dose regimen was 1 dose (IM). Concomitant medications were not reported. A physician reported that a pt developed a fever of 99F, swelling at the injection site and was crying and inconsolable on 25Apr05. It was unk to the caller if the vaccines administered were given in the same or separate sites. The pt was treated with ibuprofen. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Hypersensitivity
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a pt who experienced a (non specific) allergic reaction. The pt received a dose in Jun 2005. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered in Jun05. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The pt experienced a allergic reaction in Jun 2005. No additional information was available at the time of this report.
Age: 0.27
Sex: M
Vaccine: PNC
Symptoms: Irritability
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 month old male pt who experienced prolonged fussiness 3 hrs after the administration of Prevnar. At 3 months of age, the pt received the first dose on 18Jun05. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 18Jun05. Dose regimen was 1 dose (IM). Concomitant medications were not reported. The pt experienced prolonged fussiness 3 hrs after the administration of Prevnar on 18Jun05. The child was taken to the ER at 7:00PM of the night of administration. No treatment was given in the ER. Pt recovered with 24 hrs (19Jun05). No additional information was available at the time of this report.
Sex: U
Vaccine: HIBV, PNC
Symptoms: Rash
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a pt who experienced rash after receiving vaccines. The pt received the third dose in Mar 2005. The pt also received a dose of Hib Vaccine (manf unk) in Mar 2005. The pt's concurrent illness includes latex allergy. Indication for Prevnar was immunization. Product was administered in Mar 2005. Dose regimen was 1 dose. Concomitant medications were not reported. The pt experienced a rash after receiving vaccines on an unspecified date in Mar 2005. No additional  information was available at the time of this report.
Age: 0.29
Sex: F
Vaccine: HIBV, PNC
Symptoms: Injection site urticaria
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 month old female pt who experienced urticaria at the injection site. At 3 months of age, the pt received a dose on 22Aug05. No significant medical history. Indication for Prevnar was immunization. Product was administered on 22Aug05. Dose regimen was 1 dose (IM). Concomitant therapy  included Hib Titer vaccine (haemophilus b conjugate vaccine (diphtheria crm197 protein conjugate) injection) and Amoxicillin (suspension). Within 24 hrs, the infant developed urticaria at the site of Prevnar administration. The urticaria resolved within 24 to 48 hrs.
Sex: U
Vaccine: PNC
Symptoms: Hyperpyrexia
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding an unspecified number of patients who experienced extremely high fevers. The patients received doses on unspecified dates. Relevant medical history was not provided. Indication for Prevnar was not provided. product was administered on an unspecified date. Dose regimen was not provided. Additional suspect medication included Polio vaccine (poliomyelitis vaccine inactivated). Concomitant medications were nor reported. An unspecified number of patients experienced extremely high fevers (hyperpyrexia) after receiving both the Prevnar vaccine and Poli vaccine at the same time. No additional information was available at the time of this report. The reporter was unable to specify the number if patients who experienced this event. Additional reports will be generated when identifying information is provided.
Sex: U
Vaccine: DTAPHEPBIP, HEP, PNC
Symptoms: Rash
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a child who experienced rash. The patient received a dose Prevnar, Pediarix and Hepatitis B vaccines (date not specified). Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Additional suspect vaccines included Pediarix (diphtheria vaccine/tetanus vaccine/acellular pertussis vaccine/polio virus inactivated/hepatitis B vaccine). The reporter noted that that the rash was possibly  from vitamins or cereal not vaccines started at the time of vaccination. Concomitant medications were not reported. The patient experienced a rash two 2 days post vaccination (date not provided). The reporter stated that the child also started cereal and vitamins at the time of vaccination and that the rash is possibly from vitamins or cereal not vaccines. The mother reported to the pediatrician that her child is doing fine (recovery date unknown). Information regarding this event has been forwarded to the manufacturers of the concomitantly administered vaccines. No additional information was available at the time of this report.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema, Skin discolouration
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 month old patient who experienced red area measuring 1.5 inches in diameter at injection site, swollen area at injection site measuring 1.5 inches in diameter and hard area 1.5 inches in diameter surrounding the injection site. At 3 months of age, the patient received the second dose on 8/11/2005. Relevant medical history was not provided. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on 8/11/2005. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant therapy included Act Hib (haemophilus B conjugate vaccine tetanus), Tripedia (diphtheria tetanus toxoid, acellular pertussis vaccine), IPOL (poliomyelitis vaccine inactivated). On 8/12/2005, the infant developed a red (injection site erythema), swollen, (injection site swelling) and hard (injection site induration) area measuring 1.5 inches in diameter surrounding the injection site. The following day, the area became darker red in color and was more swollen. By 8/15/2005, the events had resolved. This is one of three children from this facility who experienced an injection site reaction following receipt of Prevnar. See related case HQWYE973817AUG05 and MCN HQWYE973917AUG05.
Age: 4.0
Sex: F
Vaccine: PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Tenderness
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 year old female patient who experienced swelling of entire upper arm, red injection site and tender injection site. At 3 year of age, the patient received the fourth dose on 8/9/2005. Indication for Prevnar was immunization. Product was administered on 8/9/2005. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant therapy none. On 8/11/2005, the child developed a 3 inch area of redness (injection site erythema) and tenderness (injection site pain) at the injection site. The mother also reported that the child's entire upper arm was swollen (injection site swelling). By 8/15/2005, the event had resolved. This is one of three children from the same facility who developed an injection site reaction following receipt of Prevnar lot A56117B. See MCN HQWYE949616AUG05 and MCN HQWYE973917AUG05.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema, Injection site pain, Tenderness
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 35 month old female patient who experienced red area measuring 1-2 inches in diameter on arm, 3 inch diameter hard area surrounding injection site and 3 inch diameter tender area. At 35 months of age, the patient received the fourth dose on 8/9/2005. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant medications were not reported. on 8/11/2005, the child developed a red (injection site erythema), hard (injection site induration), swollen (injection site swelling), tender area (injection site pain) measuring 3 inches in diameter at the injection site. She recovered by 8/15/2005. This is one of three children from the same facility who developed an injection site reaction following receipt of Prevnar lot A56117B. See MCN HQWYE949616AUG and MCN HQWYE973817AUG05.
Age: 0.5
Sex: M
Vaccine: PNC
Symptoms: Irritability, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 6 month old male patient who experienced fever as high a 103 degrees F and became irritable. At 6 months of age, the patient received the third dose on 2/10/2005. The patient previously experienced pyrexia and agitation while taking Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection). Indication for Prevnar was immunisation. Product was administered on 2/10/2005. Dose regimen was 1 dose intramuscular. Concomitant medications were not reported. A mother reported that her son developed fever as high as 103 degrees F (pyrexia) and became irritable (agitation) on 2/10/2005 after receiving a Prevnar injection. The child recovered within a couple days. See related case HQWYE270407SEP05 Adverse event, non expedited, and HQWYE997413OCT05 adverse event, non expedited). No additional information was available at the time of this report.
Age: 0.34
Sex: M
Vaccine: PNC
Symptoms: Irritability, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 4 month old male patient who experienced fever as high as 103 degs F and became irritable. At 4 months of age, the patient received the second dose on 12/13/2004. The patient previously experienced pyrexia and agitation while taking Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection). Indication for Prevnar was immunisation. Product was administered on 12/13/2004. Dose regimen was 1 dose intramuscular. Concomitant medications were not reported. A mother reported that her son developed fever as high as 103 Degs F and became irritable (agitation) on 12/13/2004 after receiving Prevnar injection. The child recovered within a couple of days. See related case HQWYE270407SEP05 (adverse event non expedited) and HQWYE997313OCT05 (adverse event non expedited. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Medication error
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding the administration of Prevnar that was exposed to -8 degrees C. The dates of administration was not specified. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. it was reported that Prevnar was exposed to 8 degrees C, the vaccine was administered (medication error). The number of patients who experienced this event was not specified. Additional reports will be generated when identifying information is provided.
Sex: F
Vaccine: PNC
Symptoms: Eye irritation, Medication error
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse regarding a female physician who inadvertently experienced Prevnar squirted into her eye. Relevant medical history was not provided. Inadvertent exposure to Prevnar being squirted into her eye. Concomitant medications were not reported. The physician inadvertently experienced Prevnar being squirted into her eye on 7/11/2005. The physician noted that it was due to a faulty needle. The reported noted that the physician rinsed her eyes with water and stated that the physician experienced very mild irritation, Accidental exposure. No additional information was available at the time of this report.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Injection site hypersensitivity, Injection site oedema, Lethargy
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 4 month old male patient who experienced injection site redness, injection site swelling, crying episodes and lethargy. The patient received a dose on 9/13/2005, along with doses of Hib titer vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate injection). Polio vaccine (not specified) (poliomyelitis vaccine inactivated) and diphtheria tetanus toxoids acellular pertussis vaccine manufacturer unknown diphtheria tetanus toxoid acellular pertussis vaccine) on 9/13/2005. Child in good overall health. No known allergies. Indication for Prevnar was immunisation. Product was administered on 9/13/2005. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant medications were not reported. The patient experienced injection site redness (injection site erythema) and injection site swelling on both legs. He also experienced erratic crying episodes and was lethargic (lethargy) on 9/13/2005. The sites of each vaccine administered on the infants legs was not provided. The infant recovered after three days. no additional information was available at the time of this report.
Age: 10.0
Sex: F
Vaccine: PNC
Symptoms: Drug administration error, Injection site hypersensitivity, Injection site oedema, Injection site warmth, Medication error
Clinical narrative: Information was received from a physician regarding a 9 year old female child who was prescribed Pneumovax but received Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) inadvertently. In addition, the child may have received the drug subcutaneously instead of intramuscularly. The child experienced swelling, heat and redness in a 4 inch area at the injection site of the right deltoid. At 9 years of age, the child received a dose on 10/24/2005. The patients concurrent illness includes seasonal allergies. Indication for Prevnar was immunisation. Product was administered on 10/24/2005. Dose regimen was 1 dose. Concomitant therapy included Zyrtec (cetirizine Hydrochloride). On 10/24/2005, the child was prescribed Pneumovax but received Prevnar inadvertently (wrong drug administered) and may have received the drug subcutaneously instead of intramuscularly (incorrect route of drug administration). The child experienced swelling, heat and redness in a 4 inch area at the injection site of the right deltoid (injection site swelling), (injection site warmth), (injection site erythema), beginning the evening of the injection. She did not receive any other injections. The patient was rechecked two days later and the swelling was much improved. The physician reported that the child had recovered.
Age: 1.37
Sex: M
Vaccine: FLUX, PNC
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site infection, Injection site inflammation
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 16 month old male patient who experienced a golf ball sized red and purple area at the injection site. At 16 months of age, the patient received the third dose on 12/6/2005. The patient has a past history of a neutrophil count problem at birth, The patient received two prior doses of Prevnar without incident. Indication for Prevnar was immunisation. Product was administered on 12/6/2005. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant therapy included Zantac (ranitidine Hydrochloride), Prevacid (lansoprozaole) and Flu shot (influenza virus vaccine polyvalent). On 12/08/2005, the patient developed a golf ball sized red and purple area on his upper right arm at Prevnar injection site (injection site inflammation), injection site erythema, injection site discoloration. The area was described as warm to the touch and hard, with an open spot (injection site warmth, injection site induration. The patient visited the pediatrician who believed it was an infection and treated the patient with an antibiotic (injection site infection). The reporter stated that the area has improved though there is still a red and purple appearance and a hardness. Additional information has been requested.
Age: 1.37
Sex: M
Vaccine: FLUX, PNC
Symptoms: Injection site warmth, Skin discolouration
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 16 month old male patient who experienced a golf ball sized red and purple area at the injection site. At 16 months of age, the patient received the third dose on 12/6/2005. The patient has a past history of a neutrophil count problem at birth, The patient received two prior doses of Prevnar without incident. Indication for Prevnar was immunisation. Product was administered on 12/6/2005. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant therapy included Zantac (ranitidine Hydrochloride), Prevacid (lansoprozaole) and Flu shot (influenza virus vaccine polyvalent). On 12/08/2005, the patient developed a golf ball sized red and purple area on his upper right arm at Prevnar injection site (injection site inflammation), injection site erythema, injection site discoloration. The area was described as warm to the touch and hard, with an open spot (injection site warmth, injection site induration. The patient visited the pediatrician who believed it was an infection and treated the patient with an antibiotic (injection site infection). The reporter stated that the area has improved though there is still a red and purple appearance and a hardness. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: PNC
Symptoms: Drug administration error, Injection site hypersensitivity, Medication error
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 17 year old male patient who developed slight redness at the injection site. The patient had received an unintentional dose of Prevnar that was administered subcutaneously. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on 6/8/2005. Dose regimen was 1 dose subcutaneous. Concomitant therapy included unspecified product. A physician reported that on 6/8/2005 he gave a patient a dose of Prevnar, he intended to administer a dose of TB (drug dispensing error). The Prevnar was given subcutaneously (incorrect route of drug administration) (medication error). The patient developed slight redness at the injection site (injection site erythema). No additional adverse events were noted.
Age: 1.0
Sex: M
Vaccine: HEP, HIBV, PNC
Symptoms: Injection site abscess, Injection site hypersensitivity
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 12 month old male patient who developed a 7 cm area of redness and 3 cm area of abscess. At 12 months of age, the patient received the fourth dose on 1/13/2006. The patient also received a dose of Haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate injection) manufacturer unknown, a dose of Varicella virus vaccine, love manufacturer unknown and a dose of Hepatitis B vaccine manufacturer unknown on 1/13/2006. Medical history reported as none. Indication for Prevnar was immunization. Product was administered on 1/13/2006, Dose regimen was 1 dose intramuscular. Additional suspect medication included varicella virus vaccine, live, administered on the same day an in the same thigh. The patient was not taking concomitant therapy. A physician reported that on 1/13/2006 the patient received a Prevnar and varicella vaccine in his left thigh (specific sties on the thigh were not noted). The next day the child developed a 3cm area of abscess (injection site abscess) and a 6 to 7 cm area of redness (injection site erythema) on his left thigh. The patient was treated in the ER with intravenous clindamycin and sent home on oral Bactrim (sulfamethoxazole Trimethoprim). All erythema resolved with 2 hours of returning home. The child was seen for a recheck on 1/16/2006. AT this time there was no fever, no tenderness and no warmth, touch was without discomfort. No other swellings or issues were reported, events pretty much resolved. Varicella reaction was doubted. An ell allergy test performed on 1/19/2006 was negative.
Sex: U
Vaccine: PNC
Symptoms: Medication error
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding six patient who were administered improperly stored vaccine (1 degree C). The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were nor reported. Six patients were administered the Prevnar vaccine that was stored at 1 degree c (poor quality drug administered). No additional information was available at the time of this report. The reporter indicated that six patients were administered improperly stored vaccine, however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Sex: M
Vaccine: PNC
Symptoms: Otitis media
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a male patient who experienced ear infections. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was unspecified intramuscular. Concomitant medications were not reported. The patient received 2 of the 4 doses of the Prevnar vaccine and experienced ear infections. The patient required implantation of ear tubes. (See case HQYWYE499103MAY05 adverse event non expedited). No additional information was available at the time of this report.
Age: 0.85
Sex: F
Vaccine: HIBV, PNC
Symptoms: Agitation, Crying, Decreased appetite, Injection site erythema, Injection site warmth
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse, the grandmother of a 10 month old female patient who received a first dose of Prevnar in her left leg on 9/13/2005. On the same day, the patient also received a first dose of Hib titer vaccine (haemophilus B conjugate vaccine ( diphtheria crm 197 protein conjugate) in the right leg. Later that day, the patient developed erythema, warmth and tenderness at the injection site in the left leg and crying. On 9/14/2005, the patient experienced a decreased appetite. The patients concurrent illnesses included ear disorder ( reported as fluid in right ear) and tympanic membrane perforation (reported as ruptured right ear drum (possibly due to airplane flight. Indication for Prevnar was immunization. On  9/13/2005, the product was administered in the left leg. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant therapy included Hib titer vaccine (haemophilus B conjugate vaccine ( diphtheria crm 197 protein conjugate) injection, Amoxicillin suspension and Ciprofloxacin ear drops. On 9/13/2005, at approximately 2:30pm, the patient received a dose of Prevnar. Later that day at 7:00pm, the patient developed injection site erythema, injection site tenderness, and it was noted that the left leg was slightly warm to the touch. The patient started crying and was inconsolable. Treatment included Tylenol. On 9/14/2005, it was reported that the patient would not eat her breakfast (decreased appetite) although she drank an 8 ounce bottle of formula. As of 9/14/2005, the crying, injection site erythema and tenderness had resolved, but the outcome of the injection site warmth is unknown. The decreased appetite was reported as not recovered. No additional information was available at the time of this report.
Age: 0.85
Sex: F
Vaccine: HIBV, PNC
Symptoms: Tenderness
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse, the grandmother of a 10 month old female patient who received a first dose of Prevnar in her left leg on 9/13/2005. On the same day, the patient also received a first dose of Hib titer vaccine (haemophilus B conjugate vaccine ( diphtheria crm 197 protein conjugate) in the right leg. Later that day, the patient developed erythema, warmth and tenderness at the injection site in the left leg and crying. On 9/14/2005, the patient experienced a decreased appetite. The patients concurrent illnesses included ear disorder ( reported as fluid in right ear) and tympanic membrane perforation (reported as ruptured right ear drum (possibly due to airplane flight. Indication for Prevnar was immunization. On  9/13/2005, the product was administered in the left leg. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant therapy included Hib titer vaccine (haemophilus B conjugate vaccine ( diphtheria crm 197 protein conjugate) injection, Amoxicillin suspension and Ciprofloxacin ear drops. On 9/13/2005, at approximately 2:30pm, the patient received a dose of Prevnar. Later that day at 7:00pm, the patient developed injection site erythema, injection site tenderness, and it was noted that the left leg was slightly warm to the touch. The patient started crying and was inconsolable. Treatment included Tylenol. On 9/14/2005, it was reported that the patient would not eat her breakfast (decreased appetite) although she drank an 8 ounce bottle of formula. As of 9/14/2005, the crying, injection site erythema and tenderness had resolved, but the outcome of the injection site warmth is unknown. The decreased appetite was reported as not recovered. No additional information was available at the time of this report.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC
Symptoms: Decreased appetite, Injection site hypersensitivity, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 6 month old male patient who experienced RSV bronchiolitis and ear infection. At 6 months of age, the patient received the third dose on 4/7/2005. The patient also received the third dose of Pediarix (diphtheria vaccine/tetanus vaccine/acellular pertussis vaccine/polio virus inactivated/hepatitis B vaccine), a dose of Act Hib (haemophilus B conjugate vaccine (tetanus) and the third dose of Hepatitis B vaccine (manufacturer unknown) on 4/7/2005. The patients concurrent illness includes gastroesophageal reflux disease.  Indication for Prevnar was immunization. Product was administered on 4/7/2005. Dose regimen was 1 dosage form. Patient was not taking concomitant therapy. The patient experienced a fever and redness at the injection site of the Act Hib on 4/7/2005. The following day, 4/8/2005, his body temp was between 100 and 102.5 deg Rectally. He was given three doses of Tylenol Acetaminophen. The fever persisted. On 4/9/2005, the patient was noted to have sneezing, runny nose and a small raspy cough. Then on the evening of 4/10/2005, the patient was taken to the ER because his fever did not break 103.5 deg F rectally. Mom stated that her son has had a fever for three days and decreased appetite. The mom also reported that his son had pain, redness and hardness on the left leg at the injection site of the Act Hib. In the ER, his fever came down to 101.9 deg F. The injection site of the Act Hib was still red and raised. The emergency room physician diagnosed the patient with fever and acute febrile illness. He was discharged from the ER at 11:35 pm. The following day, 4/11/2005, the patients physician diagnosed RSV (respiratory syncytial virus infection) and an ear infection (ear infection). Treatment included Xopenex (levalbuterol hydrochloride) and amoxicillin. The patient recovered from the respiratory syncytial virus infection on 4/28/2005. The patient also recovered from the ear infection 2005. Body temperature (results ranged between 100 degrees and 102.5 degrees rectally) and body temperature (results 101.9 deg F while in the ER. were done on 4/10/2005. Virus serology test results positive and viral test results influenza A and B negative were done on 4/11/2005.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC
Symptoms: Otitis media, Pyrexia, Respiratory syncytial virus infection, Rhinorrhoea, Sneezing
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 6 month old male patient who experienced RSV bronchiolitis and ear infection. At 6 months of age, the patient received the third dose on 4/7/2005. The patient also received the third dose of Pediarix (diphtheria vaccine/tetanus vaccine/acellular pertussis vaccine/polio virus inactivated/hepatitis B vaccine), a dose of Act Hib (haemophilus B conjugate vaccine (tetanus) and the third dose of Hepatitis B vaccine (manufacturer unknown) on 4/7/2005. The patients concurrent illness includes gastroesophageal reflux disease.  Indication for Prevnar was immunization. Product was administered on 4/7/2005. Dose regimen was 1 dosage form. Patient was not taking concomitant therapy. The patient experienced a fever and redness at the injection site of the Act Hib on 4/7/2005. The following day, 4/8/2005, his body temp was between 100 and 102.5 deg Rectally. He was given three doses of Tylenol Acetaminophen. The fever persisted. On 4/9/2005, the patient was noted to have sneezing, runny nose and a small raspy cough. Then on the evening of 4/10/2005, the patient was taken to the ER because his fever did not break 103.5 deg F rectally. Mom stated that her son has had a fever for three days and decreased appetite. The mom also reported that his son had pain, redness and hardness on the left leg at the injection site of the Act Hib. In the ER, his fever came down to 101.9 deg F. The injection site of the Act Hib was still red and raised. The emergency room physician diagnosed the patient with fever and acute febrile illness. He was discharged from the ER at 11:35 pm. The following day, 4/11/2005, the patients physician diagnosed RSV (respiratory syncytial virus infection) and an ear infection (ear infection). Treatment included Xopenex (levalbuterol hydrochloride) and amoxicillin. The patient recovered from the respiratory syncytial virus infection on 4/28/2005. The patient also recovered from the ear infection 2005. Body temperature (results ranged between 100 degrees and 102.5 degrees rectally) and body temperature (results 101.9 deg F while in the ER. were done on 4/10/2005. Virus serology test results positive and viral test results influenza A and B negative were done on 4/11/2005.
Sex: M
Vaccine: PNC
Symptoms: Unevaluable event
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a father regarding his 12 year old son who was messed up due to vaccine. The patient received a dose on an unspecified date. Relevant medical history was not provided. The indication for Prevnar was immunization. The product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The reporter described his son as messed up because of the vaccines he got (unevaluable event). No additional information was available at the time of this report. This is one of two patients who experienced this event following receipt of Prevnar. See related case HQWYE501716JUN05.
Sex: M
Vaccine: PNC
Symptoms: Otitis media
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a male patient who experienced ear infections. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was unspecified (intramuscular). Concomitant medications were not reported. The patient received 2 of the 4 doses of the Prevnar vaccine and experienced ear infections. The patient required implantation of ear tubes. The patients brother also experienced ear infections and required implantation of ear tubes (See case HQWYE499103MAY05 adverse event non expedited). No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Unevaluable event
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a father regarding his 8 year old son who was described as messed up due to vaccine. The patient received a dose of an unspecified date. Relevant medical history was not provided. The indication for Prevnar was immunization. The product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The reporter stated that his son was messed up because of the vaccines he got (unevaluable event). No additional information was available at the time of this report. This is one of two patients who experienced this event following receipt of Prevnar. See related case HQWYE471915JUN05.
Age: 1.36
Sex: F
Vaccine: PNC
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site urticaria, Injection site warmth, Tenderness
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 16 month old female patient who experienced injection area warm to touch, tender injection site area and red welt on right thigh measuring 8x5 cm. At 16 months of age, the patient received the fourth dose on 9/6/2005. Relevant medical history was not found. Indication for Prevnar was immunization. Product was administered on 9/6/2005. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant medications were nor reported. The patient was taken to the pediatricians office on 9/9/2005 with a red welt on right thigh measuring 8x5 CMS injection site urticaria. The area was also warm to touch (injection site warmth) and tender (injection site pain). No fever was noted at the time of the visit. Outcome was unknown. No additional information was available at the time of this report.
Age: 1.36
Sex: F
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 16 month old female patient who experienced injection area warm to touch, tender injection site area and red welt on right thigh measuring 8x5 cm. At 16 months of age, the patient received the fourth dose on 9/6/2005. Relevant medical history was not found. Indication for Prevnar was immunization. Product was administered on 9/6/2005. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant medications were nor reported. The patient was taken to the pediatricians office on 9/9/2005 with a red welt on right thigh measuring 8x5 CMS injection site urticaria. The area was also warm to touch (injection site warmth) and tender (injection site pain). No fever was noted at the time of the visit. Outcome was unknown. No additional information was available at the time of this report.
Age: 0.25
Sex: M
Vaccine: IPV, PNC
Symptoms: Condition aggravated, Eczema, Injection site rash, Rash
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 month old male patient who developed a rash on the back of his head, a rash all over his body and mild eczema at site of injection. At 3 months of age the patient received the first dose on an unspecified date. The patient has a past history of eczema. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant therapy included Poliomyelitis vaccine inactivated. Allergist reported that within 24 hours following injection, the child developed mild eczema at the site of injection (date unspecified). Two days later, the patient developed a rash on the back of his head. The patients mother applied triple antibiotic cream (bacitracin/neomycin sulfate/polymyxin B sulfate). The next day the child developed a rash all over his body. Outcome is unknown. No additional information was available at the time of this report.