chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A healthcare professional reported that a pt received an injection of Pnu-Imune 23 and subsequently developed an injection site reaction characterized by redness, swelling and warmth. No further information was available at the date of this report. The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A physician reported that a 46 year old pt received an injection of Pnu-Imune 23 on 9/29/00. On 9/30/00, the pt developed an injection site reaction characterized by redness, swelling and pain. Additional information received from the physician on 12/5/00, indicated that the pt recovered.
Sex: M
Vaccine: PPV
Symptoms: Blister, Blood lactate dehydrogenase increased, Pemphigoid, Pruritus, Pyrexia
Clinical narrative: A healthcare professional reported that a male received an injection of Pnu-Imune 23 in 09/00. One day post-vaccination, the patient developed a fever and an "itchy rash on the back of his hands like a blister that pops and moves to different parts of the hand". A physician described this as a "pemphigoid rash". He was also found to have an increased LDL (lactic dehydrogenase level).
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pain, Urticaria
Clinical narrative: A physician reported that a 59 year old female received an injection of Pnu-Imune 23. On 09/27/00, she developed an injection site reaction characterized by a large red welt, swelling, heat, and achiness.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: A physician reported that a 57 year old female received an injection of Pnu-Imune 23 on 9/26/00. The next day, the pt developed an injection site reaction characterized by a red welt, "covering her entire arm from shoulder to elbow", swelling, warmth and pain. She was seen by the physician. This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23 lot 466788.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Discomfort, Injection site swelling, Serum sickness
Clinical narrative: A physician reported that a 41 year old female received an inadvertent Intradermal injection of Pnu-Imune 23 in her forearm on 10/24/00. PPD was to have been administered. Within 24 hours, the pt experienced diarrhea. Additionally, she experienced total body discomfort, serum sickness symptoms and swelling at the injection site, described as a "quarter-size" local reaction.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: A MA reported that a 79 year old female received an injection of Pnu-Imune 23 on 10/17/00 and within a few hours, post vax, she developed an injection site reaction characterized by swelling, heat, redness and pain. It was also reported that this pt had received a dose of Pnu-Imune 23 in 1994. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23, lot 463015.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: A physician reported that his mother-in-law received an injection of pneumococcal vaccine and subsequently became "very ill". The reporter stated that she was told she was allergic to the vaccine. No further information was available at the date of this report.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A physician reported that an 83 year old female received an injection of Pnu-Imune 23 on 11/7/00. That same day, she developed an injection site reaction characterized by redness and swelling. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot 470588. Follow-up information received on 3/27/01, from the physician, indicated that the pt recovered.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: An MA reported that 75 year old male received a dose of Pnu-Imune 23 vaccine on 6/7/01. The next day, he developed an injection site reaction. He was seen in the ER and was prescribed antibiotics for cellulitis. The pt recovered. This is 1 of 3 pts from this facility who experienced this event following receipt of Pnu-Imune 23, lot 468147. (See HQ 2484325JUN2001 and HQ 3428818JUL2001).
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: An MA reported that a 70 year old male received a dose of Pnu-Imune 23 vaccine in 6/01. He subsequently, developed an injection site reaction. He was seen in the ER and prescribed antibiotics for cellulitis. He recovered. This is 1 of 3 pts from this facility who experienced this event following receipt of Pnu-Imune 23, lot 468147. (See HQ 2484325JUN2001 and HQ 3428718JUL2001).
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Scar
Clinical narrative: A 71 year old female reported that she received an injection of Pnu-Imune 23 in 11/99. Subsequently, she developed a slight fever and an injection site reaction characterized by a 3.5" area of redness, burning and pain. The pt stated that the redness lasted for 3 months. She also stated that she still has a "mark" at the site of vaccine administration.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test abnormal
Clinical narrative: A nurse reported that a male in his 30's, dx'd with HIV, received an injection of Pnu-Imune 23 in 10/00. Approx. 3 weeks later, the pt's anergy panel test-PPD/with candida and mumps results were negative. The reporter indicated that the pt should have a positive result because of "his good immune system".
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: A nurse reported that a 56 year old female received an injection of Pnu-Imune 23 on 11/16/00 and within hours, post vax, the pt developed an injection site reaction characterized by redness, pruritus and swelling which extended from the site of the injection to the elbow. She was treated with Atarax (hydroxyzine) and Medrol (methylprednisolone). This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot 474939.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: A nurse reported that a 37 year old female received an injection of Pnu-Imune 23 on 11/16/00. Within hours, post vax, she developed an injection site reaction characterized by swelling, redness and a "softball-size" knot. The pt was treated with Atarax (hydroxyzine) and Medrol (methylprednisolone). This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot 474939.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A pharmacist reported that a pt recvd Pnu-Immune-23 on 11/14/00. The following day, pt developed an injection site reaction characterized by a red, raised rash. No further info was available at the date of this report. Manufacturer's Comment: The reporter indicated that 40 to 50 pts experienced this event; however, they are not presently identifiable. Addtl reports will be generated when identifying info is provided.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A pharmacist reported that a pt received an injection of Pnu-Imune 23 and subsequently, developed an injection site reaction characterized by redness and swelling "the size of a golf ball". No further information was available at the date of this report.
Age: 2.0
Sex: U
Vaccine: PPV
Symptoms: Drug ineffective, Immune system disorder
Clinical narrative: A pharmacist reported a 35 month old child (gender not specified) received an injection of Pnu-Imune 23 on 10/13/00. The child reported immunocompromised, but reporter "is unsure how". "Humoral immunity testing" showed the child only converted to serotypes 14, 19 and 23 but did not convert to serotypes 1, 3 and 51. The date and time of the humoral immunity testing was not specified and it was unclear whether the testing was done before or after vaccination. No further information was available at the date of this report.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: An MA reported that a 77 year old male received an injection of Pnu-Imune 23 on 11/14/00. The following day, he developed on injection site reaction characterized by redness and swelling. The reporter described this as a "cellulitis-like" reaction. He was seen by the physician and treated with Medrol (methylprednisolone), Tylenol (acetaminophen) and applications of ice. The pt had previously received an injection of Pnu-Imune 23 on 11/2/95. This is 1 of 4 pts from this facility who experienced an adverse reaction following receipt of 2 different lots of Pnu-Imune 23. Follow-up information received from the physician on 3/20/01, indicated that the pt recovered.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A healthcare professional reported that a pt received an injection of Pnu-Imune 23. Approx. 4 hours to 1 day, post vax, the pt developed an injection site reaction characterized by swelling, redness and pain. The symptoms resolved in 2 days. The reporter indicated that 4 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: A nurse reported that a pt received an injection of Pnu-Imune 23 and subsequently, developed an injection site reaction characterized by a "large" area of redness and pain. No further information was available at the date of this report. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23. The reporter indicated that 4 pts experienced an adverse event; however, only 3 are presently identifiable. An additional report will be generated when identifying information is provided.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A sales representative reported that a pt received an injection of Pnu-Imune 23 on 11/28/00 and subsequently, developed an injection site reaction characterized by redness and swelling from the top of the shoulder to the elbow. As of 11/29/00, no further information was available. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Pnu-Imune 23.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: A pharmacist reported that he received an injection of Pnu-Imune 23 on 12/8/00. The following day, he developed an injection site reaction characterized by a 8" by 4" area of redness, swelling, warmth and pain. The reporter stated that the symptoms have decreased; however, the pain has "moved down to elbow area". This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23 lot 468148. Follow-up received on 5/30/01, indicated that the pt recovered.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: A nurse reported that a pt received an injection of Pnu-Imune 23. Within 3 days of vaccination, the pt developed an injection site reaction characterized by soreness and redness extending from elbow to shoulder. The pt was seen by the physician. The reporter indicated that 6 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: A pharmacist reported that a pt received an injection of Pnu-Imune 23 and subsequently, the pt developed warmth, pain and redness at the injection site. The reporter described this as cellulitis. The reporter Indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Pt reported that 1 day post vax she developed an injection site reaction characterized by a red, hot, flaming area extending from elbow to shoulder and arm pit. On 10/18/00 she developed a fever of 102F. As of 10/19/00, her symptoms were resolving. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune-23, lot 468-136. Follow-up info recvd from MD on 3/12/01 indicated that the pt was seen twice by MD. She recovered.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A nurse reported that a pt received an injection of Pnu-Imune 23 in 12/00. Subsequently, the pt developed an injection site reaction characterized by redness, swelling and warmth extending from shoulder to elbow. The symptoms resolved within 72 hours. The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A territory representative reported that a 74 year old male received Pnu-Imune 23 vaccine on 11/27/00. On 11/28/00, he developed "large" cellulitis at the injection site. The reporter noted that the pt received a previous dose of Pnu-Imune 23 on 12/9/99. He was seen in the ER and treated with cephalexin. He recovered.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Anorexia, Arthralgia, Injection site reaction, Muscular weakness, Myalgia
Clinical narrative: A nurse reported that a 51 year old female received an injection of Pnu-Imune 23 on 12/20/00. On 12/22/00, the pt developed myalgia, arthralgia, muscle weakness, loss of appetite and a pink, macular rash on the arms, back, chest and abdomen. She also developed a local reaction which the reporter did not describe. Follow-up information received from the physician on 5/30/01, indicated that the pt recovered.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: A nurse reported that a 51 year old female received an injection of Pnu-Imune 23 on 12/20/00. On 12/22/00, the pt developed myalgia, arthralgia, muscle weakness, loss of appetite and a pink, macular rash on the arms, back, chest and abdomen. She also developed a local reaction which the reporter did not describe. Follow-up information received from the physician on 5/30/01, indicated that the pt recovered.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: A respiratory therapist reported that a patient received an injection of Pnu-Imune 23. Within 48 hours of vaccine administration, the patient developed an injection site reaction characterized by redness, swelling, and warmth. MANUFACTURER'S COMMENT: The reporter indicated that 3 patients experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying info is provided.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: A physician reported that a 70 year old female received an initial injection of Pnu-Imune 23 on 01/09/01. That same day, the patient developed an injection site reaction characterized by 6 cm by 6 cm area of erythema and induration. She was treated with tapering doses of Prednisone "60, 40, 30, 20, 10 mg". The patient was also treated with diphenhydramine 25 mg every 4 hours for 4 or 5 doses.  The patient recovered.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: A medical assistant reported that a 58 year old female received an injection of Pnu-Imune 23 on 09/14/00. Within a few hours of vaccine administration, she developed an injection site reaction characterized by heat, redness, pain, and swelling. It was also reported that this patient had received a dose of Pnu-Imune 23 on 10/20/94. This is 1 of 3 patients from this facility who had an adverse experienced following receipt of Pnu-Imune 23 lot 463-015. Follow-up info received from the physician on 03/06/01, indicated that the patient recovered.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: A medical assistant reported that a patient received an injection of Pnu-Imune 23 and subsequently developed an injection site reaction characterized by pain, redness, heat, and swelling. No further information was available at the date of this report. This is 1 of 3 patients from this facility who had an adverse experience following receipt of Pnu-Imune 23 lot 463-015.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A nurse reported that a patient received an injection of Pnu-Imune 23. Subsequently, the patient  developed an injection site reaction characterized by redness and swelling which extended from the elbow to middle of the lower arm. The reporter indicated that this was a "booster shot" with the previous injection given >5 years ago. No further info was available at the date of this report. MANUFACTURER'S COMMENT: The reporter indicated that 3 patients experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying info is provided.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Malaise
Clinical narrative: A nurse reported that a male received an injection of Pnu-Imune 23 on 01/16/01. Subsequently, he developed  "general" malaise and "severe" pain at the injection site. The reporter indicated that the patient is "feeling better" but his arm still remains sore.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Dizziness, Headache, Nausea, Pain
Clinical narrative: A physician reported that his 64 year old wife received an injection of Pnu-Imune 23 on 01/24/01. The reporter indicated that this was a booster dose with a previous dose given 5 years ago. Subsequently, she developed a "severe" reaction described as dizziness, head pressure, nausea, and back ache. The patient recovered in 5 minutes. Follow-up info received from the physician on 05/30/01, indicated that the patient also experienced pain of her upper posterior thighs along with the previous reported events within 60 seconds of vaccine administration. All symptoms resolved within 5 minutes with no sequelae.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Nausea, Vomiting
Clinical narrative: A medical assistant reported that a 38 year old female received an injection of Pnu-Imune 23 on 01/22/01. That same day, the patient developed nausea and vomited. On 01/25/01, she developed an injection site reaction characterized by redness, soreness, and swelling the "size of a grapefruit". The patient was treated with Keflex and applications of cold packs.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity, Injection site oedema
Clinical narrative: A nurse reported that a 71 year old male received an injection of Pnu-Imune 23 on 01/18/01. The following day, the patient developed "severe" swelling at the injection site extending from the shoulder to below the elbow. The reporter stated that the reaction "progressed to a cellulitis". He recovered.  This is 1 of 2 patients from this facility who experienced this event following receipt of Pnu-Imune 23 lot 469-401. Follow-up info received on 06/26/01 indicated that the patient developed "increased" swelling. He was seen in an ER and treated with Rocephin and doxycycline. The patient was diagnosed with cellulitis and an allergic reaction. He recovered in 1 week.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Oedema peripheral, Pyrexia
Clinical narrative: A physician reported that a male in his 70's received an injection of Pnu-Imune 23 in 01/01. Subsequently, he developed an injection site reaction characterized by "pronounced swelling and hardness of entire upper arm". The patient also developed a fever. He recovered. MANUFACTURER'S COMMENT: The reporter indicated that 2 patient's experienced this event; however, only 1 is presently identifiable. An additional report will be generated when identifying information is provided.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: A pharmacist reported that a 70 year old female received an injection of Pnu-Imune 23 on 01/30/01. Within 1 day of  vaccine administration,the patient developed an injection site reaction characterized by redness, swelling, warmth, and tenderness. She was treated "symptomatically". This is 1 of 2 patients from this facility who experienced this event following receipt of Pnu-Imune 23 lot 469-132. Follow-up info received on 06/06/01 indicated that the patient recovered.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pruritus, Vomiting
Clinical narrative: Three days post vax pt developed an injection site reaction characterized by swelling, redness and itching. The pt also developed vomiting and chills. She was treated with cephalexin and diphenhydramine. On 11/6/00 the pt was seen by MD who noted improvement. The MD added loratadine to her treatment. By 11/17/00 the reaction had resolved. This is 1 of 4 pts from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune-23.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site swelling, Injection site warmth, Pruritus, Skin burning sensation
Clinical narrative: The day of receiving vax pt developed an injection site reaction characterized by burning, swelling, itching and warmth extending from clavicle area to antecubital. On 11/27/00 he was seen by MD and treated with cephalexin and loratadine. The pt had previously recvd an injection of Pnu-Imune-23 in 1994. This is 1 of 4 pts from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune 23. Follow-up info recvd on 3/27/01 from the MD indicated that the pt recovered.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Post vax, pt developed an injection site reaction characterized by redness and swelling. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23. Manufacturer's Comment: The reporter indicated that 4 pts developed an injection site rx; however, only 3 are presently identifiable. An additional report will be generated when identifying info is provided. Follow-up info recvd from MD on 4/3/01 indicated the pt recovered.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Approximately 24 hrs post vax pt developed a fever and an injection site reaction characterized by redness and swelling. No further info was available at the date of this report. Manufacturer's Comment: The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Addtl reports will be generated when identifying info is provided.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The afternoon of receiving vax, pt developed an injection site reaction characterized by swelling and redness. He was treated with applications of warm compresses and Tylenol. This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23, lot 469-132. Follow-up info recvd from MD on 6/25/01 indicated that the pt recovered.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Within 24 hours post vax, pt developed a fever of 102F, "aches, pains" and an injection site reaction characterized by redness and swelling. On 3/8/01, pt reported "she feels much better."
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: A physician reported that a patient received an injection of Pnu-Imune 23 vaccine  and developed a delayed post-immunization. The reporter described the reaction as "red, almost cellulitic" which lasted for several days. The reporter stated that 7 patients experienced this event following receipt of Pnu-Imune lot 473-556. MANUFACTRER'S COMMENT:  The 7 patients were not presently identifiable. Additional reports will be generated when identifying information is provided. Additional information  received from the reporter on 08/30/02 provided patient identifiers for 1 patient and the lot number changed from 473-556 to 470-594. The patient remained recovered.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Later in the day of receiving vax pt developed an injection site reaction characterized by pain, erythema, and hardness. She recovered. Manufacturer's Comment: This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: One day post vax pt developed an injection site reaction characterized by redness, swelling, pain, and warmth. Raising her arm was painful. Her mother treated her with acetaminophen and diphenhydramine without relief. MD recommended treatment with loratadine.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Lymphadenopathy
Clinical narrative: Post vax pt developed an injection site reaction characterized by redness, warmth, and pain. She also developed lymphadenopathy. She was seen by MD who made a diagnosis of cellulitis and prescribed cephalexin. The pt recovered. This is 1 of 2 pts from this facility who developed cellulitis following receipt of Pnu-Imune 23 lot 468-484.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: One day post vax pt developed a fever of 103F and an injection site reaction characterized by redness and swelling, which extended from shoulder to elbow. The fever resolved after 48 hours. The pt was treated with erythromycin and recovered.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Post vax pt developed an injection site reaction characterized by redness, swelling, warmth, and tenderness. No further info was available at the date of this report. Manufacturer's Comment: The reporter indicated that 5 or 6 pts experienced this event; however, they are not presently identifiable. Addtl reports will be generated when identifying info is provided.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Lymphadenopathy, Skin striae
Clinical narrative: A nurse practitioner reported that a 65 year old female inadvertently received an intradermal injection of Pnu-Imune 23 vaccine on 03/28/01. That same day, she experienced an injection site reaction characterized by a 2 cm area of warmth, redness, two streaks going up her arms and axillary nodes swelling. No further information was available at the date of the report. Additional information received fromn the reporter on 07/02/01 provided additional information and responsible physician and stated that the patient recovered.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Drug ineffective
Clinical narrative: Pt received 3 doses of 23-valent polysaccharide vaccine (manufacturer unk) and "failed on three separate occasions to mount any immune response" to the vaccine. No further info was available at the date of this report.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: a nurse reported tha a 74 year old male received his second dose of Pnu-Imune 23on 03/15/01. Within 48 hours post vax, the pt developed an injection site reaction characterized by redness and swelling which extended to his elbow. The pt was treated "symptomatically" and he recovered. No further info was available at the date of this report. Manufacturer's Comment: This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot #470-592. See related report HQ1201422MAY2001. FOLLOW-UP information was received from the nurse on 07/13/01. On 03/16/01, the patient experienced injection site pain which kept him awake for two nights following vaccine administration. The patient remained recovered.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: One day post vax the pt developed "severe" cellulitis. She went to the ER and was prescribed a Medrol dose-pack and Benadryl. As of 3/5/01 the reporter stated that the pt had not yet responded to the prescribed meds. This is 1 of 2 pt from this facility who developed cellulitis following receipt of Pnu-Imune lot # 471-040. Addtl info recvd from the reporter on 6/8/01 stated that the pt recovered.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: One day post vax pt developed "severe" cellulitis. She was seen by MD 3/29/01 and prescribed Keflex 500mg qid for 14 days. This is 1 of 2 pts from this facility who developed cellulitis following receipt of Pnu-Immune 23 lot # 471-040. Follow-up info recvd from the reporter on 5/18/01 provided the following information: time of immunization, addtl concomitant meds, no laboratory tests required and that the pt recovered.
Sex: U
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site induration, Nausea, Pyrexia
Clinical narrative: Six hours post vax pt developed an injection site reaction characterized by a 30mm area of redness and induration and inability to move the arm. The pt experienced nausea and vomiting and developed a fever of 101F. The symptoms resolved within a few days. No further info was available at the date of this report. The reporter indicated that 4 pts experienced these events following receipt of Pnu-Imune 23 vaccine, lot 469-401. See HQ1777307JUN2001, HQ1777407JUN2001 & HQ1777507JUN2001.
Sex: U
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Six hours post vax pt developed an injection site reaction characterized by a 30mm area of redness and induration and inability to move the arm. The pt experienced nausea and vomiting and developed a fever of 101F. The symptoms resolved within a few days. No further info was available at the date of this report. The reporter indicated that 4 pts experienced these events following receipt of Pnu-Imune 23 vaccine, lot 469-401. See HQ1777307JUN2001, HQ1777407JUN2001 & HQ1777507JUN2001.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Post vax pt developed generalized itching as well as an injection site reaction characterized by warmth, redness, and swelling. The reporter indicated that the pt is a healthcare professional and self-treated her symptoms (treatment was unspecified). The itching, warmth, redness and swelling resolved. As of 4/12/01 a "small" lump at the site Pnu-Imune-23 administration persisted. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Pnu-Imune-23 lot 474-936.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The day of receiving vax the pt developed an injection site reaction characterized by tenderness, swelling, redness and warmth. She was treated with Benadryl and applications of moist heat. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune-23 lot 466-440.
Age: 31.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site induration, Nausea, Pyrexia, Vomiting
Clinical narrative: The evening of receiving vax the pt developed a fever, nausea and vomiting. She also developed induration at the site of Pnu-Imune-23 administration. She recovered. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune-23 lot 470-592. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of Td vax.
Age: 32.0
Sex: F
Vaccine: PPV, TD
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: A nurse reported that a 32 year old female received Pnu-Imune-23 and Td vaccine on 04/11/01 On 04/12/01, the patient developed an injection site reaction characterized by redness, soreness and induration at the site of Pnu-Imune-23 administration. As of 04/14/01, her symptoms persisted. This is 1 of 2 patients from this facility who had an adverse experience following receipt of Pnu-Imune 23 (lot 470-592). FOLLOW-UP information received from the physician on 07/03/01 indicated that the patient received vaccines on 04/12/01. On 04/13/01, the patient developed an injection site reaction characterized by a 3-inch area of redness and soreness which "continued to enlarge over the next several days." On 04/14/01, the patient was advised to treat her symptoms with "local care, including ice" On 04/16/01, the patient was seen by the physician who noted that the patient had developed an area of erythema, "slight warmth, "Mild" induration and tenderness "covering the shoulder and half-way down the elbow." The physician considered the reaction to be "possibly a cellulitis" and treated the patient with "IV" Rocephin (ceftriaxone). The patient was subsequently treated with unspecified oral antibiotics. A blood culture was negative and the patient's white blood cell count was 9,100 cells/cubic mm. the physician indicated that the patient recovered "completly."
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Post vax pt developed an injection site reaction characterized by redness and swelling. The pt recovered the same day. This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23 lot 469-401. Manufacturer's Comment: The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An addtl report will be generated when identifying info is provided
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within 1 day of receiving vax, pt developed an injection site reaction characterized by redness, swelling, warmth, and tenderness. Pt was treated symptomatically. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune-23 lot 469-132. Follow-up info recvd on 6/11/01 indicated that the pt recovered.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Post vax pt developed an injection site reaction characterized by redness, warmth, and pain. He was seen by MD who made a diagnosis of cellulitis and prescribed dicloxacillin. The pt recovered. This is 1 of 2 pts from this facility who developed cellulitis following receipt of Pnu-Imune 23 lot 468-484.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: On 4/21/01, pt developed a fever of 104F and a swollen axillary lymph node. Addtl info rcvd from MD on 5/29/01 indicated that the pt recovered.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Approximately 45 mins post vax, pt developed pain at the injection site. The reporter described this as "excruciating right interior shoulder pain that is going down through her arm" and is exacerbated with "movement." She was seen by the MD who noted that the injection site "looks good." The pt recovered.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Post vax pt developed swelling at the injection site. No further info was available at the date of this report.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Post vax pt developed pain at the injection site. No further info was available at the date of this report. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23. Manufacturer's Comment: The reporter indicated that 4 pts developed an injection site reaction; however, only 3 are presently identifiable. An addtl report will be generated when identifying info is provided. Follow-up info recvd 4/3/01 from MD indicated that the pt recovered.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Post vax pt developed a local reaction which the reporter did not describe. Manufacturer's Comment: The reporter indicated that 2 pts developed a local reaction; however, they are not presently identifiable. An addtl report will be generated when identifying info is provided.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Post vax pt developed an injection site reaction characterized by tenderness and swelling. This is 1 of 10 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23. As of 8/15/00, no further info was available. Manufacturer's Comment: The reporter indicated that 10 pts experienced this event; however, they are not presently identifiable. Addtl reports will be generated when identifying info is provided.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Pt reported that on 4/6/01 he developed "marked myalgia" in his right leg that subsequently "spread" to his left leg. As of 4/20/01, the reporter indicated that the myalgia is resolving, and he is treating the symptoms with ibuprofen.
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Anorexia, Antinuclear antibody, Bleeding time prolonged, Blood lactate dehydrogenase increased, Brain oedema
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Disseminated intravascular coagulation, Haemolytic anaemia, Hypoxia, Laboratory test abnormal, Leukocytosis
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."
Age: 0.3
Sex: U
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Pyrexia, Somnolence, Stupor, Subarachnoid haemorrhage, Thrombocythaemia
Clinical narrative: "Four days after the vaccinations given at 4 months of age, the pt presented with a low-grade fever, lethargy and decreased oral intake. The results of a urine leukocyte esterase test were positive. She was treated with Rocephin, 250mg IM, Bactrim, 3/4 tsp po Q12 hr and acetaminophen for a possible UTI. The results of the urine culture were negative. Three days later, the pt was admitted to the hospital with severe anemia and a HB of 2.3 g/dl, WBC 65,000/mm3, platelet count of 275,000/mm3 and lactate dehydrogenase level of 3,185 U/L. At the time of admission, the pt was unresponsive, ventilator dependent and showed evidence of disseminated intravascular coagulation. Her PT was 45 sec. PTT was 92.8 sec and D-dimer was more than 8,000 ng/mL. The direct antiglobulin test (DAT or Coombs test) was positive for anti IgG (3+), anti C3bd (1+) and negative for anti IgM and anti IgA. A warm auto-antibody (panagglutinin), optimally reactive at 37C and without demonstrable specificity was identified in both the serum and the red cell eluate. She was treated with 2 units of RBC's, 1 unit of platelets, 2 units of cryoprecipitate and 2 units of fresh frozen plasma. She was also treated with IV immune globulin; (IVIG 2.8g), ampicillin (700mg IV X 1 dose then 350mg IV Q 12 hrs X 2-4 doses) and Solu-Medrol (350mg IV Q6 hrs X 8 doses after a loading dose). Red blood cell antibody to Rocephin, Ham test, blood cultures, viral serologies and latex agglutination tests were all negative or noncontributory. Severe hemolysis continued and the infant died 41 hours after admission. The autopsy demonstrated cerebral edema and diffuse subarachnoid hemorrhage but was otherwise noncontributory." "The authors felt that, after excluding other causes, the development of warm AIHA in this pt suggests a causal relationship to the 2nd DTP + HIB + Poliovirus vaccine live oral vaccination." Autopsy reports states cause of death as disseminated intravascular coagulation and multiple system organ failure due to autoimmune hemolytic anemia, etiology undetermined. From F/U received on 9/4/01, it was reported: "the baby presented with adverse event 4 days after she received an injection of OPV and Hib+DTP (Tetramune). It seems that the baby did not receive any vaccines produced by AVP". From faxed correspondecne received on 09/04/01 reported "According to the attached article cocnerning WAES01070885, the baby presented with adverse event four days after she received an injection of OPV and HIb-DTP. It seems that the baby did not received any vaccines produced by another manufacterer."