chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Injection site erythema; injection site induration; injection site warmth. Information has been rec'd from a RN concerning a pt with allergies to nitrofurantolin and with migraines who on 4/27/00 was vaccinated at 13:00 with pneumococcal vaccine 23 polyvalent (lot 630096/0044J) IM in the L deltoid. Concomitant vaccines included tetanus toxoid vaccine (lot 467-047) administered IM in the L deltoid. Subsequently the pt experienced injection site redness, warmth and a knot. A visit to a phys was required. Subsequently, the pt recovered. Other pt's had a similar reactions following vaccination with pneumococcal vaccine 23 polyvalent (WAES00061196 and 00111855). No further information is available. The pneumococcal vaccine 23 polyvalent infection site was changed from IM left deltoid to SC right deltoid. The time of vaccination was changed from 13:00 to 13:30 and venue of vaccination was added. The county in which the vaccinee was administered was added. The narrative was edited.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site pain
Clinical narrative: Information has been received concerning a pt who post vaccination, had a site reaction with pain at the injection site and redness from his shoulder to his wrist.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site reaction
Clinical narrative: Information has been received concerning a 90 year old female, who post vaccination developed cellulitis in her right arm from her elbow to her shoulder and she had chills.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site reaction, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received concerning a female who post vaccination, experienced a temperature of 101, chills, and injection site reaction that was 4 X 4 inches, swollen and warm to touch.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received concerning a pt who post vaccination experienced a severe local reaction, the entire upper arm was very swollen,red, hot, tight and severely painful. On 11/17/00 it was reported the pt had dizziness and unspecified medical attention was sought.  The pt recovered from her experience on 11/20/2000.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received concerning a female who post vaccination experienced a severe local reaction that started within 24 hours and lasted 3 days. The entire arm was very swollen, red, hot, tight and severely painful. It was reported that the pt's experience resolved on 11/27/00.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received concerning a vaccinee who experienced a sore arm and swelling in the arm and didn't feel well all night. Unspecified medical attention was sought.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: On 11/22/00 at 8:00 PM, the pt experienced slight redness at the injection site. The pt also complained of pain, warmth and the site was hard to the touch. A physician was consulted and the pt was prescribed moist compresses and diphenhydramine hydrochloride every four hours as needed. Subsequently, the pt recovered. No additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Post vaccination the pt developed a local injection site reaction described as redness and pain. The pt sought unspecified medical attention. No further information is available.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: One day post vaccination the pt experienced a localized reaction in her left arm including pain that radiated to the shoulder area, redness, and swelling. The pt sought unspecified medical attention. Additional information ha been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Fatigue, Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a pt's husband and a RN that post vaccination the pt developed a fever on 2 occasions of up to 102 F. the pt was seen the the Dr's office a few days later with a skin reaction of left deltoid, are 6X8 cm indurated with erythema, aching,. At this time the pt was afebrile. The local reaction resolved by 11/20/2000. The pt's Dr reported that the pt developed a moderately severe local reaction. The pt complained of chills and general malaise. The husband reported that she had a nodule in the back of her throat which has gone away. The pt has been developing a fever off and on with weakness and fatigue.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: Information has been received from a pt's husband and a RN that post vaccination the pt developed a fever on 2 occasions of up to 102 F. the pt was seen the the Dr's office a few days later with a skin reaction of left deltoid, are 6X8 cm indurated with erythema, aching,. At this time the pt was afebrile. The local reaction resolved by 11/20/2000. The pt's Dr reported that the pt developed a moderately severe local reaction. The pt complained of chills and general malaise. The husband reported that she had a nodule in the back of her throat which has gone away. The pt has been developing a fever off and on with weakness and fatigue.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Two days post vaccination the pt experienced severe redness, swelling, and muscle in the right arm. the pt did not seek medical attention and recovered around 10/25/1996
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Injection site pain, Injection site swelling
Clinical narrative: On 11/17/00, the pt developed swelling and pain in the arm that had the injection. The pt's physician diagnosed the pt with a bacterial infection. the pt was put on antibiotics for a few weeks.  the pt's condition resolved.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Information has been received from a wife concerning her 47 year old husband who was vaccinated on 11/28/00. 5 minutes after the vaccination, the pt experienced hot and cold sweat, nausea, and was dizzy. The physician's  office also noted that the pt's blood pressure dropped. The wife states the the physician felt that the pt's experiences were related to the vaccination.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning 4 or 5 pt who in 2000 were vaccinated with pneumovax-23. The LPN stated that it seems 4 or 5 of our younger pts that got this vaccine this year had some mild site reaction. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Within the hour post vaccination the pt experienced a local reaction which included erythema, warmth, which spread distally to the elbow. 20 cmX20 cm with difficulty extending the arm and right thumb.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Rash, Urticaria
Clinical narrative: Information has been received concerning a person who experienced a swollen arm with hive like red rashy skin. She also developed 3 lumps that were 2 inches in diameter each at injection site. The pt sought unspecified medical attention.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received concerning a 70 year old who, 2 days post vaccination developed a large amount of swelling at the injection site. The nurse reported that it was hot to the touch. the pt also developed redness which traveled down the pt's arm. The pt saw her physician who advised her to use an ice pack and observe for infection. The physician prescribed Atarax.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Pain
Clinical narrative: Information has been received concerning a pt who post vaccination, experienced excruciating arm pain within 10 hours of vaccination. The pt told nurse the pain was so severe that she soaked in the tub and could not sleep all night. The pt also experienced nausea. Unspecified medical attention was sought. The intervention for this pt was hot compresses and anti-inflamatory.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Vomiting
Clinical narrative: Information has been received concerning a pt who post vaccination, experienced excruciating arm pain within 10 hours of vaccination. The pt told nurse the pain was so severe that she soaked in the tub and could not sleep all night. The pt also experienced nausea. Unspecified medical attention was sought. The intervention for this pt was hot compresses and anti-inflamatory.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Pain
Clinical narrative: Information has been received concerning a pt who post vaccination, experienced severe pain of the left arm and vomiting. The pain was so severe that she used Celebrex and hot compress for intervention. Unspecified medical attention was sought.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Vomiting
Clinical narrative: Information has been received concerning a pt who post vaccination, experienced severe pain of the left arm and vomiting. The pain was so severe that she used Celebrex and hot compress for intervention. Unspecified medical attention was sought.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received concerning a male who post vaccination had an adverse reaction. Unspecified medical attention was sought. There is not any more information, additional information has been requested.
Age: 23.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received concerning a pt,  who after 2 days post vaccination returned to his physician with redness, swelling, and soreness in left arm and fever of 100.3 F.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Information has been received concerning a pt who on the same day of vaccination developed localized significant redness, swelling, and warmth of the third outer aspect of his upper arm. The pt also developed a fever of 103 and experienced malaise. The pt received unspecified over the counter medications for the fever. The pt recovered in 4 to 5 days.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received regarding a case involved in litigation concerning a pt who may or may not have experienced an unspecified adverse event.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Pyrexia, Urticaria
Clinical narrative: Information has been received concerning a pt who on 1 day post vaccination complained of a swollen arm at the site of injection, welt in the same area which grew to the size of a golf ball. She complains of aches over entire body and fever of 100 F. The pt stated that she reported this to her physician.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Nausea, Pain
Clinical narrative: Information has been received concerning a person who was vaccinated and 6 to 8 hours later she experienced soreness, redness and induration of the right arm, body aches, nausea and vomiting and a fever of 102 F. She sought unspecified medical attention. The pt's fever went down after taken Motrin.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received concerning a person who was vaccinated and 6 to 8 hours later she experienced soreness, redness and induration of the right arm, body aches, nausea and vomiting and a fever of 102 F. She sought unspecified medical attention. The pt's fever went down after taken Motrin.
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness
Clinical narrative: Information has been received concerning a male pharmacist who post vaccination experienced some mild flu like symptoms. In follow up the pharmacist reported that the flu was going around, so the injection probably didn't cause the problem
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information had been received concerning a pt who was post vaccination 1 day and she experienced 5 inch area on upper arm that the skin was red, hot, and swollen.  The pt recovered.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Information has been received regarding 2 males who both experienced injection site soreness, swelling and injection site rash. Unspecified medical attention was sought.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia
Clinical narrative: Information has been received concerning a pt who 1 day post vaccination experienced deep muscle pain with some redness across the arm. It was reported that the pt gets some relief by alternating ibuprofen and Tylenol about every 3 hours. The outcome of the redness is unknown. Follow up information said the pt was seen at Dr's office and was grimacing in pain. No significant swelling was noted. No laboratory work was done. Her Dr feels that her arm is sore due to her building up a good immuno response to vaccination.  The pt called and said she was doing great.
Sex: M
Vaccine: PPV
Symptoms: Difficulty in walking, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received concerning a male physician who experienced post vaccination a localized reaction that was 6 to 7 inches wide with swelling and tenderness that continued to spread until it was 210 degrees around circumference of the thigh. The site was warm to touch and he was unable to walk for 48 hours.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Rash, Urticaria
Clinical narrative: Information has been recvd from a registered nurse. On 11/2/00, pt developed redness, warmth and hives on the upper arm. The pt observed this, and on an unspecified date, the symptoms subsided. The pt was seen on 1/4/01 for a non-associated visit. Conflicting follow-up info recvd from the registered nurse reported that the pt was vaccinated on 11/2/00, and the pt stated that she "had a local irritation and generalized rash approximately one week later." The pt did not inform the MD's office of the adverse experienced until 1/4/01. It was reported that the pt recovered in 12/2000. No further info is expected.
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Injection site reaction
Clinical narrative: Post vax, the pt experienced an injection site reaction and flu-like symptoms. Unspecified medical attention was sought. The reported also reported an additional pt (WAES 01020057). Addtl info has been requested.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a 53 year old male consumer with allergies to NSAID's who on 12/21/00 was vaccinated with ine dose of pneumococcal vaccine 23 polyvalent. It was noted that the paatient was not sure if the vaccine was pneumococcal vaccine 23 polyvalnet, he just stated "pneumonia shot". Concomitant medications include levothyroxine sodium (Synthroid), folic acid, "Lomoto", sildenafil citrate (Viagra), ascorbic acid (vitamin C0, vitamin E, calcium, cetirizine hydrochloride (Zyrtec), diphenhydramin (Benadryl), "Desoin", amcininide (Cylocort). A couple of days later the patient developed a rash under the armpits and then it started to spread to his arms and legs. The patient sought medical attention from a dermatologist. The patient had received a pneumonia shot thirteen years ago and had no side effects. On an unspecified date, the patient also experienced fever. It was reported that no serious criteria were met. This was originally reported by a physician. Additional information has been requested. FOLLOW-UP information received 10/10/02 states, " A male reported that he received an injection of Pnu-Imune-23. The following day, he developed a fever which lasted for one day. Subsequently, he developed a rash under his arm and down his side. The patient was seen by a dermatologist and treated with an unspecified antihistamine. The reporeter indicated that the rash is improving; however, it is starting to spread to his chest and stomach. CANCELLED: Follow Up information received on 07/02/01 indicated that the patient received Pneumomavax 23 vaccine on 12/21/00. This information has been to the manufacturer of Pneumovax 23."
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Rash
Clinical narrative: Information has been received from a 53 year old male consumer with allergies to NSAID's who on 12/21/00 was vaccinated with ine dose of pneumococcal vaccine 23 polyvalent. It was noted that the paatient was not sure if the vaccine was pneumococcal vaccine 23 polyvalnet, he just stated "pneumonia shot". Concomitant medications include levothyroxine sodium (Synthroid), folic acid, "Lomoto", sildenafil citrate (Viagra), ascorbic acid (vitamin C0, vitamin E, calcium, cetirizine hydrochloride (Zyrtec), diphenhydramin (Benadryl), "Desoin", amcininide (Cylocort). A couple of days later the patient developed a rash under the armpits and then it started to spread to his arms and legs. The patient sought medical attention from a dermatologist. The patient had received a pneumonia shot thirteen years ago and had no side effects. On an unspecified date, the patient also experienced fever. It was reported that no serious criteria were met. This was originally reported by a physician. Additional information has been requested. FOLLOW-UP information received 10/10/02 states, " A male reported that he received an injection of Pnu-Imune-23. The following day, he developed a fever which lasted for one day. Subsequently, he developed a rash under his arm and down his side. The patient was seen by a dermatologist and treated with an unspecified antihistamine. The reporeter indicated that the rash is improving; however, it is starting to spread to his chest and stomach. CANCELLED: Follow Up information received on 07/02/01 indicated that the patient received Pneumomavax 23 vaccine on 12/21/00. This information has been to the manufacturer of Pneumovax 23."
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Info has been recvd from a registered nurse. On 12/14/00, pt recvd vax. On 12/15/00, pt experienced raised rash from shoulder to elbow. The pt did not have any pain, fever or swelling. Subsequently, as of 12/19/00, pt's symptoms were almost completely resolved. No follow-up, work-up or hospitalization was necessary. Unspecified medical attention was sought. No further info is expected.
Sex: U
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site pain
Clinical narrative: Information has been recvd from an MD concerning an unspecified number of patients who were vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent (lot #1448K). The MD reported that over the past couple of months (prior to reporting the events on 1/15/01) it seems that a lot of pts developed "red, sore arms" post vax. The MD stated "We have been using your vaccine for many years for a (pneumococcal vaccine 23 polyvalent) but we're having an unusual amount of local reactions to the shots that we're giving patients to the point where they're really quite angry, red, sore, more so than in the past. Is this just peculiar to a Lot Number that we might have or is this something new that you put in the vaccine that you've been having trouble with?" It was also noted that the pts "can't use (their arm) for 2 or 3 days." The MD was unable to provide specific pt information at the time of the report. Medical attention was sought. Also noted, the MD stated that more than one lot was involved. The records of testing prior to release of lot #1448K have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biological Evaluation and Research and was released. Follow-up info for the MD stated that he has given this drug in the past years and "I don't think I've had more than 1 or 2 sore arms in whole year." It was also noted that the MD checked his records and noted having a total of 6 "reactions" this year already. Addtl info has been requested.
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Information has been recvd from 2 registered nurses concerning a male who in approximately 1/1998 was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, pt experienced swelling at the injection site. The injection area was red, and he also experienced nausea and fatigue for a few days. The swelling went down without any medical treatment. Addtl info is not expected.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Alopecia
Clinical narrative: Pt was vaccinated in 2000 with pneumococcal vaccine 23 polyvalent (site unk). Since approximately 1999, pt was also vaccinated with hepatitis A vaccine, hepatitis B vaccine and influenza virus vaccine. With each subsequent vaccination, pt developed greater hair loss, even on her arms. No further info is available.
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site reaction
Clinical narrative: Post vax, pt experienced an injection site reaction and flu-like symptoms. Unspecified medical attention was sought. The reporter also reported an additional pt (WAES 01010737). Addtl info has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: On 10/5/00, pt's left arm was very swollen, red and tender. Therapy with acetaminophen (Tylenol) was initiated along with cold compresses. At the time of this report, the pt had not recovered. Addtl info has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 74 year old female with hypothyroidism and post menopause who on 10/4/00 was vaccinated with pneumococcal vaccine 23 polyvalent in the left deltoid (633103/lot 1216J). On 10/5/00, the pt developed left upper arm redness, heat and minimal swelling. She was treated with methylprednisolone (Medrol Dosepak). Subsequently, the pt recovered. The reporter indicated that other pts experienced events following vaccination (WAES 01020487, 01020489, 01020490 and 00102088.) Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Rash erythematous, Swelling, Vasculitis
Clinical narrative: In approximately 10/2000, pt was vaccinated with pneumococcal vaccine 23 polyvalent. On 10/04/00, pt experienced swelling and redness on the day after vaccination. The pt was seen by MD who noted several bright red spots on the left arm, one over the bicep, not palpable but almost vasculitic in nature. There was some diffuse redness in the lower arm. Possible allergic reaction or vasculitis. No infection. Subsequently, the pt recovered. The reporter indicated that other pts experienced events post vax: WAES 01020487, 01020488, 01020490 and 00102088. Addtl info has been requested. Pt has a history of vaccination with pneumococcal vaccine 23 polyvalent in 1/1992.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: One day post vax, 10/20/00, pt developed a red, hot, tender, swollen area on the inner aspect of her left lower arm measuring 17 cm by 24 cm. Therapy with cephalexin (Keflex) and diphenhydramine HCl (Benadryl) was initiated. The symptoms resolved on 10/27/00. The reporter indicated that other pts experienced events post vax: WAES 01020487, 01020488, 01020489 and 00102088. Addtl info has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Pt developed a "severe cellulitis" about 2 weeks after receiving vaccine. It was reported that the nurse alluded to the fact that this was "not an isolated case." Unspecified medical attention was sought. Addtl info has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been recvd from a pharmacist concerning a patient. Pt's first dose of pneumococcal vaccine 23 polyvalent was administered in 1995. Pt recvd concomitant therapy in the same arm but administered with a different syringe. On 2/19/00, pt experienced a fever and redness, pain and swelling of the injection sites from the shoulder to the elbow. On 2/23/01, pt was seen by MD and was placed on prednisone. Subsequently, the symptoms are subsiding. No further info was provided. Addtl info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a hospital worker concerning two pts who in 2/2001 were vaccinated with pneumococcal vaccine 23 polyvalent (lot #1237K). Subsequently, pts experienced cellulitis. Unspecified medical attention was sought. No other information was available. It was reported that another pt (WAES 01030309) had an adverse experience after receiving same vax with the same lot #. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Addtl info has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Irritable bowel syndrome, Malaise, Nausea, Oedema peripheral
Clinical narrative: On 3/6/01, pt's left arm (which was the arm in which she recvd injection) swelled, and she experienced malaise. Later in the evening, pt became "ill" and was sweating, nauseous (vomited), had "irritable bowel syndrome" (not confirmed by MD). On the following day, pt's arm was still swollen, she was still "sick" and could not get out of bed or eat. The swelling then went up to the elbow and a rash occurred on her upper arm. On 3/12/01, pt recovered from the arm swelling and malaise and all of the pt's other "symptoms" resolved after 3-4 days. Addtl info is not expected. Of note, the pt reported that the vaccine was administered and symptoms began on 3/7/01 rather than 3/6/01 as reported by MD.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Oral intake reduced, Rash, Vomiting
Clinical narrative: On 3/6/01, pt's left arm (which was the arm in which she recvd injection) swelled, and she experienced malaise. Later in the evening, pt became "ill" and was sweating, nauseous (vomited), had "irritable bowel syndrome" (not confirmed by MD). On the following day, pt's arm was still swollen, she was still "sick" and could not get out of bed or eat. The swelling then went up to the elbow and a rash occurred on her upper arm. On 3/12/01, pt recovered from the arm swelling and malaise and all of the pt's other "symptoms" resolved after 3-4 days. Addtl info is not expected. Of note, the pt reported that the vaccine was administered and symptoms began on 3/7/01 rather than 3/6/01 as reported by MD.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: On 12/8/00, pt experienced local erythema and induration at site of injection. Addtl info is not expected. Pt had recvd first dose of pneumococcal vaccine 23 polyvalent on 10/20/99.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: On 3/14/01 pt was seen for "cellulitis below the deltoid injection site." It was reported that the pt was started on cephalexin (Keflex) 250mg qid. The total dose was not available. On 3/17/01, pt was seen and improvement was noted. Another pt (WAES 01033128) who recvd the same vax with the same lot # had a similar experience. Addtl info has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Fifteen minutes post vax, pt developed redness at the site of injection which was reported as about 2" in diameter. The pt sought unspecified medical attention. Addtl info has been requested.
Age: 41.0
Sex: U
Vaccine: PPV
Symptoms: Drug ineffective
Clinical narrative: Pt recvd pneumococcal vaccine 23 polyvalent (lot # 1531J or 0677K) and subsequently tested negative for antibodies. The reporter was wondering if there had been "any reports of subpotency with these lots." The records of testing prior to release of lots 0677K and 1531J have been checked by Biological Quality Assurance and found to be satisfactory. Lot #s 0677K and 1531J comply with the standards of the Center for Biologics Evaluation and Research and were released. Unspecified medical attention was sought. Addtl info has been requested.
Age: 51.0
Sex: U
Vaccine: PPV
Symptoms: Drug ineffective
Clinical narrative: Pt was vaccinated with pneumococcal vaccine 23 polyvalent (lot # 1531J or 0677K). Subsequently the pt tested negative for antibodies. The reporter was wondering if there have been "any reports of subpotency with these lots." The records of testing prior to release of lots 0677K and 1531J have been checked by Biological Quality Assurance and found to be satisfactory. Lot 0677K and 1531J comply with the standards of the Center for Biologics Evaluation and Research and were released. Unspecified medical attention was sought. Addtl info has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: On 3/19/01, pt was seen for an injection site reaction. It was reported that no medication was ordered. Unspecified medical attention was sought. Another pt (WAES 01032345) who recvd same vax with same lot # had a similar experience. Addtl info has been requested.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Urticaria
Clinical narrative: One week post vax, pt developed urticaria and headache. Unspecified medical attention was sought. No further info is available.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a health professional concerning a patient who stated she had received a dose of pneumococcal vaccine 23 polyvalent in February 2001, when she received her tuberculin purified protein derivative, however nothing was documented in the chart about the patient receiving pneumococcal vaccine 23 polyvanet in February 2001. On 03/27/2001 the patient was vaccinated with a dose, presumably the second dose of pneumococcal vaccine 23 polyvalent. On 03/28/2001 the patient experienced swelling and redness of the upper arm. The patient was given prednisone and Benadryl and recovered. Additional information is not expected.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On approximately 03/20/2001 the patient experienced redness and swelling at the injection site. Subsequently, the patient recovered from redness at the injection site. Subsequently, the patient recovered from redness at the injection site and swelling at the injection site up to the neck. On approximately on 04/02/2001 the patient recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an office manager at a physician's office concerning "as many as" seven patients who in 2001 were vaccinated with pneumococcal vaccine 23 polyvalent. The patients experienced redness, swelling/edema and warmth at the injection sites and localized joint pain. No further details were provided. Unspecified medical attention was sought. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Information has beenreceived from a physician concerning a 76 year old female patient with "tetanus shot" allergy (rash) who on 04/27/01 at 11:00 was vaccinated in the left deltoid with the first dose of pneumococcal vaccine 23 polyvalent (lot 635892/1197K). Concomitant therapy included alendronate sodium and celecoxib (Celebrex). On 04/17/01, as soon as the patient left her physician's offices, the injection site became swollen, red and itchy. This feeling spread to her inner arm and elbow and her arm became painful to the touch and yellow in color. Subsequently, the patient's arm felt better but was still a little swollen. Thepatient did not seek medical attention. No further infotrmation is available
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Yellow skin
Clinical narrative: Information has beenreceived from a physician concerning a 76 year old female patient with "tetanus shot" allergy (rash) who on 04/27/01 at 11:00 was vaccinated in the left deltoid with the first dose of pneumococcal vaccine 23 polyvalent (lot 635892/1197K). Concomitant therapy included alendronate sodium and celecoxib (Celebrex). On 04/17/01, as soon as the patient left her physician's offices, the injection site became swollen, red and itchy. This feeling spread to her inner arm and elbow and her arm became painful to the touch and yellow in color. Subsequently, the patient's arm felt better but was still a little swollen. Thepatient did not seek medical attention. No further infotrmation is available
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Post vax, in 2001 the patient experienced severe arm soreness which resolved within 2 days. The medical assistant also reported that 2 other patients experienced adverse events after being vaccinated with the pneumococcal vaccine 23 polyvalen. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Pain
Clinical narrative: In May 2001, the patient experienced severe arm soreness and general weakness. Subsequently, the patient recovered within 2 days. Additional information has been requested. The medical assistant also reported on 2 additional patients, one patient experienced injection site swelling and redness and cellulitis and the other patient experienced severe arm soreness.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: On 05/03/2001 the patient experienced redness and warmth at the injection site. The patient went to the local emergency room and was treated with antibiotics. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: The morning following vaccination, the patient experienced a worsening "high" fever, pain and swelling in the arm where she was injected. It was indicated that the patient had sought medical attention. The patient's experiences persisted for 10 days. Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Post vax, on 05/23/2001 the patient now has symptoms of a sore left arm and fever of 101F. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a LPN concerning a few patients who were vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently the patients experienced injection site reactions, injection site redness, hotness at injection site, injection site inflammed and pain at the injection site. The patient sought medical attention. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: PNC, PNC, PNC
Symptoms: Angioneurotic oedema, Injection site erythema, Injection site swelling
Clinical narrative: A mother reported that her 3 year old son received his 1st dose of Prevnar on 7/11/01 and developed an injection site reaction characterized by redness and swelling. These symptoms resolved. Her son subsequently, developed "facial swelling or angioedema" which persisted at the date of the report. This event was considered "Medically Important". No further information was available at the date of the report.
Age: 3.0
Sex: M
Vaccine: PNC, PNC, PNC
Symptoms: Eye swelling, Oedema peripheral, Purpura, Swelling face, Urticaria
Clinical narrative: A mother reported that her 3 year old son received his 1st dose of Prevnar on 7/11/01 and developed an injection site reaction characterized by redness and swelling. These symptoms resolved. Her son subsequently, developed "facial swelling or angioedema" which persisted at the date of the report. This event was considered "Medically Important". No further information was available at the date of the report.
Age: 3.0
Sex: M
Vaccine: PNC, PNC, PNC
Symptoms: Urticaria
Clinical narrative: A mother reported that her 3 year old son received his 1st dose of Prevnar on 7/11/01 and developed an injection site reaction characterized by redness and swelling. These symptoms resolved. Her son subsequently, developed "facial swelling or angioedema" which persisted at the date of the report. This event was considered "Medically Important". No further information was available at the date of the report.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Disturbance in attention, Dizziness, Headache, Memory impairment, Vertigo
Clinical narrative: Severe vertigo, headache for 2 weeks. Headache persisted and was recurrent for about 2 months. It was bad enough to miss school over 6 weeks. I hope there is no residual problem. Per annual report-She got better after 2 months. But she no longer function at schol. Poor memory. Poor concentration.  Chronic daily headache and dizziness.
Age: 1.5
Sex: M
Vaccine: DT, HIBV, MMR
Symptoms: Abnormal behaviour, Antisocial behaviour, Aphasia, Autism, Cognitive disorder
Clinical narrative: On 3/10/97, pt had a fever of 104.4F and started within an hour of administration. He was lifeless, no body movement, limp, no response to any activity (such as his name). No seizure or convulsing of any type. Right leg where shot was given, was hot to touch for several hours. From 3/10/97, he lost speech, eye contact, response to name, etc. Has been dx'd with autism. Doc 204502, 60-Day follow up states the followings: No speech, no distinguishable language, constant supervision, requires one on one assistance. Before vaccine, patient could speak words. After the vaccination, he gets no response to verbal communication or eye contact. Follow up information received 09/18/02 states "(The child) has not recovered from this event, He is now labeled autistic, He has no speech and has to have 24 hours 7 days a week adult supervision. My child was a normal, healthy, little boy until the date the vaccine was given. He regressed so fast it was unbelieverable. His regression which included speech, which he has not gained any to this day, eye contact, normal body function,bowel movement, etc,and repetious behavior all started after his vaccine was administered on this date above. The annual follow-up states "pt has not recovered from this event, he is now labeled autistic, he has no speech and has to have 24 hour 7 days a week adult supervision. My child was a normal, healthy little boy until the date the vaccine was given-he regressed so fast it was unbelievable. His regression which included speech, which he has not gained any to this day, eye contact, normal bodily functions, bowel movement, etc. and repetitious behavior all started after his vaccine was administered on this date above."
Age: 1.5
Sex: M
Vaccine: DT, HIBV, MMR
Symptoms: Coma, Gastrointestinal disorder, Hypotonia, Injection site warmth, Pyrexia
Clinical narrative: On 3/10/97, pt had a fever of 104.4F and started within an hour of administration. He was lifeless, no body movement, limp, no response to any activity (such as his name). No seizure or convulsing of any type. Right leg where shot was given, was hot to touch for several hours. From 3/10/97, he lost speech, eye contact, response to name, etc. Has been dx'd with autism. Doc 204502, 60-Day follow up states the followings: No speech, no distinguishable language, constant supervision, requires one on one assistance. Before vaccine, patient could speak words. After the vaccination, he gets no response to verbal communication or eye contact. Follow up information received 09/18/02 states "(The child) has not recovered from this event, He is now labeled autistic, He has no speech and has to have 24 hours 7 days a week adult supervision. My child was a normal, healthy, little boy until the date the vaccine was given. He regressed so fast it was unbelieverable. His regression which included speech, which he has not gained any to this day, eye contact, normal body function,bowel movement, etc,and repetious behavior all started after his vaccine was administered on this date above. The annual follow-up states "pt has not recovered from this event, he is now labeled autistic, he has no speech and has to have 24 hour 7 days a week adult supervision. My child was a normal, healthy little boy until the date the vaccine was given-he regressed so fast it was unbelievable. His regression which included speech, which he has not gained any to this day, eye contact, normal bodily functions, bowel movement, etc. and repetitious behavior all started after his vaccine was administered on this date above."
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Choking, Coma, Convulsion, Cyanosis, Hypotonia
Clinical narrative: Pt found in crib, cyanotic, limp and unresponsive. Apparent seizure or choking episode. Remained cyanotic until placed on O2 by EMS. Taken to ER.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Pyrexia, White blood cell count increased
Clinical narrative: Pt received immunizations on 7/26/01. Parents phoned our on call MD at 20:30 on 7/27/01 with complaint of a 4 X 4 area of redness on right thigh. Declined to go to ER at that time. Went to ER at 23:30. ER wanted to admit him and parents refused. Was admitted later to a hospital with fever. Given IV Unasyn. Discharged home on oral Augmentin. Dx'd with cellulitis.
Age: 2.0
Sex: F
Vaccine: DTP, IPV
Symptoms: Apnoea, Crying, Epilepsy, Pyrexia
Clinical narrative: In the night, pt was whining and had a fever. The next morning, she stopped breathing and turned blue. CPR and was rushed to a nearby doctor's office. She has epilepsy.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Injection site rash, Pruritus, Rash erythematous
Clinical narrative: Started soon after IZ, as small red dots all over body at site of IZ. Then progressed, the next day, to larger red areas (nickel-sized) raised and hard. Mom reported not very itchy. Called pt 3 days later and mom stated was improving.
Age: 0.8
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Pt received Prevnar along with DTAP, Hib and IPV at 10:30 on 7/31/01 and within 2-3 hours, had a fever to 103F. Subsequently, it increased to 104F and decreased with Tylenol. Resolved over the next 48 hours.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: 2 days, post vax, pt had pink, raised rash starting at forehead and covering body. Temperature was 104F for 4 days.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site erythema
Clinical narrative: Shot site on right deltoid with 5cm to 6cm erythematous area with erythema progressing toward axillary area in large (Y) configuration. It looked like marks produced by vaccine. Pt had been held while watching mother. Erythema faded in 4-5 days.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Injection site swelling, Pruritus
Clinical narrative: One day, post vax, pt developed localized swelling of the leg around vaccine site. Swelling was 8cm in diameter and itchy. Treated with Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Convulsion
Clinical narrative: Family stated that pt had a "seizure" the afternoon, post vax, and went to ER. After multiple attempts to contact father for records release to get copy of ER visit, there has been no response.
Age: 15.0
Sex: F
Vaccine: RAB
Symptoms: Chest discomfort, Dyspnoea, Hypersensitivity, Rash erythematous
Clinical narrative: Acute allergic reaction with erythema, diffuse rash on face and upper torso. BP-stable; no wheezing, (+) SOB and chest tightness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Flushing, Micturition urgency, Rash macular, Somnolence
Clinical narrative: Mother calls about 45 minutes, post vax, saying that pt had urinary urgency right after getting vaccines then developed drowsiness and a stomach ache. She says he soon became flushed and "like he passed out a little". She says he's rested for 5 minutes and seems himself again. She says he feels fine but has blotches of red, everywhere and feels hot. Advised to call doctor. The doctor advised mom to give pt Benadryl and Motrin. She did this and he was better within 1 hour.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Abasia, Anorexia, Diarrhoea, Pyrexia, Weight decreased
Clinical narrative: Pt had a fever for 1 week, treated with Tylenol. He had a loss of weight and appetite over a period of 6 weeks and loose bowels for 4-5 weeks and he also stopped walking for 2 weeks.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Urticaria
Clinical narrative: Pt developed a warm, red and swollen wheal (3"-5") around site of DTAP injection. Pt complained of pain at site. Signs appeared on 8/1/01.
Age: 0.25
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Pyrexia, Screaming, Viral infection
Clinical narrative: High-pitched cry with fever and irritable. Consoled after 12 hours. No erythema and normal neuro exam. Observation and supportive care. Dx: Antecedent viral syndrome.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Swelling face
Clinical narrative: Pt had a fever of 103F, face swelled on right side of face, and right eye swelled shut. Mom called health dept. Benadryl given.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Asthma, Erythema, Hypersensitivity, Pain, Pruritus
Clinical narrative: Vaccine given on 6/5/01. On 6/15/01, hives began on right foot. She presented with redness, swelling, pain, itching and heat. Preceded to spread throughout body (hands, feet, arms, legs, torso, neck and head). Seen by MD in ER and was given prednisone and Allegra. Seen again in ER and was given a higher dose of prednisone, Cimetidine and Benadryl. Seen by another MD for asthma and allergies and was Allegra 180mg; Cimetidine 400mg and Zyrtec 10mgs. These medicines finally brought the hive under control. None of the previous medicines had provided much relief. The ER doctor as well as the other doctor provided a dx of urticaria.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Swelling, Urticaria
Clinical narrative: Vaccine given on 6/5/01. On 6/15/01, hives began on right foot. She presented with redness, swelling, pain, itching and heat. Preceded to spread throughout body (hands, feet, arms, legs, torso, neck and head). Seen by MD in ER and was given prednisone and Allegra. Seen again in ER and was given a higher dose of prednisone, Cimetidine and Benadryl. Seen by another MD for asthma and allergies and was Allegra 180mg; Cimetidine 400mg and Zyrtec 10mgs. These medicines finally brought the hive under control. None of the previous medicines had provided much relief. The ER doctor as well as the other doctor provided a dx of urticaria.