chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia, Tachycardia
Clinical narrative: A 54 year old male pt experienced encephalopathy following treatment with RabAvert for post exposure prophylaxis. the pt was bitten and scratched by a stray cat. He had previously received two full courses of human rabies immune globulin and 5 injections of post exposure rabies vaccine in the US about 9 to 10 years ago. He had not received any rabies booster shots since that time. The pt received one dose of post exposure RabAvert without human rabies immune globulin on 30-JAN-01 after stray cat bite. He did not receive his second dose because he experienced "encephalopathy" after the first RabAvert dose and the pt was hesitant to obtain either RabAvert or Imovax for the second dose. No titer was taken prior to the first dose and at the time of this report, it had been 7 days since the first dose. Follow up information is pending. ADDITIONAL INFORMATION: Follow up information was received on 27-FEB-01. The pt was 56 years of age (correction). Twenty-four hours after his last dose of RabAvert on 30-JAN-01 at 1600, he experienced tachycardia, a fever 100 degrees F, and chills which lasted 24 hours; menigismus which lasted 2 to 3 days; and difficulty concentrating which lasted 5 days. His diagnosis was mild encephalitis and he recovered on 21-FEB-01.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Fatigue, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: A 49 year old female experienced fatigue and arm pain on 28-NOV-2000 following vaccination with RabAvert for post exposure prophylaxis. Three or four days before her first RabAvert injection (21-NOV-2000), the pt was providing food to a raccoon and was bitten on the bottom of her left hand. She received a small "barely broken" skin wound which she cleaned with hydrogen peroxide and alcohol. At the time of this report, 10-JAN-01 she has since seen the raccoon alive. The pt was vaccinated with RabAvert on 21-NOV-2000 in the deltoid and also treated with human rabies immune globulin in the hips. No adverse events occurred. On 25-NOV-2000, she was vaccinated at a different clinic in her hips. She experienced fatigue. On 28-NOV-2000, she was vaccinated with her third vaccination in the arm. She experienced fatigue and arm pain at the injection site, sweating which she felt was "hormonal", headaches which she has recovered from and an achy jaw which she stated was from her history of temporomandibular joint disorder. the pt stated that her achy jaw symptoms improved with treatments from her chiropractor. On 05-DEC-2000 and 19-DEC-2000 she received her fourth and fifth vaccinations respectively and experienced weakness and arm pain at the injection sites both times. She stated that her fatigue has improved but she has not fully recovered. her arm pain and weakness are still persisting. Around 08-JAN-2001, the pt experienced weakness in the legs, back and neck which she does not feel is due to the RabAvert vaccinations. Her physician states that he will investigate possible rheumatoid arthritis or lupus.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Pain in jaw
Clinical narrative: A 49 year old female experienced fatigue and arm pain on 28-NOV-2000 following vaccination with RabAvert for post exposure prophylaxis. Three or four days before her first RabAvert injection (21-NOV-2000), the pt was providing food to a raccoon and was bitten on the bottom of her left hand. She received a small "barely broken" skin wound which she cleaned with hydrogen peroxide and alcohol. At the time of this report, 10-JAN-01 she has since seen the raccoon alive. The pt was vaccinated with RabAvert on 21-NOV-2000 in the deltoid and also treated with human rabies immune globulin in the hips. No adverse events occurred. On 25-NOV-2000, she was vaccinated at a different clinic in her hips. She experienced fatigue. On 28-NOV-2000, she was vaccinated with her third vaccination in the arm. She experienced fatigue and arm pain at the injection site, sweating which she felt was "hormonal", headaches which she has recovered from and an achy jaw which she stated was from her history of temporomandibular joint disorder. the pt stated that her achy jaw symptoms improved with treatments from her chiropractor. On 05-DEC-2000 and 19-DEC-2000 she received her fourth and fifth vaccinations respectively and experienced weakness and arm pain at the injection sites both times. She stated that her fatigue has improved but she has not fully recovered. her arm pain and weakness are still persisting. Around 08-JAN-2001, the pt experienced weakness in the legs, back and neck which she does not feel is due to the RabAvert vaccinations. Her physician states that he will investigate possible rheumatoid arthritis or lupus.
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: A 20 year old male experienced fever, headache, and vomiting on 12/11/2000 after receiving  RabAvertfor postexposure prophylaxis. The patient was previously immunized two years ago, in 1998, with 3 doses of rabies vaccine.   he was bitten by a skunk while working at the zoo. Twenty-four hours after his first dose of RabAvert on 12/10/2000, the patient developed a fever of 192 degrees F, headache, nausea and vomiting. He recovered on 12/13/2000. On 12/14/2000, the subject was vaccinated with Imovax Im lot #R1105.  the treating physician believed that the adverse events were due to gastroenteritis and not related to the RabAvert vaccine. The patient is currently taking oral Augmentin.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Nausea
Clinical narrative: A 30 year old female pt experienced nausea and dizziness on the evening of 29-DEC-2000 following her vaccination with RabAvert that day. On 19-DEC-2000, the pt had been working in a veterinarian's office when she received approximately 6 wounds to her hand from a dog bite. the dog had terminal cancer and was euthanized at another location before tissue samples for rabies analysis were obtained. The dog owner had refused to quarantine the dog for the required 10 days after the bite despite being informed of his obligations. The pt received her first dose of RabAvert on friday, 29-DEC-2000. She also received human rabies immune globulin. That evening, she had complaints of nausea, dizziness and was unable to stand. She also experienced severe abdominal pain at approximately 0100 Saturday morning. All events resolved that evening. The pt discovered that she was pregnant on approximately 01-JAN-2001. This is her third pregnancy. Her pregnancy due date is 10-SEP-2001. On Tuesday, 02-JAN-2001, the pt received her second dose of RabAvert. She again experienced dizziness which resolved on Wednesday morning. On Friday, 05-JAN-2001, the pt received her third dose of RabAvert with no adverse events experienced. She stated that she will be seen soon for prenatal care.
Age: 9.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain upper, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: A 9 year old male experienced fever, flu-like symptoms, headache, stomach ache, and leg pain following vaccination with RabAvert for post exposure prophylaxis. The pt was exposed to a bat which was tested positive for rabies, received RabAvert and human rabies immune globulin. After the first dose of RabAvert, he developed fever and flu-like symptoms. There were no adverse events after the second dose. After the third dose, the pt experienced headache, stomach ache and one of his legs was hurt. Follow up information is pending.
Sex: F
Vaccine: RAB
Symptoms: Agitation, Chest pain, Hypertension, Nausea, Pyrexia
Clinical narrative: A female patient (age unknown) experienced nausea, vomiting, chest pain, fever, and hypertension on 4/14/01 following treatment with RabAvert for postexposure prophylaxis. The patient was bitten by a raccoon on 4/9/01 and began postexposure vaccination on 4/13/01. On 4/13/01 she received human rabies immune globulin into an around the site of the wound, and RabAvert was given IM in her arm. Approximately 2 hours later, the patient began to feel edgy, hot and sick to her stomach. The next day, she presented to the emergency room with nausea, vomiting, chest pain, fever, and hypertension. She was treated with IV fluids and sent home. On 4/16/01, the patient returned to the emergency room for her second dose of RabAvert. She did not develop any adverse experiences following the second dose of RabAvert. The patient missed her third and fourth doses of RabAvert. She was due into the clinic on 4/30/01 for her third dose of postexposure RabAvert and would then try to complete the postexposure schedule per the approved regimen. The Drug Safety physician assessed that human rabies immune globulin as a secondary suspect product. Follow up information has been requested.
Sex: F
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: A female patient (age unknown) experienced nausea, vomiting, chest pain, fever, and hypertension on 4/14/01 following treatment with RabAvert for postexposure prophylaxis. The patient was bitten by a raccoon on 4/9/01 and began postexposure vaccination on 4/13/01. On 4/13/01 she received human rabies immune globulin into an around the site of the wound, and RabAvert was given IM in her arm. Approximately 2 hours later, the patient began to feel edgy, hot and sick to her stomach. The next day, she presented to the emergency room with nausea, vomiting, chest pain, fever, and hypertension. She was treated with IV fluids and sent home. On 4/16/01, the patient returned to the emergency room for her second dose of RabAvert. She did not develop any adverse experiences following the second dose of RabAvert. The patient missed her third and fourth doses of RabAvert. She was due into the clinic on 4/30/01 for her third dose of postexposure RabAvert and would then try to complete the postexposure schedule per the approved regimen. The Drug Safety physician assessed that human rabies immune globulin as a secondary suspect product. Follow up information has been requested.
Age: 37.0
Sex: M
Vaccine: RAB
Symptoms: Lethargy, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: A 37-year old male consumer reported experiencing a fever, a sore throat and tiredness coincident with RabAvert post-exposure vaccination therapy.    The consumer's medical history included occasional pollen allergy for which he takes Proventil via an inhaler and no known drug allergies. He received day 0 and day3 of post-exposure therapy for RabAvert 1 ml IM (exact date unk. He developed a fever of 100-degrees F. As of 06/21/2001, the subject was scheduled to receive day vaccination and it is unknown whether the events had resolved.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Lethargy, Tongue oedema
Clinical narrative: A fifty-one female experienced fatigue following the third dose of post-exposure RabAvert. Following her forth dose of RabAvert, the patient experienced a headache, swelling in the gums and taste buds, and severe fatigue. The patient received B-12 concurrently with the forth dose of RabAvert.
Sex: F
Vaccine: RAB
Symptoms: Pyrexia, Vomiting
Clinical narrative: A female patient, in her early forties, experienced fever and vomiting after receiving RabAvert. The patient is an animal handler with no medical diagnosis. she received her first dose of RabAvert for pre-exposure prophylaxis on 07/11/2001. On 07/14/2001, the patient complained of fever of 103 degrees and vomiting. The fever was self treated with acetaminophen and the vomiting was untreated. The symptoms resolved after two days.
Age: 4.0
Sex: U
Vaccine: RAB
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: A 4 year old male experienced muscle pain, fever of 103F, headache and nausea and vomiting after being treated with RabAvert. The pt received RabAvert post-exposure rabies prophylaxis. He received his 3rd dose (date unknown) and experienced the adverse events. Concurrent medications were unknown. Follow-up information has been requested.
Age: 18.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Dizziness, Hyperventilation, Hypoaesthesia, Nausea
Clinical narrative: A pharmacist reported that an 18 year old female experienced nausea, left-sided numbness and dizziness coincident with RabAvert post-exposure vaccine therapy. The pt was reported to have an allergy to shellfish. The pt was exposed to a bat in a cabin while camping. The pt received her 5th post-exposure RabAvert injection (all doses were reportedly given on time) in the left deltoid on 8/16/01. She experienced nausea, weakness, left-sided numbness, dizziness and was hyperventilating. There was no local reaction at the injection site. On 8/17/01, a physician in an ER dx'd her as having "hyperventilation syndrome" and possible "mild serum sickness" and felt that the pt had probable "viral syndrome". The pt also experienced numbness to her fingertips, nausea, dizziness and questionable consciousness. The pt was treated with Vistaril 50mg, IM, in the ER. As of 8/29/01, it is unknown whether the pt received any further injections of RabAvert or whether the events resolved.
Age: 18.0
Sex: F
Vaccine: RAB
Symptoms: Serum sickness, Viral infection
Clinical narrative: A pharmacist reported that an 18 year old female experienced nausea, left-sided numbness and dizziness coincident with RabAvert post-exposure vaccine therapy. The pt was reported to have an allergy to shellfish. The pt was exposed to a bat in a cabin while camping. The pt received her 5th post-exposure RabAvert injection (all doses were reportedly given on time) in the left deltoid on 8/16/01. She experienced nausea, weakness, left-sided numbness, dizziness and was hyperventilating. There was no local reaction at the injection site. On 8/17/01, a physician in an ER dx'd her as having "hyperventilation syndrome" and possible "mild serum sickness" and felt that the pt had probable "viral syndrome". The pt also experienced numbness to her fingertips, nausea, dizziness and questionable consciousness. The pt was treated with Vistaril 50mg, IM, in the ER. As of 8/29/01, it is unknown whether the pt received any further injections of RabAvert or whether the events resolved.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Blood calcium decreased, Dizziness, Fatigue, Injection site pain
Clinical narrative: A 21 year old female experienced dizziness, pain at the injection site, weakness and left arm tenderness after receiving RabAvert. The pt, along with another female, was exposed to a bat in a cabin at a camp. She received her 5th post-exposure RabAvert injection in the left deltoid on 8/16/01. She presented to the ER with dizziness, pain at the injection site, weakness and left arm tenderness. The physician in the ER dx'd her as having exhaustion and possibly "mild serum sickness". The physician recommended taking Tylenol or Advil. Subsequent follow-up, revealed that a 3rd female, exposed from the same cabin and treated with Imovax, presented to the ER complaining of similar symptoms. The physician determined that each pt had a probable "viral syndrome". The events did not meet any of the serious criteria. The outcome, is unknown, as the pt was visiting the area when the events occurred.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Serum sickness, Viral infection
Clinical narrative: A 21 year old female experienced dizziness, pain at the injection site, weakness and left arm tenderness after receiving RabAvert. The pt, along with another female, was exposed to a bat in a cabin at a camp. She received her 5th post-exposure RabAvert injection in the left deltoid on 8/16/01. She presented to the ER with dizziness, pain at the injection site, weakness and left arm tenderness. The physician in the ER dx'd her as having exhaustion and possibly "mild serum sickness". The physician recommended taking Tylenol or Advil. Subsequent follow-up, revealed that a 3rd female, exposed from the same cabin and treated with Imovax, presented to the ER complaining of similar symptoms. The physician determined that each pt had a probable "viral syndrome". The events did not meet any of the serious criteria. The outcome, is unknown, as the pt was visiting the area when the events occurred.
Age: 4.0
Sex: F
Vaccine: RAB
Symptoms: Rash
Clinical narrative: A 4 year old female developed a rash following RabAvert administration. The pt received her 2nd dose of RabAvert 1ml, IM, in her leg on 8/28/01 (Day 3) for post-exposure vaccination. On 8/31/01, the pt developed a rash on her arms.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: A 27 year old female experienced a severe headache, chills, sweating and gastrointestinal discomfort (nausea and vomiting) following the 2nd and 3rd doses of post-exposure RabAvert vaccination. Symptoms began on 9/4/01 and persisted for approx. 3 days.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Alopecia
Clinical narrative: A 47 year old female experienced hair loss coincident with RabAvert therapy. The pt received her 1st dose of post-exposure RabAvert on 6/1/01. She noticed hair loss at the beginning of August. The pt reported that the hair loss was severe and bald spots on her scalp were noticeable. In the beginning, the bald spots were the size of a dime, however as of 9/18/01, one bald spot was the size of a half-dollar and the 2nd one was the size of a quarter. The pt's physician treated her condition with an injection of corticosteroid into the scalp area (8-10 injections per spot).
Age: 2.0
Sex: F
Vaccine: RAB
Symptoms: Swelling face, Urticaria
Clinical narrative: A 2 3/4 year old female was exposed to a rabid bat and was treated with RabAvert and rabies immune globulin for post-exposure prophylaxis. Twenty minutes, post vax, the pt developed urticaria and facial swelling which was successfully treated with Benadryl. The pt has had no previously known drug allergies. Follow-up information is pending.
Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site warmth, Pruritus, Pyrexia, Urticaria
Clinical narrative: A 35 year old female experienced hives, fever and injection site redness and warmth on 12/24/00 following RabAvert vaccination for post-exposure prophylaxis. The pt received post-exposure RabAvert because she was caring for a sick kitten who was attacked by a raccoon. She received her 1st RabAvert vaccine on 12/17/00 and the 2nd vaccine on 12/20/00 with no adverse events experienced. After the 3rd vaccine was given on 12/24/00 (lot 273011), the pt developed hives from the mid-chest down to her feet which were raised, red ant itchy. She also had a fever and experienced redness and warmth at the site of the injection on her arm. The pt, an RN, treated herself with Benadryl (dose unknown) and the hives were resolved. After the 4th RabAvert vaccine on 12/31/00 (lot 273011), the pt again developed hives from the mid-chest down to her feet (raised, red and itchy), but the intensity was less than after the 3rd dose. She again treated herself with Benadryl (dose unknown) and the problem was resolved. (She did not pre-medicate herself with Benadryl prior to the 4th vaccine). The pt also experienced redness and warmth at the site of the injection on her arm after the 4th dose. The pt has no known medical conditions, allergies or long-term medications. The pt's son also received post-exposure RabAvert vaccinations with lot 273011, but he had not experienced any adverse events.
Age: 8.5
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: An 8 year old female experienced fever on 1/12/01 after receiving RabAvert for post-exposure prophylaxis. The pt was bitten by a stray cat and the cat was not found. She received human rabies immune globulin and the 1st dose of RabAvert on day 0, 1/9/01, with no adverse events. By day 3, 1/12/01, the pt had a fever of 100F, probably from bronchitis. She was given her 2nd dose of RabAvert. That night, her fever rose to 106F and her mother gave her Advil and Tylenol. The fever subsided, and she recovered on 1/16/01. The pt then received RabAvert on 1/18/01, 1/22/01 and 2/5/01. She is currently taking Cefzil for bronchitis, Albuterol inhaler for chronic asthma and Delsym. No further problems were noted.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: A 45 year old female experienced muscle ache, tiredness, headache, sweating and chills on 1/27/01 following vaccination with RabAvert for pre-exposure prophylaxis for potential future exposure to rabid animals at work. The subject received her 1st dose of RabAvert on 1/19/01 without experiencing any significant adverse events. At approx. 03:00 on 1/27/01, after the 2nd RabAvert vaccination on 1/26/01, the pt experienced generalized muscle aches, feeling tired, headache, sweating and chills. She treated herself with ibuprofen for 2 days. She recovered on 1/30/01. The pt received her 3rd vaccination on 2/9/01 and experienced no adverse events.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Lymphadenopathy
Clinical narrative: A 29 year old female experienced generalized muscle aches, tiredness, headaches, sweating, chills and swollen lymph glands of 1/27/01, following vaccination with RabAvert for pre-exposure prophylaxis for potential future exposure to rabid animals at work. The subject received her 1st dose of RabAvert without experiencing any significant adverse events on 1/19/01. Twelve hours after the 2nd RabAvert vaccination on 1/26/01 at 03:00 AM, the pt experienced generalized muscle aches, feeling tired, headaches, sweating and chills. She also experienced swollen lymph glands in the axillary area of the arm that received the RabAvert injection. The subject received the 3rd RabAvert vaccination on 2/9/01. She recovered from the adverse events.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia
Clinical narrative: A 29 year old female experienced generalized muscle aches, tiredness, headaches, sweating, chills and swollen lymph glands of 1/27/01, following vaccination with RabAvert for pre-exposure prophylaxis for potential future exposure to rabid animals at work. The subject received her 1st dose of RabAvert without experiencing any significant adverse events on 1/19/01. Twelve hours after the 2nd RabAvert vaccination on 1/26/01 at 03:00 AM, the pt experienced generalized muscle aches, feeling tired, headaches, sweating and chills. She also experienced swollen lymph glands in the axillary area of the arm that received the RabAvert injection. The subject received the 3rd RabAvert vaccination on 2/9/01. She recovered from the adverse events.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Rash erythematous, Skin burning sensation
Clinical narrative: A 45 year old female experienced a severe pruritic rash on 2/19/01 after receiving RabAvert for pre-exposure vaccination on 1/31/01 and 2/7/01. On 2/19/01, after the 2nd RabAvert injection, the pt developed a severe rash on about 90% of her body surface; the rash was on her torso, arms, thighs, buttocks and feet. The rash was red, very itchy, burning, raised and bumpy in some places and smooth in other areas. There were spots the size of a quarter to the size of dinner plates. The pt had no trouble breathing. She was treated with oral Benadryl and Benadryl cream for 1 1/2 weeks, and soaked herself in Aveeno bath. The rash resolved on 3/7/01. Her physician had told her not to receive the 3rd injection because of the rash. The pt had no medical dx and no other medication. She had no known allergies and no changes in soap, lotion, cosmetics, jewelry or clothes.
Age: 1.08
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: A mother reported that her 13 month old daughter developed a fever following post-exposure rabies vaccination with RabAvert. The child received RabAvert (quantity and route of administration not reported) and HRIG at 17:30 in 8/01 (exact date unk). The child developed a fever of 101F at 03:30, the following morning. The child was treated with Tylenol and the fever resolved in 2 hours. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: RAB
Symptoms: Injection site pain, Pyrexia
Clinical narrative: An 8 year old male developed a fever and injection site pain following post-exposure RabAvert administration. The pt received rabies immune globulin, human, and RabAvert on day 0 and RabAvert on days 3 and 7. Following the 1st 2 doses of RabAvert, the pt experienced some minor pain at the site of the injection. Approx. 24 hours, after the 3rd dose of RabAvert, the pt developed a fever of 103F. Within 24 hours, the fever subsided.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: The pt had a PMH of ITP in 1998 during his adjuvant chemotherapy for colorectal cancer. , treated with IGIV. Two weeks, post vax, he presented with recurrent ITP. The pt complained of bruising. He was treated with WinRho, prednisone and platelet transfusion. He is currently taking 60mg of prednisone. In 17 years of clinical practice, I don't ever recall seeing ITP related to influenza vaccine. Seeing 2 pts in the same week was more than a coincidence for me. I thought this would be of interest to you.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Palpitations
Clinical narrative: Patient c/o of painful cardiac palpitations, some SOB, lightheadedness and weakness (mod), which required her to sit and rest about 15 minutes.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Condition aggravated, Dyspnoea, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from an RN concerning a 65 year old Caucasian female who on 11/9/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. Subsequently, about 6-8 hours, post vax, the pt developed a fever, weakness, muscle aches, injection site redness and soreness, chills, a rash, a swollen arm and dyspnea. On 11/15/01, the pt was admitted to the hospital. While hospitalized, she was treated with steroids and antibiotics. The pt was discharged on 11/18/01 with a dx of adverse drug reaction and exacerbation of COPD. It was noted that the pt had a visit at the doctor's office since her discharge and all her symptoms had resolved except the dyspnea, which was being treated with portable oxygen that was used at night. Follow up information indicated that the patient recovered in December 2001. As of 2/23/02 she had no complaints of the symptoms.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Information has been received from an RN concerning a 65 year old Caucasian female who on 11/9/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. Subsequently, about 6-8 hours, post vax, the pt developed a fever, weakness, muscle aches, injection site redness and soreness, chills, a rash, a swollen arm and dyspnea. On 11/15/01, the pt was admitted to the hospital. While hospitalized, she was treated with steroids and antibiotics. The pt was discharged on 11/18/01 with a dx of adverse drug reaction and exacerbation of COPD. It was noted that the pt had a visit at the doctor's office since her discharge and all her symptoms had resolved except the dyspnea, which was being treated with portable oxygen that was used at night. Follow up information indicated that the patient recovered in December 2001. As of 2/23/02 she had no complaints of the symptoms.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Abnormal behaviour, Coma, Diarrhoea, Pyrexia
Clinical narrative: A mother reported that her 3 year old daughter received injections of Prevnar, Infanrix, IPV and haemophilus influenzae type B conjugate vaccines on 10-DEC-2001 and 1 hour following immunization, developed diarrhea. Later that same evening, she developed fever of 104 degrees F and would not respond to her mother. She was hospitalized that evening and according to the pt's mother, "it was not determined what was wrong with her." As f 13-DEC-2001, her fever and diarrhea had resolved and she was discharged from the hospital. her mother reported that her daughter was "still not acting normal". As of the date of this report, no further information was available. Follow up info received 2/5/02 indicated that the pt reportedly developed fever of 104.7 deg F.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Bacterial infection, Bronchitis, CSF test abnormal, Hepatomegaly, Laboratory test abnormal
Clinical narrative: A physician reported that a 5 month old female received her second dose of Prevnar in May 2001. On 09-NOV-2001 at 11 months of age, the infant developed a fever and viral infection. On 16-NOV-2001, she was seen in an ER where she was diagnosed with meningitis. A lumbar puncture was positive for Streptococcus pneumoniae and the infant was admitted for hospitalization. Additional information received from the same reporter on 20-NOV-2001 indicated that the infant received her second dose of Prevnar along with DTaP, IPV and haemophilus b conjugate vaccines on 23-MAy-2001. Approximately 1 and 1/2 weeks prior to admission, the infant had been diagnosed with bronchitis and treated with an unspecified decongestant. On 16-NOV-2001, she developed a fever of 101.6 and was listless. the infant was seen by a physician who sent the infant  directly to the ER. She was treated with vanomycin abd ceftriaxone. On 18-NOV-2001, the infant was examined by a physician who noted that the infant's neck was stiff and unable to flex. Her abdomen was bulging with an enlarged liver and an additional diagnosis of hepatomegaly was made. Information regarding this event has been forwarded to the manufacturer. Follow up information received from the physician on 25-DEC-2001 indicated hat the infant received her second dose of Prevnar, Acae-Imune, Hib-titer and IPV vaccines. The pt recovered.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Listless, Meningitis, Musculoskeletal stiffness, Platelet count increased, Pyrexia
Clinical narrative: A physician reported that a 5 month old female received her second dose of Prevnar in May 2001. On 09-NOV-2001 at 11 months of age, the infant developed a fever and viral infection. On 16-NOV-2001, she was seen in an ER where she was diagnosed with meningitis. A lumbar puncture was positive for Streptococcus pneumoniae and the infant was admitted for hospitalization. Additional information received from the same reporter on 20-NOV-2001 indicated that the infant received her second dose of Prevnar along with DTaP, IPV and haemophilus b conjugate vaccines on 23-MAy-2001. Approximately 1 and 1/2 weeks prior to admission, the infant had been diagnosed with bronchitis and treated with an unspecified decongestant. On 16-NOV-2001, she developed a fever of 101.6 and was listless. the infant was seen by a physician who sent the infant  directly to the ER. She was treated with vanomycin abd ceftriaxone. On 18-NOV-2001, the infant was examined by a physician who noted that the infant's neck was stiff and unable to flex. Her abdomen was bulging with an enlarged liver and an additional diagnosis of hepatomegaly was made. Information regarding this event has been forwarded to the manufacturer. Follow up information received from the physician on 25-DEC-2001 indicated hat the infant received her second dose of Prevnar, Acae-Imune, Hib-titer and IPV vaccines. The pt recovered.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Viral infection, White blood cell count increased
Clinical narrative: A physician reported that a 5 month old female received her second dose of Prevnar in May 2001. On 09-NOV-2001 at 11 months of age, the infant developed a fever and viral infection. On 16-NOV-2001, she was seen in an ER where she was diagnosed with meningitis. A lumbar puncture was positive for Streptococcus pneumoniae and the infant was admitted for hospitalization. Additional information received from the same reporter on 20-NOV-2001 indicated that the infant received her second dose of Prevnar along with DTaP, IPV and haemophilus b conjugate vaccines on 23-MAy-2001. Approximately 1 and 1/2 weeks prior to admission, the infant had been diagnosed with bronchitis and treated with an unspecified decongestant. On 16-NOV-2001, she developed a fever of 101.6 and was listless. the infant was seen by a physician who sent the infant  directly to the ER. She was treated with vanomycin abd ceftriaxone. On 18-NOV-2001, the infant was examined by a physician who noted that the infant's neck was stiff and unable to flex. Her abdomen was bulging with an enlarged liver and an additional diagnosis of hepatomegaly was made. Information regarding this event has been forwarded to the manufacturer. Follow up information received from the physician on 25-DEC-2001 indicated hat the infant received her second dose of Prevnar, Acae-Imune, Hib-titer and IPV vaccines. The pt recovered.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Difficulty in walking, Dizziness, Multiple sclerosis, Pyrexia
Clinical narrative: On 10/29/2001 Pt received Flu vaccine at approximately 1200. Pt has received flu immunization for many years without incident. Approximately 18 hours post flu vaccine pt has fever. Approximately 24 hours post vaccination pt becomes dizzy and has difficulty walking. Weakness progresses but pt waits until following week to see neurologist. At that office visit pt received Solu-Medrol infusion followed by 1 week of oral prednisone. Exacerbation of MS lasted in totality about 2.5 weeks and did not resolve until completion of oral prednisone. Pt's spouse decided that her husband should not receive the flu shot in the future.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Anorexia, Epistaxis, Fatigue, Pain, Pharyngitis
Clinical narrative: Fever 102.7 F, runny nose, sore throat, body aches. Had bloody nose 5 days, discontinued 81 mg aspirin per doctor instruction. Severe fatigue and body aches, no appetite, stomach upset.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rhinitis, Stomach discomfort
Clinical narrative: Fever 102.7 F, runny nose, sore throat, body aches. Had bloody nose 5 days, discontinued 81 mg aspirin per doctor instruction. Severe fatigue and body aches, no appetite, stomach upset.
Age: 56.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site hypersensitivity, Injection site induration, Oedema
Clinical narrative: Swollen, red 3.5 by 4 inch induration right arm.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Demyelination, Paraesthesia, Skin ulcer
Clinical narrative: Two to three days after flu vaccination case developed bilateral tingling hands and feet, more pronounced when flexing neck.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Fatigue, Nausea, Neck pain, Pharyngitis
Clinical narrative: 12/04/2001 5:30 AM woke up with sore neck, puffy eyes; fatigue, achy, nausea, sore throat and later that day complained of chills. Took two Tylenol at 6 AM, noon and 5 PM on 12/04/2001. 12/05/2001 Still with nasal complaints, no sneezing, but neck still sore. Continued 2 Tylenol every 4 hours. Did not call PCP but did see chiropractor for sore neck with relief by Friday 12/07/2001 symptoms were gone.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Hypoaesthesia, Skin discolouration, Swelling face
Clinical narrative: 1:05 PM Five minutes after injection complained of lightheadedness, slight numb feeling left arm. Reseolved after sitting for 20 minutes (Opened outside door to increased air in room). After 20 minutes pt wanted leave, RN walked outside. Pt states she is going to PCP for complaint of hip pain which she had prior to immunization. At 2 PM at increased numbness in left arm, white lips, swollen lips. Given O2, EKG by physician. No epinephrine given by MD. Resolved on own. Pt also had lobster salad for lunch 1/2 prior to immunization. Never had a problem before. Advised to never have flu vaccine. Telephone call on 12/19/2001, pt feeling much better.
Age: 0.4
Sex: F
Vaccine: DTAP, HBPV, PNC
Symptoms: Rash
Clinical narrative: Index had rash on her genital region which started on 12/05 and lasted for 8 days. Treatment: MD prescribed Nystatin cream, gave to index mother.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Eye movement disorder, Hypotonia, Hypoventilation, Lethargy
Clinical narrative: Signs and symptoms developed 2 hours, post vax. The pt had a temperature of 101F, generalized tremors and shaking. Questionable seizures. The shaking and tremors lasted 5 minutes, then his eyes rolled back, the infant was lethargic and limp with shallow breathing. The mother called 911. The paramedics monitored the infant. The pt received Tylenol alternating with Motrin. The mother called the doctor and was told that if the signs and symptoms continue or persist to call 911 again and go to ER. No further RX necessary.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Tremor
Clinical narrative: Signs and symptoms developed 2 hours, post vax. The pt had a temperature of 101F, generalized tremors and shaking. Questionable seizures. The shaking and tremors lasted 5 minutes, then his eyes rolled back, the infant was lethargic and limp with shallow breathing. The mother called 911. The paramedics monitored the infant. The pt received Tylenol alternating with Motrin. The mother called the doctor and was told that if the signs and symptoms continue or persist to call 911 again and go to ER. No further RX necessary.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site reaction, Livedo reticularis, Screaming
Clinical narrative: The pt had inconsolable crying for almost 24 hours. Her leg at the site of the vaccination was mottled and blue which resolved. Was seen in ER.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Infection
Clinical narrative: The pt developed varicella within 10 days of varivax dose. She is still ill.
Age: 73.0
Sex: F
Vaccine: HEPA
Symptoms: Arthritis, Diarrhoea, Myalgia, Vomiting
Clinical narrative: The pt had profuse vomiting and diarrhea, simultaneously, every 2 hours (3 times) on the morning following Hep-A shot. Then she had muscle pain in her lower back migrating upward on the right and moving to left kidney, down left leg to buttock, thigh and behind knee to calf.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Pallor, Staring
Clinical narrative: The pt was staring, unresponsive and extremely pale X 10 minutes. After 5 hours, seemed to be back to normal.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: The pt developed a fever of 103F, generalized aches and headaches after the 3rd rabies vaccine. She went to ER.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Feeling hot, Oedema
Clinical narrative: Redness, swelling, warm to touch. Cellulitis to right thigh. Keflex 200 mg QID for 7 days.
Sex: M
Vaccine: IPV
Symptoms: Cyst
Clinical narrative: School nurse reports pt has 1", 1/4" raised cyst like lump on wrist. Pt states occurred after IPV injection. No redness or tenderness.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Listless, Pyrexia, Tremor
Clinical narrative: Mother states child woke up shaking with fever of 103. Continued to shake with teeth chattering, then was very listless and hard to awaken. She gave Tylenol, called MD office told her to give Tylenol and Motrin together. Child no better, still had fever of > 103. told mother to take to MD or go to ER.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Severe local reaction with cellulitis right deltoid area down to elbow then below wrist for 4 days. Treatment: Augmentin 875 PO BID and Zyrtec 1 for 3 days QID.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: Right arm red, swollen and itchy.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Headache, Oedema, Pain, Pyrexia
Clinical narrative: Fever for 3 days, severe upper right arm pain, cough, headache, edema of right axilla area 6 days post injection.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Nausea, Oedema, Pyrexia, Tremor
Clinical narrative: Dizziness, fever, nausea, vomiting, bad swelling of hands, feet and face. Swelling is intermittent. Nausea over 7 days. Episodes of blurred vision, hands shaky.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Vision blurred, Vomiting
Clinical narrative: Dizziness, fever, nausea, vomiting, bad swelling of hands, feet and face. Swelling is intermittent. Nausea over 7 days. Episodes of blurred vision, hands shaky.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Broke out with 20-30 chicken pox 12/21/2001.
Age: 2.0
Sex: M
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Abasia, Agitation, Disturbance in attention
Clinical narrative: aug-patient could not stand/walk well screaming and very clingy from morning to bedtime. Stopped speaking immediately. Began to not listen/ pay attention. Lost muscle tone.
Age: 0.2
Sex: M
Vaccine: IPV
Symptoms: Asphyxia
Clinical narrative: It was reported that a 2 month old male pt received IPOL vaccination on 18-JAN-2001. On 31-JAN-2001 the pt died. No specifics were provided. Further information is requested. COD as per autopsy report was asphyxia due to aspiration of foreign object
Age: 0.2
Sex: U
Vaccine: HEP
Symptoms: Asphyxia
Clinical narrative: Information has been received concerning a 2 month old male who on 18-JAN-2001 was vaccinated with hepatitis b vaccine recombinant (yeast). It was reported that on 31-JAN-2001 the child died. At the time of this report, the cause of death was unknown. No further information is available. The child's age was changed from 2 months to 10 weeks. In follow-up, it was revealed that the child had been enrolled in a Streptocococcus pneumoniae vaccine study in which vaccination with hep b vaccine recombinant wsa given concomitantly. It was reported that on 01/31/2001 at approx. 12:45 the child's mother left the child in his swing in the living room while she took a shower. The mother gave her three year old niece and her two year old son some grapes and juice. Her sister-in-law was with the children. After answering a telephone call, the child's aunt discovered the child to be unresponsive, and was apneic and pulseless. 911 emergency was called and CPR was initiated. While performing CPR, a grape was discovered lodged in the child's throat. Emergency personnel arrived at 13:12 and transported the child to the hospital. despite resuscitation measures, hospital personnel were unable to revive the child. The child ws pronounced dead at 13:51 and the cause of death was asphyxia due to aspiration of a foreign object. This event was deemed to be unrelated to therapy with hep b vaccine. No further info is expected. This report no longer meets criteria for submission because further information received indicated that this is a manufacturer sponsored Prevnar study where the drug relationship for Recombivax is no.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anxiety, Blood pressure increased, Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from an RN concerning a 64 year old white, obese female who on 11/14/01, at 11:00 AM, was vaccinated IM in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot 637263/1448K). Within the 1st 24 to 36 hours, she developed a fever. She also awoke in the middle of the night with swelling and redness at the injection site and the skin was hot to the touch and tender. It was approx. the size of a 50 cents piece. It was reported that the pt's temperature went to 101F. She had no other generalized or systemic symptoms. (Also reported achy feeling with her fever). The pt was seen in the doctor's office on 11/15/01 and was given diphenhydramine hydrochloride (Benadryl) (50mg q 6) and acetaminophen + propoxyphene napsylate (Darvocet 100 prn). She was also instructed to use cold compresses. Despite these actions, she had a worsening of the redness in her left upper arm and worsened tenderness. She was hospitalized on 11/16/01 because the physician was concerned she either had an allergic reaction to the vaccine, an early cellulitis or a necrotizing infection. Upon admission, her physical exam was normal except a fever of 100.5F and a soft ball size area of redness, tenderness and some heat on the left upper extremity. It was noted that while hospitalized she would be cultured and would continue on the Benadryl, Darvocet and cold compresses. She would also be started on IV antibiotics including vancomycin, gatifloxacin (Tequin) and metronidazole (Flagyl). It was reported upon discharge on 11/19/01 that the pt defervesed promptly from her admission fever. Her electrolytes were unremarkable. Her blood culture showed no growth. The pt was stable and afebrile with a marked decrease in the size of inflammation without evidence of fluctuates. Her blood pressure was elevated due to anxiety. She was discharged on Tequin 400mg 1 po daily for 10 days. It was noted that the pt had recovered.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from an RN concerning a 64 year old white, obese female who on 11/14/01, at 11:00 AM, was vaccinated IM in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot 637263/1448K). Within the 1st 24 to 36 hours, she developed a fever. She also awoke in the middle of the night with swelling and redness at the injection site and the skin was hot to the touch and tender. It was approx. the size of a 50 cents piece. It was reported that the pt's temperature went to 101F. She had no other generalized or systemic symptoms. (Also reported achy feeling with her fever). The pt was seen in the doctor's office on 11/15/01 and was given diphenhydramine hydrochloride (Benadryl) (50mg q 6) and acetaminophen + propoxyphene napsylate (Darvocet 100 prn). She was also instructed to use cold compresses. Despite these actions, she had a worsening of the redness in her left upper arm and worsened tenderness. She was hospitalized on 11/16/01 because the physician was concerned she either had an allergic reaction to the vaccine, an early cellulitis or a necrotizing infection. Upon admission, her physical exam was normal except a fever of 100.5F and a soft ball size area of redness, tenderness and some heat on the left upper extremity. It was noted that while hospitalized she would be cultured and would continue on the Benadryl, Darvocet and cold compresses. She would also be started on IV antibiotics including vancomycin, gatifloxacin (Tequin) and metronidazole (Flagyl). It was reported upon discharge on 11/19/01 that the pt defervesed promptly from her admission fever. Her electrolytes were unremarkable. Her blood culture showed no growth. The pt was stable and afebrile with a marked decrease in the size of inflammation without evidence of fluctuates. Her blood pressure was elevated due to anxiety. She was discharged on Tequin 400mg 1 po daily for 10 days. It was noted that the pt had recovered.