chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature fluctuation, Body temperature increased, Influenza like illness, Injection site rash, Rash
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 40 year old female patient with endometriosis and allergies to Cefzil and tetracycline and a history of vaginal cyst removal and tonsillectomy who on 10-MAY-2007 was vaccinated IM with a dose of Pneumovax 23, lot #655499/0988F. Concomitant therapy included Flonase, Elidel, Metrogel, Loestrin, Astelin and Pro-Air. On 11-MAY-2007, 24 hours after receiving the injection, the patient developed flu-like symptoms, was "burning all over the body", and had a temperature of 102-102.7 F. Red blotches developed on the same arm that the injection was administered. There was one red blotch that was the size of a quarter at the injection site. The red blotches covered most of her arm but were not continuous. The blotches were painful and warm to touch, but not itchy. The worst area was the inside of her arm. As of the report date, the patient had not recovered. Additional information has been requested. The reporter indicated that another patient also had red blotches on the arm that Pneumovax 23 was administered in. This is in follow-up to report(s) previously submitted on 7/30/2007. Information has been received from a Certified Medical Assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX and on 11-MAY-2007 was seen in the office with large red blotches on the arm that the injection was administered in. The patient was started on unspecified antibiotics. The patient's outcome was unknown. Follow up information has been received from a health care professional concerning the 40 year old female homemaker with allergies to cefzil and tetracycline who on 10-MAY-2007 received her first dose of PNEUMOVAX (lot #655499/0985F) IM in left deltoid. The patient woke up the next day with flu like symptoms, fever of 100.2-102.7, burning sensation over body. She presented to office with erythematous patches on upper left arm. The patient also had a low blood pressure of 98/74. She was given 2 liters of IV fluid. After fluids her blood pressure went back to 121/80. On 14-MAY-2007 a CBC was within normal limits except high white blood cell count (11.0 thousand/uL); high absolute neutrophils (8712 cells/uL); and high C-Reactive protein (28.99 mg/dL). on 15-MAY-2007 the patient recovered. Additional information is not expected. The reporter indicated that another patient developed red blotches after receiving a dose of PNEUMOVAX.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Skin burning sensation, Skin warm
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 40 year old female patient with endometriosis and allergies to Cefzil and tetracycline and a history of vaginal cyst removal and tonsillectomy who on 10-MAY-2007 was vaccinated IM with a dose of Pneumovax 23, lot #655499/0988F. Concomitant therapy included Flonase, Elidel, Metrogel, Loestrin, Astelin and Pro-Air. On 11-MAY-2007, 24 hours after receiving the injection, the patient developed flu-like symptoms, was "burning all over the body", and had a temperature of 102-102.7 F. Red blotches developed on the same arm that the injection was administered. There was one red blotch that was the size of a quarter at the injection site. The red blotches covered most of her arm but were not continuous. The blotches were painful and warm to touch, but not itchy. The worst area was the inside of her arm. As of the report date, the patient had not recovered. Additional information has been requested. The reporter indicated that another patient also had red blotches on the arm that Pneumovax 23 was administered in. This is in follow-up to report(s) previously submitted on 7/30/2007. Information has been received from a Certified Medical Assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX and on 11-MAY-2007 was seen in the office with large red blotches on the arm that the injection was administered in. The patient was started on unspecified antibiotics. The patient's outcome was unknown. Follow up information has been received from a health care professional concerning the 40 year old female homemaker with allergies to cefzil and tetracycline who on 10-MAY-2007 received her first dose of PNEUMOVAX (lot #655499/0985F) IM in left deltoid. The patient woke up the next day with flu like symptoms, fever of 100.2-102.7, burning sensation over body. She presented to office with erythematous patches on upper left arm. The patient also had a low blood pressure of 98/74. She was given 2 liters of IV fluid. After fluids her blood pressure went back to 121/80. On 14-MAY-2007 a CBC was within normal limits except high white blood cell count (11.0 thousand/uL); high absolute neutrophils (8712 cells/uL); and high C-Reactive protein (28.99 mg/dL). on 15-MAY-2007 the patient recovered. Additional information is not expected. The reporter indicated that another patient developed red blotches after receiving a dose of PNEUMOVAX.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female (demographics not reported) with hyperlipidaemia, diabetes, urinary tract infection, sinus infection and drug hypersensitivity to prochlorperazine maleate and a history of immunoglobin g decreased. On 29-MAR-2007 was vaccinated intramuscularly with Pneumovax 23 (Lot#655290/0959F). On 31-MAR-2007 the patient experienced injection site redness, injection site swelling, injection site pain and cellulitis at injection site. The patient was seen by the physician and treated with prednisone and Keflex. At the time of this report the patient was recovering from the events. Additional information has been requested.  07/30/2008 This is in follow-up to report(s) previously submitted on 7/30/2007. Initial and follow up information has been received from a physician concerning a 54 year old female with oesophageal acid reflux, hyperlipidemia, decreased immunoglobulin g, diabetes, urinary tract infection, sinus infection and a drug hypersensitivity to prochlorperazine maleate. On 29-MAR-2007 at 10 am was vaccinated intramuscularly with PNEUMOVAX (Lot#655290/0959F). Concomitant therpies included NEXIUM, VYTORIN, AVANDIA, DIOVAN, HUMALOG and GLUCOPHAGE. On 29-MAR-2007 at 10 amthe patient developed a large local reaction "the size of a softball". On 31-MAR-2007 the patient experienced injection site redness, injection site swelling, injection site pain and cellulitis at injection site. The patient was seen by the physician and treated with prednisone and KEFLEX. At the time of this report the patient had not recovered from the large local reaction and was recovering from the injection site redness, swelling, pain and cellulitis. The physician reported that the patient had been referred for allergy testing (NOS). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inflammation, Rash
Clinical narrative: Information has been received from a physician concerning a patient (age and sex not reported) who on an unspecified date was vaccinated with Pneumovax 23 (lot 3 not reported). Subsequently, the patient experienced inflammed rash. The outcome of the rash was not reported. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a pateint who was vaccinated with a dose of Pneumovax 23 and on 11-MAY-2007 was seen in the office with large red blotches on the arm that the injection was administered in. The patient was started on unspecified antibiotics. The patient's outcome was unknown. Additional information has been requested. The reporter indicated that another developed red blotches after receiving a dose of Pneumovax 23.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Lymphadenopathy
Clinical narrative: Information has been received from a medical assistant concerning a 71 year old female with osteopenia and drug hypersensitivity to Paxil who on 14-MAY-2007 was vaccinated with a dose of Pneumovax 23 (lot #655152/0889F) IM in the right arm. Concomitant therapy included estrogens, Premarin, calcium (unspecified), and aspirin. On 14-MAY-2007, the patient experienced redness of the medical aspect of right upper arm and a swollen right axillary lymph node. The reaction is under the arm not at the injection site. The patient sought medical attention. The pateint did not have a fever. The pateint did not report any difficulties with movement of her right arm. The pateint was treated with Ceftin. At the time of reporting, the patient was recovering. No additional information was available at the time of reporting. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a female with no pertinent medical history who on 15-MAY-2007 was a 0.1 ml dose of vaccinated intradermally with Pneumovax 23 (lot # 655766/0038U) instead of tuberculin purified protein derivative. On 15-MAY-2007, the patient experienced redness, hardness and swelling at the injection site. On 15-MAY-2007 in the evening, the patient went to the emergency room for the local reaction. There were no laboratory or diagnostic tests performed. 16-MAY-2007, the patient followed up with the physician. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a  69 year old female consumer with penicillin allergy, allergic reaction to cefaclor, erythromycin and progesterone, who was vaccinated with a dose of Pneumovax 23. Concomitant therapy included penicillin (unspecified), Ceclor, erythromycin and Prometrium. Unspecified medical attention was sought. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/30/2007. Initial and follow up information has been received from a 69 year old female patient with allergies to CECLOR, erythromycin, PROMETRIUM, aspirin, and INDERAL, who on 16-JUN-2000 was vaccinated intramuscularly in the right deltoid with a first dose of PNEUMOVAX  vaccine (Lot# "466785"). Subsequently the patient had an allergic reaction to PNEUMOVAX vaccine. The injection site was red, swollen, sore and hard. The patient also developed red blotches and experienced soreness under the arm. The patient was advised not to have another shot of PNEUMOVAX vaccine. The outcome was unknown. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Rash macular
Clinical narrative: Information has been received from a  69 year old female consumer with penicillin allergy, allergic reaction to cefaclor, erythromycin and progesterone, who was vaccinated with a dose of Pneumovax 23. Concomitant therapy included penicillin (unspecified), Ceclor, erythromycin and Prometrium. Unspecified medical attention was sought. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/30/2007. Initial and follow up information has been received from a 69 year old female patient with allergies to CECLOR, erythromycin, PROMETRIUM, aspirin, and INDERAL, who on 16-JUN-2000 was vaccinated intramuscularly in the right deltoid with a first dose of PNEUMOVAX  vaccine (Lot# "466785"). Subsequently the patient had an allergic reaction to PNEUMOVAX vaccine. The injection site was red, swollen, sore and hard. The patient also developed red blotches and experienced soreness under the arm. The patient was advised not to have another shot of PNEUMOVAX vaccine. The outcome was unknown. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Overdose
Clinical narrative: Information has been received from a physician concerning a 40 year old female who was vaccinated with a 1 ml dose of Pneumovax 23 (lot# 655587/0882F). Subsequently the patient experienced arm swelling from shoulder to wrist. Unspecified medical attention was sought, this patient may have sought medical attention in the emergency room. This is one of 3 reports from the same source. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 58 year old male patient with drug hypersensitivity to "horse serum" and a history of cholecystectomy who on 16-MAY-2007 was vaccinated with a dose of Pneumovax 23. Concomitant therapy included Lipitor and Synthroid . On 16-MAY-2007, three hours after receiving the Pneumovax 23 the patient experienced severe pain in his left arm in the area of injection site. He also had a fever and flu-like symptoms. On 17-MAY-2007 patient still had a fever and flu like symptoms but the pain in his left arm had diminished somewhat. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Body temperature fluctuation, Pyrexia
Clinical narrative: Information has been received from a practice manager concerning a 24 year old female patient with rash who on 14-MAY-2007 was vaccinated IM in left gluteus with Pneumovax 23 lot# 654977/0888F. The reporter stated that patient was having increasing fevers after getting the Pneumovax 23. The fever started out as mild then went really high. Since 15-MAY-2007 patient had been taking Advil. As soon as the Advil wears off the fever comes back and then goes up. On 16-MAY-2007 patient had a temperature of 103 F then she took Advil and fever went down to 99.2 F then the fever started going up to 102F. The patient's fever persisted. The reporter has requested A lot check on behalf of the physician. The reporter indicated there was "other patients" who received Pneumovax 23 lot#654977/0888F and subsequently "got ill". The records of testing prior to release of the lot in question, having been rechecked and found to be satisfactory. The lot complies with the standards, and was released. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Body temperature fluctuation, Pyrexia
Clinical narrative: Information has been received from a practice manager concerning a 24 year old female patient with rash who on 14-MAY-2007 was vaccinated IM in left gluteus with PNEUMOVAX 23 having increasing fevers after getting the PNEUMOVAX 23. The fever started out as mild then went really high. Since 15-MAY-2007 patient had been taking ADVILl. As soon as the ADVIL wears off the fever comes back and then goes up. On 16-MAY-2007 patient had a temperature of 103 F then she took Advil and fever went down to 99.2 F then the fever started going to 102F. The patient called the office on 16-MAY-2007 and she was told to take TYLENOL. She did not take TYLENOL and continued to take ADVIL. She will be seen in the office on 17-MAY-2007. The patient's fever persisted. The reporter has requested A lot check on behalf of the physician. The reporter indicated there was "other patients" who received Pnuemovax 23 lot# 654977/0888F and subsequently "got ill". In telephone follow up the practice manager mentioned that the patient who received PNUMOVAX 23 vaccine was having increase fevers taking ADVIL causes the fever to go down, but spikes when it wears off. The patient was seen in the office on 17-MAY-2007. The physician indicated that every patient who got this vaccine with lot #654977/0888F gotten ill. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 65 year old female patient, who on approximately 17-NOV-2006 ("six months ago") was vaccinated "incorrectly on the shoulder joints" with the first dose, 0.5ml of Pneumovax23. The physician reported that the patient had consequently been experiencing soreness and pain since the vaccination, and at the time of this report had not yet recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Overdose, Swelling
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a 1 ml dose of Pneumovax 23 (lot #655587/0882F). Subsequently the patient experienced are swelling from shoulder to wrist. Unspecified medical attention was sought, this patient may have sought medical attention in the emergency room. This is one of 3 reports from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Overdose
Clinical narrative: Information has been received from a physician concerning a 70 year old female who was vaccinated with a 1 ml dose of Pneumovax 23 (lot #655587/0882F). Subsequently the patient experienced arm swelling from shoulder to wrist. Unspecified medical attention was sought, this patient may have sought medical attention in the emergency room. This is one of 3 reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Information has been received from a medical assistant (MA), concerning a 67 year old female patient, with penicillin and caffeine hypersensitivity, who on 16-MAY-2007 was vaccinated with a dose, 0.5ml, IM, of Pneumovax 23 (Lot #655765/0061U). Concomitant therapy included simvastatin (MSD), NIASPAN, and vitamins (unspecified). On 17-MAY-2007 the patient experienced slight redness and tenderness on her left arm at the injection site, and had chills, a fever (not specified) and was achy. On 18-MAY-2007 the patient was seen in the office, and the NA reported the area was swollen and red. At the time of this report, the patient had not recovered from the events. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Information has been received from a registered nurse, concerning a 56 year old female patient with a sulfonamide allergy and drug hypersensitivity to Ziac, who on 18-MAY-2007 was vaccinated IM, with a dose, 0.5ml, of Pneumovax 23 (Lot #655499/0988F). Concomitant therapy included Advair, albuterol (not specified), losartan potassium-HCTZ (MSD) and Norvasc. On 19-MAY-2007, the patient developed a "large local reaction at injection site" that was described as red, swollen, and warm, and measured 6cm by 3cm in size. At the time of this report, the patient was recovering from the local reaction. The patient sought unspecified medical attention. Additional information has been requested.  02/19/2010 Nurse later added that the symptoms involve the "entire left upper arm, " and also included the area of induration. Treatment included applying ice packs and taking Ibuprofen (manufacturer not specified). At the time of this report, the patient had recovered from the events (date not specified). The patient sought unspecified medical attention. No further information is expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Polymyalgia rheumatica
Clinical narrative: Information has been received from a physician concerning a 65 year old female with a history of myalgia who on 30-MAR-2007 in the afternoon was vaccinated with a second dose of Pneumovax 23. (Her first dose of Pneumovax 23 was reportedly several years ago). On 30-MAR-2007, in the evening, the patient had pain in her arms, legs and back. She visited the rheumatologist was diagnosed with polymyalgia rheumatica. Subsequently, the patient recovered from polymyalgia rheumatica on an unspecified date. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Haemorrhage, Injected limb mobility decreased, Injection site pain, Muscle swelling
Clinical narrative: Information has been received from a 66 year old male, healthy professional, emergency medical technician (E.M.T.) with aspirin and yellow food dye allergy, "thyroid", elevated eye pressure and a history of depression who reported that he received a dose of Pneumovax 23 in the year 2000 and he reported that he might have received a dose of Pneumovax 23 2 years ago, with no adverse symptoms noted. In approximately, February 2007, was vaccinated into the right arm with a 0.5 mL dose of Pneumovax 23 (Lot # 655290/0959F). The patient concomitantly was vaccinated with tetanus toxoid into the left arm. Concomitant therapy included LEXAPRO, SYNTHROID and XALATAN. The next day, approximately in February 2007, his right arm was very sore, difficult to raise the arm over his head and the deltoid was sore and swollen. The next day he had pain and tenderness in the bicep. Treated with an unnamed antibiotic and prednisone tapered dose pack. The symptoms continued for about 10 days. There was injection site tenderness and petechial hemorrhage for two weeks. he then had pain in the right finger joints, especially index finger, middle finger and thumb for 5 days. Finger symptoms were diagnosed as osteoarthritis. The patient sought unspecified attention. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Osteoarthritis, Pain in extremity, Petechiae
Clinical narrative: Information has been received from a 66 year old male, healthy professional, emergency medical technician (E.M.T.) with aspirin and yellow food dye allergy, "thyroid", elevated eye pressure and a history of depression who reported that he received a dose of Pneumovax 23 in the year 2000 and he reported that he might have received a dose of Pneumovax 23 2 years ago, with no adverse symptoms noted. In approximately, February 2007, was vaccinated into the right arm with a 0.5 mL dose of Pneumovax 23 (Lot # 655290/0959F). The patient concomitantly was vaccinated with tetanus toxoid into the left arm. Concomitant therapy included LEXAPRO, SYNTHROID and XALATAN. The next day, approximately in February 2007, his right arm was very sore, difficult to raise the arm over his head and the deltoid was sore and swollen. The next day he had pain and tenderness in the bicep. Treated with an unnamed antibiotic and prednisone tapered dose pack. The symptoms continued for about 10 days. There was injection site tenderness and petechial hemorrhage for two weeks. he then had pain in the right finger joints, especially index finger, middle finger and thumb for 5 days. Finger symptoms were diagnosed as osteoarthritis. The patient sought unspecified attention. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning a 75 year old female with asthma, sulfa, penicillin, Macrobid and Actonel allergy and a history of skin cancer in the past and pneumonia in the past who on 22-MAY-2007 was vaccinated intramuscularly with a 0.5 mL dose of the Pneumovax 23 (Lot # 655501/1035F). Concomitant therapy included Advair, ("ASTHMANEX"), LORTAB and PROVENTIL. On 23-MAY-2007 the patient developed cellulitis. The cellulitis was not at the injection site but underside of the same arm. There was no visible reaction on the injection site. At the time of the report, the patient had not recovered. The reporter requested a lot check. A Lot check of concern was requested. The records of the testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: Information has been received from a physician, concerning a 73 year old female pateint, who on 06-OCT-1995 was vaccinated with the first dose, 0.5ml, IM, of Pneumovax 23, and on 22-MAY-2007 was vaccinated with the second dose, 0.5ml, IM, of Pneumovax 23. Concomitant therapy included vitamins (unspecified) and calcium (unspecified). On 22-MAY-2007, following the second vaccination, the patient experienced soreness, erythema, swelling and warmth around injection site on her left upper arm. The pateint took Benadryl and applied cold compresses to treat the symptoms. On 24-MAY-2007, the physician saw the patient, and reported her left arm was then swollen from her upper left to the mid part of her forearm, and continued to be red and warm, and had become painful with decreased mobility. At the time of this report, the patient had not recovered from the events. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician, concerning a 73 year old female pateint, who on 06-OCT-1995 was vaccinated with the first dose, 0.5ml, IM, of Pneumovax 23, and on 22-MAY-2007 was vaccinated with the second dose, 0.5ml, IM, of Pneumovax 23. Concomitant therapy included vitamins (unspecified) and calcium (unspecified). On 22-MAY-2007, following the second vaccination, the patient experienced soreness, erythema, swelling and warmth around injection site on her left upper arm. The pateint took Benadryl and applied cold compresses to treat the symptoms. On 24-MAY-2007, the physician saw the patient, and reported her left arm was then swollen from her upper left to the mid part of her forearm, and continued to be red and warm, and had become painful with decreased mobility. At the time of this report, the patient had not recovered from the events. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Blood sodium normal, Chills, Full blood count normal, Injection site erythema
Clinical narrative: Information has been received from a 75 year old female who on 24-JAN-2007 was vaccinated IM with Pneumovax 23 (Lot # not reported). On 24-JAN-2007 the patient developed chills. On 25-JAN-2007 she developed a fever and the arm (NOS) she received the vaccination in became swollen. A day or so later she developed a rash covering her whole body except her face. She went to the ER, but was admitted. She had "every kind of test possible" (NOS). Subsequently, the patient reported that she recovered from the events 10 days after it started. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/30/2007. Information has been received from a 75 year old female with a history of osteoarthritis, diverticulitis, ischemia colitis, anxiety, osteopenia and no allergies who on 24-JAN-2007, was vaccinated IM into the right arm with a dose of PNEUMOVAX. Illness at the time of vaccination included left knee pain. On 25-JAN-2007 on awakening, the patient experienced right arm soreness, a mild temperature of 100 and progression to chills reported by phone 12 hours later. On 26-JAN-2007 the patient was seen in the office. It was reported that her temperature was 98.9. She had localized injection site reaction with mild erythema and moderate edema. She was also anxious. On 28-JAN-2007, the patient developed a fever of 102. She was sent to the emergency room where her temperature was reported to be 101.1. It was reported per the ER report, her skin was warm and dry. She had a diffuse macular pink rash over her torso and extremities. The patient felt awful. On 26-JAN-2007, laboratory diagnostic studies included a WBC of 12.2, Na level of 134. On 28-JAN-2007, in the ER laboratory diagnostic studies included a CBC and CMP. The patient stated she had every kind of test possible in the ER. Subsequently, the patient reported that she recovered from the events 10 days after it started. She was vaccinated with TETANUS and influenza virus vaccine (unspecified) in the past. No product quality complaint was involved. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site reaction, Metabolic function test, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 75 year old female who on 24-JAN-2007 was vaccinated IM with Pneumovax 23 (Lot # not reported). On 24-JAN-2007 the patient developed chills. On 25-JAN-2007 she developed a fever and the arm (NOS) she received the vaccination in became swollen. A day or so later she developed a rash covering her whole body except her face. She went to the ER, but was admitted. She had "every kind of test possible" (NOS). Subsequently, the patient reported that she recovered from the events 10 days after it started. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/30/2007. Information has been received from a 75 year old female with a history of osteoarthritis, diverticulitis, ischemia colitis, anxiety, osteopenia and no allergies who on 24-JAN-2007, was vaccinated IM into the right arm with a dose of PNEUMOVAX. Illness at the time of vaccination included left knee pain. On 25-JAN-2007 on awakening, the patient experienced right arm soreness, a mild temperature of 100 and progression to chills reported by phone 12 hours later. On 26-JAN-2007 the patient was seen in the office. It was reported that her temperature was 98.9. She had localized injection site reaction with mild erythema and moderate edema. She was also anxious. On 28-JAN-2007, the patient developed a fever of 102. She was sent to the emergency room where her temperature was reported to be 101.1. It was reported per the ER report, her skin was warm and dry. She had a diffuse macular pink rash over her torso and extremities. The patient felt awful. On 26-JAN-2007, laboratory diagnostic studies included a WBC of 12.2, Na level of 134. On 28-JAN-2007, in the ER laboratory diagnostic studies included a CBC and CMP. The patient stated she had every kind of test possible in the ER. Subsequently, the patient reported that she recovered from the events 10 days after it started. She was vaccinated with TETANUS and influenza virus vaccine (unspecified) in the past. No product quality complaint was involved. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash generalised, Rash macular, White blood cell count
Clinical narrative: Information has been received from a 75 year old female who on 24-JAN-2007 was vaccinated IM with Pneumovax 23 (Lot # not reported). On 24-JAN-2007 the patient developed chills. On 25-JAN-2007 she developed a fever and the arm (NOS) she received the vaccination in became swollen. A day or so later she developed a rash covering her whole body except her face. She went to the ER, but was admitted. She had "every kind of test possible" (NOS). Subsequently, the patient reported that she recovered from the events 10 days after it started. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/30/2007. Information has been received from a 75 year old female with a history of osteoarthritis, diverticulitis, ischemia colitis, anxiety, osteopenia and no allergies who on 24-JAN-2007, was vaccinated IM into the right arm with a dose of PNEUMOVAX. Illness at the time of vaccination included left knee pain. On 25-JAN-2007 on awakening, the patient experienced right arm soreness, a mild temperature of 100 and progression to chills reported by phone 12 hours later. On 26-JAN-2007 the patient was seen in the office. It was reported that her temperature was 98.9. She had localized injection site reaction with mild erythema and moderate edema. She was also anxious. On 28-JAN-2007, the patient developed a fever of 102. She was sent to the emergency room where her temperature was reported to be 101.1. It was reported per the ER report, her skin was warm and dry. She had a diffuse macular pink rash over her torso and extremities. The patient felt awful. On 26-JAN-2007, laboratory diagnostic studies included a WBC of 12.2, Na level of 134. On 28-JAN-2007, in the ER laboratory diagnostic studies included a CBC and CMP. The patient stated she had every kind of test possible in the ER. Subsequently, the patient reported that she recovered from the events 10 days after it started. She was vaccinated with TETANUS and influenza virus vaccine (unspecified) in the past. No product quality complaint was involved. Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site streaking
Clinical narrative: Information has been received from a pharmacist, concerning an 84 year old female with high cholesterol, who in May 1997 (ten years ago), was vaccinated with the first dose of Pneumovax 23. Concomitant therapy included Paxil and Zocor. The patient reported that following the vaccination, she immediately developed red streaks down her arm. Treatment with Benadryl caused the red streaks to subside by the next morning. No further information is expected.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician assistant and a certified medical assistant (CMA), concerning a 46 year old female patient with drug hypersensitivities to hydrocodone (Lortab), Percocet and minocycline (manufacturer unspecified), arthritis and environmental allergies, who on 19-OCT-2006 was vaccinated SW in the left arm with a dose of Pneumovax 23. Concomitant therapy included Advair, lisinopril (MSD), Nasonex, Nexium, Paxil, Robinul and Stahist. The day following the vaccination, 20-OCT-2006, the patient developed pain, redness, swelling, and warmth at the injection site; the patient also reported "not feeling quite right." The CMA added that "a few weeks ago," patient was treated with a 10-day course of Keflex. On 31-May-2007, the patient visited the physician's assistant, who identified a hard nodule of <1cm at the injection site; it was noted that lymphadenopathy was not present. At the time of this report, the patient's symptoms had not resolved. A follow up visit was planned for 3 weeks. The CMA considered one or more of the events to be significantly disabling/incapacitating. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient (age not reported) who on an unspecified date was vaccinated with a dose of Pneumovax 23. Subsequently the patient developed cellulitis. The patient sought unspecified medical attention. It was unknown if the patient recovered. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning an adult female who was "recently" vaccinated intramuscularly with 0.5 mL dose of Pneumovax 23 (lot # 651319/1007P). Subsequently the patient developed injection site pain, redness and swelling. The patient sought medical attention and was treated with OTC Advil. Subsequently, the patient recovered. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Body temperature increased, Cardiac enzymes normal, Chest X-ray normal, Chest pain
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old female co-worker with oesophaeal acid reflux who on 09-JUL-2007 was vaccinated SQ with a dose of Zostavax. Concomitant therapy included esomeprazole magnesium (NEXIUM). On 12-JUL-2007 the co-worker started to have body aches and a fever that went to 102 F. The family physician gave the co-worker started to have body aches and a fever that went to 102 F. The family physician gave the co-worker cefaclor (CECLOR) on 14-JUL-2007 and then on 15-JUL-2007 the patient started having the chest pains. The co-worker was hospitalized and a heart monitor, cardiac enzyme and an "echo" were found to be normal. The co-worker was also having a worsening of acid reflux, felt lifeless/could not get around and her joints ached. At the time of the report the co-worker was not recovered. The reporter considered the events to be important medical events and feeling lifeless/could not get around to be disabling. No further information is available.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Echocardiogram normal, Influenza like illness, Lethargy
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old female co-worker with oesophaeal acid reflux who on 09-JUL-2007 was vaccinated SQ with a dose of Zostavax. Concomitant therapy included esomeprazole magnesium (NEXIUM). On 12-JUL-2007 the co-worker started to have body aches and a fever that went to 102 F. The family physician gave the co-worker started to have body aches and a fever that went to 102 F. The family physician gave the co-worker cefaclor (CECLOR) on 14-JUL-2007 and then on 15-JUL-2007 the patient started having the chest pains. The co-worker was hospitalized and a heart monitor, cardiac enzyme and an "echo" were found to be normal. The co-worker was also having a worsening of acid reflux, felt lifeless/could not get around and her joints ached. At the time of the report the co-worker was not recovered. The reporter considered the events to be important medical events and feeling lifeless/could not get around to be disabling. No further information is available.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Cardiac enzymes normal, Cardiac monitoring normal, Chest pain, Condition aggravated
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old female co-worker with oesophaeal acid reflux who on 09-JUL-2007 was vaccinated SQ with a dose of Zostavax. Concomitant therapy included esomeprazole magnesium (NEXIUM). On 12-JUL-2007 the co-worker started to have body aches and a fever that went to 102 F. The family physician gave the co-worker started to have body aches and a fever that went to 102 F. The family physician gave the co-worker cefaclor (CECLOR) on 14-JUL-2007 and then on 15-JUL-2007 the patient started having the chest pains. The co-worker was hospitalized and a heart monitor, cardiac enzyme and an "echo" were found to be normal. The co-worker was also having a worsening of acid reflux, felt lifeless/could not get around and her joints ached. At the time of the report the co-worker was not recovered. The reporter considered the events to be important medical events and feeling lifeless/could not get around to be disabling. No further information is available.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Echocardiogram normal, Gastrooesophageal reflux disease, Mobility decreased, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old female co-worker with oesophaeal acid reflux who on 09-JUL-2007 was vaccinated SQ with a dose of Zostavax. Concomitant therapy included esomeprazole magnesium (NEXIUM). On 12-JUL-2007 the co-worker started to have body aches and a fever that went to 102 F. The family physician gave the co-worker started to have body aches and a fever that went to 102 F. The family physician gave the co-worker cefaclor (CECLOR) on 14-JUL-2007 and then on 15-JUL-2007 the patient started having the chest pains. The co-worker was hospitalized and a heart monitor, cardiac enzyme and an "echo" were found to be normal. The co-worker was also having a worsening of acid reflux, felt lifeless/could not get around and her joints ached. At the time of the report the co-worker was not recovered. The reporter considered the events to be important medical events and feeling lifeless/could not get around to be disabling. No further information is available.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site cellulitis
Clinical narrative: Two days post anthrax virus vaccine administration, patient presented with cellulitis at injection site.  He was given dicloxacillin 250mg QID for 7 days and symptoms resolved.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Intra-uterine death, Smear cervix, Ultrasound scan
Clinical narrative: Information has been received from the Merck Pregnancy Registry via a medical assistant concerning a 17 Year old female with no pertinent past medical history who on 18-JAN-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot #655619/1427F). On an unspecified date the patient was vaccinated intramuscularly with the second dose of Gardasil (657005/0188U). There were no concomitant therapies. It was reported by the medical assistant that the patient did not let the staff know she was pregnant and the first and second doses of Gardasil were administered respectively. The patient's last menstrual period was 26-SEP-2006. Estimated the patient's pregnancy to be at least 37 weeks gestation. Subsequently the patient's pregnancy ended in a fetal demise. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion missed, Drug exposure during pregnancy, Laboratory test normal, Ultrasound scan abnormal, Uterine dilation and curettage
Clinical narrative: Initial and follow-up information has been received for the Merck Pregnancy Registry from a nurse and a certified nurse midwife concerning a 26 year old female who on 12-DEC-2006 was vaccinated with a first dose of Gardasil (Lot # 654389/0961F). On 07-FEB-2007, the patient vaccinated with a second dose of Gardasil (Lot #653736/0014U). Subsequently the patient became pregnant. The estimated date of conception was 02-JUN-2007. On 07-JUN-2007 the patient was vaccinated IM with a third dose of Gardasil (Lot #657737/0522U). Concomitant therapy included Percocet. Unspecified medical attention was sought. All "prenatal labs" were normal. The date of the patient's last menstrual period was 18-MAY-2007. The estimated date of delivery was 22-FEB-2008. On 23-JUL-2007 the patient underwent an ultrasound for viability which revealed missed abortion. On 24-JUL-2007, the patient underwent a uterine dilation and curettage. Other medications used during this pregnancy included prenatal vitamins. Upon internal review, the missed abortion was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Tachycardia
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient with a penicillin allergy who on 09-JAN-2007, was vaccinated with a dose of Gardasil. On 16-JUL-2007, the patient experienced tachycardia and was hospitalized. On 20-JUL-2007, it was reported that the patient was released from the hospital. On an unspecified date, the patient recovered. No product quality complaint was involved. The reporter considered tachycardia to be life threatening and an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Fall, Immediate post-injection reaction, Syncope, Tremor
Clinical narrative: Information has been received from a certified medical assistant concerning a 16 year old female patient with no history of seizures or fainting in the past and an allergy to cefixme (SUPRAX) who on 01-MAY-2007, was vaccinated with a first dose of Gardasil (Lot# 658094/0524U). On 11-JUL-2007, the patient was very afraid to receive the second dose. There was no concomitant medication. It was reported that 30 seconds after the vaccine was given the patient fainted. The patient was standing and fell to the floor and did not hit her head. She fell to her knees and her upper body went backwards, head did not hit the floor. The nurse guided the patient to the floor. The patient's entire body shook like she was having a seizure for 5 to 10 seconds. Unspecified medical attention was sought. It was reported that the patient became conscious and rested. On 11-JUL-2007, the patient recovered. No product quality complaint was involved. Upon internal review, entire body shaking  like she was having a seizure was considered to be an other important medical event.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ectopic pregnancy
Clinical narrative: Information has been received from a Registered Nurse, through the Merck pregnancy registry, concerning a 24 year old female patient who in March 2007, was vaccinated with a first dose of Gardasil and in May 2007 received the second dose of Gardasil. On 25-JUN-2007 Methotrexate was given for treatment of the ectopic pregnancy. Pregnancy was confirmed 1 week before 25-JUN-2007. No further information was available. Upon internal review, ectopic pregnancy, spontaneous abortion was determined to be an other Important Medical Event. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Barium enema, Computerised tomogram abnormal, Intussusception, Surgery
Clinical narrative: This is just for statistical information. This baby developed intussusception 7/4/07 at 6 months of age. He had two doses of Rotateq at 2 and 4 months of age (with other shots). He had not received the third dose.  8/10/07 Received pcp medical records including vax records which confirm RO dose & lot # as reported.  Records reveal patient experienced good development & was healthy on day of vax.  Seen in ER on 7/4 s/p vomiting & bloody stools.  CT confirmed IS.  BE could not reduce & had surgery.  Returned to office on 7/30 for post op check & doing well.  8/24/07 Received hospital medical records which reveal patient experienced nonbilious emesis, abdominal pain & distention, low grade fever & jelly like stool x 2 days.  Admitted 7/5-7/6/07.  Air enema x 3 unable to reduce IS.  Taken to OR for laproscopic reduction of IS.  Progressed well & d/c to home. FINAL DX: Ileocolic intussusception, surgically reduced.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Back pain, Headache, Lumbar puncture, Myalgia, Nausea
Clinical narrative: 18 years old with complaints of fever 102. Headache nausea, back pain, muscle pain, started at 12 midnight. 12 hours after imm. pt went to ER for treatment. Received a spinal tap
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: 18 years old with complaints of fever 102. Headache nausea, back pain, muscle pain, started at 12 midnight. 12 hours after imm. pt went to ER for treatment. Received a spinal tap
Age: 42.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pain, Skin nodule, Swelling
Clinical narrative: Started 6/30/07, swelling under rt arm. no redness or swelling noted at injection site. States lump under arm painful to touch. 7/2 talked with Dr-did not seem to think it is vaccine related. Advised to go to primary physician
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Rash, Rash generalised
Clinical narrative: 6/16/07 Grandmother noticed a few red spots on patients trunk. 6/18/07 other grandmother noticed red spots on hands, top of feet and buttocks. GM states was not itching, just uncomfortable, with no fever present. Instructed GM if fever rises to take her to her PCP for further eval.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Body temperature increased, Headache, Rash, Rash generalised, Skin warm
Clinical narrative: Mother ph'd from cell out of country. Child developed rash on trunk mostly lt. side of body, slight temp not hot touch, rash on face and body. Will be out of country for 1 month and was concerned. C/O headache (today), advised to take child to Dr. Ph'd 6-4-07 to check on child - rec'd voice message. Called 9 more times.