chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.1
Sex: F
Vaccine: PNC, VARZOS
Symptoms: Ear infection, Eye infection, Lower respiratory tract infection, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 month old female who inadvertently on 09-DEC-2008 was vaccinated SQ with a dose of ZOSTAVAX vaccine (Oka/Merck) (Lot #663197/1418X) 0.5ml instead of varicella virus vaccine live (Oka/Merck). The patient has not experienced any known symptoms. The nurse practitioner also confirmed that this was a case of product confusion. She also mentioned that the varicella virus vaccine live (Oka/Merck) and ZOSTAVAX vaccine (Oka/Merck) are stored in the same freezer but he bags were not labeled and this is why it happened even though they were separated. The freezer now contains bags with labels to avoid confusion. The nurse practitioner also mentioned that the patient did not receive the full dose of the vaccine since the nurse thought she was administering the varicella vaccine live (Oka/Merck). The nurse drew up the vaccine in the syringe and took it down to the 0.5 ml and discarded the rest thinking it was extra. There have not been any adverse events reported that the nurse is aware of.  The nurse stated that all the vaccines are packed the same and has similar names and so this is what is confusing for them because they work with so many that look alike and they find it hard to differentiate. Follow-up information has been received from the registered nurse indicating that she was a 13 month old female, weighing 20 1/2 pounds and 28 1/2 inches in height (on 17-NOV-2008), with no known drug reaction/allergies and no pertinent medical history, who on 09-DEC-2008 at 13:30, was inadvertently vaccinated ZOSTAVAX vaccine (Oka/Merck) (Lot # 663197/1418X), 0.5ml, subcutaneously in the right thigh. There were no illnesses at the time of vaccination. There was no adverse events following vaccination. Other concomitant therapy included the fourth dose of PREVNAR vaccine given intramuscularly in the left thigh on 09-DEC-2008 at 13:30. The registered nurse stated that the patient visited the doctor on week if DEC 15th for bilateral ear infections and bilateral eye infection. The patient was given eye drops and oral antibiotic. The patient also had chest cold. No further information is expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a medical assistant concerning a 74 year old female patient who had an episode of shingles prior to receiving ZOSTAVAX (Oka/Merck). In May 2008 the patient was vaccinated with ZOSTAVAX (Oka/Merck) (no lot # provided), and subsequently, on an unspecified date in 2998, the patient experienced shingles again. Patient came into office seeking medical attention. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia, Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning an 87 year old female patient with hypertension, hyperlipidaemia and hypothyroidism, no drug reactions/allergies, who in approximately December 2007, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SYNTHROID and ACTONEL. On 7-DEC-2008 the patient had a rash which was red and vesicular. It did not cross the midline. Rather, it went down her right flank area, sown her back and down her right posterior leg. The patient had associated numbness and tingling. the patient was prescribed VALTREX. The patient sought medical attention. AT the time of reporting, the patient had not recovered. This is one of several cases from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a store manager concerning a female patient who on 12-NOV-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot #663198/1419X). In November 2008, the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 66 year old female patient with codeine allergy, hypertension and hypothyroidism who 2 months ago, in approximately October 2008, at a different facility, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) 0.5 mL SQ. There was no concomitant medication. One week after the vaccination, in approximately October 2008, the patient developed injection site reaction. The patient had been having pain, redness and swelling at the injection site. The patient's injection site reaction persisted. The patient sought medical attention, she saw the physician. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Subsequently the patient developed shingles "really bad". It is unknown if the patient sought medical attention. At the time of reporting, the patient's outcome is unknown. No further information is unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a female consumer who on 25-NOV-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 28-NOV-2008 the patient developed giant urticaria. On 5-DEC-2008 the patient developed low grade fever, 100.4 degrees. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a 46 year old male patient with history of drug hypersensitivity to penicillin and shellfish based medications such as finasteride (MSD) WAES # 0812USA02142) who on 3-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 663198/1419X) on the arm. There was no concomitant medication. On 4-DEC-2008 the patient experienced redness at injection site, swelling at injection site and bump under the skin at injection site. Patient stated that the bump is approximately the size of half a dollar and the redness is about 4 times the size of the bump. Patient sought medical attention going to see the pharmacists. At  the time of the report the patient had not recovered. This is one of several reports from the same patient. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her sister, a female patient who according to the consumer she had already had a very bad outbreak of the shingles previously and then received a dose of ZOSTAVAX (Oka/Merck) (lot # not provided) and sometime after the vaccination she broke out with shingles again. The consumer reported that one of her physician's did not think it was the shingles and another physician believed it to be the shingles. No further information is available.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 1 year old patient who on 24-NOV-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot # 663197/1418X) by mistake, the vaccine that the patient should have received was VARIVAX (Oka/Merck) (MSD). there was no localized symptoms, no swelling and the patient was fine. No further information is available.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Myalgia, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a nurse practitioner concerning a 67 year old male patient with sleep apnoea and a history of head injury recovered (patient fully mentally alert) with no drug reactions/allergies, who on 12-SEP-2008 was vaccinated subcutaneously with a 0.7 mL dose of ZOSTATVAX (Oka/Merck) (Lot # 658859/0411X).  Concomitant therapy included LIPITOR.  On approximately 26-SEP-2008, 2 weeks post vaccination, the patient developed joint and muscle pain, and had been taking PREDNISONE for the joint and muscle pain but the pain still persisted.  It was unknown when started on PREDNISONE.  The patient sought unspecified medical attention.  At the time of reporting, the patient had not recovered.  On 12-DEC-2008 follow-up information was received from a phone call from the patient.  The pain began in his left shoulder and then moved to his right shoulder and later included the joints in his left hand.  The patient did not remember which arm he received the vaccination in.  On an unspecified date, his sedimentation rate was initially 77 and later 7.  He had a PREDNISONE injection in his right shoulder.  No further information is available.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Herpes zoster, Therapeutic response unexpected
Clinical narrative: Information has been received from a 64 year old male with high blood pressure and shingles with post herpetic neuralgia (PHN) and a history of stent placement "2 stents for 3 years" who in approximately October 2007, was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included NORVASC and PLAVIX. The report was as follows: when patient was 28 years old he developed the shingles and then the shingles came back after that. He then developed PHN after developing the shingles and extreme back pain. Approximately 14 months ago after receiving the vaccine, his back pain went away, and then for the last two weeks his lower back pain started to come back. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 60 year old female who, "in last week", on approximately 24-Nov-2008 was vaccinated with a dose of ZOSTAVAX. Subsequently the patient experienced blisters, fever and aching. The patient was not taking any new medications and she was otherwise healthy. At the time of this report, 03-Dec-2008, the outcome was unknown. Follow-up information was received from a physician. The physician did not remember the details of the reaction. Further information was not available.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Iritis, Pain, Scleritis
Clinical narrative: Information has been received from a female patient, who in February 2008, was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (Lot. # unspecified). In 2008, the patient had developed shingles on a side of her face. It is unknown if the patient sought medical attention. At the time of reporting (02-DEC-2008) the outcome of the patient was not recovered. Additional information has been requested. Follow up information has been received from a completed Herpes Zoster questionnaire, from a physician concerning a female patient with a history of chickenpox in her childhood, who in January 2008, was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). In December 2008, the patient developed shingles on the right trigeminal. The patient also developed iritis and scleritis quantifying the pain as 5 from 0 to 10 (Most) (December 2008). On an unspecified date the patient recovered (200*0. The physician also stated that the ZOSTAVAX vaccine (Oka/Merck) was not administered in his clinic. Additional information is not expected.  Following information has been received from a completed Herpes Zoster questionnaire, from a physician concerning a female patient with history of chickenpox in her childhood, who in January 2008, was vaccinated with a dose of ZOSTAVX. In December 2008, the patient developed shingles on the right trigeminal. The patient also developed laities and sclerosis quantifying the pain as 5 form 0 to 10(December 2008). On an unspecified date the patient recovered (2008). The physician also stated that the ZOSTAVAX was not administered in his clinic. Additional information has been received on 20-MAR-2009 from the 74 year old health female patient, who on 09-JUK-2008 received a dose of ZOSTAVAX (lot not reported). On 29-NOV-2009 the patient developed shingles. The reporter stated that she was still being treated by her "eye doctor" because she might loose her eye sight; the patient also stated that she had suffered so much pain over two months. Additional information is not expected.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Anorexia, Pain in extremity, Pruritus generalised
Clinical narrative: Information has been received from a 73 year old male patient with history of prostatic disorder and no known drug reactions/allergies, who on approximately 1-NOV-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # was not available) in an arm. Concomitant therapy included unspecified medications. The caller reported that 2 to 3 days after starting the therapy, he experienced itching all over his body. He mentioned that did not have a rash and had not had one at any point. At the time of the report, the patient had not recovered. The patient sought medical attention and was seen by a physician. In follow-up, patient called to report that he is experiencing hands and leg pain and also loss of appetite after getting the vaccine. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Rash macular
Clinical narrative: Information has been received from a physician concerning a 77 year old female patient who in February 2007, was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). On 22-NOV-2008 the patient visited the physician with shingles. The physician reported that it started with a pain in her right elbow and then the "blotches" appeared. The physician determined it was shingles. At he time of reporting the patient was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a patient who about a year ago was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The pharmacist reported that the patient experiencing persistent urticaria about one month after receiving the vaccine. The pharmacist did not think the urticaria was from ZOSTAVAX (Oka/Merck), he states, "this was not an adverse event from ZOSTAVAV (Oka/Merck) and he did not want to report this". The patient sought unspecific medical attention. AT the time of reporting the patient was not recovered. No further information is available.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Haematology test normal, Pruritus, Rash macular
Clinical narrative: Information has been received from an 88 year old female consumer with a blood pressure condition and no pertinent medical history, who on 18-Nov-2008 was vaccinated with adose of ZOSTAVAX (Oka/Merck)". Concomitant therapy included "blood pressure medicine." About a week later (26-Nov-2008) she" started noticing a little bit of breaking out on her left arm. That progressed to her right side of her body, under arm, chest and back and it looks like "big red splotches" however there is no pain or itchiness associated with it. The patient had blood work (unspecified) which "came out okay". Follow up information was received from the patient's home care aid, who called because the patient's rash was spreading and was worse than when she saw the physician on 29-Nov-2008. At that time the physician prescribed Hydroxyzine (manufacturer unknown) for itching. As of 02-Dec-2008, the outcome of the patient was not recovered. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning her father, an 83 year old male with a history of macular degeneration and "neuropathies" who was vaccinated with a dose of ZOSTAVAX (lot# not reported) in Feb 2008. Concomitant therapy included COUMADIN and "NORAGEN". In Nov 2008, the patient experienced shingles. The shingles rash extended from ear to head. The patient sought medical attention at the physician's office. PCR analysis not requested at this time. The patient had not recovered at the time of reporting. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Herpes zoster ophthalmic, Malaise, Pain
Clinical narrative: Information has been received from a physician concerning a 74 year old male with hypertension, dyslipidaemia and penicillin allergy and a history of chickenpox who on 13-NOV-2008 was vaccinated with 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # 658859/0411X) into the left upper arm.  Concomitant therapy included QUINAPRIL, FENOFIBRATE, SIMVASTATIN (manufacturer unknown), aspirin and OTC MVI supplement.  On 17-NOV-2008, 5 days after being vaccinated, the patient experienced shingles in the right eye.  It was also reported that herpes ZOSTER  distributed on the right scalp and in the right eye and the rash type included popular and vesicular.  The systemic symptoms included scalp tenderness, tingling, redness and vesicular/popular lesions.  On an unspecified date the patient also experienced general malaise.  There was no recent exposure to chickenpox  or shingles.  The patient reported pain of 6-7 on a scale of 1 to 10.  Subsequently, the patient recovered on an unspecified date.  The patient sought unspecified medical attention.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Paraesthesia, Rash papular
Clinical narrative: Information has been received from a physician concerning a 74 year old male with hypertension, dyslipidaemia and penicillin allergy and a history of chickenpox who on 13-NOV-2008 was vaccinated with 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # 658859/0411X) into the left upper arm.  Concomitant therapy included QUINAPRIL, FENOFIBRATE, SIMVASTATIN (manufacturer unknown), aspirin and OTC MVI supplement.  On 17-NOV-2008, 5 days after being vaccinated, the patient experienced shingles in the right eye.  It was also reported that herpes ZOSTER  distributed on the right scalp and in the right eye and the rash type included popular and vesicular.  The systemic symptoms included scalp tenderness, tingling, redness and vesicular/popular lesions.  On an unspecified date the patient also experienced general malaise.  There was no recent exposure to chickenpox  or shingles.  The patient reported pain of 6-7 on a scale of 1 to 10.  Subsequently, the patient recovered on an unspecified date.  The patient sought unspecified medical attention.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Ear haemorrhage, Hypertension
Clinical narrative: Information has been received from a consumer concerning her 75 year old mother with leukemia, memory loss and a history of two strokes, and "allergic to sulfate drugs" who on 20-NOV-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 662971/1213X). Concomitant therapy included COUMADIN, PAXIL and VALIUM. It was reported that the patient experienced high blood pressure (160-98), a stomachache and she has been bleeding out of her ears. The reporter also mentioned that her mother was immunosuppressed due to leukemia. The patient had not recovered at the time of the report. The patient sought medical attention with the physician. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacists concerning a patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot not reported) subcutaneously. After three days post vaccination the patient developed injection site welt that was warm to the touch. As of 7-JAN-2009 the present patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a registered pharmacists concerning a patient who was vaccinated with a dose of ZOSTAVAX (Merck) (Lot not reported) subcutaneously.  After three days post vaccination the patient developed injection site welts that was 1x1 1/2 inches.  As of 07-JAN-2009 the present patient's outcome was unknown.  This is one of several reports from the same source.  Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Lymphadenopathy
Clinical narrative: Information has been received from a 54 year old female with a history of shingles in right eye in Feb 1998 and no drug allergies who was vaccinated with a 0.65ml dose of ZOSTAVAX (Oka/Merck) (lot # not reported0 for prevention of shingles on 17-DEC-2008.  It was reported that the patient experienced pain on the left side of her face, ear ache and swollen glands 2 days ago, on 06-JAN-2009.  The patient sought medical attention.  No lab tests were performed.  As of 08-JAN-2009, the patient was not recovered.  Additional information is not expected.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Paraesthesia, Rash
Clinical narrative: Information has been received from an 88 year old male with no pertinent medical history who on 15-DEC-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). On 06-JAN-2009 the patient developed warmth, tingling and a rash on his back. Unspecified medical attention was sought. At the time of the report, 08-JAN-2009, the patient had not recovered from the events. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site haematoma, Injection site swelling
Clinical narrative: Information has been received from a 61 year old female with sulfonamide allergy and no pertinent medical history who on 05-Jan-2009 was vaccinated with a 0.65ml dose of ZOSTAVAX (lot# not reported) for prevention of shingles. Concomitant medication included MSD. On 06-Jan-2009 the patient experienced swelling on her arm at the injection site and bruising. The patient sought medical attention. "Routine labs" were performed. At the time of the report, 08-Jan-2009, the patient's injection site swelling on arm and bruising persisted. Follow-up information was received from a physician on 15-Jan-2009. It was reported that on 07-Jan-2009 the patient with allergic to erythromycin experienced redness at the injection site after receiving ZOSTAVAX (lot# 66280/1617X). As of 15-Jan-2009, the patient's outcome was unknown. Follow up information was received via medical records which indicated that the patient was a female with osteopenia who on 05-Jan-2009 at 10:54 am was vaccinated subcutaneously with a second dose of ZOSTAVAX (lot# 662860/1617X). Concomitant therapy included MSD, calcium (unspecified), chondroitin sulfate sodium + glucosamine sulfate and vitamins (unspecified). On 07-Jan-2009, the patient visited the office and stated having erythema at the site of injection and no nausea , vomiting short of breath and chest pain. The physician impression was cellulitis vs. localized shingles vaccine reaction, and "openia". The plan was to encourage the patient to do weight-bearing exercise and take bisposhate. Vitamin D and immunoreactive parathyroid hormone were checked. The cellulitis was treated with KEFLEX and the area was marked. the patient was advised to call the office if the event became worse or was not improving in the next 48 hours. Deep vein thrombosis was doubted as well. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 74 year old female with sulfa allergy and allergic to an antibiotics (unspecified) who on 6-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On approximately 8-JAN-2009, "about 48 hours" post vaccination, the patient experienced an injection site reaction which included itchiness, redness, swelling and warmth around injection site area which was about 3" x 1" in diameter. The patient did not seek medical attention. Additional information has requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who was vaccinated with a dose of ZOSTAVAX (Merck) (Lot not reported) subcutaneously.  After three days post vaccination the patient developed injection site welts.  As of 07-JAN-2009 the present patient's outcome was unknown.  Follow up information received on 12-JAN-2009 from the registered pharmacist indicated that at the time of the occurrences he did not think to record any information of the patient.  The reporter said that on an unspecified date the patient recovered.  Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Gait disturbance, Pain in extremity
Clinical narrative: Information has been received from a 66 year old male patient with high cholesterol and a history of quadruple vessel bypass graft in 1990, shingles and a drug reaction to CODEINE (unspecified) who on 05-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included METOPROLOL TARTRATE, ENALAPRIL MALEATE, EZETIMIBE (MSD) and LIPITOR.  On 06-JAN-2009 the patient experienced pain/ tenderness on the left side of his lower back that is just above his belt line and right above his behind.  The consumer reported that his was having pain when moving in any direction and nasty discomfort in his left heel to the point that it was starting to be painful to walk, he stated that it felt like a heel spur.  The patient was taking ibuprofen (manufacturer unknown) which had masked some of the pain.  He did not seek medical attention.  The patient's pain/tenderness on the left side of his lower back and pain when moving in any direction and nasty discomfort in his left heel that is painful to walk persisted.  No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Information has been received from pharmacist concerning a 73 year old female who on 03-JAN-2009 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot # 663175/1553X) 0.65mL,  subcutaneously into her left arm. Concomitant therapy included ACTONEL. The patient developed an injection site reaction after receiving ZOSTAVAX vaccine (Oka/Merck). It was described as a 1 inch area that remained red and itchy at the injection site several days post vaccination. Patient was told to take BENADRYL. At the time of reporting, the patient had not recovered. The patient sought medical attention and called the pharmacy. Follow up information was received from the pharmacist who reported that the patient had a PERCODAN and a COMPAZINE allergy. It was reported that the patient experienced redness and itching on 04-JAN-2009. On an unspecified date the patient recovered. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Initial and follow-up information has been received from a registered pharmacist concerning a 75 year old male patient with no known drug reaction/allergies who on 04-JAN-2009 was vaccinated subcutaneously with a single dose of ZOSTAVAX (Oka/Merck) (lot # 662856/1559X). The pharmacist reported that the patient developed a headache on 04-JAN-2009. The headache had not resolved at the time of the report. The pharmacist reported that she had not heard back from the patient as of today, so could not report if the headache still continues.  The patient sought medical attention by phone.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient who on 05-DEC-2008 was vaccinated with a 0.65ml dose of ZOSTAVAX (Oka/Merck) (lot # not provided).  On 12-DEC-2008 the patient experienced rash on her wrist on the arm she was vaccinated.  The patient was diagnosed with shingles and was prescribed VALTREX.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a female Registered Nurse, who "5-6 weeks ago", was vaccinated with ZOSTAVAX vaccine (Oka/Merck) subcutaneously. "2 weeks after receiving the vaccine", the patient developed itchy rash on several areas of both lower extremities. The nurse was examined by an unspecified nurse practitioner and was prescribed an unspecified topical cream. The nurse is scheduled to see her physician, on 09-JAN-2009. At the time of the report the patient was not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow up information has been received from a 62 year old female R.N who was vaccinated with a dose of ZOSTAVAX (Merck) around the second week of December (approximately 15-DEC-2008).  It was reported that right before New Year's Day she developed a "bite" on her left thigh that was very itchy.  It was reported that it would wake her up from a sound sleep.  Then the patient got another one on her chest and then one on her leg and one on her right wrist.  A few more for a total of 8 or 9 developed.  It was reported that they were horribly itchy.  The ones that the patient could see did not look like shingles.  The patient tried a number of over the counter medications such as BENADRYL gel but it only helped temporarily.  It was reported that she and her husband had recently been travelling and so they wondered if she had gotten bedbug bites.  It was reported that the patient realized that the time frame was similar to an incubation period for chickenpox.  The patient spoke with the drug representative for her area.  (The patient was an R.N.).  It was reported that the patient went to see the doctor to determine if she had a reaction to the ZOSTAVAX (Merck).  It was reported that all of the lesions were dry so there were no specimens to be taken.  The doctor had never seen a reaction to ZOSTAVAX (Merck) so was not sure what it was.  It was reported that after two weeks the lesions faded out and finally stopped itching.  Additional information was received from a completed questionnaire: it was reported that the patient was vaccinated with ZOSTAVAX (Merck) into her left arm.  It was reported that there was not a rash at the site of injection post vaccination.  It was determined that the lesion type was a papule and there were no vesicles present to culture.  This is one of several cases from the same source.  No further information is available.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Laboratory test, Oedema peripheral
Clinical narrative: Information has been received from a 70 year old male with sulfonamide allergy who on 24-DEC-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included simvastatin (unspecified). The reporter stated that he experienced pain at injection site after receiving the ZOSTATVAX vaccine (Oka/Merck) on 24-DEC-2008, and on the same date also had swelling on his arm. Routine labs were performed. On 27-DEC-2008 the patient recovered. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female patient with hypothyroidism, arthritis, diverticulitis and interstitial cystitis who on 29-DEC-2008 was vaccinated subcutaneously in the left upper arm with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (Lot # 662997/1619X).  Concomitant therapy included SYNTHROID, potassium (unspecified), BUFFERIN and BIOTIN (unspecified).  The pharmacist reported that on 30-DEC-2008 at 7:00 pm the patient experienced pain, redness and swelling at the injection site.  The redness and swelling was "the size of a baseball".  Over the next couple of days, the reaction extended from her shoulder to her elbow with pain in the entire area.  The patient went to the emergency room two times because of the reaction, one on 30-DEC-2008 and then revisited the ER at a different but unspecified time.  The ER physician thought that she had an infection and prescribed BACTRIM.  The patient had a follow-up on 02-JAN-2009 and had another one at the time of reporting.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute myeloid leukaemia, Dyspnoea, Nausea, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 year old female with asthma and attention deficit/hyperactivity disorder and a history of "MR" (not otherwise specified) on 18-DEC-2008 was vaccinated intramuscularly with a third dose of GARDASIL (lot number 661703/0651X) in the left arm. Concomitant therapy included clonidine, albuterol and montelukast. On 17-DEC-2008 the patient experienced nausea and vomiting. The patient's mother took the patient to the emergency room. On 19-DEC-2008 the patient's mother took the patient to emergency for shortness of breath. The patient was diagnosed with acute myeloid leukemia. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID # is 339525. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pulmonary embolism
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female with blood clot on 28-APR-2008 was vaccinated with the third dose of GARDASIL (lot # reported as 659964/1978U), vaccination route and site not reported). The patient was a healthy, active teenager. On 26-OCT-2008, the patient developed a pulmonary embolism after having 3 rounds of GARDASIL. The patient complained of cough and congestion which lasted several days. Emergency department records for the date of surgery on 26-OCT-2008 was received on 09-MAR-2009, which reported that the patient presented in full cardiac arrest after suffering a full and prolonged cardiac arrest, asystole. The patient expired. Autopsy report was received on 23-FEB-2009 which revealed that immediate cause of death: massive pulmonary embolism, mild cardiomegaly. The original reporting source was not provided. The VAERS ID # is 339771. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Autopsy, Cardiac arrest, Cardiomegaly, Cough, Death
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female with blood clot on 28-APR-2008 was vaccinated with the third dose of GARDASIL (lot # reported as 659964/1978U), vaccination route and site not reported). The patient was a healthy, active teenager. On 26-OCT-2008, the patient developed a pulmonary embolism after having 3 rounds of GARDASIL. The patient complained of cough and congestion which lasted several days. Emergency department records for the date of surgery on 26-OCT-2008 was received on 09-MAR-2009, which reported that the patient presented in full cardiac arrest after suffering a full and prolonged cardiac arrest, asystole. The patient expired. Autopsy report was received on 23-FEB-2009 which revealed that immediate cause of death: massive pulmonary embolism, mild cardiomegaly. The original reporting source was not provided. The VAERS ID # is 339771. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pulmonary embolism, Respiratory tract congestion, White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female with blood clot on 28-APR-2008 was vaccinated with the third dose of GARDASIL (lot # reported as 659964/1978U), vaccination route and site not reported). The patient was a healthy, active teenager. On 26-OCT-2008, the patient developed a pulmonary embolism after having 3 rounds of GARDASIL. The patient complained of cough and congestion which lasted several days. Emergency department records for the date of surgery on 26-OCT-2008 was received on 09-MAR-2009, which reported that the patient presented in full cardiac arrest after suffering a full and prolonged cardiac arrest, asystole. The patient expired. Autopsy report was received on 23-FEB-2009 which revealed that immediate cause of death: massive pulmonary embolism, mild cardiomegaly. The original reporting source was not provided. The VAERS ID # is 339771. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Death
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female with blood clot on 28-APR-2008 was vaccinated with the third dose of GARDASIL (lot # reported as 659964/1978U), vaccination route and site not reported). The patient was a healthy, active teenager. On 26-OCT-2008, the patient developed a pulmonary embolism after having 3 rounds of GARDASIL. The patient complained of cough and congestion which lasted several days. Emergency department records for the date of surgery on 26-OCT-2008 was received on 09-MAR-2009, which reported that the patient presented in full cardiac arrest after suffering a full and prolonged cardiac arrest, asystole. The patient expired. Autopsy report was received on 23-FEB-2009 which revealed that immediate cause of death: massive pulmonary embolism, mild cardiomegaly. The original reporting source was not provided. The VAERS ID # is 339771. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Agitation, Alopecia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 17 year old female who on 13-MAR-2007 was vaccinated with a third dose of GARDASIL intramuscularly into the left arm. After the first dose of GARDASIL (administered on 13-SEP-2006) the patient experienced dizziness, light-headed, nauseous, headache, leg cramps and shooting leg pain. After the second dose of GARDASIL (administered on 13-NOV-2006) the patient experienced same symptoms after first dose plus hair loss, abdominal bloating, menstrual cycle stopped, weakness, poor circulation. After the third dose of GARDASIL the patient experienced all symptoms listed above plus excessive hair loss, pale/purple skin, always cold, loud ringing in ears, extreme digestive, stomach pain, gastrointestinal discomfort, chronic constipation, joint pain, facial swelling, chronic fatigue, irritability, easily agitated, extreme weakness and all-over muscle fatigue (with difficulty in walking, talking, moving, etc.) The patient was diagnosed with thrombocytopenia, pancytopenia, amenorrhea, hypothyroidism, anemia, low blood pressure, antoimmune disorder, partial organ failure, digestive disorder, Epstein Barre, orthopnoea, hormonal imbalance, urinary tract infection. The patient had to seek alternative medicine doctors to receive nutritional supplementation because other doctors could do nothing for her. Recently she has been referred to a clinic (Scheduled appointment for 30-Mar-2009). This was originally reported by a consumer. A standard lot check investigation was performed. All in-process quality checks for the lot number 0263U in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Alpha-1 anti-trypsin normal, Amenorrhoea, Anaemia, Arrhythmia, Arthralgia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 17 year old female who on 13-MAR-2007 was vaccinated with a third dose of GARDASIL intramuscularly into the left arm. After the first dose of GARDASIL (administered on 13-SEP-2006) the patient experienced dizziness, light-headed, nauseous, headache, leg cramps and shooting leg pain. After the second dose of GARDASIL (administered on 13-NOV-2006) the patient experienced same symptoms after first dose plus hair loss, abdominal bloating, menstrual cycle stopped, weakness, poor circulation. After the third dose of GARDASIL the patient experienced all symptoms listed above plus excessive hair loss, pale/purple skin, always cold, loud ringing in ears, extreme digestive, stomach pain, gastrointestinal discomfort, chronic constipation, joint pain, facial swelling, chronic fatigue, irritability, easily agitated, extreme weakness and all-over muscle fatigue (with difficulty in walking, talking, moving, etc.) The patient was diagnosed with thrombocytopenia, pancytopenia, amenorrhea, hypothyroidism, anemia, low blood pressure, antoimmune disorder, partial organ failure, digestive disorder, Epstein Barre, orthopnoea, hormonal imbalance, urinary tract infection. The patient had to seek alternative medicine doctors to receive nutritional supplementation because other doctors could do nothing for her. Recently she has been referred to a clinic (Scheduled appointment for 30-Mar-2009). This was originally reported by a consumer. A standard lot check investigation was performed. All in-process quality checks for the lot number 0263U in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Autoimmune disorder, Body temperature decreased, C-reactive protein normal, Cardiovascular insufficiency
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 17 year old female who on 13-MAR-2007 was vaccinated with a third dose of GARDASIL intramuscularly into the left arm. After the first dose of GARDASIL (administered on 13-SEP-2006) the patient experienced dizziness, light-headed, nauseous, headache, leg cramps and shooting leg pain. After the second dose of GARDASIL (administered on 13-NOV-2006) the patient experienced same symptoms after first dose plus hair loss, abdominal bloating, menstrual cycle stopped, weakness, poor circulation. After the third dose of GARDASIL the patient experienced all symptoms listed above plus excessive hair loss, pale/purple skin, always cold, loud ringing in ears, extreme digestive, stomach pain, gastrointestinal discomfort, chronic constipation, joint pain, facial swelling, chronic fatigue, irritability, easily agitated, extreme weakness and all-over muscle fatigue (with difficulty in walking, talking, moving, etc.) The patient was diagnosed with thrombocytopenia, pancytopenia, amenorrhea, hypothyroidism, anemia, low blood pressure, antoimmune disorder, partial organ failure, digestive disorder, Epstein Barre, orthopnoea, hormonal imbalance, urinary tract infection. The patient had to seek alternative medicine doctors to receive nutritional supplementation because other doctors could do nothing for her. Recently she has been referred to a clinic (Scheduled appointment for 30-Mar-2009). This was originally reported by a consumer. A standard lot check investigation was performed. All in-process quality checks for the lot number 0263U in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.