chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Injection site rash, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old male with no drug reaction or allergies, who on 11-JUN-2010 was subcutaneously vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot #664502/0687Y). There was no concomitant medication. On 24-JUN-2010, about 13 days after the first dose of VARIVAX (Merck) was administered, a rash appeared on the patient's left shoulder, trunk, and back. The nurse practitioner reported the rash was a scattered, maculopapular rash, which went away shortly after it appeared. No lab diagnostics studies were performed. The nurse practitioner stated that "she would not be administering a second dose to the patient." The patient sought unspecified medical attention. Follow-up information has been received from the nurse practitioner concerning the 20 year old male volunteer with no medical history and illness at time of vaccination who on 11-JUN-2010 was subcutaneously vaccinated with the first dose of VARIVAX (Merck) (lot #664502/0687Y) to the left arm. The patient reported rash on left shoulder on 24-JUN-2010. The patient was examined by registered nurse of employee health revealing scattered maculopapular rash among both shoulders. Patient complained of headache without itch and fever. On 10-JUL-2010, the patient recovered from the events. No diagnostic laboratory tests performed. No further information is available.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 04-DEC-1997 was vaccinated with a dose of VARIVAX (Merck) (lot #, expire date and route not reported). Around 05-AUG-2010 the patient "got chicken pox". The patient sought unspecified medical attention. At the time of the report the patient's outcome was unknown. Follow up information has been received from a registered nurse. It was reported that the 12 year old male patient was vaccinated with a dose of VARIVAX (Merck) (lot number not reported) on 07-DEC-1998. The patient experienced an outbreak of varicella in August 2010. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. No further information is expected.
Age: 11.0
Sex: F
Vaccine: FLUX, HPV4, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a healthcare worker concerning an approximately 11 year old female patient with no pertinent medical history and no drug reactions/allergies, who on 19-NOV-1999 was vaccinated with a first dose of VARIVAX (Merck) (Lot # not reported) and a second dose on 20-OCT-2010 (Lot # 668533/0969Z) SQ. Patient also received on 20-OCT-2010, a dose of GARDASIL and influenza virus vaccine (unspecified). Patient's mother called the physician and stated that on an unspecified date the patient had developed chicken pox marks on her body. There were no Lab diagnosis/studies performed. At the time of the report the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
Age: 20.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old patient, whom their 13 year old sibling on approximately 22-SEP-2010, six weeks ago, was vaccinated with a dose of VARIVAX (Merck) (Lot # not reported). Concomitant therapy included VALTREX. Medical assistant reported that the patient (13 year old's sibling) had developed shingles. The patient was diagnosed on 02-NOV-2010. The medical assistant did not report any adverse effect to the 13 year old patient who was vaccinated with VARIVAX (Merck) (Lot # not reported). The patient sought unspecified medical attention. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a female patient who " A few years ago" was vaccinated with a dose of VARIVAX (Merck) (Lot# not reported), SQ. The physician stated that a female patient had experienced chicken pox after receiving a dose of VARIVAX (Merck) years before (duration of time unspecified). It was reported that the therapy was discontinued "A few years ago". At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised, Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner and the mother of a 13 month old female patient with no pertinent medical history and no drug reaction or allergies who on 23-SEP-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # not provided). There was no concomitant medication. On 04-NOV-2010, the child broke out with a rash around her neck and the rash had spread all over her body. Nurse practitioner stated it was chickenpox. She was treating the child with CALAMINE lotion. No lab diagnostics studies were performed. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a 47 month old female with significant disability and cerebral palsy and with no drug allergies who on 06-NOV-2010 was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). Subsequently patient's mom called the office to report the patient broke out with rash one day after receiving VARIVAX (Merck) (on 07-NOV-2010). Dose was not administered at the physician's office. Physician has not seen the patient yet as of 15-NOV-2010. Lab diagnostics studies were not performed. The patient sought medical attention by telephone. At the time of report, the outcome was unknown. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: FLU3, PPV, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning her 14 month old son who on 02-NOV-2010 was vaccined with a first dose of VARIVAX, (therapy route not reported). Second suspect therapy included AFLURIA (manufacturer unspecified). Concomitant therapy included pneumococcal vaccine (manufacturer unspecified). On 02-NOV-2010 hours after leaving the physician's office, the patient developed a low grade fever. The low grade fever persisted for three days followed by a high grade fever for three days. Then, on 08-NOV-2010, the patient broke out rashes. Patient's present was not recovered. Consumer stated that she wanted to check the lot number of the vaccine. The lot number reported as 604063/0901V, which is not a valid lot number for VARIVAX, is a valid lot number for MMR II (MSD). Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning an 8 week old patient who on 11-NOV-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot# unknown) and a dose of MMR II (Lot# unknown). No adverse effect was reported. Follow up information has been received from the medical assistant concerning the 8 week old male patient with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions who on 04-NOV-2010 at 10:30 (previously reported as 11-NOV-2010) was vaccinated subcutaneously with a first dose of VARIVAX (Merck) (Lot# 668255/0904Z) and a first dose of MMR II (Lot# 664455/0588Z). The medical assistant reported that wrong vaccines were given to baby. Patient did well with no fever and no adverse reaction. The patient did not seek medical attention. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from a Registered Pharmacist concerning a female child patient who on 09-NOV-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot# unknown) from an unknown provider. The pharmacist reported that on 11-NOV-2010, the patient developed blisters. At the time of the report, the outcome of the patient was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Adverse event, Erythema, Local reaction, Local swelling
Clinical narrative: Information has been received from a Bachelor of Science in Nursing concerning a patient who, "a few days ago", was vaccinated with a dose of VARIVAX (Merck) (lot #, expire date and route not reported). On an unspecified date, the patient could be experiencing an adverse event, but the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from the Bachelor of Science in Nursing who reported that the child patient experienced normal local response, such a redness and swelling but it was no true allergic reaction. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Malaise, Vomiting
Clinical narrative: Information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registered product, concerning a 25 year old female refugee patient with pain in calf and no drug allergies, who on 18-OCT-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot# 668406/0999Z), Exp 10-28-2012). The patient also started Isoniazid ("INH"). The nurse stated that the patient had reported 10 to 12 days, on approximately 28-OCT-2010; after starting isoniazid and receiving the dose of VARIVAX (Merck) that she began not feeling well and vomiting. Patient discontinued Isoniazid (date not reported) and on 14-NOV-2010 patient had been to the emergency room because she was "sick" and she had discovered she was 7 weeks pregnant (LMP 17-SEP-2010; EDD on 24-Jun-2011). At the time of the report the patient had not recovered from all these symptoms. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Mobility decreased, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12 year old male who on 17-NOV-2010 was vaccinated with the second dose of VARIVAX (Merck) (lot#, dose and route not reported). It was reported that the patient called the physician on 18-NOV-2010 to report that his whole arm swelled up to the point where he was having a difficult time moving his arm. The physician instructed the patient to go to his primary care doctor. The patient did not seek medical attention. At the time of reporting, the outcome as unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot # and route not reported). It was reported that the patient might also received a dose of influenza virus vaccine (unspecified) (Lot# unknown (manufactured unknown). The nurse reported that the patient experienced a localized reaction after receiving VARIVAX (Merck). The patient went to the emergency room but was not admitted to the hospital. On 19-OCT-2010, the patient had recovered. Follow up information has been received via telephone call from the nurse indicating that the female patient was seen the next day by the physician and had recovered. The health care professional contacted during telephone follow up could not supply the following information: patient name, date of birth, dates of vaccination, lot number. This is one of several reports from the same source. No further information is available.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Folliculitis, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning an a 24 year old female who on 03-AUG-2010 was vaccinated with 0.5 ml a dose of VARIVAX (Merck) (lot # 667291/0753Z, dose and route of injection unspecified, expiration date: 20-MAY-2012). The reported stated that approximately "8-10" days later (approximately on 11-AUG-2010) the patient developed small lesions on the upper trunk and face, and had a "fever". Patient was initially given antibiotics for a diagnosis of folliculitis. The physician made a diagnosis of chicken pox. At the time of reporting, the patient recovered from chicken pox in August 2010. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash vesicular, Varicella virus test positive, Viral test positive
Clinical narrative: Information has been received from a nurse concerning a 42 month old male patient who in July 2001 (also reported as July 2008 by the nurse) was vaccinated with a 0.5 ml first dose of VARIVAX (Merck) (Lot #, expire date and route not reported). The patient recently presented with a zoster like rash. On an unspecified date, either the patient was taken to the health department or a culture was sent to the health department. The results from laboratory confirmation for zoster came back positive for shingles and the Health Department believed that it was from the vaccine. The patient had not received any dose of VARIVAX (Merck) after the first one. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Fatigue
Clinical narrative: Information has been received from a husband, for VARIVAX (Merck), a Pregnancy Registry product, concerning his 27 year old wife with no medical history and no drug reaction or allergies, who on 09-NOV-2010 was vaccinated with VARIVAX (Merck) (lot # not reported). Other suspect therapy included MMR II ( lot # not reported) on the same day. The husband reported that his wife took a pregnancy test on 05-NOV-2010 and it was negative. On 09-NOV-2010, the patient received VARIVAX (Merck) and MMR II. About a week ago (approximately on 24-NOV-2010), the patient took a pregnancy test and it was positive. At the time of report, the patient's gestation age was "about a month" (last menstrual period in approximately November 2010, estimated delivery date in approximately 08-AUG 2011). It was reported that the patient "was feeling tired and had pregnancy symptoms". The husband was "going to make an appointment with an OBGYN (Obstetrician/Gynecologist) physician for his wife". At the time of reporting, the outcome of the events was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a current 8 year old female patient with no pertinent medical history, no drug reactions/allergies, who a few years ago was vaccinated with a first dose of VARIVAX (Merck) (Lot # not reported) IM. The nurse reported that the patient broke out in shingles sometime after her first dose of VARIVAX (Merck) few years ago. There were no Lab diagnosis/studies performed. The patient sought unspecified medical attention. The patient recovered a few years ago. Follow up information has been received from a nurse indicating that this was not her patient and she was not practicing at this time. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: No therapeutic response, Varicella virus test negative
Clinical narrative: Information has been received from a physician concerning a 46 year old female patient who 10 or more years ago in approximately 2000 was vaccinated with a dose of VARIVAX (Merck) (Lot# Unknown). The physician stated that the patient inquired about getting either VARIVAX (Merck) or ZOSTAVAX (Merck) for protection against chicken pox and/or shingles. The patient could not remember having chickenpox or varicella vaccine so physician did a titer and found that the patient did not have antibodies against varicella. When the results came back and were reported to the patient, the patient said that she did have a varicella immunization 10 or more years ago from another doctor. The physician also stated that she felt it was more likely the patient did not receive the immunization than she did not seroconvert. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Feeling hot
Clinical narrative: Information has been received from a female nurse who on 06-DEC-2010 had a vaccine splash from a VARIVAX (Merck) (Lot # and expire date not reported) syringe onto her forehead and around eyes. The nurse flushed the eyes for a few minutes but wished to continue to flush the eyes some more. She had a warm feeling on her eyelids that had not resolved yet. There were no laboratory diagnostics test performed. The nurse did not seek medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pain, Pyrexia, Rash pruritic, Vaginal lesion
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female patient with mentally challenged, trisomy 9, blindness, osteoporosis, scoliosis, allergy to KEFLEX, SEPTRA, amoxicillin, CECLOR, DEMEROL, kidney stones and "nebutol", and a history of delayed puberty, who on 30-AUG-1996 was vaccinated with a first dose of VARIVAX (Merck) (route and Lot # not reported). On 19-OCT-2006, the patient was vaccinated with a second dose of VARIVAX (Merck) (route and Lot # not reported). Concomitant therapy included DIURIL, LORABID, DULCOLAX, BENEFIBER, NEXIUM, FLAGYL and KLONOPIN. The nurse reported that on 03-DEC-2010 the patient developed chicken pox, "about two weeks", after the patient's mother developed shingles. The patient presented with a severe case of the lesions which were also present in her vagina. A fever of 101.6 was reported. The rash was described as painful, blistering and very itchy. The patient was treated with BENADRYL, AVENO oatmeal baths and as needed TYLENOL for pain. There were no Lab diagnosis/studies performed. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female patient with mentally challenged, trisomy 9, blindness, osteoporosis, scoliosis, allergy to KEFLEX, SEPTRA, amoxicillin, CECLOR, DEMEROL, kidney stones and "nebutol", and a history of delayed puberty, who on 30-AUG-1996 was vaccinated with a first dose of VARIVAX (Merck) (route and Lot # not reported). On 19-OCT-2006, the patient was vaccinated with a second dose of VARIVAX (Merck) (route and Lot # not reported). Concomitant therapy included DIURIL, LORABID, DULCOLAX, BENEFIBER, NEXIUM, FLAGYL and KLONOPIN. The nurse reported that on 03-DEC-2010 the patient developed chicken pox, "about two weeks", after the patient's mother developed shingles. The patient presented with a severe case of the lesions which were also present in her vagina. A fever of 101.6 was reported. The rash was described as painful, blistering and very itchy. The patient was treated with BENADRYL, AVENO oatmeal baths and as needed TYLENOL for pain. There were no Lab diagnosis/studies performed. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a currently 12 year old male patient who on 01-OCT-1999 was vaccinated with a dose of VARIVAX (Merck) (lot number not provided). In September 2010, the patient experienced an outbreak of varicella. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female patient who on 04-SEP-1998 was vaccinated with a dose of VARIVAX (Merck) (lot number not provided). In September 2010, the patient experienced an outbreak of varicella. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female patient who on 07-AUG-2006 was vaccinated with a dose of VARIVAX (Merck) (lot number not provided). In October 2010, the patient experienced an outbreak of varicella. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered of pharmacist concerning a female who on approximately 24-NOV-2010 inadvertently was vaccinated with a dose of VARIVAX (Merck) (Lot# not reported) instead of a dose of ZOSTAVAX (Merck). No symptoms were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Hypersomnia, Polydipsia
Clinical narrative: This report was received from Novartis (manufacturer report number S2010US32233) concerning an 11 year old female patient with a history of 2 cases of chickenpox even after receiving VARIVAX (Merck), who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot # and route not reported). It was reported that the patient increased in sleep patterns, drinking like there is no tomorrow and exposed to chickenpox. At the time of the report, the outcome of the patient was not reported. This was originally reported by a consumer. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 16 year old female patient with no illness at time of vaccination who on 17-SEP-2010 was vaccinated at right upper arm with the third dose of VARIVAX (Merck) (LOT# 666865/0468Z). On 18-SEP-2010 the patient's mother called doctor to report red, swollen and painful reaction on right arm, think it's from VARIVAX (Merck). On 19-SEP-2010 patient came to be seen, diagnosed with cellulitis. The patient was given AUGMENTIN and BENADRYL. At the time of this report, the patient's outcome was unknown. This is an amended report. The LOT# had been changed from 638902/0468L to 666865/0468Z. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 62 year old female patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot #, expire date and route not reported) instead of ZOSTAVAX (Merck). The pharmacist reported that the physician wrote the prescription for VARIVAX (Merck) in error. No adverse reaction was reported. Follow up information has been received from the pharmacist indicating that the patient received a dose of ZOSTAVAX (Merck) (Lot # not reported) 30 days after the dose of VARIVAX (Merck) was administered. No adverse experiences were reported after receiving ZOSTAVAX (Merck). No further information is available.
Age: 81.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker concerning an 81 year old female patient (79 year old reported) who on 14-DEC-2010 was vaccinated with a 0.5ml dose of VARIVAX (Merck) (Lot#665004/0929Y) (Exp date. 11-JUN-2013), SQ. The healthcare worker stated that the patient received VARIVAX (Merck) instead of ZOSTAVAX (Merck). No adverse effect reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse and a practice manager concerning a 72 year old female who on an unspecified date was inadvertently vaccinated with VARIVAX (Merck) (lot number not provided) instead of ZOSTAVAX (Merck). No adverse event was reported. It was unknown if the patient sought medical attention. Follow-up information received from the nurse stated that this was a case of the wrong product was grabbed by mistake. The nurse explained that they do not usually have VARIVAX (Merck), and the nurse grabbed it by mistake. It was not a case of product confusion. This is one of the several reports received from the same source. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a licensed practical nurse concerning a 10 year old female with seasonal allergies and no pertinent medical history who on 17-DEC-2001 was vaccinated subcutaneously with a first dose of 0.5 ml VARIVAX (Merck) (lot# 639434/0788L). On 28-JAN-2008 the patient was vaccinated subcutaneously with a second dose of 0.5 ml VARIVAX (Merck) (lot# 659533/1594U). There was no concomitant medication. On 12-DEC-2010 the patient experienced pain in her right arm. On 13-DEC-2010 a zoster rash developed on the back of her shoulder and patch on her triceps. She had about 20 lesions. At the time of the report, the patient was not recovered. No diagnostic laboratory tests were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Information has been received from a physician assistant concerning a 24 month old male who on 20-AUG-2010 was vaccinated subcutaneously with a first dose of VARIVAX (Merck) (dose not reported, lot # 665960/1742Y). The patient experienced a "breakout of lesions around injection site several days after administration of VARIVAX (Merck)". At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is an amended report. "Vaccinated at: Unknown and vaccine purchased with: Unknown" have been added. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 08-OCT-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot# unknown) and a dose of VAQTA (Lot# unknown). In October 2010, the patient developed a headache that lasted for "1 week", resolved on its own. On 15-OCT-2010, the patient recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 4 year old patient, who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (dose, route and Lot # not reported). The physician reported that the patient developed a small, local bubbling at the injection site after administration of VARIVAX (Merck). At the time of the report, the outcome of the patient was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a practice manager concerning a 74 year old male who on an unspecified date was inadvertently vaccinated with VARIVAX (Merck) (lot number not provided). Follow-up information received from the nurse who stated that the patient was given VARIVAX (Merck) (lot number not provided) instead of ZOSTAVAX (Merck). This was a case of the wrong product was grabbed by mistake. The nurse explained that they did not usually have VARIVAX (Merck), and the nurse grabbed it by mistake. It was not a case of product confusion. This is one of the several reports received from the same source. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a practice manager concerning a 69 year old female who on an unspecified date was inadvertently vaccinated with VARIVAX (Merck) (lot number not provided). Follow-up information received from the nurse who stated that the patient was given VARIVAX (Merck) (lot number not provided) instead of ZOSTAVAX (Merck). This was a case of the wrong product was grabbed by mistake. The nurse explained that they did not usually have VARIVAX (Merck), and the nurse grabbed it by mistake. It was not a case of product confusion. This is one of the several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a post partum female patient who on 21-DEC-2010 was vaccinated with the first dose of VARIVAX (Merck) (lot # not reported). On 21-DEC-2010 or 22-DEC-2010 the patient experienced a rash on her wrist where the hospital name band had been. She had no history of irritation or rash when previously wearing a hospital name band. At the time of reporting, the patient's rash on her wrist persisted. The patient had sought unspecified medical attention. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Axillary pain, Blood immunoglobulin G increased, Blood immunoglobulin M increased, Pruritus, Rash erythematous
Clinical narrative: Information has been received from a Family Nurse Practitioner (FNP) and medical records regarding a 5 yr old male who was given a dose of VARIVAX (Merck), 0.5ML subcutaneous inj (not further specified) and a second dose of VARIVAX (Merck), 0.5mL subcutaneously inj (lot #0807) on 02JUN2010. On 07SEP2010, the patient "broke out in red spots on upper torso after being in the woods, itching". Varicella zoster IGG was positive (2.35). Assessment: chicken pox-primary varicella. Patient started on acyclovir 20 mg/kg QID times five days. On 29SEP2010, pt complained of rash, open areas under lt arm and itching. Assessment: left arm pit chicken pox, questionable secondary infection from scratching. Patient's nails were to be cut, no scratching, restart acyclovir 200mg/5 ml, 10ml po QID times five days, calamine lotion OTC, and BENADRYL OTC po. On 30SEP2010, the patient's mother called the office stating her child complained of pain under left arm, noticed more lesions on body. Continue acyclovir, start zithromycin 200mg/5ml first day 5 ml, 2-5 days 2.5ml and BACTROBAN ointment 2% 22 gm apply to area TID times 5 days. On 04OCT2010, patient seen for follow up of chicken pox-infection, spreading area with rash and itching. Assessment: left arm pit chicken pox with secondary infection greatly improved. All available medical records will be provided upon request. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine, Viral test
Clinical narrative: Information has been received from a Family Nurse Practitioner (FNP) and medical records regarding a 5 yr old male who was given a dose of VARIVAX (Merck), 0.5ML subcutaneous inj (not further specified) and a second dose of VARIVAX (Merck), 0.5mL subcutaneously inj (lot #0807) on 02JUN2010. On 07SEP2010, the patient "broke out in red spots on upper torso after being in the woods, itching". Varicella zoster IGG was positive (2.35). Assessment: chicken pox-primary varicella. Patient started on acyclovir 20 mg/kg QID times five days. On 29SEP2010, pt complained of rash, open areas under lt arm and itching. Assessment: left arm pit chicken pox, questionable secondary infection from scratching. Patient's nails were to be cut, no scratching, restart acyclovir 200mg/5 ml, 10ml po QID times five days, calamine lotion OTC, and BENADRYL OTC po. On 30SEP2010, the patient's mother called the office stating her child complained of pain under left arm, noticed more lesions on body. Continue acyclovir, start zithromycin 200mg/5ml first day 5 ml, 2-5 days 2.5ml and BACTROBAN ointment 2% 22 gm apply to area TID times 5 days. On 04OCT2010, patient seen for follow up of chicken pox-infection, spreading area with rash and itching. Assessment: left arm pit chicken pox with secondary infection greatly improved. All available medical records will be provided upon request. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Antineutrophil cytoplasmic antibody, Condition aggravated, Varicella post vaccine, Varicella virus test negative
Clinical narrative: Information has been received from pharmacist (Pharm. D.) concerning a 24 year old male who on unknown dates was vaccinated with 2 doses of VARIVAX (Merck) (lot # not reported). The reporter stated that patient developed chickenpox. After having chickenpox, patient was given 2 doses of VARIVAX (Merck). A recent varicella titer was "low". At the time of reporting, the outcome of the patient was not recovered. Varicella titer was performed. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on an unspecified date was supposed to receive ZOSTAVAX (Merck) and was inadvertently vaccinated with VARIVAX (Merck) (lot #, expire date and route not reported) instead. No adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practitioner nurse concerning a 60 year old female who on 28-DEC-2010 was vaccinated with VARIVAX (Merck) (lot # 668256/0903Z, expiration date 09-JUL-2012) rather than ZOSTAVAX (Merck) for the prevention of Herpes Zoster. No problems reported with the VARIVAX (Merck) vaccination. The nurse stated that the medical assistant that made the medication error was confused. The VARIVAX (Merck) and ZOSTAVAX (Merck) were contained in the same freezer and the medical assistant became confused when she could not find the ZOSTAVAX (Merck) (ZOSTAVAX (Merck) was reported to be out of stock at the office). The nurse could not explain what exactly confused the medical assistant, but stated that the VARIVAX (Merck) and the ZOSTAVAX (Merck) packing were very similar. The patient sought unspecified medical attention. Follow up information has been received from the nurse indicating that on 28-DEC-2010 the 60 year old female with no illness at time of vaccination was vaccinated SC with the first dose of VARIVAX (Merck) (lot # 668256/0903Z). No adverse events. No lab diagnostic tests were performed. It was unknown if the patient sought medical attention. On follow-up information received via telephone call from a receptionist indicated that VARIVAX (Merck) was pulled off the shelf by mistake and it was not product confusion. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Vomiting
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning an 18 year old female patient who was vaccinated with the first dose of VARIVAX (Merck) (lot number unknown) on 11-AUG-2003, and the second 0.5 ml dose (lot number 667922/0758Z) in the right arm on 21-DEC-2010. There was no concomitant medication. On an unknown date after receiving the VARIVAX (Merck) the patient began to vomit. On 27-DEC-2010 the patient went to the doctor and was administered a pregnancy test which came back positive. As of 28-DEC-2010, it was unknown if the patient would continue to receive the VARIVAX (Merck), and the outcome of the vomiting was unknown. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Angiotensin converting enzyme, Anti-SS-A antibody negative, Anti-SS-B antibody negative, Antibody test negative, Antinuclear antibody
Clinical narrative: This is a followup report to VAERS #27592. The pt is a 34 y/o, male who received FLUMIST on 13Nov08 according to the medical record and the Vaccine Adverse Event Report (VAERS) 27592. On 15Dec08 the pt reported a 4 day hx of severe (9/10) pain between the shoulder blades and the front of his chest. (Per the pt's wife he was healthy until this time.) The next day he reported 10/10, burning pain near his shoulder blades (T8-T10), R>L. On PE a "slight rash" was noted in the affected area. The pt was diagnosed with Shingles and prescribed VALTREX. The pt was seen in the ER on 20Dec08 with complaints of severe upper back pain, itching and a blister-type rash on bilateral axilla and scapula. The pt was prescribed ATARAX and released. The pt was then seen several times by his PCM for anxiety and difficulty sleeping. The pt was admitted to Medical Center of 25Dec08 for mental status changes ("slowed/slurred speech, blunted affect, slightly confused") and muscle weakness ("generalized weakness X4, slightly ataxic gait, 2+ DTRs, CN 2-12 grossly intact, good anal tone"). On 26Dec08, the pt was intubated due to respiratory distress and difficulty clearing his secretions. The pt was treated with high dose steroids for 5 days during which the pt continued to "worsen neurologically" and acyclovir until viral studies were reported negative (timeframe unknown). On 31Dec08 plasmapheresis was initiated qod for 14d. Trach and PEG tube were placed. The pt was transferred to MC for further neurologic evaluation and rehab on 21Jan09 with the following diagnosis: tetraparesis C2-T10 due to myelitis of unknown etiology; vent dependent; neurogenic bowel/bladder, anxiety/depression and hyperphosphatemia. He regained near normal lower limb strength. The pt remained ventilator dependent although he had been off the ventilator using humidified oxygen for approx. 4 hours. The pt regained bladder control but required functional assistance. He was on a bowel program with no incontinence. When discharged on 11Dec09 severe weakness of the neck, trunk, UE and diaphragm muscles persisted. Additionally, he had ongoing pain in his shoulders, upper back and arms. He was discharged to home with 18 hours of skilled nursing care. As of 28 April 2011, the pt is able to be off the ventilator for up to 12 hours/day. He ambulates without assistance although he uses a walker when he ambulates with the ventilator. He continues with a bowel program and remains continent (bowel and bladder). The pt continues to have difficulty with UE fine motor skills. He continues to have 18 hours/day of skilled nursing care. Per his wife he is on a waiting list for advanced rehab with the hope of becoming independent of the ventilator. The pt is in individual and marriage counseling. He remains on the TDRL with a 100% disability rating. Of note, the pt has had no vaccinations since this event; although his wife, child, and caregivers are fully vaccinated.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Antinuclear antibody negative, Antiphospholipid antibodies negative, Anxiety, Ataxia, Back pain
Clinical narrative: This is a followup report to VAERS #27592. The pt is a 34 y/o, male who received FLUMIST on 13Nov08 according to the medical record and the Vaccine Adverse Event Report (VAERS) 27592. On 15Dec08 the pt reported a 4 day hx of severe (9/10) pain between the shoulder blades and the front of his chest. (Per the pt's wife he was healthy until this time.) The next day he reported 10/10, burning pain near his shoulder blades (T8-T10), R>L. On PE a "slight rash" was noted in the affected area. The pt was diagnosed with Shingles and prescribed VALTREX. The pt was seen in the ER on 20Dec08 with complaints of severe upper back pain, itching and a blister-type rash on bilateral axilla and scapula. The pt was prescribed ATARAX and released. The pt was then seen several times by his PCM for anxiety and difficulty sleeping. The pt was admitted to Medical Center of 25Dec08 for mental status changes ("slowed/slurred speech, blunted affect, slightly confused") and muscle weakness ("generalized weakness X4, slightly ataxic gait, 2+ DTRs, CN 2-12 grossly intact, good anal tone"). On 26Dec08, the pt was intubated due to respiratory distress and difficulty clearing his secretions. The pt was treated with high dose steroids for 5 days during which the pt continued to "worsen neurologically" and acyclovir until viral studies were reported negative (timeframe unknown). On 31Dec08 plasmapheresis was initiated qod for 14d. Trach and PEG tube were placed. The pt was transferred to MC for further neurologic evaluation and rehab on 21Jan09 with the following diagnosis: tetraparesis C2-T10 due to myelitis of unknown etiology; vent dependent; neurogenic bowel/bladder, anxiety/depression and hyperphosphatemia. He regained near normal lower limb strength. The pt remained ventilator dependent although he had been off the ventilator using humidified oxygen for approx. 4 hours. The pt regained bladder control but required functional assistance. He was on a bowel program with no incontinence. When discharged on 11Dec09 severe weakness of the neck, trunk, UE and diaphragm muscles persisted. Additionally, he had ongoing pain in his shoulders, upper back and arms. He was discharged to home with 18 hours of skilled nursing care. As of 28 April 2011, the pt is able to be off the ventilator for up to 12 hours/day. He ambulates without assistance although he uses a walker when he ambulates with the ventilator. He continues with a bowel program and remains continent (bowel and bladder). The pt continues to have difficulty with UE fine motor skills. He continues to have 18 hours/day of skilled nursing care. Per his wife he is on a waiting list for advanced rehab with the hope of becoming independent of the ventilator. The pt is in individual and marriage counseling. He remains on the TDRL with a 100% disability rating. Of note, the pt has had no vaccinations since this event; although his wife, child, and caregivers are fully vaccinated.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Bacterial test negative, Blood creatine phosphokinase increased, Blood folate normal, Blood magnesium increased, Blood phosphorus increased
Clinical narrative: This is a followup report to VAERS #27592. The pt is a 34 y/o, male who received FLUMIST on 13Nov08 according to the medical record and the Vaccine Adverse Event Report (VAERS) 27592. On 15Dec08 the pt reported a 4 day hx of severe (9/10) pain between the shoulder blades and the front of his chest. (Per the pt's wife he was healthy until this time.) The next day he reported 10/10, burning pain near his shoulder blades (T8-T10), R>L. On PE a "slight rash" was noted in the affected area. The pt was diagnosed with Shingles and prescribed VALTREX. The pt was seen in the ER on 20Dec08 with complaints of severe upper back pain, itching and a blister-type rash on bilateral axilla and scapula. The pt was prescribed ATARAX and released. The pt was then seen several times by his PCM for anxiety and difficulty sleeping. The pt was admitted to Medical Center of 25Dec08 for mental status changes ("slowed/slurred speech, blunted affect, slightly confused") and muscle weakness ("generalized weakness X4, slightly ataxic gait, 2+ DTRs, CN 2-12 grossly intact, good anal tone"). On 26Dec08, the pt was intubated due to respiratory distress and difficulty clearing his secretions. The pt was treated with high dose steroids for 5 days during which the pt continued to "worsen neurologically" and acyclovir until viral studies were reported negative (timeframe unknown). On 31Dec08 plasmapheresis was initiated qod for 14d. Trach and PEG tube were placed. The pt was transferred to MC for further neurologic evaluation and rehab on 21Jan09 with the following diagnosis: tetraparesis C2-T10 due to myelitis of unknown etiology; vent dependent; neurogenic bowel/bladder, anxiety/depression and hyperphosphatemia. He regained near normal lower limb strength. The pt remained ventilator dependent although he had been off the ventilator using humidified oxygen for approx. 4 hours. The pt regained bladder control but required functional assistance. He was on a bowel program with no incontinence. When discharged on 11Dec09 severe weakness of the neck, trunk, UE and diaphragm muscles persisted. Additionally, he had ongoing pain in his shoulders, upper back and arms. He was discharged to home with 18 hours of skilled nursing care. As of 28 April 2011, the pt is able to be off the ventilator for up to 12 hours/day. He ambulates without assistance although he uses a walker when he ambulates with the ventilator. He continues with a bowel program and remains continent (bowel and bladder). The pt continues to have difficulty with UE fine motor skills. He continues to have 18 hours/day of skilled nursing care. Per his wife he is on a waiting list for advanced rehab with the hope of becoming independent of the ventilator. The pt is in individual and marriage counseling. He remains on the TDRL with a 100% disability rating. Of note, the pt has had no vaccinations since this event; although his wife, child, and caregivers are fully vaccinated.