chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Inflammation, Mobility decreased, Musculoskeletal pain, Neuropathy peripheral
Clinical narrative: Information has been received from medical records regarding a case in litigation (MARRS # 2012SP017341) concerning a 20 year old female with no known drug allergies and a history of acute tonsillitis who received the GARDASIL. On 11APR2007 the patient was seen by a physician for complaints of left arm pain. She had a GARDASIL on 03APR2007 into her left shoulder and arm. At the time of her injection she had some numbness shooting down into her arm and hands. Since then she had been complaining of numbness and tingling in her left arm and shoulder. The patient reported it was more difficult to lift her arm up above her head and she could not lie on that side. The physician noted the patient had not had any redness, swelling or warmth at the injection site and could not tell where the injection was given on the skin. The physician assessed the patient with left arm neuritis. The physician noted the only possibility for the etiology of her symptoms was that the medicine may have been injected near a nerve site or a nerve sheath and that she had some local inflammation around the nerve causing her to have some numbness and tingling into her left arm and pain in the shoulder. The patient correlated the beginning of her symptoms directly with receiving the GARDASIL into her left shoulder. The physician treated her with NARPROSYN, range of motion exercises and a sling to take the weight off of her shoulder. Additional information has been requested. All available medical records will be provided upon request.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: Information has been received from medical records regarding a case in litigation (MARRS # 2012SP017341) concerning a 20 year old female with no known drug allergies and a history of acute tonsillitis who received the GARDASIL. On 11APR2007 the patient was seen by a physician for complaints of left arm pain. She had a GARDASIL on 03APR2007 into her left shoulder and arm. At the time of her injection she had some numbness shooting down into her arm and hands. Since then she had been complaining of numbness and tingling in her left arm and shoulder. The patient reported it was more difficult to lift her arm up above her head and she could not lie on that side. The physician noted the patient had not had any redness, swelling or warmth at the injection site and could not tell where the injection was given on the skin. The physician assessed the patient with left arm neuritis. The physician noted the only possibility for the etiology of her symptoms was that the medicine may have been injected near a nerve site or a nerve sheath and that she had some local inflammation around the nerve causing her to have some numbness and tingling into her left arm and pain in the shoulder. The patient correlated the beginning of her symptoms directly with receiving the GARDASIL into her left shoulder. The physician treated her with NARPROSYN, range of motion exercises and a sling to take the weight off of her shoulder. Additional information has been requested. All available medical records will be provided upon request.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Rash erythematous
Clinical narrative: This spontaneous report as received from a physician refers to a 62 years old female patient. The patient was vaccinated with the first and only 0.65 ml ZOSTAVAX (lot number unknown) on 20-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 02-AUG-2012 the patient experienced "small red and white pimple like bumps on the right eye-lid". The patient called the office on 02-AUG-2012 upon the adverse onset and the doctor urged her to go to a "Urgent Care facility" (Facility name unspecified) which the patient did go the following day on 03-AUG-2012. The patient was only at this Urgent Care facility for just the morning and she was given an antiviral ointment (product unknown) and the patient said she was doing well. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to 4 patients of unknown age. On an unspecified date The patients were vaccinated with, 0.65 ml ZOSTAVAX that had been stored in a refrigerator for over 72 hours (lot number unspecified). No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. It was unknown if the patient had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Neck pain, Pain, Polymyalgia rheumatica
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on 27-JUL-2012. No other co-suspects and no concomitant medications were reported. On 28-JUL-2012 the patient experienced upper body, neck, wrist and ankle pains, headaches, and said she developed polymyalgia rheumatica after getting vaccination. It was unknown if the patient sought medical attention. No treatment information was reported. The outcome of upper body, neck, wrist and ankle pains, headaches, and polymyalgia rheumatica was reported as recovering. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site induration, Injection site nodule
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a female patient who on 07-JUL-2012 was vaccinated SQ with a single 0.65 mL dose of ZOSTAVAX (lot # not provided). On 08-JUL-2012, the patient went to the pharmacy and had a hard knot at the injection site and had diarrhea. No treatment was given for the events. At the time of the report, the patient had not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. The patient did not seek medical attention. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 years old female patient with drug allergies to sulfa and cephalosporin. The patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot # 671662/1160AA, expiration date 18-OCT-2012) on 19-JUL-2012. In July 2012 the patient experienced redness around injection site after receiving ZOSTAVAX. The patient sought for medical attention via speaking to the pharmacist. No treatment was given. The outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning unspecified patients who on an unspecified date were vaccinated with hepatitis B virus vaccine rHBsAg that stored at colder than recommended temperatures. No adverse symptoms noted. It was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. 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: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to unknown number of patients. On an unspecified date the patients were vaccinated with a dose of GARDASIL (lot # not reported) that were exposed to negative 1 degrees C for 3 hours. No adverse effect reported. It was unknown if the patient sought medical attention or not. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient was vaccinated subcutaneously with an expired (expiration date 16-JUN-2012) dose of 0.5 ml M-M-R II lot # (667879/0788Z), on 27-JUL-2012. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: The spontaneous report as received from nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with 0.65 ml ZOSTAVAX (Lot# unspecified) within the past 2 weeks in approximately August 2012. No other co-suspects were reported. No concomitant medications were reported. Within the past 2 weeks in 2012 after given ZOSTAVAX the patient experienced severe headache. The patient was still having severe headaches but the reporter didn't specify if they are any better or worse than they were when they started. The patient had sought unspecified medical attention. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse refers to a 8 years old male patient who was inadvertently vaccinated with a dose of GARDASIL (lot # reported as H009746; Exp Date: 11-JAN-2015) on 01-AUG-2012. No adverse effects reported. The reporter stated that the patient was currently in an exam with the physician for a follow up check up. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a male patient in his 60's to 70's. The patient was vaccinated with a "standard first shot" 0.5 ml dose of PNEUMOVAX23 (Lot# and route not reported) on an unspecified date. There were no concomitant medications. The patient experienced swollen cellulitis after being vaccinated with PNEUMOVAX23, date unspecified. The nurse told the patient to take BENADRYL and TYLENOL for the reaction and if that didn't help to come back in for a follow up visit but the patient hasn't come back in the date so the nurse thought he was fine. At the time of this report the patient's status was not known. The nurse said that the patient should not get another dose of PNEUMOVAX23 because of the reaction. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a doctor of pharmacist refers to a newborn patient. The patient was inadvertently vaccinated IM with a dose of PNEUMOVAX23 (0.5 ml, lot# not reported) instead of RECOMBIVAX HB Pediatric dose on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a female patient of unknown age who on an unknown date, in 2010 received the first dose of 1 GARDASIL (route, lot number and expiration date were not provided) and in May 2012 received the second dose of GARDASIL (route, lot number and expiration date were not provided). No adverse events were reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain, Skin reaction, Skin warm
Clinical narrative: This spontaneous report as received from a 68 years old female consumer refers to herself with cancer and sulfamethoxazole, BACTRIM allergy. The patient was vaccinated with a dose of PNEUMOVAX23 (lot number, route and site not reported) on 07-AUG-2012. No other co-suspects were reported. Concomitant medications included CRESTOR, TOPROL XL tablets, CELEBREX and VALTREX. On 07-AUG-2012 immediately after the injection, the patient had a bad skin reaction. She had a raised area the size of a nickel and grew to be the size of an orange; the area was red and hot. Her arm muscle was sore and painful to move. By the second day after the shot on 08-AUG-2012, her arm was red from shoulder to elbow. The patient saw the doctor for medical attention. No treatment or laboratory diagnostics studies were performed. The outcome was reported as recovering/resolving. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with lot # (667881/0661Z) M-M-R II (dose and route not reported on 06-AUG-2012 that expired on 04-MAY-2012. The patient was not experiencing any known symptoms. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Full blood count normal, HIV test negative, Myalgia, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a female patient "25 or 28 years" with no pertinent medical history. The patient was vaccinated with M-M-R II (dose, route and lot # not reported) on 31-MAY-2012 and developed adverse event 6 to 10 days later. The patient broke out in head to toe measles rash, and developed joint and muscle aches. These symptoms wax and wane. The patient has had 3 more lighter episodes within the past six weeks. Right now the patient got has rash on her face. In addition, the patient had some tachycardia symptoms and was placed on a beta blocker as treatment given for AE. No other co-suspects were reported. No concomitant medications were reported. The outcome was reported as not recovered/not resolved. Physician thought the Tachycardia symptoms is not related to M-M-R II. The patient had full chemistry panel including CBC and Sed Rate all normal, in addition HIV test negative, Rheumatoid Arthritis test negative, Vitamin A test pending and sought medical attention via physician followup. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rash morbilliform, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Tachycardia
Clinical narrative: This spontaneous report as received from a physician refers to a female patient "25 or 28 years" with no pertinent medical history. The patient was vaccinated with M-M-R II (dose, route and lot # not reported) on 31-MAY-2012 and developed adverse event 6 to 10 days later. The patient broke out in head to toe measles rash, and developed joint and muscle aches. These symptoms wax and wane. The patient has had 3 more lighter episodes within the past six weeks. Right now the patient got has rash on her face. In addition, the patient had some tachycardia symptoms and was placed on a beta blocker as treatment given for AE. No other co-suspects were reported. No concomitant medications were reported. The outcome was reported as not recovered/not resolved. Physician thought the Tachycardia symptoms is not related to M-M-R II. The patient had full chemistry panel including CBC and Sed Rate all normal, in addition HIV test negative, Rheumatoid Arthritis test negative, Vitamin A test pending and sought medical attention via physician followup. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Malaise, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to her son, a 16 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with dose 1 GARDASIL on 24-JUL-2012. No other co-suspects were reported. There was no concomitant medication. The consumer reported that on 29-JUL-2012 her son said he "wasn't feeling well". On 30-JUL-2012 he developed a fever of 103 degrees F. The patient called physician for medical attention. TYLENOL and ADVIL were given for treatment. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated intramuscularly with the first and second 0.5 ml dose of GARDASIL (Lot # not reported) in 2007 and December of 2011. It was not known if the patient sought for medical attention. No adverse effect reported. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician and a registered nurse refers to a 3 year old female child patient. The patient was subcutaneously vaccinated at lower right arm with 0.5ml of M-M-R II (Lot#/Exp:668015/0810Z/10-JUN-2012) on 07-AUG-2012 "today". No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient received an expired M-M-R II on an unspecified date. No adverse symptoms reported. It was unspecified whether the patient had sought medical attention or not. No treatment information was reported. At the time of reporting the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a unknown source via company representative refers to a female patient of unknown age. The patient was vaccinated with third standard dose of GARDASIL (lot # was unknown) through injection in deltoid muscle for prevention of HPV on an unknown date. On an unknown date the patient experienced pain at the injection site. The outcome of the AE was unknown. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site pruritus
Clinical narrative: Information has been received from a registered pharmacist concerning a 63 year old female with blood pressure high, a history of depression and no known drug reactions/allergies who on 13-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#1657AA, dose and route not reported). Concomitant medication included: unspecified blood pressure medication and unspecified antidepressant medication. The pharmacist reported that the patient developed an injection site reaction following vaccination. The injection site reaction was described as a red area that was itchy with some bruising at the injection site that was about an inch and one half in diameter (no rash noted). The patient sought medical attention by contacting pharmacist. No treatment was given and no lab diagnostics were performed. At the time of reporting, the patient was recovering. Follow up information was received from the registered pharmacist regarding the patient which received a dose of ZOSTAVAX (Merck) (Lot#1657AA), administered subcutaneously in right arm. The reaction described as a round red rash about 3 cm in diameter at the injection site. Also there was some bruising at the injection site. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Lumbar puncture abnormal, Post herpetic neuralgia, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a pharmacist refers to her father, who is a male patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) on an unspecified date described as several years ago, prior to initiation of chemotherapy. It was reported that subsequently the patient developed a severe case of shingles and the patient still suffered from post-herpetic neuralgia. And a spinal tap confirmed the presence of the virus in the spinal fluid. Whether the patient sought for medical attention was not reported. The outcome of severe shingles was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 17-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 670986/0730AA, exp. date: 17-AUG-2012). The pharmacist reported that on 17-MAY-2012 the patient received a dose of ZOSTAVAX (Merck) that had been reconstituted with expired sterile water dilution (lot# G000672, exp. date: 30-APR-2012). No adverse effect reported. It was unspecified if the patient sought medical attention. Follow up information was received from the pharmacist who reported that the patient received the third dose of ZOSTAVAX and there were no adverse events at the time of vaccination. The event was reported due to noticing on the next prescription for ZOSTAVAX that the sterile diluent expired at a different time (earlier date) than the live vaccine. The patient did not seek medical attention. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old female who on 27-APR-2012 was vaccinated with a dose of ZOSTAVAX (lot # 672609/1733AA, expiry date 04-FEB-2013), 0.65 mL, subcutaneously. On 28-APR-2012 the patient experienced cellulitis at the injection site (deltoid region). The patient sought unspecified medical attention. The patient put on cephalexin, 500 mg, 3 times daily for 7 days for the adverse effect. At the time of reporting, the patient's status was unknown. Follow up information has been received from the pharmacist concerning a 60 year old female patient who on 28-APR-2012 experienced swelling at injection site, redness and warm and was diagnosis with cellulitis. On 30-APR-2012, the patient saw doctor. The patient was given cephalexin, 500 mg, 3 times daily for 7 days. The patient required emergency room/doctor visit. At the time of reporting, the patient's outcome was unknown. Follow up information was received from a health care professional who stated that on 28-APR-2012 the patient with not known illness at time of vaccination developed small rash around the injection site and was diagnosed by physician with cellulitis. The patient prescribed cephalexin, 500 mg, 3 times daily for 7 days and in 2012 the symptoms resolved. The relatedness for cellulitis at the injection site (deltoid region) is unknown for ZOSTAVAX. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella virus test positive
Clinical narrative: Information has been received from a 71 year old male patient with hay fever, pollen, dust and mold allergy and s history of back surgery "about ten or fifteen-years-ago", in approximately 2002 who "about three years ago", in approximately 2009 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot number not reported), 0.5ml. Concomitant therapy included clonazepam, ZOLOFT and unspecified heartburn medication. The patient mentioned that "about one month ago", in approximately April 2012 he experienced or came down with shingles while visiting his brother in other country. The patient had sought unspecified medical attention and was given valacyclovir hydrochloride. The patient had done annual check-ups and tests. At the time of the report, the patient was not recovered. Follow-up information has been received via FAX concerning the patient who was vaccinated with 0.5 ml ZOSTAVAX (lot# 664029/0196Y) at left arm on 13-JUL-2009. As reported 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 strain. The patient developed shingles on 04-MAY-2012, 3 years after vaccine, no rash occurred at the site of injection post-vaccination and rash was not cultured. Also no culture done at health medical. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Eye irritation, Ocular hyperaemia
Clinical narrative: This spontaneous report was received from a x-ray technician refers to herself who was exposed with ZOSTAVAX (Lot# reported as 0363AE, exp date 13-MAR-2013) into her eyes on an unspecified date. It was reported when she went to reconstitute the ZOSTAVAX liquid host out of the vial and got in her eyes and face when she was adding the Sterile Water Diluent (lot # H004947) to the vial of ZOSTAVAX on 03-AUG-2012. The x-ray technician reported that on 03-AUG-2012 she flushed her eyes with water for at least 15 minutes and now her eyes are red and irritated. At the time of reporting, the patient was not recovered. It was unknown whether the patient sought medical attention. PQC was filed. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Herpes zoster, Herpes zoster ophthalmic
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient's wife was vaccinated with a dose of ZOSTAVAX on approximately two weeks ago at an unspecified pharmacy but he was not vaccinated with ZOSTAVAX. On 27-JUL-2012 (reported as three days ago) the patient experienced shingles lesions on the left side of his head and also his left eye. The patient was prescribed acyclovir and  VIROPTIC for the adverse events. The outcome of the patient was unknown. The nurse was not aware of the patient's wife developing any kind of lesions or symptoms after receiving ZOSTAVAX. The nurse did not know who her physician was or if she had needed to seek medical attention. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report received from a physician's office manager who is a 61 years old female patient. The patient was vaccinated SC with a dose of ZOSTAVAX on 04-NOV-2010. On 29-DEC-2011 the patient developed shingles. The patient sought unspecified medical attention. Antiviral (unspecified) and corticosteroids (unspecified) cream was given for treatment. The outcome of shingles was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with three doses of GARDASIL (lot #, dose/frequency, route and indication were unspecified) on 08-NOV-2007; 06-MAR-2008; 30-MAY-2012 respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified whether the patient had sought medical attention. The outcome was unknown. Additional information has been requested.
Age: 98.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 98 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated SC with a 0.65 ml dose of ZOSTAVAX on 19-JUL-2012. No other co-suspects were reported. There was no concomitant medication. The pharmacist reported that on 31-JUL-2012 ("last night") the patient developed burning and pain at the injection site after receiving ZOSTAVAX. The patient contacted the pharmacist for medical attention. ALEVE was given for treatment. No lab diagnostics studies were performed. The outcome of burning and pain at the injection site was reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age with egg allergy. On an unspecified date, the patient was vaccinated with 0.5 ml dose GARDASIL (lot # was not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced injection site reaction after getting a GARDASIL. The patient sought unspecified medical attention. No treatment information was reported. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Headache, Influenza like illness, Periorbital haematoma, Visual impairment
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on an unknown date was vaccinated with the 2nd dose of GARDASIL (dose and lot # not provided). On 05-JUN-2012, the patient experienced flu like symptoms after her 2nd dose of GARDASIL. No treatment was given for the event. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. Follow up information as received from a health professional refers to a 14 years old female patient with no preexisting allergies, birth defects, medical conditions or illness at the time of vaccination. The patient was vaccinated in the left deltoid with lot # (672193/1524AA) dose 2 GARDASIL on 05-JUN-2012 at 11:00 am (route not reported). No other co-suspects were reported. No concomitant medications were reported. On 05-JUN-2012 at 15:00 the patient experienced flu like symptoms. She couldn't go to practice at 18:00 nor throughout the night. The patient complained of visual disturbance, lower half black on one eye. The patient had a headache for 1 week. No treatment information was reported. The patient never went to the doctor. No laboratory diagnostic studies were performed. The outcome of visual disturbance, half black on one eye, headache and flu like symptoms was unknown. The relatedness for flu like symptoms, headache and visual disturbance, half back on one eye was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (L.P.N.) refers to unspecified patients. The patients were vaccinated with improperly stored GARDASIL. It was reported that the first excursion occurred in May, 2011 were GARDASIL were exposed to 31 F for 4 hours and the second excursion occurred on 29-MAY-2012, where GARDASIL were exposed to 30F for 12 hours. No adverse effects reported. 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: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth, Pruritus
Clinical narrative: This spontaneous report was received from a 65 years old female patient reporting on herself with high blood pressure and sulfur drugs allergy who on 29-JUN-2012 was vaccinated SQ with 0.65 mL of ZOSTAVAX (lot # not provided). No other co-suspects were reported. Concomitant medications included NORVASC and LIPITOR. On 30-JUN-2012 "within one day of getting the shot", the patient had redness from the site of the injection to her elbow, there was extreme itchiness for 4-5 days and the area felt red hot to touch, there were small little bumps at the area. In July 2012 "in the last week and 1/2", the patient felt like she had had a chicken pox-like rash. The patient had a rash on her face and ears and they itch. The patient stated that new poxes appeared daily but none had gotten to the blistering stage. She had not called or seen her doctor and no treatment was given for the events. No laboratory tests were performed. At the time of the report, the patient had not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a 65 years old female patient reporting on herself with high blood pressure and sulfur drugs allergy who on 29-JUN-2012 was vaccinated SQ with 0.65 mL of ZOSTAVAX (lot # not provided). No other co-suspects were reported. Concomitant medications included NORVASC and LIPITOR. On 30-JUN-2012 "within one day of getting the shot", the patient had redness from the site of the injection to her elbow, there was extreme itchiness for 4-5 days and the area felt red hot to touch, there were small little bumps at the area. In July 2012 "in the last week and 1/2", the patient felt like she had had a chicken pox-like rash. The patient had a rash on her face and ears and they itch. The patient stated that new poxes appeared daily but none had gotten to the blistering stage. She had not called or seen her doctor and no treatment was given for the events. No laboratory tests were performed. At the time of the report, the patient had not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a college aged patient. The patient was intramuscularly vaccinated wit a 0.5 ml second dose of M-M-R II (lot number not reported) on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. No treatment information was reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a patient's friend refers to a 64 years old female patient (110- 120lbs). In approximately 2008 (reported as 3-4 year ago) the patient was vaccinated with a dose of ZOSTAVAX (lot# was noted reported, one injection under the skin). About 3-4 years after was vaccinated with ZOSTAVAX in early January 2012, the patient got shingles. . The patient seemed to get over the shingles in about 4 weeks or so. The patient's friend had no idea what all concomitant medications were, but stated "was alot". The patient was gave some medication for the treatment of the AE but her friend was not sure. The patient was always going to the doctor and sought medical attention so maybe lab diagnostics studies were performed. Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, CSF glucose, CSF protein increased, CSF white blood cell count increased, Chest X-ray normal
Clinical narrative: A serious spontaneous report of post-vaccination encephalitis manifested by weakness, body aches, low grade fever, severe headache, vomiting and confusion and non-serious events of pneumonia manifested with pleuritic chest pain, diaphoresis, anterior lymph node swelling and sore throat has been received from a health professional concerning a 39-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST intranasally in 2007. The patient was well on the day of vaccination but developed a sore throat, body aches, and a low grade fever two days after vaccination. The next day she awoke feeling weak with diaphoresis and pleuritic chest pain. Her primary care physician made a clinical diagnosis of possible pneumonia and she was treated with clarithromycin; however, her chest radiograph was normal. Three days later she developed worsening sore throat, anterior lymph node swelling, generalized weakness, and a severe headache. On day 11 after vaccination she presented to an emergency room with vomiting and confusion. Cerebrospinal fluid (CSF) revealed a white blood cell count of 480/mm3, protein 97 g/l, glucose 2 mmol/l, and PCR for herpes simplex virus was negative. She was admitted with a presumptive diagnosis of meningitis/encephalitis caused by the live influenza vaccine. She was treated with acyclovir, vancomycin, and cefuroxime. Her illness resolved quickly and she was discharged after three days of hospitalization with a diagnosis of post-vaccination encephalitis. The reporter informed that the cause of patient's illness was not the vaccine. The outcome of the events post-vaccination encephalitis, pneumonia, diaphoresis, anterior lymph node swelling and sore throat was resolved. The reporter assessed all the events as not related to FLUMIST. Additional information was received on 26-Apr-2012 and incorporated in the narrative; suspect drug information and narrative description. Other additional information received was patient's city.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Confusional state, Encephalitis post immunisation, Headache, Herpes simplex serology negative, Hyperhidrosis
Clinical narrative: A serious spontaneous report of post-vaccination encephalitis manifested by weakness, body aches, low grade fever, severe headache, vomiting and confusion and non-serious events of pneumonia manifested with pleuritic chest pain, diaphoresis, anterior lymph node swelling and sore throat has been received from a health professional concerning a 39-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST intranasally in 2007. The patient was well on the day of vaccination but developed a sore throat, body aches, and a low grade fever two days after vaccination. The next day she awoke feeling weak with diaphoresis and pleuritic chest pain. Her primary care physician made a clinical diagnosis of possible pneumonia and she was treated with clarithromycin; however, her chest radiograph was normal. Three days later she developed worsening sore throat, anterior lymph node swelling, generalized weakness, and a severe headache. On day 11 after vaccination she presented to an emergency room with vomiting and confusion. Cerebrospinal fluid (CSF) revealed a white blood cell count of 480/mm3, protein 97 g/l, glucose 2 mmol/l, and PCR for herpes simplex virus was negative. She was admitted with a presumptive diagnosis of meningitis/encephalitis caused by the live influenza vaccine. She was treated with acyclovir, vancomycin, and cefuroxime. Her illness resolved quickly and she was discharged after three days of hospitalization with a diagnosis of post-vaccination encephalitis. The reporter informed that the cause of patient's illness was not the vaccine. The outcome of the events post-vaccination encephalitis, pneumonia, diaphoresis, anterior lymph node swelling and sore throat was resolved. The reporter assessed all the events as not related to FLUMIST. Additional information was received on 26-Apr-2012 and incorporated in the narrative; suspect drug information and narrative description. Other additional information received was patient's city.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain, Pleuritic pain, Pneumonia
Clinical narrative: A serious spontaneous report of post-vaccination encephalitis manifested by weakness, body aches, low grade fever, severe headache, vomiting and confusion and non-serious events of pneumonia manifested with pleuritic chest pain, diaphoresis, anterior lymph node swelling and sore throat has been received from a health professional concerning a 39-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST intranasally in 2007. The patient was well on the day of vaccination but developed a sore throat, body aches, and a low grade fever two days after vaccination. The next day she awoke feeling weak with diaphoresis and pleuritic chest pain. Her primary care physician made a clinical diagnosis of possible pneumonia and she was treated with clarithromycin; however, her chest radiograph was normal. Three days later she developed worsening sore throat, anterior lymph node swelling, generalized weakness, and a severe headache. On day 11 after vaccination she presented to an emergency room with vomiting and confusion. Cerebrospinal fluid (CSF) revealed a white blood cell count of 480/mm3, protein 97 g/l, glucose 2 mmol/l, and PCR for herpes simplex virus was negative. She was admitted with a presumptive diagnosis of meningitis/encephalitis caused by the live influenza vaccine. She was treated with acyclovir, vancomycin, and cefuroxime. Her illness resolved quickly and she was discharged after three days of hospitalization with a diagnosis of post-vaccination encephalitis. The reporter informed that the cause of patient's illness was not the vaccine. The outcome of the events post-vaccination encephalitis, pneumonia, diaphoresis, anterior lymph node swelling and sore throat was resolved. The reporter assessed all the events as not related to FLUMIST. Additional information was received on 26-Apr-2012 and incorporated in the narrative; suspect drug information and narrative description. Other additional information received was patient's city.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Polymerase chain reaction, Pyrexia, Vomiting
Clinical narrative: A serious spontaneous report of post-vaccination encephalitis manifested by weakness, body aches, low grade fever, severe headache, vomiting and confusion and non-serious events of pneumonia manifested with pleuritic chest pain, diaphoresis, anterior lymph node swelling and sore throat has been received from a health professional concerning a 39-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST intranasally in 2007. The patient was well on the day of vaccination but developed a sore throat, body aches, and a low grade fever two days after vaccination. The next day she awoke feeling weak with diaphoresis and pleuritic chest pain. Her primary care physician made a clinical diagnosis of possible pneumonia and she was treated with clarithromycin; however, her chest radiograph was normal. Three days later she developed worsening sore throat, anterior lymph node swelling, generalized weakness, and a severe headache. On day 11 after vaccination she presented to an emergency room with vomiting and confusion. Cerebrospinal fluid (CSF) revealed a white blood cell count of 480/mm3, protein 97 g/l, glucose 2 mmol/l, and PCR for herpes simplex virus was negative. She was admitted with a presumptive diagnosis of meningitis/encephalitis caused by the live influenza vaccine. She was treated with acyclovir, vancomycin, and cefuroxime. Her illness resolved quickly and she was discharged after three days of hospitalization with a diagnosis of post-vaccination encephalitis. The reporter informed that the cause of patient's illness was not the vaccine. The outcome of the events post-vaccination encephalitis, pneumonia, diaphoresis, anterior lymph node swelling and sore throat was resolved. The reporter assessed all the events as not related to FLUMIST. Additional information was received on 26-Apr-2012 and incorporated in the narrative; suspect drug information and narrative description. Other additional information received was patient's city.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Angiogram, Angiogram abnormal, Antinuclear antibody negative, Aspartate aminotransferase increased
Clinical narrative: A report has been received from Regulatory concerning a 41 year old, female patient. The patient's past medical history included morphine, KEFLEX, LORTAB, gynecological problems, heart problems. Concomitant medications included digoxin, vitamins NOS, ramipril, calcium and fish oil. On 22-Oct-2008 the patient received nasal FLUMIST. On 23-Oct-2008 the patient experienced body aches, fever (temperature 102), chills, and temp returned to normal with TYLENOL and MOTRIN. (The 1 day interval shown refers to myalgias, but it was 13 days before admission with discharged dx of rhabdo.) The patient improved with intravenous fluids and was discharged to home. On 23-Oct-2008 patient had all over body aches T-102, chills, temp returned to normal with TYLENOL and MOTRIN. On 27-Oct-2008 finally felt well enough to go to work. Was shaky with walking, heavy head, hands, feet, tired. On 04-Nov-2008 the patient had chest pain radiating up to neck and left arm, nausea diarrhea x5 decreased heart rate and B/P. On 17-Feb-2009 the patient was admitted to the hospital. Suspect viral syndrome possibly secondary to nasal flu vaccine, left bundle branch block, mild congestive cardiomyopathy with left ventricular dysfunction, bradycardia, diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort. Cardio and Neuro consult done. On 05-Nov-2008 laboratory values was as follows: heart cath with Ef of 45-50%, ana-neg, rheumatoid factor <5, CBC-nonsign, BMP-NL, 11/4-CK-4280, LDH- 278, AST-95, CRP-52, digoxin level-0.5, TSH-2.05, T3-1.11, urine-neg, CTA chest-mild atelectasis negative for PE, GB sono-Nl, echo-nonsignif. According to the reporter the assessment of the Serious criteria for the report was as follows: Hospitalised.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Atelectasis, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Blood pressure decreased, Blood thyroid stimulating hormone normal
Clinical narrative: A report has been received from Regulatory concerning a 41 year old, female patient. The patient's past medical history included morphine, KEFLEX, LORTAB, gynecological problems, heart problems. Concomitant medications included digoxin, vitamins NOS, ramipril, calcium and fish oil. On 22-Oct-2008 the patient received nasal FLUMIST. On 23-Oct-2008 the patient experienced body aches, fever (temperature 102), chills, and temp returned to normal with TYLENOL and MOTRIN. (The 1 day interval shown refers to myalgias, but it was 13 days before admission with discharged dx of rhabdo.) The patient improved with intravenous fluids and was discharged to home. On 23-Oct-2008 patient had all over body aches T-102, chills, temp returned to normal with TYLENOL and MOTRIN. On 27-Oct-2008 finally felt well enough to go to work. Was shaky with walking, heavy head, hands, feet, tired. On 04-Nov-2008 the patient had chest pain radiating up to neck and left arm, nausea diarrhea x5 decreased heart rate and B/P. On 17-Feb-2009 the patient was admitted to the hospital. Suspect viral syndrome possibly secondary to nasal flu vaccine, left bundle branch block, mild congestive cardiomyopathy with left ventricular dysfunction, bradycardia, diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort. Cardio and Neuro consult done. On 05-Nov-2008 laboratory values was as follows: heart cath with Ef of 45-50%, ana-neg, rheumatoid factor <5, CBC-nonsign, BMP-NL, 11/4-CK-4280, LDH- 278, AST-95, CRP-52, digoxin level-0.5, TSH-2.05, T3-1.11, urine-neg, CTA chest-mild atelectasis negative for PE, GB sono-Nl, echo-nonsignif. According to the reporter the assessment of the Serious criteria for the report was as follows: Hospitalised.