chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blister, Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer of unknown age refers to himself. The patient was vaccinated with ZOSTAVAX (lot number unknown) on 28-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On 06-JUN-2012 the patient experienced severe pain in upper back, right side. Pain persisted for left few days and after a week the patient had a case of shingles, completed with blisters up and down his right arm. The patient still had pain, but it was alleviating, so the patient was confident pain was temporary. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blister, Herpes zoster, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer of unknown age refers to himself. The patient was vaccinated with ZOSTAVAX (lot number unknown) on 28-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On 06-JUN-2012 the patient experienced severe pain in upper back, right side. Pain persisted for left few days and after a week the patient had a case of shingles, completed with blisters up and down his right arm. The patient still had pain, but it was alleviating, so the patient was confident pain was temporary. The outcome was unknown. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Blister, Pyrexia, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 13 months 3 weeks old patient. The nurse reported that" a patient was administered VARIVAX (lot# 0306AE), concomitant with an unspecified hepatitis A vaccine, on 02-JUL-2012". 12 days later, on 14-JUL-2012 the patient experienced fever of 104F and 10 disseminated vesicles of varicella. The patient was seen in the office but no treatment was prescribed. The outcome of the AEs was unknown. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Insomnia, Joint swelling, Pain, X-ray
Clinical narrative: This spontaneous report as received from a 78 years old female consumer with hypothyroidism and cortisone allergic and can't take any cholesterol medications refers to herself. The patient was vaccinated with the first dose of ZOSTAVAX (Lot# and exp date unspecified) intramuscular in May 2011. No other co-suspects were reported. Concomitant medications included estrogens, PREMARIN, SYNTHROID and aspirin. The patient stated that, in June 2011, about a month or so after she received ZOSTAVAX she noticed her wrist started hurting and swelling. She stated it was worst in her right wrist. She describes the pain as gradual and is now intense at times and increases with movement. The swelling and pain almost daily and keep her awake at night often. She also side that ice packs do help some and aspirin takes some of the pain away. The patient had sought unspecified medical attention. The patient had performed with X-rays laboratory diagnostics (result not provided). The outcome of "wrist started swelling, pain as gradual and is now intense at times and increases with movement and wrist started hurting" was reported as not recovered/not resolved at the time of reporting. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from an 82 years old female patient with arthritis, codeine allergy and sulfate allergy refers to herself. The patient's medical history included shingles and gall bladder removed. The patient was vaccinated with ZOSTAVAX on an unspecified date after she had shingles. No other co-suspects were reported. Concomitant medications included aspirin and MOTRIN. The patient mentioned that she had experienced post herpetic neuralgia for the past 4 years, in 2008. She had tried morphine and oxycodone no relieve the pain, but they did not work. The patient mentioned that wearing a bra was painful. The patient experienced shooting pains. All AE responses are for ZOSTAVAX. The patient had visited the doctor for medical attention. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Staphylococcal infection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient was vaccinated with ZOSTAVAX on 18-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 22-JUL-2012 the patient experienced staph infection (staphylococcus) on face after receiving ZOSTAVAX. The patient sought unspecified medical attention from the pharmacist. He was treated with sulfamethoxazole, BACTRIM. At the time of reporting, the outcome of staph infection (staphylococcus) on face was not recovered. Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 15 months old male patient who on 22-JUN-2012, was vaccinated with a dose of M-M-R II in the arm (dose, route and lot number not reported). No other co-suspects were reported. Concomitant therapy included penicillin. It was stated that on the same day, on 22-JUN-2012, the patient broke out with a rash and hives. No treatment was given for the experienced. On an unspecified date in 2012, the patient recovered. The patient sought unspecified medical attention. The relatedness for patient broke out with a rash and hives was unknown for M-M-R II. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age who on 26-SEP-2010, was vaccinated with the first dose of VAQTA and on 10-MAR-2011, 16 days prior to six month minimal interval from the first dose, was vaccinated with the second dose of VAQTA (doses, routes and lot numbers not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender, who on unknown dates, were vaccinated with a dose of VARIVAX (lot number, dose, route not reported). No other co-suspects were reported. No concomitant medications were reported. Physician reported that "every patient she saw who had received VARIVAX testes negative for titers" (date unspecified). No specific patient mentioned. No treatment information was reported. At the time of report, the patients' outcomes were unknown. The relatedness for the patient's events was not reported for VARIVAX. 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. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Haemorrhage, Mouth haemorrhage
Clinical narrative: This spontaneous report as received from a 67 years old male consumer reporting on himself with no drug reaction or allergies who on 09-JUL-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (Dose and lot number not reported). No other co-suspects were reported. Concomitant medications included lisinopril (manufacturer unknown), clopidogrel, carvedilol, omeprazole, CRESTOR and aspirin. The consumer stated that on 10-JUL-2012 in the morning, he woke up to a large amount of blood on his pillow. He stated that it looked like blood mixed with water and that the bleeding was coming from his mouth and arm. No lab diagnostics studies were performed. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. The relatedness for patient awoke up to a large amount of blood on his pillow, the bleeding was coming from his mouth and his arm was unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from an actually 60 years old female consumer reporting on herself with an allergy to REMICADE who on 17-JUL-2012, was vaccinated subcutaneously on her left arm with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer stated that on 19-JUL-2012, it was not a rash but was red about 3 inches around the injection site. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for red about 3 inches around the injection site was unknown for ZOSTAVAX. Additional information is not available.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old male patient who on 30-APR-2012, was vaccinated with a dose of PNEUMOVAX 23 (lot number: 672781/1706AA, dose and route not reported). On 01-MAY-2012, the patient started experiencing fever and around injection site, there was a patch of redness that was about size of "2 by 5 inches". The patient sought medical attention by visiting the office. He was treated with "antibiotics" (unspecified). No lab diagnostics studies were performed. At the time of the report the patient did not recovered. Follow up information has been received from the registered nurse concerning the 74 year old male patient with none medical history who on 30-APR-2012 was vaccinated intramuscularly with the second dose of PNEUMOVAX 23 (lot number: 672781/1706AA) on left arm. On 02-MAY-2012 the patient experienced left arm swollen and red and low grade fever. Cephalexin and TYLENOL were given respectively for the AE. The patient was recovered on an unspecified date. No information is expected.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 years old patient. The patient was vaccinated subcutaneously with lot # (667002/0441Z; exp date 25-MAR-2012) of M-M-R II on 23-JUL-2012 around 11:30am. No other co-suspects and no concomitant medications were reported. No adverse effect were reported. No treatment information was reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Affect lability, Crying, Disorientation, Disturbance in attention
Clinical narrative: Information has been received from a physician concerning a female patient with allergy to other unspecified vaccine and a history of becoming disoriented and loopy when other vaccines administered who on an unspecified date was vaccinated with the first 0.5 mL dose of GARDASIL. Subsequently the patient experienced becoming disoriented, lethargic and loopy. She would not receive any further treatment following the first dose. After vaccination the adverse event improved. There was no treatment given for the adverse events. The vaccination of GARDASIL was discontinued and not reintroduced. The patient did not seek medical attention. At the time of the report, the patient recovered from the events. Follow up information has been received from the physician concerning the 18 years old student patient with no illness at the time of vaccination and no pre-existing allergies, birth defects and medical conditions who on 24-APR-2012 at 15:02, was vaccinated with first dose of GARDASIL (lot # 672652/0022AE) IM in the left arm. It was reported that on 25-APR-2012, the patient felt hot, felt emotionally unstable, unstoppable crying, patient felt "off today" and had trouble focusing. Parents stated that she was speaking slowly and was not herself. On an unspecified date, flu test showed negative result and blood pressure was normal. On 26-APR-2012, the patient recovered. The patient required and ER visit. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Feeling hot, Influenza virus test negative, Lethargy, Mental disorder
Clinical narrative: Information has been received from a physician concerning a female patient with allergy to other unspecified vaccine and a history of becoming disoriented and loopy when other vaccines administered who on an unspecified date was vaccinated with the first 0.5 mL dose of GARDASIL. Subsequently the patient experienced becoming disoriented, lethargic and loopy. She would not receive any further treatment following the first dose. After vaccination the adverse event improved. There was no treatment given for the adverse events. The vaccination of GARDASIL was discontinued and not reintroduced. The patient did not seek medical attention. At the time of the report, the patient recovered from the events. Follow up information has been received from the physician concerning the 18 years old student patient with no illness at the time of vaccination and no pre-existing allergies, birth defects and medical conditions who on 24-APR-2012 at 15:02, was vaccinated with first dose of GARDASIL (lot # 672652/0022AE) IM in the left arm. It was reported that on 25-APR-2012, the patient felt hot, felt emotionally unstable, unstoppable crying, patient felt "off today" and had trouble focusing. Parents stated that she was speaking slowly and was not herself. On an unspecified date, flu test showed negative result and blood pressure was normal. On 26-APR-2012, the patient recovered. The patient required and ER visit. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Slow speech
Clinical narrative: Information has been received from a physician concerning a female patient with allergy to other unspecified vaccine and a history of becoming disoriented and loopy when other vaccines administered who on an unspecified date was vaccinated with the first 0.5 mL dose of GARDASIL. Subsequently the patient experienced becoming disoriented, lethargic and loopy. She would not receive any further treatment following the first dose. After vaccination the adverse event improved. There was no treatment given for the adverse events. The vaccination of GARDASIL was discontinued and not reintroduced. The patient did not seek medical attention. At the time of the report, the patient recovered from the events. Follow up information has been received from the physician concerning the 18 years old student patient with no illness at the time of vaccination and no pre-existing allergies, birth defects and medical conditions who on 24-APR-2012 at 15:02, was vaccinated with first dose of GARDASIL (lot # 672652/0022AE) IM in the left arm. It was reported that on 25-APR-2012, the patient felt hot, felt emotionally unstable, unstoppable crying, patient felt "off today" and had trouble focusing. Parents stated that she was speaking slowly and was not herself. On an unspecified date, flu test showed negative result and blood pressure was normal. On 26-APR-2012, the patient recovered. The patient required and ER visit. No further information is available.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Chills, Heart rate increased, Pyrexia
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 23 years old male student patient with no illness at time of vaccination, no adverse events following prior vaccination and carnitine-palitoyl transferase II deficiency (neuromuscular disorder). The patient was vaccinated with dose 1 GARDASIL on 11-MAY-2012 and with dose 2 GARDASIL, IM, left deltoid (dose not reported, lot # 672233/1561AA, exp. 26-AUG-2014) on 10-JUL-2012 at 12:10 PM. No other co-suspects were reported. There was no concomitant medications. On 10-JUL-2012 at 12:30 PM (also reported as "1 hour after vaccine"), the patient experienced fever to 100 and shaking chills. Chills occurred again 1 hour later. The Registered Nurse reported that 3 hours later examination and vital signs were normal except heart rate raised to 92. There was no nausea, itching, hives, etc. No treatment information was reported. The patient recovered on 10-JUL-2012. Laboratory tests done: T=98, O2 sat = 95%, BP 110/70. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Adnexa uteri pain, Back pain, Diarrhoea, Musculoskeletal stiffness, Myalgia
Clinical narrative: This spontaneous report as received from a physician refers to a 23 years old female patient with rash on her hands, most likely from a cosmetic and no pertinent medical history, who 3-4 months ago, in March 2012, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported) and no adverse experiences reported for the first dose. On 07-JUL-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on 07-JUL-2012 "within one hour" the patient noted pain in her ovaries as well as lower back pain; later that evening she experienced fever, vomiting and diarrhea and went to the emergency room. The patient was treated with ibuprofen and LEVAQUIN. Her platelet count was 101,000 when testing was done in the emergency room and 100,000 group B strep was noted in a urine sample. The patient was not admitted to the hospital. On 08-JUL-2012, the patient was seen at the physician's office and he noted that she was feeling better and was afebrile but her platelet count was 8,500. The patient was seen again in the physician's office on 11-JUL-2012 and the patient was experiencing diffuse stiffness as well as muscle pain and the patient might go to the emergency room again. At the time of the report, the patient's outcome for 100,000 groups b strep in a urine sample, muscle pain and diffuse stiffness was unknown. The relatedness for patient noted pain in her ovaries, patient experienced muscle pain, diffuse stiffness, patient had 100,000 groups b strep in a urine sample, patient experienced diarrhea, vomiting, fever and lower back pain was unknown for GARDASIL. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Platelet count decreased, Pyrexia, Streptococcus test positive, Urine analysis abnormal, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 23 years old female patient with rash on her hands, most likely from a cosmetic and no pertinent medical history, who 3-4 months ago, in March 2012, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported) and no adverse experiences reported for the first dose. On 07-JUL-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on 07-JUL-2012 "within one hour" the patient noted pain in her ovaries as well as lower back pain; later that evening she experienced fever, vomiting and diarrhea and went to the emergency room. The patient was treated with ibuprofen and LEVAQUIN. Her platelet count was 101,000 when testing was done in the emergency room and 100,000 group B strep was noted in a urine sample. The patient was not admitted to the hospital. On 08-JUL-2012, the patient was seen at the physician's office and he noted that she was feeling better and was afebrile but her platelet count was 8,500. The patient was seen again in the physician's office on 11-JUL-2012 and the patient was experiencing diffuse stiffness as well as muscle pain and the patient might go to the emergency room again. At the time of the report, the patient's outcome for 100,000 groups b strep in a urine sample, muscle pain and diffuse stiffness was unknown. The relatedness for patient noted pain in her ovaries, patient experienced muscle pain, diffuse stiffness, patient had 100,000 groups b strep in a urine sample, patient experienced diarrhea, vomiting, fever and lower back pain was unknown for GARDASIL. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 9 months old patient who in April 2012, was vaccinated with a 0.5 ml dose of VAQTA intramuscularly (lot number not reported). No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old patient who on 29-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck). The nurse practitioner prescribed the ZOSTAVAX (Merck) for the patient. No product confusion discovered. No adverse event reported. Follow-up information was received from registered nurse refers to 18 years old female student. No other co-suspects were reported. No concomitant medications were reported. The patient did not seek medical attention. No adverse event reported. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fall, Jaw fracture, Surgery, Syncope
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 16 years old male patient with attention deficit hyperactivity and prophylaxis. The patient was vaccinated with dose 0 GARDASIL on 24-APR-2012, Other suspect therapies included LEXAPRO and clonidine. Concomitant medications included MENACTRA and STRATTERA. On 24-APR-2012 the patient experienced jaw fracture, 1 day after onset of therapy, syncope, surgery and fall. No treatment information was reported. The outcome of jaw fracture, syncope, surgery and fall is unknown. The relatedness for jaw fracture, syncope, surgery and fall is unknown for GARDASIL. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasal congestion, Nasopharyngitis, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 62 years old male patient with no pertinent medical history and no drug reactions or allergies, who on 20-JUL-2012, was vaccinated with a dose of ZOSTAVAX (lot number /0257AE, Exp. Date: 13-MAR-2015) (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that on 25-JUL-2012, the patient developed a head cold following vaccination with ZOSTAVAX. The head cold was described as a stuffy runny nose with a possible fever. No lab diagnostics studies were performed. No treatment was given for the experience. At the time of the report, the patient had not recovered. The patient sought medical attention by contacting the pharmacist. The relatedness for patient developed a head cold described as a stuffy runny nose and possible fever was unknown for ZOSTAVAX. 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 registered nurse refers to a patient of unknown age. The patient was vaccinated intramuscularly with dose 1, 0.5 ml of GARDASIL (lot # not reported) on 12-JUL-2011. On 19-JUL-2012 the patient was vaccinated with dose 2 of GARDASIL (lot #, dose and route not reported). No other co-suspect and no concomitant medications were reported. No adverse effects were reported. No treatment information was reported. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy site unspecified abnormal, Drug administered to patient of inappropriate age
Clinical narrative: This literature marketed report as received from a physician who is also an author of the literature article refers to a 59 years old healthy female patient. The patient was vaccinated with 3 doses of GARDASIL (lot#s not reported) in her arm in July 2010, September 2010, and January 2011, respectively for treatment of recalcitrant plantar warts. The patient presented in October 2009 with a 5-year history of recalcitrant plantar warts, Four large warts were present on her feet; the largest measured 4.6 cm in diameter. She had previously been treated with numerous therapies, including liquid nitrogen cryotherapy, topical iminiquimod 5%, 40% salicylic acid, pulsed dye laser, and oral cimetidine without improvement. A shave biopsy was performed and findings confirmed the diagnosis. On the basis of the classic and histopathologic findings, human papillomavirus (HPV) typing was not performed initially. Treatment was initiated, with aggressive liquid nitrogen cryotherapy in conjunction with topical tretinoin 0.025% with the plaques occluded by 40% salicylic acid tape for several weeks without improvement. Subsequently, a series of 12 intralesional bleomycin 1% injections were administered approximately every 2 weeks. Minimal improvement was observed; the largest wart still measured 4 cm after the final injection. On the basis of isolated literature reports of cross-protection of the GARDASIL, this vaccine was administered in the patient's arm in 3 doses at 0, 2, and 6 months (July 2010, September 2010, and January 2011, respectively). Other treatments were discontinued at that time for lack of efficacy. When the patient returned for follow-up in November 2010, the largest wart had decreased in size and thickness, measuring 2.5 cm. By February 2011, only 2 warts left remained, the largest measuring 0.5 cm in diameter. By April 2011, the warts had completely regressed. Given the patient's response to the vaccination, HPV in situ hybridization studies were performed on paraffin-embedded tissue sections from the original biopsy specimen. They were negative for HPV types 6, 11, 16, and 18 but positive for a general probe for HPV. In July 2011, the patient's feet remained wart free with no evidence of recurrence. Spontaneous regression of warts independent of treatment certainly occurred, and this might have occurred in this patient. However, HPV vaccines had been proven to show cross-protein against other strains, and it was possible that this was the mechanism for resolution of the long-standing, recalcitrant walls in this patient. Further clinical trials might be warranted. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a medical assistant concerning a 73 year old female patient who on an unspecified date was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 671076/1198AA; Exp on 25-OCT-2012). On an unspecified date, the patient came down with shingles. The patient had sought unspecific medical attention. Acyclovir was prescribed for the event. At the time of reporting, the patient's outcome was unknown. 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 other healthcare worker refers to a patient of unknown age. The patient was vaccinated with dose 2 of GARDASIL (Lot # not reported) in February 2010 and dose 3 of GARDASIL (Lot # not reported) on 30-JUL-2012. NO adverse effect was reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 60 years old male consumer reporting on himself with high blood pressure and high cholesterol and no drug reactions/allergies who on 26-JUL-201 was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose and lot # not provided). No other co-suspects were reported. Concomitant medications included hypertension and cholesterol medications (unspecified). On 28-JUL-2012, the patient developed redness, swelling and fever at the injection site. The patient wanted to know how long it would last. No treatment was given for the events. The patient's outcome was unknown. The relatedness for redness, swelling and fever at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to patient of unknown age and gender. The patient was vaccinated with 0.65 ml SQ lot # (669746/0356AA, exp 09-JUN-2012) ZOSTAVAX expired dose on 02-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. 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 registered nurse concerning a female consumer who in July 2011 was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided), in August 2011 received the second dose of GARDASIL (dose, route and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. On 30-JUL-2012, the patient was in the office to receive her third dose of GARDASIL (dose, route and lot # not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
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 dose 1 of GARDASIL (lot #, dose and route not reported) in July 2009. The medical assistant reported that on 19-JUL-2012, the patient was in the office to receive dose 2 of GARDASIL (lot #, dose and route not reported) which would be late. No other co-suspects and no concomitant medications were reported. No symptoms were reported. No treatment information was reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Arthralgia, Fatigue, Hand-foot-and-mouth disease, Pyrexia, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 11 years old female patient with prophylaxis was vaccinated IM into left arm with GARDASIL (lot # 672193/1524AA, expired date 23-AUG-2012) on 09-MAR-2012. No other co-suspects were reported. Concomitant medications include: vaccinated IM into left arm with ZYRTEC, ADACEL (lot # C4034AA) and vaccinated IM into right arm with MENACTRA (lot # U3906AA). On 09-MAR-2012, 1 and 1/2 hours after onset of therapy, the patient developed achy joints. The patient was sleepy for 2 days but still tired. The patient had slight cough before shot and still had it. On 14-MAR-2012 the patient broke out with rash on hands which was diagnosis as hand foot mouth. No treatment information was reported. The outcome of achy joints, sleepy for 2 days, rash on hands, hand foot mouth and tired were unknown. The outcome of 104 fever was reported as recovered. This report was considered not serious, the patient required ER visit. The original reporting source was not provided. The VAERS IS # is 451874-1. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Somnolence
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 11 years old female patient with prophylaxis was vaccinated IM into left arm with GARDASIL (lot # 672193/1524AA, expired date 23-AUG-2012) on 09-MAR-2012. No other co-suspects were reported. Concomitant medications include: vaccinated IM into left arm with ZYRTEC, ADACEL (lot # C4034AA) and vaccinated IM into right arm with MENACTRA (lot # U3906AA). On 09-MAR-2012, 1 and 1/2 hours after onset of therapy, the patient developed achy joints. The patient was sleepy for 2 days but still tired. The patient had slight cough before shot and still had it. On 14-MAR-2012 the patient broke out with rash on hands which was diagnosis as hand foot mouth. No treatment information was reported. The outcome of achy joints, sleepy for 2 days, rash on hands, hand foot mouth and tired were unknown. The outcome of 104 fever was reported as recovered. This report was considered not serious, the patient required ER visit. The original reporting source was not provided. The VAERS IS # is 451874-1. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Arthralgia, Body temperature increased, Fatigue, Hand-foot-and-mouth disease, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 11 years old female patient with prophylaxis was vaccinated IM into left arm with GARDASIL (lot # 672193/1524AA, expired date 23-AUG-2012) on 09-MAR-2012. No other co-suspects were reported. Concomitant medications include: vaccinated IM into left arm with ZYRTEC, ADACEL (lot # C4034AA) and vaccinated IM into right arm with MENACTRA (lot # U3906AA). On 09-MAR-2012, 1 and 1/2 hours after onset of therapy, the patient developed achy joints. The patient was sleepy for 2 days but still tired. The patient had slight cough before shot and still had it. On 14-MAR-2012 the patient broke out with rash on hands which was diagnosis as hand foot mouth. No treatment information was reported. The outcome of achy joints, sleepy for 2 days, rash on hands, hand foot mouth and tired were unknown. The outcome of 104 fever was reported as recovered. This report was considered not serious, the patient required ER visit. The original reporting source was not provided. The VAERS IS # is 451874-1. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Rash pruritic
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient with AUGMENTIN allergy was vaccinated into left arm with lot # (672233/1561AA) dose 1 GARDASIL on 21-MAR-2012. On the morning of 22-MAR-2012, the patient developed rash after immunization administered. Patient had rash to trunk, bilateral legs and arms. Rash was pruritic. No other symptoms noted. Patient was given BENADRYL to help with itching. No laboratory tests were done. The outcome of the events was unknown. The patient did not seek medical attention. The events were considered to be non serious. The original reporting source was not provided. VAERS ID is 452326. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Back pain, Cardiac monitoring abnormal, Cervix carcinoma, Convulsion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient with no medical history on 26-MAR-2008 was vaccinated with dose 4 GARDASIL onto left arm (dose, route and lot # not reported). The patient had no previous illness. No other co-suspects were reported. No concomitant medications were reported. On 01-APR-2008 the patient experienced Heart palpitations, headaches, back and neck aches, hair loss, weight loss, fainting, convulsions (medically significant), severe fatigue, lesions, dizziness, HPV and cervical cancer (medically significant). MRI-negative spinal tap- negative heart monitors- showed 180 per minute several medications with no help or worse side effects. Outcome was unknown at the time of reporting. The patient made ER visit. No further information is available. The original reporting source was not provided. The VAERS ID # is 453027.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Fatigue, Headache, Lumbar puncture normal, Neck pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient with no medical history on 26-MAR-2008 was vaccinated with dose 4 GARDASIL onto left arm (dose, route and lot # not reported). The patient had no previous illness. No other co-suspects were reported. No concomitant medications were reported. On 01-APR-2008 the patient experienced Heart palpitations, headaches, back and neck aches, hair loss, weight loss, fainting, convulsions (medically significant), severe fatigue, lesions, dizziness, HPV and cervical cancer (medically significant). MRI-negative spinal tap- negative heart monitors- showed 180 per minute several medications with no help or worse side effects. Outcome was unknown at the time of reporting. The patient made ER visit. No further information is available. The original reporting source was not provided. The VAERS ID # is 453027.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Palpitations, Papilloma viral infection, Skin lesion, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient with no medical history on 26-MAR-2008 was vaccinated with dose 4 GARDASIL onto left arm (dose, route and lot # not reported). The patient had no previous illness. No other co-suspects were reported. No concomitant medications were reported. On 01-APR-2008 the patient experienced Heart palpitations, headaches, back and neck aches, hair loss, weight loss, fainting, convulsions (medically significant), severe fatigue, lesions, dizziness, HPV and cervical cancer (medically significant). MRI-negative spinal tap- negative heart monitors- showed 180 per minute several medications with no help or worse side effects. Outcome was unknown at the time of reporting. The patient made ER visit. No further information is available. The original reporting source was not provided. The VAERS ID # is 453027.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Back pain, Cardiac monitoring, Cervix carcinoma, Convulsion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient with no medical history on 26-MAR-2008 was vaccinated with dose 4 GARDASIL onto left arm (dose, route and lot # not reported). The patient had no previous illness. No other co-suspects were reported. No concomitant medications were reported. On 01-APR-2008 the patient experienced Heart palpitations, headaches, back and neck aches, hair loss, weight loss, fainting, convulsions (medically significant), severe fatigue, lesions, dizziness, HPV and cervical cancer (medically significant). MRI-negative spinal tap- negative heart monitors- showed 180 per minute several medications with no help or worse side effects. Outcome was unknown at the time of reporting. The patient made ER visit. No further information is available. The original reporting source was not provided. The VAERS ID # is 453027.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Weight decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient with no medical history on 26-MAR-2008 was vaccinated with dose 4 GARDASIL onto left arm (dose, route and lot # not reported). The patient had no previous illness. No other co-suspects were reported. No concomitant medications were reported. On 01-APR-2008 the patient experienced Heart palpitations, headaches, back and neck aches, hair loss, weight loss, fainting, convulsions (medically significant), severe fatigue, lesions, dizziness, HPV and cervical cancer (medically significant). MRI-negative spinal tap- negative heart monitors- showed 180 per minute several medications with no help or worse side effects. Outcome was unknown at the time of reporting. The patient made ER visit. No further information is available. The original reporting source was not provided. The VAERS ID # is 453027.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Borrelia test, Borrelia test positive, Mononucleosis heterophile test positive, Rash macular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 9 years old female patient with environmental allergy only (pollen) was vaccinated with lot # (671994/1537AA) dose 1 GARDASIL (dose not reported) IM into her left arm on 16-MAR-2012. On 19-MAR-2012 (also reported as 18-MAR-2012) the patient experienced rash macular, 4 days after onset of therapy. It was unclear if it was coincidental or directly related to vaccine and macular rash was evaluated 22-MAR-2012. It was also with (+) Mono, (+) Lyme antibodies, IgG, IgM 23. The patient's sibling had experienced rash when vaccinated with unspecified HPV vaccine. At the time of reporting, the outcome was unknown. ER visit was required. The reporter considered the events as not serious. The original reporting source was not provided. The VAERS ID # is 453812. No further information is available.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antibody test positive, Blood immunoglobulin G, Blood immunoglobulin M normal, Borrelia test positive, Monocyte count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 9 years old female patient with environmental allergy only (pollen) was vaccinated with lot # (671994/1537AA) dose 1 GARDASIL (dose not reported) IM into her left arm on 16-MAR-2012. On 19-MAR-2012 (also reported as 18-MAR-2012) the patient experienced rash macular, 4 days after onset of therapy. It was unclear if it was coincidental or directly related to vaccine and macular rash was evaluated 22-MAR-2012. It was also with (+) Mono, (+) Lyme antibodies, IgG, IgM 23. The patient's sibling had experienced rash when vaccinated with unspecified HPV vaccine. At the time of reporting, the outcome was unknown. ER visit was required. The reporter considered the events as not serious. The original reporting source was not provided. The VAERS ID # is 453812. No further information is available.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash macular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 9 years old female patient with environmental allergy only (pollen) was vaccinated with lot # (671994/1537AA) dose 1 GARDASIL (dose not reported) IM into her left arm on 16-MAR-2012. On 19-MAR-2012 (also reported as 18-MAR-2012) the patient experienced rash macular, 4 days after onset of therapy. It was unclear if it was coincidental or directly related to vaccine and macular rash was evaluated 22-MAR-2012. It was also with (+) Mono, (+) Lyme antibodies, IgG, IgM 23. The patient's sibling had experienced rash when vaccinated with unspecified HPV vaccine. At the time of reporting, the outcome was unknown. ER visit was required. The reporter considered the events as not serious. The original reporting source was not provided. The VAERS ID # is 453812. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old female patient with no medical history and no illness at vaccination was vaccinated with lot # (669795/1317AA) dose 1 GARDASIL IM into her left arm on 11-APR-2012. Concomitant medications included: the first dose of MENACTRA (lot# U4080AA) IM into her left arm on 11-APR-2012. On 11-APR-2012 the patient experienced erythema, edema and warmth at site of injection proximal upper (L) arm. At the time of reporting, the outcome was unknown. ER visit was required. The reporter considered the events as not serious. The original reporting source was not provided. The VAERS ID# is 453876. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Rash macular, Skin warm
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old male patient was vaccinated IM with lot # (669795/1317AA) dose 1 GARDASIL (dose not reported) on 06-APR-2012. Concomitant medications included the first dose of intramuscular ADACEL (lot # C3837BA) and the first dose of intramuscular MENACTRA (lot # U3837AA). On 07-APR-2012 the patient's right arm with redness 41/2 cm in heigh and 4 1/4 cm width. It was non tender and warm to touch. Redness with blotchy spots was noted also. No fever was noted. AUGMENTIN 400/5, 10 ml PO BIX x 10 days and ibuprofen 100/5 2-4 tsp (10-40ml every hour) were given. Primary care nursing (PCN) fever or pain. At the time of reporting, the outcome was unknown. ER visit was required. The reporter considered the events as not serious. The original reporting source was not provided. The VAERS ID# is 453913. No further information is available.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Electroencephalogram abnormal, Grand mal convulsion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 17 years old male patient. The patient's medical history included myringotomy tubes, strabismus surgery, scholastically delayed with some cognitive issues surrounding speech development and no known allergy. The patient was vaccinated IM into the right arm with lot # (672652/0022AE) dose 3 GARDASIL on 05-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On 06-APR-2012 the patient had a tonic clonic seizure. He was hospitalized and found to have an abnormal EEG. He was now on anti-seizure medication. The following information was obtained through follow-up and/or provided by the government on 03-MAY-2012. Hospital records (date of service) 06-APR-2012 - 07-APR-2012. Diagnostics: seizure, first time episode. Concurrent condition: fell; found in tonic position with disconjugate gaze; unresponsive for 10 minutes; confused postictally for 30 minutes. Admitted overnight. Uneventful hospitalization. Discharge in stable condition to follow up with cardiologist and primary care physician. Labs/diagnostics: White blood cell count 4.4 K/mm3 (L), Neutrophil count 44% (L), lymphocyte count 44% (H). Nuclear magnetic resonance imaging brain: unremarkable. Chest X-ray: suggestive of cardiomegaly. Electroencephalogram: abnormal. Electrocardiogram: slightly prolonged QT interval; left ventricular hypertrophy. The events required to ER visit and hospitalization. The original reporting source was not provided. The VAERS ID # is 453967-1. Additional information is not expected.