chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. On 20-JUL-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and the patient was in the office on 08-AUG-2013 (reported as today) to receive the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot # were unknown). On an unknown date the patient developed shingles 2 weeks after receiving a dose of ZOSTAVAX. The outcome of shingles was unknown. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 46 year old male patient. On an unspecified date in June 2013 the patient was vaccinated with the first dose of GARDASIL (lot# unspecified). No adverse symptoms reported. The outcome of the report was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a male patient of unknown age. On 25-JUL-2013 the patient was vaccinated intramuscularly with second dose of GARDASIL (lot number, strength, dose, frequency, indication unspecified). The patient did not receive a full dose. During administration of the vaccine, the needle separated from the syringe hub and the nurse stated "about half the vaccine leaked out". No adverse effects are reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 29-JAN-2013 the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date not reported) intramuscularly into the hip muscle. On 28-FEB-2013 the patient was vaccinated with dose 2, GARDASIL (lot#, expiration date not reported) intramuscularly into the hip muscle. No known adverse events. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Pleural effusion, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 64 year old male patient with celiac disease who experienced an adverse effect 10 days after receiving vaccinated with ZOSTAVAX. On 01-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot # not reported). On 11-JUL-2013, approximately 10 days later, this patient called this physician to be evaluated for fever, shortness of breath and chest pain. This patient was prescribed an unspecified dose of AUGMENTIN for a 10 day course of treatment. The patient called this physician back on 15-JUL-2013 to report that he was not feeling any better. This physician informed the patient to go get an outpatient CAT scan on 15-JUL-2013 which the results showed that the patient had a pleural effusion in his right lung. This physician stated that he planned to drain the pleural effusion from this patient tomorrow (07-AUG-2013) since the course of antibiotics did not clear the pleural effusion and since the patient was still not recovered. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL, MMRV
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a consumer refers to her 5 year old female daughter with no drug reaction and no medical history. On 15-JUL-2013 the patient was vaccinated with a dose of VARIVAX (Merck), one time injection. There was no concomitant medication. On 28-JUL-2013, the patient developed "chickenpox" after receiving the VARIVAX (Merck) vaccine. The lab diagnostics did not perform. No treatment was given for AE. The patient sought medical attention and saw the doctor. The patient present status was recovering. The AE was not reintroduced. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL, MMRV
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a consumer refers to her 5 year old female daughter with no drug reaction and no medical history. On 15-JUL-2013 the patient was vaccinated with a dose of VARIVAX (Merck), one time injection. There was no concomitant medication. On 28-JUL-2013, the patient developed "chickenpox" after receiving the VARIVAX (Merck) vaccine. The lab diagnostics did not perform. No treatment was given for AE. The patient sought medical attention and saw the doctor. The patient present status was recovering. The AE was not reintroduced. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects.
Age: 2.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Unevaluable event
Clinical narrative: No adverse effects.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Hypersensitivity, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: 8" x 8" area of swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: 8" x 8" area of swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: 8" x 8" area of swelling.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Generalised oedema, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient has a 30 x 17cm warm, erythematous area around injection site, (right deltoid).  Patient c/o 7/10 pain to site and c/o difficultly with ROM with RUE, probably due to pain.  Area also has generalized edema.  Patient was given 50mg benedryl IV and 250mg Naproxen PO BID for discomfort and edema.  Will follow up with him daily for next 3 days or PRN.
Age: 44.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Headache, Hyperhidrosis, Mobility decreased, Pain
Clinical narrative: SWELLING, REDNESS, SWEATS, HEADACHE, INABILITY TO MOVE ARM, PAIN.
Age: 44.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Swelling
Clinical narrative: SWELLING, REDNESS, SWEATS, HEADACHE, INABILITY TO MOVE ARM, PAIN.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 56 year old female patient with no drug reactions or allergies. Current condition of the patient included Hepatitis C. The patient had a previous history of shingles. On 02-AUG-2013, the patient was vaccinated with dose of ZOSTAVAX (lot number and expiry date reported as J001694 and 08-MAY-2013 respectively, dose and route unspecified). Concomitant medications included an unspecified pain and anxiety medication. On 05-AUG-2013, the patient developed itchy and painful blisters all over after receiving ZOSTAVAX. Some of the blisters were on the face of the patient. The patient sought medical attention (contacted pharmacist). No treated was provided. No lab tests were performed. The patient was not recovered from the event. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: 7/30/13 received VARIVAX and MMR. Mom called 8/10/13 stating 4 days after vaccines given had fever and vomiting. Total fever x 6 days TM 102-103. DX with by M.D. friend and started Z-max. Rash onset 8/9/13 and spreading. Referred to ER for evaluation.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Incorrect dose administered
Clinical narrative: An 18 year-old male patient had received an intramuscular booster dose of MENACTRA vaccine (lot number: U4594AB and site of administration was not reported) on 21-JUNE-2013. This the patient received an extra dose of MENACTRA. The patient had no known allergies to drugs and had no illness at time of vaccination. Concomitant medications were not reported. On an unspecified date 5 to 6 days after vaccination, the patient experienced headaches. The patient was seen on 01-JULY-2013. Laboratory investigations and corrective treatments were not reported. On 03-JULY-2013, the patient had recovered from event. Documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Incorrect dose administered
Clinical narrative: Initial report received from a healthcare professional on 08 July 2013. An 18-year-old male patient had received an intramuscular booster dose of MENACTRA (batch number: U4597AB, site of administration was not reported) on 02 July 2013. Thus the patient was administered extra dose of MENACTRA. The patient had no illness at the time of vaccination and no known allergy to the drugs. Medical conditions and concomitant medication were not reported. On an unspecified date, 5 to 6 days after vaccination, the patient experienced headache. Laboratory investigations and corrective treatment were not reported. On 08 July 2013, the patient still experienced headaches and had not recovered from the event. Documents held by sender: none.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 18 July 2013. A female patient (age at the time of event was not reported) had received a dose of MENACTRA (Lot number: U4412BA, route and site of vaccination: not reported) and also received GARDASIL (Merck), (Lot number: H020002, route and site of vaccination: not reported) on 10 July 2013. At the time of vaccination the patient had strep throat since 02 July 2013. The patient was allergic to amoxicillin. Concomitant medications cephalexin 500 mg (for 10 days) TID for strep which began on 02 July 2013. On 12 July 2013, 48 hours  after vaccination, the patient experienced vomiting, headache and fever. Laboratory tests and corrective treatment details were not reported. On an unspecified date, the patient had recovered from the events. Documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Dizziness, Hypoaesthesia, Muscular weakness
Clinical narrative: Initial report received from healthcare professional on 22 July 2013 and follow-up information received on 23 July 2013. This case is invalid as individual patient identifiable were not reported. The three patients (gender, date of birth and age at the time of administration was not reported), whose medical history and concomitant medications were not reported, had received a dose of MENACTRA, batch number U4414AA (dose number and route of administration were not reported) having expiry date 18 April 2014 in arm on an unspecified date. It was reported that on an unspecified date, after receiving MENACTRA, the patients experienced numbness, weakness in arm at which vaccine was administered and dizziness which was lasted for either 1 or 1 and half days for each patient. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was recovered. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Ear injury, Fall, Seizure like phenomena, Syncope
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 22 year old male patient. On 16-JUL-2013 the patient was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscularly, lot # not reported. On 06-JUL-2013, the patient experienced syncope, seizure like movements and cut on back of right ear, from falling after vaccination. The patient responded quickly and "sat on floor for 15 minutes". The patient refused medical treatment. The outcome of adverse events was unknown. The relatedness between GARDASIL and adverse events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a unknown number of patients of unknown age and gender. The consumer reported that she had read reports on the internet of various unspecified patients. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot#, dose/frequency, route and duration were unspecified). Subsequently the patients developed shingles (exact dates unspecified). The outcome of shingles was not reported. The relatedness between shingles and the vaccination with ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Convulsion
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a currently 14 years old female patient with no pertinent medical history and no drug reactions/allergies. On an unknown date, when the patient was 11 years old, she was vaccinated with a dose of GARDASIL, intramuscularly, dose and lot # unspecified. (Nurse confirmed this was documented in the patient's chart, but the patient's mother denies the child received the GARDASIL). There were no concomitant medications. On an unknown date, 9 months after vaccination the patient experienced seizures resulting in a two weeks hospital admission to an unspecified hospital. Nurse reported that six months after being discharged from the hospital, patient again experienced seizures (date unknown), resulting in a two day admission to an unspecified hospital. Patient was discharged from the hospital on an unspecified date. The nurse reported that seizures had affected activities of patient's daily living and determined seizures to be disabling. Nurse was unaware of patient's treatment. The outcome of seizures was reported as not recovered/not resolved. The relatedness between GARDASIL and adverse event was unknown. Upon internal review, seizures were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On an unknown date, the patient developed shingles a few years later after receiving ZOSTAVAX. The outcome of shingles was unknown. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Flank pain, Herpes zoster, Muscle twitching
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 62 year old male patient. On 18-JUL-2013 the patient was vaccinated with ZOSTAVAX lot # J001006, subcutaneous. Nurse reported that the patient presented to the pharmacy on 18-JUL-2013 with right sided flank pain as well as the twitching of nerves. Physician related these symptoms to patients recent work on machinery and patient was administered the ZOSTAVAX. Patient reported that as of 22-JUL-2013 or 23-JUL-2013 he had a "mild case of shingles" which was not painful. There was no laboratory studies performed. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. On an unknown date, the unspecified number of patients were vaccinated with RECOMBIVAX HB (lot#, expiry not reported) off schedule. No adverse symptoms reported. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Pain, Rash, Scab
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 73 year old male patient with high blood pressure and dyslipidemia. The patient had no known drug allergies. On 16-FEB-2010 the patient was vaccinated with ZOSTAVAX lot # 665310/1195Y, exp. 21-FEB-2010, 0.65 ml, subcutaneous. Concomitant therapy included LOPRESSOR. On 28-JUL-2013, the patient developed a case of shingles. The patient noted a rash and called his unspecified physician on 30-JUL-2013 to have the rash evaluated. The patient was examined in the physician's office on 31-JUL-2013 and found to have on the right trunk and flank region of his body a bad of skin with 3 to 4 drying lesions. The patient reported that the skin where the lesions were located was sensitive and the patient was experiencing mild pain. No treatment was given. No lab test was done. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 73 year old male patient with high blood pressure and dyslipidemia. The patient had no known drug allergies. On 16-FEB-2010 the patient was vaccinated with ZOSTAVAX lot # 665310/1195Y, exp. 21-FEB-2010, 0.65 ml, subcutaneous. Concomitant therapy included LOPRESSOR. On 28-JUL-2013, the patient developed a case of shingles. The patient noted a rash and called his unspecified physician on 30-JUL-2013 to have the rash evaluated. The patient was examined in the physician's office on 31-JUL-2013 and found to have on the right trunk and flank region of his body a bad of skin with 3 to 4 drying lesions. The patient reported that the skin where the lesions were located was sensitive and the patient was experiencing mild pain. No treatment was given. No lab test was done. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from the healthcare worker refers to a 19 year old female patient. On 28-DEC-1992 the patient was vaccinated with the first dose of RECOMBIVAX HB 2.5 mcg/0.5 ml (dose and route not reported), on 27-JAN-1993 the patient was vaccinated with the second dose of RECOMBIVAX HB 2.5 mcg/0.5 ml (dose and route not reported) and on 27-SEP-1993 the patient was vaccinated with the third dose of RECOMBIVAX HB 2.5 mcg/0.5 ml (dose and route not reported). On 10-JUL-2013, 7500 days after onset of therapy the patient who had RECOMBIVAX HB series had indeterminate titers. The titers were drawn on 10-JUL-2013 and the results were indeterminate. The patient sought medical attention. No treatment was given for the adverse event. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Brain scan abnormal, Neuralgia, Sleep disorder, Temporal arteritis
Clinical narrative: This spontaneous report as received from a 70 year old female patient with allergy to "sulfer" refers to herself. Patient's weight was reported as: 123. On 06-JUN-2012 the patient was vaccinated with ZOSTAVAX (route, dose, lot number and exp. date not reported). Concomitant therapies included FOSAMAX and prednisone. On 25-JUN-2012 the patient experienced facial nerve pain. The pain went from her eyes down to her jaw on both sides. The pain was long term and lasted weeks and around December 2012 the pain moved its way up to the top of her head and forehead. She described it at a tight band across her head. The pain interrupted her sleep. The patient sought medical attention. She was hospitalized and Temporal Arteritis was diagnosed. The outcome of event at the time of report was unknown. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Muscular weakness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 49 years old female patient with codeine allergy, back pain and depression. Pharmacist reported that on 14-MAY-2010 a patient who had a history of ongoing shingles, was vaccinated with one dose of ZOSTAVAX (lot number not provided) 0.65 ml, subcutaneous. Concomitant therapies included MOTRIN and NEURONTIN. Pharmacist stated that a year later, in approximately May 2011, after receiving the ZOSTAVAX vaccination, the patient developed a recurrence of shingle-like symptoms, including blistering and muscle weakness. Pharmacist noted that at the moment of the report, the patient was experiencing more shingle-like symptom episodes that are more frequent and have become more intense. The patient was treated with acyclovir (unspecified). Patient contacted the physician. The outcome of blistering and muscle weakness was reported as recovering/resolving. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old male patient, with no drug reactions/allergies and unspecified chronic pain resulting in a recent unspecified surgery. On 19-JUL-2013 the patient was vaccinated intramuscularly with ZOSTAVAX (lot # J001700, exp. date 08-MAY-2014) (dose unspecified). Concomitant medications were not provided. Pharmacist reported that patient called and presented to the pharmacy because the injection site in which the ZOSTAVAX was administered was warm, swollen and had a knot in it. The patient, reported that the administering pharmacist, administered the ZOSTAVAX intramuscularly rather than subcutaneously on the back portion of the deltoid. It was reported that the pharmacist, "always gives the vaccine that way" if subcutaneous syringes are not available (MARRS case # 1307USA015759). The unspecified pharmacist used a "25 gauge, 1 inch needle". Reporter stated that the patient's arm was still red, warm and swollen. The outcome of injection site warm, knot at the injection site and injection site swollen and red was reported as recovering/resolving. The relationship between the ZOSTAVAX and the events was not reported. No lab diagnostics studies were performed. Additional information has been requested.
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to her 12 month old son with no pertinent medical history and with no drug reactions or allergies. On 24-JUL-2013 the patient was vaccinated with the first dose of VARIVAX (Merck) (Lot# H020671, exp. 14-NOV-2014, dose and route not reported). There was no concomitant medication. On 30-JUL-2013 the patient experienced chicken pox after receiving VARIVAX (Merck). The patient visited office for medical attention. TYLENOL was given for treatment. No lab diagnostics studies were performed. At the time of this report the patient was recovering from chicken pox. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to a 68 year old male patient. The patient had None Pertinent Medical history and drug reactions/allergies. On 22-JUL-2013 the patient was vaccinated with PNEUMOVAX23 (25mcg/0.5ml) lot # J001180, exp. date: 18-AUG-2014, 0.5 ml, intramuscular. The reporter stated that the patient had and extensive list of medications (not specified). On 24-JUL-2013, 3 days after onset of therapy the patient experienced erythema and tenderness surrounding the injection site after receiving PNEUMOVAX23. The patient called the physician on 25-JUL-2013 and informed about adverse events. The patient sought medical attention on 25-JUL-2013 afternoon. The physician marked erythema area surrounding the injection site of PNEUMOVAX23. On 26-JUL-2013 the reported stated that the erythema spread past the mark. No lab test was performed. The doxycycline was prescribed to treat the adverse events. The patient would be seen again by the physician on 29-JUL-2013. The outcome of erythema and tenderness surrounding the injection site after receiving PNEUMOVAX23 was reported as not recovered/not resolved. The relatedness between PNEUMOVAX23 and adverse events was not reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer (a relative of the patient) refers to a 31 year old female patient. The patient had no pertinent medical history and no history of drug reactions/allergies. On 19-JUN-2013 the patient was vaccinated with a dose of M-M-R II and on 01-JUL-2013 the patient was vaccinated with a dose of VARIVAX (Merck) against varicella. Lot number, route, strength and dose were not reported. Concomitant therapies included TOPAMAX. On 20-JUL-2013 the patient discovered that she was pregnant. The patient was reported to be 6 weeks pregnant. LMP calculated from the number of gestational weeks was 14-JUN-2013 with an EDD of 21-MAR-2014. The vaccine exposure during pregnancy occurred in the first trimester of pregnancy. At the time of report the patient had no adverse reactions. It was unknown if there had been any adverse reactions to the fetus as the patient did not have a doctor. The patient did not seek medical attention. Lab diagnostic studies were not performed. The pregnancy outcome was unknown. No contact details for follow-up were provided, so this pregnancy report was lost to f/u. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient with none of pertinent medical history and drug reactions/allergies. On 31-JUL-2013 the patient was vaccinated with ZOSTAVAX, 1 vial, subcutaneous and had a small blood drop presented on the injection site right after ZOSTAVAX vaccination. Concomitant medication included "high blood pressure and cholesterol medication". No sought medical attention. No treatment was given for AE. None lab diagnostics studies performed. On 31-JUL-2013, the outcome of event was recovered. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 54 year old female patient. No medical history was reported. The patient is allergic to erythromycin. On 28-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot# J002777, expiry: 07-JUN-2014), subcutaneously. Concomitant therapies included AMITIZA, lorazepam, lisinopril (manufacturer unknown) and SINGULAIR. On 28-JUL-2013, the patient developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as a large localized injection site reaction red accompanied by a low grade fever (no rash). Patient sought medical attention: contacted office. Patient received treatment with TYLENOL and antihistamine (unspecified). Laboratory diagnostics studies performed were none. The outcome of low grade fever and injection site red was reported as not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Anxiety, Dizziness, Incorrect dose administered, Nausea
Clinical narrative: This spontaneous report as received from a consumer's mother refers to a currently 16 years old female patient. At age of eleven the patient was vaccinated with the complete series of GARDASIL dose unknown, intramuscularly. At age of fourteen the patient was vaccinated second time with the complete series of GARDASIL dose unknown, intramuscularly. On an unknown date, after second series of vaccination at age 14, the patient experienced dizzy and nauseas. She had stomach pains and anxiety. The outcome of adverse events was unknown. The relatedness between GARDASIL and adverse events was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report as received from a 60 year old female Nurse Practitioner referring to herself. Medical history included "lipids" and many drug unspecified allergies. On 23-JUL-2013, in the morning, the patient was administered ZOSTAVAX, subcutaneous. Concomitant therapies included PRAVACHOL. On 23-JUL-2013, not long afterward the injection, the patient had injection site itchy, inflamed, and had a red rash. By the evening, the area was indurated and it was so painful, that she had trouble sleeping. The patient did not seek medical attention. No laboratories were performed. There was given a cold pack on the area, as treatment for the events. On 24-JUL-2013, the next day, the area was less painful and less inflamed, but the induration was 3 inches by 4 inches. The outcome of injection site was itchy, she had trouble sleeping, by the evening the area was indurated/induration was 3 inches by 4 inches and injection site had a red rash was not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Rash erythematous
Clinical narrative: This spontaneous report as received from a 60 year old female Nurse Practitioner referring to herself. Medical history included "lipids" and many drug unspecified allergies. On 23-JUL-2013, in the morning, the patient was administered ZOSTAVAX, subcutaneous. Concomitant therapies included PRAVACHOL. On 23-JUL-2013, not long afterward the injection, the patient had injection site itchy, inflamed, and had a red rash. By the evening, the area was indurated and it was so painful, that she had trouble sleeping. The patient did not seek medical attention. No laboratories were performed. There was given a cold pack on the area, as treatment for the events. On 24-JUL-2013, the next day, the area was less painful and less inflamed, but the induration was 3 inches by 4 inches. The outcome of injection site was itchy, she had trouble sleeping, by the evening the area was indurated/induration was 3 inches by 4 inches and injection site had a red rash was not recovered/not resolved. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 33 year old male patient. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, a blood work was performed and rubella came back with negative titer results. The patient was able to provide documentation regarding health history showing that he received all necessary doses of M-M-R II on unspecified dates. No treatment was provided. Outcome of the event was unknown. The relatedness for the event was unknown for M-M-R II. Additional information has been requested.
Age: 0.14
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Blood test, Faeces discoloured, Haematochezia, Intussusception, Miliaria
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 month old male patient with no pertinent medical history and no drug reactions or allergies who on 19-JUL-2013 was vaccinated with the first dose of ROTATEQ (lot number reported as H017667, Exp. Date: 12-APR-2014). No concomitant medications were reported. The health care professional reported that on 29-JUL-2013, the patient developed a rash and intussusception after receiving vaccination with ROTATEQ. The health care professional reported that the patient was seen on the office on 29-JUL-2013, with a rash that was described as a "heat rash" and mentioned that the patient's family contact the office on 03-AUG-2013 because the patient was having orange colored stools. The patient was seen in the office on 05-AUG-2013 for red blood in his stools and mentioned that the patient had been vomiting. On 06-AUG-2013, the patient was admitted to the hospital and he was scheduled for surgery for intussusception. A blood work was performed but results were not provided. At the time of the report, the patient had not recovered. Intussusception and heat rash were considered to be disabling, immediately life threatening and medically significant by the certified medical assistant. The relatedness for intussusception and heat rash and ROTATEQ was unknown. Additional information has been requested.
Age: 0.14
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 month old male patient with no pertinent medical history and no drug reactions or allergies who on 19-JUL-2013 was vaccinated with the first dose of ROTATEQ (lot number reported as H017667, Exp. Date: 12-APR-2014). No concomitant medications were reported. The health care professional reported that on 29-JUL-2013, the patient developed a rash and intussusception after receiving vaccination with ROTATEQ. The health care professional reported that the patient was seen on the office on 29-JUL-2013, with a rash that was described as a "heat rash" and mentioned that the patient's family contact the office on 03-AUG-2013 because the patient was having orange colored stools. The patient was seen in the office on 05-AUG-2013 for red blood in his stools and mentioned that the patient had been vomiting. On 06-AUG-2013, the patient was admitted to the hospital and he was scheduled for surgery for intussusception. A blood work was performed but results were not provided. At the time of the report, the patient had not recovered. Intussusception and heat rash were considered to be disabling, immediately life threatening and medically significant by the certified medical assistant. The relatedness for intussusception and heat rash and ROTATEQ was unknown. Additional information has been requested.
Age: 0.14
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Blood test, Faeces discoloured, Haematochezia, Heat rash, Intussusception
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 month old male patient with no pertinent medical history and no drug reactions or allergies who on 19-JUL-2013 was vaccinated with the first dose of ROTATEQ (lot number reported as H017667, Exp. Date: 12-APR-2014). No concomitant medications were reported. The health care professional reported that on 29-JUL-2013, the patient developed a rash and intussusception after receiving vaccination with ROTATEQ. The health care professional reported that the patient was seen on the office on 29-JUL-2013, with a rash that was described as a "heat rash" and mentioned that the patient's family contact the office on 03-AUG-2013 because the patient was having orange colored stools. The patient was seen in the office on 05-AUG-2013 for red blood in his stools and mentioned that the patient had been vomiting. On 06-AUG-2013, the patient was admitted to the hospital and he was scheduled for surgery for intussusception. A blood work was performed but results were not provided. At the time of the report, the patient had not recovered. Intussusception and heat rash were considered to be disabling, immediately life threatening and medically significant by the certified medical assistant. The relatedness for intussusception and heat rash and ROTATEQ was unknown. Additional information has been requested.
Age: 0.14
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Blood test, Faeces discoloured, Haematochezia, Intussusception, Miliaria
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 month old male patient with no pertinent medical history and no drug reactions or allergies who on 19-JUL-2013, was vaccinated with the first dose of ROTATEQ (lot number reported as H017667, Exp. Date: 12-APR-2014). No concomitant medications were reported. The health care professional reported that on 29-JUL-2013, the patient developed a rash and intussusception after receiving vaccination with ROTATEQ. The health care professional reported that the patient was seen on the office on 29-JUL-2013, with a rash that was described as a heat rash and mentioned that the patient's family contacted the office on 03-AUG-2013 because the patient was having orange colored stools. The patient was seen in the office on 05-AUG-2013 for red blood in his stools and mentioned that the patient had been vomiting. On 06-AUG-2013, the patient was admitted to the hospital and he was scheduled for surgery for intussusception. A blood work was performed but results were not provided. At the time of the report, the patient had not recovered. Intussusception and heat rash were considered to be disabling, immediately life threatening and medically significant by the certified medical assistant. The relatedness for intussusception and heat rash and ROTATEQ was unknown. Additional information has been requested.
Age: 0.14
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 month old male patient with no pertinent medical history and no drug reactions or allergies who on 19-JUL-2013, was vaccinated with the first dose of ROTATEQ (lot number reported as H017667, Exp. Date: 12-APR-2014). No concomitant medications were reported. The health care professional reported that on 29-JUL-2013, the patient developed a rash and intussusception after receiving vaccination with ROTATEQ. The health care professional reported that the patient was seen on the office on 29-JUL-2013, with a rash that was described as a heat rash and mentioned that the patient's family contacted the office on 03-AUG-2013 because the patient was having orange colored stools. The patient was seen in the office on 05-AUG-2013 for red blood in his stools and mentioned that the patient had been vomiting. On 06-AUG-2013, the patient was admitted to the hospital and he was scheduled for surgery for intussusception. A blood work was performed but results were not provided. At the time of the report, the patient had not recovered. Intussusception and heat rash were considered to be disabling, immediately life threatening and medically significant by the certified medical assistant. The relatedness for intussusception and heat rash and ROTATEQ was unknown. Additional information has been requested.
Age: 0.14
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Blood test, Faeces discoloured, Haematochezia, Heat rash, Intussusception
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 month old male patient with no pertinent medical history and no drug reactions or allergies who on 19-JUL-2013, was vaccinated with the first dose of ROTATEQ (lot number reported as H017667, Exp. Date: 12-APR-2014). No concomitant medications were reported. The health care professional reported that on 29-JUL-2013, the patient developed a rash and intussusception after receiving vaccination with ROTATEQ. The health care professional reported that the patient was seen on the office on 29-JUL-2013, with a rash that was described as a heat rash and mentioned that the patient's family contacted the office on 03-AUG-2013 because the patient was having orange colored stools. The patient was seen in the office on 05-AUG-2013 for red blood in his stools and mentioned that the patient had been vomiting. On 06-AUG-2013, the patient was admitted to the hospital and he was scheduled for surgery for intussusception. A blood work was performed but results were not provided. At the time of the report, the patient had not recovered. Intussusception and heat rash were considered to be disabling, immediately life threatening and medically significant by the certified medical assistant. The relatedness for intussusception and heat rash and ROTATEQ was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis contact, Erythema
Clinical narrative: This spontaneous report as received from health worker refers to a 19 year old female patient with none of pertinent medical history and none of drug reactions/allergies. On an unknown date of June 2013 the patient was vaccinated with the first dose of GARDASIL injection (strength, dose, frequency and lot # were not provided). None concomitant medication. On 04-AUG-2013 the patient experienced "poison ivy" and was red all over her body. The patient went to physician's office. No treatment was given for AE. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Accident, Dizziness, Echocardiogram normal, Electrocardiogram normal, Loss of consciousness
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 81 year old female patient with no drug reactions/allergies. Current conditions included high blood pressure. On 09-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date not reported), subcutaneously. On 16-JUL-2013 (one week after patient received ZOSTAVAX), the patient experienced dizziness and "passed out", resulting in a minor accident. It was unspecified if patient was taken to a hospital. Pharmacist reported that patients doctor ruled out cardiovascular and neurological events such as stroke and "TIA's" by the completing of an echocardiogram (ECHO) and electrocardiogram (ECG). Pharmacist noted that patient had a recent change in her blood pressure medication but did not know specifics. The patient recovered on an unspecified date in 2013. The patient sought medical attention. Treatment information was unspecified. Causality was not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPVX
Symptoms: Headache
Clinical narrative: Significant headache for 7-10 days after receiving HPV #1.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Eye pain, Headache, Hypoaesthesia oral, Pain in jaw
Clinical narrative: 1/16 AM numb tingling tongue. Radiating pain jawline. 1/16 (evening after 9 PM) extreme pain right ear. Some jaw pain. 1/17 2:00 AM extreme pain in back of head right eye and forehead awakened. 7:00 AM onset paralysis.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Paralysis, VIIth nerve paralysis
Clinical narrative: 1/16 AM numb tingling tongue. Radiating pain jawline. 1/16 (evening after 9 PM) extreme pain right ear. Some jaw pain. 1/17 2:00 AM extreme pain in back of head right eye and forehead awakened. 7:00 AM onset paralysis.
Age: 20.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter concerning a 20 year old patient of unknown gender. On an unknown date in June 2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On an unknown date in November 2011, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, and dose unspecified), intramuscularly. The third dose was never administered. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a consumer concerning her approximately 17 year old daughter. On an unknown date in June 2012, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and was told by her doctor that it was ok for the second dose to be given this August 2013 and to return 4 months after second dose for the final (third) dose. No concomitant therapy was reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from an approximately 65 year old male physician (patient) regarding himself. There was no pertinent medical history. Concurrent condition of the patient included allergy to inhalants - not drug related. On an unknown date in the summer of 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included AVODART, HYTRIN and aspirin (reported as baby aspirin). Approximately on an unknown date in June 2013 (reported as 2 months ago), the patient developed shingles. The patient sought medical attention. He was treated with VALTREX. No lab tests were performed. The patient recovered by 30-JUN-2013 (also reported as the exact date of recovery was unknown). The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Bursitis, Injection site pain, Pain
Clinical narrative: Right shoulder where vaccine was administered, was very sore, to touch and to movement, this soreness is still there today sometime worse then other. Saw dr, my physician, he said it was bursitis and gave me some range of motion exercises to do and warned that it would probably get worse before it got better, this was 07-18-2013. No other treatment has been sought.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, vomiting after 3rd dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: Pt. developed large inflamed, red area around injection site approx. 4" in diameter - "cellulitis" - which required pt. to seek medical attention and go through a course of Azithromycin 250 mg. Condition resolved after tx.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: 8/10/13 developed vomiting, chills, body and head aches, fever 102.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Ataxia, Body temperature increased, Gait disturbance
Clinical narrative: Received MMR and varicella vaccine at time of 1 year old check up. 2 days later developed 101 degree F temp for 24 hours, then unsteady gait suggested of acute mild ataxia.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: Tender thigh muscles, fever, Rhinorrhea x 1 Day. Swollen quadriceps with erythema at injection site (right leg). Orders MOTRIN/TYLENOL as needed. Thinking pertussis reaction.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site erythema
Clinical narrative: Reddened area where vaccine was administered. Patient on way to see PCP.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site swelling
Clinical narrative: 07/30/13 pt received the Menactra and the HPV (# 1 for him) in left deltoid. Since then the area has become increasingly swollen and edematous; erythema noted. Pt. states no pain, but a lot of itching in area.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Insomnia, Pain in extremity, Paraesthesia, Swelling
Clinical narrative: C/O pain and tingling down left arm to fingertips day after injection. Had difficulty sleeping the night after the injection. Felt better by 8/4/13. Feels very little residual effects 8/5/13. Had slight swelling for 1 day. No treatment needed per Dr.