chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a physician via a sales representative refers to a currently 15 year old male patient. The patient's current conditions were not reported. Pertinent medical history was none. On an unknown date, the patient was vaccinated with first dose and second dose of GARDASIL injection 120 Y (unknown and dose) intramuscularly at a standard dose. Concomitant therapies included VARIVAX (Merck), MENACTRA and unspecified hepatitis A vaccine. No adverse effects were reported for the first dose. On an unknown date, after receiving the second dose of GARDASIL, the patient experienced swelling and pain in the upper region of his right arm which had begun to extend down his elbow. No treatment was received in response to the events. The outcome of the events was reported as recovered. Causality assessment was not provided. There was no product quality complaint (PQC) involved and no PQC was filed. Additional information is not expected as the reporter denied contact.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Measles, Pyrexia, Respiratory tract congestion
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 18 month old male patient. The patient's pertinent medical history was unspecified and was allergic to egg. On an unknown date, the patient was vaccinated with MMR II subcutaneously for prevention of measles, mumps and rubella. Concomitant medications were unspecified. On an unknown date, the patient developed measles-like symptoms, a high fever of 103 degrees and congestion. The patient sought medical attention and treatment provided was unspecified. The outcome of the events was reported as recovered/resolved on an unspecified date. No product quality complaint (PQC) was reported for MMR II. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 18-MAY-2015, the patient was vaccinated with oral, ROTATEQ which had been improperly stored (oral, lot # reported as: K020183, expiry date: 25-JUN-2016, dosage not provided). The product had not been supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 18-MAY-2015, the patient was vaccinated with ROTATEQ which had been improperly stored (oral, lot # reported as: K020183, expiry date: 25-JUN-2016, dosage not provided). The product had not been supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 18-MAY-2015, the patient was vaccinated with ROTATEQ which had been improperly stored (oral, lot # K016314, expiry date: 05-JUN-2016, dosage not provided). The product had not been supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 08-MAY-2015, the patient was administered with a dose of improperly stored ZOSTAVAX, lot # L002422, expiration date 23-APR-2016 (dose not provided), subcutaneous. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A.)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 12-MAY-2015, the patient was administered with a dose of improperly stored ZOSTAVAX, lot# L002422, expiration date 23-APR-2016 (dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning an unknown number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On unknown dates over the past year, the patients were administered with improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 26-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 10-FEB-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 05-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2007 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 08-SEP-2014, the patient was vaccinated with a dose of GARDASIL and with another dose on 25-MAR-2015. Dosage, lot numbers, route of administration were not reported. No adverse symptoms were reported. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: Extreme fatigue, slight fever, severe headache, joint aches.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Migraine, Myalgia, Vision blurred
Clinical narrative: Migraine headaches, muscle aches, chills began 24 to 48 hours after immunization. Blurred vision alternating between left and right eye onset 5/31/2015 to present date.
Age: 49.0
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia
Clinical narrative: Joint pain in neck, took prescription pain killers, did not work. Will probably return to center, if pain still exists.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Anxiety, Increased upper airway secretion, Throat tightness
Clinical narrative: Patient was anxious receiving vaccine.  About 15 minutes after she stated she felt like she had mucus and needed to clear her throat or something was blocking her throat.  She was not experiencing any other signs of anaphylaxis, so a 50 mg dose of Benadryl was given.  She remained in the pharmacy for about 10 more minutes (total time about 25-30 minutes) and went home since no other symptoms were experienced. Patient felt like maybe she just made herself paranoid.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture negative, Full blood count normal, Injection site abscess, Ultrasound scan
Clinical narrative: Child received 2 mo vaccines (PEDIARIX, Hib, PCV, Rota) without reaction. Rec'd 4 mth vaccines (as above), 12/5/14 developed abscess in bl thighs-1/23/15, culture negative, then rec'd PEDIARIX at center on 3/18/15 -> abscess. Culture negative. TX cephalexin.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Dizziness, Syncope, Tinnitus, Visual impairment
Clinical narrative: Pt received vaccine, and after a few minutes, he said he started feeling dizzy, lightheaded, chills, ringing in the ear, and vision changes. He was taken to the vaccine room where he fainted. He regained consciousness within a few seconds. He felt better after a few minutes, firemen came and evaluated him. They did not find anything wrong with him. His blood pressure was also checked.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Complex regional pain syndrome, Erythema, Fall
Clinical narrative: This spontaneous report as received from a health care worker refers to a 60 year old female patient with intervertebral disc disorder and unspecified drug reactions/allergies to OXYCONTIN, morphine and COMPAZINE. On 11-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneous (lot # K014834, expiration date 14-DEC-2015). There was not concomitant therapy reported. On an unknown date after ZOSTAVAX administration, the patient developed bilateral weakness of her upper extremities, bilateral hand tremors, swelling and redness in her upper chest and was diagnosed with reflex sympathetic dystrophy. On 20-DEC-2014, the patient had scheduled a back surgery for intervertebral disc disorder and was discharged from hospital on 21-DEC-2014. On 14-MAY-2015, the patient fell down and injured her knee, she had swelling and arthralgia reported as "she had an unresolved knee pain and swelling after the fall." On an unknown date, blood work laboratory test was performed but not result was provided. It was also reported that the patient sought medical attention, she visited the office. The patient received treatment with prednisone (manufacturer unknown) and with TYLENOL for the adverse events. The outcome of complex regional pain syndrome, intervertebral disc disorder, arthralgia, fall, joint swelling and joint injury was reported as not recovered/not resolved. Action taken with ZOSTAVAX was not applicable. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint injury, Joint swelling, Muscular weakness, Swelling, Tremor
Clinical narrative: This spontaneous report as received from a health care worker refers to a 60 year old female patient with intervertebral disc disorder and unspecified drug reactions/allergies to OXYCONTIN, morphine and COMPAZINE. On 11-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneous (lot # K014834, expiration date 14-DEC-2015). There was not concomitant therapy reported. On an unknown date after ZOSTAVAX administration, the patient developed bilateral weakness of her upper extremities, bilateral hand tremors, swelling and redness in her upper chest and was diagnosed with reflex sympathetic dystrophy. On 20-DEC-2014, the patient had scheduled a back surgery for intervertebral disc disorder and was discharged from hospital on 21-DEC-2014. On 14-MAY-2015, the patient fell down and injured her knee, she had swelling and arthralgia reported as "she had an unresolved knee pain and swelling after the fall." On an unknown date, blood work laboratory test was performed but not result was provided. It was also reported that the patient sought medical attention, she visited the office. The patient received treatment with prednisone (manufacturer unknown) and with TYLENOL for the adverse events. The outcome of complex regional pain syndrome, intervertebral disc disorder, arthralgia, fall, joint swelling and joint injury was reported as not recovered/not resolved. Action taken with ZOSTAVAX was not applicable. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Incontinence, Seizure like phenomena, Syncope
Clinical narrative: GARDASIL vaccine administered in (L) deltoid. Patient had syncope episode with seizure like activity and loss of urine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Swelling, Vomiting
Clinical narrative: Swollen arm, vomiting.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site rash
Clinical narrative: Rash on both thighs starting 1 day after immunization and still present on day 4.
Age: 1.1
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: DTaP #4 given at 13 mo of age does not count.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Fainting, vomiting.
Age: 31.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt. received a TYPHIM (typhoid) vaccine on 5/18/15. She developed hives on both arms and legs the next day, very itchy. The hives resolved in about 3 days on their own.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Activities of daily living impaired, Arthralgia, Joint instability, Malaise
Clinical narrative: My daughter took the GARDASIL shot in August 2012. She got sick with a virus which set off a reaction to the shot. She got very sick in December 2012 and my daughter had pain in all her joints and could not move. She has been sick for 2 and a half years. She can't walk and has recently had another relapse that has left her neck unstable. She has been in 4 hospitals.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Viral infection
Clinical narrative: My daughter took the GARDASIL shot in August 2012. She got sick with a virus which set off a reaction to the shot. She got very sick in December 2012 and my daughter had pain in all her joints and could not move. She has been sick for 2 and a half years. She can't walk and has recently had another relapse that has left her neck unstable. She has been in 4 hospitals.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Cough, Laboratory test normal, Musculoskeletal stiffness
Clinical narrative: On 5/22/2015 I had my yearly physical and checkup with my primary care MD. For a 75 year old I am very healthy, and was that day also, with complete physical exam all normal for heart and lungs. Before leaving I accepted the PCV13 vaccine, PREVNAR. I returned home about 10 AM, feeling fine. That evening my arm felt stiff but nothing bothersome. I went to bed, slept well, woke up next day at 7AM with a slight cough. Later in the day my cough became strong, hacking and productive. For the following 3 days I became much worse, fever, chills and extremely weak. The cough became uncontrollable, very deep, and weakened me even more, to the point that I couldn't get out of bed. On 5/28 I finally had to get to the doctor. I was examined and she told me I had pneumonia. I have been and am finishing up my prescription of antibiotics today and feel much better, but still have a productive cough, very hard at times. My doctor tried to tell me the vaccine can't cause this but I know better. I had no signs whatsoever of an upcoming sickness the day I got the vaccine, and hadn't been exposed to anyone sick. Doctors need to have this information to give to patients before the patient accepts this vaccine. I have always trusted my doctor but am not sure now if I will get any more vaccines. I think I have gotten all of them needed up to today with no previous side effects. I am not one of those people who oppose vaccines.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Productive cough, Pyrexia, White blood cell count
Clinical narrative: On 5/22/2015 I had my yearly physical and checkup with my primary care MD. For a 75 year old I am very healthy, and was that day also, with complete physical exam all normal for heart and lungs. Before leaving I accepted the PCV13 vaccine, PREVNAR. I returned home about 10 AM, feeling fine. That evening my arm felt stiff but nothing bothersome. I went to bed, slept well, woke up next day at 7AM with a slight cough. Later in the day my cough became strong, hacking and productive. For the following 3 days I became much worse, fever, chills and extremely weak. The cough became uncontrollable, very deep, and weakened me even more, to the point that I couldn't get out of bed. On 5/28 I finally had to get to the doctor. I was examined and she told me I had pneumonia. I have been and am finishing up my prescription of antibiotics today and feel much better, but still have a productive cough, very hard at times. My doctor tried to tell me the vaccine can't cause this but I know better. I had no signs whatsoever of an upcoming sickness the day I got the vaccine, and hadn't been exposed to anyone sick. Doctors need to have this information to give to patients before the patient accepts this vaccine. I have always trusted my doctor but am not sure now if I will get any more vaccines. I think I have gotten all of them needed up to today with no previous side effects. I am not one of those people who oppose vaccines.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 24-FEB-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. On 15-MAY-2015, the patient was vaccinated with expired dose of ZOSTAVAX vial of strength 19400 plaque-forming units (PFU) given in unspecified route (lot # K000326 which is valid and expiry date: 27-FEB-2015). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of expired product administered was unknown. The reporter considered expired vaccine administered to be not related to ZOSTAVAX. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 03-FEB-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several report received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 26-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided)), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 28-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 19-FEB-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This is one of several reports received form the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 08-MAY-2015, the patient was administered with a dose of improperly stored ZOSTAVAX, lot# L002422, expiration date 23-APR-2016 (dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 20-FEB-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 06-FEB-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 25-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot #K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A.)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 15-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 23-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 18-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 11-FEB-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 13-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical assistant (C.MA)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 13-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical assistant (C.MA)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 19-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 12-MAY-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. No concurrent or historical conditions were reported. The reporter stated that the patient was inadvertently vaccinated with the third dose of GARDASIL (dose, frequency, route, lot # and expiration date were not reported) only 11 weeks after the second dose on unspecified dates. Concomitant therapies were not reported. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer of unknown age and refers to himself. No medical history was reported. The patient stated that he was not sure if he ever received ZOSTAVAX. In May 2015 (reported as 'over the weekend"), the patient visited a urgent care clinic and was told that he had shingles. Since there was a possibility patient might have received ZOSTAVAX (lot number, dose, frequency and route of administration not reported) on unspecified previoous date. No concomitant medications were reported. The patient sought for the medical attention and visited the clinic on unspecified date. The outocme of herpes zoster was unknown. The causality was not reported. The patient did not want to give further information. No product quality complaint (PQC) was filed. Additional information has been requesteed.
Sex: F
Vaccine: RV5
Symptoms: Ear infection
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age (one of twins). No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with ROTATEQ (lot#, expiration date and dose unspecified), orally. No concomitant medication was reported. She sought medical attention at the office of nurse for a routine exam on 29-MAY-2015 and was diagnosed with an ear infection. No lab diagnostics studies were performed. The outcome of event was reported as not resolved. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 11-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 31.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis A antibody positive, Hepatitis B antibody negative, Vaccination failure
Clinical narrative: Pt got TWINRIX. Developed aby to HAV only but not HBV after proper dosing. Has happened to other patients. Is HBV vaccine part not effective?
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Swelling
Clinical narrative: Had swelling to his left upper arm which was much greater several days ago. Today has slight swelling and slightly red area 09/14/2010.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV, FLU3
Symptoms: Drooling, Headache, Hypoaesthesia
Clinical narrative: 11/04/2009 contacted clinic complaining pain in the back of head, numbness of face and drooling.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Headache, Pain
Clinical narrative: Has received influenza inj 13 other times at medical center without any noted problems. Headache and sore ribs, sharp pain from left flank to left axillary and left breast, dull achy pains still ogoing 2 months after inj.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Axillary pain, Breast pain, Flank pain, Headache, Musculoskeletal chest pain
Clinical narrative: Has received influenza inj 13 other times at medical center without any noted problems. Headache and sore ribs, sharp pain from left flank to left axillary and left breast, dull achy pains still ogoing 2 months after inj.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 11-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a medical assistant via a Company Representative refers to a female patient over the age of 65 years old. There were no concurrent condition and medical history reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX "1 dose, 1 time", subcutaneously (lot number and expiration date were not reported). No concomitant medication was reported. On an unknown date, the patient developed shingles and a rash. The patient sought medical attention via an office visit. The outcome of shingles and rash was reported as not recovered/not resolved. The patient received the treatment, an unspecified pain medication. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a Registered Medical Assistant (R.M.A.) referring to a 20 year old patient of unknown gender. No concurrent conditions or medical history were reported. On 11-MAY-2015, the patient accidentally was vaccinated with a pediatric dose of VAQTA, 0.5 ml, intramuscular, instead of an adult dose. No concomitant therapy was provided. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with M-M-R II via intradermal route, instead of via the subcutaneous route (dose, lot # and albumin status not provided). Moreover the patient was seeking appointment with the physician to rule out cellulitis due to redness at the injection site (dates not provided). The outcome of the events was unknown. Relatedness between the events and suspect product was not specified. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from the company representative who was reported by the physician and refers to a male patient of unknown age. No demographics were provided for the patient. No medical history and concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (lot number, dose, frequency, route and site of administration not reported). No concomitant medications were reported. On an unknown date, the patient experienced shingles after receiving ZOSTAVAX which was treated with VALTREX (unspecified dose, frequency and manufacturer). The patient sought for the medical attention and visited the office on an unspecified date. The outcome of shingles was unknown. The reported events were not considered as hospitalisation, cancer, life-threatening, disability or overdose. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 10-FEB-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route, lot number and expiration date were not provided). No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Ear infection
Clinical narrative: Information has been received from a nurse referring to a male patient of unknown age (one of twins). No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with ROTATEQ (lot#, expiration date and dose unspecified), orally. No concomitant medication was reported. He sought medical attention at the office of nurse for a routine exam on 29-MAY-2015 and was diagnosed with an ear infection. No lab diagnostics studies were performed. The outcome of the event was reported as not resolved. This is one of several reports received from the same source. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Vaccination site pruritus, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Patient was seen by provider and told to take NSAIDs and BENADRYL OTC. Urticaria pruritus and red, hot area where vaccine was given.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a non medical healthcare worker refers to three unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concurrent conditions and concomitant medications was reported. On an unknown date in March 2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck), lot # K009759, expiration date: 09-JUL-2016, (dose, route of administration and injection site were not reported). No adverse events were reported. Follow up information has been received on 25-MAY-2015 from the reporting non medical healthcare worker. The reporter provided patient identifiers. It was stated that the patient was vaccinated with improperly stored VARIVAX (Merck) on 31-MAR-2015. This is one of several reports received from the same reporter. Additional information has been requested. Patient details, suspect therapy details, event details and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a non medical healthcare worker refers to three unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concurrent conditions and concomitant medications was reported. On an unknown date in March 2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck), lot # K009759, expiration date: 09-JUL-2016, (dose, route and injection site were not reported). No adverse events were reported. Follow up information has been received on 25-MAY-2015 from the reporting non medical healthcare worker. The reporter provided patient identifiers. It was stated that the patient was vaccinated with improperly stored VARIVAX (Merck) on 14-APR-2015 (previously reported as in March 2015). This is one of several reports received from the same reporter. Additional information has been requested. Patient details, suspect therapy details, event details and narrative were updated.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria, pruritus. Ibuprofen 800 mg TID, hydroxyzine 25 mg TID.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from the consumer refers to a female patient of unknown age with hypertension. The patient's medical history included anxiety. Sometime in 2013, the patient was vaccinated with ZOSTAVAX vial, 0.65 milliliter (ml) of single dose subcutaneous (lot number was not reported). On 28-APR-2015, the patient was presented with symptoms of pain in the head, pain behind her ear and up the right of her head along with reddish colored rash. The patient went to see the physician assistant where she was diagnosed as shingles on unspecified date in 2015. The patient also reported that the shingles were also very close to her eyes she was referred to an unspecified physician for follow up on unspecified date. The patient sought for the medical attention and visited the physician and was not hospitalized. The outcome of herpes zoster was reported as not recovered/not resolved. The causality was not reported. No additional adverse event information was provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Musculoskeletal stiffness, Pain, Pyrexia, Vaccination complication
Clinical narrative: Patient had reaction from TDAP - H/A, stiff neck, body aches all over, fever of 100.5 lasted 6-8 hours.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema, Chest discomfort, Dyspnoea
Clinical narrative: Angioedema and chest tightness and shortness of breathe.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 19-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 11-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash, Swelling
Clinical narrative: Headache, rash and swelling.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: Per documented telephone call received on 6/25/13: I think I had a reaction to the tetanus shot you gave me. That night I felt lousy. Yesterday I had nausea, a fever and my joints hurt.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 13-MAY-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Tenderness
Clinical narrative: Redness and swelling to left bicep area. Pt received a PNEUMOVAX injection on 1/16/13, pt stated tenderness and pain that evening. Bag ice in cloth ML every day.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event, Product label confusion
Clinical narrative: This spontaneous report as received from a Practice Manager (Health professional) refers to a patient of unknown age and gender. medical history and concurrent conditions were not provided. ON 08-MAY-2015, the patient received an expired dose of PNEUMOVAX23 0.5ml, lot # J008799, expiry date: 16-APR-2015 (dose and route were not reported). There was confusion reading the expiration date on the vial (product label confusion). "The vaccine was believed to had an expiration of 15-APR-2016 prior to administration. It was not until the Medical Assistance (MA) was charting that they realized the expiration date was 16-APR-2015". No adverse effect was reported. There was no concomitant medication provided. The reporter also stated that, she will contact her sales representative to request replacement for 7 unused vials with the confusing expiration date that they placed in the sharp container. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Joint swelling, Rash
Clinical narrative: Diffuse joint pain with some swelling, rash.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 04-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.