chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary tract infection
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016552021) on 13-Dec-2016. This case involves a female patient (onset age not reported) who was vaccinated with a dose of Influenza high dose seasonal (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 31-Oct-2011. Patient's medical history included back surgery in 2010, joint replacement of left rotator cuff in 2005, hysterectomy complete/total in 1980 and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination the patient experienced atrial fibrillation, Malignant hypertensive chronic kidney disease renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled, neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg, excluding foot, osteoarthritis of knee, gastroesophageal reflux disease, chest pain, dyspnea, allergic rhinitis due to pollen, nausea, bacterial infection disease, chronic bronchitis, diarrhea, dyslipidemia, shoulder joint pain, low back pain and headache. Patient received influenza, seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 09 November 2015, influenza seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 05 October 2012. Laboratory investigations and corrective treatment were not reported. The outcome of the events was not reported. The reporter had considered the case serious for the important medical event for: atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled with symptoms of neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg. List of documents held by sender: none. Sender's Comments: Patient with history of multiple surgeries and was on multiple medication received INFLUENZA HIGH DOSE SEASONAL (manufacturer unknown) and experienced atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, Type 2 diabetes mellitus uncontrolled, Organic sleep apnea, Status asthmaticus, Urinary tract infection, Cellulitis of leg, excluding foot and multiple events. Time of onset was unknown. This is poorly documented case. More details regarding concurrent condition, concomitant medication, exact time to onset, investigation reports to rule out the alternative cause are needed for complete assessment of the case. Based on the available information, no conclusion can be drawn.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Erythema, Hypersensitivity, Incorrect dose administered, Influenza
Clinical narrative: Initial unsolicited misuse report received from a consumer (patient) via other company (Pfizer) (Manufacturer Report Number: 2016549962) on 13-Dec-2016. This case involves as 76-year-old patient (gender not specified) who was vaccinated with a double dose of INFLUENZA VACCINE (Batch number, expiry date dose form frequency route and site of administration not reported) on an unspecified date few weeks ago. Relevant medical history included allergies. Concomitant medications were not reported. On 22-Nov-2016, within four days of vaccination, the patient was down and out, was sick for two weeks had flu with fever, vomiting and coughing, cheeks were bright red. On an unspecified date, following vaccination, the patient had sinus congestion and pain, had allergy, cheecks were bright red. The patient reported of 'sinuses blew up' and being in terrible pain. It was a case 'extra dose of flu vaccine as patient received double dose. It was also a case of extra dose administered. Relevant laboratory investigations were not reported. It was reported that patient had unspecified labortory tests two weeks back. The patient received ibuprofen/pseudoephedrine hydrochloride (Advil Sinus congestion and pain) from 21-Nov-2016 to 22-Nov-2016 and Ibuprofen 200 mg as corrective medication. The patient received three shots of cortisone, pain shot and antibiotic shot. On an unspecified date, the sinuses were so bad and received three shots and one day before received two shots of advil. At the time of the report the patient was recovering ("Improved") from all the events. List of documents held by the sender: None
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pyrexia, Sinus congestion, Sinus pain, Vomiting
Clinical narrative: Initial unsolicited misuse report received from a consumer (patient) via other company (Pfizer) (Manufacturer Report Number: 2016549962) on 13-Dec-2016. This case involves as 76-year-old patient (gender not specified) who was vaccinated with a double dose of INFLUENZA VACCINE (Batch number, expiry date dose form frequency route and site of administration not reported) on an unspecified date few weeks ago. Relevant medical history included allergies. Concomitant medications were not reported. On 22-Nov-2016, within four days of vaccination, the patient was down and out, was sick for two weeks had flu with fever, vomiting and coughing, cheeks were bright red. On an unspecified date, following vaccination, the patient had sinus congestion and pain, had allergy, cheecks were bright red. The patient reported of 'sinuses blew up' and being in terrible pain. It was a case 'extra dose of flu vaccine as patient received double dose. It was also a case of extra dose administered. Relevant laboratory investigations were not reported. It was reported that patient had unspecified labortory tests two weeks back. The patient received ibuprofen/pseudoephedrine hydrochloride (Advil Sinus congestion and pain) from 21-Nov-2016 to 22-Nov-2016 and Ibuprofen 200 mg as corrective medication. The patient received three shots of cortisone, pain shot and antibiotic shot. On an unspecified date, the sinuses were so bad and received three shots and one day before received two shots of advil. At the time of the report the patient was recovering ("Improved") from all the events. List of documents held by the sender: None
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Allergy to influenza virus vaccine; Initial unsolicited report received from a Physician via other company (Manufacturer report number 2015282222) on 13 December 2016. This case involves 73 years old female patient who was vaccinated with an unknown dose of INFLUENZA VACCINE (INFLUENZA VIRUS VACCINE) (batch number, expiry date, dose in series was not reported) in an unknown site on an unknown date. The patient's medical history and concomitant medications were not reported. On unspecified date, unknown timeframe following the vaccination, the patient developed Allergy to vaccine. lab data and thecorrective treatment was not reported. The patient's outcome was reported as unknown. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: Initial unsolicited report received from consumer (patient's mother) via other company (Pfizer) (Manufacturer Report Number: 2016553075) on 13-Dec-2016. This case involves a male patient (onset age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unspecified date, unspecified timeframe (reported as one month ago) following vaccination the patient experienced cold. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injury associated with device, No adverse event
Clinical narrative: Initial unsolicited misuse report received from a non-health care professional on 13 December 2016. It was reported that, a nurse while giving the intradermal dose of FLUZONE Intradermal (lot number, expiration date, dose, dose in series were not reported) to patient, patient jumped. The patient's medical history and concomitant medications were not reported. The nurse believed that, needle went through glove and had a scratch. It was a case of Occupational exposure to product. Patient event scratch outcome was not reported. No adverse event reported. List of the documents held by sender: none.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Skin warm, Swelling
Clinical narrative: Initial unsolicited report received from a Physician (pediatrician) on 14 December 2016. This case involves a 3-year-old male patient who was vaccinated with doses of INFLUENZA VACCINE (Flu Vaccine) (batch number, expiry date, dose, dose in series and route were not reported) in the left arm on 12 December 2016. Illness at the time of vaccination and Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also reported as none. On 13 December 2016 in the morning, one day following the vaccination, the patient's arm was noted to have significant swelling from his shoulder to his antecubital area, and the swelling was circumferential and the area was warm to touch, and was non-tender. The physician doses not beleived that, this was a cellulitis. The patient had previous dose of Flu vaccine in the last year. The patient required emergency room (ER) and doctor visit. Laboratory investigations were as none. Corrective treatment was reported as unknown. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer report number: 2016554605) on 09 Dec 2016. This case involves a 66-year-old male patient who was vaccinated with a dose of FLU SHOT (batch number, expiry date, dose, dose in series, route and site of administration were not reported) and also received RAPAMUNE on an unknown date. The patient's medical history and concomitant medications were not reported. On 26 Nov 2016, 03 months following the Flu shot vaccination, the patient had flu (diagnosed on the same day). The patient was hospitalized on 27 Nov 2016 morning. The patient's laboratory data and corrective treatment was not reported. The patient was not recovered from the event. List of documents held by sender: none. Sender's Comments: A 66 year old male patient had Flu, three months after receiving a dose of INFLUENZA VACCINE. It was reported that the patient under treatment with RAPAMUNE, an immunosuppressant. However additional information regarding medical history, infectious work-up results, patient's immune status at the time of vaccination, exact chronology of the events as well as confirmatory investigation results (details of specific influenza A strain identified in PCR) are needed to further assess this case.
Sex: F
Vaccine: FLUX
Symptoms: Facial paralysis, Facial paresis
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016554707) on 15 December 2016. This case involves a female patient (age at onset unspecified; reported as 'should be at least five years ago') who was vaccinated with Flu shot (dose, dose in series, batch number, expiry date of the product, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date and time following the vaccination (reported as 'should be at least five years ago'), the patient developed Bell's palsy with facial weakness. Laboratory data and corrective treatment was not reported. The outcome of the events was not recovered (reported as 'persisting'). Upon internal review the company decided to capture the case as serious due to Bell's palsy with facial weakness. List of documents held by sender: none. Sender's Comments: Bell's palsy was suspected in this case after vaccination with INFLUENZA VACCINE of unknown manufacturer however diagnosis was not confirmed. Time to onset is unknown. Additional information on investigation results ruling out a concurrent infection and exploration of alternate etiologies and patient's history of reaction after previous vaccinations is needed to further assess this case. Based on information role of vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Accidental exposure to product, Injury associated with device, No adverse event
Clinical narrative: Initial unsolicited misuse report received from a nurse on 13 Dec 2016. This case involves patient who was vaccinated with valid dose of FLUZONE ID on an unknown date. It was reported that when nurse attempted to deploy the safety shield her grazed her thumb. It was a case of needle injury and occupational exposure. No adverse event was reported. List of documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Eye swelling, Lip swelling, Mucosal erosion, Mycoplasma test negative, Papule
Clinical narrative: Initial unsolicited report received from the literature on 16 Dec 2016. Abstract: A 20-year-old woman presented with a new skin eruption. She described a prodrome of fever and rhinorrhea. Two days before presentation, she had noted orbital, lip, and vaginal swelling and a rash on both her arms and chest. She was a member of the military and had received the smallpox vaccination 3 weeks earlier in preparation for active duty. She denied a history of cold sores, genital herpes, other skin conditions, or the use of medications. The physical examination was significant for scattered targetoid papules and mucosal erosions. Skin and respiratory viral cultures, as well as mycoplasma testing, were negative. This case involves a 20-year-old female patient who was vaccinated with a dose of Smallpox vaccine (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date (reported as three weeks earlier in preparation for active duty). Patient's medical history was reported that the patient denied a history of cold sores, genital herpes, other skin conditions, or the use of medications. Concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient was presented with a new skin eruption and described a prodrome of fever and rhinorrhea and also had noted orbital, lip, and vaginal swelling and a rash on both her arms and chest two days before presentation and also developed scattered targetoid papules and mucosal erosions. Laboratory examinations including significant physical examination, skin and respiratory viral cultures, as well as mycoplasma testing, were negative. Corrective treatment were not reported. The outcome of events was not reported. Upon internal review, the company decided to consider the event serious because of important medical event orbital, lip, and vaginal swelling. List of documents held by sender: none. Sender's Comments: A 20-year-old woman presented with a new skin eruption, fever, rhinorrhea. The physical examination was significant for scattered targetoid papules and mucosal erosions. Two days before presentation, she had noted orbital, lip, and vaginal swelling and a rash on both her arms and chest. Time to onset is unknown. She was a member of the military and had received the smallpox vaccination 3 weeks earlier in preparation for active duty. She denied a history of cold sores, genital herpes, other skin conditions, or the use of medications. Scattered targetoid papules and mucosal erosions. Skin and respiratory viral cultures, as well as mycoplasma testing, were negative. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time to onset, date of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Pyrexia, Rash, Rhinorrhoea, Skin test negative, Viral test negative
Clinical narrative: Initial unsolicited report received from the literature on 16 Dec 2016. Abstract: A 20-year-old woman presented with a new skin eruption. She described a prodrome of fever and rhinorrhea. Two days before presentation, she had noted orbital, lip, and vaginal swelling and a rash on both her arms and chest. She was a member of the military and had received the smallpox vaccination 3 weeks earlier in preparation for active duty. She denied a history of cold sores, genital herpes, other skin conditions, or the use of medications. The physical examination was significant for scattered targetoid papules and mucosal erosions. Skin and respiratory viral cultures, as well as mycoplasma testing, were negative. This case involves a 20-year-old female patient who was vaccinated with a dose of Smallpox vaccine (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date (reported as three weeks earlier in preparation for active duty). Patient's medical history was reported that the patient denied a history of cold sores, genital herpes, other skin conditions, or the use of medications. Concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient was presented with a new skin eruption and described a prodrome of fever and rhinorrhea and also had noted orbital, lip, and vaginal swelling and a rash on both her arms and chest two days before presentation and also developed scattered targetoid papules and mucosal erosions. Laboratory examinations including significant physical examination, skin and respiratory viral cultures, as well as mycoplasma testing, were negative. Corrective treatment were not reported. The outcome of events was not reported. Upon internal review, the company decided to consider the event serious because of important medical event orbital, lip, and vaginal swelling. List of documents held by sender: none. Sender's Comments: A 20-year-old woman presented with a new skin eruption, fever, rhinorrhea. The physical examination was significant for scattered targetoid papules and mucosal erosions. Two days before presentation, she had noted orbital, lip, and vaginal swelling and a rash on both her arms and chest. Time to onset is unknown. She was a member of the military and had received the smallpox vaccination 3 weeks earlier in preparation for active duty. She denied a history of cold sores, genital herpes, other skin conditions, or the use of medications. Scattered targetoid papules and mucosal erosions. Skin and respiratory viral cultures, as well as mycoplasma testing, were negative. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time to onset, date of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Vulvovaginal swelling
Clinical narrative: Initial unsolicited report received from the literature on 16 Dec 2016. Abstract: A 20-year-old woman presented with a new skin eruption. She described a prodrome of fever and rhinorrhea. Two days before presentation, she had noted orbital, lip, and vaginal swelling and a rash on both her arms and chest. She was a member of the military and had received the smallpox vaccination 3 weeks earlier in preparation for active duty. She denied a history of cold sores, genital herpes, other skin conditions, or the use of medications. The physical examination was significant for scattered targetoid papules and mucosal erosions. Skin and respiratory viral cultures, as well as mycoplasma testing, were negative. This case involves a 20-year-old female patient who was vaccinated with a dose of Smallpox vaccine (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date (reported as three weeks earlier in preparation for active duty). Patient's medical history was reported that the patient denied a history of cold sores, genital herpes, other skin conditions, or the use of medications. Concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient was presented with a new skin eruption and described a prodrome of fever and rhinorrhea and also had noted orbital, lip, and vaginal swelling and a rash on both her arms and chest two days before presentation and also developed scattered targetoid papules and mucosal erosions. Laboratory examinations including significant physical examination, skin and respiratory viral cultures, as well as mycoplasma testing, were negative. Corrective treatment were not reported. The outcome of events was not reported. Upon internal review, the company decided to consider the event serious because of important medical event orbital, lip, and vaginal swelling. List of documents held by sender: none. Sender's Comments: A 20-year-old woman presented with a new skin eruption, fever, rhinorrhea. The physical examination was significant for scattered targetoid papules and mucosal erosions. Two days before presentation, she had noted orbital, lip, and vaginal swelling and a rash on both her arms and chest. Time to onset is unknown. She was a member of the military and had received the smallpox vaccination 3 weeks earlier in preparation for active duty. She denied a history of cold sores, genital herpes, other skin conditions, or the use of medications. Scattered targetoid papules and mucosal erosions. Skin and respiratory viral cultures, as well as mycoplasma testing, were negative. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time to onset, date of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: Initial unsolicited report received from a nurse on 14 Dec 2016. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed Flu caused by strain A (retrieved in culture examination). It was a case of vaccination failure. The patient's other laboratory data and corrective treatment was not reported. The outcome of event was not reported. Upon medical review, the case was considered as serious due to important medical event: Flu caused by strain A. List of documents held by sender: none. Sender's Comments: As with any other vaccine, INFLUENZA QUADRIVAL A-B VACCINE may not protect 100% of susceptible individuals. Aspects such as patient's immune status at the time of vaccination might interfere with the immune response to the vaccine. PCR confirmation test showed Flu caused by strain A. However patient's immune status, medical history, concomitant medication etc. is required to further assess this case.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 22 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with the dose of PNEUMOVAX23 (lot # L035882, subcutaneously, in the abdomen; dose was not reported) for prophylaxis (reported as vaccination). In September 2016, the patient developed a 2 inch by 1 inch yellow/purple blister like reaction at injection site with redness extending into the surrounding tissue. The outcome of the adverse events was reported as not recovered at the time of this report. The relatedness between the adverse events and PNEUMOVAX23 was not provided. Additional information has been requested. This is a corrected report that events were corrected. Sender's Comments: MERCK 1609USA009304: Mfr number.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, concomitant therapies, drug reactions or allergies was provided.   On unknown dates in 2016, between 11-NOV-2016 and 01-DEC-2016, the patients might have vaccinated with improperly stored RECOMBIVAX HB)lot# M026309, expiration date: 11-NOV-2018 (dose, route of administration were not reported). The administered doses of vaccine were stored in the temperature of 1.1 degrees Celsius for 6 hours and 30 minutes. Previously the vaccine was improperly stored in the temperature of 1.3 degrees Celsius for 11 hours 18 minutes, in the temperature of 1.4 degrees Celsius for 5 hours 32 minutes, in the temperature of 1.5 degrees Celsius for 9 hours and 42 minutes and in the temperature of 1.1 degrees Celsius for 6 hours and 30 minutes. Cumulatively the vaccine was stored in the temperature of 1.1 degrees Celsius for 43 hours and 18 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA009209: US-009507513-1612USA009210:
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Chemotherapy
Clinical narrative: This spontaneous report was received from a pharmacist, referring to an approximatelly 70 year old female patient. The patient's concurrent conditions and medical history, drug reactions or allergies, were not provided. Concomitant therapies were not mentioned. On an unknown date reported "as some time in the past", the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, frequency, lot # and expiration date not reported) for prophylaxis. Subsequently, the patient underwent chemotherapy for an unspecifed reason since an unknown date.    Additionally, the reporting pharmacist stated that the patient "seems to be doing okay", however the outcome of adverse event was unknown.   No causal relationship was provided between vaccination with ZOSTAVAX and the event. Additional information is not expected as there was no constent to contact the reporter.
Age: 84.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician, via company representative, referring to an 84 year old patient, of unknown gender. Medical history, concurrent conditions and concomitant therapies were not reported. On 30-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M037669, expiration date 09-MAY-2018, for prophylaxis (strength, frequency, dose, route and lot/batch number were not reported). On 01-DEC-2016, the patient sought medical attention by calling to the office and spoke with unspecified nurse to report that since unknown date he experienced redness, swelling and warmth at he injection site. At the time of the report, the outcome of the adverse events was unknown. The causality between the redness, swelling and warmth at he injection site and therapy with PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a currently 36 year old female medical assistant referring to herself. There was no information about concurrent condition, concomitant medication and medical history. On an unknown date at the unspecified age of over 26 years, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route, lot# and expiration date unknown) for prophylaxis (inappropriate age at vaccine administration). She did not experience an adverse effect. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain
Clinical narrative: This spontaneous report as received from a pharmacist via Pfizer (MRF# 2016537371) refers to an over 65 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route and frequency were not reported)  to protect against pneumococcal pneumonia. On an unknown date the patient felt sick for a couple days and had feeling of achiness. The outcome of the events was unknown. The reporter did not provide the causality between the PNEUMOVAX23 and the events. This is one of the two reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA013567:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # M018957 with expiration date 22-NOV-2017, dose was unknown), orally for prophylaxis. The vaccine was exposed under temperature of 1.46 degree centigrade for 1hour 30 minutes. There were no previous temperature excursions. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the doses of improperly stored GARDASIL 9 (lot # M030380 with expiration date 31-MAR-2019, lot # M030380 with expiration date 01-FEB-2019 and lot # M032650 with expiration date 31-MAR-2019; dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. The vaccines were stored in 34.71 F for 24 hours and previously in 32.28 F for 8 hours and 46 minutes as well as 29.29 F for 96 hours. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1612USA013573: US-009507513-1612USA013574.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a 16 year old male patient. The reporter did not have information on the patient's medical history or concurrent conditions. On 07-JUL-2016, the patient was vaccinated with a properly stored first dose of GARDASIL 9 (dose, route of administration, lot number and expiration date not reported). Subsequently, on 20-OCT-2016, he received a properly stored second dose of GARDASIL 9 (dose, route of administration, lot number and expiration date not reported). Finally, on 17-DEC-2016, he received his third dose of GARDASIL 9 (dose, route of administration, lot number and expiration date not reported). All the vaccines were administered for prophylaxis. No concomitant medication was reported. In December 2016, following his third dose of GARDASIL 9, the patient "was running a temperature of 101" (units not reported). At the time of the report, the outcome of body temperature abnormal was unknown. Additional information is not expected as the reporter did not wish to be contacted.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Herpes zoster cutaneous disseminated, Hyperaesthesia, Pain
Clinical narrative: This spontaneous report was received from a consumer referring to herself, a 71 year old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.     On an unknown date in 2011, reported as "five years ago in the fall", the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU injection, for prevention of shingles (route, anatomical location, dose, lot/batch number and expiration date were not reported). On 15-NOV-2016, reported as "five weeks ago", the patient was diagnosed with shingles that were around her rectum and down her "left cheek and left leg". She reported that she could not "stand her clothes touching the left side of her body". The patient sought medical attention and was treated with an unspecified antiviral medicine and topical cream for seven days. Finishing this treatment the patient was prescribed an unspecified lidocaine and TYLENOL for pain, and an unspecified "antibiotic because the blisters were opening" and the physician "wanted to prevent an infection". The patient referred that the rash was almost gone, but "they (the shingles) upset her whole system", she felt that the shingles "might have gone internal" and may see a gastroenterologist. The outcome of herpes zoster, herpes zoster and herpes zoster cutaneous disseminated was not recovered/not resolved. The relationship between Herpes zoster disseminated, and herpes zoster and therapy with ZOSTAVAX was not reported. Upon internal review, the event of herpes zoster disseminated were considered to be medically significant events. Additional information is not expected as there is no consent to follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-DEC-2016, the patient was vaccinated with a dose of VARIVAX, intramuscularly rather that subcutaneously, for prophylaxis (dose, anatomical location, lot/batch number and expiration date were not reported). No adverse effects were reported by patient. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain
Clinical narrative: This spontaneous report as received from a pharmacist via Pfizer (MRF# 2016537371) refers to an over 65 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and frequency were not reported)  to protect against pneumococcal pneumonia. On an unknown date the patient felt sick for a couple days and had feeling of achiness. The outcome of the events was unknown. The reporter did not provide the causality between the PNEUMOVAX 23 and the events. This is one of the two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA013567.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the doses of improperly stored ROTATEQ (orally, lot # M006111 with expiration date 18-NOV-2017, lot # M019706 with expiration date 24-OCT-2017, lot # M019707 with expiration date 18-NOV-2017, lot # M004508 with expiration date 29-JUN-2017; dose was not reported) for prophylaxis. No adverse effects were reported. The vaccines were stored in 34.71F for 24 hours and previously in 32.28 F for 8 hours and 46 minutes as well as 29.29 F for 96 hours. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1612USA013574: US-009507513-1612USA008513.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the doses of improperly stored PEDVAXHIB (lot # M027882 with expiration date 14-APR-2019, lot # M014925 with expiration date 19-FEB-2019; dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. The vaccines were stored in 34.71F for 24 hours and previously in 32.28 F for 8 hours and 46 minutes as well as 29.29 F for 96 hours. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1612USA008513: US-009507513-1612USA013573.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Contusion, Decreased appetite, Depression, Fatigue
Clinical narrative: This spontaneous report was received from a patient's wife and was assigned manufacturer report number 2016US015482 for XTANDI on 28-NOV-2016, referring to a 67-years-old male patient with pain (details unknown). The patient received XTANDI, capsule, (160 mg, start/stop date unknown) (lot# reported as 1539683PC; 1543982PC; 1553886PC), orally, once daily, for prostate cancer with metastasis. On an unspecified date, the patient developed loss of appetite, joint aches, fatigue (first episode), headache and there were no changes since starting on XTANDI. In July 2016, the patient experienced fatigue (second episode), hot flashes (ongoing), bruising (ongoing) that came and went and patient seemed depressed sometimes (ongoing). On an unspecified date in October 2016, the patient developed fatigue (third episode) (ongoing). In October 2016, XTANDI dose was reduced to 120mg daily due to the event fatigue. On 07-NOV-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, route, lot # and expiration date were not reported) and influenza virus vaccine (unspecified) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On unknown date in November 2016, patient had soreness in his arm and achiness at the injection sites. No lab test was performed. At the time of reporting, the patient did not recover from soreness in his arm and achiness at the injection sites. Action taken with XTANDI due to the event was unknown. The events Soreness in the arm and Achiness at injection sites were not related to XTANDI. The causality between pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), influenza virus vaccine (unspecified) and the events were not provided. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Headache, Hot flush, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a patient's wife and was assigned manufacturer report number 2016US015482 for XTANDI on 28-NOV-2016, referring to a 67-years-old male patient with pain (details unknown). The patient received XTANDI, capsule, (160 mg, start/stop date unknown) (lot# reported as 1539683PC; 1543982PC; 1553886PC), orally, once daily, for prostate cancer with metastasis. On an unspecified date, the patient developed loss of appetite, joint aches, fatigue (first episode), headache and there were no changes since starting on XTANDI. In July 2016, the patient experienced fatigue (second episode), hot flashes (ongoing), bruising (ongoing) that came and went and patient seemed depressed sometimes (ongoing). On an unspecified date in October 2016, the patient developed fatigue (third episode) (ongoing). In October 2016, XTANDI dose was reduced to 120mg daily due to the event fatigue. On 07-NOV-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, route, lot # and expiration date were not reported) and influenza virus vaccine (unspecified) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On unknown date in November 2016, patient had soreness in his arm and achiness at the injection sites. No lab test was performed. At the time of reporting, the patient did not recover from soreness in his arm and achiness at the injection sites. Action taken with XTANDI due to the event was unknown. The events Soreness in the arm and Achiness at injection sites were not related to XTANDI. The causality between pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), influenza virus vaccine (unspecified) and the events were not provided. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial unsolicited report received from a pharmacist  on 15 December 2016. This case involves a 74-year-old female patient who was vaccinated with a dose of FLUZONE HD (Batch number, expiration date, dose, dose in series and site of administration were not reported) via intramuscular route on 27 October 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as allergies were none unknown. Illness at the time of vaccination was reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 30 October 2016, three days following the vaccination, the patient had below the waist weakness, numbness and tingling. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as not recovered. List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Feeling abnormal, Incomplete course of vaccination, Influenza like illness, Nausea
Clinical narrative: Initial unsolicited report received from a consumer on 15 Dec 2016. This case involves a 45 years old female patient who was vaccinated with third dose of Imovax (batch number, expiry date, dose and site of administration- were not reported) intramuscularly and Imogam (batch number, expiry date, dose and site of administration- were not reported) intramuscularly on 04 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Any other vaccinations within 4 weeks of vaccination was not reported. The patient concomitant medications were not reported. On 12 Nov 2016, eight days following the vaccination, the patient experienced flu like illness, nausea, dizziness, abnormal feeling (reported as overall felt "really lousy"), she thinks she ran fever but didn't checked it and shooting pain throughout the body since vaccination anytime she had a drink (alcoholic). It was reported that patient refused 5th dose due to reaction. Laboratory investigations were reported as none. Patient's corrective treatment were not reported. The patient's outcome was unknown. List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 15 Dec 2016. This case involves a 45 years old female patient who was vaccinated with third dose of Imovax (batch number, expiry date, dose and site of administration- were not reported) intramuscularly and Imogam (batch number, expiry date, dose and site of administration- were not reported) intramuscularly on 04 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Any other vaccinations within 4 weeks of vaccination was not reported. The patient concomitant medications were not reported. On 12 Nov 2016, eight days following the vaccination, the patient experienced flu like illness, nausea, dizziness, abnormal feeling (reported as overall felt "really lousy"), she thinks she ran fever but didn't checked it and shooting pain throughout the body since vaccination anytime she had a drink (alcoholic). It was reported that patient refused 5th dose due to reaction. Laboratory investigations were reported as none. Patient's corrective treatment were not reported. The patient's outcome was unknown. List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Meningitis
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016566576) on 16-Dec-2016. This case involves a patient (onset age and gender were not reported) who was vaccinated with a dose of Menactra (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination the patient experienced meningitis. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. The reporter had considered the case serious for the important medical event: meningitis. List of documents held by sender: none. Sender's Comments: This case concerns adolescent patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and developed meningitis. Time to onset was not provided. However in this particular case very limited information has been provided. Further information regarding etiological work up, concomitant medication, concurrent condition at the time of vaccination and reaction to previous vaccination to rule out the alternative cause are needed for complete assessment of the case.
Age: 15.0
Sex: M
Vaccine: DTAP, HEP, MEN
Symptoms: Activities of daily living impaired, Blindness, Fatigue, Impaired work ability, Major depression
Clinical narrative: Started losing eyesight in early August, doctors thought it was nothing. Then intense pain in my legs, then a week later I try to get out of bed and I'm paralyzed from the waist down. Uncureable, I'm in a clinical trial now for treatment. But I have to wear diapers all the time, I can't play sports, chronic fatigue, major depression. Can't work ag62, waiting for disability. Devics disease.
Age: 15.0
Sex: M
Vaccine: DTAP, HEP, MEN
Symptoms: Pain in extremity, Paralysis
Clinical narrative: Started losing eyesight in early August, doctors thought it was nothing. Then intense pain in my legs, then a week later I try to get out of bed and I'm paralyzed from the waist down. Uncureable, I'm in a clinical trial now for treatment. But I have to wear diapers all the time, I can't play sports, chronic fatigue, major depression. Can't work ag62, waiting for disability. Devics disease.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Excessive eye blinking, Eye movement disorder, Neck pain, Pyrexia, Tic
Clinical narrative: He began excessive blinking.  Then woke up in the night with fever, sore neck.  Went to Pediatricians, found nothing.  He has had eye rolls and tics ever since.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Dry skin, Erythema, Pruritus, Rash
Clinical narrative: Dry patches initially formed around thighs, then to the arms forming bumps, redness, and itching.