chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site rash
Clinical narrative: This spontaneous report was received from a consumer's father, and refers to a 4 year old female patient. The patients pertinent medical history included an urinary tract infection, for which the patient had "finished antibiotics (unspecified) 5-6 days prior to vaccination." The patient had none concomitant, drugs reactions or allergies. On 26-FEB-2018, the patient was vaccinated with her second dose of Oka/Merck VARIVAX for prevention from varicella (route reported as "injection") (anatomical location, lot #, and expiration date were not reported). On the same day, immediately after being administered the second dose of the Oka/Merck VARIVAX, the patient experienced a reaction at the injection site. Also, the patient experienced a rash the size of a golf ball at the injection site. The patient was monitored in the office for an extra half hour after being administered Oka/Merck VARIVAX. The office drew a circle around the rash. The physician's office was been calling the patient's father daily to check on the patient. The reporter stated that the patient is "physically fine," it's just the injection site reaction." The outcome of injection site reaction and injection site rash was reported as not recovered/not resolved. No treatment was given for the adverse events. The relatedness between the events and the varicella Oka/Merck VARIVAX was not reported.
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant refers to a male patient of unknown age. The patient's past medications included ciprofloxacin, codeine, morphine, ROCEPHIN and propoxyphene. The patient was allergic to ciprofloxacin, clindamycin, codeine, morphine, ROCEPHIN and propoxyphene. Information on patient's concomitant medications were not reported. On 27-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose were frequency were not reported) (lot # N025563, expiration date: 08-APR-2019) intramuscularly for vaccination. On 27-FEB-2018, the patient developed redness, swelling and pain at the injection site (hospitalization) that lasted for weeks. The patient sought medical attention and the patient went and treated at the emergency room of an unknown hospital on the same day where he received an unknown treatment. Treatment was given for the adverse events. The outcome of injection site swelling, injection site pain and injection site erythema was reported as not recovered/not resolved. The relationship between events and PNEUMOVAX 23 was not provided. There was no product quality complaint (PQC) reported. The reporter considered the events as serious due to hospitalization. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA001659.
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Hypersensitivity, Pain, Rash, Swelling
Clinical narrative: This spontaneous report was received from a medical assistant refers to a male patient of unknown age. The patient's past medications included ciprofloxacin, codeine, morphine, ROCEPHIN and propoxyphene. The patient was allergic to ciprofloxacin, clindamycin, codeine, morphine, ROCEPHIN and propoxyphene. Information on patient's concomitant medications were not reported. On 27-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose were frequency were not reported) (lot # N025563, expiration date: 08-APR-2019) intramuscularly for vaccination. On 27-FEB-2018, the patient developed redness, swelling and pain at the injection site (hospitalization) that lasted for weeks. The patient sought medical attention and the patient went and treated at the emergency room of an unknown hospital on the same day where he received an unknown treatment. Treatment was given for the adverse events. The outcome of injection site swelling, injection site pain and injection site erythema was reported as not recovered/not resolved. The relationship between events and PNEUMOVAX 23 was not provided. There was no product quality complaint (PQC) reported. The reporter considered the events as serious due to hospitalization. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA001659.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a Physician Assisstant refers to a patient of unknown age. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On 28-FEB-2018, the patient was vaccinated with (wistar ra 27-3) M-M-R II, intramuscularly (lot# N019126, 22-JUN-2019, dose, frequency were not provided) for prophylaxis, sterile diluent (lot#, Exp date unknown, dose, frequency, indication were not specified) which were reconstituted intramuscularly for prophylaxis rather than subcutaneous (Subcutaneous injection formulation administered by other route), (inappropriate route of vaccination). Lot# N019126 has been verified to be valid lot for (wistar ra 27-3) M-M-R II.
Age: 1.5
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 18 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 01-MAR-2018, the patient was vaccinated with GARDASIL 9 injection (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. (Drug administered to patient of inappropriate age), however, no adverse effect were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 18-MAR-2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also known as shingles and other complications. On or about 30-SEP-2015, for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 18-MAY-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also known as shingles and other complications. During 2016, the patient broke out in severe blistering lesions.  The patient was treated at a medical center for the vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-JUL-2007, the patient was vaccinated at physician's with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Within the same day of ZOSTAVAX, he was treated for blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, he has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Induration, Oedema peripheral, Skin irritation, Skin warm
Clinical narrative: This spontaneous report was received from a consumer of unknown age and gender who is also an administrator, via a company representative, referring to her/himself. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 26-FEB-2018, the patient was vaccinated with ZOSTAVAX 194000 plaque forming unites (PFU), lot # N025703 with expiration date 16-DEC-2018, for prophylaxis (dose and route of administration were not reported). On an unspecified date in 2018, the patient experienced the following symptoms: hard, indurated (induration), warm to touch center (feeling hot), surrounded by oedema that wrapped about half way around the arm (oedema peripheral). It was irritated (skin irritation) but not painful. No other symptoms were reported. The patient stated that the center was a little larger at the time of reporting than the day before. The outcome of the events was unknown. The causality assessment between the events and ZOSTAVAX was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-JAN-2015, the patient was vaccinated at a   physician office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 11-JUL-2015, the patient was treated for  blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-MAY-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 16-APR-2015, the patient was treated for blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir and gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 01-MAR-2018 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route during 2008, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of shingles. On or about 01-MAR-2016, the patient was treated at a medical center for blistering vesicular outbreaks that were diagnosed as severe shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 17-APR-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 24-OCT-2016, the patient was treated at a medical group for blistering vesicular outbreaks that were diagnosed as severe shingles. The patient has been prescribed valacyclovir and gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-NOV-2011, the patient was vaccinated at physician office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 12-MAR-2016, the patient was treated for blistering vesicular outbreaks that were diagnosed as severe shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 01-MAR-2018 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route during 2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of shingles. On or about 07-MAR-2016, the patient was treated at a medical center for blistering vesicular outbreaks that were diagnosed as severe shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-SEP-2017, the patient was vaccinated with first dose of GARDASIL 9 (lot # and expiry date was not reported) for prophylaxis. On 22-FEB-2018, the patient was vaccinated with second dose of GARDASIL 9 (lot # N022727, Expiry date: 12-JUN-2020) for prophylaxis (inappropriate schedule of drug administration). There was no adverse event reported. There was no product quality complaint involved.
Sex: F
Vaccine: PPV
Symptoms: Exposure via skin contact, Injection site pain, Underdose
Clinical narrative: This spontaneous report was received from a consumer referring herself as a 68 year old female patient. The patient's concurrent conditions included elevated cholesterol. The patient was allergic to peanuts and flower. The patient's concomitant medication included pravastatin (manufacturer unknown). On 01-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (0.5 ml, once) (lot # N024385 and expiration date: 18-05-2019) intramuscularly at left arm as pneumonia vaccination. On 01-MAR-2018, patient received less than a full dose of PNEUMOVAX 23 and reported that patient was unsure how much vaccine patient received because patient left arm felt wet (accidental underdose, accidental exposure to product and exposure via skin contact) after receiving dose of PNEUMOVAX 23. It was also reported that, patient experienced unspecified soreness at injection site in left arm (injection site pain). The patient did not seek any medical attention and did not receive any treatment for the events. The outcome of the event injection site pain was reported as recovering. The reporter did not provide the causal relationship for the event injection site pain with suspect therapy PNEUMOVAX 23. No product quality complaint was involved.
Age: 4.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to a 4 year old male patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 02-MAR-2018, the patient was vaccinated with GARDASIL 9 unknown route of administration, lot # N021572, expiration date 01-MAY-2020, for prophylaxis (strength, dose and frequency were not reported). No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Dry eye, Eye pain, Herpes zoster, Ocular discomfort, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. On an unknown date after receiving ZOSTAVAX, the patient was diagnosed with shingles inside his left eye and on his forehead, which contributed to diminished eyesight and sensitivity to light. The patient continues to suffer from residual pain in his left eye, along with left eye discomfort and dryness. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, persistent strain of herpes zoster/shingles inside his left eye and on his forehead was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Photophobia, Visual impairment
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. On an unknown date after receiving ZOSTAVAX, the patient was diagnosed with shingles inside his left eye and on his forehead, which contributed to diminished eyesight and sensitivity to light. The patient continues to suffer from residual pain in his left eye, along with left eye discomfort and dryness. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, persistent strain of herpes zoster/shingles inside his left eye and on his forehead was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No medical history, concurrent condition and concomitant medications were reported. On 02-MAR-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N007930, expiry date 08-MAR-2019) via subcutaneous route for prophylaxis. The vaccine was reconstituted with properly stored Merck sterile diluent (lot# N026288, Expiry date 08-FEB-2020). The vaccine was exposed to the temperature of -9 degree Celsius to 8 degree Celsius (-7.5 degree Celsius) for 4 hours 34 minutes. Previous temperature excursion included -14 degree Celsius to -10 degree Celsius (-12.9 degree Celsius) for 2 hours 35 minutes. A data logger was involved. No product quality complaint was present.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. The patient's concomitant therapy included sterile diluent (DILUENT MRK INJ). On 28-FEB-2018 the patient was vaccinated with a properly stored but expired dose of ZOSTAVAX (dose, units, frequency not reported) lot # M038350, expiration date: 06-DEC-2017 via subcutaneous route (expired product administered). The sterile diluent (DILUENT MRK INJ) used for reconstitution of ZOSTAVAX was properly stored. No adverse effects were reported (no adverse event). No further details were provided. No product quality complaint (PQC) was present.
Sex: F
Vaccine: PNC13
Symptoms: Impaired driving ability, Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This female patient of unknown age and race/ethnicity received in Feb2018 (about 2.5 weeks as of 26Feb2018) a single dose of PREVNAR 13 in the left arm for immunization. Medical history and concomitant medications were not reported. Patient received in the past a flu shot for immunization. It was reported that patient was experiencing severe arm pain started 2 days after vaccination (Feb2018) that has not improved or gone away. Patient described the pain as terrible anytime she puts pressure on it, such as sitting at the kitchen table (not hurt if there is no pressure on it). Additionally patient reported having trouble turning her head and neck to the left and not being able to drive. Patient stated that prior to vaccination with PREVENAR 13, she got a flu shot in the same arm on an unknown date and it did not hurt at all.  She has been to multiple physicians and they are unsure what to do. They advised her that they do not think it was related to the vaccine but she thought that it was. She tried treating it with pain killers and creams but nothing was working for the pain. Outcome was not recovered. Information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Epistaxis, Haematochezia, Scab
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, from a contactable consumer reporting for herself. A 64-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 16Feb2018 at single dose for immunisation, ELIQUIS, oral from/to an unspecified date at 5 mg, 2x/day for an unspecified indication, BRILINTA, via an unspecified route of administration from/to an unspecified date at unknown dose for an unspecified indication. Medical history included pulmonary embolism from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient responded to an email from pneumococcal 13-val conj vac (dipht crm197 protein) regarding sharing her story of being diagnosed with pneumococcal pneumonia, but she couldn't confirm an official diagnosis of pneumococcal pneumonia. The patient experienced blood in her stool (medically significant) on an unspecified date with outcome of recovered, nosebleeds (non-serious) on an unspecified date with outcome of unknown, scraped her leg (non-serious) on an unspecified date with outcome of unknown, pulled off a scab and it is bleeding (non-serious) on an unspecified date with outcome of unknown. The action taken in response to the events for apixaban and for ticagrelor was unknown. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.
Sex: M
Vaccine: PNC13
Symptoms: Irritability, Nausea, Pain, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her husband. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arms swelled up, rash, pain, nausea, irritability, fever, on an unspecified date. All the events were non serious with outcome of unknown. The information on the batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her husband. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arms swelled up, rash, pain, nausea, irritability, fever, on an unspecified date. All the events were non serious with outcome of unknown. The information on the batch number has been requested.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Contusion, Death, Decreased appetite, Depression
Clinical narrative: Based on information received on 15 Nov 2017, the following information has been amended: vaccine preferred name changed from "INFLUENZA QUADRIVALENT RECOMBINANT VACCINE" to "INFLUENZA VACCINE". Initial unsolicited case received from a consumer (patient wife) via other company Astellas Pharma under the MFR control number: 2016US015482 on 15 Nov 2017. This case involves 67-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE and a dose of PNEUMOCOCCAL VACCINE (Batch numbers, expiry date, dose, dose in series, route and site of administration were not reported for both the vaccines) on 07 Nov 2016. The patient also started treatment with 160 mg and 120 mg dose of XTANDI (Manufacturer: Astellas Pharma) (Batch numbers reported as 1539683PC and 1543982PC, expiry date not reported) daily once orally from an unknown dates for prostate cancer with metastasis and metastatic castrate resistant prostate cancer. (It was reported as patient had no changes after starting the drug and patient was enrolled in patient support program). Patient current condition was reported as pain. Other medical history was not reported. Concomitant medications were not reported. On an unknown date, after receiving the treatment with XTANDI, patient developed first episode of fatigue. On an unknown date in Jul 2016 and Oct 2016, after receiving the treatment with XTANDI, patient developed fatigue (second and third episode). On an unknown date in Nov 2016, following the vaccination and after the administration of XTANDI patient developed soreness in the arm and achiness at injection sites. On an unknown date, following the vaccination and after the administration of XTANDI, patient developed bruising, depression, hot flashes, loss of appetite, joint aches and headache. On an unknown date, following the vaccination and after the administration of XTANDI, patient died due to unknown cause. Patient relevant lab tests and corrective treatment were not reported. The outcome of the events fatigue, Hot flashes, soreness in the arm and achiness at injection sites were reported as not recovered and the outcome of all the other events were not reported. It was not known, whether autopsy was performed to the patient. The patient wife assessed the causal relationship between the suspect drug XTANDI and with the event soreness in arm as not related. List of documents held by sender: none. Sender's Comments: The patient died post vaccination with influenza vaccine (Mfr Unk) and Pneumococcal vaccine. Time to onset was not reported. Patient had an ongoing medical condition of prostate cancer with metastasis and metastatic castrate resistant prostate cancer for which he was being treated with XTANDI. No autopsy results were available. Reported events may be related to preexisting medical condition which could have as well resulted in death. Based upon reported information the role of the vaccine cannot be established. Autopsy report confirming the cause of death is required to further assess the case. Reported Cause(s) of Death: Deceased.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Fatigue, Headache, Hot flush, Injection site pain, Limb discomfort
Clinical narrative: Based on information received on 15 Nov 2017, the following information has been amended: vaccine preferred name changed from "INFLUENZA QUADRIVALENT RECOMBINANT VACCINE" to "INFLUENZA VACCINE". Initial unsolicited case received from a consumer (patient wife) via other company Astellas Pharma under the MFR control number: 2016US015482 on 15 Nov 2017. This case involves 67-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE and a dose of PNEUMOCOCCAL VACCINE (Batch numbers, expiry date, dose, dose in series, route and site of administration were not reported for both the vaccines) on 07 Nov 2016. The patient also started treatment with 160 mg and 120 mg dose of XTANDI (Manufacturer: Astellas Pharma) (Batch numbers reported as 1539683PC and 1543982PC, expiry date not reported) daily once orally from an unknown dates for prostate cancer with metastasis and metastatic castrate resistant prostate cancer. (It was reported as patient had no changes after starting the drug and patient was enrolled in patient support program). Patient current condition was reported as pain. Other medical history was not reported. Concomitant medications were not reported. On an unknown date, after receiving the treatment with XTANDI, patient developed first episode of fatigue. On an unknown date in Jul 2016 and Oct 2016, after receiving the treatment with XTANDI, patient developed fatigue (second and third episode). On an unknown date in Nov 2016, following the vaccination and after the administration of XTANDI patient developed soreness in the arm and achiness at injection sites. On an unknown date, following the vaccination and after the administration of XTANDI, patient developed bruising, depression, hot flashes, loss of appetite, joint aches and headache. On an unknown date, following the vaccination and after the administration of XTANDI, patient died due to unknown cause. Patient relevant lab tests and corrective treatment were not reported. The outcome of the events fatigue, Hot flashes, soreness in the arm and achiness at injection sites were reported as not recovered and the outcome of all the other events were not reported. It was not known, whether autopsy was performed to the patient. The patient wife assessed the causal relationship between the suspect drug XTANDI and with the event soreness in arm as not related. List of documents held by sender: none. Sender's Comments: The patient died post vaccination with influenza vaccine (Mfr Unk) and Pneumococcal vaccine. Time to onset was not reported. Patient had an ongoing medical condition of prostate cancer with metastasis and metastatic castrate resistant prostate cancer for which he was being treated with XTANDI. No autopsy results were available. Reported events may be related to preexisting medical condition which could have as well resulted in death. Based upon reported information the role of the vaccine cannot be established. Autopsy report confirming the cause of death is required to further assess the case. Reported Cause(s) of Death: Deceased.
Sex: U
Vaccine: FLUX, HEPA, IPV, MEN, TD, YF
Symptoms: Cardiac disorder, Pericarditis
Clinical narrative: Initial unsolicited report received from the literature on 21-FEB-2018. The following is verbatim from the article: Abstract: Reports of myocarditis and pericarditis following smallpox vaccination in adults suggested a need to assess inflammatory cardiac disease risk among adults who receive live viral vaccinations. From 1996 through 2007, among 416,629 vaccinated adults in the Vaccine Safety Datalink, we identified one probable pericarditis case and no cases of myocarditis in the 42 days following a live viral vaccination. Our self-controlled risk interval analysis found that, based on one case identified during the risk interval and 10 cases during the control interval, there is no increased risk of myopericarditis in the 42 days following vaccination (IRR, 0.57; 95% CI, 0.07, 4.51). Our study suggests that the occurrence of myopericarditis following live viral vaccination is rare with an estimated incidence of 0.24 per 100,000 vaccinated, which is not higher than the background rate and is much lower than the incidence rates reported following smallpox vaccination. This case involves a patient (age and gender unknown) who was vaccinated with a dose of YELLOW FEVER VACCINE, INFLUENZA VACCINE, TD vaccine and MENINGOCOCCAL VACCINE, POLIOMYELITIS VACCINE (INACTIVATED) and HEPATITIS A VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown dates for all vaccines. Patient's medical history was not reported. Concomitant medications were not reported. On an unknown date, 42 days post vaccinations, patient developed probable pericarditis. Lab tests and corrective treatment were not reported. Outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event: probable pericarditis. Documents held by sender: none. Sender's Comments: Time to onset was compatible. No information regarding product name, lot number, medical history and condition at the time of vaccination was not reported. Patient received multiple vaccines. There is a possibility of underlying infection that pre dates vaccinations. Lab tests confirming the diagnosis and ruling out alternate etiologies must be provided. Due to vaccination with multiple products the role of one vaccine cannot be assessed.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Pain at site of injection that now radiates to neck, shoulder, arm and hand, also silver dolor size pink discoloration at site of injection.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth, Pain
Clinical narrative: Pt Returned to pharmacy to report that the site of immunization was still sore from IMZ administered on 2/4/18. On examination skin was intact, the area was warm to touch, pain when pressure applied, No redness swelling or rash. She stated that it hurt when she elevated her arm or used arm to push down on lotion bottle at home.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Vesicular rash at the site of SQ inj, left arm.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to currently 12-year-old patient. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapies included sterile diluents. On 12-FEB-2018, the patient was vaccinated with improperly stored VARIVAX (Lot # N012619 and expiration date 21-APR-2019), (Lot # N025932 and expiration date 19-SEP-2019) for prophylaxis. The nurse stated that she has spoken to someone at Merck who determined that VARIVAX (lot # N012619) could still be used. Temperature excursion details were provided. Temperature/Time frame was -14 degree Celsius to -10 degree Celsius (-14.3 degree Celsius) for 1 hour 6 minutes. There were no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of the six reports linked via same reporter link. Sender's Comments: US-009507513-1802USA007855.
Age: 12.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Abnormal behaviour, Drug screen negative, Feeling abnormal, Hallucination, Headache
Clinical narrative: Episode of hallucinations last night and went to Hospital ER. Mother worried that was shots. Had a headache as well. Still not feeling well. ATIVAN helped get her settled down. Slept last night and slept late, still felt fuzzy. Mother wanted lot numbers of the shots given and I supplied the manufacturer and lot number to her of the flu, MENACTRA and Tdap. She feels might be related to the flu vaccine. I shared that I had not seen this type of reaction with that vaccine, nor was I aware of any reported in the medical community. Patient is a 12yo with history of PTSD, generalized anxiety disorder, and report of sexual abuse in the past, presenting with abnormal behavior. Her symptoms occur most prominently when they are being discussed during the HPI and otherwise seem to be relatively distractible/suppressible. She follows complex commands and has a normal neurologic exam, and is alert and oriented to numerous questions on my exam. Differential includes toxic ingestion (although no history of ingestion), anxiety, psychosis, conversion disorder. Less likely encephalitis, meningitis, intracranial hemorrhage or increased ICP given lack of fevers and distractibility of her symptoms. Will send labs including urine and serum tox screen, VBG, CBC, chem, LFTs and lipase. Will consult Neurology, and possibly psychiatry pending progression of her symptoms and labs. Will give a dose of ATIVAN for nausea and possible anxiety component of her symptoms. After receiving lorazepam, the patient had returned to her baseline mental status and resolution of her hallucinations. Neurology team evaluated the patient and agree low suspicion for organic etiology of her symptoms. She was observed for multiple hours in the ED without recurrent symptoms. After her mental status improved, I discussed with patient in private and she denied SI, HI, ongoing hallucinations. She endorsed to me that she feels very stressed regarding an upcoming court appearance. I discussed with the patient and her mother that this episode may represent a component of conversion disorder. I discussed the stressors with her mother as well who states that she has significant in home and in school therapeutic resources, and is scheduled to see her therapist tomorrow. I discussed with the psychiatry team who are in agreement with discharge to home with close best team and primary outpatient therapy follow-up. Family is in agreement with this plan, patient can contract for safety, and they understand signs and symptoms to return to care.
Age: 12.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Malaise, Mental status changes, Neurological examination normal, Stress
Clinical narrative: Episode of hallucinations last night and went to Hospital ER. Mother worried that was shots. Had a headache as well. Still not feeling well. ATIVAN helped get her settled down. Slept last night and slept late, still felt fuzzy. Mother wanted lot numbers of the shots given and I supplied the manufacturer and lot number to her of the flu, MENACTRA and Tdap. She feels might be related to the flu vaccine. I shared that I had not seen this type of reaction with that vaccine, nor was I aware of any reported in the medical community. Patient is a 12yo with history of PTSD, generalized anxiety disorder, and report of sexual abuse in the past, presenting with abnormal behavior. Her symptoms occur most prominently when they are being discussed during the HPI and otherwise seem to be relatively distractible/suppressible. She follows complex commands and has a normal neurologic exam, and is alert and oriented to numerous questions on my exam. Differential includes toxic ingestion (although no history of ingestion), anxiety, psychosis, conversion disorder. Less likely encephalitis, meningitis, intracranial hemorrhage or increased ICP given lack of fevers and distractibility of her symptoms. Will send labs including urine and serum tox screen, VBG, CBC, chem, LFTs and lipase. Will consult Neurology, and possibly psychiatry pending progression of her symptoms and labs. Will give a dose of ATIVAN for nausea and possible anxiety component of her symptoms. After receiving lorazepam, the patient had returned to her baseline mental status and resolution of her hallucinations. Neurology team evaluated the patient and agree low suspicion for organic etiology of her symptoms. She was observed for multiple hours in the ED without recurrent symptoms. After her mental status improved, I discussed with patient in private and she denied SI, HI, ongoing hallucinations. She endorsed to me that she feels very stressed regarding an upcoming court appearance. I discussed with the patient and her mother that this episode may represent a component of conversion disorder. I discussed the stressors with her mother as well who states that she has significant in home and in school therapeutic resources, and is scheduled to see her therapist tomorrow. I discussed with the psychiatry team who are in agreement with discharge to home with close best team and primary outpatient therapy follow-up. Family is in agreement with this plan, patient can contract for safety, and they understand signs and symptoms to return to care.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site swelling, Pain
Clinical narrative: Significant pain 12 hours after vaccine given; inflammation, approximately 8 cm round and mild swelling at site.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Paraesthesia
Clinical narrative: PT. SAID FELT TINGLING IN ARM, UPPER THIGH, AND FACE ALL ON RIGHT SIDE (same as side of injection).
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to device use error, Erythema, Fatigue, Feeling abnormal, Mass
Clinical narrative: I am not sure if it was the MMR II, I just know that is was the MMR vaccine. What happened was, I took my 4 year old daughter in for her four year check-up and she received four vaccines. During the vaccines the nurse crossed my daughter's arms and asked me to hold them and her still to prevent her from moving while the shots were being given. During one of her shots she jerked her leg and the needle ended up scratching her leg pretty bad and managed to poke me in the back of my right arm. (The vaccine had already been injected into her leg, I just got poked with the needle after.) At the time it kind of hurt but then started stinging pretty bad for about 5 minutes. The nurse checked my arm and it was just a tiny red dot. At the time I wasn't worried about it, and it was a total accident, and once the stinging went away I even forgot about it for a while. At home that night I was fine, but the following day my arm was a bit sore. I figured it was just from getting poked, still no big deal, and went on with my day. Sunday night (the accident happened Friday) I felt an itch on my arm, forgetting about the poke I naturally went to scratch it and that's when I felt the huge lump. It looked like a huge welt with redness in the middle and was still sore and itched. Monday morning I woke up and the lump was bigger and wider and more red. Still sore and itchy. The whole weekend I didn't feel normal and I was extra tired. I called my daughter's pediatrician to find out which vaccine I was accidently poked with and it was the MMR. I was told to go see my doctor to have him take a look and to put a cool rag on it and to take BENADRYL. My stepmom was a medical assistant and told me to report it just in case and provided this link. It was an absolute accident, just wanted to report my reaction to it.