chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Metabolic function test normal, Myalgia
Clinical narrative: TDaP and PPSV 23 administered 1pm 12 hrs after excess fatigue, bedridden x 2wks. Mild HA myalgia, weakness, dizziness.
Sex: F
Vaccine: HEPAB
Symptoms: Unevaluable event
Clinical narrative: The reporter was inquiring about administration of TWINRIX and the dates of vaccination of previous dose of Hep A and Hep B was not provided. The patient did not receive the vaccine till the time of reporting. Therefore, the case was deleted from core.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Unevaluable event
Clinical narrative: No adverse event has occurred, no treatment required, patient outcome has not been effected.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Throat irritation
Clinical narrative: At about 8:15pm patient stated his throat itched on the inside. Gave him BENADRYL at that time. 30 min after taking BENADRYL symptoms started to improve.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: ERYTHEMATOUS LESION WITH DEMENSION ON AND A HALF INCHES BY 2 AND A HALF INCHES.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Injection site rash, Urticaria
Clinical narrative: MOP states 3hrs after getting the vaccinations pt states having a rash on bilateral thighs with hives on his chest. MOP denies pt having any other symptoms, fevers or SOB. MOP denies any treatment. MOP states symptoms lasted for 36hrs.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Febrile convulsion
Clinical narrative: On 6/9/17 the patient had a febrile seizure and was taken to an ED by parents.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 14-JUL-2017 from a nurse who reported that multiple unspecified patients were administered improperly stored VARIVAX (lot#/expiration unknown) reconstituted with properly stored sterile diluent (lot#/expiration unknown) on multiple unspecified dates. Temperature was 15 degrees F to 46 degrees F for a time frame of less than 72 hours. Previous temperature excursion was unknown by reporter. Call was because of a "data logger". No adverse effects reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (lot # L038018 with expiration date 13-SEP-2017, lot # L048848 with expiration date 09-AUG-2018, lot # reported as M00442 with expiration date 31-MAR-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature 47.1°F for 24 days without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006677: US-009507513-1707USA006678: US-009507513-1707USA006679: US-009507513-1707USA006675: US-009507513-1707USA006676:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with M-M-R II (lot # M007277 with expiration date 09-SEP-2018, lot # M029230 with expiration date 08-JUN-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature 47.1°F for 24 days without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006677:  US-009507513-1707USA006507: US-009507513-1707USA006679: US-009507513-1707USA006675: US-009507513-1707USA006676:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis.  Other suspect therapies included sterile diluent. On an unknown date, the patient experienced vaccination site pain, injection site itching, vaccination site swelling and vaccination site redness.  The outcome of the events vaccination site pain, injection site pruritus, vaccination site swelling and vaccination site erythema was reported as recovered/resolved. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report was received from a nurse at physician's office via company representative regarding a patient of unknown demographics. Information on pertinent medical history and concomitant medications were not reported. On 05-JUL-2017, the patient was vaccinated with GARDASIL 9 for prophylaxis (dosing details not reported). Patient had syringe malfunction while receiving GARDASIL 9, resulting in an incomplete dose being administered. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 19-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, or concomitant medication was not provided. It was reported that the patient was vaccinated on an unreported date, with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy 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. On or about 18-MAR-2015,  the patient was treated by a physician for the onset of a blistering vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed Lipoderm 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, pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information was received 19-JUL-2017 from a lawyer regarding a case in litigation concerning a male plaintiff who was inoculated with ZOSTAVAX in 2014 at a pharmacy as recommended for routine health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended but rather caused the plaintiff to contract a persistent strain of herpes zoster. On or about 14-JAN-2015 the plaintiff was treated by a physician and nurse practitioner at an internal medicine clinic for a painful and blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. The plaintiff was prescribed valacyclovir (VALTREX) and mupriocin (BACTROBAN) for management of his painful symptoms. As a direct and proximate result for these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff had suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash, Rash vesicular
Clinical narrative: Information had been received on 19-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 13-APR-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster.  On or about 22-AUG-2016, the patient was treated by a physician at a clinic for a painful and blistering vesicular outbreak, which was diagnosed as Herpes Zoster, or shingles. The patient continued to outbreak after being treated for this condition, and she has been prescribed a continuous dose of valacyclovir hydrochloride(VALTREX) to curb her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, 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 on 19-JUL-2017 regarding a case in litigation regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 02-MAR-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous at a pharmacy 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. On or about 19-DEC-2015, the patient was treated at the Emergency Room for a painful and blistering vesicular outbreak, which was diagnosed as 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with PROQUAD (lot #: M033215 with expiration date: 09-JAN-2018, lot# M038229 with expiration date 06-MAR-2018 and lot# M034691 with expiration date 21-JAN-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 47°F but less than 77°F for 52 hours, at temperature greater than 15°F but less than 46°F for 3.5 hours and at temperature greater than 6°F but less than 14°F for 30 minutes without any previous temperature excursion. It was unknown if this information was registered in a digital data logger. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA006628.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patient of unknown age and gender. No information about patients' medical history, concomitant medication and concurrent conditions was reported. On an unspecified dates, the patient were vaccinated with improperly stored doses ROTATEQ, oral, from lot# M046000 with expiry: 27-JUN-2018, for prophylaxis. No adverse effects reported. The vaccine was stored at a temperate of 9 degree Celsius to 25 degree Celsius for 34 minutes. The temperature excursion was detected by digital data logger. The vaccine had no previous temperature excursion. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1707USA008351: US-009507513-1707USA008350:
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 77 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 17-JUL-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N003997 with expiration date of 20-OCT-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was reported that the patient returned to the pharmacy on 20-JUL-2017 (reported as today) to report that on an unspecified day in July 2017, he experienced "blisters" or a bump (vaccination site vesicles) and itching at injection site (vaccination site pruritus). There had been no treatment for the events. At the time of reporting, the patient had not been recovered from the vaccination site vesicles and the vaccination site pruritus. The causal relationship between the events and the PNEUMOVAX 23 was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist (who is also the female patient of unknown age) referring to herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The pharmacist reported that while she was drawing up ZOSTAVAX into a syringe, a few drops leaked out of the syringe onto her hand on 20-JUL-2017. No adverse effects were reported. It was also reported that the dose of ZOSTAVAX was not administered to a patient.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patient of unknown age and gender. No information about patients' medical history, concomitant medication and concurrent conditions was reported. On an unspecified dates, the patients were vaccinated with improperly stored doses with GARDASIL 9 from lot # N001533 with expiry: 16-OCT-2019,  for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 9 degree Celsius to 25 degree Celsius for 34 minutes. The temperature excursion was detected by digital data logger. The vaccine had no previous temperature excursion. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1707USA007839.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patient of unknown age and gender. No information about patients' medical history, concomitant medication and concurrent conditions was reported. On an unspecified dates, the patient were vaccinated with improperly stored doses of PNEUMOVAX 23 from lot# N001007 with expiry: 19-SEP-2018, for prophylaxis. No adverse effects reported. The vaccine was stored at a temperate of 9 degree Celsius to 25 degree Celsius for 34 minutes. The temperature excursion was detected by digital data logger. The vaccine had no previous temperature excursion. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1707USA007839:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an 11 year old female patient. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On 18-JUL-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # reported as N007931, expiration date 17-NOV-2019) (dose, dose number and route were not reported) for prophylaxis. On 18-JUL-2017, the patient "fainted" in the examination room after having an injection of GARDASIL 9. The patient did not receive treatment and not seek medical attention. The outcome of syncope was reported as recovered/resolved on 18-JUL- 2017. There was no product quality complain reported.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from contactable nurse via a Pfizer Sales Representative. A patient of unspecified age, race, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at the injection site on an unspecified date. The patient recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received a single dose of PREVNAR 13, on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced sore arm: the arm was still sore 11 days after vaccination. Final outcome of the event was unknown.
Age: 43.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Back pain, Pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 07-Jul-2017. This case was linked with: 2017SA127752 (Same patient). This case involves a 43-year-old male patient, who was vaccinated once with 0.5 ml of TYPHIM VI via intramuscular route (batch number, expiry date, site of administration not reported) on 30-Jun-2017. Patient had no known drug allergies and was traveling on the 08-July, eats eggs without any trouble, took no medications. He had surgery for cyst removal in the past but no other major operations. Concomitant medications included 0.5 ml STAMARIL via subcutaneous route for one time (batch number: M51761V) and once with 0.5 ml HAVRIX via intramuscular route (batch number, expiry date, site of administration not reported) on 30-Jun-2017. On 06-Jul-2017, six days following the vaccination, the patient had felt slightly achy (generalized) for a day or two and went for a deep tissue massage on 06-Jul-2017 and woke up on 07-Jul-2017, one week after the vaccination, patient had severe lower back pain. Patient then had a large breakfast and reported feeling completely fine. Lab test not reported. Other corrective treatment was not reported. On 07-Jul-2017, patient got recovered completely. Documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Morning after injection- soreness, warmth around injection site redness, swelling marks - 2 welts 4inches across arm. Did resolve after 3-4 day.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Morning after injection- soreness, warmth around injection site redness, swelling marks - 2 welts 4inches across arm. Did resolve after 3-4 day.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Large local reaction (red patch sl raised on (R) thigh after DTaP. Smaller red patch (L) thigh after Varicella.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Influenza like illness, Malaise, Myalgia
Clinical narrative: 30 yo M with fever, myalgias, fatigue and flu-like symptoms 2 days after receiving Tdap vaccination. T is 101.2. He has headache and "feels really sick". He has no meningeal signs on exam and no localized neurologic symptoms, or findings to suggest Guillain Barre syndrome. No evidence of anaphylaxis. There is no evidence of cellulitis on exam and the injection site looks remarkable. He does have muscle tenderness and pain with movement. This seems to be more in the muscle rather than in the joint. Symptoms seem most consistent with systemic reaction to the Tdap vaccination. Advised close follow-up, or return to the clinic if he is not continually improving over the next 24-48 hours. RN also met with him in the exam room and emphasized the follow up care, IE drinking plenty of fluids, taking TYLENOL alternating with ibuprofen. Pt. instructed to get into the shower if temp is greater than 101. Pt. instructed to call clinic if temp is greater than 101.4.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: 30 yo M with fever, myalgias, fatigue and flu-like symptoms 2 days after receiving Tdap vaccination. T is 101.2. He has headache and "feels really sick". He has no meningeal signs on exam and no localized neurologic symptoms, or findings to suggest Guillain Barre syndrome. No evidence of anaphylaxis. There is no evidence of cellulitis on exam and the injection site looks remarkable. He does have muscle tenderness and pain with movement. This seems to be more in the muscle rather than in the joint. Symptoms seem most consistent with systemic reaction to the Tdap vaccination. Advised close follow-up, or return to the clinic if he is not continually improving over the next 24-48 hours. RN also met with him in the exam room and emphasized the follow up care, IE drinking plenty of fluids, taking TYLENOL alternating with ibuprofen. Pt. instructed to get into the shower if temp is greater than 101. Pt. instructed to call clinic if temp is greater than 101.4.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Dizziness, Erythema, Pruritus
Clinical narrative: Received VARIVAX and within 10 minutes began having symptoms of erythema to face, neck and upper body, severe dizziness, itchng, and "feeling like I'm on fire". Treated in ER with IV Benadryl and steroid. Discharged to home.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Red rash to chest area with no pain noted per patient. Swelling around injection site, per client tender & red.
Age: 8.0
Sex: F
Vaccine: HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom notes that shortly after vaccines were administered she developed swelling and redness at the injection site. Warm to the touch.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Malaise, Nonspecific reaction, Pain, Pruritus
Clinical narrative: Malaise, STA, hives beginning at the site red raised pustules 1/2 to 2 mm in diameter, Temp 99, Itching pain . Next day progressesd through the rest of body.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pustular
Clinical narrative: Malaise, STA, hives beginning at the site red raised pustules 1/2 to 2 mm in diameter, Temp 99, Itching pain . Next day progressesd through the rest of body.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site shortly after vaccine was administered.
Age: 12.0
Sex: M
Vaccine: DTAP, HPV9, MNQ, TDAP
Symptoms: Immunisation, Wrong drug administered
Clinical narrative: DTaP given in error, TDaP then given to correct error.
Age: 12.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Wrong drug administered
Clinical narrative: DTaP given in error, TDaP given to correct error.
Age: 24.0
Sex: F
Vaccine: JEV1, TYP
Symptoms: Dizziness, Migraine, Nausea
Clinical narrative: Patient reported migraine headache in lower head/neck, nausea, and dizziness.
Age: 1.08
Sex: M
Vaccine: MMR, HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 05-JUL-2017 from a registered nurse who was reporting on a 13 month old male patient. No medical history or concomitant mediations were reported. On 05-JUL-2017, the patient was administered an expired dose of MMRII (lot L024266, expired 01-JUL-2017)(site, dose and route not reported) for prophylaxis. This was supported by post-expiry memo. No temperature excursions and no adverse effects reported. No additional information was reported. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: MMR, HEPA, MMR, VARCEL
Symptoms: Constipation, Pyrexia, Vomiting
Clinical narrative: Information was received on 05-JUL-2017 from a registered nurse who was reporting on a 13 month old male patient. No medical history or concomitant mediations were reported. On 05-JUL-2017, the patient was administered an expired dose of MMRII (lot L024266, expired 01-JUL-2017)(site, dose and route not reported) for prophylaxis. This was supported by post-expiry memo. No temperature excursions and no adverse effects reported. No additional information was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective, No adverse event
Clinical narrative: This spontaneous report was received from a female consumer of unknown age referring to herself.The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, site of administration, lot number and expiration date were not provided) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT) (manufacturer unknown) (lot # and expiration date were not provided) and acyclovir (ACYCLOVIR) (dose, frequency, lot #, and indication were not provided). The patient reported that she received ZOSTAVAX on an unspecified date while taking acyclovir (ACYCLOVIR) (manufacturer unknown).  It was reported that the patient's physician informed the patient on an unspecified date that the ZOSTAVAX was not effective because she was taking acyclovir (ACYCLOVIR). The outcome of the event was not reported. No adverse experiences were reported. No further information was reported. Additional information is not expected. as no contact details were provided and consent to contact was denied.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information had been received on 19-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient (age not reported) who was inoculated with ZOSTAVAX (dosage and lot#/expiration not reported) on or about 21-APR-2015 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused patient to contract a persistent strain of herpes zoster. On or about the dates of 30-SEP-2015, 22-OCT-2015 and 11-DEC-2015, patient was treated by physician for repeated blistering vesicular outbreaks, which were diagnosed as severe shingles. On or about the dates of 17-OCT-2015 and 23-OCT-2015, patient was further treated by physician for ongoing and worsening symptoms of shingles. Patient has been prescribed acyclovir, gabapentin and hydrocodone-acetaminophen for management of her painful condition. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, 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 was received 19-JUL-2017 from a lawyer regarding a case in litigation concerning a female plaintiff who was inoculated with ZOSTAVAX on or about 13-FEB-2009, administered by a physician as recommended for routine health maintenance and for the prevention of shingles.  It was reported that the vaccine did not prevent shingles as intended but rather caused the plaintiff to contract a persistent strain of herpes zoster.  On or about 09-AUG-2014 the plaintiff was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. On or about 27-JUL-2015 the plaintiff was treated by a physician for new and continued shingles outbreaks.  On or about 29-AUG-2015 was treated by a physician for worsening and persistent vesicular lesions.  The plaintiff had been prescribed acyclovir (ZOVIRAX) and pain medicine for management of her painful symptoms.  As a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff had suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Age: 1.0
Sex: F
Vaccine: MENB, MMR, VARCEL
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a contactable physician. A 12-month and four days-old female patient of an unspecified ethnicity received the 1st dose of TRUMENBA (Lot # R4758, Expiry Date 31Jul2018, NDC # 00005010010) intramuscular at 0.5 ml, single at left thigh on 14Jul2017 13:20 for immunization. The patient medical history were none. Concomitant medication included MMR (Merck, Lot # M045101, Exp 10Nov2018) subcutaneous at left thigh, VARICELLA VACCINE (Merck, Lot # M04915, Exp 15Dec2018) subcutaneous at right thigh, both on 14Jul2017 for immunization. No vaccinations received within 4 weeks. On 14Jul2017 the patient received TRUMBENA instead of the 4th dose of PREVNAR 13 at single dose, and experienced low grade fever on 16Jul2017 with outcome of recovered. The event did not require a visit to Emergency Room, nor Physician's office. No investigations. Reporter seriousness for received TRUMENBA instead of PREVNAR 13 was assessed as Medically significant. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician (Internal medicine/pediatrician) via a Pfizer sales representative. A 19-year-old male patient of an unspecified ethnicity received the 2nd dose of TRUMENBA via an unspecified route of administration on 21Jun2017 at single dose for immunisation. Medical history included ongoing allergy to oak, grasses and pollen. The patient's concomitant medications were not reported. The patient previously took TRUMENBA. The patient experienced hives all over upper body on 21Jun2017 Course of events: Patient came in for annual checkup on 21Jun2017.  During his checkup he received his second TRUMENBA vaccine. Patient or his mother called the MD office to report patient had hives all over his upper body on 21Jun2017.  Patient came back into the office the next day, 22Jun2017, to see the MD.  MD prescribed him BENADRYL 50mg twice daily for 3 days.  Patient told to use topical hydrocortisone cream 1-2 times daily for 3 to 5 days.  Patient also told to use special soap, LEVER 2000 with no fragrance.  The MD's nurse called patient back on 28Jun2017 and the rash had cleared up.  Patient has recovered completely on 28Jun2017. No other vaccines given at 21Jun2017 checkup.  No concomitant medications or investigations provided.
Age: 6.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Eyelid rash, Petechiae
Clinical narrative: 24 hours after receiving the Hep A and Hep B vaccines she developed a petechiae rash on her right eyelid. The next morning, she woke with a petechiae rash on the left eyelid as well.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmth, tenderness, Erythema 11x13cm at times of exam which is "slightly better" than the past 24 hours.
Age: 59.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Decreased appetite, Fatigue, Injection site erythema, Pain
Clinical narrative: Redness at and around injection site continuing at least 4 days (observed at time of report). Fever, chills body aches, appetite loss, tiredness continuing at least 4 days at time of reported reaction.
Age: 59.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Redness at and around injection site continuing at least 4 days (observed at time of report). Fever, chills body aches, appetite loss, tiredness continuing at least 4 days at time of reported reaction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Patient got ZOSTAVAX on 7/19/17. On 7/20/17 she took off the Band Aid and had a mark from adhesive (allergy to adhesive) and everything else was fine. On 7/21/17 patient noticed her arm felt hot at injection site and it felt bruised when she moves muscle. There is no bruise but we can see a red area at site. There is no rash or itching at site, just hurts and feels hot. Patient does not feel like she needs to see a doctor at this point. She just wanted to let us know.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Scratch
Clinical narrative: Next day following vaccine (07/19/2017) child showing  swelling and redness to about two thirds of the leg with most of the swelling on the lateral side where vaccine injected. Per parent information child started to scratch the area and swelling worsened. when parent brought in child to clinic, parent stated swelling was decreasing compared to how it looked the previous day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Patient called pharmacy on 7/21/17, and reported that after receiving ZOSTAVAX, on 7/19/17, she had a headache, which lasted for about 2 days, as well as a hard, golf ball side bump that is red and itchy at the injection site. As per patient report, the headache was relieved by taking TYLENOL and has subsided. The hard, golf ball size lump is still apparent at the injection site. Advised the patient to take BENADRYL to relief itchiness and redness, and to report to Urgent Care if no relief in symptoms over the weekend.
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, myalgias.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Localized rednes and irritation at site of injection - treatment, monitoring and OTC benadryl and tylenol for inflammation.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: Patient's tongue swelled, he took some benedryl and swelling resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Muscle spasms
Clinical narrative: Cramps; chills; upset stomach.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Dizziness, Feeling abnormal, Panic reaction
Clinical narrative: Dizzy, racing heart, panic/anxiety in the middle of a college lecture, felt like I was going to pass out, felt like I had been hit by a train starting at 11:30am. By 4:30pm I went to bed feeling so horrible.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: Large local skin reaction located distal to injection site, posterior upper arm extending into axilla mild erythema, + swelling and warmth.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness and pain at the injection site.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red and swollen from deltoid elbow.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Pain, Pyrexia
Clinical narrative: Child said she had fever, body aches and shortness of breath in the middle of night for 3 hrs.
Age: 0.08
Sex: M
Vaccine: HIBV
Symptoms: Immediate post-injection reaction, Injection site discolouration, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 8-week-old male patient who received HIBERIX (batch number 2S27K, expiry date 17th September 2017). Co-suspect products included HIBERIX (batch number 4294M, expiry date 20th January 2018), HIBERIX (batch number 5FC3Z, expiry date 20th January 2017), HIBERIX (batch number 4B745, expiry date 23rd February 2018) and MENVEO. On 2nd February 2017, the patient received the 1st dose of HIBERIX. On 12th April 2017, the patient received the 2nd dose of HIBERIX. On 7th June 2017, the patient received the 3rd dose of HIBERIX. On an unknown date, the patient received HIBERIX and MENVEO at an unknown dose. On 2nd February 2017, immediately after receiving HIBERIX and not applicable after receiving HIBERIX, HIBERIX, HIBERIX and MENVEO, the patient experienced injection site hyperpigmentation. On 12th April 2017, the patient experienced injection site hyperpigmentation. On 7th June 2017, the patient experienced injection site hyperpigmentation. On an unknown date, the patient experienced injection site hyperpigmentation and injection site hyperpigmentation. Rechallenge with HIBERIX was positive. Rechallenge with HIBERIX was positive. Rechallenge with HIBERIX was positive. On an unknown date, the outcome of the injection site hyperpigmentation, injection site hyperpigmentation and injection site hyperpigmentation were recovered/resolved and the outcome of the injection site hyperpigmentation and injection site hyperpigmentation were unknown. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported. After the administration of HIBERIX a black dot was left on the patient, may be MENVEO as well. The black dot had not gone away from the patients after months of administration. The health care professional said that it may be up to six patients and 4 different lots. Only two patients information was given. When probing a little more the health care professional felt it could be MENVEO as well. The spots appear immediately, at the time of vaccination, after vaccination. The reported lot number (2527K) for HIBERIX did not exist and was updated to 2S27K, according to sales database. This is 1 of the 2 reports reported by same reporter.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema multiforme, Swelling
Clinical narrative: Erythema Multiform and swelling.
Age: 18.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Chest pain, Fear, Malaise, Oropharyngeal pain, Presyncope
Clinical narrative: 07/21/2017 Patient was here in clinic for immunization appointment. During appointment she stated she had been recently injured and needed a Tetanus shot. Other immunizations available were reviewed with her and she stated she did not want to get the HPV9 immunization. She stated she did want the Hepatitis A Vaccine, tetanus immunization, and the meningococcal vaccine. Immunizations were drawn up and forms were completed in EHR. Patient was alert and oriented and cousin was at her side. She did state to me and her cousin that she was extremely scared of shots. Right deltoid area cleansed with alcohol and administered HAV IM and covered with bandaid. Area below in the right deltoid muscle cleansed with alcohol and Td was administered. As soon as this bandaid was applied patient stated she did feel well. I applied a instant ice compress to her chest and one to her neck. Patient remained conscious at all times. I called for help in patient care. Ammonia inhalant opened and waved under nostril a few times and patient commented about odor of it. She stated her throat was sore and her chest was hurting. I asked her if I could call a ambulance and she stated she was scared. I called 911 and told them I needed an ambulance immediately. B/P was taken and was 93/61. Heart rate was 88. Wet wash cloths applied to patients for head and neck. She remained conscious but kept complaining of chest pain and a very sore throat. Two first responders arrived. We were in the process of applying oxygen when the ambulance service arrived. The patient stood, turned and sat on the stretcher. She was taken to the ambulance. There a EMT tried to start an IV in her left antecubital area with no success times. I started a IV in her right antecubital area and it was flushed. EMT administered meds, through it per IV push. Patient transferred to Hospital where she was seen per MD. He stated he thought it was a vasovagal response from fear of injections. Once patient's caregiver and Mother arrived at hospital I returned to the clinic.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Bandaemia, Chest X-ray normal, Chest pain, Chills, Differential white blood cell count normal
Clinical narrative: Approx 1 HR after receiving vaccines started to have chills, leg pain, chest pain, headache, heart racing, felt hot. Went to Hospital ER and was seen 20:31, Had fever, given ATIVAN, Decadron, TORODOL. Had UA, EKG, Drug screen, CBC w/diff, chest XRay. All normal (except Leukocytosis w/bandemia. Later WBC down and Afebrile. Diagnosis SITS-Systemic inflammatory Response Syndrome.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Drug screen negative, Electrocardiogram normal, Feeling hot, Full blood count, Headache
Clinical narrative: Approx 1 HR after receiving vaccines started to have chills, leg pain, chest pain, headache, heart racing, felt hot. Went to Hospital ER and was seen 20:31, Had fever, given ATIVAN, Decadron, TORODOL. Had UA, EKG, Drug screen, CBC w/diff, chest XRay. All normal (except Leukocytosis w/bandemia. Later WBC down and Afebrile. Diagnosis SITS-Systemic inflammatory Response Syndrome.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Leukocytosis, Pain in extremity, Palpitations, Pyrexia, Systemic inflammatory response syndrome
Clinical narrative: Approx 1 HR after receiving vaccines started to have chills, leg pain, chest pain, headache, heart racing, felt hot. Went to Hospital ER and was seen 20:31, Had fever, given ATIVAN, Decadron, TORODOL. Had UA, EKG, Drug screen, CBC w/diff, chest XRay. All normal (except Leukocytosis w/bandemia. Later WBC down and Afebrile. Diagnosis SITS-Systemic inflammatory Response Syndrome.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: Approx 1 HR after receiving vaccines started to have chills, leg pain, chest pain, headache, heart racing, felt hot. Went to Hospital ER and was seen 20:31, Had fever, given ATIVAN, Decadron, TORODOL. Had UA, EKG, Drug screen, CBC w/diff, chest XRay. All normal (except Leukocytosis w/bandemia. Later WBC down and Afebrile. Diagnosis SITS-Systemic inflammatory Response Syndrome.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: 24-48 hrs. after getting vaccine arm (L. Deltoid) became red, swollen, blistering and painful. May have gone swimming in lake day after vaccine. Never told or showed arm to mom. Came into Dr. office 7/18/17 with redness and blistering after showing mother. Given local antibiotic cream-mupirocin.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 17-year-old female patient who received BEXSERO (batch number 168101, expiry date 30th November 2018). Concomitant products included MENACTRA and Tuberculin PPD. On 3rd July 2017, the patient received the 1st dose of BEXSERO (intramuscular). On 3rd July 2017, several minutes after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown. The reporter considered the extensive swelling of vaccinated limb and injection site erythema to be almost certainly related to BEXSERO. Additional details were reported as follows: This case was reported by a Medical Assistant (MA). The patient received BEXSERO in the left deltoid. On the same day, the patient received MENACTRA in the right deltoid and tuberculin purified protein derivative (PPD) on the left arm concomitantly. It was reported that the patient had swelling and redness at the injection site down to the elbow.
Age: 1.17
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Feeling abnormal, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Mom called today (7/17/17) and reports that a rash came up on child and has very fine red bumps that is spread all over body mom also says that a night child runs a fever and gets miserable. Has MD appt on Wednesday (7/19). Rash still present but only has fever at night.
Age: 50.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Nerve injury, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's left arm became red, swollen, and painful. Patient was given a steroid pack on 7/10 to relieve swelling and redness.  Patient still has pain radiating from left shoulder to left elbow as of 7/22/17.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Headache, chills, subjective fever, n/v/d, and redness/swelling around injection site.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, chills, subjective fever, n/v/d, and redness/swelling around injection site.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PT PRESENTED 7/22 WITH REDNESS, WARMTH, AND SLIGHT SWELLING OF THE LEFT ARM NEAR THE INJECTION SITE. IT BEGAN 7/21, ONE DAY AFTER RECEIVING THE VACCINE. PT STATED IT HAD IMPROVED SLIGHTLY, BUT WAS STILL BOTHERSOME. RECOMMENDED USING AN ICE PACK.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient came back to the pharmacy on 7/21 and complained of neck pain, headache and nausea. He said his arm hurt when he raised it. The area of the injection looked good, not red or hot to the touch.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Developed hives almost immediately on the back of thighs. Now there are large welts/hives present on all extremities.