chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health care worker (C.M.A) who refers to a patient of unknown age. On 21APR2015, the patient was vaccinated with VARIVAX 0.5 ml/ a dose subcutaneous. The healthcare worker reported a single dose of VARIVAX that expired on 31JAN2015 (supported) was inadvertently administered to a patient. No adverse effects reported. The outcome of expired product administered and no adverse event is unknown. No further information was provided. Additional information was provided. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 68 year old patient. On 23-APR-2015 the patient was vaccinated with VARIVAX (Merck) dose 1, .5 ml. No co suspect were reported. No relevant medical history were reported. On 23-APR-2015, 1 day after onset of therapy the patient experienced wrong drug administered. No concomitant medication or treatment were reported. The outcome of wrong drug administered is unknown. Action taken with the suspect drug is unknown. The reporter considered wrong drug administered to be not related to VARIVAX (Merck). Additional information is not expected.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper thigh bright red with extension to below the knee, with mild swelling. Redness was slight at time of exam-no swelling.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site. (4-5 days). TX-apply ice, seen by PCP, Abx given. No fever or itching noted.
Age: 73.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Had redness at injection site about size of baseball not warm. Patient denies itching. Patient informed by PCP to apply BENADRYL cream to area.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Vomiting, chills, nausea with 1 hour of administration. ZOFRAN 8 mg tid prn nausea.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Erythema, Local swelling, Pain, Skin warm
Clinical narrative: Area of increased redness, swollen, warm to touch. SOB like someone sitting on chest. Area of redness has improved-still pain laying or leaning on it, itchy-mottled. SOB unchange.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella like rash.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Local rxn to rt thigh. Erythema, induration, 10.5 cm x 7 cm.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site rash
Clinical narrative: Mild rash at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Abdominal pain, Apnoea, Blood glucose normal, Crying, Cyanosis
Clinical narrative: 5/1/2015 Pt received vaccines DTaP and MMR and w/in 2-5 minutes, mom noted that pt was turning pale and witnessed pt "slumped over" and fell backwards while sitting on chair in exam room. Pt. was picked up and laid supine on floor. Pt. was noted to be apneic, pale, with perioral cyanosis, with copious oral secretions from mouth, eyes were rolled back. Pt was noted to be tonic with increased tone in extremities x 4. Additional help was summoned for as well as airway/emergency kit was retrieved. As suction was about to be applied to oral cavity pt. regained consciousness with return of color to face. Pt. had carotid/radial pulse present throughout event. Paramedics 911 was called but cancelled when pt. regained consciousness and cried. Vitals taken. Pulse 101 POX 98% RA BP 82/60 Blood glucose 123. Exam unchanged from 30 min prior. No focal findings on neuro exam. Pt. was observed in office for 90 minutes during which time, pt was postictal for about 45-55 minutes. After which pt regained normal disposition, laughing, smiling and telling jokes. Pt c/o of abd pain and was subsequently given Rx for azithromycin x 5 d as brother has strep (+). Gave mom referral for neurology outpt ASAP. Will telephone f/u with mom in next few days. Pt to return or mom to call for any concerns, observing for any neuro changes or vomiting or any abnormality.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Drooling, Eye movement disorder, Fall, Hypertonia, Neurological examination normal
Clinical narrative: 5/1/2015 Pt received vaccines DTaP and MMR and w/in 2-5 minutes, mom noted that pt was turning pale and witnessed pt "slumped over" and fell backwards while sitting on chair in exam room. Pt. was picked up and laid supine on floor. Pt. was noted to be apneic, pale, with perioral cyanosis, with copious oral secretions from mouth, eyes were rolled back. Pt was noted to be tonic with increased tone in extremities x 4. Additional help was summoned for as well as airway/emergency kit was retrieved. As suction was about to be applied to oral cavity pt. regained consciousness with return of color to face. Pt. had carotid/radial pulse present throughout event. Paramedics 911 was called but cancelled when pt. regained consciousness and cried. Vitals taken. Pulse 101 POX 98% RA BP 82/60 Blood glucose 123. Exam unchanged from 30 min prior. No focal findings on neuro exam. Pt. was observed in office for 90 minutes during which time, pt was postictal for about 45-55 minutes. After which pt regained normal disposition, laughing, smiling and telling jokes. Pt c/o of abd pain and was subsequently given Rx for azithromycin x 5 d as brother has strep (+). Gave mom referral for neurology outpt ASAP. Will telephone f/u with mom in next few days. Pt to return or mom to call for any concerns, observing for any neuro changes or vomiting or any abnormality.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pallor, Postictal state, Posture abnormal
Clinical narrative: 5/1/2015 Pt received vaccines DTaP and MMR and w/in 2-5 minutes, mom noted that pt was turning pale and witnessed pt "slumped over" and fell backwards while sitting on chair in exam room. Pt. was picked up and laid supine on floor. Pt. was noted to be apneic, pale, with perioral cyanosis, with copious oral secretions from mouth, eyes were rolled back. Pt was noted to be tonic with increased tone in extremities x 4. Additional help was summoned for as well as airway/emergency kit was retrieved. As suction was about to be applied to oral cavity pt. regained consciousness with return of color to face. Pt. had carotid/radial pulse present throughout event. Paramedics 911 was called but cancelled when pt. regained consciousness and cried. Vitals taken. Pulse 101 POX 98% RA BP 82/60 Blood glucose 123. Exam unchanged from 30 min prior. No focal findings on neuro exam. Pt. was observed in office for 90 minutes during which time, pt was postictal for about 45-55 minutes. After which pt regained normal disposition, laughing, smiling and telling jokes. Pt c/o of abd pain and was subsequently given Rx for azithromycin x 5 d as brother has strep (+). Gave mom referral for neurology outpt ASAP. Will telephone f/u with mom in next few days. Pt to return or mom to call for any concerns, observing for any neuro changes or vomiting or any abnormality.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Nodule, Pain, Pruritus, Swelling
Clinical narrative: Pt. started having soreness and itching on 5/3/15. Noticed some swelling. Pt. been feeling tired all weekend. Knot noted to left arm 1/75 in. from top of shoulder and 2in. wide.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to an over the age of 60 year old Adult male patient. Concurrent conditions, medical history and allergies were not reported. On an unspecified date in February 2015, the patient was vaccinated with a dose of ZOSTAVAX, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date in 2015 (reported as "recently"), the patient experienced injection site pain which was described as "deep tissue soreness". The patient sought medical attention on an unspecified date. There was unspecified if treatment was given for the adverse event and if lab diagnostics studies were performed. The outcome of injection site pain was reported as recovered/resolved on an unknown date in 2015. The relatedness between injection site pain and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (also the site supervisor) referring to unspecified number of patients of unknown age and gender. On an unknown date in March 2015 or April 2015, the patients were vaccinated with improperly stored ROTATEQ orally (dose number, dose and lot# not reported). No symptoms reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 01-MAY-2015 the patient was inadvertently vaccinated with an expired dose of 2 ml ROTATEQ (lot # J010984, expiration date 23-APR-2015), oral (expired product administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (also the site supervisor) referring to unspecified number of patients of unknown age and gender. on an unknown date in March 2015 or April 2015, the patients were vaccinated with improperly stored PEDVAXHIB (dose number, dose, route and lot# not reported). No symptoms reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) lot # K020758 with expiration date: 31-OCT-2016 and lot number (reported as) L000453, expiration date: 06-JAN-2017 (administration route was not reported). No concomitant therapies were reported. The vaccine doses that were administrated were exposed to a support temperature excursion (+1C for 4.5 hours) on unspecified dates. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with a dose of VARIVAX (Merck) (lot # K006132, Exp. 29-APR-2015, K016131 Exp. 23-SEP-2016, K020758 Exp. 31-OCT-2016) subcutaneous, which was exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse events were observed or reported. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 year old patient of an unknown gender. Concurrent conditions medical history and allergies were not reported. On 31-MAR-2015, the patient was vaccinated with a single dose of PNEUMOVAX 23, 0.5 ml, intramuscular, (lot # K005957, expiration date: 08-MAR-2015), inadvertently which had expired. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (also the site supervisor) referring to unspecified number of patients of unknown age and gender. On an unknown date in march 2015 or April 2015, the patients were vaccinated with improperly stored VARIVAX (dose number, dose, route and lot# not reported). No symptoms reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (dose, route and lot number not provided). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (also the site supervisor) referring to unspecified number patients of unknown age and gender. On an unknown date in March 2015 or April 2015, the patients was vaccinated with improperly stored PNEUMOVAX 23 (dose number, dose, route and lot# not reported). No symptoms reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 51 year old female patient with no current illness at the time of vaccination. On the 16-Sep-2014, the patient received AFLURIA (batch number T58006) dose 1 via the intramuscular route in the right arm. The patient also received ZOSTAVAX (batch number K000327) via the subcutaneous route in the left arm. On the 17-Sep-2014, the patient developed a raised red area at the injection site. On the 29-Sep-2014, the patient presented to the pharmacy. The patient felt like it was full of fluid the previous night. It was agreed with the primary care physician that it was an injection site reaction and no treatment was necessary. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out-of-specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically-derived process control limits. In conclusion, there were no batch-related issues identified that may have caused the adverse events reported. Follow-up (23-Apr-2015): Batch Record Review results.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 59 year-old male patient. On 15-Sep-2014, the patient received AFLURIA vaccine (batch number T58006) in the left arm. On the same day, the patient also received PNEUMOVAX (batch K009105) in the left arm. On 15-Sep-2014, the patient experienced red and sore on the left upper arm. He went to the doctor and was diagnosed with cellulitis. Outcome was unknown. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out of specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically derived process control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported. Reporter's comments: The regulatory authority assessed the events as non-serious. Follow-up (23-Apr-2015): Batch Record Review results.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Skin infection, Swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 34 year-old female patient. On 26-Sep-2014, the patient received AFLURIA vaccine (batch number T58006), in the left arm. On the same day, the patient also received PNEUMOVAX (batch number K007822) in the left arm. On 26-Sep-2014, the patient experienced redness, swelling and pain. She went to the emergency room for a skin infection and received antibiotic. Outcome was reported as recovered. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seed lot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seed lot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seed lot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out of specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically derived process control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported. Reporter's comments: The regulatory authority assessed the events as non-serious. Follow-up (23-Apr-2015): Batch Record Review results.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Vaccination complication
Clinical narrative: This medically confirmed health authority report (initial receipt 02-Dec-2014) concerns a 60 year old female patient. On an unspecified date, the patient received AFLURIA, (batch number T58006) via the intramuscular route in the left arm. On an unspecified date, five minutes after the patient was administered the AFLURIA shot, the patient felt tingling sensation on both sides of her forehead. Her blood pressure was 206/110 with a pulse of 85. She was rushed to her doctor who is at the same building who monitored her and told her it is from the flu shot. The patient went to the Emergency Room. Outcome was recovered. Reporter comments: The regulator reported the case non-serious and reported the term 'vaccination complication'. Batch record review for lot T58006 noted; Batch records and QA batch review checklists for the seedlot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out-of specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically-derived process control limits. In conclusion, there were no batch-related issues identified that may have caused the adverse events reported. Follow-up (23-Apr-2015): Batch Record Review results.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Erythema, Hypersensitivity, Skin warm
Clinical narrative: This medically confirmed health authority report (initial receipt- 15-Dec-2014), concerns a 46 year old female patient with no current illness. On 25-Oct-2014, the patient received AFLURIA (batch number: T58006) in the right arm. The same day, the patient also received PNEUMOVAX (batch number: K009106) in the right arm and ADACEL (batch number: U4869AA) in the left arm. On 26-Oct-2014, the patient experienced redness and hot in the right arm. the patient was treated in the emergency room for allergic reaction/cellulitis. The patient was prescribed antibiotics and steroids. The outcome was reported as recovered. Reporter comments: The health authority assessed the events as non-serious. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out-of-specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically-derived process control limits. In conclusion, there were no batch-related issues identified that may have caused the adverse events reported. Follow-up (23-Apr-2015): Batch Record Review results.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Headache, Peripheral swelling, Skin warm
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 51 year-old female patient. On 23-Oct-2014, the patient received subcutaneous AFLURIA (batch number T58006) and subcutaneous PNEUMOVAX (batch number K009105). Both vaccines were administered in the left arm. On the 25-Oct-2014, the patient presented with headache and red/warm swollen arm which started on 24-Oct-2014. Patient was sent to the Emergency Room. She was diagnosed with cellulitis, hospitalised for 1 day, and sent home with antibiotic. The outcome was unknown. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out of specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically derived process control limits. In conclusion, there were no batch related issues identified that may have caused the adverse events reported. Reporter's comments: The regulatory authority assessed the case as serious (led to hospitalisation), and reported the symptom of 'local swelling'. Follow-up (23-Apr-2015): Batch Record Review results.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: Case number PHHY2015US033867, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554359) website on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 360073) on 26 Mar 2015, with the follow-up information received from Quality Assurance Department  (reference number: 360073) on 22 Apr 2015. This report refers to a 75-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 1413301), along with PNEUMOVAX (other manufacturer, batch number: K007773) intramuscularly into the left arm on 07 Oct 2014. On 08 Oct 2014, the patient developed cellulitis in arm from shoulder down to elbow. Further, the patient had severe pain and redness. The outcome of the events was complete recovery. The events were assessed as non-serious. The causality assessment of the events was not reported. Seriousness of the event cellulitis in arm from shoulder down to elbow was upgraded based on NVS-IME list. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1413301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 360073) on 26 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 360073) on 22 Apr 2015: Updated FLUVIRIN batch review report.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Musculoskeletal stiffness, Neuralgia, Radiculitis brachial
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a 42 year old female patient who had no current illness at the time of vaccination, no medical history and no medications at the time of vaccination. On the 01-Oct-2014, the patient received AFLURIA (batch number T58006) via the intramuscular route in the left arm. On the 04-Oct-2014, the patient was diagnosed with brachial neuritis. The patient had a stiff neck and arm, nerve pain and spasms. Treatment included steroids and cyclobenzaprine. Outcome was unknown. Reporter comments: the regulator reported the case as non-serious. Batch record review for lot T58006 noted: Batch records and QA batch review checklists for the seedlot, MPH, formulated bulk vaccine and filling and inspection were inspected to determine if there were any issues or atypical events during processing which could be considered to be related to the adverse events reported. No events or results were identified which could be considered to be related to the adverse events reported. All deviations relating to the seedlot, MPH, formulated bulk vaccine and finished product lot T58006 were reviewed and none were considered to have contributed to the adverse events reported. All QC test results for the seedlot, MPH, formulated bulk vaccine and finished product process stages associated with lot T58006 were reviewed, and all results were satisfactory with no out-of-specification results reported. Trend analysis of the product attributes which were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically-derived process control limits. In conclusion, there were no batch-related issues identified that may have caused the adverse events reported. Follow-up (23-Apr-2015): Batch Record Review results.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Admitted to Hospital 11/11/2014.
Age: 1.37
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: MOC noted redness to the leg the afternoon after administration, worsened through night.  At time of assessment in office these were the findings: LEFT UPPER THIGH 7CM X 9 CM ERYTHEMATOUS (SPLOTCHY) SLIGHTLY RAISED AREA, NOT HOT TO TOUCH , MINIMALLY TENDER, NL GAIT, NO LIMP , RIGHT UPPER LEG CIRCUMFERENCE 10.5 INCHES VS LEFT UPPER LEG 11.25 INCHES.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site reaction (swelling, redness and itching).
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, Incorrect route of drug administration, No adverse event
Clinical narrative: Patient was administered a ProQuad (MMR/Varicella) vaccine IM (intramuscular) in the left arm, when it should have been given SC. A second dose of Proquad given in Left arm subcutaneously. Parent notified of the incident. Child monitored, appears in no distress. Parents given information about what to expect after the shots, VIS given, and "after the Shots sheet" with information about what to expect after the shots. Phone number of clinic provided to patients to call if any questions.
Age: 0.54
Sex: M
Vaccine: DTAPIPV, FLU4, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable health care professional who reported on behalf of a physician. A 66 years old female patient received PREVNAR 13 on 22Apr2015 at 0.5 ml single. Medical history included hypertension, vitamin D deficiency reflex and colon problems. Concomitant medications were not provided. Reporter mentioned that on 22Apr2015 PREVNAR 13 was the only product administered to the patient. On 24Apr2015 the patient experienced local cellulitis and pain at and below the injection site. Events outcome was not provided.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Autoimmune disorder, Death, Eating disorder, Respiratory disorder
Clinical narrative: After flu shot developed autoimmune disease which kept her from eating and eventually her airway which led to her death 3-25-15.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Apparent life threatening event, Autoimmune disorder, Death, Feeding disorder, Respiratory disorder
Clinical narrative: After flu shot developed autoimmune disease which kept her from eating and eventually her airway which led to her death 3-25-15.
Sex: F
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a nurse refers to a female child "under 2 years old". Concurrent conditions and medical history were not reported. The patient received three doses of ROTATEQ (oral; lot number, dose, frequency not reported) however the reporter did not have dates of vaccination at a time of a call. On unknown date, the patient was hospitalized for three days due to unknown reason. The reporter stated that the patient was seen for follow up appointment approximately in April 2015 (reported as "last month") and "was doing great" (recovering/resolving). The causality assessment was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: After injection (1 d later) injection site red and swollen 4 cm x 6 cm. No noted fever.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not provided. On an unknown dates, the patients were vaccinated three doses of hepatitis b vaccine (manufacturer unknown) (dose, frequency, route of administration and indication were not provided). The patients had titers drawn on an unspecified date, which had shown that the patients did not have immunity to hepatitis B. The outcome of event was unknown. No product quality complaint (PQC) was involved. Additional information is not expected as reporter was not willing to participate in the adverse event report.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Diarrhoea, Faeces discoloured, Irritability, Pyrexia
Clinical narrative: Information was received from the parents of a 5 year old male patient with no pertinent medical history. On 05-JAN-2010, the patient received a routine vaccination with RECOMBIVAX HB (dose and route of administration not provided). Subsequent doses of RECOMBIVAX HB were received on 09-MAR-2010, 09-JUN-2010, and 12-AUG-2010. There were no concomitant medications. The parents explained that their son had adverse reactions after receipt of RECOMBIVAX HB with specific symptoms reported as: developing a fever of up to 104F, "yellowey" runny stools, pain in his joints, and irritability that lasted several days after receiving each dose. The parents stated that the symptoms began shortly after receipt of each dose and lasted for about 1 week. The patient experienced the same symptoms after receiving M-M-R II and VARIVAX (Merck) (WAES#1505USA001794). The patient has not had any further vaccinations with any of these products since 2011. The physician's office was called and treatment was reported as MOTRIN and tepid bath. The patient recovered about 1 week after each vaccination. No further information was provided. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Tdap administered on 4/29/15 and on 4/30/15 left arm began to swell with redness noted to upper arm. Itching also noted to upper region. Patient took ibuprofen at home. Seen in clinic on 5/5/15 and prescribed CLARITIN, warm compresses and MEDROL dose pak.
Age: 0.17
Sex: U
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 8 week old patient of unknown gender. On 30-AUG-2014, the patient was vaccinated, at another facility, with what may have been either PREVNAR or PNEUMOVAX 23 (route of administration and dose were not reported, lot reported as: H45594, expiry date not reported). No adverse effect was reported. Additional information is not expected, because there is not consent to contact the reporter.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to a 66 year old male patient. In approximately 2012, three years ago the patient was vaccinated with a dose of ZOSTAVAX, 19400 plaque forming unit (PFU) (subcutaneous, 0.65 ml, 1 dose, lot# and expiration date were unknown). In approximately 2013, two years ago the patient experienced shingles after receiving the vaccine. The outcome of shingles was unknown. The relationship of shingles and ZOSTAVAX was not reported. Additional information is not expected as the pharmacist did not wish to be contacted and did not wish to provide physician demographics.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a office manager regarding several unspecified patients of unknown age and demographics. The patients concurrent condition and medical history was not provided. On or after 12-FEB-2015 at unspecified times, the patients were vaccinated with improperly stored GARDASIL lot # K001631; expiration date: 06-NOV-2016 and lot # K007828; expiration date: 02-MAR-2017. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Faeces discoloured, Irritability, Pyrexia
Clinical narrative: Information was received from the parent of a 5 year old male patient with no pertinent medical history. On 11-MAR-2011, the patient received route vaccinations with MMR II (dose and route of administration not provided) and (Merck) VARIVAX (dose and route of administration not provided). There were no concomitant medications. The parents explained that their son had adverse reactions after receipt of the MMR II and (Merck) VARIVAX with specific symptoms reported as: developing a fever of up to 104F, "yellowey" runny stools, pain in his joints, and irritability that lasted several days after receiving the vaccinations. The parents had experienced the same symptoms after receiving multiple doses of RECOMBIVAX HB (WAES#1504USA024423). The pateitn has not had any further vacciantions with any of these products since 2011. The physician's office was called and treatment was reported as MOTRIN and a tepid bath. The patient recovered about 1 week after the vaccinations. No further information was provided. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Rash erythematous, Vaccination site pain, Vaccination site reaction
Clinical narrative: Client has pink rash that is tender to the touch about 2cmX 2.5cm on right arm where vaccine was given. No fever, no signs of infection noted. HPV was given 5.5 weeks after 1st dose. Vaccine given during school outreach.
Age: 53.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Blister, Injection site reaction, Polymerase chain reaction, Rash vesicular, Scab
Clinical narrative: Vesicular rash on RUE (near site of injection) and throughout (face, chest, back, bilateral upper extremities) in various stages (some encrusted, some intact vesicles).
Age: 53.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Varicella virus test
Clinical narrative: Vesicular rash on RUE (near site of injection) and throughout (face, chest, back, bilateral upper extremities) in various stages (some encrusted, some intact vesicles).
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Anaphylactic reaction, Cough, Crying, Immediate post-injection reaction, Respiratory distress
Clinical narrative: Coughing immediately after vaccination. Coughing led to stridor and respiratory distress. Within one minute, the adverse event was recognized as anaphylaxis. 1 dose of epi-junior was administered in her left thigh. Over the next five minutes patient's respirations returned to normal with a slight cough and occasional stridor when crying.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Stridor
Clinical narrative: Coughing immediately after vaccination. Coughing led to stridor and respiratory distress. Within one minute, the adverse event was recognized as anaphylaxis. 1 dose of epi-junior was administered in her left thigh. Over the next five minutes patient's respirations returned to normal with a slight cough and occasional stridor when crying.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient had a history of shingles in the past. On an unspecified date in 2011 the patient was vaccinated with ZOSTAVAX (strength, lot#, dosage and route unspecified). On an unspecified date in May 2014 the patient had an outbreak of shingles. The patient was recovered on an unspecified date. Varicella zoster virus packet offered to pharmacist and declined. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: BLISTERS AROUND A LARGE AREA OF INJECTION SITE (LEFT ARM).
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Chest discomfort, Hypersensitivity, Musculoskeletal chest pain, Swelling
Clinical narrative: Approx 15 min after injection in R deltoid, patient noted "tightening", pain, swelling and hypersensitivity of the muscles and soft tissues of the L upper anterior chest wall. She described the swelling as approximately the size of her palm. No unusual rxn at injection site. No pulmonary, cardiac or systemic sx. Sx continued to increase for about 12 hours, but by the next morning had subsided by about 75%. At 4 days post-incident, sx resolved by about 95%. It is interesting to note that vaccine administrators at this facility who are very familiar with the anthrax vaccine, have noted a significant increase in adverse reactions to this particular lot of vaccine in other patients including 1 anaphylactic reaction.
Age: 0.3
Sex: M
Vaccine: DTAP, HEPAB, MMR
Symptoms: Death
Clinical narrative: Death.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and current conditions were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA (dose, frequency, route of administration, lot# and expiration date were not reported) all of which underwent a supported temperature excursion on an unknown date. No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 27-APR-2015 the patient was vaccinated with improperly stored PEDVAXHIB of dose 0.5 ml via intramuscular route. Also reported that the patient was vaccinated with M-M-R II (date unspecified) (medication error). No adverse effects were reported. Product quality complaint was not reported. The outcome of the events was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, FLUN4, HPV4, MEN, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to an 11-year-old male patient with Horner's syndrome. On the following dates: 04-SEP-2014, 05-JAN-2015, and 29-APR-2015, the patient received all three doses of GARDASIL injection, administered intramuscularly in the left arm (strength, dose, lot# and expiry date unspecified for all). It was also stated that the patient received his 2nd and 3rd doses at 5 and 8 months after the 1st dose, which was other-than-indicated in the Prescribing information. Concomitant therapies included meningococcal vaccine (unspecified) and FLUMIST and T-DAT. On 04-SEP-2014, the patient fainted 8 times after receiving the 1st dose of GARDASIL. The patient sought unspecified medical attention. No treatment was given and no laboratory tests were performed. Therapy with GARDASIL was continued. The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients. On an unknown date, the patients were vaccinated with GARDASIL (lot # J010668, expiration date 29-APR-2016, lot # K007264, expiration date 02-MAR-2017) (dose, route and site of administration were not reported) post vaccine excursion. No adverse effects were noted. Additional information has been requested. This is one of several reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with incorrectly stored VARIVAX (Merck) (lot number J006695, expiry date 30-MAY-2015) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse event was reported. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VARIVAX (Merck) was unknown. There was no product quality issue reported. This case is linked to case number 1504USA022809 via same reporter link. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: MMR
Symptoms: Generalised erythema, Rash
Clinical narrative: This spontaneous report as received from the patient's grandmother refers to a 15 month old female patient. On 05-FEB-2015 the patient was vaccinated with M-M-R II (lot number not reported, circular # uspi-v205c-i-1406r004). On 07-FEB-2015, 3 days after onset of therapy the patient experienced rash. It was also reported that since the patient was vaccinated with M-M-R II, whenever she eats watermelon, yogurt, dairy, egg, cheese and pickles she becomes red all over her body and face. The patient did seek medical attention with office visit. Treatment included corn starch on her body and oatmeal bath. It was reported blood work was done for allergies (results not reported). The outcome of rash is unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and current conditions were not reported. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (dose, frequency, route of administration, lot# and expiration date were not reported) all of which underwent a supported temperature excursion on an unknown date. No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.