chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company employee refers to a patient of unknown gender and unknown age. It was reported that on an unspecified day in February 2014, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, dose number, lot/batch number were not reported). On an unknown date, approximately in 2014 (couple of week ago), the patient was diagnosed with shingles. The outcome of shingles was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot# and expiration date not provided) (dose not reported). On an unknown date the patient received dose of VARIVAX (Merck) that was exposed to temperature above the recommended temperature range. No adverse effect was reported. This is one of several reports from the same reporter (Same Reporter Link: MARRS#1405USA014687, MARRS#1405USA015421, MARRS#1405USA015422, MARRS#1405USA015423). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to five patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (lot# was not reported) which were improperly stored. No adverse events was reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: This spontaneous report as received from a physician refers to an 11 year old female patient. On an unknown date, the patient was vaccinated with a second 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly. The physician reported that the patient had not a menstrual period for the past 3 months after receiving GARDASIL. The outcome of had not a menstrual period for the past 3 months was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to unspecified patients of unknown age. On an unknown date the unspecified patients was vaccinated with ZOSTAVAX (lot# not reported) (start date, dose, route not reported). It was reported that unspecified patient developed shingles after receiving ZOSTAVAX. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to five patients of unknown age. On an unknown date the patients was vaccinated with ROTATEQ (lot# was not reported) which were improperly stored. No adverse events was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (lot# and expiration date not provided) (dose not reported). On an unknown date the patient deceived dose of VARIVAX that was exposed to temperature above the recommended temperature range. No adverse effect was reported. This is one of several reports from the same reporter (Same Reporter Link: MARRS#1405USA014687, MARRS#1405USA015420, MARRS#1405USA015422, MARRS#1405USA015423). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with unspecified improperly stored doses of GARDASIL (lot # not reported) that were exposed to 33.6 F for 1 hour. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with unspecified improperly stored doses of ROTATEQ (lot # not reported) that were exposed to 33.6 F for 1 hour. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Gastrointestinal disorder
Clinical narrative: Gastrointestinal side effects.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Mechanical urticaria, Pyrexia, Upper respiratory tract infection, Urticaria
Clinical narrative: Day after vaccine developed fever and URI symptoms. Since then has urticaria and dermatographia.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure 8 days after administration of MMR and VZV.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left arm, started on KEFLEX oral antibiotics. Worsening cellulitis, sent to ED.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient reports low grade fever on day of admin. Presented to pharmacy with hard, red injection site that was warm to touch. Site surrounded by large swollen area of light red skin approx. 8" in diameter.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Pain/stiffness, decreased mobility in bicep/arm
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Dermatitis contact, Dry skin, Pruritus, Rash, Skin exfoliation
Clinical narrative: Had contact dermatitis reaction. Rash fine and itching then rash became worse and ended with dry scaling skin. Mom took to doctor. Had same reaction to PPD test given 6-2-14.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Heart rate increased
Clinical narrative: 5-19-14 - GARDASIL vaccine given at local health dept. 5-27-14 - pt mother calls health dept to state patient has been reporting problems since "night of injection". S/S include rapid heart rate, no appetite, diarrhea and dizzy. Took her to local health clinic - no dx made, no treatment, s/s persist. I enc take her to E.R. and told her I would do VAERS. I not be able to contact pt or mother since 5-27-14. 3 attempts made.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Malaise, Rash macular
Clinical narrative: At area surrounding injection site (L) deltoid. Pt reports a "red, flat, blotchy rash". Four to five "lesions" in this area that are very tender. These are all approximately nickel-sized. Generalized malaise as well.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Rash to R arm in SQ area, rash red and warm
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Diarrhoea, Erythema, Pain, Pruritus
Clinical narrative: Patient went to MD and diagnosed with cellulitis. Very red, warm to touch, burning pain. Patient also had diarrhea and itchy palms. Patient went to doctor on 6/4/14.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Patient went to MD and diagnosed with cellulitis. Very red, warm to touch, burning pain. Patient also had diarrhea and itchy palms. Patient went to doctor on 6/4/14.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm, tender lump at injection site measuring 7x7 cm.
Age: 0.01
Sex: M
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Incorrect vaccine administered to patient, Hep A was given instead of the Hep B that was ordered.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Local reaction to immunization, no fever. (L) arm with erythema meaning 10x10cm, central induration off aprox 4x4cm. Mother instructed coll compresses.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest pain, Condition aggravated, Dyspnoea, Hyperhidrosis
Clinical narrative: Case number PHHY2012US111095 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 465454) on 04 Dec 2012 with a follow up information received from the quality assurance department (QA reference number: 210168) on 30 May 2014. This case refers to 51-year-old female patient. The patient's medical history included asthma, diabetes and high blood pressure. Concomitant medications included enalapril and hydrocodone/APAP. The patient was vaccinated with FLUVIRIN (batch number: 1204701, expiry date: May 2013) intramuscularly in left arm on 12 Sep 2012. On 12 Sep 2012, approximately 10 minutes after the vaccination, the patient complained of heart palpitation, diaphoresis, chest pain and difficulty breathing. She had to sit down and try to relax. The emergency medical technician (EMT) arrived within 5-10 minutes after which the patient felt better. The EMT concluded that patient needed to be transported to the hospital. EMT also reported that patient had increased blood pressure. The outcome of the events was reported as condition unchanged as of 12 Sep 2012. The causality of the events was not reported. Upon follow up receipt from the quality assurance department (reference number: 210168), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 30 May 2014: Batch summary and expiry date updated.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: Case number PHHY2012US111095 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 465454) on 04 Dec 2012 with a follow up information received from the quality assurance department (QA reference number: 210168) on 30 May 2014. This case refers to 51-year-old female patient. The patient's medical history included asthma, diabetes and high blood pressure. Concomitant medications included enalapril and hydrocodone/APAP. The patient was vaccinated with FLUVIRIN (batch number: 1204701, expiry date: May 2013) intramuscularly in left arm on 12 Sep 2012. On 12 Sep 2012, approximately 10 minutes after the vaccination, the patient complained of heart palpitation, diaphoresis, chest pain and difficulty breathing. She had to sit down and try to relax. The emergency medical technician (EMT) arrived within 5-10 minutes after which the patient felt better. The EMT concluded that patient needed to be transported to the hospital. EMT also reported that patient had increased blood pressure. The outcome of the events was reported as condition unchanged as of 12 Sep 2012. The causality of the events was not reported. Upon follow up receipt from the quality assurance department (reference number: 210168), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 30 May 2014: Batch summary and expiry date updated.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Full blood count, Heart rate increased, Hypotension, Influenza like illness, Intensive care
Clinical narrative: Case number PHHY2012US111144 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 465542) web site on 04 Dec 2012 with a follow up information received from the quality assurance department (QA reference number: 210354) on 30 May 2014. This report refers to a 43-year-old male patient. His current conditions Behcet's autoimmune disease and sore mouth. His concomitant medications were folic acid, tramadol, gabapentin, methotrexate, prednisone and pantoprazole. He was vaccinated with FLUVIRIN (batch number: 1204001, expiry date: 31 May 2013) and PNEUMOVAX (other manufacturer, batch number: 1477AA) both vaccines intramuscularly on to left arm on 24 Aug 2012. On the same date, two hours later vaccination, his arm got swollen and he had fever. The next day he experienced flu like symptoms. He went to the emergency room. Complete blood count was performed and his white blood cell count was high. He also had increased heart rate and hypotension. It was reported that he was hospitalized and was in intensive care unit from 26 Aug 2012 to 09 Sep 2012. The outcome of the events was reported as complete recovery as of 15 Sep 2012. Upon follow up receipt from the quality assurance department (reference number: 210354), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 30 May 2014: Batch summary and expiry date updated.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pyrexia, White blood cell count increased
Clinical narrative: Case number PHHY2012US111144 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 465542) web site on 04 Dec 2012 with a follow up information received from the quality assurance department (QA reference number: 210354) on 30 May 2014. This report refers to a 43-year-old male patient. His current conditions Behcet's autoimmune disease and sore mouth. His concomitant medications were folic acid, tramadol, gabapentin, methotrexate, prednisone and pantoprazole. He was vaccinated with FLUVIRIN (batch number: 1204001, expiry date: 31 May 2013) and PNEUMOVAX (other manufacturer, batch number: 1477AA) both vaccines intramuscularly on to left arm on 24 Aug 2012. On the same date, two hours later vaccination, his arm got swollen and he had fever. The next day he experienced flu like symptoms. He went to the emergency room. Complete blood count was performed and his white blood cell count was high. He also had increased heart rate and hypotension. It was reported that he was hospitalized and was in intensive care unit from 26 Aug 2012 to 09 Sep 2012. The outcome of the events was reported as complete recovery as of 15 Sep 2012. Upon follow up receipt from the quality assurance department (reference number: 210354), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 30 May 2014: Batch summary and expiry date updated.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Hypotension, Paraesthesia, Tachycardia
Clinical narrative: Case number PHHY2012US111206 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 465588) web site on 04 Dec 2012 with a follow up report received from the Quality Assurance department (QA reference number: 210158) on 30 May 2014: This report refers to a 59 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1204401, expiry date: 31 May 2013 intramuscularly on to left arm on 19 Sep 2012. On the same day within 15 to 30 minutes after vaccination, she reported tachycardia with a heart rate of 115 beats per minute, lightheadedness and numb and tingly feet. She was taken to the emergency room. Her oxygen saturation was 96 percent and there was not complaints of dyspnea. Her blood pressure value was 157/76 and heart rate became 109 later The outcome of the event was reported as condition unchanged. Based on the review performed, it was concluded that this batch of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 210158) on 30 May 2014: The expiry date, EMEA labeling and the batch review report were updated.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Amnesia, Headache, Nausea, Tinnitus, Vomiting
Clinical narrative: Case number PHHY2012US110859 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System website (VAERS reference number: 466060) on 04 Dec 2012, with a follow up received from Quality Assurance Department (reference number: 210081) on 30 May 2014: This report refers to a 67-year-old female patient. Her concomitant medications included Epidural steroid on 13 Sep 2012; Trazodone; Tramadol; Levothyroxine and Norco. She was vaccinated with FLUVIRIN (batch number: 1204701 and expiry date: May 2013) intramuscularly in to the right arm along with ZOSTAVAX (other manufacturer, batch number: 0468AE) subcutaneously in to the left arm on 19 Sep 2012. On the same day she experienced headache, nausea, vomiting, memory loss, ear ringing shortly after vaccines were given. Vomiting continued through the night and all symptoms were present 24 hours later also. After 36 hours she started feeling better with memory; however nausea continued even after 48 hours. The final outcome was reported as condition unchanged as on 20 Sep 2012. No further information about seriousness and causality was reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1204701) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received the Quality Assurance Department (reference number: 210081) on 30 May 2014: Updated batch review report.
Age: 79.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Malaise, Varicella
Clinical narrative: Case number PHHY2012US110947 an initial spontaneous report from vaccine adverse event reporting system (VAERS reference number: 466114) on 04 Dec 2012 and a follow up report from the QA department received on 30 May 2014. This case refers 79-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1203901) intramuscularly in right arm and ZOSTAVAX (batch number: 0242AE) intramuscularly in left arm on 07 Sep 2012. On 15 Sep 2012, the patient was ill. She was seen and treated at urgent care. On 28 Sep 2012, the patient was diagnosed with disseminated shingles/chicken pox. The patient was prescribed prednisolone by the physician. The outcome of events was reported as condition unchanged as of an unspecified date. The seriousness of the events was reported as life threatening. The causality of the events was not reported. Based on the document review for the reference number 210082, it was stated that the FLUVIRIN, batch number 1203901 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 30 May 2014: Updated batch review report.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Malaise, Pain in extremity, Tremor
Clinical narrative: Case number PHHY2012US110967 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 466137) web site on 04 Dec 2012, and with a follow up report received from a QA department (reference number: 210086) on 30 May 2014. This report refers to a 72-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1204901, expiry date: 31 May 2013) intramuscularly on to left arm and PNEUMOVAX (batch number: H009826, other manufacturer) intramuscularly on to right arm on 19 Sep 2012. On 21 Sep 2012 she experienced chills and shaking uncontrollably. She was feeling very ill and her both arms were sore. Emergency medical technicians were called. She went to emergency room. The final outcome of the events was reported as complete recovery as of 24 Sep 2012. Based on the document review, it was stated that the FLUVIRIN, batch number 1204901 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from a QA department (reference number: 210086) on 30 May 2014. Updated batch review report and expiry date of vaccine.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Case number PHHY2012US111018 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 466284) web site on 04 Dec 2012, and with a follow up received from Quality Assurance Department (reference number: 210125) on 30 May 2014. This report refers to a 47 year old female patient. Her medical history was not reported. She had flu vaccines in past (unknown) with no reactions. Concomitant medication included PROVENTIL HFA. She was vaccinated with FLUVIRIN (batch number: 1204701, expiry date: May 2013) into the left arm intramuscularly on 18 Sep 2012. On the same day, the patient developed slight swelling of lower lips at home. She took BENADRYL and after 4 hours it went away. The event outcome was completely recovered. Seriousness and causality was not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1204701 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from a QA department (reference number: 210125) on 30 May 2014. Updated batch review report and expiry date of vaccine.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dyspnoea, Hypoaesthesia, Injection site pain
Clinical narrative: Case number: PHHY2012US110957 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 466888) website on 04 Dec 2012 with a follow-up was received from Quality Assurance Department (reference number: 210083) on 30 May 2014. This report refers to a 52-year-old female patient. Her concomitant medication and medical history was not reported. She was vaccinated with FLUVIRIN (batch number: 1204521) intramuscularly in to the right arm on 18 Sep 2012. On the same day after vaccination, she experienced tingling and pain in right arm and hand with overall weakness, localized pain at injection site, faintness, numbness in right hand and shortness of breath. Her condition improved after 15 minutes. Outcome was reported as complete recovery. Batch review report concluded that, based on the document review, it was stated that, the concerned with FLUVIRIN (batch number: 1204521) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No further information about seriousness and causality was reported. Follow up report received from quality assurance department on 30 May 2014: Updated batch review report.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Case number: PHHY2012US110957 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 466888) website on 04 Dec 2012 with a follow-up was received from Quality Assurance Department (reference number: 210083) on 30 May 2014. This report refers to a 52-year-old female patient. Her concomitant medication and medical history was not reported. She was vaccinated with FLUVIRIN (batch number: 1204521) intramuscularly in to the right arm on 18 Sep 2012. On the same day after vaccination, she experienced tingling and pain in right arm and hand with overall weakness, localized pain at injection site, faintness, numbness in right hand and shortness of breath. Her condition improved after 15 minutes. Outcome was reported as complete recovery. Batch review report concluded that, based on the document review, it was stated that, the concerned with FLUVIRIN (batch number: 1204521) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No further information about seriousness and causality was reported. Follow up report received from quality assurance department on 30 May 2014: Updated batch review report.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: C-reactive protein increased, Erythema, Injected limb mobility decreased, Leukocytosis, Local swelling
Clinical narrative: Case number PHHY2012US111458 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 467010) web site on 04 Dec 2012 with a follow up report received from the Quality Assurance department (QA reference number: 210298) on 30 May 2014. This report refers to a 43-year-old female patient. She did not have any pre-existing allergies. Her medical history included hypothyroidism, asthma, kidney stones, recurrent pneumonia and left bundle branch block. Her concomitant medications included Benadryl 25 mg every 6 hours and Synthroid 175 ug daily. She was vaccinated with FLUVIRIN (batch number: 1203901, expiry date: 31 May 2013) intramuscularly on to left arm and PNEUMOVAX (other manufacturer, batch number: NO13581) intramuscularly on to right arm on 27 Sep 2012. On the same day, she had increasing pain and swelling of her left upper extremity and she could not move her arm at all. She went to the emergency department and she was found to have a leukocytosis and elevated C-reactive protein (CRP). An infectious disease consult was obtained who felt that this was most likely an adverse reaction to the PNEUMOVAX vaccine. She was admitted in the hospital the next day after vaccination. She also had significant fever, erythema and swelling. She was treated with clindamycin 900 mg intravenous every 8 hourly. It was reported that the events significantly improved. On 29 Sep 2012, she had a maximum temperature of 101.1 (units not reported). It was reported that she was later afebrile over the last 36 hours and was discharged with a prescription for clindamycin 450 mg per oral every 8 hours. She was also prescribed Vicodin for pain and was asked to resume home medications. The outcome of the events was reported as complete recovery as of 01 Oct 2012. Based on the review performed, it was concluded that this batch of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 210298) on 30 May 2014: The expiry date of FLUVIRIN, EMEA labeling of the events and the batch review report were updated.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Swelling, Vaccination complication, White blood cell count increased
Clinical narrative: Case number PHHY2012US111458 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 467010) web site on 04 Dec 2012 with a follow up report received from the Quality Assurance department (QA reference number: 210298) on 30 May 2014. This report refers to a 43-year-old female patient. She did not have any pre-existing allergies. Her medical history included hypothyroidism, asthma, kidney stones, recurrent pneumonia and left bundle branch block. Her concomitant medications included Benadryl 25 mg every 6 hours and Synthroid 175 ug daily. She was vaccinated with FLUVIRIN (batch number: 1203901, expiry date: 31 May 2013) intramuscularly on to left arm and PNEUMOVAX (other manufacturer, batch number: NO13581) intramuscularly on to right arm on 27 Sep 2012. On the same day, she had increasing pain and swelling of her left upper extremity and she could not move her arm at all. She went to the emergency department and she was found to have a leukocytosis and elevated C-reactive protein (CRP). An infectious disease consult was obtained who felt that this was most likely an adverse reaction to the PNEUMOVAX vaccine. She was admitted in the hospital the next day after vaccination. She also had significant fever, erythema and swelling. She was treated with clindamycin 900 mg intravenous every 8 hourly. It was reported that the events significantly improved. On 29 Sep 2012, she had a maximum temperature of 101.1 (units not reported). It was reported that she was later afebrile over the last 36 hours and was discharged with a prescription for clindamycin 450 mg per oral every 8 hours. She was also prescribed Vicodin for pain and was asked to resume home medications. The outcome of the events was reported as complete recovery as of 01 Oct 2012. Based on the review performed, it was concluded that this batch of FLUVIRIN was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 210298) on 30 May 2014: The expiry date of FLUVIRIN, EMEA labeling of the events and the batch review report were updated.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypotension, Pyrexia
Clinical narrative: Case number PHHY2012US111299 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number 467078) received on 04 Dec 2012 and a follow-up information was received from Quality Assurance Department (reference number: 210324) on 30 May 2014. This report refers to a 54-year-old male patient. The patient was vaccinated with FLUVIRIN (batch number 12262P) and PNEUMOVAX (batch number 1417AA) in the left arm on 18 Sep 2012. On 19 Sep 2012, the patient had fever of 103 degrees, his deltoid muscle became red. He went to emergency room (ER). He was admitted after a hypotensive episode. The outcome of the events was reported as not recovered as of 27 Sep 2012. The seriousness criteria and causality assessment of the events was unknown. Batch review report (reference number: 210324) received from quality assurance department on 30 May 2014. Based on the batch review performed, it was stated that FLUVIRIN (batch number 12262P) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from Quality Assurance Department (reference number: 210324) on 30 May 2014: Updated batch review report.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site pruritus, Orbital oedema, Rash erythematous, Rash generalised
Clinical narrative: Case number PHHY2012US111342 is an initial spontaneous report from vaccine adverse event reporting system (VAERS reference number: 467148) on 04 Dec 2012, with a follow up received from Quality Assurance Department (reference number: 210300) on 03 Jun 2014. This case refers to 59-year-old female patient. The patient's medical history included penicillin allergy, hypertension, hyperlipidemia, osteoarthritis and right total knee replacement. The polymedicated patient was vaccinated with FLUVIRIN (batch number: 1206001) intramuscularly in right arm on 27 Sep 2012. On 27 Sep 2012, after the vaccination, the patient experienced itching at injection site (no redness or swelling reported). On the same day at approximately 2 PM, she developed warm red rash on right cheek, right side of neck and under chin. She was given Benadryl IM but she refused Benadryl IM and took her own Benadryl orally at approximately 3:30 pm. At approximately 5:30pm, she noticed one hive on upper right chest. The following day she woke with red warm rash on both upper arms, upper chest, entire neck and face, and orbital edema. She had called off her work. The final outcome of the events was reported as complete recovery as of 02 Oct 2012. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1206001) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up received from the Quality Assurance Department (reference number: 210300) on 03 Jun 2014: Updated batch review report.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Urticaria
Clinical narrative: Case number PHHY2012US111342 is an initial spontaneous report from vaccine adverse event reporting system (VAERS reference number: 467148) on 04 Dec 2012, with a follow up received from Quality Assurance Department (reference number: 210300) on 03 Jun 2014. This case refers to 59-year-old female patient. The patient's medical history included penicillin allergy, hypertension, hyperlipidemia, osteoarthritis and right total knee replacement. The polymedicated patient was vaccinated with FLUVIRIN (batch number: 1206001) intramuscularly in right arm on 27 Sep 2012. On 27 Sep 2012, after the vaccination, the patient experienced itching at injection site (no redness or swelling reported). On the same day at approximately 2 PM, she developed warm red rash on right cheek, right side of neck and under chin. She was given Benadryl IM but she refused Benadryl IM and took her own Benadryl orally at approximately 3:30 pm. At approximately 5:30pm, she noticed one hive on upper right chest. The following day she woke with red warm rash on both upper arms, upper chest, entire neck and face, and orbital edema. She had called off her work. The final outcome of the events was reported as complete recovery as of 02 Oct 2012. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1206001) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up received from the Quality Assurance Department (reference number: 210300) on 03 Jun 2014: Updated batch review report.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Fatigue, Tooth extraction
Clinical narrative: Case number PHHY2012US111829 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 468670) web site on 04 Dec 2012, with a follow up received from Quality Assurance Department (reference number: 210392) on 03 Jun 2014. This report refers to a 57-year-old female patient. Her medical history included sinusitis and temporomandibular jaw joint disease symptoms. Her concomitant medications included Buspirone 7.5 mg since 2003. She was feeling fine before vaccination. She was vaccinated with FLUVIRIN (batch number: 111774P1) on 17 Sep 2010. ON an unknown date in 2010, for a week, she felt unbalanced. She felt that she would fell flat without being dizzy. She felt super tired and fatigued all the time. No lab tests were done in 2010. She was further vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date in 2011. It was reported that she experienced the same events in 2011 for 2 weeks. On an unknown date in 2011, she had a tooth pulled and had 30 antibiotics (unspecified) and pain killers. The health authority assessed the seriousness as life threatening. The outcome of the events was reported as complete recovery as of 03 Oct 2012. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 111774P1) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up received from the Quality Assurance Department (reference number: 210392) on 03 Jun 2014: Updated batch review report.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Contusion, Diarrhoea, Dizziness
Clinical narrative: Case number PHHY2012US111497 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 468684) website on 04 Dec 2012 and a follow up report from the QA department received on 30 May 2014. This report refers to a 56-year-old polymedicated (unspecified) female patient. Her historical conditions include diabetes and depression. Concomitant medications were unspecified. She was vaccinated with FLUVIRIN (batch number: 1100501) intramuscularly to her right arm on 08 Oct 2011. On the same day the patient started sweating really bad and experienced high fever, sick of the stomach, was extremely weak, extremely dizzy, diarrhea really bad, "throwing up over and over", blacked out twice, two head injuries, extremely bruised ribs, and after being admitted into hospital, had to have surgery in stomach from throwing up so bad. It was reported that her "esophagus had a big hole in it, large rip". The patient stated that her immune system was totally destroyed. Outcome of the events were reported as not recovered. Patient visited emergency room. No further information was available. Based on the document review for the reference number 210045, it was stated that the FLUVIRIN, batch number 1100501 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 30 May 2014: Updated batch review report.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Gastric operation, Head injury, Hyperhidrosis, Immune system disorder, Loss of consciousness
Clinical narrative: Case number PHHY2012US111497 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 468684) website on 04 Dec 2012 and a follow up report from the QA department received on 30 May 2014. This report refers to a 56-year-old polymedicated (unspecified) female patient. Her historical conditions include diabetes and depression. Concomitant medications were unspecified. She was vaccinated with FLUVIRIN (batch number: 1100501) intramuscularly to her right arm on 08 Oct 2011. On the same day the patient started sweating really bad and experienced high fever, sick of the stomach, was extremely weak, extremely dizzy, diarrhea really bad, "throwing up over and over", blacked out twice, two head injuries, extremely bruised ribs, and after being admitted into hospital, had to have surgery in stomach from throwing up so bad. It was reported that her "esophagus had a big hole in it, large rip". The patient stated that her immune system was totally destroyed. Outcome of the events were reported as not recovered. Patient visited emergency room. No further information was available. Based on the document review for the reference number 210045, it was stated that the FLUVIRIN, batch number 1100501 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 30 May 2014: Updated batch review report.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Oesophageal perforation, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2012US111497 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 468684) website on 04 Dec 2012 and a follow up report from the QA department received on 30 May 2014. This report refers to a 56-year-old polymedicated (unspecified) female patient. Her historical conditions include diabetes and depression. Concomitant medications were unspecified. She was vaccinated with FLUVIRIN (batch number: 1100501) intramuscularly to her right arm on 08 Oct 2011. On the same day the patient started sweating really bad and experienced high fever, sick of the stomach, was extremely weak, extremely dizzy, diarrhea really bad, "throwing up over and over", blacked out twice, two head injuries, extremely bruised ribs, and after being admitted into hospital, had to have surgery in stomach from throwing up so bad. It was reported that her "esophagus had a big hole in it, large rip". The patient stated that her immune system was totally destroyed. Outcome of the events were reported as not recovered. Patient visited emergency room. No further information was available. Based on the document review for the reference number 210045, it was stated that the FLUVIRIN, batch number 1100501 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 30 May 2014: Updated batch review report.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: 14 yo female (mother present) after #2/3 Gardasil HPV quadravalent vaccination 0.5mL IM once.  Pt fainted, caught by MA (no fall), and quickly recovered (within seconds) able to stand and walk without difficulty.  Pt reported seeing 'lights' before fainting and mother reported pt in anxious state about receiving vaccine.  Outpatient returned home.  Pt BP 104/68, pulse 60.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Photopsia, Syncope
Clinical narrative: 14 yo female (mother present) after #2/3 Gardasil HPV quadravalent vaccination 0.5mL IM once.  Pt fainted, caught by MA (no fall), and quickly recovered (within seconds) able to stand and walk without difficulty.  Pt reported seeing 'lights' before fainting and mother reported pt in anxious state about receiving vaccine.  Outpatient returned home.  Pt BP 104/68, pulse 60.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chills, Decreased appetite, Erythema, Fatigue, Headache
Clinical narrative: Approximately 2 hours after Tdap patient reports scratchy throat, pounding headache, several hours later severe fatigue, appetite decreased, shaking chills, and depressed. Next day had intermittent brief dry cough, and (L) arm at site red, swollen, itchy and painful. Took BENADRYL and topical hydrocortisone.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Approximately 2 hours after Tdap patient reports scratchy throat, pounding headache, several hours later severe fatigue, appetite decreased, shaking chills, and depressed. Next day had intermittent brief dry cough, and (L) arm at site red, swollen, itchy and painful. Took BENADRYL and topical hydrocortisone.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chills, Cough, Decreased appetite, Depression, Fatigue
Clinical narrative: Approximately 2 hours after Tdap patient reports scratchy throat, pounding headache, several hours later severe fatigue, appetite decreased, shaking chills, and depressed. Next day had intermittent brief dry cough, and (L) arm at site red, swollen, itchy and painful. Took BENADRYL and topical hydrocortisone.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Approximately 2 hours after Tdap patient reports scratchy throat, pounding headache, several hours later severe fatigue, appetite decreased, shaking chills, and depressed. Next day had intermittent brief dry cough, and (L) arm at site red, swollen, itchy and painful. Took BENADRYL and topical hydrocortisone.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Throat irritation
Clinical narrative: Approximately 2 hours after Tdap patient reports scratchy throat, pounding headache, several hours later severe fatigue, appetite decreased, shaking chills, and depressed. Next day had intermittent brief dry cough, and (L) arm at site red, swollen, itchy and painful. Took BENADRYL and topical hydrocortisone.
Age: 33.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: I started having pain in the injection site that radiated to my shoulder and neck on the right side. I received a muscle relaxer and have gone to the chiropractor.  If I don't use the arm the pain is under control. If I do any activity then I have sever pain.
Sex: M
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD. No other concomitant medication were reported. It was reported that the patient received PROQUAD at an unspecified time in the past and developed Down's Syndrome (congenital anomaly) at an unspecified time in the past. Reporter stated that patient "was grown now" (no details provided). The outcome of Down's syndrome was unknown. No product quality complaint was involved. Causality assessment was not provided. Upon internal review, the event of Down's syndrome was considered to be a congenital anomaly. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Aphasia, Brain injury, Computerised tomogram head abnormal, Dyskinesia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 77 years old female patient of. The patient's pertinent medical history included type II diabetes, hypertension and history of breast cancer (remission). The patient had no drug reactions/Allergies. On 27-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported) at a local pharmacy. Concomitant therapies included aspirin (81mg), QUESTRAN, vitamin d (unspecified), hydrochlorothiazide, triamterene and verapamil. On 01-MAR-2014 the patient was presented to the Hospital with difficulty breathing - and diagnosed as having an allergic reaction to ZOSTAVAX. The patient was admitted, intubated and remained in the intensive care unit of the hospital for several days, total hospital time was "several" weeks. The nurse practitioner reported that patient was then transferred to an unspecified nursing facility for rehabilitation in which she was discharged on 24-APR-2014 and required physical therapy in the home. The nursing home diagnosis was anaphylaxis, chicken pox pneumonia, hypoxia, ischemic brain injury (TIA's) -which was ruled by CT Scan. The nurse practitioner reported that she saw patient in the office on 05-MAY-2014 and the patient presented with a weak, low voice; progressive problems swallowing, right eye drooping, use of a walker to walk. The nurse practitioner reported that she ordered a CT Scan looking for additional stroke symptoms, but the scan showed negative. Nurse practitioner then sent the patient to a gastrointestinal specialist who diagnosed patient with esophageal dysphagia, disturbance of speech and gastric reflux - which was diagnosed via an upper endoscopy. The nurse practitioner reported that on 13-MAY-2014, patient presented to her office and could not speak (patient was writing notes on paper). She stated that she no longer could speak, the dysphagia had gotten worse and continued to get progressively worse. Nurse practitioner reported that on 20-MAY-2014, she received a phone call from the patient's family member who stated the patient could not swallow, could not speak, could not close her mouth and could not open her eyes without holding them open with her fingers. The nurse practitioner sent patient to the emergency room at Medical Center, in which the patient has remained since. Patient has had a feeding tube inserted since the admission and has been diagnosed with Myasthenia gravis. At time of the report, outcome of these events was reported as not recovered. The reporter considered these events to be medically significant and life threatening. Additional information has been requested.