chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Altered state of consciousness, Hyperhidrosis, Hypotonia, Loss of consciousness, Pallor
Clinical narrative: Case number PHHY2014US000804 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507237) website on 06 Jan 2014, with a follow up received from the Quality Assurance department (reference number: 273889) on 07 Feb 2014. This report refers to a 65-year-old male patient. The patient's current condition included penicillin allergy. His concomitant medications were not reported. On 14 Oct 2013, he was vaccinated with FLUVIRIN (batch number: 13432P, expiry date: 30 Apr 2014) intramuscularly in the right arm. Two minutes after vaccination, the patient became unresponsive and was limp while sitting in a chair. On the same day, patient was then vaccinated with ZOSTAVAX (other manufacturer, batch number: J001002) subcutaneously in his right arm. He first lost consciousness while receiving his second immunization with ZOSTAVAX. He was in and out of consciousness and was conversing when awake. It was reported that he did not have fever within the last three days from the reporting date. Following these events he was taken to the emergency room. He became pale and profusely diaphoretic while waiting for the Emergency Medical Team (EMT). His pulse was monitored while waiting for first responders. The final outcome was reported as condition unchanged as of 14 Oct 2013. The seriousness and causality of the events were not assessed. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 13432P was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (reference number: 273889) on 07 Feb 2014: Updated batch report.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Unresponsive to stimuli
Clinical narrative: Case number PHHY2014US000804 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507237) website on 06 Jan 2014, with a follow up received from the Quality Assurance department (reference number: 273889) on 07 Feb 2014. This report refers to a 65-year-old male patient. The patient's current condition included penicillin allergy. His concomitant medications were not reported. On 14 Oct 2013, he was vaccinated with FLUVIRIN (batch number: 13432P, expiry date: 30 Apr 2014) intramuscularly in the right arm. Two minutes after vaccination, the patient became unresponsive and was limp while sitting in a chair. On the same day, patient was then vaccinated with ZOSTAVAX (other manufacturer, batch number: J001002) subcutaneously in his right arm. He first lost consciousness while receiving his second immunization with ZOSTAVAX. He was in and out of consciousness and was conversing when awake. It was reported that he did not have fever within the last three days from the reporting date. Following these events he was taken to the emergency room. He became pale and profusely diaphoretic while waiting for the Emergency Medical Team (EMT). His pulse was monitored while waiting for first responders. The final outcome was reported as condition unchanged as of 14 Oct 2013. The seriousness and causality of the events were not assessed. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 13432P was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (reference number: 273889) on 07 Feb 2014: Updated batch report.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Heart rate decreased, Hypotension, Loss of consciousness, Pallor
Clinical narrative: Case number PHHY2014US000869, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507867) website on 06 Jan 2014, with a follow up received from the Quality Assurance department (reference number: 273901) on 07 Feb 2014. This report refers to a 50-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1309601, expiry date: 30 Apr 2014) intramuscularly in the left arm on 15 Oct 2013. After vaccination while walking out of the store he became clammy, lost color, and briefly lost consciousness. His blood pressure was 96/70 (units not reported) and pulse was 58 (units not reported). The patient recovered on the same day. The seriousness and causality of the events were not reported. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 1309601 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (reference number: 273901) on 07 Feb 2014: Updated batch report.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Case number PHHY2014US001175 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 508499) website on 06 Jan 2014 with a follow up information received from the quality assurance department (QA reference number: 274032) on 13 Jan 2014 and 10 Feb 2014: This report refers to a 65-year-old female patient. Her medical history was not reported and her concomitant medications included CELEXA. She was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly in to the left arm along with ZOSTAVAX (other manufacturer, batch number: J004267) subcutaneously in to the left arm on 12 Oct 2013. On 13 Oct 2013, she experienced cellulitis and three inches wide red mark at the injection site area. She visited the emergency room (ER) following these events. Final outcome of the events was reported as condition unchanged as on 14 Oct 2013. No further information about seriousness and causality was provided. Based on the batch review report received from the quality assurance department, it was concluded that FLUVIRIN batch number 1309301 was manufactured in accordance with the approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the QA department (reference number: 274032) on 13 Jan 2014: Updated QA reference number. Follow-up received from the Quality Assurance Department (reference number: 274032) on 10 Feb 2014: Updated batch review report.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Case number PHHY2014US001180 is an initial spontaneous report received from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 508523) website on 06 Jan 2014 with a follow up information received from the quality assurance department (QA reference number: 274197) on 13 Jan 2014 and 10 Feb 2014: This case refers to 28-year-old female patient. Her medical history included asthma. The patient was vaccinated with FLUVIRIN (batch number: 1309301) in left arm and PNEUMOVAX (other manufacturer, batch number: J004242) in left arm both on 03 Oct 2013. On 04 Oct 2013, after the vaccination, the patient developed cellulitis. She was treated with AUGMENTIN 875 mg twice daily. She went to emergency room for the event. The outcome of event was reported as recovery as of 11 Oct 2013. The seriousness and causality of event was not reported. Based on the batch review report received from the quality assurance department, it was concluded that FLUVIRIN batch number 1309301 was manufactured in accordance with the approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the QA department (reference number: 274197) on 13 Jan 2014: Updated QA reference number. Follow-up received from the Quality Assurance Department (reference number: 274197) on 10 Feb 2014: Updated batch review report.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Facial asymmetry, Hypoaesthesia, Paraesthesia, VIIth nerve paralysis
Clinical narrative: Case number PHHY2014US001224 is an initial spontaneous report received from the vaccine adverse event reporting system (reference number: 509567) on 06 Jan 2014, with the follow-up received from Quality Assurance Department (reference number: 274047) on 11 Feb 2014: This report refers to a 20 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308101) in the left arm on 22 Oct 2013. On 23 Oct 2013, 24 hours after vaccination, she experienced tingling and numbness in left arm, leg and left side of her body. Forty eight hours after vaccination, she experienced facial numbness in left side, 75 percent loss of strength in left arm and leg and left side facial partial paralysis with asymmetrical smile. She underwent physical examination (results were not provided). The outcome of the events was reported as condition unchanged as of 24 Oct 2013. The seriousness and causality of the events were not reported. Based on the investigation performed, QA department concluded that the FLUVIRIN (batch number: 1308101) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 274047) on 11 Feb 2014: Updated batch review report.
Age: 95.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Case number PHHY2014US001310 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 509765) on 06 Jan 2014 and a follow up was received from Quality Assurance Department (QA reference number: 274402) on 11 Feb 2014. This report refers to a 95-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309701) and PNEUMOVAX (Other manufacturer; batch number: H016283) intramuscularly to her left arm on 21 Oct 2013. On 22 Oct 2013 she developed cellulitis in the vaccinated arm. Patient received Cephalexin as treatment. Outcome of the event was reported as condition unchanged as of 25 Oct 2013. Seriousness and causality were not reported. Based on the investigation performed, QA department concluded that the FLUVIRIN vaccine (batch number: 1309701) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (QA, reference number: 274402) on 14 Jan 2014: Updated QA reference number only. Follow-up received from Quality Assurance Department (reference number: 274402) on 11 Feb 2014: Updated batch review report.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Case number PHHY2014US001342, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509936) website on 06 Jan 2014, with the follow-up received from Quality Assurance Department (reference number: 274414) on 11 Feb 2014. This report refers to a 47-year-old female patient. Her medical history included heart disease. She was vaccinated with FLUVIRIN (batch number: 1309601) intramuscularly in the left arm and PNEUMOVAX (other manufacturer, batch number: H021941) intramuscularly in the right arm on 29 Sep 2013. On 30 Sep 2013, her arm became red and swollen. The patient visited the emergency room. Her doctor thought it might be cellulitis and gave her antibiotic. The final outcome of the events reported as not recovered as of 30 Sep 2013. The seriousness and causality of the events were not reported. Based on the investigation performed, QA department concluded that the FLUVIRIN (batch number: 1309601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 274414) on 14 Jan 2014: Updated QA reference number only. Follow-up received from Quality Assurance Department (reference number: 274414) on 11 Feb 2014: Updated batch review report.
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenitis, Rash, Rash erythematous
Clinical narrative: Case number PHHY2014US000809 is an initial spontaneous report received from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 510084) website on 06 Jan 2014, with a follow up received from the Quality Assurance department (reference number: 273893) on 07 Feb 2014. This case refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: 13453P, expiry date: 31 May 2014) intramuscularly in right arm on 24 Oct 2013. On the same date, after the vaccination, the patient developed lymphadenitis of (L) posterior neck and raised erythematous rash on (L) posterior neck and upper chest. The outcome of the events was reported as condition unchanged as of 28 Oct 2013. The seriousness and causality of events was not reported. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 13453P was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (reference number: 273893) on 07 Feb 2014: Updated batch report.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Diarrhoea, Erythema, Local reaction, Pain
Clinical narrative: Case number PHHY2014US000822 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 510166) website on 06 Jan 2014 and a follow up report received from the QA department (QA number: 274041) received on 10 Feb 2014. This case refers to a 49-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 13375P) and PNEUMOVAX (batch number J007786, other manufacturer) intramuscularly in her left arm on 25 Oct 2013. On the same date after vaccination she had a severe local reaction of cellulitis (6 inch) along with redness, soreness and fever. The patient also experienced diarrhea. Following the event the patient visited emergency room. She was treated with KEFLEX and DIFLUCAN. The outcome of the events was reported as complete recovery as of 29 Oct 2013. The seriousness and causality assessment of the events were not reported. Batch review report (reference number: 274041) received from quality assurance department on 10 Feb 2014. Based on the batch review report, it was concluded that the concerned FLUVIRIN batch number 13375P was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from the QA department received on 10 Feb 2014: QA reference number and Batch investigation summary was updated.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2014US000822 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 510166) website on 06 Jan 2014 and a follow up report received from the QA department (QA number: 274041) received on 10 Feb 2014. This case refers to a 49-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 13375P) and PNEUMOVAX (batch number J007786, other manufacturer) intramuscularly in her left arm on 25 Oct 2013. On the same date after vaccination she had a severe local reaction of cellulitis (6 inch) along with redness, soreness and fever. The patient also experienced diarrhea. Following the event the patient visited emergency room. She was treated with KEFLEX and DIFLUCAN. The outcome of the events was reported as complete recovery as of 29 Oct 2013. The seriousness and causality assessment of the events were not reported. Batch review report (reference number: 274041) received from quality assurance department on 10 Feb 2014. Based on the batch review report, it was concluded that the concerned FLUVIRIN batch number 13375P was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from the QA department received on 10 Feb 2014: QA reference number and Batch investigation summary was updated.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Axillary pain, Body temperature increased, Cellulitis, Erythema
Clinical narrative: Case number PHHY2014US001125 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 511150) website on 06 Jan 2014, with a follow up received from the Quality Assurance department (reference number: 273777) on 07 Feb 2014. This case refers to a 24-year-old patient female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 1309001) and PNEUMOVAX (other manufacturer, batch number H022280) in her left arm on 21 Oct 2013. On 22 Oct 2013 after vaccination she had 6x5 inches area which was red, warm and swollen. She had intense pain from clavicle to elbow including axilla, her body temperature was 101.5. She also had headache. Aggressive cellulitis was diagnosed and was treated with KEFLEX. Following the events she visited emergency room. The outcome of the events was reported as condition unchanged as of 25 Oct 2013. The seriousness and causality assessment of the events was not reported. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 1309001 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (reference number: 273777) on 07 Feb 2014: Updated batch report.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Case number PHHY2014US001125 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 511150) website on 06 Jan 2014, with a follow up received from the Quality Assurance department (reference number: 273777) on 07 Feb 2014. This case refers to a 24-year-old patient female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 1309001) and PNEUMOVAX (other manufacturer, batch number H022280) in her left arm on 21 Oct 2013. On 22 Oct 2013 after vaccination she had 6x5 inches area which was red, warm and swollen. She had intense pain from clavicle to elbow including axilla, her body temperature was 101.5. She also had headache. Aggressive cellulitis was diagnosed and was treated with KEFLEX. Following the events she visited emergency room. The outcome of the events was reported as condition unchanged as of 25 Oct 2013. The seriousness and causality assessment of the events was not reported. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 1309001 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (reference number: 273777) on 07 Feb 2014: Updated batch report.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2014US001048 is an initial spontaneous report received from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 512376) website on 06 Jan 2014 with follow-up information received on 10 Jan 2014 and 07 Feb 2014. This case refers to 52-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1310101) and PNEUMOVAX (other manufacturer, batch number: J005067) both intramuscularly in left arm both on 06 Nov 2013. On 08 Nov 2013, two days after the vaccination, the patient noticed raised red line from injection site towards elbow. She went to emergency room for urgent care and was diagnosed with cellulitis and given KEFLEX. The patient did well after 2 days on antibiotics. The outcome of event was reported as recovery. The seriousness and causality of event was not reported. Based on the batch review performed, it was concluded that the concerned FLUVIRIN batch number 1310101 was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 273768) on 10 Jan 2014: Updated QA reference number. Follow-up received from Quality Assurance Department (reference number: 273768) on 07 Feb 2014: Updated batch review report.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure, Concussion, Head injury, Loss of consciousness, Syncope
Clinical narrative: Case number PHHY2014US001061 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 512402) website on 06 Jan 2014 with a follow up information received from the quality assurance department (QA reference number: 274112) on 11 Feb 2014. This report refers to a 17-years-old male patient. He was vaccinated with FLUVIRIN (batch number: 1309701) intramuscularly in the left arm on 05 Nov 2013. On the same date, after vaccination the patient passed out and fainted and while walking hit his head. He was taken to emergency room via ambulance and he had a concussion. He underwent blood pressure test (results: not reported). The patient was doing fine on 06 Nov 2013. The seriousness and causality of the events were not reported. Upon follow up receipt from the quality assurance department (reference number: 274112), it was reported that based on the batch review, it was concluded that FLUVIRIN batch number 1309701 was manufactured in accordance with the approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the QA department (reference number: 274112) on 13 Jan 2014: Updated QA reference number. Follow up information received from the quality assurance department on 11 Feb 2014: Batch summary updated.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Ear abrasion, Ear haemorrhage, Fall, Head injury
Clinical narrative: Case number PHHY2014US013419, is an initial report received from the vaccine adverse event reporting system (VAERS reference number: 515255) website on 03 Feb 2014 with a follow up information received from the Quality Assurance department on 07 Feb 2014. This report refers to 12-year-old male patient. The patient had no pre-existing conditions. His concomitant medication was not reported. He was vaccinated with 0.5 ml of FLUVIRIN (batch number: not reported) intramuscularly in the right deltoid on 30 Nov 2013. After vaccination, he slid from a sitting position (fainting) off the chair and fell hitting the floor head-first. He was conscious and was able to speak, but explained his head hurt from the fall. He was taken to the emergency room for further evaluation since his blood pressure was dropping. His ear had a drop of blood on it. The paramedic explained it was due to a superficial scrape from hitting the floor. Mother explained that her son does not have a seizure diagnosis, but a similar incident occurred one time, years ago at the dentist. She felt that his fainting was due to white coat syndrome or being afraid of needles. The event outcome was completely recovered. The seriousness and causality was not reported. Upon follow up receipt from the quality assurance department on 07 Feb 2014, it was confirmed that the initially reported FLUVIRIN batch number 130101 was not complete and hence this report was considered as a case without valid batch number and therefore no QA investigation would be done. Follow up information received from the quality assurance department on 07 Feb 2014: Batch number was confirmed to be invalid and no QA investigation would be performed.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Syncope
Clinical narrative: Case number PHHY2014US013419, is an initial report received from the vaccine adverse event reporting system (VAERS reference number: 515255) website on 03 Feb 2014 with a follow up information received from the Quality Assurance department on 07 Feb 2014. This report refers to 12-year-old male patient. The patient had no pre-existing conditions. His concomitant medication was not reported. He was vaccinated with 0.5 ml of FLUVIRIN (batch number: not reported) intramuscularly in the right deltoid on 30 Nov 2013. After vaccination, he slid from a sitting position (fainting) off the chair and fell hitting the floor head-first. He was conscious and was able to speak, but explained his head hurt from the fall. He was taken to the emergency room for further evaluation since his blood pressure was dropping. His ear had a drop of blood on it. The paramedic explained it was due to a superficial scrape from hitting the floor. Mother explained that her son does not have a seizure diagnosis, but a similar incident occurred one time, years ago at the dentist. She felt that his fainting was due to white coat syndrome or being afraid of needles. The event outcome was completely recovered. The seriousness and causality was not reported. Upon follow up receipt from the quality assurance department on 07 Feb 2014, it was confirmed that the initially reported FLUVIRIN batch number 130101 was not complete and hence this report was considered as a case without valid batch number and therefore no QA investigation would be done. Follow up information received from the quality assurance department on 07 Feb 2014: Batch number was confirmed to be invalid and no QA investigation would be performed.
Age: 49.0
Sex: F
Vaccine: FLUR3
Symptoms: Burning sensation, Pruritus generalised, Urticaria
Clinical narrative: This is an initial report of an Adverse Event, received on 12/Dec/2013, for Protein Sciences FLUBLOK. A 49-year-old female received FLUBLOK Intramuscular on 26/Nov/2013. On Day 2 of receiving FLUBLOK, 28/Nov/2013 (FLUBLOK administered on 26/Nov/2013 at 9:00 PM (Lot # 340503F), the subject experienced itching burning all over and hives on her arms, legs and back. The subject required an emergency room or doctor visit for these events. At the time of this report, the subject had not recovered. Medical/surgical history for the subject reported that the subject was not ill at the time of vaccination and multiple allergies to eggs and "others" (others not specified). Concomitant medications were reported to have been: hydroxyzine, triamterene and amlodipine. Causality information was not provided.
Age: 0.18
Sex: M
Vaccine: HIBV
Symptoms: Cardio-respiratory arrest, Death, Hepatitis B surface antibody positive, Transfusion
Clinical narrative: Patient received PEDIARIX vaccine 11/13/13, pt coded and died 11/18/13. Pt's tissues to be donated. Lab testing (+) Hepatitis BsAg. Mom Hepatitis B status (-) confirmed by prenatal labs and subsequent testing after infant (+). Pt received blood transfusion - investigation - donor tested (-) for Hepatitis B.
Age: 45.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Chest discomfort, Chest pain, Dry throat, Dysphagia, Headache
Clinical narrative: Case number PHEH2014US002884 is an initial spontaneous report received from a consumer on 04 Feb 2014. This report refers to a 45 year old female patient. She was bitten by a dog and was concomitantly taking OMNICEF. It was reported that the dog eventually tested negative for rabies. She began vaccination with post-exposure RABAVERT (batch number: not reported) series on 29 Nov 2013, with second dose on an unspecified date (see case PHHY2014US017171), third dose on 07 Dec 2013 (see case PHEH2013US026655) and her last dose (fourth dose) of RABAVERT (batch number: not reported) series on 14 Dec 2013 (incomplete course of vaccination). After her vaccination with the last dose of RABAVERT on 14 Dec 2013, she had difficulty in swallowing again. She went back home but had flu like symptoms. She also had tightness and pain under her left breast and ribs. She had pain in her head and her ears felt pressure like they would pop and crack. The patient had numbness in her right leg and foot. The patient developed a rash on her stomach on 30 Dec 2013 for which she used cortisone as a treatment and it resolved. She took FLONASE (manufacturer: not reported, batch number: not reported) on 01 Feb 2014 and on 02 Feb 2014. She noticed a rash on her stomach again on 02 Feb 2014. The patient's physician then gave her NASONEX. The patient stated that she was visiting physicians and was fine before the vaccination. The outcome of the events was not reported. The seriousness and causality of the events were not reported.
Age: 45.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Sensation of pressure, Tension headache
Clinical narrative: Case number PHEH2014US002884 is an initial spontaneous report received from a consumer on 04 Feb 2014. This report refers to a 45 year old female patient. She was bitten by a dog and was concomitantly taking OMNICEF. It was reported that the dog eventually tested negative for rabies. She began vaccination with post-exposure RABAVERT (batch number: not reported) series on 29 Nov 2013, with second dose on an unspecified date (see case PHHY2014US017171), third dose on 07 Dec 2013 (see case PHEH2013US026655) and her last dose (fourth dose) of RABAVERT (batch number: not reported) series on 14 Dec 2013 (incomplete course of vaccination). After her vaccination with the last dose of RABAVERT on 14 Dec 2013, she had difficulty in swallowing again. She went back home but had flu like symptoms. She also had tightness and pain under her left breast and ribs. She had pain in her head and her ears felt pressure like they would pop and crack. The patient had numbness in her right leg and foot. The patient developed a rash on her stomach on 30 Dec 2013 for which she used cortisone as a treatment and it resolved. She took FLONASE (manufacturer: not reported, batch number: not reported) on 01 Feb 2014 and on 02 Feb 2014. She noticed a rash on her stomach again on 02 Feb 2014. The patient's physician then gave her NASONEX. The patient stated that she was visiting physicians and was fine before the vaccination. The outcome of the events was not reported. The seriousness and causality of the events were not reported.
Age: 45.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Chest discomfort, Chest pain, Dysphagia, Ear discomfort, Headache
Clinical narrative: Case number PHEH2014US002884 is an initial spontaneous report received from a consumer on 04 Feb 2014. This report refers to a 45 year old female patient. She was bitten by a dog and was concomitantly taking OMNICEF. It was reported that the dog eventually tested negative for rabies. She began vaccination with post-exposure RABAVERT (batch number: not reported) series on 29 Nov 2013, with second dose on an unspecified date (see case PHHY2014US017171), third dose on 07 Dec 2013 (see case PHEH2013US026655) and her last dose (fourth dose) of RABAVERT (batch number: not reported) series on 14 Dec 2013 (incomplete course of vaccination). After her vaccination with the last dose of RABAVERT on 14 Dec 2013, she had difficulty in swallowing again. She went back home but had flu like symptoms. She also had tightness and pain under her left breast and ribs. She had pain in her head and her ears felt pressure like they would pop and crack. The patient had numbness in her right leg and foot. The patient developed a rash on her stomach on 30 Dec 2013 for which she used cortisone as a treatment and it resolved. She took FLONASE (manufacturer: not reported, batch number: not reported) on 01 Feb 2014 and on 02 Feb 2014. She noticed a rash on her stomach again on 02 Feb 2014. The patient's physician then gave her NASONEX. The patient stated that she was visiting physicians and was fine before the vaccination. The outcome of the events was not reported. The seriousness and causality of the events were not reported.
Age: 45.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypoaesthesia, Incomplete course of vaccination, Influenza like illness, Rash
Clinical narrative: Case number PHEH2014US002884 is an initial spontaneous report received from a consumer on 04 Feb 2014. This report refers to a 45 year old female patient. She was bitten by a dog and was concomitantly taking OMNICEF. It was reported that the dog eventually tested negative for rabies. She began vaccination with post-exposure RABAVERT (batch number: not reported) series on 29 Nov 2013, with second dose on an unspecified date (see case PHHY2014US017171), third dose on 07 Dec 2013 (see case PHEH2013US026655) and her last dose (fourth dose) of RABAVERT (batch number: not reported) series on 14 Dec 2013 (incomplete course of vaccination). After her vaccination with the last dose of RABAVERT on 14 Dec 2013, she had difficulty in swallowing again. She went back home but had flu like symptoms. She also had tightness and pain under her left breast and ribs. She had pain in her head and her ears felt pressure like they would pop and crack. The patient had numbness in her right leg and foot. The patient developed a rash on her stomach on 30 Dec 2013 for which she used cortisone as a treatment and it resolved. She took FLONASE (manufacturer: not reported, batch number: not reported) on 01 Feb 2014 and on 02 Feb 2014. She noticed a rash on her stomach again on 02 Feb 2014. The patient's physician then gave her NASONEX. The patient stated that she was visiting physicians and was fine before the vaccination. The outcome of the events was not reported. The seriousness and causality of the events were not reported.
Age: 1.0
Sex: M
Vaccine: MMR, VARZOS, VARZOS, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to his son, a 1 year old male patient. On 24-JAN-2014 the patient was vaccinated with ZOSTAVAX, dosing information was not reported. ON 24-JAN-2014 the patient went into his physician's office and was to receive VARIVAX, but he received ZOSTAVAX instead. No side effects were reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARZOS, VARZOS, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to his son, a 1 year old male patient. On 24-JAN-2014 the patient was vaccinated with ZOSTAVAX, dosing information was not reported. ON 24-JAN-2014 the patient went into his physician's office and was to receive VARIVAX, but he received ZOSTAVAX instead. No side effects were reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Pallor
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 year old male patient with no pertinent medical history and no drug reactions or allergies. On 31-JAN-2014, the patient was vaccinated with GARDASIL lot # J012212, exp. 18-FEB-2016, in left arm (dose is series and route not reported). Concomitant therapies included dtap (unspecified), tetanus toxoid administered on the same day in right arm. It was reported that on 31-JAN-2014, after receiving GARDASIL, while still in the physician's office, the patient became pale, began to feel ill, became disoriented, experienced rapid breathing and had a blood pressure of 130/65 (units not provided). Emergency medical services were called and the patient was taken to the emergency room. The patient was evaluated and discharged home within 30 minutes (not hospitalized). The patient's outcome was unknown. Causality was not provided. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Disorientation, Malaise, Pallor, Respiratory rate increased
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 year old male patient with no pertinent medical history and no drug reactions or allergies. On 31-JAN-2014, the patient was vaccinated with GARDASIL lot # J012212, exp. 18-FEB-2016, in left arm (dose is series and route not reported). Concomitant therapies included dtap (unspecified), tetanus toxoid administered on the same day in right arm. It was reported that on 31-JAN-2014, after receiving GARDASIL, while still in the physician's office, the patient became pale, began to feel ill, became disoriented, experienced rapid breathing and had a blood pressure of 130/65 (units not provided). Emergency medical services were called and the patient was taken to the emergency room. The patient was evaluated and discharged home within 30 minutes (not hospitalized). The patient's outcome was unknown. Causality was not provided. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Discomfort, Immediate post-injection reaction, Incorrect route of drug administration, Injection site pain, Pain
Clinical narrative: Muscle aches/soreness. Unable to lift arm - put on jacket, etc.
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Muscle aches/soreness. Unable to lift arm - put on jacket, etc.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash macular
Clinical narrative: Fever up to 102 degrees F. Generalized macular rash.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Computerised tomogram, Eye inflammation, Laboratory test, Nuclear magnetic resonance imaging, Papilloedema
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Retinal exudates, Tumour marker test, Visual impairment, Vitreous floaters
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Retinal exudates, Visual impairment, Vitreous floaters
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blindness, Blood test, Computerised tomogram head, Lumbar puncture normal, Nuclear magnetic resonance imaging brain
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Papilloedema, Visual impairment, Vitreous floaters
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Alanine aminotransferase increased, B-lymphocyte count, Blindness, Blood albumin normal, Blood bilirubin increased
Clinical narrative: This spontaneous report was received from a 63 year old female patient concerning herself. Allergy to Penicillin (details unspecified). Pertinent medical history was none. On 01-NOV-2013, the patient was vaccinated with ZOSTAVAX (reported as directed dosage) (lot# and strength unknown) subcutaneous. Concomitant therapies included ZYRTEC and AFLURIA (also reported as unspecified flu vaccine) received on 15-OCT-2013. On 14-NOV-2013, about 2 weeks after having the vaccine, the patient developed a lot of floaters in her eyes (hospitalization). Approximately on an unknown date in November 2013, within less than 1 month the patient developed papilledema with inflammation (hospitalization). She was then tested for tumors and last week on approximately 05-FEB-2014, star showed exudate was present on her retina (hospitalization). These reactions have caused vision problems in both eyes (hospitalization). She had been treated with Prednisone and Acyclovir (details unspecified), and in hospital for these conditions and has been hospitalized from 20-DEC-2013 to 21-DEC-2013. On an unknown date, patient had MRI (Nuclear magnetic resonance imaging), CAT (Computerised tomogram) scan and other unspecified tests and results unspecified. She sought medical attention and visited physician's office. Product quality complaint was not reported. The patient had not recovered from all the events. The causality of the events with suspect product was unknown. Additional information has been requested.