chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Epistaxis
Clinical narrative: Case number PHHY2012US111719 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 469374) on 04 Dec 2012, and with a follow up report received from a QA department (reference number: 210009) on 30 May 2014. This report refers to a 23-year-old male patient. The patient was vaccinated with FLUVIRIN (batch number: 1205501, expiry date: Jun 2013) intramuscularly on right arm on 12 Oct 2012. On the same day, the patient experienced nose bleed and reported that no treatment was necessary. Outcome of the event was reported as recovered. Seriousness and causality of the event was not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1205501 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 a QA department (reference number: 210009) on 30 May 2014. Updated batch review report and expiry date of vaccine.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Joint swelling, Local swelling, Pain
Clinical narrative: Case number PHHY2012US111765, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 469471) website on 04 Dec 2012 with a follow up report received from the Quality Assurance Department (QA reference number: 209971) on 30 May 2014. This report refers to 80-years-old male patient. His medical history included asthma, atrial fibrillation, congestive heart failure and diabetes and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 122221) in the right arm on 26 Sep 2012. On 29 Sep 2012, he came to clinic with "4 day history" (as reported) of swelling and erythema over below wrist and thumb. He stated that, it started "4 days ago" (as reported) over left wrist and thumb and then one-day later it also occurred on right wrist and thumb. There is pain on movement of hand over wrist joint and thumb. The swelling and erythema over left hand has been decreasing progressively and almost reduced to none, while the right hand still had swelling and erythema. He denied any trauma, no new medications or foods and no history of exposure to any new substance. He stated that, he had flu shot 2 days before the swelling started. He had flu shots in past years but never had any allergic reaction. He did not have fever, chills, itching, other joint swelling or erythema. The outcome of the events was reported as condition unchanged as of 12 Oct 2012. The causality and seriousness of the events was not reported. Based on the review performed, 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: 209971) on 30 May 2014: The batch review report was updated.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2012US111765, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 469471) website on 04 Dec 2012 with a follow up report received from the Quality Assurance Department (QA reference number: 209971) on 30 May 2014. This report refers to 80-years-old male patient. His medical history included asthma, atrial fibrillation, congestive heart failure and diabetes and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 122221) in the right arm on 26 Sep 2012. On 29 Sep 2012, he came to clinic with "4 day history" (as reported) of swelling and erythema over below wrist and thumb. He stated that, it started "4 days ago" (as reported) over left wrist and thumb and then one-day later it also occurred on right wrist and thumb. There is pain on movement of hand over wrist joint and thumb. The swelling and erythema over left hand has been decreasing progressively and almost reduced to none, while the right hand still had swelling and erythema. He denied any trauma, no new medications or foods and no history of exposure to any new substance. He stated that, he had flu shot 2 days before the swelling started. He had flu shots in past years but never had any allergic reaction. He did not have fever, chills, itching, other joint swelling or erythema. The outcome of the events was reported as condition unchanged as of 12 Oct 2012. The causality and seriousness of the events was not reported. Based on the review performed, 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: 209971) on 30 May 2014: The batch review report was updated.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Erythema, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2013US000616 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 474242) on 02 Jan 2013 with a follow up report received from Quality Assurance Department (reference number: 229110) on 30 May 2014. This report refers to a 50-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1203901) on right arm and PNEUMOVAX (batch number: H013394) on left arm both on 30 Oct 2012. On 31 Oct 2012, the patient experienced fever (101 temp), chills, left arm very sore, redness and swelling. The patient was diagnosed with cellulitis. The patient had a visit to emergency room. Outcome of the events were reported as recovered. Seriousness and causality of the events was not reported. No further information was available. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 1203901 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received on 30 May 2014: Updated batch review report.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Case number PHHY2013US000616 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 474242) on 02 Jan 2013 with a follow up report received from Quality Assurance Department (reference number: 229110) on 30 May 2014. This report refers to a 50-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1203901) on right arm and PNEUMOVAX (batch number: H013394) on left arm both on 30 Oct 2012. On 31 Oct 2012, the patient experienced fever (101 temp), chills, left arm very sore, redness and swelling. The patient was diagnosed with cellulitis. The patient had a visit to emergency room. Outcome of the events were reported as recovered. Seriousness and causality of the events was not reported. No further information was available. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 1203901 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received on 30 May 2014: Updated batch review report.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Chills, Dyspnoea, Erythema, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2013US012471 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 476122) on 08 Feb 2013 with a follow up report received from Quality Assurance Department (reference number: 215589) on 30 May 2014. This report refers to a 29-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1204501) intramuscularly in to the left arm along with PNEUMOVAX (other manufacturer, batch number: H010515) intramuscularly in to the left arm on 02 Oct 2012. Three hours after vaccinations, her left arm felt heavy and sore, she had fever and chills and was achy. Her arm was painful from midnight on. Muscle felt knotted up. On the next day, her arm turned really red and was better within four days. She went to doctor and started on anti-inflammatory medication. Her chest felt tight and she found it hard to breathe. The physician prescribed Z-PAK as a treatment measure. Final outcome was reported as complete recovery as on 03 Dec 2012. No further information about causality and seriousness was provided. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 1204501 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received from QA department on 30 May 2014: Updated batch review report.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Sensation of heaviness
Clinical narrative: Case number PHHY2013US012471 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 476122) on 08 Feb 2013 with a follow up report received from Quality Assurance Department (reference number: 215589) on 30 May 2014. This report refers to a 29-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1204501) intramuscularly in to the left arm along with PNEUMOVAX (other manufacturer, batch number: H010515) intramuscularly in to the left arm on 02 Oct 2012. Three hours after vaccinations, her left arm felt heavy and sore, she had fever and chills and was achy. Her arm was painful from midnight on. Muscle felt knotted up. On the next day, her arm turned really red and was better within four days. She went to doctor and started on anti-inflammatory medication. Her chest felt tight and she found it hard to breathe. The physician prescribed Z-PAK as a treatment measure. Final outcome was reported as complete recovery as on 03 Dec 2012. No further information about causality and seriousness was provided. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 1204501 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received from QA department on 30 May 2014: Updated batch review report.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate increased, Pruritus, Rash, Respiratory tract congestion, Urticaria
Clinical narrative: Case number PHHY2013US069461, is an initial spontaneous report received from health care professional via Vaccine Adverse Event Reporting System (VAERS Ref: 478933) web site on 03 Jul 2013 with a follow up report received from Quality Assurance Department (reference number: 239745) on 30 May 2014. This is also a quality complaint (239745) report. This report refers to 25-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1204901) intramuscularly into the left arm on 09 Nov 2012. On the same day he developed rash, hives, itching, chest congestion and increase in pulse. He visited the emergency. Outcome of the event was condition unchanged as of 20 Dec 2012. The causality was not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 1204901 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Non-significant follow up received from QA department on 09 Jul 2013: QA reference number updated. Follow up report received on 30 May 2014: Updated batch review report.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood creatine phosphokinase increased, Blood test normal, Chest X-ray normal, Chest pain
Clinical narrative: Case number PHHY2013US020795, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480191) website on 04 Mar 2013 with a follow-up information received from the quality assurance department (QA reference number: 227382) on 30 May 2014. This report refers to a 62-years-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1204501, expiry date: May 2013) intramuscularly in the left arm on 04 Oct 2012. On the same day after vaccination, she experienced pain in right arm. On the next day, she experienced pain in arms, neck and upper back and chest. Over the weekend she experienced upper and lower body pain. By Sunday, she developed weakness in legs and hands bilaterally. On 09 Oct 2012, she consulted a neurologist and underwent computed tomography scan (CAT), chest x-ray, electrocardiogram (EKG), blood work ruled out Guillain-Barre syndrome (GBS). However, her Creatine phosphokinase (CPK) level increased to 1298. The outcome of these events was reported as condition unchanged as of 03 Jan 2013. The causality and seriousness of the event was not reported. Upon follow up receipt from the quality assurance department (reference number: 227382), 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: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Muscular weakness, Neck pain, Pain
Clinical narrative: Case number PHHY2013US020795, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480191) website on 04 Mar 2013 with a follow-up information received from the quality assurance department (QA reference number: 227382) on 30 May 2014. This report refers to a 62-years-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1204501, expiry date: May 2013) intramuscularly in the left arm on 04 Oct 2012. On the same day after vaccination, she experienced pain in right arm. On the next day, she experienced pain in arms, neck and upper back and chest. Over the weekend she experienced upper and lower body pain. By Sunday, she developed weakness in legs and hands bilaterally. On 09 Oct 2012, she consulted a neurologist and underwent computed tomography scan (CAT), chest x-ray, electrocardiogram (EKG), blood work ruled out Guillain-Barre syndrome (GBS). However, her Creatine phosphokinase (CPK) level increased to 1298. The outcome of these events was reported as condition unchanged as of 03 Jan 2013. The causality and seriousness of the event was not reported. Upon follow up receipt from the quality assurance department (reference number: 227382), 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: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2013US020795, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480191) website on 04 Mar 2013 with a follow-up information received from the quality assurance department (QA reference number: 227382) on 30 May 2014. This report refers to a 62-years-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1204501, expiry date: May 2013) intramuscularly in the left arm on 04 Oct 2012. On the same day after vaccination, she experienced pain in right arm. On the next day, she experienced pain in arms, neck and upper back and chest. Over the weekend she experienced upper and lower body pain. By Sunday, she developed weakness in legs and hands bilaterally. On 09 Oct 2012, she consulted a neurologist and underwent computed tomography scan (CAT), chest x-ray, electrocardiogram (EKG), blood work ruled out Guillain-Barre syndrome (GBS). However, her Creatine phosphokinase (CPK) level increased to 1298. The outcome of these events was reported as condition unchanged as of 03 Jan 2013. The causality and seriousness of the event was not reported. Upon follow up receipt from the quality assurance department (reference number: 227382), 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: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2013US020935 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 480353) on 04 Mar 2013 with a follow up information received from the quality assurance department (QA reference number: 214196) on 30 May 2014. This case refers to a 58-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1205501, expiry date: Jun 2013) intramuscularly in his arm on 05 Jan 2013. On the same day after vaccination, he fainted. He sat down and had some water, later he got up and left. Emergency service was called but he refused further help. He was called at 1.00 PM and found that he was fine. He had recovered completely. The seriousness and causality was not reported. Upon follow up receipt from the quality assurance department (reference number: 214196), 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. No other information was available. Follow up information received from the quality assurance department on 30 May 2014: Batch summary and expiry date updated.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Dizziness, Heart rate increased, Heart rate irregular, Hyperacusis
Clinical narrative: Case number PHHY2013US032482 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 481056) website on 04 Apr 2013 with a follow up information received from the quality assurance department (QA reference number: 221035) on 30 May 2014. This report refers to a 55-year-old female patient. She was allergic to pollen, cats and dust mites. She was vaccinated with FLUVIRIN (batch number: 1205501, expiry date: Jun 2013) intramuscularly in the right arm on 12 Jan 2013. On the same date, after vaccination she became pale, dizzy, disoriented, had rapid and irregular heart beat and had sensitivity to light and sound. The outcome of the events was reported as recovered as of 13 Jan 2013. The seriousness and causality of the events were not reported. Upon follow up receipt from the quality assurance department (reference number: 221035), 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. No further information was available. Follow up information received from the quality assurance department on 30 May 2014: Batch summary and expiry date updated.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Photophobia
Clinical narrative: Case number PHHY2013US032482 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 481056) website on 04 Apr 2013 with a follow up information received from the quality assurance department (QA reference number: 221035) on 30 May 2014. This report refers to a 55-year-old female patient. She was allergic to pollen, cats and dust mites. She was vaccinated with FLUVIRIN (batch number: 1205501, expiry date: Jun 2013) intramuscularly in the right arm on 12 Jan 2013. On the same date, after vaccination she became pale, dizzy, disoriented, had rapid and irregular heart beat and had sensitivity to light and sound. The outcome of the events was reported as recovered as of 13 Jan 2013. The seriousness and causality of the events were not reported. Upon follow up receipt from the quality assurance department (reference number: 221035), 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. No further information was available. Follow up information received from the quality assurance department on 30 May 2014: Batch summary and expiry date updated.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site reaction, Paraesthesia, VIIth nerve paralysis
Clinical narrative: Case number PHHY2013US032525, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 481472) website on 04 Apr 2013 with a follow up report received from Quality Assurance Department (reference number: 221870) on 30 May 2014. This report refers to 19-year-old female patient. Her medical history included allergy to KEFLEX. She was vaccinated with FLUVIRIN (batch number: 1205501, expiry date: Jun 2013) intramuscularly in the right arm on 09 Jan 2013. On the same day of vaccination, she experienced numbness and tingling along the jaw. She experienced a slight drooping in the corner of the mouth. After several minutes, she experienced numbness and tingling from the site of injection shot up till her arm. Patient visited emergency room. Hospital inquired if the vaccine contained thiomersal as they thought she was having a reaction to it. The event outcome was reported as condition unchanged. The seriousness and causality was not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 1205501 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report received on 30 May 2014: Updated vaccine expiry date and batch review report.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Borrelia test, Drooling, Eyelid function disorder, Facial paresis, Renal function test
Clinical narrative: Case number PHHY2013US032565, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 481611) website on 04 Apr 2013 with a follow up report received from Quality Assurance Department (reference number: 221544) on 30 May 2014. This report refers to a 55-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN  (batch number: 12262P) intramuscularly in the right arm on 10 Jan 2013. Hours after vaccination, he experienced drooling from the left side of the lips and started losing sensation on left side of face. He was unable to close his left eye. He was diagnosed with Bell's palsy and was prescribed prednisone 60 mg for 10 days, valacyclovir 1000 mg for 7 days, Natural tears and erythromycin ointment for eye. Lab test done for Lyme disease and kidney function test was also performed. Facial physiotherapy was done to bring strength back to face and also to improve his speech. He was sent to the virologist and ophthalmologist. The event outcome was reported as condition unchanged. The seriousness and causality was not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 12262P was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report from QA department on 30 May 2014: Updated batch review report.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Sensory loss, Speech disorder, VIIth nerve paralysis
Clinical narrative: Case number PHHY2013US032565, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 481611) website on 04 Apr 2013 with a follow up report received from Quality Assurance Department (reference number: 221544) on 30 May 2014. This report refers to a 55-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN  (batch number: 12262P) intramuscularly in the right arm on 10 Jan 2013. Hours after vaccination, he experienced drooling from the left side of the lips and started losing sensation on left side of face. He was unable to close his left eye. He was diagnosed with Bell's palsy and was prescribed prednisone 60 mg for 10 days, valacyclovir 1000 mg for 7 days, Natural tears and erythromycin ointment for eye. Lab test done for Lyme disease and kidney function test was also performed. Facial physiotherapy was done to bring strength back to face and also to improve his speech. He was sent to the virologist and ophthalmologist. The event outcome was reported as condition unchanged. The seriousness and causality was not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number: 12262P was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Follow up report from QA department on 30 May 2014: Updated batch review report.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Ear infection viral, Hearing aid user, Nuclear magnetic resonance imaging, Tinnitus
Clinical narrative: Case number PHHY2013US032562 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 483603) website on 04 Apr 2013 with a follow up report received from agency on 30 May 2014. This report refers to a 60-year-old female patient. Current condition of this patient included allergy to penicillin. Concomitant medication of this patient included vitamins and PREVACID. She was vaccinated with FLUVIRIN  (batch number: not reported) intramuscularly to left arm on 12 Sep 2012. On 24 Sep 2012, the patient began to have buzzing and ringing in right ear. Few days later, the patient consulted with doctor who said it was probably a viral infection in ear. She consulted with ENT specialist as well. An MRI was done (result not reported). Patient currently wore hearing aid at the time of reporting. Patient was being given oral steroids, with no improvement. Outcome of the events were reported as complete recovery as of 06 Feb 2013. Causality and seriousness were not reported. Follow up report received from agency on 30 May 2014: Upon follow up agency confirmed that the reported batch number for FLUVIRIN (batch number: 124801) was not valid. Hence, without a valid batch number batch investigation could not be performed.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Drooling, Sensory loss, VIIth nerve paralysis
Clinical narrative: Case number PHHY2013US044406 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 486186) on 06 May 2013, and with a follow up report received from a QA department (reference number: 227798) on 30 May 2014. This case refers to a 55-year-old male patient. His concomitant medications included of LIPITOR and omeprazole. His medical history was not reported. He was vaccinated with FLUVIRIN (batch number: 12262P, expiry date: 30 Jun 2013) intramuscularly in his right arm on 10 Jan 2013. On the same day of vaccination, he experienced loss of sensation on left face and drooling. On the morning of 11 Jan 2013, he had an emergency doctor visit. He was diagnosed with Bell's palsy. He was given prednisolone and antiviral medication as treatment, and he was asked to follow up with primary care physician. The final outcome was reported as completely recovered on an unspecified date. The seriousness and causality were not reported. Based on the batch review report, it was concluded that the FLUVIRIN, batch number 12262P 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: 227798) on 30 May 2014. Updated batch review report and expiry date of vaccine.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Erythema, Injection site cellulitis, Injection site erythema
Clinical narrative: Case number PHHY2014US013293, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516036) website on 03 Feb 2014 and a follow up report received from the QA department on 28 May 2014. This report refers to a 64-year-old female patient. Past medical history was not reported. Concomitant medications included Vitamin D and fish oil. She was vaccinated with FLUVIRIN (batch number: 13442P) intramuscularly and with PNEUMOVAX (other manufacturer, batch number: J004058) subcutaneously on 18 Nov 2013. On the same day after vaccination, she experienced fever with a body temperature of 101.2 (units: not reported), chills, rigors and severe body aches. Also her entire left upper arm was red, hot, swollen, painful and went on to cellulitis. Treatment for the events was rendered with KEFLEX. The final outcome of the events was recovered. The seriousness and causality of the events were not reported. Based on the document review for the reference number 296239, it was stated that the FLUVIRIN, batch number 13442P 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 the QA department on 28 May 2014: Updated batch review report.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Local swelling, Pain
Clinical narrative: Case number PHHY2014US013293, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516036) website on 03 Feb 2014 and a follow up report received from the QA department on 28 May 2014. This report refers to a 64-year-old female patient. Past medical history was not reported. Concomitant medications included Vitamin D and fish oil. She was vaccinated with FLUVIRIN (batch number: 13442P) intramuscularly and with PNEUMOVAX (other manufacturer, batch number: J004058) subcutaneously on 18 Nov 2013. On the same day after vaccination, she experienced fever with a body temperature of 101.2 (units: not reported), chills, rigors and severe body aches. Also her entire left upper arm was red, hot, swollen, painful and went on to cellulitis. Treatment for the events was rendered with KEFLEX. The final outcome of the events was recovered. The seriousness and causality of the events were not reported. Based on the document review for the reference number 296239, it was stated that the FLUVIRIN, batch number 13442P 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 the QA department on 28 May 2014: Updated batch review report.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Case number PHHY2014US013293, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516036) website on 03 Feb 2014 and a follow up report received from the QA department on 28 May 2014. This report refers to a 64-year-old female patient. Past medical history was not reported. Concomitant medications included Vitamin D and fish oil. She was vaccinated with FLUVIRIN (batch number: 13442P) intramuscularly and with PNEUMOVAX (other manufacturer, batch number: J004058) subcutaneously on 18 Nov 2013. On the same day after vaccination, she experienced fever with a body temperature of 101.2 (units: not reported), chills, rigors and severe body aches. Also her entire left upper arm was red, hot, swollen, painful and went on to cellulitis. Treatment for the events was rendered with KEFLEX. The final outcome of the events was recovered. The seriousness and causality of the events were not reported. Based on the document review for the reference number 296239, it was stated that the FLUVIRIN, batch number 13442P 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 the QA department on 28 May 2014: Updated batch review report.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy bone marrow, Blood test, Dyspepsia, Platelet count decreased, Thrombocytopenia
Clinical narrative: Case number PHHY2014US054648, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 522906) website on 06 May 2014 and a follow-up information was received from Quality Assurance Department (reference number: 298024) on 27 May 2014. This report refers to a 57-year-old male patient. Past medical history included ankylosing spondylitis. Concomitant medications included NAPROSYN. He was vaccinated with FLUVIRIN (batch number: 1307801) intramuscularly into the right arm on 18 Nov 2013. On 05 Dec 2013, he underwent a blood test for a digestive problem and his platelet count was found to be 85,000. On 30 Jan 2014, his platelet count was 4,000. On an unknown date, he underwent bone marrow tests and he was given a diagnosis of acquired amegakaryocytic thrombocytopenia. He was hospitalized on an unknown date for six days. The final outcome of the events was condition unchanged. The seriousness of the events was reported as life threatening, permanent disability and hospitalization. Causality was not reported. Batch review report (reference number: 298024) received from quality assurance department on 27 May 2014. Based on the batch review performed, it was concluded FLUVIRIN (batch number: 1307801) 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 Quality Assurance Department (reference number: 298024) on 27 May 2014: Updated batch review report.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy bone marrow abnormal, Dyspepsia, Platelet count decreased, Thrombocytopenia
Clinical narrative: Case number PHHY2014US054648, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 522906) website on 06 May 2014 and a follow-up information was received from Quality Assurance Department (reference number: 298024) on 27 May 2014. This report refers to a 57-year-old male patient. Past medical history included ankylosing spondylitis. Concomitant medications included NAPROSYN. He was vaccinated with FLUVIRIN (batch number: 1307801) intramuscularly into the right arm on 18 Nov 2013. On 05 Dec 2013, he underwent a blood test for a digestive problem and his platelet count was found to be 85,000. On 30 Jan 2014, his platelet count was 4,000. On an unknown date, he underwent bone marrow tests and he was given a diagnosis of acquired amegakaryocytic thrombocytopenia. He was hospitalized on an unknown date for six days. The final outcome of the events was condition unchanged. The seriousness of the events was reported as life threatening, permanent disability and hospitalization. Causality was not reported. Batch review report (reference number: 298024) received from quality assurance department on 27 May 2014. Based on the batch review performed, it was concluded FLUVIRIN (batch number: 1307801) 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 Quality Assurance Department (reference number: 298024) on 27 May 2014: Updated batch review report.
Age: 11.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 11 year old patient who had previously received 2 doses of VARIVAX. On 20-MAY-2014 the patient was inadvertently vaccinated with a third 0.5 ml dose of VARIVAX via subcutaneous route. No adverse effects were reported. NO PQC. This is one of several reports from the same patient. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site rash
Clinical narrative: Mother of child noticed rash at the site of injection.
Age: 1.01
Sex: F
Vaccine: HEPA, PPV, VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Rash generalised
Clinical narrative: Extreme diarrhea still ongoing 1 week later. Full body rash. Half dollar size hard dark red lump where shot was administered.
Age: 1.51
Sex: M
Vaccine: HEPA
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: Asthenia, Blood thyroid stimulating hormone normal, Dizziness, Fatigue, Full blood count normal
Clinical narrative: Fever, dizziness, weakness, fatigue.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: Metabolic function test normal, Pyrexia, Thyroid function test normal
Clinical narrative: Fever, dizziness, weakness, fatigue.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: Dizziness, Immediate post-injection reaction, Lethargy, Pyrexia, X-ray
Clinical narrative: Fever, dizziness, weakness, fatigue.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Musculoskeletal disorder, Pain in extremity
Clinical narrative: This spontaneous report was received from a nurse refers to a 26 year old female patient. The patient's allergies included: drug allergies to penicillin (manufacturer unknown). Medical history included: abnormal menstrual bleeding which was treated DEPO PROVERA prior to start of GARDASIL series. On 24-MAR-2014 the patient was vaccinated with first dose of GARDASIL. On 19-MAY-2014 the patient was vaccinated with second dose of GARDASIL in her right arm. On 27-MAY-2014, the patient developed weakness and pain in her right arm. No tingling or lack of sensation was present in right arm. The patient stated to physician that she felt disabled because she could not use her arm fully (disability). The physician directed to administer ibuprofen (manufacturer unknown) and apply ice to the site. The patient had no relief and contacted the physician's office on 02-JUN-2014. There was no product quality complaint involved. The outcome of disabled because she could not use her arm fully, pain in her right arm and weakness was unknown. The relatedness of the events with GARDASIL was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy to vaccine, Musculoskeletal pain, Skin warm, Swelling
Clinical narrative: Shoulder pain, swollen, raised spot about the shape of an egg. Hot and painful.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Headache, Influenza like illness
Clinical narrative: Headache (sometimes severe), fatigue, and flu-like achiness lasting five days.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Area red and swollen; itchy; noted increase in temperature; size of welt increased to 3x4 inches when seen in Urgent care on 6/8; had hives, increase in itching, temp; Give steroid shot and steroid pack; reports better 6/9 7:30 am.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Right upper arm, two red warm areas- approx. 6 cm, circular, and 4 cm circular. Temp 97 degrees. No treatment.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 04 June 2014. A 41 year-old male subject (date of birth not reported) with no reported past medical history had received on an unspecified day in September 2008 a ACAM2000 (lot number, route and site of administration not reported) and 2096 days later was found to have on 29 May 2014 a positive rapid Troponin I. No symptoms were noted and no other adverse events were reported. He did do a rigorous hike on 25 May 2014. The subject had a normal ECG on 29 May 2014. Action taken was none. No further information was available at the time of the report. The subject's outcome was still present, no treatment (not recovered). According to the investigator, the event of elevated Troponin was considered mild, other important medical event and remotely related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Initial report was received on 04 June 2014 from a healthcare professional. This is a cluster of two unidentified patients who had received on 29 May 2014 and 02 June 2014 an intramuscular injection of ADACEL, lot number U4875AA and an unspecified amount of time later, developed cellulitis at the injection site. The patient's required and ER/doctor visit. No further information was provided at the time of the event. Outcomes were unknown. Documents held by sender: none.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (registered nurse, RN) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unspecified dates, improperly stored doses of GARDASIL (strength, dose number, dose, frequency, lot number and indication were not reported) were administered to an unspecified number of unspecified patients. No adverse effects were reported.  Concomitant medications were not specified. This is one of several reports received from the same reporter (linked to MARRS # 1406USA000382, 1406USA000549, 1406USA000550, 1406USA000552). Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 months old patient of unknown gender. On 03-JUN-2014 the 4 month old patient of was vaccinated with first dose of ROTATEQ (oral, dose unknown). Pertinent medical history and concomitant medications were unknown. No drug allergies and diagnostic tests were reported. No adverse effects reported. No further information provided. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (registered nurse, RN) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unspecified dates, improperly stored doses of VAQTA (strength, dose number, dose, frequency, lot number and indication were not reported) were administered to an unspecified number of unspecified patients. No adverse effects were reported. Concomitant medications were not specified. This is one several reports received from the same reporter (linked to MARRS # 1406USA000549, 1406USA000550, 1406USA000551, 1406USA000552). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients. It was reported that unspecified patients. It was reported that unspecified patients were vaccinated with improperly stored M-M-R II (lot#, dose, strength and frequency were unknown) subcutaneous. No adverse effects were reported. Follow up information has been received from registered nurse. 61 unspecified patients received the improperly stored M-M-R II, lot #J003785 and expiration date: 28-MAR-2015. She stated that the dates of administration of the M-M-R II for the 61 unspecified patients were as followed: 09-JAN-2014, 13-JAN-2014, 14-JAN-2014, 15-JAN-2014, 17-JAN-2014, 20-JAN-2014, 21-JAN-2014, 22-JAN-2014, 24-JAN-2014, 27-JAN-2014, 28-JAN-2014, 29-JAN-2014, 31-JAN-2014, 03-FEB-2014, 05-FEB-2014, 06-FEB-2014, 10-FEB-2014, 11-FEB-2014, 12-FEB-2014, 13-FEB-2014, 20-FEB-2014, 21-FEB-2014, 24-FEB-2014, 25-FEB-2014, 26-FEB-2014, and 27-FEB-2014. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients. It was reported that unspecified patients were vaccinated with improperly stored MMR II (lot#, dose, strength and frequency were unknown) subcutaneous. No adverse effects were reported. Follow up information has been received from registered nurse. 61 unspecified patients received the improperly stored MMR II, lot #J003785 and expiration date: 28-MAR-2015. She states that the dates of administration of MMR II for the 61 unspecified patients were as followed: 09-JAN-2014, 13-JAN-2014, 14-JAN-2014, 15-JAN-2014, 17-JAN-2014, 20-JAN-2014, 21-JAN-2014, 22-JAN-2014, 24-JAN-2014, 27-JAN-2014, 28-JAN-2014, 29-JAN-2014, 31-JAN-2014, 03-FEB-2014, 05-FEB-2014, 06-FEB-2014, 10-FEB-2014, 11-FEB-2014, 12-FEB-2014, 13-FEB-2014, 20-FEB-2014, 21-FEB-2014, 24-FEB-2014, 25-FEB-2014, 26-FEB-2014, and 27-FEB-2014. This is one of several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: NONE - ADMINISTERED BEFORE RECOMMENDED TIME HAD ELAPSED.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Noticed softball sized lump on left arm at injection site. Showered and went to bed. Fever of unknown intensity until 2:00 AM, 6/3/14; 100.3 degrees. Site red, very sore and hot to the touch. Swelling slightly decreased at injection site; swelling moving to encompass bicep and tricep areas. Six to 8 hives around swelling and on left leg. Extremely sore at shoulder and tricep. Called doctor @ 8:00 Am, 6/3/14. Temp @ 100.1 degrees. Advised to alternate cold an hot packs, take Tylenol. Temp continued to drop throughout the day until normal; swelling did not dissipate. Visited urgent care clinic on 6/8/2014. Dr. diagnosed reaction and cellulitis. Steroids and antibiotics prescribed. Steroid treatment completed; swelling gone. Antibiotics still being taken.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Injection site warmth, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Noticed softball sized lump on left arm at injection site. Showered and went to bed. Fever of unknown intensity until 2:00 AM, 6/3/14; 100.3 degrees. Site red, very sore and hot to the touch. Swelling slightly decreased at injection site; swelling moving to encompass bicep and tricep areas. Six to 8 hives around swelling and on left leg. Extremely sore at shoulder and tricep. Called doctor @ 8:00 Am, 6/3/14. Temp @ 100.1 degrees. Advised to alternate cold an hot packs, take Tylenol. Temp continued to drop throughout the day until normal; swelling did not dissipate. Visited urgent care clinic on 6/8/2014. Dr. diagnosed reaction and cellulitis. Steroids and antibiotics prescribed. Steroid treatment completed; swelling gone. Antibiotics still being taken.