chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Feeding disorder, Generalised tonic-clonic seizure, Hyperacusis, Myocardial infarction
Clinical narrative: Initial and follow up information has been received from a physician, referring to a 18 year old female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. The physician obtained the information in a public post, which was posted by the mother of the patient. In approximately 2013 (reported as "about 3 years ago"), the patient was vaccinated with the first dose of GARDASIL (dose, route, lot # expiration date were not reported). Then, in approximately 2014 (reported as "about 2 years ago") the patient received the second dose of GARDASIL (dose, route, lot # and expiration date were not reported). There was no concomitant medication reported. It was reported that, on an unknown date, the patient experienced a "general fatigue" after receipt of the second dose of GARDASIL in approximately 2014. The patient did not seek for medical attention at this time. At the end, the reporter stated that 5 days after receiving the dose (unspecified dose number), the patient died on an unspecified date (discrepant information as it was also reported that the patient died "some time last week, January 2016"). The cause of death was not provided. The patient did not seek any medical attention. No product quality complaint was involved. It was reported that the patient's mother was blaming GARDASIL for causing her daughter's death. At the time of the report, the outcome of general fatigue was unknown. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Pain, Parenteral nutrition, Photophobia, Seizure, Tachycardia
Clinical narrative: Initial and follow up information has been received from a physician, referring to a 18 year old female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. The physician obtained the information in a public post, which was posted by the mother of the patient. In approximately 2013 (reported as "about 3 years ago"), the patient was vaccinated with the first dose of GARDASIL (dose, route, lot # expiration date were not reported). Then, in approximately 2014 (reported as "about 2 years ago") the patient received the second dose of GARDASIL (dose, route, lot # and expiration date were not reported). There was no concomitant medication reported. It was reported that, on an unknown date, the patient experienced a "general fatigue" after receipt of the second dose of GARDASIL in approximately 2014. The patient did not seek for medical attention at this time. At the end, the reporter stated that 5 days after receiving the dose (unspecified dose number), the patient died on an unspecified date (discrepant information as it was also reported that the patient died "some time last week, January 2016"). The cause of death was not provided. The patient did not seek any medical attention. No product quality complaint was involved. It was reported that the patient's mother was blaming GARDASIL for causing her daughter's death. At the time of the report, the outcome of general fatigue was unknown. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Vaccination complication
Clinical narrative: Initial and follow up information has been received from a physician, referring to a 18 year old female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. The physician obtained the information in a public post, which was posted by the mother of the patient. In approximately 2013 (reported as "about 3 years ago"), the patient was vaccinated with the first dose of GARDASIL (dose, route, lot # expiration date were not reported). Then, in approximately 2014 (reported as "about 2 years ago") the patient received the second dose of GARDASIL (dose, route, lot # and expiration date were not reported). There was no concomitant medication reported. It was reported that, on an unknown date, the patient experienced a "general fatigue" after receipt of the second dose of GARDASIL in approximately 2014. The patient did not seek for medical attention at this time. At the end, the reporter stated that 5 days after receiving the dose (unspecified dose number), the patient died on an unspecified date (discrepant information as it was also reported that the patient died "some time last week, January 2016"). The cause of death was not provided. The patient did not seek any medical attention. No product quality complaint was involved. It was reported that the patient's mother was blaming GARDASIL for causing her daughter's death. At the time of the report, the outcome of general fatigue was unknown. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Fatigue, Inappropriate schedule of drug administration
Clinical narrative: Initial and follow up information has been received from a physician, referring to a 18 year old female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. The physician obtained the information in a public post, which was posted by the mother of the patient. In approximately 2013 (reported as "about 3 years ago"), the patient was vaccinated with the first dose of GARDASIL (dose, route, lot # expiration date were not reported). Then, in approximately 2014 (reported as "about 2 years ago") the patient received the second dose of GARDASIL (dose, route, lot # and expiration date were not reported). There was no concomitant medication reported. It was reported that, on an unknown date, the patient experienced a "general fatigue" after receipt of the second dose of GARDASIL in approximately 2014. The patient did not seek for medical attention at this time. At the end, the reporter stated that 5 days after receiving the dose (unspecified dose number), the patient died on an unspecified date (discrepant information as it was also reported that the patient died "some time last week, January 2016"). The cause of death was not provided. The patient did not seek any medical attention. No product quality complaint was involved. It was reported that the patient's mother was blaming GARDASIL for causing her daughter's death. At the time of the report, the outcome of general fatigue was unknown. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Seizure
Clinical narrative: Initial and follow up information has been received from a physician, referring to a 18 year old female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. The physician obtained the information in a public post, which was posted by the mother of the patient. In approximately 2013 (reported as "about 3 years ago"), the patient was vaccinated with the first dose of GARDASIL (dose, route, lot # expiration date were not reported). Then, in approximately 2014 (reported as "about 2 years ago") the patient received the second dose of GARDASIL (dose, route, lot # and expiration date were not reported). There was no concomitant medication reported. It was reported that, on an unknown date, the patient experienced a "general fatigue" after receipt of the second dose of GARDASIL in approximately 2014. The patient did not seek for medical attention at this time. At the end, the reporter stated that 5 days after receiving the dose (unspecified dose number), the patient died on an unspecified date (discrepant information as it was also reported that the patient died "some time last week, January 2016"). The cause of death was not provided. The patient did not seek any medical attention. No product quality complaint was involved. It was reported that the patient's mother was blaming GARDASIL for causing her daughter's death. At the time of the report, the outcome of general fatigue was unknown. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Gastrointestinal tube insertion, Pain
Clinical narrative: Initial and follow up information has been received from a physician, referring to a 18 year old female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. The physician obtained the information in a public post, which was posted by the mother of the patient. In approximately 2013 (reported as "about 3 years ago"), the patient was vaccinated with the first dose of GARDASIL (dose, route, lot # expiration date were not reported). Then, in approximately 2014 (reported as "about 2 years ago") the patient received the second dose of GARDASIL (dose, route, lot # and expiration date were not reported). There was no concomitant medication reported. It was reported that, on an unknown date, the patient experienced a "general fatigue" after receipt of the second dose of GARDASIL in approximately 2014. The patient did not seek for medical attention at this time. At the end, the reporter stated that 5 days after receiving the dose (unspecified dose number), the patient died on an unspecified date (discrepant information as it was also reported that the patient died "some time last week, January 2016"). The cause of death was not provided. The patient did not seek any medical attention. No product quality complaint was involved. It was reported that the patient's mother was blaming GARDASIL for causing her daughter's death. At the time of the report, the outcome of general fatigue was unknown. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Head injury, Syncope
Clinical narrative: PT WAS ASKED IF SHE  WAS OK AFTER 20 MIN MOTHER AND PT STATED SHE WAS FINE. PT WALKED OUT WHILE THEY WERE FRONT OFFICE SCHEDULING NEXT FOLLOW UP APPT. PT FAINTED FELL AND HIT HER HEAD ON THE COUNTER ON HER WAY DOWN.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024325, is an initial spontaneous report received from a nurse on 02 Dec 2014 with a follow information received from the nurse on 19 Jan 2015. This report refers to a 14 year old male patient. Medical history and concomitant medication were not reported. His vaccination history included administration of previous FLUVIRIN (batch number: not reported) which was previously tolerated. He was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly in the right deltoid at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that pre-filled syringe (PFS) of FLUVIRINI was stored at 49 degree F for 1 hour and 15 minutes. The reporter confirmed that the patient did not experience any adverse reaction following administration of incorrectly stored vaccine. Follow up information received from the nurse on 19 Jan 2015: Updated vaccination history, site of vaccination and reporter's comment.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024323 is an initial spontaneous report from a nurse received on 02 Dec 2014, and with a follow up reported from nurse on 19 Jan 2015. This report refers to a 59 years old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml on 05 Nov 2014 into left deltoid. The nurse reported that before vaccination the prefilled syringe of FLUVIRIN was stored at 49 degree F 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow up report received from nurse on 19 Jan 2015. Updated site of vaccination.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024322 is an initial spontaneous report from a nurse received on 02 Dec 2014 with a follow up information received from the nurse on 19 Jan 2015. This report refers to a 59 years old female patient. Historical conditions were not reported. No concomitant medication was reported. Her vaccination history included administration of previous FLUVIRIN (batch number: not reported) which was previously tolerated. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml in the right deltoid on 05 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The reporter confirmed that the patient did not experience any adverse reaction following administration of incorrectly stored vaccine. Follow up information received from the nurse on 19 Jan 2015: Updated vaccination history, site of vaccination and reporter's comment.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024333, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 08 years old male patient. His medical history and concomitant medications were not reported. His past vaccinations (unspecified) were well tolerated. He was vaccinated with FLUVIRIN (batch number: 14511P expiry date: Mar 2015) intramuscularly in left deltoid at a dose of 0.5 ml on 05 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this medication error (incorrect storage of drug). Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US24321, is an initial spontaneous report from a nurse received on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 59 years old male patient. Historical condition and concomitant medication were not reported. His past vaccinations (unspecified) were well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscular in left deltoid at a dose of 0.5 ml on 12 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this medication error. Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024320 is an initial spontaneous report from a nurse received on 02 Dec 2014 and a follow up report from the nurse received on 19 Jan 2015. This report refers to a 64 years old male patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included flu vaccine (manufacturer and batch number: not reported) and it was well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly in the left deltoid at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow up report from the nurse received on 19 Jan 2015: Vaccination history and site of FLUVIRIN vaccination were updated.
Age: 1.21
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Blood culture negative, Chest X-ray normal, Death, Febrile convulsion, Full blood count normal
Clinical narrative: Parents reported that pt. had a seizure after receiving PENTACEL and VARIVAX on 8/8/13 - his seizure occurred on 8/12/13 in conjunction with fever. Pt was evaluated at ED and released. Dx'd with febrile seizures. On 12/18/2015 pt was found unresponsive in his bed and was DOA after transport to Medical Center.
Age: 1.21
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Pyrexia, Seizure, Unresponsive to stimuli
Clinical narrative: Parents reported that pt. had a seizure after receiving PENTACEL and VARIVAX on 8/8/13 - his seizure occurred on 8/12/13 in conjunction with fever. Pt was evaluated at ED and released. Dx'd with febrile seizures. On 12/18/2015 pt was found unresponsive in his bed and was DOA after transport to Medical Center.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024319 is an initial spontaneous report from a nurse received on 02 Dec 2014, and with a follow up report received from nurse on 19 Jan 2015. This report refers to a 64 years old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml on 05 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up report received from nurse on 19 Jan 2015. No adverse event reported to vaccine.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024318 is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 64 years old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. Concomitant vaccinations included PNEUMOVAX 23 (other manufacturer and batch number: J001194) and TDAP (other manufacturer and batch number: U4515AA). The patient was vaccinated with FLUVIRIN (batch number, 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 07 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid), concomitant vaccinations and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, CSF protein increased, Computerised tomogram head, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Back pain started 12/26 lower back pain got progressively worse, on 12/29 leg weakness started, on 12/31 AM (R) fingers got numb, on 1/2 numbness started in (L) fingers, on 1/4 the left mouth drooped. Diagnosed with Guillain Barre on 1/5/16; IVIG started 1/5/16 at approx. 6 pm 5 days Ig received.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Muscular weakness, Nerve conduction studies, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Back pain started 12/26 lower back pain got progressively worse, on 12/29 leg weakness started, on 12/31 AM (R) fingers got numb, on 1/2 numbness started in (L) fingers, on 1/4 the left mouth drooped. Diagnosed with Guillain Barre on 1/5/16; IVIG started 1/5/16 at approx. 6 pm 5 days Ig received.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Back pain started 12/26 lower back pain got progressively worse, on 12/29 leg weakness started, on 12/31 AM (R) fingers got numb, on 1/2 numbness started in (L) fingers, on 1/4 the left mouth drooped. Diagnosed with Guillain Barre on 1/5/16; IVIG started 1/5/16 at approx. 6 pm 5 days Ig received.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024317 is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This reports to a 63 years old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into right deltoid intramuscularly at a dose of 0.5 ml on 14 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration 9incorrect storage of drug). No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (right deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test negative, Choking, Increased upper airway secretion, Respiratory tract congestion, Throat irritation
Clinical narrative: Did not have cold - healthy before on 10/26/15 48 hours after shot given 10/26/15, I developed sudden extreme congestion choking wheezing for 3 days. Mucous was so viscous it would not come out - at times it could be pulled out in one long 24 inches string without breaking with bristles of toothbrush scraping the throat.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Did not have cold - healthy before on 10/26/15 48 hours after shot given 10/26/15, I developed sudden extreme congestion choking wheezing for 3 days. Mucous was so viscous it would not come out - at times it could be pulled out in one long 24 inches string without breaking with bristles of toothbrush scraping the throat.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024316 is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 63 years old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 13 Nov 2014. The nurse reported that before vaccination the prefilled syringe of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Intestinal resection, Intussusception, Vomiting
Clinical narrative: Patient developed intussusception requiring bowel resection on 1/20/2015. Pt. developed symptoms of vomiting and diarrhea on 1/18/2015.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024315, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 62-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 17 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024334, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 22 Jan 2015. This report refers to a 73-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 22 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014024314, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to 60-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 13 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024335, is an initial spontaneous report from a nurse received on 02 Dec 2014 with a follow up information received from the nurse on 19 Jan 2015. This report refers to a 73-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. His vaccination history included administration of previous FLUVIRIN (batch number: not reported) which were previously tolerated. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly in the left deltoid at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN prefilled syringe stored at 49 F for 1 hour and 15 minutes was administered to the patient. The reporter confirmed that the patient did not experience any adverse reaction following administration of incorrectly stored vaccine. Follow up information received from the nurse on 19 Jan 2015: Updated gender of the patient, vaccination history, site of vaccination and reporter's comment.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024313, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 60-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 18 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024312, is an initial spontaneous report from a nurse received on 02 Dec 2014, with a follow up received from nurse on 19 Jan 2015. This report refers to a 64-year-old female patient. Her medical history was not reported. Concomitant medications were none. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml into the left deltoid on 05 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration. Follow up received from nurse on 19 Jan 2015: updated site of vaccination and reporter comment.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024311, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. Her medical history and concomitant medications were not reported. She had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 12 Nov 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024308, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 19 Jan 2015. This report refers to a 39 years old female patient. Her medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml into the left deltoid on 06 Nov 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. The patient did not experience and any adverse reaction due to the maladministration (incorrect storage of drug). Follow up received from nurse on 19 Jan 2015: updated site of vaccination and reporter comment.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024307 is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a combine follow up information received from the nurse on 22 Jan 2015 and on 26 Jan 2015 respectively. This report refers to a 42 year old male patient. Historical conditions were not reported. No concomitant medication was reported.  The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly in left deltoid at a dose of 0.5 ml on 17 Nov 2014. The nurse reported that FLUVIRIN was stored at 49 F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No adverse events occurred due to vaccine only there was a temperature fluctuation in storage. No further information was provided. Combined follow up information received from the nurse on 22 Jan 2015 and on 26 Jan 2015 respectively: Updated site of vaccination and reporter comment in narrative only.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient complains of soreness and pain at injection site. (Required physical therapy).
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Pt complained of feeling dizzy approximately 1 minute after receiving injections. Had her lay down on exam table and propped up lower legs with blankets. Got her cup of water and crackers (she hadn't eaten breakfast). Felt better in approximately 5 minutes.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Extensive erythema, pain and swelling of arm. Began soon after immunization. Lasted 3d. Resolved spontaneously.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024337, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with follow-up from a nurse received on 19 Jan 2015. This report refers to a 71-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN prefilled syringe at 49 F for 1 hour and 15 minutes was administered to the patient. No adverse event reported following this medication error. Follow-up from a nurse received on 19 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 47.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site joint pain, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: Patient received PNEUMOVAX 23 on 1/27/2016. Right deltoid; reported pain, swelling, joint pain, warm to touch, streak formation at injection site.
Age: 47.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Injection site warmth
Clinical narrative: Patient received PNEUMOVAX 23 on 1/27/2016. Right deltoid; reported pain, swelling, joint pain, warm to touch, streak formation at injection site.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Musculoskeletal pain, Peripheral swelling, Sleep disorder, Tendonitis
Clinical narrative: Shoulder pain bursitis, tendonitis of shoulder and shoulder pain, aching all day all night, unable to sleep due to pain. Treatment - cortisone shot - worked for 18 hours. 4 weeks of physical therapy, no relief still attempting physical ther.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray limb
Clinical narrative: Shoulder pain bursitis, tendonitis of shoulder and shoulder pain, aching all day all night, unable to sleep due to pain. Treatment - cortisone shot - worked for 18 hours. 4 weeks of physical therapy, no relief still attempting physical ther.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024331, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with follow-up from a nurse received on 19 Jan 2015. This report refers to an 11 years old female patient. Her medical history and concomitant medications were not reported. She had tolerated vaccines (no further details provided) well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 05 Nov 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. No adverse event was reported following this maladministration. Follow-up from a nurse received on 19 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Sex: U
Vaccine: FLU3, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Tdap administered 1/21/16 when patient had received Tdap 9 years earlier. Current recommendation is for one dose Tdap in a lifetime. Patient experienced no adverse reactions following vaccination.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024336, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 73 year old male patient. Historical condition and concomitant medication were not reported. His past vaccinations (unspecified) were well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly in left deltoid at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN prefilled syringe stored at 49 F for 1 hour and 15 minutes was administered to the patient. Patient did not experience any adverse event. No adverse event was reported following this medication error. Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024338, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with follow-up from a nurse received on 19 Jan 2015. This report refers to a 71-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 17 Nov 2014. THe nurse reported that FLUVIRIN prefilled syringe stored at 49 F for 1 hour and 15 minutes was administered to the patient. No adverse event reported following this medication error (incorrect storage of drug). Follow-up from a nurse received on 19 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024352, is an initial spontaneous report from a nurse received on 02 Dec 2014 with a follow up information received from the nurse on 19 Jan 2015. This report refers to a 76-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. His vaccination history included administration of previous FLUVIRIN (batch number: not reported) which was previously tolerated. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly in the right deltoid at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The reporter confirmed that the patient did not experience any adverse reaction following administration of incorrectly stored vaccine. Follow up information received from the nurse on 19 Jan 2015: Updated vaccination history, site of vaccination and reporter's comment.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024329, is an initial spontaneous report received from a nurse on 02 Dec 2014 with a follow up information received from the nurse on 19 Jan 2015. This report refers to an 11 years old female patient. Her medical history an concomitant medications were not reported. Her vaccination history included administration of previous FLUVIRIN (batch number: not reported) which was previously tolerated. She was vaccinated with FLUVIRIN (batch number: 14511P expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml in the right deltoid on 05 Nov 2014. It was reported that the patient received FLUVIRIN pre-filled syringe (PFS) that was stored at 49 degree F for 1 hour 15 minutes. The reported confirmed that the patient did not experience any adverse reaction following administration of incorrectly stored vaccine. Follow up information received form the nurse on 19 Jan 2015: Updated site of vaccination and reporter's comment.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Same day arm swollen red in injection spot (flu shot arm).
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024306 is an initial spontaneous report from a nurse received on 02 Dec 2014 and a follow up report from the nurse received on 19 Jan 2015. This report refers to a 43 years old male patient. Historical conditions were not reported. Vaccination history included flu vaccine (manufacturer and batch number: not reported) and it was well tolerated. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly in the right deltoid at a dose of 0.5 ml on 05 Nov 2014. The nurse reported that FLUVIRIN was stored at 49 F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up report from the nurse received on 19 Jan 2015: Vaccination history and site of FLUVIRIN vaccination were updated.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at sight of injection.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture negative, Blood lactic acid normal, CSF culture negative, Culture urine negative, Full blood count normal
Clinical narrative: POSSIBLE SEIZURE.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Herpes simplex serology negative, Metabolic function test normal, Neurological examination normal, Nuclear magnetic resonance imaging normal, Polymerase chain reaction
Clinical narrative: POSSIBLE SEIZURE.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Seizure
Clinical narrative: POSSIBLE SEIZURE.
Age: 75.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Myalgia, Vertigo
Clinical narrative: Vertigo and generalized muscle pain in upper arms not in shoulder.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm swollen/red same day when shot given. (PNEUMOVAX shot arm).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024339, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with follow-up from a nurse received on 21 Jan 2015. This report refers to a 71-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into right deltoid intramuscularly at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that FLUVIRIN prefilled syringe stored at 49 F for 1 hour and 15 minutes was administered to the patient. No adverse event reported following this medication error (incorrect storage of drug). Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (right deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient received Flu vaccine at pharmacy in Nov 2015. Reported to our office during appointment: (R) deltoid pain since receiving vaccination.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: 1 wk after vaccination noticed redness and increased skin temper. at vaccination site and also on inside of upper arm.
Age: 18.0
Sex: F
Vaccine: FLUX, MNQ
Symptoms: Condition aggravated, Lip swelling, Pruritus
Clinical narrative: Swollen mild upper lip. Reported head itchy last night.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024346, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 78 year old female patient. Past medical history and concomitant medication were not reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Had redness to left deltoid the size of softball per mom and slight swelling. Mom requested to fill this out.
Age: 99.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024949, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 99 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 13 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursion lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: The day after vaccine began itching around lower legs by today 1/25/16 the itching and rash spread to arms chest etc...