chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Fatigue, Generalised erythema, Generalised oedema, Headache, Influenza virus test negative
Clinical narrative: Information has been received from a certified medical assistant referring to a 14 year old female patient with mild persistent asthma, well controlled. On 18-JAN-2016 at 11:36, the patient was vaccinated with the first dose of PNEUMOVAX 23, injection, intramuscular in the left deltoid, lot # L033707, (dose, concentration and expiration date were not provided), indicated, vaccinated at private doctor's office/hospital with private funds. Concomitant therapies included the first dose of FLUZONE, intramuscular in the right deltoid, lot# UI507AAA. On 20-JAN-2016 at 08:00 (reported as "2 days after injection"), the patient experienced rash generalized, fatigue, headache, nausea, myalgia, pyrexia, generalized oedema, injection site swelling (reported as "raised and swollen at injection site") and generalized erythema. On an unknown date in January 2016, was performed a "flu test" with negative results. At the time of the report, the outcome of generalized erythema, fatigue, headache, myalgia, pyrexia, injection site swelling, nausea, rash generalized and generalized oedema was unknown. This is one of two reports received from the same source (linked report MARRS#1512USA008017, 1602US001349 and 1512USA003027). Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Injection site swelling, Myalgia, Nausea, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a certified medical assistant referring to a 14 year old female patient with mild persistent asthma, well controlled. On 18-JAN-2016 at 11:36, the patient was vaccinated with the first dose of PNEUMOVAX 23, injection, intramuscular in the left deltoid, lot # L033707, (dose, concentration and expiration date were not provided), indicated, vaccinated at private doctor's office/hospital with private funds. Concomitant therapies included the first dose of FLUZONE, intramuscular in the right deltoid, lot# UI507AAA. On 20-JAN-2016 at 08:00 (reported as "2 days after injection"), the patient experienced rash generalized, fatigue, headache, nausea, myalgia, pyrexia, generalized oedema, injection site swelling (reported as "raised and swollen at injection site") and generalized erythema. On an unknown date in January 2016, was performed a "flu test" with negative results. At the time of the report, the outcome of generalized erythema, fatigue, headache, myalgia, pyrexia, injection site swelling, nausea, rash generalized and generalized oedema was unknown. This is one of two reports received from the same source (linked report MARRS#1512USA008017, 1602US001349 and 1512USA003027). Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025142, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 74 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration (incorrect storage of drug).
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Erythema and swelling of left upper arm with itching.
Age: 68.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Fatigue
Clinical narrative: Upon internal review on 08 February 2016, correction has been amended to correct the company modifier for suspect drug PRALUENT. Upon second medical examination of the case during internal review, a significant correction performed on 21 December 2015 to change ALIROCUMAB from concomitant drug to suspect. Initial unsolicited report received from a consumer on 3 December 2015. This case involves a 68-year-old female patient who was vaccinated with a dose of Flu shot (batch number, route and site of administration were not reported) on 02 December 2015. The patient had a medical history of high cholesterol. On 30 November 2015, the patient began with 75 mg pen injection of praluent (every two weeks) (batch number- 5F010A, expiry date - 30 September 2016) for high cholesterol as concomitant medication. On 03 December 2015, one day following the vaccination, the patient had experienced fatigue. Laboratory data and corrective treatment were not reported. On an unspecified date, the patient was recovered from the event. List of documents held by sender: none. Addendum: 21 December 2015. Upon second medical examination of case at time of internal review the following has been modified in this case ALIROCUMAB has been considered as a suspect drug. Follow up information received from a Consumer on 07 January 2016. No additional information provided. Addendum: 08 February 2016. Upon second medical examination of case at time of internal review the following has been modified in this case company modifier for suspect drug PRALUENT was corrected.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in upper arm above elbow and if I raise the arms there is pain. Never had this pain before the shots.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: Patient stated that she has severe pain at the injection site, lightheadedness, weakness, diaphoresis, nausea. These symptoms lasted for about 20 minutes and then it passed. Currently there was just pain at the injection site. She is currently taking Advil for the pain.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Aphasia, Dyspnoea, Grip strength decreased, Guillain-Barre syndrome, Pain in extremity
Clinical narrative: Tingling pains in hands and arms. Days later same tingling in legs and feet. Difficulty breathing; could not talk or grab/hold on to anything. Diagnosed with Guillain Barre Syndrome.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: Tingling pains in hands and arms. Days later same tingling in legs and feet. Difficulty breathing; could not talk or grab/hold on to anything. Diagnosed with Guillain Barre Syndrome.
Sex: U
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Initial unsolicited report received from a physician on 27-Jan-2016. This case involves a patient (age and gender not reported) who was vaccinated with Fluzone (batch number: unknown, dose, dose in series, route and site of administration were not reported) on an unknown date. Medical history and concomitant medications were not reported. On an unknown date, after vaccination, the patient experienced knee pain. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain
Clinical narrative: Pt called to state that her right arm where the Prevnar was given is sore to the touch. Pt denied fever, swelling, rash and redness. MD advised pt take Tylenol and ice to site.  On 1/28, right arm ok but hurts when lifting arm over her head.  On 1/29, pt came to MD office for check.  MD prescribed Voltaren EC 50mg BID. On 1/31, pt reported arm better and Voltaren continued x 2 wks. On 2/11, pt had residual pain & MD referred pt to PT.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Acoustic stimulation tests normal, Deafness, Tinnitus
Clinical narrative: Sudden onset of tinnitus and significant hearing loss, predominantly in left ear 24 hours after receiving flu vaccine (Fluzone High-Dose IM Susp. Lot# UI453AA) and pneumococus vaccine (Prevnar 13 IM Susp. Lot# m16258). Saw Dr. who administered vaccine on Monday 11/23/15. Saw an ENT Dr. on Wed 11/25/15. Prescribed high dose oral prednisone for 10 days. Subjectively much improved after 36 hours of treatment. Follow-up hearing evaluation on 12/17/15 showed return on hearing to "normal". Tinnitus gone with 36 hr of prednisone.
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Laryngospasm
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of asthma in a adult female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. In December 2015, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced asthma (serious criteria hospitalization) and laryngospasm (serious criteria hospitalization). On an unknown date, the outcome of the asthma and laryngospasm were recovering/resolving. It was unknown if the reporter considered the asthma and laryngospasm to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The reporter stated that, apparently the event occurred in the month of December 2015.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Clostridium difficile colitis, Erythema
Clinical narrative: The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 01Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer and from a contactable medical assistant via Pfizer Sales Representative. This medical assistant reported similar events on five patients. This is the fifth of five reports. A 94-year-old female patient of unspecified ethnicity received, at the age of 93 year-old, PREVNAR 13 (lot number M20639 and expiration date 30Apr2017, NDC number 0005-1971-02) via an unspecified route of administration, on the deltoid on 17Nov2015 at 0.5 ml single. Relevant medical history was not reported and concomitant medications were none. The patient experienced cellulitis on 17Nov2015 and redness on 19Nov2015. The patient was admitted to the hospital due to the events from 28Nov2015 to 06Dec2015 and C. difficile colitis was diagnosed. The patient was treated with AUGMENTIN. The patient recovered from cellulitis while the outcome of redness was not provided.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 02Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer and from a contactable medical assistant via Pfizer Sales Representative. This medical assistant reported similar events on five patients. This is the fourth of five reports. A 73-year-old female patient of unspecified ethnicity received PREVNAR 13 (NDC number 0005-1971-02) via an unspecified route of administration, on the deltoid on 19Nov2015 at 0.5 ml single. Relevant medical history and concomitant medications were not reported. The patient experienced cellulitis on 19Nov2015. The event did not require admission to the hospital. The patient was treated with KEFLEX and recovered from the event on unknown date. Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: SMALL
Symptoms: Rash papular
Clinical narrative: Non itchy popular rash.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site mass, Local reaction
Clinical narrative: Immediate, local reaction post zoster vaccine. Approximately golfball sized mass formed at injection site on left upper arm. Treated with warm compress. No SOB. No anaphylaxis. No wheezing.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Decreased appetite, Lethargy, Pyrexia, Vomiting
Clinical narrative: Fever of 102 when he work up.  Started on Tylenol.  Fever by the evening was 103-104 at times. Very lethargic and throwing up.  No appetite.
Sex: U
Vaccine: DTAPIPV
Symptoms: Febrile convulsion
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of febrile seizure in a patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, an unknown time after receiving KINRIX, the patient experienced febrile seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the febrile seizure was unknown. It was unknown if the reporter considered the febrile seizure to be related to KINRIX. Additional details were provided as follows: The reporter reviewed KINRIX product information (PI) and asked if Medical Science Liaison (MSL) could assist this case. The sales representative reviewed BOOSTRIX with adult provider and gain commitment that history of Tdap was reviewed and asked on appropriate patients.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a consumer referring to a 14 year old male patient. The patient's concurrent conditions and medical history were not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot # and expiration date were not provided). Concomitant therapies were not reported. On an unspecified date the patient died. It was unknown if an autopsy was performed and which was the exact cause of death. On an unknown date the reporter wrote on the "Merck Corporate Twitter Account". The relatedness between death and GARDASIL was unknown. Additional information is not expected as the reporter did not provide contact details.
Age: 63.0
Sex: M
Vaccine: FLUC3
Symptoms: Blood pressure decreased, Bradycardia, Dizziness, Dyspnoea, Heart rate decreased
Clinical narrative: At nurse visit, pt given flu shot and within 3 minutes became diaphoretic, bp dropped, pulse dropped and pt felt light headed and sl short of breath. Placed in Trendelenburg, given oxygen and monitored bp pulse q5 minutes. Sx cleared and BP rose within 10 minutes without use of epi pen. Hypotension, Bradycardia.
Age: 63.0
Sex: M
Vaccine: FLUC3
Symptoms: Hyperhidrosis, Hypotension
Clinical narrative: At nurse visit, pt given flu shot and within 3 minutes became diaphoretic, bp dropped, pulse dropped and pt felt light headed and sl short of breath. Placed in Trendelenburg, given oxygen and monitored bp pulse q5 minutes. Sx cleared and BP rose within 10 minutes without use of epi pen. Hypotension, Bradycardia.
Age: 39.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local swelling, Pyrexia
Clinical narrative: Fever, left deltoid redness, swelling and tenderness, left axillae swelling.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Feeling abnormal, Irritability, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: On 12/21/2015 patient was given a Tdap vaccine as part of a new hire assessment. She denied contraindications to Tdap. Two days after receiving the vaccine she developed fatigue, irritability, sore throat, denies redness and swelling of arm. She denied having fever or airway reaction. Her dad remembered that she had a rxn as a child to a DTP and was advised to never be vaccinated with DTP/TD vaccine again. She states she was unaware that she had a contraindication until she had the current reaction. Her symptoms progressed to vomiting. She saw her PCP. On 01/13/2016 she came to EH and reported incident. She had vomiting yesterday and now has gland swelling on the L cervical node. She reports she had no airway rxn. Still feeling poorly. Denies fever. She was advised to complete a PSA. She is advised to seek medical care for increase in gland swelling and given information that it could cause airway impingement if swelling increases. If there are in airway symptoms she should seek immediate emergency care including use of ambulance. She demonstrates an understanding of directions. (Created on 1/11/2016 and 8:59).
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: On 12/21/2015 patient was given a Tdap vaccine as part of a new hire assessment. She denied contraindications to Tdap. Two days after receiving the vaccine she developed fatigue, irritability, sore throat, denies redness and swelling of arm. She denied having fever or airway reaction. Her dad remembered that she had a rxn as a child to a DTP and was advised to never be vaccinated with DTP/TD vaccine again. She states she was unaware that she had a contraindication until she had the current reaction. Her symptoms progressed to vomiting. She saw her PCP. On 01/13/2016 she came to EH and reported incident. She had vomiting yesterday and now has gland swelling on the L cervical node. She reports she had no airway rxn. Still feeling poorly. Denies fever. She was advised to complete a PSA. She is advised to seek medical care for increase in gland swelling and given information that it could cause airway impingement if swelling increases. If there are in airway symptoms she should seek immediate emergency care including use of ambulance. She demonstrates an understanding of directions. (Created on 1/11/2016 and 8:59).
Age: 13.0
Sex: M
Vaccine: HPV9, MMR
Symptoms: Asthenia, Dizziness, Feeling abnormal, Feeling hot, Headache
Clinical narrative: Severe headache, blurred vision, fever, feeling hot, dizziness, weakness, feeling disconnected. Administered Tylenol.
Age: 13.0
Sex: M
Vaccine: HPV9, MMR
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Severe headache, blurred vision, fever, feeling hot, dizziness, weakness, feeling disconnected. Administered Tylenol.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling and erythema at injection site (L) arm.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain, Pyrexia, Rash, Swelling
Clinical narrative: Emesis, fever of 103. Swelling, rash, painful to touch and limited range of motion of arm.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Emesis, fever of 103. Swelling, rash, painful to touch and limited range of motion of arm.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025120, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 78-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 30 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US02551116, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to an 89-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025146, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 45 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025148, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 29 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025149, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 19 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration (incorrect storage of drug).
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025154, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to an 87 years old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 22 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025125, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 76-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 19 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursions began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2014US025133, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 57-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperatures was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025139, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 28 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No previous events reported after the maladministration.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025134, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 56-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 19 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursions began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025131, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 62-year-old female patient. Historical conditions were reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperatures excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025141, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 66 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025137, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 78-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025136, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 72-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 11 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025370, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 62 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 23 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this maladministration error (incorrect storage of drug).
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025130, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 78-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursions began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025356, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 65 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 16 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this maladministration error (incorrect storage of drug).
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000674, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 64-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 10 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration (incorrect storage of drug). No further information was provided.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025129, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to an 83-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000675, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 59-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 08 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration (incorrect storage of drug). No further information was provided.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000676, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 69 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 14554P) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours.  The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration (incorrect storage of drug). No further information was provided.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025128, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 62-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 19 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000677, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to an adult female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 14554P) intramuscularly at a dose of 0.5 ml on an unknown date. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration. No further information was provided.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000688, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 49 years old male patient. Medical history and concomitant medications were not reported. On 31 Oct 2014, the patient received FLUVIRIN (batch number: 145205) at a dose of 0.5 ml intramuscularly. It was reported that the patient received FLUVIRIN that reached below 36 F for 3.5 non-consecutive days; vaccine reached 33.1 F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought it might be due to thermometer malfunction. The case was assessed as non-serious. No adverse event was reported following this medication error.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000678, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 62 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 14554P) intramuscularly at a dose of 0.5 ml on 31 Dec 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration. No further information was provided.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025127, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 77-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal
Clinical narrative: Vaccine administered 9/3/15, patient came by today 2/11/16 said that her arm does not hurt but doesn't "feel right" and she said she read an article how other people have had the same situation following a flu vaccine.  Patient did not state any treatment or therapy following vaccine administration.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Localized 4"round, red, slightly raised circle around injection site and painful.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000679, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 64 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 11 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration. No further information was provided.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Anticonvulsant drug level, Generalised tonic-clonic seizure, Urine analysis normal
Clinical narrative: Grand Mal seizure. 911 called and transported to Pediatric ER.
Age: 11.0
Sex: M
Vaccine: FLUN4, HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Presyncope
Clinical narrative: Student stated felt light headed and was mildly diaphoretic, then felt like "going to black out", placed in reverse Trendelenberg b/p 92/64, felt better in 5 min b/p 102/78 gradually recovered with return to normal within 15 min, near syncope episode.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: NO adverse evident noted by patient.  Wrong diluent for vaccine used for vaccine.
Age: 38.0
Sex: F
Vaccine: PNC13
Symptoms: Henoch-Schonlein purpura, Laboratory test, Pain in extremity, Rash, Ultrasound Doppler
Clinical narrative: Rash and pain bilateral LEs. Both progressively worsened prompting patient to be evaluated in the ER 11/28/2015. Patient was diagnosed with Henoch Schonlein purpura. No biopsy was done.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received Zostavax vaccine on 1/10/16 at Pharmacy and complained that she contracted the shingles virus approximately 11 days later.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025126, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 51-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000680, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 59 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 25 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration. No further information was provided.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000681, is an initial spontaneous report received from a pharmacist on 05 Jan 2015. This report refers to a 62 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 24 Oct 2014. It was reported that the patient received FLUVIRIN which reached temperature below 36 degree F for 3.5 non-consecutive days and 33.1 degree F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought that it could be due to thermometer malfunction. But she was not sure. No adverse event was reported following this medication error.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025124, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 66-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000682, is an initial spontaneous report received from a pharmacist on 05 Jan 2015. This report refers to a 62 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 17 Oct 2014. It was reported that the patient received FLUVIRIN which reached temperature below 36 degree F for 3.5 non-consecutive days and 33.1 degree F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought that it could be due to thermometer malfunction. But she was not sure. No adverse event was reported following this medication error.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000683, is an initial spontaneous report received from a pharmacist on 05 Jan 2015. This report refers to a 27 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 12 Oct 2014. It was reported that the patient received FLUVIRIN which reached temperature below 36 degree F for 3.5 non-consecutive days and 33.1 degree F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought that it could be due to thermometer malfunction. But she was not sure. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000684, is an initial spontaneous report received from a pharmacist on 05 Jan 2015. This report refers to a 52 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 08 Oct 2014. It was reported that the patient received FLUVIRIN which reached temperature below 36 degree F for 3.5 non-consecutive days and 33.1 degree F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought that it could be due to thermometer malfunction. But she was not sure. No adverse event was reported following this medication error.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025123, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to an 84-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000686, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 60 years old male patient. Medical history and concomitant medications were not reported. On 28 Oct 2014, the patient received FLUVIRIN (batch number: 145205) at a dose of 0.5 ml intramuscularly. It was reported that the patient received FLULVIRIN that reached below 36 F for 3.5 non-consecutive days; vaccine reached 33.1 F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought it might be due to thermometer malfunction. The case was assessed as non-serious. No adverse event was reported following this medication error (incorrect storage of drug).