chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Case number PHEH2014US001201 is an initial spontaneous report from a nurse received on 14 Jan 2014. This report refers to a male child. The patient received FLUVIRIN (batch number: 1308401, expiry Mar 2014) intramuscularly on 09 Jan 2014. The nurse stated that patient was under the age of four and received FLUVIRIN. No further information was reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Case number PHEH2014US000913 is an initial spontaneous report received from a medical assistant on 08 Jan 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308801) subcutaneously on 06 Jan 2014. It was reported that her vaccination site had redness on the same date. The event outcome was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US000818 is an initial spontaneous report received from a pharmacist on 07 Jan 2014. This report refers to an adult male patient. On 07 Jun 2014, he was vaccinated with one dose of FLUVIRIN (batch number: not reported) intramuscularly, from a pre filled syringe which reached at a temperature of 34 F for the first time excursion. This pre filled syringe was placed in the refrigerator at a temperature of 38 F, since discovery of the temperature excursion. No adverse event was reported following this administration error.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Influenza, Pain
Clinical narrative: Case number PHEH2014US000529 is an initial spontaneous report received from a consumer on 02 Jan 2014: This report refers to a female patient of unknown age. She was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly on 13 Sep 2013. On an undetermined date after vaccination, she experienced flu symptoms which were described as fever, body aches, chills and a cough. Outcome of the events was reported as unknown. No further information about seriousness and causality was mentioned.
Sex: U
Vaccine: FLU3
Symptoms: Accidental exposure to product, No adverse event, Product container seal issue
Clinical narrative: Case number PHEH2013US027051, is an initial spontaneous report received from a health care professional (who is also patient) via product technical complaint department (QA reference numbers: 257815 and 260059) on 22 Oct 2013. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was inadvertently exposed to FLUVIRIN (batch number: 1308401, expiry date: 30 mar 2014) which rundown the patient arm when the patient was drawing a dose form a vial after the seventh or eight puncture to the multiuse vial of FLUVIRIN. It was reported that there was significant leakage of vials. The patient used 23 gauge one inch needles which were standard for flu shot. The problem seemed to start after second of third needle when used in the same area where previous needle was punctured. After each successive needle punctured the stopper was leaking and got worse. It seemed like the rubber of the stopper was acting like it was old or had got frozen. There no damage of the original vial box (carton, packaging). No adverse events reported after the maladministration.
Age: 76.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US016220, is an initial spontaneous report received from a pharmacist on 11 Aug 2014. This report refers to a 76 year old patient of unknown gender. The patient received FLUVIRIN (batch number: unknown) 0.5 ml intramuscularly on 09 Aug 2014. The pharmacist reported that the patient received FLUVIRIN from either an unopened MDV or an opened MDV after it reached 74.3F for 4-6 hours on 08 Aug 2014. No adverse event was reported. No further information was provided.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US016215, is an initial spontaneous report received from a pharmacist on 11 Aug 2014. This report refers to a 70 year old patient of unknown gender. The patient received FLUVIRIN, (batch number: unknown) 0.5 ml intramuscularly on 09 Aug 2014. The pharmacist reported that the patient received FLUVIRIN from either an unopened MDV or an opened MDV after it reached 74.3F for 4-6 hours on 08 Aug 2014. No adverse event was reported. No further information was provided.
Sex: U
Vaccine: FLU3
Symptoms: Lacrimation increased, Lip swelling
Clinical narrative: Case number PHEH2014US011642 is an initial spontaneous report received from a consumer on 09 Jun 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1309401, expiry date: 30 Apr 2014) on an unknown date. On an unknown date after vaccination, the patient experienced swelling of lips and tearing of the eyes. The outcome, causality and seriousness were not reported.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: Case number PHEH2014US011570 is an initial spontaneous report from a consumer received on 05 Jun 2014. This report refers to a 69-year-old female patient. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: 1308201) intramuscularly on 13 Oct 2013. On the same day, post vaccination, her pulse slightly elevated and irregular. Outcome of the event was reported as recovered. Seriousness and causality of the event was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US010626 is an initial spontaneous report from a pharmacist received on 22 may 2014. This report refers to a patient of an unknown age and gender. The patient was vaccinated with FLUVIRIN (batch number: unknown) on 21 May 2014 or 22 May 2014 which was expired. No adverse reaction was reported following this medication error.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US010455, in an initial spontaneous report received from a pharmacist on 20 MAY 2014. The report refers to a 37 or 38 year old male patient. Pharmacist reported that the he administered an expired dose of FLUVIRIN 2013/2014 (batch number: unknown) intramuscular to the patient on 19 MAY 2014. The patient had no complaints of adverse reaction. No further information was provided.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US010051 is an initial spontaneous report received from a nurse on 14 May 2014. This report refers to an adult female patient whose age was in 50s. Her medical history and concomitant medications were not reported. She was vaccinated with an expired dose of FLUVIRIN (batch number: 1308801, expiry date; Apr 2014) intramuscularly on 13 May 2014. No adverse events were reported following the maladministration.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Wrong drug administered
Clinical narrative: Case number PHEH2014US005880 is an initial spontaneous report from a nurse received on 24 Mar 2014. This report refers to a 40-year-old female patient. Her medical history and concomitant medications were not reported. She was mistakenly administered 0.1 cc of FLUVIRIN (batch number: 1309601) intradermally when TB test was intended on 24 Mar 2014. On an unknown date after vaccination she experienced red mark at the site. Seriousness, outcome of the event were not reported.
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain in extremity, Poor quality sleep
Clinical narrative: Case number PHEH2014US005535 is an initial spontaneous report received from a consumer on 18 MAR 2014: This report refers to a female patient of unknown age. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) and with BOOSTRIX (other manufacturer, batch number: unknown) on an undetermined date. On 02 SEP 2013, after vaccinations, she experienced severe pain all down her right arm. She had to avoid using that arm and pain kept her up at night. She went to her doctor about the pain. Pain completely resolved on 01 DEC 2013. Outcome for the other event (pain kept her up) was not reported. No further information about seriousness and causality was reported.
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Case number HEH2014US017899 is an initial spontaneous report received from the pharmacist on 04 SEP 2014. This report refers to a 59 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145221) subcutaneously at a dose of 0.5 ml on 03 SEP 2014. It was reported that on the same day after vaccination, she experienced swelling under arm. The event outcome was unknown. The seriousness and causality were not reported.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Case number PHEH2014US017897 is an initial spontaneous report received from a pharmacist on 04 SEP 2014. This report refers to a 60 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 145221) subcutaneously at a dose of 0.5 ml on 03 SEP 2014. It was reported that on the same day after vaccination, he experienced swelling under arm. The event outcome was unknown. The seriousness and causality were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Expired product administered, Incorrect route of drug administration, Wrong drug administered
Clinical narrative: Case number PHEH2014US017731, is an initial spontaneous report received from a nurse on 02 SEP 2014 and a follow up report from the nurse received on 03 OCT 2014, with a follow up report from the nurse received on 10 OCT 2014. This report refers to a adult female patient (in her 50's). She had no medical history. Concomitant medication was not reported. She tolerated FLUVIRIN well in the past. Nurse reported that the staff member erroneously gave the patient expired FLUVIRIN 2013/2014 (batch number 1307801) intradermally (instead of intramuscularly) on 02 SEP 2014 instead of a PPD (0.1 ml). They meant to give a PPD test. Nurse put some hydrocortisone on there because it was a little red. The nurse contacted in order to see if there were any side effects (symptoms/complications to be monitored. It was reported that the patient was doing fine and no adverse reactions were noted. The seriousness and causality assessment were not reported. The nurse asked to close the case. No additional details available.  Follow up report from the nurse received on 03 OCT 2014: Updated outcome of the event.   Follow up report from the nurse received 10 OCT 2014: updated vaccination history and reporter comment.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US017501 is an initial spontaneous report received from a medical assistant on 27 AUG 2014. This report refers to an 83 year old female patient. Her medical history and concomitant medications were not reported. It was reported that unopened FLUVIRIN MDV's reached 50.7F for 4 hours. Reported as one tie excursion. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 1410801) at a dose 0f 0.5 ml intramuscularly on 25 AUG 2014 from the MDV after the excursion. No adverse event was reported. No further information was provided.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US017500 is an initial spontaneous report received from a medical assistant on 27 Aug 2014. This report refers to an 86 year old male patient. His medical history and concomitant medications were not reported. It was reported that unopened FLUVIRIN MDVs reached 50.7. F for 4 hours. Reported as one time excursion. The patient was vaccinated with FLUVIRIN (batch number: 1410801 at a dose of 0.5 ml intramuscularly on 25 Aug 2014, from the MDV after the excursion. No adverse event was reported. No further information was provided.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US017291 is an initial spontaneous report received from a medical assistant on 26 Aug 2014. This report refers to a 4 years old male patient. His medical history and concomitant medications were not reported. he was vaccinated with 0.25 ml dose of FLUVIRIN (batch number: 1412201) intramuscularly from a multidose vial on 18 Aug 2014. No adverse events were reported following the maladministration.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Flushing
Clinical narrative: Case number PHEH2014US017044 is an initial spontaneous report received from a pharmacist on 25 Aug 2014. This report refers to a 52 year old male patient. His past medical history included flushing in the past, the last episode in spring. On 23 Aug 2014, at 04:00 pm, he was vaccinated with FLUVIRIN (batch number: 145302) intramuscularly and at 08:00 PM, he took NIASPAN (other manufacturer, batch number: not reported). On the same day, at 11:00 PM, he experienced flushing which was so severe that he had to jump into a pool just to cool off. The patient completely recovered from flushing after 3-4 hours of onset. The seriousness and causality of the event were not reported.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US018325, is an initial spontaneous report from a pharmacist received on 10 Sep 2014. This report refers to a 73-year-old male patient. Past medical history and concomitant medications were not reported. On 09 Sep 2014, the patient received 5 ml dose of FLUVIRIN (batch number: 1411201) intramuscularly instead of 0.5 ml dose. No adverse events were reported following the maladministration. No additional information was available.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018085 is an initial spontaneous report received from a pharmacist on 08 Sep 2014. This report refers to a 58 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145402) intramuscularly on 08 Sep 2014, which was stored at a temperature of 32 Fahrenheit for a couple of hours. It was reported that the vaccine was not frozen. No adverse events were reported following this medication error.
Sex: M
Vaccine: FLU3
Symptoms: Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US016826, is an initial spontaneous report received from a pharmacist on 18 Aug 2014. This report refers to a male patient of unknown age. His medical history and concomitant medication was not reported. The pharmacist reported that this pharmacy instructed him to administer vaccinations to patients only with vanishing point syringes. Caller reported that in order to get a full 0.5 ml dose of FLUVIRIN for a patient, pharmacist withdrew the contents of 2 prefilled syringes (PFS) of FLUVIRIN into one vanishing point syringe. The patient was vaccinated with 0.5 ml of FLUVIRIN (batch number: 145303) intramuscularly on 18 Aug 2014. Caller explained that he poked the needle of the Vanishing Point syringe through the PFS tip cap to withdraw enough vaccine from 2 PFS to amount to 0.5 ml on the Vanishing Point syringe. No further information was provided. No adverse event was reported.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US016777 is an initial spontaneous report received from a pharmacist on 19 Aug 2014 with a follow up information received from a pharmacist on 30 Sep 2014. This case refers to a 51 year old female patient. Past medical history was not reported and concomitant medication included spironolactone 100 mg oral once daily. She had annual flu shot and her vaccination history included administration of FLUVIRIN (batch number: not reported) which was well tolerated. She was vaccinated with FLUVIRIN (batch number: 145204, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml on 19 Aug 2014 at 11:18 am. Reporter stated that, at another store they administered FLUVIRIN prefilled syringe to her without first shaking it. No adverse reaction was reported following this administration error. Follow up information received from a pharmacist on 30 Sep 2014: Updated concomitant medication, vaccination history, expiry date, dose and time of vaccination.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Case number PHEH2014US017903 is an initial spontaneous report received from the pharmacist on 04 Sep 2014. This report refers to a 61 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145221) subcutaneously at a dose of 0.5 ml on 03 Sep 2014. It was reported that on the same day after vaccination, she experienced swelling under arm. The event outcome was unknown. The seriousness and causality were not reported.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue
Clinical narrative: Case number PHEH2014US017926, is an initial spontaneous report from a pharmacist received on 04 Sep 2014. This report refers to a 73-year-old female patient. Past medical history and concomitant medications were not reported. On 04 Sep 2014, the patient received an intramuscular dose of FLUVIRIN (batch number: 145302). It was reported that prefilled syringe leaked out during administration and the patient did not received full dose. No adverse event was reported following this medication error (underdose).
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018028, is an initial spontaneous report received from a nurse on 05 Sep 2014. This report refers to a 63 year old female patient. Her medical history and concomitant medication was not reported. It was reported that patient was administered FLUVIRIN (batch number: 145223) vaccine that was stored below 36 degree F but not for frozen. No adverse reaction was reported. No further information was provided.
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US018194 is an initial spontaneous report received from a pharmacist on 09 Sep 2014. This report refers to an adult male patient who was in his twenties (20's). His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) subcutaneously approximately two weeks before reporting (no exact date provided). No adverse event was reported following this administration error (inappropriate route of vaccination).
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHEH2014US018195, is an initial spontaneous report from a pharmacist received on 10 Sep 2014. This report refers to a 42-year-old female patient. Past medical history and concomitant medication were not provided. She received a full 5 ml (10 doses) of FLUVIRIN (batch number: not reported) intramuscularly in one dose on an unknown date of Sep 2014 (vaccination date was reported as within past two days). No adverse events were reported following the maladministration. No additional information was available.
Age: 1.02
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US018197 is an initial spontaneous report received from a Healthcare Professional on 09 Sep 2014. This report refers to a 01 year old female infant. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145303) intramuscularly on 03 Sep 2014. No adverse event was reported following this administration error.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018201, is an initial spontaneous report from a pharmacist received on 09 Sep 2014. This report refers to a 46-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN, (batch number: 145205) intramuscularly at a dose of 0.5 ml on 04 Sep 2014. It was reported that the FLUVIRIN received by her was stored at 49 F for two hours. No adverse event was reported following the medication errors (incorrect storage of drug).
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018203, is an initial spontaneous report from a pharmacist received on 09 Sep 2014. This report refers to a 41-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 29 Aug 2014. It was reported that the FLUVIRIN received by her was stored at 49 F for two hours. No adverse event was reported following the medication errors.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018204 is an initial spontaneous report received from a pharmacist (pharm D) on 09 Sep 2014. This report refers to a 50 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 27 Aug 2014. It was reported that FLUVIRIN was stored at a temperature of 49 degree F (9.4 degree C) for 2 hours. No adverse events reported after the maladministration.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018206 is an initial spontaneous report received from a consumer on 09 Sep 2014. This report refers to an adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145402) intramuscularly at a dose of 0.5 ml on an unspecified date. It was reported that FLUVIRIN was stored at temperature of 32 degree F (0 degree C) for 10 hours. No adverse events reported after the maladministration.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018213 is an initial spontaneous report from a nurse received on 09 Sep 2014. This report refers to a 49-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1412701) at a dose of 0.5 ml intramuscularly on 09 Sep 2014. It was reported that the vaccine received by the patient reached 50 F for 30 minutes before administration to the patient. No adverse event reported following this medication error.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age. On an unknown dates the patients were vaccinated with a improperly stored dose of GARDASIL (route, dose, strength, lot # and expiration date was not provided). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 25-NOV-2013 the patient was vaccinated with the first dose of LIQUID PEDVAXHIB (dose and lot# were not provided). On 27-JAN-2014 the patient received the second dose of LIQUID PEDVAXHIB (dose and lot# were not provided). A third (dose and lot# were not provided) was received on 27-MAR-2014. The patient received LIQUID OEDVAXHIB outside of the recommended dosing schedule. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: This case was reported by a nurse and described the occurrence of vaccine underdose in a female patient who received HAVRIX PEDIATRIC (batch number 3J9AM, expiry date 5th September 2016. On an unknown date the patient received HAVRIX PEDIATRIC. On an unknown date, an unknown time after receiving HAVRIX PEDIATRIC, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown.
Sex: F
Vaccine: MMR
Symptoms: Exposure to vaccinated person, Mumps antibody test, No therapeutic response, Rubella, Therapy naive
Clinical narrative: This spontaneous report as received from a registered nurse refers to her. The patient's medical history included NTH barr and fibromyalgia. The patient's current condition included with latex allergy. On an unknown date, the patient was vaccinated with M-M-R II vaccine (strength, dose, route of administration, anatomical location, indication, lot # and expiration date not reported). She had received 4 separate M-M-R II injections over her lifetime. The patient was not pregnant. No concomitant medication was reported. The patient stated that she had never seroconverted for mumps. On an unknown date in October 1966, the patient was exposed to her cousin shortly after he got M-M-R II vaccine. This resulted in her developing rubella on an unknown date in 1966. On an unknown date, the patient was separate M-M-R II naive. The outcome the event she has never seroconverted for mumps was reported as not recovered. The outcome of rubella and MMR naive was reported as recovered. The patient did not receive treatment for the events but sought medical attention. On an unknown date, titers for mumps were completed. A product quality complaint (PQC) was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age. On an unknown dates the patients were vaccinated with a improperly stored dose of VAQTA (route, dose, strength, lot # and expiration date was not provided). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received ENGERIX B (batch number ahbvc253aa, expiry date unknown. On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: From 11 October 2013 to 18 November 2013, ENGERIX B was stored at temperature as low as 27F. Vaccine was administered to an unknown number of patients.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint injection, Musculoskeletal pain, Osteoarthritis, X-ray limb abnormal
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 65-year-old female patient. The patient's medical history included biceps tendon tear in 2009. On 18-DEC-2014 the patient was vaccinated with ZOSTAVAX (strength, route, dose, lot, batch # and expiration date not reported). On an unknown date in December 2014, reported as "about a week ago" from the time of reporting (23-DEC-2014), the patient experienced pain in her right shoulder. Patient sought medical attention (saw the physician) and received a KENALOG injection to the right shoulder. Lab diagnostics studies performed included X-ray shoulder that showed degenerative disease. The outcome of pain in her right shoulder and degenerative disease was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of unknown age. On an unknown dates the patients were vaccinated with a improperly stored dose of RECOMBIVAX HB, (route, dose, strength, lot # and expiration date was not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rheumatoid arthritis
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Concurrent conditions and medical history were not reported. No known allergies. On 12-DEC-2014 (reported as 10 days ago), the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously, (strength, frequency, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. Pharmacist stated that physician wanted to place patient, on methotrexate therapy for rheumatoid arthritis on an unspecified date in December 2014. Pharmacist stated that to her knowledge, patient did not have pre-existing history of rheumatoid arthritis. It was reported that treatment with methotrexate was given for the adverse event, and it was unspecified if the patient sought medical attention. The outcome of rheumatoid arthritis was unknown. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information is not expected. The reporter did not consent contact for further follow up.
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Underdose
Clinical narrative: This case was reported by a nurse and described the occurrence of vaccine underdose in a adult female patient who received ENGERIX B pediatric (batch number 337A5, expiry date 26th November 2015). On an unknown date, the patient received ENGERIX B pediatric 10 pg. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. Additional information received: A 10 mcg dose of ENGERIX B was inadvertently given to an adult female patient.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old patient of unknown gender. On 23-DEC-2014 the patient was inadvertently received both VARIVAX (Merck) (0.5 ml, subcutaneous, lot# not reported) and PROQUAD (Merck) (0.5 ml, subcutaneous, lot# not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 12-NOV-2014, the patient was vaccinated with the first dose of VARIVAX (Merck), 0.5 ml (lot# and expiration date were not reported), subcutaneously which was improperly stored at 6F for an unknown amount of time. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (Lot number J014129 and expiration date 07-NOV-2014) (dose and route were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an older than 26 years old male patient. On an unspecified date in 2014, the patient was vaccinated with the first dose of GARDASIL (dose, frequency and lot number not provide) when he was older than 26 years of age. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 29-DEC-2014 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck), (lot#, dose and route not reported). No adverse effects were reported. No further information provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a registered nurse who was also a mother of the patient and refers to a 18 years old female patient with no medical history and no drug allergies. On 03-NOV-2014 the patient was vaccinated with the first dose of GARDASIL (injection, route of administration, lot number and expiration date were not reported) and on 29-DEC-2014 with the second dose of GARDASIL (injection, route of administration, lot number and expiration date were not reported). There was no concomitant therapy. In approximately 2014, after receiving both doses of GARDASIL, the patient experienced soreness at the injection site. There was no treatment given for adverse event and no lab diagnostic was performed. The patient did not seek medical attention. The outcome of soreness at the injection site was reported as recovered (unknown date). The relatedness between GARDASIL and the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. On 13-AUG-2014 the patient was vaccinated with the first dose of GARDASIL (dose, lot #, route and application site not reported). On 05-JAN-2015 the patient was vaccinated with the second dose of GARDASIL (dose, lot #, route and application site not reported). No adverse events were reported. The outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker (Medical Assistant) refers to an unspecified number of patients (age and gender unknown). The healthcare worker stated that improperly stored VARIVAX (Merck) (administration/dosage details unspecified) had been possibly administered to these patients between 17-DEC-2014 and 05-JAN-2015. Concomitant medications were not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, Infantile spitting up
Clinical narrative: This spontaneous report as received from a physician refers to a 2 month old patient of unknown gender. On an unknown date at age of 2 months, the patient was vaccinated with a first dose of ROTATEQ (oral, dose, lot# and expiration date were not reported), then "spit up" the dose. Patient's parents declined to continue the series at that time. The reporter stated that the patient was then inadvertently administered a second dose of ROTATEQ at age 15 months on an unspecified date. It could not be clarified whether any additional adverse effect occurred following this second administration. The outcome of the event of "spit up" the dose was unknown. The relatedness between the event of "spit up" the dose and ROTATEQ was not reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Injection site swelling, Local reaction, Nausea
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 17-DEC-2014 the patient was vaccinated with PNEUMOVAX 23, (intramuscular; dosage and dose number unknown; lot number reported as K019386 EXP 09-JUN-2016). The nurse reported that within 48 hours after receiving PNEUMOVAX 23 the female patient experienced fever, nausea, headache, generalized aches and pain and local reactions of tenderness and swelling at the injection site. The patient sought medical attention (was seen by physician). Lot check requested, not time sensitive. The outcome of the events was unknown. Another female patient was vaccinated with the same lot of PNEUMOVAX 23 and experienced the same events (MARRS case no. 1412USA011762). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 17-DEC-2014 the patient was vaccinated with PNEUMOVAX 23, (intramuscular; dosage and dose number unknown; lot number reported as K019386 EXP 09-JUN-2016). The nurse reported that within 48 hours after receiving PNEUMOVAX 23 the female patient experienced fever, nausea, headache, generalized aches and pain and local reactions of tenderness and swelling at the injection site. The patient sought medical attention (was seen by physician). Lot check requested, not time sensitive. The outcome of the events was unknown. Another female patient was vaccinated with the same lot of PNEUMOVAX 23 and experienced the same events (MARRS case no. 1412USA011762). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-NOV-2014, the patient was vaccinated with the first dose of VARIVAX (Merck), 0.5 ml (lot# and expiration date were not reported), subcutaneously which was improperly stored at 6F for an unknown amount of time. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 52 year old female patient with penicillin, sulfa and many antibiotics allergy. On 13-OCT-2014 the patient was vaccinated with ZOSTAVAX (strength, dose and lot # were not reported). Concomitant therapies included ADVAIR and unspecified emergency inhaler. On 13-OCT-2014 (reported as right after receiving the vaccine), the patient experienced adverse experience at the injection site: arm was swollen, red and hot to the touch at the injection site. Even though the patient stated that these adverse experiences had subsided she was still had a lump at the injection site at the time of this report. Then on the night of 22-DEC-2014, the patient started to have symptoms of shingles on her "rear end". The symptom she was experiencing is a "red blistering rash". The patient had not spoken with her physician at the time of this report; however, the patient did speak to her pharmacist about her adverse experiences. The patient was speaking with the pharmacist because she had received the ZOSTAVAX vaccine there. There were no laboratory diagnostics studies performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Injection site erythema, Injection site mass, Injection site reaction
Clinical narrative: This spontaneous report was received from a 52 year old female patient with penicillin, sulfa and many antibiotics allergy. On 13-OCT-2014 the patient was vaccinated with ZOSTAVAX (strength, dose and lot # were not reported). Concomitant therapies included ADVAIR and unspecified emergency inhaler. On 13-OCT-2014 (reported as right after receiving the vaccine), the patient experienced adverse experience at the injection site: arm was swollen, red and hot to the touch at the injection site. Even though the patient stated that these adverse experiences had subsided she was still had a lump at the injection site at the time of this report. Then on the night of 22-DEC-2014, the patient started to have symptoms of shingles on her "rear end". The symptom she was experiencing is a "red blistering rash". The patient had not spoken with her physician at the time of this report; however, the patient did speak to her pharmacist about her adverse experiences. The patient was speaking with the pharmacist because she had received the ZOSTAVAX vaccine there. There were no laboratory diagnostics studies performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: This spontaneous report was received from a 52 year old female patient with penicillin, sulfa and many antibiotics allergy. On 13-OCT-2014 the patient was vaccinated with ZOSTAVAX (strength, dose and lot # were not reported). Concomitant therapies included ADVAIR and unspecified emergency inhaler. On 13-OCT-2014 (reported as right after receiving the vaccine), the patient experienced adverse experience at the injection site: arm was swollen, red and hot to the touch at the injection site. Even though the patient stated that these adverse experiences had subsided she was still had a lump at the injection site at the time of this report. Then on the night of 22-DEC-2014, the patient started to have symptoms of shingles on her "rear end". The symptom she was experiencing is a "red blistering rash". The patient had not spoken with her physician at the time of this report; however, the patient did speak to her pharmacist about her adverse experiences. The patient was speaking with the pharmacist because she had received the ZOSTAVAX vaccine there. There were no laboratory diagnostics studies performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 1 month old female patient with no pertinent medical history, drug reactions or allergies. The nurse reported that the original hepatitis b vaccine (manufacturer unknown) (therapy type, dose, route, lot# and expiration date were not reported) series patient received total of 4 doses, in May 1994, July 1994, November 1994 and August 1995. The nurse could not provide why the patient received 4 doses of hepatitis b vaccine (manufacturer unknown). The patient did not take any concomitant medication. The patient entered nursing school and titer was drawn for hepatitis B in June 2014 but result was low titer and she was recommended for revaccination(also reported as a treatment for low titers). The patient started RECOMBIVAX HB (therapy type, dose, route, lot# and expiration date were not reported) series for revaccination in July 2014 and received second dose in August 2014 and third dose on 05-JAN-2015, The nurse reported that the third dose of RECOMBIVAX HB for revaccination was administered a few days earlier than recommended schedule. The outcome of the event of "low titers for hepatitis B" was unknown. The patient sought an unspecified medical attention. The relatedness between the event of "low titers for hepatitis B" and RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Injection site swelling, Local reaction, Nausea
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 15-DEC-2014 the patient was vaccinated with PNEUMOVAX 23, (intramuscular; dosage and dose number unknown; lot number reported as K019386 EXP 09-JUN-2016). The nurse reported that within 48 hours after receiving PNEUMOVAX 23 the female patient experienced fever, nausea, headache, generalized aches and pain and local reactions of tenderness and swelling, at the injection site. The patient sought medical attention (was seen by physician). Lot check requested, not time sensitive. The outcome of the events was unknown. Another female patient was vaccinated with the same lot of PNEUMOVAX 23 and experienced the same events (MARRS case no. 1501USA001475). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 15-DEC-2014 the patient was vaccinated with PNEUMOVAX 23, (intramuscular; dosage and dose number unknown; lot number reported as K019386 EXP 09-JUN-2016). The nurse reported that within 48 hours after receiving PNEUMOVAX 23 the female patient experienced fever, nausea, headache, generalized aches and pain and local reactions of tenderness and swelling, at the injection site. The patient sought medical attention (was seen by physician). Lot check requested, not time sensitive. The outcome of the events was unknown. Another female patient was vaccinated with the same lot of PNEUMOVAX 23 and experienced the same events (MARRS case no. 1501USA001475). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker (Medical Assistant) refers to an unspecified number of patients (age and gender unknown). The healthcare worker stated that improperly stored PEDVAXHIB (administration/dosage details unspecified) had been possibly administered to these patients between 17-DEC-2014 and 05-JAN-2015. Concomitant medications were not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. The nurse reported that a patient received the GARDASIL injection (strength, dose, route of administration, lot# and expiry date unspecified) series "off schedule" on the following dates: first dose was administered on 27-MAR-2014, second dose on 10-JUN-2014, and third dose on 22-JUL-2014. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLUX, HPV4, MEN, TDAP
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 11-year-old male patient. Information about concurrent conditions and medical history was not provided. On 13-NOV-2014 the patient was vaccinated with GARDASIL (lot # K004205, expiration date 12-JAN-2017, dose 1, 0.5 ml) intramuscular. Concomitant therapies included influenza virus vaccine reported as flu vaccine; TDAP reported as TDAT vaccine; tuberculin purified protein derivative (PPD) and meningococcal vaccine. The physician reported that the patient experienced being lightheaded, becoming pale and then fainting after receiving GARDASIL. Physician stated that the patient lay down for 15 minutes and was fine afterward (outcome recovered). Additional information has been requested.