chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Dizziness, Neck pain, Overdose
Clinical narrative: Initial report received from a consumer on 27 Jul 2010: This patient was vaccinated with MENVEO (batch number and dose unknown) on an unspecified date. It was reported that, the patient received multiple doses of MENVEO (might be 02 doses on the same day). The patient experienced knee pain, neck pain and dizziness on an unspecified date. The outcome of the events was not reported.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Antibody test, Incorrect product formulation administered
Clinical narrative: Initial healthcare professional report received on 27 Jul 2010: This patient received MENVEO (batch number: 029011) unknown dose intramuscularly on 13 Jul 2010. It was reported that on 13 Jul 2010, the patient was administered only the liquid Men CWY conjugate component of MENVEO instead of being reconstituted with Men A conjugate component. No adverse event had occurred due to this. The outcome and causality was not reported. Follow up report received health care professional on 09 Aug 2010: It was reported that the reporter was not sure if the patient received only MenCYW-135 liquid conjugate component of MENVEO. The titers of the patient were reported as A: 6.9, C: 6.5, Y: 15.2 and W: 0.5 on an unknown date. Follow up report received health care professional on 27 Aug 2010: The patient potentially received a partial dose of MENVEO, only liquid component. The titers were drawn but too early, only 10 days after the immunization to determine if the patient received the full dose of MENVEO. As the titers were drawn too early the results might be inconclusive. It was reported that, they would send titers and based on results of titers they would determine full dose of patient.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY2011US29939 is an initial spontaneous report received from a nurse on 04 Apr 2011 with a follow up received from a nurse on 26 Apr 2011. This report refers to an 11 year old female patient. She was given only the CYW-135 liquid component of MENVEO vaccine (batch number 090901) intramuscularly) on 30 Mar 2011. NO other adverse reaction was reported. It was reported that the immunization would be repeated in two years. Follow up received on 26 Apr 2011: Updated information about patient demographics, batch number and dosage of the vaccine was provided.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHHY2011US39090 is an initial report from a nurse received on 09 May 2011: This report refers to a 19-year-old female patient. The patient was vaccinated with MENVEO (batch number X10028) on 09 May 2011. The patient received only the MenCYW-135 liquid vaccine component of MENVEO on 09 May 2011. The patient did not present any adverse reaction to vaccine.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial nurse report received on 20 Jul 2010: This patient received MENVEO (batch number: 100022, expiration date Apr 2012), 0.5 ml intramuscularly on an unknown date. It was reported that the patient inadvertently received 0.5 ml dose of only the liquid conjugate component of MENVEO instead of being reconstituted with Men A component. The outcome of the event was not reported. The causality was not reported.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Initial report received from the health care professional on 29 Jul 2010: On an unspecified date, this patient inadvertently received a intramuscular dose of MenA component of MENVEO (batch number: not reported) that was diluted with sterile diluent instead of MenCWY liquid conjugate component.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial report received from a health care professional (medical assistant) on 13 Jul 2010: This patient accidentally received a 0.5 ml intramuscular dose of MENVEO (batch no: 027011) that was reconstituted with sterile water instead of lyophilized component on 02 Jul 2010. No adverse events were noted following this administration.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial physician report received on 19 Jul 2010: This patient was inadvertently vaccinated with only the liquid conjugate component of MENVEO (batch number: 100003) intramuscularly, without mixing with lyophilized Men A conjugate component on an unspecified date. No adverse event had occurred due to this medication error.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 24 Jun 2010: This patient was inadvertently vaccinated with only the liquid conjugate of MENVEO (batch number: 100003), (dose: unknown) intramuscularly on an unspecified date. No adverse reaction had occurred following this administration. Follow up report received from physician on 20 Jul 2010: The patient's demographics was provided. The patient didn't had any adverse event, the patient was inadvertently vaccinated with only the liquid conjugate of MENVEO vaccine on 15 Jun 2010: The patient was taking ZYRTEC (10 mg, daily), and SINGULAIR (5 mg, daily). from an unknown date, for allergic reaction. No further information was provided.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHHY2011US41580 is an initial spontaneous report received from a health care professional on 02 May 2011. This report refers to an adult male patient. He was given only the CYW-135 liquid component of MENVEO vaccine (batch number 090901, expiry date: Aug 2011) on an unspecified date. No other adverse reaction was reported.
Age: 2.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial report received from a health care professional on 02 Jul 2010: This 2 year old infant inadvertently received 0.5 ml dose of MENVEO (batch no: 091001), intramuscularly on 01 Jul 2010. No adverse effects were noted following this administration.
Age: 52.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 22 Jun 2010: This patient was vaccinated with only the diluent portion of MENVEO (batch number: 090901), (dose: unknown) intramuscularly on 22 Jun 2010. The lyophilized portion was not reconstituted. No adverse event was reported following this administration. Follow-up report received from the nurse on 07 Jul 2010: This patient was vaccinated with MENVEO at dose 0.5 ml on 22 Jun 2010. It was reported that, the patient planned to receive MENACTRA in Dec 2010 with second dose of HAVRIX. No other information was provided.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a consumer on 13 Jul 2010: A patient received a 0.5 ml, intramuscular dose of liquid conjugate of MENVEO (batch number not reported) without being reconstituted with MenA conjugate component on 12 Jul 2010. No adverse events were noted following this administration.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial information received from a health care professional on 16 Jul 2010: This patient received the MENVEO (batch number 100005, expiry date unknown), intramuscular on 14 Jul 2010. The patient not received the lyophilized conjugate component of MENVEO. No other adverse event was reported. The outcome of the event was not reported.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial nurse report received on 20 Jul 2010: The patient received MENVEO (box lot. No. 100022), 0.5 ml, intramuscularly, on an unspecified date. The patient received 0.5 ml IM dose MenCYW instead of being reconstituted with MenA on an unspecified date. The outcome of event was not reported.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHHY2011US29455 is an initial spontaneous report received from a health care professional on 04 Apr 2011. This report refers to a 15 years old female patient. She was given only the Men CYW-135 liquid vaccine component of MENVEO vaccine (batch number unknown) intramuscularly on 09 Mar 2011. No other adverse reaction was reported.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHHY2011US29832 is an initial spontaneous report received from a physician on 06 Apr 2011. This report concerns a 12 year old male patient. He was vaccinated with MENVEO (batch number: unknown) intramuscularly on unspecified date. The patient received only the Men A lyophilized powder component of MENVEO without reconstituting it with Men CYW liquid conjugate. No adverse event was reported following this drug administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHHY2011US30327, is an initial report from a nurse received on 11 Apr 2011: This report refer to a adult patient. The patient was vaccinated with MENVEO (batch number M10030) intramuscularly on an unspecified date. The patient only received the Men-CYW-135 liquid component and did not received the Men A lyophilized conjugate component of MENVEO. No adverse event had been reported. Non significant follow up received on 12 Apr 2011: No new information was provided.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report from a healthcare professional (nurse) on 22 Jun 2010: This patient was vaccinated with only the liquid conjugate component of MENVEO (batch number: 100004), (dose: unknown) intramuscularly on 22 Jun 2010. No adverse event was reported following this administration.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial report received from a health care professional on 28 Jun 2010: This patient was vaccinated with MENVEO (batch no: 100005 (box)), (dose: 0.5 ml) intramuscularly on 28 Jun 2010. The patient was administered lyophilized component of the vaccine with sterile water instead of liquid conjugate component of the vaccine. The patient had no adverse events. No further information was reported. Follow-up report received from a health care professional on 07 Jul 2010: Batch number of vaccine was reported as 029011 (previously reported as 100005). This patient had a medical history of vesicoureteral reflux and was concomitantly using LOTRIMIN ULTRA topically for keratosis pilaris since 02 Feb 2010. The reporter stated that the patient didn't experience any adverse event after administration of lyophilized component of the vaccine with sterile water instead of liquid conjugate component of the vaccine. The patient will be revaccinated with MENVEO in 2 months.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Wrong drug administered
Clinical narrative: Initial report received from a physician on 06 Jul 2010: It was reported that on 02 Jun 2010, the patient was inadvertently received an intramuscular dose of MENVEO (batch number 027011) instead of GARDASIL in her left arm. The patient complained of burning, swelling and warmth at the injection site that spread down to her arm on 02 Jun 2010. The patient also received varicella injection and TDAP vaccine on 03 Jun 2010. The outcome of the events was reported as complete recovery on 04 Jun 2010. The seriousness and causality were not reported.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 06 Jul 2010: This patient inadvertently received a 0.5ml intramuscular dose of the liquid component of MENVEO (batch no (box): 100005) instead of being reconstituted with the lyophilized component. No adverse effects were noted following this administration.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 09 May 2010. This patient was vaccinated with MENVEO (batch no: 028011), (dose: unknown) intramuscularly on 07 Jun 2010. The patient received only liquid conjugate component of MENVEO that was not reconstituted before administration and the lyophilized portion was not administered. No adverse event had occurred. Following an internal review on 07 Jul 2010 of the data received on 09 Jun 2010, the following information was added: Initial report was received on 09 Jun 2010. Follow up report received from the health care professional on 07 Jul 2010: The patient was also vaccinated with GARDASIL (batch number 11784), (dose: 0.5 ml) intramuscularly on 07 Jun 2010.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 09 Jul 2010: This patient inadvertently received a intramuscular dose of the liquid component (only) on MENVEO (batch number: 1000005) instead of being reconstituted with the lyophilized component. No adverse effects were noted following this administration. MENVEO that was not reconstituted with powder before administration and the lyophilized portion was not administered. No re-vaccination performed. No adverse event had occurred. Follow up information report from healthcare professional received on 30 Jul 2010: The patient demographics were updated. The outcome of event was unknown.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache, Vomiting
Clinical narrative: Case number PHHY2011US32267 is a combined initial and follow-up spontaneous report received on 15 Apr 2011. This report refers to a 15 years old female patient. She was vaccinated with meningococcal vaccine (manufacturer and batch number unknown) on an unspecified date, when she was 12 years old and was given another shot of MENVEO vaccine (batch number: M100130) intramuscularly on 11 Apr 2011. On the same day of vaccination she experienced vomiting, fatigue and headache. The outcome of the event was reported as condition unchanged as of 14 Apr 2011. Following internal review of the data received on 15 Apr 2011, the following significant correction was done on 11 May 2011: The event "inappropriate schedule of vaccine administered" was deleted.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever. Acetaminophen 1000 MG once.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 01 Mar 2011: On 01 Mar 2011, this patient was vaccinated with only the MenCYW-135 liquid conjugate component of MENVEO (batch number: M10029), intramuscularly without being reconstituted with the MenA conjugate component. No adverse events were noted following this administration. Follow up report received from a health care professional (nurse) on 08 Mar 2011. Patient demographics updated.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 25 May 2010: This patient was vaccinated with MENVEO (batch no: 100001), (dose: unknown) intramuscularly on 24 May 2010. The patient was administered only the diluent portion of MENVEO. No adverse event had occurred. Follow up report received from a physician on 16 Jun 2010: The patient was not vaccinated again, no action was taken. The patient was on concomitant drug ORTHO-TRI-CYLEN for contraception since an unknown date.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a health care professional on 25 May 2010: This patient was vaccinated with MENVEO (batch no: 02701), 0.5 ml, intramuscular, on 25 May 2010. The patient was administered with lyophilized MenA CRM component diluted in sterile water instead of the MenCWY liquid component. No adverse events were noted.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error
Clinical narrative: Initial report received from a health care professional on 23 Feb 2011: This patient was vaccinated with MENVEO (batch number unknown) on an unspecified date. The vial of CYW-135 left in stock and the patient was administered only the Men-A lyophilized portion of the vaccine. No other information was reported.
Age: 65.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error
Clinical narrative: Initial report received from a health care professional (nurse) on 09 Jun 2010: This patient was vaccinated with MENVEO (batch number: 100001), (dose: unknown) intramuscularly on an unspecified date. The patient was vaccinated with only the diluent component without reconstitution. The patient was re vaccinated with all 4 serogroups. No further information provided at the time of this report.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Pt got vaccine on 6/8/16 in (R) deltoid noticed this AM that she had some itching and swelling of (R) arm. (+) pain with deep palpitation.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On an unknown date, the patient was inadvertently administered expired PROQUAD (lot # K025765, expiration date 08-JUN-2016, subcutaneous). No adverse effects were reported. There was no product quality issue (PQC) involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Nausea
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of nausea in a female patient who received BEXSERO. On 7th June 2016, the patient received BEXSERO (intramuscular). On 7th June 2016, less than an hour after receiving BEXSERO, the patient experienced nausea (serious criteria other: serious as per reporter) and diarrhea. In June 2016, the outcome of the nausea and diarrhea were recovered/resolved. The reporter considered the nausea and diarrhea to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. Within one hour after receiving BEXSERO, the patient required emergency room (ER) visit for nausea and diarrhea.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition was not reported. On 25-MAY-2016 (also reported "20-MAY-2016") the patient was vaccinated with a dose of ZOSTAVAX (lot # L036823, expired on 24-DEC-2016) (dose, frequency and route unknown). No concomitant therapy was reported. On an unspecified date of May 2016 the patient experienced a large red itchy spot at the injection site, upper arm swelling. The pharmacist had instructed the patient to apply BENADRYL cream or hydrocortisone cream for the itching and oral ibuprofen for the swelling. The patient had recovered from all the events in 2016. The causality was not reported. Pharmacist had requested a lot check. This is one of 4 reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Injection site erythema, Injection site pruritus, Joint swelling, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 56 years old female patient. The patient had no known medical history or drug allergy. On 25-MAY-2016 the patient received a dose of ZOSTAVAX (lot # L036823, expired on 24-DEC-2016) 0.65 ml, once, subcutaneously. No concomitant therapy was reported. On an unspecified date of May 2016, after receiving the ZOSTAVAX, the patient experienced a large red itchy spot at the injection site, upper arm swelling, swelling of her ankles and her blood pressure increased, "higher than her normal blood pressure". The patient stated that she applied unspecified alcohol to the injection site for relief. No lab diagnosis was performed. The pharmacist saw the patient on 01-JUN-2016 and all symptoms had resolved. The causality was not reported. The pharmacist had requested a lot check. The pharmacist did not plan to use this specific lot of ZOSTAVAX, until she received the response. This is one of 4 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist via field representative referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. In June 2012 (reported as "4 years ago") the patient received a dose of ZOSTAVAX (route unknown). No concomitant therapy was reported. On an unspecified time after receiving the vaccination, the patient developed redness at the injection site. The patient was seen in an unspecified emergency room on an unspecified date after receiving ZOSTAVAX for an unspecified reason and was diagnosed with shingles. The patient was prescribed acyclovir for treatment of the shingles on an unspecified date. It was not specified if the patient was admitted to the hospital. The outcomes of events were not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot# L033693, expiration date 31-MAY-2017, dose was not reported, orally). On the same day, the patient was also vaccinated with an improperly stored dose of PEDVAXHIB (lot# L035880, expiration date 11-AUG-2018; dose, anatomical location and route of administration were not reported). No adverse events were reported and there was no previous temperature excursion. The data logger was involved. Temperature was 21.1 degrees Fahrenheit for 2 hours and 5 minutes, 33.4 degrees Fahrenheit for 6 hours and 5 minutes and 31 degrees Fahrenheit for 3 hours and 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies of medical history provided. On 17-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot# L033693, expiration date 31-MAY-2017, dose was not reported, orally). No adverse events were reported and there was no previous temperature excursion. The data logger was involved. Temperature was 21.1 degrees Fahrenheit for 2 hours and 5 minutes, 33.4 degrees Fahrenheit for 6 hours and 5 minutes and 31 degrees Fahrenheit for 3 hours and 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood glucose decreased, Dizziness, Syncope
Clinical narrative: Patient felt dizzy while walking to car, and then he fainted, was brought back in to office, MA checked vs, RN checked BS (69). Patient drank a glass of water. Drank apple juice ate peanut butter and crackers. Felt better and went home.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 07-JUN-2016, the patient was vaccinated with improperly stored M-M-R II (lot number reported as L01248, expiration date 10-APR-2017, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 50F and the time frame was 6 hours. There was no previous temperature excursion. It was stated that it was due to a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 06-JUN-2016, the patient was vaccinated with improperly stored M-M-R II (lot number reported as L01248, expiration date 10-APR-2017, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 50F and the time frame was 6 hours. There was no previous temperature excursion. It was stated that it was due to a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient's of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 03-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot number reported as L01248, expiration date 10-APR-2017, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 50F and the time frame was 6 hours. There was no previous temperature excursion. It was stated that it was due to a data logger. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated orally with improperly stored ROTATEQ (lot number reported as L01026, expiration date 22-JAN-2017, dose was not reported). Concomitant therapy was not reported. The temperature of excursion was 50F and the time frame was 6 hours. There was no previous temperature excursion. It was stated that it was due to a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager concerning an unknown number of unspecified patients unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. From 08-APR-2016 to 12-MAY-2016, the patients were vaccinated with improperly stored doses of M-M-R II (dose, route not reported, lot # L026551 with expiration date 16-JUL-2017 and L030162 with expiration date 11-AUG-2017, both therapy type RHA). The vaccines were exposed to 50.7F for 12 hours. No previous temperature excursion was reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L000610, expiry date: 31-JAN-2017; lot # L019297, expiry date: 18-AUG-2017; lot # M004116, expiry date: 12-OCT-2017). Medical assistant reported that the vaccine underwent temperature excursion at 54 degree Fahrenheit for 36 hours and 30 minutes. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K018180, expiry date: 17-SEP-2016). Medical assistant reported that the vaccine underwent temperature excursion at 54 degree Fahrenheit for 36 hours and 30 minutes. She stated that the vaccine underwent temperature excursion at 48 degree Fahrenheit for 3 hours and 10 minutes, previously as well. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. The patient's concurrent conditions and medical history were not provided. On 14-JUN-2016 the patient was vaccinated with improperly stored PROQUAD, 0.5 ml, subcutaneously (dose#, site of administration and lot# not reported). Concomitant medication was not mentioned. The registered nurse could not specify improperly stored conditions on PROQUAD. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a 1 month old patient of unknown gender. The patient's medical history and concurrent condition was not reported. On 09-JUN-2016 the patient received a dose of ROTATEQ (lot# L027726, expired on 10-MAY-2017) 2 ml, orally, which is outside the recommendations of the prescribed information (drug administered to patient of inappropriate age). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (dose and route not reported, lot # M006139 and expiration date 13-MAY-2017). The vaccines were exposed to 46.9F for 1 hour and 15 minutes. No previous temperature excursion was reported. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (dose and route not reported, lot # L038534 and expiration date 19-AUG-2017). The vaccines were exposed to 46.9F for 1 hour 15 minutes. No previous temperature excursion was reported. No adverse events were reported. This is one of several reported received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (dose and route not reported, lot # L043213 and expiration date 28-AUG-2017. The vaccines were exposed to 46.9F for 1 hour 15 minutes. No previous temperature excursion was reported. No adverse events were reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles/DX on 6/9/16.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Skin warm
Clinical narrative: Rash developed and area felt hot for a number of days.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: Significant local swelling right deltoid and upper arm - prednisone and BENADRYL.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Swelling and redness with heat and tenderness started 6-9-16, continued to worsen - 20 cm x 12 cm. Antibiotics given if cellulitis, BENADRYL for today. Swelling and cool compresses.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Irritability, Rash, Rash papular, Vaccination site reaction
Clinical narrative: Dtap - Hib given in L thigh. Presented in office 6-7-16 w/ red papular rash. Had began around vaccine site per mom. At apt it was a red papular rash L leg. L lower abd and R calf. (+) fussy BENADRYL and Hydrocortisone cream Rx.
Age: 1.26
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: -Right thigh - 2 cm round erythema and tender. -Left thigh - 5 cm round erythema and tender. Getting smaller per Mom.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to 4 patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates in April 2016 (reported as "within the last month"), the patients were vaccinated with doses of ZOSTAVAX 1 dose (lot # M003486, expiration date: 27-MAR-2107; route was not provided). On unknown dates in 2016 (reported as "a couple of days after receiving the vaccine"), all patients developed cellulitis, warmth, a raised area and itchiness around the injection site and returned to the physician's office due to the events. The outcome of the events was unknown. The relatedness between the events and the ZOSTAVAX was not reported. This is on of two reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis of skin, left arm.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L042259, expiry date 18-AUG-2018; dose and route of administration were not reported). The doses were stored under the temperature of 50F for 35 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in April 2016 (reported as "within the last month"), the patient was vaccinated with a dose of ZOSTAVAX 1 dose (lot # reported as M006117, expiration date: 08-AUG-2017; route was not provided). On an unknown date in 2016 (reported as "a couple of days after receiving the vaccine"), the patient developed cellulitis, warmth, a raised area and itchiness around the injection site and returned to the physician's office due to the events. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse provided that in May 2016, she had a temperature excursion (to 34.4F for 8 hours and 24 minutes) with PEDVAXHIB (lot # L012835 with expiration date 11-MAR-2018). On unknown dates in 2016, the patients were administered the improperly stored doses of PEDVAXHIB (dose and route were not reported). On an unknown date in 2016, the vaccines had a second excursion to 28.9F for 8 hours cycling every 20 minutes. No vaccines were administered since the second excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L016428, expiry date 30-JUL-2017; dose and route of administration were not reported). The doses were stored under the temperature of 50F for 35 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse provided that in May 2016, she had a temperature excursion (to 34. 4 for 8 hours and 24 minutes) with PNEUMOVAX 23 (lot # L019836 with expiration date 24-MAR-2017). On unknown dates in 2016, the patients were administered the improperly stored doses of PNEUMOVAX 23 (dose and route were not reported). On an unknown date in 2016, the vaccines had a second excursion to 28.9F for 8 hours cycling every 20 minutes. No vaccines were administered since the second excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated orally with unknown doses of ROTATEQ (lot # L033543, expiry date 30-MAY-2017), which were improperly stored under the temperature of 50F for 35 minutes. The data logger was involved. There was no previous temperature excursion. No adverse effect was reported. This in one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse provided that in May 2016, she had a temperature excursion (to 34.4F for 8 hours and 24 minutes) with ROTATEQ (lot# K022990 with expiration date 26-JUN-2016). On unknown dates in 2016, the patients were administered the improperly stored doses of ROTATEQ (orally; dose was not reported). On an unknown date in 2016, the vaccines had a second excursion to 28.9F for 8 hours cycling every 20 minutes. No vaccines were administered since the second excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
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. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # reported as L04475, expiration date reported as 12-MAY-2017, lot # M004116, expiration date reported as 12-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 13.9 degrees Celsius for 3 hours 20 minutes. There was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition was not reported. On 20-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot # L036823, expired on 24-DEC-2016) (dose, frequency and route unknown). No concomitant therapy was reported. On an unspecified date of May 2016 the patient experienced a large red itchy spot at the injection site, upper arm swelling. The pharmacist had instructed the patient to apply BENADRYL cream or hydrocortisone cream for the itching and oral ibuprofen for the swelling. The patient had recovered from all the events in 2016. The causality was not reported. Pharmacist had requested a lot check. This is one of 4 reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Epistaxis, Platelet count normal
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old male patient. On an unknown date the patient was vaccinated with a dose of GARDASIL 9, intramuscularly. On an unknown date the patient experienced recurrent nose bleeding after being administered GARDASIL 9. It was not reported which number shot was administered in the series. The physician had lab values from days preceding nosebleeds and platelet count looked good (dates and labs were unspecified). The patient contacted doctors' office to seek unspecified medical attention. The outcome of recurrent nose bleeding and the causality between recurrent nose bleeding and GARDASIL 9 were not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition was not reported. On 23-MAY-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot # L036823, expired on 24-DEC-2016)(dose, frequency and route unknown). No concomitant therapy was reported. On an unspecified date of May 2016 the patient experienced a large red itchy spot at the injection site, upper arm swelling. The pharmacist has instructed the patient to apply BENADRYL cream or hydrocortisone cream for the itching and oral ibuprofen for the swelling. The patient has recovered from all the events in 2016. The causality was not reported. Pharmacist has requested a lot check. This is one of 4 reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MENB, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Mydriasis, Presyncope
Clinical narrative: Patient given Tdap, MENACTRA, VARIVAX and was fine. About 10-15 minutes later TRUMENBA vaccine given when she developed sudden dizziness, dilation of pupils and near syncope. Advised to lay down. Patient sweating. Offered water and perked up some. I saw patient within 30 seconds of vaccine administration was sitting up then but reported dizziness. Back to baseline in 10 to 15 minutes.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Pt received TDAP IM LD at 10:00 am 6/16/16 at appointment. No ASE at appt. Around 1:00 pm pt reports hives starting at feet then spreading all over body, took BENADRYL x 3. Resolved rash. Denies SOB, trouble swallowing. No redness or hot to touch. Muscle soreness. TYLENOL helps.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 26-MAY-2016, the patient was vaccinated with and improperly stored dose of M-M-R II lot # L027431, expiration date reported as 22-JUL-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 13.9 degrees Celsius for 3 hours 20 minutes. There was previous excursion of 14.2 degrees Celsius for 5 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 24-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L027431, expiration date reported as 22-JUL-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 13.9 degrees Celsius for 3 hours 20 minutes. There was previous excursion of 14.2 degrees Celsius for 5 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.