chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Crying, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Initial report received from a healthcare professional on 13 August 2013 and follow up information received on 15 August 2013. A 02-month-old female patient had received intramuscular first dose of PENTACEL vaccine (lot number: C4485AB) in the left thigh, a dose of PREVNAR vaccine from Pfizer (lot number G57196 and route of administration was not reported) in the right thigh and intramuscular dose of Hepatitis B vaccine from other manufacturer (lot number J005078) in the left deltoid on 13 August 2013. The patient was well and had no illness at time of vaccination. On 13 August 2013, the patient developed large area of redness that spread to the entire left thigh (front and back) to the knee and up to hip and leg immediately after vaccination and the patient was crying immediately after vaccination. Laboratory investigation and corrective treatments were not reported. As of 13 August 2013, the outcome of the events was unknown. List of documents held by the sender: None. Follow-up information received from a healthcare professional on 21 October 2013. The patient had not undergone any laboratory test. The adverse reaction was occurred on the whole thigh. The patient had received the PREVNAR vaccine intramuscularly. The patient was recovered from adverse events.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 5 June 2013. This is an invalid case as individual patient identifiers are not reported. Some patients (No information was provided regarding the patient) had received PENTACEL vaccine subcutaneously; also the reporter informed that the patient received only half dose. No adverse event was reported. List of documents held by sender: none.
Age: 1.3
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 07 June 2013. It was reported that a patient was administered fourth dose of PENTACEL at 10 months of age only 4 months after the 3rd dose, and then fifth dose was administered on 7 June 2013 when patient was 15-month-old. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: This case is linked to case number 2013-07089 (same reporter, same vaccine). Initial misuse report received from a healthcare professional on 07 June 2013. It was reported that a nurse mixed ACTHIB powder from PENTACEL with Merck sterile water and administered to a child. The nurse never gave the DTaP/IPV. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 19 June 2013. A child had received DTaP-IPV portion of PENTACEL vaccine without the HIB portion. No adverse event was reported. Documents held by sender: None.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 19 June 2013. It was reported that one vial of ActHIB which was not reconstituted was found in the PENTACEL box, so a patient received only DTaP-IPV portion from PENTACEL vaccine. No information was provided regarding the patinet. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 21 June 2013. It was reported that ACTHIB portion of PENTACEL vaccine was reconstituted with sterile water and administered to a child and DTaP-IPV was not administered. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 08 July 2013. It was reported that a child was administered only DTAP-IPV portion of PENTACEL. No more information was provided regarding the patient. No adverse event was reported. Documents held by sender: none
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 02 July 2013. A child patient received only the DTaP/IPV component from PENTACEL vaccine. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 10 July 2013. A child patient of unspecified age had received only DTAP-IPV component from PENTACEL. The ACTHIB component of PENTACEL was not given. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from healthcare professional on 11 July 2013. A patient (No information was provided regarding the patient) had received a dose of only Dtap-IPV portion as the 4th IPV and 5th DTAP of PENTACEL to the patient as KINRIX on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 09 July 2013. A 4-year-old patient received the DTAP/IPV component of PENTACEL vaccine instead of DTAP/IPV combination or separate DTAP and IPV vaccines. The patient already had 4 doses of Hib vaccines previously. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 01 July 2013. A child patient (No other information was provided regarding the patient) had received ACTHIB component of PENTACEL vaccine which was reconstituted with sterile water and DTAP/IPB was not administered. No adverse event was reported. List of documents held by sender: none.
Age: 0.2
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: Initial report received from a healthcare professional on 23 July 2013. A 02-month-old patient, whose date of birth, gender, medical history and concomitant medications were not reported, had received a dose of PENTACEL (batch number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date, after vaccination the patient had started to cry for 6 hours. It was reported that reporter had believed it was due to pertussis allergy. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of event was not reported. Documents held by sender: none.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Vomiting
Clinical narrative: Initial report received from a healthcare professional on 25 July 2013. A 7-month-old male patient, whose medical history and concomitant medications were not reported, had received a dose of PENTACEL (batch number: C4483AA, expiry date: 10/04/2014, route and site of administration were not reported) on 24 July 2013 at about 10.00 hours. On 24 July 2013 at 16:45 hours, the patient's mother called to report that the patient had experienced vomiting and had vomited 3 to 4 times. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of event was unknown. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 July 2013. A child was administered only the DTaP/IPV component of PENTACEL vaccine and ACT-HIB component was not administered. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 17 July 2013. A child received only the DTaP/IPV portion from PENTACEL vaccine and ACTHIB portion was not administered. No adverse events was reported. Documents held by sender: none.
Age: 1.68
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US010470, is an initial spontaneous report received from a physician on 08 May 2013. This report refers to a 20-months old infant female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO, (batch number: not reported) intramuscularly on 08 May 2013. No adverse reaction was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US010532, is an initial spontaneous report received from a medical assistant on 09 May 2013. This report refers to an 11-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M11072 and expiry date: Jun 2014) at dose of 0.5 ml, intramuscularly on 19 Feb 2013, which was stored below 36F. The vaccine reached 34.5F multiple times since 07 Feb 2013 for collective total times of 9-hours and 20-minutes. No adverse event was reported following this administration error.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH213US010540, is an initial spontaneous report received from a medical assistant on 09 May 2013. This report refers to a 15-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: M11072 and expiry date: Jun 2014) at dose of 0.5 ml, intramuscularly on 14 Mar 2013, which was stored below 36F. The vaccine reached 34.5F multiple times since 07 Feb 2013 for collective total times of 9-hours and 20-minutes. No adverse event was reported following this administration error.
Age: 82.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site haemorrhage, Injection site rash, Injection site vesicles
Clinical narrative: Case number PHEH2013US010556, is an initial spontaneous report received from a pharmacist on 09 May 2013. This report refers to an 82-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: A11078) intramuscularly on 09 May 2013. After vaccination, a moment later, she experienced injection site blistered and a high raised rash that bled appeared. The events outcome was reported as ongoing. The causality and seriousness of the events was not reported.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Cas number PHEH2013US012015, is an initial spontaneous report received from a pharmacist on 31 May 2013: This case refers to a 19-year-old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO, (batch number: A12011), intramuscularly without being reconstituted with Men A component on 31 May 2013. No adverse reaction reported following this administration error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US012142, is an initial spontaneous report received from a pharmacist on 01 Jun 2013 and a follow up received from the pharmacist on 21 Jun 2013. This report refers to a 12-year-old male patient. He received only Men C, Y, W-135 liquid conjugated component of MENVEO vaccine (batch number: not reported), intramuscularly into his left deltoid, without being reconstituted with Men A component on 01 Jun 2013. No adverse reaction reported following this administration error. Follow up information received from the pharmacist on 21 Jun 2013: Updated site of vaccination and patient's height and weight.
Age: 1.05
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US012265, is an initial spontaneous report received from a physician on 30 May 2013 with the follow-up received from physician on 30 May 2013. This report refers to a 1-year-old male patient. Past medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: A12118 and expiry date: Aug 2014) intramuscularly on 30 May 2013. No adverse event was reported following this administration error. Follow-up received from physician on 30 May 2013: Updated vaccine expiry date.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US013035 is an initial spontaneous report from the medical assistant received on 13 JUN 2013. This report refers to a 17-year-old female patient. His medical history was not reported. On an unknown date, the patient was accidentally vaccinated with only MenCYW-135 liquid component of MENVEO (batch number: A12026) and did not receive Men A lyophilized conjugate. No adverse event was reported after the mal-administration. No other information was available.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US012281, is an initial spontaneous report received from a nurse on 04 JUN 2013 with the follow-up received on 28 JUN 2013. This report refers to an 18-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO  (batch number: X11042) intramuscularly in left deltoid, without being reconstituted with Men A component on 28 May 2013 at 18:00 PM. No adverse reaction was reported following this administration error.  Follow-up received from nurse on 28 JUN 2013: Updated batch number, vaccination site and time.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US010669, is an initial spontaneous report received from a nurse on 09 MAY 2013, and a follow up received from the nurse on 09 MAY 2013. This report refers to 15-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: X12002, expiration date: OCT2014) intramuscularly on 26 APR 2013. She received only MenCWY-135 liquid conjugate component, instead of being reconstituted with MenA lyophilized conjugate vaccine of MENVEO. No adverse reaction was reported.  Follow up information received from a nurse on 09 MAY 2013: Updated expiration date of MENVEO.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US012428 is an initial spontaneous report received from a medical assistant on 05 JUN 2013, with a follow-up received on 09 JUL 2013: This report refers to a 17-year-old female patient. She was given only Men CYW liquid component of MENVEO (batch number: M12006/X12006) intramuscularly into right deltoid on 05 JUN 2013 (without being reconstituted with Men A powder component). Patient had no symptoms following this administration error (inappropriate preparation of medication). Patient asked whether revaccination required.   Follow-up was received on 09 JUL 2013: Patient demographics, vaccination site and information that patient had no symptoms were updated.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US013248, is an initial spontaneous report received from a nurse on 14  JUN 2013, with a follow-up received from a nurse on 09 JUL 2013. The case refers to a 17-year-old female patient. Her medical history and concomitant medication were not provided. She was vaccinated with MENVEO (batch number: M12025 and expiry date: 31 DEC 2014) at a dose of 0.5 ml intramuscularly into left deltoid on 07 JUN 2013. Reporter stated that, un-reconstituted MENVEO reached -1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 JUN 2013 (vaccine did not freeze). No adverse event was experienced following this administration error.  Follow-up was received on 09 JUL 2013: Patient demographics, vaccination site and date were updated.
Age: 48.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US012433, is an initial spontaneous report received from a consumer on 05 JUN 2013. This report refers to a 48-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported), intramuscularly without being reconstituted with Men A component on 05 JUN 2013. He stated that, he saw the liquid and powder vials in the box and a statement that they needed to be mixed before administration, but the person who administrated did not mix the vaccine. No adverse reaction was reported following this administration error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US010972, is an initial spontaneous report received from a nurse on 15 MAY 2013. This report refers to an 18-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: X12013) intramuscularly on 15 MAY 2013. He received only MenCWY-135 liquid conjugate component, instead of being reconstituted with MenA lyophilized conjugate vaccine of MENVEO. No adverse reaction reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US012479, is an initial spontaneous report received from a nurse on 04 Jun 2013: This case refers to an 18-year-old female patient. She received only Men A lyophilized conjugate of MENVEO vaccine (batch number: A11042) reconstituted with sterile diluent intramuscularly on 23 May 2013. She did not receive Men C, Y, W-135 liquid conjugate component of MENVEO vaccine. No adverse reaction was reported following this administration error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Headache, Injection site pain, Pain, Paraesthesia
Clinical narrative: Case number PHEH20143US011039 is an initial spontaneous report received from a physician on 16 MAY 2013 and a follow up report from the consumer (patients mother) received on 14 JUN 2013. This case refers to an 18-year-old male patient. His medical history included allergies (unspecified). His vaccination history included vaccination with DTap (other manufacturer) on 28 NOV 1994, 10 FEB 1995, 15 MAR 1995, 02 MAY 1996 and on 01 MAY 2000, TDap  (other manufacturer) on 16 AUG 2007, polio (unknown manufacturer, batch number: not reported) (refer to case: PHHYY013US061999), HIB (unknown manufacturer, batch number: not reported) on 28 NOV 1994, on 10 FEB 1995, on 16 MAR 1995 and on 07 FEB 1996, MMR (other manufacturer) on 07 FEB 1996 and on 01 MAY 2000, hepatitis B (other manufacturer) on 28 NOV 1995, on 10 FEB 1995, and on 15 SEP 1995, varicella (other manufacturer) on 15 SEP 1995 and on 28 JAN 2009 and complete immunization with pneumonia conjugate (other manufacturer) on an unknown date. He was vaccinated with MENVEO (batch number: A12118) intramuscularly at left deltoid on 15 MAY 2013 at a dose of 0.5 ml. On the same day, after vaccination he experienced pain at site, body aches, skin tingling, headache and fatigue. The final outcome was reported as recovered on an unknown date. The seriousness and causality were not reported. The patient transferred his records and so no follow date available.   Follow up report from the consumer (patients mother) received on 14 JUN 2013: Vaccination history and event (pain at site) were added. The MENVEO details (dose and site of vaccination) and outcome of the events were updated.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US013318, is an initial spontaneous report received from a nurse on 18 Jun 2013. This report refers to a 13 year old male patient. His medical history and concomitant medications were not reported. The patient received Men A lyophilized conjugate component diluted with sterile water, and not Men CWY liquid conjugate component of MENVEO (batch number: M12118) on 18 June 2013. No adverse event was reported following this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US012628, is an initial spontaneous report received from a nurse on 07 Jun 2013 with a follow-up received on 02 Jul 2013: This case refers to an 11-year-old male patient. He received only Men A lyophilized conjugate component of MENVEO (batch number: M12094) reconstituted with sterile water, intramuscularly on 05 Jun 2013. He did not receive Men C, Y, W-135 liquid conjugate component of MENVEO vaccine. No adverse reaction was reported following this administration error. The nurse commented that there was no problem caused due to the medication error and the patient would be vaccinated with the correctly constituted MENVEO. Follow-up received from the nurse on 02 Jul 2013: Updated nurse's comment.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Immunisation, No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US012727, is an initial spontaneous report received from a nurse on 11 Jun 2013 with a follow up information received on 01 Jul 2013: This case refers to a 12-year-old male patient. He received only Men A lyophilized conjugate component of MENVEO (batch number: X12118/A12118) reconstituted with sterile water at a dose of 0.5 ml intramuscularly in the left arm on 10 Jun 2013. He did not receive Men CYW-135 liquid conjugate component of MENVEO. No adverse reaction was reported following this administration error. He was revaccinated with a complete dose of MENVEO on 20 Jun 2013. Follow up information received on 01 Jul 2013: Patient demographics (weight), suspect vaccine site of administration and re-vaccination details updated.
Age: 35.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Headache
Clinical narrative: Case number PHEH2013US012825, is an initial spontaneous report received from a pharmacist on 11 Jun 2013 with a follow-up received on 09 Jul 2013. This report refers to a 35-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with expired MENVEO (batch number: A10047 and expiry date: Dec 2012) intramuscularly on 11 Jun 2013. He had a headache that night and went to the Emergency Room (ER) just to be sure and left the ER shortly after that. Outcome was reported as complete recovery of the patient. No additional information was provided. Follow-up received from the pharmacist on 09 Jul 2013: Updated event (headache).
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US013158, is an initial spontaneous report received from a nurse on 13 Jun 2013, with a follow-up received on 16 Oct 2013. This report refers to an adolescent male patient. He was vaccinated with MENVEO, batch number: M11082/A11082 at a dose of 0.5 ml intramuscularly into left deltoid on 05 Aug 2013 (09:45). The reporter stated that, MENVEO was stored in refrigerator that dropped to 32.6 F for less than one hour on 19 Apr 2013 (vaccine compromised due to refrigeration malfunction). He was vaccination with another dose on 07 Aug 2013. No adverse reaction was reported following this administration error. Follow-up was received on 16 Oct 2013: Patient demographics, vaccination date, site and revaccination information was updated. Report type was changed from incomplete to spontaneous upon follow-up.
Age: 1.0
Sex: U
Vaccine: MMR, MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US013679 is an initial spontaneous report received from a nurse on 20 Jun 2013. This case refers to a 1-year-old infant of unspecified gender. The nurser stated that the MMR vaccine (other manufacturer, batch number: not reported) was reconstitute with the MenCYW component of MENVEO (batch number: not reported) and was administered to this patient on an unspecified date. No adverse event was reported at the time of this report. No other information was available.
Age: 62.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US011950, is an initial spontaneous report received from a pharmacist on 30 May 2013. This report refers to a 62-year-old male patient. His medical history and concomitant were not reported. He was vaccinated with MENVEO (batch number: not reported, expiry date: Dec 2013) on 24 May 2013. No adverse event was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US013228 is an initial spontaneous report received from a nurse on 14 Jan 2013 with a follow up information received from a nurse on 09 Jul 2013. This case refers to a 12-year-old female patient. Her medical history and concomitant medication were not provided. She was vaccinated with MENVEO (batch number: M12025 and expiry date: 31 Dec 2014), at a dose of 0.5 ml intramuscularly in the right on 11 Jun 2013. Reporter stated that the un-reconstituted MENVEO reached minus 1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up information received from a nurse on 09 Jul 2013: Patient demographics (height and weight), site and date of vaccination updated.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US011413, is an initial spontaneous report received from a pharmacist on 21 May 2013. This case refers to a patient of unspecified age and gender. The pharmacist stated that they found an unused vial of Men A lyophilized powder component of MENVEO, (batch number: not reported). The pharmacist was unsure if the patient was administered only the liquid component of MENVEO. No adverse event was reported. No other information available.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US013237 is an initial spontaneous report received from a nurse on 14 Jun 2013 with a follow up information received from a nurse on 09 Jul 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014), at a dose of 0.5 ml intramuscularly in the left deltoid on 13 Jun 2013. Reporter stated that the un-reconstituted MENVEO reached minus 1 degree Celsius at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up information received from nurse on 09 Jul 2013. Patient demographics (height and weight), site and date of vaccination updated.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US013252, is an initial spontaneous report received from a nurse on 14 Jun 2013 with the follow-up received on 09 Jul 2013. This case refers to a 12-year-old female patient. Her medical history and concomitant medication were not provided. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014), at a dose of 0.5 ml in the right deltoid intramuscular on 13 Jun 2013. Reporter stated that, un-reconstituted MENVEO reached -1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow-up received from nurse on 09 Jul 2013: Updated patient demographics (gender, weight and height), vaccination site and date.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2013US011412 is an initial spontaneous report received from a health care professional on 22 May 2013, and with a follow up report received from nurse on 12 Jul 2013. This report refers to an 11 year old female patient. The patient's medical history and concomitant medications were not reported. The patient received an intramuscular dose of 0.5 ml MENVEO (batch number: 12013) on 23 Mar 2013. It was reported that the patient possibly received MenA lyophilized conjugate of MENVEO diluted with sterile water instead of being reconstituted with MenCYW-135 liquid conjugate. It was reported that a box of MENVEO was found with one full dose and one vial of powder, but without diluent. No adverse reaction was reported following maladministration. No further information was provided. Follow up report received from nurse on 12 Jul 2013. Updated patient demographics, batch number and vaccination date.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US011155 is an initial spontaneous report received from nurse on 20 May 2013. This case refers to a 23-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated inadvertently with expired MENVEO vaccine (batch number: A10133 and expiry date: 13 Feb 2013) intramuscularly on 15 May 2013. No adverse event was reported following this administration error.
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US013262, is an initial spontaneous report received  from a medical assistant on 17 JUN 2013. This report refers to a female patient of unspecified age. She received only Men Cy, Y, W-135 liquid conjugate component of MENVEO (batch number: M12027) intramuscularly without being reconstituted with Men A component on an unspecified date (sometime last week). No adverse reaction was reported following this administration error.
Age: 59.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US011951, is an initial spontaneous report received from a pharmacist on 30 MAY 2013. This report refers to 59-year-old male patient. He was vaccinated with MENVEO (batch number: A11064M, expiry date: DEC 2013) on 23 MAY 2013. No adverse event was reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US013956, is an initial spontaneous report received from the nurse on 26 JUN 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medication were not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: A12097) reconstituted with sterile water intramuscularly on 26 JUN 2013. No adverse reaction was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US013238, is an initial spontaneous report received from a nurse on 14 Jun 2013. This case refers to an 11-year-old female patient. her medical history and concomitant medication were not provided. She was vaccinated with MENVEO, batch number: M11082 and expiry date: 31 May 2014), at a dose of 0.5 ml intramuscularly in between 07 Jun 2013 to 14 Jun 2013. Reporter stated that, un-reconstituted MENVEO reached-1 degree Celsius for atleast 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US013240, is an initial spontaneous report received from a nurse on 14 Jun 2013 and a follow up report from the nurse received on 09 Jul 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014), at a dose of 0.5 ml intramuscularly in the left deltoid on 12 Jun 2013. Reporter stated that, an un-reconstituted MENVEO reached-1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up report from the nurse received on 09 Jul 2013: The therapy dates of MENVEO vaccine and site of vaccination were updated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US013241 is an initial spontaneous report received from a nurse on 14 Jun 2013 with a follow up information received from a nurse on 09 Jul 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medication were not provided. It was reported that previous vaccinations were tolerated in the past. he was vaccinated with MENVEO (batch number: M12025 and expiry date: 31 Dec 2014) at a dose of 0.5 ml intramuscularly in the left deltoid on 11 Jun 2013. Reporter stated that un-reconstituted MENVEO reached minus 1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up information received from a nurse on 09 Jul 2013: Patient demographics (gender, height and weight), site and date of vaccination updated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US013242, is an initial spontaneous report received from a nurse on 14 Jun 2013, with a follow-up received on 09 Jul 2013. This case refers to a 12-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: M12025 and expiry date: 31 Dec 2014), at a dose of 0.5 ml intramuscularly into right thigh on 11 Jun 2013. Reporter stated that, un-reconstituted MENVEO reached-1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow-up was received on 09 Jul 2013: Patient demographics, vaccination date and site was updated.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US013245, is an initial spontaneous report received from a nurse on 14 Jun 2013, with a follow-up received on 09 Jul 2013. This case refers to a 14-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: M12025 and expiry date: 31 Dec 2014). at a dose of 0.5 ml intramuscularly into left deltoid on 07 Jun 2013. Reporter stated that, un-reconstituted MENVEO reached -1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013. No adverse event was reported following this administration error. Follow-up received on 09 Jul 2013: Patient demographics, vaccination date and site were updated.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US013333, is an initial spontaneous report received from a nurse on 14 Jun 2013. This case refers to a 14-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: M12025 and expiry date: 31 Dec 2014), at a dose of 0.5 ml intramuscularly in between 07 Jun 2013 to 14 Jun 2013. Reporter stated that, un-reconstituted MENVEO reached -1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US013250, is an initial spontaneous report received from a nurse on 14 Jun 2013, and with a follow up report received from nurse on 09 Jul 2013. This case refers to an 18-year-old female patient. Her medical history and concomitant medication were not provided. She was vaccinated with MENVEO, (batch number: M11082 and expiry date: 31 may 2014), at a dose of 0.5 ml intramuscularly into left deltoid on 13 Jun 2013. Reporter stated that, un-reconstituted MENVEO reached -1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up report received from nurse on 09 Jul 2013. Updated patient demographics, site of vaccination and date of vaccination.
Age: 16.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US0101616 is an initial spontaneous report received from a nurse on 09 May 2013, with a follow-up received from a health care professional on 05 Jun 2013. This report refers to a 16-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: X12003/M12003) at a dose of 0.5 ml intramuscularly into left arm on 08 May 2013 (at 12.00). On the same day, he needed a MMR, but accidentally received powder of MMR (other manufacturer, batch number: H010133) mixed with liquid component CYW-135 of MENVEO (batch number: X12003/M12003) at a dose of 0.5 ml subcutaneously in to right arm at the same time. No adverse event was reported following this medication error. Follow-up was received on 05 Jun 2013: Information about batch number of MMR, vaccination site, vaccination route and vaccination dose were updated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Influenza like illness, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age with allergic reaction to sulphur and asthma. Patient historical drug includes sulphur. On 05-FEB-2015 the patient was vaccinated with ZOSTAVAX (strength, dose and frequency not reported). Other co-suspects and concomitant medication was not reported. On an unknown date the patient experienced chest pain, swollen neck glands and flu-like symptoms after receiving ZOSTAVAX. The outcome of the events was reported as not recovered. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH213US010663, is an initial spontaneous report from a nurse on 13 May 2013. This report refers to an 11 year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with MENVEO (batch number: 12023) subcutaneously on 10 May 2013. No adverse event was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US010828, is an initial spontaneous report received from a medical assistant on 14 May 2013 and a follow up report from the medical assistant received on 05 Jun 3013. This report refers to a patient of an unspecified age and gender. The patient inadvertently received only Men A lyophilized conjugate component of MENVEO (batch number: M12013) reconstituted with sterile water intramuscularly on an unspecified date instead of Men C, Y, W-135 liquid conjugate vaccine component. It was reported that, the patient who received half the dose initially was re-vaccinated with the fill dose on an unknown date. No adverse reaction reported following this administration error. Follow up report from the medical assistant received on 05 Jun 2013: The information related to the revaccination of MENVEO was updated.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Burning sensation, Discomfort, Injection site discolouration, Injection site erythema, Injection site oedema
Clinical narrative: 31 yo healthy female presented to HC for evaluation of a vaccine reaction to her (R) upper arm. She received MMR (MFX TSR lot # not recorded) to her Right Arm on 26 January at 14:30 and Varicella to her left arm. She states she had no initial reaction: no urticarial lesions, no oral or throat swelling, chest pain, increased HR, dizziness or nausea or emesis. The next evening she noted severe pruritus and burning starting to her upper arm. Her boyfriend noted redness and swelling on her upper arm and gave her a topical steroid (type unknown) and BENADRYL, which provided relief and she continued to dose. The next morning she noted a raised area at the injection site, and the affected area has continued to enlarge to include her shoulder and chest wall, and burning radiating distal to her wrist and hand. Her (R) earlobe itches and external (R) neck. There is no shortness of breath, oral itching, burning or swelling. There was no numbness or tingling. She had tenderness at the injection site, affected pruritic areas and axilla. She did not have joint pain including shoulder and elbow. She felt otherwise well, without fever or chills or malaise. She had normal strength and function, and only mild discomfort. Physical exam demonstrated 2x2 inch area of edema and erythema at posterior upper arm injection site surrounded by less severe very large patch 13 x 12 inches to right upper posterior arm and extending posterior and lateral across scapula, (R) chest wall, palpable lymphadenopathy to (R) axilla with tenderness and tenderness only to supraclavicular area. Increased warmth, tenderness, darker skin tone and edema to involved area. Edema noted to posterior axilla. She was treated with oral prednisone 60 mg daily and topical LIDEX and oral cetirizine three times a day. She was much improved in 24 hours per telephone follow-up. She was seen in clinic at 48 hours with symptoms nearly resolved in the medications were stopped.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Lymphadenopathy, Oedema
Clinical narrative: 31 yo healthy female presented to HC for evaluation of a vaccine reaction to her (R) upper arm. She received MMR (MFX TSR lot # not recorded) to her Right Arm on 26 January at 14:30 and Varicella to her left arm. She states she had no initial reaction: no urticarial lesions, no oral or throat swelling, chest pain, increased HR, dizziness or nausea or emesis. The next evening she noted severe pruritus and burning starting to her upper arm. Her boyfriend noted redness and swelling on her upper arm and gave her a topical steroid (type unknown) and BENADRYL, which provided relief and she continued to dose. The next morning she noted a raised area at the injection site, and the affected area has continued to enlarge to include her shoulder and chest wall, and burning radiating distal to her wrist and hand. Her (R) earlobe itches and external (R) neck. There is no shortness of breath, oral itching, burning or swelling. There was no numbness or tingling. She had tenderness at the injection site, affected pruritic areas and axilla. She did not have joint pain including shoulder and elbow. She felt otherwise well, without fever or chills or malaise. She had normal strength and function, and only mild discomfort. Physical exam demonstrated 2x2 inch area of edema and erythema at posterior upper arm injection site surrounded by less severe very large patch 13 x 12 inches to right upper posterior arm and extending posterior and lateral across scapula, (R) chest wall, palpable lymphadenopathy to (R) axilla with tenderness and tenderness only to supraclavicular area. Increased warmth, tenderness, darker skin tone and edema to involved area. Edema noted to posterior axilla. She was treated with oral prednisone 60 mg daily and topical LIDEX and oral cetirizine three times a day. She was much improved in 24 hours per telephone follow-up. She was seen in clinic at 48 hours with symptoms nearly resolved in the medications were stopped.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Swelling, Tenderness
Clinical narrative: 31 yo healthy female presented to HC for evaluation of a vaccine reaction to her (R) upper arm. She received MMR (MFX TSR lot # not recorded) to her Right Arm on 26 January at 14:30 and Varicella to her left arm. She states she had no initial reaction: no urticarial lesions, no oral or throat swelling, chest pain, increased HR, dizziness or nausea or emesis. The next evening she noted severe pruritus and burning starting to her upper arm. Her boyfriend noted redness and swelling on her upper arm and gave her a topical steroid (type unknown) and BENADRYL, which provided relief and she continued to dose. The next morning she noted a raised area at the injection site, and the affected area has continued to enlarge to include her shoulder and chest wall, and burning radiating distal to her wrist and hand. Her (R) earlobe itches and external (R) neck. There is no shortness of breath, oral itching, burning or swelling. There was no numbness or tingling. She had tenderness at the injection site, affected pruritic areas and axilla. She did not have joint pain including shoulder and elbow. She felt otherwise well, without fever or chills or malaise. She had normal strength and function, and only mild discomfort. Physical exam demonstrated 2x2 inch area of edema and erythema at posterior upper arm injection site surrounded by less severe very large patch 13 x 12 inches to right upper posterior arm and extending posterior and lateral across scapula, (R) chest wall, palpable lymphadenopathy to (R) axilla with tenderness and tenderness only to supraclavicular area. Increased warmth, tenderness, darker skin tone and edema to involved area. Edema noted to posterior axilla. She was treated with oral prednisone 60 mg daily and topical LIDEX and oral cetirizine three times a day. She was much improved in 24 hours per telephone follow-up. She was seen in clinic at 48 hours with symptoms nearly resolved in the medications were stopped.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US010965 is an initial spontaneous report received from a pharmacist on 15 may 2013: This report refers to an 18-year old male patient. He was given only MenCYW liquid conjugate component of MENVEO (batch number: X11078) intramuscularly on 13 may 2013. No adverse event was reported following this administration error (inappropriate preparation of medication).