chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US015699 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 11 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 30 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration (incorrect storage of drug).
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US015701 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 17 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 01 Aug 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Product reconstitution issue
Clinical narrative: Case number PHEH2014US015714, is an initial spontaneous report received from a pharmacist on 05 Aug 2014 with a follow-up received from a nurse on 20 Oct 2014. This report refers to a 14-year-old female patient. Her medical history and concomitant medications were not reported. She was inadvertently vaccinated only with MenCYW-135 liquid component of MENVEO (batch number: X13054) intramuscularly into left deltoid on 04 Aug 2014 at 12:40 pm without reconstituting it with MenA lyophilized conjugate. On the same day, within the minutes of vaccination, she experienced mild dizziness and a headache. After 20 to 30 minutes of vaccination, the symptoms improved with drinking juice at the clinic. Outcome of the events was reported as improving. Seriousness and causality of the events was not reported. Follow-up received from a nurse on 20 Oct 2014: New events (dizziness, headache), patient demographics (height and weight), reporter details (nurse), site and time of vaccination were updated.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US015858 is an initial spontaneous report received from the physician assistant on 06 Aug 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: X14024) intramuscularly on 05 Aug 2014. It was reported that the patient received only Men CYW-135 liquid component of vaccine without reconstituting it with Men A lyophilized component. No adverse event was reported following the maladministration.
Age: 0.51
Sex: F
Vaccine: MNQ
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Case number PHEH2014US015872 is an initial spontaneous report received from a nurse on 06 Aug 2014. This report refers to a six month old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with the first dose of MENVEO (batch number: not reported) intramuscularly according to the four dose infant series at six months of age on 18 Dec 2013. No additional doses of MENVEO were administered to the patient since the first dose on 18 Dec 2013. No adverse events were reported following these medication errors (inappropriate age at vaccine administration , incomplete course of vaccination).
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US015873 is an initial spontaneous report received from a pharmacist on 06 AUG 2014. This report refers to a patient of an unspecified age and gender. The past medical history and concomitant medications of the patient were not reported. The patient received only MEN CWY-135 liquid conjugate component of MENVEO (batch number: not reported) intramuscularly without reconstitution with MEN A lyophilized powder component on an unspecified date. One week after the maladministration, the patient received a complete dose of MENVEO. No adverse events were reported following this maladministration (inappropriate preparation of medication).
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US015874 is an initial spontaneous report from a nurse received on 06 Aug 2014 with a follow up report received from another nurse on 16 Sep 2014. This report refers to a 12 year old female patient. Her medical history and concomitant medication were not reported. On 06 Aug 2014, she was vaccinated with an initial application of MENVEO (batch number: M14022/A14022) at a dose of 0.5 ml intramuscularly where MenA lyophilized conjugate component was not mixed with proper diluent (MenCWY). Rather it was reconstituted with sterile water. No adverse event was reported following this medication error (wrong solution used in drug reconstitution). It was reported that patient would return for revaccination. Follow up report received from the nurse on 16 Sep 2014: Updated patient demographics (height and weight), updated alternative batch number (A14022) and added reporter's statement regarding revaccination.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US016228, is an initial spontaneous report from a nurse on 12 Aug 2014. This report refers to a 15-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was administered MenA powder component of MENVEO (batch number: not reported) reconstituted with sterile diluent instead of Men-CYW-135, intramuscularly on 12 Aug 2014. No adverse reactions had occurred since the administration error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US016235, is an initial spontaneous report received from a nurse on 11 Aug 2014. This report refers to an 18 year old male patient. Nurse reported that the patient received only the MenCYW-135 liquid component of MENVEO (batch number: M41024) intramuscular on 09 Aug 2014, without being reconstituted with MenA lyophilized component. No adverse event was reported. No further information was provided.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US016993 is an initial spontaneous report received from the health care professional on 20 Aug 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with only Men C, Y, W-135 liquid component of MENVEO (batch number: not reported) intramuscularly without being reconstituted with Men A lyophilized component of vaccines on unspecified date. No adverse event reported after the maladministration.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US016472, is an initial spontaneous report from a nurse received on 15 Aug 2014. This report refers to a 10-year-old male patient. Past medical history and concomitant medication was not reported. The patient received intramuscular dose of Men A lyophilized component of MENVEO (batch number: M13054) that was erroneously reconstituted with a sterile diluent instead of Men CYW-135 liquid component on 15 Aug 20154. No adverse event reported following this medication error (wrong solution used in drug reconstitution).
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US016492, is an initial spontaneous report received from a nurse on 14 Aug 2014 with a follow up information received from the nurse on 16 Sep 2014. This report refers to a 16 years old male patient. Past medical history and concomitant medication were not reported. His vaccination history included administration of MENACTRA (other manufacturer, batch number: not reported) on unspecified dates and was well tolerated. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: X139054) without being reconstitution with Men A lyophilized component intramuscularly in the left arm on 13 Aug 2014. No adverse event was reported following this medication error. His vaccination status was reported as up to date. Follow up information received from the nurse on 16 Sep 2014: Updated patient identifiers (age, age group. height and weight), vaccination history, site of vaccination, date of vaccination and vaccination status in the narrative.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Gait disturbance, Hypersensitivity, Induration
Clinical narrative: 28 hours post-blotchy redness & pain about 2" in diameter around site. 36 hours post- raised swelling, redness 3" redness & pain. 50 hours post-hard, very red, warm to the touch, significant swelling 5" of redness. 54 hours post-very hot, swollen, raised significantly, pain, unable to walk normally. 65 hours post-very hot, swollen, raised significantly, cellulitis appearance, 8-9" is diameter, pain, unable to walk normally-saw nurse practitioner in the urgent care-diagnosis of allergic reaction, was put on Prednisone (5 days), BENADRYL, and CLARITIN for 10 days. 90 post-swelling started to go down, still warm to the touch and less painful. 1 week post-swelling and less redness, cool to the touch but discoloration where the 8-9" of cellulitis appearing 1 mo post-continued discoloration, no swelling, no redness.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Rash macular, Skin discolouration, Skin warm, Swelling
Clinical narrative: 28 hours post-blotchy redness & pain about 2" in diameter around site. 36 hours post- raised swelling, redness 3" redness & pain. 50 hours post-hard, very red, warm to the touch, significant swelling 5" of redness. 54 hours post-very hot, swollen, raised significantly, pain, unable to walk normally. 65 hours post-very hot, swollen, raised significantly, cellulitis appearance, 8-9" is diameter, pain, unable to walk normally-saw nurse practitioner in the urgent care-diagnosis of allergic reaction, was put on Prednisone (5 days), BENADRYL, and CLARITIN for 10 days. 90 post-swelling started to go down, still warm to the touch and less painful. 1 week post-swelling and less redness, cool to the touch but discoloration where the 8-9" of cellulitis appearing 1 mo post-continued discoloration, no swelling, no redness.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US016495, is an initial spontaneous report received from a nurse on 14 Aug 2014 and with a follow up information received from the nurse on 16 Sep 2014. This report refers to a 13 years old male patient. His medical history was not reported. His vaccination history included administration of MENACTRA (other manufacturer, batch number: not reported) on unspecified date and was well tolerated. His concomitant vaccinations included administration of GARDASIL (other manufacturer, batch number: J015378) intramuscularly at a dose of 0.5 ml in the left arm on 13 Aug 2014. He was administered only MenCYW-135 liquid component of MENVEO (batch number: X13054) without being reconstituted with MenA lyophilized powder, intramuscularly in the right arm on 13 Aug 2014. No adverse reaction was reported following the administration error (inappropriate preparation of medication). His vaccination status was reported as up to date. Follow up information received from the nurse on 16 Sep 2014: Updated patient demographics (height), vaccination history, concomitant vaccination, site of vaccination and vaccination status in the narrative.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV, MMRV
Symptoms: Morbillivirus test positive, Patient isolation, Polymerase chain reaction positive, Rash morbilliform
Clinical narrative: Severe measles type rash requiring temporary isolation for evaluation.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Crying, Cyanosis, Depressed level of consciousness, Eye swelling, Glassy eyes
Clinical narrative: Stopped breathing, turned blue on extremities, stopped being alert, became jaundice, stopped crying, eyes always glassed over and swollen.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Jaundice, Respiratory arrest
Clinical narrative: Stopped breathing, turned blue on extremities, stopped being alert, became jaundice, stopped crying, eyes always glassed over and swollen.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Eye haemorrhage, Haemorrhage, Rash erythematous, Rash morbilliform
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of broken blood vessel in eye in a 74-year-old female patient who received BOOSTRIX. On 23rd September 2015, the patient received BOOSTRIX. In September 2015, 2 days after receiving BOOSTRIX, the patient experienced vascular injury, measles-like rash and itchy rash. On an unknown date, the patient experienced broken blood vessel in eye (serious criteria GSK medically significant) and blister. On an unknown date, the outcome of the broken blood vessel in eye, vascular injury, measles-like rash, itchy rash and blister were unknown. It was unknown if the reporter considered the broken blood vessel in eye, measles-like rash, itchy rash and blister to be related to BOOSTRIX. The reporter considered the vascular injury to be related to BOOSTRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient experienced breaking out of measles-like bumps all over the back of both hands, both arms, neck, and shoulders within approximately two to three days after the initial immunization with BOOSTRIX. The bumps were bright red and itchy. The blood vessels broke under the bumps. The blood got spread on the sheets and pillow case at night because the patient thought that she might be itching them during the night. The patient felt that the sun irritated the bumps and caused them to become large and blister. The patient described the bumps as they looked like boils. In the beginning of the Spring 2016, several months after vaccination, the patient had a broken blood vessel in her left eye. The reporter stated that her pharmacist called regarding this situation, but was unable to find the report and she was referred to her healthcare professional.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic, Vascular injury
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of broken blood vessel in eye in a 74-year-old female patient who received BOOSTRIX. On 23rd September 2015, the patient received BOOSTRIX. In September 2015, 2 days after receiving BOOSTRIX, the patient experienced vascular injury, measles-like rash and itchy rash. On an unknown date, the patient experienced broken blood vessel in eye (serious criteria GSK medically significant) and blister. On an unknown date, the outcome of the broken blood vessel in eye, vascular injury, measles-like rash, itchy rash and blister were unknown. It was unknown if the reporter considered the broken blood vessel in eye, measles-like rash, itchy rash and blister to be related to BOOSTRIX. The reporter considered the vascular injury to be related to BOOSTRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient experienced breaking out of measles-like bumps all over the back of both hands, both arms, neck, and shoulders within approximately two to three days after the initial immunization with BOOSTRIX. The bumps were bright red and itchy. The blood vessels broke under the bumps. The blood got spread on the sheets and pillow case at night because the patient thought that she might be itching them during the night. The patient felt that the sun irritated the bumps and caused them to become large and blister. The patient described the bumps as they looked like boils. In the beginning of the Spring 2016, several months after vaccination, the patient had a broken blood vessel in her left eye. The reporter stated that her pharmacist called regarding this situation, but was unable to find the report and she was referred to her healthcare professional.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US022749, is an initial spontaneous report from a health care professional (medical assistant) received on 11 Nov 2014, and with a follow up report received from physician on 16 Dec 2014. This report refers to an 11-year-old female patient. Past medical history and concomitant medications were not reported. Physician reported that the patient had initially received Men A lyophilized component (batch number: unknown) reconstituted with sterile water for injection rather than liquid component of MENVEO. Later on 10 Nov 2014, the patient had received MENVEO (batch number: A14068) powder correctly mixed with liquid conjugate. On the same day she also received ADACEL (batch number: 04955AA, other manufacturer) and GARDASIL (batch number: K006191, other manufacturer) both 0.5 ml intramuscularly. No adverse event was reported. No further information was provided. Follow up report received from physician on 16 Dec 2014. Updated patient demographics, event details.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US022730, is an initial spontaneous report from a health care professional (office manager) received on 11 Nov 2014. This report refers to a 17-year-old male patient. Past medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO, batch number: X14055) without being reconstituted with Men A lyophilized conjugated component intramuscularly on 07 Nov 2014. No adverse reaction reported following this medication error (inappropriate preparation of medication).
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US017807, is an initial spontaneous report from a nurse received on 03 Sep 2014 with a follow-up from a health care professional received on 07 Oct 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medications were not reported. Past vaccination included administration of MENVEO (batch number: unknown) on 24 Jul 2014 which was tolerated. On 02 Sep 2014, at 5:13 pm, the patient was vaccinated an intramuscular dose of MENVEO (batch number: A13058) into left deltoid where MenA lyophilized conjugate component reconstituted with a sterile diluent (other than MenCWY). No adverse event was reported following this administration error (wrong solution used in drug reconstitution). Follow-up from a health care professional received on 08 Oct 2014: Patient's demographics (height and weight), reporter details, vaccination history, site and time of vaccination were updated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US008762 is an initial spontaneous report from the nurse received on 29 Apr 2014 with a follow-up received on 24 Jun 2014. This report refers to an 11-years-old male child. He did not have any relevant medical history. Concomitant medications were not reported. On 29 Apr 2014 at 2.00 pm, the child was vaccinated intramuscularly with only MenCYW-135, the liquid component of MENVEO (batch number: M13015) and did not receive Men A lyophilized conjugate. It was reported that the child did not experience any adverse event following this administration error (inappropriate preparation of medication). Mother was advised about the error and was given information regarding the rarity of Mena. Mother was given option to revaccinate now or later, if the child left the country. Mother stated that she would wait for the booster dose at 16 years of age unless there would be a foreign travel (which was not likely). Follow-up received from the nurse on 24 Jun 2014: Updated patient demographics, medical history, time of vaccination and comment from mother.
Age: 12.0
Sex: M
Vaccine: DTP, HPVX, MEN, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US019128, is an initial spontaneous report from a nurse received on 22 Sep 2014, with a follow up received from other health professional on 16 Oct 2014. This report refers to a 12-year-old male patient. Historical conditions were not reported. Vaccination history included administration of DTP (batch number: not reported) on 22 Apr 2002, 14 Jun  2002, 15 Aug 2002, 09 Sep 2003 and 23 Feb 2007; hepatitis B vaccine (manufacturer unknown batch number: not reported) on 25 Feb 2002, 28 Mar 2002, and 15 Aug 2002; haemophilus influenza type B vaccine (manufacturer unknown, batch number: not reported) on 22 Apr 2002, 14 Jun 2002, 15 Aug 2002, 19 Mar 2003; measles, mumps, and rubella vaccine (manufacturer unknown, batch number: not reported): on 17 Jun 2003 and 23 Feb 2007; pneumococcal vaccine (manufacturer unknown, batch number: not reported): on 22 Apr 2002, 14 June 2002, 15 Aug 2002, 17 Jun 2003; polio vaccine (manufacturer unknown, batch number: not reported): on 22 Apr 2002, 14 Jun 2002, 09 Sep 2003 and 23 Feb 2007; varicella vaccine (manufacturer unknown, batch number: not reported): on 19 Mar 2003 and 23  Feb 2007. He was concomitantly vaccinated with human papilloma virus vaccine (manufacturer unknown, batch number: not reported), DTP (batch number: not reported) and meningococcal vaccine (manufacturer unknown, batch number: not reported) on 22 Sep 2014. He was administered Men A lyophilized conjugate component of MENVEO (batch number: A14044) reconstituted with a diluent from Merck instead of Men-CYW-135 liquid conjugate component intramuscularly into the right deltoid on 22 Sep 2014 at 14:30. The patient was contacted and notified of the error and patient did not report any signs or symptoms of adverse reaction. No adverse reaction was noted in the patient following the maladministration (wrong solution used in drug reconstitution). The patient was scheduled for revaccination with MENVEO on 18 Nov 2014 at 03:00 PM. It was reported that the patient was due to receive Flu vaccine and hepatitis A vaccine. Follow up received from other health professional on 16 Oct 2014: updated patient demographics (gender), vaccination history, concomitant vaccines, site and time of vaccination of MENVEO and other clinically relevant information in the narrative.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Induration, Rash macular, Skin warm
Clinical narrative: Case number PHEH2014US008956 is an  initial spontaneous report from the healthcare professional (medical assistant) received on 01 May 2014. This report refers to a 11-year-old female patient. She was vaccinated with MENVEO (batch number: A12092) intramuscularly on 30 Apr 2014. On the same date, 15 minutes after vaccination she experienced red blotches on her arm and the area was hot and hard to touch. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 70.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Case number PHEH2014US019561, is an initial spontaneous report from a pharmacist received on 26 Sep 2014. This report refers to a 70-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered MenCYW-135 liquid component of MENVEO (batch number: X14022) intramuscularly inadvertently instead of intended different vaccine very similar to PNEUMOVAX on 16 Sep 2014. No adverse event was reported following the administration error (wrong vaccine administered).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022760, is an initial spontaneous report received from a nurse on 12 Nov 2014 and with a follow up information received from the nurse on 30 Jan 2015. This report refers to 11 years old female patient. Her medical history and concomitant medications were not reported. The nurse stated that MENVEO (batch number: not reported) reached below the recommended temperature with lowest documented temperature being 32 F since 12 Aug 2014. MENVEO reached temperature below 36 F on 12 Aug 2014, 13 Aug 2014 and 18 Aug 2014 and the patient was vaccinated with this vaccine intramuscularly in the right deltoid at a dose of 0.5 ml on 18 Aug 2014. The vaccine dropped to 32 F between the hours of 2:15 pm on 18 Aug 2014 afternoon until 8:45 am in the next morning. The other days that the refrigerator detected MENVEO reaching temperatures below 36 F to a documented minimum temperature of 32 F were 21 Aug 2014, 25 Aug 2014, 28 Aug 2014, 08 Sep 2014, 09 Sep 2014, 01 Oct 2014, 02 Oct 2014, 03 Oct 2014 and 07 Oct 2014. The nurse insisted that she was not aware of any freezing that occurred with MENVEO. No adverse events were reported following the inadvertent administration. Follow up information received from the nurse on 30 Jan 2015: Updated patient identifiers (date of birth, age, gender), site and dose of vaccination.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US016593, is an initial spontaneous report received from a medical assistant on 18 Aug 2014. This report refers to a 19 year old male patient. Past medical history and concomitant medications were not reported. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X13066), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 18 Aug 2014. No adverse event was reported following this administration error.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US016598, is an initial spontaneous report received from a pharmacist on 18 Aug 2014. This report refers to a 12-year-old male patient. Past medical history was not provided. Concomitant vaccination included TDAP. The patient only received the CYW-125 liquid component of MENVEO (batch number: M14024) intramuscularly on 29 Jul 2014. No adverse reaction reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US016737, is an initial spontaneous report from a physician received on 18 Aug 2014. This report refers to a patient of an unknown demographics. Past medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: not reported) without reconstitution with Men A lyophilized component intramuscularly on an unknown date. No adverse event was reported following this medication error.
Age: 25.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US016852, is an initial spontaneous report from a health care professional received on 21 Aug 2014 with a follow up information received from a physician on 25 Sep 2014. This report refers to a 16-year-old male patient. Past medical history and concomitant medications were not reported. On 14 Aug 2014, approximately at 8:30 am, the patient received an initial intramuscular dose of MENVEO (batch number: M13054) into right arm where MenA lyophilized conjugate component reconstituted with a diluent (other than MenCWY). No adverse event was reported following this administration error. Follow-up received from a physician on 25 Sep 2014: Patient demographics (height and weight), vaccination site and vaccination time updated.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US016857 is an initial spontaneous report from a health care professional received on 21 Aug 2014 with a follow up information received from a physician on 22 Sep 2014. This report refers to an 11-year-old female patient. Past medical history was not reported. Her vaccination status was up to date. On 11 Aug 2014 at 9:44 am, she was vaccinated with an initial intramuscular dose of MENVEO (batch number: M13054) at a dose of 0.5 ml in the left deltoid and it was reported that she only received Men A lyophilized powder conjugate component reconstituted with a diluent and did not receive MenCYW-135 liquid component of the vaccine. No adverse event was reported following this administration error (wrong solution used in drug reconstitution). She was concomitantly administered BOOSTRIX (other manufacturer, batch number: 7KM4D) and GARDASIL (other manufacturer, batch number: J015378); both vaccines administered at a dose of 0.5 ml intramuscularly on 14 Aug 2014. No further information was provided. Follow up information received from a physician on 22 Sep 2014: Patient demographics (height and weight), vaccination status, vaccination site and concomitant vaccinations updated.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error
Clinical narrative: Case number PHEH2014US016872 is an initial report received from the medical assistant on 20 Aug 2014 with a follow up information received from a physician on 22 Sep 2014. This report refers to 19 years old male patient. He had no medical history and concomitant medications. His vaccination status was up to date. His vaccination history included a dose of meningococcal ACYW-135 vaccine (unknown manufacturer, batch number: not reported) on 08 Aug 2007. He was vaccinated with a dose of MENVEO (batch number: not reported) on 21 Oct 2013 which was well tolerated. It was reported that within a gap of 10 months, she received another dose of MENVEO (batch number: M14044) intramuscularly at a dose of 0.5 ml in the left deltoid on 19 Aug 2014 at 15:28. No adverse event reported after the maladministration. Follow up information received from a physician on 22 Sep 2014: Patient demographics (height and weight), dose, site and time of MENVEO vaccination updated.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US016878 is an initial spontaneous report received from a nurse on 20 Aug 2014. This report refers to 19 years old male patient. His medical history and concomitant medications were not reported. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported) without being reconstituted with Men A lyophilized conjugate component intramuscularly on 18 Aug 2014. No adverse event was reported following this administration error (inappropriate preparation of medication). Non-significant follow up report received from the nurse on 01 Oct 2014: Reporter did not want to fill the follow up form.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error
Clinical narrative: Case number PHEH2014US016971 is an initial spontaneous report received from a physician on 21 Aug 2014. This report refers to an 18 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported) intramuscularly on 27 June 2008. He was again vaccinated with MENVEO on 10 Jun 2011 and on 20 Aug 2014 (batch number: A14203). No adverse event was reported following this administration error (inappropriate schedule of vaccine administered).
Sex: U
Vaccine: FLUX, MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US016973 is an initial spontaneous report received from a pharmacist on 21 AUG 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: not reported) subcutaneously on 19 AUG 2014. On the same day, the patient was concomitantly vaccinated with an influenza vaccine (manufacturer and batch number: not reported). It was reported that the MENVEO was administered on one arm and the flu shot was administered on other arm. No adverse event was reported following this administration error (wrong route of administration).
Age: 15.0
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US016991, is an initial spontaneous report received from a healthcare professional on 21 Aug 2014. This report refers to a 15 year old unknown gender patient. The reporter stated that, the patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M14044), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component and then administered a correct dose of Men A reconstituted with the Men C, Y, W-135 at dose of 0.5 ml on 20 Aug 2014. No adverse event was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US016992, is an initial spontaneous report from a nurse received on 21 Aug 2014, and with a follow up report received from nurse on 29 Sep 2014. This report refers to an 11-year-old male patient. His medical history reported using of nebulizer and inhaler. Concomitant vaccination included Tdap (manufacturer and batch number unknown) 0.5 ml intramuscular on 21 Aug 2014. The patient received expired MENVEO (batch number: M11072) intramuscularly on 21 Aug 2014. The patient's mother reported that he had no adverse events after vaccination. No further information was provided. Follow up report received from nurse on 29 Sep 2014. Updated medical history and concomitant vaccine.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US017378 is an initial spontaneous report received from a nurse on 27 Aug 2014. This report refers to a 17 year old female patient. Past medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: M14024), intramuscularly reconstituted with a sterile diluent instead of MenCYW-135 liquid component on 07 Aug 2014. Reporter stated that, they have scheduled patient for revaccination tomorrow. No adverse reaction was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US008997 is an initial spontaneous report received from a health care professional on 01 May 2014. This report refers to patient of unknown age and gender. Past medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated intramuscularly with only MenCYW-135, the liquid component of MENVEO (batch number: not reported) and did not receive Men A lyophilized conjugate. No adverse event was reported following this administration error.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US017383 is an initial spontaneous report received from a nurse on 27 Aug 2014. this report refers to a 13 year old female patient. Past medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: M14024), intramuscularly reconstituted with a sterile diluent instead of MenCYW-135 liquid component on 07 Aug 2014. Reporter stated that, they have scheduled patient for revaccination tomorrow. No adverse reaction reported following this administration error.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US017394, is an initial spontaneous report received from a nurse on 27 Aug 2014. This report refers to a 20 year old male patient. Past medical history and concomitant medication were not reported. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X14022), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 22 Aug 2014. No adverse event was reported following this administration error.
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US017606 is an initial spontaneous report received from the nurse on the 29 Aug 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported) intramuscularly without being reconstituted with Men A lyophilized component of vaccine on 29 Aug 2014. No adverse events reported after the maladministration. The patient was also vaccinated with another dose of only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported) intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 29 Aug 2014 (see related case number: PHEH2014US017718).
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US017718 is an initial spontaneous report received from the nurse on 29 Aug 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported) intramuscularly without being reconstituted with Men A lyophilized component of vaccine on 29 Aug 2014 (see related case number: PHEH2014US017606). On the same date, 29 Aug 2014 the patient was also vaccinated with another dose of only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported) intramuscularly without being reconstituted with Men A lyophilized component of vaccine. No adverse event reported after maladministration.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US017616 is an initial spontaneous report received from a nurse on 28 Aug 2014. This report refers to a 16 year old female patient. Past medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: A13015), intramuscularly reconstituted with a sterile diluent instead of MenCYW-135 liquid component on 27 Aug 2014. No adverse reaction was reported following this administration error.
Age: 66.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US017769 is an initial spontaneous report received from a pharmacist on 04 Sep 2014. This report refers to a 66 year old male patient. His medical history and concomitant medication were not reported. On 04 Sep 2014, he was erroneously vaccinated with the liquid component of MENVEO (batch number: X14022) intramuscularly instead of the pneumonia vaccine (other manufacturer) which he was supposed to get. He was only due to receive the pneumonia vaccine and there was no plan to administer MENVEO to him. Men CYW-135 was mistaken for the pneumonia vaccine. Reporter as not aware of any adverse event at the time of reporting. No adverse event was reported following this administration error (wrong vaccine administered).
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US017776 is an initial spontaneous report from the nurse received on 04 Sep 2014. This report refers to a patient of an unknown age and gender. The patient was vaccinated with MENVEO (batch number: not reported) on an unknown date. It was reported that the vaccine which was administered to the patient was exposed to temperatures of down to 30 F since 30 Jul 2014. No adverse event reported following this medication error (incorrect storage of drug).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018222 is an initial spontaneous report from the health care professional (medical assistant) received on 09 Sep 2014. This report refers to a 11 year old female patient. She was vaccinated with MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly on 02 Sep 2014. It was reported that the vaccine received by the patient had been stored at 47 F for 10 minutes before administration to the patient. No adverse event reported following this medication error (incorrect storage of drug).
Age: 18.0
Sex: F
Vaccine: FLU3, MENB, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient was given Tdap, Influenza and BEXSERO in this order. After the BEXSERO was given, patient had loss of consciousness. LOC lasted approx 1-2 minutes. Prior to LOC she was talking to me without difficulty.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022570, is an initial spontaneous report received from a nurse on 10 Nov 2014, with a follow up report received from the nurse on 15 Dec 2014. This report refers to an 11 year old female patient. Her medical history and concomitant medication were not reported. Her vaccination history include administration of HVP4 (human papilloma vaccine), FLUMIST and TDAP vaccines in the past. On 24 Oct 2014, she was given the initial application of MENVEO (batch number: M14023) intramuscularly at a dose of 0.5 ml. It was reported that before administration the MENVEO had a temperature excursion of 1.4 degree C for 12 minutes (not frozen). No adverse event was reported following this administration error (incorrect storage of drug). Follow up report received from the nurse on 15 Dec 2014: Updated patient demographics (initials and age), vaccination history and suspect vaccination details (initial application, at 0.5 ml).
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US022723, is an initial spontaneous report from a health care professional (office manager) received on 11 Nov 2014. This report refers to a 21-year-old male patient. Past medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO, (batch number: X14055) without being reconstituted with Men A lyophilized conjugate component intramuscularly on 07 Nov 2014. No adverse reaction reported following this medication error (inappropriate preparation of medication).
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US022564, is an initial spontaneous report received from a pharmacist on 07 Nov 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with only Men C, Y, W-135 liquid component of MENVEO (batch number: not reported) intramuscularly on 15 Aug 2014 without being reconstituted with Men A lyophilized component of vaccine on unspecified date. No adverse event reported after the maladministration (inappropriate preparation of medication). No additional information was available at this moment.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US009005, is an initial spontaneous report received from a physician on 01 May 2014. This report refers to an 11 year old female child. The patient received MenA powder component of MENVEO (batch number: A13059) intramuscularly reconstituted with sterile water, did not received MENVEO liquid component. No adverse reaction reported.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US009109, is an initial spontaneous report received from a nurse on 02 May 2014 with a follow-up received on 12 Jun 2014. This report refers to 13 year old female patient. Her vaccination history was up to date. Nurse reported that the patient received only the Men CYW-135 liquid component of MENVEO (batch number: M13017) intramuscularly into left arm on 30 April 2014 at 4 pm. On the same day, the patient was also vaccinated with 0.5 ml dose of HARIX (batch number: 3996J) intramuscularly. No adverse event was reported. No further information was provided. Upon follow-up the nurse reported that the patient returned to repeat the shot on 20 Jun 2014. Follow-up received from a nurse received on 12 Jun 2014: Site of vaccination, time of vaccination, concomitant vaccination and narrative updated. Follow-up received from the nurse on 20 Jun 2014: Updated information on repeat vaccination of the patient.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US018105 is an initial spontaneous report from a pharmacist received on 08 Sep 2014. This report refers to an 18-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: M11077 and expiry date: not reported), at a dose of 0.5 ml intramuscularly on 28 Aug 2014. It was reported that, the patient accidentally received an expired MENVEO vaccine. No adverse event reported following this medication error (expired vaccine used).
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US009390, is an initial spontaneous report received from medical assistant on 05 May 2014. This report refers to 13 year old female child. She was vaccinated with MENVEO (batch number: M12103, expiry date: Sep 2014) 0.5 ml intramuscular on 05 May 2014. It was reported that the unreconstituted MENVEO reached 33.8 degree Fahrenheit for 8 hours and 31 minutes. No adverse event was reported following this mal administration.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US009393 is an initial spontaneous report received from the physician assistant on 05 May 2014, with a follow up received from physician assistant on 06 Jun 2014. This report refers to a patient of unknown identifiers. The patient medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: X13015, X13059) intramuscularly on 07 Apr 2014. It was reported that the patient received MenA lyophilized conjugate component reconstituted with a sterile diluent other than MenCYW-135 liquid conjugate. No adverse event was reported after the administration error. The physician assistant was unable to provide the patient identifiers. Follow up received from physician assistant on 06 Jun 2014: Updated physician assistant comment.