chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nerve damage, Injection site pain, Middle insomnia, Pain in extremity, Sleep disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 379MY, expiry date 31st May 2015). Concurrent medical conditions including high blood pressure. Concomitant products included amlodipine, losartan, omeprazole and pravastatin. On 17th November 2014, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 17th November 2014, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain, pain in arm and sleep disorder. The patient was treated with ibuprofen and gabapentin. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pain in arm and sleep disorder were not recovered/not resolved. The reporter considered the injection site pain, pain in arm and sleep disorder to be related to FLULAVAL QUADRIVALENT. Additional information received: Pharmacist reports a patient who has been experiencing pain in her left arm since receiving a FLULAVAL QUADRIVALENT injection on 11/17/2014. The injection itself was very painful for the patient and she cried out during the injection. Since that time she has experienced pain in her upper left arm, that goes up the back of her arm and down towards her breast. She has been taking ibuprofen around the clock to treat the pain, as well as some gabapentin cream. The gabapentin cream does seem to help the pain. The pain is significant enough that it wakes her up at night and she cannot sleep on her left arm. Sunday night and into Monday she had a significant pain day, but she is feeling 90% better today, Tuesday. The reporter thinks it is likely that a nerve was hit during the injection and that is the cause of the continuing pain. The reporter spoke with the pharmacist who performed the injection, and it is not thought that bone was hit, so the reporter does not think it is a bone problem. The patient thinks the injection was placed too high, but the reporter believes the injection was in the correct place. The reporter thinks it is possible the patient overdid it over the weekend with shopping, and that is why her arm hurt so much on Monday. The patient has seen her HCP, and an MRI will be performed if the pain does not improve.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 379MY, expiry date 31st May 2015). Concurrent medical conditions including high blood pressure. Concomitant products included amlodipine, losartan, omeprazole and pravastatin. On 17th November 2014, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 17th November 2014, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain, pain in arm and sleep disorder. The patient was treated with ibuprofen and gabapentin. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pain in arm and sleep disorder were not recovered/not resolved. The reporter considered the injection site pain, pain in arm and sleep disorder to be related to FLULAVAL QUADRIVALENT. Additional information received: Pharmacist reports a patient who has been experiencing pain in her left arm since receiving a FLULAVAL QUADRIVALENT injection on 11/17/2014. The injection itself was very painful for the patient and she cried out during the injection. Since that time she has experienced pain in her upper left arm, that goes up the back of her arm and down towards her breast. She has been taking ibuprofen around the clock to treat the pain, as well as some gabapentin cream. The gabapentin cream does seem to help the pain. The pain is significant enough that it wakes her up at night and she cannot sleep on her left arm. Sunday night and into Monday she had a significant pain day, but she is feeling 90% better today, Tuesday. The reporter thinks it is likely that a nerve was hit during the injection and that is the cause of the continuing pain. The reporter spoke with the pharmacist who performed the injection, and it is not thought that bone was hit, so the reporter does not think it is a bone problem. The patient thinks the injection was placed too high, but the reporter believes the injection was in the correct place. The reporter thinks it is possible the patient overdid it over the weekend with shopping, and that is why her arm hurt so much on Monday. The patient has seen her HCP, and an MRI will be performed if the pain does not improve.
Age: 7.0
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 7-year-old patient who received FLUARIX QUADRIVALENT (batch number UNKNOWN, expiry date unknown). On 2nd December 2014, the patient received the 2nd dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 2nd December 2014, an unknown time after receiving FUARIX QUADRIVALENT, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information received: Caller reports that 7 year old received second dose of FLUARIX QUADRIVALENT three weeks after initial dose instead of 4 weeks. No adverse events were stated.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red raised welt at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 September 2014, the subject received unspecified dose of FLULAVAL (.5 ml, unknown route and unknown deltoid). On 20 September 2014, 1 day after vaccination with FLULAVAL, the subject experienced red raised welt at injection site. At the time of reporting, the even was improved after 3 days. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red raised welt at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 September 2014, the subject received unspecified dose of FLULAVAL (.5 ml, unknown route and unknown deltoid). On 20 September 2014, 1 day after vaccination with FLULAVAL, the subject experienced red raised welt at injection site. At the time of reporting, the event was improved after 3 days. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received a certified medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ROTATEQ oral which had been previously exposed to 33.6F for 1 hour. No adverse effects reported. Additional information is not expected due to the reporter did not want to be contacted again.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 14-JAN-2015 the patient was vaccinated with a dose ROTATEQ (lot# was unspecified, 2 ml, oral) and a dose of PEDVAXHIB (lot# was unspecified, 0.5 ml, intramuscular) which both underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: This case was reported by a pharmacist via claims management company and described the occurrence of adverse event(s) in a subject of unspecified age and gender who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 25 January 2014 the subject received a dose of FLULAVAL (unknown details). In January 2014, within days of vaccination with FLULAVAL, the subject experienced adverse event(s). At the time of reporting the outcome of the event(s) was unspecified.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: This case was reported by a physician and described the occurrence of adverse reaction in a 12-week-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccinations included HIB (manufacturer unspecified, unknown route, injection site and batch number), DTaP+HIB+IPV (GlaxoSmithKline, unknown route, injection site and batch number) and PREVNAR 13 (Non-GSK manufacturer, unknown route, injection site and batch number), all given on 16 August 2014. On 16 August 2014, the subject received erroneously 1st dose of ROTARIX via intramuscularly that led to inappropriate route of vaccination. At the time of reporting, the outcome of the event was unspecified. Follow-up information received on 05 February 2015: No new information. Follow-up can  e done with the nurse if needed.
Sex: M
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: This case was reported by a pharmacist via claims management company and described the occurrence of adverse event(s) in a male subject of unspecified age who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 25 January 2014 the subject received a dose of FLULAVAL (unknown details). In January 2014, within days of vaccination with FLULAVAL, the subject experienced adverse event(s). At the time of reporting the outcome of the event(s) was unspecified.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 08-JAN-2015 the patient was vaccinated with a dose of ROTATEQ (lot# was unspecified, 2 ml, oral) and a dose of PEDVAXHIB (lot# was unspecified, 0.5 ml, intramuscular) which both underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of adverse reaction in a female subject of unspecified age who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 7 January 2014 the subject received a dose of FLULAVAL TETRA (unknown details). At an unspecified time after vaccination with FLULAVAL TETRA, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: TDAP
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of adverse reaction in a male patient who received BOOSTRIX (batch number 75354, expiry date unknown). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to BOOSTRIX.
Sex: M
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of adverse reaction in a male subject of unspecified age who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 6 January 2014 the subject received a dose of FLULAVAL TETRA (unknown details). At an unspecified time after vaccination with FLULAVAL TETRA, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Cough, Feeling abnormal, Hypoaesthesia, Influenza like illness
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of flu-like symptoms in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. In February 2014 the subject received a dose of FLULAVAL (unknown details). The subject reported that he received the vaccine "the other day". In February 2014, within days of vaccination with FLULAVAL, the subject experienced flu-like symptoms (also described as "feel weird"), cough, fever, numbness, runny nose and low energy. The subject stated that he received the vaccine "the other day and then started to feel weird which he eventually described as flu-like symptoms." The subject refused to provide further information and stated the he "was going to contact a lawyer because he received a product that had mercury in it." At the time of reporting the outcome of the events were unspecified.
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of flu-like symptoms in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. In February 2014 the subject received a dose of FLULAVAL (unknown details). The subject reported that he received the vaccine "the other day". In February 2014, within days of vaccination with FLULAVAL, the subject experienced flu-like symptoms (also described as "feel weird"), cough, fever, numbness, runny nose and low energy. The subject stated that he received the vaccine "the other day and then started to feel weird which he eventually described as flu-like symptoms." The subject refused to provide further information and stated the he "was going to contact a lawyer because he received a product that had mercury in it." At the time of reporting the outcome of the events were unspecified.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Gait disturbance, Headache, Myalgia
Clinical narrative: Extreme head pain, joint pain, shooting pain in muscles especially left arm (shot was administered in left arm). For 2 days couldn't leave home due to being unstable while walking. Still have pain in joints and muscles. Never again will I get this shot.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Diarrhoea, Malaise, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, malaise, rhinorrhea, body aches, vomiting, diarrhea on same day as vaccination and for 3 days afterwards.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Vomiting
Clinical narrative: Fever, malaise, rhinorrhea, body aches, vomiting, diarrhea on same day as vaccination and for 3 days afterwards.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Oedema, Pain
Clinical narrative: Local reaction - edema and erythema, pain (pt. only now recalled having a reaction to Td in past).
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site rash, Pyrexia, Rash, Rash pruritic, Rhinorrhoea
Clinical narrative: Rash for 8 days that started on his face and then to upper body and legs with minimal itching. 4 days before the rash; patient started on AMOXIL and given MMR. Patient had slight fever with sniffles after vaccine and possible otitis media. AMOXIL discontinued and azithromycin started.
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of adverse reaction in a female subject of unspecified age who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 6 January 2014 the subject received a dose of FLULAVAL TETRA (unknown details). At an unspecified time after vaccination with FLULAVAL TETRA, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red raised welt at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 September 2014, the subject received unspecified dose of FLULAVAL (.5 ml, unknown route and unknown deltoid). On 20 September 2014, 1 day after vaccination with FLULAVAL, the subject experienced red raised welt at injection site. The subject noticed 1/2 dollar sized big red welt at injection site. At the time of reporting, the event was improved after 3 days. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red raised welt at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 September 2014, the subject received unspecified dose of FLULAVAL (.5 ml, unknown route and unknown deltoid). On 19 September 2014, 1 day after vaccination with FLULAVAL, the subject experienced red raised welt at injection site. At the time of reporting, the event was improved after 3 days. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Age: 0.2
Sex: M
Vaccine: RV1
Symptoms: Incorrect product formulation administered, Wrong technique in drug usage process
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a 2-month-old male patient who received ROTARIX (batch number A41FB422A, expiry date 3rd September 2015). On an unknown date, the patient received ROTARIX. On an unknown date, an unknown time after receiving ROTARIX, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. It was unknown if the reporter considered the inappropriate preparation of medication to be related to ROTARIX. Additional information received: A nurse gave 2 male twin patients just the diluent of ROTARIX. The lot number and expiration date are the same for both doses. No AEs have been reported. The HCP already discarded the pairing lyophilized portion of the vaccine. The HCP planned to re-vaccinate these patients.
Sex: U
Vaccine: HEP, TDAP
Symptoms: Unevaluable event
Clinical narrative: Look alike.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Pallor
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site redness in a 76-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included egg allergy as a child. On 6 November 2013, the subject received a dose of FLULAVAL (route unknown, right arm,  batch number not provided). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site redness, injection site warmth and after injection went white. It happened periodically, it turns warm, white and red and then faded away within minutes. At the time of reporting, the events were unresolved.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Mom called within 24 hrs of vaccination to report 4-7 hive like areas on arm, smaller than dimes and raised; not at injection site further down arm; itchy when woke up; not itchy later in day as well as smaller without medicine. No other signs or symptoms. Played soccer this day.
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old male patient who received Hepatitis B vaccine. Previously administered products included hepatitis B (dose 1) and hepatitis B (dose 2). On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information received: Pharmacist reporting a patient received two Hepatitis B vaccines (manufacturer unknown) from a different facility two years ago, but did not receive the third of three in the series.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 16 May 2013. It was reported that a child was given only DTaP/IPV component of PENTACEL without the powder. No adverse event was reported. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US009705, is an initial spontaneous report received from the nurse on 29 Apr 2013 with the follow-up received on 08 May 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO vaccine (batch number: M12023) reconstituted with sterile water diluent intramuscularly on 19 Apr 2013. No adverse reaction reported following this administration error. Follow-up received from nurse on 08 May 2013: Updated patient demographics (initials, date of birth and gender) and date of vaccination.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US009706, is an initial spontaneous report received from a nurse on 25 Apr 2013: This case refers to a 11-years-old male patient. He received only MENVEO vaccine (batch number: M11047) reconstituted with sterile diluent on 24 Apr 2013. He did not received MENVEO vaccine. No adverse reaction reported following this adminsitration error.
Sex: U
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US009894 is an initial spontaneous report received from a registered nurse on 30 Apr 2013. This report refers to an adult patient (over 55-year-old) of unspecified gender. The reporter stated that the patient was vaccinated with a dose of MENVEO (batch number: not reported) on an unspecified date. No adverse reaction was reported following this administration error. The reporter refused to provide additional information.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US010020 is an initial spontaneous report received from a pharmacist on 02 May 2013. This report refers to a 14-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an intramuscular dose of expired MENVEO (batch number: A10047, expiry date: not reported) on 01 May 2013. No adverse reaction was reported. No further information was provided.
Age: 51.0
Sex: M
Vaccine: MNQ, YF
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US010152, is an initial spontaneous report received from a nurse on 02 May 2013, with a follow-up received on 26 Jul 2013. This case refers to a 51-years-old male patient. His medical history included rash due to Penicillin allergy. His vaccination history included administration of typhoid vaccine, tetanus/diphtheria/acellular pertussis vaccine, polio vaccine, hepatitis B series and hepatitis A series(manufacturer and batch number were unknown for all vaccines). His concomitant medication included yellow fever vaccine (other manufacturer, batch number: UH597AA) subcutaneously at a dose of 0.5 ml of 02 May 2013. On the same day, he received only MENVEO (batch number: X12027) at a dose of 0.5 ml, intramuscularly into left deltoid, without being reconstituted with Men A lyophilized powder. Nurse administered the complete vaccine of MENVEO immediately following the error without any ill effects to the patient. Patient was informed at the error. No adverse event was reported following this administration error. Follow-up received on 26 Jul 2013: Medical history, concomitant medication, vaccination history, vaccination site and revaccination information was updated.
Age: 31.0
Sex: F
Vaccine: HEP, HEPA, MNQ
Symptoms: Immunisation, No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US010204, is an initial spontaneous report received from a nurse on 02 May 2013 with a follow up information received on 24 May 2013: This case refers to a 31-years-old female patient. She received only Men A lyophilized conjugate component of MENVEO (batch number: A11042 / M11042) reconstituted with sterile diluent instead of MenCYW-135 liquid conjugate intramuscularly on 02 May 2013. She also concomitantly received hepatitis A vaccine (manufacturer and batch number: not reported) and hepatitis B vaccine (manufacturer and batch number: not reported) on the same date. No adverse reaction reported following the administration error. It was reported that she returned to the clinic and was revaccinated with correct liquid conjugate. She left without any complaints or events. Follow up information received on 24 May 2013: Concomitant vaccine and re-vaccination details updated.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US010207, is an initial spontaneous report received from the health care professional on 02 May 2013. This report refers to a male patient of unspecified age. He received only the MENVEO (batch number: not reported) intramuscularly without being reconstituted with Men A component on 28 Apr 2013. No adverse event was reported following this administration error. No additional information was available.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US010221, is an initial spontaneous report received from a nurse on 06 May 2013. This report refers to a male patient of unspecified age. His medical history and concomitant medication was not reported. He was vaccinated with expired MENVEO (batch number: M11062 and expired date: Jan 2013) intramuscularly on 03 May 2013. No adverse event was reported following this administration error. No additional information was available.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US009500, is an initial spontaneous report received from a nurse on 25 Apr 2013 and a follow up received from a nurse on 16 May 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medications was not reported. She received only Men C, Y, W-135 liquid conjugated of MENVEO vaccine, (batch number: X11079A) intramuscularly in her left deltoid, without being reconstituted with Men A component on 18 Apr 2013. On the same day she was also vaccinated with BOOSTRIX (other manufacturer, batch number: AC52B093BA) at a dose of 0.5 ml intramuscularly in her right deltoid. It was reported that the patient had no redness or swelling at the injection site. The reporter assessed this case as non-serious. Follow up information received from a nurse on 16 May 2013: Updated concomitant vaccination, site of MENVEO vaccination, seriousness, and confirmed that the patient had no vaccination site reactions.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US009517 is an initial spontaneous report from the nurse received on 25 Apr 2013. This report refers to a patient of unknown age and gender. On an unknown date, the patient was accidentally vaccinated with only Men A lyophilized conjugate of MENVEO (batch number : not reported) reconstituted with a sterile diluent via intramuscular route and did not receive MenCYW-135 liquid component. It was reported that the patient did not experience any adverse event after the mal-administration. No other information was available.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Case number PHEH2013US009605, is an initial spontaneous report received from the physician on 26 Apr 2013. This report refers to a 17-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with expired MENVEO (batch number: M10051 and expiry date: Jan 2013) intramuscularly on 26 Apr 2013. No additional information was available.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US008348 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to an 18-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: X12013 and expiry date: Oct 2014) at 0.5 ml intramuscularly on 19 Mar 2013. MENVEO vaccine was stored at 33-36F for 19 days and vaccine was not frozen. No adverse event was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2013US008349 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to an 11-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M102006, expiry date: Oct 2014) at a dose of 0.5 ml intramuscularly on 04 Apr 2013. It was reported that the vaccine was at 33 to 36 F for 1 days and it was not frozen. No further information was provided.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2013US008350 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to a 16-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M102006, expiry date: Oct 2014) at a dose of 0.5 ml intramuscularly on 04 Mar 2013. It was reported that the vaccine was at 33 F to 36 F for 19 days and it was not frozen. No further information was provided.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US008351 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to an 18-years-old female patient whose medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number :M102006, expiry date: Oct 2014) at a dose of 0.5 ml intramuscularly on 22 Mar 2013. It was reported that the vaccine had been at 33 to 36 F for 19 days and it was not frozen. No adverse events were reported following the administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US008352 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to an 18-years-old female patient whose medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M102006, expiry date: Oct 2014) at a dose of 0.5 ml intramuscularly on 21 Mar 2013. It was reported that the vaccine had been at 33 to 36 F for 19 days and it was not frozen. No adverse events were reported following the administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US008353 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M102006, expiry date: Oct 2014) at a dose of 0.5 ml intramuscularly on 20 Mar 2013. It was reported that the vaccine was stored at 33 to 36 F for 19 days and it was not frozen. No side effect was reported following the medication error. No further information was provided.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US008354 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to an 16-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M102006, expiry date: Oct 2014) at a dose of 0.5 ml intramuscularly on 05 Apr 2013. It was reported that the vaccine was stored at 33 to 26 F for 19 days and it was not frozen. No side effects was reported following the medication error. No further information was provided.
Sex: U
Vaccine: MNQ
Symptoms: Injection site extravasation
Clinical narrative: Case number PHEH2013US008443, is an initial spontaneous report received from a pharmacist on 10 Apr 2013. This report refers to an unspecified age and gender patient. The patient medical history and concomitant medication was not reported. The patient was vaccinated with MENVEO (batch number: not reported), intramuscularly on an unspecified date. The reporter reported that, the patient received some of the MENVEO vaccine and small amount leaked out of the injection site. No more information was available.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, MNQ, PNC13, RVX
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US008451 is an initial spontaneous report received from a nurse on 11 Apr 2013 with a follow up received from the physician on 29 May 2013. This report refers to a 6-months-old female patient. Her medical history was not reported. Her concomitant medications included vaccinated with PEDIARIX (other manufacturer, diphtheria, hepatitis b vaccine, pertussis, polio, tetanus vaccine, batch number: not reported) PCV 13 (other manufacturer, batch number: not reported) both at a dose of 0.5 ml into left and right thigh respectively and with rotavirus vaccine at a dose of 2 ml orally on 10 Apr 2013. It was reported that she was inadvertently vaccinated 0.5 ml intramuscular dose of MENVEO (batch number: A11076, expiry date: Apr 2014) into the left thigh on 10 April 2013. It was reported that physician spoke with her mother on 15 Apr 2013, and mother reported that there were no symptoms. No adverse event was reported. Follow up received from the physician on 29 May 2013: Updated patient demographics (height, weight), concomitant medication, vaccination anatomical location and reporter comments.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, MNQ, PNC13, RVX
Symptoms: Irritability, Somnolence
Clinical narrative: Case number PHEH2013US008455 is an initial spontaneous report received from a nurse on 11 Apr 2013 with a follow-up received on 29 May 2013: This report refers to a 6-month-old female patient. Her medical history and concomitant medications were not reported. It was reported that she was inadvertently vaccinated 0.5 ml intramuscular dose of MENVEO (batch number: A11076, expiry date: Apr 2014) on 10 Apr 2013. On the same day she was also vaccinated with PEDIARIX (other manufacturer, batch number: unknown) at 0.5 ml into the left thigh, along with PREVNAR 13 (other manufacturer, batch number: unknown) at 0.5ml in to the right thigh and with rotavirus (other manufacturer, batch number: unknown) at 2ml orally. After vaccinations, her mother brought her back to the clinic on 12 Apr 2013, for a follow-up checkup and reported some irritability and sleepiness. The events subsided on an unknown date. Mother was instructed to bring the patient back to the clinic if there was any change in patient's mental status, abnormal behavior, irritability and fever. Follow-up received from the physician on 29 May 2013: Updated patient demographics, co-suspect vaccinations, event (irritability and sleepiness) and outcome.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US008690, is an initial spontaneous report received from a medical assistant on 12 Apr 2013. This report refers to a patient of unspecified age and gender. The patient medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: M11082) intramuscularly on an unspecified date. Caller reported that they found MenA lyophilized conjugate vaccine component of MENVEO vial and was not sure if a patient received partial dose of MENVEO. Caller stated that a patient may had received only the MenCYW-135 liquid conjugate vaccine without the MenA lyophilized conjugate vaccine component of MENVEO. No adverse reaction was reported following this administration error.
Age: 25.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US008711, is an initial spontaneous report received from a pharmacist on 16 Apr 2013. This case refers to a 26-years-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (ACWY (conjugated-CRM 197), batch number: M11041), intramuscularly without being reconstituted with Men A component on 21 Feb 2013. No adverse reaction was reported following this administration error.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US005286, is an initial spontaneous report received from a nurse on 04 Mar 2013. This report refers to a 13-year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with MenCYW-135 liquid component of MENVEO (batch number: X11082) on 03 Mar 2013 and did not receive MenA lyophilized conjugate. No adverse event was reported following this administration error.
Age: 85.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US006931 is an initial spontaneous report received from a pharmacist on 11 Mar 2013. This case refers to an 85-year-old elderly male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A10053, expiration date: Jan 2013) on 07 Nov 2012. No adverse events were reported following vaccination. It was also confirmed by the reporter that the patient was not revaccinated. No other information was available.
Age: 70.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US008973 is an initial spontaneous report received from a nurse on 18 Apr 2013. This report refers to a 70-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12013) intramuscularly on 18 Apr 2013. It was reported that the patient would be undergoing spleen removal. No adverse event was reported following the maladministration.
Sex: F
Vaccine: MNQ
Symptoms: Accidental exposure to product, No adverse event, Product physical issue
Clinical narrative: Case number PHEH2013US009429 is an initial spontaneous report received from a consumer who is a nurse on 06 Feb 2013. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. It was reported that on an unknown date when she picked up the MENVEO (batch number; M12004, expiry date: 30 Sep 2014), the vaccine leaked out onto her hand from a crack in the bottom edge of the vial. The carton was previously unopened and all other vials within the carton were found intact and undamaged. Both the inner and outer cartons were not damaged and customer did not observe liquid damage to the carton. No dose was administered to patient. No adverse event was reported. The quality assurance department registered a complaint with reference number 209045. No further information was provided.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US0008935 is an initial spontaneous report received from a nurse on 17 Apr 2013. This report refers to a male patient. His medical history and concomitant medications were not reported. It was reported that on an unspecified date he was vaccinated with 0.5 ml MENVEO (batch number: M11081, expiry date: Apr 2014) intramuscularly and did not receive MenA lyophilized conjugate. No adverse reactions were reported. No further information was provided.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US008933 is an initial spontaneous report received from a nurse on 17 Apr 2013. This report refers to a male patient. His medical history and concomitant medications were not reported. It was reported that on an unspecified date he was vaccinated with 0.5 ml MENVEO (batch number: M11081, expiry date: Apr 2014) intramuscularly and did not receive MenA lyophilized conjugate. No adverse reactions were reported. No further information was provided.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US009414, is an initial spontaneous report received from a physician on 23 Apr 2013: This case refers to an 11-years-old male patient. He received only MENVEO vaccine (batch number: X12013), intramuscularly without being reconstituted with Men A component on 18 Apr 2013. No adverse reaction was reported following this administration error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Case number PHEH2013US009267, is an initial spontaneous report received from a nurse on 23 Apr 2013: This case refers to a 16-years-old male patient. He received only Men A lyophilized component of MENVEO vaccine (batch number: M12024) reconstituted with sterile diluent intramuscularly on 22 Apr 2013. No adverse reaction reported following this administration error.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Immunisation, Pain in extremity, Pyrexia, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US009498, is an initial spontaneous report received from a nurse on 24 Apr 2013 with a follow up received from a nurse on 21 May 2013 and 31 Jan 2014: This case refers to a 16-years-old female patient. She received only Men A lyophilized conjugate component of MENVEO vaccine (batch number: M12023) reconstituted with sterile water by mistake (instead of liquid component Men CYW) intramuscularly into right deltoid on 23 Apr 2013. On the same day, she was vaccinated with Tdap (manufacturer unknown, batch number: 44431AA) at a dose of 0.5 ml intramuscularly into her deltoid. On an unknown date, after vaccination, she had a fever for 1-2 days. She had a sore arm on an unspecified date. She was completely recovered from the fever as of 28 Apr 2013. She was revaccinated with MENVEO (batch number: unknown) which was missed correctly on 29 Apr 2013. outcome of sore warm was not reported. The causality and seriousness of events were not reported. Follow up received from a nurse on 21 May 2013: Updated reporter comment, vaccination anatomical location (right deltoid), event (fever, sore arm), suspect product (Tdap) and revaccination information. Follow-up received from the nurse on 31 Jan 2014: Updated patient demographics (height and weight).
Age: 31.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US005052 is an initial spontaneous report received from a pharmacist on 27 Feb 2013. This report refers to a 31-year-old female patient. It was reported that she received only MenA of MENVEO (batch number: A110411) diluted with a sterile diluent intramuscularly on 18 Feb 2013 and did not receive MenCYW-135 liquid conjugate. No adverse event was reported after this inadvertent administration. No other information was available.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US005084, is an initial spontaneous report received from a nurse on 27 Feb 2013, and with a follow up report received from physician on 15 Mar 2013: This case refers to a 12-years-old female patient. Her medical history included allergies to dairy products. She received only Men A lyophilized conjugated component of MENVEO vaccine (batch number: A11071, expiry date: Dec 2013) reconstituted with sterile diluent intramuscularly on 27 Feb 2013. No adverse reaction reported following this administration error. Follow up report received from physician on 15 March 2013. Patient initials, medical history and expiry date on vaccine updated.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US008712, is an initial spontaneous report received from a nurse on 16 Apr 2013 with a follow up information received on 13 May 2013: This case refers to a female patient of unspecified age. She received only the Men A component of MENVEO (batch number: not reported), reconstituted with sterile water intramuscularly on 09 Apr 2013. Reporter stated that, since there was an extra MenCYW-135 liquid conjugate vaccine component of MENVEO vial in the package and all the powder vials were gone. Reporter also stated that, they documented a sterile water lot number for MENVEO administration for this patient. The nurse stated that she called to ask about a possibly compromised dose, however through a more thorough investigation, the powder vial was recovered. The powder vial was recovered. The powder vial was placed incorrectly in a different box. No adverse reaction was reported following this administration error. Follow up information received on 13 May 2013: Reporter comment updated.
Age: 27.0
Sex: F
Vaccine: MNQ
Symptoms: Accidental exposure to product, Exposure during pregnancy, No adverse event, Syringe issue
Clinical narrative: Case number PHEH2013US008868 is an initial combined report received from a consumer (nurse) on 18 Apr 2013 with a follow up information received from quality assurance department (QA reference number: 224311) on 22 Apr 2013. This report refers to a 27-years-old female patient. It was reported that during administration of a dose of MENVEO (batch number: A12025, expiry date: Dec 2014) to a patient, some of the vaccine splashed back on to her face because the syringe had a slip tip and needle popped off on 18 Apr 2013. The vaccine administrator was pregnant. No adverse reactions were reported. The quality assurance department registered a complaint with reference number 224311. No further information was provided.
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US005315 is an initial spontaneous report received from a physician on 02 MAR 2013. This report refers to a 15-months-old male patient. It was report4ed that he was inadvertently administered an intramuscular dose of MENVEO (batch number: not reported) on 02 MAR 2013. No adverse event was reported following the maladministration.