chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US010898, is an initial spontaneous report from a pharmacist received on 27 May 2014 and a follow up information was received from the pharmacist on 09 Jul 2014. This report refers to a 19 year old female patient. Her historical condition and concomitant medications were not reported. The pharmacy intern reported that he patient erroneously received MENVEO (batch number: A11052/A13051) intramuscularly in the right deltoid at a dose of 0.5 ml. that was reconstituted with an expired liquid Men CYW-135 component on 27 May 2014. It was reported that the Men A vial had not expired. No adverse event was reported following these administration error. Follow up information was received from the pharmacist on 09 Jul 2014: Updated vaccine dosage and site of vaccine administration.
Age: 30.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Injection site bruising, Local reaction, Product reconstitution issue
Clinical narrative: Case number PHEH2014US010907 is an initial spontaneous report from a nurse received on 28 May 2014. This report refers to a 30-year-old male patient. He received only the Men CYW-135 liquid conjugate component of MENVEO (batch number: unknown) intramuscularly on 16 May 2014. On the same day, post vaccination, he experienced localized injection site reaction (area was bruised) and joint pain in his elbow. The nurse reported that the joint pain was unrelated to vaccination and causality of the other events was not reported. Seriousness and outcome of the events was not reported. Seriousness and outcome of the events was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US015337 is an initial spontaneous report received from a pharmacist on 30 Jul 2014 and with a follow up information received from the pharmacist on 02 Sep 2014. This case refers to an 11 year old male patient. Past medical history and concomitant medication were not reported. His concomitant vaccination included administration of BOOSTRIX (other manufacturer, batch number: 52PM5) at a dose of 0.5 ml in the left arm on 30 Jul 2014. He was vaccinated with MENVEO (batch number: A11042) intramuscularly at a dose of 0.5 ml in the right arm on 30 Jul 3014 in the afternoon. It was reported that he was vaccinated with MENVEO where part of vaccine was expired. No adverse events reported after the maladministration. He was revaccinated with MENVEO (batch number: not reported) on 2 Aug 2014. as per guidelines by manufacturer. Follow up information received from the pharmacist on 02 Sep 2014: Updated concomitant vaccination (BOOSTRIX), dose of MENVEO, site of administration of MENVEO. Updated revaccination details in the narrative.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US014998, is an initial spontaneous report from a medical assistant received on 24 Jul 2014 with a follow-up from a medical assistant received on 21 Oct 2014. This report refers to a 17-year-old female patient. Past medical history and concomitant medications were not provided. Her vaccination status was up-to-date. She was vaccinated with 0.5 ml of expired MENVEO (batch number: M11075) intramuscularly into left arm on 14 Jul 2014. No adverse reactions have occurred following this medication error. She was administered with another dose of MENVEO on an unknown date. No further information was provided. Follow-up information received from the medical assistant on 21 Oct 2014: Patient demographics (height and weight), site of vaccination (left arm) and narrative (revaccination details) were updated.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2014US011023 is an initial spontaneous report from the pharmacist received on 29 May 2014. This report refers to a 22-year-old female patient. She was inadvertently vaccinated with MENVEO (batch number: not reported) via subcutaneous route at a different location on 28 May 2014. On the same date, after vaccination she experienced injection site redness and her injection site raised. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US011159 is an initial spontaneous report received from a nurse sales representative on 29 May 2014. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: not reported) intramuscularly on an unknown date. It was reported that the patient only received MenA lyophilized powder component reconstituted with sterile water and did not receive MEnCYW-135 liquid conjugate. The physician's office had an extra liquid vial of MENVEO. No adverse events were reported following the maladministration. No further information was provided.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US015267 is an initial spontaneous report from a nurse received on 30 Jul 2014 with a follow-up received on 22 Aug 2014. This report refers to an 11-year-old male patient. Past medical history was not provided. Concomitant vaccination included BOOSTRIX (other manufacturer and batch number: STN9R). On 24 Jul 2014, he was vaccinated an intramuscular dose of MENVEO (batch number: A14021) where MenA lyophilized conjugate component reconstituted with a sterile water (other than MenCWY). It was reported that the patient needs to repeat MENVEO dose for maximum benefit. No adverse event was reported following this administration error (wrong solution used in drug reconstitution). Follow-up received from a nurse on 22 Aug 2014: Patient's demographics (height and weight), concomitant vaccination and narrative updated.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US016081 is an initial spontaneous report received from a healthcare professional on 11 Aug 2014. This report refers to an 11 year old male child. His medical history and concomitant medication were not reported. On 10 Aug 2014, he was vaccinated only with the MenCYW-135 liquid component of MENVEO (batch number: not reported) via intramuscular route without reconstituting it with MenA lyophilized conjugate. On the same day, he was concomitantly vaccinated with BOOSTRIX (batch number: not reported). No adverse event was reported following this administration error (inappropriate preparation of medication).
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US014995 is an initial spontaneous report received from a Healthcare Professional on 24 Jul 2014. This report refers to an 18 year old female patient. She was vaccinated with an expired dose of MENVEO (batch number: M11075) via intramuscular route at a dose of 0.5 ml on 24 Mar 2014. No adverse event was reported following this administration error (expired vaccine used).
Age: 61.0
Sex: M
Vaccine: TTOX, VARZOS, TDAP, VARZOS
Symptoms: Decreased appetite, Disorientation, Dizziness, Fluid retention, Headache
Clinical narrative: Headache followed by sore throat, muscle ache, fever, fluid retention, loss of appetite, dizzy and disoriented. chest congestion.
Age: 61.0
Sex: M
Vaccine: TTOX, VARZOS, TDAP, VARZOS
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Headache followed by sore throat, muscle ache, fever, fluid retention, loss of appetite, dizzy and disoriented. chest congestion.
Age: 61.0
Sex: M
Vaccine: TTOX, VARZOS, TDAP, VARZOS
Symptoms: Asthenia, Fatigue, Headache, Influenza like illness, Oropharyngeal pain
Clinical narrative: Headache followed by sore throat, muscle ache, fever, fluid retention, loss of appetite, dizzy and disoriented. chest congestion.
Age: 61.0
Sex: M
Vaccine: TTOX, VARZOS, TDAP, VARZOS
Symptoms: Pain, Productive cough
Clinical narrative: Headache followed by sore throat, muscle ache, fever, fluid retention, loss of appetite, dizzy and disoriented. chest congestion.
Age: 61.0
Sex: M
Vaccine: TTOX, VARZOS, TDAP, VARZOS
Symptoms: Decreased appetite, Disorientation, Dizziness, Fluid retention, Headache
Clinical narrative: Headache on 5/18/2016 then on 5/19/2016 he states he developed sore throat and flu-like symptoms, fatigue, weakness, body aches, productive cough.
Age: 61.0
Sex: M
Vaccine: TTOX, VARZOS, TDAP, VARZOS
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Headache on 5/18/2016 then on 5/19/2016 he states he developed sore throat and flu-like symptoms, fatigue, weakness, body aches, productive cough.
Age: 61.0
Sex: M
Vaccine: TTOX, VARZOS, TDAP, VARZOS
Symptoms: Asthenia, Fatigue, Headache, Influenza like illness, Oropharyngeal pain
Clinical narrative: Headache on 5/18/2016 then on 5/19/2016 he states he developed sore throat and flu-like symptoms, fatigue, weakness, body aches, productive cough.
Age: 61.0
Sex: M
Vaccine: TTOX, VARZOS, TDAP, VARZOS
Symptoms: Pain, Productive cough
Clinical narrative: Headache on 5/18/2016 then on 5/19/2016 he states he developed sore throat and flu-like symptoms, fatigue, weakness, body aches, productive cough.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US014993, is an initial spontaneous report from a medical assistant received on 24 Jul 3014 with a follow-up from a medical assistant received on 21 Oct 2014. This report refers to a 17-year-old male patient. Past medical history and concomitant medications were not provided. His vaccination status was up-to-date. He was vaccinated with 0.5 ml of expired MENVEO (batch number: M11075) intramuscularly into left arm on 11 Mar 2014. No adverse event was reported following this administration error. Follow up information received from the medical assistant on 21 Oct 2014: Patient demographics (height and weight) and site of vaccination (left arm) were updated.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US014974 is an initial spontaneous report received from a nurse on 25 Jul 2014. This report refers to 22 year old female patient. Her past medical history and concomitant medications were not reported. The patient received the Men A lyophilized powder component of MENVEO (batch number: A14031) intramuscularly which was reconstituted with sterile diluent instead of Men CWY liquid conjugate compound on 25 Jul 2014. No adverse events were reported following this medication error (wrong solution used in drug reconstitution).
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US014755, is an initial spontaneous report received from a nurse on 21 Jul 2014 and with a follow up information received from the nurse on 26 Aug 2014. This report refers to a 16 years old female patient. Her medical history and concomitant medications were not reported. Nurse reported that the patient inadvertently received only the Men CYW-135 liquid component of MENVEO (batch number: M11081) intramuscular on 16 Jul 2014 at 1.45 PM, without being reconstituted with Men A component. No adverse event was reported. No further information was provided. Follow up information received from the nurse on 26 Aug 2014: Updated patient identifiers (date of birth, age, gender, height and weight), batch number of MENVEO, date and time of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US022348, is an initial spontaneous report received from a nurse on 05 Nov 2014. This report refers to a patient of unknown age and gender. Nurse reported that one patient received an expired dose of MENVEO (batch number: A12102) intramuscularly on 03 Nov 2014. No adverse event was reported following the medication error. No further information was provided.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US011221, is an initial spontaneous report from a medical assistant received on 02 Jun 2014, with a combined follow up received from medical assistant on 02 Jun 2014 and 03 Jun 2014 respectively. This report refers to a 17-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered MenA powder component of MENVEO (batch number: A13047) reconstituted with sterile water instead of Men-CYW-135, intramuscularly on 28 May 2014. No adverse event was reported following the administration error (wrong solution used in drug reconstitution). Combined follow up received from medical assistant on 02 Jun 2014 and 03 Jun 2014 respectively: Updated reporter comment.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US022157 is a combined initial and follow-up spontaneous report received from a pharmacist on 01 Nov 2014 and 04 Nov 2014. This case refers to a 21 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with an expired dose of MENVEO (batch number: A13014 and expiry date: not reported), intramuscularly on 31 Oct 2014. No adverse event was reported following this administration error (expired vaccine used).
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US015700 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 12 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 25 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).
Sex: U
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022238 is an initial spontaneous report received from a pharmacist on 04 Nov 2014. This report refers to a patient of over the age of 55 years old and of an unknown gender. The patient was vaccinated with MENVEO (batch number: not reported) intramuscularly on 04 Nov 2014. The patient was administered MENVEO outside of age guidelines. No adverse event was reported. No further information was provided.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US015752, is an initial spontaneous report received from a nurse on 06 Aug 2014, with the follow-up received from a physician on 12 Sep 2014. This report refers to a 13-year-old male patient. Past medical history and concomitant medication were not provided. The patient received only Men CWY-135 liquid conjugate component of MENVEO (batch number: M13051) intramuscularly on 01 Aug 2014. Upon the follow-up, it was reported that, the patient did not receive the entire vaccine and no adverse events were reported following this medication error (inappropriate preparation of medication). Follow-up received from a physician on 12 Sep 2014: Updated reporter comments.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US008005 is an initial spontaneous report received from a medical assistant on 18 Apr 2014 and with a follow up information received from the medical assistant on 08 Sep 2014. This report refers to a 17-year-old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included vaccination with unknown vaccine on unknown date. She was inadvertently given a dose of MenA powder of MENVEO (batch number: M13047) reconstituted with an unspecified Merck vaccine diluent, intramuscularly on 16 Apr 2014. Trade name, generic name or batch number of the Merck vaccine was not reported. No adverse event was reported following this medication error. Follow up information received from the medical assistant on 08 Sep 2014: Updates vaccination history.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US008202 is an initial spontaneous report received from a nurse on 23 Apr 2014. This report refers to a 20 years old male patient. His medical history and concomitant medications were not reported. It was reported that he received only the MenCYW-135 liquid component of MENVEO (batch number: not reported) intramuscularly on 22 Apr 2014 and did not receive the Men A lyophilized conjugate. No adverse events were reported following the maladministration.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pain
Clinical narrative: Case number PHEH2014US008239 is an initial spontaneous report from a nurse received on 23 Apr 2014. This report refers to an 11-year-old female patient. The patient received only liquid component of MENVEO (batch number: unknown) and TDAP (other manufacturer and batch number: unknown) on 18 Apr 2014. On the same day, post vaccination, the patient experienced localized pain. By 20 Apr 2014, the patient started experiencing little bit of redness and swelling at the injection site and felt a lump under the skin. The following day the patient went to the primary provider who determined it was just a localized reaction (however, they are unable to determine which vaccine caused the reaction as they administered at the same site) and symptoms were improving at that point. Primary provider advised that patient be revaccinated. The patient stated that she was planning to revaccinate. No additional information was available.
Age: 44.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US017289 is an initial spontaneous report received from the pharmacist on 26 Aug 2014. This report refers to a 44 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M11082) intramuscularly on 14 Aug 2014. It was reported that the patient was vaccinated with expired MENVEO vaccine. No adverse events reported after the maladministration.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US018762 is an initial spontaneous report received from a nurse on 17 Sep 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: not reported), intramuscularly reconstituted with a sterile water instead f MenCYW-135 liquid component on 13 Sep 2014. No adverse reaction was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US008251 is an initial spontaneous report received from a nurse on 23 Apr 2014. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. Inadvertently, she received only Men A lyophilized conjugate component of MENVEO (batch number: not reported), reconstituted with a sterile water instead of MenCYW-135 liquid component intramuscularly on an unknown date. No adverse reaction reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US008638 is an initial spontaneous report received from a nurse on 28 Apr 2014. This report refers to an 11-years-old female patient. Her medical history and concomitant medications were not reported. It was reported that on 23 Apr 2014, she was inadvertently administered an intramuscular dose of Men A lyophilized conjugate component of MENVEO (batch number: M13047) reconstituted with another sterile diluent instead of MenCYW-135 liquid conjugate. No adverse events were reported following the maladministration.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US008651 is an initial spontaneous report received from the nurse on 29 Apr 2014. This report refers to an 11-years-old female child. On 29 Apr 2014, she was vaccinated intramuscularly with only Men A lyophilized component of MENVEO (batch number: A12129) which was reconstituted with sterile water instead of Men CYW-135 liquid component. No adverse event reported following this medication error (wrong solution used in drug reconstitution).
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US022376, is an initial spontaneous report from a nurse received on 04 Nov 2014. This report refers to a 19-year-old female patient. Medical history and concomitant medications were not reported. The patient received an intramuscular dose of Men A lyophilized component of MENVEO (batch number: M14069) that was erroneously reconstituted with a sterile water instead of Men CYW-135 liquid component on 01 Nov 2014. No adverse event reported following this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022370 is an initial spontaneous report received from a medical assistant on 05 Nov 2014. This report refers to an 11 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M14056) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. It was reported that the vaccine administered reached 50 F for 30 minutes on 03 Nov 2014. No adverse events were reported following the medication error.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022371, is an initial spontaneous report from a medical assistant received on 05 Nov 2014. This report refers to a 12-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: M14056) that reached 50 F for 30 minutes intramuscularly at a dose of 0.5 ml on 03 Nov 2014 without any reports of adverse reaction.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022369 is an initial spontaneous report received from a medical assistant on 05 Nov 2014. This report refers to a 16 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M14056) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. It was reported that the vaccine administered reached 50 F for 30 minutes on 03 Nov 2014. No adverse events were reported following the inadvertent administration.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Injection site swelling, Rash
Clinical narrative: Started with swelling of R arm then progressed to Rash on the B/L arms and across the lower back.
Age: 1.11
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Developed diffuse maculo-papular rash on both anterior thighs pruritic.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, PER
Symptoms: Crying, Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 4th HIB shot cause severe allergic reaction. Causing baseball sized swelling at site of shot. Mass was very red, hot to the touch, and extremely painful for baby. He was up crying all night, had slight fever. Caused a red patchy rash to appear on abdomen last in a week.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, PER
Symptoms: Injection site warmth, Pyrexia, Rash erythematous
Clinical narrative: 4th HIB shot cause severe allergic reaction. Causing baseball sized swelling at site of shot. Mass was very red, hot to the touch, and extremely painful for baby. He was up crying all night, had slight fever. Caused a red patchy rash to appear on abdomen last in a week.
Age: 45.0
Sex: M
Vaccine: RAB
Symptoms: Anti-aquaporin-4 antibody negative, Antibody test negative, Borrelia test negative, Central nervous system lesion, Chest pain
Clinical narrative: Cannot feel heat with right leg, but extremely sensitive to cold. After 2nd Shot - Chest Pains. After 3rd Shot - Woke up at night paralyzed from mid chest down, all muscles contracting and the most unbelievable pain I have ever experienced. Lasted about 2 minutes. Eventual MRI revealed Lesions in Spinal Chord and Brain.
Age: 45.0
Sex: M
Vaccine: RAB
Symptoms: Laboratory test normal, Lumbar puncture normal, Muscle contractions involuntary, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Cannot feel heat with right leg, but extremely sensitive to cold. After 2nd Shot - Chest Pains. After 3rd Shot - Woke up at night paralyzed from mid chest down, all muscles contracting and the most unbelievable pain I have ever experienced. Lasted about 2 minutes. Eventual MRI revealed Lesions in Spinal Chord and Brain.
Age: 45.0
Sex: M
Vaccine: RAB
Symptoms: Pain, Paralysis, Temperature difference of extremities, Temperature intolerance
Clinical narrative: Cannot feel heat with right leg, but extremely sensitive to cold. After 2nd Shot - Chest Pains. After 3rd Shot - Woke up at night paralyzed from mid chest down, all muscles contracting and the most unbelievable pain I have ever experienced. Lasted about 2 minutes. Eventual MRI revealed Lesions in Spinal Chord and Brain.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient describes pain, redness, swelling, warmth, & minor itching to injection site 2 days after receiving Prevnar vaccine. She presented to Clinic and physical exam findings include normal vital signs, 7cm X10cm area of erythema, edema, and warmth.  She was diagnosed with Cellulitis of left upper arm and treatment with Cephalexin 500mg every 6 hours for 10days was initiated.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth, Oedema, Skin warm
Clinical narrative: Patient describes pain, redness, swelling, warmth, & minor itching to injection site 2 days after receiving Prevnar vaccine. She presented to Clinic and physical exam findings include normal vital signs, 7cm X10cm area of erythema, edema, and warmth.  She was diagnosed with Cellulitis of left upper arm and treatment with Cephalexin 500mg every 6 hours for 10days was initiated.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Areflexia, Asthenia, Balance disorder, CSF protein increased, Demyelination
Clinical narrative: Loss of balance. Loss of reflexes and strength in legs and hands. Pain and generalized weakness.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Nerve conduction studies abnormal, Pain, Protein total increased
Clinical narrative: Loss of balance. Loss of reflexes and strength in legs and hands. Pain and generalized weakness.
Age: 42.0
Sex: F
Vaccine: PPV, TD
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extreme redness and swelling at injection site. 05/7/16 Chills, fevers of 101.4, joint aches, soreness of arm that I could barely move it and hurt to touch from elbow to shoulder. Went to ER were they treated for possible bronchitis/pneumonia.
Age: 42.0
Sex: F
Vaccine: PPV, TD
Symptoms: Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Extreme redness and swelling at injection site. 05/7/16 Chills, fevers of 101.4, joint aches, soreness of arm that I could barely move it and hurt to touch from elbow to shoulder. Went to ER were they treated for possible bronchitis/pneumonia.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling jittery, Headache, Influenza like illness, Injection site erythema, Injection site rash
Clinical narrative: Redness/Rash/Swelling about 6 inch wide at injection site.  Flu like symptoms (jittery, headache, etc).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Redness/Rash/Swelling about 6 inch wide at injection site.  Flu like symptoms (jittery, headache, etc).
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT WOKE UP AND HAD IRRITATION AT SITE OF INJECTION. UPON INSPECTION SHE REPORTS IT WAS RED, SWOLLEN, AND ITCHY. REPORTS ONLY USING HYDROCORTISONE 1% CREAM TO RELIEVE ITCHING.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US020714, is an initial spontaneous report from a nurse received on 14 Oct 2014. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. On 14 Oct 2014, she was vaccinated an intramuscular dose of MENVEO (batch number: M14055) where MenA lyophilized conjugate component reconstituted with a sterile diluent (and not MenCWY liquid conjugate component). No adverse event was reported following this administration error (wrong solution used in drug reconstitution).
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US020847 is an initial spontaneous report received from a pharmacist on 16 Oct 2014. This case refers to a 22 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with an expired dose of MENVEO (batch number: M12098 and expiry date: not reported) intramuscularly on 16 Oct 2014. No adverse event was reported following this administration error (expired vaccine used).
Age: 0.46
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US020859, is an initial spontaneous report from a nurse received on 15 Oct 2014. This report refers to a 5 months old female neonate. Her medical history and concomitant medications were not reported. She received an intramuscular dose of MENVEO (batch number: A13047) instead of pneumococcal conjugate vaccine (manufacturer and batch number: unknown) on 14 Oct 2014. No adverse event was reported following this medication error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, Product reconstitution issue
Clinical narrative: Case number PHEH2014US021043, is a combined initial and follow-up spontaneous report from a health care professional received on 15 Oct 2014 and 20 Oct 2014. This report refers to a 12 year old male patient. His medical history and concomitant medications were not reported. He received an intramuscular dose of MENVEO, batch number: X14031) that was reconstituted improperly on 07 Oct 2014. It was reported that the nurse mixed the Men A with sterile water and then mixed the Men CYW-135 conjugate component with the Men A and water vial (inappropriate preparation of medication). The nurse administered two injections of this into the patient as two 0.5 ml dose (drug administration error). No adverse event was reported. No further information was provided.
Sex: U
Vaccine: MNQ
Symptoms: Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US021163 is an initial spontaneous report received from a pharmacist on 17 Oct 2014. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. It was reported that on an unknown date this patient received only the Men CYW-135 liquid conjugate component of MENVEO (batch number: not reported) intramuscularly and did not receive Men A powder lyophilized conjugate component. No adverse events were reported following the medication error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US021201 is an initial spontaneous report received from a healthcare professional on 21 Oct 2014, and with a follow-up received from a healthcare professional on 01 Dec 2014. This case refers to a 17 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with an expired dose of MENVEO (batch number: A13017 and expiry date: not reported), at a dose of 0.5 ml intramuscularly into left arm on11 Oct 2014 at approximately 09:30 AM. It was reported that the patient received MENVEO 14 days after expiry date. No adverse event was reported following this administration error. Follow-up received from a healthcare professional on 01 Dec 304: Patients demographics (weight and height), vaccination details (site and time) were updated.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine administered before date due.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Fatigue, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient experienced pain down arm to fingers, stiffness, limited movement and strong pain. She also experienced chills, weakness and was very fatigued. She experienced these symptoms soon after shot and for several days.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient experienced pain down arm to fingers, stiffness, limited movement and strong pain. She also experienced chills, weakness and was very fatigued. She experienced these symptoms soon after shot and for several days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Left deltoid red warm to touch and itching.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given the MENVEO "diluent" instead of the mixed concentration.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US021205 is an initial spontaneous report received from a healthcare professional on 21 Oct 2014, and with a follow-up received from a healthcare professional on 01 Dec 2014. This case refers to an 11 year old male patient. Past medical history and concomitant medication were not reported. Concurrent condition included penicillin allergy. He was vaccinated with an expired dose of MENVEO (batch number: A13017 and expiry date: not reported), at a dose of 0.5 ml intramuscularly into left arm on 18 Oct 2013 at 09:45 AM. It was reported that the patient received MENVEO 18 days after expiry date. No adverse event was reported following this administration error (expired vaccine used). Follow-up received from a healthcare professional on 01 Dec 2014: Patient's demographics (weight and height), vaccination details (site and time) and concurrent condition were updated.
Age: 0.54
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US021277, is an initial spontaneous report from a nurse received on 22 Oct 2014. This report refers to a 6-month-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was erroneously vaccinated with MENVEO (batch number: A12024) intramuscularly instead of pneumococcal conjugate vaccine (PCV) on 22 Oct 2014, without any complaints of patient harm. No adverse event was reported.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US021278 is an initial spontaneous report received from a physician on 21 Oct 2014. This report refers to a 17 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an expired dose of MENVEO (batch number: A12098/X12098, expiry date: not reported) intramuscularly on 21 Oct 2014. It was reported that the Men A lyophilized powder conjugate vial was expired, but Men CYW-135 liquid conjugate component was not expired. No adverse events were reported following the medication error.
Age: 20.0
Sex: F
Vaccine: FLU3, HEP, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US021297 is an initial spontaneous report received from a pharmacist on 20 Oct 2014 with a follow-up received from a pharmacist on 25 Nov 2014. This report refers to  20 years old female patient. Her medical history and concomitant medications were not reported. Concomitant vaccinations included FLUVIRIN (batch number: unknown) and Hep-B (batch number: AHBVC199AA, other manufacturer). She was vaccinated with an expired dose of MENVEO (batch number A13011, expiry date: Not reported) at a dose of 0.5 ml, intramuscularly on 19 Oct 2014 at 03:00 PM in error. No adverse events were reported following the inadvertent administration. Follow-up received from a pharmacist on 25 Nov 2014: Dosage of MENVEO (0.5 ml), time of vaccination (03:00 PM), and concomitant vaccinations (FLUVIRIN and Hepa-B) were updated.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH20214US021310 is an initial spontaneous report received from a nurse on 22 Oct 2014. This case refers to a 16 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with an expired dose of MENVEO (batch number: not reported), intramuscularly on 20 Oct 2014. No adverse event was reported following this administration error.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US021511, is an initial spontaneous report received from a nurse on 23 Oct 2014. This report refers to a 21 years old female patient. Past medical history and concomitant medication were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X14031), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 23 Oct 2014. No adverse event was reported following this administration error (inappropriate preparation of medication).
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US021746, is an initial spontaneous report received from a nurse on 27 Oct 2014 and with follow-up information received from a physician on 16 Dec 2014. This report refers to a 16 years old female patient. Past medical history and concomitant medication were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X14041), intramuscularly into right arm without being reconstituted with Men A lyophilized conjugate vaccine component on 27 Oct 2014 at 17:45. On an unknown date she was re administered with the vaccine correctly. No adverse event was reported following this administration error. Follow-up information received from a physician on 16 Dec 2014: Patient's demographics (height and weight), vaccination details (site and time) and revaccination details were updated. Batch number was changed to X14041 from X14030.
Age: 46.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US021798 is an initial spontaneous report received from a pharmacist on 27 Oct 2014. This case refers to a 46 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with an expired dose of MENVEO (batch number: A12119 and expiry date: not reported), intramuscularly on 24 Oct 2014. No adverse event was reported following this administration error (expired vaccine used).
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US021810, is an initial spontaneous report from a nurse received on 28 Oct 2014. This report refers to a 24-year-old male patient. Medical history and concomitant medications were not reported. On 28 Oct 2014, the patient received an intramuscular dose of MENVEO (batch number: unknown) that was reconstituted improperly. It was reported that Men A vial was mixed with a vial of sterile water for injection erroneously. No adverse event was reported following this medication error (inappropriate preparation of medication).
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US021829, is an initial spontaneous report from a nurse received on 28 Oct 2014. This report refers to female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. The patient received MENVEO (batch number: A14031) subcutaneous injection inadvertently on 17 Oct 2014. No adverse event was reported. No further information was provided.
Age: 70.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US021910, is an initial spontaneous report from a pharmacist received on 30 Oct 2014. This report refers to a 70-year-old male patient. Medical history and concomitant medications were not reported. On 29 Oct 2014, the patient received intramuscular dose of MENVEO (batch number: X12098) that was expired on 30 Jul 2014. No adverse event was reported following this medication error (expired vaccine used).
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US022000, is an initial spontaneous report received from a health care professional on 31 Oct 2014. This report refers to a 16 years old male patient. Past medical history and concomitant medication were not reported. He inadvertently received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X14069), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 28 Oct 2014. No adverse event was reported following this administration error (inappropriate preparation of medication).
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US022002, is an initial spontaneous report from a nurse received on 29 Oct 2014. This report refers to a 23-year-old male patient. Medical history and concomitant medications were not reported. His vaccination history included administration of first dose of MENVEO (batch number: unknown). On 29 Oct 2014, during second dose, the patient received only Men CWY liquid conjugate component of MENVEO (batch number: X14031) without reconstitution with Men A lyophilized component intramuscularly. No adverse event was reported following this medication error (inappropriate preparation of medication).
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US022153, is an initial spontaneous report received from a nurse received on 31 Oct 2014 and a follow up report from the nurse received on 09 Dec 3014. This report refers to an 18-year-old female patient. Medical history and concomitant medications were not reported. The patient received only 0.5 ml of Men CWY liquid component of MENVEO (batch number: X12024) without reconstitution with Men A lyophilized component intramuscularly in the right deltoid on 16 Sep 2014 at 03:30 pm. No adverse event was reported following this medication error. Follow up report from the nurse received on 09 Dec 2014: Updated MENVEO batch number (M12024 to X12024), dose, site and time of vaccination.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US022166, is an initial spontaneous report received from a pharmacist received on 01 Nov 2014. This report refers to an 18-year-old male patient. Medical history and concomitant medications were not reported. On 01 Nov 2014, the patient received MENVEO (batch number: M14022) subcutaneously. No adverse event was reported following this medication error (inappropriate route of vaccination).
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022362 is an initial spontaneous report received from a medical assistant on 05 Nov 2014. This report refers to a 26 years old female patient. Her medical history and concomitant medications were not reported. she was vaccinated with MENVEO (batch number: M14056) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. It was reported that the vaccine administered reached 50 F for 30 minutes on 03 Nov 2014. No adverse events were reported following the medication error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US016762 is an initial spontaneous report received from a nurse on 19 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. No adverse events were reported following this maladministration (inappropriate preparation of medication).
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US016774 is an initial spontaneous report received from a consumer (patient's father) on 19 Aug 2014. This report refers to a male patient whose age was not reported. His medical history and concomitant medications were not reported. He was vaccinated with a dose of MENVEO (batch number: not reported) subcutaneously on an unknown date. The patient's father stated that he was not pissed off. No adverse event was reported following the maladministration.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US016835 is an initial spontaneous report received from a nurse on 20 Aug 2014. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. It was reported that on 19 Aug 2014, the patient received an intramuscular dose of MenCYW-135 liquid component of MENVEO (batch number: M12101) without reconstituting it with Men A lyophilized conjugate. No adverse reactions were reported following the inadvertent administration. Following an internal review of the data received on 20 Aug 2014, it was identified that the event verbatim MenCYW-135 liquid component administered without Men A lyophilized conjugate was erroneously coded to incomplete course of vaccination and hence the event was now correctly recoded as inappropriate preparation of medication.