chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Areflexia, Asthenia, Blood creatinine increased, Blood thyroid stimulating hormone normal, Borrelia test
Clinical narrative: This literature report (initial receipt 07-Jun-2016) concerns a 77 year-old female patient who had chronic kidney disease stage III and hypothyroidism. On an unspecified date, the patient received influenza vaccination (manufacturer and batch number not provided). On an unspecified date, four weeks later, the patient presented with falls from generalized weakness in the setting of a diarrheal illness.  The patient developed endorsed non-bloody watery diarrhea twice a day for the past nine days, without vomiting, pain, or fever. She developed lower extremities (LE) weakness and numbness one day prior to presentation and upper extremities (UE) weakness and difficulty with silverware on the day of presentation. Examination revealed normal vital signs, non-tender abdomen, decreased extremity sensation, decreased strength (plantar flexion R 3/5, L 2/5; dorsiflexion R 1/5, L 0/5; straight leg raise both 2-3/5; hand grip both 2-3/5; triceps both 2/5; and biceps both 3/5), and areflexia. Laboratory results showed leukocytes 6.4,000 /uL, hemoglobin 10.3 g/ dL, platelets 475,000/uL, creatinine 1.23 mg/dL, and normal TSH, B12 and Lyme reflex. Stool cultures grew Salmonella group D. Spine magnetic resonance imaging showed degenerative changes without compression. Lumbar puncture was performed given suspicion for Guillain-Barre syndrome (GBS). Cerebral spinal fluid (CSF) analysis revealed normal results with protein 36 mg/dL and nucleated cells 1 /uL. Antibiotics were held as diarrhea resolved shortly after admission. Five days of empiric IVIG (intravenous immunoglobulin) treatment led to improvement in neurologic exam (3/5 in LE, 4/5 in UE). CSF eventually returned positive for oligoclonal bands, consistent with GBS. Nerve conduction studies (NCS) were scheduled as an outpatient. The outcome was not reported (recovered for salmonellosis and diarrhea). Reporter comments: The authors reported that the trigger for her GBS was likely her antecedent Salmonella infection. Sender's Comments: Listedness: Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine GBS and associated neurological events are listed. Falls and generalised weakness are unlisted as they are complication of GBS.  Spinal (intervertebral degenerative) changes, salmonellosis and all l haematological abnormality (low haemoglobin platelet count) are unlisted.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: CSF cell count normal, CSF oligoclonal band present, CSF protein normal, Diarrhoea, Fall
Clinical narrative: This literature report (initial receipt 07-Jun-2016) concerns a 77 year-old female patient who had chronic kidney disease stage III and hypothyroidism. On an unspecified date, the patient received influenza vaccination (manufacturer and batch number not provided). On an unspecified date, four weeks later, the patient presented with falls from generalized weakness in the setting of a diarrheal illness.  The patient developed endorsed non-bloody watery diarrhea twice a day for the past nine days, without vomiting, pain, or fever. She developed lower extremities (LE) weakness and numbness one day prior to presentation and upper extremities (UE) weakness and difficulty with silverware on the day of presentation. Examination revealed normal vital signs, non-tender abdomen, decreased extremity sensation, decreased strength (plantar flexion R 3/5, L 2/5; dorsiflexion R 1/5, L 0/5; straight leg raise both 2-3/5; hand grip both 2-3/5; triceps both 2/5; and biceps both 3/5), and areflexia. Laboratory results showed leukocytes 6.4,000 /uL, hemoglobin 10.3 g/ dL, platelets 475,000/uL, creatinine 1.23 mg/dL, and normal TSH, B12 and Lyme reflex. Stool cultures grew Salmonella group D. Spine magnetic resonance imaging showed degenerative changes without compression. Lumbar puncture was performed given suspicion for Guillain-Barre syndrome (GBS). Cerebral spinal fluid (CSF) analysis revealed normal results with protein 36 mg/dL and nucleated cells 1 /uL. Antibiotics were held as diarrhea resolved shortly after admission. Five days of empiric IVIG (intravenous immunoglobulin) treatment led to improvement in neurologic exam (3/5 in LE, 4/5 in UE). CSF eventually returned positive for oligoclonal bands, consistent with GBS. Nerve conduction studies (NCS) were scheduled as an outpatient. The outcome was not reported (recovered for salmonellosis and diarrhea). Reporter comments: The authors reported that the trigger for her GBS was likely her antecedent Salmonella infection. Sender's Comments: Listedness: Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine GBS and associated neurological events are listed. Falls and generalised weakness are unlisted as they are complication of GBS.  Spinal (intervertebral degenerative) changes, salmonellosis and all l haematological abnormality (low haemoglobin platelet count) are unlisted.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Grip strength decreased, Guillain-Barre syndrome, Haemoglobin decreased, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: This literature report (initial receipt 07-Jun-2016) concerns a 77 year-old female patient who had chronic kidney disease stage III and hypothyroidism. On an unspecified date, the patient received influenza vaccination (manufacturer and batch number not provided). On an unspecified date, four weeks later, the patient presented with falls from generalized weakness in the setting of a diarrheal illness.  The patient developed endorsed non-bloody watery diarrhea twice a day for the past nine days, without vomiting, pain, or fever. She developed lower extremities (LE) weakness and numbness one day prior to presentation and upper extremities (UE) weakness and difficulty with silverware on the day of presentation. Examination revealed normal vital signs, non-tender abdomen, decreased extremity sensation, decreased strength (plantar flexion R 3/5, L 2/5; dorsiflexion R 1/5, L 0/5; straight leg raise both 2-3/5; hand grip both 2-3/5; triceps both 2/5; and biceps both 3/5), and areflexia. Laboratory results showed leukocytes 6.4,000 /uL, hemoglobin 10.3 g/ dL, platelets 475,000/uL, creatinine 1.23 mg/dL, and normal TSH, B12 and Lyme reflex. Stool cultures grew Salmonella group D. Spine magnetic resonance imaging showed degenerative changes without compression. Lumbar puncture was performed given suspicion for Guillain-Barre syndrome (GBS). Cerebral spinal fluid (CSF) analysis revealed normal results with protein 36 mg/dL and nucleated cells 1 /uL. Antibiotics were held as diarrhea resolved shortly after admission. Five days of empiric IVIG (intravenous immunoglobulin) treatment led to improvement in neurologic exam (3/5 in LE, 4/5 in UE). CSF eventually returned positive for oligoclonal bands, consistent with GBS. Nerve conduction studies (NCS) were scheduled as an outpatient. The outcome was not reported (recovered for salmonellosis and diarrhea). Reporter comments: The authors reported that the trigger for her GBS was likely her antecedent Salmonella infection. Sender's Comments: Listedness: Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine GBS and associated neurological events are listed. Falls and generalised weakness are unlisted as they are complication of GBS.  Spinal (intervertebral degenerative) changes, salmonellosis and all l haematological abnormality (low haemoglobin platelet count) are unlisted.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Neurological examination abnormal, Nuclear magnetic resonance imaging spinal abnormal, Platelet count increased, Red blood cell nucleated morphology present
Clinical narrative: This literature report (initial receipt 07-Jun-2016) concerns a 77 year-old female patient who had chronic kidney disease stage III and hypothyroidism. On an unspecified date, the patient received influenza vaccination (manufacturer and batch number not provided). On an unspecified date, four weeks later, the patient presented with falls from generalized weakness in the setting of a diarrheal illness.  The patient developed endorsed non-bloody watery diarrhea twice a day for the past nine days, without vomiting, pain, or fever. She developed lower extremities (LE) weakness and numbness one day prior to presentation and upper extremities (UE) weakness and difficulty with silverware on the day of presentation. Examination revealed normal vital signs, non-tender abdomen, decreased extremity sensation, decreased strength (plantar flexion R 3/5, L 2/5; dorsiflexion R 1/5, L 0/5; straight leg raise both 2-3/5; hand grip both 2-3/5; triceps both 2/5; and biceps both 3/5), and areflexia. Laboratory results showed leukocytes 6.4,000 /uL, hemoglobin 10.3 g/ dL, platelets 475,000/uL, creatinine 1.23 mg/dL, and normal TSH, B12 and Lyme reflex. Stool cultures grew Salmonella group D. Spine magnetic resonance imaging showed degenerative changes without compression. Lumbar puncture was performed given suspicion for Guillain-Barre syndrome (GBS). Cerebral spinal fluid (CSF) analysis revealed normal results with protein 36 mg/dL and nucleated cells 1 /uL. Antibiotics were held as diarrhea resolved shortly after admission. Five days of empiric IVIG (intravenous immunoglobulin) treatment led to improvement in neurologic exam (3/5 in LE, 4/5 in UE). CSF eventually returned positive for oligoclonal bands, consistent with GBS. Nerve conduction studies (NCS) were scheduled as an outpatient. The outcome was not reported (recovered for salmonellosis and diarrhea). Reporter comments: The authors reported that the trigger for her GBS was likely her antecedent Salmonella infection. Sender's Comments: Listedness: Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine GBS and associated neurological events are listed. Falls and generalised weakness are unlisted as they are complication of GBS.  Spinal (intervertebral degenerative) changes, salmonellosis and all l haematological abnormality (low haemoglobin platelet count) are unlisted.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Salmonella test positive, Salmonellosis, Sensory disturbance, Spinal osteoarthritis, Vitamin B12
Clinical narrative: This literature report (initial receipt 07-Jun-2016) concerns a 77 year-old female patient who had chronic kidney disease stage III and hypothyroidism. On an unspecified date, the patient received influenza vaccination (manufacturer and batch number not provided). On an unspecified date, four weeks later, the patient presented with falls from generalized weakness in the setting of a diarrheal illness.  The patient developed endorsed non-bloody watery diarrhea twice a day for the past nine days, without vomiting, pain, or fever. She developed lower extremities (LE) weakness and numbness one day prior to presentation and upper extremities (UE) weakness and difficulty with silverware on the day of presentation. Examination revealed normal vital signs, non-tender abdomen, decreased extremity sensation, decreased strength (plantar flexion R 3/5, L 2/5; dorsiflexion R 1/5, L 0/5; straight leg raise both 2-3/5; hand grip both 2-3/5; triceps both 2/5; and biceps both 3/5), and areflexia. Laboratory results showed leukocytes 6.4,000 /uL, hemoglobin 10.3 g/ dL, platelets 475,000/uL, creatinine 1.23 mg/dL, and normal TSH, B12 and Lyme reflex. Stool cultures grew Salmonella group D. Spine magnetic resonance imaging showed degenerative changes without compression. Lumbar puncture was performed given suspicion for Guillain-Barre syndrome (GBS). Cerebral spinal fluid (CSF) analysis revealed normal results with protein 36 mg/dL and nucleated cells 1 /uL. Antibiotics were held as diarrhea resolved shortly after admission. Five days of empiric IVIG (intravenous immunoglobulin) treatment led to improvement in neurologic exam (3/5 in LE, 4/5 in UE). CSF eventually returned positive for oligoclonal bands, consistent with GBS. Nerve conduction studies (NCS) were scheduled as an outpatient. The outcome was not reported (recovered for salmonellosis and diarrhea). Reporter comments: The authors reported that the trigger for her GBS was likely her antecedent Salmonella infection. Sender's Comments: Listedness: Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine GBS and associated neurological events are listed. Falls and generalised weakness are unlisted as they are complication of GBS.  Spinal (intervertebral degenerative) changes, salmonellosis and all l haematological abnormality (low haemoglobin platelet count) are unlisted.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: White blood cell count increased
Clinical narrative: This literature report (initial receipt 07-Jun-2016) concerns a 77 year-old female patient who had chronic kidney disease stage III and hypothyroidism. On an unspecified date, the patient received influenza vaccination (manufacturer and batch number not provided). On an unspecified date, four weeks later, the patient presented with falls from generalized weakness in the setting of a diarrheal illness.  The patient developed endorsed non-bloody watery diarrhea twice a day for the past nine days, without vomiting, pain, or fever. She developed lower extremities (LE) weakness and numbness one day prior to presentation and upper extremities (UE) weakness and difficulty with silverware on the day of presentation. Examination revealed normal vital signs, non-tender abdomen, decreased extremity sensation, decreased strength (plantar flexion R 3/5, L 2/5; dorsiflexion R 1/5, L 0/5; straight leg raise both 2-3/5; hand grip both 2-3/5; triceps both 2/5; and biceps both 3/5), and areflexia. Laboratory results showed leukocytes 6.4,000 /uL, hemoglobin 10.3 g/ dL, platelets 475,000/uL, creatinine 1.23 mg/dL, and normal TSH, B12 and Lyme reflex. Stool cultures grew Salmonella group D. Spine magnetic resonance imaging showed degenerative changes without compression. Lumbar puncture was performed given suspicion for Guillain-Barre syndrome (GBS). Cerebral spinal fluid (CSF) analysis revealed normal results with protein 36 mg/dL and nucleated cells 1 /uL. Antibiotics were held as diarrhea resolved shortly after admission. Five days of empiric IVIG (intravenous immunoglobulin) treatment led to improvement in neurologic exam (3/5 in LE, 4/5 in UE). CSF eventually returned positive for oligoclonal bands, consistent with GBS. Nerve conduction studies (NCS) were scheduled as an outpatient. The outcome was not reported (recovered for salmonellosis and diarrhea). Reporter comments: The authors reported that the trigger for her GBS was likely her antecedent Salmonella infection. Sender's Comments: Listedness: Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine GBS and associated neurological events are listed. Falls and generalised weakness are unlisted as they are complication of GBS.  Spinal (intervertebral degenerative) changes, salmonellosis and all l haematological abnormality (low haemoglobin platelet count) are unlisted.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pallor, Seizure
Clinical narrative: Initial unsolicited report received from nurse via other company (Pfizer) (manufacturer report number -2016273237) on 30 May 2016. This case involves a 16-year-old female patient who was vaccinated with a dose of MENACTRA (batch number, expiry date, dose, route of administration not reported) in the right arm and TRUMENBA (batch number, expiry date, dose, route of administration not reported) in the left arm on unspecified date. The patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient experienced seizure and loss of color. Lab data and corrective treatment were not reported. The outcome of events was not reported. Upon internal review, the case was considered as serious due to important medical event: seizure. List of documents held by sender: none. Sender's Comments: A 16-year-old female patient developed seizure with loss of color following vaccination with TRUMENBA and MENACTRA. The exact date of vaccination and date of event are unknown and also patient had two vaccines on the same day. Further information on patient's medical history, family history, investigation results ruling out a concurrent infection, etc. are needed to further assess the case. However, as two vaccines were administered concomitantly, the role of each component cannot be assessed.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Localized swelling, redness, and ache in right shoulder.
Age: 18.0
Sex: M
Vaccine: HPV9, MMR, TDAP, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: After administration it was identified that Tdap was given instead of HBV.  No adverse reaction.
Age: 56.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US001614 is an initial spontaneous report received from a pharmacist on 15 Jan 2013. This report refers to a 56-year-old female patient. The patient received expired MENVEO (batch number: A10047, expiration date: Dec 2012) intramuscularly on 13 Jan 2013. No adverse events were reported. No other information was available at the time of this report.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2013US002487, is an initial spontaneous report received from a healthcare professional on 23 Jan 2013: This case refers to a multiple patients (3- patients). These patients may have received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M11081) intramuscularly without being reconstituted with Men A component on an unspecified date. No adverse reaction reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US021639 is an initial spontaneous report received from a pharmacist on 23 Oct 2012. This report refers to a patient whose identifiers were not reported. The patient was vaccinated with 0.5 ml intramuscular dose of MenA lyophilized conjugate component of MENVEO (batch number: not reported) reconstituted with sterile water, instead of MenCWY liquid conjugate component on an unknown date. No adverse reaction was reported.
Age: 48.0
Sex: F
Vaccine: MNQ
Symptoms: Immunisation, No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2012US023531 is a spontaneous report initially received from a nurse on 27 Nov 2012 with a follow-up received on 03 Dec 2012: This case refers to a 48-year-old female patient. She was vaccinated only with the MenCYW-135 component of MENVEO (batch number: X12013) intramuscularly on 21 Nov 2012. No adverse event was reported following this drug administration error. She was vaccinated with another complete dose of MENVEO on an unspecified date. No other information was available. Follow-up received from the nurse on 03 Dec 2012: Updated re-vaccination information with MENVEO.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US018500 is an initial spontaneous report received from a healthcare professional on 05 Sep 2012: This case refers to an unspecified age and gender patient. The patient was received only Men A component of MENVEO (batch number: unknown) reconstituted with sterile water on an unspecified date. The patient was not re-vaccinated. No adverse reaction reported following this administration error.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site 10 x 4.5 cm. Oral BENADRYL, cool compresses.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from physician via other company (Pfizer, under the reference number 2016268466) on 26 May 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of TETANUS TOXOID ADSORBED (batch number, expiry date, route and site of administration was not reported), on unspecified date. The patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient developed allergy to vaccine. Lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dry mouth, Dyspnoea, Feeling hot, Gait disturbance, Pain in extremity
Clinical narrative: Felt warm about 3 hours later, dry mouth, then dyspnea, then legs were very sore. Dyspnea has resolved. Legs improved (still sore, but able to walk, but with some difficulty). T-102 at home about 4 hrs post vaccine. Tylenol given. Felt dizzy, but no LOC.   Patient to call with progress report later today.   Patient had same reaction with first dose, sent to ER, unsure of outcome or if reported to VAERS.   Patient only mentioned fever at this visit.  Did not mention any other side effects until after the reactions occurred today.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Felt warm about 3 hours later, dry mouth, then dyspnea, then legs were very sore. Dyspnea has resolved. Legs improved (still sore, but able to walk, but with some difficulty). T-102 at home about 4 hrs post vaccine. Tylenol given. Felt dizzy, but no LOC.   Patient to call with progress report later today.   Patient had same reaction with first dose, sent to ER, unsure of outcome or if reported to VAERS.   Patient only mentioned fever at this visit.  Did not mention any other side effects until after the reactions occurred today.
Age: 0.45
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abnormal behaviour, Bronchiolitis, Crying, Diet refusal, Fluid intake reduced
Clinical narrative: AS SOON AS SHE GAVE HIM THE VACCINE, HIS LEG BULDGED UP, TURNED PURPLE, AND HAD A RASH AROUND IT. NURSE SAID IT WAS NORMAL. THEN, HE CRIED FOR 2 DAYS WITH NO RELIEF FROM TYLENOL OR IBUPROFEN. I CALLED THEIR CLINIC AND THEY WANTED ME TO TAKE HIM BACK BUT I WOULD NOT GO BACK TO THEM BECAUSE OF WHAT THEY DID TO MY SON. HE WOULDN'T EAT, HE WOULDN'T DRINK FOR FIRST COUPLE OF DAYS, HE STOPPED CRAWLING AND SITTING UP BY HIMSELF. THE DOCTOR'S AT THE HOSPITAL WANTED ME TO TAKE HIM TO A NEUROLOGIST IN ANOTHER CITY FOR HIS NEW CONDITION. HE ALSO WAS HOSPITALIZED BECAUSE HE HAD LOW BREATHING LEVELS WHICH THEY CLASSIFIED AS RSV AND BRONCHIOLITIS.
Age: 0.45
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site discolouration, Injection site rash, Injection site swelling, Mobility decreased, Respiration abnormal
Clinical narrative: AS SOON AS SHE GAVE HIM THE VACCINE, HIS LEG BULDGED UP, TURNED PURPLE, AND HAD A RASH AROUND IT. NURSE SAID IT WAS NORMAL. THEN, HE CRIED FOR 2 DAYS WITH NO RELIEF FROM TYLENOL OR IBUPROFEN. I CALLED THEIR CLINIC AND THEY WANTED ME TO TAKE HIM BACK BUT I WOULD NOT GO BACK TO THEM BECAUSE OF WHAT THEY DID TO MY SON. HE WOULDN'T EAT, HE WOULDN'T DRINK FOR FIRST COUPLE OF DAYS, HE STOPPED CRAWLING AND SITTING UP BY HIMSELF. THE DOCTOR'S AT THE HOSPITAL WANTED ME TO TAKE HIM TO A NEUROLOGIST IN ANOTHER CITY FOR HIS NEW CONDITION. HE ALSO WAS HOSPITALIZED BECAUSE HE HAD LOW BREATHING LEVELS WHICH THEY CLASSIFIED AS RSV AND BRONCHIOLITIS.
Age: 0.45
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Respiratory syncytial virus bronchiolitis
Clinical narrative: AS SOON AS SHE GAVE HIM THE VACCINE, HIS LEG BULDGED UP, TURNED PURPLE, AND HAD A RASH AROUND IT. NURSE SAID IT WAS NORMAL. THEN, HE CRIED FOR 2 DAYS WITH NO RELIEF FROM TYLENOL OR IBUPROFEN. I CALLED THEIR CLINIC AND THEY WANTED ME TO TAKE HIM BACK BUT I WOULD NOT GO BACK TO THEM BECAUSE OF WHAT THEY DID TO MY SON. HE WOULDN'T EAT, HE WOULDN'T DRINK FOR FIRST COUPLE OF DAYS, HE STOPPED CRAWLING AND SITTING UP BY HIMSELF. THE DOCTOR'S AT THE HOSPITAL WANTED ME TO TAKE HIM TO A NEUROLOGIST IN ANOTHER CITY FOR HIS NEW CONDITION. HE ALSO WAS HOSPITALIZED BECAUSE HE HAD LOW BREATHING LEVELS WHICH THEY CLASSIFIED AS RSV AND BRONCHIOLITIS.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2012US022481 is an initial spontaneous report received from a medical assistant on 09 Nov 2012. This report refers to a male patient whose age was not reported. It was reported that he received only the MenCYW-135 liquid conjugate of MENVEO (batch number: X10133, expiry date: Sep 2013) intramuscularly and did not receive the MenA lyophilized conjugate vaccine component on 08 Nov 2012. No adverse reaction was reported.
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2012US022485 is an initial spontaneous report received from a pharmacist on 09 Nov 2012: This report refers to an adult male patient. He was given only MenCYW lyophilized conjugate component of MENVEO (batch number: X11082) intramuscularly on 09 Nov 2012 without being re-constituted with MenA. No adverse event was reported following this administration error.
Age: 42.0
Sex: M
Vaccine: MNQ
Symptoms: Injury associated with device, No adverse event
Clinical narrative: Case number PHEH2012US022503, is an initial spontaneous report received from a medical assistant on 12 Nov 2012. This report refers to 42 year old male patient. Medical assistant stated that after drawing up a dose of MENVEO (batch number: M111082) on 12 Nov 2012, the physician accidentally dropped the syringe and the needle stuck into his arm. None of the vaccine was administered to the physician or the patient. No adverse reaction was reported.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US018709, is an initial spontaneous report received from a physician on 05 Sep 2012. This report refers to an adult male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: unknown). The patient received only the lyophilized A powder component mixed with sterile water instead of CYW-135 liquid. No adverse event was reported.
Age: 17.0
Sex: M
Vaccine: FLUX, HPV4, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US018679 is an initial spontaneous report received from a health care professional on 05 Sep 2012 with a follow up information received on 16 Oct 2012: This report refers to a 17-year-old male patient. His vaccination history included administration of MENVEO (batch number: not reported) on 16 Dec 2007 which was well tolerated. His concomitant medications included influenza vaccine (unknown manufacturer, batch number: 44531AA) and GARDASIL (unknown manufacturer, batch number: H009746) at doses of 0.5 ml intramuscularly on 04 Sep 2012. He was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly on to right arm on 04 Sep 2012. This vaccine had reached up to 11 degree Celsius for 30 to 60 minutes due to power outage. It was reported that vaccine was stable and was okay to administer. No adverse event was reported following this administration error. Follow up information received on 16 Oct 2012: Patient demographics (height and weight), vaccination history, concomitant vaccines and route and site of suspect vaccine updated.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US003644, is an initial spontaneous report received from a nurse on 08 Feb 2013. This report refers to 17-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: unknown) IM dose on 05 Feb 2013. She received MenCYW liquid conjugate component only, instead of being reconstituted with MenA. No adverse reaction was reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US004035 is an initial spontaneous report received from a nurse on 13 Feb 2013. This report refers to 2 patients whose identifiers were not reported. It was reported that on 11 Feb 2013, one of the two possible patients might have received only the MenCYW-135 liquid component of MENVEO (batch number: M11042). The reporter was unsure which patient received the appropriate dose or just the liquid component. No adverse events were reported. No further information was provided.
Age: 54.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site mass
Clinical narrative: Case number PHEH2012US025492 is an initial spontaneous report received from a pharmacist on 26 Dec 2012: This report refers to a 54-year-old female patient. She was vaccinated with MENVEO (batch number: M10051) intramuscularly in to the right arm on 12 Oct 2012. She developed a lump in the right arm where the vaccine was given. The onset time and date for the reaction was not reported. No further information about seriousness, outcome and causality was available.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2013US002672 is an initial spontaneous report received from a pharmacist on 29 Jan 2013. This report refers to a 12-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A11052) intramuscularly on 16 Jan 2013. It was reported that on the same date, right after administration, he developed redness and swelling at injection site. He was given two rounds of unspecified antibiotic by a physician and the area was still red and slightly swollen. No further information was provided.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US025103 is an initial spontaneous report received from a pharmacist on 11 Dec 2012 with follow-up received on 20 Jan 2013. The report refers to an 11-year-old male patient. The patient's vaccination history included vaccination with MENVEO and was well tolerated. He was vaccinated only with MenCYW-135 component of MENVEO 0.5 ml (batch number: M10051, expiration date: Jan 2013) intramuscularly on left arm on 11 Dec 2012. Upon follow-up, parent information of incomplete vaccination and recommended repeat dose. No adverse events were reported. No further information was available. Follow-up received from a pharmacist on 20 Jan 2013. Therapy details, vaccination history and narrative updated.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US024945, is an initial spontaneous report received from a nurse on 17 Dec 2912 with a follow-up received on 08 Jan 2013. This report refers to a 12 year old female patient. Her medical history and concomitant medication as not reported. She was vaccinated with MENVEO (batch number: X11047) intramuscularly in to the left deltoid on 17 Dec 2012. The patient received only Men CYW only. The CDC confirmed that the child received partial dose of MENVEO; however no harm would come to the patient by receiving only the liquid component of the vaccine. No adverse event was reported. Follow-up received from the nurse on 08 Jan 2013: Updated site of vaccination and comment from CDC.
Age: 73.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2012US022257 is an initial spontaneous report received from a pharmacist on 07 Nov 2012. This report refers to a 74-years-old male patient. He was vaccinated with MENVEO (batch number: A10062) intramuscularly on 25 May 2012. No adverse events were reported following the inadvertent administration.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US024924 is an initial spontaneous report received from a nurse on 14 Dec 2012: This case refers to a 17-years-old male patient. He was received only Men C,Y,W-135 liquid conjugate component of MENVEO vaccine (batch number: M12009), intramuscularly without being reconstituted with Men A component on 12 Dec 2012. No adverse reaction reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US024845 is an initial spontaneous report received from a medical assistant on 14 Dec 2012: This case refers to an unspecified age and gender patient. This patient was inadvertently received only Men A lyophilized conjugate component of MENVEO (batch number: unknown) reconstituted with sterile water intramuscularly on 11 Dec 2012. No adverse reaction reported following this administration error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US015828 is an initial spontaneous report received refers to a patient of an 18-year-old male patient. He was given only the MenA powder component of MENVEO vaccine (batch number M11047 and expiry date: Apr 2014) reconstituted with sterile water on 24 Jul 2012. He was revaccinated with the correctly reconstituted MENVEO (batch number: M11051) on 25 Jul 2012. No other adverse reaction was reported following this administration error. Follow-up received from the nurse on 28 Aug 2012: Updated date of revaccination and batch number of MENVEO.
Age: 74.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2012US017217 is an initial spontaneous report received from a nurse on 28 Aug 2012. This case refers to a 74-year-old male patient. This elderly male patient was vaccinated with MENVEO (batch number: not reported) intramuscularly on 25 Aug 2012. No adverse event was reported. No other information was available.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Chills, Dizziness, Feeling hot, Nausea
Clinical narrative: After dinner patient started to feel nauseous and warm, later that evening she developed a high fever (Mom did not take), chills, dizziness and weakness. Mom did pack her in ice to bring the fever down and gave Motrin. In the morning she was still feeling weak, dizzy, running a fever of 101.6 now even with Motrin in her and nauseated. Mom giving fluids and fever reducers as needed.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: After dinner patient started to feel nauseous and warm, later that evening she developed a high fever (Mom did not take), chills, dizziness and weakness. Mom did pack her in ice to bring the fever down and gave Motrin. In the morning she was still feeling weak, dizzy, running a fever of 101.6 now even with Motrin in her and nauseated. Mom giving fluids and fever reducers as needed.
Age: 0.52
Sex: M
Vaccine: 6VAX-F
Symptoms: Anger, Crying, Diet refusal, Mood altered, Muscle tightness
Clinical narrative: Fever of 104.3, incessant crying and buckling of muscles.  Child was angry, would not eat, terribly temperamental for the week following.  I did not think I brought the same child home it was so bad.  Sitter even refused to continue watching him.  A week later, he was back to his normal self.  Granted this is minor in the realm of things but I want it noted as it was a drastic change in health and behavior following that specific vaccination set
Age: 0.52
Sex: M
Vaccine: 6VAX-F
Symptoms: Pyrexia
Clinical narrative: Fever of 104.3, incessant crying and buckling of muscles.  Child was angry, would not eat, terribly temperamental for the week following.  I did not think I brought the same child home it was so bad.  Sitter even refused to continue watching him.  A week later, he was back to his normal self.  Granted this is minor in the realm of things but I want it noted as it was a drastic change in health and behavior following that specific vaccination set
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Father states patient reported left arm at the site of the injections was red, swollen to the size of a baseball, tender to touch, itching and burning, hot to touch and a rash around the injection site.  Denies fever.  Symptoms began 6/14/2016, went to ED night of 6/15/2016.  Per father, MD in the ED diagnosed patient with a staph infection.  Prescribed Bactrim for 10 days and instructed patient to wear a sling to help with swelling.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Staphylococcal infection
Clinical narrative: Father states patient reported left arm at the site of the injections was red, swollen to the size of a baseball, tender to touch, itching and burning, hot to touch and a rash around the injection site.  Denies fever.  Symptoms began 6/14/2016, went to ED night of 6/15/2016.  Per father, MD in the ED diagnosed patient with a staph infection.  Prescribed Bactrim for 10 days and instructed patient to wear a sling to help with swelling.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction
Clinical narrative: On way back home, 30 minutes after vax, had anaphylactic reaction and taken to hospital. Received steroids and epinephrine. Stayed overnight went to doctor for follow-up on 6/6.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster disseminated, Herpes zoster infection neurological, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative, and refers to an elderly male patient in his 70's or older. Concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, lot and expiration date were not provided) by "injection" route). There were no concomitant medications and co-suspect therapies reported. On an unknown date, after the vaccination with ZOSTAVAX, the patient developed shingles in his eye, herpes zoster disseminated and herpes zoster infection neurological (reported as "spread to the optic nerve and brain). A year later, on an unspecified date, the patient died. It was unknown if an autopsy was performed. The outcome of ophthalmic herpes zoster, herpes zoster disseminated and herpes zoster infection neurological were unknown. The causality between the events and the use of ZOSTAVAX was not reported. Upon internal review, the events of ophthalmic herpes zoster, herpes zoster disseminated, herpes zoster infection neurological and death were considered medically significant. Additional information is not expected due to permission to contact the reporter was not granted.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US018710, is an initial spontaneous report received from a physician on 05 Sep 2012. This report refers to an adult male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: unknown) on unspecified date. The patient was vaccinated with only CYW-135 liquid conjugate, lyophilized A powder component was not received. No adverse event was reported.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2012US021697, is a combined initial and follow up spontaneous report received from a nurse on 29 Oct 2012. This report refers to a 12 year old male patient. He was vaccinated with the first dose of MENVEO (batch number: A10133, expiry date: Feb 2013) intramuscular on 18 Oct 2012 and inadvertently received a second dose of MENVEO (batch number: A11051, expiry date: Apr 2014) on 26 Oct 2012. No adverse event was reported following administration.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Ear discomfort, Malaise, Nausea, Syncope, Tinnitus
Clinical narrative: Reported ringing/popping in ears and not feeling well; reached parking lot and reported still not feeling well but couldn't describe how feeling. He reported nausea and fuzzy vision. Ended up fainting in parking lot of doctors clinic.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Vision blurred
Clinical narrative: Reported ringing/popping in ears and not feeling well; reached parking lot and reported still not feeling well but couldn't describe how feeling. He reported nausea and fuzzy vision. Ended up fainting in parking lot of doctors clinic.
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMRV, MMRV
Symptoms: Abscess neck, Cough, Dysphagia, Injection site abscess, Pruritus
Clinical narrative: After receiving the ProQuad vaccine 0.5 ml on right thigh, patient started scratching palm of hands and saying that the bottom of feet were itching bad.  Started coughing and trouble swallowing.  Rash appeared all over body. Abscess started appearing on right leg and right side of neck and ear. Was given 5ml tsp of Benadryl then 0.15 ml of Epinephrine injection was administered on right arm by Dr.  Patient was given water and vitals were taken.  He was kept in the clinic for 3 hours until he was stable.
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMRV, MMRV
Symptoms: Rash generalised, Subcutaneous abscess
Clinical narrative: After receiving the ProQuad vaccine 0.5 ml on right thigh, patient started scratching palm of hands and saying that the bottom of feet were itching bad.  Started coughing and trouble swallowing.  Rash appeared all over body. Abscess started appearing on right leg and right side of neck and ear. Was given 5ml tsp of Benadryl then 0.15 ml of Epinephrine injection was administered on right arm by Dr.  Patient was given water and vitals were taken.  He was kept in the clinic for 3 hours until he was stable.
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMRV, MMRV
Symptoms: Dysphagia, Immediate post-injection reaction, Pruritus generalised, Rash generalised
Clinical narrative: After receiving the ProQuad vaccine 0.5 ml on right thigh, patient started scratching palm of hands and saying that the bottom of feet were itching bad.  Started coughing and trouble swallowing.  Rash appeared all over body. Abscess started appearing on right leg and right side of neck and ear. Was given 5ml tsp of Benadryl then 0.15 ml of Epinephrine injection was administered on right arm by Dr.  Patient was given water and vitals were taken.  He was kept in the clinic for 3 hours until he was stable.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dysmorphism, Hyperhidrosis, Joint contracture, Loss of consciousness, Pallor
Clinical narrative: Convulsive syncope. After vaccine was given patient became pallor in color, diaphoretic, face twisted, hands clenched, urinated on herself and then passed out on the examination table.  LOC for less than 1 minute.  Was able to respond to questions.  Vital signs stable. Cold packs placed on her forehead and back of neck.  Child was AAOX3 at time of discharge from office with no residual affects.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Convulsive syncope. After vaccine was given patient became pallor in color, diaphoretic, face twisted, hands clenched, urinated on herself and then passed out on the examination table.  LOC for less than 1 minute.  Was able to respond to questions.  Vital signs stable. Cold packs placed on her forehead and back of neck.  Child was AAOX3 at time of discharge from office with no residual affects.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Malaise, Nausea, Pain in extremity, Somnolence
Clinical narrative: Extreme pain at injection site moving down that same arm. Nausea. Sleepiness. General malaise.
Age: 1.37
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Febrile convulsion, Pyrexia
Clinical narrative: Diarrhea and fever of 101F started 6/14/16 around 11:30pm. Had Febrile seizure this am.  Seen in local ER.
Age: 1.21
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Decreased activity, Injection site reaction, Weight bearing difficulty
Clinical narrative: Infant not as physically active as prior to vaccination, favored left side not want to put full weight on the leg that was vaccinated.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2012US017116 is an initial spontaneous report received from a nurse on 29 Aug 2012. This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A11052, and expiry date: Mar 2014) 0.5 ml intramuscularly on 27 Aug 2012. On unspecified date the patient had injection site reaction. The injection site was raised, hard, sore, red and swollen. The outcome was not reported.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2012US017119 is an initial spontaneous report received from a nurse on 29 Aug 2012. This report refers to a 12-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11052, and expiry date: Mar 2014) 0.5 ml intramuscularly on 27 Aug 2012. On unspecified date the patient had injection site reaction. The injection site was raised, hard, sore, red and swollen. The outcome was not reported.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US021213 is an initial spontaneous report received from a pharmacist on 15 Oct 2012. This case refers to an unspecified age and gender patient. The patient was received only Men A component of MENVEO (batch number: unknown) intramuscularly, reconstituted with sterile water on 15 Oct2012. The patient did not receive Men C, Y, W-135 liquid conjugate component of MENVEO. No adverse reaction reported following this maladministration error.
Sex: U
Vaccine: MNQ
Symptoms: Product reconstitution issue
Clinical narrative: Case number PHEH2012US021245 is an initial spontaneous report received from a medical assistant on 10 Oct 2012. This case refers to multiple patients (3 patients). There were total five patients who were vaccinated with MENVEO (batch number: not reported) on unspecified dates. Three out of these five patients received only the lyophilize powder A with a sterile diluent. It was not known which of these five patients received only the lyophilized powder component of MENVEO. No other information was available.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US021376 is an initial spontaneous report from nurse received on 18 Oct 2012 with a follow up information received on 18 Oct 2012. This case refers to an adult male patient. The patient received MENVEO (batch number: M12010, expiry date: 20 Feb 2014) intramuscularly on 15 Oct 2010. The patient received only the MenA lyophilized conjugate vaccine component of MENVEO reconstituted with sterile water. The patient did not receive the MenCYW-135 liquid conjugate vaccine component of the MENVEO. No adverse reaction had occurred.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US021502 is an initial spontaneous report received from a pharmacist on 23 Oct 2012: This report refers to a patient of unknown age group and gender. This patient was given MenA lyophilized conjugate component of MENVEO (batch number: unknown) intramuscularly reconstituted with sterile water, instead of MenCYW component on an unspecified date. No adverse event was reported following this administration error (wrong solution used in drug reconstitution).