chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Laboratory test, Lymphocyte percentage increased, Pneumonia, Pneumothorax, Streptococcus test positive
Clinical narrative: This is an spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 3-year-old child (gender unknown) received a dose of PREVNAR 13 (Lot E 87534) on an unspecified date. Relevant medical history included viral URI immediately prior to onset pneumonia. Concomitant vaccines included Influenza virus vaccine and Hep A. Past product history included dose one of PREVNAR on 14Jan2009, 2nd dose on 17Mar2009, 3rd dose on 12May2009 and 4th dose on 03Dec2009; the 1st dose of DTaP on 14Jan2009, 2nd dose on 15Apr2009, 3rd dose on 12May2009, 4th dose on 16Feb2010; the 1st dose of Hib on 14Jan2009, 2nd dose on 17Mar2009 and 3rd dose on 03Dec2009; 1st dose of IPV on 13Aug2009, 2nd dose on 16Feb2010, and 3rd dose on 26Jun2010; the 1st dose of Hep B on 14Jan2009, 2nd dose on15Apr2009 and 3rd dose on 13Aug2009; the 1st dose of MMR on 23Apr2010; the first dose of VARIVAX on 23Apr2010; the first dose of ROTAVIRUS VACCINE on 14Jan2009, 2nd dose on 12May2009 and 3rd dose on 11Jun2009. On 09Feb2011, following administration of the vaccination, the patient was hospitalized after having been diagnosed with pneumonia and pneumothorax. The patient underwent lab tests and procedures which included blood immunoglobulin A: 113 mg/dl on 14Feb2011, blood immunoglobulin E: 24h mg/dl on 14Feb2011, blood immunoglobulin G: 946 mg/dl on 14Feb2011, blood immunoglobulin M: 123 mg/dl on 14Feb2011. Culture Blood (09Feb2011): Strep. Pneumo Serotype: 19A MRSA Screen culture (10Feb2011): No MRSA Detected. Culture Blood: (10Feb2011): no Growth. C difficile Toxin (13Feb2011): Negative for Clostridium Toxin. HIBE (15Feb2011): 7.1 ug/ml NBT:(15Feb2011): 65 L % Sweat volume 70 UL: (16Feb2011): sweat CL(MMOL/L) 47 f (Intermediate (30-59mmol/L) CRP: (10Feb11): 30.7 Hf CRP (12Feb2011): 21.5 Hf CRP (13Feb2011): 17.8 Hf CRP (14Feb2011): 29.0 Hf CRP (15Feb2011): 22.0 Hf CRP (18Feb2011): 15 Hf CRP (21Feb2011): 7.0 Hf CRP (24Feb2011): 4.4 Hf CRP (28Feb2011): 1.9 Hf Complete TOT (14Feb2011): 250 Hf Vancomycin (12Feb2011): 8 f (mcg/ml). The outcome of the event at the time of the report was recovered. Follow-up (22Dec2011): New information reported by contactable physician provided medical history, past product history, concomitant medications, clinical course, lab data, and event outcome.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Sweat test normal
Clinical narrative: This is an spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 3-year-old child (gender unknown) received a dose of PREVNAR 13 (Lot E 87534) on an unspecified date. Relevant medical history included viral URI immediately prior to onset pneumonia. Concomitant vaccines included Influenza virus vaccine and Hep A. Past product history included dose one of PREVNAR on 14Jan2009, 2nd dose on 17Mar2009, 3rd dose on 12May2009 and 4th dose on 03Dec2009; the 1st dose of DTaP on 14Jan2009, 2nd dose on 15Apr2009, 3rd dose on 12May2009, 4th dose on 16Feb2010; the 1st dose of Hib on 14Jan2009, 2nd dose on 17Mar2009 and 3rd dose on 03Dec2009; 1st dose of IPV on 13Aug2009, 2nd dose on 16Feb2010, and 3rd dose on 26Jun2010; the 1st dose of Hep B on 14Jan2009, 2nd dose on15Apr2009 and 3rd dose on 13Aug2009; the 1st dose of MMR on 23Apr2010; the first dose of VARIVAX on 23Apr2010; the first dose of ROTAVIRUS VACCINE on 14Jan2009, 2nd dose on 12May2009 and 3rd dose on 11Jun2009. On 09Feb2011, following administration of the vaccination, the patient was hospitalized after having been diagnosed with pneumonia and pneumothorax. The patient underwent lab tests and procedures which included blood immunoglobulin A: 113 mg/dl on 14Feb2011, blood immunoglobulin E: 24h mg/dl on 14Feb2011, blood immunoglobulin G: 946 mg/dl on 14Feb2011, blood immunoglobulin M: 123 mg/dl on 14Feb2011. Culture Blood (09Feb2011): Strep. Pneumo Serotype: 19A MRSA Screen culture (10Feb2011): No MRSA Detected. Culture Blood: (10Feb2011): no Growth. C difficile Toxin (13Feb2011): Negative for Clostridium Toxin. HIBE (15Feb2011): 7.1 ug/ml NBT:(15Feb2011): 65 L % Sweat volume 70 UL: (16Feb2011): sweat CL(MMOL/L) 47 f (Intermediate (30-59mmol/L) CRP: (10Feb11): 30.7 Hf CRP (12Feb2011): 21.5 Hf CRP (13Feb2011): 17.8 Hf CRP (14Feb2011): 29.0 Hf CRP (15Feb2011): 22.0 Hf CRP (18Feb2011): 15 Hf CRP (21Feb2011): 7.0 Hf CRP (24Feb2011): 4.4 Hf CRP (28Feb2011): 1.9 Hf Complete TOT (14Feb2011): 250 Hf Vancomycin (12Feb2011): 8 f (mcg/ml). The outcome of the event at the time of the report was recovered. Follow-up (22Dec2011): New information reported by contactable physician provided medical history, past product history, concomitant medications, clinical course, lab data, and event outcome.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and tenderness at injection site.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site pain
Clinical narrative: None other than pain, was seen in office 11/21/2011 states 2-3 pain as dull ache in left lateral upper arm, with numbness, no fever, redness seen again 12-29, dull ache rated 2, no numbness redness, fever, tingling, or loss of sensation, normal range of motion, no edema.
Age: 0.67
Sex: M
Vaccine: FLUX
Symptoms: Decreased appetite, Diarrhoea, Discomfort, Irritability, Poor quality sleep
Clinical narrative: Fussiness on First Day, runny nose, crankiness & diarrhea during 2nd day (12/29). Fever started 12/29 in evening (101.5) very uncomfortable, screaming when trying to lay down, decreased appetite. Unable to sleep well.
Age: 0.67
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Rhinorrhoea, Screaming
Clinical narrative: Fussiness on First Day, runny nose, crankiness & diarrhea during 2nd day (12/29). Fever started 12/29 in evening (101.5) very uncomfortable, screaming when trying to lay down, decreased appetite. Unable to sleep well.
Age: 24.0
Sex: M
Vaccine: HEPA, IPV, TYP, YF
Symptoms: Loss of consciousness, Road traffic accident
Clinical narrative: Shortly after receiving vaccination for yellow fever, polio, hepatitis A, and typhiod, I departed the clinic and lost conciousness while driving home. I was involved in a single vehicle accident as a result. Fortunately, I suffered no injuries.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Pt presented with a red painful rash at the injection site. It is about 2 inches in diameter. She developed rash one day after injection and came to pharmacy 12/28/11. Pt says it does itch a little.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt. was in for her 1 year well check clinician ordered for her to receive MMR, Varicella and ACTHIB rather than the PREVNAR 13. Nothing adversely happened to the patient. She has now received all appropriate vaccines.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test negative, Hypersensitivity, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Developed local allergic reaction appx 5 x 6 cm (L) deltoid red, indurated, hot at the shot site.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given Tdap and MENACTRA after already receiving them at another provider's office.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site dryness, Injection site erythema, Injection site rash
Clinical narrative: Baby got very dry, red, rash on each thigh that got the shots - recurred after dose 2 & 3 also.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Mass, Pain
Clinical narrative: Knot on left arm. Raised & painful.
Age: 1.63
Sex: M
Vaccine: FLU3
Symptoms: Gastroenteritis viral, Haematemesis, Nausea, Vomiting
Clinical narrative: Mother states patient with no fever. Mother states patient has been nauseated & vomiting since receiving flu shot yesterday. States vomiting blood. Informed to see PCP ASAP - not normal adverse reaction & might be other cause.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Pain in extremity, Radicular pain
Clinical narrative: Left lumbar left leg radicular pain.
Age: 1.52
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 103.1, gave Tylenol, had fever until 12/29/11, rash developed on chest and neck 12/30/11.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia, Oropharyngeal pain, Pain in extremity
Clinical narrative: sore throat 10/28/2011 - 12/10/2011 pain in muscles & joints, arms, legs  10/20/2011 - 12/21/2011  EXTREME PAIN IN SAME 10/30/2011 -11/28/2011 methocarbamol & meloxicam
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt eye swelling approx 1/2 hr after flu vaccine also developed approx 2" inch redness, swelling, hot to touch on (L) arm where vaccine given.
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Cold sweat, Gaze palsy, Hyperhidrosis, Mydriasis, Pallor
Clinical narrative: Patient turned pale, clammy and sweaty, Eyes rolled back in head and started drawing hands up to chest, Seizure like activity. Pupils were dilated.
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Seizure like phenomena
Clinical narrative: Patient turned pale, clammy and sweaty, Eyes rolled back in head and started drawing hands up to chest, Seizure like activity. Pupils were dilated.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 24 hrs after given site was red splotchy, hot, swollen, tender and low grade fever developed after 46 hrs and continued for 48 hrs. Symptoms are lessening after 72 hrs.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: 24 hrs after given site was red splotchy, hot, swollen, tender and low grade fever developed after 46 hrs and continued for 48 hrs. Symptoms are lessening after 72 hrs.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Back pain, CSF protein increased, Gait disturbance, Immunoglobulin therapy
Clinical narrative: Progressive difficulties walking and weakness. Symptoms started 12-9-11 with increasing back pain. Transferred care to another clinic and admitted to hospital. 5 day course of IVIG. Discharged on 12-21-11 with PT and OT referral.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Lumbar puncture abnormal, Nerve root lesion, Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: Progressive difficulties walking and weakness. Symptoms started 12-9-11 with increasing back pain. Transferred care to another clinic and admitted to hospital. 5 day course of IVIG. Discharged on 12-21-11 with PT and OT referral.
Age: 0.79
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's Palsy dx - with smile-droop left mouth/sag of left side of face. EOM intact - no other cranial nerve palsy identified.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Nausea, dizziness, fever, severe arm pain.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Bronchitis, Chest X-ray normal, Cough, Hypertension, Pulmonary congestion
Clinical narrative: High grade fever. High blood pressure. Cough, congestion, chest congestion.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: High grade fever. High blood pressure. Cough, congestion, chest congestion.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Dyspnoea, Erythema, Eyelid oedema, Lacrimation increased, Ocular hyperaemia
Clinical narrative: First patient developed a chronic runny nose, led to uncontrollable sneezing. Face developed hives, red and c/o itchy. Eyes watery and red and started to swell shut. Then labored breathing developed and mom given the BENADRYL and took to ER. And 10 mins after given meds the s/s started to decrease.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Pruritus, Rhinorrhoea, Sneezing, Urticaria
Clinical narrative: First patient developed a chronic runny nose, led to uncontrollable sneezing. Face developed hives, red and c/o itchy. Eyes watery and red and started to swell shut. Then labored breathing developed and mom given the BENADRYL and took to ER. And 10 mins after given meds the s/s started to decrease.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Fall, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Right arm from shoulder to elbow became extremely painful and was hard to move. Fell that night going to bathroom, became dizzy and tripped. Was seen the next morning in the ED and rt. arm was x-rayed. She continued to have pain in her arm for 3+ weeks. Went to her family doctor who recommended she see a dermatologist because she still has a quarter sized raised redden area with the center being a beige crusted center on the middle of her right deltoid muscle. She present to this site on 12/28/11 with the same described area. She has not been seen by a dermatologist.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Scab, X-ray limb
Clinical narrative: Right arm from shoulder to elbow became extremely painful and was hard to move. Fell that night going to bathroom, became dizzy and tripped. Was seen the next morning in the ED and rt. arm was x-rayed. She continued to have pain in her arm for 3+ weeks. Went to her family doctor who recommended she see a dermatologist because she still has a quarter sized raised redden area with the center being a beige crusted center on the middle of her right deltoid muscle. She present to this site on 12/28/11 with the same described area. She has not been seen by a dermatologist.
Age: 0.18
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Area of about 6" x 6" is red, swollen and hot to the touch.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Chemotherapy, Hepatoblastoma, Papule, Rash
Clinical narrative: Pt was diagnosed with hepatoblastoma shortly after vaccination, began chemotherapy. After about 4 weeks developed papules which developed into vesicles, DFA positive for varicella, confirmed as vaccine strain by CDC. Treated with IV acyclovir 20mg/kg q8h and lesions resolved over the next week.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Pt was diagnosed with hepatoblastoma shortly after vaccination, began chemotherapy. After about 4 weeks developed papules which developed into vesicles, DFA positive for varicella, confirmed as vaccine strain by CDC. Treated with IV acyclovir 20mg/kg q8h and lesions resolved over the next week.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Rash, Tuberculin test negative
Clinical narrative: PT STATES HE NOTICED THE RASH AFTER HE GOT OUT OF THE SHOWER AND WAITED UNTIL TODAY TO NOTIFIED US BECAUSE HE CAME IN FOR THE TB READING, WHICH WAS PLACE 2 DAYS AGO. TB WAS NEGATIVE. HE HAS RASH INNER-OUTTER RIGHT ARM, ALMOST IN THE AXILLA AWAY WHERE THE PNEUMONIA WAS GIVEN. NO OTHER PROBLEMS WITH THE RASH (COUPLE OF BUMPS, BUMPS MEASURE FROM 1.5-2.0CM. HOWEVER, THE INJECTION SITE IS SENSITIVE/TENTERED, PAINFUL, AND HOT WHEN YOU TOUCHED THIS IS THE ON THE LEFT DELTOID.
Age: 0.35
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Hypersensitivity, Insomnia
Clinical narrative: Allergic reaction all over the body, face and head, he couldn't sleep.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Bursitis, Condition aggravated, Injection site induration, Injection site pruritus, Injection site reaction
Clinical narrative: Patient said she intially had pain from her thumb to her shoulder which she attributed to her bursitis. But a couple days passed and she noticed that her arm still hurt even without movement and after taking aspirin which usually helps her bursitis. She also says there is a red bump where the shot was given. It is the size of a silver dollar and is hard. The injection site is also hot and itchy.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Rash erythematous
Clinical narrative: Patient said she intially had pain from her thumb to her shoulder which she attributed to her bursitis. But a couple days passed and she noticed that her arm still hurt even without movement and after taking aspirin which usually helps her bursitis. She also says there is a red bump where the shot was given. It is the size of a silver dollar and is hard. The injection site is also hot and itchy.
Age: 0.2
Sex: F
Vaccine: PNC13
Symptoms: Ear discomfort, Ear infection
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A 2-month-old female patient received the first dose of PREVNAR 13 on an unspecified date. Relevant medical history and concomitant medications were not reported. On an unspecified date, at the age of 5 months, the patient came into the office to get the second dose of PREVNAR 13 but developed an ear infection and was pulling on her ears. The patient was being treated for the ear infection and did not receive the second dose. The outcome of the event was unknown. Follow-up (28Nov2011): Follow-up attempts completed. No further information expected.
Age: 1.28
Sex: M
Vaccine: DTP, FLUX, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable physician. A 15-month-old male patient received PREVENAR 13, a dose of DPT vaccine, and an unspecified INFLUENZA vaccine on 19SEP2011 around mid-day. Relevant medical history and concomitant medications were unknown. On 19Sep2011 after vaccination, the patient experienced febrile seizures around 7 PM and fever. The patient was taken to the Emergency Room after the events. Therapeutic measures taken as a result of the events included treatment with ibuprofen and TYLENOL. The patient had recovered from the reported on an unknown date in SEP2011. No follow-up attempts possible. No further information expected.
Age: 29.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Pain
Clinical narrative: Case number PHEH2011US03617, is an initial spontaneous report received from a pharmacist on 06 Sep 2011: This report refers to an adult female patient. She was vaccinated with MENVEO (batch number A100053), intramuscularly, on 25 Aug 2011. She subsequently developed pain in her arm where MENVEO was administered that radiated up to her neck. Pain was persisting at time of this report.
Age: 33.0
Sex: M
Vaccine: MNQ
Symptoms: Expired drug administered
Clinical narrative: Case number PHEH2011US06738 is an initial spontaneous report received from a healthcare professional (pharmacy intern) on 12 Oct 2011 with the follow-up received on 12 Oct 2011. This case refers to a 33-year-old male patient. He was vaccinated with expired MENVEO (batch number: 1000, expiry date: Aug 2011) intramuscularly on 11 Oct 2011. No additional details were reported at the time of this report. Follow up received on 12 Oct 2011: Batch number and expiry date were updated.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Case number PHEH2011US07445 is an initial spontaneous report received from a nurse on 07 Oct 2011: This report refers to an 11-year-old female child. She was given only the CYW-135 liquid component of MENVEO (batch number: X10130) intramuscularly on 06 Oct 2011. No other adverse event was reported.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Case number PHEH2011US008706 is an initial spontaneous report received from a physician on 02 Nov 2011: This report refers to a female child. She was given only the CYW-135 liquid component of MENVEO (batch number: unknown) intramuscularly on 28 Oct 2011. This was the second booster dose. No adverse event was reported following this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Case number PHEH2011US07654, is an incomplete initial spontaneous report received from a healthcare professional on 19 Oct 2011: This report refers to multiple patients. These patients were vaccinated with MENVEO (batch number: unknown) on unspecified date. MENVEO has been reached 29 Fahrenheit every few days in the mornings and then goes back with in refrigerator in the afternoon, temperature of the refrigerator had fluctuated over the past 30-days and vaccine did not freeze. No adverse events occurred following this drug administrator error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Case number PHEH2011US07814 is an initial spontaneous report received from a pharmacist on 24 Oct 2011. This case refers to a 12-year-old male patient. He was vaccinated with MENVEO (batch number: M10129) at a dose of 0.5ml subcutaneously on 24 Oct 2011. No adverse event had occurred following this administration error.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Case number PHEH2011US06968 is an initial spontaneous report received from a nurse on 13 Oct 2011. This case refers to a 15-year-old female patient. She was vaccinated with MENVEO (batch number: X10125) intramuscularly on 11 Oct 2011. The pharmacist stated that this patient received only MenCWY-135 liquid conjugate vaccine component of MENVEO; she did not receive the MenA lyophilized conjugate vaccine component of MENVEO. No adverse event was reported at the time of this report.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Case number PHEH2011US06958 is an initial spontaneous report received from a health care professional on 10 Oct 2011: This report refers to a male child. He was given only the CYW-135 liquid component MENVEO (batch number: unknown) intramuscularly on 03 Oct 2011. No other adverse event was reported.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Case number PHEH2011US06971 is an initial spontaneous report received from a health care professional on 10 Oct 2011: This report refers to a female child. She was given only the CYW-135 liquid component MENVEO (batch number: unknown) intramuscularly on 03 Oct 2011. No other adverse event was reported.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Case number PHEH2011US07093 is an initial spontaneous report received from a nurse on 13 Oct 2011 with a follow-up received from a health care professional on 02 Nov 2011: This report refers to 20-year-old male patient. His vaccination history included administration of MMR vaccine (other manufacturer) on an undetermined date. He was given only the CYW-135 liquid component of MENVEO (batch number: M10062) intramuscularly on 12 Oct 2011. No other adverse event was reported. Follow-up received from a health care professional on 02 Nov 2011: Updated vaccination history and batch number of MENVEO.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2011US04010, is an initial spontaneous report received from a medical assistant on 12 Sep 2011: This report refers to 11-year-old female patient. She was administered MENVEO (batch number A100058), 0.5 ml, intramuscularly on 09 Sep 2011. After vaccination on an unspecified date, she developed redness and swelling at injection site which was notified on 12 Sep 2011. Events were ongoing at time of this report.
Sex: U
Vaccine: MNQ
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2011US07064 is an initial incomplete spontaneous report received from a nurse on 12 Oct 2011. This case refers to multiple patients. Four patients were vaccinated with MENVEO (batch number: unknown) intramuscularly on unspecified date. Within 48-hours of vaccination patients were experienced injection site reactions of cellulitis, warmth, redness and swelling. The causality and event outcome were not reported.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: Case number PHEH2011US06695 is an initial spontaneous report received from a health care professional on 29 Sep 2011: This report refers to an adult female. She was vaccinated with MENVEO (batch number: M10061 and expiry date: Sep 2012) intramuscularly and with Varicella vaccine (batch number and manufacturer: unknown) into the same arm on 12 Sep 2011. After vaccination the arm that had received the injections had swollen up to three inches larger in circumference than the other arm. This was her second dose of MENVEO, first dose was given on an unspecified date but she did not experience any reaction after the first dose. No further information was reported.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Case number PHEH2011US02397 is an initial spontaneous report received from a nurse on 22 Aug 2011. This report refers to a male child. His medical history included asthma. He was given only the MenCYW lyophilized liquid conjugate component of MENVEO (batch number: 090901) intramuscularly on 20 Jul 2011. On the same day he was also given the booster dose of Hep A vaccine (manufacturer and batch number: unknown). No other adverse reaction was reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case number PHEH2011US02508 is an initial spontaneous report received from a pharmacist on 22 Aug 2011: This report refers to an 18-year-old female patient. She was vaccinated with a dose of MENVEO (batch number: unknown) intramuscularly on an undetermined date. She had already been given the vaccine (MENVEO or MENACTRA) three months earlier in May 2011 also. No other adverse reaction was reported.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Case number PHEH2011US02399 is an initial spontaneous report received from a nurse on 22 Aug 2011. This report refers to a male child. He was given only the CYW-135 liquid component MENVEO (batch number: 090901) intramuscularly on 18 Jul 2011. On the same day he was also vaccinated with BOOSTRIX (manufacturer and batch number: unknown) intramuscularly and varicella vaccine (manufacturer and batch number: unknown) subcutaneously. No other adverse reaction was reported.
Age: 17.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Case number PHEH2011US02925 is an initial spontaneous report received from a health care professional on 30 Aug 2011 with the follow up information received on 20 Sep 2011: This report refers to a male child. His medical history included of allergies. He was given only the MenA lyophilized powder component of MENVEO (batch number: M10053) reconstituted with the sterile diluent from VARIVAX (manufacturer and batch number: unknown) intramuscularly on 26 Aug 2011. No other adverse reaction was reported. Follow up information received from the health care professional on 20 Sep 2011: Updated medical history.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Case number PHEH2011US02546 is an initial spontaneous report received from a health care professional on 19 Aug 2011. This report refers to a female patient. The patient received only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch no: X10062) and did not received the MenA lyophilized conjugate vaccine component of MENVEO on 18 Aug 2011. No adverse reaction has occurred.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US03633, is an initial spontaneous report received from a medical assistant on 07 Sep 2011 with follow-up received on 18 Oct 2011: This report refers to a child female patient. She was administered only the MenCWY liquid conjugate component of MENVEO (batch number X10059) without being reconstituted with the MenA conjugate component, intramuscularly into right deltoid on 30 Aug 2011. She was also vaccinated BOOSTRIX into left deltoid on 30 Aug 2011. No adverse event occurred following this administration. Follow-up report received on 18 Oct 2011: Concomitant vaccines and patient demographics updated.
Sex: U
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Case number PHEH2011US04306 is an initial incomplete spontaneous report received from a nurse on 13 Sep 2011: This report refers to multiple patients of unknown age group and gender. An unknown number of patients were vaccinated with less than 0.5 ml dose of MENVEO (batch number: A10062) intramuscularly on unknown dates. No other adverse event was reported.
Age: 31.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, Syringe issue
Clinical narrative: Case number PHEH2011US05576 is a combined initial and a follow up spontaneous report received from a health care professional on 29 Sep 2011 and 30 Sep 2011 respectively. The pharmacist stated that after attempting to withdraw reconstituted MENVEO with needles ranging in gauge from 18 to 27, and using different types of needles, they ended up taking the entire foil and the plastic thing off prior to withdrawing two doses of MENVEO that were subsequently administered to two patients. This case pertains to a 31-year-old male patient who was vaccinated with one of this dose of MENVEO (batch number: M100047) on 22 Sep 2011. It was also reported that they actually reconstituted the Men A lyophilized conjugate vaccine component of MENVEO with a sterile diluent, which was the reason there was difficulty withdrawing the dose after reconstitution. The patient did not receive the MenCYW-135 liquid conjugate vaccine component of MENVEO. Potential medication error was reported due to potential that sterility of doses could have been compromised due to removal of the stopper prior to withdrawing up two separate doses of MENVEO. No adverse event was reported at the time of this report. The other patient was vaccinated 3 weeks before the time of this report (see linked case: PHEH2011US05580). Following an internal review on 10 Nov 2011 of the information received on 29 Sep 2011, following correction was done. The verbatim 'patient received dose after removal of stopper' changed to 'sterility of the vaccine doses could have been compromised due to removal of the stopper prior to withdrawing two separate doses', and coded to product sterility lacking. An event drug administration error is added.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event, Product sterility lacking
Clinical narrative: Case number PHEH2011US05580 is a combined initial and a follow up spontaneous report received from a health care professional on 29 Sep 2011 and 30 Sep 2011 respectively. The pharmacist stated that after attempting to withdraw reconstituted MENVEO vaccine with needles ranging in gauge from 18 to 27, and using different types of needles, they ended up taking the entire foil and the plastic thing off prior to withdrawing two doses of NENVEO that were subsequently administered to two patients. This case pertains to a patient of unknown age and gender who was vaccinated with one of this dose of MENVEO vaccine (batch number: M100047) three weeks before the time of this report. It was also reported that they causality reconstituted the Men A lyophilized conjugate vaccine component of MENVEO with a sterile diluent, which was the reason there was difficulty withdrawing the dose after reconstitution. The patient did not receive the MenCYW-135 liquid conjugate vaccine component of MENVEO. Potential medication error was reported due to potential that sterility of doses could have been compromised due to removal of the stopper prior to withdrawing up two separate doses of MENVEO. No additional patient administration errors were reported. No adverse event was reported at the time of the report. The other patient was vaccinated on 22 Sep 2011 (see linked case: PHEH2011US05576). Following an internal review on 10 Nov 2011 from the information received on 29 Sep 2011, following correction was done. The verbatim 'pt received dose after removal of stopper' changed to 'sterility of the vaccine doses could have been compromised due to removal of the stopper prior to withdrawing two separate doses', and coded to product sterility lacking. An event during administration error is added.
Sex: U
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Case number PHEH2011US05758 is an initial spontaneous report received from a physician on 29 Sep 2011. This case refers to four patients. These four patients inadvertently received only the MenCWY component of MENVEO (batch number: unknown) instead of being reconstituted with MenA, intramuscularly on unspecified date. No adverse reaction had occurred following this drug administration error.
Sex: M
Vaccine: MNQ
Symptoms: Expired drug administered, Incorrect drug dosage form administered
Clinical narrative: Case number PHEH2011US05842 is an initial spontaneous report received from a pharmacist on 30 Sep 2011. This report refers to a male patient of unknown age. He was vaccinated with MENVEO (batch number: unknown) intramuscularly in early or mid Sep 2011 (exact date unknown). The pharmacist stated that this patient received MENVEO that had been reconstituted with an expired MenA lyophilized conjugate vaccine component (expiration date: Aug 2011); the MenCYW-135 liquid conjugate vaccine component was not expired. No additional information was available, including vaccine batch number and patient identifying information at the time of this report.
Age: 28.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Case number PHEH2011US02596 is an initial spontaneous report received from a nurse on 11 Aug 2011. This report refers to an adult female patient. The patient was vaccinated with MENVEO vaccine (batch number: 10051) intramuscularly on 10 Aug 2011. On the same day, she experienced vomiting, nausea and headache. These symptoms persisted whole night, until she was was able to get TYLENOL down. The outcome of the events were not reported.
Age: 0.36
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US04998 is an initial spontaneous report received from a nurse on 16 Sep 2011. This report refers to 4-month-old female patient. She was given only the MenA lyophilized conjugate component of MENVEO (batch number:A10047) that was reconstituted with a sterile diluent, intramuscularly on 08 Sep 2011. No adverse reaction had occurred following this drug administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US03701, is an initial spontaneous report received from a physician on 07 Sep 2011: This report refers to 11-year-old male patient. He was administered only the MenCWY liquid conjugate component of MENVEO (batch number M10053) without being reconstituted with the MenA conjugate component, 0.5 ml, intramuscularly on 24 Aug 2011. No adverse event occurred following this administration.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US04267, is an initial spontaneous report received from a nurse on 13 Sep 2011 with the follow-up received on 29 Sep 2011: This report refers to 10-years-old male child. He was received only MenCWY liquid conjugate component of MENVEO (batch number A10062) on 31 Aug 2011 without being reconstituted with MenA lyophilized conjugate component and the powdered vial was not used to mix to-gather No adverse event reported. Follow-up received from nurse on 29 Sep 2011: The patient demographics, site of application and date of vaccination were updated.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US04984 is an initial spontaneous report received from a nurse on 22 Sep 2011. This case refers to an adult patient of unknown gender. The patient was received only the MenA lyophilized conjugated component of MENVEO vaccine (batch number: M100034) that were reconstituted with a sterile diluent, intramuscularly on unspecified date. No adverse reaction had occurred following this drug administration error.
Age: 60.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US04545 is an initial spontaneous report received from a physician on 14 Sep 2011 with following internal review done on 10 Nov 2011 of the data received on 14 Sep 2011. This case refers to 60-year-old female patient. She was vaccinated with MENVEO (batch number: A100047) subcutaneously instead of intramuscularly on 11 Sep 2011. She got MENVEO which was mixed up with MPSV4 (other manufacturer). No adverse events occurred following this administration error. Following internal review done on 10 Nov 2011 of the data received on 14 Sep 2011: Following correction was done: Recoded drug administration error to wrong drug administered and wrong route of vaccination event was deleted.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHHY2011US03780, is an initial spontaneous report received from a nurse on 07 Sep 2011: This report refers to multiple patient. One or two patients were administered only the MENVEO (batch number unknown) without being reconstituted with the MenA conjugate component, intramuscularly. No adverse event occurred following this administration.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US04301 is an initial spontaneous report from a health care professional on 15 Sep 2011 and a follow up information received from the health care professional on 04 Oct 2011. This report refers to 14-year-old male child. He was given only the MenA powder component of MENVEO (batch number: A10061) reconstituted with a sterile diluent instead of MenCYW-135 component, intramuscularly into his left deltoid on 13 Sep 2011. No other adverse reaction was reported. It was also reported that he has tolerated the vaccine in the past. Follow up information received from the physician on 04 Oct 2011: Updated age of the patient, batch number and site of vaccination.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US02198 is an initial spontaneous report received from a nurse on 05 Aug 2011 with follow-up received from a nurse on 06 Sep 2-11. This report refers to an 11-year-old female patient. She was given only the MENVEO (batch number: X10030 and expiry date: Sep 2012) intramuscularly on 01 Aug 2011. No adverse event reported following this administration error. The patient was revaccinated with MENVEO on 11 Aug 2011. No adverse event occurred after revaccination. Follow-up received on 06 Sep 2011: Patient demographics updated.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US02367 is an initial spontaneous report received from a pharmacist on 18 Aug 2011. This report refers to an adult male patient. The patient received only an intramuscular dose of MENVEO (batch no: M10047) MenCWY liquid conjugate component without being reconstituted with Men A on 17 Aug 2011. No adverse reaction was reported.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US02198 is an initial spontaneous report received from a nurse on 05 Aug 2011 with follow-up received on 06 Sep 2011. This report refers to a 19-year-old female patient. She was given only the MenCWY liquid conjugate component of MENVEO (batch number: X10030 and expiry date: Sep 2012) intramuscularly on 01 Aug 2011. No adverse event reported following this administration error. The patient was revaccinated with MENVEO on 08 Aug 2011. No adverse event occurred after revaccination. Follow-up received on 06 Sep 2011: Patient demographics updated.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US02253, is an initial spontaneous report received from a health care professional on 22 Aug 2011: This report refers to a child male patient. This patient was vaccinated with only intramuscular dose of MENVEO (batch number M100061) that was reconstituted with a sterile diluent on an unspecified date. No adverse event occurred following this administration.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US02604 is an initial spontaneous report received from a health care professional on 25 Aug 2011: This report refers to an 12-year-old female patient. She was vaccinated with only liquid component of MENVEO (batch number: X100034) without being reconstituted with the MenA conjugate component, intramuscularly, 0.5 ml, on 25 Aug 2011. No adverse reaction occurred following this drug administration error.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US02396 is an initial spontaneous report received from a nurse on 22 Aug 2011. This report refers to a male child. His medical history included asthma. He was given only the CYW-135 liquid component MENVEO (batch number: 090901) intramuscularly on 20 Jul 2011. On the same day he was also vaccinated with ADACEL (batch number: U9973CA) intramuscularly. No other adverse reaction was reported.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US02338 is an initial spontaneous report received from a physician on 22 Aug 2011. This report refers to a 13 years old female patient. She was given only the CYW-135 liquid component MENVEO (batch number: X10057) intramuscularly on 22 Aug 2011. No other adverse reaction was reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2011US02854 is an incomplete spontaneous report received from a nurse on 25 Aug 2011. This report refers to an unknown number of patients with undetermined gender and age group. An unknown number of patients were given partial dose of MENVEO (batch number: M10047) intramuscularly on undetermined dates. No other adverse event was reported following this administration error.
Sex: F
Vaccine: HPVX, MNQ, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2011US02805, is an initial spontaneous report received from a medical assistant on 26 Aug 2011 with follow-up received from a medical assistant on 12 Sep 2011: This report refers to an adult female patient. Medical history included allergy to penicillin and Acetylsalicylic acid. She was concomitantly vaccinated with Human Papiloma virus vaccine and Varicella vaccine. Concomitant medication included Albuterol and Flonase. She was administered only the MenCWY liquid conjugate component of MENVEO batch number 090601A without being reconstituted with MenA conjugate component, intramuscularly, into left deltoid on 23 Aug 2011. No adverse event occurred following this administration. Follow-up received on 12 Sep 2011: Patient demographics, medical history, vaccination site and concomitant medications updated.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US02821, is an initial spontaneous report received from a nurse on 26 Aug 2011: This report refers to a child female patient. She was administered only the MenCWY liquid component of MENVEO (batch number M10047) without being reconstituted with the MenA conjugate component, intramuscularly, on an unspecified date. No adverse event occurred following this administration.
Age: 31.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEN2011US02805, is an initial spontaneous report received from a medical assistant on 26 Aug 2011 with follow up received from a medical assistant on 12 Sep 2011: This report refers to an adult female patient. Concomitant vaccination included hepatitis A and hepatitis B vaccines. She was administered only the MenCWY liquid conjugate component of MENVEO (batch number 090601A) without being reconstituted with the MenA conjugate component, intramuscularly into left deltoid, on 23 Aug 2011. No adverse event occurred following this administration. Follow-up received on 12 Sep 2011: Patient demographics, vaccination site and concomitant medications updated.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US02400 is an initial spontaneous report received from a nurse on 22 Aug 2011. This report refers to a male child. His concomitant medication included MIRAMAX oralle at a unknown dose for an unknown indication. He was given only the MenCYW lyophilized liquid conjugate component of MENVEO (batch number: 090901) intramuscularly on 15 Jul 2011. On the same day he was also given the second dose of BOOSTRIX (batch number: unknown). No other adverse reaction was reported.
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Case number PHEH2011US06697 is an initial spontaneous report received from a health care professional on 29 Sep 2011: This report refers to a male patient of unknown age group. He was vaccinated with MENVEO (batch number:M10061 and expiry date: Sep 2012) intramuscularly and with VARICELLA (batch number and manufacturer: unknown) into the same arm on an unknown date. After vaccination he experienced reaction at the injection site. No further information was available. Following internal non serious line listing review done on 22 Nov 2011 of the date received on 28 Sep 2011 it was noted that the listedness for event vaccination site reaction was incorrectly captured as listed. Therefore, it was correctly captured as unlisted.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US02193 is an initial spontaneous report received from a health care professional on 19 Aug 2011. This report refers to a female patient. The patient received only the Men A lyophilized conjugate vaccine component of MENVEO (batch no: 10C58) and did not receive MenCYW liquid component of MENVEO on 12 Aug 2011. No adverse reaction has occurred.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US01958 is an initial spontaneous report received from health care professional on 18 Aug 2011. This report refers to a patient of an unknown age and gender. The patient was vaccinated with MENVEO (batch number: unknown) intramuscularly on unspecified date in Jul 2011. But, the patient received only the Men CWY liquid conjugate without reconstituting it with the Men A lyophilized powder component. No adverse reaction had occurred following this drug administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: Case number PHEH2011US02340, is combined initial and follow-up spontaneous report received from a nurse on 23 Aug 2011 and 30 Aug 2011 respectively: This case refers to 18-year-old female patient. She was previously using MENACTRA. She was administered on the MenCWY liquid conjugate component of MENVEO without being reconstituted with the MenA conjugate component, intramuscularly, on an unspecified date. No adverse event occurred following this administration. PTC reference number assigned to this case is 123778.