chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 13 Aug 2010: This patient was vaccinated with MENVEO, intramuscularly, on 13 Aug 2010. The reporter stated that she experienced difficulty in obtaining the full dose of MENVEO after reconstitution and the patient was administered with only 0.4ml (correct dose - 0.5 ml). However, no adverse events occurred. The outcome of the event was not reported.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Underdose
Clinical narrative: Initial report received from a health care professional on 13 Aug 2010: This patient was vaccinated with MENVEO (batch number 100001), intramuscularly, on an unspecified date. The reporter stated that the patient was administered with only 0.4 ml of MENVEO (correct dose is 0.5 ml). However, no adverse events occurred. The outcome of the event was not reported.
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error
Clinical narrative: Initial report received from a health care professional on 16 Aug 2010: This patient was vaccinated with MENVEO (batch number: unknown), intramuscularly on an unspecified date. The reporter stated that the patient received only liquid portion of the MENVEO. No associated illness occurred. CDC advised to repeat both vaccinations with complete product. The outcome of the event was not reported. Follow-up report received on 19 Aug 2010: The patient's demographics, treating physician's information and vaccine lot number (090701) were provided.
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error
Clinical narrative: Initial report received from a health care professional on 16 Aug 2010: This patient was vaccinated with MENVEO (batch unknown), intramuscularly on an unspecified date. The reporter stated that the patient received only liquid portion of the MENVEO. No associated illness occurred. CDC advised to repeat both vaccinations with complete product. The outcome of the event was not reported. Follow-up report received on 19 Aug 2010: The patient's demographics, treating physician's information and vaccine lot number (090701) were provided.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from an health care professional on 29 Jul: This patient was vaccinated with only the 0.5 ml of the MenCYW-135 component of MENVEO (batch number: (box lot: 10003 and liquid vial lot: 091001), without the lyophilized Men A conjugate compound, No adverse events had occurred following this administration.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from the health care professional on 30 Jul 2010: On 29 Jul 2010, this patient inadvertently received a intramuscular dose of the MenA lyophilized component of MENVEO (box lot No. 100005) that was diluted with sterile diluent instead of Men CWY 135 liquid conjugate component. No adverse reaction had occurred following this administration.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from an health care professional on 29 Jul: This patient was vaccinated with only the 0.5 ml of the MenCYW-135 component of MENVEO (batch numbers: (box lot: 100003 and liquid vial lot: 091001) without the lyophilized Men A conjugate compound. No adverse events had occurred following this administration.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a consumer on 16 Aug 2010: This patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number not reported), (dose: 0.5 ml) intramuscularly without being reconstituted with the MenA conjugate component. No adverse events were noted following this administration.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Initial healthcare professional report received on 17 Aug 2010: This patient received MENVEO (batch number 091101) 0.5 ml dose intramuscularly on 03 Aug 2010. On 03 Aug 2010, after receiving MENVEO, the patient experienced raised redness and swelling and pain at the injection site and got very irritable. However the patient did not experience fever. The outcome of the event was reported as unknown. The causality was not reported.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Initial healthcare professional report received on 17 Aug 2010: This patient received MENVEO (batch number 029011) 0.5 ml dose intramuscularly on 10 Aug 2010. After the vaccination with MENVEO, the patient experienced raised redness and swelling and pain at the injection site and got very irritable on 10 Aug 2010. However the patient did not experience fever. The outcome of the events was reported as unknown.
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial consumer report received on 08 Aug 2010: On an unknown date, this patient was vaccinated with only the liquid portion meningitis vaccine, taken as MENVEO (batch number: unknown), unknown dose without being reconstituted. No adverse events were noted following this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Injection site erythema, Local swelling, Pyrexia, Vomiting
Clinical narrative: Case number PHEH2012US006671 is an initial spontaneous report received from a physician on 20 Mar 2012. This case refers to an 11-year-old male patient. He was vaccinated with MENVEO vaccine (batch number: A10126) intramuscularly on 09 Mar 2012. On 10 Mar 2012, he developed fever, dizziness and vomited once. He was seen in the doctor's office on 12 Mar 2012. On examination he was found to have local swelling and erythema at the site of injection at the left deltoid. He had these symptoms over 2-3 days. He had recovered slowly on 13 Mar 2012. The causality was not reported. No other information was available.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Malaise, Nausea
Clinical narrative: Case number PHEH2012US006274 is an initial spontaneous report received from nurse on 14 Mar 2012. This report refers to an adult female patient. The patient was vaccinated with MENVEO (batch number: A10135B) intramuscularly on 13 Mar 2012. On 14 Mar 2012, patient developed nausea, headache, dizziness and general malaise. The outcome of events was not reported.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2012US004949, is an initial spontaneous report received from a physician via Novartis representative on 02 Mar 2012: This case refers to unknown age and gender patient. This patient was vaccinated with MENVEO (batch number: M10031) on unspecified date. On unspecified date, the patient experienced severe swelling, redness and heat at the injection site. The outcome and causality of the events were not reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHHY2012US037523 is an initial spontaneous report received from a physician on 30 Apr 2012. This report refers to an 11-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that she received inadvertently two doses of MENVEO (batch number: not reported) intramuscularly on to unspecified site about one month apart on 06 Apr 2012 and 29 Apr 2012. No adverse reaction was reported following the maladministration.
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2012US000902, is an initial spontaneous report received from consumer on 06 Jan 2012 with the following internal review done on 07 Apr 2012 of data received on 06 Jan 2012. This report refers to 24-years-old adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: unknown) intramuscularly on 03 Jan 2012. On 04 Jan 2012, she felt achy, chills and developed headache. On 05 Jan 2012, the injection site was warm to touch, swollen and painful. On 06 Jan 2012, her neck became sore and stiff. The outcome of the events reported as ongoing. The causality of the events was not reported. Following internal review on 07 Apr 2012 of data received on 06 Jan 2012, the following correction had been done: Changed the labeling of pain (she felt achy) from listed to unlisted.
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Case number PHEH2012US000902, is an initial spontaneous report received from consumer on 06 Jan 2012 with the following internal review done on 07 Apr 2012 of data received on 06 Jan 2012. This report refers to 24-years-old adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: unknown) intramuscularly on 03 Jan 2012. On 04 Jan 2012, she felt achy, chills and developed headache. On 05 Jan 2012, the injection site was warm to touch, swollen and painful. On 06 Jan 2012, her neck became sore and stiff. The outcome of the events reported as ongoing. The causality of the events was not reported. Following internal review on 07 Apr 2012 of data received on 06 Jan 2012, the following correction had been done: Changed the labeling of pain (she felt achy) from listed to unlisted.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT REPORTS THAT AFTER RECEIVING ZOSTAVAX IN HER LEFT ARM, SHE HAD A CASE OF SHINGLES WITHIN 24 HOURS ON HER RIGHT ARM.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, HEPA, HIBV, MMR, MMRV, MNQ, PNC, RV5, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Case number PHHY2012US014478 is an initial literature report received on 17 Feb 2012. The intent of the article was to assess the safety and immunogenicity of 4 doses of MENVEO administered concomitantly with routine vaccinations to infants at 2, 4, 6, and 12 months of age. This report refers to 1508 infants, whose age and gender were unspecified. The patient's medical history was not specified and concomitant medications given during this study included PEDIARIX (other manufacturer, batch number: not reported), INFANRIX (other manufacturer, batch number: not reported), ACT-HIB (other manufacturer, batch number: not reported), PREVNAR (other manufacturer, batch number: not reported), ROTATEQ (other manufacturer, batch number: not reported), PROQUAD (other manufacturer, batch number: not reported), MMR II (other manufacturer, batch number: not reported) and VARIVAX (other manufacturer, batch number: not reported); and hepatitis A vaccine (other manufacturer, batch number not reported). These infants were enrolled in a phase III, open-label randomized, parallel-group, multicenter study of healthy infants and were randomized 2:1 to receive MENVEO (MenACWY-CRM, batch number not specified) intramuscularly on to right thigh co administered with routine vaccines or routine vaccines only followed by MENVEO (MenACWY-CRM, batch number: not specified) in the second year of life. The patients were further enrolled into either the immunogenicity cohort or the safety-only cohort. Of the 1508 enrolled patients, 479 were enrolled into the immunogenicity cohort (320 randomized to receive 4 doses of MENVEO with routine vaccines; 159 to receive routine vaccines only followed by MENVEO at 12 and 15 months of age). The remaining 1029 were enrolled into the safety-only cohort (680 to receive 4 doses of MENVEO with routine vaccines; 349 to receive routine vaccines only followed by MENVEO in the second year of life). It was reported that on an unspecified date, 7 days after vaccination, there was 271 incidents of tenderness, 126 incidents of erythema and 89 incidents if induration at local site and incidents of rash, urticarial rash, change in eating habit, sleepiness, persistent crying, irritability, vomiting, diarrhea, and fever were 25, 7, 135, 257, 189, 416, 43, 63 and 46 respectively in MENVEO and routine vaccine, 6 months of age group. In MENVEO and routine vaccine, 12 months of age group; the incidents of local tenderness, local erythema, local induration, rash, urticarial rash, change in eating habit, sleepiness, persistent crying, irritability, vomiting, diarrhea, and fever were 177, 81, 44, 31, 3, 101, 149, 120, 271, 27, 61 and 49 respectively. The outcome of the events was not reported. The author concluded that MENVEO was highly immunogenic in infants and can be used in a 4-dose primary immunization series from 2 months of age to offer protection against these 4 meningococcal serotypes.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US003033, is an initial spontaneous report received from a nurse on 01 Feb 2012: This case refers to a female patient of unknown age. She was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: unknown) intramuscularly without reconstituting with Men A component on 30 Jan 2012. No adverse reaction had occurred following this administration error.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHEH2012US003161, is an initial spontaneous report received from a nurse on 02 Feb 2012 and with a follow up received on 27 Feb 2012. This case refers to 22-years-old male patient. The patient's medical history included of scoliosis and hernia, allergic to BACTRIM, AUGMENTIN and CT contrast. The patient was received only Men A lyophilized conjugate component of MENVEO vaccine (batch number: M10035), that was reconstituted with a sterile water instead of Men C, Y, W-135 liquid conjugate, intramuscularly into his left deltoid on 02 Feb 2012. No adverse reaction had occurred following this administration error. Later the patient was vaccinated with full product. Follow up information received from a nurse on 27 Feb 2012: Updated date of vaccination, medical history and description of the event.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Product preparation error
Clinical narrative: Case number PHEH2012US003181 is an initial spontaneous report received from a pharmacist on 31 Jan 2012 and with a follow up received on 22 Feb 2012: This report refers to a 17-year-old female patient. She was given only the Men A lyophilized component of MENVEO vaccine (batch number: A100133) reconstituted with a sterile diluent intramuscularly on 24 Jan 2012. Hence she was vaccinated with full dose of MENVEO intramuscularly on 05 Feb 2012. It was reported that the patient had a complaint of dizziness two days later (unspecified after which dose) and she had recovered within one day. Follow up information received from the pharmacist on 22 Feb 2012: Updated event and date of revaccination with full dose of MENVEO.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US003901 is an initial spontaneous report received from a physician on 14 Feb 2012 and a follow up received on 27 Feb 2012. This case refers to a 20-year-old male patient. He was vaccinated with MENVEO vaccine (batch number: X10047) intramuscularly on 30 Jan 2012. It was reported that this patient received only the MenCYW-135 liquid conjugate component of MENVEO vaccine; did not received the MenA lyophilized conjugate component of MENVEO vaccine. No adverse event was reported following this drug administration error. The patient was subsequently vaccinated with both the components. No other information was available at the time of this report. Follow up information received from the physician on 27 Feb 2012: update patient demographics and revaccinations with MENVEO.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 13 Aug 2010: This patient was vaccinated with MENVEO (batch number 100001), intramuscularly, on an unspecified date. The reporter stated that the patient was administered with only 0.4ml of MENVEO (correct dose is 0.5 ml). However, no adverse events occurred. The outcome of the event was not reported.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US003706 is an initial spontaneous report received from a nurse on 13 Feb 2012 and a follow up received from the nurse on 29 Mar 2012: This report refers to four patients of unknown age group and gender. They were given only MenA component of MENVEO vaccine (Batch number: X100062) reconstituted with another diluent instead of MenCYW component intramuscularly on undetermined dates. The reporter stated that they were not sure if the vaccines were properly mixed. The patients were doing fine and not experienced any adverse events. The physician made a decision to revaccinate these four patients in a month. Follow up information received from the nurse on 29 Mar 2012: Updated number of patients involved, and decision taken by physician for the drug administration error.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US003361 is an initial spontaneous report received from a consumer on 07 Feb 2012, with a follow up report received from consumer on 28 Feb 2012. This case refers to a 12-year-old female patient. Concomitant medications included TDAP (other manufacturer, batch number: unknown) given intramuscularly and varicella (batch number: unknown) given subcutaneously. She was inadvertently vaccinated with 0.5 ml intramuscular dose of MENVEO (batch number M100061) MenCWY liquid conjugate component without being reconstituted with MenA on 27 Dec 2011. She was it was reported that, upon realizing only one portion of the vaccine was administered, the nurse reconstituted the MenA component with MenCWY and re-administered the vaccine the same day. No adverse event had occurred since vaccination. Follow up report received from consumer on 28 Feb 2012: Updated concomitant medications.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a Novartis sales representative on 16 Apr 2010: This patient was vaccinated with MENVEO (batch number and dose unknown), intramuscular on an unspecified date. After vaccination, the patients arm began to swell up at the site of injection on an unspecified date. The physician advised the patient, to keep ice packs on the swollen site to reduce swelling. The outcome of the event was reported as unknown. Follow up report received from a physician on 26 Apr 2010: The patient was presented with localized pain, swelling at site which increased at 48 hour to 2 x 3 and cellulitis on an unspecified date. The patient was recommended with topical remedies and OTC medicines. The patient would be on antibiotics if required. The outcome of the event localized swelling at vaccination site was reported as completely recovered on 17 Apr 2010. The causality of the events were not reported. Follow up report received from a physician on 03 May 2010: The outcome of the events were reported as completely recovered and the causality of the events was assessed as related. Following an internal review on 10 May 2010 of the data received on 03 May 2010, it was noted that the event localized pain was not coded, therefore the event localized pain was added in the case.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial health care professional report received on 26 Apr 2010: This patient received inadvertently MENVEO (batch number unknown) only the MenCYW-135 liquid conjugate component of MENVEO intramuscularly whose batch was 090901 on 23 Apr 2010. It was reported that the nurse forgot to reconstitute the liquid component with the lyophilized component before vaccine administration. No adverse event had occurred.
Age: 51.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Initial consumer (Novartis Sales Representative) report received on 05 May 2010: This patient received MENVEO (unknown batch number) unknown dose, in bicep, intramuscular on 28 Apr 2010. On an unknown date, the patient experienced small dot at injection site which was itchy when the patient removed the band aid from the site. On 03 May 2010, the injection site was itchy and really red. On an unknown date, the patient applied ice pack to the affected area. On 05 may 2010, the site was warm to touch. The outcomes of the events was not reported.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 06 May 2010: This adolescent was vaccinated with MENVEO (batch number: 027011, 090901), (dose: unknown) intramuscularly on 30 Apr 2010. The patient was administered MENVEO that was not reconstituted before administration and the lyophilized portion was not administered. No adverse event had occurred.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a consumer via Novartis employee on 10 May 2010: This patient was vaccinated with MENVEO (batch number: no: 091991, 0290011), (dose: unknown) intramuscularly on 05 May 2010. The patient was administered MENVEO that was not reconstituted before administration and only the liquid portion was administered. No adverse event had occurred due to this inadvertent administration.
Age: 34.0
Sex: F
Vaccine: MNQ
Symptoms: Contusion
Clinical narrative: Initial consumer report received on 10 May 2010: This patient received MENVEO vaccine (batch no. not reported) on an unknown date. The patient experienced quarter size bruise one day after administration on 29 Apr 2010. The bruise was started to fade. The final outcome was reported as condition unchanged.
Age: 30.0
Sex: F
Vaccine: MNQ
Symptoms: Altered state of consciousness, Dizziness, Vertigo
Clinical narrative: Initial consumer report received on 10 May 2010: This patient received MENVEO vaccine (batch no. not reported) intramuscularly on 07 May 2010. After 3 hours of vaccination, the patient became very dizzy to the point that the room began to spin and that she had to hold on to the wall to ambulate. Although she felt very to passing out but she never did. The severe symptoms lasted approximately 5 hours. The dizziness lingered to a lesser degree over the weekend. The symptoms were completely resolved on 10 May 2010. Follow up report received from a consumer on 07 May 2010: The report was initially reported to Novartis on 07 May 2010 and not on 10 May 2010. Post vaccination, after one and half hours the patient became very dizzy to the point that the room began to spin and that she had to hold on to the wall to ambulate, she felt very close to passing out. The outcome of the events were reported as ongoing.  Following an internal review on 28 May 2010 for the data received on 07 May 2010: it was found that the events "hold on to the wall to ambulate" and "vertigo" were coded separate and now merged together as single event.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Induration, Mass, Peripheral swelling
Clinical narrative: Redness, swelling, hard lump on left arm.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain in L deltoid muscle at site of administration with limited range of motion with abduction of left shoulder due to pain. Radiates into left trapezius.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial health care professional report received on 11 May 2010: This patient received MENVEO (batch number for vial# 027011 and for box# 100001) unknown dose, intramuscular on an unknown date. It was reported that the patient inadvertently only received the liquid component of MENVEO without the lyophilized MenA conjugate component. No adverse event occurred.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial report from a health care professional on 10 May 2010: The patients were vaccinated with MENVEO, intramuscularly, on 10 May 2010. The  reporter stated that the vaccine was, unreconstituted and was left out at room temperature for up to 16 hrs. No further information was provided. Follow-up report received from a health care professional (medical assistant) on 26 May 2010: This child was vaccinated with MENVEO (batch no: 100003), (dose: unknown) on 10 May 2010. The reporter stated that, the vaccine that was administered was not refrigerated and it was at room temperature for 16 hours. The child had no reaction following this administration.
Age: 30.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Initial consumer (healthcare professional) report received on 07 May 2010: The patient received MENVEO (batch no. unknown), 0.5 ml once, intramuscularly, on 07 May 2010. The patient experienced lightheadedness on 07 May 2010. The outcome of event was reported ongoing.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 13 May 2010: This patient was vaccinated with MENVEO (batch no: 100003), (dose: unknown) intramuscularly on 29 Apr 2010. The patient was administered MENVEO without being reconstituted with the Men-A lyophilized component. No adverse event had occurred. The outcome of the event was not reported.
Age: 36.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: Initial report received from a health care professional on 10 May 2010: This patient was vaccinated with MENVEO (batch no: unknown), (dose: unknown), intramuscularly on 07 May 2010. On 07 May 2010, approximately 2 hours after injection, the patient experienced dizziness and nausea, the symptoms lasted for 24 hours. The outcome of the events was reported as recovered. Combined follow up report received from a consumer on 07 May 2010: The report was initially reported to Novartis on 07 May 2010 and not on 10 May 2010. It was reported that the patient was vaccinated with 0.5ml of MENVEO. It was reported that the after one and half hour of vaccination the patient experienced lightheadedness. The outcome of lightheadedness was reported as ongoing.
Age: 40.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a nurse on 10 Feb 2011: This patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number 100003) intramuscularly without being reconstituted with the MenA conjugate component on 03 Feb 2011. No adverse events were noted following this administration.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Initial report received from a nurse on 16 Feb 2011: This patient was vaccinated with MENVEO (batch number A100028) 0.5 ml dose, intramuscularly on 07 Feb 2011. The patient received MENVEO lyophilized powder reconstituted with saline instead of liquid conjugate component 07 Feb 2011. No other information reported. Follow- up report received from a nurse on 08 Mar 2011: Patient demographic updated. This patient was vaccinated with MENVEO into deltoid.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial report received from a nurse on 16 Feb 2011: This patient was vaccinated with MENVEO (batch number A100028) 0.5 ml dose, intramuscularly on 07 Feb 2011. The patient received MENVEO lyophilized powder reconstituted with saline instead of liquid conjugate component on 07 Feb 2011. No other information reported. Follow-up report received from a nurse on 08 Mar 2011: Patient demographic updated. This patient was vaccinated with MENVEO into deltoid. No adverse event occurred after following administration error.
Sex: U
Vaccine: MNQ
Symptoms: Underdose
Clinical narrative: Initial report received from a nurse on 03 Feb 2011: This patient was vaccinated with MENVEO (batch number M10030) on an unspecified date. Little less than 0.5 mL (not 0.2 mL) of MENVEO vaccine was obtained from the vial after reconstitution. The exact amount was not reported. No other information reported.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Antibody test abnormal, Antinuclear antibody positive, Arthralgia, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: Posterior Cutaneous Nerve Dysthesia.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Collagen-vascular disease, Complement factor C3, Complement factor C4 decreased, Connective tissue disorder
Clinical narrative: Posterior Cutaneous Nerve Dysthesia.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dysaesthesia, Dyspnoea, Electromyogram abnormal, Hypoaesthesia, Hyporeflexia
Clinical narrative: Posterior Cutaneous Nerve Dysthesia.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Mononeuritis, Nerve conduction studies, Neuropathy peripheral, Palpitations, Protein urine present
Clinical narrative: Posterior Cutaneous Nerve Dysthesia.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid factor negative, Systemic lupus erythematosus, X-ray
Clinical narrative: Posterior Cutaneous Nerve Dysthesia.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: About a 2 inch area around Zostavax injection site was red and swollen.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction, Pain in extremity, Skin mass, Skin reaction
Clinical narrative: I administered the Boostrix vaccine under a protocol with Dr. through pharmacy on 06/10/16. I did counsel the patient before administration on the potential side effects of the vaccine. I observed the patient after administering the vaccine and he did not report any adverse effects at that time. Patient called me on 06/14/16 to report and adverse reaction, wondering if it was from the vaccine. Patient said on 6/12/16 in the morning his immunized left arm and right leg were sore. Then that evening, hard lump under the skin developed (Dr. described as "local skin reaction" per phone call after examination 06/17/16 4:47pm) at injection site and then on knuckle on middle finger. Patient reported these reactions to me 06/14/17. I let his regular physician know about the reaction. She said he had an appointment scheduled friday 6/17/16 anyways and they would check on his reaction then. Dr. said it was difficult to tell if the lumps were from the vaccine itself, but that it could be a local skin reaction. He said there was no abcess or anything like that. He said it may be due to sensitization of the skin. Patient said he is no longer sore and that the lumps are healing. Additionally, our refrigerator went out of range on Friday June 3, 2016. It got up to 50 degrees F, and was out of range for 1 hour and 30 minutes. I called GlaxoSmithKline Manufacturer on 6/6/2016, and they faxed us information stating "From the time the vaccine arrives at the healthcare professional's (HCP) facility/pharmacy until it is administered, a maximum cumulative time of 168 hours is permitted for the vaccine to be at temperatures above 8 degrees Celsius through 25 degrees Celsius (above 46F through 77F). The stability information provided here does not apply to temperature excursions that may occur during shipping and/or transportation before arrival to the HCP facility/pharmacy. If these conditions are met, the expiry date on the vaccine's label or packaging still applies." She also told me verbally it was okay to use until the expiration date under these conditions.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Dysarthria, Electroencephalogram normal, Seizure like phenomena, Syncope
Clinical narrative: Within 24 hours of immunization patient experienced slurred speech, syncope, and seizure like episodes.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from the health care professional (nurse) on 21 Jul 2010: On 21 Jul 2010, this child was vaccinated with an intramuscular injection of only the MenCWY conjugate of MENVEO (batch number: 091101), (dose: unknown) without being reconstituted with the MenA component. No adverse effects were noted following this administration.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a health care professional (medical assistant) on 23 Jun 2010: This patient was vaccinated with only the diluent portion of MENVEO (batch number: 090901), (dose: 0.5 ml) intramuscularly on 20 Jun 2010. The lyophilized portion was not reconstituted. The patient had not yet received additional dosing with MENVEO. No adverse event was reported following this administration.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial nurse report received on 21 Jul 2010: This patient received MENVEO (batch number: 090901) unknown dose intramuscularly on 15 Jul 2010. It was report that on 15 Jul 2010, the patient was administered only the liquid Men CWY conjugate component of MENVEO instead of being reconstituted with Men A conjugate component. No adverse event had occurred due to this. The outcome and causality was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a health care professional (medical assistant) on 21 Jul 2010: This child was vaccinated with only the MenCWY conjugate of MENVEO (batch number: 091101), (dose: unknown) intramuscularly, without being reconstituted with the MenA component. No adverse effects were noted following this administration.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 28 Jul 2010: On 28 Jul 2010, this patient inadvertently received a 0.5 ml, intramuscular dose of MenA component of MENVEO (batch number: not reported) that was diluted with sterile water. No adverse effects were noted following this administration.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Nodule, Pruritus, Skin warm
Clinical narrative: Redness on left arm, 7.5 cm slightly warm circular nodule, no streaking, no pus, little itching.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Patient returned to pharmacy with a 2" diameter red circle with warm to the touch. Pharmacist recommended patient to see physician because it may be infected.
Age: 0.61
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Diarrhoea, Irritability
Clinical narrative: Temp 102 degrees x 3 days; x2 loose stools and fussiness.
Age: 23.0
Sex: F
Vaccine: FLU3, HEP, HEPA, HPV9, MNQ, TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: 6/16/2016 a client came to PHC on 5/9/16 to received vaccines which include MMR, Hep A, HPV9, MCV4 - Flu - Tdap, Hep B. She was screened as usual and denied being pregnant. Today she returned to the PHC to report to us that she is pregnant. Our plan would be to refer to her doctor and refer her to another office to assist.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose increased, Glucose urine present, Pollakiuria, Type 1 diabetes mellitus, Urine analysis abnormal
Clinical narrative: HPV vaccine was received in April and June, and she was seen in our office on June 16th for frequent urination. Tests performed in the office indicate new onset Type 1 Diabetes.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Urine ketone body present
Clinical narrative: HPV vaccine was received in April and June, and she was seen in our office on June 16th for frequent urination. Tests performed in the office indicate new onset Type 1 Diabetes.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site mass, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt had a hard lump at injection site as well as in left elbow. Pt also had a warm rash on her entire upper arm. The rash is itchy. Rash is moving down her arm.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Pt had red circular spots on arm, thigh (R), stomach. She claims spots appeared w/in 1 day of vaccine administration. No itch, pain, open sores. Pt's PCP was informed by RPH 6/17/16 and pt was instructed to go see PCP at 6/17/16 3:45 pm.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, and tenderness to left upper arm at injection site. Began one hour after vaccine administered. Treated with MEDROL dose pack.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Hypersensitivity, Injection site urticaria, Vaccination complication
Clinical narrative: Had a wheal raised 10 x 14 cm on the right upper arm, no fluctuance/no tender. Today was sent with hydroxyzine and hydrocortisone . Advised mother that if still worsening need to return to the clinic or ER. Warm compress. FU 3 days.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Local reaction, Pain, Pruritus
Clinical narrative: Patient reported localized reaction including redness, itchy and slightly painful. Patient noticed last evening and has not grown in size today. Pt reported the area to be 4x3 inches and no fever.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Administered 6/3/16. Mom advised office of rash on 6/7/16. Office visit on 6/7/16 for ongoing persistent rash. Mom states rash started 24 hours after administration of immunizations.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling hot, Nausea, Skin warm, Throat irritation, Throat tightness
Clinical narrative: 3:35 pm V/S: BP 133/75 HR 85 Pulse ox 96%. Patient c/o abdomen feeling "hot", queasiness and feeling warm all over. C/O throat tightness. No stridor. COR RRR without murmur. 8:40-4:19 pm: Rec'd epinephrine, albuterol, BENADRYL, prednisone. V/S remained stable. 5:00 pm - Throat felt tickly. Epi given and pt transported to ER 5:02 pm.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error
Clinical narrative: Initial nurse report received on 12 Jul 2010: This patient received MENVEO (batch no: 10004), (dose unspecified), intramuscularly on an unspecified date. The reporter stated that the patient was inadvertently administered with only liquid MenCWY component instead of being reconstituted with the MenA component. The outcome of the event and causality were not reported. Follow up information received from the nurse on 20 Jul 2010: It was reported that, the batch number of the MENVEO vaccine was 100004 (previously reported as 10004). It was also stated that, there were three patients who received MENVEO vaccination, but it was not clear that out of three patients which patient inadvertently administered with only liquid MenCWY component instead of being reconstituted with the MenA component. There fore all the three patients were revaccinated with MENVEO on an unspecified date.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY2011US31279 is an initial spontaneous report received from a nurse on 12 Apr 2011 with a follow up report from nurse on 03 May 2011. This report concerns an 11-year-old girl. She was vaccinated with MENVEO (batch number: 024011) 0.5 ml, intramuscularly on 21 Feb 2011. She concomitantly received BOOSTRIX (batch number: AC5B048AC) on 21 Feb 2011. She received only the Men CYW-135 liquid conjugate vaccine component of the vaccine and did not receive the Men A lyophilized conjugate component. No adverse event was reported following this drug administration error. Non significant follow up report was received on 12 Apr 2011: No new information was provided. Follow up information received on 03 May 2011: Patient demographics, vaccination details and concomitant vaccine updated.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 25 Jun 2010: This patient was vaccinated with only the liquid conjugate of MENVEO (batch number 090901), (dose: unknown) intramuscularly on an unspecified date. No adverse reaction had occurred following this administration. Follow up report received from a physician on 07 Jul 2010: The patient was vaccinated on 23 Jun 2010 and the batch number for MENVEO was reported as 100002.
Sex: U
Vaccine: MNQ
Symptoms: Product container issue, Underdose
Clinical narrative: Initial report received from a nurse on 25 Jun 2010: This patient was vaccinated with MENVEO (batch number 028011/091001), (dose unspecified), on an unknown date. The customer reported of trouble in withdrawing the full amount from the reconstituted vaccine. The reporter stated that they were withdrawing every thing from they can get out of the liquid component (which according to nurse is 0.5 ml at best), leaving a little air in the syringe and inserting into the lyophilized powder. From they were swirling/shaking for 15-20 seconds. According to the reporter the rubber stopper in the lyophilized vial is "too attached to the sides of the glass" and was unable to get full 0.5 ml dose. The reporter stated that no doses were discarded and the entire dose was administered to the patient but often they are only getting 0.3 or 0.4 ml out. The outcome of the event was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a health care professional (medical assistant) on 28 May 2010: This patient was vaccinated with MENVEO (batch number: 100001), (dose: unknown) intramuscularly on 28 May 2010, instead of combining the diluent component of MENVEO with the lyophilized component, the patient received only the diluent component of MENVEO. No adverse effects were noted after this administration.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial report received from a health care professional (nurse) on 20 Jul 2010: This patient received an intramuscular injection of only the lyophilized Men A powder of MENVEO (batch number: 029011), (dose: unknown) that was reconstituted with sterile water for injection rather than with the Men CWY conjugate component on 15 Jul 2010. No adverse events were noted following this administration. Follow up nurse report received on 02 Aug 2010: It was reported that the patient had medical history of acne and adolescent postural kyphosis. Patient's demographic was updated. No other information was reported.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a nurse on 23 Jun 2010: This patient was vaccinated with MENVEO (batch number: 091001) unknown dose, intramuscularly on 27 May 2010. The patient was only administered the diluent portion of MENVEO, rather than being reconstituted with the lyophilized portion. However, the patient received a full reconstituted dose of MENVEO on 28 May 2010. No adverse event occurred.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial nurse report received on 07 Jul 2010: This patient received MENVEO (batch no: 100022) 0.5 ml dose intramuscularly on 06 Jul 2010. It was reported that the patient only received the diluent portion of MENVEO, rather than being reconstituted with the lyophilized powder. No adverse event was reported. The outcome of the event was not reported. The causality was not reported.
Age: 30.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Underdose
Clinical narrative: Case number PHHY2011US33910 is a combined initial and follow-up spontaneous report from a pharmacist on 19 Apr 2011. This report concerns a 30-year-old female patient. She was vaccinated with MENVEO (batch number: 100001) intramuscularly on 19 Apr 2011. The pharmacist was not able to draw the 0.5 ml complete dose into the syringe. The patient received less than 0.5 ml dose (more than 0.4 ml but less than 0.5 ml). No adverse event was reported following this underdose.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a consumer on 08 Jul 2010: on 06 Jul 2010, this patient received only the 0.5 ml intramuscular dose of the diluent portion of MENVEO (batch number: 100003, 100005). No adverse effects were noted following this administration.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2011US33607 is an initial spontaneous report received from a health care professional (HCP) on 19 Apr 2011. This report concerns an 18-year-old female patient. Her medical history was not reported. She was vaccinated with MENVEO (batch number: 100003, expiry date: Aug 2011) 0.5 ml dose, intramuscularly on 18 Apr 2011 which was stored incorrectly at a temperature of 55 F, one hour every night for one month. No adverse event was reported.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a health care professional (medical assistant) on 23 Jun 2010: This patient was vaccinated with only the diluent portion of MENVEO (batch number: 090901), (dose: 0.5 ml) intramuscularly on 07 Jun 2010. The lyophilized portion was not reconstituted. The patient had not yet received additional dosing with MENVEO. No adverse event was reported following this administration.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) on 20 Jul 2010: On 19 Jul 2010, this child received 0.5 ml intramuscular dose of only the MenCWY component of MENVEO (batch number: 100001), instead of being reconstituted with the MenA lyophilized component. No adverse events were noted following this administration. Follow up report received from the health care professional (nurse) on 27 Jul 2010: The doctor's office did not consider this incidence to be an adverse event and did not wish to provide any further information.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 14 Jun 2010: This patient was vaccinated with MENVEO (batch number: 091001) intramuscularly on an unspecified date. The patient was inadvertently administered only the MenCYW-135 liquid conjugate component of MENVEO. No adverse event had occurred following this administration. Follow up information report from nurse received on 20 Jul 2010: The patient demographics were updated. This patient was vaccinated with MENVEO on 14 Jun 2010. The patient received only liquid portion of vaccine and advised to return for to receive powder-A (lyophilized) component of vaccine. The outcome of event was reported completely recovered on 14 Jun 2010.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a health care professional (nurse) via Novartis representative on 25 May 2010: This patient was vaccinated with MENVEO (batch no: 100001), (dose: unknown) intramuscularly on 24 May 2010. The patient was administered only the diluent portion of MENVEO. No adverse event had occurred. Follow up report received from a physician on 16 Jun 2010: The patient was not vaccinated again, no action was taken.