chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint stiffness, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: States that a couple of days after she got her first MMR vaccine on 3/1 she started to have pain, aching and swelling. States it was mild at first and then flared up and was more severe, a couple of days before the 2nd vaccine it was much better and her hands were better. After the  2nd MMR vaccine on 4/5/16 she has had pain and swelling in her hands and wrists every since. States she only has pain in the wrists and hands. She states that she is having pain of 7/10 in both hands and both wrists, feels like they are tight and feels like rubber bands are being pulled and every one of the joints ache. Can't put rings on. States it is hard to make a fist since hands are swollen. States she has been taking Ibuprofen 400-600 mg PO every day one dose and has been using ice to hands every night. The ice helps the pain some for a little while. States nothing makes the pain worse. Will be sending to a physician for follow up and possible treatment.
Age: 9.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine Was Given In Error.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain in extremity, Swelling
Clinical narrative: Initial unsolicited report received from a physician on 14 April 2016. This case involves a 74-year-old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HD batch number UI434AA, expiry date 04 April 2016, intramuscularly in the left deltoid on 30 March 2016 at 8:30 am. The patient also received a 0.5 ml dose of PREVENAR 13 batch number M56417, expiry date 01 June 2017, intramuscularly in the left deltoid on 30 March 2016 at 8:30 am. It was reported that no other vaccines were given within four weeks prior to the vaccination date. The patient had a medical history of arthritis (localized in left knee, Osteoarthritis of left and right knee, from 30 Mar 2016 which was ongoing), type 2 diabetes mellitus (from 30 Mar 2016 which was ongoing), hypertension (from 30 Mar 2016 to ongoing), immunization reaction (from 08 April 2016 to ongoing), obesity (unknown date, unknown outcome), endometrial cancer (unknown date, unknown outcome), lipoma (unknown date, unknown outcome), foot pain, vitamin D deficiency. The patient had no known allergies. Concomitant medications included Benazepril for hypertension (10 mg, one tablet daily by mouth, from 06 August 2013 to ongoing), Glipizide for Type 2 diabetes mellitus (5 mg, one tablet twice a day by mouth, from 05 April 2016 to ongoing), hydrochlorothiazide for Hypertension (25 mg, one tablet every day by mouth, from 13 January 2014 to ongoing), fish oil for health maintenance (1000 mg, one capsule daily by mouth, from 28 April 2011 to ongoing) and calcium for health maintenance (500 mg, one tablet per day by mouth, from 11 October 2012 to ongoing). On an unspecified date, following the vaccination, the patient experienced left arm was hurting and could barely lift it at times (she had severe pain to left upper arm), pain into her neck (arm pain was moving into her neck), swelling and possible nerve irritation due to the injection. Patient had no lab data (relevant tests). The patient received corrective treatment with over the counter pain medicines, tramadol and physical therapy. The patient required doctor visit. The outcome for the events was reported as recovering (swelling had improved, there was some improvement in the original symptoms but she still had left upper arm pain). The reporter assessed the causal relationship with suspect vaccines as related. List of documents held by sender: none.
Age: 8.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Vaccination error
Clinical narrative: Vaccine Given In Error.
Age: 12.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Vaccination error
Clinical narrative: Vaccine Was Given In Error.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Dry eye, Erythema, Eye pruritus, Fatigue
Clinical narrative: Flu shot: face redness, whites of both eyes bright red, fever, fatigue, body soreness, extreme abdominal pain lasting through the night, nasal congestion, dry itchy eyes, sleepiness, nausea, bright purple red gums, swollen lymph nodes.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Gingival discolouration, Lymphadenopathy, Nasal congestion, Nausea, Ocular hyperaemia
Clinical narrative: Flu shot: face redness, whites of both eyes bright red, fever, fatigue, body soreness, extreme abdominal pain lasting through the night, nasal congestion, dry itchy eyes, sleepiness, nausea, bright purple red gums, swollen lymph nodes.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: Flu shot: face redness, whites of both eyes bright red, fever, fatigue, body soreness, extreme abdominal pain lasting through the night, nasal congestion, dry itchy eyes, sleepiness, nausea, bright purple red gums, swollen lymph nodes.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US025262, is an initial spontaneous report received from a nurse on 12 DEC 2014. This report refers to a 17 years old female patient. Past medical history and concomitant medication were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M14025), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 13 NOV 2014. No adverse event was reported following this administration error (inappropriate preparation of medication).
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US025267, is an initial spontaneous report received from a nurse on 12 DEC 2014, with a follow up report received from the nurse 10 FEB 2015. This report refers to a 22 years old female patient. Medical history and concomitant medication were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M14025) intramuscularly in left deltoid without being reconstituted with Men A lyophilized conjugate vaccine component on 21 NOV 2014 at 11:45 AM. No adverse event was reported following this administration error (inappropriate preparation of medication). Follow up report received from the nurse on 10 FEB 2015: Updated patient demographics and vaccination details.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US025472 is an initial spontaneous report received from a medical assistant on 10 DEC 2014. This report refers to an 11 years old male patient. His medical history and concomitant medications were not reported. On an unknown date, he was intramuscularly administered Men A lyophilized powder conjugate of MENVEO (batch number: A14057) mixed with another sterile diluent instead of MenCYW-135 liquid component. No adverse events were reported following the medication error.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Computerised tomogram, Electrocardiogram, Laboratory test, Loss of consciousness, Syncope
Clinical narrative: SYNCOPE WITH LOC.
Age: 14.0
Sex: M
Vaccine: JEV1
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Nausea, Vomiting
Clinical narrative: Nausea, vomiting for 4 days, then felt better by 5/18. Was given Japanese Encephalitis Vaccine on 5/18 as she failed to give history of illness at the travel appointment. Then worse again.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US002786, is an initial spontaneous  report received from a nurse on 04 FEB 2015. This report refers to an 11 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with TDAP (unknown manufacturer, batch number: not reported) on 04 FEB 2015. She was also inadvertently vaccinated with only Men A lyophilized component of MENVEO (batch number: M14042) reconstituted with normal saline instead of Men CWY liquid component intramuscularly on 04 FEB 2015. No adverse events reported after the maladministration (inappropriate preparation of medications.
Age: 2.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Vomiting
Clinical narrative: On 05/20/2016, after receiving the Hep A and Hep B vaccine, patient had a very poor appetite. That was very rare. Saturday, patient satrted vomiting after eating applesauce followed by explosive watery diarrhea. He started complaining of stomach pain around 3PM. I started giving him children's motrin with crackers. I tried feeding him rice, bananas a and crackers. Everthing that went in, came out. Sunday, I started giving him peidalyte. He consumed about 6 ounces of pedialyte across the day.He continued taking small bites of food few times a day. He eat 1/2 cup of chicken noodle soup with 1 package of children's probiotics that was mixed in 1 full can of soup. He had a BM 1 hour later. The Bm had chunks of stool for the first time since Saturday. The BM still had plenty of water in it. Today is Monday, he is still vomiting, complaining of stomach pain, poor apetite and having loose stools. Patient's last normal BM was around 12:45 PM on 5/20/2016.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pruritus
Clinical narrative: The area where she received Immunization is pink. It was itching 2 days ago but is not itching anymore.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: About 30 minutes after leaving office, patient described pain and numbness of arms and legs, then chest pain and sudden onset of pounding headache.  Nausea and vomiting, loss of consciousness.  Transported to ER and treated with IV steroid and diphenhydramine; improved.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Headache, Pain, Vomiting
Clinical narrative: Since 12:00 AM pt states she has been vomiting, experiencing abdominal pain, headache and body aches. Pt denies fevers or redness to injection site.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Infant was well on examination at visit when got her vaccines but was  apparently found unresponsive that night.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Diplopia, Dizziness, Electrocardiogram, Gait disturbance
Clinical narrative: Dizziness, double vision, numbness in the arms and legs, tingling in the hands and feet. Muscle weakness, vomiting and difficulty walking.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Dizziness, double vision, numbness in the arms and legs, tingling in the hands and feet. Muscle weakness, vomiting and difficulty walking.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Scan with contrast, Ultrasound scan, Vomiting, X-ray
Clinical narrative: Dizziness, double vision, numbness in the arms and legs, tingling in the hands and feet. Muscle weakness, vomiting and difficulty walking.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US002129, is an initial spontaneous report received from a nurse on 28 JAN 2015. This report refers to a male patient of unknown age. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M14069) intramuscularly on 21 JAN 2015. It was reported that MENVEO was stored at temperature of -0.8 degree C and 2 degree C on an doff for one to six hours. It was also reported that MENVEO was not frozen during this temperature excursion based on visual inspection. No adverse events reported after the maladministration (incorrect storage of drug).
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Myalgia, Pyrexia
Clinical narrative: Case number PHEH2014US022984 is an initial spontaneous report received from a nurse on 13 NOV 2014. This report refers to an 18 year old male patient. His past medical and concomitant medications were not reported. On 12 NOV 2014, he was vaccinated with MENVEO (batch number: A14071) intramuscularly. On the same day after the vaccination, he developed fever, muscle aches and had dizziness. The outcome, seriousness and causality of the events was not reported.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003141, is an initial spontaneous report received from a nurse on 10 FEB 2015. This report refers to a n 11 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 14 JAN 2015, MENVEO (batch number: M14071, expiry date: NOV 2015) was at 0.4 degree Celsius for 1 hour and 16 minutes and the patient received 0.5 ml intramuscular dose of this frozen vaccine with excursion on 30  JAN 2015. The vaccine had two more other excursion as follows: on 26 JAN 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 JAN 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2015US000477, is an initial spontaneous report received from a physician on 02 JAN 2015, with a follow up received from physician on 28 JAN 2015. This report refers to a 16 years old female patient. Past medical history and concomitant medication were not reported. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: unknown) intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 02 JAN 2015. The patient did not experience any side effects following this administration error (inappropriate preparation of medication). Follow up received from physician on 28 JAN 2015: updated physician comment.
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2014US018594, is an initial spontaneous report from a nurse received on 12 SEP 2014. This report refers to a 24-year-old female pregnant patient. Past medical history and concomitant medications were not reported. Her last menstrual date was 10 APR 2014. This pregnant patient received MENVEO (batch number: unknown) intramuscularly on 04 AUG 2014. No adverse event reported after vaccination.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2015US001680, is an initial spontaneous report from a pharmacist received on 20 Jan 2015. This report refers to an 18-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: X14044) without being reconstituted with MenA intramuscularly on 12 Jan 2015. No adverse event was reported following the administration error (inappropriate preparation of medication).
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Case number PHEH2014US016823 is an initial spontaneous report received from a nurse on 20 Aug 2014 with a follow up information received from a nurse on 23 Sep 2014. This report refers to a 14-year-old female patient. Past medical history and concomitant medication were not provided. She was vaccinated with initial dose of 0.5 ml MENVEO (batch number: M14031) intramuscularly in the right arm on 08 Aug 2014. On the same day, she was also concomitantly vaccinated with 0.5 ml of GARDASIL (other manufacturer and batch number: K001500) intramuscularly in the left arm. On 09 Aug 2014, a day after vaccinations, she experienced arm swelling at injection site of right arm larger than a baseball and pain in arm. She started KEFLEX as treatment for 10 days. The outcome was reported as complete recovery. Seriousness and causality of the event were not reported. Follow up information received from a nurse on 23 Sep 2014: Patient demographics (height and weight), site of vaccination of MENVEO and GARDASIL, event (pain in arm), treatment and outcome updated. GARDASIL was changed as concomitant vaccination.
Age: 11.0
Sex: F
Vaccine: MNQ, PNC, TTOX
Symptoms: Pyrexia
Clinical narrative: Case number PHEH2014US017356, is an initial spontaneous report from a physician received on 26 Aug 2014. This report refers to an 11-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: unknown) intramuscularly on an unknown date. On the same day, she was also vaccinated with tetanus vaccine (manufacturer and batch number unknown) and PREVNAR (batch number: unknown, other manufacturer). It was reported that she experienced fever with temperature of 103.5 degrees Fahrenheit about 5 hours after receiving vaccinations. Seriousness, outcome and causality of the event were not reported.
Age: 44.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Case number PHEH2014US016989, is an initial spontaneous report from a pharmacist received on 21 Aug 2014. This report refers to a 44-year-old male patient. Past medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: A13011) intramuscularly on 20 Aug 2014. On the same day, post vaccination, he experienced fever, nausea and headache. Seriousness, outcome and causality of the events were not reported.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2014US071306 is an initial spontaneous report from a medical assistant received on 26 Aug 2014, with a follow up received from physician on 29 Sep 2014. This report refers to a 13 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml of MENVEO (batch number: A14022) intramuscularly into left arm on 25 Aug 2014 at 04:00 PM. On the same day after vaccination, he experienced swelling and mass of baseball size at the injection site that was warm to touch. He called on 26 Aug 2014 and stated he was feeling better. The final outcome of the events was completely recovery on an unknown date. Seriousness and causality was not reported. Follow up received from physician on 29 Sep 2014: updated patient demographics, time of vaccination, batch number, event onset dates, outcome of the events and other clinically relevant information in the narrative.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Vaccination site erythema, Vaccination site oedema
Clinical narrative: Case number PHEH2014US017313 is an initial spontaneous report received from a health care professional on 22 Aug 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medications were not reported. Her vaccination status was reported as up to date. She was vaccinated with initial dose of MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly in the left deltoid on 23 Jul 2014 at 9:09. It was reported that 18 to 24 hours after vaccination, on 24 Jul 2014, she experienced red and edematous area at the area of vaccination (site). It was reported that the patient was diagnosed with a vaccine reaction. The events outcome was reported as complete recovery on 27 Jul 2014. The seriousness and causality were not reported.
Age: 21.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2015US003393, is an initial spontaneous report from a pharmacist received on 16 Feb 2015 and with a follow up report received on 24 Mar 2015. This report refers to a 21-year-old male patient. Historical conditions were not reported. Concomitant medication included BOOSTRIX. He was administered only MenCYW-135 liquid component of MENVEO (batch number: X13064) without being reconstituted with Men A, intramuscularly on 14 Feb 2015. No adverse event was reported following the administration error (inappropriate preparation of medication). Follow up report received on 24 Mar 2015: Added concomitant medication BOOSTRIX and narrative was updated.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site oedema
Clinical narrative: Case number PHEH2014US017316 is an initial spontaneous report received from a health care professional on 22 Aug 2014. This report refers to a 12 years old male patient. His medical history and concomitant medications were not reported. His vaccination status was reported as up to date. He was vaccinated with initial dose of MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly in the left deltoid on 24 Jul 2014 at 11:47. It was reported that 18 to 24 hours after vaccination, on 24 Jul 2014, he experienced red and edematous area at the area of vaccination. It was reported that the patient was diagnosed with a vaccine reaction. The events outcome was reported as complete recovery on 28 Jul 2014. The seriousness and causality were not reported.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024164 is an initial spontaneous report received from a health care professional on 01 Dec 2014. This report refers to a 16 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A14030) intramuscularly at a dose of 0.5 ml on 18 Nov 2014. It was reported that the vaccine reached 0 to 1 degree C sporadically for 3 days when it was not reconstituted and was subsequently administered to the patient. The reporter stated that the vaccine did not freeze and it was the first occurrence. No adverse events were reported following the maladministration.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination site erythema, Vaccination site oedema
Clinical narrative: Case number PHEH2014US017320 is an initial spontaneous report received from a health care professional on 22 Aug 2014. This report refers to a 12 years old male patient. His medical history and concomitant medications were not reported. His vaccination status was reported as up to date. He was vaccinated with initial dose of MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly in the right deltoid on 22 Jul 2014 at 10:36. It was reported that 18 to 24 hours after vaccination, on 22 Jul 2014, he experienced red and edematous area at the vaccination (site). It was reported that the patient was diagnosed with a vaccine reaction. The events outcome was reported as complete recovery on 26 Jul 2014. The seriousness and causality were not reported.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2015US003408, is an initial spontaneous report received from the nurse on 16 Feb 2015. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with partial dose of Men A component of MENVEO (batch number: M14089) reconstituted with sterile water intramuscularly on 12 Feb 2015. No adverse events reported after the maladministration (wrong solution used in drug reconstitution).
Age: 36.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Injection site pain, Myalgia, Nausea
Clinical narrative: Case number PHEH2014US019131, is an initial spontaneous report from a nurse received on 22 Sep 2014. This report refers to a 36-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: A12104) intramuscularly on 19 Sep 2014. On 22 Sep 2014 around 5:00 AM, he experienced heat and pain at the injection site, muscle aches, felling tired and nausea. He took over the counter (OTC) strengths of TYLENOL and ibuprofen for the pain. The outcome of the events was unknown. Seriousness and causality was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Case number PHEH2014US019258, is an initial spontaneous report received from a health care professional on 23 Sep 2014, with the follow-up received on 27 Oct 2014. This report refers to an 11 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13014), at a dose of 0.5 ml intramuscularly on 21 Apr 2014 at 11:32 AM. Post vaccination, on an unknown date, she experienced redness and knot at the injection site. Outcome of the events was reported as complete recovery. Seriousness and causality of the events was not reported. Follow-up received from health care professional on 27 Oct 2014: Updated patient demographics (gender, height and weight), vaccine batch number, dose, route, date and time of vaccination and event outcome.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003159, is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to a 17 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 29 Jan 2015, the patient received MENVEO (batch number: M14701, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly. It was reported that the patient received the vaccine that was frozen with excursions as follows: on 14 Jan 2015, the vaccine was 0.4 degree Celsius for 1 hour and 16 minutes and on 26 Jan 2015, the vaccine was 0.8 degree Celsius for 36 minutes. No adverse events were reported following the maladministration.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Extensive swelling of vaccinated limb, Headache, Peripheral swelling, Pyrexia
Clinical narrative: Case number PHEH2014US020299, is an initial spontaneous report received from a consumer on 08 Oct 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A14030) intramuscular on 13 Aug 2014. On the same day he experienced fever, headache, swollen arm including armpit and raised lacy rash which lasted 3 days. The final outcome of the events was recovered on 16 Aug 2014. Seriousness and causality assessment was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2014US012541 is an initial spontaneous report received from a nurse on 19 Jun 2014. This report refers to an 11 year old female child. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12098, expiry date: 03 Jul 2015) intramuscularly at a dose of 0.5 ml on 17 Jun 2014. On 18 Jun 2014, she developed swelling and redness at vaccination site which was about the size of a baseball. The outcome, causality and seriousness were not reported.
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003157, is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 12 year old patient of an unknown gender. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly on 09 Feb 2015. It was reported that the vaccine was frozen with excursion at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, 0.8 C for 36 minutes on 24 Jan 2015 and 0.6 C for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error (incorrect storage of drug).
Age: 13.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003158, is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to a 13 years old patient whose gender was not reported. This patient's medical history and concomitant medications were not reported. On 04 Feb 2015, the patient received MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly. It was reported that the patient received the vaccine that was frozen with excursions as follows: on 14 Jan 2015, the vaccine was 0.4 degree Celsius for 1 hour and 16 minutes, on 26 Jan 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 Jan 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003162, is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to a 12 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 03 Feb 2015, the patient received MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly. It was reported that the patient received the vaccine that was frozen with excursions as follows: on 14 Jan 2015, the vaccine was at 0.4 degree Celsius for 1 hour and 16 minutes, on 26 Jan 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 Jan 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.
Age: 58.0
Sex: F
Vaccine: MNQ
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Case number PHEH2015US003414, is an initial spontaneous report received from a nurse on 13 Feb 2015, with a follow up report received on 18 Mar 2015. This report refers to a 58-year-old female patient. Historical condition and concomitant medication were not reported. On 13 Feb 2015, the nurse was about to vaccinate a subject when the MENVEO (batch number: A14057) accidentally splashed onto nurse cheeks and face. It was reported that before vaccine withdrawal, nurse did not attach the needle tightly with the syringe. She tried to withdraw the syringe from Men-CYW-135 vial and the vaccine component splashed on her face (cheeks). She immediately washed her face and insisted that it did not enter into her eyes. The patient also reported that there was no fault with the vaccine and the incident happened due to human error. Patient did not experience any event except inadvertent exposure of vaccine. Follow up report received on 18 Mar 2015: Information regarding patient demographics was updated and batch number of MENVEO was update from M14057 to A14057.
Age: 74.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: RED WARM RASH NOTED ON OVER LEFT DELTOID AREA WARM TO TOUCH ITCHY.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Nausea
Clinical narrative: Case number PHEH2014US005998 is an initial spontaneous report from the physician received on 25 Mar 2014, with a follow up received from physician on 08 Apr 2014. This report refers to a 17-year-old female patient. Past medical history was not reported. Concomitant medications were none. She had no vaccination history. She was vaccinated with MENVEO (batch number: A13059) on 24 Mar 2014. On 25 Mar 2014, she experienced headaches and nausea for a couple of days. it was reported that she did not have vomiting or diarrhea symptoms. The final outcome of the events headache and nausea was completely recovery. Seriousness and causality of the events were not reported. Follow up received from physician on 08 Apr 2014: Updated outcome of the events.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003136, is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to an 11 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 14 Jan 2015, MENVEO (batch number: M14071, expiry date: Nov 2015) was at 0.4 degree Celsius for 1 hour and 16 minutes and the patient received 0.5 ml intramuscular dose of this frozen vaccine with excursion on 09 Feb 2015. The vaccine had two more other excursion as follows: on 26 Jan 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 Jan 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema
Clinical narrative: Case number PHEH2014US007736 is an initial spontaneous report received from a medical assistant on 16 Apr 2014. This report refers to a 17 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M11042) intramuscularly on 30 Mar 2014. On31 Mar 2014, next day after vaccination, the vaccination site was red. Warm compressions were applied on the vaccination site and it became bigger by the third day. The outcome of the event was condition deteriorated by the third day. The seriousness and causality of the event were not reported.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Injection site erythema, Injection site inflammation, Injection site mass, Injection site warmth
Clinical narrative: Case number PHEH214US009913, is a spontaneous report from a nurse received on 13 May 2014, with follow up received from a nurse on 30 Jun 2014. This report refers to a 17-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO(batch number: NOVM13017) at a dose of 0.5 ml intramuscularly into the left deltoid on 07 May 2014. On 08 May 2014, she experienced low grade fever, body aches, dizziness and a lump at the injection site. The quarter size redness at site of vaccination increased each day. Also she had warmth at site of vaccination. She was examined on 12 May 2014, as redness had increased to 4 into 4 cm area with a slight appearance of inflammation at site. The final outcome of the events was complete recovery. Causality was not reported. Follow up received from a nurse on 30 Jun 2014: Updated patient demographics, date; route; site of vaccination, batch number of vaccine, new events (body aches, dizziness, vaccination site erythema, vaccination site warmth and vaccination site inflammation), outcome of the events and other clinically relevant information in the narrative.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: Case number PHEH214US009913, is a spontaneous report from a nurse received on 13 May 2014, with follow up received from a nurse on 30 Jun 2014. This report refers to a 17-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO(batch number: NOVM13017) at a dose of 0.5 ml intramuscularly into the left deltoid on 07 May 2014. On 08 May 2014, she experienced low grade fever, body aches, dizziness and a lump at the injection site. The quarter size redness at site of vaccination increased each day. Also she had warmth at site of vaccination. She was examined on 12 May 2014, as redness had increased to 4 into 4 cm area with a slight appearance of inflammation at site. The final outcome of the events was complete recovery. Causality was not reported. Follow up received from a nurse on 30 Jun 2014: Updated patient demographics, date; route; site of vaccination, batch number of vaccine, new events (body aches, dizziness, vaccination site erythema, vaccination site warmth and vaccination site inflammation), outcome of the events and other clinically relevant information in the narrative.
Sex: M
Vaccine: MNQ
Symptoms: Fatigue
Clinical narrative: Case number PHEH2014US016760 is an initial spontaneous report received from a pharmacist on 20 Aug 2014. This report refers to a male patient of an unspecified age. His past medical history and concomitant medications were not reported. Two weeks prior to this report, he was vaccinated with MENVEO (batch number: not reported) intramuscularly. Approximately one week after the vaccination, he began to experience fatigue. The patient was taken to a personal physician. The outcome of fatigue was not reported. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Injection site erythema, Injection site swelling, Somnolence
Clinical narrative: Case number PHEH2014US011891 is an initial spontaneous report received from the nurse on 11 Jun 2014. This report refers to a female patient between the age of 20-30 years. Her medical history and concomitant medications were not reported. On 04 Feb 2014, she was vaccinated with MENVEO (batch number: not reported) intramuscularly at a dose of 0.5 ml. Following the vaccination, on the same day during the waiting period, she experienced sudden onset of headache. She also felt sleepy and light headed. The injection site had turned red and was about the size of a soft ball. The outcome, seriousness and causality of the events were not reported.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2014US012540 is an initial spontaneous report received from a nurse on 19 Jun 2014. This report refers to a 10 year old female child. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12098, expiry date: 03 Jul 2015) intramuscularly at a dose of 0.5 ml of 10 Jun 2014. On 11 Jun 2014, she developed swelling and redness at vaccination site which was about the size of a baseball. The outcome, causality and seriousness were not reported.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003154, is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to an 11  year old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly on 19 Jan 2015. It was reported that the vaccine was frozen with excursion at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, 0.8 C for 36 minutes on 24 Jan 2015 and 0.6 C for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error (incorrect storage of drug).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2014US015164 is an initial spontaneous report received from a nurse on 28 Jul 2014 with a follow up report received from the nurse on 28 Jul 2014. This report refers to an 11 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) intramuscularly at a dose of 0.5 ml on 22 Jul 2014. On 25 Jul 2014, the vaccination site was red, warm and raised. She also had a painful area at the vaccination site. Final outcome was condition unchanged. The seriousness and causality were not reported. Follow up report received from the nurse on 28 Jul 2014: Added MENVEO batch expiry date (30 Sep 2014).
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003155, is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 12 year old patient of an unknown gender. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly on 14 Jan 2015. It was reported that the vaccine was frozen with excursion at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, 0.8 C for 36 minutes on 24 Jan 2015 and 0.6 C for 35 minutes on 31 Jan 2015. No adverse event reported following this  medication error.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Pruritus, Vaccination site swelling
Clinical narrative: Case number PHEH2014US012628, is an initial spontaneous report received from a nurse on 19 Jun 2014, and with a follow up report received from nurse on 21 Jul 2014. This report refers to an 11 year old female child. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12098, expiry date: 03 Jul 2015) intramuscularly at a dose of 0.5 ml into right deltoid on 10 Jun 2014. On the same day she also received booster dose of BOOSTRIX (other manufacturer, batch number: YS475) at a dose of 0.5 ml intramuscular. On 11 Jun 2014, she developed swelling and redness at vaccination site which was about the size of a baseball. She also experienced itching. The outcome of the events was recovered on 16 Jun 2014. Causality assessment and seriousness of events was not reported. Follow up report received from nurse on 21 Jul 2014. Updated patient details, concomitant vaccine and event (itching).
Age: 28.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US002714, is an initial spontaneous report from a pharmacist received on 04 Feb 2015 and with a follow up report received on 24 Mar 2015. This report refers to a 28-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was administered only MenCYW-135 liquid component of MENVEO (batch number: X13051) without being reconstituted with Men A intramuscularly on 03 Feb 2q015 (at 2:55). The patient returned on 05 Feb 2015 and received full dose. No adverse event was reported following the administration error (inappropriate preparation of medication). Follow up report received on 24 Mar 2015: Added patient demographic details and narrative was updated.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2014US013453 is an initial spontaneous report from a medical assistant received on 27 Jun 2014. This report refers to a 13-year-old female patient. The patient received MENVEO (batch number: M13047) intramuscularly on 25 Jun 2014. On the same day, ten minutes after vaccination, the injection site swelled, became red and hot to the touch. On 26 Jun 2014, the injection site expanded to six inches large and the patient was unable to move her arm. She had taken ibuprofen on 26 Jun 2014 and it did help limit some pain. The physician has not seen this patient since MENVEO was administered. Patient's mother states that the swelling, pain and limb-limiting movement has significantly improved but has not completely healed. Outcome of the other events were not reported. Seriousness and causality of the events was not reported.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2014US013869 is an initial spontaneous report from a medical assistant received on 09 Jul 2014. This report refers to a 16-year-old female patient. She was vaccinated with MENVEO (batch number: M13054) intramuscularly on 08 Jul 2014. On the same day, post vaccination, she experienced localize swelling and increased temperature at the injection site. She returned to clinic to report these adverse reactions. Seriousness, outcome and causality of the events were not reported.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Case number PHEH2014US014112 is an initial spontaneous report received from a physician on 11 Jul 2014. This report refers to a 20-year-old female patient. Her medical history included asthma. It was reported that she used an inhaler due to asthma; however she did not require it as she grew older. Her concomitant medications were not reported. On 07 Jul 2014, she was vaccinated with MENVEO (batch number: A13016) intramuscularly. Following the vaccination on 10 Jul 2014, she developed a non-itching rash that closely resembled eczema or psoriasis which originated at the nape of her neck and was progressing towards her scalp. It was reported that the event was ongoing and appeared to be worsening. The seriousness and causality of the event were not reported.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2014US015162 is an initial spontaneous report received from a nurse on 28 Jul 2014 with a follow up report received from the nurse on 28 Jul 2014. This report refers to a 12 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) intramuscularly at a dose of 0.5 ml on 21 Jul 2014. On 24 Jul 2014, the vaccination site became red, warm and raised. She also had a painful area at the vaccination site. The outcome of the events was condition unchanged. The seriousness and causality of the events was not reported. Follow up report received from the nurse on 28 Jul 2014: Added MENVEO batch expiry date (30 Sep 2014).
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US003139, is an initial spontaneous report received from a pharmacist on 11 Feb 2015. This report refers to a 20 year old male patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: A13066) intramuscularly on 10 Feb 2015. It was reported that during reconstitution the Men CYW-135 liquid component was mixed with an expired Men-A (expiration date: 31 Jan 2015) component. No adverse event was reported following this administration error (expired vaccine used).
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003143, is an initial spontaneous report received from a nurse on 10 Feb 2016. This report refers to an 11 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 14 Jan 2015, MENVEO (batch number: M14071, expiry date: Nov 2015) was at 0.4 degree Celsius for 1 hour and 16 minutes and the patient received 0.5 ml intramuscular dose of this frozen vaccine with excursion on 03 Feb 2015. The vaccine had two more other excursion as follows: on 26 Jan 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 Jan 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003146 is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 11 year old patient of unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly on 14 Jan 2015. It was reported that the vaccine was frozen with excursion at 0.4 Celsius for 1 hour 16 minutes before vaccination to the patient. No adverse event reported following this medication error (incorrect storage of drug).
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003147 is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 11 year old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 30 Jan 2015. It was reported that the vaccine which was given to the patient was frozen with excursions at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015 and at 0.8 Celsius for 36 minutes on 24 Jan 2015. No adverse event reported following this medication error.