chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HPVX
Symptoms: Somnolence
Clinical narrative: This literature marketed report has been received from the authors of a published article concerning a 16 year old male patient. The patient's concurrent condition included sleep apnoea. On an unknown date, the patient was vaccinated with a second dose of HPV (manufacturer unknown) or HPV 9 (manufacturer unknown) (dose, route, lot# and expiration date were not reported). Concomitant therapy was not reported. The patient presented to the sleep clinic for evaluation of hypersomnia. This was sudden in onset and started on an unknown date after he received the second dose of the HPV (manufacturer unknown) or HPV 9 (manufacturer unknown). He had an excessive day time sleepiness with an Epworth score of 24. He had multiple sleep attacks during the day, naps were slightly refreshing and he was sleeping more than 15 hours in a 24-hour period. He had no hallucinations or rapid eye movements (REM) behavior disorders. He did have one episode of sleep paralysis. He also developed abnormal right-sided limb movements followed by weakness. These were also associated with facial drooping on the same side. These episodes were triggered by emotions such as excitement or anger and lasted about 10-15 seconds and at times occurred in clusters. He underwent a brain nuclear magnetic resonance imaging (MRI) and electroencephalogram (EEG), which were both negative for any pathology. These episodes could represent an atypical presentation of cataplexy. He underwent an in-lab sleep study followed by an Multiple Sleep Latency Test (MSLT). The sleep study ruled out sleep apnea as a cause of hypersomnia. The MSLT was consistent with a diagnosis of narcolepsy with a mean sleep latency of 0.6 seconds and five out of five naps with sleep -onset REM periods. The outcome of narcolepsy was unknown. The authors considered narcolepsy to be related to the HPV vaccination. Upon internal review, the event of narcolepsy was considered to be medically significant. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Petechiae, Platelet count decreased, Pyrexia, Thrombocytopenia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 1 year old female patient. The patient had no concomitant medications, allergies or pertinent medical history. On 19-MAY-2016, the patient was vaccinated with the first dose in series of PROQUAD (Merck), subcutaneously, lot # M003436, expiry date 19-JUL-2017 (dose was not reported). On an unknown date in 2016, the patient experienced petechial on her chest and legs. On 06-JUN-2016, the patient came to the office where she had a fever of 102 F, the petechial was observed on her chest and legs, and she had a platelet level of 6,000 (unit not provided). The nurse practitioner reported that the patient developed thrombocytopenia. The nurse practitioner sent the patient to a hematologist. The patient was observed and her platelets were monitored. The patient received treatment for the events (also reported as "no treatment and/or medication was prescribed"). The patient was seen in the office on 15-JUN-2016, and her platelet level was 167,000 (unit not provided). The outcome of the events was reported as "improving". The relatedness between the PROQUAD (Merck) and the events was not reported. Upon internal review the event of thrombocytopenia was considered to be medically significant. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Emotional distress, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Erythema, inflammation, and induration from the right hip to the right knee, patient was crying for hours from pain and was irritable and inconsolable.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Pain
Clinical narrative: Erythema, inflammation, and induration from the right hip to the right knee, patient was crying for hours from pain and was irritable and inconsolable.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Peripheral swelling
Clinical narrative: Red, swollen arm (started at injection site and traveled down arm towards wrist), itching.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Red, swollen arm (started at injection site and traveled down arm towards wrist), itching.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Rash
Clinical narrative: Stomachache, rash to torso and arms.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Dyskinesia, Feeling hot, Loss of consciousness, Muscle tightness, Tongue biting
Clinical narrative: Patient was seated, and received Gardasil 9 vaccine, second dose. No concerns with his first dose. After vaccine was administered, patient stated "he is starting to feel something come on" Nurse quickly started talking with him but patient was already leaned back and passed out. She called for another nurse, while still talking to the patient. The patient had a few jerks of his arms but then opened his eyes and sat up. He was orient to where he was and knew his name. He could talk to the nurses and said he just felt hot. A cool towel was placed on the patient's neck and he sat for another 15 minutes. Patient drank a bottle of water and stated he only had a poptart for breakfast. Patient was able to walk out of the office and was discharged home. He was complaining that he had bit his tongue and had some tightening in the opposite arm than what was vaccinated. Episode lasted less than 1 minute. No treatment was given. Just to be monitored, eat and stay hydrated.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US013849 is an initial spontaneous report received from a physician on 09 Jul 2012 with a follow up information received on 30 Jul 2012. This report refers to a female patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that she was vaccinated with only 0.5 ml MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: M11071, expiry date: Dec 2013) intramuscularly on to specified site and did not receive MenA lyophilized conjugate on 09 Jul 2012. No adverse reaction was reported following the maladministration. Follow up information received on 30 Jul 2012: Patient demographics (height and weight) and expiry date updated.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Patient had hives and difficult breathing after getting vaccine.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US015558 is an initial spontaneous report received from a pharmacist on 03 Aug 2012: This report refers to a patient of unknown age group and gender. This patient was given only the CYQ-135 liquid component of MENVEO vaccine (batch number: unknown) intramuscularly on an unspecified date, because the pharmacy discovered an extra MenA lyophilized conjugate vaccine component of MENVEO. No other adverse reaction was reported following this administration error.
Age: 44.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache
Clinical narrative: Headache.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Wife called stating she took her husband to ER due to redness and pain at injection site.  She took him 6-19-16.
Age: 18.0
Sex: M
Vaccine: MNQ, TD
Symptoms: Urticaria
Clinical narrative: HIVES AN HOUR AFTER ADMINISTRATION OF MENACTRA AND TENIVAC.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Light headed, nauseous, sweaty.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pruritus
Clinical narrative: Patient stated in Email that after the shot she " has a 10cm x 8cm raised red area, itches really bad and has a spot where it feels bruised. Looked on WebMD and these symptoms were under notify Doctor".
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Injection site joint movement impairment
Clinical narrative: Patient claims past two months after injection has increase weakness and unable to use his right shoulder, generalized weakness that started after vaccine.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV, FLUX
Symptoms: Pain in extremity, Pruritus, Swelling
Clinical narrative: After the injection I started to have itching and then as time progressed I had a lot of pain and swelling.  Today 6/20/2016 I have much more swelling and and pain down to my elbow.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV, FLUX
Symptoms: Erythema, Pruritus
Clinical narrative: After the injection I started to have itching and then as time progressed I had a lot of pain and swelling.  Today 6/20/2016 I have much more swelling and and pain down to my elbow.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV, FLUX
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: After the injection I started to have itching and then as time progressed I had a lot of pain and swelling.  Today 6/20/2016 I have much more swelling and and pain down to my elbow.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV, FLUX
Symptoms: Pain in extremity, Pruritus, Swelling
Clinical narrative: Patient began to have some itching and redness in the left arm. She noticed some streaking also.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV, FLUX
Symptoms: Erythema, Pruritus
Clinical narrative: Patient began to have some itching and redness in the left arm. She noticed some streaking also.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV, FLUX
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient began to have some itching and redness in the left arm. She noticed some streaking also.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Cerebrovascular accident, Dizziness, Electrocardiogram normal, Flushing
Clinical narrative: Patient was seen in the ER for stroke symptoms: No. Chief complaint: Diaphoretic, lightheaded, weakness. History of present illness: Patient with a history of atrial fibrillation status post ablation therapy in October 2014 is an employee at this hospital undergoing his routine hepatitis B vaccine. Patient received initial dose hepatitis B vaccine July 2015 and developed similar symptoms requiring rehydration therapy. Today patient receiving second dose of the above with significant symptoms as outlined above. Patient apparently quite diaphoretic appears minimally flushed and reports weakness and lightheaded feeling making it difficult to walk. Patient denies shortness of breath or throat tightness. No new medications. No new toiletries. Vital signs please see nurse notes. General exam patient appears exhausted but able to answer all questions appropriately. Cardiac exam: Regular rate and rhythm. Pulmonary exam clear to auscultation bilaterally. Abdominal exam positive bowel sounds, nontender nondistended no organomegaly no masses or bruits no guarding noted. Extremity exam 1+ pedal edema bilaterally no palpable cords negative Homans sign. HEENT pupils equal round reactive to light. Eyes injected bilaterally. Nose without discharge blood free fluid. Throat mucous membranes moist no erythema no exudates. Ears without discharge or erythema no free fluid seen. Neuro exam: Motor 5 out of 5 bilaterally. Sensory exam intact upper and lower extremity bilaterally. Laboratory findings: EKG findings: Sinus rhythm with a rate of 66. Patient does have criteria for left ventricular hypertrophy. No ST-T changes seen. ED course: Shortly after arrival patient given 1 L normal saline and BENADRYL 50 mg IV. Assessment and plan: Drug reaction to hepatitis B vaccine. Each reaction has been more serious than the previous. Strong consideration should be given to whether benefits outweigh risk for completing hepatitis B vaccination series.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Gait disturbance, Hyperhidrosis
Clinical narrative: Patient was seen in the ER for stroke symptoms: No. Chief complaint: Diaphoretic, lightheaded, weakness. History of present illness: Patient with a history of atrial fibrillation status post ablation therapy in October 2014 is an employee at this hospital undergoing his routine hepatitis B vaccine. Patient received initial dose hepatitis B vaccine July 2015 and developed similar symptoms requiring rehydration therapy. Today patient receiving second dose of the above with significant symptoms as outlined above. Patient apparently quite diaphoretic appears minimally flushed and reports weakness and lightheaded feeling making it difficult to walk. Patient denies shortness of breath or throat tightness. No new medications. No new toiletries. Vital signs please see nurse notes. General exam patient appears exhausted but able to answer all questions appropriately. Cardiac exam: Regular rate and rhythm. Pulmonary exam clear to auscultation bilaterally. Abdominal exam positive bowel sounds, nontender nondistended no organomegaly no masses or bruits no guarding noted. Extremity exam 1+ pedal edema bilaterally no palpable cords negative Homans sign. HEENT pupils equal round reactive to light. Eyes injected bilaterally. Nose without discharge blood free fluid. Throat mucous membranes moist no erythema no exudates. Ears without discharge or erythema no free fluid seen. Neuro exam: Motor 5 out of 5 bilaterally. Sensory exam intact upper and lower extremity bilaterally. Laboratory findings: EKG findings: Sinus rhythm with a rate of 66. Patient does have criteria for left ventricular hypertrophy. No ST-T changes seen. ED course: Shortly after arrival patient given 1 L normal saline and BENADRYL 50 mg IV. Assessment and plan: Drug reaction to hepatitis B vaccine. Each reaction has been more serious than the previous. Strong consideration should be given to whether benefits outweigh risk for completing hepatitis B vaccination series.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Decreased appetite, Nausea, Swollen tongue, Vomiting
Clinical narrative: Patient also reports loss of appetite. Nausea, Vomiting and tongue swelling.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHHY2011US33087 is an initial spontaneous report received from a physician on 14 Apr 2011. This report refers to a patient of unspecified gender and age. The patient was given only the CYW-135 liquid component of MENVEO vaccine (batch number: unknown) without being reconstituted with MenA lyophilized component, intramuscularly in 2010. No other adverse reaction was reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from nurse on 10 Jun 2010: This patient was vaccinated with MENVEO (batch number: unknown), (dose: unknown) intramuscularly, on 09 Jun 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: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Injection site erythema, Injection site hyperaesthesia, Injection site paraesthesia, Injection site swelling
Clinical narrative: Swelling of injected right upper arm w/redness. Progressively got worse & became warm & sensitive to touch. Became painful to lift arm & weak; ultimately got so bad I couldn't use arm. Pain spread to the entire length of arm, yet the shoulder joint itself was not. Put ice packs on it which helped some. Had been told by pharmacist who administered the shot that I needed to stay around for at least 30 minutes to an hour to see if I would have a severe allergic reaction, as I'd had one to the Tetanus shot many years before & was told I could never have the Tetanus shot again, whether live or killed virus. He said all they would do is call 911 & notify my doctor if I did react. So, the arm got worse & worse over the next several weeks. I probably would have gone to dr sooner, except my husband fell & broke several bones and we had all that to deal with. I did finally go to my primary care dr & got blood work to rule out infection, as all the pain seemed to be in the "meat" of my arm, not joints. That was all sent with me to the orthopedist 12/22/2015 for xrays. Nothing obvious was found to explain it. Was told it should improve over the next couple months. Still having problems today. None better.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Muscular weakness, Musculoskeletal disorder, Pain, Pain in extremity
Clinical narrative: Swelling of injected right upper arm w/redness. Progressively got worse & became warm & sensitive to touch. Became painful to lift arm & weak; ultimately got so bad I couldn't use arm. Pain spread to the entire length of arm, yet the shoulder joint itself was not. Put ice packs on it which helped some. Had been told by pharmacist who administered the shot that I needed to stay around for at least 30 minutes to an hour to see if I would have a severe allergic reaction, as I'd had one to the Tetanus shot many years before & was told I could never have the Tetanus shot again, whether live or killed virus. He said all they would do is call 911 & notify my doctor if I did react. So, the arm got worse & worse over the next several weeks. I probably would have gone to dr sooner, except my husband fell & broke several bones and we had all that to deal with. I did finally go to my primary care dr & got blood work to rule out infection, as all the pain seemed to be in the "meat" of my arm, not joints. That was all sent with me to the orthopedist 12/22/2015 for xrays. Nothing obvious was found to explain it. Was told it should improve over the next couple months. Still having problems today. None better.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray normal
Clinical narrative: Swelling of injected right upper arm w/redness. Progressively got worse & became warm & sensitive to touch. Became painful to lift arm & weak; ultimately got so bad I couldn't use arm. Pain spread to the entire length of arm, yet the shoulder joint itself was not. Put ice packs on it which helped some. Had been told by pharmacist who administered the shot that I needed to stay around for at least 30 minutes to an hour to see if I would have a severe allergic reaction, as I'd had one to the Tetanus shot many years before & was told I could never have the Tetanus shot again, whether live or killed virus. He said all they would do is call 911 & notify my doctor if I did react. So, the arm got worse & worse over the next several weeks. I probably would have gone to dr sooner, except my husband fell & broke several bones and we had all that to deal with. I did finally go to my primary care dr & got blood work to rule out infection, as all the pain seemed to be in the "meat" of my arm, not joints. That was all sent with me to the orthopedist 12/22/2015 for xrays. Nothing obvious was found to explain it. Was told it should improve over the next couple months. Still having problems today. None better.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient developed hives to her left hand and bilat popliteal fossa following administration of 5 year vaccines.  In the left arm, MMR and DTAP were given. Patient was given 7.5 mls benadryl in office.  No difficulty breathing. Site of injection without hives.  Please report to adverse event website for vaccinations.
Age: 27.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Dizziness, Hot flush, Pyrexia
Clinical narrative: In the 4 days since vaccination patient has had intermittent fevers described as "hot flashes" and light-headedness.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a nurse on 08 Jun 2010: This patient was vaccinated with MENVEO (batch number: 091001) unknown dose, intramuscularly on 08 Jun 2010. The patient only administered the diluent portion of MENVEO, rather than being reconstituted with the lyophilized portion. No adverse event occurred.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial nurse report received from 09 Jun 2010: The patient received MENVEO (box lot. No. 091001), unknown dose, on an unspecified date. The patient inadvertently received only the lyophilized portion without it being diluted with diluent on an unspecified date. The outcome of event was not reported.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHHY2011US33313 is an initial spontaneous report received from a nurse on 15 Apr 2011. This report refers to a patient of unknown age group and gender. This patient was given a portion of MENVEO vaccine (batch number: unknown) diluted with saline, intramuscularly on an unspecified date. No other adverse reaction was reported.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2011US33611 is a combined initial and follow-up spontaneous report received from a health care professional (HCP) on 19 Apr 2011. This report concerns a 16-year-old boy. His medical history was not reported. He was vaccinated with MENVEO (batch number: 100003, expiry date: Aug 2011) 0.5 ml dose, intramuscularly on 18 Apr 2011 which was stored incorrectly 55F, one hour every night for one month. No adverse event was reported.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY2011US33861 is an initial spontaneous report from a pharmacist received on 05 Apr 2011: This patient was vaccinated with MENVEO (batch number: unknown) on an unspecified date. The patient inadvertently only administered with the CWY 135 liquid conjugate component of MENVEO and did not received MenA conjugate component. No adverse reaction had occurred.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2011US33868 is a combined initial and follow-up 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 55 F, one hour every night for one month. No adverse event was reported.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHHY2011US33870 is a combined initial and follow-up spontaneous report received from a health care professional (HCP) on 19 Apr 2011. This report concerns a 15-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: 1.03
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHHY2011US34417 is an initial spontaneous case received from a physician on 19 Apr 2011 with a follow up report received from a health care professional on 16 May 2011. This report concerns a 1-year-old girl. She was vaccinated with MENVEO (batch number: 029011) intramuscularly in to the left thigh on 19 Apr 2011. On the same day, she was also given an intramuscular dose of HAVRIX (batch number: unknown) and a subcutaneous dose of varicella vaccine (batch number: unknown). No adverse event was reported following this inappropriate schedule. Follow up information received from a health care professional on 16 May 2011: Updated information about patient demographics, site of application and concomitant medication.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage
Clinical narrative: Case number PHHY2011US35344 is an initial spontaneous case received from a nurse on 22 Apr 2011. This report concerns multiple patients (exact number of patients unknown) who were vaccinated with MENVEO (batch number: 100001) intramuscularly on unspecified dates. The batch was not stored properly. The temperature of the vaccines reached below 2 C (0 or 1 C) multiple times in Jun 2010, 4 times in Aug 2010, 1 time in Sep 2010 and 3 times in Oct 2010. The temperature reached -1 C, 2 times in Oct 2010.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHHY2011US35373 is an initial spontaneous report received from a nurse on 26 Apr 2011 with a follow up report on 16 May 2011. This report refers to an adolescent female patient. She was given only the MenCYW-135 liquid component MENVEO (batch number X10034) intramuscularly into the right arm on 25 Apr 2011. She was not given the MenA lyophilized conjugate vaccine component. On the same day she was also vaccinated with Tdap (batch number: AC52B069FA) intramuscularly into the left arm. No other adverse reaction was reported. Follow up information received from a nurse on 16 May 2011: Updated information about patient demographics, vaccination date and concomitant medication.
Sex: U
Vaccine: MNQ
Symptoms: Underdose
Clinical narrative: Initial healthcare professional report received on 26 May 2010: The patient received MENVEO (box lot. No. 100003, powder lot. No. 028011, liquid lot. No. 0910010), 0.45 ml, intramuscularly, on an unspecified date. The patient received partial dose on an unspecified date. The outcome of event was not reported.
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 28 May 2010: This patient was vaccinated with MENVEO (batch number: unknown) unknown dose, intramuscularly on 27 May 2010. It was reported that, the patient received only intramuscular diluent on 27 May 2010 and not administered lyophilized portion. No any adverse event occurred. The outcome of the event was not reported. Follow up report received from a healthcare professional on 08 Jun 2010: The reporter found an extra vial of powder in the box and that is how he knew that someone received only the diluent. The reporter had no idea as who is that patient. No further information provided.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error
Clinical narrative: Initial health care professional report received on 27 May 2010: This patient received MENVEO (batch number 091001 (liquid component batch number)) unknown dose intramuscularly on 26 May 2010. It was reported that the patient inadvertently received only the liquid component of MENVEO. The outcome of the event was not reported. The causality was not reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial health care professional report received on 01 Jun 2010: This patient received MENVEO (batch number 09100 for diluent and 029011 for lyophilized powder) unknown dose intramuscularly on an unknown date. On an unknown date, the patient was only administered the diluent of MENVEO. The outcome of the event was reported as unknown. The causality was not reported.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY2011US35723 is an initial spontaneous report received from a nurse on 18 Apr 2011. This report concerns a 16-year-old male patient. He was vaccinated with MENVEO (batch number: 090901, expiry date: Sep 2011) 1 DF, on 11 Apr 2011. The patient received only the Men CYW-135 liquid conjugate without the Men A lyophilized powder conjugate. No adverse reaction was reported following this drug administration error.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY2011US35724 is an initial spontaneous report received from a nurse on 26 Apr 2011. This report refers to a patient of unknown gender and age group. This patient was given only the lyophilized Men-A component of MENVEO (batch number: 100025) intramuscularly on 22 Apr 2011. No other adverse reaction was reported.
Age: 18.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHHY2011US36763 is an initial report from a nurse received on 29 Apr 2011: This report refers to an 18-year old male patient. His medical history included vaccination with DTaP, OPV, MMR and HepB, peda/adol. He was given only the CYW-135 liquid component MENVEO (batch number 100005) intramuscularly on 28 Apr 2011 and was concomitantly also given DTaP on the same day. No other adverse reaction was reported. Follow up received from a physician on 09 May 2011: Updated information about patient's demographics, vaccination history, concomitant medication and date of vaccination.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHHY2011US37917 is an initial spontaneous report received from a vaccines sales specialist (non health care professional) on 03 May 2011. This report refers to an 11 years old female patient. She was given only the CYW-135 liquid component of MENVEO (batch number M10028) intramuscularly on 28 Apr 2011. A few hours later, she received the fully reconstituted dose of MENVEO. No other adverse reaction was reported.
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHHY2011US41580 is an initial spontaneous report received from a health care professional on 02 May 2011. This report refers to an adult female patient. She was given only the CYW-135 liquid component of MENVEO (batch number 090901, expiry date: Aug 2011) on an unspecified date. No other adverse reaction was reported.
Sex: U
Vaccine: MNQ
Symptoms: Drug administration error
Clinical narrative: Initial report received from a health care professional (nurse) on 25 May 2010: This patient was vaccinated with MENVEO (batch no: 100001), (dose: unknown) on an unspecified date. The patient was administered MENVEO that was reconstituted with sterile water and not with the active diluent. This had occurred twice. No other information provided at the time of this report.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial report received from a health care professional on 25 May 2010: This patient was vaccinated with MENVEO (batch no 100004), (dose unspecified), on an unspecified date. The reporter stated that the patient was administered vaccine diluent without reconstitution. The outcome of the event was not reported.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial report received from a health care professional (medical assistant) on 26 May 2010: This child was vaccinated with MENVEO (batch no: unknown), (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: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a health care professional on 26 May 2010: This patient was vaccinated with MENVEO (batch no: CWY lot: 091991, A lot: 100001), (dose: unknown) intramuscularly on 25 May 2010. The patient was administered only the diluent portion of the MENVEO. No adverse event had occurred due to this inadvertent administration. Follow up report received from a physician on 23 Jun 2010: The patient was vaccinated with MENVEO on 24 May 2010. The patient will return for full vaccination.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial report received from a health care professional on 25 May 2010: This adolescent was vaccinated with MENVEO (batch no: 100001, expiry date: 2011), (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. The outcome of the event was not reported. Follow up report received from a health care professional on 08 Jun 2010: The patient was revaccinated with MENVEO (dose and batch number unknown) intramuscularly on 25 May 2010. No other information provided.
Sex: F
Vaccine: MNQ
Symptoms: Accidental exposure to product, Exposure via direct contact
Clinical narrative: Initial report received from a health care professional via Novartis employee on 10 May 2010: This patient was vaccinated with MENVEO (batch no: CWY lot: 091991, A lot: 100004), (dose: unknown) intramuscularly unknown date. While withdrawing reconstituted vaccine from a vial, the vaccine ran down the nurse arm. The outcome of the event was not reported.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial report received from a health care professional on 25 May 2010: This adolescent was vaccinated with MENVEO, batch no: 027011, expiry date: Aug 2011), (dose: unknown) intramuscularly for immunization on 25 May 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: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Significant redness and swelling of her left upper arm. She states this started after getting the pneumonia shot in that arm. She noticed redness and swelling that has gotten progressively worse. Examination of the left arm shows redness encircling the entire upper arm approximately involving the distal two thirds of the upper arm. It's warm and minimally tender. Assessment and plan: Cellulitis of the left upper arm. Started on cephalexin and recommended warm compresses and keep elevated as much is possible. Follow-up with her primary physician if symptoms persist or worsen after 2-3 days on the antibiotic.
Age: 1.19
Sex: M
Vaccine: MMR, PNC13
Symptoms: Rash
Clinical narrative: Receive his MMR vaccination about 2 weeks prior and developed diffuse rash over chest about 10 days after vaccination.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Vomited twice the morning after getting vaccine.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Chest discomfort, Urticaria
Clinical narrative: Hives, chest tightness.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness 4 inches in diameter that lasted 6 weeks until gone.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Injection site pruritus, Injection site swelling, Joint swelling, Pyrexia
Clinical narrative: LOW FEVER, ITCHING AT INJECTION SITES AND SWELLING, TROUBLE BREATHING, JOINT SWELLING (ESPECIALLY AT ANKLES).
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Anger, Irritability, Tic
Clinical narrative: Began constant facial tics, stretching face, every few seconds. Unable to stop. Irritable, fits of rage.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Apnoea, Eczema
Clinical narrative: Sporadically stops breathing happened the day after vaccine. Eczema all over his body.
Age: 25.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Case number PHHY2012US058233 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 445572) on 09 Jul 2012. This refers to a 25-year-oldl male patient. He was vaccinated with MENVEO vaccine (batch number: A10047) into his left arm on an unspecified date. Ten minutes after vaccination he was dizzy. After sitting upright and drinking he was fine and left. He was followed up few hours later and he was doing well. The final outcome was reported as complete recovery. No additional information was available.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2012US099188 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 463810) on 01 Nov 2012. This report refers to 11-year-old male patient. The patient's medical history included chest congestion, wheezing, attention deficit hypersensitivity disorder, allergic rhinitis, migraines, mild persistent asthma, sleep disorder and oppositional disorder. The patient was vaccinated with MENVEO (batch number: M11082) intramuscularly in left arm on 29 Aug 2012. On 30 Aug 2012, after the vaccination, the patient experienced itching, redness, swelling, fever, hardness and pain at the injection site. The outcome of events was reported as condition unchanged as of 31 Aug 2012.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2012US099188 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 463810) on 01 Nov 2012. This report refers to 11-year-old male patient. The patient's medical history included chest congestion, wheezing, attention deficit hypersensitivity disorder, allergic rhinitis, migraines, mild persistent asthma, sleep disorder and oppositional disorder. The patient was vaccinated with MENVEO (batch number: M11082) intramuscularly in left arm on 29 Aug 2012. On 30 Aug 2012, after the vaccination, the patient experienced itching, redness, swelling, fever, hardness and pain at the injection site. The outcome of events was reported as condition unchanged as of 31 Aug 2012.
Age: 12.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Rash generalised
Clinical narrative: Mother brought child in due to rash all over body.
Age: 59.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None-Spoke with patient and she is doing fine.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2012US076889 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 457438) on 05 Sep 2012. This case refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: A10132) intramuscularly into his left arm on 11 jun 2012. On the same day he was also vaccinated with ADACEL vaccine (batch number: AC52B075BA, other manufacturer) intramuscularly into his left arm and VAQTA (batch number, batch number: 1441AA, other manufacturer) intramuscularly into his right arm. On 13 Jun 2012, the patient developed swollen red left arm. It was reported that there was a concern for cellulitis but was not confirmed. The final outcome was reported as completely recovered on an unspecified date. No other information was available.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of an unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients received unspecified number of doses of improperly stored PEDVAXHIB lot # L051122 with expiration date: 12-OCT-2018 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Extra dose administered, Measles antibody, Mumps antibody test, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via RMPDC (rocky mountain poison and drug center) regarding a 29 year old female patient. The patient's past drug history was unknown. The patient's concurrent condition included pregnancy and the date of her last menstrual period was 14-MAR-2016. The due date of pregnancy was 19-DEC-2016. Concomitant medications included prenatal vitamins. The patient's relevant laboratory data included a positive pregnancy test on 14-MAY-2016. The pharmacist confirmed that the patient should have been immune and had a measles IgG titer, mumps IgG titer, and rubella IgG titer drawn on 28-MAY-2016 however the results were still pending. On 29-MAY-2016, the patient received an extra dose of M-M-R II (lot # L049316, expiry date: 03-DEC-2017) subcutaneously in the left arm during pregnancy. The patient had previously received M-M-R II on unknown dates. The patient had not experienced any adverse reactions to the vaccine thus far. The outcome of the pregnancy was unknown. Additional information had been requested.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Pregnancy test positive, Rubella antibody test
Clinical narrative: This spontaneous report was received from a pharmacist via RMPDC (rocky mountain poison and drug center) regarding a 29 year old female patient. The patient's past drug history was unknown. The patient's concurrent condition included pregnancy and the date of her last menstrual period was 14-MAR-2016. The due date of pregnancy was 19-DEC-2016. Concomitant medications included prenatal vitamins. The patient's relevant laboratory data included a positive pregnancy test on 14-MAY-2016. The pharmacist confirmed that the patient should have been immune and had a measles IgG titer, mumps IgG titer, and rubella IgG titer drawn on 28-MAY-2016 however the results were still pending. On 29-MAY-2016, the patient received an extra dose of M-M-R II (lot # L049316, expiry date: 03-DEC-2017) subcutaneously in the left arm during pregnancy. The patient had previously received M-M-R II on unknown dates. The patient had not experienced any adverse reactions to the vaccine thus far. The outcome of the pregnancy was unknown. Additional information had been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a office manager refers to an unspecified number of patients of unknown demographics. The patient's medical history and concurrent conditions were unspecified. On an unspecified date in 2016 (reported as since May 2016), the patients were vaccinated with improperly stored VARIVAX (strength, lot#, dose#, dose, route and anatomical location unspecified). No adverse effect was reported. Product quality complaint (PQC) involved. No further information was available. Additional information has been requested.
Age: 33.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 33 year old patient of unknown age and gender. Concurrent conditions included tobacco user and diabetes mellitus. No medical history, allergy/drug reactions and concomitant medications were reported. On 07-JUN-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L035882 expiry date: 19-APR-2017 (dosing details and route of administration were not reported). No adverse effects were reported. It was reported that the vaccine was exposed to the temperature 55F for 30 minutes. The previous temperature excursion was 32.9F for 17 hours. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-JUL-2016, the patient was inadvertently vaccinated with PROQUAD lot # L030589 expiry date 10-FEB-2017 (dose, route and anatomical site of injection were not reported), and also with VARIVAX lot # L019126 expiry date 27-MAY-2017 (dose, route and anatomical site of injection were not reported); instead of receiving the intended VARIVAX and M-M-R II. No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ, lot # L000425, expiration date 21-JUN-2016, oral (dose and dose number were unspecified). No adverse effects reported. This is one of two cases received from the same reporter (US-009507513-1606USA003775). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L014415, expiration date 25-JUL-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects reported. This is one of two cases received from the same reporter (US-009507513-1606USA009149). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. Between 17-MAR-2016 and 14-JUN-2016 the patient received a dose of improperly stored PNEUMOVAX 23 (lot # L014420 with expired date 23-FEB-2017, strength, dose, frequency, route unknown). Concomitant therapy was not provided. The vaccine was stored under 33F for 112 hours. Previous excursion included 48F for 48 hours and 33 F for 120 hours. Data logger was not involved. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 07-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L040164 with expiration date of 20-FEB-2018; strength, dosage, frequency and route unspecified) (incorrect product storage). The patient did not experience any adverse effects. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date in June 2016 (reported as "between 16-JUN-2016 and 17-JUN-2016), the patient was vaccinated with improperly stored doses of M-M-R II (which had a lot number of L027591 and an expiration date of 23-JUL-2017; however, the therapy type was not reported) and VAQTA (the lot number and expiration date were unknown) (the dose, dosage number, route of administration and anatomical location, for both vaccines, were unknown). No concomitant medications were reported. The vaccines experienced a temperature excursion of 16.1 degree C for a time frame or 22 hours and was called out due to a data logger. There were, reportedly, no previous temperature excursions. Despite being vaccinated with such improperly stored vaccines, no adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.