chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Eye pain, Fatigue, Headache, Impaired work ability, Influenza like illness
Clinical narrative: I began to feel muscle soreness the next day. By the 2nd day after the vaccine the soreness was marked and i developed a headache and fever of 100 degrees which lasted into the next day. I saw my PCP's NP on day 3 who confirmed I did not have an infection and said I was experiencing a reaction to the vaccine. I had extreme fatigue and soreness with a bad headache behind the eyes that day, although the fever seemed to resolve. I could not go to work and stayed home to get extra sleep. The daytime soreness, fatigue, and headache were less on day 4 and day 5 but began to return by the end of the day. At night I continued to have marked muscle soreness which would wake me up anytime I moved in bed. I would get severe pain, especially in my legs, upon moving which lasted about 10 seconds and fully woke me up each time. The pain would  then subside to a dull soreness, as if I had run longer than usual that day. This nighttime soreness and pain upon movement has persisted now through day 9 after the vaccine.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Myalgia, Pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: I began to feel muscle soreness the next day. By the 2nd day after the vaccine the soreness was marked and i developed a headache and fever of 100 degrees which lasted into the next day. I saw my PCP's NP on day 3 who confirmed I did not have an infection and said I was experiencing a reaction to the vaccine. I had extreme fatigue and soreness with a bad headache behind the eyes that day, although the fever seemed to resolve. I could not go to work and stayed home to get extra sleep. The daytime soreness, fatigue, and headache were less on day 4 and day 5 but began to return by the end of the day. At night I continued to have marked muscle soreness which would wake me up anytime I moved in bed. I would get severe pain, especially in my legs, upon moving which lasted about 10 seconds and fully woke me up each time. The pain would  then subside to a dull soreness, as if I had run longer than usual that day. This nighttime soreness and pain upon movement has persisted now through day 9 after the vaccine.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Somnolence, Vaccination complication
Clinical narrative: I began to feel muscle soreness the next day. By the 2nd day after the vaccine the soreness was marked and i developed a headache and fever of 100 degrees which lasted into the next day. I saw my PCP's NP on day 3 who confirmed I did not have an infection and said I was experiencing a reaction to the vaccine. I had extreme fatigue and soreness with a bad headache behind the eyes that day, although the fever seemed to resolve. I could not go to work and stayed home to get extra sleep. The daytime soreness, fatigue, and headache were less on day 4 and day 5 but began to return by the end of the day. At night I continued to have marked muscle soreness which would wake me up anytime I moved in bed. I would get severe pain, especially in my legs, upon moving which lasted about 10 seconds and fully woke me up each time. The pain would  then subside to a dull soreness, as if I had run longer than usual that day. This nighttime soreness and pain upon movement has persisted now through day 9 after the vaccine.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted shortly after immunization.
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination site swelling
Clinical narrative: Swelling at the vaccine sight.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Headache, Infectious mononucleosis, Oropharyngeal pain, Pyrexia
Clinical narrative: Mononucleosis, Inflamed tonsils, sore throat, fever, headache.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Tonsillar inflammation
Clinical narrative: Mononucleosis, Inflamed tonsils, sore throat, fever, headache.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass
Clinical narrative: Immediately after inject a large red lump appeared at injection site. Meassured 20mm in size.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Blood calcium normal, Blood potassium decreased, Chills, Fatigue
Clinical narrative: 1 hour after vaccination, became nauseated with severe headache. This progressed to chills, sweating, and extreme tiredness, with all over body aches. Presented to the ED with chief complaint of severe myalgia and arthralgia head to toe.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Full blood count normal, Headache, Hyperhidrosis, Metabolic function test normal, Myalgia
Clinical narrative: 1 hour after vaccination, became nauseated with severe headache. This progressed to chills, sweating, and extreme tiredness, with all over body aches. Presented to the ED with chief complaint of severe myalgia and arthralgia head to toe.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pain
Clinical narrative: 1 hour after vaccination, became nauseated with severe headache. This progressed to chills, sweating, and extreme tiredness, with all over body aches. Presented to the ED with chief complaint of severe myalgia and arthralgia head to toe.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood chloride increased, Bradycardia, Chest X-ray normal, Electrocardiogram abnormal, Erythema
Clinical narrative: Patient reported to Clinic on 7/26/17 after injection with red warm to touch, swollen right arm, Acute care provider saw patient and recommended patient to go ED, patient went to clinic was given Predisone and Benadryl and released. We called patient back on 7/27/17 to follow up care, pt reports increased swelling, patient was scheduled to be seen in our clinic. patient's blood pressure at the time was low therefore, EMS was called. Patient seen at JPS ED with  possible sepsis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Hypotension, Peripheral swelling, Procalcitonin increased, Skin warm, White blood cell count increased
Clinical narrative: Patient reported to Clinic on 7/26/17 after injection with red warm to touch, swollen right arm, Acute care provider saw patient and recommended patient to go ED, patient went to clinic was given Predisone and Benadryl and released. We called patient back on 7/27/17 to follow up care, pt reports increased swelling, patient was scheduled to be seen in our clinic. patient's blood pressure at the time was low therefore, EMS was called. Patient seen at JPS ED with  possible sepsis.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and fever 8-10 days after administration of vaccines, resolved after a few days.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient describes arm being swollen, red, and sore.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient was at the clinic for a well child check, her health maintenance record was saying that she was overdue for her Hep A, after discussing the pros and cons of receiving it and explaining that it was mandatory for early-child education/ daycares that she should probably get started on the series. Provider ordered it. Immunization was given in left arm. While entering information into the computer and updating health maintenance it shown that this was the 3rd dose of Hep A. Provider notified, Patients mom was updated and was going to watch for any symptoms, She had no reactions while in clinic.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: Fever. Was only to 101. However malaise and fatigue seemed excessive compared to the fever.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left shoulder swelling, painful and redness. Ice compression every 30 minutes at least 2-3 times a day.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Fatigue, nausea and vomiting.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema at injection site. Very red and a bit tender.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pyrexia
Clinical narrative: Patient broke out in fever and blisters over body 8 days after receiving the varicella vaccine.
Age: 7.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, C-reactive protein normal, Chills, Differential white blood cell count normal, Fatigue
Clinical narrative: Fatigue appeared 3 days after first dose. Fevers, chills, headache, abdominal pain, rash appeared 5 days after first dose and 2 days after second dose.
Age: 7.0
Sex: M
Vaccine: TYP
Symptoms: Full blood count normal, Headache, Pyrexia, Rash
Clinical narrative: Fatigue appeared 3 days after first dose. Fevers, chills, headache, abdominal pain, rash appeared 5 days after first dose and 2 days after second dose.
Age: 60.0
Sex: F
Vaccine: MNQ
Symptoms: Abscess, Cellulitis, Erythema, Pain, Pyrexia
Clinical narrative: Patient reported pain, swelling, redness and fever the day following injection. She was seen by ER 4 different times with diagnosis of cellulitis. Dr's office also noted ER noted abscess.
Age: 60.0
Sex: F
Vaccine: MNQ
Symptoms: Swelling
Clinical narrative: Patient reported pain, swelling, redness and fever the day following injection. She was seen by ER 4 different times with diagnosis of cellulitis. Dr's office also noted ER noted abscess.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Left shoulder swelling for 2 days. Ice compression.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Incoherent, Syncope
Clinical narrative: Approximately 2 minutes after vaccine was administered the patient had a syncopal episode. At the time of the episode she was sitting in a chair and was transferred by the RN and mother to an exam table. Her vitals signs were taken with a BP of 122/82, and HR of 85 bpm. The Nurse Practitioner was called into the room after a few minutes as it appeared the child was not yet recovering from the episode. Another RN held her legs up as the NP assessed the child. After approximately 10 minutes the child was still unable to respond consistently to commands and questions and her speech was at times incoherent. A decision was made to have her evaluated by emergency personnel due to the protracted length of time to recover from the episode. When the paramedics arrived, the child was sitting up, answering questions and drinking juice. Vital signs were checked and were within normal limits. Her blood sugar was 88. The decision was made by the parent to take her home. The child was escorted from the clinic at 4:50 pm. A follow up call to the parent by the NP was made the following day and her mother reported she was doing fine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival swelling, Pruritus generalised, Skin discolouration
Clinical narrative: Patient reported feeling itching all over her body, her gums were swollen, her skin on her neck got darker a day after the shot was administered and she used cortisone cream and otc Benadryl pills for the symptoms. Patient also mentioned that she has had a similar reaction to the flu vaccine receive several years prior.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: PATIENT LEFT THE PHARMACY FEELING PERFECTLY FINE. HE WAS IN THE VITAMIN AISLE AND FAINTED. ANOTHER CUSTOMER HELPED HIM UP AND BROUGHT HIM BACK TO THE PHARMACY. HE SAID HE FELT LIGHT HEADED PRIOR TO FAINTING. I PROVIDED HIM SOME WATER, CHECKED HIS BLOOD PRESSURE, AND EVENTUALLY HE FELT FINE. HE MENTIONED HE DID NOT EACH MUCH, DRINK ENOUGH WATER, AND HAS BEEN WORKING LONG HOURS. HE LIVES CLOSE TO US AND WAS GOING HOME TO EAT SOME PIZZA AND GET SOME REST. WE OFFERED TO CALL 911 BUT HE STATED HE WAS FINE.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Anti-GAD antibody positive, Blood creatine phosphokinase increased, Blood test abnormal, Borrelia test positive, Dysstasia
Clinical narrative: I went to ER with complaints of stiffness in legs on Mar 21 2016, blood work was drawn and medicine was prescribed saying probably over worked muscle. 2nd trip to ER on Mar 27th with even more stiffness so more blood work and more meds. Mar 30 2016 went to another ER with severe stiffness, after blood work I was given 1 bag IV for Rhabdomyolysis. Apr 1 2016 went back first ER with no relief from stiffness and walking was a task as well as driving, took my results for the Rhabo and tests were done there, it had doubled so I was admitted the next day for 3 days to do nonstop IV. The test was done daily and it was going down but the stiffness was even worse and severe spasms had started
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Impaired driving ability, Impaired work ability, Laboratory test normal, Lumbar spinal stenosis
Clinical narrative: I went to ER with complaints of stiffness in legs on Mar 21 2016, blood work was drawn and medicine was prescribed saying probably over worked muscle. 2nd trip to ER on Mar 27th with even more stiffness so more blood work and more meds. Mar 30 2016 went to another ER with severe stiffness, after blood work I was given 1 bag IV for Rhabdomyolysis. Apr 1 2016 went back first ER with no relief from stiffness and walking was a task as well as driving, took my results for the Rhabo and tests were done there, it had doubled so I was admitted the next day for 3 days to do nonstop IV. The test was done daily and it was going down but the stiffness was even worse and severe spasms had started
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Muscle spasms, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: I went to ER with complaints of stiffness in legs on Mar 21 2016, blood work was drawn and medicine was prescribed saying probably over worked muscle. 2nd trip to ER on Mar 27th with even more stiffness so more blood work and more meds. Mar 30 2016 went to another ER with severe stiffness, after blood work I was given 1 bag IV for Rhabdomyolysis. Apr 1 2016 went back first ER with no relief from stiffness and walking was a task as well as driving, took my results for the Rhabo and tests were done there, it had doubled so I was admitted the next day for 3 days to do nonstop IV. The test was done daily and it was going down but the stiffness was even worse and severe spasms had started
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Paraesthesia, Rhabdomyolysis, Spinal X-ray normal, Tenderness, Walking aid user
Clinical narrative: I went to ER with complaints of stiffness in legs on Mar 21 2016, blood work was drawn and medicine was prescribed saying probably over worked muscle. 2nd trip to ER on Mar 27th with even more stiffness so more blood work and more meds. Mar 30 2016 went to another ER with severe stiffness, after blood work I was given 1 bag IV for Rhabdomyolysis. Apr 1 2016 went back first ER with no relief from stiffness and walking was a task as well as driving, took my results for the Rhabo and tests were done there, it had doubled so I was admitted the next day for 3 days to do nonstop IV. The test was done daily and it was going down but the stiffness was even worse and severe spasms had started
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose decreased, Dizziness, Dyspnoea, Ear discomfort, Hyperhidrosis
Clinical narrative: Approximately 5-10 minutes after administration, patient started sweating, feeling faint, lightheaded, tingling, shaky, pressure in the ears and SOB. Ammonia was first administered without any results. Epinephrine was then administered when patient complained that her throat and ears were closing up, followed by BENADRYL. Patient responded immediately to a single epinephrine dose before paramedics arrived.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia, Throat tightness, Tremor
Clinical narrative: Approximately 5-10 minutes after administration, patient started sweating, feeling faint, lightheaded, tingling, shaky, pressure in the ears and SOB. Ammonia was first administered without any results. Epinephrine was then administered when patient complained that her throat and ears were closing up, followed by BENADRYL. Patient responded immediately to a single epinephrine dose before paramedics arrived.
Age: 49.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Injection site pain
Clinical narrative: Pt. was asked which shoulder to place injection, he is right handed, injection was given in the left deltoid. Pt. verbalizes that the injection hurt. Then voiced it was his bad shoulder maybe that's why it hurt so bad. Pt. became dyaphoric stating that he doesn't feel right blood pressure was taken 71/36 and retaken was 82/52. No signs of a reaction at this time around the sight of injection. Possibly a vagal stimulation. Pt. was taken to emergency department. Per ED note: Patient presents to ED with c/o diaphoresis following injection in PCC. Pt states he was being routinely seen for Hep A/B injection in clinic, injection was given, pt states he became sweaty and felt dizzy. Pt reports when injection was given it felt like a nerve was hit. It was very painful.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Cold sweat, Fatigue, Feeling abnormal, Injection site erythema, Injection site induration
Clinical narrative: Injection site progressively getting redder more firm to touch and pt. feels poorly. Sx: tired, queasy but nl appetite, no fever but clammy.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea
Clinical narrative: Injection site progressively getting redder more firm to touch and pt. feels poorly. Sx: tired, queasy but nl appetite, no fever but clammy.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Dysphagia, Erythema, Urticaria
Clinical narrative: Patient returned to clinic at 100/pm having redness and hives. Patient complained of slight amount trouble swallowing.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Abdominal pain, Fatigue, Pyrexia
Clinical narrative: Fever 103.4 <12 hrs from vaccine. Abdominal pain. Fatigue >2wks.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Furuncle, Induration, Purulent discharge, Rash
Clinical narrative: Pt was seen by PCP on 18MAR16; at that time she received the TDAp vaccine in her left deltoid and noticed a boil on her arm the following gday. Pt reported she popped it and a clear, yellow tinged D/C came out. Pt then noticed it came back, not as large but she was able to drain the extra fluid. Pt dried out the boil with alcohol and covered it with a band-aid; denied any tenderness with palpation. Upon exam a 1/2 x 1/4 re of induration was noted; no pain or tenderness report with palpation. The area is slightly red with some raised bumps. No warmth noted.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Crying, Disorientation, Ill-defined disorder
Clinical narrative: Client made several snorting noises while sitting in a chair aprox. 10 minutes after vaccine. Her eyes were closed and she seemed disoriented for about a minute. When she opened her eyes she began to cry and said she was so embarrassed. Waited an additional 15 minutes and stated she felt fine.
Age: 13.0
Sex: F
Vaccine: HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Fall, Vomiting
Clinical narrative: Client received vaccines, client stayed in clinic for 25 minutes post vaccination, Client stated that she felt fine the entire time, no S/S of side effects. Client was able to leave clinic with her parents. Client was seen skipping to her family's car in the clinic parking lot when she bumped into the parked car, stepped back and fell slowly to the ground. RNs, rushed to the parking lot to help client, she was A&O, client vomited 2 times and then laid supine with legs elevated, BP unable to be assessed due to traffic noise, client started to feel better, she declined juice or candy, client drank water, ice pack was applied to back of client's neck. Client was able to sit up in a chair, client stated that she feels fine and was able to walk straight to her families car, client states that she feels fine, denies feeling nauseas or dizzy. Client's skin is warm and pink. Client declined hitting her head and declines any pain. No obvious injuries. Client's parents were counseled to seek medical attention for their child for any further S/S of a side affect. Patient was instructed to drink fluids. Client was able to leave with her parents.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received Zoster vaccine 12/19/11 and was diagnosed with shingles at an outside hospital 12/29/11. This new diagnosis required pharmacologic intervention and further evaluation by medical professionals. Patient had no history of imuunocompromise and was appropriate to receive zoster vaccine according to inclusion/exclusion criteria.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria
Clinical narrative: Developed hive at site of MMRV about 5 minutes post administration. No other symptoms noted. BENADRYL 7.5 ml given PO. Observation done. Mother instructed on S/Sxs to watch for and dosing of BENADRYL.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash, Swelling, Urticaria
Clinical narrative: Skin rash, rash, urticaria, pruritus and swelling. Ibuprofen 800 mg prn, tramadol 50 mg qid, cephalexin 250 mg tid.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea
Clinical narrative: Patient developed diarrhea on Tuesday after receiving shot on Monday (7/17/17). Still having issues with diarrhea.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: In receiving shot record, noted pt received PREVENAR 13 twice, on 4/14/15 and 9/21/15. No adverse reaction experienced by patient.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 48 hours after vaccine administration the injection site became swollen, red, and itchy. The redness is about 3-4 inches in diameter. Left deltoid.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Oculorespiratory syndrome
Clinical narrative: History of recurrent severe headache following seasonal influenza Immunization in 2014, 2015. Accompanied by oculo respiratory syndrome. Symptoms reproducible with 2015 influenza vaccination. Symptoms began in a few hours and resolved by 36 hours post vaccination.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Croup infectious, Pneumonia, Pyrexia
Clinical narrative: 18 mo with fever to 103 24 hours after vaccines-dx'd with croup pneumonia.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Skin rash.
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, MNQ
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Burning sensation, Decreased appetite, Differential white blood cell count
Clinical narrative: Initial unsolicited report received from a non-health care professional (Office Staff) on 14-Jul-2017. This case involves a male patient (age at time of the reaction was not reported) who was vaccinated with a dose of MENACTRA (Batch number: U5462AA, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced burning in muscles, pain in thighs, legs and thighs were numb, upper thigh was sensitive and hurting. Laboratory investigations and corrective treatment were not reported. The outcome of all the events was not reported. List of documents held by sender: none.
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, MNQ
Symptoms: Full blood count, Hypoaesthesia, Metabolic function test, Pain in extremity, Sensory disturbance
Clinical narrative: Initial unsolicited report received from a non-health care professional (Office Staff) on 14-Jul-2017. This case involves a male patient (age at time of the reaction was not reported) who was vaccinated with a dose of MENACTRA (Batch number: U5462AA, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced burning in muscles, pain in thighs, legs and thighs were numb, upper thigh was sensitive and hurting. Laboratory investigations and corrective treatment were not reported. The outcome of all the events was not reported. List of documents held by sender: none.
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, MNQ
Symptoms: Burning sensation, Hyperaesthesia, Hypoaesthesia, Myalgia, Pain
Clinical narrative: Initial unsolicited report received from a non-health care professional (Office Staff) on 14-Jul-2017. This case involves a male patient (age at time of the reaction was not reported) who was vaccinated with a dose of MENACTRA (Batch number: U5462AA, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced burning in muscles, pain in thighs, legs and thighs were numb, upper thigh was sensitive and hurting. Laboratory investigations and corrective treatment were not reported. The outcome of all the events was not reported. List of documents held by sender: none.
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, MNQ
Symptoms: Hyperaesthesia, Hypoaesthesia, Myalgia, Pain in extremity
Clinical narrative: Initial unsolicited report received from a non-health care professional (Office Staff) on 14-Jul-2017. This case involves a male patient (age at time of the reaction was not reported) who was vaccinated with a dose of MENACTRA (Batch number: U5462AA, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced burning in muscles, pain in thighs, legs and thighs were numb, upper thigh was sensitive and hurting. Laboratory investigations and corrective treatment were not reported. The outcome of all the events was not reported. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash macular
Clinical narrative: Severe swelling and redness, associated with itching, burning and pain.
Age: 68.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Burning sensation, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Severe swelling and redness, associated with itching, burning and pain.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Inflammation from shoulder to elbow, red and sore.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: Inflammation from shoulder to elbow, red and sore.
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-JUL-2017, the patient was vaccinated with an expired dose of GARDASIL 9 (lot # L044475, expiry date: 12-MAY-2017) (route: intramuscular). No symptoms reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-JUL-2017, the patient was vaccinated with an expired dose of GARDASIL 9 (lot # L044475, expiry date: 12-MAY-2017) (route: intramuscular). No symptoms reported. The outcome of the events was unknown. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: 10 days post imms patient started with rash on his trunk that is now front and back of trunk and neck. No fever, nausea or vomiting. Patient is eating and drinking fluids. Mom stated behavior is normal. Family also just returned from a trip. Went to beach.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding a 42 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 11-JUL-2017, the patient was vaccinated with two doses of PNEUMOVAX 23 (dose, route and site of administration were not provided) lot # N003997, and expiration date of 20-OCT-2018 pertain to both doses of PNEUMOVAX 23 for prophylaxis. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Cough, Dyspnoea, Ear pain, Hypersensitivity, Nausea
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old male patient. In July 2016, the RECOMBIVAX HB (lot # M04031 exp: February 2019) series started. On 02-NOV-2016 the patient was vaccinated with a dose of RECOMBIVAX HB for prophylaxis. On 02-MAY-2017 the patient experienced pyrexia, vomiting and nausea. On approximately 04-MAY-2017 the patient experienced dyspnoea and cough. On approximately 11-MAY-2017 the patient experienced hypersensitivity. On approximately 22-MAY-2017 the patient experienced ear pain and wheezing. The outcome of pyrexia, hypersensitivity, wheezing, ear pain, cough, dyspnoea, vomiting and nausea is unknown.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Vomiting, Wheezing
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old male patient. In July 2016, the RECOMBIVAX HB (lot # M04031 exp: February 2019) series started. On 02-NOV-2016 the patient was vaccinated with a dose of RECOMBIVAX HB for prophylaxis. On 02-MAY-2017 the patient experienced pyrexia, vomiting and nausea. On approximately 04-MAY-2017 the patient experienced dyspnoea and cough. On approximately 11-MAY-2017 the patient experienced hypersensitivity. On approximately 22-MAY-2017 the patient experienced ear pain and wheezing. The outcome of pyrexia, hypersensitivity, wheezing, ear pain, cough, dyspnoea, vomiting and nausea is unknown.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 24 year old male patient. In December 2016, the patient was vaccinated with GARDASIL 9 dose 1 for prophylaxis. The drug was administered to a patient of inappropriate age. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 70 year old male patient.  Pertinent medical history included unknown type of cancer. Concomitant therapies and drug allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported) reconstituted with sterile water diluent (manufacturer unknown, dose, lot # and expiration date not reported), to prevent shingles. On an unknown date, approximately 4 weeks from administration, the patient experienced a shingles like rash. The patient did not seek medical attention. The outcome of rash was reported as not recovered/not resolved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about concomitant therapy, concurrent condition, drug reactions/allergies and medical history was unknown. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # M040624 (therapy type unknown) with expiry date 03-OCT-2018, lot # M027637 (therapy type unknown) with expiry date 02-JUN-2018, route unknown for prophylaxis. No adverse effects reported. The vaccines had been exposed under temperature 47 Fahrenheit (F) to 77 F for 4 hours and 18 minutes. Previous temperature excursion included 47 F to 77 F for 7 hours. A data logger was used.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Eye inflammation, Glaucoma, Herpes zoster, Iridocyclitis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient was inoculated with ZOSTAVAX on or about 29-JUL-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about the dates of 12-MAR-2014; 23-MAY-2014; 10-JUL-2014; 17-SEP-2014; 04-AUG-2015; and 11-NOV-2015, the patient was treated by a physician for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles, which had spread to the eyes. The patient received ongoing care from the physician for repeated severe outbreaks and glaucoma and ocular inflammation secondary to herpes zoster. On or about 24-APR-2017 the patient was diagnosed by the physician as having herpes zoster anterior uveitis OD, a serious condition caused by worsening shingles that had persisted despite aggressive treatment with antivirals. The patient was prescribed VALTREX, COMBIGAN, AZOPT eye drops and DUREZOL eye drops management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review herpes zoster anterior uveitis OD and glaucoma were considered to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient was inoculated with ZOSTAVAX on or about 29-JUL-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about the dates of 12-MAR-2014; 23-MAY-2014; 10-JUL-2014; 17-SEP-2014; 04-AUG-2015; and 11-NOV-2015, the patient was treated by a physician for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles, which had spread to the eyes. The patient received ongoing care from the physician for repeated severe outbreaks and glaucoma and ocular inflammation secondary to herpes zoster. On or about 24-APR-2017 the patient was diagnosed by the physician as having herpes zoster anterior uveitis OD, a serious condition caused by worsening shingles that had persisted despite aggressive treatment with antivirals. The patient was prescribed VALTREX, COMBIGAN, AZOPT eye drops and DUREZOL eye drops management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review herpes zoster anterior uveitis OD and glaucoma were considered to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 25-JUL-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration were not reported) subcutaneous on or about 04-APR-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 04-APR-2016, the patient was treated by physician at a hospital emergency department for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed hydrocodone, acyclovir and acetaminophen, NORCO to help manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ, oral for prophylaxis.  Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.; Sender's Comments: US-009507513-1707USA010527: US-009507513-1707USA010532: US-009507513-1707USA010529: US-009507513-1707USA010530: US-009507513-1707USA010531: US-009507513-1707USA010451: US-009507513-1707USA010528:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ, oral for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.; Sender's Comments: US-009507513-1707USA010451: US-009507513-1707USA010532: US-009507513-1707USA010529: US-009507513-1707USA010530: US-009507513-1707USA010531: US-009507513-1707USA010526: US-009507513-1707USA010528:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of ROTATEQ, oral for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.; Sender's Comments: US-009507513-1707USA010451: US-009507513-1707USA010526: US-009507513-1707USA010527: US-009507513-1707USA010529: US-009507513-1707USA010530: US-009507513-1707USA010531: US-009507513-1707USA010532:
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of M-M-R II for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II.; Sender's Comments: US-009507513-1707USA010451: US-009507513-1707USA010526: US-009507513-1707USA010527: US-009507513-1707USA010528: US-009507513-1707USA010530: US-009507513-1707USA010531: US-009507513-1707USA010532:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an other refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of GARDASIL 9 for prophylaxis which was stored from 9 Celsius degrees (°C) to 25°C. Concomitant therapies included sterile diluent(STERILE DILUENT).  On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9.; Sender's Comments:  US-009507513-1707USA010451: US-009507513-1707USA010526: US-009507513-1707USA010527: US-009507513-1707USA010528: US-009507513-1707USA010529: US-009507513-1707USA010531: US-009507513-1707USA010532:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to an adult patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 13-JUL-2017, the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB (lot# N002914, expiry date: 04-NOV-2019, dosing details were not provided) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to approximately 15 years old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Nurse reported that on 28-MAY-2015, the patient was vaccinated with first dose of with GARDASIL 9 (lot# K007826, expiry date: not reported) at the age of 13 years, for prophylaxis. The patient received second vaccine dose on 20-JUL-2016, which was outside of the dosage recommendations in the product prescribing information. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to 5 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (N012134 expiration date: 17-APR-2019; M044349 expiration date:  04-NOV-2018 and M044349 expiration date:  14-SEP-2018; dosage, frequency and route unspecified) for prophylaxis and sterile diluent (lot and expiration date unknown). No adverse effects were reported. Temperature was 6 degree F to 14 degree F. Time frame was 30 minutes. Previous temperature excursion was reported as VARIVAX 47 degree F to 77 degree F for 1 hour.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA011322:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager, who was also a medical assistant regarding an unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with GARDASIL 9 (Lot # M042859 with expiration date 17-JUL-2019, Lot # M040412 with expiration date 30-JUN-2019, dose and route were unknown) for prophylaxis. The vaccine was exposed to a temperature of 53 Fahrenheit degrees for 30 hours (Lot #M042859) and a temperature of 49 Fahrenheit degrees for 56 hours (Lot #M040412). There was no previous temperature excursion and the call was not because of a "data logger". No adverse reactions reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA010395:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old male patient. There was no pertinent medical history and drug reactions/allergies. On 01-JUL-2017 the patient was vaccinated with ZOSTAVAX (lot # M034765, Expiration Date 26-OCT-2017) subcutaneous in his left arm for prophylaxis. Concomitant therapies included FLOMAX, prednisolone (manufacture unknown) and gatifloxacin. On an unknown date in July 2017, the patient experienced soreness at the injection site further described as pain when he lift his arm which was ongoing. Pharmacist denied any redness, swelling or rash. No treatment was given. No lab diagnostics/studies was performed. The patient did not seek medical attention. The causality was not provided.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date, the patient was vaccinated with M-M-R II lot # J008534 for prophylaxis. Other suspect therapies included VARIVAX lot # J012211. On an unknown date, the patient experienced adverse event. The outcome of adverse event is unknown. The relatedness between the event and the vaccines was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M031651, expiration date: 30-MAR-2018, dose, frequency and route were unknown) for prophylaxis(incorrect product storage). The ROTATEQ was exposed to 31 Fahrenheit degree or colder for a time frame of 13 hours. Data logger was involved. No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent(manufacturer unknown). On 26-JUL-2017, the patient was vaccinated with and expired dose of ZOSTAVAX lot # M015925 expiration date on 15-JUN-2017, for prophylaxis. No adverse events were reported. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 46 years-old female patient. On 08-NOV-2016, the patient was vaccinated with M-M-R II for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced rubella antibody negative. The outcome of rubella antibody negative was unknown.       Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On OCT-2014 the patient was vaccinated with RECOMBIVAX HB dose 2 for prophylaxis. On OCT-2014 the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to RECOMBIVAX HB.