chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Injection site pain, Injection site warmth, Nausea, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: 42 yo F with moderate persistent asthma, tobacco abuse and other comorbidies was seen in clinic following treatment of URI/asthma exacerbation that included steroid burst x 5 days.  At the time of the 11/28 visit, patient had improved dry cough and continued to have nasal discharge.  During clinic visit patient was vaccinated with PNEUMOVAX 23 IM in left deltoid and Influenza vaccine was given IM in right deltoid at 1601.  Patient developed nausea, emesis, diarrhea, arm became painful overnight. On 11/29 she presented to Clinic with ongoing nausea, sense of "heat" but no fever, right upper arm warm, erthyematous and tender. Also had wheezing and some shortness of breath (Hx asthma) which required an albuterol breathing treatment. It is unreported if the patient started Dulera prior to onset of SOB and wheezing.  Patient to take diphenhydramine q6h over next few days and to purchase a nebulizer.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Vomiting
Clinical narrative: 42 yo F with moderate persistent asthma, tobacco abuse and other comorbidies was seen in clinic following treatment of URI/asthma exacerbation that included steroid burst x 5 days.  At the time of the 11/28 visit, patient had improved dry cough and continued to have nasal discharge.  During clinic visit patient was vaccinated with PNEUMOVAX 23 IM in left deltoid and Influenza vaccine was given IM in right deltoid at 1601.  Patient developed nausea, emesis, diarrhea, arm became painful overnight. On 11/29 she presented to Clinic with ongoing nausea, sense of "heat" but no fever, right upper arm warm, erthyematous and tender. Also had wheezing and some shortness of breath (Hx asthma) which required an albuterol breathing treatment. It is unreported if the patient started Dulera prior to onset of SOB and wheezing.  Patient to take diphenhydramine q6h over next few days and to purchase a nebulizer.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Culture negative, Dehydration, Imaging procedure abnormal, Immunoglobulin therapy, Kawasaki's disease
Clinical narrative: By 11/18, also had a diffuse, splotchy rash, and fever to 102; she also had some emesis. Initially presented to ED, where (per our EMR notes), she had a WBC of 20, without substantial left shift, and received Motrin and ceftriaxone. She was sent home, but with first feed, had emesis, and thus family came to hospital. Had Temp up to 39.2, imaging showed L lung basilar opacity - patient given dose of oral Amoxicillin, but threw up, and thus given another dose of ceftriaxone. Monitored for 2 days treated for dehydration (no additional antibiotics given). Subsequently diagnosed with Kawasaki Disease. Treated with IVIG and ASA, improved quickly and discharged home. Notably has had a previous event after 2 month vaccination (7 days after vaccination) with clinically "viral sepsis" presented with Edema and rash. Pan cultured (negative) and treated with abx. Clinically improved after 2 days and discharged home.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Pyrexia, Rash macular, Vomiting, White blood cell count increased
Clinical narrative: By 11/18, also had a diffuse, splotchy rash, and fever to 102; she also had some emesis. Initially presented to ED, where (per our EMR notes), she had a WBC of 20, without substantial left shift, and received Motrin and ceftriaxone. She was sent home, but with first feed, had emesis, and thus family came to hospital. Had Temp up to 39.2, imaging showed L lung basilar opacity - patient given dose of oral Amoxicillin, but threw up, and thus given another dose of ceftriaxone. Monitored for 2 days treated for dehydration (no additional antibiotics given). Subsequently diagnosed with Kawasaki Disease. Treated with IVIG and ASA, improved quickly and discharged home. Notably has had a previous event after 2 month vaccination (7 days after vaccination) with clinically "viral sepsis" presented with Edema and rash. Pan cultured (negative) and treated with abx. Clinically improved after 2 days and discharged home.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Chest X-ray, Headache, Muscular weakness, Paraesthesia
Clinical narrative: Very weak arms and legs, burning under the skin, headaches, tingling feelings in hands.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Skin burning sensation
Clinical narrative: Very weak arms and legs, burning under the skin, headaches, tingling feelings in hands.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patient stated caused redness and swelling.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Alopecia, Alopecia totalis, Blood iron normal, Full blood count normal, Thyroid function test normal
Clinical narrative: Acute hair loss, starting 4/2016, 5 weeks after meningitis B vaccine. Progressed to alopecia totalis over 6 months.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood culture negative, Blood lactic acid decreased, Pain in extremity, Peripheral swelling, White blood cell count increased
Clinical narrative: Swollen, painful, left arm.
Age: 43.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site pain
Clinical narrative: Patient is experiencing shoulder pain in the shoulder where vaccine was administered.
Age: 1.83
Sex: M
Vaccine: HEP, PNC13
Symptoms: Aggression, Insomnia, Irritability, Poor feeding infant, Pyrexia
Clinical narrative: Fevers, irritability, temper tantrums, poor feeding, scratching himself, biting, not sleeping well.
Age: 1.83
Sex: M
Vaccine: HEP, PNC13
Symptoms: Scratch
Clinical narrative: Fevers, irritability, temper tantrums, poor feeding, scratching himself, biting, not sleeping well.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient came to pharmacy asking for quadrivalent flu shot, however, was administered the high dose flu shot. Patient and doctor are aware. No adverse event currently reported.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Echocardiogram, Electrocardiogram, Heart rate increased, Laboratory test, Palpitations
Clinical narrative: Daily erratic,spontaneous heart palpitations varying in strength and length of episode duration. 11/30/2016 Ambulance transport to hospital ER with symptoms of elevated, pounding, erratic heart rate with pressure across chest. BP in transit 200/90.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Urine analysis
Clinical narrative: Daily erratic,spontaneous heart palpitations varying in strength and length of episode duration. 11/30/2016 Ambulance transport to hospital ER with symptoms of elevated, pounding, erratic heart rate with pressure across chest. BP in transit 200/90.
Sex: M
Vaccine: MEN, PPV
Symptoms: Asthma
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer), from a contactable Consumer (patient's mother). A male patient of an unspecified age and ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein) and meningococcal group b rlp2086 via an unspecified route of administration on an unspecified date to an unspecified date at single dose for immunisation.  The patient's had two siblings, one older and one younger. Family medical history included maternal history of pertussis vaccination, psoriasis, varicella, influenza, ear infection from an unknown date, and paternal history of influenza immunisation, and sikness on an unknown date.  The patient's concomitant medications were not reported. The patient experienced asthma on an unspecified date and was hospitalized. The outcome was unknown. Pfizer is the marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) and meningococcal group b rlp2086  in the reporter s country. This may be a duplicate report in situations where another Marketing Authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) or meningococcal group b rlp2086  has submitted the same report to the regulatory authorities. No follow up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 81-year-old female patient received PREVNAR 13 via an unspecified route of administration at 0.5ml, single on right bicept on 07Oct2016 for immunization, since she was older than 65 years old. The patient medical history was not reported. Concomitant medication included influenza vaccine on left bicept on 07Oct2016 for immunization. The patient experienced right bicept pain in 2016 with outcome of not recovered.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: COLD LIKE SYMPTOMS GREW TO GUILLAIN BARRE; IVIG TREATMENT. HOSPITALIZED 5-6 WEEKS. PT & OT THROUGH END OF YEAR.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Chills, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Restless night with chills, some body aches. By noon (12/04/2016), severe chills, rigors, fatigue, temp just below 103 F. Swelling at injection site. Large red welts several inches long. By 12/4/16, fever persisting of 103 F. By morning of 12/05/2016, fever had broken. still fatigued. Welts and swelling still present at vaccine site. Otherwise, doing better.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site urticaria, Pain, Restlessness
Clinical narrative: Restless night with chills, some body aches. By noon (12/04/2016), severe chills, rigors, fatigue, temp just below 103 F. Swelling at injection site. Large red welts several inches long. By 12/4/16, fever persisting of 103 F. By morning of 12/05/2016, fever had broken. still fatigued. Welts and swelling still present at vaccine site. Otherwise, doing better.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling redness and hot to touch, patient complained of pain.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity
Clinical narrative: She was observed after influenza injection for 15 minutes with no adverse SE noted.  Later that evening she states that her arm became red and pain progressed up to her neck and then she got a headache.  She states she did not go to her doctor.  She states pain was relieved by 1/2 Aleve.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient received quadrivalent flu shot. Came in 12/5/16 saying that she experienced a rash with hives and itching about 30min-1hour after receiving shot. After talking to patient, sounds like she has various allergies to different things although she indicated no allergies on the questionnaire. She did state that she has had flu shots in the past with no problems noted. She did call her dr and sounds like she took some prednisone to help counter reaction she had.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose increased, Cold sweat, Dizziness
Clinical narrative: Patient became clammy and felt light-headed..had to sit down.  We called 911 to come check him out, but the patient insisted he was starting to feel better.  Vital signs all checked out ok.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Red, warm, itching, swelling in the entire upper arm.
Age: 84.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Initial pain localized at injection site over time the pain intensified and spread to shoulder and abdomen.  Pain was intense with expansion of lungs and rib cage.  Pain continued at the intense stage for several days and then slowly decreased to present day (12/5/16) and patient is now experiencing mild pain and discomfort at the injection site.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram normal, Extrasystoles, Hypoaesthesia
Clinical narrative: 0930 flu shot obtained in employee health, 1030: felt palpitations connected myself to monitor in trigeminy. Numbness/ tingling front part of tongue and rt arm hand. Went with help to lie down to rest. about 1 HR later felt worse  tingling traveling to back head and left arm  wheeled to ED via wheelchair. Dr aware as well.  Numbness mostly top of body hard to breath....eventually unable to move can not lift arms up and legs extremely weak. Feels like an elephant laying on top of my chest and arms.  Then about an hour or so later numbness went away tingling back and able to move. Dc'd home after 5 hrs. Saturday 12/3 in trigeminy occasionally, 12/4 no cardiac arrhythmia felt great. 12/5 in trigeminy saw cardiologist.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Laboratory test normal, Mobility decreased, Muscular weakness, Nuclear magnetic resonance imaging brain normal
Clinical narrative: 0930 flu shot obtained in employee health, 1030: felt palpitations connected myself to monitor in trigeminy. Numbness/ tingling front part of tongue and rt arm hand. Went with help to lie down to rest. about 1 HR later felt worse  tingling traveling to back head and left arm  wheeled to ED via wheelchair. Dr aware as well.  Numbness mostly top of body hard to breath....eventually unable to move can not lift arms up and legs extremely weak. Feels like an elephant laying on top of my chest and arms.  Then about an hour or so later numbness went away tingling back and able to move. Dc'd home after 5 hrs. Saturday 12/3 in trigeminy occasionally, 12/4 no cardiac arrhythmia felt great. 12/5 in trigeminy saw cardiologist.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging spinal normal, Palpitations, Paraesthesia, Paraesthesia oral
Clinical narrative: 0930 flu shot obtained in employee health, 1030: felt palpitations connected myself to monitor in trigeminy. Numbness/ tingling front part of tongue and rt arm hand. Went with help to lie down to rest. about 1 HR later felt worse  tingling traveling to back head and left arm  wheeled to ED via wheelchair. Dr aware as well.  Numbness mostly top of body hard to breath....eventually unable to move can not lift arms up and legs extremely weak. Feels like an elephant laying on top of my chest and arms.  Then about an hour or so later numbness went away tingling back and able to move. Dc'd home after 5 hrs. Saturday 12/3 in trigeminy occasionally, 12/4 no cardiac arrhythmia felt great. 12/5 in trigeminy saw cardiologist.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Nausea, Pyrexia
Clinical narrative: Ran fever 12-2-16 then on 12-3-16 shoulder pain and sick stomach thru 12-5-16. Now stomach is ok but shoulder is still hurting.  I have been using heat and taking nor out for pain.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Herpes zoster, Injection site erythema, Injection site reaction, Injection site vesicles, Musculoskeletal pain
Clinical narrative: Red raised lesions on near left shoulder area- some appeared to be filled with yellow clear fluid, Arm and shoulder stiffness and soreness. Dr. diagnosed patient with herpes zoster. Patient was prescribed Valacyclovir.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Pain in extremity, Skin lesion
Clinical narrative: Red raised lesions on near left shoulder area- some appeared to be filled with yellow clear fluid, Arm and shoulder stiffness and soreness. Dr. diagnosed patient with herpes zoster. Patient was prescribed Valacyclovir.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site irritation, Injection site pruritus, Injection site warmth
Clinical narrative: SKIN IRRITATION (REDNESS, WARM TO TOUCH) APPROX 4-5 INCHES AROUND INJECTION SITE WITH DARKER AREA LOCATED APPROX 1 INCH AROUND INJECTION SITE. PATIENT REPORTED MILD ITCH BUT NO PAIN.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient reported sore arm on the same day after vaccine was given.  Two days later, felt more pain in her arm which woke her up in her sleep. She applied Biofreeze, took ibuprofen 800 mg every 8 hours, and did muscle exercises. Still complains of soreness around her shoulder. Patient has not had any adverse reactions to past flu shots.  Will see her doctor on 12/27/16.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Arm became red and swollen from shoulder to elbow and was very sore and warm to touch.  After about 4 days the redness and swelling eased but the soreness has continued and there is pain when lifting arm.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Influenza like illness, Injection site inflammation, Injection site swelling, Paraesthesia
Clinical narrative: Injection site reaction, swelling and inflammation running length of inside of arm/along inner forearm to wrist/hand, feeling of pins and needles, flu-like symptoms.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Balance disorder, Dizziness, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Injection site reaction, swelling and inflammation running length of inside of arm/along inner forearm to wrist/hand, feeling of pins and needles, flu-like symptoms.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Blood test normal, Headache, Nausea
Clinical narrative: Headache, nausea, stomach cramps.  Still today as of Dec 5 th 2016 still having all day intense headaches and intermittent nausea.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal discomfort, Dyspnoea, Lethargy
Clinical narrative: Twenty minutes after receiving his vaccines the child developed difficulty breathing, upset stomach and lethargy.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Emotional distress, Injected limb mobility decreased, Injection site pain, Injection site rash
Clinical narrative: Information has been received regarding a case in litigation. It is alleged in litigation that a male patient of unspecified age was prescribed ZOSTAVAX, and has sustained severe and permanent personal injuries. In DEC-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous in the right arm. Within days after receiving ZOSTAVAX, the patient experienced pain and rash in his right shoulder surrounding the injection area. The patient has ever since suffered from pain in both arms and has trouble moving them. As a direct and proximate result of ZOSTAVAX, the patient continues to experience ongoing symptoms, including pain syndrome, that has resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a direct and proximate result of ZOSTAVAX, the patient suffered serious,  progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. Pain in both arms,  trouble moving arms, pain and rash in his right shoulder surrounding the injection area, and emotional distress were considered disabling. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injury, Mobility decreased, Pain, Pain in extremity, Physical disability
Clinical narrative: Information has been received regarding a case in litigation. It is alleged in litigation that a male patient of unspecified age was prescribed ZOSTAVAX, and has sustained severe and permanent personal injuries. In DEC-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous in the right arm. Within days after receiving ZOSTAVAX, the patient experienced pain and rash in his right shoulder surrounding the injection area. The patient has ever since suffered from pain in both arms and has trouble moving them. As a direct and proximate result of ZOSTAVAX, the patient continues to experience ongoing symptoms, including pain syndrome, that has resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a direct and proximate result of ZOSTAVAX, the patient suffered serious,  progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. Pain in both arms,  trouble moving arms, pain and rash in his right shoulder surrounding the injection area, and emotional distress were considered disabling. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Quality of life decreased
Clinical narrative: Information has been received regarding a case in litigation. It is alleged in litigation that a male patient of unspecified age was prescribed ZOSTAVAX, and has sustained severe and permanent personal injuries. In DEC-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous in the right arm. Within days after receiving ZOSTAVAX, the patient experienced pain and rash in his right shoulder surrounding the injection area. The patient has ever since suffered from pain in both arms and has trouble moving them. As a direct and proximate result of ZOSTAVAX, the patient continues to experience ongoing symptoms, including pain syndrome, that has resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a direct and proximate result of ZOSTAVAX, the patient suffered serious,  progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. Pain in both arms,  trouble moving arms, pain and rash in his right shoulder surrounding the injection area, and emotional distress were considered disabling. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Fatigue, Pain, Urticaria
Clinical narrative: Had Flu shot 11/29/16 - SOB - tiredness fatigue - lightheaded - body aches - same evening -Friday itching and Sunday noticed hives -Monday hives subsided.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pt complained of pain, swelling, difficulty moving left arm administered 11-19-2016 Reported symptoms to pharmacy 11/27/2016.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Thrombosis
Clinical narrative: Patient's flu shot was administered in the left deltoid muscle on 11/17/16. The patient called on 11/21/16 to complain of bruising after receiving vaccine. Bruise was 2" x 2" square with clots at bottom. Was painful the first day but not anymore as of 11/23/16. Patient still has bruise as of 11/23/16.
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Peripheral swelling, Skin warm, Tenderness, Urticaria
Clinical narrative: Intense reaction to (R) arm from Meningitis - swelling - tender heat 2inch x 2inch welt.
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Cellulitis, Erythema, Inflammation, Pain, Skin warm
Clinical narrative: Warmth, redness, tenderness, pain, inflammation. The left arm, from elbow to shoulder. Dr diagnosed Cellulitis. Prescribed Levofloxacin, Mupirocin and LOTRISONE.
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Tenderness
Clinical narrative: Warmth, redness, tenderness, pain, inflammation. The left arm, from elbow to shoulder. Dr diagnosed Cellulitis. Prescribed Levofloxacin, Mupirocin and LOTRISONE.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Gave high zone flu to someone under 65 yrs old. No reaction.
Age: 57.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Cheilitis, Injection site swelling, Paraesthesia, Rash
Clinical narrative: Tingling in the face rash and swelling around injection sites and rash around lips/face.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt received PREVNAR 13 and FLUZONE HD one in each arm 10/26/16. On 12-2-2016 she returned to pharmacy stating her left upper arm is still painful and has difficulty moving it.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Lip blister, Lip swelling, Wheezing
Clinical narrative: Lip swelling, blister on upper lip, wheezing developed at 2 after injection (flu shot). Patient took 50mg BENADRYL, symptoms resolved several hours later. Reported to center on 11/28/16.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Vaccination site pain
Clinical narrative: Complains of pain radiating from vaccine site up to neck. Woke up with symptoms the day after the flu vaccine. Now complains of increased pain and spreading beyond neck. Still C/O symptoms 11/23/16.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Mobility decreased, Muscle spasms, Nausea, Vomiting
Clinical narrative: Muscle spasms, dizzy, vomiting, nausea lasted 3 to 4 days, started 15 to 20 min after flu shot Pt couldn't get out of bed, muscle spasms and vomiting.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Loss of consciousness, Mydriasis, Seizure
Clinical narrative: Patient noted that she fainted once before for a vaccine due to fear of needles. Explained we could watch for 15 mins post vaccination. Patient administered vaccine at 1:15 and immediately after, she slumped into the chair, convulsed, eyes pupils fully dilated for 30 secs and was resumed consciousness 60-90 secs later. Patients mom aware, patient was able to remain in vaccine room for observation for 20 mins for full recovery. Recommended that patient be seen by provider asap for further evaluation. Mom agreed.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Cough, Culture throat negative, Influenza
Clinical narrative: Rec'd 10/10/16 - 24 hrs later chills and fever, 103 plus. Fainted twice (10/11/16) no strength in legs. Fever 3 days, cold or flu symptoms continue and today 11/30/16, still coughing. Had 102 temp 3 more days. Dr. prescribed Z-pack. Which I took. Throat culture negative, white count high.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Nasopharyngitis, Pyrexia, Syncope, White blood cell count increased
Clinical narrative: Rec'd 10/10/16 - 24 hrs later chills and fever, 103 plus. Fainted twice (10/11/16) no strength in legs. Fever 3 days, cold or flu symptoms continue and today 11/30/16, still coughing. Had 102 temp 3 more days. Dr. prescribed Z-pack. Which I took. Throat culture negative, white count high.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Received flu vaccine 11/11/16. Since injection L arm painful. Worse with movement No swelling or redness Full ROM ALEVE for pain.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Soreness in arm noted after vaccine administration yesterday 11-3-16 redness and itching noted this morning 11-4-16.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased
Clinical narrative: Temperature 102.7 at 10pm on 10-27-16 ran fever thru 9am on 10-28-16. No fever after 9AM 10-28-16. No other symptoms. Called mother 10-31-16 child doing well.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Body temperature increased, Chills, Headache, Nausea
Clinical narrative: Experienced feeling weak the night following vaccine administration (10-21-16) Saturday 10-22 - experienced nausea/ H/A, chills Sunday-10-23 experienced chills-temp 100.0 dry heaves, nausea.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Retching
Clinical narrative: Experienced feeling weak the night following vaccine administration (10-21-16) Saturday 10-22 - experienced nausea/ H/A, chills Sunday-10-23 experienced chills-temp 100.0 dry heaves, nausea.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: Pt. complained of difficulty breathing and shortness of breath. Vitals obtained: BP 130/80, Pulse 80, and resp. 20 (unlabored). No noted wheezing or stridor. No respiratory distress noted.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Bradycardia, Cold sweat, Feeling cold, Lethargy, Pallor
Clinical narrative: Ten minutes after given flu vaccine child became pale, cold and clammy skin, slightly lethargic and bradycardic. O2 inhalation given. EMS activated. Brought to ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Body temperature increased, Facial pain, Fatigue, Influenza virus test negative, Oral pain
Clinical narrative: 12/3/16 pt fatigued in the afternoon and C/O mouth/cheek pain. Temp 99. 12/4/16 afternoon C/O cheek pain again. Was given TYLENOL then woke with (B) cheek swelling - By time of ER visit, (R) cheek nl, (L) still swollen at office visit today.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Swelling
Clinical narrative: 12/3/16 pt fatigued in the afternoon and C/O mouth/cheek pain. Temp 99. 12/4/16 afternoon C/O cheek pain again. Was given TYLENOL then woke with (B) cheek swelling - By time of ER visit, (R) cheek nl, (L) still swollen at office visit today.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Neck pain, Pain in extremity, Scab
Clinical narrative: Patient has white crusting around area of vaccination. Pt states he is experiencing pain from injection from injection site down arm. States pain from injection site to neck.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Erythema, Pain, Swelling
Clinical narrative: On 12/1/16 patient received Flu and Pneumonia vaccine. By 12/31/16 patient noticed soreness, redness and swelling. Was concerned so patient called pharmacy. MD was notified. Patient had been taking BENADRYL and swelling is down, but now notices bruising.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a 75 year old female patient. Concurrent conditions included glaucoma. The patient refused to answer whether she was taking concomitant medications of had any drug reactions/allergies. On 27-OCT-2016, the patient received ZOSTAVAX subcutaneously. On an unspecified date, the patient developed a rash and blisters on her left cheek, left side of her nose and under and close to her eye. She also developed painful swelling and shooting pains at the back of her head. She sought medical treatment from the physician who administered the vaccine who advised her that she may have impetigo. The patient visited two Urgent Care facilities on two unspecified dates for treatment. A physician prescribed gabapentin for nerve pain as well as sulfamethoxazole, Valacyclovir and methylprednisolone. The patient status at the time of the report was not recovered (also reported that she has one blister on her nose remaining). Additional information is not expected as the patient refused to provide contact information.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Headache, Impetigo, Pain, Rash
Clinical narrative: This spontaneous report was received from a 75 year old female patient. Concurrent conditions included glaucoma. The patient refused to answer whether she was taking concomitant medications of had any drug reactions/allergies. On 27-OCT-2016, the patient received ZOSTAVAX subcutaneously. On an unspecified date, the patient developed a rash and blisters on her left cheek, left side of her nose and under and close to her eye. She also developed painful swelling and shooting pains at the back of her head. She sought medical treatment from the physician who administered the vaccine who advised her that she may have impetigo. The patient visited two Urgent Care facilities on two unspecified dates for treatment. A physician prescribed gabapentin for nerve pain as well as sulfamethoxazole, Valacyclovir and methylprednisolone. The patient status at the time of the report was not recovered (also reported that she has one blister on her nose remaining). Additional information is not expected as the patient refused to provide contact information.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: This spontaneous report was received from a 75 year old female patient. Concurrent conditions included glaucoma. The patient refused to answer whether she was taking concomitant medications of had any drug reactions/allergies. On 27-OCT-2016, the patient received ZOSTAVAX subcutaneously. On an unspecified date, the patient developed a rash and blisters on her left cheek, left side of her nose and under and close to her eye. She also developed painful swelling and shooting pains at the back of her head. She sought medical treatment from the physician who administered the vaccine who advised her that she may have impetigo. The patient visited two Urgent Care facilities on two unspecified dates for treatment. A physician prescribed gabapentin for nerve pain as well as sulfamethoxazole, Valacyclovir and methylprednisolone. The patient status at the time of the report was not recovered (also reported that she has one blister on her nose remaining). Additional information is not expected as the patient refused to provide contact information.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. Since 01-NOV-2016, an unknown number of patients were vaccinated with improperly stored doses of PEDVAX HIB lot number not reported. Other vaccines improperly stored included VAQTA, RECOMBIVAX HB, GARDASIL 9, M-M-R II, and ROTATEQ. No adverse effects reported. No further information provided. This is one of several reports from the same source. Additional information is not expected. No contact information provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to 20 unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in March 2015, the patients were vaccinated with improperly stored doses of M-M-R II recombinant human albumin (rHA) lot # K018965 and expiration date 15-OCT-2016, (dose and route were not reported). It was stated that the temperature excursion was 74 degrees F for 37 minutes. No previous temperature excursions were reported. It was stated that the call was made because a data logger. No adverse effects reported. There was not a product quality complaint (PQC) involved. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to 12 unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose and route unknown, lot # L036301, expiration date: 20-DEC-2017). No adverse effects were reported. This is one of three reports received from the same reporter. 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 2 unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route unknown, lot # L019835, expiration date: 23-MAR-2017). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to 7 unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (dose and route unknown, lot # M027883, expiration date: 15-APR-2019). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a female patient of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml (route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the patient visited the pharmacist for the second time after received the ZOSTAVAX due to a "large swelling at the injection site". At the time of the report, the outcome of the injection site swelling was unknown. The relatedness between the event and therapy with ZOSTAVAX was not reported. 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 medical assistant referring to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. Since 01-NOV-2016, an unknown number of patients were vaccinated with improperly stored doses of ROTATEQ lot number not reported. Other vaccines improperly stored included VAQTA, RECOMBIVAX HB, GARDASIL 9, M-M-R II, and PEDVAX HIB. No adverse effects reported. No further information provided. No contact information was provided. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from consumer who reported on a social media. This report refers to 49 individuals, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown date, the patients were vaccinated with Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recomb, Vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 34 52 58 vlp vaccine (manufacturer unknown), route, dose, frequency, batch/lot number, expiration date were not reported). On an unknown date, the patients experienced an adverse event, it was reported as: "getting a vaccine that can do more harm than good" the reporter stated that the patients were "victims for harm resulting from the vaccine". The outcome of adverse event was unknown. Additional information is not expected as there is no contact information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients. On unknown dates, the patients were vaccinated with ROTATEQ (lot # M017514, expiration date 07-NOV-2017; L048854, expiration date 31-AUG-2017), which was improperly stored at 50.9 F for 10 hours. No adverse effect reported. No data logger was involved. There was no previous excursion. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a male patient of unknown age regarding himself. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in 2016, the patient had been vaccinated with the second dose of GARDASIL 9 (dosing details, lot# and expiry date were not reported). It has been more than 6 months since the patient had received the second dose of GARDASIL 9. The PI indicated he should have received the third dose at six months. No adverse reactions were reported. There were no product quality complaints (PQC) involved. Additional information is not expected as reporter contact details were not provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. Since 01-NOV-2016, an unknown number of patients were vaccinated with improperly stored doses of GARDASIL 9, lot number not reported. Improperly stored vaccines included VAQTA, RECOMBIVAX HB, M-M-R II, PEDVAXHIB and ROTATEQ. No adverse effects reported. No further information provided. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. Since 01-NOV-2016, an unknown number of patients were vaccinated with improperly stored doses of M-M-R II, lot number not reported. Other vaccines improperly stored included VAQTA, RECOMBIVAX HB, GARDASIL 9, PEDVAX HIB and ROTATEQ. No adverse effects reported. No further information provided. This is one of several reports from the same source. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Maternal exposure before pregnancy, Pregnancy test positive
Clinical narrative: Brought in by Mom on 102616 and received MENACTRA and VARIVAX without difficulty. Mom calls 120516 and reports daughter is pregnant. Has had 4 positive pregnancy tests at home. States LMP around 102616. Missed period in November. Has not seen MD yet. WIC apt tomorrow 120616, will do preg. test.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. Since 01-NOV-2016, an unknown number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot number not reported. Other vaccines improperly stored included VAQTA, GARDASIL 9, M-M-R II, PEDVAX HIB and ROTATEQ. No adverse effects reported. No further information provided. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as: M024678 with expiration date: 08-MAY-201, lot # reported as: M000997 with expiration date: 07-JAN-2018, lot # reported as: L044524 with expiration date: 09-NOV-2017 and lot # reported as: L043622 with expiration date: 03-NOV-2017 (doses and routes of administration were not reported). There were no adverse effects reported. The administered doses of vaccine experienced a temperature excursion of maximum 15.2 Fahrenheit for 2 hours and 8 minutes. Data logger was involved and there was no previous temperature excursion reported. There was any Product Quality Complaint (PQC) involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. Since 01-NOV-2016, an unknown number of patients were vaccinated with improperly stored dose of VAQTA, lot number not reported. Other vaccines improperly stored included RECOMBIVAX HB, GARDASIL 9, M-M-R II, PEDVAX HIB and ROTATEQ. No adverse effects reported. No further information provided. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. Medical history and concomitant medications were not provided. On 17-NOV-2016, the patient received one expired dose of PNEUMOVAX 23 (lot number L021356; expiration 05-NOV-2016). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 14-NOV-2016 from a registered nurse referring to multiple unspecified patients (ages and gender unknown). The patient's concurrent conditions, medical history and concomitant medications were not reported. The registered nurse reported that on unspecified dates, multiple unspecified patients may have received improperly stored doses of the following vaccines: GARDASIL 9 Lot # L040164 expiration 20-FEB-2018, L043214 expiration 30-AUG-2017, M016193 expiration 24-APR-2018, L036301 expiration 20-DEC-2017, M018810 28-MAY-2018, M031557 expiration 07-APR-2019, M030380 01-FEB-2019, L024993 17-OCT-2017, L048237 08-MAY-2017 and M018840 01-FEB-2018; GARDASIL also reported as HPV4, lot # K008931 expiration 14-MAR-2017; PNEUMOVAX 23 lot number M029680 expiration 17-JAN-2018, M022085 expiration 09-OCT-2017, L048265 expiration 10-JUN-2017, M006141 expiration 28-MAY-2017, and L027732 expiration 23-FEB-2017; RECOMBIVAX HB lot number M000442 expiration 31-MAR-2018, L048849 expiration 04-FEB-2018, and L039660 expiration 04-FEB-2018: ROTATEQ lot number M007307 30-NOV-2017, M019706 expiration 24-OCT-2017, M014318 expiration 30-SEP-2017, L048854 expiration 31-AUG-2017, L013193 expiration 20-JAN-2017 and M017574 expiration 07-NOV-2017. The vaccines were reported by a data logger at 32.4 degrees F for 2 hours with no previous excursions. No adverse effects were reported. Additional information was received on 15-NOV-2016 from a registered nurse. The nurse reported that the vaccines: GARDASIL 9, GARDASIL, PNEUMOVAX 23, RECOMBIVAX HB, and ROTATEQ were exposed to 32.4 degrees F for 4 hours (previously reported as 2 hours). No adverse effects reported. No further information was reported. Lot number M017574 is an invalid lot number for ROTATEQ. 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 Registered Nurse, referring to an unknown number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were vaccinated on unspecified dates with improperly stored doses of GARDASIL 9, (lot # M028323 expiration date: 26-SEP-2018). No adverse effect reported. No further information was received. Temperature excursion: 35.2 degree F for 1 hour and 6 minutes. This is one of two reports received from same reporter.  Additional information has been requested.