chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Nasal congestion
Clinical narrative: Left leg started with redness and rash day after the shot, the second day patient would not walk on leg and seemed worse, went to emergency department and put on BENADRYL and antibiotic. Came to see pediatrician 3 days after event, no fever, walking fine, Mom says still was the same. Nurse practitioner states rash was "impressive" itchy and painful. Mom and grandmother state pt had vaccines Friday, redness/swelling small area on L lateral thigh near injection site yesterday, worse today. No fever some nasal congestion no diff breathing. Unsure which vaccine pt got in LLE but had on R that looked okay. No allergies known. In with mom, pt seen 3 days ago, with 4yr shots. Seemed fine. That dad was C/O about leg hurting. Mom said started with redness and rash just on one leg. Was not walking on it yesterday and seemed worse. Mom took patient to ED and put on BENADRYL and antibiotic. Mom says pharmacy was closed so has not started yet. No fever. Does seem to be walking fine today. Mom says looks about the same, today.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: C-reactive protein, Differential white blood cell count, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: On Wednesday 12/6/17 less than 24 hours after receiving vaccines, patient fainted at home in the shower. Pt. was seen at Hospital ER, and referred to cardiology for evaluation and follow up.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: On Wednesday 12/6/17 less than 24 hours after receiving vaccines, patient fainted at home in the shower. Pt. was seen at Hospital ER, and referred to cardiology for evaluation and follow up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt was seen 12/12/17 for dose #2 of Men B imm. Pt was immunized at 2:30pm. Around 9pm pt states she began to feel pain and swelling on the site of the immunization. Pt feels fingers numb and there is redness and swelling about 3 inches around the immunization site.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Myalgia, Tremor, Vomiting
Clinical narrative: Shaking/trembling of hands, muscle aches, vomit x 1.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Musculoskeletal disorder, Pain
Clinical narrative: Shot was given high up in the arm, just below the top of the shoulder. I was wondering why she was going so high. Four hours later, severe pain set in and worsened. Pain is too great for me to sleep. I cannot use my right arm as pain is too great each time I lift the arm. I have never had any reaction to any shot or drug in my life.
Age: 36.0
Sex: F
Vaccine: FLUR3
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Ear pain, Glossodynia
Clinical narrative: Hives, rash, tongue and throat swelling, numbness and tingling in extremities and tongue and lower lip and chin, diarrhea, nausea, Migraines, Shortness of breath, dizziness, Jaw Pain, Ear Ache, Tongue Pain.
Age: 36.0
Sex: F
Vaccine: FLUR3
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Migraine, Nausea, Pain in jaw
Clinical narrative: Hives, rash, tongue and throat swelling, numbness and tingling in extremities and tongue and lower lip and chin, diarrhea, nausea, Migraines, Shortness of breath, dizziness, Jaw Pain, Ear Ache, Tongue Pain.
Age: 36.0
Sex: F
Vaccine: FLUR3
Symptoms: Paraesthesia, Paraesthesia oral, Pharyngeal oedema, Rash, Swollen tongue
Clinical narrative: Hives, rash, tongue and throat swelling, numbness and tingling in extremities and tongue and lower lip and chin, diarrhea, nausea, Migraines, Shortness of breath, dizziness, Jaw Pain, Ear Ache, Tongue Pain.
Age: 36.0
Sex: F
Vaccine: FLUR3
Symptoms: Urticaria
Clinical narrative: Hives, rash, tongue and throat swelling, numbness and tingling in extremities and tongue and lower lip and chin, diarrhea, nausea, Migraines, Shortness of breath, dizziness, Jaw Pain, Ear Ache, Tongue Pain.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Cough, Decreased appetite, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, coughing, fever, mucus, blocked nasal passages on both sides, loss of appetite, general weakness.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Rhinorrhoea, Sinus congestion
Clinical narrative: Sore throat, coughing, fever, mucus, blocked nasal passages on both sides, loss of appetite, general weakness.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Red rash on arm.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 20-NOV-2017,the patient was vaccinated with PNEUMOVAX 23 intramuscular (dose, frequency, and anatomical location were unknown) with lot # N025656 and expiration date 19-APR-2019 for prophylaxis. After this dose was given to the patient, the medical assistant received a call from her distributor. The distributor said "the  PNEUMOVAX 23 was unstable," but did not provide any details about how the PNEUMOVAX 23 became unstable. No known adverse effects. Medical assistant did not state that product looks different or unusual.
Age: 0.75
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other refers to a 9 month old patient of an unspecified gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 20-NOV-2017, the patient was inadvertly vaccinated with a dose of GARDASIL 9 (lot# reported as C5263AA expiration date 12-SEP-2019) for prophylaxis. No adverse effects were reported. Lot Number C5263AA is NOT valid for GARDASIL 9.
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient. The patient's drug reaction and medical history were unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On an unknown date, the patient received the first dose of PROQUAD(rHA, dose and route unknown, lot # N010865, expiration date 01-OCT-2018) for prophylaxis (drug administered to patient of inappropriate age). No adverse effect reported.  The outcome of the events was unknown.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache
Clinical narrative: Six hours after receiving the influenza vaccination; employee experienced "very bad headache, extreme chills".
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Oral discomfort
Clinical narrative: On 12/9, 5 days after vaccine, pt experienced burning sensation on face just above cheek, lasting about a minute or less and then going away. Periodically over the following days she experienced the same burning sensation also lasting about a minute on her finger, then on another day under her lip. Each episode seems to be random and lasts about a minute or less then subsides.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Injection site swelling, injection site redness, injection site welts, fever 102, vomiting.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: Injection site swelling, injection site redness, injection site welts, fever 102, vomiting.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Pruritus, Skin burning sensation, Urticaria
Clinical narrative: My body became itchy, beginning with my palms and trunk. Within 3 hours I was covered in hives. I called the nurse line and they directed me to take 50 ml BENADRYL. That took the edge off and allowed me to sleep through the night. I woke up the morning of the 14th body covered in hives, skin feeling on fire. I am 9 weeks 2 days pregnant with a healthy baby. This is my third healthy pregnancy.
Age: 1.25
Sex: M
Vaccine: FLU4, HIBV, PNC13
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Swelling of the thigh, temperature starting at 100.5 to 104.1 for the next 80 hours. Not eating, constant Epsom salt baths, cool towels, MOTRIN and TYLENOL switches. Swelling lasted till Friday 11am. Fever finally broke followed by vomiting 2 times. Baby slept continuously.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 24-AUG-2017 at 13:48, the patient was vaccinated with PNEUMOVAX 23 (lot # N011305, expiry date: 20-JAN-2019) intramuscularly for prophylaxis, then inadvertently administered a second dose of PNEUMOVAX 23 (lot # N011305, expiry date: 20-JAN-2019) on 30-AUG-2017 (extra dose administered). No adverse effects reported. Follow up information was received on 04-DEC-2017 from the registered nurse referring to a 70 year old female patient. Patient's historical drugs included penicillin and heparin. The patient was allergic to heparin, penicillin (PCN), proton pump inhibitor, bee stings and shellfish. Concurrent conditions included Barrett's esophagus, TIA (transient ischaemic attack), chronic kidney disease, hyperlipidemia, hypertension, cerebral degeneration, vascular dementia and thrombocytopenia. On 01-SEP-2017 at 08:05 (previously reported as 30-AUG-2017), the patient was inadvertently administered a second dose of PNEUMOVAX 23.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via Poison & Drug Center (PDC) regarding a 60 year old male patient. The patient's pertinent medical conditions and concomitant medications were reported as unknown. On 09-DEC-2017, the patient was vaccinated with ZOSTAVAX lot # M032141, 1 syringe once, subcutaneous (strength was reported as unknown), expiry date: 02-OCT-2017 for prophylaxis (expired product administered). It was reported that, the patient did not experience any adverse events. There was no relevant lab data. This is one of the two reports from same reporter.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain post pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) injection on an unspecified date. Outcome of the event was recovered as it lasted 24 hours. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Asthenia, Blood test normal, Decreased appetite, Diarrhoea, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 75-year-old female patient received PREVNAR 13 for Immunisation on 05-OCT-2017 10:30 via an unspecified route in the left arm at single dose and influenza vaccine in the right arm. Concomitant medication included COUMADIN it could be 2.5mg and then next be 3.9mg. Relevant medical history included blood clots, diagnosed in 1965, atrial fibrillation diagnosed probably a year ago, body height decreased. On unknown date in Oct2017 the patient experienced no appetite at all, she did not eat anything for one solid week, she only wanted Coca-Cola, diarrhea, complete fatigue, on 06Oct2017 Sweats (That Friday night she woke up and she was wet/her head would be wet and she'd have sweat on her forehead), on 05Oct2017 headaches (she woke up the next day and her head was splitting open) on unknown date lost weight, Feeling abnormal (she does not have any desire for sweets and things almost make her feel like she will throw up, just like nausea) and asthenia (she was too sick to go to the family doctor/she got to where she could not walk from one room to the next because she has no breathe/she was too weak to get up/She still has no energy and is not herself and it has been almost two months). She went to her cardiologist and he run every kind of test there was, thyroid and all blood work, echocardiogram and lung scan. This all went through Dec2016 and nothing really showed up. Information on the batch number has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Echocardiogram normal, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 75-year-old female patient received PREVNAR 13 for Immunisation on 05-OCT-2017 10:30 via an unspecified route in the left arm at single dose and influenza vaccine in the right arm. Concomitant medication included COUMADIN it could be 2.5mg and then next be 3.9mg. Relevant medical history included blood clots, diagnosed in 1965, atrial fibrillation diagnosed probably a year ago, body height decreased. On unknown date in Oct2017 the patient experienced no appetite at all, she did not eat anything for one solid week, she only wanted Coca-Cola, diarrhea, complete fatigue, on 06Oct2017 Sweats (That Friday night she woke up and she was wet/her head would be wet and she'd have sweat on her forehead), on 05Oct2017 headaches (she woke up the next day and her head was splitting open) on unknown date lost weight, Feeling abnormal (she does not have any desire for sweets and things almost make her feel like she will throw up, just like nausea) and asthenia (she was too sick to go to the family doctor/she got to where she could not walk from one room to the next because she has no breathe/she was too weak to get up/She still has no energy and is not herself and it has been almost two months). She went to her cardiologist and he run every kind of test there was, thyroid and all blood work, echocardiogram and lung scan. This all went through Dec2016 and nothing really showed up. Information on the batch number has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Nausea, Thyroid function test normal, Ventilation/perfusion scan, Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 75-year-old female patient received PREVNAR 13 for Immunisation on 05-OCT-2017 10:30 via an unspecified route in the left arm at single dose and influenza vaccine in the right arm. Concomitant medication included COUMADIN it could be 2.5mg and then next be 3.9mg. Relevant medical history included blood clots, diagnosed in 1965, atrial fibrillation diagnosed probably a year ago, body height decreased. On unknown date in Oct2017 the patient experienced no appetite at all, she did not eat anything for one solid week, she only wanted Coca-Cola, diarrhea, complete fatigue, on 06Oct2017 Sweats (That Friday night she woke up and she was wet/her head would be wet and she'd have sweat on her forehead), on 05Oct2017 headaches (she woke up the next day and her head was splitting open) on unknown date lost weight, Feeling abnormal (she does not have any desire for sweets and things almost make her feel like she will throw up, just like nausea) and asthenia (she was too sick to go to the family doctor/she got to where she could not walk from one room to the next because she has no breathe/she was too weak to get up/She still has no energy and is not herself and it has been almost two months). She went to her cardiologist and he run every kind of test there was, thyroid and all blood work, echocardiogram and lung scan. This all went through Dec2016 and nothing really showed up. Information on the batch number has been requested.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Vertigo
Clinical narrative: Flu shot administered approx 4:45 11/30/17. At midnight patient woke with vertigo/dizziness. Continued when sitting up until 12/4/17. Feels better. Instructed pt to contact MD if further dizzy. Left message w/pt after initial contact. Never called back.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt noted redness and swelling of (L) Deltoid after injection, called and made appointment to be seen on 12/12/2017.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Dizziness, Feeling abnormal, Hyperhidrosis, Influenza like illness
Clinical narrative: Patient received the Meningococcal ACWY vaccine - MenACWY and MPSV4. Specific details may be obtained through his PCP's office. He also received the Tdap vaccine. Initially he was light headed. His arm hurt through the night. He had a red bump that evening at the vaccination site. Both injections were given in the same arm. Pain persisted the following day and he needed ice packs at school. He came home from school extremely ill. The bump had more than tripled in size. He had a fever, chills, migraine and began vomiting. He vomited multiple times that evening. He was extremely miserable.  He woke up drenched in sweat in middle of the night. I assumed it was the flu. Yesterday (12/13/17), I called his PCP because of the size of the bump growing even more. His flu-like symptoms seemed to be gone. He was just worn out from the event. I was told it should be seen and that it could be cellulitis and he would need an antibiotic. It was suggested since his flu like symptoms had subsided, that I could even wait until the next morning to see how it was doing. Around 7:30 p.m. I checked it and it had grown even more and was significantly more raised. I rushed him to Clinic and he was promptly seen. The physician said he did not have cellulitis and this and his flu like symptoms were most likely due to the vaccines and most probably the Meningococcal vaccine. His fever had also returned.  Unfortunately, we cannot know for sure as the vaccines were both given in the same arm. I was given an antibiotic if the area continued to grow and if red lines developed.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Malaise, Migraine, Pain in extremity, Pyrexia
Clinical narrative: Patient received the Meningococcal ACWY vaccine - MenACWY and MPSV4. Specific details may be obtained through his PCP's office. He also received the Tdap vaccine. Initially he was light headed. His arm hurt through the night. He had a red bump that evening at the vaccination site. Both injections were given in the same arm. Pain persisted the following day and he needed ice packs at school. He came home from school extremely ill. The bump had more than tripled in size. He had a fever, chills, migraine and began vomiting. He vomited multiple times that evening. He was extremely miserable.  He woke up drenched in sweat in middle of the night. I assumed it was the flu. Yesterday (12/13/17), I called his PCP because of the size of the bump growing even more. His flu-like symptoms seemed to be gone. He was just worn out from the event. I was told it should be seen and that it could be cellulitis and he would need an antibiotic. It was suggested since his flu like symptoms had subsided, that I could even wait until the next morning to see how it was doing. Around 7:30 p.m. I checked it and it had grown even more and was significantly more raised. I rushed him to Clinic and he was promptly seen. The physician said he did not have cellulitis and this and his flu like symptoms were most likely due to the vaccines and most probably the Meningococcal vaccine. His fever had also returned.  Unfortunately, we cannot know for sure as the vaccines were both given in the same arm. I was given an antibiotic if the area continued to grow and if red lines developed.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Patient received the Meningococcal ACWY vaccine - MenACWY and MPSV4. Specific details may be obtained through his PCP's office. He also received the Tdap vaccine. Initially he was light headed. His arm hurt through the night. He had a red bump that evening at the vaccination site. Both injections were given in the same arm. Pain persisted the following day and he needed ice packs at school. He came home from school extremely ill. The bump had more than tripled in size. He had a fever, chills, migraine and began vomiting. He vomited multiple times that evening. He was extremely miserable.  He woke up drenched in sweat in middle of the night. I assumed it was the flu. Yesterday (12/13/17), I called his PCP because of the size of the bump growing even more. His flu-like symptoms seemed to be gone. He was just worn out from the event. I was told it should be seen and that it could be cellulitis and he would need an antibiotic. It was suggested since his flu like symptoms had subsided, that I could even wait until the next morning to see how it was doing. Around 7:30 p.m. I checked it and it had grown even more and was significantly more raised. I rushed him to Clinic and he was promptly seen. The physician said he did not have cellulitis and this and his flu like symptoms were most likely due to the vaccines and most probably the Meningococcal vaccine. His fever had also returned.  Unfortunately, we cannot know for sure as the vaccines were both given in the same arm. I was given an antibiotic if the area continued to grow and if red lines developed.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Injection site urticaria, Rash, Urticaria
Clinical narrative: Thick whelps rash began at site of MMR vaccine then spread to arms and face.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Burning sensation, Urticaria
Clinical narrative: Hives-burning sensation. Tx: Prednisone 5mg (8 day supply), VISTARIL 25mg (10 day supply).
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Redness at injection site, redness moving down arm, diarrhea, soreness at injection site.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Dizzy, vomiting and nausea.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: LOW GRADE FEVER. PT DID SEEK MEDICAL ATTENTION. PT WAS PRESCRIBED ANTIBIOTICS. FEVER PERSISTED DESPITE TREATMENT WITH ANTIBIOTICS DURATION 10 DAYS.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Swelling face
Clinical narrative: Facial swelling day after vaccine given. Mother gave antihistmine and swelling went down within 24 hours.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Effusion, Joint range of motion decreased, Neck pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Terrible pain in right arm and neck. Loss of Range of Motion, frozen shoulder. Bursal Effusion. High-grade bursal surface tear at the distal anterior aspect at the level of the footprint. Fluid is seen in the subacromial/subdeltoid bursa. Currently seeing a PM&R doctor for some kind of treatment. Appointment is tomorrow 12/15/17 to review MRI and figure out a Plan of Care. Currently in PT. Currently going for Medical Massage therapy. I had absolutely NO pain in my right arm prior to this shot. I was perfectly fine.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis, Ultrasound scan abnormal
Clinical narrative: Terrible pain in right arm and neck. Loss of Range of Motion, frozen shoulder. Bursal Effusion. High-grade bursal surface tear at the distal anterior aspect at the level of the footprint. Fluid is seen in the subacromial/subdeltoid bursa. Currently seeing a PM&R doctor for some kind of treatment. Appointment is tomorrow 12/15/17 to review MRI and figure out a Plan of Care. Currently in PT. Currently going for Medical Massage therapy. I had absolutely NO pain in my right arm prior to this shot. I was perfectly fine.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abnormal behaviour, Cough, Crying, Hypophagia, Irritability
Clinical narrative: Parent states baby was fussy Friday evening (12/8/17) after receiving above vaccines. Baby was up five times that night, behavior was different, randomly crying, clingy, could not be put down per parent. Not eating solids as well, shorter naps, felt warm but no fever, some cough, no runny nose per parent. No vomiting or diarrhea, no ill contacts at home, TYLENOL does not help per parent.  Parents very upset, mom crying and unable to hold baby for exam here in office on 12/12/17. Parents refused to have baby weighed or measured and state baby is a different baby since vaccines were given on 12/8/17. No bruising or swelling at imm sites.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Skin warm
Clinical narrative: Parent states baby was fussy Friday evening (12/8/17) after receiving above vaccines. Baby was up five times that night, behavior was different, randomly crying, clingy, could not be put down per parent. Not eating solids as well, shorter naps, felt warm but no fever, some cough, no runny nose per parent. No vomiting or diarrhea, no ill contacts at home, TYLENOL does not help per parent.  Parents very upset, mom crying and unable to hold baby for exam here in office on 12/12/17. Parents refused to have baby weighed or measured and state baby is a different baby since vaccines were given on 12/8/17. No bruising or swelling at imm sites.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Cardiac disorder
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported that a 68 year old female patient received the first single dose of  PREVNAR 13 on 21Sep2016, for immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced extensive heart problems. It was reported that extensive heart problems occurred after the first pneumococcal 13-val conj vac (dipht crm197 protein). Hospitalization was required on an unspecified date, at the beginning of Oct2017. Clinical outcome was unknown at time of this report. Sender's Comments: There is no plausible mechanism to implicate the suspect vaccine to the occurrence of the serious event "extensive heart problems" due to insufficient information. More information such as medical history and concomitant medications, and even term details including diagnostic workup (EKG, Echocardiography and myocardia enzymes) and the time lag between the vaccination date and the onset of the event are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2017524137 same patient, same product, different event.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiac assistance device user, Cardiac failure, Catheterisation cardiac, Echocardiogram, Pericarditis
Clinical narrative: Pericarditis and now heart failure.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pyrexia
Clinical narrative: Patient developed 103 Fever 12/08/2017. Cephalexin prescribed 12/12/2017. Patient has red area with undefined shape for past week.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Sore arm following flu shot administration, still sore as of reporting on 12/14/17. Limited range of movement.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Lethargy, Peripheral swelling, Pruritus
Clinical narrative: Arthus reactions, arm was red, swollen, hot to the touch, hard, itchy, the size of a softball for two weeks, lethargic, low grade fever.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Skin warm, Type III immune complex mediated reaction
Clinical narrative: Arthus reactions, arm was red, swollen, hot to the touch, hard, itchy, the size of a softball for two weeks, lethargic, low grade fever.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Muscular weakness, Myalgia, Pain
Clinical narrative: Muscle soreness and weakness. Limited range of motion. Pain and difficulty when getting undressed and lifting shirt over head. Pain and soreness in my arm when I lay on my left side. Symptoms have not subsided for 16 days.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Muscle soreness and weakness. Limited range of motion. Pain and difficulty when getting undressed and lifting shirt over head. Pain and soreness in my arm when I lay on my left side. Symptoms have not subsided for 16 days.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, X-ray
Clinical narrative: SEVERE PAIN IN LEFT SHOULDER AND ARM. PCP SUGGESTED MOTRIN 200 MG A DAY FOR 3 OR 4 DAYS. ER ON NOVEMBER 5, 2017 WEANING DOSE OF PREDNISONE 10 MG/SLING/EXERCISE SHEET. PCP SENT HOSPITAL FOR 6 XRAYS, SETUP HOME PHYSICAL THERAPY, ORTHOPEDIC REFERRAL/ORTHOPEDIC PRESCRIBED MOBIC 7.5 MG 1 TO 2 A DAY FOR 30 DAYS, ORDERED MONTH OF IN HOME PHYSICAL THERAPY. GO BACK 1/11/2018 IF NO IMPROVEMENT, WILL ADMINISTER CORTISONE SHOT.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Listless, Pyrexia, Rash
Clinical narrative: Fever of 103-104, rash on face, trunk, and legs, listless for 5 days.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Injection site swelling, Pyrexia
Clinical narrative: Fever 102, chills for 2 days followed by local cellulitis, swelling of deltoid area around injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Oedema, Skin warm
Clinical narrative: Erythema, edema, hot.
Age: 23.0
Sex: F
Vaccine: FLUC4, HEPA, HPV9
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a pediatric dose of Hep A vs. the adult dose of Hep A.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Body temperature increased, Heart rate increased, Vomiting
Clinical narrative: Patient reports 103F, vomiting and increased heart rate. Patient also states that they got the Pneumoccocal vaccine within previous 3 weeks of getting the influenza vaccine.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Urticaria
Clinical narrative: Patient developed hives all over body. Patient came to clinic and patient's PCP, prescribed the patient BENADRYL.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist who referred to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. On 14-NOV-2017, the patient was vaccinated with less than a full dose of ZOSTAVAX lot # M042850, expiration date 18-JAN-2017 (dose, frequency and route of administration were not reported) for prophylaxis. Concomitant therapies included sterile diluent. Less than a full dose of ZOSTAVAX was administered because the luer lock syringe that was used to administer the of vaccine leaked. No symptoms were reported.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (mother). A male patient of unspecified age and ethnicity/race received in May2016 first single dose of TRUMENBA and MENACTRA, both for immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2016 (reported as several days later), the patient broke out in very large hives probably 4 inches which lasted a little over 2 days kind of coming and going. Patient was on a three dose regimen for the meningococcal group b rlp2086 and the mother was wondering if son should go forward and get the second and third doses of meningococcal group b rlp2086. Final outcome was unknown.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Abnormal behaviour, Aphasia, Autism spectrum disorder, Decreased appetite, Decreased eye contact
Clinical narrative: Loss of speech, loss of eye contact.  Stopped eating, sleeping, walking and talking. Screaming for hours and hours. Extremely irritable. No longer wanted any affection of any kind. Has been a completely different child ever since. In his own world 100% of the time.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Gait inability, Insomnia, Irritability, Screaming
Clinical narrative: Loss of speech, loss of eye contact.  Stopped eating, sleeping, walking and talking. Screaming for hours and hours. Extremely irritable. No longer wanted any affection of any kind. Has been a completely different child ever since. In his own world 100% of the time.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administration error, No adverse event
Clinical narrative: No adverse reaction. Client had been given two doses of pediatric Hep A in 2011 and 2013 and was given an adult dose of Hepatitis A on 12/12/2017.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Fibrin D dimer increased, Headache, Hypertension, Hyporeflexia
Clinical narrative: PATIENT ADMITTED ON 12/11 THRU ED REPORTING WEAKNESS X 2 DAYS. PATIENT HAD FLU VACCINE GIVEN IN NOVEMBER. (NOT AT OUR FACILITY) DEVELOPED WEAKNESS, BILATERAL MORE SO ON LOWER EXTREMITIES, DECREASED REFLEXES BILAT, HYPERTENSION, WEAKNESS PROGRESSING. PATIENT TRANSFERRED TO HIGHER LEVEL OF CARE: HOSPITAL ON 12/13.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Pulmonary embolism
Clinical narrative: PATIENT ADMITTED ON 12/11 THRU ED REPORTING WEAKNESS X 2 DAYS. PATIENT HAD FLU VACCINE GIVEN IN NOVEMBER. (NOT AT OUR FACILITY) DEVELOPED WEAKNESS, BILATERAL MORE SO ON LOWER EXTREMITIES, DECREASED REFLEXES BILAT, HYPERTENSION, WEAKNESS PROGRESSING. PATIENT TRANSFERRED TO HIGHER LEVEL OF CARE: HOSPITAL ON 12/13.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site vesicles
Clinical narrative: Patient developed 4 blisters on left thigh around injection site the day after vaccination.
Age: 33.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Back pain, Cough, Headache, Musculoskeletal stiffness
Clinical narrative: Cough, Headache, Muscles went stiff, Back hurting.
Age: 18.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Patient returned 11/16/17 for next vaccines. At this visit, she reported no period since at least September, but maybe no period since June or July. Is unsure of dates. Pregnancy test was done, and showed positive for pregnancy. Unknown EDC due to unknown LMP dates. Referred to OB. No patient follow up since that time.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Erythema, Pain in extremity, Rash, Throat tightness
Clinical narrative: Patient states that it started with her arm being red and painful then developed a rash on her face and her throat felt like it was "tightening" and having difficulty breathing. Declined an ER visit or visit to clinic. Seen by the school nurse who cleared her to go home. She did not use her EPIPEN, or any other antihistamines.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Cellulitis right upper arm 7cm X 8cm erythema and tenderness. Cephalexin 1000mg TID x10 days.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Several hours after receiving flu shot in left arm developed pain entire left arm, shoulder and neck with swelling left arm. Stated she had fever at home. Presented to Employee Health Clinic 24 hours after receiving the shot in our office. Left arm swollen and continued to c/o pain left arm and shoulder and neck. Employee sent to Occ Health Clinic for further evaluation. Told she had adverse reaction to flu shot.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Several hours after receiving flu shot in left arm developed pain entire left arm, shoulder and neck with swelling left arm. Stated she had fever at home. Presented to Employee Health Clinic 24 hours after receiving the shot in our office. Left arm swollen and continued to c/o pain left arm and shoulder and neck. Employee sent to Occ Health Clinic for further evaluation. Told she had adverse reaction to flu shot.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: Patient complaining of tightness in the throat 5 minutes after receiving the flu vaccine. No swelling of the tongue or face, no rash, no hives, no SOB, no nausea/vomiting, no chest pain. Patient received BENADRYL 50mg IM on the right deltoid and prednisone 60mg PO. Patient had no change in symptoms at any time after receiving medications. Patient placed on oxygen 2L, EMS contacted and transported to ER.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Headache, Pain in extremity, Palpitations
Clinical narrative: Pt reported side effect of heart racing, SOB, arm pain and headache. Pt stated that it started the day after getting the vaccine. However all the other symptoms have gone except the SOB and heart racing. I advised the pt to go to the emergency room or to her Dr. office. pt voiced understanding.
Age: 65.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction notified. The zoster vaccine expired 12/12/17 and was given on 12/14/17.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Angiotensin converting enzyme, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Asthenia, Blood culture
Clinical narrative: 40 yo M who received a flu shot on Friday and started having numbness in the L lower extremity. It moved to the R lower extremity and both extremities became progressively weak. The numbness and weakness also moved up towards his abdomen and he experienced urinary retention. The patient does not claim to have a history of reaction to flu shots in the past. The patient was subsequently started on treatment with IVIG 30g q24h x 5 days. PT/OT evaluations also noted for the patient.  Update: Spoke with the patient regarding the time and administration of the influenza vaccine. Per pt, he cannot remember when exactly he received the vaccine, but mentioned that he received the vaccine after a visit to the clinic and recalls experiencing weakness starting in his legs within a few hours of the vaccination. According to the urgent care RN, he visited urgent care clinic for a toothache on 12/7 and was seen by NP, but there was no documentation of an influenza vaccine administered or offered. On his records for another clinic visit on 12/9 for abdominal pain, it was documented that he had refused the influenza vaccine. No influenza documentation in his immunization record; last documented influenza vaccine in 2015. He completes IVIG course on 12/14 (total 5 doses, 30g) and is clinically improving. He is working with PT and is able to ambulate. Lower extremity strength has significantly improved.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Borrelia test, CSF culture, Cryptococcus test, Culture urine, HIV test
Clinical narrative: 40 yo M who received a flu shot on Friday and started having numbness in the L lower extremity. It moved to the R lower extremity and both extremities became progressively weak. The numbness and weakness also moved up towards his abdomen and he experienced urinary retention. The patient does not claim to have a history of reaction to flu shots in the past. The patient was subsequently started on treatment with IVIG 30g q24h x 5 days. PT/OT evaluations also noted for the patient.  Update: Spoke with the patient regarding the time and administration of the influenza vaccine. Per pt, he cannot remember when exactly he received the vaccine, but mentioned that he received the vaccine after a visit to the clinic and recalls experiencing weakness starting in his legs within a few hours of the vaccination. According to the urgent care RN, he visited urgent care clinic for a toothache on 12/7 and was seen by NP, but there was no documentation of an influenza vaccine administered or offered. On his records for another clinic visit on 12/9 for abdominal pain, it was documented that he had refused the influenza vaccine. No influenza documentation in his immunization record; last documented influenza vaccine in 2015. He completes IVIG course on 12/14 (total 5 doses, 30g) and is clinically improving. He is working with PT and is able to ambulate. Lower extremity strength has significantly improved.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Herpes simplex test, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Polymerase chain reaction
Clinical narrative: 40 yo M who received a flu shot on Friday and started having numbness in the L lower extremity. It moved to the R lower extremity and both extremities became progressively weak. The numbness and weakness also moved up towards his abdomen and he experienced urinary retention. The patient does not claim to have a history of reaction to flu shots in the past. The patient was subsequently started on treatment with IVIG 30g q24h x 5 days. PT/OT evaluations also noted for the patient.  Update: Spoke with the patient regarding the time and administration of the influenza vaccine. Per pt, he cannot remember when exactly he received the vaccine, but mentioned that he received the vaccine after a visit to the clinic and recalls experiencing weakness starting in his legs within a few hours of the vaccination. According to the urgent care RN, he visited urgent care clinic for a toothache on 12/7 and was seen by NP, but there was no documentation of an influenza vaccine administered or offered. On his records for another clinic visit on 12/9 for abdominal pain, it was documented that he had refused the influenza vaccine. No influenza documentation in his immunization record; last documented influenza vaccine in 2015. He completes IVIG course on 12/14 (total 5 doses, 30g) and is clinically improving. He is working with PT and is able to ambulate. Lower extremity strength has significantly improved.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Staphylococcus test, Urinary retention, West Nile virus test
Clinical narrative: 40 yo M who received a flu shot on Friday and started having numbness in the L lower extremity. It moved to the R lower extremity and both extremities became progressively weak. The numbness and weakness also moved up towards his abdomen and he experienced urinary retention. The patient does not claim to have a history of reaction to flu shots in the past. The patient was subsequently started on treatment with IVIG 30g q24h x 5 days. PT/OT evaluations also noted for the patient.  Update: Spoke with the patient regarding the time and administration of the influenza vaccine. Per pt, he cannot remember when exactly he received the vaccine, but mentioned that he received the vaccine after a visit to the clinic and recalls experiencing weakness starting in his legs within a few hours of the vaccination. According to the urgent care RN, he visited urgent care clinic for a toothache on 12/7 and was seen by NP, but there was no documentation of an influenza vaccine administered or offered. On his records for another clinic visit on 12/9 for abdominal pain, it was documented that he had refused the influenza vaccine. No influenza documentation in his immunization record; last documented influenza vaccine in 2015. He completes IVIG course on 12/14 (total 5 doses, 30g) and is clinically improving. He is working with PT and is able to ambulate. Lower extremity strength has significantly improved.
Age: 1.92
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Induration, Injection site cellulitis, Skin warm, Swelling
Clinical narrative: Likely cellulitis of right thigh. Developed redness, swelling, warmth on the night after the vaccines were administered. No fevers. On exam has irregular area of warmth, induration and erythema.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Syringe issue
Clinical narrative: Medical assistant was administering High Dose Flu shot. She got it out of the refrigerator, put the needle on the syringe, and plunged the air out. While administering the injection a piece plastic came off the syringe creating a hole, the liquid went down the patient's arm. Without full knowledge of exactly what happened, the patient left. After inspecting the syringe, the medical assistant noticed the hole. She searched the room and found the piece that had broke off. The patient will return for another dose.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Muscular weakness
Clinical narrative: Patients states unresolved arm weakness and heavy arm since date of administration.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient came in and stated her arm was red, warm to touch, and achy the next day after the shot, she came into the pharmacy on 12/14/17, by this time the redness in her arm had decreased (it was still slightly red) and it was no longer warm to touch she said and she said she felt fine besides her arm still being slightly red, she felt that her arm was improving. She was going to keep an eye on her arm, and contact us if it got worse.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Middle insomnia, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Patient had normal soreness in arm for the first couple of days following injection but the soreness has still not gone away. She reported back to Employee Health on 11/7/17 and was given a MEDROL Dose Pack to help. She has just contacted me and let me know that she is still in pain. She states that the pain runs down the front edge of her muscle. She can't lift her arm up above her head, and at times the pain has woken her up at night.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site infection, Pain, Swelling
Clinical narrative: Locallized site infection to Left Deltoid area where immunization was given. Excessive pain, swelling redness was reported. Pt went to dr office and was given 5 day supply of augmentin.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: Patient says her arm was numb around injection site by the time she got home. Her arm went completely numb that evening, and she went to the doctor in the morning. It took awhile for her arm to get better. She is having other people drive her around. She missed at least one day of work.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chest X-ray, Computerised tomogram head, Differential white blood cell count, Full blood count
Clinical narrative: At about 11:15am I was driving home from getting my MRI results and an unexpected flu shot at the hospital when my shoulder at the injection site started itching intensely. Then my entire arm felt as though it was on "fire" and burning. I then PASSED OUT. I ran off the road, hit an embankment, went airborne, and rolled over in my car several times. Had to be air-vacced to nearest hospital.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Loss of consciousness, Metabolic function test, Road traffic accident, X-ray limb
Clinical narrative: At about 11:15am I was driving home from getting my MRI results and an unexpected flu shot at the hospital when my shoulder at the injection site started itching intensely. Then my entire arm felt as though it was on "fire" and burning. I then PASSED OUT. I ran off the road, hit an embankment, went airborne, and rolled over in my car several times. Had to be air-vacced to nearest hospital.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray of pelvis and hip
Clinical narrative: At about 11:15am I was driving home from getting my MRI results and an unexpected flu shot at the hospital when my shoulder at the injection site started itching intensely. Then my entire arm felt as though it was on "fire" and burning. I then PASSED OUT. I ran off the road, hit an embankment, went airborne, and rolled over in my car several times. Had to be air-vacced to nearest hospital.