chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Product container issue, Skin laceration
Clinical narrative: the "glass collar was broken" and caused the nurse to cut her finger; the "glass collar was broken" and caused the nurse to cut her finger; This spontaneous report as received from a nurse via company representative refers to a female patient of an unknown age. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported.  On an unknown date, when the patient removed one hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe from the packaging, injection, (lot # 1621934 has been verified to be a valid lot number, expiration date reported as 29-JAN-2020, but upon internal validation established as 29-JAN-2022), (exact dose and route of administration were nor provided) for prophylaxis; the "glass collar was broken" (product vial breakage) and caused the patient to cut her finger. The outcome of the event was reported as recovering "after washing cut with soap and water, no other medical treatment needed".   The relatedness between the event of cut the finger and the suspect vaccine was not provided.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Adverse reaction, Gait disturbance, Loss of personal independence in daily activities
Clinical narrative: a patient experienced a health nightmare rapidly after three doses of GARDASIL/can no longer attend school, spend time with friends or walk long distances; can no longer walk long distances; had suffered severe adverse reactions; This spontaneous report was received from a vaccine consultant via social media and refers to a 15-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown dates, the patient received three doses of unspecified human papillomavirus (HPV) vaccine (route of administration, lot# and expiry date were not reported) for prophylaxis. It was not specified if the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On an unknown date, the patient experienced a health nightmare rapidly after three doses of HPV vaccine. She could no longer attend school, spend time with friends or walk long distances. It was reported that the patient suffered severe adverse reactions. The outcome of the events and the causality assessment were not provided by the reporter.  Upon internal review, the event of health nightmare was considered to be disabling.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information; Patient was vaccinated with properly stored but expired GARDASIL 9; This spontaneous report was received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 21-NOV-2019 the patient was vaccinated with properly stored but expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R022533, expiry date: 12-NOV-2019) (dose, frequency and route were not reported) for prophylaxis (expired product administered). No adverse effects were reported. The outcome of events were unknown, at the time of the report.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, UNK
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Fainted in the waiting room as he was preparing to leave the office immediately after the doses were administered.; This spontaneous report was received from a physician via company representative, referring to a 11-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, concomitant medication and drug allergies/reactions was unknown. On 20-NOV-2019, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, schedule, lot#, expiry date and route of administration was not provided) in the left arm for prophylaxis. On the same day, the patient was also vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) and unspecified meningitis vaccine, both in the right arm (strengths, doses, schedules, lot#, expiry dates, routes of administration and indications was not reported). On the same day, the patient fainted (syncope) in the waiting room as he was preparing to leave the office immediately after the doses were administered. The patient sought medical attention in the office. It was unknown if the patient underwent any lab diagnostics/studies or received any treatment for the event. There was no associated product quality complaint. Outcome of the event was reported as unknown. Causality assessment between the suspect therapies and the event was not provided.  Upon internal review, the event of syncope was determined to be medically significant.
Sex: M
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: MY SON SICK & IN THE HOSPITAL; A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received nasal Flumist (influenza vaccine (live, attenuated)), on an unknown date.     On an unknown date, the patient experienced sick (preferred term: Malaise) and admitted in the hospital.     The outcome of the my son sick & in the hospital was unknown.    The Reporter assessed the my son sick & in the hospital as serious with the seriousness criteria of hospitalization.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: rash at injection site; soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HX44, expiry date 15th November 2021) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 2E3EH, expiry date 31st October 2021) for prophylaxis.   On 7th November 2019, the patient received Shingrix and Boostrix. On 7th November 2019, less than a day after receiving Shingrix and Boostrix, the patient experienced injection site pain. On 13th November 2019, the patient experienced injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were recovering/resolving.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Shingrix and Boostrix.  Additional details were provided as follows: The patient was injected with both Shingrix and Boostrix on the same arm, but unknown arm. The reporter consented to follow-up.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site nodule, Pyrexia
Clinical narrative: Redness, "knot" at site of injection, 101 fever, felt run down x 5 days.  Patient called and does feel better, we let him know to make an appointment if he feels worse (noted in patient chart)
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: EMPLOYEE REPORTED 11/26/19 SINCE HER VACCINE ADMINISTERED ON 10/8/19 SHE HAS PAIN AND  WEAKNESS TO LEFT ARM AND PAIN WITH RAISING THE ARM. SHE RECEIVED THE VACCINE ON 10/8/19 AND REPORTED THESE SYMPTOMS TO EMPLOYEE HEALTH OFFICE ON 11/26/19 AM. SHE HAS REPORTED SHE PLAN TO SEEK MEDICAL ATTENTION REGARDING THESE SYMTPOMS NOTED.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Flushing
Clinical narrative: Around 9:50 AM patient received a flu shot and then her son received one. One to two minutes later after she received her shot, the patient felt dizzy and flush. I had the patient sit in a chair and propped the patient's feet up in another chair. The patient never had any breathing or vision problems. I gave her a bottle of water and employee fanned her with plastic blue cards. I got another employee to activate the ice packet and get it to working. The patient put the ice pack on her forehead. I had someone else call the switch board 129 for a code white and for a member of management. The patient requested us to call an ambulance. Talked to 911 and then to the ambulance service but then while on the phone with ambulance service the patient changed her mind and canceled the ambulance request. The patient kept feeling a little better and a little better. Manager filled out a report on the Ipad and I filled out a section as a witness. The patient left at 10:12 AM.
Age: 4.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Cellulitis, Decreased appetite, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Next day, patient woke up and she told mother she was not feeling good and felt sore.  Patient was tired, sleepy, and had no appetite.    Parent noticed she was breathing heavily when sleeping  as if gasping for air but it was only lasted for a couple of minutes and went away.    On Saturday, rash evolved and worsen.  Parents contacted the doctor via email; told to use ice packs and give patient Zyrtec. Parents told that symptoms would subside over 48 hours. By evening, vaccine area was swelling, seemed to be retaining fluid and was not improving.  Parents contacted nurse, affected area was 4 inches wide, and directed to ER.  Patient was diagnosed with cellulitis and prescribed antibiotics (Cephalexin); patient released.  Patient will follow-up with PCP to see if symptoms improving.  So far, there is some improvement.  Received Flu vax in early October.
Age: 4.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Fluid retention, Injection site reaction, Pain, Rash, Somnolence
Clinical narrative: Next day, patient woke up and she told mother she was not feeling good and felt sore.  Patient was tired, sleepy, and had no appetite.    Parent noticed she was breathing heavily when sleeping  as if gasping for air but it was only lasted for a couple of minutes and went away.    On Saturday, rash evolved and worsen.  Parents contacted the doctor via email; told to use ice packs and give patient Zyrtec. Parents told that symptoms would subside over 48 hours. By evening, vaccine area was swelling, seemed to be retaining fluid and was not improving.  Parents contacted nurse, affected area was 4 inches wide, and directed to ER.  Patient was diagnosed with cellulitis and prescribed antibiotics (Cephalexin); patient released.  Patient will follow-up with PCP to see if symptoms improving.  So far, there is some improvement.  Received Flu vax in early October.
Age: 4.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Vaccination site swelling
Clinical narrative: Next day, patient woke up and she told mother she was not feeling good and felt sore.  Patient was tired, sleepy, and had no appetite.    Parent noticed she was breathing heavily when sleeping  as if gasping for air but it was only lasted for a couple of minutes and went away.    On Saturday, rash evolved and worsen.  Parents contacted the doctor via email; told to use ice packs and give patient Zyrtec. Parents told that symptoms would subside over 48 hours. By evening, vaccine area was swelling, seemed to be retaining fluid and was not improving.  Parents contacted nurse, affected area was 4 inches wide, and directed to ER.  Patient was diagnosed with cellulitis and prescribed antibiotics (Cephalexin); patient released.  Patient will follow-up with PCP to see if symptoms improving.  So far, there is some improvement.  Received Flu vax in early October.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Genital rash, Rash
Clinical narrative: Rash all over the back and private area
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Rash erythematous, Rash papular, Type III immune complex mediated reaction
Clinical narrative: Next day injection site red, painful, sore (arthus reaction) 2 days later a few raised "red dots" with "whitehead" pustules that she tried to squeeze but nothing came out. Resolved after 3 days. Possible varicella-like lesions which have resolved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza, Middle insomnia, Pain
Clinical narrative: 11/21/19 3 a.m. woke from sleep with severe headache, went back to sleep  11/21/19 7 a.m. woke up with severe headache, body aches, took Tylenol, ached until 6 p.m. 11/21/19 6 p.m. ate soup.took Nyquil severe flu, went back to bed 11/22/19 7 a.m. woke. still achy, headache present but improved, took Aleve 11/22/19 11 a.m. felt better 11/22/19 1 p.m. took Aleve
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Contusion, Induration, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patients arm was very bruised.  Severe pain began one week after shot.  By the 22nd of November, patient had almost no use of right arm and was in severe pain. Arm was swollen, hard and hot.  ER physician stated that the flu vaccine had been injected into the patients artery.
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling, Product administered at inappropriate site, Skin warm, Ultrasound scan
Clinical narrative: Patients arm was very bruised.  Severe pain began one week after shot.  By the 22nd of November, patient had almost no use of right arm and was in severe pain. Arm was swollen, hard and hot.  ER physician stated that the flu vaccine had been injected into the patients artery.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Patient states she had severe muscle cramps and muscles locked in her face and shoulder. she had seen the doctor 3 times since the vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning mouth syndrome, Hypoaesthesia oral, Influenza like illness, Injection site pain, Pharyngeal hypoaesthesia
Clinical narrative: First 48 hours were side effects as documented - soreness at site, "flu like" symptoms for 24-48 hours.  I was then back to status quo for 5 days and have now had "burning mouth syndrome" for past 5 days.  No pain to speak of, but complete/bilateral numbness to lips, tip and bottom of tongue toward throat.  It is as if I have sprayed my mouth with Chloraseptic and it has remained stable with no easing or increasing of the numbness.  I do not have any health co-morbidities such as DM, HTN, etc. and am a very healthy individual, otherwise.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Grip strength decreased, Hyperhidrosis, Pallor
Clinical narrative: RNs notified that by CMA that patient was experiencing sweating, dizziness after administration of flu vaccine.  RN exam-patient was pale, pulse steady. Notified PCP re: diaphoretic, pale, reporting dizziness.   Assessed orientation, denied difficulty breathing or chest pain. patient reported prior vasovagal episodes post blood draws.    Patient became extremely diaphoretic, head began nodding back. Responded to verbal stimulation. PERRLA. Denied difficulty breathing or chest pain. Answered all RN questions appropriately. Weak bilateral grip strength. Drank apple juice. VS assessed throughout, PCP present and recommended patient returned to supine position, patient reporting blurred vision/weakness. Transferred to low bed. CBG checked, EKG completed. BP taken. MDs reviewed EKG, reassessed patient. Pt ambulated around clinic RN to confirm gait stability; pt had no impairment to gait, oriented to person, place, time. Denies CP, AMS, difficulty breathing, visual changes/disturbances, diaphoresis/pallor subsided. Patient discharged home.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Posture abnormal, Vision blurred
Clinical narrative: RNs notified that by CMA that patient was experiencing sweating, dizziness after administration of flu vaccine.  RN exam-patient was pale, pulse steady. Notified PCP re: diaphoretic, pale, reporting dizziness.   Assessed orientation, denied difficulty breathing or chest pain. patient reported prior vasovagal episodes post blood draws.    Patient became extremely diaphoretic, head began nodding back. Responded to verbal stimulation. PERRLA. Denied difficulty breathing or chest pain. Answered all RN questions appropriately. Weak bilateral grip strength. Drank apple juice. VS assessed throughout, PCP present and recommended patient returned to supine position, patient reporting blurred vision/weakness. Transferred to low bed. CBG checked, EKG completed. BP taken. MDs reviewed EKG, reassessed patient. Pt ambulated around clinic RN to confirm gait stability; pt had no impairment to gait, oriented to person, place, time. Denies CP, AMS, difficulty breathing, visual changes/disturbances, diaphoresis/pallor subsided. Patient discharged home.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity, Radiculitis brachial
Clinical narrative: severe pain in right arm radiating from neck to hand, consistent with brachial neuritis.  Patient did not develop muscle weakness or atrophy.  Responded to course of prednisone, but symptoms lasted 2 months.  Now resolved.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Dry mouth, Flushing, Nausea
Clinical narrative: Employee given vaccine at 1445. She stayed 10 minutes in nursesd office after vaccine with no problems. She went back to work in her department. At 1515 she began to feel light-headed, nauseated, and dry mouth. She returned to the nurses station where she was checked by the RN. Findings include employee presented with facial flushing, pale, weakness, and dry mouth. Employees airway was unobstructed and breathing was normal. B/P 138/98 HR 84 and O2 Sat 99%. Employee remained in the nurses office for 45 minutes with very little changes. She did call her PCP to report the symptoms and was told to seek ER treament if condition worsened. Employee went home and called the nurse later that evening to report she had 1 bout of emesis. The following day she reported she felt fine.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Pallor, Vomiting
Clinical narrative: Employee given vaccine at 1445. She stayed 10 minutes in nursesd office after vaccine with no problems. She went back to work in her department. At 1515 she began to feel light-headed, nauseated, and dry mouth. She returned to the nurses station where she was checked by the RN. Findings include employee presented with facial flushing, pale, weakness, and dry mouth. Employees airway was unobstructed and breathing was normal. B/P 138/98 HR 84 and O2 Sat 99%. Employee remained in the nurses office for 45 minutes with very little changes. She did call her PCP to report the symptoms and was told to seek ER treament if condition worsened. Employee went home and called the nurse later that evening to report she had 1 bout of emesis. The following day she reported she felt fine.
Sex: M
Vaccine: UNK
Symptoms: Apgar score normal, Cyanosis, Drug hypersensitivity, Foetal exposure during pregnancy
Clinical narrative: intrauterine Growth Retardation; cyanotic; drug exposure in utero; Initial information received on 13 November 2019 regarding a solicited valid serious case received from a consumer/non-hcp, in the scope of post-marketing sponsored study.  Patient ID: unknown;   This case is linked to case 2019SA318338 (Mother).  This case involves a male patient who had intrauterine growth retardation (Foetal growth restriction) and was cyanotic (Cyanosis) after birth, whose mother received FLUZONE QIV vaccine and received Benzyl Alcohol. The mother's age at the time of report was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant therapy included Benzyl Alcohol.  On an unknown date, the patient's mother received a dose of suspect FLUZONE QIV lot number not reported via unknown route. It was case of drug exposure in utero. On unknown date, the patient developed a serious event of intrauterine growth retardation (Before Birth) (foetal growth restriction), following administration of FLUZONE QIV to patient's mother. It was reported that the patient's mother stated that she went to 39 weeks and 1 day and then physician inducted her because the fetus was having intrauterine Growth Retardation (IUGR).  On unknown date, the patient developed a serious event of cyanotic (cyanosis) (After birth) following the administration of FLUZONE QIV to patient's mother.  The baby was born healthy an Apgar of 09, approximately 1 hour lately when the baby was attempting to breastfeed, he turned cyanotic and had to be watched in the nursery for the next 48 hours. The HCP attributed the cyanotic episode to an allergy to Benzyl alcohol. At the time f report the child in now 3 years old and seems to be doing well.  As per company, based IME list both the event considers as medically significant.  Final diagnosis was cyanotic, intrauterine growth retardation and drug exposure in utero. The Lab data not reported. It was not reported if the patient received a corrective treatment. The event outcome of intrauterine growth retardation and cyanotic was not reported. Relationship to investigational product according to reporter: not reported, The HCP attributed the cyanotic episode to an allergy to Benzyl alcohol. The child in now 3 and seems to be doing well. Relationship to investigational product according to company: reportable.; Sender's Comments: A neonate of adult female, who received a dose of study product during pregnancy, was diagnosed with intrauterine growth retardation and cyanotic. Which occurred after mother received a dose of study vaccine. Company causality taken as reportable for reporting purpose. The event cyanosis was assessed as related to Benzyl alcohol allergy. Additional information on IUGR and past medical history, previous pregnancies, family history, concomitant medications is require to assess company causality for IUGR.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Headache, Influenza like illness
Clinical narrative: Symptoms began approximately 12 hours following the injection; fever of 104, chills, muscle and joint pain, dizziness, neck, arm and shoulder discomfort, headache, runny nose, sore throat, watery eyes  I felt like I had a really bad case of the fu.  This was the second injection of two.  I experienced the same symptoms with the first injection approximately 2 1/2 months ago.  Symptoms will last approx. 3 days if following the same duration as the first injection. Spouse has had both shots and experienced no side effects other than soreness around the injection
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lacrimation increased, Limb discomfort, Musculoskeletal discomfort, Myalgia
Clinical narrative: Symptoms began approximately 12 hours following the injection; fever of 104, chills, muscle and joint pain, dizziness, neck, arm and shoulder discomfort, headache, runny nose, sore throat, watery eyes  I felt like I had a really bad case of the fu.  This was the second injection of two.  I experienced the same symptoms with the first injection approximately 2 1/2 months ago.  Symptoms will last approx. 3 days if following the same duration as the first injection. Spouse has had both shots and experienced no side effects other than soreness around the injection
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pyrexia, Rhinorrhoea, Vaccine positive rechallenge
Clinical narrative: Symptoms began approximately 12 hours following the injection; fever of 104, chills, muscle and joint pain, dizziness, neck, arm and shoulder discomfort, headache, runny nose, sore throat, watery eyes  I felt like I had a really bad case of the fu.  This was the second injection of two.  I experienced the same symptoms with the first injection approximately 2 1/2 months ago.  Symptoms will last approx. 3 days if following the same duration as the first injection. Spouse has had both shots and experienced no side effects other than soreness around the injection
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Myalgia
Clinical narrative: Awaken at 03:00 AM with severe headache and aching muscle pain to complete right side of body. Aching pain lasted about 8 hours. Headache lasted 10.5 hours.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: patient was seen for large reaction on right thigh at the injection site measuring 15X15 mm area of erythema and warm to the touch. diagnosed with cellulitis and placed on abx.
Age: 23.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Asthenia, Eyelid ptosis, Malaise, Presyncope
Clinical narrative: Patient reported feeling weak and ill to MA after administration of vaccines.  MA offered water and warm washcloth.  Patient felt worse, her eyes drooped. MA yelled for help, PCP in room to assess, vital signs obtained.    Vital signs: BP 61/37, P 55  Notified Emergency Response team on campus. Oxygen administered, 2L.. MD stated patient had vasovagal reaction, was not allergic reaction, requested MA to let patient sit for 15-20 minutes, then walk her around the clinic. MD advised if patient does not report any dizziness or headache, patient will be fine to go. Discharged home.
Age: 4.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt was not due for this vaccine at the time of receiving it.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: ITCHING, HIVES, REDNESS
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Mucousy, blood tinged stool - 3 times.  Has not happened since then.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abdominal tenderness, Blood test, Crying, Diet refusal, Intussusception
Clinical narrative: Patient showed signs of extreme pain in the evening. He refused to nurse and was crying uncontrollably for hours. At 9pm I took him to the ED where they saw him immediately based on his crying. He eventually calmed down, most likely out of exhaustion but cried when palpated on his abdomen. During ultrasound it was confirmed he had transient intussusception which had corrected itself. He was admitted for observation and released the following day.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pain, Ultrasound abdomen abnormal
Clinical narrative: Patient showed signs of extreme pain in the evening. He refused to nurse and was crying uncontrollably for hours. At 9pm I took him to the ED where they saw him immediately based on his crying. He eventually calmed down, most likely out of exhaustion but cried when palpated on his abdomen. During ultrasound it was confirmed he had transient intussusception which had corrected itself. He was admitted for observation and released the following day.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: swelling, redness, warmth, itching.  Treated with second generation anti-histamine and topical corticosteroid. have not assessed reponse to treatment yet.  felt uncomfortable after injection, then worse next day.
Sex: M
Vaccine: UNK
Symptoms: Dyspnoea, Intensive care, Mechanical ventilation
Clinical narrative: After my son was born, he was taken from us and given unknown vaccines which we did not authorize.  He was over 10 pounds and beautifully healthy.  They came back later and said he was having trouble breathing and put him on a ventilator and he was in the NICU for 6 days.  He pulled out his tube twice; what newborn has the coordination or strength to do this?  Then they let us take him home.  He was having no trouble breathing after he was born and we are certain now that one or more of the vaccines he was giving caused this.  Six days of pain, suffering and anguish for all of us AND costing us thousands of dollars.  He was vaccine injured, we are sure of it.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV, FLU4
Symptoms: Abdominal pain, Cold sweat, Diarrhoea, Headache, Pain
Clinical narrative: Patient states she had abdominal cramping, vomiting, diarrhea, cold sweats, body aches, headache, and a very sore arm the night of and day after vaccinations were received.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV, FLU4
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Patient states she had abdominal cramping, vomiting, diarrhea, cold sweats, body aches, headache, and a very sore arm the night of and day after vaccinations were received.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV, FLU4
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Malaise
Clinical narrative: Patient states she had abdominal cramping, vomiting, diarrhea, cold sweats, body aches, headache, and a very sore arm the night of and day after vaccinations were received.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV, FLU4
Symptoms: Muscle spasms, Nausea
Clinical narrative: Patient states she had abdominal cramping, vomiting, diarrhea, cold sweats, body aches, headache, and a very sore arm the night of and day after vaccinations were received.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV, FLU4
Symptoms: Abdominal pain, Cold sweat, Diarrhoea, Headache, Pain
Clinical narrative: Abdominal pain, diarrhea, nausea, cramping, chills, fatigue/malaise lasting 24-48 hours with multiple episodes diarrhea.  Was administered in conjunction with PPSV 23 to left lower deltoid arm by nurse with Lot number S006777 from Merck. Note: Flu shot was given left upper arm.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV, FLU4
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Abdominal pain, diarrhea, nausea, cramping, chills, fatigue/malaise lasting 24-48 hours with multiple episodes diarrhea.  Was administered in conjunction with PPSV 23 to left lower deltoid arm by nurse with Lot number S006777 from Merck. Note: Flu shot was given left upper arm.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV, FLU4
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Malaise
Clinical narrative: Abdominal pain, diarrhea, nausea, cramping, chills, fatigue/malaise lasting 24-48 hours with multiple episodes diarrhea.  Was administered in conjunction with PPSV 23 to left lower deltoid arm by nurse with Lot number S006777 from Merck. Note: Flu shot was given left upper arm.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV, FLU4
Symptoms: Muscle spasms, Nausea
Clinical narrative: Abdominal pain, diarrhea, nausea, cramping, chills, fatigue/malaise lasting 24-48 hours with multiple episodes diarrhea.  Was administered in conjunction with PPSV 23 to left lower deltoid arm by nurse with Lot number S006777 from Merck. Note: Flu shot was given left upper arm.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Pain after injection, continues to be painful
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: 103 fever Sore joints  sever headache
Age: 54.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Itching, raised red warm area the size of baseball for one injection and golf ball size for the other on her left arm. She received the Shingrix and the PPSV23 in left arm on 11-22-19
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis to right thigh due to vaccine. Antibiotics, Benadryl, and instructions to ice was given.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Areflexia, CSF protein increased, Constipation, Hypoaesthesia, Paraesthesia
Clinical narrative: Bilateral leg numbness, starting from toes to hips. feeling of pins and needles under feet. No reflex in feet or knees. High amount of protein in CSF through lumbar puncture. Urinary retention, constipation.  Was admitted to hospital from November 6 -9th and received 2 dose of steroids through IV. Still in process of seeing a neurologist and neurosurgeon.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Urinary retention
Clinical narrative: Bilateral leg numbness, starting from toes to hips. feeling of pins and needles under feet. No reflex in feet or knees. High amount of protein in CSF through lumbar puncture. Urinary retention, constipation.  Was admitted to hospital from November 6 -9th and received 2 dose of steroids through IV. Still in process of seeing a neurologist and neurosurgeon.
Sex: F
Vaccine: FLU3
Symptoms: Contraindication to vaccination, Rash
Clinical narrative: was dipped in a rash because her body was covered in a rash from her head to her feet for a couple weeks; patient with history of egg allergy received Fluzone; patient with history of egg allergy received Fluzone; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a female patient of unknown age who experienced broke out in rashes all over body (Rash), while she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE].  Medical history was tested positive for an egg allergy.  At the time of the event, the patient had ongoing Asthma but had no incident since 2012.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] [lot U2743AA and expiry date not reported] via unknown route in unknown administration site.  On an unknown date, (Latency unknown) following vaccination the patient was dipped in a rash because her body was covered in a rash from her head to her feet for a couple weeks (rash).  It was also a case of contraindication to vaccination and product use in unapproved population  The patient visited emergency room due to this.  Patient stated that she received the flu shot but a couple of weeks later she broke out in rashes all over her body. Consumer states her face did not have a rash but her hands and the bottom of her feet did.   Relevant laboratory test results included: Food allergy - On an unknown date:  [Positive]  Final diagnosis was dipped in a rash because her body was covered in a rash from her head to her feet for a couple weeks.  It was not reported if the patient received a corrective treatment.  On an unknown date, the outcome of the event was reported as Unknown.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7 year old patient was administered Adacel; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 7 years old patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that 7 year old patient was administered Adacel (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Tinnitus
Clinical narrative: experienced dizziness and tinnitus; developed a mild headache; experienced dizziness and tinnitus; Initial information received on 14-Oct-2019 regarding this unsolicited valid non-serious case received from a physician.  The case involved a 62 years old female patient who experienced dizziness and tinnitus (Dizziness), developed a mild headache (Headache) and experienced dizziness and tinnitus (Tinnitus), while she received vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2019, the patient received a dose of suspect influenza quadrival A-B vaccine lot number not reported via intra-arterial route in the left arm.  The patient developed a non-serious experienced dizziness and tinnitus (tinnitus), a mild headache (headache), a non-serious experienced dizziness and tinnitus (dizziness) following the administration of influenza quadrival A-B vaccine.  Final diagnosis was mild headache and experienced dizziness and tinnitus.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as recovering for experienced dizziness and tinnitus, as recovering for she developed a mild headache and as recovering for experienced dizziness and tinnitus.  Information on the batch number was requested.
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: while administering the Fluzone Quadrivalent to an 11 year old receiving a partial dose with no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 11 years old to whom while administering the Fluzone Quadrivalent to an 11 year old receiving a partial dose with no AE [Underdose], INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Past medical treatment was unknown.  On 12-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT6647KA; Exp. Date unknown] via intramuscular route in the left deltoid for immunization.  It was a case of actual medication error due to vaccine Underdose.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: patient who received a dose of Fluzone QIV intranasal instead of intramuscular; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient (unknown demographic), who received a dose of fluzone qiv intranasal instead of intramuscular (incorrect route of product administration), while he/she vaccinated with QUADRIVALENT INFLUENZA VACCINE [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b vaccine at a dose of 0.5 ml (lot number not reported) via intranasal in unknown administration site.  On an unknown date (unknown latency), it was reported that patient who received a dose of fluzone qiv intranasal instead of intramuscular (incorrect route of product administration). It was a case of actual medication error.  It was not reported if the patient received a corrective treatment.  Outcome was Not Applicable for the event.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   No further information was reported.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Product administered at inappropriate site
Clinical narrative: arm was all red underneath of where the injection was given, between injection site and elbow it was red, inflamed and warm to the touch; arm was all red underneath of where the injection was given, between injection site and elbow it was red, inflamed and warm to the touch; arm was all red underneath of where the injection was given, between injection site and elbow it was red, inflamed and warm to the touch; received a Fluzone QD in the lateral aspect of her arm and not the deltoid muscle; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 8 years old female patient who experienced arm was all red underneath of where the injection was given, between injection site and elbow it was red, inflamed and warm to the touch (vaccination site inflammation), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  On 15-Oct-2019, the patient received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number UJ256AA, exp date Jun 30, 2020) in the lateral aspect of her arm and not the deltoid muscle via unknown route.  On an unknown date (unknown latency), the patient experienced arm was all red underneath of where the injection was given, between injection site and elbow it was red, inflamed and warm to the touch (vaccination site inflammation with vaccination site warmth and vaccination site erythema).  It was an actual medication error due to Vaccine administered at inappropriate site. It was reported that the patient received a Fluzone QD in the lateral aspect of her arm and not the deltoid muscle.  On an unknown date, it was reported that the reporter was concerned that the child will not have enough protection, as it was not given correctly by nurse.   It was not reported if the patient received a corrective treatment.  The outcome of the events were reported as unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Product quality issue
Clinical narrative: realized that the vaccines were not viable; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a unknown.  This case is linked to case 2019SA290919.  This case involves a 6 years old patient of unknown demographics who experienced realized that the vaccines were not viable(Wrong product administered), while the patient received vaccine influenza quadrival a-b vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2019, the patient received a one dose of suspect influenza quadrival a-b vaccine pre filled syring lot UT6686LA via Intramuscular route in the right thigh.  The patient developed a non-serious realized that the vaccines were not viable (wrong product administered) following the administration of influenza quadrival a-b vaccine. Final diagnosis was not applicable realized that the vaccines were not viable.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as not applicable for realized that the vaccines were not viable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical Assistant accidentally administered Fluzone High Dose to a 54 year old patient, no AE; Medical Assistant accidentally administered Fluzone High Dose to a 54 year old patient, no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked with 2019SA295846, 2019SA295847, 2019SA295848, 2019SA295849, 2019SA295850 and 2019SA295851 (same reporter).  This case involves a 54 years old male patient who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Prefilled Syringe, lot UJ285AA, expiry date: 02-Jun-2020) via intramuscular route in the right arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 41 year old patient received a dose of fluzone high dose, no AE; 41 year old patient received a dose of fluzone high dose, no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked with 2019SA295789, 2019SA295846, 2019SA295847, 2019SA295848, 2019SA295849 and 2019SA295851 (same reporter).  This case involves a 41 years old male patient who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Prefilled Syringe, lot UJ285AA, expiry date: 02-Jun-2020) via intramuscular route in the left arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.