chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Feeling hot, Nausea
Clinical narrative: She stated she felt hot on her hands while waiting after getting the shot and drank some water. She felt better and fine after 15 minutes so she left (12/10/18). She called the next day(11th)  saying she had nausea and diarrhea on the same day and discussed, consulted. I called her after finishing my shift (11th) and she said she started to feel much better. Sshe was advised to get medical help if it get worse and she said she was doing better.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, PNC13, RV5
Symptoms: Acidosis, Blood electrolytes, Crying, Enema administration, Infantile back arching
Clinical narrative: Developed large colon intussusception involving 2/3's cecum to transverse colon. Onset a.m. with sudden onset crying and arching intermittent with severe lethargy, with acidosis, resolving air contrast enema, with small bowel 12/2016.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, PNC13, RV5
Symptoms: Intussusception, Lethargy, Ultrasound scan, X-ray gastrointestinal tract
Clinical narrative: Developed large colon intussusception involving 2/3's cecum to transverse colon. Onset a.m. with sudden onset crying and arching intermittent with severe lethargy, with acidosis, resolving air contrast enema, with small bowel 12/2016.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Micturition urgency, Middle insomnia, Myalgia, Urinary incontinence
Clinical narrative: Patient reports no issues with the administration of the vaccine and having myalgias a few hours after the vaccine as she expected. The rest of the day was uneventful and she went to bed as usual. She reports waking up from sleep (approximately 16 hours after the vaccination) needing to urinate. This is unusual for her as she typically sleeps through the night without having to get up. She stood up and was immediately incontinent of a large amount of urine. Again this is unusual as she doesn't have issues with urinary incontinence normally. She cleaned up and went back to bed. In the morning she arose and again was incontinent of a large amount of urine upon standing. She denied having any other urinary symptoms at the time. The patient reported going to the toilet the rest of the day about every 2 hours and did not experience any further episodes of incontinence or any other urinary symptoms. She did not inform us of these events until her follow up appointment on 12/13/18. It should also be noted she had a normal gyn exam in July 2018.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: 20 minutes post injection, itch and few very small urticarial lesions on left forearm. BENADRYL given and pt monitored for 15 minutes more.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In June 2014, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 09-SEP-2014, the patient was treated by a physician at a medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries.  As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Headache, Lumbar puncture, Nuclear magnetic resonance imaging, Reversible cerebral vasoconstriction syndrome
Clinical narrative: This is a spontaneous report from a contactable Other HCP via Pfizer sales representative. A male patient at age 18 or 19 received TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced reversible cerebral vasoconstriction syndrome and headache with outcome of unknown. The patient underwent lab tests and procedures included on an unspecified date spinal tap and an MRI which led to the diagnosis of reversible cerebral vasoconstriction syndrome. The information on the lot number has been requested. Amendment: This follow-up report is being submitted to amend previously reported information: Case comment updated. Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: MENB
Symptoms: Meningitis
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional via a Pfizer sales representative. A patient of unspecified age and gender started to receive TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had a meningitis diagnosis so the parent was particularly concerned. The outcome of the event was unknown. Sender's Comments: The company agrees with the assessment of the investigator and reasonably does not attribute the case to blinded study therapy, concomitant drugs and clinical trial procedure based on the information currently available, the known adverse event profile of the suspect product and the pathophysiology of the event.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Cyanosis, Injection site mass, Injection site reaction
Clinical narrative: Pt developed bluish discoloration and 1 cm lump at injection site. Stable - not changing since vaccination. No limitation to activity. No pain.
Age: 71.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Discomfort, Erythema
Clinical narrative: Pt. had erythema and discomfort up the trapezius left arm. Seen in urgent care and referred to ER - received IV sodium chloride. Discharge oral antibiotic.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 11/21/18 pain, swelling, redness, hard, warm to touch started in Rt. arm - where PREVNAR was given. 11/23/18 symptoms improving - taking ibuprofen and using ice packs.
Age: 1.83
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Eczema, Irritability, Pyrexia
Clinical narrative: Vomiting, diarrhea, loss of appetite, sleeping issues, fussiness, low grade fever, hives, skin rash(eczema).
Age: 1.83
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Rash, Sleep disorder, Streptococcus test, Urticaria, Vomiting
Clinical narrative: Vomiting, diarrhea, loss of appetite, sleeping issues, fussiness, low grade fever, hives, skin rash(eczema).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Alopecia, Asthenia, Diarrhoea, Dizziness
Clinical narrative: Patient reports diarrhea, hair loss, weakness and dizziness since receiving the flu shot.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site infection, Vaccination site swelling
Clinical narrative: Swollen arm around vaccination site. Per patient, MD stated it was an infection and treated with KEFLEX.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Discomfort, Erythema, Fatigue
Clinical narrative: Redness, swelling in right arm (about 2.5 inches in diameter), extreme fatigue, muscle aches, joint pain, stomach upset, skin on right side of torso from back bone to midline of the front of torso has become very sensitive to any touch, pressure, and is accompanied by significant pain. Most of the symptoms are subsiding, the pain in the torso has become worse.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Myalgia, Pain, Peripheral swelling
Clinical narrative: Redness, swelling in right arm (about 2.5 inches in diameter), extreme fatigue, muscle aches, joint pain, stomach upset, skin on right side of torso from back bone to midline of the front of torso has become very sensitive to any touch, pressure, and is accompanied by significant pain. Most of the symptoms are subsiding, the pain in the torso has become worse.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Hypoaesthesia, Infection
Clinical narrative: Swelling of arm, vomiting, shaking, numbness and then severe pain. High grade of infection. I spent 3 days in Hospital.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Pain, Peripheral swelling, Tremor, Ultrasound scan
Clinical narrative: Swelling of arm, vomiting, shaking, numbness and then severe pain. High grade of infection. I spent 3 days in Hospital.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis, Vomiting
Clinical narrative: Swelling of arm, vomiting, shaking, numbness and then severe pain. High grade of infection. I spent 3 days in Hospital.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pain in extremity
Clinical narrative: Prolonged localized reaction. Some redness and soreness on upper arm, improved after first 3 days but still persists on day 10. Arm is still "sore" patient states. May 2018 episode of shingles was prolonged into late June, finally treated with VALTREX 1Gm TID for 7 days, then finally resolved.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Exposure during pregnancy
Clinical narrative: I was 31 weeks pregnant, estimated date of delivery is January 16, 2019. The vaccine was given on Thursday and in the middle of Friday night I woke up to stomach aches, mild fever of at least 100.3 (by the time my temperature was taken), headache, tiredness, nausea, vomiting, diarrhea, chills, sore joints, body aches.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Feeling abnormal, Headache, Nausea, Pain
Clinical narrative: I was 31 weeks pregnant, estimated date of delivery is January 16, 2019. The vaccine was given on Thursday and in the middle of Friday night I woke up to stomach aches, mild fever of at least 100.3 (by the time my temperature was taken), headache, tiredness, nausea, vomiting, diarrhea, chills, sore joints, body aches.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Streptococcus test positive, Vomiting
Clinical narrative: I was 31 weeks pregnant, estimated date of delivery is January 16, 2019. The vaccine was given on Thursday and in the middle of Friday night I woke up to stomach aches, mild fever of at least 100.3 (by the time my temperature was taken), headache, tiredness, nausea, vomiting, diarrhea, chills, sore joints, body aches.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Malaise, Nausea, Pallor, Tinnitus
Clinical narrative: After giving the vaccine, the patient immediately stood up and walked over to the drop-off window to ask the technician a question. She turned very pale and stated she did not feel well. She said she felt light headed, sick to her stomach, and had ringing in her ears. The pharmacist asked her to go sit on the bench and grabbed her a cold bottle of water. The patient stated she had had breakfast several hours ago and was on her way to lunch after getting the shot. The pharmacist asked the technician to run up front and grab her some peanut butter crackers. The pharmacist paid for the crackers. The patient sat in the waiting room, drank some water, and ate the crackers for around 10 minutes. The pharmacist made sure she was feeling better and ok to get up when she was ready to leave.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Heart rate increased, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Chills, low-grade fever, extreme soreness/pain in upper arm - had difficult time raising arm at all, rapid heart rate, some nausea.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Chills, low-grade fever, extreme soreness/pain in upper arm - had difficult time raising arm at all, rapid heart rate, some nausea.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Rash
Clinical narrative: This vaccine was given subcutaneously instead of intramuscularly. The patient is complaining of a rash on the back of her arm.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Malaise, Myalgia
Clinical narrative: Soreness and redness at injection site. Muscle aches and malaise beginning ~12 hours post injection and lasting for 24 hours.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Mouth swelling, Pruritus, Swollen tongue, Urticaria
Clinical narrative: This spontaneous report was received from a consumer concerning her 11-year-old daughter. The patient's concurrent condition included depression. Concomitant therapies included sertraline hydrochloride (ZOLOFT). Information on the patient's pertinent medical history and drug reactions or allergies was not reported. On 12-NOV-2018, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (route, lot# and expiry date unknown). On 16-NOV-2018, the patient developed hives (urticarial), swelling of her tongue (swollen tongue) and swelling of the mouth (mouth swelling). She was not hospitalized for the events. The patient went to the emergency room and received prednisone and an unspecified antihistamine. The emergency room did not do any lab diagnostics. On an unspecified date in 2018, after the emergency room visit, the patient saw an unspecified allergist and had allergy testing which was reported to be negative. As of 18-NOV-2018 or 19-NOV-2018, the patient was doing much better. However, the patient had not completely recovered because she still has slight symptoms of itching. No product quality complaint (PQC) was involved. The reporter's causality assessment was not provided. The pediatrician stated that it was possible the symptoms occurred because of the GARDASIL 9 but did not think the events were caused by GARDASIL 9 because of the timing of when the events occurred after receiving the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated, Pneumonia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions or concomitant medications was not provided. In or around 16-APR-2015, the patient was inoculated (by an unspecified person) with ZOSTAVAX (dose, route of administration, and lot # were not reported) for routine health maintenance and for its intended purpose: prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered from acute bronchial asthma exacerbation and numerous, reoccurring instances of pneumonia requiring several hospitalizations. As a direct and proximate result of the vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. The outcome of the numerous, reoccurring instances of pneumonia requiring several hospitalizations was unknown. Causality assessment was considered to be related. Upon internal review, the event of numerous, reoccurring instances of pneumonia requiring several hospitalizations was determined to be medically significant. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, Therapy non-responder
Clinical narrative: Initial Report Received: 07-Sep-2018 and 13-Sep-2018 Follow-up Report Received on 26-Oct-2016 included dates of administration of Engerix-B, dates of administration of HEPLISAV-B, and dates of titers. Patient is a 73-year-old female (race not provided) who was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. A nurse reported that the patient's titer result did not show immunity after completing the HEPLISAV-B series. Relevant medical history included Crohn's disease and a history of being a non-responder following 8 to 10 ENGERIX-B. ENGERIX-B was administered on 06-Feb- 2016, 02-Mar-2016, 02-Sep-2016, 20-Oct-2016, 22-Nov-2016, 28-Dec-2016, 07-Feb-2017, and 26-Jul-2017. Concomitant medications included Entyvio (vedolizumab). The patient received the first injection of HEPLISAV-B (Lot # 032912, expiration 15-Mar-2019) on 03-Jul-2018.   The patient received the second injection of HEPLISAV-B (same lot #/expiration as first dose) on 06-Aug-2018. On 04-Sep-2018, one month after the second HEPLISAV-B injection, a titer was drawn and the result was 9.2 (not immune).  A minimum of 9.9 was required to indicate immunity.  Of note, a previous titer was drawn on 19-Oct-2016 which was < 3.1. No other information was provided and the patient did not agree to being contacted. At the time of the report, the outcome of the event was not reported. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B USPI.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received 3 HEPLISAV-B injections [Extra dose administered] Initial Report Received: 21-Sep-2018. Patient is a 43-year-old male patient (race not provided) who was administered with HEPLISAV-B  for hepatitis B immunization. The patient, who is also a physician's assistant, reported that he received 3 HEPLISAV-B injections. Relevant medical history and concomitant medications were not provided. The patient received the first 0.5 ml HEPLISAV-B intramuscular injection in the deltoid in Jun-2018 and the second HEPLISAV-B injection in Jul-2018 (lot #/expiration date not reported, NDC 43528-002-01). On 21-Sep-2018, the patient received the third HEPLISAV-B injection (lot #/expiration date not reported, NDC 43528-002-01). The patient reported that "they lost track of how many injections he previously had and realized after he received the third injection he already had a second dose." There were no adverse reactions to any of the injections at the time of this report. No further information was provided. The reporter did not provide a seriousness assessment for the event. Company comment:  The company assessed the event of extra dose administered as non-serious. The event of extra dose administered is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of extra dose administered as non-serious. The event of extra dose administered is unlisted per HEPLISAV-B USPI.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Initial Report Received: 24-Sep-2018 Patient is a female patient (age and race not provided) who was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. The patient, a consumer, reported that she did not receive her second dose of HEPLISAV-B as it was not yet available in her area. Relevant medical history and concomitant medications were not provided. The patient received the first HEPLISAV-B injection on 13-Aug-2018 (lot #/expiration date not reported.  The patient did not receive her second dose yet as it was not yet available. No further information was provided. The reporter did not provide a seriousness assessment for the event. Company comment:  The company assessed the event of incomplete course of vaccination as non-serious. The event of incomplete course of vaccination is listed per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of incomplete course of vaccination as non-serious. The event of incomplete course of vaccination is listed per HEPLISAV-B USPI.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: Chills and fatigue. Didn't experience this with first dose.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain, puffiness along inside of left bicep down to arm fold at elbow. First noticed upon awakening less than 24 hours after vaccination. Primary Care Physician prescribed steroids and antibiotics. Followup PCP visit scheduled for 12/20/18.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, PNC13, VARCEL
Symptoms: Cough, Decreased appetite, Erythema, Extra dose administered, Injection site pustule
Clinical narrative: Pt was given PROQUAD and VARIVAX on same day. On 12/06/18 medical assistant called parent to notify them of mistake. Father states patient developed a cough, but no other symptoms noted on 12/06/18. On 12/12/18 father calls office to let us know but now has 2 bumps with liquid. Asked father to bring child in to see doctor. Doctor examined child and noted 2 sores that popped open. 1 ulcer on the right ankle, and another ulcer on the left thigh, each scabbed over, 6-8mm. Minimal surrounding erythema. There are grouped pustules on the right upper thigh. Child is breathing well and drinking, but not eating very much. Dr. also noted acute serous otitis media to the left ear. States it could be due to general varicella infection. Recommends patient support and time to heal and let it run its course. Also told patients father to give us a call if symptoms do not improve or worsen.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, PNC13, VARCEL
Symptoms: Otitis media acute, Scab, Skin ulcer, Varicella post vaccine
Clinical narrative: Pt was given PROQUAD and VARIVAX on same day. On 12/06/18 medical assistant called parent to notify them of mistake. Father states patient developed a cough, but no other symptoms noted on 12/06/18. On 12/12/18 father calls office to let us know but now has 2 bumps with liquid. Asked father to bring child in to see doctor. Doctor examined child and noted 2 sores that popped open. 1 ulcer on the right ankle, and another ulcer on the left thigh, each scabbed over, 6-8mm. Minimal surrounding erythema. There are grouped pustules on the right upper thigh. Child is breathing well and drinking, but not eating very much. Dr. also noted acute serous otitis media to the left ear. States it could be due to general varicella infection. Recommends patient support and time to heal and let it run its course. Also told patients father to give us a call if symptoms do not improve or worsen.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pain
Clinical narrative: Aching, chills, lethargic. Patient is seeking treatment. Outcome to be determined.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Lethargy, Pain in extremity
Clinical narrative: PATIENT COMPLAINED OF IMMEDIATE ARM PAIN, AND SINCE RECEIVING INJECTION HAS HAD TROUBLE LIFTING HER LEFT ARM IN WHICH SHE RECEIVED INJECTION, ALSO HAS COMPLAINED OF LETHARGY AND NOT WANTING TO GET OUT OF BED.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Ringing of the ear starting day after vaccination and hasn't gone away for over 1 month.
Age: 9.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 9 year old patient (gender was not provided) No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 13-DEC-2018, the patient was vaccinated with an adult dose of VAQTA (strength, frequency and route of administration were not provided)lot # R022983, expiration date 09-AUG-2019, for prophylaxis. No adverse event was reported. This is one of two reports from the same reporter (MARRS#1812USA007388) Sender's Comments: US-009507513-1812USA007388.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 10 year old patient (gender was not provided) No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 13-DEC-2018, the patient was vaccinated with an adult dose of VAQTA (strength, frequency and route of administration were not provided) lot # R022983, expiration date 09-AUG-2019, for prophylaxis. No adverse event was reported. This is one of two reports from the same reporter (MARRS#1812USA007232); Sender's Comments: US-009507513-1812USA007232.
Sex: M
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Gait disturbance, Injection site erythema, Weight bearing difficulty
Clinical narrative: Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a three years old male patient who experienced swelling spread to the entire thigh and to the knee, he cannot bear any weight, limping and redness was seen at the injection site (pink here and there but no discrete area of redness), while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included In 2016 he got the FLUZONE QUAD 0.25 vaccine (LOT UT5663TA)and develop redness and swelling that extended to his upper FLUZONE QUADRIVALENT in OCT-2015, FLUZONE QUADRIVALENT in DEC-2015. The patient's past medical treatment(s) and family history were not provided. On 05-Dec-2018, the patient received a 0.5 ml dose of suspect FLUZONE QUADRIVALENT VACCINE lot UT6375MA via unknown route in the left thigh. On an unknown date, the patient developed a non-serious swelling spread to the entire thigh and to the knee (extensive swelling of vaccinated limb), he cannot bear any weight, limping (gait disturbance) and redness was seen at the injection site (pink here and there but no discrete area of redness) (extensive swelling of vaccinated limb) following the administration of FLUZONE QUADRIVALENT.Other relevant tests included test for egg allergies which was negative. Final diagnosis was extensive swelling of vaccinated limb, extensive swelling of vaccinated limb, gait disturbance and weight bearing difficulty. It was not reported if the patient received a corrective treatment. The patient outcome was unknown for extensive swelling of vaccinated limb, extensive swelling of vaccinated limb, gait disturbance and weight bearing difficulty. List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: No adverse event, Product preparation error, Wrong technique in product usage process
Clinical narrative: Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old female patient who was vaccinated with PENTACEL, which was reconstituted with sterile diluent instead of ACT-HIB, on 05-Dec-2018. Batch number: (Box: NDC 49281-510-05, Lot C5507AA, expiry date 05 Sep 2019 Liquid: (Not administered) NDC 49281-560-05, Lot C5324AC, expiry date 05 Sep 2019 Lyphoized Powder: Lot NDC 49281-510-05, Lot C5507AA, expiry date 05 Sep 2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTARIX and PREVNAR for Immunisation. It was an actual medication error wrong solution used in vaccine reconstitution and Wrong technique in product usage process as 1/2 of the PENTACEL componenent given with sterile diuent for routine vaccination in the Left thigh. 1/2 component of PENTACEL given with improper diluent  The patient had no 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. List of documents held by sender: none.
Sex: F
Vaccine: TYP
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a female patient who received vaccine TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Nov-2018, the patient received a dose of suspect TYPHIM VI lot N1K811M via intramuscular route in unknown administration site. It was a case of actual medication error due to vaccine underdose. The syringe leaked between the hub, (in which the needle was attached) and the syringe itself (Syringe issue). It was unknown whether 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 and Module VI of the 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. Additional information was received on 10-Dec-2018 from a nurse. Lot number updated in field and narrative. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient of unknown demographics who received vaccine FLUZONE QUADRIVALENT. (Suspension for injection) inadvertently after there was a temperature excursion. The patient's past medical history and concomitant therapy were not provided. On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to incorrect product storage. It was reported that FLUZONE QUADRIVALENT had been exposed to temperatures below 0 degrees Celsius, and then inadvertently administered to a patient. It was unknown whether 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. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 64 years old male patient who received a dose of 0.5 ml of FLUZONE HIGH DOSE (lot UJ004AA and expiration date31-Mar-2019) via unknown route in the left deltoid on 17-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccinations were given. It was a case of actual medication error due to inappropriate age at vaccine administration and accidental overdose. The patient did not report any adverse reactions. 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 and Module VI of the 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. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Allergy test negative, Cellulitis, Erythema, Inflammation, Swelling
Clinical narrative: Initial information received on 06-Dec-2018 regarding an unsolicited valid serious case received from a physician. This case is linked to case 2018SA337505. This case involves infant male patient who experienced cellulitis, redness and swelling that extended to his upper back, while he received vaccine FLUZONE QUADRIVALENT (formulation Suspension for injection). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that, In 2015 the patient got two doses of 0.25 FLUZONE QUADRIVALENT, one in October and December (LOT for both injections was U5304FA), and he had no reaction. In 2016, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5663TA, expiry date not reported via unknown route in unknown administration site. On an unspecified date, the patient developed a serious cellulitis, redness and swelling that extended to his upper back (inflammation) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. It was reported that, patient had test for egg allergies which were negative. Final diagnosis was cellulitis, redness and swelling that extended to his upper back. The patient was treated for cellulitis with antibiotics. The event outcome was unknown for cellulitis, redness and swelling that extended to his upper back. Documents held by the sender: none. Sender's Comments: This case involves an infant patient who presented with cellulitis after vaccination. Time to onset is not known. There is, moreover, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Rash, Swelling face
Clinical narrative: Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves Adult female patient (age was not reported) who had facial swelling and truncal rash, while she received vaccine FLUZONE QUADRIVALENT. 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 FLUZONE QUADRIVALENT (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced facial swelling and rash. (Other relevant tests included no lab data.) Final diagnosis was facial swelling and rash. The patient was treated with BENADRYL. The outcome of the events was reported as recovered on an unknown date. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Initial information received on 06-Dec-2018 regarding an unsolicited valid serious case received from a physician. This case is linked to case 2018SA339705 (same patient). This case involves a male patient of unknown age who experienced cellulitis and Peripheral swelling, while he received vaccine INFLUENZA VACCINE. The patient's past medical history included minimal egg allergy (Food allergy) identified post allergy testing. The patient's past vaccination(s) included influenza vaccine in JUN-2015 with no reaction, patient also had other unspecified vaccines. The patient's past medical treatment(s) and concomitant medication were not provided. On an unknown date in 2016, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed swollen arm and shoulder/upper back (Peripheral swelling) and later diagnosed and treated it as cellulitis following the administration of INFLUENZA VACCINE (unknown manufacturer). The event, cellulitis was assessed as medically significant due to important medical event. Other lab test was not reported. Final diagnosis was cellulitis and Peripheral swelling. It was not reported if the patient received a corrective treatment. Outcome of the events was not reported.; Sender's Comments: This case involves a male patient of unknown age who presented with cellulitis and Peripheral swelling after vaccination. Time to onset is not known. There is, moreover, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 15 months old male patient who received an expired DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; and FLULAVAL for Immunisation. On 07-Dec-2018, the patient received a 0.5 ml fourth dose of DAPTACEL (lot number: C510BA and expiry date: 04-Dec-2018) via intramuscular route in the thigh NOS. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. 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 and Module VI of the 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. List of documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal pain, Rash, Swelling
Clinical narrative: Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 49 years old female patient who had shoulder pain, loss of mobility and palpable quarter sized bump under the skin, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 21-Nov-2018, the patient received a dose of 0.5 ml suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: 3JY3FF) (expiry date, dose in series and route was not reported) in the right deltoid. On an unknown date, following the vaccination the patient experienced shoulder pain, mobility decreased and rash. (Other relevant tests included no lab data.) Final diagnosis was shoulder pain, mobility decreased and rash. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for all events. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Peripheral swelling, Swelling
Clinical narrative: Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2018SA339302 same reporter. This case involves a 4 years old male patient who experienced swelling in the leg and thigh area with a slight limp, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Food allergy. The patient's past vaccination(s) included INFLUENZA VACCINE in 2015. The patient's past medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUZONE QUADRIVALENT lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious swelling in the leg and thigh area (peripheral swelling) and swelling in the leg and thigh area with a slight limp (gait disturbance) 24 hours following the administration of FLUZONE QUADRIVALENT. (Other relevant tests included no lab data.) Final diagnosis was swelling in the leg and thigh area with a slight limp. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Documents held by sender: none.
Sex: F
Vaccine: TYP
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 21-years old female patient who received a partial dose of vaccine TYPHIM VI and was revaccinated with another dose. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Nov-2018, the patient received a dose (less than 0.5 mL) of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot N1K811M via intramuscular route in the left deltoid. On 29-Nov-2018, she revaccinated with a dose of the same vaccine (batch number: N1K901M, expiry date: 24-Oct-2019), via unknown route in unknown administration site. It was actual medication error case due to vaccine underdose and syringe leak. It was reported that the vaccine leaked out from leak out between the plastic hub and the syringe, not between the needle and the hub. It was not reported whether 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. List of documents held by sender: none.
Sex: U
Vaccine: TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 11 years old patient who was vaccinated with a dose of TENIVAC lot U5541AA in the left deltoid instead of ADACEL on 27-Nov-2018. 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 wrong vaccine administered. No adverse event reported. 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 and Module VI of the 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. List of documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Dysphagia, Dyspnoea, Injection site reaction, Myalgia, Salivary hypersecretion
Clinical narrative: Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 39 years old female patient who was laying down and all of a sudden and had trouble swallowing and breathing, mouth kept filling up with saliva, injection site reaction and muscle aches in legs, while she received vaccine FLUBLOK QIV. The patient's past vaccination(s) included FLUBLOK with no reactions. The patient's past medical history, medical treatment(s) and family history were not provided. On 07-Dec-2018 at 3:30 PM, the patient received a 0.5 mL dose of suspect Influenza Quadrivalent Recombinant Vaccine lot number not reported via intramuscular route in the left deltoid. On 07-Dec-2018 between 10:00 pm and 11:00 pm, the patient developed a non-serious trouble swallowing (dysphagia), trouble in breathing (dyspnoea), mouth kept filling up with saliva (salivary hypersecretion), injection site reaction (vaccination site reaction) and muscle aches in legs (pain in extremity) on same day following the administration of Influenza Quadrivalent Recombinant Vaccine. (Other relevant tests included no lab data.) Final diagnosis was muscle aches in legs, injection site reaction, mouth kept filling up with saliva, trouble in breathing and trouble swallowing. The patient was treated with two BENADRYL and Ranitidine. On an unknown date, the patient recovered from the events (outcome considered based on sentence I am fine now and injection site reaction is down to normal). Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Dizziness, Dyspnoea, Nausea
Clinical narrative: Besides the nausea, cold sweat, and dizziness. Pt stated, "It was more like I could not get air in my lungs." Took couple of days to get over nausea and dizziness.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash all over body 10 days after SPV. Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21), PRURITUS, UNSPECIFIED(L299).
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Nodule, Pain in extremity, Skin warm
Clinical narrative: Knot on R arm came up after flu shot and has progressively gotten bigger, sore and warm to touch, and red. Treated with antibiotic with f/u if no improvement.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Blood test normal, Computerised tomogram head normal, Electroencephalogram, Nuclear magnetic resonance imaging brain, Scan with contrast normal
Clinical narrative: On December 10th Patient was seen at Emergency Room for seizure like activity (4 Days after receiving the two immunizations listed above). Head Ct with contrast and blood work all negative and Patient was discharged the following day. She was seen for follow up at PCP's office on 12/11/2018 and additional testing was ordered (Brian MRI and EEG)  to find the cause of seizure activity. MD is unsure if two events are related but felt it needed to be brought to your attention.