chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked with 2018SA304935, 2018SA304936, 2018SA304964, 2018SA304965. This case involves a 52 years old female patient for whom accidentally gave an expired (4/4/2018) was reported, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. No Other vaccines was reported. On 30-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI842AB expiry date: 04-Apr-2018 via intramuscular route in the left arm. It was a case of actual medication error due to expired vaccine used, inappropriate age at vaccine administration and overdose. It was not reported that if any adverse event occurred 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 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.
Age: 1.0
Sex: U
Vaccine: HIBV, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a non-health professional (Pharmacy manager). This case involves 12 months old patient (gender not reported) who was vaccinated with a 0.5 ml expired dose of ACT-HIB (Batch number: UI807AAA, expiration date: 01 Oct 2018) via intramuscular route in left thigh on 30-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown if patient had adverse event. 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. List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: FLUX
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 01-Nov-2018 and additional information on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On 01-Nov-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot 54G45, expiry date 30-jun-2019 via intramuscular route in the left thigh. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that patient age 4-month old was given a FLUZONE QUADRIVALENT vaccine. The patient did not experience any adverse reaction after the injection. 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. Follow-up report was received from a nurse on 05-Nov-2018. No new information was reported. List of documents held by sender- none.
Age: 1.67
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from non health professional reported as office staff. This case involves a 20 months and 3 days old male patient who received 5th dose of 0.5 ml of ACT-HIB (batch number: UI969AAA) (expiry date: 13-Mar-2020) (route and site of administration were not reported) on an 29 Oct 2018. (reported as 29-Oct-2019). Patient had received had received the recommended 4 doses of ACTHIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A for Immunization. It was case of actual medication error due to Extra dose administered as Patient received an extra ACTHIB (5th dose), that was administered by the HCP. No adverse event was experienced. 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: 10.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Hypertonia, Hypoaesthesia, Hypotonia, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: After receiving her Hep A and then her Flu vaccine, pt fainted and went stiff (Flu vaccine needle still in arm when reaction occurred). Pt.'s body was in a state of hypertonicity initially and a few seconds later she went limp. Cam to after approx 30 seconds. Was pale and c/o numbness in hands and feet. Five mins or so after, developed vomiting. Vital signs were stable. Color eventually returned to her face; hands stayed pale for some time. Pt was taken by EMS to ED for further evaluation.
Age: 10.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Pallor, Syncope, Vomiting
Clinical narrative: After receiving her Hep A and then her Flu vaccine, pt fainted and went stiff (Flu vaccine needle still in arm when reaction occurred). Pt.'s body was in a state of hypertonicity initially and a few seconds later she went limp. Cam to after approx 30 seconds. Was pale and c/o numbness in hands and feet. Five mins or so after, developed vomiting. Vital signs were stable. Color eventually returned to her face; hands stayed pale for some time. Pt was taken by EMS to ED for further evaluation.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of (L) leg possible due to varicella vaccine administration. Started antibiotics 11/8/18.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hypotension, Tremor
Clinical narrative: Pt. reports he got his flu shot on 11-6-18 and 6 hrs later he experienced shivering and shaking and BP was low 113/52 around midnight-he went to sleep and woke up feeling completely fine. States he had same rxn 3 yr ago after flu shot.
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old patient of unknown age who received 0.25 ml of vaccine FLUZONE QUADRIVALENT (batch number: UT6259OA) (expiry date:30-Jun-2019) (dose in series and route were not reported) rather than 0.5 ml in the left quad on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant mediation was not reported. It was a case of actual medication error case Vaccine underdose. It was not reported that if any adverse event was not 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 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.
Age: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from other health care professional via phone. This case involves an unknown gender 36 months old patient who received flu qiv 0.25 ml, while he/she received vaccine FLUZONE QUADRIVALENT (Batch number, expiration date, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to underdose (three year old received FLU QIV 0.25 ml). It was unknown whether patient experienced any adverse event following vaccination. 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.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a 3 years old (also reported as 3 years and 9 months) female patient who was inadvertently vaccinated with 0.25 ml one time dose of FLUZONE QUADRIVALENT (Batch number: UT6315RA and expiry date: 30-Jun-2019) via intramuscular route on 11-Jan-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccines: None. It was a case of actual medication error due to vaccine underdose because patient was vaccinated with 0.25 ml dose of the following vaccination. It was unknown if any adverse event was occurred o not following the vaccination. 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.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site discomfort, Insomnia, Loss of personal independence in daily activities, Pain
Clinical narrative: Injection site upper part of left non dominant arm. Pressure at site during and after injection. Arm became overly sore hours after injection. Within a week the arm was so sore I could not lift it without pain. ADVIL/ALEVE/Ice did nothing to alleviate pain. Loss of range of motion in arm, could not put arm over head or behind back without severe pain. Many sleepless nights due to pain and no relief with OTC meds. Pain began to travel from my upper shoulder, to my elbow and down to my fingers. I had NO prior injuries before the vaccination, I have received a flu vaccine through Agency or my job for over 15 years and have never once had any illness, lasting pain like this. I feel the nurse administering the vaccination may have felt rushed during the injection and did not ask me to relax my arm, she injected me quickly while I was tending to my two children and possibly the administration of the vaccine vs the vaccine itself caused the pain and damage to my arm. 8 weeks to the day later I am still in pain. I have lost sleep, stopped exercising. Pain has improved since the vaccination but I feel it is going to take another 1-3 months before I can lift anything heavier than my purse or raise my hand/arm without flinching.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: Injection site upper part of left non dominant arm. Pressure at site during and after injection. Arm became overly sore hours after injection. Within a week the arm was so sore I could not lift it without pain. ADVIL/ALEVE/Ice did nothing to alleviate pain. Loss of range of motion in arm, could not put arm over head or behind back without severe pain. Many sleepless nights due to pain and no relief with OTC meds. Pain began to travel from my upper shoulder, to my elbow and down to my fingers. I had NO prior injuries before the vaccination, I have received a flu vaccine through Agency or my job for over 15 years and have never once had any illness, lasting pain like this. I feel the nurse administering the vaccination may have felt rushed during the injection and did not ask me to relax my arm, she injected me quickly while I was tending to my two children and possibly the administration of the vaccine vs the vaccine itself caused the pain and damage to my arm. 8 weeks to the day later I am still in pain. I have lost sleep, stopped exercising. Pain has improved since the vaccination but I feel it is going to take another 1-3 months before I can lift anything heavier than my purse or raise my hand/arm without flinching.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Back pain, Chills, Dizziness, Headache, Influenza
Clinical narrative: Pain, redness and swelling at the injection site. Muscle ache throughout upper back torso and back of neck. Felt like I had flu symptoms with headache, dizziness, lethargy, chills and low fever. Such symptoms disappeared within 3 days. However, the injection site remained swollen, itchy, red and discolored (similar to a bruise). The redness and discoloration were slightly larger than the size of a silver dollar and lasted 7 days. Thereafter, everything disappeared. I took ADVIL and rested during this time in response to the reaction.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, redness and swelling at the injection site. Muscle ache throughout upper back torso and back of neck. Felt like I had flu symptoms with headache, dizziness, lethargy, chills and low fever. Such symptoms disappeared within 3 days. However, the injection site remained swollen, itchy, red and discolored (similar to a bruise). The redness and discoloration were slightly larger than the size of a silver dollar and lasted 7 days. Thereafter, everything disappeared. I took ADVIL and rested during this time in response to the reaction.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Lethargy, Pyrexia
Clinical narrative: Pain, redness and swelling at the injection site. Muscle ache throughout upper back torso and back of neck. Felt like I had flu symptoms with headache, dizziness, lethargy, chills and low fever. Such symptoms disappeared within 3 days. However, the injection site remained swollen, itchy, red and discolored (similar to a bruise). The redness and discoloration were slightly larger than the size of a silver dollar and lasted 7 days. Thereafter, everything disappeared. I took ADVIL and rested during this time in response to the reaction.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Pyrexia, Rash generalised, Rash papular
Clinical narrative: Vaccine give 11/5/18, Pt had low grade fever that day 99.7F, on 11/7/18 am pt started with rash all over body, crying more. On the same day 11/5/18 evening mom started EUCERIN baby lotion also for skin. Pt seen in office today for rash. Red small papular rash more intense over chest, abdomen. Less intense over extremities, face.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: PATIENT'S LEFT ARM SWELLED OVER A LARGE AREA - HER DOCTOR (WHICH ONE HER DAUGHTER WASN'T SURE) INSTRUCTED HER TO APPLY ICE AND TAKE TYLENOL. OVER A WEEK LATER SHE IS STILL SWOLLEN BUT CONSIDERABLY BETTER.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose given instead of Adult dose.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site reaction, Injection site urticaria, Rash erythematous
Clinical narrative: Patient reported on 11/6/18 she had hives appear around her injections site on her right arm. When she presented to the pharmacy on 11/8/18 it was a red, rashy area 2.5 x 3.5 inches. She also complained that it itched.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Patient came to pharmacy on 11/08/2018 for her second SHINGRIX dose. Her first dose was administered on 06/29/2018. She stated the first dose gave a red circle around the immunization spot and got significantly larger the next day. She stated it was hot to the touch and had pain associated with it as well. She said at the time she did not know if it was from the shot or maybe a spider bite so she went to an urgent care and had them look at it and they prescribed her antibiotics. She said she had pain that radiated down her arm for months after. Based on her description of the pain and size of the red spot I was concerned about giving the second dose. I consulted with our clinical services manager and we determined that it was likely just the typical adverse effects listed on the product information and should proceed with the second dose. We also discussed counseling the patient on this as well as having her take a BENADRYL, ibuprofen, and applying a cold compress after receiving the dose. I did this and verified the patient was still wanting to receive the second dose. She stated she would like to and I made these recommendations to her. I also informed her that I would follow up the next day to see how she was feeling.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: About 10 hours after injection, started experiencing headache, body aches, chills and fatigue; took acetaminophen then and every 6 hours for 24 hours; worst of symptoms eased off after about 8 hours, with slight headache and fatigue lasting another 12 hours.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site urticaria
Clinical narrative: Mild hives extending 2 inches around the injection site for influenza vaccination.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Patient's spouse called into the pharmacy at approximately 5:30 pm and reported that the patient was having arm pain, swelling, fever, nausea/vomiting, and fatigue. Pharmacist delivered cetirizine and TYLENOL to the patinet at 7pm to help with symptoms.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient's spouse called into the pharmacy at approximately 5:30 pm and reported that the patient was having arm pain, swelling, fever, nausea/vomiting, and fatigue. Pharmacist delivered cetirizine and TYLENOL to the patinet at 7pm to help with symptoms.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Audiogram abnormal, Deafness neurosensory, Deafness unilateral
Clinical narrative: Sudden hearing loss in left ear. Went to ENT one week later after it didn't get better, diagnosed with sudden sensorineural hearing loss.
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction that we are aware of. Came across the misuse of KINRIX vaccine when quarterly report was printed.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: Woke up at 4:00 AM with a fever of a 101.5, chills, body aches, nausea, dizziness, and extreme fatigue. I was too tired to get out of the bed. Later in the morning, I took two Ibuprofen (400 mg.) which helped reduce the severity of symptoms after a couple of hours. Felt like influenza without the respiratory symptoms. This was my second dosage; the first dosage I had last Spring, and had a similar experience but was not as severe as this one. I was unable to go into work today because of my symptoms.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Woke up at 4:00 AM with a fever of a 101.5, chills, body aches, nausea, dizziness, and extreme fatigue. I was too tired to get out of the bed. Later in the morning, I took two Ibuprofen (400 mg.) which helped reduce the severity of symptoms after a couple of hours. Felt like influenza without the respiratory symptoms. This was my second dosage; the first dosage I had last Spring, and had a similar experience but was not as severe as this one. I was unable to go into work today because of my symptoms.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site scab, Injection site swelling, Injection site ulcer
Clinical narrative: Patient developed multiple sores at the injection site that had scabbed over by the time I saw them - patient reported that the area of the injection site felt bumpy - doc thought patient had an infection and prescribed amoxicillin (per patient reporting) and diphenhydramine.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Myelitis, Paralysis, Sensory loss, Sexual dysfunction
Clinical narrative: Post-influenza vaccination myelitis per the patient's neurologist and various other doctors. Patient lost sensation in lower extremities and was paralyzed for several days. Patient has since regained some strength and is able to walk for now. Patient estimates that he has about 30% sensation in lower extremities, but will never regain 100% sensation. Patient also unable to engage in sexual functions at the present time.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Injection site pain, Joint range of motion decreased, Presyncope
Clinical narrative: Patient presents today (11/8/18) with chief complaint of 2 weeks of L shoulder pain which started the morning after the vaccine. He states that he had an episode of dizziness/near fainting after the injection, but recovered after lying down briefly. He went home and woke the next morning with L shoulder pain and limited movement (although he has full ROM today on exam). He has had no injury and teaches swimming and did crew, but says he hasn't injured his shoulder.
Age: 24.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased
Clinical narrative: Patient said as soon as he received immunization he couldn't move his arm. He went to ER and Md gave patient ibuprofen and range of motion improved.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: Several days (3+) of fever, chills, sweats, fatigue. Sore arm at injection site.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Sensory loss
Clinical narrative: Loss of sensory functions...
Age: 0.92
Sex: F
Vaccine: DTAPIPV, HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction that we are aware of. Came across the misuse of KINRIX vaccine when quarterly report was printed.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Pt presented to phcy on 11/08/18 and asked if it was normal to have bruising following SHINGRIX immunization. Pt had rec'd 1st SHINGRIX injxn on 04/30/18 without any SE's. Today pt reports bruising at injxn site following 11/05/18 immunization. Pt stated there was very little blood on her Band-Aid following shot, but her L deltoid started bruising & swelling following injxn.  Assessed arm on 11/08 and there was residual bruising (yellow and purple), some tenderness on palpation, no palpable bruise under the skin, no swelling present 11/08/18. The residual bruising was approx 3.5 inches from the acromion process & est'd to be less than 2 x 2 inches in length x width. Pt asked about additional sxs, and denied recalling any sxs other than bruising and swelling. Pt states she would not have mentioned the bruise if she had not come in for refills today & did not see her PCM for side-effects. Pt asked the following: any decreased range of motion? Pt denied. Any decreased grip strength? Pt denied any changes in arm mobility or feeling.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Muscle aches, fever (101), fatigue.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Mom called to report rash on abdomen, which started the evening of vaccination. He developed another area on elbow the next day. No other symptoms.
Age: 86.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient is experiencing a red warm area on the arm where the vaccine was administered. Vaccine administered 11/02 and red area did not appear until 11/07. Pt was referred to urgent care for treatment.
Age: 1.08
Sex: M
Vaccine: DTAP, FLU4, MMR, VARCEL
Symptoms: C-reactive protein increased, Influenza virus test negative, Metabolic function test normal, Mycoplasma test negative, Platelet count increased
Clinical narrative: Child developed diffuse urticarial and macular rash 6 hours after receiving MMR #1, Varicella #1, Influenza, and DTaP. Resolved in 3-4 days with BENADRYL. Then 7 days post vaccination developed worsening urticarial and macular rash, with temp to 104 on day 9 post-vaccination. IV steroids given in ER. Rash and fever resolved 3-4 days later. Unclear if allergic reaction to vaccines vs viral infection.
Age: 1.08
Sex: M
Vaccine: DTAP, FLU4, MMR, VARCEL
Symptoms: Pyrexia, Rash macular, Respiratory syncytial virus test negative, Urticaria, White blood cell count normal
Clinical narrative: Child developed diffuse urticarial and macular rash 6 hours after receiving MMR #1, Varicella #1, Influenza, and DTaP. Resolved in 3-4 days with BENADRYL. Then 7 days post vaccination developed worsening urticarial and macular rash, with temp to 104 on day 9 post-vaccination. IV steroids given in ER. Rash and fever resolved 3-4 days later. Unclear if allergic reaction to vaccines vs viral infection.
Age: 1.67
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pyrexia
Clinical narrative: Localized red, itchy rash on both right and left thigh. Father reported the rash started in only a small area, but spread the more the child itched it. Father reports putting VANICREAM on it, which helped but the child has continued to itch the rash. Father reports a fever today, but believes that is unrelated.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pyrexia
Clinical narrative: Fever, headache and shingles on right side of back below arm.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 31-OCT-2018 regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2015, the patient's healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 2015, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, 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 include 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. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited non valid case non-serious case received from a nurse. Case has been identified as non case as no specific event has been reported. On additional information was received on 02-Nov-2018, the case was considered as valid due to specific event was reported. This case is linked to cases 2018SA284495 and 2018SA284522. This case involves Adult male patient for whom vaccines were given before they were known to be inactive due to temperature stability was reported, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 02-Oct-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route in the Right Vastus Lateralis. On an unknown date, patient was given a vaccine which were given before they were known to be inactive due to temperature stability. Unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. All the patients were contacted and no patients reported any adverse events to be inactive vaccines. Final diagnosis was vaccines were given before they were known to be inactive due to temperature stability. It was an actual medication error due to incorrect product storage. Outcome of the event was not applicable. 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. Additional information was received on 02-Nov-2018. Event was updated. The case was considered as valid.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 10 years old female patient who was vaccinated with 0.25ml dose, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Oct-2018, the patient received a dose of suspect FLUZONE QUADRIVALENT (lot number: UT6259JA) via intramuscular route in the right arm. It was an actual medication error due to vaccine underdose. 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: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 75 years old female patient who was vaccinated with the dose of INFLUENZA VACCINE (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date earlier this season. She was also vaccinated with a (0.5 ml) dose of FLUZONE HIGH DOSE (Batch number: L-UI994AA, Expiry date: 02-Apr-2019) via intramuscular route in the left deltoid on 02-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered. It was unknown 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 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: 0.17
Sex: U
Vaccine: DTAPIPVHIB, PNC
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA306316 and 2018SA306332 (same reporter). This case involves a 2 months old patient who received expired 0.5 ml dose of vaccine PENTACEL (lot C5439AA and expiration date 29-Oct-2018) via unknown route in the left thigh on 01-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and RHODAVIRUS for Immunization. It was a case of actual medication error due to expired vaccine used and inappropriate age at vaccine administration. It was not reported 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 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. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA306289, 2018SA306316. This case involves unknown age of child patient who received expired PENTACEL, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect PENTACEL lot C5439AA exp date: 29-Oct-2018 via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. It was not reported whether the patient had any adverse event or not after receiving the expired vaccine. 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 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.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Headache, Malaise, Peripheral swelling
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six years old male patient who experienced arm swelling, malaise and headache, while he received vaccine QUADRACEL. 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 third dose of 0.5 ml suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (frequency once) lot C5325BA, expiry date: 14-Nov-2019 via intramuscular route in the right arm. On an unknown date, the patient developed a non-serious arm swelling, malaise and headache (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. It was reported that the patient visited to physician on 02-Oct-2018. (Other relevant tests included No lab data.) Final diagnosis was headache, malaise and arm swelling. No corrective treatment was received. On an unknown date, the patient was recovered from the events. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves patient of unknown demography who received a dose of QUADRACEL for PENTACEL (lot number not reported for both) via unknown route in unknown administration site on an unknown date. 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. It was not reported 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 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.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Mild soreness first day. Warm, slightly pink second day. Red slightly raised warm area the size of half dollar with a 3 inch pink ring around it for almost a week. Finally went away. Never had any reaction before and have been getting flu vaccinations for 6+ years.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Hypoaesthesia, Nausea, Pain
Clinical narrative: Pt in for routine visit today 11/8/18 and noted to provider that she thinks she had reaction from SHINGRIX in August. Pt got 1st dose of SHINGRIX 8/10/18 around noon. Noted that evening severe exhaustion set in which lasted 3 days. She also had decreased appetite and ended up losing 8 lbs in 10 days. She had some nausea and general body aches for a few days. She noted her arm was sore and her right hand/fingers were a bit numb as well.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Weight decreased
Clinical narrative: Pt in for routine visit today 11/8/18 and noted to provider that she thinks she had reaction from SHINGRIX in August. Pt got 1st dose of SHINGRIX 8/10/18 around noon. Noted that evening severe exhaustion set in which lasted 3 days. She also had decreased appetite and ended up losing 8 lbs in 10 days. She had some nausea and general body aches for a few days. She noted her arm was sore and her right hand/fingers were a bit numb as well.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, TDAP
Symptoms: Irritability
Clinical narrative: Dose of Tdap given in addition to PENTACEL and PCV13. Infant was more irritable than normal however appetite was good, no unusual swelling or redness noted by the mother.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: The pt reported pain in the right arm to the nurse on 10/31/2018 and again on 11/08/2018. Today 11/08/2018 she was sent by Clinic to OCC Health to be evaluated.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Malaise, Peripheral swelling
Clinical narrative: After 3-4 hours of getting the vaccine, patient's arm was swollen, red, and patient felt ill.
Age: 17.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Nausea
Clinical narrative: After 2nd shot was administered, Pt reported she was feeling light headed. Had Pt take deep breathes and put her head between her legs. Seconds later, Pt loss consciousness and fell forward to the ground. RN was able to catch Pt, but lost balance. Both Pt and RN fell to the ground. Pt did hit her forehead/side of head on the ground, but impact was less due to RN catching Pt. Pt regained consciousness seconds later. Had Pt remain on the ground and reassured her that she is going to be "ok". Pt stated she was feeling nauseous and had her on her side. Mother had to leave the room, but Father remained. Assessed her head for any open wounds/blood that may have occurred from the fall, but none noted. Checked BP - 88/65. Continued to reassure Pt and had her drink some water and eat a glucose tablet. Pt stated she was still feeling dizzy and had her remain on the ground until her symptoms resolved. Pt reported that she ate only a granola bar for breakfast. Provided education about how fainting/syncope is not an uncommon reaction after shots. Provided education on why syncope/vasovagal reaction can happen after shots. Pt reported she had similar symptoms when having dental work done but she didn't lose consciousness. Checked BP again - 90/70. Pt stated she is a cross country runner and normally has lower BP. Pt was able to sit up with slight dizziness that only lasted for a few seconds. Continued to have Pt drink water. Attempted to stand Pt but she became very lightheaded. Had to rest head on counter and gave another glucose tablet to eat. After about 5 minutes, Pt was able to sit up again and a family member provided a granola bar for Pt to eat. Checked BP again - 96/75. Pt was eventually able to stand without dizziness. RN walked Pt and her father to the car where the rest of the family was. Reassured family Pt will be fine, but stated to check in with Primary MD if they have any other concerns. Notified Primary MD: Dr. of syncope event, he stated not uncommon reaction after shots - RN agreed. Reported to MD that Pt did hit her head on the ground but impact was minimal. MD didn't express any more concern. Checked in with Parent a few hours later after the event via phone call. Parent reported that Pt was feeling better and was currently sleeping. Reported to Parent that RN notified their Primary MD of the syncope event and to call him if they have any further concerns - Parent acknowledged.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Within 3 hours of receiving the influnza vaccine he developed a warm red slightly swollen upper arm. It did not progress any further. Mom used topical BENADRYL cream and progressively improved. Resolved after approximately 48 hours.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Within 3-4 hours of receiving influenza vaccine, triceps region/lateral upper arm became red, warm and a little swollen. Patient's mother notified our clinic. Placed on 5 days of Amoxicillin. Complete resolution within 48 hours.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dizziness, Tracheal pain
Clinical narrative: Approximately 1.5 hours post vaccination patient reported coughing that was persistent, dry, hacking. No report of rash, swelling, hives, syncopy, fever, or shortness of breath. Patient did report some dizziness due to cough and buring in the trachea due to continuous cough. Referred patient to provider for care immediately.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Pt presented to the clinic for a flu shot and the immunization was given without issue. The patient returned to the clinic 2 days later with signs of infection around the injection site, including redness, warmth, swelling, and tenderness. The patient was treated for cellulitis.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: Pt presented to the clinic for a flu shot and the immunization was given without issue. The patient returned to the clinic 2 days later with signs of infection around the injection site, including redness, warmth, swelling, and tenderness. The patient was treated for cellulitis.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling cold, Hyperhidrosis, Mobility decreased, Pallor, Peripheral swelling
Clinical narrative: According to mother, this 13 year old was vaccinated at school and, within minutes, developed significant swelling in her fingers and hand. Her hand was also apparently discolored (purplish color). Her palms were sweaty and her hand also turned white (washed out color in her hand) and had a cold sensation going up her left arm (same arm as vaccine site). She was taken into the emergency room because she couldn't move her left hand. At some point she was also taken to her pediatrician. The vaccine was administered as part of the Flu campaign in schools and the Flu staff was there but was not made aware of any reactions to any vaccines on the day of the clinic.  The Flu staff were notified on November 7, 2018 by the child's pediatrician. The Flu staff contacted mom on 11/8/18 and mom said that the child is okay now.