chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5 year old patient received a dose of Flublok vaccine, no AE; 5 year old patient received a dose of Flublok vaccine in left thigh, no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old male patient who received a dose of 0.5 mL INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot: QFAA1921 and expiry date. 30-JUN-2020) via intramuscular route in left thigh on 11-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration and vaccine administered at inappropriate site.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP put a needle on the syringe, did not use the vaccine, placed it back in the refrigerator, gave the vaccine next day to patient, no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of an unknown demographics who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (prefilled syringe) (lot number, expiry date, dose, route and site of administration were not reported), which was stored with attached needle for a day.  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 Device stored with needle attached.   It was reported that HCP put a needle on the syringe, did not use the vaccine, placed it back in the refrigerator, gave the vaccine the next day to a patient.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TDAP
Symptoms: Blister, Contusion, Pruritus, Purulent discharge, Rash
Clinical narrative: little blister; bruises; deep Itching; rash is located on the hands, arms, face and legs/rash was also on the torso/having puss that crusts over; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 58 years old female patient who experienced little blister (blister), bruises (contusion), deep itching (pruritus) and rash is located on the hands, arms, face and legs/rash was also on the torso/having puss that crusts over (rash pustular), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history included Arthropod bite with placed on antibiotics. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Allergy to metals and Drug hypersensitivity.   On 10-Oct-2018, the patient received a dose  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6069BA via unknown route.  On an unknown date, The patient developed a non-serious little blister (blister), bruises (contusion), deep itching (pruritus) and rash is located on the hands, arms, face and legs/rash was also on the torso/having puss that crusts over (rash pustular) Unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Patient had allergy test showing she is allergic to: gold, nickel, thimersol, tixocortol -21 pivalate, bacitracin, neomycin; that she was given an anti itch cream that she found out contains tixocortol -21 pivalate; that the providers have treated her for poison ivy which she has an allergy too; that she has always sown with needles and that she is always in poison ivy; that the providers now are thinking this may be Uticaria or eczema like; and that she is being referred to bigger hospitals out of state now  No lab test reported.  Final diagnosis was rash is located on the hands, arms, face and legs/rash was also on the torso/having puss that crusts over, deep itching, bruises and little blister.   The patient was treated with PREDNISONE (PREDNISONE).  The patient outcome is reported as Unknown for the events.
Sex: F
Vaccine: TDAP
Symptoms: Scab
Clinical narrative: little blister; bruises; deep Itching; rash is located on the hands, arms, face and legs/rash was also on the torso/having puss that crusts over; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 58 years old female patient who experienced little blister (blister), bruises (contusion), deep itching (pruritus) and rash is located on the hands, arms, face and legs/rash was also on the torso/having puss that crusts over (rash pustular), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history included Arthropod bite with placed on antibiotics. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Allergy to metals and Drug hypersensitivity.   On 10-Oct-2018, the patient received a dose  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6069BA via unknown route.  On an unknown date, The patient developed a non-serious little blister (blister), bruises (contusion), deep itching (pruritus) and rash is located on the hands, arms, face and legs/rash was also on the torso/having puss that crusts over (rash pustular) Unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Patient had allergy test showing she is allergic to: gold, nickel, thimersol, tixocortol -21 pivalate, bacitracin, neomycin; that she was given an anti itch cream that she found out contains tixocortol -21 pivalate; that the providers have treated her for poison ivy which she has an allergy too; that she has always sown with needles and that she is always in poison ivy; that the providers now are thinking this may be Uticaria or eczema like; and that she is being referred to bigger hospitals out of state now  No lab test reported.  Final diagnosis was rash is located on the hands, arms, face and legs/rash was also on the torso/having puss that crusts over, deep itching, bruises and little blister.   The patient was treated with PREDNISONE (PREDNISONE).  The patient outcome is reported as Unknown for the events.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: patient came to pharmacy on 10/17/19 complaining her arm which she was vaccinated in (left) still hurt (ache, no tingling, no burning, no numbness). She has noticed it hurts so bad she is "babying" it. She is feeling the pain mainly from elbow up and sometimes the entire arm from shoulder to wrist. She has not been seen by MD yet.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: (L) arm Redness, Swelling Circumferential from upper (L) arm to chest area (L), & itching. Initially (99' fever @ Home), but upon recheck afebrile (@ clinic). Initially (Flu) given 10/15/2019, had a F/U for adverse Rxn. 10/17/19 & 10/18/19, Rxn. was Reported to our office on 10-17-19
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Sore arm for over 1 week
Sex: U
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Lip blister
Clinical narrative: Blisters above lip, below nose within 12 hours for a duration of about 8 days, fatigued and weak for a day or two.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: approx. 12 hours after receiving Flu shot  at work  I began having chills.  The chills became stronger, took my temperature orally and had low grade temp of 100.2.  Fever peaked out  at 103.0 for 4 to 5 hours.    Had moderate headache with fever and  moderate generalized weakness.    No other symptoms were present.   Symptoms  lasted approx.  36 hours
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Patient was administered a flu vaccine and had no issues at the time. Before administration I verified patient had no previous vaccine reactions or known allergies. Patient left after administration and came back a few minutes later for a new bandaid because he noticed he was bleeding a little. As I was changing the bandaid I noticed he had some swelling localized to the injection site. I gave the patient a new bandaid and had them sit in the immunization room while I got an ice pack. When I inspected the site a few minutes later the swelling appeared to have minimized but I still gave the patient an ice pack. I had patient sit for about 25 minutes and talked with them. Patient said they had no pain at the injection site and felt normal. They were unaware of any swelling at the time. After sitting for about 25 minutes I let the patient leave with an ice pack because they did not feel they needed to stay any longer.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Joint swelling, Lethargy, Renal impairment
Clinical narrative: 1.  Severe pain in all joint began about 14 hours after injection and continues, but rotates among all joints but for the past 3 weeks has been primarily in wrists  and continuing 7 weeks post injection.  2.  Lethargy has been evident ever since the injection which was not evident before.   3.  Swelling in the ankles, noticed within a week after the injection.  There was a change in the BP medication ~2 weeks later, thinking the  Avapro could be causing the  slight decrease in kidney function.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right thigh bump - red and raised
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: On evening of 10/15/19 patient developed itching, warmth, swelling and redness of left deltoid.  parent administered cool compress, ibuprofen and benadryl per doctor's instructions. The following day (10/16/19), swelling had not improved. Mom gave another dose of ibuprofen and brought child to be seen by me.  On exam left upper arm with firm, indurated swelling overlying entire deltoid (@10cm x 8cm).  very warm to touch, slightly tender.  I advised parent to continue with cool compresses and ibuprofen.  Dose of diphenhydramine given in office. Because of degree of warmth and swelling, I treated for cellulitis with antibiotic (augmentin).  Within 12-18 hours of starting antibiotic swelling, induration, warmth had begun to decrease.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: On evening of 10/15/19 patient developed itching, warmth, swelling and redness of left deltoid.  parent administered cool compress, ibuprofen and benadryl per doctor's instructions. The following day (10/16/19), swelling had not improved. Mom gave another dose of ibuprofen and brought child to be seen by me.  On exam left upper arm with firm, indurated swelling overlying entire deltoid (@10cm x 8cm).  very warm to touch, slightly tender.  I advised parent to continue with cool compresses and ibuprofen.  Dose of diphenhydramine given in office. Because of degree of warmth and swelling, I treated for cellulitis with antibiotic (augmentin).  Within 12-18 hours of starting antibiotic swelling, induration, warmth had begun to decrease.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: patient experienced syncope shortly after receiving vaccine, was laid on floor (did not fall) and was sweating profusely, blood pressure was monitored, patient was feeling better after about five minutes. Patient did state that they had not eaten anything yet that day.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Basophil count normal, Basophil percentage decreased
Clinical narrative: Itchy red eyes, itching skin, scratchy throat, elevated bp. (has had itching with previous flu vaccinations)
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Blood albumin normal, Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal, Blood chloride normal
Clinical narrative: Itchy red eyes, itching skin, scratchy throat, elevated bp. (has had itching with previous flu vaccinations)
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood pressure increased, Blood smear test normal
Clinical narrative: Itchy red eyes, itching skin, scratchy throat, elevated bp. (has had itching with previous flu vaccinations)
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Blood sodium normal, Blood urea decreased, Blood urea nitrogen/creatinine ratio, Carbon dioxide normal, Eosinophil count decreased
Clinical narrative: Itchy red eyes, itching skin, scratchy throat, elevated bp. (has had itching with previous flu vaccinations)
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Eosinophil percentage decreased, Eye pruritus, Haematocrit increased, Haemoglobin increased, Lymphocyte count normal
Clinical narrative: Itchy red eyes, itching skin, scratchy throat, elevated bp. (has had itching with previous flu vaccinations)
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume normal, Mean platelet volume decreased
Clinical narrative: Itchy red eyes, itching skin, scratchy throat, elevated bp. (has had itching with previous flu vaccinations)
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Monocyte count normal, Monocyte percentage, Neutrophil count normal, Neutrophil percentage increased, Ocular hyperaemia
Clinical narrative: Itchy red eyes, itching skin, scratchy throat, elevated bp. (has had itching with previous flu vaccinations)
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Platelet count normal, Protein total increased, Pruritus, Red blood cell count increased, Red cell distribution width normal
Clinical narrative: Itchy red eyes, itching skin, scratchy throat, elevated bp. (has had itching with previous flu vaccinations)
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation, White blood cell count normal
Clinical narrative: Itchy red eyes, itching skin, scratchy throat, elevated bp. (has had itching with previous flu vaccinations)
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, shakes, headache, body aches, leg pains Please note - This date was for my second injection. I had the same side effects after the first dose in July. I will say that they were more severe in July
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: Fever, chills, shakes, headache, body aches, leg pains Please note - This date was for my second injection. I had the same side effects after the first dose in July. I will say that they were more severe in July
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Swelling, Ultrasound scan
Clinical narrative: Patient has swelling and arm pain to the point of needing an ultrasound
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity, Pain in jaw, Paraesthesia
Clinical narrative: Approximately 30-60 minutes after the administration of the vaccine, I felt pain in the injection site, like I had been punched. Upon inspection, I found no redness or swelling, but I did notice that the vaccine had been given in the upper 1/3 of the deltoid, just under the bony projection of the shoulder. As of the time of this filing (11 days later), I have been experiencing constant pain, soreness, and a tingling sensation. The pain radiates from my shoulder down to my fingers and up to my jaw. Sometimes the pain is sharp and piercing. Other times it is a burning pain. My entire arms aches almost 24/7.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Moderate sized reddened area on upper left arm. Site is red and slightly swollen. Pt states minimal discomfort noted with some pruritus. Localized to the upper left arm (site of injection)
Age: 62.0
Sex: F
Vaccine: HEPAB
Symptoms: Flushing, Urticaria
Clinical narrative: Patient called on 10/16 to inform us that she had developed a hive-like rash on both arms (interior, posterior) after receiving the second twinrix shot. Rash was limited to the arms, states she was flushed everywhere though
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Back pain, Dizziness
Clinical narrative: Right after patient received the vaccine, she complained of dizziness and lower back pain. The paramedics were called and patient was evaluated. After around 15 to 20 minutes, the paramedics determined patient was alright and gave her a ride back home.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Nasal congestion, Pain in extremity
Clinical narrative: Flu shot on 10/1/18 - nose stopped up for months ended up having sinus surgery Flu shot 10/16/19 - Allergic reaction. Redness around arm where flu shot was given. Pain in arm, itching, cold compress & used benedryl
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Sinus operation, Skin warm
Clinical narrative: Flu shot on 10/1/18 - nose stopped up for months ended up having sinus surgery Flu shot 10/16/19 - Allergic reaction. Redness around arm where flu shot was given. Pain in arm, itching, cold compress & used benedryl
Age: 26.0
Sex: M
Vaccine: UNK
Symptoms: Chest X-ray normal, Chest discomfort, Dyspnoea, Electrocardiogram normal, Fibrin D dimer normal
Clinical narrative: Patient experienced a feeling of 'shortness of breath' and mild chest tightness approximately 30 minutes after receiving vaccination. He went to work for the remainder of the day.  The following day symptoms continued at work and he went to local emergency room, where EKG, CXR, and labs were performed.  EKG showed NSR.  CBC, d-dimer, troponin, and BMP were WNL. CXR read as normal.  No meds prescribed and he was discharged home. On follow up one day later, he felt a little better but still slightly short of breath and has pain in chest with deep breathing, and felt better laying prone or standing up.  Worse when sitting. He was prescribed motrin 800mg to be taken 3 times daily, and was placed on light duty.
Age: 26.0
Sex: M
Vaccine: UNK
Symptoms: Full blood count normal, Loss of personal independence in daily activities, Metabolic function test normal, Troponin normal
Clinical narrative: Patient experienced a feeling of 'shortness of breath' and mild chest tightness approximately 30 minutes after receiving vaccination. He went to work for the remainder of the day.  The following day symptoms continued at work and he went to local emergency room, where EKG, CXR, and labs were performed.  EKG showed NSR.  CBC, d-dimer, troponin, and BMP were WNL. CXR read as normal.  No meds prescribed and he was discharged home. On follow up one day later, he felt a little better but still slightly short of breath and has pain in chest with deep breathing, and felt better laying prone or standing up.  Worse when sitting. He was prescribed motrin 800mg to be taken 3 times daily, and was placed on light duty.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pyrexia
Clinical narrative: Localized erythema and pain at injection site - Mild to Moderate, lasting mainly 3 days, up to 5 days. General fever, Max <102.0 °F (38.9 °C), - Mild to Moderate, lasting mainly 2 days.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: Patient had fever night of 10/14, woke up 10/15 with hives on her neck
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dysphagia, Dyspnoea, Laboratory test
Clinical narrative: Chest tightness, cough, difficulty swallowing, then difficulty breathing.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Pruritus
Clinical narrative: The caregiver came back to Employee Health about a half hour after receiving her Flu shot. Her face looked flushed. But other than that she looked fine. Insertion site looked normal, no skin issues like rash or hives. She was complaining of itching all over. "Even my toes itch" Caregiver took 50 mg of Benadryl and watched  for signs of respiratory distress. No report of other symptoms.
Age: 83.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion, Product administered at inappropriate site, Skin discolouration
Clinical narrative: Patient called to state that her arm is covered in bruises from the flu shot. She described it as being very colorful and bruised to where she would not be comfortable to show in public. She was getting 6 month blood work and the technician there stated her arm was very bad looking and she should report to pharmacy. The technician told the patient the pharmacist put the shot into the wrong spot. This is the first time the patient has ever had this bad of a reaction from a flu shot. She stated it was discovered after the shot was given but today it was at its worst.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Pain, Swelling, Vaccination complication
Clinical narrative: Local reaction to vaccine,  very red, swollen, painful. started abx 10/10/19, sx started to improve/ resolve 10/12/19,
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: The upper right arm, from elbow to mid-arm, became bright red with fever, pain and itching.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Woke up at 4:10 am with chills and intense body aches and fever of 101.0.  Same at 7:00 am with fever of 101.5.  Worse at 8:00 a.m. with 102.1.  Went as high as 102.5.  Fever lasted for about 30 to 32 hours.  Went down gradually.  Aches last into the next day.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Skin warm, Swelling
Clinical narrative: Area became inflamed, swollen, red, warm to the touch
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Full blood count, Metabolic function test, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: (L) arm pain, weakness, swelling in axilla + groin
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: (L) arm pain, weakness, swelling in axilla + groin
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Injection site pain, Joint noise, Joint range of motion decreased
Clinical narrative: (R) arm deltoid pain/weakness/decreased ROM. No injection abnormalities supportive care (Ibuprofen or naproxen) ice. No change-no worsening or improvement. Also with B/L hip clicking x1 week.
Age: 2.33
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of Right thigh -> advised children's Ibuprofen 6 ml po q 6-8hrs. + warm compress 3x/day + Cephalexin (125mg) 4ml every 8 hours x 10 day.
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Abscess drainage, Abscess soft tissue, Nodule, Ultrasound scan
Clinical narrative: Received vaccine 9/4/19 knot noted 10/17/19. Not erythematous or tender. Ultrasound order. Reason for report is that patient developed soft tissue was in January 1 month after Pediarix vaccine and  it developed into abscess that had to be drained 2 month after the vaccine.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: given sub-q wrong route Called client @ 1455 spoke to her told her that dose valid but given wrong route. She had no questions.
Age: 82.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Erythema multiforme, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: ErythemaMultiform & Injection site on right arm has been red, hot, and painful for 3 days post injection
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extreme swelling at injection site; Redness; Pain / Leg pain; This case was reported by a consumer via patient support programs and described the occurrence of injection site swelling in a 3-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   Previously administered products included Flulaval Quadrivalent with an associated reaction of injection site swelling (received last year and had more swelling, refer case US2019AMR184239).   On 5th October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient's grandmother reported for the patient. The patient received dose of FluLaval Tetra 2019-2020 season in unknown thigh. The reporter stated that, after vaccination with dose of Flulaval quadrivalent, the patient experienced extreme swelling at injection site, redness, and pain. This case has been linked with case US2019AMR184239, reported by same reporter.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Extremely swollen; Red; Painful thigh; Fever; This case was reported by a consumer and described the occurrence of swelling of legs in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced swelling of legs, redness of legs, pain in thigh and fever. The patient was treated with paracetamol (Tylenol), benadryl (nos) (Benadryl) and antifungals nos (Antifungal). On an unknown date, the outcome of the swelling of legs, redness of legs, pain in thigh and fever were unknown.   It was unknown if the reporter considered the swelling of legs, redness of legs, pain in thigh and fever to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were proided as follows: after vaccination with dose of influenza vaccine, the patient experienced extremely swollen, red and painful thigh and a fever. The patient did not consent to follow up.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Extremely swollen; Red; Painful thigh; Fever; This case was reported by a consumer and described the occurrence of swelling of legs in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced swelling of legs, redness of legs, pain in thigh and fever. The patient was treated with paracetamol (Tylenol), benadryl (nos) (Benadryl) and antifungals nos (Antifungal). On an unknown date, the outcome of the swelling of legs, redness of legs, pain in thigh and fever were unknown.   It was unknown if the reporter considered the swelling of legs, redness of legs, pain in thigh and fever to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were proided as follows: after vaccination with dose of influenza vaccine, the patient experienced extremely swollen, red and painful thigh and a fever. The patient did not consent to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Local reaction
Clinical narrative: Several local reactions; This case was reported by a nurse via call center representative and described the occurrence of local reaction in a adult female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was recovered/resolved.   It was unknown if the reporter considered the local reaction to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was registered nurse and reported on behalf of patient. The patient was approximately in her 40s. The patient had several local reactions with prior unspecified flu vaccine. The reporter was consented to follow up. This was 1 of the 2 cases reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Redness at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness at the injection site but the health care professional (HCP) did not have further details. The reporter consented to follow up. This was 1 of the 5 cases, reported by same reporter.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: the dose was administered unknowingly following a cold temperature excursion/No AE; Based on information received on 11-OCT-2019, the report previously considered as non-valid became valid: patient identifier reported.  Based on additional information received on 11-OCT-2019, this case became medically confirmed.  Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff)/non-hcp.  This case involves a 2 months old male patient who received 0.5 mL dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ101AAA via intramuscular route in the anterolateral thigh On 26-Jul-2019, following a cold temperature excursion.  It was as actual medication error due to incorrect product storage.  The dose was administered unknowingly following a cold temperature excursion and patient was revaccinated as recommended by manufacturer.   No adverse reaction reported by the patients family.  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.  Follow-up information was received on 11-OCT-2019 regarding an unsolicited valid non-serious case received from a physician (naturopathic doctor).  The report previously considered as non-valid became valid and case became medically confirmed.  Patient details, lot number, vaccination details and event verbatim updated in field and narrative.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Fluzone Quadrivalent 0.25 was administered to a 10 year old girl instead of the Fluzone Quadrivalent 0.5 ml/No AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA281572 same reporter.  This case involves a 10 years old female patient who received 0.25 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot U6653BD, Expiration Date: 30-Jun-2020 via unknown route in the right deltoid on 04-Oct-2019, instead of 0.5 mL dose.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient didn't receive other vaccines on that day.   It was a case of actual medication error due to vaccine underdose.  No side effects noted.  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: DTAP
Symptoms: Expired product administered
Clinical narrative: accidentally administered expired Daptacel to an 18 month old/no AE; Initial information received on 09-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old male patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation; INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 08-Oct-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5281AA (expiry date: 05-OCT-2019) via intramuscular route in right leg.  It was of action medication error due to expired vaccine used.  It was unknown whether adverse event was experienced 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.
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Joint stiffness, Mobility decreased, Pain, Tendon rupture
Clinical narrative: hands and wrists "seized up"; ripped tendons; unable to "move her arms up; hands and wrists "seized up" and she was in excruciating pain; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 57 years old female patient whose hands and wrists "seized up" (joint stiffness), unable to "move her arms up (injected limb mobility decreased), has excruciating pain (Pain in extremity) and ripped tendons (Tendon rupture), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  On 19-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE injection lot UJ209AB (Expiry date 31-Dec-2019) via intramuscular route in the left deltoid.  On 20-Sep-2019, the patient's hands and wrists "seized up" (joint stiffness) and she was in excruciating pain. The patient was unable to "move her arms up" in the morning (injected limb mobility decreased) and at night which causes excruciating pain (Pain in extremity), one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient went to the ER on 20Sep2019 because of this. Patient feels like having ripped tendons (Tendon rupture). The same pains continued and then the patient went back to the ER on 08Oct2019   (Other relevant tests included no lab data.)  Final diagnosis was hands and wrists "seized up" (joint stiffness), unable to "move her arms up (injected limb mobility decreased), has excruciating pain (Pain in extremity) and ripped tendons (Tendon rupture).  The patient was treated with NAPROXEN (NAPROXEN) and METHYLPREDNISOLONE (METHYLPREDNISOLONE).  The event outcome is reported as Unknown for all the events.
Sex: F
Vaccine: FLU3, FLU3, FLU4
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: 31 year old pregnant patient mistakenlyreceived Fluzone High-Dose; 31 year old pregnant patient to receive Fluzone High-Dose; 31 year old pregnant patient to receive Fluzone High-Dose; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 31 years old female patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] in context of 31 year old pregnant patient to receive Fluzone High-Dose (exposure during pregnancy), (product administered to patient of inappropriate age) and (overdose). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. Gestation period was unknown.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's previous pregnancy was unknown.  On 10-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  It was a case of vaccine exposure during pregnancy.  It was unknown if the patient had any adverse event.  The patient outcome is reported as Not Applicable for drug exposure during pregnancy.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3, FLU3, FLU4
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 31 year old pregnant patient mistakenlyreceived Fluzone High-Dose; 31 year old pregnant patient to receive Fluzone High-Dose; 31 year old pregnant patient to receive Fluzone High-Dose; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 31 years old female patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] in context of 31 year old pregnant patient to receive Fluzone High-Dose (exposure during pregnancy), (product administered to patient of inappropriate age) and (overdose). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. Gestation period was unknown.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's previous pregnancy was unknown.  On 10-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  It was a case of vaccine exposure during pregnancy.  It was unknown if the patient had any adverse event.  The patient outcome is reported as Not Applicable for drug exposure during pregnancy.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Feeling abnormal, Pyrexia
Clinical narrative: fever of 102 degrees F; felt like he was dying; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 75 years old male patient who experienced fever of 102 degrees F and felt like he was dying, while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Oct-2019 at 12:30, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ282AA, expiry date:  via unknown route in the left deltoid.  On 09-Oct-2019, the patient developed a non-serious felt like he was dying (chest pain) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient developed a non-serious fever of 102 degrees f (pyrexia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the patient had chest pain, felt like he was dying, and went to the ER (Emergency Room) around 20:30. He has been running a fever of 102 degrees F ever since and is still at the ER.   Other relevant tests were not reported.  Final diagnosis was felt like he was dying and fever of 102 degrees F.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for both the events.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of IPOL, no AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 years old male patient who was inadvertently vaccinated with an expired 0.5 mL second dose of IPV (VERO) [IPOL] (frequency once) lot N1J451M, expiry date: 05-Oct-2019 unknown route in the Right Thigh on 10-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and HIB VACCINE CONJ (OMPC) (PEDVAXHIB).  It is an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain
Clinical narrative: painful flu shot; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a female patient (age unknown) who experienced painful flu shot (pain), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA 1937, QFAA 1917, QFAA 1924, QFAA 1933 via unknown route in unknown administration site.   On an unknown date, the patient developed a non-serious painful flu shot (pain) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was painful flu shot.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for painful flu shot.