chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Injection site discomfort, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site discomfort in a male patient who received FLUARIX QUADRIVALENT (batch number 2RG54, expiry date 30th June 2017). In October 2016, the patient received FLUARIX QUADRIVALENT. In November 2016, 21 days after receiving FLUARIX QUADRIVALENT, the patient experienced general body pain and sweating. On an unknown date, the patient experienced injection site discomfort, muscle pain and fever. On an unknown date, the outcome of the injection site discomfort and muscle pain were recovered/resolved and the outcome of the fever, general body pain and sweating were not recovered/not resolved. It was unknown if the reporter considered the injection site discomfort, muscle pain, fever, general body pain and sweating to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The GlaxoSmithKline had not been previously contacted about any adverse event for this patient. The permission to contact reporter was granted. The age at vaccination was not reported. The patient experienced initially discomfort at the injection site, muscle ache, and a low grade fever, after receiving FLUARIX QUADRIVALENT 3 weeks ago, which went away. At the time of reporting (now), approximately 3 weeks after vaccination, the patient was experiencing fever (102 degree F), body aches, and sweats.
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Rash generalised
Clinical narrative: This case was reported by other health professional via sales rep and described the occurrence of generalized rash in a female patient who received FLUARIX QUADRIVALENT. Previously administered products included Flu vaccine with an associated reaction of adverse reaction (for tolerance to the previous dose of Flu vaccine refer case US2016GSK169577). On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. The reporter considered the generalized rash to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient's age at vaccination was not provided. The patient had injection site rash which spread to chest and body. This was 6th case of 6 cases reported by the same reporter. This case was linked with US2016GSK169577 for the same patient.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus, Rash erythematous, Skin warm
Clinical narrative: Woke to itchy on arm middle of night. Next day, hot, red itchy rash enlarging and migrating to cover area up to about 4 inch radius from injection site on left upper arm by 11/10/16 PM when they came to report back to me. Patient estimates rash came on 12-15 hours after shot. Patient had been self treating with benadryl, advised to continue and add hydrocortisone cream which they agreed to do.
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Chest discomfort, Dysphagia, Dyspnoea, Peripheral swelling, Pruritus
Clinical narrative: Hands itchy. Progressed later that night to whole body itching and hives present. Then hands became swollen.  On second day began having difficulty swallowing and shortness of breath with chest tightness.
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Hands itchy. Progressed later that night to whole body itching and hives present. Then hands became swollen.  On second day began having difficulty swallowing and shortness of breath with chest tightness.
Age: 1.75
Sex: M
Vaccine: FLU4
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Throat irritation
Clinical narrative: Headache, dizziness and irritated throat.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 30-year-old female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site induration and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site induration and injection site swelling were unknown. The reporter considered the injection site pain, injection site induration and injection site swelling to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient developed pain localized to deltoid where the vaccine was injected and induration (small bump at injection site). The reporter did not have any vaccine information including batch number.
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a 37-year-old female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not provided. The details of the reaction was not reported. For tolerability after FLUARIX QUADRIVALENT, please see case US2016GSK166608.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: I have visited and shown him my PCP on 9-30-16, 1:30 pm and same as above. Dermatologist on 10-12-16 at 9:30 am.
Age: 65.0
Sex: U
Vaccine: FLU3, FLU4
Symptoms: Product label confusion
Clinical narrative: Reporting look-alike concern. High-Dose FLUZONE and "regular" dose look very similar. The syringe with grey writing is more potent/high dose. The less potent syringe features blue writing. Due to the mix-up potential we have had to put several mitigation strategies in place to prevent the wrong dose of vaccine from being administered.
Age: 13.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: I gave the adult dose (1ml) of Hepatitis B to a child age 13 instead of the children's dose (0.5ml) by accident.
Age: 28.0
Sex: M
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Pt. states he had severe arm pain.  Arm that received in injection.  He was not sure if it was because of work, heavy lifting or vaccine given on 11/9/16.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Antinuclear antibody negative, Back pain, Blood immunoglobulin A normal, CSF glucose increased, CSF protein increased
Clinical narrative: Patient reports tingling sensation/numbness in the hands and feet which she states started after receiving the pneumonia vaccine. She also reports Upper Respiratory Illness symptoms after that. Since the onset, the patient has noted increased numbness in the right leg and some tongue numbness. The patient has some left facial droop (more so since her Bell's palsy incident). Complaining of mid back pain.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Facial paralysis, Full blood count normal, Hypoaesthesia, Hypoaesthesia oral, Metabolic function test normal
Clinical narrative: Patient reports tingling sensation/numbness in the hands and feet which she states started after receiving the pneumonia vaccine. She also reports Upper Respiratory Illness symptoms after that. Since the onset, the patient has noted increased numbness in the right leg and some tongue numbness. The patient has some left facial droop (more so since her Bell's palsy incident). Complaining of mid back pain.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal normal, Nuclear magnetic resonance imaging thoracic abnormal, Paraesthesia, Respiratory symptom
Clinical narrative: Patient reports tingling sensation/numbness in the hands and feet which she states started after receiving the pneumonia vaccine. She also reports Upper Respiratory Illness symptoms after that. Since the onset, the patient has noted increased numbness in the right leg and some tongue numbness. The patient has some left facial droop (more so since her Bell's palsy incident). Complaining of mid back pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Congenital thrombocyte disorder, Full blood count abnormal, Injection site erythema, Injection site pain
Clinical narrative: Swelling, erythema, itch, burning sensation at site of vaccine. Elevated BP.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, erythema, itch, burning sensation at site of vaccine. Elevated BP.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Constipation, Haematochezia, Intussusception
Clinical narrative: Seen 11/12/2016 for complaints of constipation. He was also having some vomiting but was keeping fluids down. Abdomen was distended. He had air/fluid levels on abdominal x-ray. He was sent home with instructions to use glycerin suppositories. He stooled after one suppository was used. The stool passed was bloody/mucousy. He returned for evaluation and was then diagnosed with intussusception. He required surgical correction for this.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, RV5
Symptoms: Mucous stools, Surgery, Vomiting, X-ray abnormal
Clinical narrative: Seen 11/12/2016 for complaints of constipation. He was also having some vomiting but was keeping fluids down. Abdomen was distended. He had air/fluid levels on abdominal x-ray. He was sent home with instructions to use glycerin suppositories. He stooled after one suppository was used. The stool passed was bloody/mucousy. He returned for evaluation and was then diagnosed with intussusception. He required surgical correction for this.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pain, Pruritus, Skin warm
Clinical narrative: Pt recieved ZOSTAVAX without issues or problems.  Awoke next day with pain, redness, and itching. Continued to worsen through the day.  Presented at pharmacy today (11/18/2016) with an area of about 1 inch diameter inflamed, hot to touch, painful, and itchy.  Surrounding area of 4 to 5 inches diameter red, tender, itchy but less involved with definite border.  pt to use cold compresses, anti-inflamatory, and diphenhydramine.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site reaction
Clinical narrative: Induration and retraction at injection site L upper arm.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Abdominal discomfort, Chills, Cystitis, Erythema, Feeling hot
Clinical narrative: Left arm was a little sore and felt hot.  The next morning her arm was swollen, had chills, upset stomach, redness.  patient did NOT have a rash, fever, or trouble breathing.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Urine analysis abnormal
Clinical narrative: Left arm was a little sore and felt hot.  The next morning her arm was swollen, had chills, upset stomach, redness.  patient did NOT have a rash, fever, or trouble breathing.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Inflammation, Muscular weakness
Clinical narrative: About 6 days my other RPH said patient needs to talk to me. 2 days later I saw the patient's arm and it had a slight inflammation in a 4 in circle. Later (1 week) he talked about muscle weakness.
Age: 55.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Injection site infection
Clinical narrative: On Nov 9th, 2016 the patient developed an infection at the injection site. According to patient, he was prescribed antibiotics to help fight the infection and was told to go to the ER if the infection got worse.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Pain in extremity, Swelling
Clinical narrative: Felt a pop after giving a flu shot. Pain in arm. Swelling. Rx for ibuprofen given by nurse practitioner.
Age: 29.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: After receiving BOOSTRIX and FLUZONE, complained of feeling dizzy, faint (lightheaded), short of breath, "chest tightness" within 5 minutes of vaccine. Oxygen administered, BP checked continuously, EMS called, patient to hospital alert/oriented x 3.
Age: 56.0
Sex: U
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient feels radiating pain from deltoid muscle to hands. Which has limit mobility of her arm. It had lasted for almost 3 weeks from date of injection.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: Patient had difficulty lifting her arm next morning after administration of vaccination. She saw MD on 11/17/16. Got Rx for Meloxicam and referred to Physical therapy. Has to do MRI in 1 month if no progress.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: A 5 year old male was given FLUZONE instead FLUARIA.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain and stiffness in the upper arms muscles, pain and stiffnes in the muscles around the hip.  Kept getting worse until unable to sleep at night. We were at a spiritual retreat.  Finally saw a doctor there on 11/1/2016 and he gave paracetemol which gives temporary relief.  But as soon as I stop taking, the pain returns.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site mass, Injection site pain
Clinical narrative: Lump in arm at vaccine site. Pain at injecting site and pain radiating into underarm area.
Age: 2.0
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: I administered a 3 and older 0.5ml dose of Flu vaccine to a patient 24 months old.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Cough, Dyskinesia, Dyspnoea, Feeling abnormal
Clinical narrative: By 7 pm horrible pain at injection site. Could hardly move it. Hard and swollen, red from elbow to shoulder. It was so swollen that couldn't rest hand down; the arm was about 3 inches thicker than other arm due to swelling. Had fever, chills, legs jumping, felt horrible. Sister had similar problems so gave her BENADRYL and double her current antibiotics dosage. Pt's sister and brother in law got same shot 50 miles away. Sister got same horrible reaction and had to take BENADRYL and antibiotics. Her doctor said it could be the same batch. It took about 10 days for symptoms to go away. Had cough and problems breathing. 10/4 went to scheduled cardiologist visit and arm was still red and swollen. Swelling went down very slowly. Received HD vaccine 2 years prior with no problem.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: By 7 pm horrible pain at injection site. Could hardly move it. Hard and swollen, red from elbow to shoulder. It was so swollen that couldn't rest hand down; the arm was about 3 inches thicker than other arm due to swelling. Had fever, chills, legs jumping, felt horrible. Sister had similar problems so gave her BENADRYL and double her current antibiotics dosage. Pt's sister and brother in law got same shot 50 miles away. Sister got same horrible reaction and had to take BENADRYL and antibiotics. Her doctor said it could be the same batch. It took about 10 days for symptoms to go away. Had cough and problems breathing. 10/4 went to scheduled cardiologist visit and arm was still red and swollen. Swelling went down very slowly. Received HD vaccine 2 years prior with no problem.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: By 7 pm horrible pain at injection site. Could hardly move it. Hard and swollen, red from elbow to shoulder. It was so swollen that couldn't rest hand down; the arm was about 3 inches thicker than other arm due to swelling. Had fever, chills, legs jumping, felt horrible. Sister had similar problems so gave her BENADRYL and double her current antibiotics dosage. Pt's sister and brother in law got same shot 50 miles away. Sister got same horrible reaction and had to take BENADRYL and antibiotics. Her doctor said it could be the same batch. It took about 10 days for symptoms to go away. Had cough and problems breathing. 10/4 went to scheduled cardiologist visit and arm was still red and swollen. Swelling went down very slowly. Received HD vaccine 2 years prior with no problem.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: A 37 year old man was given FLUZONE HIGH-DOSE instead of FLUZONE QUADARIVALENT.
Age: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUZONE PED QUADRILVALENT syringe injection was administered to three patients all over 36 months_ one 3 1/2 yrs old and her adults parents. The vaccine was incorrectly identified as for older than 36 months. My prefilled syringe is labeled in light punk overlying a lighter pink glass of the syringe; in addition the Lot and Date info is in faded grey on a white back ground; the only easily read black on white info is the bar code and NDC #. Even though the font size is exceedingly small, if it stood out better than pink on pink, perhaps this mistake and error on my part would occur less often. What disturbs me the most is that I looked at the syringe to confirm what I thought was the older >36 month syringe 2 or 3 times. The patients were informed and were very understanding. Thank you.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Cough, Dysphonia, Dyspnoea
Clinical narrative: Hoarseness, cough, red eyes, fever, aches, headache,backache, fatigue, waekness, difficulty brathing, fast heartbeat. Paracetamol, eye drops, antihistamine.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Heart rate increased, Ocular hyperaemia, Pain
Clinical narrative: Hoarseness, cough, red eyes, fever, aches, headache,backache, fatigue, waekness, difficulty brathing, fast heartbeat. Paracetamol, eye drops, antihistamine.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Hoarseness, cough, red eyes, fever, aches, headache,backache, fatigue, waekness, difficulty brathing, fast heartbeat. Paracetamol, eye drops, antihistamine.
Age: 28.0
Sex: F
Vaccine: FLUN4
Symptoms: Dyspnoea, Palpitations, Urticaria
Clinical narrative: Hives, heart palpitations, and shortness of breath.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site infection
Clinical narrative: Patient came in on 11/18 in the AM and showed me her arm and showed me the site of injection.  It looked infected and I suggested she go to her MD.  The MD prescribed her an antibiotic for cellulitis.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Skin reaction
Clinical narrative: Red rash around the neckline area and around the face. The neckline area was warm to the touch. Slight irritation felt in the neckline area.  Patient's face and neckline remain red color as of 11/18/2016 @ 1350 (1:50 pm).  Patient contacted Dr and telephone on 11/18/2016 to report adverse event. When the patient called again later on that same 11/18/2016, patient was informed by the Patient Services Representative of Clinic that Medical Assistant to Dr. received patient's email, and would be informing Dr.who according to the Patient Services Representative would be following up with patient.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia, Vertigo positional
Clinical narrative: Chills, no fever. On 11/15/2016 at 7 AM i experienced severe positional vertigo and constant nausea.  It was severe for 12 hours, and slowly subsided.  I am now 72 hours out and almost back to normal.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient is complaining of severe pain in the shoulder and in the arm where the shot was given. She has been experiencing this pain for 3 weeks.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Large area of swelling and erythema entire upper extremity.
Age: 62.0
Sex: F
Vaccine: FLU3, PNC, VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain of injection site. Patient states she has been having pain for since the date of the shot. She said her pain medication has not dampened the pain. We are keeping up with the patient to see if she is getting better.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Pain and swelling of the supraclavicular lymph nodes in the left collar bone.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Hypersomnia, Injection site swelling, Vomiting
Clinical narrative: Full leg swelling, vomiting, excessive crying, excessive sleeping.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis.
Age: 11.0
Sex: M
Vaccine: DTAP, FLUX, MEN
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Redness of entire arm above the elbow. Hot to the touch. Pain.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Abasia, Asthenia, Diarrhoea, Fall, Guillain-Barre syndrome
Clinical narrative: Sought care in Emergency Dept. on 11/14/16 and transferred to ICU on 11/17/16 with diagnosis of Guillain-Barre. Had fallen several times at home prior to ED with history of generalized weakness, nausea, diarrhea, and inability to walk. LP on 11/16/16, plasmapheresis started 11/17/16.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Intensive care, Nausea, Plasmapheresis
Clinical narrative: Sought care in Emergency Dept. on 11/14/16 and transferred to ICU on 11/17/16 with diagnosis of Guillain-Barre. Had fallen several times at home prior to ED with history of generalized weakness, nausea, diarrhea, and inability to walk. LP on 11/16/16, plasmapheresis started 11/17/16.
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The patient's age at vaccination was not reported. The details of the reaction was not reported. For tolerability after FLUARIX QUADRIVALENT, please see case US2016GSK166611.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not provided. The details of the reaction was not reported. For tolerability after FLUARIX QUADRIVALENT, please see case US2016GSK166609.
Age: 1.3
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: The 0.5mg dose was given instead of the 0.25mg.
Age: 1.2
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 14 month old infant given FLUZONE QUAD for 3-18YO - Given 0.5ml instead of the infant flu preservative free 0.25ml.
Age: 36.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Pt had received the vaccination of PCV13 when it was suppose to be the Flu vaccination.
Age: 4.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient received MMRV and MMR II today.
Age: 0.7
Sex: U
Vaccine: DTAPIPV, HIBV, MMR
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: I had 6 vaccines to give a child before lunch break. The nurse on duty and me went to the vaccine room because she said she was helping me. After we looked over the official assessment report, I started to pick out the vaccines, naming them as I put them down on the counter, while the nurse watched me. I realized that we didn't have Dtap/Hib/IPV on my floor, so I grabbed Dtap/IPV and the Hib by itself. I felt confident in my choice because I thought the nurse was aware of what I grabbed because I told her we didn't have the combo in the order. I confirmed what I had with her and then we went to administer the vaccines together. Once done, I needed the doctor to change the order to match what I gave, still unaware of what had happened. Finally, the doctor then pointed out the error that I gave the wrong vaccine, and that the patient wasn't old enough to receive the vaccine.
Age: 34.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient presented for varicella vaccine, I administered MMR. After realizing the error, I administered VARIVAX, patient immediately notified of error.
Age: 1.5
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Gave adult dose to 6-35month.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The patient's age at vaccination was not provided. The details of the reaction was not reported. For tolerability after FLUARIX QUADRIVALENT, please see case US2016GSK166610.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: Patient reported left cheek swelling/itching redness about 1.5-2hr after administration of vaccine. No injection site reaction. Given 50mg PO BENADRYL and elevated in clinic, improvement of symptoms. ZYTREC 10mg PO TID for next 3 days.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, and warm to the touch (slightly raised) area of injection site to elbow.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: L upper arm with irregular shaped firm, red, warm area extending about 2 cm proximal to injection site, 3-4 cm laterally and up to 6 cm distal.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Persistent, uncontrollable itching all over. Not relieved by BENADRYL. Stated 20 min after and has been continued for 1 wk.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PREVNAR 13. Patient reports large area of right shoulder that is red, raised and hot to the touch. The area is approx 3 inches wide. She will follow up with PCP Monday 11/7/16.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Haemorrhage, Head injury, Hypoaesthesia
Clinical narrative: 935 AM walked in on porch next thing I'm on the floor hit my head on the cement floor my left knee was bleeding my hands were numb from hitting the floor. It took ten minutes or so before I could crawl to step to sit up and a few more minutes before I got in the house to get help. Went to hospital arrived at 1245.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUC4, MMRV
Symptoms: Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: KINRIX, PROQUAD, Flu vaccine and TYLENOL (generic) given at 1155 am on 11/14/16. At 12:10 pm the family came back in with patient who was itching and covered in hives head to toe. Swelling in face and bottom lip. No respiratory distress. BENADRYL (generic) given at 12:20. Pt monitored for 1 hour. Vitals taken every 15 min and were stable. Swelling and hive decreased at D/C. Instructed to monitor for increased SX. BENADRYL rec. q 6 hours and follow up call in am. 11/15/16 8:38 (follow up call) 100% recovery.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a patient who received FLUARIX QUADRIVALENT. Previously administered products included Flu vaccine with an associated reaction of adverse reaction (for tolerance refer case US2016GSK169626). On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site erythema were unknown. The reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional details were provided follows: The patient's age at vaccination was not provided. The reporter had limited vaccination details. This was 5th case of 6 cases reported by the same reporter. This case linked with US2016GSK169626, for the same patient.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swelling on left deltoid and left inner arm.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Had vaccine, 1030 AM 11/16/16. Developed itchy on scalp and hives on neck and forehead. Was taken to ED.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Muscle pain at injection site.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Muscle pain at injection site.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Muscle pain at injection site.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Muscle pain at injection site.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Muscle pain at injection site.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Left arm cellulitis and fever within 24 hours of flu shot.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Left arm cellulitis and fever 24 hours following flu shot.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Left arm red and warm. Low fever following flu vaccine x24 hours.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Redness/swelling in left shoulder, minimal pain, slightly pruritic, warmth.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: Rash, red, swollen, warm to touch 24-48 hours after vaccine given.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever, left shoulder-redness, swollen.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Left leg-rash, warm to touch.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort
Clinical narrative: Experienced discomfort in (L) upper arm several hours after receiving flu vaccine in (L) deltoid on 11/1/16. Now on 11/17/16 states has had continued discomfort in (L) upper arm ever since 11/1/16. Pt ref to PCP.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting starting at approximately.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain, Rash, Swelling
Clinical narrative: Rash, swelling, pain, pt was given Triamcinolone crm, Hydroxyzine and SEPTRA DS.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Hypoaesthesia, Pain
Clinical narrative: Pain, numbness and weakness, treatment unknown.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles rash on 11/11/16, 6 days after vaccine given. She went to Dr. and prescribed valacyclovir 500mg - 2 tabs by mouth 3 times a day for 1 week. Patient self treated with hydrogen peroxide and triple antibiotic before MD visit. Rash not resolved as of 11/18/16.
Sex: F
Vaccine: PPV, PPV
Symptoms: Fatigue, Inflammation, Injection site erythema, Musculoskeletal stiffness, Nausea
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 09-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not reported), lot # M018766 and expiry date October 2017. On the same day, the patient experienced swelling, heat, pain, and redness on her left arm after receiving PNEUMOVAX 23. The reaction covered her left arm entirely and not just the injection site area. It was not specified how long it took for the patient to develop those side effects after the vaccine was administered. The patient sought medical attention and treatment was given for the events. The outcome of the events was reported as recovering. The causality was not reported. There was no product quality complaint involved. Additional information is not expected as the physician cannot be contacted.
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 09-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not reported), lot # M018766 and expiry date October 2017. On the same day, the patient experienced swelling, heat, pain, and redness on her left arm after receiving PNEUMOVAX 23. The reaction covered her left arm entirely and not just the injection site area. It was not specified how long it took for the patient to develop those side effects after the vaccine was administered. The patient sought medical attention and treatment was given for the events. The outcome of the events was reported as recovering. The causality was not reported. There was no product quality complaint involved. Additional information is not expected as the physician cannot be contacted.
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 09-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not reported), lot # M018766 and expiry date October 2017. On the same day, the patient experienced swelling, heat, pain, and redness on her left arm after receiving PNEUMOVAX 23. The reaction covered her left arm entirely and not just the injection site area. It was not specified how long it took for the patient to develop those side effects after the vaccine was administered. The patient sought medical attention and treatment was given for the events. The outcome of the events was reported as recovering. The causality was not reported. There was no product quality complaint involved. Additional information is not expected as the physician cannot be contacted.
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 09-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not reported), lot # M018766 and expiry date October 2017. On the same day, the patient experienced swelling, heat, pain, and redness on her left arm after receiving PNEUMOVAX 23. The reaction covered her left arm entirely and not just the injection site area. It was not specified how long it took for the patient to develop those side effects after the vaccine was administered. The patient sought medical attention and treatment was given for the events. The outcome of the events was reported as recovering. The causality was not reported. There was no product quality complaint involved. Additional information is not expected as the physician cannot be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients. Their pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II lot# M007277, expiration date 09-FEB-2018 (dose and route of administration were not reported). Vaccines were stored at the temperature of 8.5 Celsius degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with ROTATEQ (Lot #M004544, expiry date: 18-OCT-2017; lot #M005733, expiry date: 01-OCT-2017) (route: oral) following a temperature excursion to 51F for 24 hours. No adverse effects were reported in any patients. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown ages and genders. The patient's pertinent medical history, concomitant therapies and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of GARDASIL lot # K008621, expiration date 04-MAR-2017, (dosages and therapy routes were not provided), (unknown dosage, lot no. M013638 exp 19-NOV-2018; M017521 exp 12-OCT-2018). Concomitant therapies were not informed. No adverse effects were reported. Temperature: Minimum of 0.09 degrees C from 01-JUL-2016 through 02-OCT-2016. Time frame: multiple excursions from 01-JUL-2016 through 02-OCT-2016 (total time frame not determined at time of call). There was no a previous temperature excursion and it was not because of a data logger issue. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient (of unknown age and gender) was vaccinated with an improperly stored dose of PROQUAD with lot number M022401 (unspecified expiration date). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Injection site urticaria, Pruritus, Rash, Urticaria
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions and allergies and concomitant medications were not reported. On an unknown date, also reported as when the patient was 12 years old, the patient received two doses of GARDASIL intramuscularly (lot# and expiration date were not reported) or GARDASIL 9 intramuscularly (lot# and expiration date were not reported). On an unknown date, after receiving the first dose of GARDASIL or GARDASIL 9, the patient developed a "rash, a little itchiness, and a little welt". On an unknown date, after the second dose of GARDASIL or GARDASIL 9, the patient developed a "rash on their face, arms, and chest, and a bigger welt at the injection site". The patient did not seek medical attention. The patient was not given any treatment for the adverse events. The outcome of the adverse events was unknown. The relatedness between the adverse events and GARDASIL or GARDASIL 9 was not reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 5 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016 the patient was vaccinated with improperly stored PROQUAD lot # M032497 22-JAN-2018. No adverse effects were reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of generalized urticarial in a 19-year-old male patient who received BEXSERO (batch number 156801A, expiry date August 2017). On 10th November 2016, the patient received the 1st dose of BEXSERO 0.5 ml. On 11th November 2016, 1 days after receiving BEXSERO, the patient experienced generalized urticarial. The patient was treated with BENADRYL. On an unknown date, the outcome of the generalized urticaria was unknown. The reporter considered the generalized urticarial to be almost certainly related to BEXSERO. Additional details were provided as follows: Concurrent medical conditions was reported as no known allergies. The patient called the pediatrician because he had hives all over his body. He went to an Urgent Care and was given oral BENADRYL.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of VAQTA, (lot# M015290 and expiry date 20-SEP-2017) (lot# M030598 and expiry date 13-OCT-2017) (lot# M036459 and expiry date 18-JAN-2018) (lot# M032492 and expiry date 02-MAR-2018) (lot# M033611 and expiry date 02-MAR-2018) (lot# M031696 and expiry date 26-MAY-2018) and (lot# M034896 and expiry date 26-MAY-2017) subcutaneously (also reported as depends on the vaccine). The vaccine was exposed to temperature excursion of 1.4C for 21 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 08-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M025870 and expiration date 18-MAY-2018. (Dose and route of administration were not reported). It was stated that the temperature excursion was 6C (Celsius degrees), the time frame was 1 hour and there were not previous temperature excursions. It was stated that the alert of the temperature excursion was not because of a data logger. There was not a product quality complaint (PQC) involved. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 08-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M025870 and expiration date 18-MAY-2018. (Dose and route of administration were not reported). It was stated that the temperature excursion was 6 degrees C (Celsius degrees), the time frame was 1 hour and there were not previous temperature excursions. It was stated that the alert of the temperature excursion was not because of a data logger. There was not a product quality complaint (PQC) involved. This is one of two reports from the same reporter. Additional information has been requested.