chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation, Tremor, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of malaise (1st dose received in April 2018, refer case US2018178351). On 28th September 2018, the patient received the 2nd dose of SHINGRIX. On 29th September 2018, 1 days after receiving SHINGRIX, the patient experienced sickness, chills, headache, fever, tremor and hypersomnia. On 1st October 2018, the patient experienced skin peeling. Rechallenge with SHINGRIX was positive. On 30th September 2018, the outcome of the fever was recovered/resolved. On 1st October 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the sickness and hypersomnia were unknown and the outcome of the skin peeling was not recovered/not resolved and the outcome of the chills and tremor were recovering/resolving. It was unknown if the reporter considered the sickness, skin peeling, chills, headache, fever, tremor and hypersomnia to be related to SHINGRIX. Additional information was received as follows: At 3:00 pm in the afternoon, the patient received SHINGRIX on the left arm. The patient got sick again but the symptoms were more intense than sickness after the 1st dose of SHINGRIX. On Saturday, she woke up with fever, chills, shaking and a headache. She slept most of the day. It felt as if her fever was gone by Sunday and her headache was gone in morning of the reporting day. However, she noticed at work in morning of the reporting day, that her skin was peeling on the palm and inside of her fingers of her left hand. The contact details of the physician was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details reported as follows: This case was reported by a physician assistant-certified (PA-C). The patient's body temperature was recorded to be 101 degree F. The reporter did not agree to be followed up from GlaxoSmithKline. Lab Comments: Lab test was done on an unknown date.
Age: 62.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Burning sensation, Erythema, Injection site pain, Swelling
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of swelling in a 62-year-old female patient who received SHINGRIX (batch number EH9Z7, expiry date unknown) for prophylaxis. Concurrent medical conditions included Sjogren's syndrome. Concomitant products included TWINRIX. On 4th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced swelling, erythema and injection site burning. On an unknown date, the outcome of the swelling and erythema were recovering/resolving and the outcome of the injection site burning was not recovered/not resolved. It was unknown if the reporter considered the swelling, erythema and injection site burning to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. On 4th October 2018, the patient received last dose of TWINRIX (batch number: 53AT5) on left arm. No complaints were observed with TWINRIX. Swelling, redness and burning were experienced after receiving SHINGRIX and the redness and swelling was disappearing at the time of reporting. Burning feeling persisted at the time of reporting and it started at injection site but felt like it was spreading down the right arm, right shoulder and neck area. The patient had not seen a physician prior to reporting this case, pharmacist would advise patient to follow up with physician provider. The reporter agreed to be followed up from GlaxoSmithKline.
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (age less than 65 years, gender unknown) who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that FLUZONE HIGH DOSE administered in patient less than 65 y/o. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: FLUR4, VARZOS
Symptoms: Rash
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves Adult patient who experienced rash, while he/she received vaccines SHINGRIX and 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 number not reported via unknown route. On an unknown date, the patient received a dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. The patient developed a non-serious rash following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and following the administration of SHINGRIX. (Other relevant tests included No lab test.) Final diagnosis was rash. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for rash.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and gender three patients who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect Influenza Quadrival A-B Vaccine, lot UT6301NA, expiry date 30-Jun-2019 via unknown route in unknown administration site. It was an actual medication error due to vaccine underdose and syringe leak. It was reported by nurse that they had 3 of 0.5ml prefilled syringes that leaked around hub during administration/ nurses were unable to deliver full dose to those 3 patients. It was unknown whether patients experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid serious case received from a other health professional. This case is linked to cases 2018SA279494 and 2018SA279814 (same reporter). This case involves a male patient (patient 01) who experienced cellulitis and reactions between the injection site and elbow, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medications were not provided. On  03-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ004AB (expiry date: 30-Mar-2019) via intramuscular route in unknown administration site. On an unknown date, The patient developed a serious cellulitis following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On an unknown date, The patient developed a non-serious reactions between the injection site and elbow (local reaction) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab test reported.) Final diagnosis was reactions vaccination site reaction and cellulitis. The patient was treated with amoxicillin sodium, clavulanate potassium (augmentin [amoxicillin sodium;clavulanate potassium]) for Cellulitis. The patient outcome is reported as Recovering / Resolving for both events. list of documents held : none; Sender's Comments: This case involves a male patient who presented with cellulitis. Time to onset is not known. There is, however, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Complaining of left upper arm pain and decreased range of motion with no redness and swelling secondary to tetanus vaccine given 2 weeks ago in this office.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Face injury, Fall, Loss of consciousness, Syncope
Clinical narrative: Collapsed (passed out) and bumped face on check- out counter as he was falling down; syncope. He was taken back to an exam room to lay down and was given and ice pack for his face, and the doctor came in to check that he was okay. This happened approximately 5 minutes after the vaccine was given.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Pain; sharp stabbing; Decreased range of motion of R Upper Extremity.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fever, nausea, headache.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Vaccine given in error. Patient already had vaccine.
Age: 1.58
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine delivered into the muscle (IM) rather than SQ.
Age: 39.0
Sex: F
Vaccine: FLUA3
Symptoms: Urticaria
Clinical narrative: Hives on arms and chest. On the 14 October 2018.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Discomfort, Dizziness, Erythema, Fatigue
Clinical narrative: I felt a bit nauseous and dizzy about 15 minutes after receiving the vaccine, but it subsided. My arm has been achy ever since getting vaccinated. And, when I woke up the next day, on 10/10/18, my arm was very red below the injection site and it became raised, hot, itchy, and painful to touch as the day went on. When I woke up on 10/11/18, my arm hurt in the area of my armpit. It still feels uncomfortable there and the redness remains on the outside of my arm. The red area is itchy and warm to the touch. I also feel quite tired.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain, Pain in extremity, Pruritus, Skin warm
Clinical narrative: I felt a bit nauseous and dizzy about 15 minutes after receiving the vaccine, but it subsided. My arm has been achy ever since getting vaccinated. And, when I woke up the next day, on 10/10/18, my arm was very red below the injection site and it became raised, hot, itchy, and painful to touch as the day went on. When I woke up on 10/11/18, my arm hurt in the area of my armpit. It still feels uncomfortable there and the redness remains on the outside of my arm. The red area is itchy and warm to the touch. I also feel quite tired.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: I felt a bit nauseous and dizzy about 15 minutes after receiving the vaccine, but it subsided. My arm has been achy ever since getting vaccinated. And, when I woke up the next day, on 10/10/18, my arm was very red below the injection site and it became raised, hot, itchy, and painful to touch as the day went on. When I woke up on 10/11/18, my arm hurt in the area of my armpit. It still feels uncomfortable there and the redness remains on the outside of my arm. The red area is itchy and warm to the touch. I also feel quite tired.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: 76yr old patient presented to PCP on 10/8/18 for annual well visit. MD ordered for patient to receive PNEUMOVAX 23 and HIGH DOSE INFLUENZA vaccines. CMA prepared vaccines and administered PNEUMOVAX 23 vaccine IM in patient's right deltoid (LOT # R012550) and Influenza IIV3, IM High Dose vaccine IM in patient's left deltoid (LOT # UJ004AA). On 10/9, patient returned to office complaining of rash, erythema, swelling, itching & throbbing. Patient noted redness started at the site of injection on right arm and quickly spread circumferentially. Patient denied fever, chills, headache or drainage.  Patient did not take OTC medications for relief. MD noted "4 cm are MD noted "4 cm area of erythema and swelling noted over lateral aspect of right upper shoulder, tenderness to palpation. No fluid pockets palpated, no drainage". Per progress note diagnosis differential included cellulitis or clot or infection.  MD prescribed cephalexin 250 MG capsule; Take 2 capsules (500 mg total) by mouth 2 (two) times daily for 5 days. Patient instructed to report to ED or urgent care if need of ultrasound of right arm was needed. No further information available at this time.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Rash, Swelling
Clinical narrative: 76yr old patient presented to PCP on 10/8/18 for annual well visit. MD ordered for patient to receive PNEUMOVAX 23 and HIGH DOSE INFLUENZA vaccines. CMA prepared vaccines and administered PNEUMOVAX 23 vaccine IM in patient's right deltoid (LOT # R012550) and Influenza IIV3, IM High Dose vaccine IM in patient's left deltoid (LOT # UJ004AA). On 10/9, patient returned to office complaining of rash, erythema, swelling, itching & throbbing. Patient noted redness started at the site of injection on right arm and quickly spread circumferentially. Patient denied fever, chills, headache or drainage.  Patient did not take OTC medications for relief. MD noted "4 cm are MD noted "4 cm area of erythema and swelling noted over lateral aspect of right upper shoulder, tenderness to palpation. No fluid pockets palpated, no drainage". Per progress note diagnosis differential included cellulitis or clot or infection.  MD prescribed cephalexin 250 MG capsule; Take 2 capsules (500 mg total) by mouth 2 (two) times daily for 5 days. Patient instructed to report to ED or urgent care if need of ultrasound of right arm was needed. No further information available at this time.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: 76yr old patient presented to PCP on 10/8/18 for annual well visit. MD ordered for patient to receive PNEUMOVAX 23 and HIGH DOSE INFLUENZA vaccines. CMA prepared vaccines and administered PNEUMOVAX 23 vaccine IM in patient's right deltoid (LOT # R012550) and Influenza IIV3, IM High Dose vaccine IM in patient's left deltoid (LOT # UJ004AA). On 10/9, patient returned to office complaining of rash, erythema, swelling, itching & throbbing. Patient noted redness started at the site of injection on right arm and quickly spread circumferentially. Patient denied fever, chills, headache or drainage.  Patient did not take OTC medications for relief. MD noted "4 cm are MD noted "4 cm area of erythema and swelling noted over lateral aspect of right upper shoulder, tenderness to palpation. No fluid pockets palpated, no drainage". Per progress note diagnosis differential included cellulitis or clot or infection.  MD prescribed cephalexin 250 MG capsule; Take 2 capsules (500 mg total) by mouth 2 (two) times daily for 5 days. Patient instructed to report to ED or urgent care if need of ultrasound of right arm was needed. No further information available at this time.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Urticaria
Clinical narrative: Had HPV vaccine on 10/5 the next day felt fatigued and developed hives first on extremities and then on her face. No self care for this. Denies respiratory or throat symptoms. Now has hives only on her face. 10/5 was her second HPV vaccine. Has never had hives in the past.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Nausea, headache, and chills starting 2 hours after vaccination and lasting 12-24 hours. Redness, swelling, and soreness from left shoulder to left elbow slowly resolving.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea
Clinical narrative: Nausea, headache, and chills starting 2 hours after vaccination and lasting 12-24 hours. Redness, swelling, and soreness from left shoulder to left elbow slowly resolving.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-APR-2015, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 01-MAR-2016, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 12-SEP-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster or shingles. On or about 11-MAY-2016, the patient was treated by a physician for herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested. .
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On an unknown date later in 2011, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Kawasaki's disease, Pyrexia, Rash, Roseola
Clinical narrative: First signs of reaction on 01/05/2018, reason for office visit, fever at 10:15 am. Fever reading 101.7F. Weight 27.8 lbs. 01/06/2018, reason for emergency nurse triage visit, rash (Rosela) at 18:48:59. 01/08/2018 emergency/admission to hospital. Noted on 01/08/2018 Atypical Kawasaki disease.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Flu shot caused me to wheeze, have a croupy cough, and have difficulty breathing.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Burning sensation, Fatigue, Pain, Vomiting
Clinical narrative: Starting about 11 pm and getting worse by midnight I started throwing up, my body hurts so badly, particularly my lower back and I felt like I was burning up. I did stop vomiting after a few hours but am still in bed right now (11am) feeling like I was hit by a truck. I feel utterly exhausted and can hardly get out of bed. I have never had a reaction like this before, just the usual achey body etc.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness and pain at L deltoid muscle, beginning about 10 hours? after vaccine given.  Also, feeling quite tired. Today is 2 days post-vaccination and swelling and tiredness are slowly beginning to lessen.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness and pain at L deltoid muscle, beginning about 10 hours? after vaccine given.  Also, feeling quite tired. Today is 2 days post-vaccination and swelling and tiredness are slowly beginning to lessen.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Intense pain in left arm--at infection site and radiating down the arm. Left fingers numb (tingle became numb feeling 10/11/2018). Full range of motion-with pain. Doing exercises that might be done with a frozen shoulder, iuprophen 600 mg 3 times a day. Ice at injection site 3 times a day for 15 minutes.   Pain is worse when crossing arm in front of body and any motion to the front. At night-arm needs to be propped up while sleeping on the right side.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: Intense pain in left arm--at infection site and radiating down the arm. Left fingers numb (tingle became numb feeling 10/11/2018). Full range of motion-with pain. Doing exercises that might be done with a frozen shoulder, iuprophen 600 mg 3 times a day. Ice at injection site 3 times a day for 15 minutes.   Pain is worse when crossing arm in front of body and any motion to the front. At night-arm needs to be propped up while sleeping on the right side.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, increased warmth left upper arm. Patient reports pain occurred soon after receiving the injection and has progressively became worse.
Age: 56.0
Sex: F
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Bandaemia, Chills, Dysphagia, Erythema, Inflammation
Clinical narrative: 56yr old patient with history breast cancer, right shoulder arthroscopy (2017), Crohn's disease and other comorbidities presented to PCP on 9/5 for well visit. Patient endorsed weight loss without trying despite eating three meals daily, no nausea/diarrhea. MD ordered for PNEUMOVAX-23 and SHINGRIX vaccine to be administered. CMA prepared and administered PNEUMOVAX 23 vaccine IM in patient's right deltoid and SHINGRIX vaccine IM in right deltoid. Patient stated unable to receive vaccine in left arm (unknown reason). On 9/6, patient called PCP complaining of fever (100.8), nausea, and shivering. Patient took TYLEMOL and MOTRIN with some relief. Patient denied rash, shortness of breath, or heart palpitations. On 9/7, patient returned to PCP office. UA positive however, Urine culture grew mixed flora (suspected to be contaminated). Patient prescribed nitrofurantoin and ondansetron ODT for nausea. Patient with increased emesis after PCP visit and instructed to go to ED. Patient presented to Hospital on 9/7 with large red welts on right arm, arm soreness, nausea, vomiting, fever, body aches, and difficulty swallowing. Patient with noted bandemia (WBC = 15.8). Ultrasound normal, no abscess or fluid collection noted. Per admission note, symptoms most likely local inflammatory reaction from vaccine and post vaccine viral type syndrome which improved with antiemetic and antipyretic. Patient prescribed doxycycline 100mg BID x 6 days for possible cellulitis. Unknown of further follow up.
Age: 56.0
Sex: F
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Ultrasound scan normal
Clinical narrative: 56yr old patient with history breast cancer, right shoulder arthroscopy (2017), Crohn's disease and other comorbidities presented to PCP on 9/5 for well visit. Patient endorsed weight loss without trying despite eating three meals daily, no nausea/diarrhea. MD ordered for PNEUMOVAX-23 and SHINGRIX vaccine to be administered. CMA prepared and administered PNEUMOVAX 23 vaccine IM in patient's right deltoid and SHINGRIX vaccine IM in right deltoid. Patient stated unable to receive vaccine in left arm (unknown reason). On 9/6, patient called PCP complaining of fever (100.8), nausea, and shivering. Patient took TYLEMOL and MOTRIN with some relief. Patient denied rash, shortness of breath, or heart palpitations. On 9/7, patient returned to PCP office. UA positive however, Urine culture grew mixed flora (suspected to be contaminated). Patient prescribed nitrofurantoin and ondansetron ODT for nausea. Patient with increased emesis after PCP visit and instructed to go to ED. Patient presented to Hospital on 9/7 with large red welts on right arm, arm soreness, nausea, vomiting, fever, body aches, and difficulty swallowing. Patient with noted bandemia (WBC = 15.8). Ultrasound normal, no abscess or fluid collection noted. Per admission note, symptoms most likely local inflammatory reaction from vaccine and post vaccine viral type syndrome which improved with antiemetic and antipyretic. Patient prescribed doxycycline 100mg BID x 6 days for possible cellulitis. Unknown of further follow up.
Age: 56.0
Sex: F
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Urine analysis abnormal, Urticaria, Viral infection, Vomiting, White blood cell count increased
Clinical narrative: 56yr old patient with history breast cancer, right shoulder arthroscopy (2017), Crohn's disease and other comorbidities presented to PCP on 9/5 for well visit. Patient endorsed weight loss without trying despite eating three meals daily, no nausea/diarrhea. MD ordered for PNEUMOVAX-23 and SHINGRIX vaccine to be administered. CMA prepared and administered PNEUMOVAX 23 vaccine IM in patient's right deltoid and SHINGRIX vaccine IM in right deltoid. Patient stated unable to receive vaccine in left arm (unknown reason). On 9/6, patient called PCP complaining of fever (100.8), nausea, and shivering. Patient took TYLEMOL and MOTRIN with some relief. Patient denied rash, shortness of breath, or heart palpitations. On 9/7, patient returned to PCP office. UA positive however, Urine culture grew mixed flora (suspected to be contaminated). Patient prescribed nitrofurantoin and ondansetron ODT for nausea. Patient with increased emesis after PCP visit and instructed to go to ED. Patient presented to Hospital on 9/7 with large red welts on right arm, arm soreness, nausea, vomiting, fever, body aches, and difficulty swallowing. Patient with noted bandemia (WBC = 15.8). Ultrasound normal, no abscess or fluid collection noted. Per admission note, symptoms most likely local inflammatory reaction from vaccine and post vaccine viral type syndrome which improved with antiemetic and antipyretic. Patient prescribed doxycycline 100mg BID x 6 days for possible cellulitis. Unknown of further follow up.
Age: 56.0
Sex: F
Vaccine: PPV, VARZOS, FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: 56yr old patient with history breast cancer, right shoulder arthroscopy (2017), Crohn's disease and other comorbidities presented to PCP on 9/5 for well visit. Patient endorsed weight loss without trying despite eating three meals daily, no nausea/diarrhea. MD ordered for PNEUMOVAX-23 and SHINGRIX vaccine to be administered. CMA prepared and administered PNEUMOVAX 23 vaccine IM in patient's right deltoid and SHINGRIX vaccine IM in right deltoid. Patient stated unable to receive vaccine in left arm (unknown reason). On 9/6, patient called PCP complaining of fever (100.8), nausea, and shivering. Patient took TYLEMOL and MOTRIN with some relief. Patient denied rash, shortness of breath, or heart palpitations. On 9/7, patient returned to PCP office. UA positive however, Urine culture grew mixed flora (suspected to be contaminated). Patient prescribed nitrofurantoin and ondansetron ODT for nausea. Patient with increased emesis after PCP visit and instructed to go to ED. Patient presented to Hospital on 9/7 with large red welts on right arm, arm soreness, nausea, vomiting, fever, body aches, and difficulty swallowing. Patient with noted bandemia (WBC = 15.8). Ultrasound normal, no abscess or fluid collection noted. Per admission note, symptoms most likely local inflammatory reaction from vaccine and post vaccine viral type syndrome which improved with antiemetic and antipyretic. Patient prescribed doxycycline 100mg BID x 6 days for possible cellulitis. Unknown of further follow up.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's upper arm became red, swollen and painful.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: No adverse reaction was noted at the time of the administration. No adverse reaction has been reported since the time of the administration. Patient was ordered VAQTA 0.5ml dosage. Patient was administered VAQTA 1ml dosage. No other treatment for administering the 1ml dosage was provided.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Patient developed body aches, dizziness, decreased appetite with nausea and dry heaves, chills, diaphoresis on Saturday Oct 6th. Still going on 10/10/18. Prescribed ZOFRAN ODT 8 mg by mouth ever 6-8 hours as needed for nausea.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Retching
Clinical narrative: Patient developed body aches, dizziness, decreased appetite with nausea and dry heaves, chills, diaphoresis on Saturday Oct 6th. Still going on 10/10/18. Prescribed ZOFRAN ODT 8 mg by mouth ever 6-8 hours as needed for nausea.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9, IPV
Symptoms: Blepharospasm, Full blood count, Metabolic function test, Musculoskeletal stiffness
Clinical narrative: Directly after giving HPV injection, patient appeared to have possible seizure lasting approximately 3 seconds with quick body stiffening and eye witches, then immediately went acid. Immediately placed patient on right side and monitored for 30 minutes. Vital signs assessed and within normal limits x2.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: The shot hurt for the first time in 3 years. Pharmacist is great, always gentle and kind. My arm is very sore and have developed a red rash that is hot to the touch. It is almost 2 days later and the arm still hurts and the rash still is there.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient says he developed large urticaria within 24 hours of the vaccination. He can not attribute the hives to anything else so he believes it was from the vaccination. He took a course of prednisone to treat the hives. He did not have any other reactions or symptoms.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Pt given flu vaccine in office on 10/8/18. Did not show any redness swelling until 10/9/18. Seen in office 10/10/18. Per Dr, cool compresses and cephalexin prescribed.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Began with redness and swelling at site about 1 hr after injection. Tried cold compresses and Ibuprofen with no relief on 10/01/18. Patient was then seen 10/3/18 at Urgent Care. Started ZYRTEC and reaction improved day 4 after reaction.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site induration, Peripheral swelling, Tenderness
Clinical narrative: Increasing induration at site (12cm x 12cm); increased bicep girth; tenderness with muscle use.
Age: 26.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Body temperature increased, Erythema, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Presented Sept 20th with scattered erythematous papules on forehead, neck, torso and scalp first noted 3-4 hours earlier, also site of varicella vaccination given Sept 4th red, raised; experiencing fatigue, body aches; Temp 101.3 PS, pulse 108; minimal enlargement posterior cervical lymph nodes, left side; seen by dermatologist Sept 21st, diagnosed with varicella disease, uncomplicated course, supportive treatment; cleared for return Sept 28th.
Age: 26.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Lymphadenopathy, Pain, Papule, Streptococcus test negative, Varicella post vaccine
Clinical narrative: Presented Sept 20th with scattered erythematous papules on forehead, neck, torso and scalp first noted 3-4 hours earlier, also site of varicella vaccination given Sept 4th red, raised; experiencing fatigue, body aches; Temp 101.3 PS, pulse 108; minimal enlargement posterior cervical lymph nodes, left side; seen by dermatologist Sept 21st, diagnosed with varicella disease, uncomplicated course, supportive treatment; cleared for return Sept 28th.
Age: 26.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Viral test negative
Clinical narrative: Presented Sept 20th with scattered erythematous papules on forehead, neck, torso and scalp first noted 3-4 hours earlier, also site of varicella vaccination given Sept 4th red, raised; experiencing fatigue, body aches; Temp 101.3 PS, pulse 108; minimal enlargement posterior cervical lymph nodes, left side; seen by dermatologist Sept 21st, diagnosed with varicella disease, uncomplicated course, supportive treatment; cleared for return Sept 28th.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: Erythema and warmth at vaccination site w/palpable lump beneath injection site; pt report low grade fever and achiness.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Redness, hot/warm to touch, inflammation 50mm x 42mm dk red inner, 60mm x 60mm pink, outer. 10/03/18-only pinkness remains-smaller 40x50mm negative pain.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: (R) shoulder pain w/radiation to neck posteriorly and along collar bone. Pain, swelling, and erythema at injection site; pain worse with movement; injection site below deltoid muscle.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: (R) shoulder pain w/radiation to neck posteriorly and along collar bone. Pain, swelling, and erythema at injection site; pain worse with movement; injection site below deltoid muscle.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pyrexia
Clinical narrative: Patient started to experience a fever around 2 pm that afternoon and was followed by a heart rate of 95-105, no increased blood pressure, a fever of 102, and numb fingers. ADVIL was taken around 10pm at night and the fever broke around 3 am. By the next morning all symptoms had disappeared.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Decreased appetite, Dyspnoea, Headache, Nausea
Clinical narrative: Approximately 12:00 noon  headache began. At approximately 16:30 chills, shortness of breath, nausea, loss of appetite. shakiness, nausea, vomiting. lasted through out night.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor, Vomiting
Clinical narrative: Approximately 12:00 noon  headache began. At approximately 16:30 chills, shortness of breath, nausea, loss of appetite. shakiness, nausea, vomiting. lasted through out night.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash
Clinical narrative: 10:15am on 10/11/2018 patient called to report broke out with rash over arms legs back and shoulders this morning. She started itching last evening before went to bed. Flu vaccine was give 10/09/2018 12:15 pm. She went on to say that she received her 2nd dose of HPV vaccine on 10/10/18 at the clinic. When asked how her 1st dose of HPV went she stated that she had Hives around that same time. Instructed her she needed to talk to the clinic about weather or not to get her 3rd dose of HPV. I am thinking it is probably from the HPV but still reporting that she did receive the FLUCELVAX. Clinic was called this am to report s/sx of events.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, Swollen and Hot.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Patient reports a large welt and pain at the injection site. She has applied hydrocortisone cream, BENADRYL cream and NEOSPORIN to the site with some improvement.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Flushing, Pruritus
Clinical narrative: ". I was at patients home yesterday and I began to feel really flushed to my head to the point where it felt like my face was burning. My back of my scalp became itchy. So I ended my visit and took some Benadryl. The redness spread to my upper chest and arms. I slept for several hours and felt much better when I got up. I feel fine today. "
Age: 46.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Local reaction, Skin warm
Clinical narrative: Patient called on 10.11.2018 stating that her arm is hot to the touch, she stated she does not have a fever and there is no red streak going down her arm.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Tremor, Vomiting
Clinical narrative: Chills, Vomiting, shaking, cold sweats, This is ongoing at this time. I vomited several times this morning (10-11-2018 in the AM ). I am laying down and using cool cloths on my head, neck and face.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Duplicate vaccine given.
Age: 77.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Asthenia, Micturition urgency, Paralysis
Clinical narrative: Patient awoke around midnight (as usual w/urge to urinate) and felt "paralyzed" and was too weak to get up. He wet the bed several times before regaining enough strength to get up and remained weak for 24 hours.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site urticaria, Pyrexia, Urticaria
Clinical narrative: Area of injection (R) upper arm large welt. Hives on neck, chest, both arms, both legs, fever, fatigue.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt states left arm pain 2 weeks after shot. States it hurts to raise left arm. He states he received his flu shot in the left arm. Our records show he was given SHINGRIX in left arm. He was advised to see his doctor who prescribed Lidocaine patches. Still has pain.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Throat tightness
Clinical narrative: Pt states she started having "tightness" in her throat about 1 hour after recieving the vaccine, this continued to get worse with chest tightness and shortness of air until after she got home. Pt states she had her neighbor take her to the emergency department at this point.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Fever 101~ Tender and swollen at injection site. Red and raised Rash on entire deltoid at the injection site.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: 15 minutes after receiving the FLUBLOK vaccine the patient reported feeling short of breath with difficulty breathing and throat tightness.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis of Left Lower Extremity. Large, Red, Warm, Swollen area of Left thigh.
Age: 0.5
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Symptoms. Child was 6 months old and given Varicella, MMR and Hep A in error.
Age: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Day after FLUBLOK vaccine given Right arm developed redness, swelling, hot to touch with erythema size of Grapefruit. Will follow-up with PCP/UC regarding reaction.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm sore, very swollen, and warm after shot. To relieve the pain, I took two ALEVE Pain Reliever and rubbed arm with alcohol. After two days, left arm developed a red ring around the upper arm at shot injection site. The area is very sore and it hurts when touched.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Nausea, Pain, Peripheral swelling
Clinical narrative: About eight hours after the shot, I had chills,nausea and aches. Thirteen hours later and two TYLENOL, I'm not feeling better. In 2016 and 2017 my shot arm was red and swollen, but BENADRYL helped. I have not gotten the nausea, aches,chills since college in the 60's.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: About 12 hours after receipt of vaccine, spiked a fever of 101.5 degrees F with chills and tremors. This continued for about 36 hours. Then fever subsided to 100 degrees F for another 24 hours, temperature returning to normal afterwards.
Age: 11.0
Sex: M
Vaccine: FLU4, HEPA, MNQ, TDAP, HEPA
Symptoms: Injection site pain
Clinical narrative: This patient is 11 yrs old and was given the adult dose of vaccine. Patient's mother is aware. Stated at current time patient is doing well, did complain of soreness at the site.
Age: 11.0
Sex: M
Vaccine: FLU4, HEPA, MNQ, TDAP, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This patient is 11 yrs old and was given the adult dose of vaccine. Patient's mother is aware. Stated at current time patient is doing well, did complain of soreness at the site.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Neuralgia, Pain, Paraesthesia, Pyrexia
Clinical narrative: Patient had a high fever of 102 degrees F, severe body pains for 2 weeks, nerve pain and tingling sensation for weeks. Pt didn't feel well at all and is unwilling to get the vaccine second dose.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in and received PCV-13 on 10/08/2018, on site of vaccine left arm it was swollen, red and hot on the touch... Patient was seen by provider Dr. and has prescribed Bactrim abx, pt verbalized understanding and consent and teaching was given, if symptoms get worse pt to go to Urgent care or ER....
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Confusional state, Feeling hot, Headache, Muscle twitching
Clinical narrative: Patient reported confusion, soreness in arm, bad headache and twitching, feeling hot and clammy. All symptoms resolved by morning. Patient requested that this reaction be reported. Did not occur with dose #1.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reported confusion, soreness in arm, bad headache and twitching, feeling hot and clammy. All symptoms resolved by morning. Patient requested that this reaction be reported. Did not occur with dose #1.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, via company representative, referring to a 75 year-old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions or concomitant medications was unknown. On an unspecified date in February 2018, the patient was administered PNEUMOVAX 23 and again on unspecified date around August 2018 (Inappropriate schedule of drug administration) because the patient initially said she never received the PNEUMOVAX 23 before; no clarifying information was provided. No adverse effects were reported.