chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, X-ray limb
Clinical narrative: Case number PHHY2017US034129, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 666442) website on 21 Feb 2017. This report refers to a 29 years old female patient. Past medical history included as endometriosis. Current conditions included as benign hemangioma in left hand, wrist and fingers, duplicated ureter system on right kidney. Concomitant medications included as LYRICA, CYMBALTA and ZOLOFT. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185888) into right shoulder, intramuscularly on 21 Oct 2016. On 22 Oct 2016, the patient experienced severe right shoulder pain. The patient had 03 view right shoulder x-ray and right shoulder Magnetic resonance imaging (MRI) test with no results on an unspecified date. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 60.0
Sex: F
Vaccine: FLUC4, PPV, TDAP, VARZOS
Symptoms: Contusion, Induration, Mass
Clinical narrative: Case number PHHY2017US033020, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 666675) website on 21 Feb 2017. This report refers to a 60 years old female patient. Medical history and current illness were reported as none. Concomitant medications included diclofenac DR and escitalopram. She was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186868) intramuscularly into the right arm. PNEUMOVAX (other manufacturer, batch number: M040804) intramuscularly into the right arm, BOOSTRIX (other manufacturer, batch number: P754B) intramuscularly into the left arm and ZOSTAVAX (other manufacturer, batch number: M035148) subcutaneously into the right arm: on 16 Nov 2016. After vaccination, on the same day, she developed hard lump about the size of a ping pong ball and there was also slight bruising in the area. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the event were not reported.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Acne, Contusion, Erythema, Peripheral swelling, Swelling
Clinical narrative: Case number PHHY2017US016850, is an initial spontaneous report received from a pharmacist via Vaccine Adverse Events Reporting System (VAERS reference number: 666823) on 23 Jan 2017. This report refers to a 71 years old female patient. Medical history was not reported. Vaccination history included administration of PREVNAR 13 (other manufacturer), batch number: not reported) on an unknown date in 2015 and it caused no adverse event. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) and PNEUMOVAX 23 (other manufacturer), batch number: L027732, expiry date: 23 Feb 2017) both on opposite arms on 21 Oct 2016. On an unknown date in Oct 2016 after vaccination, the patient's arm that received PNEUMOVAX 23 had redness and swelling that extended to her back and a bruise under her arm that began 1 or 2 days after the vaccination that worsened after 3 to 4 days. It was reported that, the redness continued and was present a week ago. On an unknown date, the patient also experienced pimples on her abdomen and the front of her legs and it was treated with BENADRYL on unspecified dates. The patient went to an unspecified urgent care center on 23 Oct 2016. The outcome of the event pimples was reported as resolving (condition improving) and for other events it was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported.
Age: 5.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Vaccination site inflammation, Vaccination site macule, Vaccination site warmth
Clinical narrative: Case number PHHY2017US033101, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667024) website on 21 Feb 2017. This report refers to a 5 years old female patient. Historical condition was not reported. Current conditions included asthma and environmental allergies. Concomitant medications included Albuterol and FLOVENT. She was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186686) intramuscularly into the left arm on 05 Nov 2016. Within 1 to 2 hours after vaccination, area became red and warm, she had a macular, pink-red inflamed area size approximately 4 inches across left deltoid. No red streaks were observed. She was treated with ibuprofen and ice for the events. The events were reported to be improving after day 1. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Hypoaesthesia, Pain
Clinical narrative: Case number PHHY2017US033401, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 667069) website on 21 Feb 2017. This report refers to a 26 years old female patient. Past medical history was not reported. Current condition included pollen allergy. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185327) in left arm on 31 Oct 2016. On 01 Nov 2016 after vaccination, the patient experienced bruising, dull ache since then and on and off numbness that last for a few seconds. Bruising was resolved on 12 Nov 2016 and ache and numbness were not resolved and worse when laying on left side. The outcome of the event bruising was reported as complete recovery as of 12 Nov 2016 and outcome of rest of events were reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Injection site discomfort, Swelling
Clinical narrative: Case number PHHY2017US034283, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 667137) website on 21 Feb 2017. This report refers to a 09 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185888) into left arm on 15 Nov 2016. On the same day after vaccination, the patient experienced discomfort at injection site, redness and swelling, no streaking and no fever. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal discomfort, Nausea, Vomiting
Clinical narrative: Case number PHHY2017US033604, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667187) website on 21 Feb 2017. This report refers to a 60 years old female patient. Historical condition was not reported. Current conditions included egg allergy and hypothyroid. Concomitant medication included levothyroxine. She was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186685) intramuscularly into the right arm on 15 Nov 2016. After vaccination, on 16 Nov 2016, she experienced nausea, vomiting and GI upset (gastrointestinal upset). The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 60.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Abdominal discomfort, Malaise, Skin reaction, Urticaria
Clinical narrative: Case number PHHY2017US033176, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 667446) website on 21 Feb 2017. This report refers to a 60 years old female patient. Past medical history was not reported. Current condition included as reaction to latex allergy. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) into left arm, intramuscularly on 18 Nov 2016. The patient also vaccinated with PNEUMOVAX vaccine (other manufacture and batch number: not reported) into left arm, intramuscularly on 18 Nov 2016. On the same day after vaccination, the patient experienced stomach felt sick and stomach upset, skin reaction, small welts and welts on hand. It was reported that, it went away after 02 days. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 55.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Case number PHHY2017US034729, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667998) website on 21 Feb 2017. This report refers to a 55 years old male patient. Historical condition included vitamin B12 deficiency. Current conditions included chronic obstructive pulmonary disease, hypertension, degenerative disc disease, polyneuropathy and restrictive lung disease. Concomitant medication was not reported. He was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 169404) and PNEUMOVAX (other manufacturer, batch number: M041394); intramuscularly into the left arm on 21 Nov 2016. After vaccination, on the same day, he experienced left arm red, hot and swollen below point of PPV23 injection. He was treated with MEDROL and Cephalexin Monohydrate for the events. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Case number PHHY2017US034769, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668077) website on 21 Feb 2017. This report refers to a 31 years old female patient. Vaccination history included she was vaccinated with unspecified flu shots (results unspecified). Current condition included seizures. Concomitant medications included carbamazepine. She was vaccinated with the first dose of FLUCELVAX QUADRIVALENT (batch number: 186685) intramuscularly into the right arm on 22 Nov 2016. After vaccination, on 23 Nov 2016, she started to get nausea and headache around 1 and then began vomiting. She received treatment with fluids and was asked to take the rest. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash, Rash macular, Skin warm
Clinical narrative: Case number PHHY2017US033798, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 668124) website on 21 Feb 2017. This report refers to a 26-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (lot number: 185284) into left arm intramuscular 18 Nov 2016. On 18 Nov 2016, the patient experienced felt itchy, warm, large circular blotches started on arms and legs and then extended to chest and neck rash persisted until 22 Nov 2016. Outcome of the events was completely recovered. Seriousness of the events was reported as non serious and causality was not reported.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion
Clinical narrative: Case number PHHY2017US034720 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668128) website on 21 Feb 2017. This report refers to a 55 year old female patient. Historical condition was not reported. Past medication included codeine.  It was reported that patient had no current illness. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185325A) intramuscularly into left arm on 04 Nov 2016. After vaccination on 05 Nov 2016 (reported as day after vaccine), the patient developed bruising and still bruised as of this report. The outcome of the event was reported as condition unchanged (still bruised). The seriousness of the event was reported as non serious and causality was not reported.
Age: 79.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2017US033589 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668172) website on 21 Feb 2017. This report refers to a 79 year old female patient. Medical history was reported as none. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185327) into right arm on 04 Oct 2016. The patient was also vaccinated with PNEUMOVAX (other manufacturer, batch number: M035104) into left arm on 04 Oct 2016. After vaccination on an unknown date, patient experienced itchy, red and swollen in right deltoid for 24 hours. The lab data of the patient was reported as none. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Pityriasis rosea, Pruritus, Rash, Skin lesion
Clinical narrative: Case number PHHY2017US013564 is an initial spontaneous report received from consumer (patient mother) via Vaccine Adverse Event Reporting System (VAERS reference number: 668210) website on 23 Jan 2017. This report refers to 04 year old male patient. Medical history and concomitant medications were not reported. It was reported that patient had no known allergies. He was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185286) intramuscularly into the left deltoid on 11 Nov 2016. After vaccination on 13 Nov 2016, he developed rashes on lower back and legs and his mother noticed the rash on 13 Nov 2016 (reported as yesterday morning) around 8:00 AM. He took BENADRYL to treat and it had helped slightly. He experienced itchiness and denied fever, swelling or pain at injection site (left deltoid), vomiting, nausea, diarrhea and no eruption near injection site. His physical examination showed well appearing and well hydrated with NAD (no appreciable disease). On an unknown date, his pulse was 108 (normal range and units not reported), respiratory rate was 22 (normal range and units not reported) and body temperature was 98.1 Fahrenheit (normal range not reported). It was reported that, a 3 cm x 6 cm ovoid red lesion on posterior lateral left thigh was seen, a partially blanching with slightly raised border but not scaly. Proximal lower extremities and lower trunk had scattered red, ovoid lesions which were blanching, slightly raised, and 6x9 mm to 1.2 cm in longest dimension and there were no obviously aligned with Blaschko's lines. The antierioposterior examination showed Pityriasis Rosea (L42) confirmed by a red ovoid, slightly raised lesions on trunk and lower extremities and herald lesion on lateral left thigh indicated rash was possibly Pityriasis Rosea. It was reported that the adverse reaction was caused by viral vaccines and cannot ignore the coincidental timing. It was also reported that, could not find a report a Pityriasis Rosea associated with flu vaccine. The outcome of the events was reported as unknown. The events were assessed as non serious and causality was reported as suspected with the vaccine.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Case number PHHY2017US034174 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668224) website on 21 Feb 2017. This report refers to a 62 year old female patient. Medical history was reported as none. Concomitant medications included low dose of Aspirin and SUBUTEX. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186868) intramuscularly into right arm on 26 Nov 2016. On the same day after vaccination, the patient experienced excessive bleeding with swelling at injection site. It was reported that the patient was recommended to visit emergency room on advice of urgent care and even the emergency room was called to let know that the patient was on her way. It was reported that the patient called later and informed that she did not want to go to emergency room but visited her sister who was a registered nurse and was treated with ice and then heat. It was reported that the patient was much better and the swelling had gone down and the bleeding had stopped on an unknown date. The lab data of the patient was reported as none. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Age: 70.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Case number PHHY2017US025558, is an initial spontaneous report received from pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 668333) website on 23 Jan 2017. This report refers to a 70 years old male patient. Past medical history was not reported. Current condition included penicillin allergy. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on an unspecified date. The patient was also vaccinated with PNEUMOVAX 23 (batch number: M037669) intramuscularly on an unspecified date. On an unspecified date (approximately in Nov 2016) after vaccination, the patient experienced swelling, redness and induration below the site of injection. There were no diagnostic studies performed. The outcome of the events was reported as condition improving. The relatedness between the events and the suspect vaccines was not reported. The seriousness of the events were not reported.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Musculoskeletal pain, Paraesthesia
Clinical narrative: Case number PHHY2017US034760 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668470) website on 21 Feb 2017. This report refers to a 49 year old female patient. It was reported that patient had no medical history. Concomitant medications were not reported and it was reported that patient was not taking any medications. The patient was vaccinated with first dose of FLUCELVAX QUADRIVALENT (batch number: 186868) intramuscularly into left arm on 16 Nov 2016. After vaccination patient came to pharmacy on 28 Nov 2016 and reported that on an unknown date (reported as exact time course of these events were unknown), the patient had numbness and tingling in the hand and shoulder was sore. Following the events patient visited emergency room on an unknown date. It was reported that patient had no adverse events when the shot was given and the numbness in hand was improving and the manufacturer was contacted on 28 Nov 2016. The patient was advised to visit physician by the manufacturer and reported that they would submit a report as well. It was reported that no diagnostic tests or laboratory data was completed by the pharmacy and patient stated that she would visit the physician on an unknown date (reported as today). The outcome of the event hypoaesthesia was reported as condition improving and for the events paraesthesia and musculoskeletal pain was reported as not reported. The seriousness of the events was reported as non serious and causality was not reported.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site warmth, Local reaction, Pain
Clinical narrative: Case number PHHY2017US022623 is an initial spontaneous report received from physician via company representative via vaccine adverse event reporting system (Vaers number: 669355) website on 23 Jan 2017. This report refers to 66 year old male patient. Medical history and concomitant medication was not reported. The prior vaccination history included PNEUMOVAX 23 and unspecified flu vaccine at same time in same arm. The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown, batch number not reported) and PNEUMOVAX 23 (other manufacturer) on an unspecified date into arm (details not reported). In 2016 (date not reported) after PNEUMOVAX 23 was administered, the patient experienced local and systemic reactions. He experienced fever, body aches, pains, swelling and chills. He also experienced redness and warmth near the injection site. The patient did not seek medical attention. The patient was fine. There was no product quality complaint (PQC). The causal relationship between PNEUMOVAX 23 and the events was unknown. The outcome of the events was reported as complete recovery on an unknown date, seriousness of the events was non serious and causality of the events was not reported.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Case number PHHY2017US022623 is an initial spontaneous report received from physician via company representative via vaccine adverse event reporting system (Vaers number: 669355) website on 23 Jan 2017. This report refers to 66 year old male patient. Medical history and concomitant medication was not reported. The prior vaccination history included PNEUMOVAX 23 and unspecified flu vaccine at same time in same arm. The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown, batch number not reported) and PNEUMOVAX 23 (other manufacturer) on an unspecified date into arm (details not reported). In 2016 (date not reported) after PNEUMOVAX 23 was administered, the patient experienced local and systemic reactions. He experienced fever, body aches, pains, swelling and chills. He also experienced redness and warmth near the injection site. The patient did not seek medical attention. The patient was fine. There was no product quality complaint (PQC). The causal relationship between PNEUMOVAX 23 and the events was unknown. The outcome of the events was reported as complete recovery on an unknown date, seriousness of the events was non serious and causality of the events was not reported.
Sex: M
Vaccine: FLUC4
Symptoms: Bursitis, Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2017US029520, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 669542) website on 21 Feb 2017. This report refers to a 25 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185327) into left arm, intramuscularly on 29 Sep 2016. On the same day after vaccination, the patient experienced arm was sore and pain/soreness worsened over time, trouble moving and raising her arm. Patient went and saw her physician and was diagnosed with bursitis on 29 Sep 2016. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: Case number PHHY2017US033602, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 669554) website on 21 Feb 2017. This report refers to a 24 years old female patient. Past medical history was not reported. Current condition included shrimp, tomatoes, dust mites, latex, grass pollen, dog dander allergy. Concomitant medications included VYVANSE and ZOLOFT. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185285) intramuscularly in left arm on 09 Nov 2016. On 29 Nov 2016 after vaccination, the patient experienced left upper brachium pain, especially when lifting left arm or putting any pressure on it and tender. The patient received treatment with ADVIL. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 45.0
Sex: M
Vaccine: FLUC4
Symptoms: Discomfort, Urticaria
Clinical narrative: Case number PHHY2017US033594 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 670052) website on 21 Feb 2017. This report refers to a 45 year old male patient. Historical condition was not reported. Current illness were reported as none. Concomitant medications included simvastatin, Metoprolol ER, famotidine, and zolpidem. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186868) intramuscularly into left arm on 02 Dec 2016. After vaccination on 03 Dec 2016 (reported as day following the vaccination), patient developed hives on back and shoulder. It was reported that the hydrocortisone cream helped the patient with discomfort. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events were reported as non serious and causality was not reported.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Infection, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2017US034990, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 670057) on 21 Feb 2017. This report refers to a 39-year-old female patient. Historical conditions included injection site rough and irritated skin at injection site. Concomitant medication was not reported. The patient received FLUCELVAX QUADRIVALENT (lot number: 186868) into right arm intramuscularly on 05 Dec 2016. On 06 Dec 2016 the patient experienced swollen, warm, red injection site. Physician husband suspects infection, and they will see primary care physician tomorrow. The patient visited to the emergency room. Outcome of the events was unknown. Seriousness of the events was reported as non-serious. Causality was not reported.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Case number PHHY2017US033597, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 670279) website on 21 Feb 2017. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186867) intramuscularly in left arm on 21 Nov 2016. On 22 Nov 2016 after vaccination, the patient experienced muscle soreness and unable to raise and use arm to full extent. The outcome of the event was reported as complete recovery on an unspecified date. The seriousness and causality of the event were not reported.
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Body temperature increased, Pain in extremity
Clinical narrative: Case number PHHY2017US031804, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 671155) website on 21 Feb 2017. This report refers to a 57 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with first dose of FLUCELVAX QUADRIVALENT (batch number: 186867) into right arm, intramuscularly on 06 Dec 2016. The patient also vaccinated with first dose of PNEUMOVAX Vaccine (other manufacture and batch number: M038216) into right arm, intramuscularly on 06 Dec 2016. On 08 Dec 2016, the patient experienced sore arm and body temperature of 99 to 100 (unit unspecified). The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Case number PHHY2017US030356, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 671734) on 21 Feb 2017. This report refers to an 11 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186686) intramuscularly on 06 Dec 2016. On 08 Dec 2016, the patient developed 02 inch red warm lump at immunization site. The patient fully recovered from these events on an unknown date. Seriousness of the events were reported as non-serious. The causality of the events were not reported.
Age: 59.0
Sex: M
Vaccine: FLUC4, PPV, TDAP
Symptoms: Impaired work ability, Injection site induration, Injection site pain, Pancreatic disorder
Clinical narrative: Case number PHHY2017US030920, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 671946) on 21 Feb 2017. This report refers to a 59 years old male patient. Historical condition was not reported. Current condition included diabetes. The patient vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186867A), PNEUMOVAX (batch number: M033086) intramuscularly in left arm and ADACEL (batch number: U5502AA) intramuscularly in right arm on 07 Dec 2017. On 08 Dec 2016, the patient had hard painful six in area at injection site. Also sore arm caused him to miss two days work. The patient fully recovered from these events on an unknown date. Seriousness of the events were reported as non-serious. The causality of the events were not reported.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: Case number PHHY2017US034170, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 672239) website on 21 Feb 2017. This report refers to a 50 years old female patient. Past medical history was not reported. Historical medications included as codeine and iodine. Concomitant medications included as levothyroxine, allopurinol, metformin, meloxicam, citalopram, pravastatin and gabapentin. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186867) into left arm, intramuscularly on 10 Dec 2016. On 11 Dec 2016, the patient experienced arm was swollen and red ring around injection site. Patient received CLARITIN and reaction was mild and the reaction would dissipate. Patient arm was better and that the swelling was almost gone and the red ring was going away. The patient visited emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 73.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Burning sensation, Mobility decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2017US032447, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 672366) on 21 Feb 2017. This report refers to a 73 years old female patient. Historical condition was not reported. Current condition included penicillin allergy. Concomitant medication included naproxen, simvastatin, levothyroxine and RESTASIS. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186867A) and PNEUMOVAX (batch number: M037669) on 13 Dec 2016 intramuscularly in left arm. On 13 Dec 2016, patient developed, severe pain in shoulder, burning sensation and difficulty/inability to move arm a few hours following vaccination. The patient was treated with TYLENOL WITH CODEINE NO. 3 and Ice compress for treatment of musculoskeletal pain. Patient reported still having pain a day later, but it was not as bad. Patient visited emergency room and primary care continued treatment with TYLENOL WITH CODEINE NO. 3 for pain. The outcome of the events burning sensation, mobility decreased was unknown. Outcome of the event musculoskeletal pain was condition unchanged (reported as still having pain a day later). Seriousness of the events were reported as non-serious. The causality of the events were not reported.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, TDAP, FLU3, PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 1/10/18 PM I got two shots in left arm, whooping cough and pneumonia, plus this accelerated flu shot in my right arm for age 65 plus. The right arm was fine. The left arm was fine until Sunday and Monday after (6 days) then a large red hot to touch and swollen left arm was suddenly there. All symptoms went away by Thursday 4 days later. Then arm was fine.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, TDAP, FLU3, PNC13, TDAP
Symptoms: Erythema, Peripheral swelling, Pertussis, Pneumonia, Skin warm
Clinical narrative: On 1/10/18 PM I got two shots in left arm, whooping cough and pneumonia, plus this accelerated flu shot in my right arm for age 65 plus. The right arm was fine. The left arm was fine until Sunday and Monday after (6 days) then a large red hot to touch and swollen left arm was suddenly there. All symptoms went away by Thursday 4 days later. Then arm was fine.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Balance disorder, Dizziness
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 66 year old male patient. He had no pertinent concurrent conditions, medical history, illnesses at the time of the vaccination, concomitant medications, pre-existing physician diagnosed allergies, birth defects and medical conditions. On 12-JAN-2018, the patient was vaccinated with first dose of PNEUMOVAX 23 (lot # N019837-valid (expiry:21-FEB-2019), 1 DF, intramuscular in the right arm) for pneumococcal vaccination. There was no temperature excursion from digital data logger. On 13-JAN-2018, 36 hours after the vaccination, the patient was dizzy. On the same day, the patient was feeling strange (feeling abnormal) and vertigo. On 14-JAN-2018, the vertigo worsened. On 15-JAN-2018, the patient made an appointment to visit a physician. The physician gave the patient prescriptions for unspecified doses of over-the-counter (OTC) loratadine (CLARITIN) and fluticasone (FLONASE). For feeling abnormal and vertigo. After treatment, the patient's symptoms immediately resolved on an unknown date in January 2018. On 17-JAN-2018, the pharmacist spoke with the patient who stated that he recovered from the events. Causality of the events was unknown.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dizziness, Feeling abnormal, Vertigo
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 66 year old male patient. He had no pertinent concurrent conditions, medical history, illnesses at the time of the vaccination, concomitant medications, pre-existing physician diagnosed allergies, birth defects and medical conditions. On 12-JAN-2018, the patient was vaccinated with first dose of PNEUMOVAX 23 (lot # N019837-valid (expiry:21-FEB-2019), 1 DF, intramuscular in the right arm) for pneumococcal vaccination. There was no temperature excursion from digital data logger. On 13-JAN-2018, 36 hours after the vaccination, the patient was dizzy. On the same day, the patient was feeling strange (feeling abnormal) and vertigo. On 14-JAN-2018, the vertigo worsened. On 15-JAN-2018, the patient made an appointment to visit a physician. The physician gave the patient prescriptions for unspecified doses of over-the-counter (OTC) loratadine (CLARITIN) and fluticasone (FLONASE). For feeling abnormal and vertigo. After treatment, the patient's symptoms immediately resolved on an unknown date in January 2018. On 17-JAN-2018, the pharmacist spoke with the patient who stated that he recovered from the events. Causality of the events was unknown.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, marked erythema on upper arm at injection site.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Hyporesponsive to stimuli, Loss of consciousness, Pallor, Vomiting
Clinical narrative: Patient was fine, about 10 minutes after vaccine, went to stand up to leave. Patient passed out very slowly, to the point the father and I thought he was joking. He came to about 1 second later saying he didn't know what happened. Patient was very pale and started vomiting. He was minimally responsive. Paramedics were called and he was taken via ambulance.
Age: 24.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Received shot in the AM of 12/18/17 in the left arm and the flu shot in the right arm. Arms were tender by the end of the night and could barely raise them up. Morning of the 19th, a red blotchy area around the PREVNAR shot formed and was sore, couldn't lift arm or get out of bed without it throbbing. A fever was present on an off all day with shivering and lack of appetite. The night of the 19th couldn't sleep/rollover onto either arm as the pain increased and still couldn't lift my left arm at all. Woke up twice in the AM and expelled whatever was in my stomach from a late dinner. The morning of the 20th a fever was still present and uncontrollable shivering still continued as it did during the night before. The size of the injection site red area grew to 2.5 in. in diameter. The day of the 19th I was pretty tacky at a constant 120+ and then the morning of the 20th in the ER I was around 144 with a fever of 104. The morning of the 21st the red area grew to covering more than half of my upper arm and was still warm as it had been since the night of the 18th. Released from the hospital on the 21st and the red area didn't completely fade until the week of January 8th.
Age: 24.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site warmth, Insomnia, Pyrexia, Rash macular
Clinical narrative: Received shot in the AM of 12/18/17 in the left arm and the flu shot in the right arm. Arms were tender by the end of the night and could barely raise them up. Morning of the 19th, a red blotchy area around the PREVNAR shot formed and was sore, couldn't lift arm or get out of bed without it throbbing. A fever was present on an off all day with shivering and lack of appetite. The night of the 19th couldn't sleep/rollover onto either arm as the pain increased and still couldn't lift my left arm at all. Woke up twice in the AM and expelled whatever was in my stomach from a late dinner. The morning of the 20th a fever was still present and uncontrollable shivering still continued as it did during the night before. The size of the injection site red area grew to 2.5 in. in diameter. The day of the 19th I was pretty tacky at a constant 120+ and then the morning of the 20th in the ER I was around 144 with a fever of 104. The morning of the 21st the red area grew to covering more than half of my upper arm and was still warm as it had been since the night of the 18th. Released from the hospital on the 21st and the red area didn't completely fade until the week of January 8th.
Age: 24.0
Sex: F
Vaccine: PNC13
Symptoms: Tachycardia, Tenderness, Vomiting
Clinical narrative: Received shot in the AM of 12/18/17 in the left arm and the flu shot in the right arm. Arms were tender by the end of the night and could barely raise them up. Morning of the 19th, a red blotchy area around the PREVNAR shot formed and was sore, couldn't lift arm or get out of bed without it throbbing. A fever was present on an off all day with shivering and lack of appetite. The night of the 19th couldn't sleep/rollover onto either arm as the pain increased and still couldn't lift my left arm at all. Woke up twice in the AM and expelled whatever was in my stomach from a late dinner. The morning of the 20th a fever was still present and uncontrollable shivering still continued as it did during the night before. The size of the injection site red area grew to 2.5 in. in diameter. The day of the 19th I was pretty tacky at a constant 120+ and then the morning of the 20th in the ER I was around 144 with a fever of 104. The morning of the 21st the red area grew to covering more than half of my upper arm and was still warm as it had been since the night of the 18th. Released from the hospital on the 21st and the red area didn't completely fade until the week of January 8th.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Candida test, Chills, Cognitive disorder, Craniocerebral injury, Disability
Clinical narrative: Red, hot itchy raised after injection. Started with sore throats, fever, chills, Muscle aches, Cold, Flu. Now permanently disabled.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Fibromyalgia, Headache, Influenza, Insomnia
Clinical narrative: Red, hot itchy raised after injection. Started with sore throats, fever, chills, Muscle aches, Cold, Flu. Now permanently disabled.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Lyme disease, Mental impairment, Myalgia, Nasopharyngitis, Nervous system disorder
Clinical narrative: Red, hot itchy raised after injection. Started with sore throats, fever, chills, Muscle aches, Cold, Flu. Now permanently disabled.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Physical disability, Pneumonia chlamydial, Pruritus, Pyrexia
Clinical narrative: Red, hot itchy raised after injection. Started with sore throats, fever, chills, Muscle aches, Cold, Flu. Now permanently disabled.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Streptococcus test, Swelling
Clinical narrative: Red, hot itchy raised after injection. Started with sore throats, fever, chills, Muscle aches, Cold, Flu. Now permanently disabled.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies and concurrent conditions were not reported. Concomitant therapies included sterile diluent. On 12-JAN-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # M000996, expiration date 07-JAN-2018, for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site pruritus, Mobility decreased, Pain, Tenderness, Urticaria
Clinical narrative: This spontaneous report was received from a 61 year old female patient regarding herself. Pertinent medical history was reported as none. Drug reactions/allergies to sulfa drugs. Patient had a dose of PREVNAR 13 in 2016 but had not had any reaction. Concomitant medication included a dose of tetanus vaccine in the other arm on 16-JAN-2018. On 16-JAN-2018, the patient received PNEUMOVAX 23 intramuscularly for prevention of pneumococcal disease (dose, lot# and expiry date were not reported). The patient experienced itching at the site of injection within a couple of hours after receiving the vaccine (Vaccination site pruritus). Patient stated that it started with itching at the area of the injection then progressed. Patient had a welt the size of a dollar which tripled in size (Urticaria) and was extremely painful. It then spread to the upper quadrant of my back and was so painful that she couldn't move her arm (Injected limb mobility decreased) or touch it (Administration site hypersensitivity) on unspecified dates. Laboratory tests were reported as none. The patient had reported the event to her provider who directed her to apply ice pack and take ibuprofen (ADVIL). Outcome and causality of the events were not reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On 05-JAN-2018, the patient received improperly stored M-M-R II lot# N010496 with expiry date of 31-MAR-2019 for prophylaxis. No adverse effect was reported. Temperature/time frame: 9 C to 25 C (13.2 C) for 14 hours. There was no previous temperature excursion. The call was because of data logger.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 9 months 19 days old infant. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 18-JAN-2018, the patient received the third dose of ROTATEQ lot# N011647 with expiry date of 17-NOV-2018 orally for prophylaxis (Inappropriate schedule of drug administration). No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Hypersensitivity, Rhinorrhoea, Sneezing, Swelling
Clinical narrative: This spontaneous report was received from a nurse refers to herself a 51 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced hypersensitivity (hives, swelling, runny nose, sneezing, hard time breathing). The outcome of hypersensitivity was unknown. The reporter considered hypersensitivity to be related to PNEUMOVAX 23.
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a nurse refers to herself a 51 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced hypersensitivity (hives, swelling, runny nose, sneezing, hard time breathing). The outcome of hypersensitivity was unknown. The reporter considered hypersensitivity to be related to PNEUMOVAX 23.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Pain, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist and a control nurse via a company representative and refers to a 68 years old non-pregnant female patient. The patient's pertinent medical history, and concurrent conditions were not reported. The patient's historical drugs included PREVNAR 13. Concomitant therapies included LEXAPRO, metoprolol XL, nitroglycerin SL, atorvastatin, MURO 128 OPHTHALMIC SOLUTION and XIIDRA. On 16-JAN-2018 (also reported as 19-JAN-2018), the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration were not reported, lot # N019348 and expiration date: 08-FEB-2019) for routine vaccination. On 18-JAN-2018 (reported as 48 hours post vaccination with PNEUMOVAX 23), the patient experienced a problem with cellulitis; the signs were reported as redness, swelling, pain and heat. The patient sought medical attention but, it was unknown if laboratory diagnostic tests were performed. As treatment for the event, the patient received KEFLEX. At the time of this report, the patient was recovering from the event cellulitis. The reporting nurse request a lot check to determine contamination and offered to send a sample it would help with the investigation. The nurse stated that the vaccine was quarantined. Additionally, the clinic had many sites but the reactions only occurred in one site. The causality between cellulitis and PNEUMOVAX 23 was not reported. Upon internal review cellulitis was determined to be medically significant. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1801USA007997: US-009507513-1801USA008061.