chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Discomfort, Pruritus generalised
Clinical narrative: Patient experienced large bruising on the shoulder and upper arm and generalized soreness.  Patient was uncomfortable for a few days.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase, Fibrin D dimer, Metabolic function test, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Bilateral lower extremity weakness, pain, stiffness hours after flu vaccine.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Bilateral lower extremity weakness, pain, stiffness hours after flu vaccine.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: PT CAME IN 2 DAYS LATER AND SHOWED ME HER ARM. IT WAS SWOLLEN AND RED AND HOT TO THE TOUCH. SHE SAID IT STARTED THAT NIGHT. I WOULD OF SENT HER TO THE DR. BUT SHE SAID IT WAS LOOKING BETTER AND NOT AS SWOLLEN. I TOLD HER TO TAKE BENADRYL 50 MG EVERY 6 HOURS, AND TO ICE BACK EVERY 2 HOURS.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site irritation, Injection site swelling
Clinical narrative: Redness, irritation, swelling, inflammation at injection area and down arm appearing day following injections. Patient in today (3rd day after) saying redness is improving but wanted to consult about effects. Advised patient to take oral antihistamine and use topical steroid cream. Also ibuprofen if pain/swelling is present. Advised to monitor area and consult dr if symptoms worsen or do not begin to improve in next few days.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site rash, Pyrexia, Vomiting
Clinical narrative: Spoke with Pt mother and she stated that the Pt was not ill prior to receiving the vaccine (no fever, diarrhea, or vomitting). She stated that she started throwing up around 9pm 09/06/2017 and her fever reached 100.5. She stated that all three vaccines were red and the leg that had 2 vaccines on them (R leg) had bumps. The vaccine on the upper R thigh was the size of a dime and the vaccine on the lower R thigh was a nickel. She denied any rash. I advised her to return to UC if symptoms persist and she is always welcome to call our office and speak with me regarding any vaccine questions. Pt was evaluated by UC, but no treatments were given on 09/06/2017. They returned to UC on 09/08/2017 for vomiting and an US was ordered to r/o pyloric stenosis.
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram, Milk allergy
Clinical narrative: This spontaneous report was received from a 53 year old male consumer, reporting on himself. The patient's medical history included vertigo and depression. Concomitant therapies included citalopram (CITALOPRAM). The patient had no pertinent drug reactions/allergies. On 10-AUG-2017 the patient was vaccinated with ZOSTAVAX 19400 Plaque Forming Units (PFU), subcutaneously for prevention of herpes zoster (dose, units or lot number were not reported). On approximately 17-AUG-2017, about a week after onset of therapy the patient experienced shortness of breath, tightness in upper left side of chest, and a sensitivity to milk products. No treatment was given for the adverse events. On 07-SEP-2017 the patient had a doctor appointment where an Electrocardiogram (EKG) and vital sign test were performed (the results were not provided). The outcome for shortness of breath, tightness in upper left side of chest, and sensitivity to milk products was reported as not recovered. Causality assessment was not provided.
Age: 0.92
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an 11 month old patient of unknown gender. Patient's pertinent medical history and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with the first dose of VAQTA (25/0.5), for prophylaxis (lot number and expiry date were not reported). The reporter described that the first dose occurred one week before the patient's first birthday (Drug administered to patient of inappropriate age). The second dose of VAQTA was administered six months after the first dose. No concomitant medications were reported. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 14-SEP-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU, lot # N020943, expiration date 26-OCT-2018 (dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with a proprly stored dose of  sterile diluent (DILUENT MRK) lot #N016189, expiration date 13-AUG-2019.    On an unspecified date, the vaccine was exposed to temperature ranges between -9° Celcius (C) to 8°C during a time frame of 11 days. There was not previous temperature excursion, the temperature excursion was not called by a data logger. Adverse effects were not reported.
Age: 5.0
Sex: F
Vaccine: FLUX, MMRV
Symptoms: Pyrexia, Sialoadenitis, Swelling, Swelling face, Viral infection
Clinical narrative: This spontaneous report was received from the patient's father via company representative, referring to a 5 year old female patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 10-SEP-2017 (also reported as "10 years ago"), the patient was vaccinated with PROQUAD (strength, dose, route of administration, lot number and expiration date were not provided) which was diluted with sterile diluent, for prophylaxis. The patient also received a dose of an unspecified flu vaccine (manufacturer unknown). Subsequently on unspecified time, the patient developed "a fever and swelling on the left side of her cheek and neck"; no further clarifying information was provided. The patient was seen by an unspecified healthcare provider on 20-SEP-2017, in regards to the reaction and was diagnosed with a viral infection of the salivary glands. At the reporting time, the outcome of the patient was not reported. The reporter did not assess the causality between the event and PROQUAD. Upon internal review the event of sialoadenitis was considered to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9, lot# : N004798, expiration date: 31-OCT-2019 for prophylaxis (route of administration was not reported). The administered dose of the vaccine experienced a temperature excursion 32 Fahrenheit  (°F) to 35° Fahrenheit  (°F) for 6 hours, as recorded by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010758.
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report based on information received by Pfizer from Merck & Co., Inc. (Manufacturer Control Number: 00556191). The primary reporter was a nurse reporting that on 17Aug2017 a patient of unspecified age and gender was given a single dose of PREVNAR 13 for immunisation. Nurse reported that the patient had an unspecified allergic reaction following administration, and received unspecified treatment. Event outcome was unknown. This information had not been reported to the FDA. No follow-up attempts possible. No further information expected.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Paraesthesia oral
Clinical narrative: Metallic taste, tingling of tongue approximately 3 hrs. after vaccinations. Sx improved overnight.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site reaction, Rash vesicular
Clinical narrative: 5 minutes after injections were given, patient had a hive-like rash develop on her lower extremities. Redness also noted to her extremities from the knee down.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Blister, Erythema, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: Patient received MENVEO vaccine two days ago. The afternoon of vaccine the arm was warm and achy that has continued to worsen. The patient started to have blisters yesterday. The patient received ibuprofen yesterday x 2 and last night a dose of BENADRYL x 1. The patient has redness, warm to arm and extending to cheek. The area also itches but denies pain. (Note taken directly from Dr.'s office visit).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Skin warm
Clinical narrative: Patient received MENVEO vaccine two days ago. The afternoon of vaccine the arm was warm and achy that has continued to worsen. The patient started to have blisters yesterday. The patient received ibuprofen yesterday x 2 and last night a dose of BENADRYL x 1. The patient has redness, warm to arm and extending to cheek. The area also itches but denies pain. (Note taken directly from Dr.'s office visit).
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, MEN, TDAPIPV, VARCEL
Symptoms: Cellulitis
Clinical narrative: Patient received x7 vaccines on 9/19/17. Now has upper left arm cellulitis. Pt received Hep A, Hep B, Meningo, Polio, Td/Tdap/Varicella. Please contact Health Clinic for details. Pt is being treated with BACTRIM as of 9/21/2017. That is all the information I have. Thank you.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: 36 hours after getting the vaccine I noticed an itchy rashes on the left side of my neck and face. Rash looks like red, flat blotches.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Swollen tongue, Vision blurred
Clinical narrative: About an hour after he got the shot on Wednesday 9/20/17 (around 9:15pm- got shot around 8:10pm ) when he went to leave the store and drive home, he said he felt like he was a little dizzy, his vision was "kind of blurry", and felt almost like his tongue felt like swollen. Said when he got home he took some Benadryl and felt fine after that. Said he wasn't sure if it was even related to the vaccine, but I thought it best to report it just in case. He needed no further treatment. He reported this 2 days later 9/22/17 to me at the store via a phone call.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Oral herpes
Clinical narrative: The morning after my shot, I woke up with a multitude of cold sores, and inside my mouth too. I have had cold sores before, but never in my mouth. There were a number of them along my gum line. This is a first for me.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Asthenia, Cold sweat, Dizziness, Nausea, Pallor
Clinical narrative: GARADASIL 9 and MENACTRA were given on upper and lower right deltoid. A few minutes after vaccine administration, lthe pt. had a vaso-vagal response. He became pale, nauseous, cold-clammy, feeling faint. Responsive, talking but weak. Pt. laid down Dr. aware, in room evaluating pt. Vitals taken, serial BP and Pulse rate. Offered water and juice. BP and Pulse improved after 10 minutes. Color pink, warm with brisk capillary refill. Alert, oriented. Observed for another 10 mins. Sent home with Mom.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Presyncope
Clinical narrative: GARADASIL 9 and MENACTRA were given on upper and lower right deltoid. A few minutes after vaccine administration, lthe pt. had a vaso-vagal response. He became pale, nauseous, cold-clammy, feeling faint. Responsive, talking but weak. Pt. laid down Dr. aware, in room evaluating pt. Vitals taken, serial BP and Pulse rate. Offered water and juice. BP and Pulse improved after 10 minutes. Color pink, warm with brisk capillary refill. Alert, oriented. Observed for another 10 mins. Sent home with Mom.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood creatine phosphokinase, C-reactive protein, Computerised tomogram head, Eye movement disorder, Full blood count
Clinical narrative: Approximately 15 hours after immunizations, presented to the emergency room with possible seizure activity. Mother states - child with rapid eye movement and shaking. Patient discharged from ER with follow up appointment in the am with pediatric clinic. On 13Sep17, patient follow up with Dr. Patient transferred to ER for further evaluation and management. After labs and CT of head, patient transferred to another Hospital for admission to PICU for ongoing monitoring and workup.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intensive care, Metabolic function test, Red blood cell sedimentation rate, Tremor, Urine analysis
Clinical narrative: Approximately 15 hours after immunizations, presented to the emergency room with possible seizure activity. Mother states - child with rapid eye movement and shaking. Patient discharged from ER with follow up appointment in the am with pediatric clinic. On 13Sep17, patient follow up with Dr. Patient transferred to ER for further evaluation and management. After labs and CT of head, patient transferred to another Hospital for admission to PICU for ongoing monitoring and workup.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at injection site beginning about 24 hours post vaccination. No systemic symptoms. Appears to be injection site reaction. Recommended acetaminophen for analgesic and ice to area. Recommended follow up with MD if symptoms worsen or fever develops.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Pain in extremity
Clinical narrative: PAIN and INFLAMMATION TO LEFT UPPER ARM.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Arthralgia, Chest pain, Electroencephalogram abnormal, Fatigue
Clinical narrative: Patient's mother reports that approximately between April - May of 2016 the patient began to experience hip pain, elbow pain, swollen lymph nodes, lost 20 lbs. Over the winter into 2017 mother reports the patient began to experience chronic fatigue, chest pains, memory loss, forgetfulness, irregular menses, irritability, hand tremors, and a seizure disorder. PLEASE NOTE THE PRACTITIONER COMPLETING THIS FORM IS NOT THE SAME AS THAT WHO ADMINISTERED OR ORDERED VACCINE. THE PRACTITIONER TREATING THE PATIENT DURING THIS SPAN OF TIME HAS SINCE LEFT THE ORGANIZATION.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Irritability, Lymphadenopathy, Memory impairment, Menstruation irregular, Seizure
Clinical narrative: Patient's mother reports that approximately between April - May of 2016 the patient began to experience hip pain, elbow pain, swollen lymph nodes, lost 20 lbs. Over the winter into 2017 mother reports the patient began to experience chronic fatigue, chest pains, memory loss, forgetfulness, irregular menses, irritability, hand tremors, and a seizure disorder. PLEASE NOTE THE PRACTITIONER COMPLETING THIS FORM IS NOT THE SAME AS THAT WHO ADMINISTERED OR ORDERED VACCINE. THE PRACTITIONER TREATING THE PATIENT DURING THIS SPAN OF TIME HAS SINCE LEFT THE ORGANIZATION.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor, Weight decreased
Clinical narrative: Patient's mother reports that approximately between April - May of 2016 the patient began to experience hip pain, elbow pain, swollen lymph nodes, lost 20 lbs. Over the winter into 2017 mother reports the patient began to experience chronic fatigue, chest pains, memory loss, forgetfulness, irregular menses, irritability, hand tremors, and a seizure disorder. PLEASE NOTE THE PRACTITIONER COMPLETING THIS FORM IS NOT THE SAME AS THAT WHO ADMINISTERED OR ORDERED VACCINE. THE PRACTITIONER TREATING THE PATIENT DURING THIS SPAN OF TIME HAS SINCE LEFT THE ORGANIZATION.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site irritation, Joint effusion
Clinical narrative: Redness, irritation around injection site that then migrated to the inside of the arm. There also appeared to be some fluid accumulation near the elbow.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Throat tightness
Clinical narrative: Patient experienced egg-like bump at injection site. Area around injection site and below became hot to touch and a red thick band around the arm for an appearance. Patient also experienced a tightness in her throat.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Ultrasound scan normal, X-ray normal
Clinical narrative: Patient complaining of severe left shoulder pain.
Age: 80.0
Sex: M
Vaccine: FLU3, HEPAB, TDAP
Symptoms: Herpes zoster
Clinical narrative: Patient's daughter reported the vaccines given caused him to be hospitalized with internal shingles. Patient had shingles and was on valacyclovir for 7 days and finished course on 9/4/17 when he came to get vaccines he checked that he had no fever or illness. Daughter said that the 3 vaccines given caused the shingles to attacked his organs.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction. Patient received KINRIX instead individual doses of Dtap & IPV.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Malaise, Myalgia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Malaise. Muscle aches. Sore throat. Runny nose. Cough - 3 days.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Bone pain, Cough, Headache, Influenza, Nasal congestion
Clinical narrative: NDC 19515-912-52.  Patient started suffering from flu symptoms including fever, stuffy nose, headache, post nasal drip, achy bones, and cough.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Upper-airway cough syndrome
Clinical narrative: NDC 19515-912-52.  Patient started suffering from flu symptoms including fever, stuffy nose, headache, post nasal drip, achy bones, and cough.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Patient had a low grade fever the next day and the site of injection was red, circular, hot, and painful.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure increased, Chills, Dyspnoea, Vision blurred
Clinical narrative: P.t has blurry vision, chills, weakness, shortness of breath and elevated blood pressure.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: 5-10 minutes after receiving the vaccine, the patient fainted. She regained consciousness within 20-30 seconds. Paramedics were called and made the decision to transport her to the ED. Treatment after leaving the pharmacy is unknown.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Back pain, Chills, Decreased appetite, Fatigue
Clinical narrative: Very sore injection site, red rash moving down shoulder to arm pit with swelling in shoulder, head aches, alternating chills and fevers, loss of apatite, pain in joints and back, severe back itching, limited arm use/movement, frequent urination, general fatigue.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Mobility decreased, Pollakiuria, Pruritus
Clinical narrative: Very sore injection site, red rash moving down shoulder to arm pit with swelling in shoulder, head aches, alternating chills and fevers, loss of apatite, pain in joints and back, severe back itching, limited arm use/movement, frequent urination, general fatigue.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Rash erythematous, Swelling
Clinical narrative: Very sore injection site, red rash moving down shoulder to arm pit with swelling in shoulder, head aches, alternating chills and fevers, loss of apatite, pain in joints and back, severe back itching, limited arm use/movement, frequent urination, general fatigue.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Pallor, Posture abnormal, Syncope
Clinical narrative: Patient developed syncope within a minute or 2 after getting flu shot. Was sitting down, complained about getting dizzy turned pale and started sliding off the chair. I grabbed him by shoulders to prevent from falling and tapped his cheek. He opened his eyes almost immediately. I told him to bend down and keep his head between his legs. Called 911. He said he felt better but after few min of sitting straight turned pale again so I told him to keep his head down till paramedics came. Told him to make sure to get someone to walk with him home since he didn't want to go with paramedics. But he just left.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Nasopharyngitis, Paraesthesia
Clinical narrative: After flu shot, patient got a cold shortly without any treatment. School didn't start at that time. Patient didn't go out. We, parents, weren't not sick. A week ago (9/16/2017), patient got this tingling feeling, but he didn't tell us. The symptom got worse due patient's PE class, and he finally complained to us. First we thought maybe he played computer too much, but the more we asked, the more we felt something wrong. We went online to search and found something called Guillain-Barre Syndrome with tingling leg which may lead to death. I can't stand those words. Patient is such a bright boy. We try to do good for the society. Why does it happen to him? Maybe it's not. But please help! help! help! Patient is a heathy boy. Why is this?!
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient received the flu vaccine around 11:30 am, towards the end of her WCC appointment today. She reports developing a couple itchy red bumps around noon while at school. States she developed more itchy red bumps to stomach, chest, shoulders over the course of the afternoon. Father brought patient back to the clinic at about 4:30 pm. There were no other changes to meds, foods, detergents, lotions or any other possible cause of allergic reaction. Denies respiratory or swallowing concerns - vitals stable. Patient was given BENADRYL 25 mg PO x 1 and she can receive every 6 hours. ER precautions provided for any respiratory involvement or difficulty swallowing.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large, red and warm area at injection site. Advised patient to apply cool compress until swelling began to subside and report to physician if it continued to get larger.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENTS ARM IS RED, SWOLLEN AND HOT TO THE TOUCH. AREA AROUND INJECTION SITE AFFECTED IS ABOUT 2 INCHES IN DIAMETER.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Headache, Nausea, Peripheral swelling
Clinical narrative: Arm swelling, redness, fever/chills, headache, nausea.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Arm swelling, redness, fever/chills, headache, nausea.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Influenza like illness, Limb discomfort, Malaise
Clinical narrative: Patient indicated he felt sick since getting the 2 vaccines, starting right after receiving the 2 vaccines. He states he felt like he had the flu and had arm discomfort.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient called pharmacy 5 days after administration of vaccine to report rash at injection site, about 1.5" across.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site warmth, Rash, Rash erythematous, Rash macular
Clinical narrative: An itchy, blotchy red rash and small red bumps appeared on my arms, neck, and abdomen approximately 30 minutes after injection. The injection site was sore and warm to the touch. I took 25mg of diphenhydramine approximately 35 minutes after injection, with some relief of symptoms. Symptoms had totally cleared at approximately 4:00pm the same day.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash pruritic
Clinical narrative: An itchy, blotchy red rash and small red bumps appeared on my arms, neck, and abdomen approximately 30 minutes after injection. The injection site was sore and warm to the touch. I took 25mg of diphenhydramine approximately 35 minutes after injection, with some relief of symptoms. Symptoms had totally cleared at approximately 4:00pm the same day.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal stiffness
Clinical narrative: Patient stated that about 2-3 hours after receiving the shot she started to get a stiff neck. She said the soreness extended all the way down to the back of her arm that she received the shot in behind the shoulder. The patient did not seek treatment from a medical facility; she said she would take her prescription pain medication for the pain. She stated she would go to an urgent care if she got worse. The patient wanted to make sure this was reported as she felt this was a direct correlation to the shot she received earlier.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose - 8/16/2017 - was given. No adverse reaction - 9/22/17.
Age: 84.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Chills, Feeling of body temperature change, Injection site erythema, Pain, Pyrexia
Clinical narrative: Hot/cold (chills); fever; achy feeling; redness down arm and red band below where shot was given and above elbow. Advised to see MD.
Age: 48.0
Sex: F
Vaccine: FLU4, HEPAB, PPV
Symptoms: Asthenia, Breast swelling, Confusional state, Decreased appetite, Erythema
Clinical narrative: 9/15/17 weakness, headache, nausea, decreased appetite started in evening. 9/16/17 Fever 102 degrees, back discomfort, redness and swelling right upper arm about 3 1/2" wide band extending from outer arm, inner arm to right axillary and over breast area. Some confusion with fever for 48 hours. Redness and swelling improving by 9/19/17.
Age: 48.0
Sex: F
Vaccine: FLU4, HEPAB, PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Musculoskeletal discomfort, Nausea
Clinical narrative: 9/15/17 weakness, headache, nausea, decreased appetite started in evening. 9/16/17 Fever 102 degrees, back discomfort, redness and swelling right upper arm about 3 1/2" wide band extending from outer arm, inner arm to right axillary and over breast area. Some confusion with fever for 48 hours. Redness and swelling improving by 9/19/17.
Age: 48.0
Sex: F
Vaccine: FLU4, HEPAB, PPV
Symptoms: Pyrexia
Clinical narrative: 9/15/17 weakness, headache, nausea, decreased appetite started in evening. 9/16/17 Fever 102 degrees, back discomfort, redness and swelling right upper arm about 3 1/2" wide band extending from outer arm, inner arm to right axillary and over breast area. Some confusion with fever for 48 hours. Redness and swelling improving by 9/19/17.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Dizziness, Nasopharyngitis, Visual impairment
Clinical narrative: Dizziness, lightheaded, cold, vision trouble. 911 called. Vitals checked, stable. Sat for 30min, refused emergency room. Went home with parents.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Entire upper arm red and swollen. Slightly painful.
Age: 78.0
Sex: F
Vaccine: PNC13, TTOX
Symptoms: Asthenia, Back pain, Chills, Decreased appetite, Dizziness
Clinical narrative: Nausea - sick to stomach. Can't lift small items. Dizzy, hot, tired, weakness, loss of appetite, back pain, chills, constant pain in right arm on going.
Age: 78.0
Sex: F
Vaccine: PNC13, TTOX
Symptoms: Fatigue, Feeling hot, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Nausea - sick to stomach. Can't lift small items. Dizzy, hot, tired, weakness, loss of appetite, back pain, chills, constant pain in right arm on going.
Sex: U
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of lymphadenopathy cervical in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced lymphadenopathy cervical. On an unknown date, the outcome of the lymphadenopathy cervical was unknown. It was unknown if the reporter considered the lymphadenopathy cervical to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that, the patient developed left-sided neck lymphadenopathy which was goiter size after receiving FLUARIX QUADRIVALENT. The patient was already hospitalized at the time of receiving the product (reason not specified). No other symptoms were reported. No further information was available at the time of repot regarding the incident.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Differential white blood cell count, Electrocardiogram, Erythema, Full blood count
Clinical narrative: Pt. had localized swelling, redness and fever after having both vaccines administered in office. Patient developed cellulitis requiring antibiotic treatment . Pt preference for both in same arm.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Lipids, Prostatic specific antigen, Pyrexia, Swelling
Clinical narrative: Pt. had localized swelling, redness and fever after having both vaccines administered in office. Patient developed cellulitis requiring antibiotic treatment . Pt preference for both in same arm.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction, redness, swelling tenderness at the site of injection on Lt. deltoid region. 5" x 4".
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Eye swelling, Visual impairment
Clinical narrative: The morning after receiving vaccine my right eye was swollen, making it hard to see out of my right eye. This lasted for four days.
Sex: F
Vaccine: MENB
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 19-year-old female patient received BEXSERO. Previously administered products included BEXSERO (received 1st dose in spring of 2017). On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site pain, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site pain to be related to BEXSERO. It was unknown if the reporter considered the injection site erythema to be related to BEXSERO. Additional details were provided as follows: The nurse reported on behalf of her daughter. The age of vaccination was not reported. In spring of 2017, the patient received 1st dose of BEXSERO. The patient received the 2nd dose of BEXSERO, approximately spaced from her first one. The patient complained about hurting at the injection site, redness at the injection site and tenderness at the injection site. The patient had redness in a large area of her arm and it took about 4 to 5 days to go away. When the reporter looked at the patient's arm, she realized that the patient had received BEXSERO subcutaneously instead of intramuscularly, which led to inappropriate route of vaccination.
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient got flu shot on 9-13-17. That evening rash, swollen where shot given. No itching to report.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: About 9 hours after receiving vaccine, pt had chills (was shaking) for 30 mins to an hour. She has never had reaction to vaccine before.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: The patient developed cellulitis 2 days after receiving the vaccine. She was treated at urgent care on 8-6. She received AUGMENTIN 500-125 BID.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Pt bleed after injection for a while. Held cotton ball on for several minutes when removed I noticed she had a significant bump (or swelling) got nurse practitioner and we put ice on had her wait 30 minutes bleeding stopped.
Age: 1.0
Sex: F
Vaccine: FLU4, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain on left thigh.
Age: 99.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure abnormal, Feeling cold, Influenza like illness
Clinical narrative: Per daughter pt. experienced flu-like symptoms: felt cold and heating pad could not warm her up. BP was not normal. Brought to ER where treated.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, hard, raised, warm area of injection 48 hours post injection. Red area still growing approximately 48 hours post injection.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient requested for flu vaccine and was given more than recommended dose of FLULAVAL.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Blood test normal, Chills, Electrocardiogram normal, Erythema
Clinical narrative: Stated approximately 1 hour after receiving vaccine started experienced palpitations, shaking/shivering. Blood pressure elevated, redness on face. Patient went to ER stated they did EKG and blood work but found nothing conclusive and discharged.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Tremor
Clinical narrative: Stated approximately 1 hour after receiving vaccine started experienced palpitations, shaking/shivering. Blood pressure elevated, redness on face. Patient went to ER stated they did EKG and blood work but found nothing conclusive and discharged.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: Patient called pharmacy an hour after injection her lips started to swell and tingle she did not do anything about it but problem continued over next couple of days. She went to urgent care on 9/22/2017 and was told to take BENADRYL.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Contusion, Pyrexia, Swelling
Clinical narrative: Pt had bruise and bump on deltoid after 1 hour of injection. Pt had fever and chills later that day. 9/21/17 pt went to Dr. office and assistant told her she didn't need antibiotics and pt didn't see MD on 9/21/17. I recommended Ibuprofen for fever 9/22/17. Pt feels a lot better today. Said daughter had same reaction a year ago but she never had that reaction.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Inflammatory marker increased, Pyrexia
Clinical narrative: My 3 year old received the flu shot and 3 hours later he started having fevers which lasted 7 days straight. He had to stay at hospital for 4 days straight and now is developing very bad coughs.
Age: 74.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Allergy to chemicals, Blood test normal, Rash, Urticaria
Clinical narrative: Upon receiving a dose of flu vaccine at 1500 hours on 09/29/2016 I had broken out with an extreme case of hives and rash over my back torso thighs and crotch area and proceeded to the ER for treatment. I was given a Cortisone shot and prednisone tablet which had relieved the symptoms. Since then I have been to allergists oncologist dermatologists receiving shots of cortisone again. I have had blood work done which all effects have come back negative for indication of any blood-liver and or kidney maladies as of this week I have been to an allergist with some indication of allergies to certain manmade byproducts (formaldehyde), which still leaves me in limbo on why I had the outbreaks throughout the year.
Age: 74.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Upon receiving a dose of flu vaccine at 1500 hours on 09/29/2016 I had broken out with an extreme case of hives and rash over my back torso thighs and crotch area and proceeded to the ER for treatment. I was given a Cortisone shot and prednisone tablet which had relieved the symptoms. Since then I have been to allergists oncologist dermatologists receiving shots of cortisone again. I have had blood work done which all effects have come back negative for indication of any blood-liver and or kidney maladies as of this week I have been to an allergist with some indication of allergies to certain manmade byproducts (formaldehyde), which still leaves me in limbo on why I had the outbreaks throughout the year.
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Arthralgia, Dyspepsia, Fatigue, Irritability
Clinical narrative: Strange thoughts, neck pain, dyspepsia, esophageal spasms, hives, itching, itchy nose, runny nose, sore joints, irritability, anxiety, fatigue, tingly head.
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Nasal pruritus, Neck pain, Oesophageal spasm, Paraesthesia, Pruritus
Clinical narrative: Strange thoughts, neck pain, dyspepsia, esophageal spasms, hives, itching, itchy nose, runny nose, sore joints, irritability, anxiety, fatigue, tingly head.
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Rhinorrhoea, Thinking abnormal, Urticaria
Clinical narrative: Strange thoughts, neck pain, dyspepsia, esophageal spasms, hives, itching, itchy nose, runny nose, sore joints, irritability, anxiety, fatigue, tingly head.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, Body aches, light fever.
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray, Chest injury, Face injury, Head injury, Joint injury
Clinical narrative: I received the second dose of the GARDASIL vaccine a year and a few days after I received the first dose, after receiving the injection, about 2 minutes later, I fainted, I hit my head, left cheek, left upper ribs and sternum and left hip bone, everything has resolves besides left upper rib and sternum which are still moderately swollen and it occasionally pops out of place. I have gotten chest x rays and am waiting to hear back. I am concerned that I had an allergic reaction to the vaccination or if my blood sugar was just low that day being it was early morning and I had only a protein bar before that. I have never fainted before so that's why this is concerning to me. I am not sure if I should get the third dose due to hearing horror stories of the serious side effects such as paralysis and weakness, especially after having a reaction to the second dose. Is this a red flag?
Sex: F
Vaccine: HPV4
Symptoms: Sternal injury, Swelling, Syncope
Clinical narrative: I received the second dose of the GARDASIL vaccine a year and a few days after I received the first dose, after receiving the injection, about 2 minutes later, I fainted, I hit my head, left cheek, left upper ribs and sternum and left hip bone, everything has resolves besides left upper rib and sternum which are still moderately swollen and it occasionally pops out of place. I have gotten chest x rays and am waiting to hear back. I am concerned that I had an allergic reaction to the vaccination or if my blood sugar was just low that day being it was early morning and I had only a protein bar before that. I have never fainted before so that's why this is concerning to me. I am not sure if I should get the third dose due to hearing horror stories of the serious side effects such as paralysis and weakness, especially after having a reaction to the second dose. Is this a red flag?
Age: 66.0
Sex: M
Vaccine: FLUA3, PNC13, TDAP, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Pt reported nausea and fever the next day after receiving vaccines.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pt. said flu shot hurt during administration. Over 3 weeks later she said it still hurts and hurts when she lifts her arm up. (reported to pharmacy 9/22/17).
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Dizziness, Syncope, Urine analysis normal
Clinical narrative: Syncopal episode w/prodromal dizziness/mild abd pain. Brief, fine before and after. Will see cardiology.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Pt. immediately begin to have urticaria that began on chest then on both (L) and (R) aspects of neck. There were a total of 11 hives. This was the only reaction the Pt. had. No resp. distress. It did not worsen. A steroid was given IM as well as diphenhydramine. The Pt. was monitored for approx. 1 hour. Pt. received  2 mg. dexamethasone IM and 12.5 mg. of diphenhydramine. He was monitored for about 1 hour. His urticaria did go away. Mom was educated to give diphenhydramine every 6 hours around the clock for the next 48 hours. She was advised to monitor the pt. and if he began to have any additional skin problems such as urticaria and/or rash and especially if he began to have difficulty breathing, she was advised to take him immediately to the ER.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Crying, Musculoskeletal pain, Nausea, Pain in extremity
Clinical narrative: Arm/shoulder hurting, nausea, crying in pain. Advice - Ibuprofen/acetaminophen, fluids, rest, ice/heat.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Administration site pain, Pain
Clinical narrative: My 13 year old daughter received the 2nd dose of the GARDASIL shot and has experienced pain on the administration site since. She complains it hurts when raising her arm and shot site hurts. She complains it feels like a sharp needle stick.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient's left arm is visibly red and swollen. It is warm and raised upon touching. Patient said she has some itching.
Age: 52.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: Patient arm got swollen and it was painful, she could not sleep, went to the ER next day and got Med.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Blood pressure increased, Dysgeusia, Myalgia
Clinical narrative: (L) arm muscular pain. Metallic taste in mouth. Elevated blood pressure.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and pain in the right arm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, MMR
Symptoms: Erythema infectiosum, Measles post vaccine, Pruritus, Pyrexia, Rash
Clinical narrative: He ran a fever a few days after the shot and was sent home from Daycare twice during the week following his shots. He continued to run a low grade temperature until approximately 11 days after the shot when we noticed patches of hives. After a weekend of hives and him not feeling good with a low grade temperature, he was taken to Dr. at agency where he was diagnoses with the measles on 9/11/17 .
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, MMR
Symptoms: Rash erythematous
Clinical narrative: He ran a fever a few days after the shot and was sent home from Daycare twice during the week following his shots. He continued to run a low grade temperature until approximately 11 days after the shot when we noticed patches of hives. After a weekend of hives and him not feeling good with a low grade temperature, he was taken to Dr. at agency where he was diagnoses with the measles on 9/11/17 .
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, MMR
Symptoms: Feeling abnormal, Measles, Pyrexia, Urticaria
Clinical narrative: He ran a fever a few days after the shot and was sent home from Daycare twice during the week following his shots. He continued to run a low grade temperature until approximately 11 days after the shot when we noticed patches of hives. After a weekend of hives and him not feeling good with a low grade temperature, he was taken to Dr. at agency where he was diagnoses with the measles on 9/11/17 .
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure decreased, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: The patient fainted after shot. He became unresponsive and came to about 30 seconds later. Blood pressure dropped to74 over 40.
Age: 15.0
Sex: F
Vaccine: MEN, MENB, MNQHIB
Symptoms: Chills, Gait inability, Headache, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Fever, chill, headache, vertigo, leg muscles pain/ weakness/ stiffness and not able to walk for 3 days post vaccination. Patient is slowly gaining motility but still vertigo and headache to now.
Age: 15.0
Sex: F
Vaccine: MEN, MENB, MNQHIB
Symptoms: Myalgia, Pyrexia, Vertigo
Clinical narrative: Fever, chill, headache, vertigo, leg muscles pain/ weakness/ stiffness and not able to walk for 3 days post vaccination. Patient is slowly gaining motility but still vertigo and headache to now.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Shortly after getting the flu vaccine, the shoulder where the vaccine has been administered began to get sore. Within one day, it was achy and is very painful when I try to use the arm/shoulder.  Lifting my arm to shoulder height causes pain and continues for the past 6 days with no relief.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: PATIENT RECEIVED VACCINATION AND LATER THAT EVENING HE STARTED ITCHING AND NOTICED HE HAD HIVES UNDER HIS ARMS, WHICH SPREAD TO BACK. THE HIVES SPREAD TO TRUNK, GROIN, AND BUTTOCKS. PATIENT ENDED UP GOING TO EMERGENCY ROOM AND RECEIVED  A STEROID INJECTION AND PREDNISONE DOSEPACK TO TREAT REACTION. PATIENT HAS RECEIVED FLU VACCINATIONS ANNUALLY AND HAS NEVER HAD A REACTION. UPON SPEAKING WITH THE PATIENT, HE DID TELL US THAT HE HAD BEEN STUNG 3 DAYS PRIOR TO RECEIVING THE VACCINE AND IS ALLERGIC. WHEN PATIENT CAME INTO PHARMACY TO SHOW US REACTION AND PICK UP PRESCRIPTION AFTER ER VISIT, I NOTICED THERE WAS NO REACTION AT THE INJECTION SITE.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Tenderness
Clinical narrative: Patient reported shoulder pain and inability to sleep on arm. Patient acknowledged location of immunization in deltoid. Recommendation was made to ice area, use naproxen, and check with physician.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: Patient states has body aches and headache morning following her influenza vaccine. Patient states she has "flu-like" symptoms. Recommended patient take OTC acetaminophen for body aches and pains and for relief of any fever should one be present.
Age: 30.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Anion gap, Back pain, Blood calcium decreased, Blood chloride decreased, Blood glucose increased
Clinical narrative: Pt went to clinic on 9/15/17 at 8am reported he had received Tdap and PNEUMOVAX vaccines yesterday (9/14/17) at his annual check-up and last night developed fever, chills, nausea and body aches. Pt reported temp was 100.9 F this AM. Pt reported soreness in R arm and radiating pain across upper back. Pt reported rash, red bumps on the back of his neck and scalp. Pt assessed, treated and instructed to start promethazine, ibuprofen, TYLENOL, CLARITIN. Rapid influenza test was negative. Pt went to ER on 9/16/17 at 11:17 AM and reported fever, headaches, general aches. Pt assessed, treated and discharged for fever, dehydration. Pt went to office on 9/18/17 to follow up with PCP for ER visit. Pt reported at last communication with treating Provider that his symptoms are improving.