chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Injection site reaction, Pain in extremity, Pruritus
Clinical narrative: Despite pt having a shoulder injection site rxn 1 day after injection, she didn't report time until 10-20-17. Redness extended 1/2 way around arm, elbow, itchy, painful, hot, hard to touch. Still red in areas. Advised pt to take BENADRYL, ice, hydrocortisone but she didn't.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Despite pt having a shoulder injection site rxn 1 day after injection, she didn't report time until 10-20-17. Redness extended 1/2 way around arm, elbow, itchy, painful, hot, hard to touch. Still red in areas. Advised pt to take BENADRYL, ice, hydrocortisone but she didn't.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Itching from AFLURIA.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Increased redness at flu vaccine injection site. F/U vaccine given x 2 days ago. Hurts when you push on it and states hurts to walk on L. leg. Skin normal except 4" round, erythema flat slightly warm to touch localized inflammatory reaction.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Flushing, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pt said few hours after injection started with aches, pain chills, progressed 8 hours later to fever of 101 degrees, significant pain in injected arm, rash on chest, flushing and aches, pains and child. Visited ER gave BENADRYL.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt said few hours after injection started with aches, pain chills, progressed 8 hours later to fever of 101 degrees, significant pain in injected arm, rash on chest, flushing and aches, pains and child. Visited ER gave BENADRYL.
Age: 16.0
Sex: F
Vaccine: FLU4, HIBV
Symptoms: Wrong drug administered
Clinical narrative: Patient was suppose to be receiving a meningococcal conjugate vaccine and received a Haemophilus b Conjugate Vaccine in error.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Patient experienced pain and redness day after injection. She was told this was normal. Then, swelling increased and injection site is still tender. Patient visited ER. She can't raise her left arm and can't move it to perform activities of daily living. She has not had fever and no recent signs of inflammation. Movement of upper limb affected--heading toward frozen shoulder per doctor. No dates for events available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Ultrasound scan normal, X-ray limb normal
Clinical narrative: Patient experienced pain and redness day after injection. She was told this was normal. Then, swelling increased and injection site is still tender. Patient visited ER. She can't raise her left arm and can't move it to perform activities of daily living. She has not had fever and no recent signs of inflammation. Movement of upper limb affected--heading toward frozen shoulder per doctor. No dates for events available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Dermatitis psoriasiform, Rash
Clinical narrative: Rash, Psoriasis like rash, bruising on legs.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Differential white blood cell count normal, Erythema, Full blood count normal, Haemoglobin normal, Immune thrombocytopenic purpura
Clinical narrative: Patient developed swelling, erythema, itching, and warmth on left arm a few hours after receiving the above vaccinations. Over the course of the next day, the arm became more swollen and spread around the side of her arm. She took ibuprofen and diphenhydramine to relieve the discomfort. Symptoms continued to worsen, and medical care sought at local ER. She was prescribed the following medications: -Cephalexin 500 mg every 12 hours for 7 days -Hydroxyzine 25 mg every 8 hours for 5 days -Prednisone 20 mg once daily for 5 days. Left arm showed improvement after initiation of above therapy.  Meanwhile, patient started to develop small red dots on her left wrist and later on anterior thighs, lower legs, and bilateral upper arms. Continued cephalexin but held prednisone and hydroxyzine. Subsequently diagnosed with idiopathic thrombocytopenic purpura (ITP). Concern that vaccines precipitated/caused ITP in this patient.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Injection site reaction, Limb discomfort, Metabolic function test normal, Peripheral swelling, Platelet count decreased
Clinical narrative: Patient developed swelling, erythema, itching, and warmth on left arm a few hours after receiving the above vaccinations. Over the course of the next day, the arm became more swollen and spread around the side of her arm. She took ibuprofen and diphenhydramine to relieve the discomfort. Symptoms continued to worsen, and medical care sought at local ER. She was prescribed the following medications: -Cephalexin 500 mg every 12 hours for 7 days -Hydroxyzine 25 mg every 8 hours for 5 days -Prednisone 20 mg once daily for 5 days. Left arm showed improvement after initiation of above therapy.  Meanwhile, patient started to develop small red dots on her left wrist and later on anterior thighs, lower legs, and bilateral upper arms. Continued cephalexin but held prednisone and hydroxyzine. Subsequently diagnosed with idiopathic thrombocytopenic purpura (ITP). Concern that vaccines precipitated/caused ITP in this patient.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Pruritus, Rash, Rash erythematous, Skin warm, Ultrasound scan normal
Clinical narrative: Patient developed swelling, erythema, itching, and warmth on left arm a few hours after receiving the above vaccinations. Over the course of the next day, the arm became more swollen and spread around the side of her arm. She took ibuprofen and diphenhydramine to relieve the discomfort. Symptoms continued to worsen, and medical care sought at local ER. She was prescribed the following medications: -Cephalexin 500 mg every 12 hours for 7 days -Hydroxyzine 25 mg every 8 hours for 5 days -Prednisone 20 mg once daily for 5 days. Left arm showed improvement after initiation of above therapy.  Meanwhile, patient started to develop small red dots on her left wrist and later on anterior thighs, lower legs, and bilateral upper arms. Continued cephalexin but held prednisone and hydroxyzine. Subsequently diagnosed with idiopathic thrombocytopenic purpura (ITP). Concern that vaccines precipitated/caused ITP in this patient.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Limb discomfort, Metabolic function test normal, Peripheral swelling, Platelet count decreased, Pruritus
Clinical narrative: Patient developed swelling, erythema, itching, and warmth on left arm a few hours after receiving the above vaccinations. Over the course of the next day, the arm became more swollen and spread around the side of her arm. She took ibuprofen and diphenhydramine to relieve the discomfort. Symptoms continued to worsen, and medical care sought at local ER. She was prescribed the following medications: -Cephalexin 500 mg every 12 hours for 7 days -Hydroxyzine 25 mg every 8 hours for 5 days -Prednisone 20 mg once daily for 5 days. Left arm showed improvement after initiation of above therapy.  Meanwhile, patient started to develop small red dots on her left wrist and later on anterior thighs, lower legs, and bilateral upper arms. Continued cephalexin but held prednisone and hydroxyzine. Subsequently diagnosed with idiopathic thrombocytopenic purpura (ITP). Concern that vaccines precipitated/caused ITP in this patient.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Rash, Rash erythematous, Skin warm, Ultrasound scan normal, White blood cell count normal
Clinical narrative: Patient developed swelling, erythema, itching, and warmth on left arm a few hours after receiving the above vaccinations. Over the course of the next day, the arm became more swollen and spread around the side of her arm. She took ibuprofen and diphenhydramine to relieve the discomfort. Symptoms continued to worsen, and medical care sought at local ER. She was prescribed the following medications: -Cephalexin 500 mg every 12 hours for 7 days -Hydroxyzine 25 mg every 8 hours for 5 days -Prednisone 20 mg once daily for 5 days. Left arm showed improvement after initiation of above therapy.  Meanwhile, patient started to develop small red dots on her left wrist and later on anterior thighs, lower legs, and bilateral upper arms. Continued cephalexin but held prednisone and hydroxyzine. Subsequently diagnosed with idiopathic thrombocytopenic purpura (ITP). Concern that vaccines precipitated/caused ITP in this patient.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: The patient is still experiencing arm soreness even now, a month after the injection. He happened to be visiting his doctor for another issue and his doctor mentioned that the injection may have been given up too high on the arm. The patient is currently only using over the counter remedies like ICY HOT.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Horrible pain all night from shoulder blade to elbow. Ibuprofen not touching it. This morning I started with a very severe mid/upper back pain on the right side also.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Skin warm, Tenderness, Urticaria
Clinical narrative: Patient reports abnormal (extreme) soreness in her arm where she cannot even lay on the right side. It was warm to the touch yesterday but that has subsided a bit. Red welts started appearing today (11/29).
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia
Clinical narrative: Severe pain in shoulder joint. Through the night and continues.
Age: 66.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Fatigue, Headache, Malaise, Nausea
Clinical narrative: RECEIVED VACCINES 11/28/17 11:30 AM, DEVELOPED SYMPTOMS-HEADACHE, INTERMITTENT NAUSEA, MALAISE, SIGNIFICANT FATIGUE AT 07:00PM SAME DAY. EVALUATED BY PCP IN OFFICE @ 09:00AM 11/29/17. EVALUATED AND DISCHARGED FROM OFFICE VISIT TO HOME WITH HUSBAND IN ATTENDANCE- TO STAY HOME AND MONITOR SYMPTOMS, IF SYMPTOMS INCREASE OR BECOME URGENT, TO SEEK EMERGENCY CARE.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Joint range of motion measurement, Laboratory test normal
Clinical narrative: Left shoulder pain with handball size rash warm to touch, pain to touch, afebrile, c/o medial left arm shooting pain from armpit to elbow and left fingers 2-5 with tingling, and left arm weakness. Antibiotics through personal MD given. Outcome not yet determined.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain, Paraesthesia, Phalen's test positive, Sensory level normal
Clinical narrative: Left shoulder pain with handball size rash warm to touch, pain to touch, afebrile, c/o medial left arm shooting pain from armpit to elbow and left fingers 2-5 with tingling, and left arm weakness. Antibiotics through personal MD given. Outcome not yet determined.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: 65 yo presents for follow up of injection site reaction. Not as red this AM, but at bottom looks red underneath. Misshaped circle. Still lumpy in middle. Itchy, no fever. Did not take claritin or benadryl. Did not keep her up. Looks like a localized reaction, cool compresses clartitin, benadryl, follow up for increasing redness, warmth.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's left arm was swollen from the bottom of the deltoid down to the middle of the forearm, with a red rash that was spreading from the day before. Patient described pain in the arm, with mild pain in the deltoid where administered.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Patient's left arm was swollen from the bottom of the deltoid down to the middle of the forearm, with a red rash that was spreading from the day before. Patient described pain in the arm, with mild pain in the deltoid where administered.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse regarding a 16 year old male patient. Patient had no illness at time of vaccination and no known allergies. Patient's medical history and concomitant therapies were not provided. On 30-OCT-2017, the patient was vaccinated with an expired dose of VAQTA intramuscular injection in the left deltoid for prophylaxis, lot # M003025 expiration date 26-MAY-2017. There was no adverse effects. Patients had no complains. The point in the process the medication error occurred was preparation for administration. No treatment was required for the event. No temperature excursion reading was reported.
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a nurse on 31 Oct 2017. This case involves a five separate female patients (age reported as ranging from 30-90 year-old) who were vaccinated with 0.5 ml one dose of FLUZONE QUADRIVALENT (Batch number: UT5899LA, expiry date, dose series and site of administration were not reported) intramuscularly on an unknown date. It was reported as all the patients were administered vaccine by physician. Patients' medical history and concomitant medications were not reported. On an unknown date, following the vaccination, all the five patients experienced severe arm pain and arm pain was so severe that it was difficult for all the patients to move their arm. Relevant lab tests was not reported. It was reported as all the five patients received corrective treatment with TYLENOL but did not help reduce the pain, so they were given oxycodone. One patient received a DEPO-MEDROL (injection). As of 31 Oct 2017, the outcome of all the patients was reported as recovering. List of documents held by sender: none.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Pt was given Flu 6m-35m dose. 0.25mg instead of 3yr and up dose 0.50mg.
Age: 0.42
Sex: F
Vaccine: HIBV
Symptoms: Connective tissue disorder, Injection site haematoma
Clinical narrative: Left thigh subcutaneous calcified hematoma with connective tissue remolding causing skin dimpling.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: FEVER, REDNESS SWELLING, PAIN. CLINDAMYCIN 300MG EVERY 6 HOURS FOR 10 DAYS.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Employee experienced prolonged right arm pain lasting over 2 weeks limiting range of motion. Saw PCP.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient experienced a red, swollen, itching spot about 4-5cm across at the injection site. Patient sought treatment from her NP who thought the injection was given too low on the arm. The NP instructed the patient to use BENADRYL cream and ice on the spot. She also called in prednisone 20mg tabs 1 daily for 5 days. Which the patient has yet to start due to concerns over decreased immune response.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm pain limiting range of motion lasting over 2 weeks.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Productive cough, Respiratory tract congestion, Sinus congestion
Clinical narrative: Has had a lot of chest and head congestion. Coughing and expectorating about 5 to 10 times per day.  Has not gone down or decrease in severity since receiving his flu shot.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm pain limiting range of motion lasting over 2 weeks.
Age: 0.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Ruptured cerebral aneurysm, Strabismus, Vomiting
Clinical narrative: Vomiting, weakness, crossed eyes...these symptoms led me to call his doctor. It was found that he'd had an aneurysm rupture near his brain.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pain, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Red rash, induration, warm area. Itching and mild pain.
Age: 9.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large raised red warm-to-touch area, at injection site of influenza, tender to touch. Not impact on breathing. Child has received influenza vaccines yearly since birth with no previous reaction, as had all siblings. Strangely this child and all siblings reacted in the same way to this vaccination. Concerned about issues with the product lot.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large raised red warm-to-touch area, at injection site, mildly tender to touch. Not impact on breathing.  Child has received influenza vaccines yearly since birth with no previous reaction, as had all siblings.  Strangely this child and all siblings reacted in the same way to this vaccination. Concerned about issues with the product lot.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site infection, Injection site pain, Lymph node pain
Clinical narrative: Patient said arm was sore and bruised at injection site and then lymph nodes in right armpit hurt the evening of receiving the vaccinations. The next day her right upper arm became infected.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large raised red warm-to-touch area, at injection site, significantly tender to touch. Not impact on breathing. Child has received influenza vaccines yearly since birth with no previous reaction, as had all siblings. Strangely this child and all siblings reacted in the same way to this vaccination. Concerned about issues with the product lot. No VIS form provided for this child or any siblings from physicians' office. Same lot for all children experiencing this reaction.
Age: 60.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Urticaria
Clinical narrative: I was given the preservative free flu vaccine via injection (I don't know which one but am trying to find out) during the afternoon of Oct 19. Within a couple of hours, my torso was covered in hives. I waited until Oct 23 before going to my doctor who prescribed prednisone for 6 days. Two days after finishing the prednisone, the hives were back and were also beginning to appear on my arms and legs in addition to the torso. Nov 3 I was prescribed 12 days of prednisone and after completing the prescription, the hives are gone. I have been getting the flu shot for years and have received both the preservative free and the non preservative free version without any side effects. I do not have egg allergies.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site 2 weeks after immunization given.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site rash, Lip pruritus, Lip swelling, Paraesthesia oral
Clinical narrative: Received shot Monday night, awoke yesterday with swollen lips and tingling in mouth, had some bumps around site, as better today without swelling but states she was itchy around lips. Denies any new foods, denies latex allergy, denies reaction to any prior vaccine.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Pruritus
Clinical narrative: Patient came and told me that she had her flu shot about 3 weeks ago and she started to itch on her legs, chest, and arms about 2 days after the shot. She stated that this is her first time having a reaction to a flu shot, being that she gets one every year. She also stated that she is positive that it was the flu shot that caused it and not any of her medications.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pain, Pain in extremity
Clinical narrative: About 20 hours after injection my left arm was in a MASSIVE amount of pain and ANY movement was like getting punched by a professional boxer! I was in agony for 6 days after the shot. It was also VERY red and VERY hot and spread ALL over my left arm. I will NOT be getting this vaccination again and I am telling everyone I know not to get it.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: About 20 hours after injection my left arm was in a MASSIVE amount of pain and ANY movement was like getting punched by a professional boxer! I was in agony for 6 days after the shot. It was also VERY red and VERY hot and spread ALL over my left arm. I will NOT be getting this vaccination again and I am telling everyone I know not to get it.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Audiogram abnormal, Chills, Deafness unilateral, Discomfort, Nausea
Clinical narrative: Patient had the flu and pneumonia shots on 11/3/17 around 2:05pm. Later that evening the patient was experiencing nausea, chills, and a fever of 101.1 F (which lasted for a few days). In addition to the discomfort that evening, the patient went into the kitchen to take her night time medications and noticed a "wooshing" noise in her right ear then noticed she could no longer hear out of that ear. The patient then had an audiology exam done by her ENT, which confirmed the hearing loss in the right ear. ENT has referred her for an MRI of the head to ensure no mini stroke or other neurologic issues, which she has scheduled to be completed.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Patient had the flu and pneumonia shots on 11/3/17 around 2:05pm. Later that evening the patient was experiencing nausea, chills, and a fever of 101.1 F (which lasted for a few days). In addition to the discomfort that evening, the patient went into the kitchen to take her night time medications and noticed a "wooshing" noise in her right ear then noticed she could no longer hear out of that ear. The patient then had an audiology exam done by her ENT, which confirmed the hearing loss in the right ear. ENT has referred her for an MRI of the head to ensure no mini stroke or other neurologic issues, which she has scheduled to be completed.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Musculoskeletal stiffness
Clinical narrative: PATIENT REPORTS STIFFNESS IN LOWER ARM AND IN AREA OF INJECTION.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: Pt claims to have pain right after shot was worse next day and continued to get worse to the point where she couldn't lift her arm she call on 11/29 and stated this information and that she received her flu shot here on 11/14 she was directed to see a Dr to have it checked out.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain, Swelling, Urticaria
Clinical narrative: I was given the influenza (flu) vaccine (inactivated or recombinant) and suffered from wheal, redness, swelling, and soreness immediately after receiving the vaccine. I have never before suffered a reaction like that. The reaction lasted for several days.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Polymerase chain reaction positive, Skin lesion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Activation of varicella.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Blood thyroid stimulating hormone, Full blood count, Headache, Hypoaesthesia, Metabolic function test
Clinical narrative: Headache and fever of 38.3 on 10/20/2017, then on 10/21/2017 developed intermittent numbness on right thigh, shin and calf lasting 10-20 seconds at a time, occurring about every 4 hours for 2 weeks, then became less frequent to 4x/day until present time. She will be referred to a neurologist for evaluation.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Vitamin B12
Clinical narrative: Headache and fever of 38.3 on 10/20/2017, then on 10/21/2017 developed intermittent numbness on right thigh, shin and calf lasting 10-20 seconds at a time, occurring about every 4 hours for 2 weeks, then became less frequent to 4x/day until present time. She will be referred to a neurologist for evaluation.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient states that the site of her flu shot given on 11/14/17 became "feverish, red and very sore" beginning on Sunday after church on 11/19/2017. According to pharmacist, patient reported to pharmacy on 11/22/2017 with "a circle of feverish redness approximately 3 inches in diameter" on left arm at site of flu shot injection. Upon my first consultation with patient regarding the adverse event today, she stated that pharmacist instructed her to place an ice pack on the area of warm redness. Patient states that the redness and warmth completely cleared up 3 days later on 11/25/2017.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness and headache, 2 hours after flu shot until now, fluids, same.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Rash generalised, Urticaria
Clinical narrative: 11-29-2017 PATIENT COMES BACK AFTER 2 WEEKS AND REPORT OF HIVES/RASH ALL OVER HIS BODY AFTER 2 HOURS RECEIVING THE SHOT. THE RASH CONTINUE FOR TOO LONG THAT HE DECIDED TO SEE HIS DOCTOR. HIS DOCTOR PUT HIM ON STEROIDS (PREDNISONE 50MG ONCE A DAY) AND TOLD HIM TO PICK IT UP 11-29-2017.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Influenza like illness, Vertigo
Clinical narrative: FLU-LIKE SYMPTOMS, VERTIGO, FATIGUE, ACHES IN ALL MAJOR JOINTS - ALL LASTING FOR 5-6 DAYS - RESOLVED ON ITS OWN OVER TIME.
Age: 39.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: REDNESS, SWELLING, HOT TO TOUCH. Cephalexin 500 mg capsule take 1 capsule(s) every 6 hours by oral route for 7 days.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Swelling, Tenderness
Clinical narrative: " A 1/2 inch raised tender bump, not red".
Age: 60.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site pain, Radiculopathy
Clinical narrative: Pain worsening at injection site for days after vaccine. Finally went to orthopedist, who said it is  irritation of the nerve. She is currently receiving physical therapy.
Age: 60.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Burning sensation, Discomfort, Injection site pain, Injection site reaction, Pain
Clinical narrative: Pain worsening at injection site for days after vaccine. Finally went to orthopedist, who said it is  irritation of the nerve. She is currently receiving physical therapy.
Age: 60.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Pain in extremity, Sleep disorder, X-ray limb normal
Clinical narrative: Pain worsening at injection site for days after vaccine. Finally went to orthopedist, who said it is  irritation of the nerve. She is currently receiving physical therapy.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Syncope
Clinical narrative: A few minutes after patient given flu shot she fainted and fell to the floor.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Immediate post-injection reaction, Injection site bruising, Injection site erythema
Clinical narrative: Pt. bruised immediately after injection (she said that she is anemic and bruises easily and it isn't uncommon for her to bruise from a shot) but she came back today (1 day post shot) and the bruise is much larger and show has a red circle about 2 inches in diameter with the administration site in the middle.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Bruising at the injection site, redness with heat, and red circle about the size of a fried egg.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient complains of shoulder pain in the shoulder the vaccination was delivered. He says he as visited the doctor about the pain and his lack of mobility in the arm.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Dizziness, Heart rate increased
Clinical narrative: Patient experienced increase Heart rate (117) and increase blood pressure. Patient felt lightheaded and woozy. Contacted 911 and was removed from pharmacy by ambulance.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Insomnia, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Received flu vaccine in right arm, had immediate pain, but worsened through the day. Pain going down arm, and in shoulder, pin prickling feeling, at about 10:00 am, after vaccine. Applied ice after my shift about 6:45 pm, when I got home, but symptoms worsened. Unable to sleep because of a feeling of a thousand pin pricks in my right shoulder. This is still continuing to happen. Sought medical attention, received steroid inj in right shoulder, and was given a gel to apply (Diclofenac sodium topical gel 1%).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Peripheral swelling, Skin warm
Clinical narrative: Extensive swelling (arm is 2X normal size), hot, injection site hard.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Skin warm, Swelling
Clinical narrative: Extensive swelling, hot, injection site is hard.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Discomfort, Loss of personal independence in daily activities, Pain, Swelling
Clinical narrative: Patient called reporting she has pain, swelling, and pressure on right side of body day after flu shot. She described the pain as minor-moderate where she has trouble doing some of her usual jog. Told the patient to monitor symptoms in case of improvement and to seek medical attention if it gets worse the next day. Couldn't reach patient for follow-up.
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4, HIBV, MMR
Symptoms: Diarrhoea, Injection site rash, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Pt presented with rash approximately 2 weeks after receiving 15 month vaccines. Pt has visible rash on face, trunk, arms and legs. Pt. had a previous fever (max temp of 100.3), however was afebrile at time of visit. P.'s parent stated she had watery stools. Pt. went to urgent care 1 day prior to seeing Dr. Urgent care gave patient a diagnosis of tonsillitis and was given a prescription of KEFLEX. A rapid Strep test was also administered during urgent care visit which resulted as negative. Pt was seen by Dr. today, 11/6/17 for persistent rash after examination. Dr. diagnosed patient with an adverse reaction from MMR vaccine. Plan is to discontinue KEFLEX antibiotic prescribed by Urgent Care and to treat symptoms with BENADRYL.
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4, HIBV, MMR
Symptoms: Tonsillitis, Vaccination complication
Clinical narrative: Pt presented with rash approximately 2 weeks after receiving 15 month vaccines. Pt has visible rash on face, trunk, arms and legs. Pt. had a previous fever (max temp of 100.3), however was afebrile at time of visit. P.'s parent stated she had watery stools. Pt. went to urgent care 1 day prior to seeing Dr. Urgent care gave patient a diagnosis of tonsillitis and was given a prescription of KEFLEX. A rapid Strep test was also administered during urgent care visit which resulted as negative. Pt was seen by Dr. today, 11/6/17 for persistent rash after examination. Dr. diagnosed patient with an adverse reaction from MMR vaccine. Plan is to discontinue KEFLEX antibiotic prescribed by Urgent Care and to treat symptoms with BENADRYL.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Local reaction
Clinical narrative: Pt developed cellulitis and local reaction.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed redness, swelling, warmth, pain, and itchiness at the site of injection (right deltoid) of TDaP and MENACTRA vaccines and symptoms started two days ago 11/20/17.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Bone pain, Erythema, Induration, Joint swelling, Pain in extremity
Clinical narrative: Nov 16-17 PM vaccine PPSV 23 given on right side top of arm by shoulder area. Left arm blood taken for A1G test. That evening and night right side hard swelling, painful, bone area felt like being hit by shot. Left arm swelling but not as bad. Nov 17-17 - Fri. morning joints in both arms and knees start swelling and painful mostly on right arm. Notice hives on both joints of arms and knees and redness on arms and legs and toes, fingers.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Nov 16-17 PM vaccine PPSV 23 given on right side top of arm by shoulder area. Left arm blood taken for A1G test. That evening and night right side hard swelling, painful, bone area felt like being hit by shot. Left arm swelling but not as bad. Nov 17-17 - Fri. morning joints in both arms and knees start swelling and painful mostly on right arm. Notice hives on both joints of arms and knees and redness on arms and legs and toes, fingers.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Patient complaint of severe, prolonged pain in arm following vaccination. Feels the vaccine may not have been given in appropriate location on arm.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injury associated with device
Clinical narrative: After the pharmacist administered the vaccine, she accidentally poked her left palm with the needle before the safety device was activated. It is unknown if skin was broken. There was no blood.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness bilateral, Ear discomfort
Clinical narrative: This initial serious spontaneous case, was received on 16-Nov-2017, from a consumer, concerning 64-year-old adult, female patient. The patient's historical condition included asthma and had no concomitant medications. On 11-Nov-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, anatomical location: left upper arm, batch number: 179905P, expiry date: May-2018, route of administration: not reported). On 13-Nov-2017, after 3 days of vaccination, the patient lost hearing of both ears (described as clogged). It was pronounced in left ear. The patient was treated with prednisone. At the time of the report, the patient had not recovered from the event.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: "Immediately, it was quite painful with sharp stinging. Discomfort became worse about 2 days following vaccination and persists one week later. It is not severe - but persistent and limiting my activities it even hurts to lift my arm to drive. My entire deltoid is sore to palpation, especially the medial and outer deltoid area and it hurts to abduct my arm on 11/14/17". (L) arm is still a little sore for about 8 to 10 cm directly over flu shot site if I palpate it.
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Anxiety, Blepharospasm, Facial paralysis, Fear
Clinical narrative: This serious initial spontaneous case, was received from other non-health professional on 14-Nov-2017, concerning a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with AFLURIA (TIV) (batch number: 14449221A, expiry date: Jun-2018, dose, route of administration, anatomical location: not reported). It was reported that after the patient received vaccine, the side effects varied from one day to another. She experienced "allergies in the body" and headache at night. She also experienced facial paralysis and twitching in her eyes that would not stop. There was a tingling sensation in her right arm and right hand, which extended to her toes and hands. She also lost taste sensation in her mouth and had difficulty moving her tongue that caused difficulty to eat. Her vision also began to blur, causing her to see only shadows at one point. The patient was treated with EXCEDRIN for headache. On an unspecified date, the patient was hospitalized for the events and was discharged on unspecified date (she states that she was no longer hospitalized but it affected her). She had trouble sleeping, was very anxious and feared due to experiencing of these side effects. At the time of this report, the patient had not yet recovered from the events. The reporter considered the case as serious due to hospitalization and causality as related.
Sex: F
Vaccine: FLU3
Symptoms: Feeding disorder, Headache, Hypersensitivity, Insomnia, Paraesthesia
Clinical narrative: This serious initial spontaneous case, was received from other non-health professional on 14-Nov-2017, concerning a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with AFLURIA (TIV) (batch number: 14449221A, expiry date: Jun-2018, dose, route of administration, anatomical location: not reported). It was reported that after the patient received vaccine, the side effects varied from one day to another. She experienced "allergies in the body" and headache at night. She also experienced facial paralysis and twitching in her eyes that would not stop. There was a tingling sensation in her right arm and right hand, which extended to her toes and hands. She also lost taste sensation in her mouth and had difficulty moving her tongue that caused difficulty to eat. Her vision also began to blur, causing her to see only shadows at one point. The patient was treated with EXCEDRIN for headache. On an unspecified date, the patient was hospitalized for the events and was discharged on unspecified date (she states that she was no longer hospitalized but it affected her). She had trouble sleeping, was very anxious and feared due to experiencing of these side effects. At the time of this report, the patient had not yet recovered from the events. The reporter considered the case as serious due to hospitalization and causality as related.
Sex: F
Vaccine: FLU3
Symptoms: Tongue movement disturbance, Vision blurred
Clinical narrative: This serious initial spontaneous case, was received from other non-health professional on 14-Nov-2017, concerning a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with AFLURIA (TIV) (batch number: 14449221A, expiry date: Jun-2018, dose, route of administration, anatomical location: not reported). It was reported that after the patient received vaccine, the side effects varied from one day to another. She experienced "allergies in the body" and headache at night. She also experienced facial paralysis and twitching in her eyes that would not stop. There was a tingling sensation in her right arm and right hand, which extended to her toes and hands. She also lost taste sensation in her mouth and had difficulty moving her tongue that caused difficulty to eat. Her vision also began to blur, causing her to see only shadows at one point. The patient was treated with EXCEDRIN for headache. On an unspecified date, the patient was hospitalized for the events and was discharged on unspecified date (she states that she was no longer hospitalized but it affected her). She had trouble sleeping, was very anxious and feared due to experiencing of these side effects. At the time of this report, the patient had not yet recovered from the events. The reporter considered the case as serious due to hospitalization and causality as related.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a pharmacist on 14-OCT-2017. This case involves a 66-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE HD (batch number- UI877AA) (expiry date, dose in series was not reported) via intramuscular in the left deltoid on 12-OCT-2017.. Patient's medical history included hypertension as underlying condition. Concomitant medications were not reported. On 14-Oct-2017, 2 days after the vaccination, the patient experienced an area of redness, warmth and tenderness underneath the left arm down from the injection site. Patient was in no acute distress. but known hypertensive on medication. Laboratory data and corrective treatment were not reported. Pharmacist did not suggest OTC treatments to the patient and informed her about physician for evaluation. The patient's outcome was not reported. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Initial unsolicited report received from a pharmacist on 14-OCT-2017. This case involves a 66-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE HD (batch number- UI877AA) (expiry date, dose in series was not reported) via intramuscular in the left deltoid on 12-OCT-2017.. Patient's medical history included hypertension as underlying condition. Concomitant medications were not reported. On 14-Oct-2017, 2 days after the vaccination, the patient experienced an area of redness, warmth and tenderness underneath the left arm down from the injection site. Patient was in no acute distress. but known hypertensive on medication. Laboratory data and corrective treatment were not reported. Pharmacist did not suggest OTC treatments to the patient and informed her about physician for evaluation. The patient's outcome was not reported. List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Bacterial infection, Erythema, Peripheral swelling, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist and refers to a 23-year-old female patient. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies. The patient's medical history included tuberculin (TB) skin test. On 01-NOV-2017, the patient was vaccinated with VARIVAX injection, 1 dose, 0.5 ml, subcutaneous for prophylaxis (lot # M012992 with expiration date on 14-MAR-2018) reconstituted with sterile diluent. On 02-NOV-2017, the patient began experiencing a rash at the injection site as well as a large raised area at the injection site shortly after receiving the vaccine. At the pharmacy, the patient was advised to take a BENADRYL for the events. It was confirmed with the primary reporter that the "rash" was not a "varicella like rash." No laboratory diagnostic studies were performed. On approximately 03-NOV-2017 (reported as next day), the patient came back and the rash got bigger and worst. The patient was advised to go to the urgent care. The physician diagnosed the patient with bacterial infection and gave the patient 7 day course of cephalexin: (03-NOV-2017- 09-NOV-2017). The outcome of a rash at the injection site and large raised area at the injection site was reported as recovered/resolved at the time of the report. The outcome of bacterial infection was not reported. The reporter did not assess the relatedness between the events and VARIVAX.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Bacterial infection, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist and refers to a 23-year-old female patient. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies. The patient's medical history included tuberculin (TB) skin test. On 01-NOV-2017, the patient was vaccinated with VARIVAX injection, 1 dose, 0.5 ml, subcutaneous for prophylaxis (lot # M012992 with expiration date on 14-MAR-2018) reconstituted with sterile diluent. On 02-NOV-2017, the patient began experiencing a rash at the injection site as well as a large raised area at the injection site shortly after receiving the vaccine. At the pharmacy, the patient was advised to take a BENADRYL for the events. It was confirmed with the primary reporter that the "rash" was not a "varicella like rash." No laboratory diagnostic studies were performed. On approximately 03-NOV-2017 (reported as next day), the patient came back and the rash got bigger and worst. The patient was advised to go to the urgent care. The physician diagnosed the patient with bacterial infection and gave the patient 7 day course of cephalexin: (03-NOV-2017- 09-NOV-2017). The outcome of a rash at the injection site and large raised area at the injection site was reported as recovered/resolved at the time of the report. The outcome of bacterial infection was not reported. The reporter did not assess the relatedness between the events and VARIVAX.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist, regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 09-NOV-2017, the patient was vaccinated with an expired dose ZOSTAVAX which had a lot # M032141 with expiration date on 02-OCT-2017 (dose, anatomical location and route of administration were not mentioned) for prophylaxis. Other suspect therapies included sterile diluent. At the reporting time, no adverse events were experienced.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 09-NOV-2017, the patient was vaccinated with an expired dose ZOSTAVAX which had a lot # M032141 with expiration date on 02-OCT-2017 (dose, anatomical location and route of administration were not mentioned) for prophylaxis. Other suspect therapies included sterile diluent. At the reporting time, no adverse events were experienced.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Nerve root compression
Clinical narrative: Patient reports shoulder pain and numbness after receiving flu vaccine. Went to doctor and initial diagnosis is impingment of nerve.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reports shoulder pain and numbness after receiving flu vaccine. Went to doctor and initial diagnosis is impingment of nerve.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Musculoskeletal pain, Nerve root compression
Clinical narrative: Patient reports shoulder pain and numbness after receiving flu vaccine. Went to doctor and initial diagnosis is impingment of nerve.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Patient stated she had severe pain and redness in her arm 11/26/17 (two days later). She saw urgent care and was prescribed steroids which helped the same day.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient stated she had severe pain and redness in her arm 11/26/17 (two days later). She saw urgent care and was prescribed steroids which helped the same day.
Age: 28.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Acne, Injection site pain
Clinical narrative: Patient still complaining of dull pain in left arm, cannot pinpoint exact place, says it internal and generally all over. More painful after sleeping on it over night.