chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Received ADACEL in left deltoid; FLUARIX QUAD and PNEUMOVAX in right deltoid on 10/03/16. Patient has had TDAP and flu shots previously with no adverse reactions. Experienced immediate pain upon injection of the Pnemovax that never ceased. Could not sleep on right arm the night following the vaccines. Following day (10/04/16) had headache that was non-responsive to OTC painkillers and was unable to lift right arm without extreme pain. Later that night began experiencing chills and a fever of 100.4. The next morning (10/05/16) at 5am, fever was at 101.4. Went into doctor at 9am and discussed steroids to lessen immune response or tramadol for headache/arm pain. Only tramadol was given. Went home, took tramadol, and took a nap. Waking up from nap with chills, fever was 102.7. Promptly went to urgent care at 6pm to get steroids. 24 mg of methylprednisolone taken at 7pm. All symptoms were resolved the following morning. Hard to say which vaccine caused adverse reaction or if one large immune response to getting 3 vaccines at once.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Feeling cold, Headache, Lipids
Clinical narrative: Fever, chills, joint & body aches, headache, fatigue.  Arm was extremely painful.  All symptoms severe for two days.  But fatigue and achy, off and on sore throat, headaches have continued to present day.  Plus the weak, sore arm where shot administered.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Metabolic function test, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever, chills, joint & body aches, headache, fatigue.  Arm was extremely painful.  All symptoms severe for two days.  But fatigue and achy, off and on sore throat, headaches have continued to present day.  Plus the weak, sore arm where shot administered.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Patient said that arm is still tender and sore 6 weeks after the administration.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was administered PREVNAR 13 on 10/11/2016, and we administered on 11/11/2016 PNEUMOVAX 23 when we were supposed to administer a year later instead of a month later.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness and hot to touch. Continued to get more swollen and hot as the days progressed. It is now Thursday afternoon and there is an additional hot spot that is sore further down from the injection site.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Blood thyroid stimulating hormone normal, Fatigue, Feeling cold
Clinical narrative: Severe chills, achy joints and muscles, fatigue, weak, headache, fever.  All those symptoms were severe for two days and then have had achy, fatigue, off and on sore throat, headaches ever since then up to current time of this report.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Metabolic function test normal, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Severe chills, achy joints and muscles, fatigue, weak, headache, fever.  All those symptoms were severe for two days and then have had achy, fatigue, off and on sore throat, headaches ever since then up to current time of this report.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Thyroxine free normal
Clinical narrative: Severe chills, achy joints and muscles, fatigue, weak, headache, fever.  All those symptoms were severe for two days and then have had achy, fatigue, off and on sore throat, headaches ever since then up to current time of this report.
Age: 88.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Called today complaining of arm being very sore since receiving vaccine; throbs at night and keeps him awake.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Nodule, Peripheral swelling, Skin reaction
Clinical narrative: PT STATED THAT A WEEK AFTER GETTING THE PREVNAR 13 SHOT HER ARM BEGAIN TO SWELL, GET RED AND HAS A KNOT IN IT.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain
Clinical narrative: SORENESS AND PAIN TO LEFT ARM AT INJECTION SITE.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Painful arm, bursitis near shoulder area.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Nausea, Pruritus, Tremor, Vomiting
Clinical narrative: Nausea, vomiting, tremor, pruritus, dyspnea a few minutes after vaccine was administered.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site irritation, Injection site swelling
Clinical narrative: Patient reported irritation around the injection site.  She could not give a scale for the pain. She also noticed swollen around the injection site. She was advised by the pharmacist to use ice pack and take tylenol. The pharmacy will follow up with her the next morning. Also the patient was instructed that in case she has any sign of breathing problem, she should call 911.
Age: 1.0
Sex: F
Vaccine: HEP, HEPA, MMRV
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Small raised red dots all over body.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Pruritus
Clinical narrative: Itchy back and arms, itchy chin, hoarse. Tried benedryl.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Peripheral swelling, Skin reaction
Clinical narrative: In the evening after the vaccination she stated her arm swelled and throbbed and was red. 11/17 She phoned the pharmacy and said the swelling had gone down but it the area was still red and swollen .  I recommended she see her Dr.  He thinks it is an injection site reaction and drew a circle around the redness and told patient to contact him if it gets worse or does not get better in 3 days.  The Dr. recommended she ice and elevate and take Naproxen
Age: 1.08
Sex: F
Vaccine: MMR, MMRV
Symptoms: Computerised tomogram head normal, Febrile convulsion, Full blood count normal
Clinical narrative: Febrile complex seizure.
Age: 1.08
Sex: F
Vaccine: MMR, MMRV
Symptoms: Pyrexia, Seizure
Clinical narrative: Febrile complex seizure.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Feeling abnormal, Flushing, Neck pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of chest pain in a female patient who received FLUARIX QUADRIVALENT. On 23rd September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced chest pain, facial flushing, neck pain and feeling abnormal. On an unknown date, the outcome of the chest pain and neck pain were recovered/resolved and the outcome of the facial flushing and feeling abnormal were unknown. It was unknown if the reporter considered the chest pain, facial flushing, neck pain and feeling abnormal to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced chest pain that ran up neck, face flushed and felt icky after receiving FLUARIX QUADRIVALENT. No other information was provided.
Age: 4.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Gait disturbance, Vaccination site bruising, Vaccination site discolouration, Vaccination site erythema, Vaccination site pain
Clinical narrative: 1-2 day after vaccination site with increased erythema, swelling, then purple/bruise hue and tenderness, limp.
Age: 4.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Vaccination site swelling
Clinical narrative: 1-2 day after vaccination site with increased erythema, swelling, then purple/bruise hue and tenderness, limp.
Age: 30.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Altered state of consciousness, Hyperhidrosis, Loss of consciousness, Nervousness, Posture abnormal
Clinical narrative: 8:30 am a few minutes after giving FLUVIRIN he said he felt like he was going to pass out. As he was sitting, he slumped over. I asked if he was ok, got him to sit back up and it seemed as if he was breathing heavier, sweating and possibly seizing. My tech called 911. Soon he was alert and talking, but unaware of what happened. He was still sweating for awhile. Paramedics said he did pass out, but not have a seizure. They took his vitals and they were fine. (After having him sit for awhile, they suggested I give him his Tdap vaccine while they were there). He told them he was nervous about getting the vaccines. His wife was in hospital and was going to have a baby, about a month early. He hadn't have a lot of sleep lately, and did not have breakfast. They waited while I gave him the Tdap and he was fine. I called him later that afternoon and he said he was fine.
Age: 30.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Respiration abnormal
Clinical narrative: 8:30 am a few minutes after giving FLUVIRIN he said he felt like he was going to pass out. As he was sitting, he slumped over. I asked if he was ok, got him to sit back up and it seemed as if he was breathing heavier, sweating and possibly seizing. My tech called 911. Soon he was alert and talking, but unaware of what happened. He was still sweating for awhile. Paramedics said he did pass out, but not have a seizure. They took his vitals and they were fine. (After having him sit for awhile, they suggested I give him his Tdap vaccine while they were there). He told them he was nervous about getting the vaccines. His wife was in hospital and was going to have a baby, about a month early. He hadn't have a lot of sleep lately, and did not have breakfast. They waited while I gave him the Tdap and he was fine. I called him later that afternoon and he said he was fine.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Eye movement disorder, Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 7-year-old male patient who received FLUARIX QUADRIVALENT (batch number A2Z34, expiry date 30th June 2017). Concurrent medical conditions included allergic reaction. On 3rd November 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 5th November 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced vomiting and exhaustion. On 6th November 2016, the patient experienced eye rolling. In November 2016, the patient experienced injection site pain, injection site itching, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site itching, injection site swelling and eye rolling were recovered/resolved and the outcome of the injection site erythema and exhaustion were unknown and the outcome of the vomiting was recovering/resolving. The reporter considered the injection site pain, injection site itching, injection site swelling, injection site erythema, vomiting, exhaustion and eye rolling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. Allergic reaction to Pez candy product, when he was around three years old and the patient's lips got red. On 3rd November 2016 at 17:30, the patient received FLUARIX QUADRIVALENT on the right deltoid. On 4th November 2016 (Friday), approximately 18 hours after vaccination, the patient experienced hurting and itching all day in his arm. When the patient's mother looked at patient's arm, she described that the area around the injection site was raised up to 1/4 of an inch and there was a fiery red area that was circular, approximately 5 inches in diameter. The patient's mother called the Minute Clinic and was told to ice it and give him BENADRYL. On 5th November 2016, the area was less raised, pink with a white area in the center the size of a fifty cent piece and by the 12:00 noon, redness and raised area were fully resolved, however the patient began to start vomiting. He initially was vomiting every 15 minutes for 8 episodes, then went to sleep and vomited on and off throughout Saturday into Sunday. The reporter described that the patient would pass out from exhaustion after vomiting which she clarified as he went right back to sleep. On 6th November 2016, 3 days after vaccination, on Sunday, after one episode of vomiting, the patient's eyes rolled back into his head. The reporter called his physician and was told to give him bland diet and keep him hydrated. The patient was referred to his physician.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Pain in extremity, Pruritus, Somnolence, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 7-year-old male patient who received FLUARIX QUADRIVALENT (batch number A2Z34, expiry date 30th June 2017). Concurrent medical conditions included allergic reaction. On 3rd November 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 5th November 2016, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced vomiting and exhaustion. On 6th November 2016, the patient experienced eye rolling. In November 2016, the patient experienced injection site pain, injection site itching, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site itching, injection site swelling and eye rolling were recovered/resolved and the outcome of the injection site erythema and exhaustion were unknown and the outcome of the vomiting was recovering/resolving. The reporter considered the injection site pain, injection site itching, injection site swelling, injection site erythema, vomiting, exhaustion and eye rolling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. Allergic reaction to Pez candy product, when he was around three years old and the patient's lips got red. On 3rd November 2016 at 17:30, the patient received FLUARIX QUADRIVALENT on the right deltoid. On 4th November 2016 (Friday), approximately 18 hours after vaccination, the patient experienced hurting and itching all day in his arm. When the patient's mother looked at patient's arm, she described that the area around the injection site was raised up to 1/4 of an inch and there was a fiery red area that was circular, approximately 5 inches in diameter. The patient's mother called the Minute Clinic and was told to ice it and give him BENADRYL. On 5th November 2016, the area was less raised, pink with a white area in the center the size of a fifty cent piece and by the 12:00 noon, redness and raised area were fully resolved, however the patient began to start vomiting. He initially was vomiting every 15 minutes for 8 episodes, then went to sleep and vomited on and off throughout Saturday into Sunday. The reporter described that the patient would pass out from exhaustion after vomiting which she clarified as he went right back to sleep. On 6th November 2016, 3 days after vaccination, on Sunday, after one episode of vomiting, the patient's eyes rolled back into his head. The reporter called his physician and was told to give him bland diet and keep him hydrated. The patient was referred to his physician.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Pallor, Pruritus
Clinical narrative: Left arm with erythema and edema from shoulder to elbow. Circumf 2cm > L compared to Rt. Blanching/pruritic.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Nerve injury, Pain in extremity
Clinical narrative: About 1 day after immunization customer complained of extreme soreness and loss of motion in vaccinated arm.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient said arm was sore.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Pt received flu vaccine on 11/14/16 to left arm early in the afternoon. Mother states area was red, warm and firm to the injection area also states child said it was sore. The area was noted to be slightly large than a 1/2 dollar coin. Ibuprofen was given for pain.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face, Throat irritation
Clinical narrative: Facial swelling. Itching/burning throat.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Soreness and stiffness of the left arm following injection. Patient complains of inability to lift arm over head even after 2 weeks of injection.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site infection
Clinical narrative: Per mom, patient got infection in injection site area necessitating antibiotics.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Ocular hyperaemia, Pruritus generalised, Urticaria
Clinical narrative: Hives by the arm and itching all over red and itchy eyes.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Eye discharge, Pruritus, Urticaria
Clinical narrative: Hives all over body and very itchy, sticky eyes.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Pain in the right arm at all times, decreased range of motion. Can't sleep on the right side.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Hypoaesthesia, Pain
Clinical narrative: Noticed bruising the day after given the flu shot experienced dull ache since then and on and off numbness that last for a few seconds. Bruising resolved 11/12/16. Ache and numbness had not resolved. Worse when laying on left side.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pt called me in the office at 10:45 am 11/8/16 to report her arm being sore. She received her flu injection on 10/11/16. She stated her arm was sore 2-3 days post injection, felt better then, a week or so ago started to hurt. Today she states it feels just like it did post injection. Tried ice, Ibuprofen, Tylenol and not much relief. Injection per pt was 2-3 fingers breath below shoulder. Pt to follow-up with MD.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain
Clinical narrative: 11/8/16 received email from HR at pt's worksite stating pt contacted them about a reaction after flu shot. Pt stated she got bursitis. Pt C/O pain to front side of shoulder (L). Pt was given exercises, to help alleviate the pain, by her MD.
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Rash generalised
Clinical narrative: Per pt, about 2-3 days after received, broke out in rash and bumps. On 11/8/16 pt came to pharmacy and pharmacist, myself instructed him to see MD, possible viral rash or allergy all over body. Saw his PCP 11/9 given Valacyclovir and prednisone. Once prednisone computed, returned again but worse. Required ER visit and repeat of prednisone and repeat visit to dermatologist 11/15/16.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Hives just below the site about the size a dollar bill. Onset approximately 1 hr post injection. Pt took a 24 hour CLARITIN (own supply) and rash resolved. Advised discussing reaction with MD to get reaction documented. Advised continue CLARITIN if rash persists. Pt to follow up with MD as needed.
Age: 43.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Middle insomnia
Clinical narrative: Client stated on phone that woke up night of 11/1/16 with extreme pain, warm at injection site, relieved by Ibuprofen. Felt better while active next day but pain returned night of 11-2-16. On 11-3-16 she noted injection site(s) were red and hot and hardened, area = to "the palm of my hand". Resolved in 2 days after with no lasting effects. Had both vaccinations in (L) deltoid due to HX shoulder surgery.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None. Vaccine recipient denies any adverse signs or symptoms from the event.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Had senior flu shot up high in left shoulder 8/28/15. Within 6 hours, could not move left arm. Had a lot of pain, went to urgent care 9/30/15. Also doctor 10/13/15, it still pains mostly at nite. I reported it to pharmacy. I don't use a computer.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Disorientation, Dizziness, Malaise, Palpitations
Clinical narrative: Pt received vaccine 9/26/16 - in the next 3 weeks he experienced weakness, dizziness, disorientation and palpitations. He is on COREG for cardio-myopathy and thought it may have conflicted. Still feels ill. No treatment from MD.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling
Clinical narrative: Pt received flu vaccine (L) upper arm on 11/9/16. Seen in office 11/10/16 for localized redness and swelling. Area of erythema 7.5 cm diameter. Pt otherwise well.
Age: 10.0
Sex: F
Vaccine: DTAP, FLU4, HEPA
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Patient was given sisters DTaP that was on same tray as patients, as well as sisters PF Flu .25 mL.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient received FLUZONE HIGH DOSE 2016-17 flu shot on 10/10/16 and complained of shoulder/arm pain on 10/12/16. Patient reported incident to pharmacy on 11/11/16. Patient has appointment with his physician on 11/22/16.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Sensory loss
Clinical narrative: Weakness and loss of sensation in arm.
Age: 37.0
Sex: F
Vaccine: FLU4, PNC
Symptoms: Erythema, Fatigue, Nausea, Peripheral swelling, Vomiting
Clinical narrative: 2/3 days after patient arm swelled and turned red for 2 weeks. Pt states she had felt tired and has had nausea/vomiting since then.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Pt came in with severe resolving bruise on arm of FLUZONE HD administration. Arm was sore the night after the injection. Pt sleeps on that arm. Noticed next morning. Arm warm, tender and bruised. Discussed with pt. She is on blood thinners.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Pt states she feels achy. Both shoulders and neck within 6 hrs and persists at 2 pm today. Achy neck and shoulders resolved in 2 days.
Age: 62.0
Sex: U
Vaccine: FLUX
Symptoms: Chest discomfort, Erythema, Malaise, Muscle spasms, Pruritus
Clinical narrative: I took the flu shot around 7:30 a.m. on Thurs. Oct. 27-16 about 15-20 min. after the shot, I start to feel tight in chest, and my face was warm and red and itching. I was itching all over when I got home 30 min later my face was broke out and I started having muscle spasms in my heart and both sides of my chest. I took BENADRYL, TYLENOL. I went back to the clinic on Fri. Oct 28th. I saw doctor, I was given Methylprednisolone. I am better but not completely well. I am still having minor muscle spasms. My face is still broke out, not as bad. As of 11-14-16 I am better. For 2 wks. after flu shot I was very sick.
Age: 62.0
Sex: U
Vaccine: FLUX
Symptoms: Pruritus generalised, Rash, Skin warm
Clinical narrative: I took the flu shot around 7:30 a.m. on Thurs. Oct. 27-16 about 15-20 min. after the shot, I start to feel tight in chest, and my face was warm and red and itching. I was itching all over when I got home 30 min later my face was broke out and I started having muscle spasms in my heart and both sides of my chest. I took BENADRYL, TYLENOL. I went back to the clinic on Fri. Oct 28th. I saw doctor, I was given Methylprednisolone. I am better but not completely well. I am still having minor muscle spasms. My face is still broke out, not as bad. As of 11-14-16 I am better. For 2 wks. after flu shot I was very sick.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient states symptoms started less than 10 minutes after flu injections. Skin level numbness in left forearm and wrist. At times would tingle. By 30 minutes tingling up left side of neck and face. Within 1/2 hours tingling in left collar bone and shoulder blade. Tingling came and went. Mostly in left wrist, jaw and eyebrow. BENADRYL 25mg, second dose 50mg not helpful.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Large localized reaction - several centimeters in diameter - redness and swelling.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Pt. felt dizzy and light headed when at checkout station.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEP, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash papular
Clinical narrative: Papular, erythematous rash on both thighs, worse on (R) rash very itchy.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Urticarial rash at neck, face and lips several minutes after receiving annual flu vaccine. Sent to ED for observation - resolved fully after IM BENADRYL 50 mg, ALLEGRA 60 mg PO, Ranitidine 150 mg PO.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Received injection on 10/28/16. On 10/30/16 he started experiencing itching on his (L) hand with a rash (hives). The rash and itching would move to another area of body every day or 2. Never had a fever or difficulty breathing. Given prednisone taper on 11-17-16.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness the size of a softball.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Discomfort, Erythema, Swelling
Clinical narrative: Redness, swelling, and discomfort.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: At night patient had a lot of itching in the vaccine administration area. In the morning, the arm was inflamed, red and with pain. She went to doctors office and prescribed antibiotics.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Discomfort at inj site. Redness and swelling. No streaking. No fever.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mom called to report 5 in x 3 in red, hot, swollen and tender area to left deltoid that appeared on 11-15-16. Pt. received flu shot to left deltoid on 11-14-16. Mother instructed to apply warm compresses and give MOTRIN PRN.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site discolouration, Injection site swelling, Myalgia
Clinical narrative: The patient has a dark pigmented, raised bump where she was immunized. She also continues to have muscle pain in the arm 2 1/2 months after immunization.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Site swollen with pain. Patient can't lift arm without pain symptoms continue.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Erythema, Joint swelling, Peripheral swelling, Syncope
Clinical narrative: Redness of bilateral feet night of injection. Selling of hands, feet and knees the following dat. (48 hours after, Fainting episode 72 hours after. Possibly related).
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Malaise, Neck pain, Pain in extremity
Clinical narrative: Arm pain, back pain, neck pain, general malaise.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Seizure
Clinical narrative: Seizure reported by patient day after vaccine. Patient has history of seizures.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis
Clinical narrative: Pain in the left arm, red area. She when to emergency hospital area. The physician prescribed CIPRO 500 mg, DURAGESIC, and RANITIDINE 300 mg.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis, Erythema, Pain in extremity
Clinical narrative: Pain in the left arm, red area. She when to emergency hospital area. The physician prescribed CIPRO 500 mg, DURAGESIC, and RANITIDINE 300 mg.
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Myalgia
Clinical narrative: This spontaneous report as received from a physician refers to a 41 year old female patient. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 22-OCT-2016 the patient was vaccinated with M-M-R II (lot # M008589 and expiry date 16-FEB-2018) 0.5 ml, subcutaneously for medical clearance. On an unknown date of October 2016 (reported as with in 6 days of receiving of MMRII), the patient experienced severe thigh muscle pain, shoulder muscle pain, pain in the small joints of hand, and both knees pain. The physician stated that she told the patient's husband that the patient can take an anti-inflammatory for the events. The physician stated that the patient's husband called her on 11-NOV-2016, and reported that the patient is unable to care for her children due to the adverse events. The outcome of the events were reported as not recovered. The causality assessment was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (medical assistant) refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II, lot # L049455 with expiry date: 03-DEC-2017, (dosing details not reported). No adverse effect was reported. The vaccine was exposed to a temperature of excursion of 12.4 degree Celsius for 2 hours and 30 minutes, and it had no previous temperature excursion. The call was because of data logger. No further details provided. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (medical assistant) refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX which had lot # L010148 with expiry date: 24-MAR-2017 and lot # L016123 with expiry date: 06-MAY-2017, (dosing details not reported). No adverse effect was reported. The vaccine was exposed to a temperature excursion of -9.6 degree Celsius for 17 hours and 30 minutes, and it had previous temperature excursion of -13.5 degree Celsius for 3 hours and 30 minutes. The call was because of data logger. No further details provided. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored VARIVAX (lot # M028552, expiration date 07-JUN-2018). Temperature and time frame: 5.7 F for 1 hour and 34 minutes. This information was reported as a result of a digital data logger. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Injection site warmth, Peripheral swelling, Purpura
Clinical narrative: Pt reports that she received a Shingles vaccine on Tues, had some redness and swelling shortly after injection in lt arm. Then last night redness and swelling of lt arm became much worse. Then this am developed red blotches around site and very warm to touch. Pt denies any difficulty breathing at this time. HPI: 61 yo female presents with c/o had a ZOSTAVAX injection medially just above the antecubital LUE. She now has redness, increased heat and swelling that is progressing down the arm. Swelling in hand she had to remove her rings. No ice applied. She spoke with triage and was directed to the UCC. She wants to get back to work. Skin Rash and Purpura. Cephalexin 250mg QID.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: Pt reports that she received a Shingles vaccine on Tues, had some redness and swelling shortly after injection in lt arm. Then last night redness and swelling of lt arm became much worse. Then this am developed red blotches around site and very warm to touch. Pt denies any difficulty breathing at this time. HPI: 61 yo female presents with c/o had a ZOSTAVAX injection medially just above the antecubital LUE. She now has redness, increased heat and swelling that is progressing down the arm. Swelling in hand she had to remove her rings. No ice applied. She spoke with triage and was directed to the UCC. She wants to get back to work. Skin Rash and Purpura. Cephalexin 250mg QID.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 12-SEP-2016, the patient received his first dose of VAQTA (strength, lot number and expiration date were not reported) and received the second dose of VAQTA (strength, lot number and expiration date were not reported), on 13-OCT-2016 (also reported as about a month after the first dose). No adverse effects were reported and no product quality complaint was involved. Additional information is not expected as the pharmacist did not consent for a follow up.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not reported. On unspecified dates, the patient was vaccinated with a series of doses of RECOMBIVAX HB injection (doses, routes of administration, lot # and expiry dates were not reported). After completion of the series, the patient failed to produce titers. Therefore, on unspecified dates, the patient received a second full series of doses of RECOMBIVAX HB injection (doses, routes of administration, lot # and expiry dates were not reported). After the second series of RECOMBIVAX HB was completed, the patient still did not produce any titers. The outcome of the events and causal relationship between RECOMBIVAX HB and the events were not reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cough, Malaise
Clinical narrative: Information has been received from a pharmacist who is also the patient's sister via a company representative, concerning a male patient of unknown age. The patient's concurrent conditions included diabetes. The patient's historical conditions included hospitalisation. No drug reactions or allergies were reported. On an unspecified date in approximately November 2015 (reported as one year ago), the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 (dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. The day following the vaccination, the patient was more sick (malaise) that when he was in the hospital (unknown date). The patient also developed cough the day after receiving PNEUMOVAX 23. No product quality complaint was involved. The outcome of malaise and cough was unknown at the time of reporting. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Ear pain, Gait disturbance, Immediate post-injection reaction, Injection site pain, Injection site urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 4-year-old female patient who received KINRIX. Concomitant products included MMR. On 4th November 2016, the patient received KINRIX (intramuscular). On 4th November 2016, immediately after receiving KINRIX, the patient experienced injection site pain, throat pain, walking difficulty, facial swelling and ear pain. In November 2016, the patient experienced injection site wheal and injection site warmth. The patient was treated with epinephrine, steroid shot and BENADRYL. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site wheal and injection site warmth were not recovered/not resolved and the outcome of the throat pain, facial swelling and ear pain were recovered/resolved and the outcome of the walking difficulty was unknown. The reporter considered the injection site pain, injection site wheal, injection site warmth, throat pain, walking difficulty, facial swelling and ear pain to be related to KINRIX. Additional details were provided as follows: At 12:30, the patient received KINRIX in her right thigh. The batch number of the KINRIX was unknown. On the same day the patient received MMR vaccine in her Left thigh. On the same day of vaccination, right away the patient started complaining that her right leg hurt, and within 10 min she couldn't walk. The patient went home and was fine until 5:30 that evening, several hours after vaccination (when she had to lie down) was complaining of an earache. The reporter went to get some medication, thinking the patient might be getting sick. Five hours after vaccination, the patient experienced swollen face and sore throat. The reporter called around to urgent care offices until she spoke with a nurse and was told to administer 1 table spoon of BENADRYL and took the patient to the emergency room. At the emergency room the patient was treated with epinephrine and a steroid shot right away. The patient was observed for about 6 hours before being released home. At the time of reporting, less than week after vaccination, the patient had a hot welt the size of a softball on her right thigh. The patient was walking, but her leg was tender and she was sitting a lot more than normal. The patient's mother did not know when the welt appeared, but she did not see it when she took the patient to the emergency room.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site warmth, Oropharyngeal pain, Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 4-year-old female patient who received KINRIX. Concomitant products included MMR. On 4th November 2016, the patient received KINRIX (intramuscular). On 4th November 2016, immediately after receiving KINRIX, the patient experienced injection site pain, throat pain, walking difficulty, facial swelling and ear pain. In November 2016, the patient experienced injection site wheal and injection site warmth. The patient was treated with epinephrine, steroid shot and BENADRYL. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site wheal and injection site warmth were not recovered/not resolved and the outcome of the throat pain, facial swelling and ear pain were recovered/resolved and the outcome of the walking difficulty was unknown. The reporter considered the injection site pain, injection site wheal, injection site warmth, throat pain, walking difficulty, facial swelling and ear pain to be related to KINRIX. Additional details were provided as follows: At 12:30, the patient received KINRIX in her right thigh. The batch number of the KINRIX was unknown. On the same day the patient received MMR vaccine in her Left thigh. On the same day of vaccination, right away the patient started complaining that her right leg hurt, and within 10 min she couldn't walk. The patient went home and was fine until 5:30 that evening, several hours after vaccination (when she had to lie down) was complaining of an earache. The reporter went to get some medication, thinking the patient might be getting sick. Five hours after vaccination, the patient experienced swollen face and sore throat. The reporter called around to urgent care offices until she spoke with a nurse and was told to administer 1 table spoon of BENADRYL and took the patient to the emergency room. At the emergency room the patient was treated with epinephrine and a steroid shot right away. The patient was observed for about 6 hours before being released home. At the time of reporting, less than week after vaccination, the patient had a hot welt the size of a softball on her right thigh. The patient was walking, but her leg was tender and she was sitting a lot more than normal. The patient's mother did not know when the welt appeared, but she did not see it when she took the patient to the emergency room.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates between 18-AUG-2016 and 15-NOV-2016, the patients received unspecified doses in series of VARIVAX (lot # M008171 with expiration date 16-FEB-2018; lot # M004326 with expiration date 25-JAN-2-18; lot # M006724 with expiration date 08-FEB-2018; lot # L044525, expiration date 09-NOV-2017; dose and route were unknown) that were improperly stored. The vaccines were stored under the temperature 15.5 Fahrenheit degree for 1 hours 11 minutes. There was a previous temperature excursion for lot # M008171 and lot # M004326 (10 Fahrenheit degree, 37 minutes). A digital logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 13-OCT-2016, the patient was subcutaneously vaccinated with an expired 0.5 ml dose of M-M-R II injection, expiration date 26-AUG-2016 (site of administration, lot number and albumin status were not reported). No adverse events were noted. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker (medical assistant) refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot # L014415 with expiry: 25-JUL-2017 and lot # L037554 with expiry: 25-DEC-2017, (dosing details not reported). No adverse effect was reported. The vaccine was exposed to a temperature excursion of 12.4 degree Celsius for 2 hours and 30 minutes, and it had no previous temperature excursion. The call was because of data logger. No further details provided. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patient were vaccinated with improperly stored doses of M-M-R II (lot # K021950, expiration date: 10-NOV-2016 and reported lot # 002036, expiration date: 10-FEB-2016) (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports from the same reporter. It was determined that Lot number 002036 is not valid for M-M-R II, however lot number K002036 is valid for M-M-R II with status albumin: rHA. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical as, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PROQUAD (route, dose and anatomical location were not reported) (lot # M022399, expiration date 01-NOV-2017). Temperature and time frame: 5.7 degrees F for 1 hour and 34 minutes. Data logger was reported as yes. No adverse effects were reported. There was no product quality (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 22 year old male patient. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On 18-DEC-2013, the patient was vaccinated with the first dose of GARDASIL (dose, route, anatomical location, Lot # and expiration date were not reported). Then, on 20-DEC-2013, the patient received the second dose of GARDASIL (dose, route, anatomical location, Lot # and expiration date were not reported). The reporter stated that the patient received (also reported as would receive) on 01-NOV-2016 a dose of GARDASIL 9 (lot # L038503, expiration date 18-DEC-2017, dose, route and anatomical location were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (dosing details were not reported) (lot # K019502, expiry date: 04-FEB-2016) which was expired. The reporter could not provide a date of administration for the expired dose. No adverse effects were observed in the patient. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.