chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Axillary pain, Insomnia, Pain in extremity
Clinical narrative: Patient started experiencing pain and soreness in arm and under the arm after the immunization. She said it got really bad under the arm the night after the immunization so that she couldn't sleep and that TYLENOL did not help much. Pt will contact her doctor if it's not better tomorrow.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Erythema, Facial pain, Headache, Hypoaesthesia
Clinical narrative: Patient reports tingling and numbness below left eye on cheekbone. Area was red, inflamed, and painful. Later the same day, blisters formed on right side of forehead at hairline. Patient states when she touched areas, her skin "fell off". Also, reported intermittent fever and headaches.  Patient was advised to take BENADRYL by mouth and use Cortizone-10 cream topically. Patient states some improvement the next day, but areas still remained for 5 to 6 day. There was no breathing issues or injection site reactions.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Paraesthesia, Pyrexia, Skin exfoliation
Clinical narrative: Patient reports tingling and numbness below left eye on cheekbone. Area was red, inflamed, and painful. Later the same day, blisters formed on right side of forehead at hairline. Patient states when she touched areas, her skin "fell off". Also, reported intermittent fever and headaches.  Patient was advised to take BENADRYL by mouth and use Cortizone-10 cream topically. Patient states some improvement the next day, but areas still remained for 5 to 6 day. There was no breathing issues or injection site reactions.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Patient called in the morning saying that she had pain in her joint. At first, I thought it was at the injection site which is normal after a vaccination. I told her the pain will subside after a few days. She told me that the pain was at several joints and that she think it maybe the Guillain Barre. I told her to call her doctor.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site discomfort, Injection site erythema, Pyrexia
Clinical narrative: Fever (102 F) chills, headache, soreness at site of injection, redness at site of injection. All Sx resolved at 18 hours.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient got a SHINGRIX vaccine, her arm became red and swollen after the vaccine below the injection site. It was hot to the touch at red area.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: In the early afternoon hours of 11/9/2018, my physician injected a "seasonal flu shot" into my right arm. On the night of 11/10/2018, my body started having a mild hive reaction. The mild hive reaction appeared throughout my arm, stomach and legs. On the night of 11/11/2018, my body started to become itchy and eventually I start seeing symptoms of hives. I examined my body and saw a more severe case of hives than the prior night. Immediately, my family took me to hospital and the doctor there examine my vital signs and symptoms. The results showed that my heart rate is normal and I had no signs of a fever. The register nurse, provide three forms of medications: diphenhydramine (BENADRYL) @ 11:23PM, famotidine (PEPCID) @ 11:23 PM, and prednisone (DELTASONE) @ 11:22PM. The hives eventually subsided overnight but my body start showing symptoms of hives approximately @ 2:00PM.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Musculoskeletal disorder, Pain in extremity, Pyrexia
Clinical narrative: Patient had her vaccine, traveled with her husband for an appointment that was 220+ miles from home and arm started to ache as she sat at husbands appointment. Throughout the day she said her arm got worse and she was unable to use it, also developed fever and chills. Next day chills were better but arm continued to ache, 2 days later arm was more functional, today on day # 3 she is able to lift arm and use it some, no further chills or fever since first day.
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Burning sensation, Fatigue, Injection site erythema, Injection site reaction, Rash erythematous
Clinical narrative: Three red spots appeared at injection site on 11/08/2018. As of 11/12/2018 cluster of red bumps have appeared at injection site. Rash is itchy and burns. Patient reports no fever, just feeling very fatigued. Patient was given a prescription for Prednisone 20 MG tab. Instructed to take 1 tablet twice a day for 3 days. Patient was instructed to take BENADRYL as needed. Not to operate heavy machinery while on it.
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Three red spots appeared at injection site on 11/08/2018. As of 11/12/2018 cluster of red bumps have appeared at injection site. Rash is itchy and burns. Patient reports no fever, just feeling very fatigued. Patient was given a prescription for Prednisone 20 MG tab. Instructed to take 1 tablet twice a day for 3 days. Patient was instructed to take BENADRYL as needed. Not to operate heavy machinery while on it.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came down with cellulitis (Red, warm and swollen) on her Left Arm starting from the injection site but kept expanding until she went to urgent care clinic today.
Age: 65.0
Sex: M
Vaccine: TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was to receive BOOSTRIX and received TENIVAC in error. No adverse events were reported.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Reddened, warm area with hives around injection site; measuring 9cm x 7cm.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Seizure like phenomena, Tremor
Clinical narrative: Pt states he experienced major shaking/shivering or even trembling day after vaccine - he woke up from it, his wife had to sit on him to minimize shaking, lasted for about 30 minutes and was about to call 911 when it stopped. They thought he was having a seizure, but not sure and also reported this effect to his MD. The next day after church pt says he experience a lesser degree of shaking and maybe due to cold air outside, because when he reached hot car the shaking stopped. No injection site reaction reported. Patient is doing fine today 11/12/18.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained of redness, warmth and a rash of grapefruit size at injection site. Symptoms started on 11/8/18. Patient reported event to pharmacy on 11/12 and said that rash and swelling at kept expanding.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever 101 F for 2 days. Headache 1 day. Sore arm 4 days.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Loss of consciousness, Urinary incontinence
Clinical narrative: Patient received flu vaccine. Was with husband. Left and did not state any issues at that time. Her and her husband came back to the pharmacy stating she passed out. She did not fall, her husband caught her. She urinated herself while passed out. She stated she has a fear of needles but has never passed out. She was sweating. Gave her a cold cloth for face. Sat with patient for about 10-15 minutes. Offered twice to call abulance, husband and patient refused. Husband was going to take her home and monitor. Called husand 1 hour later and patient was home, showered and doing well.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Headache, Laboratory test, Meningitis viral, Nuclear magnetic resonance imaging brain normal, Pain
Clinical narrative: Started with HA and soreness, developed fever. Over the next couple days had two emergency room visits for ha and vomiting, second visit lead to admission to hospital 11-6-18 with suspected meningitis.  Final diagnosis probable viral meningitis, but no positive cultures.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Pyrexia, Vomiting
Clinical narrative: Started with HA and soreness, developed fever. Over the next couple days had two emergency room visits for ha and vomiting, second visit lead to admission to hospital 11-6-18 with suspected meningitis.  Final diagnosis probable viral meningitis, but no positive cultures.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills, shivering from 10:00 p.m. to 5:00 a.m.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient, with both doses of the series, encountered a fever greater than 100 F, chills all over, and aches around the body. The symptoms lasted for less than a day and then went away.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Arm swelling and rash.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: Patient got a fever that night of 104.0 with chills.....fever and chills lasted 2 days. He did not seek medical attention.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: Pt experienced a seizure event 1 day after vaccine admin. Has a prior history of seizures only during drug abuse, however states she's been clean for greater than 3 years. Hasn't had seizure since substance abuse period. Pt checked "no" to every question on consent form, indicating she was a candidate for vaccination.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Limb discomfort, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: The patient had soreness at the injection site and the soreness persisted for several days, on average the pain was 3/10. She was able to move her arms, but there was some limitation due to the discomfort. She does regular intense exercise. About 20 days after the vaccination, she noted the pain to her left arm was more pronounced than the previous days about 5/10  and her left arm feeling stiff with some limits on range of motion.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Influenza like illness, Lymphadenopathy
Clinical narrative: Flu like symptoms a day after the shot. Fever, chills, upset stomach, extreme dizziness, swollen lymph nodes, sore throat.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Flu like symptoms a day after the shot. Fever, chills, upset stomach, extreme dizziness, swollen lymph nodes, sore throat.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Patient called the pharmacy today to report significant shoulder pain in her left arm from her flu shot given over two weeks ago. She stated her right arm is very painful and when she touches her shoulder she feels "a lump." Patient is not having any other symptoms other than significant shoulder pain.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Chills, Crying, Dyskinesia, Gaze palsy, Irritability
Clinical narrative: "Patient was warm but afebrile and a little grumpy in the evening after 12mo WCC+imms today Then he vomited his dinner and as mom walked him upstairs he began to seize. Total activity about 1min, total body stiffening, BUE and BLE jerking, and eyes rolling back. Initially he did not gasp or make noises, but after 2 min cried out. No cyanosis. After 2 minutes, cried, breathed normally, and continued to shiver but not jerk. EMT evaluated and did not find fever or VS abnormality, to dad's understanding. They all agreed to monitor at home together and when patient's behavior was back to baseline, EMT left. Dad and I reviewed seizure first aid, plan to call 911 if seizure recurs tonight, and will schedule for appt tmrw morning." Patient has a history of febrile seizures. Immunizations were given at approx. 10:30 in the morning.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Musculoskeletal stiffness, Seizure, Vomiting
Clinical narrative: "Patient was warm but afebrile and a little grumpy in the evening after 12mo WCC+imms today Then he vomited his dinner and as mom walked him upstairs he began to seize. Total activity about 1min, total body stiffening, BUE and BLE jerking, and eyes rolling back. Initially he did not gasp or make noises, but after 2 min cried out. No cyanosis. After 2 minutes, cried, breathed normally, and continued to shiver but not jerk. EMT evaluated and did not find fever or VS abnormality, to dad's understanding. They all agreed to monitor at home together and when patient's behavior was back to baseline, EMT left. Dad and I reviewed seizure first aid, plan to call 911 if seizure recurs tonight, and will schedule for appt tmrw morning." Patient has a history of febrile seizures. Immunizations were given at approx. 10:30 in the morning.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt arm was red, swollen, and hot to the touch. Per pt, arm was in pain and also had body aches that did not improve with time or treatment with ice or MOTRIN. Pt was advised to continue to treat w/MOTRIN, ice, and also add on BENADRYL as well as see MD asap. Pt said she will see MD in the afternoon the day after.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Blood test normal, Discomfort, Gait disturbance, Headache
Clinical narrative: I received the shot on 10/15/18 and the next day my right arm was paralyzed with tingling in fingers and toes on right side. The paralysis lasted about 4-5 hrs. On the third day I experience pain in left leg and ankle and could barely walk. I also had a very bad headache and felt very heavy to carry myself. Inside of my mouth on right side felt like it was closing up on me so I went to E.D with the bad leg. I was diagnosed with sciatica nerve! I went to see my doctor and she stated inflammation of tendons! My friend told her doctor about my symptoms and he stated GBS. Please help me because my pain in left foot is still there and now I'm starting physical therapy 11/13/18. I was fine til I received this flu shot!
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Monoplegia, Oral disorder, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: I received the shot on 10/15/18 and the next day my right arm was paralyzed with tingling in fingers and toes on right side. The paralysis lasted about 4-5 hrs. On the third day I experience pain in left leg and ankle and could barely walk. I also had a very bad headache and felt very heavy to carry myself. Inside of my mouth on right side felt like it was closing up on me so I went to E.D with the bad leg. I was diagnosed with sciatica nerve! I went to see my doctor and she stated inflammation of tendons! My friend told her doctor about my symptoms and he stated GBS. Please help me because my pain in left foot is still there and now I'm starting physical therapy 11/13/18. I was fine til I received this flu shot!
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Sciatica, Tendonitis, X-ray limb
Clinical narrative: I received the shot on 10/15/18 and the next day my right arm was paralyzed with tingling in fingers and toes on right side. The paralysis lasted about 4-5 hrs. On the third day I experience pain in left leg and ankle and could barely walk. I also had a very bad headache and felt very heavy to carry myself. Inside of my mouth on right side felt like it was closing up on me so I went to E.D with the bad leg. I was diagnosed with sciatica nerve! I went to see my doctor and she stated inflammation of tendons! My friend told her doctor about my symptoms and he stated GBS. Please help me because my pain in left foot is still there and now I'm starting physical therapy 11/13/18. I was fine til I received this flu shot!
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pain in extremity, Pyrexia
Clinical narrative: Patient experienced soreness / inflammation, pain on left arm and fever next day after getting the vaccine up until 11/12/18 when she came to the store to show me the reaction.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Chills, Fatigue, Headache
Clinical narrative: Chills and fever headaches treated with ADVIL and TYLENOL lasting four weeks sweating episodes lasting five weeks extreme exhaustion and weakness unable to perform normal physical activities severe scalps pain treated with VALIUM 5 mg for 10 days  lasting 2 weeks debilitating back and neck spasms and pain lasting 6 plus weeks (see above for VALIUM 5 mg for 10 days) Physical Therapy 2 times a week for massage and TENS therapy and strength exercises prior to vaccine I was extremely fit and painfree..I use to walk (jog) 5-11 miles 4 times a week now only able to walk 2-3 miles with back spasms and discomfort.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Laboratory test, Loss of personal independence in daily activities, Muscle spasms, Musculoskeletal discomfort
Clinical narrative: Chills and fever headaches treated with ADVIL and TYLENOL lasting four weeks sweating episodes lasting five weeks extreme exhaustion and weakness unable to perform normal physical activities severe scalps pain treated with VALIUM 5 mg for 10 days  lasting 2 weeks debilitating back and neck spasms and pain lasting 6 plus weeks (see above for VALIUM 5 mg for 10 days) Physical Therapy 2 times a week for massage and TENS therapy and strength exercises prior to vaccine I was extremely fit and painfree..I use to walk (jog) 5-11 miles 4 times a week now only able to walk 2-3 miles with back spasms and discomfort.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain of skin, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Chills and fever headaches treated with ADVIL and TYLENOL lasting four weeks sweating episodes lasting five weeks extreme exhaustion and weakness unable to perform normal physical activities severe scalps pain treated with VALIUM 5 mg for 10 days  lasting 2 weeks debilitating back and neck spasms and pain lasting 6 plus weeks (see above for VALIUM 5 mg for 10 days) Physical Therapy 2 times a week for massage and TENS therapy and strength exercises prior to vaccine I was extremely fit and painfree..I use to walk (jog) 5-11 miles 4 times a week now only able to walk 2-3 miles with back spasms and discomfort.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Condition aggravated, Cough, Hypersensitivity, Rash papular
Clinical narrative: Dry cough started around 3 pm, cough similar to that of mild asthma. About 7 pm, about 3 itchy bumps on chin appeared. At 10 pm, small hives appeared on neck, chin, cheeks, forehead, chest, and back. The 24/7 registered nurse service was called. Symptoms were described to nurse as well as answering additional questions on severity or signs of other symptoms. Nurse identified symptoms as an allergic reaction to the vaccine and advised to take benadryl and seek immediate medical attention with worsening symptoms. 2 benadryl tablets were taken (as prescribed on the bottle for adults). Symptoms were clearly lessened after two hours, including breathing noticeably returning to normal and no cough. No sign of hives or other symptoms by morning.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic, Respiration abnormal, Urticaria
Clinical narrative: Dry cough started around 3 pm, cough similar to that of mild asthma. About 7 pm, about 3 itchy bumps on chin appeared. At 10 pm, small hives appeared on neck, chin, cheeks, forehead, chest, and back. The 24/7 registered nurse service was called. Symptoms were described to nurse as well as answering additional questions on severity or signs of other symptoms. Nurse identified symptoms as an allergic reaction to the vaccine and advised to take benadryl and seek immediate medical attention with worsening symptoms. 2 benadryl tablets were taken (as prescribed on the bottle for adults). Symptoms were clearly lessened after two hours, including breathing noticeably returning to normal and no cough. No sign of hives or other symptoms by morning.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Face injury, Fall, Feeling cold, Hyperhidrosis, Hypersensitivity
Clinical narrative: Patient states that around 3:00 AM the morning after the injections she started to feel cold and was sweating. The patient says that about 4 days later she passed out and busted her face and had to be hospitalized. Patient went to hospital and was transferred to another hospital. Pt. is unaware of any tests that were ran. Pt. said she had no markings or swelling at the injection site. Pt. had re-hab for about 6 weeks following her fall. This was the 2nd dose of SHINGRIX for the patient. She received the 1st dose of SHINGRIX on 4/24/18 and did not have any signs or symptoms of an allergic reaction. We first learned of the patient's allergic reaction via fax from her primary care physician. Dr. stated in fax that he gave the patient instructions not to get 2 immunizations in same day and he is upset with us B/C we told the patient 2 injections of non-live immunizations in the same day was ok per CDC guidelines. The patient asked before getting the immunizations if it was ok to get both in the same day and I told her it was ok per CDC guidelines but it was up to her if she wanted to space them out. Dr. also stated the patient is immunocompromised and he sent in prescriptions for both immunizations but neither Rx stated the patient's disease state or gave instructions to space out the 2 immunizations.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Loss of consciousness
Clinical narrative: Patient states that around 3:00 AM the morning after the injections she started to feel cold and was sweating. The patient says that about 4 days later she passed out and busted her face and had to be hospitalized. Patient went to hospital and was transferred to another hospital. Pt. is unaware of any tests that were ran. Pt. said she had no markings or swelling at the injection site. Pt. had re-hab for about 6 weeks following her fall. This was the 2nd dose of SHINGRIX for the patient. She received the 1st dose of SHINGRIX on 4/24/18 and did not have any signs or symptoms of an allergic reaction. We first learned of the patient's allergic reaction via fax from her primary care physician. Dr. stated in fax that he gave the patient instructions not to get 2 immunizations in same day and he is upset with us B/C we told the patient 2 injections of non-live immunizations in the same day was ok per CDC guidelines. The patient asked before getting the immunizations if it was ok to get both in the same day and I told her it was ok per CDC guidelines but it was up to her if she wanted to space them out. Dr. also stated the patient is immunocompromised and he sent in prescriptions for both immunizations but neither Rx stated the patient's disease state or gave instructions to space out the 2 immunizations.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Immunodeficiency
Clinical narrative: Patient states that around 3:00 AM the morning after the injections she started to feel cold and was sweating. The patient says that about 4 days later she passed out and busted her face and had to be hospitalized. Patient went to hospital and was transferred to another hospital. Pt. is unaware of any tests that were ran. Pt. said she had no markings or swelling at the injection site. Pt. had re-hab for about 6 weeks following her fall. This was the 2nd dose of SHINGRIX for the patient. She received the 1st dose of SHINGRIX on 4/24/18 and did not have any signs or symptoms of an allergic reaction. We first learned of the patient's allergic reaction via fax from her primary care physician. Dr. stated in fax that he gave the patient instructions not to get 2 immunizations in same day and he is upset with us B/C we told the patient 2 injections of non-live immunizations in the same day was ok per CDC guidelines. The patient asked before getting the immunizations if it was ok to get both in the same day and I told her it was ok per CDC guidelines but it was up to her if she wanted to space them out. Dr. also stated the patient is immunocompromised and he sent in prescriptions for both immunizations but neither Rx stated the patient's disease state or gave instructions to space out the 2 immunizations.
Sex: M
Vaccine: FLUC4
Symptoms: Lymphadenopathy
Clinical narrative: This serious spontaneous case, initially received from pharmacist on 29-Oct-2018, concerns a male patient of an unspecified age. Since an unspecified date, the patient was on chemotherapy. On an unspecified date, the patient was administered FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number and expiry date: not reported]. On an unspecified date, after vaccination, the patient had large, swollen lymph nodes under his arm. It was reported that the patient would receive a steroid injection as a treatment. At the time of this report, the outcome of the event was not reported. This case: 201805077 was cross-linked to case: 201805075 due to same reporter.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth, Paraesthesia
Clinical narrative: L facial paresthesia, injection site warmth, redness, firm nodule approx. 2.5 cm enduration.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Blepharospasm, Erythema, Injection site pain, Limb discomfort
Clinical narrative: 10/25 Received FLUBLOK. 10/26 (R) deltoid and lower arm red and sore. 10/28 (R) upper eyelid involuntarily twitch and 1/2 closes multiple times to once daily - now.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm red circle 6.5 cm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Laryngitis, Lip swelling, Pruritus, Swelling face, Throat tightness
Clinical narrative: Severe hives, itchy, swelling of lips and face, tightening of throat resulting in laryngitis.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Severe hives, itchy, swelling of lips and face, tightening of throat resulting in laryngitis.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site lasting more than one month.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Joint stiffness, Myalgia, Pyrexia
Clinical narrative: Fever, muscle aches, joint stiffness.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on the chest, abdomen, and back.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose decreased, Syncope
Clinical narrative: Syncope. Paramedic admin 50 gm oral glucose pt. left under her own power.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Pt stated she had pain the day of shot and redness and swollenness. Monday 11/5/18 she had a visit with MD. He stated cellulitis - prescribed - AUGMENTIN.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Disorientation, Migraine with aura
Clinical narrative: Within 24 hours migraine with aura, disoriented, confused.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Pruritus, Vomiting
Clinical narrative: Anaphylaxis-vomiting, itching.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blister, Rash, Skin striae
Clinical narrative: The next day developed rash on arms and streaking. By 1 week patient had blisters between fingers and around anus and genitals.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose decreased, Cold sweat, Dizziness, Pallor, Visual impairment
Clinical narrative: Approximately after receiving vaccine 10 minutes later father and brother brought patient back to pharmacy. Father was carrying patient and said she felt faint. Patient appeared pale and clammy. Had no breathing difficulty but had visual disturbances. Paramedics were called. Vitals were in normal limits but blood sugar 62. Patient recovered within 15 minutes and felt better.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Myalgia, Pain in extremity
Clinical narrative: Patient came back to pharmacy complaining of redness/soreness in same arm that the vaccine was administered. It started in muscle of forearm radiating to inside of arm and up to inside of upper arm single red line. Upon investigation the shot was administered about a month prior to complaint. Pt has had previous cancer spot removed from same arm and was told to get that reviewed by medical doctor.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Nausea
Clinical narrative: Patient says he experienced nausea that was relieved upon eating, and redness/reaction at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left upper arm is fine. Right upper arm has redness, warmth and induration. It is non-tender. Patient has full range of motion. Almost entire right upper arm is affected.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 6 x 6 cm, round, area of left deltoid, erythema, induration, warmth, no fever, mild itch, mild pain with palpation.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Pt received pneumonia vaccine 10/29/18 to the (R) arm. Came to office on 10/30/18 to be evaluated. C/O redness, swelling, pain. Exam shows diffuse swelling to (R) upper arm, lateral aspect (measures 6.6 x 5 inches). Inflamed, erythematous, tender. (Portal message sent 11/4/18 to check status-no reply).
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The day after the immunization developed redness, swelling, warmth. Positive mild itch and mild pain. No shortness of breath or cough. Has normal range of motion. Area is about 8 cm diameter, oval shape, left upper arm, includes the injection site. Given ZYRTEC.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left upper arm redness, induration, and warmth of most of the upper arm. No apparent discomfort with direct palpation. No fever or pus. Is using the arm normally. Given TYLENOL at home.
Age: 33.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Burning sensation, Hypersensitivity, Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 33-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number D4E29, expiry date 30th June 2019) for prophylaxis. On 30th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 31st October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema (serious criteria other: As per reporter), injection site swelling (serious criteria other: As per reporter), injection site warmth (serious criteria other: As per reporter), numbness of upper extremities (serious criteria other: As per reporter), tingling of extremity (serious criteria other: As per reporter), burning sensation (serious criteria other: As per reporter) and allergy to vaccine. The patient was treated with BENADRYL, SOLUMEDROL and MEDROL DOSEPAK. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, numbness of upper extremities, tingling of extremity, burning sensation and allergy to vaccine were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, numbness of upper extremities, tingling of extremity, burning sensation and allergy to vaccine to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: On Tuesday the patient received FLUARIX QUADRIVALENT 2018-2019 season. On Wednesday morning the patient had a site reaction morning measuring 1 and 1/2 inches by 3 inches. The area was swollen, red and hot. At 9:00 she noticed her arm was going numb down to her wrist. At 9:30 it started tingling and burning in the same area. At 10:00 it started going numb to her shoulder, across her back and shoulder blades and up the back of her neck with burning and tingling. The patient called the nurse that had given her the vaccine and was advised to call her primary care physician (PCP). At 11: 30 the patient called the nurse and he advised her to go to the emergency room (ER). At 12:00 the patient went to the ER. The ER physician said that the patient was having an allergic reaction to the vaccine. He ordered BENADRYL and SOLUMEDROL intravenous. Upon discharge from the ER the physician gave her a MEDROL DOSE PACK. The patient might finish it on the next day from the reporting date. As of 5th November 2018 the patient was having numbness in the right arm and tingling, burning, and numbness up the neck and the upper back. Consented to follow up was given by the reporter. The reporter stated, the patient required ER Visit.
Age: 33.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Injection site paraesthesia, Injection site swelling, Injection site warmth, Paraesthesia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 33-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number D4E29, expiry date 30th June 2019) for prophylaxis. On 30th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 31st October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema (serious criteria other: As per reporter), injection site swelling (serious criteria other: As per reporter), injection site warmth (serious criteria other: As per reporter), numbness of upper extremities (serious criteria other: As per reporter), tingling of extremity (serious criteria other: As per reporter), burning sensation (serious criteria other: As per reporter) and allergy to vaccine. The patient was treated with BENADRYL, SOLUMEDROL and MEDROL DOSEPAK. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, numbness of upper extremities, tingling of extremity, burning sensation and allergy to vaccine were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, numbness of upper extremities, tingling of extremity, burning sensation and allergy to vaccine to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: On Tuesday the patient received FLUARIX QUADRIVALENT 2018-2019 season. On Wednesday morning the patient had a site reaction morning measuring 1 and 1/2 inches by 3 inches. The area was swollen, red and hot. At 9:00 she noticed her arm was going numb down to her wrist. At 9:30 it started tingling and burning in the same area. At 10:00 it started going numb to her shoulder, across her back and shoulder blades and up the back of her neck with burning and tingling. The patient called the nurse that had given her the vaccine and was advised to call her primary care physician (PCP). At 11: 30 the patient called the nurse and he advised her to go to the emergency room (ER). At 12:00 the patient went to the ER. The ER physician said that the patient was having an allergic reaction to the vaccine. He ordered BENADRYL and SOLUMEDROL intravenous. Upon discharge from the ER the physician gave her a MEDROL DOSE PACK. The patient might finish it on the next day from the reporting date. As of 5th November 2018 the patient was having numbness in the right arm and tingling, burning, and numbness up the neck and the upper back. Consented to follow up was given by the reporter. The reporter stated, the patient required ER Visit.
Age: 33.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Allergy to vaccine, Burning sensation, Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 33-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number D4E29, expiry date 30th June 2019) for prophylaxis. On 30th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 31st October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema (serious criteria other: As per reporter), injection site swelling (serious criteria other: As per reporter), injection site warmth (serious criteria other: As per reporter), numbness of upper extremities (serious criteria other: As per reporter), tingling of extremity (serious criteria other: As per reporter), burning sensation (serious criteria other: As per reporter) and allergy to vaccine. The patient was treated with BENADRYL, SOLUMEDROL and MEDROL DOSEPAK. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, numbness of upper extremities, tingling of extremity, burning sensation and allergy to vaccine were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, numbness of upper extremities, tingling of extremity, burning sensation and allergy to vaccine to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: On Tuesday the patient received FLUARIX QUADRIVALENT 2018-2019 season. On Wednesday morning the patient had a site reaction morning measuring 1 and 1/2 inches by 3 inches. The area was swollen, red and hot. At 9:00 she noticed her arm was going numb down to her wrist. At 9:30 it started tingling and burning in the same area. At 10:00 it started going numb to her shoulder, across her back and shoulder blades and up the back of her neck with burning and tingling. The patient called the nurse that had given her the vaccine and was advised to call her primary care physician (PCP). At 11: 30 the patient called the nurse and he advised her to go to the emergency room (ER). At 12:00 the patient went to the ER. The ER physician said that the patient was having an allergic reaction to the vaccine. He ordered BENADRYL and SOLUMEDROL intravenous. Upon discharge from the ER the physician gave her a MEDROL DOSE PACK. The patient might finish it on the next day from the reporting date. As of 5th November 2018 the patient was having numbness in the right arm and tingling, burning, and numbness up the neck and the upper back. Consented to follow up was given by the reporter. The reporter stated, the patient required ER Visit.
Age: 33.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site warmth, Paraesthesia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 33-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number D4E29, expiry date 30th June 2019) for prophylaxis. On 30th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 31st October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema (serious criteria other: As per reporter), injection site swelling (serious criteria other: As per reporter), injection site warmth (serious criteria other: As per reporter), numbness of upper extremities (serious criteria other: As per reporter), tingling of extremity (serious criteria other: As per reporter), burning sensation (serious criteria other: As per reporter) and allergy to vaccine. The patient was treated with BENADRYL, SOLUMEDROL and MEDROL DOSEPAK. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, numbness of upper extremities, tingling of extremity, burning sensation and allergy to vaccine were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, numbness of upper extremities, tingling of extremity, burning sensation and allergy to vaccine to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: On Tuesday the patient received FLUARIX QUADRIVALENT 2018-2019 season. On Wednesday morning the patient had a site reaction morning measuring 1 and 1/2 inches by 3 inches. The area was swollen, red and hot. At 9:00 she noticed her arm was going numb down to her wrist. At 9:30 it started tingling and burning in the same area. At 10:00 it started going numb to her shoulder, across her back and shoulder blades and up the back of her neck with burning and tingling. The patient called the nurse that had given her the vaccine and was advised to call her primary care physician (PCP). At 11: 30 the patient called the nurse and he advised her to go to the emergency room (ER). At 12:00 the patient went to the ER. The ER physician said that the patient was having an allergic reaction to the vaccine. He ordered BENADRYL and SOLUMEDROL intravenous. Upon discharge from the ER the physician gave her a MEDROL DOSE PACK. The patient might finish it on the next day from the reporting date. As of 5th November 2018 the patient was having numbness in the right arm and tingling, burning, and numbness up the neck and the upper back. Consented to follow up was given by the reporter. The reporter stated, the patient required ER Visit.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Aggression, Condition aggravated, Feeding disorder, Obsessive-compulsive disorder, Pyrexia
Clinical narrative: Patient began spending pretty much her whole time awake with both fists tightly balled up. Tried to pick up things and play with them like that. Meltdowns have been nonstop off and on for hours. She ended up sick a few days after the shot and her fever got as high as 104. Her feeding has worsened dramatically. Her OCD tendencies have become much worse.
Age: 22.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Mobility decreased, Musculoskeletal discomfort
Clinical narrative: Severe muscle discomfort and difficulty lifting arm in different positions. (Left arm).
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Erythema, Incoherent, Malaise
Clinical narrative: SHOT WAS GIVEN ABOUT 1 INCH ABOVE ELBOW. ARM WAS SWOLLEN, RED AND SORE. ON 10/29/18, CLIENT STARTED NOT FEELING WELL (WEAK, STOMACH PAIN, ETC.). BY 11/1/18, HE WAS SO WEAK HE COULDN'T GET WOULD OF BED, EVEN TO GO TO THE BATHROOM. HE WAS INCOHERENT. 911 WAS CALLED. HE WAS ADMITTED TO HOSPITAL, WHERE HE STAYED FOR 3 DAYS.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: SHOT WAS GIVEN ABOUT 1 INCH ABOVE ELBOW. ARM WAS SWOLLEN, RED AND SORE. ON 10/29/18, CLIENT STARTED NOT FEELING WELL (WEAK, STOMACH PAIN, ETC.). BY 11/1/18, HE WAS SO WEAK HE COULDN'T GET WOULD OF BED, EVEN TO GO TO THE BATHROOM. HE WAS INCOHERENT. 911 WAS CALLED. HE WAS ADMITTED TO HOSPITAL, WHERE HE STAYED FOR 3 DAYS.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This case was previously received from a medical assistant considered non-valid as there was no patient identity on 31-MAY-2018. Follow up information has been received from a medical assistant during a phone call on 30-OCT-2018. The phone call was answered by the receptionist and transferred to the medical assistant. This spontaneous report refers to a 10 weeks years old male patient. Information of concurrent condition, medical history and concomitant therapy was not provided. On 01-MAY-2018, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, strength and frequency were unknown, lot # N022008, expiry date 18-FEB-2019) orally for prophylaxis. No adverse effects reported. The administered doses of ROTATEQ underwent a temperature excursion between 9 and 25 Celsius degrees for 1 hour. There was no previous temperature excursion. Data Logger was involved. This is one of the four reports received from the same reporter. Sender's Comments: US-009507513-1811USA001370: US-009507513-1811USA001371: US-009507513-1811USA001369.
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to a male patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On 15-OCT-2018 the patient was vaccinated with ROTATEQ orally for prophylaxis (lot # N005617, expired date 03-OCT-2018, dose and frequency were not reported) No adverse effect was reported. No lab diagnostics and medical attention was performed.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Speech disorder
Clinical narrative: This spontaneous report as received from the patient's mother via a company representative and refers to a currently 20-year-old male patient. The patient's concurrent condition included Down's syndrome. The patient's medical history and concomitant therapies were not reported. In approximately 2005, at the age of about 7-year-old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, lot number, expiration date were not provided) for prophylaxis. He was vaccinated. Other suspect therapies included sterile diluent (manufacturer unknown). On unknown day in approximately 2005, reported as day after receiving the vaccine, the patient became non-verbal and he remained that way ever since. The patient sought medical attention. The relatedness between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and sterile diluent (manufacturer unknown) was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Peripheral swelling
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis. She stated that she did not experience an adverse effect after receiving the ZOSTAVAX. Then on an unspecified date in 2018, the patient received the first dose of SHINGRIX. After receiving the SHINGRIX, the patient stated that her "arm blew up" and she experienced unspecified adverse effects. The outcome of the events was unknown. The causality was not reported.