chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: On Sept 11, 2018 (the day after receiving FLUARIX) patient began "to have sweats, felt sick, odd sensations, prickling in feet and difficulty with workout". By Sept 24, "half of mouth and tongue went numb. Left arm, shoulder, and neck seized. Blood pressure became abnormally high". On Sept 25th, she "saw a Dr for an EKG and stroke check. Lots of pain on left side, tongue felt scalded for a week". On Sept 30th, she "began a new blood pressure medication". On October 3rd, she "was admitted to the hospital with a blood pressure of 226/130, was rechecked for stroke and heart problems (tests came back negative). Blood pressure resistant to lowering. Started on more blood pressure and some anxiety medications. On Oct 5th, she was released from hospital. Patient reports that she "continued to get weaker, lots of reactions to medications, spent 2 weeks going to the Dr, laying on couch, having difficulty eating, and tongue feeling like tripping over it when talking. Basement stairs felt like a mountain. Lots of burning tingling and cramping at night, full body shaking, and balance off."  From Oct 17 through 22, "full facial numbness, made my teeth hurt".  Patient indicates "starting to improve but muscles still weak, fatigued easily, and still nighttime numbness and tingling". She has been referred to see a neurologist in December.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Impaired work ability, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased
Clinical narrative: The shot was given in my upper shoulder, and something didn't feel right. I have been getting flu shots for 18 years now, ever since starting working in the medical field, and never had an issue. It hurt much more than normal and my arm felt a very strange nerve like feeling after, where it almost moved on its own after the injection for a second as if it was a twitch feeling. Within a couple of hours I had a hard time even barely lifting my arm from my side, it felt very painful and heavy, my range of motion was very poor. This progressed over the next couple of weeks and effected my daily activities, even sleep. It felt heavy and dead, and when I woke up in the morning it was the first thing that I felt. It never went away. It was especially hard doing my job at work since I am a dental hygienist. Hard "tasks" included just pulling my pants up or down to go to the bathroom or get dressed, reaching for things, driving (lifting my arm to steering wheel) basically any movement of my arm hurt. After a couple doctors appointments, I was diagnosed with Bursitis in my left shoulder resulting from improper placement of the shot into my bursa sac, not in the muscle where it should have been. I completed two rounds of steroids, and a shot in my shoulder of steroids and 4 weeks of physical therapy and still dealing with this problem. I continue to do the home physical therapy as instructed which takes a lot of time every day- about an hour and a half per day. These exercises are to continue until I get to a point where I am pain free, plus an additional 3 weeks. I have not reached that point yet. I thought I was getting better after round 1 of steroids, but once I finished them, the pain crept back in.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Loss of personal independence in daily activities, Muscle twitching, Product administered at inappropriate site
Clinical narrative: The shot was given in my upper shoulder, and something didn't feel right. I have been getting flu shots for 18 years now, ever since starting working in the medical field, and never had an issue. It hurt much more than normal and my arm felt a very strange nerve like feeling after, where it almost moved on its own after the injection for a second as if it was a twitch feeling. Within a couple of hours I had a hard time even barely lifting my arm from my side, it felt very painful and heavy, my range of motion was very poor. This progressed over the next couple of weeks and effected my daily activities, even sleep. It felt heavy and dead, and when I woke up in the morning it was the first thing that I felt. It never went away. It was especially hard doing my job at work since I am a dental hygienist. Hard "tasks" included just pulling my pants up or down to go to the bathroom or get dressed, reaching for things, driving (lifting my arm to steering wheel) basically any movement of my arm hurt. After a couple doctors appointments, I was diagnosed with Bursitis in my left shoulder resulting from improper placement of the shot into my bursa sac, not in the muscle where it should have been. I completed two rounds of steroids, and a shot in my shoulder of steroids and 4 weeks of physical therapy and still dealing with this problem. I continue to do the home physical therapy as instructed which takes a lot of time every day- about an hour and a half per day. These exercises are to continue until I get to a point where I am pain free, plus an additional 3 weeks. I have not reached that point yet. I thought I was getting better after round 1 of steroids, but once I finished them, the pain crept back in.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Chest pain, Chills, Echocardiogram, Electrocardiogram change, Headache
Clinical narrative: Received 3rd dose in the HPV series vaccine and flu vaccine at approximately 1130 am on Oct 19, 2018. At approximately 2130 on Oct 19, 2018 he develops a fever 101-102, headache, aches, and chills that lasted until Oct 20th at 1600. Oct 22nd at 9am, he developed severe chest pain and was taken to local emergency room. ER shipped him by ambulance to hospital for elevated troponins and EKG changes. More lab work was completed. Troponins were >8, echocardiogram and MRI were completed and diagnosis of myocarditis was made.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Laboratory test, Myocarditis, Nuclear magnetic resonance imaging, Pain, Pyrexia
Clinical narrative: Received 3rd dose in the HPV series vaccine and flu vaccine at approximately 1130 am on Oct 19, 2018. At approximately 2130 on Oct 19, 2018 he develops a fever 101-102, headache, aches, and chills that lasted until Oct 20th at 1600. Oct 22nd at 9am, he developed severe chest pain and was taken to local emergency room. ER shipped him by ambulance to hospital for elevated troponins and EKG changes. More lab work was completed. Troponins were >8, echocardiogram and MRI were completed and diagnosis of myocarditis was made.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Troponin increased
Clinical narrative: Received 3rd dose in the HPV series vaccine and flu vaccine at approximately 1130 am on Oct 19, 2018. At approximately 2130 on Oct 19, 2018 he develops a fever 101-102, headache, aches, and chills that lasted until Oct 20th at 1600. Oct 22nd at 9am, he developed severe chest pain and was taken to local emergency room. ER shipped him by ambulance to hospital for elevated troponins and EKG changes. More lab work was completed. Troponins were >8, echocardiogram and MRI were completed and diagnosis of myocarditis was made.
Age: 10.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Fatigue, Pyrexia, Respiratory tract congestion, Speech disorder, Vomiting
Clinical narrative: Patient woke up Sunday morning with congestion and unable to speak clearly and had a low grade fever. He woke up Monday morning with a temp of 100 and still congested. Went all day Monday with a temperature of 100. Monday night around 5:00 patient became tired. Checked his temp again and it was 103. Within an hour it shot up to 105 and he's throwing up. I'm planning to take him in to see his pediatrician in the morning unless an emergency takes place and I need to get him seen sooner.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Severe headache lasting seven hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Patient received 1st dose of SHINGRIX on 8/22/2018. She experienced redness near the injection site and feeling sick for about 24 hours. Patient received 2nd dose of SHINGRIX on 11/2/2018. She felt sick again and experienced redness and swelling near the injection site for about 48 hours. Given BENADRYL cream to apply to area.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood uric acid normal, Full blood count normal, Gout, Joint warmth
Clinical narrative: Received SHINGRIX in right deltoid on 10/20/18. On 10/23 began to have pain in right wrist. Over next few days symptoms progressed to pain at an 8/10 level, swelling, inability to actively move fingers, pain on movement of wrist, pain touching wrist, and heat in joint. Pain was a constant ache with sharp pains with movement or contact. CBC normal, uric acid at upper level of normal (6.2). NP (urgent care) called with diagnosis of gout. I am just now beginning to be able to use my right hand. Splinting, NSAIDs, heat have helped with pain. Have follow up appt with PCP tomorrow for plan of care.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Splint application, Swelling, Tenderness
Clinical narrative: Received SHINGRIX in right deltoid on 10/20/18. On 10/23 began to have pain in right wrist. Over next few days symptoms progressed to pain at an 8/10 level, swelling, inability to actively move fingers, pain on movement of wrist, pain touching wrist, and heat in joint. Pain was a constant ache with sharp pains with movement or contact. CBC normal, uric acid at upper level of normal (6.2). NP (urgent care) called with diagnosis of gout. I am just now beginning to be able to use my right hand. Splinting, NSAIDs, heat have helped with pain. Have follow up appt with PCP tomorrow for plan of care.
Sex: F
Vaccine: VARZOS
Symptoms: X-ray abnormal
Clinical narrative: Received SHINGRIX in right deltoid on 10/20/18. On 10/23 began to have pain in right wrist. Over next few days symptoms progressed to pain at an 8/10 level, swelling, inability to actively move fingers, pain on movement of wrist, pain touching wrist, and heat in joint. Pain was a constant ache with sharp pains with movement or contact. CBC normal, uric acid at upper level of normal (6.2). NP (urgent care) called with diagnosis of gout. I am just now beginning to be able to use my right hand. Splinting, NSAIDs, heat have helped with pain. Have follow up appt with PCP tomorrow for plan of care.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: I received the AFLURIA QUAD PF 2018-19 INJ, 0.5 ML flu shot at Pharmacy on 11/1. I developed hives as a suspected allergic reaction to the vaccine on 11/2. I had hives on my back with severe itching, which I have never experienced in my life. I don't have an egg allergy or any known allergies to medications.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Aura, Disorientation, Dizziness, Headache, Visual field defect
Clinical narrative: I received the AFLURIA QUAD (2018-2019) Flu Vaccine at a Pharmacy. Manufacturer: Seqirus Inc. The Lot # of the vaccine was YF43109. Volume 0.5 mL. Administered IM in Left Deltoid. Within a couple of minutes a pulsing rainbow aura appeared in my left eye. This was accompanied by loss of peripheral vision on the left side of that eye and a sense of disorientation and dizziness. The aura diminished after 15 minutes and was gone after 45 minutes. Peripheral vision seemed back to normal as well. However, as the aura diminished, I got a headache on the opposite (right) side. Headache persisted for 24 hours (ADVIL helped but did not eliminate it).
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Rash and itch and swelling.
Age: 8.0
Sex: M
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: On 10-25-18 around 2:30 pm I saw that patient had orders pending for a flu and Hep A vaccine. I looked at the orders and walked to the fridge to draw them up and mistakenly grabbed the HPV instead of Hep A, feeling rushed to help out the other MA's I rushed into the room and gave the vaccines before taking them out of the computer, which was my own mistake. I then caught my mistake after talking to the mom after giving the vaccines. I then stayed calm in the room even though I mentally was panicking, told the mom and patient I would be right back and rushed right to the nurse and shortly after explaining what had happened to the nurse, I explained the situation and mistake to Dr then went and explained what had happened to the patient and mom. I then after the doctor gave the Hep A and apologized to both the mom and patient. We checked in with the local health department to make sure there was no extra monitoring that needed to be done  for the patient.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis, Pruritus, Rash
Clinical narrative: Full body dermatitis (rash and itching) (5day). Pt prescribed prednisone oral and topical CETAPHIL. ATARAX for itching.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 7.5cm x 6cm area of redness, warmth and tenderness to palpation on the left upper outer arm. I am treating for cellulitis with BACTRIM BID for 7 days.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Face injury, Fall, Loss of consciousness, Tooth fracture
Clinical narrative: Had a blackout, fell and hit my face on concrete - chip two teeth.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Headache, Tremor
Clinical narrative: Approximately 1 hour after receiving above vaccines pt. began to have severe frontal bitemporal headache 10 out of 10. Was shivering and shaking due to being so upset from pain. No medication was given no loc no seizures went to ER for evaluation. Headache began to resolve on its own down to a 5/10 in ER. No fever, vomiting, diarrhea or rash. Received MOTRIN in ER and pain was down to 1/10 at discharge time (1 1/2 hr between MOTRIN 600 mg and discharge time) DC plan: MOTRIN q 6 hours x 24 hours - q 6 hours PRN. Rest and fluids encouraged. Can resume normal activity the next day. Over the next 3 days at time patient had headache 2-3/10. She has fully recovered ROM. ER timeline 9/20/2018 1511 - arrived 1549 - MOTRIN/Ibuprofen 600 mg 1718 - Discharged home DX: headaches; possible reaction to vaccine component discussed with family.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient reported to pharmacist that he is experiencing pain down his left arm that started after receiving flu vaccination. Patient was advised to seek care from PCP if it persists. Which he did on 10/31/18. His MD prescribed ibuprofen to help with the pain. The patient reports that the MD advised him to follow up with office if ibuprofen does not help or if pain persists. Patient reported that he received a vaccination at his MD office around the time he received the flu vaccine here.
Age: 70.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site swelling, Pyrexia, Skin exfoliation
Clinical narrative: Patient reported to have developed a fever, swelling of upper arm around injection site, skin on torso turned red and later peeled.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Crying, Fatigue, Inappropriate affect, Pyrexia, Screaming
Clinical narrative: On 11-2-18 fever 102. On 11-4-18 acting "very" tired and "emotional per mom". Crying, screaming, laughing.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: The vaccine was administered high on the left arm. A nerve or bone may have been hit. Pt had very sore arm, very painful when trying to raise arm for removing clothes, driving etc.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Immediately after administering flu shot, patient fainted. Patient was sitting in chair and slid off the chair. Patient's father picked up patient right away and patient woke up. Pharmacy staff called 911 to further assess patient. While waiting patient was alert with normal breathing. Once first responders came to the pharmacy, vitals of patient were normal. After second check of vitals father of patient confirmed patient was ok to go home. Patient went home (did not go to the ER/hospital).
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Erythema, Fatigue, Headache, Induration
Clinical narrative: By the late evening of date of injection my arm was very red, sore, hot, hard, swollen and very painful. The next early morning I couldn't get up. I had a fever, headache (strong), muscle pain, my arm was swollen from the elbow to the shoulder, and I was very weak! It took be 3 days to recuperate. I called the pharmacist and she told me the side effects were normal and a good sign that I had a strong immune system which was trying to fight the vaccine. I slept all Monday and part of Tuesday. I took TYLENOL every six hours for 3 days. Today is 4 days after the vaccine, and the redness and swelling are almost gone except on the underarm area closer to the elbow. I still have a headache-although bearable-and feel tired.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: By the late evening of date of injection my arm was very red, sore, hot, hard, swollen and very painful. The next early morning I couldn't get up. I had a fever, headache (strong), muscle pain, my arm was swollen from the elbow to the shoulder, and I was very weak! It took be 3 days to recuperate. I called the pharmacist and she told me the side effects were normal and a good sign that I had a strong immune system which was trying to fight the vaccine. I slept all Monday and part of Tuesday. I took TYLENOL every six hours for 3 days. Today is 4 days after the vaccine, and the redness and swelling are almost gone except on the underarm area closer to the elbow. I still have a headache-although bearable-and feel tired.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: By the late evening of date of injection my arm was very red, sore, hot, hard, swollen and very painful. The next early morning I couldn't get up. I had a fever, headache (strong), muscle pain, my arm was swollen from the elbow to the shoulder, and I was very weak! It took be 3 days to recuperate. I called the pharmacist and she told me the side effects were normal and a good sign that I had a strong immune system which was trying to fight the vaccine. I slept all Monday and part of Tuesday. I took TYLENOL every six hours for 3 days. Today is 4 days after the vaccine, and the redness and swelling are almost gone except on the underarm area closer to the elbow. I still have a headache-although bearable-and feel tired.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Diarrhoea, Herpes zoster, Hyperhidrosis
Clinical narrative: Day 1 arm swollen, Day 2 nausea, vomiting, chills sweats, diarrhea, arm swelling. Lasted 7 days. Shingles outbreak (day 21 s/d injection).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling, Vomiting
Clinical narrative: Day 1 arm swollen, Day 2 nausea, vomiting, chills sweats, diarrhea, arm swelling. Lasted 7 days. Shingles outbreak (day 21 s/d injection).
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Limb discomfort, Pain in extremity
Clinical narrative: Patient had arm pain immediately after immunization. Patient called 10/25/18 and still had arm discomfort and soreness.
Age: 0.83
Sex: F
Vaccine: DTAP, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 11 month old child was inadvertently administered flu vaccine dose from multi dose vial (with thimerosal) rather than single dose preservative free vial. Multi dose vial was labeled for 6 month and older by manufacturer though. No adverse reaction noted.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The morning after immunization, pt developed swelling/redness/warmth, reported itching from shoulder down to elbow.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urticaria
Clinical narrative: Received vaccines 1230AM - Broke out in welts and mother called 311pm - BENADRYL given. Seen by Doctor 410pm.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash generalised, Rash pruritic
Clinical narrative: Swelling/redness at injection site. Prickly, itchy rash on entire body.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Mobility decreased, Pain in extremity
Clinical narrative: Patient complained of sore arm following flu shot. Returned to pharmacy 10/25/18 stating she still had arm discomfort and limited mobility.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, and warmth surrounding the injection site. Started around 11/3/18. Progressively getting worse.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Headache, Peripheral swelling, Pyrexia
Clinical narrative: This initial spontaneous report was received from a pharmacist (a Pharm D) and refers to a 70 year old female patient. The patient was allergic to penicillin. Medical history, concurrent conditions, and concomitant medications were unknown by the pharmacist. On 30-OCT-2018, the patient received a dose of PNEUMOVAX 23 at a pharmacy (route and dose not provided). Lot # was R017900 and expiration date was 26-MAR-2020. The patient called the pharmacy on 02-NOV-2018 and reported that she had chills, fever of 102 degrees F, an extreme headache, malaise, elevated heart rate, double vision, elevated blood pressure, and her arm was "swollen like a sausage". The patient was given TYLENOL and BENADRYL in the Emergency Room (ER). The outcome of the events was unknown. Causality assessment was not specified. The pharmacist reported that the patient was requesting reimbursement for medical costs from the ER visit. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood pressure increased, Chills, Diplopia, Headache, Heart rate increased
Clinical narrative: This initial spontaneous report was received from a pharmacist (a Pharm D) and refers to a 70 year old female patient. The patient was allergic to penicillin. Medical history, concurrent conditions, and concomitant medications were unknown by the pharmacist. On 30-OCT-2018, the patient received a dose of PNEUMOVAX 23 at a pharmacy (route and dose not provided). Lot # was R017900 and expiration date was 26-MAR-2020. The patient called the pharmacy on 02-NOV-2018 and reported that she had chills, fever of 102 degrees F, an extreme headache, malaise, elevated heart rate, double vision, elevated blood pressure, and her arm was "swollen like a sausage". The patient was given TYLENOL and BENADRYL in the Emergency Room (ER). The outcome of the events was unknown. Causality assessment was not specified. The pharmacist reported that the patient was requesting reimbursement for medical costs from the ER visit. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Malaise, Peripheral swelling, Pyrexia
Clinical narrative: This initial spontaneous report was received from a pharmacist (a Pharm D) and refers to a 70 year old female patient. The patient was allergic to penicillin. Medical history, concurrent conditions, and concomitant medications were unknown by the pharmacist. On 30-OCT-2018, the patient received a dose of PNEUMOVAX 23 at a pharmacy (route and dose not provided). Lot # was R017900 and expiration date was 26-MAR-2020. The patient called the pharmacy on 02-NOV-2018 and reported that she had chills, fever of 102 degrees F, an extreme headache, malaise, elevated heart rate, double vision, elevated blood pressure, and her arm was "swollen like a sausage". The patient was given TYLENOL and BENADRYL in the Emergency Room (ER). The outcome of the events was unknown. Causality assessment was not specified. The pharmacist reported that the patient was requesting reimbursement for medical costs from the ER visit. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizures, occured in clinic with physician present a little over one month after vaccination. Now every time pt gets even a slight elevation of temperature, she has seizures. A recent pediatrician visit suggested reporting just to be safe as this initial event occurred in 2016, and is still a concern.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: C/o right upper arm pain, pain at injection site and sting sensation and numbness involving the whole arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: Actually I had adverse reactions to SHINGRIX on both shots in the series, given by the same clinic. I experienced headache, rapid heartbeat, dizziness, unusual fatigue, chills and shivering. After the first shot these symptoms lasted 2 days, after the second shot it lasted a full day. I drank fluids and rested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever 103.3; chills; aches, stiffness; pain and swelling at injection site.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Atrial fibrillation, Chest X-ray, Dyspnoea, Electrocardiogram, Heart rate increased
Clinical narrative: Had injection. Next day cut the grass. On Saturday woke up with rapid heart rate and shortness of breathe. Went to ER. New onset atrial fibrillation. Placed on medications for same.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: Itchy rash 4 days and gone.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood test, Incorrect route of product administration, Musculoskeletal disorder, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shot given in the top of the right shoulder, pain started around 4:30. Called pharmacy talked to pharmacist who gave the shot told her I was having pain and she suggested Tylenol and Ice. Tried this and pain got progressively worse until no longer could stand the  pain. Went to ER that evening. They gave me a shot for pain, X-rays and blood work. They thought the pain was probably caused by the injection given into the tendon. I have seen my primary care doctor and they suggested seeing an orthopedic doctor. Also have seen a Chiropractor and received Myofascial Acoustic Compression Therapy. Starting physical theropy today. Have had very little use of right arm in the past two weeks.  No pain in this arm or shoulder prior to this shot.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: X-ray
Clinical narrative: Shot given in the top of the right shoulder, pain started around 4:30. Called pharmacy talked to pharmacist who gave the shot told her I was having pain and she suggested Tylenol and Ice. Tried this and pain got progressively worse until no longer could stand the  pain. Went to ER that evening. They gave me a shot for pain, X-rays and blood work. They thought the pain was probably caused by the injection given into the tendon. I have seen my primary care doctor and they suggested seeing an orthopedic doctor. Also have seen a Chiropractor and received Myofascial Acoustic Compression Therapy. Starting physical theropy today. Have had very little use of right arm in the past two weeks.  No pain in this arm or shoulder prior to this shot.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This non-valid spontaneous report was received from a nurse and refers to an unspecified patient. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not reported. On 10-OCT-2018, the patient was vaccinated with an expired dose of ROTATEQ orally (lot # M041814 and expiration date in an unknown date in June 2018) for prophylaxis. Furthermore, ROTATEQ was stored properly. Additionally, no adverse events were reported. This is an invalid report because of lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information has been received from the nurse refers to a 6 month old female patient (currently the patient is 7 month old). The patient's birth weight was 5 lbs. On 10-OCT-2018, the patient was vaccinated with expired dose of ROTATEQ (lot # M041814, expiry date June-2018, dose 3) orally for prophylaxis. Concomitant therapies included vaccination with PENTACEL and PREVNAR 13. Patient did not experience any adverse reaction (reported as 'No reaction').
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine negative
Clinical narrative: This spontaneous report was received from a Nurse Prescriber referring to a 22 years old female patient. The patient had no concomitant medication, medical history or drug reactions. On 21-AUG-2018, the patient was vaccinated with VARIVAX (lot # N027001 and expiration date 28-SEP-2019; dose and route were not provided) for prophylaxis (reported as vaccination), which was reconstituted with sterile diluent (dose, route, lot #, expiration date and indication were not reported). At that same visit, a urine pregnancy test was performed and the result was negative. On 11-OCT-2018, the patient returned to the office and was 10 and 1/2 weeks pregnant. The last menstrual period (LMP) was calculated as 29-JUL-2018 and estimated date of delivery (EDD) was calculated as 05-MAY-2019. Patient was planning to continue the pregnant. The pregnancy outcome was pending. The fetal outcome was unknown. There was no treatment given for the event and the patient sought medical attention.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an immunocompetent currently 72 years old female patient. The patient's current conditions, concomitant medication and medical history were not reported. On 10-OCT-2018, the patient was administered a dose of PNEUMOVAX 23 (lot # R016640, expiration date 28-JAN-2020) intramuscularly for prophylaxis. The patient thought she had never received PNEUMOVAX 23. The patient discovered a receipt from an unknown date in "2013" that showed she was administered PNEUMOVAX 23 (lot # and expiration date were unknown) when she was 67 or 68 years old, therefore the dose she was administered on 10-OCT-2018 was actually a second dose. No adverse effect reported.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist referring to a 71 year old male patient. The patient had no concomitant therapy, pertinent medical history or drug reactions/allergies. On 04-MAY-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # N024384, expiration date: 18-MAY-2019, one dose, route: intramuscular) for prophylaxis at the pharmacy. On 11-OCT-2018, the patient returned to the pharmacy to explain that on an unspecified date after injection, he experienced pain at injection site which had persisted. The pharmacist was unable to specify if pain was constant or intensity of pain. No treatment was given for the event. No lab diagnostics or studies were performed for the event. The patient had sought medical attention. The outcome of the event was not recovered. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 28-SEP-2018, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, lot number and expiration date were not provided) for prophylaxis. On 12-OCT-2018 (2 weeks after receiving first dose of GARDASIL 9, the patient vaccinated with a second dose of GARDASIL 9 (lot # R008163, expiration date:18-NOV-2020, dose and route were unknown) for prophylaxis (inappropriate schedule of drug administration). No adverse effects were reported. This is one of two linked cases due to same reporter. Sender's Comments: US-009507513-1810USA008238.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 28-SEP-2018, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, lot number and expiration date were not provided) for prophylaxis. On 12-OCT-2018 (2 weeks after receiving first dose of GARDASIL 9, the patient was vaccinated with a second dose of GARDASIL 9 (lot # R008163, expiration date: 18-NOV-2020, dose and route were unknown) for prophylaxis. No adverse effects were reported. This is one of two linked cases due to same reporter. Sender's Comments: US-009507513-1810USA006713.
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 67 days old patient of unknown gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On 26-OCT-2018, the patient was inadvertently vaccinated with one dose of VAQTA 25/0.5 (units not provided) injection, lot # R013859, expiration date 14-JUN-2019, intramuscularly, instead of RECOMBIVAX HB that was intended (wrong vaccine administered, inappropriate age at vaccine administration). No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 40 year old patient. On 29-OCT-2018, the patient was inadvertently vaccinated with a dose of PROQUAD (route and lot # not reported) and a dose of VARIVAX (dose, route and lot # not reported) instead of VARIVAX and M-M-R II. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, recommended and or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 05-OCT-2016, a physician's assistant (at the office) administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 05-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist as conveyed by the physician regarding a female patient of unknown age. The patient's medical history included an episode of ocular shingles on an unspecified date. The patient concurrent conditions and concomitant therapies unknown. It was unknown if the patient had drug reactions/allergies. On an unknown date (Also reported as 2.5 years later), the patient was vaccinated with a dose of ZOSTAVAX (Strength, frequency, anatomical location, route, lot # and expiry date were not reported) for prophylaxis. On an unknown date, 2.5 years later, the patient was diagnosed with ocular shingles for the second time. It was unknown if the patient received any treatment. It was unknown if any lab diagnostics/studies were performed. There was no product quality complaint (PQC) associated with this report. The outcome of the event of ophthalmic herpes zoster was reported to be recovered. The causality assessment was not provided. Upon internal review, the event of ophthalmic herpes zoster was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 31-OCT-2018 from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2010, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2010, the patient was treated by a healthcare provider at a health center or shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 31-OCT-2018 from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a pharmacist, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2017, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 24-NOV-2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 16-NOV-2012, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 13-JUN-2013, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old female patient who had body ache, stiff neck, headache, 102.1 Fahrenheit temperature, vomiting and dizziness, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 24-Sep-2018, the patient received a dose of suspect MENACTRA (lot number: U6016AA) (expiry date, dose and dose in series was not reported) via intramuscular route in the left deltoid. On an unknown date, following the vaccination the patient experienced body ache, stiff neck, headache, fever, vomiting and dizziness. Relevant laboratory test results included: Body temperature - On an unknown date: 102.1 Fahrenheit Final diagnosis was dizziness, vomiting, 102.1 Fahrenheit temperature, headache, stiff neck and body ache. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as recovered on an unknown date. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old female patient who had body ache, stiff neck, headache, 102.1 Fahrenheit temperature, vomiting and dizziness, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 24-Sep-2018, the patient received a dose of suspect MENACTRA (lot number: U6016AA) (expiry date, dose and dose in series was not reported) via intramuscular route in the left deltoid. On an unknown date, following the vaccination the patient experienced body ache, stiff neck, headache, fever, vomiting and dizziness. Relevant laboratory test results included: Body temperature - On an unknown date: 102.1 Fahrenheit Final diagnosis was dizziness, vomiting, 102.1 Fahrenheit temperature, headache, stiff neck and body ache. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as recovered on an unknown date. List of documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Limb injury, Musculoskeletal pain, Periarthritis, Rotator cuff syndrome
Clinical narrative: Shoulder injury/pain. Frozen shoulder, injury to rotator cuff.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: REDNESS, SWELLING, HOT TO TOUCH AT INJECTION SITE, FEVER. IMPROVED WITH BENEDRYL AND MOTRIN.
Age: 13.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Local reaction, Peripheral swelling, Pruritus
Clinical narrative: Patient reports itching approx. 15-30 minutes after injection, following by redness and swelling that progressively worsened over next 24 hours. Patient returned to clinic the next day with patients mother to report a reaction. Right arm swollen and redness diameter was 2 inches by 2.5 inches. Patients mother had already given patient Benadryl and applied over the counter cortisone cream. Patient was prescribed oral prednisone, reaction is localized upon office visit.  Follow up call to patient on 11/6/18 - patients symptoms (localized redness, swelling and itching) have improved with prednisone. Patient and patients mother are asked to contact clinic if symptoms are not resolved in next 24-48 hours and or with any questions or concerns.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Pain in extremity
Clinical narrative: Patient stated his right arm was very sore and painful, beginning later that evening after receiving the shot in the morning. He came in to have it looked at on 11/2/2018. The actual injection site looked fine, however, 3" down from the site his arm was pink to dark pink in color along the inside of his upper arm. The area measured 6" in length by 4" in width. Stated his arm was still very sore and hurts to move it. He had his flu shot the same day in the left arm and had no problems or pain.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Patient received shot Saturday 11/3 AM. Began vomiting that afternoon. Continued to vomit throughout the weekend. Was seen in our office on Monday 11/5 and was given Rx for ZOFRAN. Today Tuesday 11/6 patient has gone overnight without vomiting, just kept down applesauce, but still nauseous.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Dyskinesia, Hypoaesthesia, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Involuntary movement of arm after needle injection extreme pain radiating from injection site down to hand. Tingling, numbness, inability to lift arm. Present symptoms still exist.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Involuntary movement of arm after needle injection extreme pain radiating from injection site down to hand. Tingling, numbness, inability to lift arm. Present symptoms still exist.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Head injury, Loss of consciousness, Syncope
Clinical narrative: Patient experienced syncope within 8 minutes of receiving vaccine. Fainted and hit her head on the floor. Regained consciousness within 10 seconds of falling. Patient receives vaccine every year.