chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Malaise, Nausea, Thirst
Clinical narrative: I am pregnant and due Dec 23, 2018. I received the flu shot at my OBGYN yesterday. This morning I woke up at 6 AM feeling week and sick with my left arm where the shot was given significantly sore. I rallied and got ready and went to work despite feeling very ill and extremely thirsty.  I drank two bottles of water. At 11 AM I decided I didn't feel well enough to stay and would go home. As I got to the car I had uncontrollable explosive diarrhea. I have had it two additional times in the next three hours. I am resting now but extremely nauseated and feel lightheaded and not well at all. My stomach is still very upset.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hypoaesthesia, Impaired driving ability, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: By 1pm patient could not move left arm. Patient reports feeling on fingers but could not move hand at all--it was numb; felt like it was not there. Had pulsating pain at injection site; it did not radiate. Could not drive and it was hard to continue daily activities. Took 2 ALEVE and that did not help; took 1 more and it finally helped. Took TYLENOL when it was time and put hot compresses; it helped a little bit. Finally went to bed. Went to work the next day and it was very hard because had limited movement on arm. Patient called the ER and talked to a nurse who recommended follow-up with doctor or to go to ER. Patient mentions that they did not have a fever or nausea. Today patient can move arm up and down but could not get it above head without help. Right arm is fine.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Migraine with aura
Clinical narrative: Ocular Migraine.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Dental care, Hypoaesthesia
Clinical narrative: NUMBNESS IN THE CHIN AREA FOR OVER A WEEK.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Oedema, Skin warm, Tenderness
Clinical narrative: Redness, warmth, edema, tender.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Puffy/red arm at injection site. Patient states no pain when touched/pushed.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling, Swelling face, Urticaria
Clinical narrative: Hives and swelling to face and chest. Shot given 10/3/18. Called for seeking treatment on 10/5/18. Sent to work comp MD. Dx: urticaria OTC, BENADRYL. No follow up, released.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Injection site pain, Lymphadenopathy
Clinical narrative: Enlarged lymph nodes under left arm painful. Pain all around left upper arm bicep. Took Ibuprofen and applied heat ROM affect in left arm.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, raised, warm/hot to touch. Area 2 inches diameter. Ice applied to area. Advised to see provider if not better in 24 hrs.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Headache, Nausea, Pain in extremity
Clinical narrative: Head ache, frontal and back of head, arm pain into hand for 2 days then sore 2 wks. Felt badly bruised. Vertigo, nausea, stomach, chills and low grade fever. Still have vertigo and headache.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vertigo
Clinical narrative: Head ache, frontal and back of head, arm pain into hand for 2 days then sore 2 wks. Felt badly bruised. Vertigo, nausea, stomach, chills and low grade fever. Still have vertigo and headache.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Headache, Injection site pain, Presyncope
Clinical narrative: Headaches, dizziness, near syncope 2 days after vaccination. Severe pain at injection site 1 day after vaccination.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: 12 hours post vaccine administration pt developed "hot" swollen area around injection up and down arm (L) shoulder to elbow.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 19-NOV-2014, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On or about 16-NOV-2011 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2012 the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Urticaria
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 49-year-old female patient who experienced uriticaria and rash which began on her abdomen and thighs. is now spreading body wide and it is in her hairline and her hands, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included allergy with Sulfa. The patient's concomitant medication included Tri-Lo-Mariza 25mcg daily. The patient's family history was not provided. Notes: Received the flu shot previous three years without developing the current symptoms she is experiencing. On 01-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI997AA, expiry date 30 Jun 2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious uriticaria and rash which began on her abdomen and thighs. is now spreading body wide and it was in her hairline and her hands (urticaria) less than 48 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient denied any pain, redness or swelling at injection site. Nurse may be sending the employee to the Emergency room for evaluation and possible treatment of presenting symptoms. Lab data was not provided. Final diagnosis was uriticaria and rash which began on her abdomen and thighs. is now spreading body wide and it is in her hairline and her hands. The patient was treated with BENADRYL, however symptoms persist and continue to worsen. The patient outcome was reported as Not Recovered / Not Resolved on an unknown date for uriticaria and rash which began on her abdomen and thighs. is now spreading body wide and it is in her hairline and her hands. List of documents held by sender- none.
Age: 17.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277148, 2018SA278726 and 2018SA278737 (same reporter). This case involves 17 years female patient who received vaccine IPOL (Lot: P1A171M, expiry date: 20-Apr-2024) via unknown route in the left deltoid on 28-Sep-2018, which was stored incorrectly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that IPOL was exposed to temperature elevation for 3 days to 46.6 Fahrenheit and 48 Fahrenheit. It was that these IPOL will be discarded and all consumers will be re-vaccinated with new IPOL. It was reported that no reactions were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case is linked to cases 2018SA279226, 2018SA279234, 2018SA279235 and 2018SA279236 (same reporter and same suspect). This case involves a three- years old patient was vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT lot UT6259KA, expiry date: 30-Jun-2019 on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to underdose. No Adverse Events have been noted at time of the call. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAP, IPV
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received from nurse on 05-Oct-2018. This case is linked with case 2018SA279699. This case involves a [9 months old] unknown gender patient who was vaccinated with a 0.5 ml dose of IPOL (Batch number: N1K92, expiration date: 14-NOV-2019, route: subcutaneous and site of administration: left thigh) on 14-Sep-2018. The patient's medical history was not reported. Concomitant medication includes DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. It was an actual medication error due to incorrect product storage (vaccinated with an IPOL multi-dose vial that was out of temperature range for 30 minutes). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: Initial unsolicited report received from pharmacist on 05-Oct-2018. This case involves a [77 years old] male patient who was vaccinated with a 0.5 ml dose of vaccine FLUZONE HIGH DOSE (Batch number: UJ038AB, expiration date: 03-May-2019, site of administration: left deltoid route and was not reported) on 05-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to syringe issue (she screws the needle, it is tight and sealed but there must be a crack or something because it is leaking out) and exposure via skin contact (dose leaked all over him). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: Within 4 hours arm was red, sore and patient felt she couldn't bend it. She had hand numbness and tingling. Temperature of 102 for 2 days.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: Within 4 hours arm was red, sore and patient felt she couldn't bend it. She had hand numbness and tingling. Temperature of 102 for 2 days.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Facial paralysis, Herpes zoster oticus, Musculoskeletal pain, Neck pain
Clinical narrative: 08/24/18- received flu vaccination. 08/27/18-08/30/18 symptoms of severe pain on my scalp behind my right ear. Right neck pain into right clavicle, pain to back of right scapula. 08/31/18- woke up with complete right sided facial paralysis- went in to see my doctor- dx with Bell's Palsy 09/11/18- developed mild right ear pain- dx with Ramsey Hunt Syndrome. 09/18/18- follow-up appointment- Right ear pain more severe- face is still paralyzed. 09/19/19- developed zit-like rash behind right ear and a few bumps on right side of neck. Ear pain severe at this point. Prescribed pain meds and nerve medications. Present- still having right ear pain and facial paralysis.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain of skin, Rash pustular
Clinical narrative: 08/24/18- received flu vaccination. 08/27/18-08/30/18 symptoms of severe pain on my scalp behind my right ear. Right neck pain into right clavicle, pain to back of right scapula. 08/31/18- woke up with complete right sided facial paralysis- went in to see my doctor- dx with Bell's Palsy 09/11/18- developed mild right ear pain- dx with Ramsey Hunt Syndrome. 09/18/18- follow-up appointment- Right ear pain more severe- face is still paralyzed. 09/19/19- developed zit-like rash behind right ear and a few bumps on right side of neck. Ear pain severe at this point. Prescribed pain meds and nerve medications. Present- still having right ear pain and facial paralysis.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient received PNEUMOVAX 23 and FLUZONE high-dose on 10/08/18 at approximately 2pm. Pt's wife call pharmacy at approx. 5pm on 10/09/18 saying that her husband's left arm was swollen, red, and hot. Redness extended to elbow. I said for him to go to walk-in or ER. Pt's wife called again this morning, 10/10/18; told me husband went to walk-in, who in turn sent her to ER. By that time the redness had progressed to his fingertips. Diagnosis: Cellulitis. Given antibiotics and seemed to be getting better today.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Feeling abnormal, Nausea
Clinical narrative: Received vaccination on 10/3/18. That evening she started feeling very light headed/foggy as well as having extreme joint pain all over her body, legs, hips, arms, hands. On 10/4/18 she was still feeling foggy headed and very nauseous. Her joint pain improved, but was still feeling pain of like 6 to 7. She was not having any pain or swelling at the injection site at all.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Rash generalised
Clinical narrative: Broke out in body rash head to toe. No symptoms, no fever, not accompanied with itching or discomfort. Doctor reported that it was a viral-type of rash. Reported that heart/lungs were strong and healthy. No sinus-related issues. Temperature within normal range. No virus had been present and determined it was an adverse reaction to the flu vaccination. Benadryl at 1 tsp every 6 hours for 48 hours was prescribed. Rash was managed well, but still is not completely gone 2 weeks post flu vaccine.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Decreased appetite, Dizziness, Erythema, Gait disturbance
Clinical narrative: 5 years ago received ZOSTAVAX with no problem. At the doctor office, patient was not asked to sit down for 15 minutes. About 3 hours later started getting pain/soreness on arm--did not expect to get it that fast. Also got a headache. The shot itself was painful. Next day, more pain/soreness in arm than the day before, also swelling and redness. Equilibrium problems started so had problem walking and/or driving. By mid-day got dry heaves and dizzinessit got so bad that could not drive car. Patient could not eat much for 2 days and just drank fluids. On the 2nd day called pharmacist. Patient put Benadryl gel on arm and took liquid Benadryl but did not help. On the 4th day, arm blew up like balloon (2 times, balloon (2 times the size), red and hot. Patient did not have fever, but was very sore and then stayed sick with dizziness for 5 days straight. Eventually arm peeled like had severe sunburn. For 2 days after, had baby rash going down and across the arm. Patient did not contact doctor at any point. Today, patient finally feeling better. The arm still hurts, swelling has gone down as well as dizziness.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Impaired driving ability, Injection site pain, Malaise, Pain
Clinical narrative: 5 years ago received ZOSTAVAX with no problem. At the doctor office, patient was not asked to sit down for 15 minutes. About 3 hours later started getting pain/soreness on arm--did not expect to get it that fast. Also got a headache. The shot itself was painful. Next day, more pain/soreness in arm than the day before, also swelling and redness. Equilibrium problems started so had problem walking and/or driving. By mid-day got dry heaves and dizzinessit got so bad that could not drive car. Patient could not eat much for 2 days and just drank fluids. On the 2nd day called pharmacist. Patient put Benadryl gel on arm and took liquid Benadryl but did not help. On the 4th day, arm blew up like balloon (2 times, balloon (2 times the size), red and hot. Patient did not have fever, but was very sore and then stayed sick with dizziness for 5 days straight. Eventually arm peeled like had severe sunburn. For 2 days after, had baby rash going down and across the arm. Patient did not contact doctor at any point. Today, patient finally feeling better. The arm still hurts, swelling has gone down as well as dizziness.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash, Retching, Skin exfoliation
Clinical narrative: 5 years ago received ZOSTAVAX with no problem. At the doctor office, patient was not asked to sit down for 15 minutes. About 3 hours later started getting pain/soreness on arm--did not expect to get it that fast. Also got a headache. The shot itself was painful. Next day, more pain/soreness in arm than the day before, also swelling and redness. Equilibrium problems started so had problem walking and/or driving. By mid-day got dry heaves and dizzinessit got so bad that could not drive car. Patient could not eat much for 2 days and just drank fluids. On the 2nd day called pharmacist. Patient put Benadryl gel on arm and took liquid Benadryl but did not help. On the 4th day, arm blew up like balloon (2 times, balloon (2 times the size), red and hot. Patient did not have fever, but was very sore and then stayed sick with dizziness for 5 days straight. Eventually arm peeled like had severe sunburn. For 2 days after, had baby rash going down and across the arm. Patient did not contact doctor at any point. Today, patient finally feeling better. The arm still hurts, swelling has gone down as well as dizziness.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: 5 years ago received ZOSTAVAX with no problem. At the doctor office, patient was not asked to sit down for 15 minutes. About 3 hours later started getting pain/soreness on arm--did not expect to get it that fast. Also got a headache. The shot itself was painful. Next day, more pain/soreness in arm than the day before, also swelling and redness. Equilibrium problems started so had problem walking and/or driving. By mid-day got dry heaves and dizzinessit got so bad that could not drive car. Patient could not eat much for 2 days and just drank fluids. On the 2nd day called pharmacist. Patient put Benadryl gel on arm and took liquid Benadryl but did not help. On the 4th day, arm blew up like balloon (2 times, balloon (2 times the size), red and hot. Patient did not have fever, but was very sore and then stayed sick with dizziness for 5 days straight. Eventually arm peeled like had severe sunburn. For 2 days after, had baby rash going down and across the arm. Patient did not contact doctor at any point. Today, patient finally feeling better. The arm still hurts, swelling has gone down as well as dizziness.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Blood lactic acid increased, Chest X-ray normal, Dizziness, Feeling hot
Clinical narrative: Unsure about the exact type of flu shot and pneumococcal vaccine that patient received. She had pain and erythema at both of her arms at both injection sites. More noteworthy is that she became dizzy, profound weakness, nausea, and had internal warmth/sweats. Upon arrival to hospital, she was found to have an elevated WBC of 12.0 and a lactic acid of 3.4. She had been in her normal state of health in the days prior to vaccination. CXR clear. Urinalysis normal. Her WBC and lactic acidosis returned to normal range within 12 hours. She had been given IV fluids.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Lactic acidosis, Nausea
Clinical narrative: Unsure about the exact type of flu shot and pneumococcal vaccine that patient received. She had pain and erythema at both of her arms at both injection sites. More noteworthy is that she became dizzy, profound weakness, nausea, and had internal warmth/sweats. Upon arrival to hospital, she was found to have an elevated WBC of 12.0 and a lactic acid of 3.4. She had been in her normal state of health in the days prior to vaccination. CXR clear. Urinalysis normal. Her WBC and lactic acidosis returned to normal range within 12 hours. She had been given IV fluids.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: Unsure about the exact type of flu shot and pneumococcal vaccine that patient received. She had pain and erythema at both of her arms at both injection sites. More noteworthy is that she became dizzy, profound weakness, nausea, and had internal warmth/sweats. Upon arrival to hospital, she was found to have an elevated WBC of 12.0 and a lactic acid of 3.4. She had been in her normal state of health in the days prior to vaccination. CXR clear. Urinalysis normal. Her WBC and lactic acidosis returned to normal range within 12 hours. She had been given IV fluids.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site abscess
Clinical narrative: She complained of abscess near injection site.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Headache
Clinical narrative: I was vaccinated approximately at noon. By 9:30 pm I felt unusually tired. During the night I felt feverish. At 7:30 am the next day I woke up lightheaded and had a fever of 100.6°F. I also had a headache, upset stomach, chills, was nauseous and very tired. I started taking 650 mg. acetaminophen, every 4 hours, for a total of 4 doses, and began to feel better. By the following morning all the symptoms had resolved.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: I was vaccinated approximately at noon. By 9:30 pm I felt unusually tired. During the night I felt feverish. At 7:30 am the next day I woke up lightheaded and had a fever of 100.6°F. I also had a headache, upset stomach, chills, was nauseous and very tired. I started taking 650 mg. acetaminophen, every 4 hours, for a total of 4 doses, and began to feel better. By the following morning all the symptoms had resolved.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Fever of 99.9 on 10/10, cellulitis of upper arm around injection site - advised BENADRYL PRN and given prescription for antibiotic.
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Rotator cuff syndrome, X-ray
Clinical narrative: Pt received FLUBLOK QUADRIVALENT and PNEUMOVAX 23 in the right deltoid on 10/1/18 at 14:37. Pt describes severe shoulder pain and limited range of motion about 2 hours later. Pt self-reported significant shoulder pain and severely limited range of motion to PCP on 10/5/18. Orthopedist was consulted and dx of shoulder injury related to vaccine administration (SIRVA) was discussed; pt was referred to orthopedic specialist on that same day for evaluation. Pt seen by PA in orthopedist's office. Per notes from 10/5/18 ortho visit, pt's pain and limited ROM persisted over the 4 days with some improvement, but still reported intermittent pain at 10/10, despite naproxen twice daily, which provided no relief. Physical findings from ortho exam: bandaids from vaccine administration were in place 3 fingers below the right acromion of the lateral arm; non-tender to palpation. passive range of motion caused pain over 160 degrees of forward flexion, 90 degrees of abduction. Pain was present with Hawkins and Neer impingement; Positive drop arm. Deltoid strength 2/5 in neutral; triceps strength 1/5; biceps strength intact. Assessment from PA and attending physician was that patient may have developed SIRVA. Pt was referred to PT and given a Medrol Dose Pak.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis, Injection site pain, Pyrexia
Clinical narrative: Developed pain and cellulitis to right upper arm shoulder area and fever up to 104. She received both the flu and pneumococcal vaccine in same arm on 10/4.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Headache, Hyperhidrosis, Pain
Clinical narrative: Quick sharp pain in left chest and legs at store. Later that night severe shakes, vomiting, sweats, severe pain in all parts of body especially back and head.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tremor, Vomiting
Clinical narrative: Quick sharp pain in left chest and legs at store. Later that night severe shakes, vomiting, sweats, severe pain in all parts of body especially back and head.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Receive Influenza vaccine at 8am, noted hives on back at 4pm. Treated with Benadryl cream and hydrocortisone cream.
Age: 66.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Arthralgia, Condition aggravated, Meniscus injury, Pain in extremity
Clinical narrative: As my left arm became increasingly sore, as was expected, my left torn knee meniscus, that hasn't bothered me since May, following ski season, flared proportionate with arm pain. Coincident?
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip swelling, Mouth swelling, Oral pain, Swelling face, Swollen tongue
Clinical narrative: I did go to the emergency room Friday 10/5/18, I had a small reaction. The bottom half of my face (mouth/lips/tongue) did swell a medium amount so I was given stuff to reduce the swelling. I was given Benadryl and Prednisone, so I didn't need anything more. The swelling is almost gone today 10/8/18, but my mouth is still recovering (more tight and sore now).
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Paraesthesia
Clinical narrative: Patient is a 66 year old female who presents with redness and pain left upper arm at site of SHINGRIX vaccine, received 2d ago. Redness started within 30 min. of receiving it. She marked it yesterday and it expanded about 5mm outside that area today. Took a dose of ibuprofen 200mg and it did help. No itching. Had left side body tingling immediately after vaccine, lasted 15 min. and resolved. Otherwise feels well. No fever, chills, H/A, dizziness, body aches, CP, dyspnea, arthralgias, N/V.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction, Diarrhoea, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: Patient is a 66 year old female who presents with redness and pain left upper arm at site of SHINGRIX vaccine, received 2d ago. Redness started within 30 min. of receiving it. She marked it yesterday and it expanded about 5mm outside that area today. Took a dose of ibuprofen 200mg and it did help. No itching. Had left side body tingling immediately after vaccine, lasted 15 min. and resolved. Otherwise feels well. No fever, chills, H/A, dizziness, body aches, CP, dyspnea, arthralgias, N/V.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Insomnia, Nausea, Paraesthesia
Clinical narrative: Patient is a 66 year old female who presents with redness and pain left upper arm at site of SHINGRIX vaccine, received 2d ago. Redness started within 30 min. of receiving it. She marked it yesterday and it expanded about 5mm outside that area today. Took a dose of ibuprofen 200mg and it did help. No itching. Had left side body tingling immediately after vaccine, lasted 15 min. and resolved. Otherwise feels well. No fever, chills, H/A, dizziness, body aches, CP, dyspnea, arthralgias, N/V.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site bruising, Swelling
Clinical narrative: Swelling, redness that streaked downward towards elbow that has lasted longer than 3 days, and bruise at injection site.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm was red and swollen. Treating with TYLENOL.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Skin discolouration
Clinical narrative: Pt presented with a large area of discoloration on the forearm of the arm she received her immunization in. It was not red, raised, hot, or itchy. It looked like an old bruise (kind of yellowy/brown). She stated that her father had previously had a similar reaction to an immunization, but did not know what immunization he had received that caused the discoloration. She had not treated it in any way, as it was not causing any discomfort. I recommended diphenhydramine should it start to itch, and to consult her physician if it changed in any way.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Hypertension, Tremor
Clinical narrative: After I gave her the shot, she left and came back in about 30 seconds saying she couldn't breathe. I gave her an epinephrine shot in the thigh. She started breathing easier. She said she felt better. We gave her diphenhydramine 25mg and called 911. The paramedics came and talked to her and checked her oxygen levels and blood pressure, which was high. They said that was probably due to the epinephrine. She does not have high blood pressure normally. They said her lungs sounded fine. She said she felt light headed and her hands were shaking a little, but her breathing was fine. They called an ambulance because they wanted her to go to the hospital because of her blood pressure being high. She said she would go, but not in an ambulance. Her partner would take her. Her partner arrived and then the ambulance arrived. They checked her blood pressure again and it seemed to be going down a little. They said it didn't look like an anaphylactic reaction. The patient said she was going right to  Hospital (about 15 minutes away).
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Injection site erythema, Injection site pain
Clinical narrative: Arm pain, redness, swelling reached 5" below injection site and around arm even with site. Loss of appetite, fever, chills, headache, all lasted 2 days, started to see improvement on 3rd day. Took extra strength Tylenol.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Arm pain, redness, swelling reached 5" below injection site and around arm even with site. Loss of appetite, fever, chills, headache, all lasted 2 days, started to see improvement on 3rd day. Took extra strength Tylenol.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal pain
Clinical narrative: Patient experienced shoulder pain and weakness in legs that extended day after the faccination. After 10 days of vaccination, patient pain/discomfort has subsided but is still experiencing weakness in the legs.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Cellulitis, Erythema, Induration, Injection site erythema, Injection site swelling
Clinical narrative: 20 yr old patient presented to PCP for flu vaccination, however, also requested Pneumococcal vaccine due to history of asthma. Patient ordered both flu vaccine and pneumococcal vaccine by MD. RN administered Pneumococcal polysaccharide 23 valent vaccine IM in patient's right deltoid and influenza quadrivalent vaccine in patient's left deltoid on 9/6. On 9/10, patient emailed provider complaining "over past three days area around PNEUMOVAX vaccine site has turned red and began to swell. Patient noted it has started to spread". Patient presented to PCP on 9/11 complaining of 5 days of fever (102.5 at home), body aches, and rash, right arm pain (4-5/10) over vaccination site. MD noted "4x5 cm area on right upper with erythema, warmth, swelling, induration, and tenderness. No fluid pockets palpated. No drainage". Patient reported taking ibuprofen and TYLENOL with minimal improvements. MD diagnosed cellulitis and prescribed cephalexin 250mg PO QID x 10 days. Unknown if cellulitis is resolved as no documentation in chart.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Pain, Pyrexia, Rash, Swelling, Tenderness
Clinical narrative: 20 yr old patient presented to PCP for flu vaccination, however, also requested Pneumococcal vaccine due to history of asthma. Patient ordered both flu vaccine and pneumococcal vaccine by MD. RN administered Pneumococcal polysaccharide 23 valent vaccine IM in patient's right deltoid and influenza quadrivalent vaccine in patient's left deltoid on 9/6. On 9/10, patient emailed provider complaining "over past three days area around PNEUMOVAX vaccine site has turned red and began to swell. Patient noted it has started to spread". Patient presented to PCP on 9/11 complaining of 5 days of fever (102.5 at home), body aches, and rash, right arm pain (4-5/10) over vaccination site. MD noted "4x5 cm area on right upper with erythema, warmth, swelling, induration, and tenderness. No fluid pockets palpated. No drainage". Patient reported taking ibuprofen and TYLENOL with minimal improvements. MD diagnosed cellulitis and prescribed cephalexin 250mg PO QID x 10 days. Unknown if cellulitis is resolved as no documentation in chart.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Vaccination site pain
Clinical narrative: 20 yr old patient presented to PCP for flu vaccination, however, also requested Pneumococcal vaccine due to history of asthma. Patient ordered both flu vaccine and pneumococcal vaccine by MD. RN administered Pneumococcal polysaccharide 23 valent vaccine IM in patient's right deltoid and influenza quadrivalent vaccine in patient's left deltoid on 9/6. On 9/10, patient emailed provider complaining "over past three days area around PNEUMOVAX vaccine site has turned red and began to swell. Patient noted it has started to spread". Patient presented to PCP on 9/11 complaining of 5 days of fever (102.5 at home), body aches, and rash, right arm pain (4-5/10) over vaccination site. MD noted "4x5 cm area on right upper with erythema, warmth, swelling, induration, and tenderness. No fluid pockets palpated. No drainage". Patient reported taking ibuprofen and TYLENOL with minimal improvements. MD diagnosed cellulitis and prescribed cephalexin 250mg PO QID x 10 days. Unknown if cellulitis is resolved as no documentation in chart.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: 20 yr old patient presented to PCP for flu vaccination, however, also requested Pneumococcal vaccine due to history of asthma. Patient ordered both flu vaccine and pneumococcal vaccine by MD. RN administered Pneumococcal polysaccharide 23 valent vaccine IM in patient's right deltoid and influenza quadrivalent vaccine in patient's left deltoid on 9/6. On 9/10, patient emailed provider complaining "over past three days area around PNEUMOVAX vaccine site has turned red and began to swell. Patient noted it has started to spread". Patient presented to PCP on 9/11 complaining of 5 days of fever (102.5 at home), body aches, and rash, right arm pain (4-5/10) over vaccination site. MD noted "4x5 cm area on right upper with erythema, warmth, swelling, induration, and tenderness. No fluid pockets palpated. No drainage". Patient reported taking ibuprofen and TYLENOL with minimal improvements. MD diagnosed cellulitis and prescribed cephalexin 250mg PO QID x 10 days. Unknown if cellulitis is resolved as no documentation in chart.
Age: 75.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pain, Rash erythematous, Rash vesicular, Scab
Clinical narrative: 5 crusting, dark grey scabs on erythematous bases, 3 in a tight cluster, on L superomedial thigh. Filled w clear fluid before bursting. Burning pain radiates down medial leg to ankle, dermatomal-like pain distribution, improving (8->6/10). Denies new soap, irritating contact. Given gabapentin for pain.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Headache, Immediate post-injection reaction
Clinical narrative: Pt reported immediate chest pain. This was followed by headache, persisting chest pain and heavines/pain/weakness in b/l arms. Normal CXR/EKG Sx persisted x 2 w. steroids ordered 1 d ago.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Limb discomfort, Muscular weakness, Pain in extremity
Clinical narrative: Pt reported immediate chest pain. This was followed by headache, persisting chest pain and heavines/pain/weakness in b/l arms. Normal CXR/EKG Sx persisted x 2 w. steroids ordered 1 d ago.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Anal incontinence, Balance disorder, Fall, Head injury, Skin haemorrhage
Clinical narrative: Had previously called neurologist to verify that she could receive the high dose flu vaccine. At 11:30 A was walking out the door after the shot and felt that balance was worse (little harder to walk) but used cane normally. 9PM she tried to sit in a chair and fell, hitting her head. She stated she also lost control of her bowels and vomited. Her scalp was bleeding. 911 was called and she was transported to ER where "9 staples were put in the back and left side of her scalp". She returned home that night. She called her pcp today but he was not there but she has an apt. for 10/16/2018, and then she called Dr., her neurologist, and left a message. As of 1P she had not received a call back. She feels better today 10/10/18.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Had previously called neurologist to verify that she could receive the high dose flu vaccine. At 11:30 A was walking out the door after the shot and felt that balance was worse (little harder to walk) but used cane normally. 9PM she tried to sit in a chair and fell, hitting her head. She stated she also lost control of her bowels and vomited. Her scalp was bleeding. 911 was called and she was transported to ER where "9 staples were put in the back and left side of her scalp". She returned home that night. She called her pcp today but he was not there but she has an apt. for 10/16/2018, and then she called Dr., her neurologist, and left a message. As of 1P she had not received a call back. She feels better today 10/10/18.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle pain after injection for several hours.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Adverse event: myalgia (muscle aches) shivering. Treatment: ibuprofen Time course: 36 hours.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Paraesthesia, Paraesthesia oral, Peripheral swelling, Swelling face
Clinical narrative: Patient awoke morning after flu vaccine with facial swelling, redness of face, hives on forehead and around eyes. She reported tingling of face and lips and her hands were swollen. She was treated with BENADRY and Prednisolone as well as advised to take ZYRTEC daily.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient awoke morning after flu vaccine with facial swelling, redness of face, hives on forehead and around eyes. She reported tingling of face and lips and her hands were swollen. She was treated with BENADRY and Prednisolone as well as advised to take ZYRTEC daily.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Muscular weakness, Neck pain
Clinical narrative: Generalized fatigue and muscle weakness. Neck ache and diffuse headache. Started in the evening, a few hours after receiving the vaccination. The next morning, all symptoms were much worse. Came into the clinic that afternoon concerned about new onset of symptoms so closely related to vaccination administration.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: 1 1/2" needle, 22 gauge, used to administer the flu vaccine. Caregiver describes the following: "I  received my flu shot yesterday. The shot itself was awesome and did not hurt at all. By the time I had walked back to my office I had pain down my arm and into my fingers and it was neuropathic like in nature. Sort of tingly but also hurt. I was just thinking it was due to something with the shot but that it would go away. It still feels that same way today". In follow-up she reported that by Sunday, her fingers were no longer numb and her arm felt pretty good.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: 6 inch swelling at injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pain in extremity
Clinical narrative: Patient reported radiating pain down her arm for several weeks after vaccination. She also said her injection site swelled up a little. She did have a pinched arm in her neck at the time of vaccination and takes pain medication for other issues. She did not report any loss of range of motion. When I talked to her, she said her pain had mostly resolved. I apologized and recommended that she follow up with her doctor. I saw that she had been to the emergency room for pain, I do not know if it was due to her pinched nerve in her neck or not. She did not say that her doctor said the issue was due to the vaccination.
Age: 59.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Headache, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: Patient states mouth and tongue went numb immediately after shot. Patient said mouth numbness has worn off but tongue is still numb and patient has been experiencing headaches as well.
Age: 59.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chest pain, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Patient states mouth and tongue went numb immediately after shot. Patient said mouth numbness has worn off but tongue is still numb and patient has been experiencing headaches as well.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Developed small red, hot raised blisters close to the site of injection. This developed into one fluid filled blister that drained clear liquid.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Crying, Fatigue, Irritability, Speech disorder
Clinical narrative: Since receiving her shots she was very tired (which i figured was normal) but since she doesn't smile, laugh, goo, or baby talk as much as she used to. She is just quiet & sits there unless she is fussy & crying which is more frequently as well.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On or about 21-OCT-2011 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 19-AUG-2016 the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. She was prescribed acyclovoir for her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.