chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-FEB-2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 05-SEP-2016, the patient was treated for a vesicular outbreak, which were diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine 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. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
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. On or about 03-OCT-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-OCT-2016, the patient was treated by an emergency medicine physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
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. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the 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. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient developed a rash on both arms within 2 weeks of being vaccinated on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Sex: U
Vaccine: FLU3
Symptoms: Device use issue, Wrong technique in product usage process
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from another healthcare professional. This case is linked to case 2018SA290872. This case involves an unknown demographics patient who was vaccinated with FLUZONE QUADRIVALENT and with a 5/8th inch needle rather than a 1-inch needle (lot number not reported) via intramuscular route and in an unknown administration site on an unknown date. The patients past medical history, medical treatments, vaccinations and family history were not provided. It is an actual medication error due to wrong technique in product usage process. It was reported that influenza vaccine was given with a 5/8th inch needle rather than a 1 inch needle which is recommended for intramuscular administration. No reactions reported. 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: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Pain in extremity, Tenderness
Clinical narrative: Redness at injection site, pain/tenderness in arm. Pain resolved when patient took dose of ADVIL.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test, Condition aggravated, Dyskinesia, Electroencephalogram normal, Gastrooesophageal reflux disease
Clinical narrative: Patient experienced unusual movements involving arms and legs 4 days after vaccines were administered. Patient was admitted to the local hospital, where an EEG was completed that did not show any evidence of seizure. No antiepileptic medications needed per hospital. Patient was rechecked in PCP office 10 days after vaccines were given. Started on medication for GERD and plan to recheck in 4 days. Patient hospitalized for 1 day.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blister, Injection site cellulitis, Injection site erythema, Injection site vesicles, Myalgia
Clinical narrative: 10/9/2018 @ ~2:08pm: Approximately 30 minutes after receiving the PNEUMOVAX-23 vaccine, patient began to experience tingling in her fingers & slight muscle aches in her arm. Patient went to the Dr.'s office. Dr. did not prescribe any antibiotics or pain medications. 10/9/2018 @ ~7:00pm: Patient's arm was very painful. Patient described the pain as feeling like a ton of bricks & could not move her arm without pain. Patient said, she felt like biting her arm off. The pain lasted all night long. Patient's arm had blisters. 10/10/2018 @ ~7:00am: Patient felt better, but still could not move her arm; it was painful with movement. 10/11/2018: Patient went back to Dr.'s office because she experienced blisters all night long & woke up with redness & blisters at the injection site. Dr. diagnosed as cellulitis & prescribed Cephalexin 500mg 1 capsule 3 times daily x10 days. 10/13/2018: Patient still had a couple blisters, but the pain is gone.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: 10/9/2018 @ ~2:08pm: Approximately 30 minutes after receiving the PNEUMOVAX-23 vaccine, patient began to experience tingling in her fingers & slight muscle aches in her arm. Patient went to the Dr.'s office. Dr. did not prescribe any antibiotics or pain medications. 10/9/2018 @ ~7:00pm: Patient's arm was very painful. Patient described the pain as feeling like a ton of bricks & could not move her arm without pain. Patient said, she felt like biting her arm off. The pain lasted all night long. Patient's arm had blisters. 10/10/2018 @ ~7:00am: Patient felt better, but still could not move her arm; it was painful with movement. 10/11/2018: Patient went back to Dr.'s office because she experienced blisters all night long & woke up with redness & blisters at the injection site. Dr. diagnosed as cellulitis & prescribed Cephalexin 500mg 1 capsule 3 times daily x10 days. 10/13/2018: Patient still had a couple blisters, but the pain is gone.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Headache, arm pain, lethargy, flu like symptoms, fever. Subsided in 2 days.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Tongue blistering
Clinical narrative: Pt got blisters on tongue same day vaccine was administered. Pt states he is unsure whether the vaccine was the cause or not...States he did not have anything corrosive (spicy,hot,fried) to eat.  And doesn't believe he injured his tongue. Started with one blister and now has 3 blisters... pt came back to pharmacy 4 days later to show adverse effect.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Hallucination, visual, Screaming, Skin warm
Clinical narrative: Patient's mother reports that on 10/18/18 (the night that FLUARIX vaccine was given) that the patient woke up around 2:00 screaming and grasping at the air. Patient reported seeing "pink stuff flying in the room" and was grabbing at things coming out of her hands." She felt warm to touch and mother gave Tylenol but did not take temperature. Since that date, patient has been fearful of bedtime and naptime. She will occasionally swing at things in the air or grasp at her hands. Patient had a second occurance of waking from sleep screaming and seeing "blue stuff flying in the air" on 10/23/18.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Injection site pain, Joint range of motion decreased, Neck pain
Clinical narrative: Developed pain in neck and pack and sore at injection site. Having trouble with range of motion specifically reaching back with arm.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Paraesthesia, Urticaria
Clinical narrative: Hives, Eye Swelling, tingling, Benadryl, prednisone, hydroxyzine, cetirizine. Hives and swelling are gone.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Influenza
Clinical narrative: Patient went from healthy to 104 fever within 5 hours of vaccination. He had high fever, chills, headache, sore throat, runny nose, body aches, fatigue, loss of appetite. Background: 3 children, oldest is the one with the adverse reaction. The youngest is 5 months old and was born with a Congenital Heart Defect, corrected at 4 days old. Despite asking many different people on different occasions if the nasal mist would negatively affect them OR the baby as it is a live but weakened virus, we were given the OK. As everything online states, we were reassured that the vaccine itself would not cause the virus. 5 Hours after the vaccination was given-- patient (4) starts becoming ill. I called the doctors office the next morning, the doctor called me about an hour later to inform me she had called Infectious Disease and they all had the same conclusions: there was no need to actually test him for influenza as it would come back positive due to the nasal mist vaccination anyways, but that he did indeed have influenza caused from the vaccination. We were told to separate both patient and our middle child (who also received the nasal mist, although she had only a runny nose and a 'normal' reaction) from our baby to hopefully prevent him from contracting it as well, as it may be very bad for him being so young and with his history. Both Dr. and Infectious Disease recommend we start our infant on TAMIFLU to prevent him from developing influenza. Patient was sick for 4 days with high fever and influenza symptoms. We did separate our family during the time; my niece whom he was exposed to once contracted the illness as well.
Age: 4.0
Sex: M
Vaccine: FLUN4
Symptoms: Malaise, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Patient went from healthy to 104 fever within 5 hours of vaccination. He had high fever, chills, headache, sore throat, runny nose, body aches, fatigue, loss of appetite. Background: 3 children, oldest is the one with the adverse reaction. The youngest is 5 months old and was born with a Congenital Heart Defect, corrected at 4 days old. Despite asking many different people on different occasions if the nasal mist would negatively affect them OR the baby as it is a live but weakened virus, we were given the OK. As everything online states, we were reassured that the vaccine itself would not cause the virus. 5 Hours after the vaccination was given-- patient (4) starts becoming ill. I called the doctors office the next morning, the doctor called me about an hour later to inform me she had called Infectious Disease and they all had the same conclusions: there was no need to actually test him for influenza as it would come back positive due to the nasal mist vaccination anyways, but that he did indeed have influenza caused from the vaccination. We were told to separate both patient and our middle child (who also received the nasal mist, although she had only a runny nose and a 'normal' reaction) from our baby to hopefully prevent him from contracting it as well, as it may be very bad for him being so young and with his history. Both Dr. and Infectious Disease recommend we start our infant on TAMIFLU to prevent him from developing influenza. Patient was sick for 4 days with high fever and influenza symptoms. We did separate our family during the time; my niece whom he was exposed to once contracted the illness as well.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient got the IMZ on Sat Oct 20. He came in on Monday Oct 22 saying that his left arm had been sore ever since he received the IMZ. He also had less range of motion with arm and difficulty lifting his left arm up. His right arm with flu shot was fine. I advised him that this is listed as a possible side effect and is listed on the VIS sheet. I asked if he had iced it, taken TYLENOL or ibuprofen. He said he took ALEVE one night but didn't ice it. I advised to take TYLENOL, ibuprofen or ALEVE and could use ice compresses and warm compresses and give it a couple more days. On Tuesday patient said he was still having pain and went to see his doctor. His Dr advised warm compresses.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermal cyst, Fatigue, Feeling abnormal, Feeling hot, Hyperhidrosis
Clinical narrative: At first it was the usual pain in arm, muscle aches, and fatigue, then within a day or two I started getting cysts on my face and little bubbly and itching patch on my arm, then I started feeling really lousy and sweating and hot sensations all over-like I was standing in front of an oven-, and itchy more than usual. I also started getting a sore throat and runny nose. Now this morning I woke up to find tiny pustules all over my face.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Oropharyngeal pain, Pain in extremity, Pruritus, Rash pustular
Clinical narrative: At first it was the usual pain in arm, muscle aches, and fatigue, then within a day or two I started getting cysts on my face and little bubbly and itching patch on my arm, then I started feeling really lousy and sweating and hot sensations all over-like I was standing in front of an oven-, and itchy more than usual. I also started getting a sore throat and runny nose. Now this morning I woke up to find tiny pustules all over my face.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: At first it was the usual pain in arm, muscle aches, and fatigue, then within a day or two I started getting cysts on my face and little bubbly and itching patch on my arm, then I started feeling really lousy and sweating and hot sensations all over-like I was standing in front of an oven-, and itchy more than usual. I also started getting a sore throat and runny nose. Now this morning I woke up to find tiny pustules all over my face.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Mother reports flu vaccine was given 10/22/2018, 7:50 pm that night noticed site was red, swollen, and hard.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Blood test normal, C-reactive protein increased, Fatigue, Impaired work ability
Clinical narrative: 10/14/18 patient woke with joint pain, fever 101.4, fatigue. Symptoms continued, joint pain and muscle pain worsened. Went to ED on 10/18/18, diagnosed with serum sickness and pneumonia. Patient's 3 yr old daughter history of cough x 4 weeks- she was also seen on same day and dx with pneumonia. Patient treated with IV abx and fluids and pain meds. Admitted overnight. Treated with ZITHROMAX, and Ceftriaxone, DILAUDID, TORADOL, ATIVAN, NORCO. Discharged on 10/19/18 with ZITHROMAX 1 pill, Ibuprofen NORCO. Is recovering but not back to work yet. Will follow up with PCP on 10/24/18.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Myalgia, Pneumonia
Clinical narrative: 10/14/18 patient woke with joint pain, fever 101.4, fatigue. Symptoms continued, joint pain and muscle pain worsened. Went to ED on 10/18/18, diagnosed with serum sickness and pneumonia. Patient's 3 yr old daughter history of cough x 4 weeks- she was also seen on same day and dx with pneumonia. Patient treated with IV abx and fluids and pain meds. Admitted overnight. Treated with ZITHROMAX, and Ceftriaxone, DILAUDID, TORADOL, ATIVAN, NORCO. Discharged on 10/19/18 with ZITHROMAX 1 pill, Ibuprofen NORCO. Is recovering but not back to work yet. Will follow up with PCP on 10/24/18.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Serum sickness, White blood cell count normal
Clinical narrative: 10/14/18 patient woke with joint pain, fever 101.4, fatigue. Symptoms continued, joint pain and muscle pain worsened. Went to ED on 10/18/18, diagnosed with serum sickness and pneumonia. Patient's 3 yr old daughter history of cough x 4 weeks- she was also seen on same day and dx with pneumonia. Patient treated with IV abx and fluids and pain meds. Admitted overnight. Treated with ZITHROMAX, and Ceftriaxone, DILAUDID, TORADOL, ATIVAN, NORCO. Discharged on 10/19/18 with ZITHROMAX 1 pill, Ibuprofen NORCO. Is recovering but not back to work yet. Will follow up with PCP on 10/24/18.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Altered state of consciousness, Dizziness, Immediate post-injection reaction
Clinical narrative: Was nervous before the injection. Immediately afterwards, he stood up and stated, "I feel like I am going to pass out." Sat back down in the chair, but we asked him to lie on the floor, as that seems to stop all of the symptoms right away. BP normal 107/80. After approximately 5 minutes assisted to sitting position, where he was able to drink fluids, and then to a standing position with no further symptoms. Left ambulatory to car with father and siblings, accompanied by nurse with instructions if dizziness returns (usually it doesn't) to lie down.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Muscle tightness, Musculoskeletal pain, Pain, Sleep disorder
Clinical narrative: Patient received pneumococcal vaccine in the R deltoid at 20:59 on 9/25/18. At 0300, patient woke up with "immense pain" radiating from shoulder down into the shoulder blade and within the deltoid on the R side. Patient describes an increase of intense pain with movement of arm, but  neither positioning or lack of movement relieves pain. Patient is tensing back and neck muscles on the R side. Cannot fall back to sleep. Medications given (650mg TYLENOL at 0329; 50mg Tramadol at 0300), gentle massage, heat and ice tried to relieve pain - patient states none of it helped.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy to vaccine, Vaccine positive rechallenge
Clinical narrative: Suspect allergy to Neomycin or other ingredient in shot. Suggest seeing allergy for testing and recommendations for further flu vaccines. Due to recurrence last year and this year and quickness of onset infection not likely. Ibuprofen, ice pack as needed. Reviewed that these reactions are unlikely to be infectious and is rather his immune response to the vaccine. Mom feels more comfortable doing the antibiotic they used last year, as the swelling improved a day later.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: 39 year old patient received DTap instead of Tdap.
Age: 69.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Dehydration, Epistaxis, Pollakiuria, Sinus headache
Clinical narrative: The Patient received both PREVNAR 13 and FLUAD on 10/18/18. On 10/19/18 he had increased urination, a severe sinus headache and bloody nasal passages. He was able to function but had to go to the emergency room because he was so severely dehydrated. He would not give me his name so I can't look up lot numbers for any of these vaccines.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Vaccine given on 10/22/18 at 145 pm. Patient began with erythema and pain to left deltoid area at 4 pm. She took "2" VISTARIL at 6 pm without symptom improvement. She took "2" VISTARIL again at 2 am on 10/23/18 without symptom improvement. Site is erythematous, warm, tender, hived. Cold compress and BENADRYL 50 mg given by mouth. Patient then went to the ER with her mother.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Decreased appetite, Headache, Malaise, Peripheral swelling
Clinical narrative: Within 3 hours the patient began feeling feverish and was shaking. For the following 48 hours the patient felt unwell and didn't go out. Her arm had a 4 inch diameter rash and was swollen. This was still visible 72 hours later. She reported aching joints, no appetite and a severe headache for the first 48 hours.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash, Tremor
Clinical narrative: Within 3 hours the patient began feeling feverish and was shaking. For the following 48 hours the patient felt unwell and didn't go out. Her arm had a 4 inch diameter rash and was swollen. This was still visible 72 hours later. She reported aching joints, no appetite and a severe headache for the first 48 hours.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Ear infection, Malaise, Vaccination complication, Weight decreased
Clinical narrative: Patient stated that he had a negative reaction to getting the flu shot. He fell ill due to the flu shot.  He stated at the time that he was not sick at the time of the flu shot, but now he is saying that his doctor told him his ear infection got worse or did not get better because he got the flu shot. He stated that he lost 10 pounds due to filling ill after the flu shot.
Age: 72.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Balance disorder, Dysstasia, Gait disturbance
Clinical narrative: PT HAD DIFFICULTY WITH BALANCE WHILE WALKING/STANDING.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity, Palpitations
Clinical narrative: My arm hurt immediately down to my fingertips. Later that night my heart was racing. The next day I needed a TYLENOL to be able to work. My body ached everywhere.
Age: 50.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Arthralgia, Joint noise, Mobility decreased, Pain in extremity
Clinical narrative: My arm and shoulder joint hurt. I had pain starting the evening of the shot and for a week or more, could barely move my upper arm. I continue to have restricted movement and a lot of pain, and some popping in my shoulder. It is especially bad at night when trying to sleep. It has been almost a month and my symptoms aren't much better.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Pt has an all over body rash, not just in the injection site area. Doesn't know if this is causing or not.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Injection site erythema, Injection site rash, Myalgia
Clinical narrative: Severe muscle pain, large red rash at injection site, slight fever, pain in all joints, dizziness.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe muscle pain, large red rash at injection site, slight fever, pain in all joints, dizziness.
Age: 51.0
Sex: F
Vaccine: FLUC4, HEP, HEPA, PPV, TDAP, VARZOS
Symptoms: Lip swelling, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient arms swelling and pain, Fever, Swelling of Lips.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Developed Bell's palsy S/P flu shot.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site pain, Pain
Clinical narrative: Left upper arm was entirely covered in dark bruise and very sore to touch and movement.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had the same vaccine on 10/03/18 and got the same vaccine 10/23/18. Patient did not have any adverse events.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: Skin elevated rash along both elbows, arm pits, front of belly area, buttocks. The rash appeared about 7-8 hours after injection, became pronounced. I took Benadryl 50mg  every 4-6 hours and applied Hydrocortisone cream over skin affected. By 10/22 the rash was less pronounced, however new areas appeared mid day, much less severe than 10/21. Still responding to Benadryl.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site inflammation, Pain, Peripheral swelling, Skin warm
Clinical narrative: Left arm swollen and hot, red and raised the size of a good sized hand. Inflammation below the injection site. Hot and painful. Patient applied ice off and on throughout the day today 10/23/18. She took 2 TYLENOL at 5:30pm today and a generic BENADRYL 25mg about at 6:15pm. Will watch and wait to see if BENADRYL helps at all. Will watch and wait until tomorrow to see if area decreases in size/inflammation response. If not better tomorrow am patient will contact primary care physician.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Dizziness, Feeling hot, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient complained of missing awareness for approximately 2-5 minutes. She felt light headed and hot/clammy. She also experience tingling/numbness in both hands. She had come for her shot with a friend who stated that she may be experiencing some anxiety as she had been apprehensive before recieving the shot. She sat down on our waiting bench during this time. She did not experience any shortness of breath or other allergic symptoms.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: The vaccine was given on 10/20/2018. Pt states her Left arm started hurting about 3 hours after and with a red swollen circle going around the injection site. The vaccine was injected subq of the left arm. The red circle begin to get larger and is not going under the pt arm near her armpit.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Urticaria
Clinical narrative: Patient developed hives 7 days after injection which continued to recur for several months and was treated with antihistamines and topical steroids.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site swelling
Clinical narrative: Pt experienced swelling and a small lump immediately upon injection, pt states no previous reaction to flu vaccine.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Eye movement disorder, Loss of consciousness, Muscle twitching, Retching
Clinical narrative: Skin clammy, gray; briefly seemed to lose consciousness w/ right arm twitching & eyes rolled back in head, retching (did not vomit), shaking. Left by ambulance; treated w/ IV @ hospital where symptoms reappeared w/ needlestick there, released same day. Patient stated after the vaccine he had only had a bowl of Cheerios that day to eat. Sister stated he has had the same rxn after blood draws.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin discolouration, Tremor
Clinical narrative: Skin clammy, gray; briefly seemed to lose consciousness w/ right arm twitching & eyes rolled back in head, retching (did not vomit), shaking. Left by ambulance; treated w/ IV @ hospital where symptoms reappeared w/ needlestick there, released same day. Patient stated after the vaccine he had only had a bowl of Cheerios that day to eat. Sister stated he has had the same rxn after blood draws.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Lip swelling, Pyrexia
Clinical narrative: Patient's wife called the pharmacy on 10/23/18 stating that the patient experienced fever, chills and upper lip swelling on the day of the immunization. The fever and chills resolved however the patient stated that his lip still felt swollen. Wife stated that his lip didn't appear swollen to her visually.
Age: 66.0
Sex: M
Vaccine: FLU4, FLUX, PPV
Symptoms: Urticaria
Clinical narrative: Hives starting day after injection and treated with antihistamines, ranitidine and loratadine.
Age: 66.0
Sex: M
Vaccine: FLU4, FLUX, PPV
Symptoms: Allergy test, Immunoglobulins, Urticaria
Clinical narrative: Hives starting day after injection and treated with antihistamines, ranitidine and loratadine.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Injection site swelling, Injection site warmth, Migraine
Clinical narrative: Patient initially reported feeling tired and achy the next day, as well as having a migraine. She then developed diarrhea, as well as a rash on her trunk and neck, which spread to her arms and legs. She said she became "puffy", and the injection site became swollen and hot. These symptoms persisted for about 7 - 10 days, after which they resolved.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rash, Swelling
Clinical narrative: Patient initially reported feeling tired and achy the next day, as well as having a migraine. She then developed diarrhea, as well as a rash on her trunk and neck, which spread to her arms and legs. She said she became "puffy", and the injection site became swollen and hot. These symptoms persisted for about 7 - 10 days, after which they resolved.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Feeling abnormal, Pyrexia, Tremor, Viral infection
Clinical narrative: 10/18/2018 Started feeling really bad - shaking & extremly weak around 6:00 pm & fever 102 - took 2 Acetaminophen 500mg ea - on 10/19/2018 felt really weak took 2 Acetaminophen 500mg. Took him to Pediatrics - said has a virus - Felt ok thru weekend then Monday AM shaking & fever took 2 MOTRIN 500mg then took him to Urgent Care, said not sure could be flu but didn't have all the flu symptoms, probably a virus or reaction to vaccine. Patient has been taking 2 Acetaminophen 500 mg every 6 hours & MOTRIN 500 mg every 6 hours alternating both every 3 hours the last 2 days.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness
Clinical narrative: Extremely dizzy. Had to lie down.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Swelling at the site of injection that extends almost to the elbow. Redness, itching and very painful. Patient advised to take BENADRYL and TYLENOL and report prognosis the next day.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Ear pain, Fatigue, Headache, Pyrexia
Clinical narrative: Low fever, fatigue, passing headache, passing stomach discomfort, passing ear ache.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood test, Injury associated with device, Prophylaxis against HIV infection
Clinical narrative: Patient was receiving vaccine from pharmacist, as pharmacist was inserting needle, needle went through the patients skin and punctured the pharmacist. Exchange of blood occurred, pharmacist is currently receiving blood tests and PEP and patient is currently being contacted to start the treatment process.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Blood test abnormal, Borrelia test negative, Cyst, Full blood count, Gait inability
Clinical narrative: Both thighs swelled, turned red, had fever over 105, injection site had large lumps and small drainage hole along with petechiae all over the body. Dr thought it was a bug bite, sent to the ER. ER did Lymes - negative and ruled it an unknown infection. Sent home with BACTRIM. Returned to the dr for well visit 7/2/2018 as dr said it was OK to get shots. He then received Dtap & Hep B, days later he developed the same red legs and lumps. Continued to treat with compress and Mupirocin 2%. Went down some but baby had fever on and off throughout September, redness never went away, baby started to refuse to walk, grabbing and screaming at legs expressing he was hurt/hurting and in pain. On October 11th, fever spiked 105 again, red legs worse and now had rashes on his leg and torso. Went to the ER, where they diagnosed it as a cyst/granulomas from vaccines, baby was almost septic given high dose clindamycin to treat. Improving within days of treatment, redness still very slight. Unknown of any long term issues.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Granuloma, Infection, Injection site discharge, Injection site erythema, Injection site mass
Clinical narrative: Both thighs swelled, turned red, had fever over 105, injection site had large lumps and small drainage hole along with petechiae all over the body. Dr thought it was a bug bite, sent to the ER. ER did Lymes - negative and ruled it an unknown infection. Sent home with BACTRIM. Returned to the dr for well visit 7/2/2018 as dr said it was OK to get shots. He then received Dtap & Hep B, days later he developed the same red legs and lumps. Continued to treat with compress and Mupirocin 2%. Went down some but baby had fever on and off throughout September, redness never went away, baby started to refuse to walk, grabbing and screaming at legs expressing he was hurt/hurting and in pain. On October 11th, fever spiked 105 again, red legs worse and now had rashes on his leg and torso. Went to the ER, where they diagnosed it as a cyst/granulomas from vaccines, baby was almost septic given high dose clindamycin to treat. Improving within days of treatment, redness still very slight. Unknown of any long term issues.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Petechiae, Pyrexia
Clinical narrative: Both thighs swelled, turned red, had fever over 105, injection site had large lumps and small drainage hole along with petechiae all over the body. Dr thought it was a bug bite, sent to the ER. ER did Lymes - negative and ruled it an unknown infection. Sent home with BACTRIM. Returned to the dr for well visit 7/2/2018 as dr said it was OK to get shots. He then received Dtap & Hep B, days later he developed the same red legs and lumps. Continued to treat with compress and Mupirocin 2%. Went down some but baby had fever on and off throughout September, redness never went away, baby started to refuse to walk, grabbing and screaming at legs expressing he was hurt/hurting and in pain. On October 11th, fever spiked 105 again, red legs worse and now had rashes on his leg and torso. Went to the ER, where they diagnosed it as a cyst/granulomas from vaccines, baby was almost septic given high dose clindamycin to treat. Improving within days of treatment, redness still very slight. Unknown of any long term issues.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Rash, Screaming
Clinical narrative: Both thighs swelled, turned red, had fever over 105, injection site had large lumps and small drainage hole along with petechiae all over the body. Dr thought it was a bug bite, sent to the ER. ER did Lymes - negative and ruled it an unknown infection. Sent home with BACTRIM. Returned to the dr for well visit 7/2/2018 as dr said it was OK to get shots. He then received Dtap & Hep B, days later he developed the same red legs and lumps. Continued to treat with compress and Mupirocin 2%. Went down some but baby had fever on and off throughout September, redness never went away, baby started to refuse to walk, grabbing and screaming at legs expressing he was hurt/hurting and in pain. On October 11th, fever spiked 105 again, red legs worse and now had rashes on his leg and torso. Went to the ER, where they diagnosed it as a cyst/granulomas from vaccines, baby was almost septic given high dose clindamycin to treat. Improving within days of treatment, redness still very slight. Unknown of any long term issues.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site infection, Peripheral swelling, Skin warm
Clinical narrative: The patient stated she was diagnosed with an "infection at the injection site" after she received the first dose of a SHINGRIX vaccine. She discribed her arm as being "swelled, red and hot" She was treated at an emergency department and given antibiotics for this.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Patient got very ill and went to the hospital for treatment.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: Had a red itchy rash, about the diameter of a tennis ball around the injection site. Site was slightly swollen and slightly painful to the touch. Appeared about a day after administration and lasted for 3 days. Did not seek treatment and resolved by itself.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Condition aggravated, Dehydration, Headache, Nausea, Pain in extremity
Clinical narrative: Patient was fine when shot was given after she got up about 3 minutes later she had a bad headache and right arm ached (shot was in left arm was holding moms hand tightly with right arm) started to fall over and pass out and mom caught her. Did not ever loose conciousness. 911 was called and paramedics came close to an hour later. Patient was awake alert and orientated when sitting by pharmacy afterwards was feeling thirsty and had had a slight headache before shot.  Thought she might get sick at some point. Paramedics checked vitals and all were good decided patient was probably just dehydrated. She sat and drank more water and was able to leave and get in car with mom. Did not want to go to the hospital.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Presyncope
Clinical narrative: Patient was fine when shot was given after she got up about 3 minutes later she had a bad headache and right arm ached (shot was in left arm was holding moms hand tightly with right arm) started to fall over and pass out and mom caught her. Did not ever loose conciousness. 911 was called and paramedics came close to an hour later. Patient was awake alert and orientated when sitting by pharmacy afterwards was feeling thirsty and had had a slight headache before shot.  Thought she might get sick at some point. Paramedics checked vitals and all were good decided patient was probably just dehydrated. She sat and drank more water and was able to leave and get in car with mom. Did not want to go to the hospital.
Age: 68.0
Sex: F
Vaccine: TYP
Symptoms: Asthenia, Hypertension, Palpitations
Clinical narrative: Pt states she experienced weakness, heart palpitations and hypertension beginning 2 days after first dose. Pt was seen in ER, and it is unclear whether her symptoms were a result of the oral vaccine.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lymphadenopathy, Oedema, Oedema peripheral, Pruritus
Clinical narrative: Patient came into pharmacy on 10/22/18 with a red upper arm, a small amount of edema, and reporting itching. Patient also reported swollen lymph node under the arm (in arm pit) of arm that received injection. Pharmacist advised BENADRYL. Patient reports that she has taken BENADRYL for past 2 days with no relief. Pharmacist advised patient to call or visit MD due to swollen lymph node being abnormal. Patient said she was going by the doctor's office that day. Pharmacist called MD ahead of time to make him aware of patient's situation.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Patient started having pain at the injection site later that night. Stated the next morning the site of injection was hard as a rock. The site was sore to touch and warm to touch. She stated she was unable to move and function Monday.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient was very fatigued, has a fever and aches in her arm. Patient's arm is still swollen with redness surrounding the injection site.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: CUSTOMER HAD A LARGE SITE REACTION ON HER LEFT ARM.  IT WAS REPORTED TO BE RED AND WARM TO THE TOUCH. REPORTED BY THE NURSE FROM HER DOCTORS OFFICE.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Joint injury, Syncope
Clinical narrative: Ptn walked out of the immunization room and collapse in front of the pharmacy counter (About 25 feets). Maybe about 2-3 minutes after the shot. By the time I reach to her she was already awoken but unaware of surrounding. No head injury from the fall but did hit the knee on her way down.    Gave her some Orange Juice and she sat at the waiting area for about another 20 minutes.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Middle insomnia, Musculoskeletal pain, Pain, Pruritus, Rash
Clinical narrative: I received the shot on a Friday and slept more than usual that weekend but that was not a big deal as I often will "fight" a virus off by sleeping. Starting a week after the shot I had an odd burning pain in my mid-back at the shoulder blades that awakened me every night for 3 nights in a row and then my mid-back started itching beyond relief and I scratched a lot using a back scratcher. After a week of these symptoms I look in the mirror and was shocked. I had a huge rash over my mid-back up to the neck and now my right breast is itching with a spreading rash from my armpit on the right into my mid chest. The back is still full of the rash and itching often with pain that comes and goes in these areas. It is a burning pain and I have self-diagnosed myself with shingles. I had chicken pox as a child and as an RN I have had patients with shingles and am familiar with what they look like. I have also verified it from pictures on the internet.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Somnolence
Clinical narrative: I received the shot on a Friday and slept more than usual that weekend but that was not a big deal as I often will "fight" a virus off by sleeping. Starting a week after the shot I had an odd burning pain in my mid-back at the shoulder blades that awakened me every night for 3 nights in a row and then my mid-back started itching beyond relief and I scratched a lot using a back scratcher. After a week of these symptoms I look in the mirror and was shocked. I had a huge rash over my mid-back up to the neck and now my right breast is itching with a spreading rash from my armpit on the right into my mid chest. The back is still full of the rash and itching often with pain that comes and goes in these areas. It is a burning pain and I have self-diagnosed myself with shingles. I had chicken pox as a child and as an RN I have had patients with shingles and am familiar with what they look like. I have also verified it from pictures on the internet.
Age: 17.0
Sex: F
Vaccine: FLUX
Symptoms: Computerised tomogram head, Dizziness, Laboratory test, Muscle twitching, Pain
Clinical narrative: Body aches, fever, severe muscle twitching, dizziness.
Age: 17.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Body aches, fever, severe muscle twitching, dizziness.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Patient was administered the immunization and within 30 seconds of giving the administration, the site of injection became swollen (around the size of a quarter). There was minimal bleeding at the site of injection. Patient sat the full 15 minutes at the pharmacy to ensure no other reaction occurred. The swelling at the site of injection went down during that time and patient did not have any other complaints or other adverse reactions. Followed up with the patient 3 hours after receiving the immunization via phone call, and was told by caregiver that the swelling had gone down and patient did not have any other complaints or side effects.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood test, Burning sensation, Chest pain, Computerised tomogram, Electrocardiogram
Clinical narrative: Cheeks became flushed and I had a burning across the top of my chest. The pain increased throughout the day and my chest hurt when I took a breath. By 5:00 pm, I was uncomfortable and went to an Urgent Care. Because it was chest pain, they did a couple of tests and sent me to the ER.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Flushing, Heart rate increased, Painful respiration, Ultrasound scan
Clinical narrative: Cheeks became flushed and I had a burning across the top of my chest. The pain increased throughout the day and my chest hurt when I took a breath. By 5:00 pm, I was uncomfortable and went to an Urgent Care. Because it was chest pain, they did a couple of tests and sent me to the ER.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Feeling cold, Influenza, Myalgia, Pain of skin
Clinical narrative: 6 hours after receiving the flu shot, I was shivering uncontrollably and cold, though I was under the covers. I had muscle aches and my skin felt pain when having the flu.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chest pain, Dyspnoea, Erythema, Fatigue, Injection site pain
Clinical narrative: Had a fever of 100 on Sunday night after shot. In pain all night with shoulder (shot site) and in chest. Shortness of breath. The next morning very tired and laid around all day. Painful in shoulder that night. Woke up Tuesday morning with red arm and shoulder. My muscle on that arm was swollen and very red. Tonight the site is the same but pain is in chest. I called pharmacy this morning and described my symptoms but he said it would go away. So far it has not. I took 1 tablet of BENADRYL tonight.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Muscle swelling, Pyrexia
Clinical narrative: Had a fever of 100 on Sunday night after shot. In pain all night with shoulder (shot site) and in chest. Shortness of breath. The next morning very tired and laid around all day. Painful in shoulder that night. Woke up Tuesday morning with red arm and shoulder. My muscle on that arm was swollen and very red. Tonight the site is the same but pain is in chest. I called pharmacy this morning and described my symptoms but he said it would go away. So far it has not. I took 1 tablet of BENADRYL tonight.