chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPVHIB, HEP
Symptoms: No adverse event, Product preparation issue, Wrong product administered
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old patient who had vaccine that was mixed with the wrong diluent, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B Vaccine for Immunisation. On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine, lot C5422AA, expiration date- 15-Sep-2019 via unknown route. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event 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.
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Paraesthesia oral
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves female patient (more than 65 years) who experienced loss of taste and tongue tingling, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. The patient had previously received FLUZONE QUADRIVALENT without problems. On an unknown date in Sep 2017, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date not reported via intramuscular route in unknown administration site. On an unknown date, the patient developed a non-serious loss of taste with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious tongue tingling with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not provided. Final diagnosis was tongue tingling and loss of taste. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for tongue tingling and as Recovered / Resolved on an unknown date for loss of taste. Events lasted for six months. List of documents held by sender- none.
Sex: M
Vaccine: FLU3
Symptoms: Contraindication to vaccination
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 78 years old male patient who had a fluzone high-dose injection to a patient that has an egg allergy, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history included egg allergy. On an unknown date, the patient received a  0.5 ml once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ023AA, expiry date- 25-Apr-2019. It was a case of contraindication to vaccination. (Other relevant tests included No lab test.) Final diagnosis was gave a fluzone high-dose injection to a patient that has an egg allergy. Patient had experienced no side effects at this time.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site macule
Clinical narrative: (L) arm deltoid area with 8cm diameter of erythema with mild induration; round appearing macule.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Patient develop cellulitis on her left upper arm when the PREVNAR-13 vaccine was administered. She was treated by her doctor with antibiotics (SEPTRA) for 7 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle injury, Peripheral swelling
Clinical narrative: Patient called the pharmacy and said that her arm is swollen and think that her muscle was damaged. We called PCP to notify about patient complaints and was told that pt. already called. Patient mentioned on VM that she will be going to hosp.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Injection site below the deltoid muscle, caused a reaction and patient saw her doctor who prescribed KEFLEX 50 mg for 7 days.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Nausea, Pain in extremity, Swelling, Tenderness
Clinical narrative: Pt received vaccine on 9-21-18, PNEUMOVAX and FLUZONE QUAD. In the evening, she had pain in the Right arm, tenderness. Swelling on the next day. By Sunday afternoon she went to ER. She felt nauseous headache.w/BENADRYL/ice pack - ER gave her Cephalosporin and released the same day. But she feels better.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypersomnia
Clinical narrative: Pt slept more after immunization for next 24 hrs. Pt seen 1 day later with normal exam.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, VARCEL
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Site redness and swelling with right arm numbness.
Age: 67.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Musculoskeletal disorder, Pain in extremity
Clinical narrative: I could not use my arm for 1 1/2 days. It hurt so badly. My husband had to help me get undressed. I had to take off work. It took over a month to get where it wasn't hurting. This was the shingles shot.  Now I'm afraid to get the 2nd dose.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Dizziness, Eye movement disorder, Muscle twitching, Nervousness, Syncope
Clinical narrative: After flu shot patient had no complaints, then after administering PREVNAR 13 patient complained she felt light headed. After sitting with her several minutes and providing her with water and crackers she began to slump down in her sit, eyes rolled back, and her leg was slightly twitching. I was able to catch the patient and her husband helped hold her while I checked her pulse. Her pulse was fine and she never had any issues breathing or swallowing. After patient came to, she said she felt shaky and thought her blood sugar was low. Patient then had another snack and left the pharmacy in a wheel chair to prevent a fall walking to her car.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Large area of swelling and redness to left arm after vaccine (3-4 inches in diameter) - persisted for 4 weeks after vaccination.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Grip strength decreased, Mobility decreased, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient came into pharmacy on 9/26/18 to report he has been experiencing extremely pain arm movement that limited his motion, and difficulty grasping objects with his hand. He said he had tried to use ice and heat but it wasn't helping. He said he didn't have these effects until 'a few days after' the vaccine but didn't state a specific date to me. He said the pain/issues have increased and decreased but not gone away. He also stated he thought the vaccine was administered 'pretty high' on his arm, and that it 'surprised him'. Patient does not have a primary care doctor here yet but will find one in a few days if NSAIDs don't help.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Gastric disorder, Gastritis, Migraine
Clinical narrative: Stomach illness, chronic inflammation of stomach, migraines confirmed by neurologist.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Eye inflammation, Eye pruritus, Eye swelling
Clinical narrative: Child reported to nurse one hour [12:15] after being giving Flu shots. Child reported with symptoms of Swelling, Itching and inflammation of Left eye. Ice pack IMMEDIATELY APPLIED.  Mom works at the school also gave BENADRYL 24 mgs that she keeps on hand due to the childs environmental allergies. By 1 pm child reported to be in good spirits eating lunch in cafeteria. Swelling and inflammation had decreased. 8:30 am on 9-25-2018 all symptoms had cleared completely reports School nurse. Mom states symptoms had cleared the same day on 9-24-2018 in evening. NO RESPIRATORY DISTRESS noted at any time. No redness or swelling noted at injection site.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local reaction, Swelling
Clinical narrative: Adverse local reaction with localized redness and swelling/induration 2.5 x 2.5 inches.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Pt presented to pharmacy 9/26/18 and said she thought she might be having an allergic reaction to the flu shot recieved on 9/20/18. She said she started feeling very itchy over the weekend (around 9/22/18) and the only thing she could contribute it to was the flu shot. I advised for the patient to take some BENADRYL and counseled on signs and symptoms should the allergy progress (wheezing, trouble breathing, swelling, chest tightness) and told her to seek immediate attention should a reaction occur.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L arm above elbow 13 cm vertical x 18 cm circumference erythema, warm to the touch, mild swelling.
Age: 87.0
Sex: F
Vaccine: FLUA3
Symptoms: Atrial fibrillation, Condition aggravated, Feeling abnormal, Hypertension, Palpitations
Clinical narrative: Patient reported that 2 & 1/2 HOURS after the immunization she began to feel badly.....with heart racing, a-Fib, her blood pressure was high 150/74 at 5pm pulse 96 and at 5:45pm BP was 158/78 pulse 79. She called the pharmacy, we told her to call her doctor or go to the ER and she called the doctor but they were closed. She refused to go to the ER. She said after eating and using her oxygen and lying down she felt better at 9:30pm.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Tenderness at the site of injection with ongoing, intermittent, mild aching and weakness in affected limb.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chest pain, Injection site pain, Musculoskeletal pain
Clinical narrative: Had same reaction w/both shots...Left arm on 6/29/18, Right arm on 9/15/18. Slight ache in area of shot, progressing over the course of a week to shoulder, then upper back, front upper chest, then continuing to elbow and lower arm on top. Deep burning nerve pain. Pain lasted the first time for about a month, in my 2nd week of pain after the 2nd shot now. First time, they thought I might be having a heart attack and advised me to go to the ER, cardiac workout done, no problems found, referred to my PCP. She diagnosed me w/trigger pain in my uper back radiating to the other areas, referred me to PT for 4 weeks, and a lidocaine injection(never got the injection as the doc couldn't get me in for a month and pain was improving by then. She also prescribed me Flexeril, but that gave me no relief, neither did Tylenol or Motrin. After 2 weeks of PT it was improving, but wasn't sure if it was just time or the PT that helped. I was discharged from PT after 3 weeks when it was feeling a bit better. Kept asking if it could be vaccine related and ER doc, PCP, and PT all said probably not, because it wasn't immediate. Forgot all about it, until I got the 2nd shot, then realized it was starting all over again on the other side. Since nothing helped before, this time I told my doctor about it, but am just doing the PT exercises on my own and using heat which either masks it, or helps relieve the pain a bit. Never had a reaction to any vaccine previously.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Vaccine positive rechallenge
Clinical narrative: Had same reaction w/both shots...Left arm on 6/29/18, Right arm on 9/15/18. Slight ache in area of shot, progressing over the course of a week to shoulder, then upper back, front upper chest, then continuing to elbow and lower arm on top. Deep burning nerve pain. Pain lasted the first time for about a month, in my 2nd week of pain after the 2nd shot now. First time, they thought I might be having a heart attack and advised me to go to the ER, cardiac workout done, no problems found, referred to my PCP. She diagnosed me w/trigger pain in my uper back radiating to the other areas, referred me to PT for 4 weeks, and a lidocaine injection(never got the injection as the doc couldn't get me in for a month and pain was improving by then. She also prescribed me Flexeril, but that gave me no relief, neither did Tylenol or Motrin. After 2 weeks of PT it was improving, but wasn't sure if it was just time or the PT that helped. I was discharged from PT after 3 weeks when it was feeling a bit better. Kept asking if it could be vaccine related and ER doc, PCP, and PT all said probably not, because it wasn't immediate. Forgot all about it, until I got the 2nd shot, then realized it was starting all over again on the other side. Since nothing helped before, this time I told my doctor about it, but am just doing the PT exercises on my own and using heat which either masks it, or helps relieve the pain a bit. Never had a reaction to any vaccine previously.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Nausea, Paraesthesia oral
Clinical narrative: Patient reported some lip swelling/tingling at 11 AM soon after SHINGRIX. Took 2 BENADRYL, slept, reported symptoms mostly subsided at 7:30 PM - felt a bit nauseous still but mostly better.
Age: 74.0
Sex: M
Vaccine: TDAP
Symptoms: Allergy test, Biopsy, Rash
Clinical narrative: Patient noticed rash along back 5 days after vaccine given, site of injection was not affected.  Patient is unsure if rash is vaccine related so contacted dermatologist. Derm unable to determine cause so ordered tests.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Pain, Pruritus, Skin warm
Clinical narrative: SWOLLEN, RED, TENDER TO TOUCH AND VERY WARM , HARD AND ITCHES/HURTS.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling, Tenderness
Clinical narrative: SWOLLEN, RED, TENDER TO TOUCH AND VERY WARM , HARD AND ITCHES/HURTS.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Urticaria
Clinical narrative: Vaccines were administered at 9am on 9/25/18. At 12am on 9/26/18 patient started having hives all over body. He also complained of right arm pain at the location of the injection.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Mother called in to our office on 9/25/18 stating she noticed patient's left arm was hot to touch and swollen around 4:33pm. Was told to give patient TYLENOL and BENADRYL and had a follow up appointment on 9/26/18.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injected limb mobility decreased
Clinical narrative: Redness in arm, difficulty raising left arm.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscle strain, Product administered at inappropriate site
Clinical narrative: Patient reports persistent right shoulder pain since vaccine, which she thinks is related to the vaccination being given at too high of a location on her right shoulder.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Headache, Induration, Pain in extremity
Clinical narrative: Reaction started in the car on the way home. Right arm felt hard and hurt. Redness and swelling appeared shortly there after. Swelling was from a few inches below the injection site to the mid forearm when I saw it on 9/21/18, patient reports that later that night it went all the way to her wrist. The arm was swollen, red, hot, and painful on the day of the vaccination. Patient also reported having a headache that evening. She doesn't normally get headaches. She put ice on it and took ADVIL. By the next day, still having discomfort and it was painful to the touch, but better. Swelling also subsided some. She went to her Dr. on the morning of 9-21-18 (this was the 1st time she had reported the reaction to anyone). He felt it was an allergic reaction and told her to take ZYRTEC and continue with icing the area and to see him again in a week if no improvement. After that she came to the pharmacy to report the reaction and to get the ZYRTEC. Arm still quite swollen from bicep to mid forearm. Still felt hot to the touch. 9/26/18: Follow up with patient. Her arm is still a little pink and tender, but much better. She only took 1 dose of ZYRTEC, but continued with icing the arm. Her Dr. found in her records that she actually had PNEUMOVAX 23 in 2006 and she had an injection site reaction at that time. The reaction was similar, but limited to the injection site. Patient reports being allergic to bees.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Reaction started in the car on the way home. Right arm felt hard and hurt. Redness and swelling appeared shortly there after. Swelling was from a few inches below the injection site to the mid forearm when I saw it on 9/21/18, patient reports that later that night it went all the way to her wrist. The arm was swollen, red, hot, and painful on the day of the vaccination. Patient also reported having a headache that evening. She doesn't normally get headaches. She put ice on it and took ADVIL. By the next day, still having discomfort and it was painful to the touch, but better. Swelling also subsided some. She went to her Dr. on the morning of 9-21-18 (this was the 1st time she had reported the reaction to anyone). He felt it was an allergic reaction and told her to take ZYRTEC and continue with icing the area and to see him again in a week if no improvement. After that she came to the pharmacy to report the reaction and to get the ZYRTEC. Arm still quite swollen from bicep to mid forearm. Still felt hot to the touch. 9/26/18: Follow up with patient. Her arm is still a little pink and tender, but much better. She only took 1 dose of ZYRTEC, but continued with icing the arm. Her Dr. found in her records that she actually had PNEUMOVAX 23 in 2006 and she had an injection site reaction at that time. The reaction was similar, but limited to the injection site. Patient reports being allergic to bees.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Rash erythematous, Swelling
Clinical narrative: Patient appears to have had a cellulitis type of reaction with red rash and swelling.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Vaccines were given in early afternoon. Redness and firmness began later that same day, and the following morning it was much more red and widespread to the Lt upper arm. Today 9/26/18 it was worse, warm to the touch indurated and tender. Had limited ability to fully abduct Lt. arm due to pain.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site warmth, Mobility decreased
Clinical narrative: Vaccines were given in early afternoon. Redness and firmness began later that same day, and the following morning it was much more red and widespread to the Lt upper arm. Today 9/26/18 it was worse, warm to the touch indurated and tender. Had limited ability to fully abduct Lt. arm due to pain.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin lesion
Clinical narrative: Left upper arm with area of erythema and swelling 7 x 3.5cm, warm to touch. Injection mark seen anterior to lesion.
Age: 79.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Swelling
Clinical narrative: Swelling 8x5cm.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Bone pain
Clinical narrative: Patient complains of pain in the bone and pain in knee joint.
Age: 3.0
Sex: F
Vaccine: BCG
Symptoms: Circumstance or information capable of leading to medication error, Injection site erythema, Injection site induration, Injection site inflammation, Injection site swelling
Clinical narrative: Injection given 8/23/18. Pt was uncooperative and was poked 2x. Vaccine was diluted with 2ml sterile water, then 0.3ml was administered percutaneously. Site was initially swollen and red, then improved. Around 9/10/18 site started getting red - increased over 1x, marginally increased 9/16/18-9/17/18. 4cm area of induration with 2.5cm X 2.7cm central area of inflammation with central area of ulceration 1cm X 1.3cm. No fever. Treatment- none, watch and wait, anticipated it will improve over the next couple months.
Age: 3.0
Sex: F
Vaccine: BCG
Symptoms: Injection site ulcer
Clinical narrative: Injection given 8/23/18. Pt was uncooperative and was poked 2x. Vaccine was diluted with 2ml sterile water, then 0.3ml was administered percutaneously. Site was initially swollen and red, then improved. Around 9/10/18 site started getting red - increased over 1x, marginally increased 9/16/18-9/17/18. 4cm area of induration with 2.5cm X 2.7cm central area of inflammation with central area of ulceration 1cm X 1.3cm. No fever. Treatment- none, watch and wait, anticipated it will improve over the next couple months.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Gait disturbance, Groin pain, Walking aid user
Clinical narrative: Approximately 10 minutes after receiving FLUAD, the patient stated she felt intense pain in her groin region and had difficulty walking. She was asked to sit down and stay sitting down to be monitored. She refused the offer to call an ambulance. After approximately 20 minutes, the patient stood up and walked a few feet with a cane. She then proceeded to walk to a bathroom several feet away. Upon returning, the patient stated that she was feeling better but had never felt as bad or as sharp of a pain ever before. She has no previous reactions to the same vaccination.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: Beginning on Tuesday 9/18 late afternoon I began to not feel well and was very tired and a little achy. Every day from Wednesday through Tuesday 9/25 I experienced chills all day and about 2-3 p.m. began feeling extremely achy, headaches and fatigue. Today, 9/26 is the first day that I have felt somewhat better and am not in pain from the aches. I have taken only ibuprofen to manage the symptoms and the dosage ranged from 400 mg to 800 mg.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Extreme body ache over entire body (even on bottom of feet), vomiting, shaking chills and fever of 102. It took three days to feel better and the fever to stop. I also noticed my vision was not as good as prior to the shot. I tire easily and get back pain.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Visual impairment, Vomiting
Clinical narrative: Extreme body ache over entire body (even on bottom of feet), vomiting, shaking chills and fever of 102. It took three days to feel better and the fever to stop. I also noticed my vision was not as good as prior to the shot. I tire easily and get back pain.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Got vaccine around noon on 9/19/18 and by the next morning (9/20/18) her arm and armpit area were very swollen, red, warm, and very itchy. She also reported a slight fever. Today is 1 week later and most symptoms have resolved, but the site is still very itchy.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Got vaccine around noon on 9/19/18 and by the next morning (9/20/18) her arm and armpit area were very swollen, red, warm, and very itchy. She also reported a slight fever. Today is 1 week later and most symptoms have resolved, but the site is still very itchy.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Joint range of motion decreased, Musculoskeletal stiffness, Swelling, Vascular injury
Clinical narrative: Patient reported bruising, muscle stiffness and swelling, loss of range of motion and that her doctor suspected a blood vessel was hit.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Inflammation, swelling around the injection site.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Peripheral swelling, Rash
Clinical narrative: Patient reported a rash on right side of face from the neck down to shoulder. Tricep and elbow swelling.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site vesicles
Clinical narrative: Patient reported day after vaccination of presentation of a blister around the injection site.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Hypoaesthesia, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Right after the pt was vaccinated he experienced itching at the site of injection. The night of when PNEUMOVAX was given his arm was painful and numbness and tingling in his fingers of left arm. The next day opposite side of the injection site was swollen red and warm to touch. Same night the pt started vomiting, and had diarrhea. Fever was under control with TYLENOL. The third morning his arm from shoulder to elbow was swollen and red, pt described it as "cartoon arm". Pt visited his PCP on third day. He is getting better from 4th day. I spoke to him on 5th day - redness has disappeared but his inside of the arm is still swollen. Pt has never had any rxn to other vaccines or meds. I had reported the same incident on Sunday 9/23/18 with limited info that I had.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Pain in extremity, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: Right after the pt was vaccinated he experienced itching at the site of injection. The night of when PNEUMOVAX was given his arm was painful and numbness and tingling in his fingers of left arm. The next day opposite side of the injection site was swollen red and warm to touch. Same night the pt started vomiting, and had diarrhea. Fever was under control with TYLENOL. The third morning his arm from shoulder to elbow was swollen and red, pt described it as "cartoon arm". Pt visited his PCP on third day. He is getting better from 4th day. I spoke to him on 5th day - redness has disappeared but his inside of the arm is still swollen. Pt has never had any rxn to other vaccines or meds. I had reported the same incident on Sunday 9/23/18 with limited info that I had.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal disorder, Nausea, Pain
Clinical narrative: Patient described pain, intense soreness, inability to use the arm, headache and nasuea for the first 36 hours after her second dose of SHINGRIX. The soreness persisted for approximately a week, although her other symptoms reportedly subsided after the initial 36 hours.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reported (seen visually) redness and swollen right arm from injection site to elbow. I reported to patient's provider. Provider ordered methylprednisolone dosepack and cephalexin.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: After explaining side effects, patient received 1st dose of SHINGRIX vaccine at approx. 2:15pm. She left shortly after and was told to call if she has a reaction other than sore arm/site redness. She returned approx. 2:32pm, stating that about 10 mins after the vaccine, her throat started to feel constricted (similar to her reaction to contrast dye in the past), but stated she didn't have trouble breathing or lightheadedness. She agreed to diphenhydramine and I gave her 50mg (20ml x 12.5mg/ml). After about 5 minutes I checked in with her and she stated that the constriction was not as severe and she could tell it was getting better at 2:41pm. I asked where she was at mentally as far as feeling comfortable leaving or wanting to stick around for a while longer; she said she was comfortable leaving and did so at 2:45pm. I called her physician's office and explained the situation with the nurse at 4:04pm.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Pain
Clinical narrative: Around 6pm of the day of vaccine, patient started having chills and body ache and was tired and felt weak and lasted for 3 days.
Age: 29.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Discomfort, Erythema, Flank pain, Injection site pain, Injection site swelling
Clinical narrative: Per client: "Two hours after the vaccine I started feeling pains in my arms the next day the pain continued also spreading to my sides and legs. The area where I got the shot was very swollen, hot to touch and very painful. The next day pain continued and area spreaded, Will be going to urgent care." This CHN observed erythema approx. 70mm x 70mm, warm to the touch. Client advised to seek medical attention, continue taking medication for discomfort (taking Ibuprofen) apply cool compress to area. Client states is going to urgent care.
Age: 29.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site warmth, Pain in extremity, Skin warm
Clinical narrative: Per client: "Two hours after the vaccine I started feeling pains in my arms the next day the pain continued also spreading to my sides and legs. The area where I got the shot was very swollen, hot to touch and very painful. The next day pain continued and area spreaded, Will be going to urgent care." This CHN observed erythema approx. 70mm x 70mm, warm to the touch. Client advised to seek medical attention, continue taking medication for discomfort (taking Ibuprofen) apply cool compress to area. Client states is going to urgent care.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pyrexia, Swelling
Clinical narrative: Patient came to the pharmacy on 09/25/2018 to receive PNEUMOVAX 23 as recommended by her primary care doctor. Patient received the vaccine at approximately 3:24pm in the afternoon and left ok. During the night, while at home she began to feel bad with muscle aches and fever. She followed up with her primary doctor the following morning on 09/26/2018. She was told by the doctor to get rest and take TYLENOL for fever/pain. Patient presented with a raised area on her left arm in the shape of a circle that was red and swollen.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed a red ring around left arm at level of injection. It was swollen and "hard as can be" pt began taking diphenhydramine 25mg every 4 hours and iced the injection site. She came in at 1140am on 9/26 and I directed her to take at least one more dose of diphenhydramine. Her arm no longer had the red ring and felt slightly warm to the touch.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Gait inability, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Patient stated she experienced chills and sweats the evening following vaccine administration. The following morning she began to feel numbness throughout her body. For most of 4 days the patient was unable to feel her legs and was completely unable to walk. As of 09/26/18 the patient said she had fully recovered. The patient refused medical attention and was adamant that her physician not be contacted.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Pt came in around 430PM on 9/26/2018 to show the pharmacist the reaction beyond his injection site. Area had involved most of bicep and interior of left arm above the elbow. No reaction below elbow, tricep or lower arm/hand. Area was extremely hot to the touch and mildly swollen. I asked pt to ice the area, elevate the arm take TYLENOL for the pain and take oral BENADRYL and apply a little topical BENADRYL GEL. I warned him to see MD immediately if hot red area spreads or lower arm/hand swells.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site pruritus, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Soreness and stiff at injection site. Could not lift up arm and some itching at the site.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injected limb mobility decreased, Myalgia, Nausea, Pain
Clinical narrative: Patient complained of muscle soreness and inability to move her left arm, with body aches. Patient took TYLENOL and symptoms have improved throughout the day, but still with muscle soreness at the moment and some nausea. She is calling the pharmacy back in the morning on 9/27/18.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Feeling abnormal, Pain in extremity, Pharyngeal oedema, Swollen tongue
Clinical narrative: Patient said received flu shot then had regular check up with doctor and 10 minutes later was done. When patient was ready to leave 15 minutes after the flu shot said felt funny. Then when she got home 30 minutes later could not breathe, tongue had swollen in back of throat. Called ambulance who administered IV BENADRYL then was taken to ER where she was told she had a mild reaction to the flu shot and administered an IV steroid. She was sent home 3 hours later with some ibuprofen. She has severe arm pain still and is afraid of taking any medication due to thinking her throat might close.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased, Chest X-ray normal, Crying, Decreased appetite, Dyspnoea
Clinical narrative: 103 degree temp taken rectally starting around 5 hours after vaccine was administered to present-2 days-11hours after vaccine. Congestion, loss of appetite, extreme fatigue, fussiness, restless sleep, crying out randomly, especially when asleep, difficulty breathing.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Influenza virus test negative, Irritability, Poor quality sleep, Respiratory tract congestion
Clinical narrative: 103 degree temp taken rectally starting around 5 hours after vaccine was administered to present-2 days-11hours after vaccine. Congestion, loss of appetite, extreme fatigue, fussiness, restless sleep, crying out randomly, especially when asleep, difficulty breathing.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Viral test positive
Clinical narrative: 103 degree temp taken rectally starting around 5 hours after vaccine was administered to present-2 days-11hours after vaccine. Congestion, loss of appetite, extreme fatigue, fussiness, restless sleep, crying out randomly, especially when asleep, difficulty breathing.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Headache
Clinical narrative: Per pt, complaint of headache and bone aches evening following 2nd dose of SHINGRIX. No issues first time. Symptoms have let up this morning but still there. Discuss common side effects to patient and that these were possible, except muscle pain vs bone ache. Recommended patient to use at home pain relievers and if doesn't let up/gets worse in next couple days please contact pharmacy again. Pharmacy will also followup in a couple days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Malaise, Pain
Clinical narrative: Next day after vaccine, patient said she felt really sick with flu like symptoms. She had chills and body aches that lasted 3 to 4 days.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Pain progressing from shoulder up through neck.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Swelling face
Clinical narrative: Patient had right side face swelling, from eye to top of lip. Stated shortness of breath.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Negativism, Psychomotor hyperactivity, Pyrexia, Sleep terror
Clinical narrative: Patient experienced 6 days of high fever (up to 103.4), vomiting x 2, night terrors for 2 weeks, and behavioral changes (very hyperactive with oppositional behavior).
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Patient experienced 6 days of high fever (up to 103.4), vomiting x 2, night terrors for 2 weeks, and behavioral changes (very hyperactive with oppositional behavior).
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Nerve conduction studies normal, Paraesthesia, Raynaud's phenomenon, Vasoconstriction
Clinical narrative: Approximately one week after having the vaccine in my right arm, I developed parasthesia in my right hand. It was later diagnosed as Raynaud's Syndrome. Prior to the vaccine, I had no history of Raynaud's in that hand. My left hand/arm were unaffected. I continue to have parasthesia, numbness and significant blood vessel constriction on a daily basis in my right hand.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache, body aches, stomachache, fever (99.7-100.8, chills).
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain, Neck pain, Odynophagia
Clinical narrative: Patient experienced soreness in left arm; soreness in injection site went away, but general shoulder pain persisted and got worse; pain is spreading to neck; patient has difficulty turning neck; swallowing is sometime uncomfortable; patient has seen PCP who has recommended physical therapy; patient is trying Bengay, hot showers and heating pads.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient experienced soreness in left arm; soreness in injection site went away, but general shoulder pain persisted and got worse; pain is spreading to neck; patient has difficulty turning neck; swallowing is sometime uncomfortable; patient has seen PCP who has recommended physical therapy; patient is trying Bengay, hot showers and heating pads.
Age: 0.33
Sex: F
Vaccine: DTAP, HEP, PNC13
Symptoms: Decreased appetite, Rash generalised, Somnolence
Clinical narrative: Day after receiving her vaccinations patient became very sleepy and has not been wanting to eat. Then today 9/26/2018 at 11 am she developed a rash all over her body that still hasn't went away and it is now 11pm. Nothing in our household has changed (no new soaps or anything).
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Pain, Peripheral swelling, Skin warm
Clinical narrative: Patient returned to the pharmacy today with a sore right arm where he got the PNEUMOVAX vaccine. His arm is noticeably swollen, red and warm to the touch. The patient reported he has pain when he tries to raise his arm above shoulder level. I recommended oral BENADRYL, TYLENOL, and to apply an ice pack. If it isn't improving by Friday to contact his physician.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, HEPA
Symptoms: Gait disturbance, Injection site mass, Pain in extremity
Clinical narrative: Mom states she noticed a red lump on childs Rt thigh the size of a baseball on the morning of 9/21/18. Leg sore, child limping. Child recovered without incidence.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Patient came in with his entire upper left arm red and warm to the touch, the redness was complete wrapped under his arm. Patient had no difficulty in breathing. I suggested BENADRYL and if no relief by Thursday to make appt with his physician and to call me on Thursday to let me know how is was doing.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chest discomfort, Pyrexia, Tremor
Clinical narrative: Fever and tremor, chest tightness, abdominal discomfort.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Muscle spasms, Pain, Pain in jaw
Clinical narrative: Pt with large amount of redness and swelling at and distal to injection site. Muscle spasm and pain in entire body prompting ER visit. Jaw pain, mouth sores.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Stomatitis
Clinical narrative: Pt with large amount of redness and swelling at and distal to injection site. Muscle spasm and pain in entire body prompting ER visit. Jaw pain, mouth sores.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient came in with her entire upper left arm red and warm to the touch, the redness was complete wrapped under her arm and down by her elbow. Patient had no difficulty breathing. I suggested BENADRYL and if no relief by Thursday to make appt with her physician and let me know. Her husband had the same reaction.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Severe headaches at night since administration of second dose.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Fatigue, Feeling hot, Flushing, Pyrexia
Clinical narrative: About 1 minute after receiving 2nd vaccine, PREVNAR-13 patient sat down in waiting room chair and said she felt hot. I went out to observe her and could see a flushing on her neck and chest. She said her left ear felt hot. I had her sit behind privacy screen and went to pharmacy to call 911. Tech made call and I brought emergency bag to patient. I observed pt. for worsening symptoms, asked pt. if any throat, lip involvement. Patient had one year old child with her. We talked about her family while I was observing her. EMS arrived and took over medical care. They talked to and examined patient. They said they could take her to hospital. She declined. They advised 25 mg diphenhydramine. She took that and left. EMS told her to call them if anything got worse as it could get worse for about 8 hours. I called and spoke to patient at 8 PM. She said she felt tired, light-headed and had approximately 100 degree fever, but was giving kids a bath.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain
Clinical narrative: Pt arm became painful and red at injection site. Joint pain as well.
Age: 71.0
Sex: U
Vaccine: FLU3
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, chills, aches, nausea, vomiting symptoms started evening of the day of shot. Nausea/vomiting 9/26/18 morning after shot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Redness measured 2.5 in x 2 in diameter around injection site. No pain. Hard to touch and warm. Site swollen. No fever. Symptoms started last night. Blistered and raised at site.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU4, HEP, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Got vaccines last Thursday 9/20/18 and now has lump on left upper thigh that is warm to the touch and red. Cephalexin 250/5 ml 2.75 ml PO BID, 10 days for cellulitis.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Immediate post-injection reaction, Peripheral swelling, Skin discolouration
Clinical narrative: Patient received PREVENAR 13 shot on 9-22-18. On the next day she returned with a noticeably swollen arm. She says that she had an immediate reaction to the shot. Re: right arm. Her arm has shades of red and blue.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Disturbance in attention, Headache, Nausea, Peripheral swelling, Pruritus
Clinical narrative: Feelings of Nausea, headache, restlessness, unable to concentrate, skin rash, swelling down arm, itchiness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Restlessness
Clinical narrative: Feelings of Nausea, headache, restlessness, unable to concentrate, skin rash, swelling down arm, itchiness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Dizziness, Syncope, Visual impairment
Clinical narrative: Pt. started experiencing side effects on Saturday (lightheaded per her description her vision was white). Sunday morning, in church around 9 AM, pt. fainted and leaned her head on the person sitting next to her in church for couple of seconds then restored consciousness, walked out of church by herself. There was a PA sitting in front of her who asked her questions to answer, then her BP was taken and was normal.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Healthcare professional verified active Chickenpox started breaking out 6 days after vaccination.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Raised band around arm, warm and itchy, presenting 2 days after injection. Instructed to contact PCP and report back to us.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Erythema multiforme, Skin lesion
Clinical narrative: Patient presented 36-48 hrs after 4 month immunizations with raised, erythematous, target like lesions, likely resembling erythema multiforme. There were no other illness symptoms, fevers, or other new exposures.
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Eye swelling, Rash, Swelling face
Clinical narrative: Child received MMR on 01/13/18 and family was flying overseas in a few hours. But just before flying, baby ate slightly cooked egg and baby had swelling of eyes and face and rash. Flight cancelled. BENADRYL given - improved in 1 hour.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Ultrasound Doppler
Clinical narrative: Patients arm was red, painful and swollen. We treated her for cellulitis of left upper extremity. She was started on cephalexin 500mg capsule and was sent for a ultrasound of her arm to rule out blood clots in arm.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Pt presented with redness and urticaria approximately 4cm from injection site of MMR on (R) thigh and varicella on (L) thigh. (no reaction around) gave BENADRYL and applied cold pack (flu shot). Improved w/in 20 minutes.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received the QUADRACEL in (L) arm 12:20pm. Mom noticed redness from his shoulder to his elbow. On 9/26/18 mom noticed severe swelling from shoulder to elbow - his lightweight cotton short sleeve is tight on that arm. Area is hot, hard, painful.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Flatulence, Headache, Myalgia, Nausea
Clinical narrative: Diarrhea, blister at the injection site, severe shoulder pain, headache, swelling at the site, shivering, fever, stomach pain, severe soreness in arm, severe muscle soreness, tiredness.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Rash
Clinical narrative: Diarrhea, blister at the injection site, severe shoulder pain, headache, swelling at the site, shivering, fever, stomach pain, severe soreness in arm, severe muscle soreness, tiredness.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site vesicles
Clinical narrative: Diarrhea, blister at the injection site, severe shoulder pain, headache, swelling at the site, shivering, fever, stomach pain, severe soreness in arm, severe muscle soreness, tiredness.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Diarrhea, blister at the injection site, severe shoulder pain, headache, swelling at the site, shivering, fever, stomach pain, severe soreness in arm, severe muscle soreness, tiredness.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Diarrhea, blister at the injection site, severe shoulder pain, headache, swelling at the site, shivering, fever, stomach pain, severe soreness in arm, severe muscle soreness, tiredness.