chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus, Pyrexia, Tenderness
Clinical narrative: MY ARM STARTED SWELLING, TURNED RED, ITCHED, AND WAS TENDER TO TOUCH. I ALSO HAD A LOW GRADE FEVER. I WENT TO APRN AND SHE MEASURED THE SWELLING AND I HAVE TAKEN PICTURES AND MEASURED ALMOST EVERYDAY SINCE THE VACCINATION.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: About 90 minutes after administration of flu vaccine, patient developed hives.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: Facial swelling, hives, rash, urticarial.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash pustular
Clinical narrative: PATIENT DEVELOPED WHAT LOOKS LIKE FIRE ANT BITES ON BOTH ARMS. INTENSE ITCHING. SEEN AT CONVENIENT CARE ON 10-13-17. GIVEN BACTRIM DS, MEDROL DOSEPAK, HYDROCORTISONE 1% CREAM.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash macular, Swelling
Clinical narrative: Area observed approximately 7 cm below injection site reddened, macular rash, puffy not hard or painful to touch. Area 9x 9.5 cm in size. Denies fever or other s/s.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever ranging from 100 to 103, chills, muscle aches for four days. Took ibuprofen. Did not see physician. Staring to feel better today (afternoon of fourth day) but still has temperature.
Age: 82.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Hypoaesthesia, Muscle twitching
Clinical narrative: On Oct 12 (5-6pm) left arm started twitching and numbness; especially on the hand/fingertips. Will follow-up with neurologist on 10/16. Today, symptoms are about the same and no other symptoms.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Red swollen rash 3" by 3" in size under the shot area. Went to my doctors and was diagnosed with Cellulitis. Now on antibiotics and Benadryl.
Age: 20.0
Sex: M
Vaccine: HEPA, HPV9, PNC13
Symptoms: Immunisation, Underdose
Clinical narrative: Pediatric dose given and should have been Adult dose. Client notified before left office and a second pediatric dose was given per recommendations.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Myalgia, Pyrexia, Tremor
Clinical narrative: Vaccine given: 10/9/17 6:30pm - PT fine at time of vaccination. Next day patient had to ice site of PNEUMOVAX 23 injection on left arm. Patient stated she needed to be wheeled out of work to her car. Was shaking, week, heart rate of 109, fever of 101, experiencing muscle pain and weakness x 3 days. Reached out today 10/13 to patent no response as to resolution of symptoms.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Pain, Swelling
Clinical narrative: Patient presented with 4 inch (approximate) wide red/bluish bruise area. She also reported a small bump on arm and arm being sore after immunization.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's arm was red and swollen from the injection site down toward her elbow.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: One week after vaccination, reported right arm and right scapular weakness, numbness, tingling and pain.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site streaking
Clinical narrative: Redness to site reaction leading to red streaks for 1 week. Site reaction had resolved by 10/13/17 when personally got to see it.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Rash pruritic
Clinical narrative: Pt. developed an itchy rash with bumps on her back left arm left leg and abdomen. Pt. was advised to take Zyrtec allergy medication and to call if symptoms got worse.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Patient received the two immunizations listed above on 10/2/2017, in the left arm separated roughly 2 inches apart. Patient woke up the following morning with a 103 degree fever and hive like reaction on his left arm. Patient went to the hospital for medical attention on 10/3/2017. After several days, his fever finally broke and the swelling and redness on his arm began to subside. Patient's wife then came in to the pharmacy on 10/13/2017 to describe his reactions.
Age: 37.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Patient received both vaccines around 4pm, she reports that she started feeling nausea around 7pm and began around 9pm which continued until 3am. She took a zofran and the nausea/vomiting resolved.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Aspiration, Chills, Eructation, Headache, Malaise
Clinical narrative: THE REACTION STARTED ON 09/20/17 FOR THE PATIENT. HER STATEMENT WAS THE FOLLOWING:  "I WAS DEATHLY SICK AND HAD PAIN IN MY LEFT ARM FOR ABOUT 48 HOURS (STARTING THE EVENING OF THE DAY I GOT THE VACCINATIONS). I HAD TERRIBLE CHILLS, FEVER, RUNNY NOSE, ASPIRATIONS IN MY LUNGS, A POUNDING HEADACHE AND i KEPT BURPING UP BILE.  MY LEFT ARM WAS SO SORE THAT I COULDN'T USE IT OR EVEN  TOUCH IT. MY TOTAL BODY WAS IN SHOCK...IT WAS BAD..."
Age: 54.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Mobility decreased, Pain in extremity, Pyrexia, Rhinorrhoea, Tenderness
Clinical narrative: THE REACTION STARTED ON 09/20/17 FOR THE PATIENT. HER STATEMENT WAS THE FOLLOWING:  "I WAS DEATHLY SICK AND HAD PAIN IN MY LEFT ARM FOR ABOUT 48 HOURS (STARTING THE EVENING OF THE DAY I GOT THE VACCINATIONS). I HAD TERRIBLE CHILLS, FEVER, RUNNY NOSE, ASPIRATIONS IN MY LUNGS, A POUNDING HEADACHE AND i KEPT BURPING UP BILE.  MY LEFT ARM WAS SO SORE THAT I COULDN'T USE IT OR EVEN  TOUCH IT. MY TOTAL BODY WAS IN SHOCK...IT WAS BAD..."
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site reaction, Pain in extremity, Rash macular, Skin warm
Clinical narrative: Left arm became very sore, and hot. It was red and blotchy for several inches by the injection site of the flu shot. She said she never felt that bad after a shot before.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: One week after the shot, hives on back, chest, stomach, upper legs, neck.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness and pain below and at site of injection.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pruritus
Clinical narrative: Patient had redness and swelling in left arm that extended all the way around and went from elbow to shoulder. Patient took TYLENOL and BENADRYL which helped the itching. Patient also reported feeling nausea but wasn't sure if it was from the immunization. Patient to follow up with Dr and monitor for worsening of symptoms.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on upper arms and thighs.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Per patient, her left arm from her shoulder to about 5 inches below shoulder is hot, red, and has a burning feeling. She is not reporting any signs of anaphylaxis (trouble breathing, wheezing, swelling of tongue/lips). She reports having prior flu vaccinations without complications. I referred her to her physician for further evaluation.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Per employee email: I want to let you know that I believe I had an adverse reaction to the flu shot I received Wednesday evening. Within a few hours of the vaccine, I felt nauseous and vomited. I tried to work the next day, but had to leave work due to vomiting. I also had a low grade fever. I have never had an adverse reaction to the flu shot, and have gotten one every year for 20-30 years. I am not sure what happened and what I should do next year. I was fine by Friday evening. I wonder if having the surgery on my pancreas has anything to do with how I responded.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Patient developed a red, hot rash from immunization. Patient was instructed to take BENADRYL.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Patient got a red rash from immunization beginning the day after he received the immunization. Was instructed to take BENADRYL.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Dizziness, Electrocardiogram, Flushing, Headache
Clinical narrative: 10/10/17: At approximately 1030, I was informed by MA, that the patient was experiencing nausea and dizziness post HBIG and Hb immunization. The patient was sitting on the edge of the chair, leaning forward, and appearing visibly distressed. She was flushed, had an ice pack on her neck and was holding an emesis bag and spitting clear sputum into it. Pt stated that she has had similar reactions, like this one, after getting the FLU shot, but did not experience a reaction to this years flu shot. Pt BP was 170/90 and temperature 96.7. As I was talking to the pt, she started to have c/o a HA. Encouraged pt to take slow breaths and got her a cup of water, encouraging her to take small sips. I asked patient what has helped her getting over this feeling, in the past, and she said stated "time" and agreed that lying down might help. MA and I talked and agreed that when a room opened up that patient could go and lie down. At approximately 1045, I observed MA helping patient into room 4. I suggested we raise the head of the bed slightly. Patient said her headache was getting worse and we asked her if there was anything else we could get her. She said another ice pack would help, so MA grabbed one for her forehead and the other one was placed behind her neck. Pt had her emesis bag and tissues nearby. The lights were shut off and the door was closed over and left cracked open. I encouraged her to relax and take slow breaths. Around 1055, 2 MA's came and told me that patient was looking for me. I entered room 4 and observed the patient sitting on the edge of the table, leaning over and spitting into her emesis bag, with increased facial flushing. Patient reported having chest pain and that her headache was worse. Vitals checked: BP 172/100, P 98, RR 24, Sp02 99% on RA. Pulse oximeter was left on the patient to monitor her. Pt described central chest pain, just below her clavicle, but denied SOB or difficulty breathing. I informed MA that patient needed to go to the ER and to call 911. I stayed with patient and tried to calm her down. Around 11:03, MA walked in with a 81mg baby ASA and informed me that he was instructed to have the patient chew it and to not have anything else to eat or drink. He stated that EMS should arrive shortly. I gave patient the ASA and she chewed and swallowed it. Within a few minutes, EMS arrived and entered the room. They performed an EKG, started an IV, gave the patient 243mg of 81mg ASA (for a total of 324mg) and gave her SL Nitro. They then, assisted the patient onto the gurney and took her to hospital in stable condition. Last BP prior to leaving was 170/93, P 100. After EMS left, I called report to Dr. in the ER and completed the Transfer document; handing it to MA to fax over to the ER staff.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: 10/10/17: At approximately 1030, I was informed by MA, that the patient was experiencing nausea and dizziness post HBIG and Hb immunization. The patient was sitting on the edge of the chair, leaning forward, and appearing visibly distressed. She was flushed, had an ice pack on her neck and was holding an emesis bag and spitting clear sputum into it. Pt stated that she has had similar reactions, like this one, after getting the FLU shot, but did not experience a reaction to this years flu shot. Pt BP was 170/90 and temperature 96.7. As I was talking to the pt, she started to have c/o a HA. Encouraged pt to take slow breaths and got her a cup of water, encouraging her to take small sips. I asked patient what has helped her getting over this feeling, in the past, and she said stated "time" and agreed that lying down might help. MA and I talked and agreed that when a room opened up that patient could go and lie down. At approximately 1045, I observed MA helping patient into room 4. I suggested we raise the head of the bed slightly. Patient said her headache was getting worse and we asked her if there was anything else we could get her. She said another ice pack would help, so MA grabbed one for her forehead and the other one was placed behind her neck. Pt had her emesis bag and tissues nearby. The lights were shut off and the door was closed over and left cracked open. I encouraged her to relax and take slow breaths. Around 1055, 2 MA's came and told me that patient was looking for me. I entered room 4 and observed the patient sitting on the edge of the table, leaning over and spitting into her emesis bag, with increased facial flushing. Patient reported having chest pain and that her headache was worse. Vitals checked: BP 172/100, P 98, RR 24, Sp02 99% on RA. Pulse oximeter was left on the patient to monitor her. Pt described central chest pain, just below her clavicle, but denied SOB or difficulty breathing. I informed MA that patient needed to go to the ER and to call 911. I stayed with patient and tried to calm her down. Around 11:03, MA walked in with a 81mg baby ASA and informed me that he was instructed to have the patient chew it and to not have anything else to eat or drink. He stated that EMS should arrive shortly. I gave patient the ASA and she chewed and swallowed it. Within a few minutes, EMS arrived and entered the room. They performed an EKG, started an IV, gave the patient 243mg of 81mg ASA (for a total of 324mg) and gave her SL Nitro. They then, assisted the patient onto the gurney and took her to hospital in stable condition. Last BP prior to leaving was 170/93, P 100. After EMS left, I called report to Dr. in the ER and completed the Transfer document; handing it to MA to fax over to the ER staff.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Fatigue, Hypersomnia, Myalgia
Clinical narrative: Patient described significant bone and muscle pain as well as extreme fatigue causing her to sleep for 2 days. This began approximately 4 to 5 hr after the vaccine was administered. The patient reported this several days later. Symptoms had resolved by that time and no treatment recommendations were offered.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swollen, hardened, reddened area approx 3 inches around site the day after injection (Oct 11th). On October 12th, area still hardened, less swollen, but temp of 101.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram head normal, Eye pain, Facial paralysis, Headache
Clinical narrative: Vaccinated as part of Employee Health Vaccination Clinic 10/19/16. No previous history of reactions to flu vaccine reported. No contraindications upon screening. Had severe weakness, right sided facial numbness, blurred vision, headache and right eye ache on 10/28/16. Sought treatment in ED. Dx Bell's Palsy.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Vision blurred
Clinical narrative: Vaccinated as part of Employee Health Vaccination Clinic 10/19/16. No previous history of reactions to flu vaccine reported. No contraindications upon screening. Had severe weakness, right sided facial numbness, blurred vision, headache and right eye ache on 10/28/16. Sought treatment in ED. Dx Bell's Palsy.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Consistent Pain in arm, shoulder and neck 24 hours later- still going on.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection in lower arm on Oct 10th. On Oct. 12th in the evening, right arm brightly reddened approx 1 inch around injection site. Warm. Borders of redness marked. Next day (Oct 13th) redness noted beyond where borders were marked the night before, but the color of redness was less.
Age: 1.25
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood culture, Blood lactate dehydrogenase, Blood uric acid, C-reactive protein, Culture urine
Clinical narrative: Brief episode of trembling and staring off.
Age: 1.25
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Full blood count, Influenza A virus test, Influenza B virus test, Metabolic function test, Respiratory viral panel
Clinical narrative: Brief episode of trembling and staring off.
Age: 1.25
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Staring, Tremor, Urine analysis
Clinical narrative: Brief episode of trembling and staring off.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: C-reactive protein, Full blood count, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Fever, pain and swelling at injection site. Red, and warm to touch. Intermittent nausea. Clinician ordered treatment of Keflex and prednisone course of medication and Zofran to manage symptoms of nausea.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Nausea, Pyrexia, White blood cell count
Clinical narrative: Fever, pain and swelling at injection site. Red, and warm to touch. Intermittent nausea. Clinician ordered treatment of Keflex and prednisone course of medication and Zofran to manage symptoms of nausea.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Feeling abnormal, Seizure
Clinical narrative: Patient reported that around 6:30 of the day she received her flu shot, she experienced what she explained as convulsions. She also described them as thrashing movements. Then from about 7:00-10:00 she "didn't feel like herself." By 10:00 PM she felt completely fine and hasn't had any issues since.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Aunt called clinic today; stated that child's arm had swollen to "3x the normal size" from the shoulder to the elbow. Arm is red, hot and hard to the touch.
Age: 1.42
Sex: F
Vaccine: FLUA3, HIBV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives came up on the kid's face, 23 hours after multiple vaccines that were given. Called the doctor's office they suggested me to give my kid Benadryl.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Headache, Hypersensitivity, Lacrimation increased, Medical device pain
Clinical narrative: Allergic reaction: pt states that since getting the pneumococcal vaccine in July, she has experienced a number of problems. She lost all her fingernails. She has burning in her fingertips, Left arm pain, watery eyes, headaches, throat feels swollen and raw. She also cannot tolerate her partial as well and had some sores in her mouth. Skin eruptions.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Onychomadesis, Pain in extremity, Pharyngeal oedema, Rash, Stomatitis
Clinical narrative: Allergic reaction: pt states that since getting the pneumococcal vaccine in July, she has experienced a number of problems. She lost all her fingernails. She has burning in her fingertips, Left arm pain, watery eyes, headaches, throat feels swollen and raw. She also cannot tolerate her partial as well and had some sores in her mouth. Skin eruptions.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Throat irritation
Clinical narrative: Allergic reaction: pt states that since getting the pneumococcal vaccine in July, she has experienced a number of problems. She lost all her fingernails. She has burning in her fingertips, Left arm pain, watery eyes, headaches, throat feels swollen and raw. She also cannot tolerate her partial as well and had some sores in her mouth. Skin eruptions.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PAIN, REDNESS, SWELLING, HOT TO TOUCH AT INJECTION SITE.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Next morning after shot fever (100.2), headache, achy.
Age: 74.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: Possible cellulitis per Dr. gave patient amoxicillin 500mg 3 times daily for 7 days.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The same afternoon of the shot her arm started turning red and warm with a raised bump on it at injection site. It has been 2 days and still having redness and itching with warmth. I told her to ice it and use BENADRYL cream or BENADRYL capsules. When I called her back later on in the afternoon she had used both and has went down a little. If still bad Saturday will go to the doctor to have it checked.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Right arm induration, pain, tenderness, increased warmth, and erythema. Rash at site and wrapped around right deltoid. Better today, erythema and warmth down towards right elbow now and right forearm tingles.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Paraesthesia, Skin warm, Tenderness
Clinical narrative: Right arm induration, pain, tenderness, increased warmth, and erythema. Rash at site and wrapped around right deltoid. Better today, erythema and warmth down towards right elbow now and right forearm tingles.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: The patient passed out approximately 5 min after receiving shot - no injuries reported from patient.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Raised welts which looked like tiger stripes from her hand going up her neck on her left arm. This also radiated across her chest and into her arm pit. She denies difficulty breathing or SOB. She did state she was very itchy. Medical director for the center came back and was able to evaluate what was going on. She was given 10mg oral Claritin and the symptoms resolved within 30 -45 minutes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Basophil percentage decreased, Eosinophil percentage increased, Haematocrit normal, Haemoglobin normal, Joint swelling
Clinical narrative: Swelling near injection site and swelling of right knee. Right knee tender to palpation. Painful to ambulate.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased, Monocyte percentage
Clinical narrative: Swelling near injection site and swelling of right knee. Right knee tender to palpation. Painful to ambulate.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Neutrophil percentage, Pain, Red blood cell count normal, Red cell distribution width normal, Swelling
Clinical narrative: Swelling near injection site and swelling of right knee. Right knee tender to palpation. Painful to ambulate.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Tenderness, White blood cell count increased
Clinical narrative: Swelling near injection site and swelling of right knee. Right knee tender to palpation. Painful to ambulate.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swollen, redness, warm to touch on backside of arm. Started 10/13/17 approximately 2 days after receiving vaccine.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Patient reported nausea, vomiting, and abdominal cramps one day after the vaccination. He went to a doctor. Patient reports that the doctor did not treat his cramping. Two days after the vaccination, patient came into the pharmacy reporting symptoms were much better, but he still reported small amounts of abdominal cramping.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Malaise, Pain, Peripheral swelling
Clinical narrative: Arm began to swell about 30 minutes after injection. Patient says whole body began to ache and she became very sick over the next several days. She called her Dr. who told her to put ice pack over the area. Patient stated could not put ice over her entire body. Asked us to add pneumonia vaccine allergy to her record which we did.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had redness, and swelling in the arm below the injection site. She also had pain in the arm that was injected that began the evening after the injections. The next day the pharmacist advised her to take TYLENOL for the pain and BENADRYL for the reaction. The patient also used ice. The patient went to the doctor two days after the injection and was told to switch to heat on the area. The doctor also prescribed an antibiotic and steroid cream for the patient to use if she felt it was needed. The patient declined the prescriptions.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Pt reported itchy red bumps covering entire body head to toe which started late Saturday 10/7/17 and fully developed on Sunday 10/8/2017. Pt  got medical attention on Monday 10/9/2017 - received steroid shot. Got better but still has some redness at the time of encounter on 10/13/2017.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient stated that she had pain in the arm, and in progressed to the point that should could not lift or move. It went away and then came back 5 days later. She then went to and urgent care and was given anti-inflammatory and told to ice the arm.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT'S LEFT ARM GOT VERY SWOLLEN AND PAINFUL AND SHE WAS UNABLE TO MOVE IT UPON WAKING THE DAY AFTER INJECTION WAS GIVEN.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt has a red swollen left arm. Red from injection site down to the inside elbow. There is swelling from bicep down to elbow with a red line at the edge of the swelling.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Asthenia, Dyspnoea, Injection site erythema, Injection site rash
Clinical narrative: Within 6-8 hours of receiving vaccines, patient experienced difficulty breathing and shaking (lasted 10-12 hours after onset); raised, red rash that extended down to elbow from vaccine site (rash gone in 4 days, swelling/raised gone in 5 days from onset); sore joints and extreme stiffness - debilitating, could not get out of bed for a few days (patient is still sore as of 10/13/13 but is mobile). Patient called physician and took NSAIDs to relieve stiffness. Breathing difficulty subsided and physician did not feel therapy was necessary. No antivirals were taken and no hospitalization occurred.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Joint stiffness, Mobility decreased, Tremor
Clinical narrative: Within 6-8 hours of receiving vaccines, patient experienced difficulty breathing and shaking (lasted 10-12 hours after onset); raised, red rash that extended down to elbow from vaccine site (rash gone in 4 days, swelling/raised gone in 5 days from onset); sore joints and extreme stiffness - debilitating, could not get out of bed for a few days (patient is still sore as of 10/13/13 but is mobile). Patient called physician and took NSAIDs to relieve stiffness. Breathing difficulty subsided and physician did not feel therapy was necessary. No antivirals were taken and no hospitalization occurred.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Aching pain at injection site (Left Arm).
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Haemorrhage, Headache, Hypersensitivity, Laceration
Clinical narrative: Per patient, after vaccine was given returned to school. States he was not feeling well after the vaccine. Felt nauseous and had a headache. Returned home and while eating dinner, got up to cut a lemon when he felt like he was going to faint and cut his index fever. Finger started to bleed when he felt "he went somewhere else" and passed out. Next woke up on the ground in his Mom's arms. Was aware of surroundings per patient. Got up to sit in a chair where he passed out again. Ambulance was called and taken to the Emergency Room. Noted to have "allergic" reaction vs. seizure and advised to followup.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Loss of consciousness, Malaise, Nausea, Seizure
Clinical narrative: Per patient, after vaccine was given returned to school. States he was not feeling well after the vaccine. Felt nauseous and had a headache. Returned home and while eating dinner, got up to cut a lemon when he felt like he was going to faint and cut his index fever. Finger started to bleed when he felt "he went somewhere else" and passed out. Next woke up on the ground in his Mom's arms. Was aware of surroundings per patient. Got up to sit in a chair where he passed out again. Ambulance was called and taken to the Emergency Room. Noted to have "allergic" reaction vs. seizure and advised to followup.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient reports that arm is red and swollen, warm to the touch. She stated that the redness is nearly all the way around her arm including the inside. She received a PNEUMOVAX shot in the opposite arm at the same time and that arm is fine and showing no symptoms.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Full blood count normal, Joint swelling, Malaise, Rash
Clinical narrative: This patient experienced rash on the arms and back 7 hours after the injection. He also experienced general malaise at first which progressed to severe arthralgia and swelling of the joints within 3 days.
Age: 6.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction. Patient was given a PROQUAD and a Varicella today.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Haematoma
Clinical narrative: Patient developed a large bruise (hematoma) that diminished over time and was not painful.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Vaccines administered on 10/9- pt states on 10/10, her arm began showing signs of redness, swelling, and tender to touch. I observed pt on 10/13 and effects were still present. Pt received rx for BACTRIM DS 1 po bid on 10/11 and KEFLEX 500 po q8h on 10/13.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Patient was observed for about 20 min after the vaccine. She reported no issues. The next day she experienced Nausea and Chills which subsided in 24 hours. She came into the Pharmacy the following day and was feeling much better however her left forearm has some swelling and pain. The site where she was vaccinated seemed fine. She indicated that she would go to the Drs office if she felt the need.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient experience fever along with redness and swelling at site of injections.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: PATIENT COMPLAINS OF SEVERE SHOULDER PAIN AND INABILITY TO LIFT ARM. PATIENT EXPRESSED THAT SHOULDER PAIN INTENSITY INCREASES AT NIGHT. PATIENT DENIED ANY SWELLING, PAIN OR REDNESS IN THE AREA OF VACCINE ADMINISTRATION.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Immediate post-injection reaction, Mass
Clinical narrative: Arm began itching immediately after injection, big lump and hurt. Pharmacist said to take BENADRYL. The face and neck developed raw round blistery spots that oozed, hurt and burned.  They then began to crust over. Dermatologist didn't biopsy because none were still oozing but said it was definitely shingles. Some are still hurting and burning.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Scab, Secretion discharge, Skin erosion
Clinical narrative: Arm began itching immediately after injection, big lump and hurt. Pharmacist said to take BENADRYL. The face and neck developed raw round blistery spots that oozed, hurt and burned.  They then began to crust over. Dermatologist didn't biopsy because none were still oozing but said it was definitely shingles. Some are still hurting and burning.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Injection site erythema, Injection site warmth
Clinical narrative: Red, round circle, warm to touch, ~4in around injection site, with flushed cheeks. No fever. Taking BENADRYL and PEPCID for the reaction.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia, Mobility decreased, Pain
Clinical narrative: Patient in pain, cannot sleep and move arm.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Injection site erythema, Injection site pain
Clinical narrative: PATIENT RECIEVED FLU SHOT ON 10/10/17 AND STARTED EXPERIENCING REDNESS, SORNESS AND PAIN TENDER TO TOUCH ON THE LOWER PORTION OF HER UPPER ARM. THE PAIN, SORENESS, AND REDNESS WORSENED AND RADIATED TO LOWER PORTION OF RIGHT ARM WHICH SPANNED FROM RADIUS TO ULNAR BONE. PATIENT REPORTED SX TO PHARMACIST ON DUTY AND WAS ADVISED TO GO TO URGENT CARE. PATIENT WENT TO URGENT CARE AND WAS ADVISED TO GO TO ER.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PT HAD GOTTEN A RED HOT PUFFY AREA NEAR INJECTION SITE THAT DISSEMINATED AROUND AND BELOW INJECTION SITE THE UNDER SIDE OF THE UPPER ARM.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity, Tendon disorder
Clinical narrative: ABOUT 4 HOURS AFTER GETTING THE VACCINE, HER ARM STARTED HURTING REALLY BAD AND SHE SAID SHE COULDN'T MOVE IT. HER HUSBAND HELPED HER MOVE IT AROUND AND SHE SAID IT STILL HURT, BUT HAD LOOSENED UP A LITTLE. SHE WENT AND LAID DOWN. AFTER 1 HOUR, SHE STATED THAT SHE "COULDN'T FEEL HER ARM AT ALL." SHE WENT TO THE ER AND WAS TOLD THAT IT "WAS A PROBLEM WITH THE TENDON, AND LIKELY DUE TO THE PNEUMOVAX VACCINE." I'M NOT SURE WHAT THEY TREATED HER WITH IN THE ER, BUT SHE DID REGAIN FEELING IN HER ARM, BUT STILL STATES THAT HER ARM IS "VERY SORE."
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: THE ZOSTAVAX SITE WAS RED, HOT, AND HARD IN AN AREA THE SIZE OF A SOFTBALL ABOVE HER RIGHT ELBOW. PATIENT WANTED TO RETURN TO WORK, SO WE GAVE HER 2-25MG DIPHENHYDRAMINE TABLETS AND INSTRUCTED HER TO TAKE 2 MORE IN 4 HOURS. I MARKED THE AREA IN RED MARKER AND INSTRUCTED PATIENT TO GO TO THE ER OR URGENT CARE IF IT GROWS AN INCH FURTHER THAN THE MARKS AFTER TAKING THE BENADRYL. UNCLEAR IF THIS IS AN ADVERSE REACTION OR ALLERGY AT THIS POINT.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Body temperature decreased, Headache, Hypoaesthesia, Nausea, Pallor
Clinical narrative: About an hour after receiving injection he started having a severe headache, nausea, numbness in arms and legs. He was pale, his temperature at 3:00 was 95.1 oral. He began vomiting about 5 hours after injection and continued with the headache throughout the night. We gave him Vitamin C 2000mg, Magnesium and Omega 3 at 8:00pm that night and again at 7:00am on 10/13/17.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Vomiting
Clinical narrative: About an hour after receiving injection he started having a severe headache, nausea, numbness in arms and legs. He was pale, his temperature at 3:00 was 95.1 oral. He began vomiting about 5 hours after injection and continued with the headache throughout the night. We gave him Vitamin C 2000mg, Magnesium and Omega 3 at 8:00pm that night and again at 7:00am on 10/13/17.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Headache, Nausea, Paraesthesia, Vision blurred, Vomiting
Clinical narrative: About an hour after receiving injection he started having a severe headache, nausea, numbness in arms and legs. He was pale, his temperature at 3:00 was 95.1 oral. He began vomiting about 5 hours after injection and continued with the headache throughout the night. We gave him Vitamin C 2000mg, Magnesium and Omega 3 at 8:00pm that night and again at 7:00am on 10/13/17.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient came in for immunization on October 9,2017. Then came back on October 12, 2017 to show me a large rash she had developed around the injection site. She said that it had started on October 11, 2017 and that it was very red and a little raised. She said that as the days progressed, it was getting a little better.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Ear infection, Measles post vaccine, Pyrexia, Rash
Clinical narrative: Outbreak of measles - rash, fever, ear infection.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: PHARMACIST RECEIVED A CALL FROM A NURSE AT HOSPITAL ER TO REPORT PATIENT LOCAL REACTION TO THE VACCINE ON 10/13/17. NURSE STATED THAT PATIENT EXPERIENCE REDNESS AND SWELLING AT THE INJECTION SITE AND IT IS VERY PAINFUL TO TOUCH.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Swollen glands and fever at night. Lasted a month.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Death, Endotracheal intubation, Resuscitation
Clinical narrative: Patient was brought to ED at Hospital by family member and was DOA. Patient was intubated and CPR was performed for 25 minutes until patient was pronounced dead at 16:18 on 10/5/17.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Blister, Erythema
Clinical narrative: KINREX given L deltoid on 1050 10-11-2017. Given to left arm per mother's request at 8:10. On 10-13-2017 mother phoned in stating that very large reddened area with blister. Which was getting worse at time she called. She was advised to consult physician as soon as possible.
Age: 36.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Pain, Soft tissue infection, Swelling
Clinical narrative: The night after flu vax was given patient developed redness, pain, and swelling. Was seen 2 days after injection. Treated for possible soft tissue infection.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling abnormal, Induration, Nodule, Rash
Clinical narrative: Developed a hard red knot with bumps and felt horrible for 3 days.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Pt had MENVEO vaccine on 10/9, on 10/10 R arm started swelling, redness and sore. Seen in our office on 10/11 and advised cool compress and MOTRIN.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen and warm to touch at injection site.
Age: 23.0
Sex: F
Vaccine: HPVX
Symptoms: C-reactive protein, Haematocrit normal, Haemoglobin normal, Myalgia, Platelet count decreased
Clinical narrative: Itching of hand 3-4 days after injection. Developed diffuse urticaria. Upon arrival at ED on 10/12, pt febrile, tachycardia with c/o urticaria, muscle aches. V/s: 124/79 HR 114 20RR 39.0 degrees C oral 98% on ra. No improvement to v/s with IL N.S IV or 975 mg TYLENOL.
Age: 23.0
Sex: F
Vaccine: HPVX
Symptoms: Pruritus, Red blood cell count normal, Red blood cell sedimentation rate normal, Tachycardia, Urticaria
Clinical narrative: Itching of hand 3-4 days after injection. Developed diffuse urticaria. Upon arrival at ED on 10/12, pt febrile, tachycardia with c/o urticaria, muscle aches. V/s: 124/79 HR 114 20RR 39.0 degrees C oral 98% on ra. No improvement to v/s with IL N.S IV or 975 mg TYLENOL.
Age: 23.0
Sex: F
Vaccine: HPVX
Symptoms: White blood cell count normal
Clinical narrative: Itching of hand 3-4 days after injection. Developed diffuse urticaria. Upon arrival at ED on 10/12, pt febrile, tachycardia with c/o urticaria, muscle aches. V/s: 124/79 HR 114 20RR 39.0 degrees C oral 98% on ra. No improvement to v/s with IL N.S IV or 975 mg TYLENOL.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HEP, HEPA, HIBV, MMRV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt given expired ACTHIB, mother notified, provider checking o pt. daily as now no s/s of reaction. Report completed for MMRV as well on 10-12-17.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Local pain/swelling/tenderness Rt. deltoid injection site.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 102.1 documented in office today.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Discomfort, Dizziness, Fatigue, Injected limb mobility decreased
Clinical narrative: Received PNEUMOVAX 23 25MCG/.05ML INJ on Wednesday afternoon, 10/4/17, at pharmacy. Felt light-headed for about 45 minutes while at pharmacy. Pain and hard swelling about 4" x 5" started in the evening around the injection site. At 2 AM on Thursday, was in enough pain that I could not sleep. Got up. Could not lift arm more than a few inches because of pain and area was very warm. Took 2 Ibuprofen (which I rarely take). Got up Thursday and still a lot of pain when moving my arm. Husband accidently touched area and I screamed out from the pain. We had to run some errands. Around noon on Thursday, I took 1 Ibuprofen. Pain dully radiated from arm to wrist. I could withstand that. Was tired. Later that evening, the area had less pain, but the area was still swollen, hard, and warm to the touch. Iced it down. During the evening, the swelling then started down the inside of my left arm lower than the injection site. The swollen area was about 2" x 1". VERY tender and red. Went to bed. About 2 AM on Friday, I was uncomfortable because of the new area that was swollen. Took 1 Ibuprofen. Got up Friday. I was able to touch the original area that swelled without wincing in pain. It was still a little tender and warm to the touch, but not nearly as bad as yesterday. The new swollen area was warmer than the older area and was tender and swollen. I called the Pharmacy and talked to the Pharmacist. He said that he had another complaint similar to mine within the last two weeks. He said if the area gets worse to go to the ER. I have almost full range with my arm at this time (0:30 AM), however it still has some uncomfortableness because of the swelling and hurts a little when I put my hand straight above my head.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received PNEUMOVAX 23 25MCG/.05ML INJ on Wednesday afternoon, 10/4/17, at pharmacy. Felt light-headed for about 45 minutes while at pharmacy. Pain and hard swelling about 4" x 5" started in the evening around the injection site. At 2 AM on Thursday, was in enough pain that I could not sleep. Got up. Could not lift arm more than a few inches because of pain and area was very warm. Took 2 Ibuprofen (which I rarely take). Got up Thursday and still a lot of pain when moving my arm. Husband accidently touched area and I screamed out from the pain. We had to run some errands. Around noon on Thursday, I took 1 Ibuprofen. Pain dully radiated from arm to wrist. I could withstand that. Was tired. Later that evening, the area had less pain, but the area was still swollen, hard, and warm to the touch. Iced it down. During the evening, the swelling then started down the inside of my left arm lower than the injection site. The swollen area was about 2" x 1". VERY tender and red. Went to bed. About 2 AM on Friday, I was uncomfortable because of the new area that was swollen. Took 1 Ibuprofen. Got up Friday. I was able to touch the original area that swelled without wincing in pain. It was still a little tender and warm to the touch, but not nearly as bad as yesterday. The new swollen area was warmer than the older area and was tender and swollen. I called the Pharmacy and talked to the Pharmacist. He said that he had another complaint similar to mine within the last two weeks. He said if the area gets worse to go to the ER. I have almost full range with my arm at this time (0:30 AM), however it still has some uncomfortableness because of the swelling and hurts a little when I put my hand straight above my head.
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Received PNEUMOVAX 23 25MCG/.05ML INJ on Wednesday afternoon, 10/4/17, at pharmacy. Felt light-headed for about 45 minutes while at pharmacy. Pain and hard swelling about 4" x 5" started in the evening around the injection site. At 2 AM on Thursday, was in enough pain that I could not sleep. Got up. Could not lift arm more than a few inches because of pain and area was very warm. Took 2 Ibuprofen (which I rarely take). Got up Thursday and still a lot of pain when moving my arm. Husband accidently touched area and I screamed out from the pain. We had to run some errands. Around noon on Thursday, I took 1 Ibuprofen. Pain dully radiated from arm to wrist. I could withstand that. Was tired. Later that evening, the area had less pain, but the area was still swollen, hard, and warm to the touch. Iced it down. During the evening, the swelling then started down the inside of my left arm lower than the injection site. The swollen area was about 2" x 1". VERY tender and red. Went to bed. About 2 AM on Friday, I was uncomfortable because of the new area that was swollen. Took 1 Ibuprofen. Got up Friday. I was able to touch the original area that swelled without wincing in pain. It was still a little tender and warm to the touch, but not nearly as bad as yesterday. The new swollen area was warmer than the older area and was tender and swollen. I called the Pharmacy and talked to the Pharmacist. He said that he had another complaint similar to mine within the last two weeks. He said if the area gets worse to go to the ER. I have almost full range with my arm at this time (0:30 AM), however it still has some uncomfortableness because of the swelling and hurts a little when I put my hand straight above my head.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extensive swelling of vaccinated limb, Rash, Skin warm
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 11-year-old male patient who received MENVEO (batch number M16172, expiry date 30th October 2018). Concomitant products included BOOSTRIX. On 2nd October 2017 14:30, the patient received MENVEO (intramuscular) .5 ml. In October 2017, less than a week after receiving MENVEO, the patient experienced extensive swelling of vaccinated limb, rash and skin warm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, rash and skin warm were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, rash and skin warm to be related to MENVEO. Additional details were provided as follows: The case was reported by an office manager. At 14:30 hours, the patient received MENVEO in right arm. The patient experienced a severe rash with swelling down the entire arm where the injection was administered that was hot to the touch. The office manager did not have access to the full records at the time of reporting. She did not indicate filing a quality assurance, so no quality assurance was completed at the time of reporting. The reporter indicated this had already been called in by a Medical Science Liaison, so this event had been marked as a follow up. This case had been linked with case US2017GSK154366, reported by the same reporter.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Rash occurred after vaccination given.