chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Angioedema, Device leakage, Electrocardiogram, Exposure via skin contact
Clinical narrative: Hives, itching and angioedema requiring ER visit. One week later exposed to flu vaccine that had leaked from a multi dose vial and had full anaphylactic reaction requiring another ER visit and hospitalization.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count, Metabolic function test, Pruritus, Urticaria
Clinical narrative: Hives, itching and angioedema requiring ER visit. One week later exposed to flu vaccine that had leaked from a multi dose vial and had full anaphylactic reaction requiring another ER visit and hospitalization.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: ~8 x 9 in diameter, erythema on the injection site.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Hypotension, Rash
Clinical narrative: Rashes on arms, neck, hypotension, taken to ED, epinephrine inj, Benadryl tab and prednisone tab for 2 days.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Influenza like illness, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt felt severe pain in arm after shot and could not lift arm that night. He woke next day and felt very ill like the flu. He could not get warm that night or all day today. His body was very sore. No fever.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called the morning after receiving the PNEUMOVAX 23 vaccine and complained of her entire upper right arm being swollen, painful and warm to touch. I advised her to ice the area and take ibuprofen for relief of pain and swelling. I also advised her to call the doctor if it does not improve within the week.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient came to the pharmacy on 10/20/2018 to mention she had received PREVNAR 13 earlier in the week and thought given too high...arm/shoulder hurt for several days. At the time she came to the pharmacy, said it was feeling better.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy to left side of face.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling and erythema ~ 10X12 cm over left deltoid (location of vaccination administration yesterday) - was administered at a different clinic and came to WIC to be evaluated.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site mass, Injection site scab
Clinical narrative: Patient noticed a small "knot-like" mass at injection site, about the size of an eraserhead which seemed to scab over. Did not report any pain associated with mass.
Age: 60.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Computerised tomogram, Facial paralysis, Headache, Paraesthesia oral, Swelling
Clinical narrative: Pt started having some tingling of lips a few hours later and took an ADVIL pm. Woke the next morning and went to ER for facial drooping. (Mouth mostly it sounds), headache, swelling.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Injection site pain
Clinical narrative: Developed soreness in L arm at injection site that has persisted since. Now 5 weeks post vaccination and still with discomfort. Of note, also received immunotherapy from his allergist in L arm. Had at least 2 and maybe 3 immunotherapy injections since receiving his 2nd SHINGRIX.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient called almost a month later stating her whole arm hurts still from the shot. All the way from injection site to her fingers. Told patient to ice and take APAP or MOTRIN to see if it helps with discomfort.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Swelling
Clinical narrative: Extreme swelling and bruising.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, redness at the site. Pt felt fatigued, and weak.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Eye discharge, Feeling cold, Hypertension, Tremor, Vomiting
Clinical narrative: Chills, uncontrollable shaking for 40 minutes, high blood pressure (150/80) taken by EMT, vomiting, oozing eyes (no redness), afebrile went away after vomiting.
Age: 79.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has redness and swelling to the left arm at the injection site, she was seen by the provider and informed to apply cold compresses to the area. Antibiotics prescribed.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dysstasia, Malaise, Nausea, Pain
Clinical narrative: Patient called in the morning on 10/25/18 and said starting last night he felt unwell. He described his symptoms as achy, having nausea and dizziness that makes it difficult to stand. He went to work and found he was very dizzy and called the pharmacy. I asked if he felt like he should be seen by a doctor he said not at this time.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Neck pain, Nodule, Swelling
Clinical narrative: Experienced pain in neck. Subsequently a large swollen nodule appeared on shoulder at base of neck on right side. Pain and stiffness going up neck.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient had a huge bruise on the injection site, did not hurt but was worried about it.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Injection site pain, Rash generalised, Tachycardia
Clinical narrative: In addition to a very sore arm, at injection site: alternating feelings of being hot and cold throughout the night following injection. Tachycardia (110-120 bpm) throughout the night and into the next day. Two days following injection, extensive rash over most of body, lasting at least the entire day. (My report is being written on this third day, after consulting my PCP and being advised that I should go to the ER if any symptoms worsen.)
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema nodosum, Full blood count normal, Metabolic function test normal, Mycobacterium tuberculosis complex test negative, Rash
Clinical narrative: Patient started with a rash C/W Erythema Nodosum that began just a few days after his flu vaccine; there were no other inciting illnesses. So far rash has been present for over 2 weeks.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Red blood cell sedimentation rate increased, Streptococcus test
Clinical narrative: Patient started with a rash C/W Erythema Nodosum that began just a few days after his flu vaccine; there were no other inciting illnesses. So far rash has been present for over 2 weeks.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient's father said in was hard as a rock, swollen, and warm to the touch. Patient's parents took him to the Dr.'s office. Patient's father said Dr took a picture of it and prescribed Diphenhydramine and Ibuprofen.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Chills, Fatigue, Headache, Neck pain
Clinical narrative: Severe aching, headache, chills, fever, tiredness from 6 pm on night of vaccine and lasted for 36 hours. After the 36 hour period I am still extremely tired and have sore back and neck.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Severe aching, headache, chills, fever, tiredness from 6 pm on night of vaccine and lasted for 36 hours. After the 36 hour period I am still extremely tired and have sore back and neck.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Lymphadenopathy
Clinical narrative: Patient presented to the pharmacy the morning after receiving the shot with redness around the right arm in the area of the injection sites and swelling of the lymph node area of the right armpit. The patient had no swelling of the neck or other complaints, so the patient was advised to follow up with her physician. An attempt was made later in the evening to follow up with the patient to see if she had seen her physician, but  she did not answer.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Migraine
Clinical narrative: I received  the flu shot and got a migraine headache afterwards.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Developed severe cellulitis with warm redness swelling and induration to L arm from shoulder to elbow region; started on PO antibiotics.
Age: 31.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: Patient reported a history of lightheadedness with immunizations. Gave patient his influenza immunizationin his right deltoid. Patient seemed fine and was talking. About a minute later while still talking to patient, patient put his head in his hands. When asked if he was feeling OK, he responded he was feeling lightheaded. He then slumped forward in the chair, fell forward, and fell onto the ground. I rushed to his side to see if he was OK. He was unconscious for approximately 10-15 seconds on the ground, then regained consciousness. I then noticed he had a large gash on his forehead and was bleeding from it. An off the clock EMT was in the area and came over to help. I called 911 and had paramedics come to the pharmacy. The EMT, myself, and management stayed with the patient until the paramedics arrived. The paramedics said he seemed fine except for his gash, and recommended going to the hospital if he began to not feel well. He was doing better by that time and the paramedics offered to walk him to his car and assess him along the way. Nothing else is known about the patient or the situation at this time.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Feeling abnormal, Lacrimation increased, Myalgia
Clinical narrative: Weak, runny nose, watery eyes, 99.9 degrees fever, achy muscles, foggy brain (I kept forgetting well known words), mild cough, sore throat.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Weak, runny nose, watery eyes, 99.9 degrees fever, achy muscles, foggy brain (I kept forgetting well known words), mild cough, sore throat.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Chest pain, Pain
Clinical narrative: Pt said her started hurting the day after the vaccination. The pain spread the following week to her chest and back. Pt is taking naproxen and tylenol to relieve the pain. Breathing is normal but the pain in unbearable. Pt got ADACEL and FLUCELVAX at the same time.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Malaise, Myalgia
Clinical narrative: Fatigue, muscle aches, malaise, difficulty sleeping due to muscle aches. Like a bad cold. Duration approximately 36 hours. This recurred with the second SHINGRIX vaccination 4 months later.
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13, VARZOS
Symptoms: Chills, Hypersomnia, Pyrexia
Clinical narrative: 101 fever/chills - sleep 24 hours - more sleep.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Lymph node pain, Sensory disturbance, Somnolence
Clinical narrative: Painful left axillary lymph node - 4 days. Extreme drowsiness 3 -4 days, lightheadness 3-4 days, feeling faint (stopped what I was doing)- brief transient on two or three occasions over 1 week,  mild altered sensation left lower leg most noticeable for two days, 1 week after flu shot.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: Extreme Vertigo started aprox 1 and 1/2 days after vaccine, bad for a couple days, lasted for about 1 week. Per pt symptoms tapered off in about 1 week time and resolved.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pain in jaw
Clinical narrative: Patient calls pharmacy about 1 hour after administration complaining of painful right side from fingertips to jaw. Patient rates the pain 6 out 10.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Patient stated that vaccine caused pain immediately after and that pain has persisted over the past year in the shoulder. Patient says the pain does go away at times but does come back. It is also stated that there is pain when moving the shoulder and arm behind the patient.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt presented to pharmacy complaining of a painful red rash on her right arm she states developed after she recieved her PNEUMOVAX and FLUZONE vaccines on 10/23. Pt will visit her PCP office to be examined and treated.
Age: 35.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling of the LUE in a descending pattern just distal to the elbow. Tx: prednisone resulted in resolution.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Joint fluid drainage, Pain, Swelling
Clinical narrative: Pain and swelling were reported by a friend of the pt a day after vaccine was administered. A few days later Dr. office reported fluid had to be drained from the shoulder due to swelling.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Blood test normal, Feeling hot, Hypopnoea, Irritability, Pyrexia
Clinical narrative: Extremely irritable, fever of 101.6 at 8:30pm, felt warm for several hours before. Contacted doctor, was told to go to ER. Had fast shallow breathing around 9:30pm for 2ish hours. ER ran blood and urine, looked normal, confirmed vaccine reaction. Left ER at 1am on 10/25/18. At 9am 10/25 fever was at 100.5. At 9pm 10/25, fever was at 100.0. Follow up with doctor scheduled for 10/26.
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Respiratory rate increased, Urine analysis normal
Clinical narrative: Extremely irritable, fever of 101.6 at 8:30pm, felt warm for several hours before. Contacted doctor, was told to go to ER. Had fast shallow breathing around 9:30pm for 2ish hours. ER ran blood and urine, looked normal, confirmed vaccine reaction. Left ER at 1am on 10/25/18. At 9am 10/25 fever was at 100.5. At 9pm 10/25, fever was at 100.0. Follow up with doctor scheduled for 10/26.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Induration, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Day 1: Arm ached a lot. Day 2: a lot of swelling with pain in deltoid area down to bicep; arm was also very hard. Day 3: swelling travelled to forearm and decreased in other affected muscles. No allergic symptoms such as rash or asthma reactions at all.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Skin swelling
Clinical narrative: A skin bump appeared near the flu shot spot on the arm.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Dyskinesia, Electroencephalogram normal, Full blood count normal, Hiccups, Metabolic function test normal
Clinical narrative: Approximately 2 1/2 to 3 hours after vaccines mom noted a loud hiccup noise then a head and chest thrust with a "nerve twitch" in his face lasted a few seconds. It was occurring every few minutes for about 30-60 minutes. Baby was admitted for observation. Had normal 4 hour EEG BMP, CBC, U/A normal. No further episodes.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Muscle twitching, Urine analysis normal
Clinical narrative: Approximately 2 1/2 to 3 hours after vaccines mom noted a loud hiccup noise then a head and chest thrust with a "nerve twitch" in his face lasted a few seconds. It was occurring every few minutes for about 30-60 minutes. Baby was admitted for observation. Had normal 4 hour EEG BMP, CBC, U/A normal. No further episodes.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache, Malaise, Neuropathy peripheral, Oropharyngeal pain, Pain
Clinical narrative: Had FLUAD for seniors flu shot at Pharmacy. Started not feeling well later that p.m. Progressively worse. Headaches, aches, sore throat. Never had reactions to the high dose in the past. Even had neuropathy in hands and feet for a couple of days. Is the FLUAD new this year? Noticed it had an immune booster in it. I don't think that's a good idea. Any antidote for this or does it have to run its course?
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Hallucination, Somnolence
Clinical narrative: After receiving PCV13 vaccine, left office. Became very drowsy and needed wife to finish driving car home. Slept approx one hour and began hallucinating. Awakened and called out to wife. Drank water and had an energy bar. Slept for three more hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of (R) upper arm measured 8x9 cms, non-tender. Advised to apply ice to the ares.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Parotitis, Swelling face, Tenderness
Clinical narrative: Received MMR yesterday; this AM (R) side of face swollen, arm tender no erythema. Pt had no fever or other symptoms- DIAG: parotitis, following MMR.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.5ml of FLUZONE vaccine instead of 0.25ml on 10/22/18.
Age: 60.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt. c/o pain to Lt arm x 2 mos. Thought it was the vaccine, came into clinic today for visit with doctor with c/o burning pain to entire arm. Pain/burning to Lt arm x 2 months, got the SHINGRIX vaccine at last visit in August.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Blood culture, Erythema, Full blood count, Pruritus, Skin warm
Clinical narrative: Day after flu vaccine, developed local erythema, warmth and tenderness. Improved over following 24-48 hrs. 1 week after vaccine, had return of itching, tender to palpation. Labs checked, started on antibiotic. No fevers, no other systemic symptoms.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Day after flu vaccine, developed local erythema, warmth and tenderness. Improved over following 24-48 hrs. 1 week after vaccine, had return of itching, tender to palpation. Labs checked, started on antibiotic. No fevers, no other systemic symptoms.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Chills, fever, flu-like symptoms for a few days.
Age: 78.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Constipation, Headache, Influenza like illness, Musculoskeletal pain
Clinical narrative: Patient experienced chills, fever, flu-like symptoms constipation, and headache. She got flu shot on 9/6/18. Then on 9/17/18 she experienced pain in shoulder, buttocks, both arms so she went to MD and they gave her Ibuprofen 200mg x 3 (600mg) 2x a day.
Age: 78.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient experienced chills, fever, flu-like symptoms constipation, and headache. She got flu shot on 9/6/18. Then on 9/17/18 she experienced pain in shoulder, buttocks, both arms so she went to MD and they gave her Ibuprofen 200mg x 3 (600mg) 2x a day.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Peripheral swelling, Tenderness
Clinical narrative: Developed increased pain at injection site within first 8 hours, then developed significant redness swelling to proximal upper arm that was first noticed at approximately 20 hours after injection. By approximately 24 hours, swelling, redness had progressed to proximal forearm with tenderness.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site discomfort
Clinical narrative: Patient complaining of continued discomfort on injection site. He said a nurse who he knows advised him it may be a high injection. He has not seen his doctor about the injection yet, but is planning on it.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site haematoma, Injection site swelling
Clinical narrative: Huge bruise w/hematoma on upper left arm. 9 days later still black and blue and swollen. Never had reaction to flu shot in 25+ years I've been getting them.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: The patient have a severe red area in the left arm (in the inside part of the arm). The patient have the area hot and with pain. If the area don't improve, the patient in Friday October 26 tell to the pharmacist that she want to visit her primary doctor.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: On 10/23/2018, patient came to the pharmacy and complained that she was able to move her left arm but unable to raise her arm higher than her head. She thought that limited movement was due to the injection. I looked at her arm and found no rash or swollen. I recommended her to take some ADVIL and apply some heating pad on her left shoulder. I talked to her on 10/24 and she said she felt a little bit better. I left her a voice mail today 10/25 to follow up.
Age: 17.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Injection site erythema, Rash, Rash pruritic
Clinical narrative: Started with bumps on face 8 hours later and also on neck a few hours later and the bumps are itchy. Redness on Rt arm deltoid at injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Full blood count, Metabolic function test, Nausea, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 15th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In September 2018, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, stomach pain, fatigue, nausea, fever and myalgia. The patient was treated with PEPCID. On an unknown date, the outcome of the influenza-like symptoms, chills, fatigue, fever and myalgia were recovered/resolved and the outcome of the stomach pain and nausea were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, chills, stomach pain, fatigue, nausea, fever and myalgia to be related to SHINGRIX. Additional information was reported as follows: The patient was a retired nurse. The patient experienced typical reaction to vaccine with flu like reaction, fever, chills, myalgia and fatigue which had resolved. The patient also experienced nausea and stomach pain which got worsened and eventually on 26th September 2018 the patient had to go to the emergency room. The patient was treated with a high dose of PEPCID of 40 mg twice daily. Two weeks after starting the treatment with PEPCID, she was still continuing the treatment with PEPCID 20mg three times in a day, however the events nausea and stomach pain had not resolved. The patient woke up three mornings in a row of the reporting week due to stomach pain. The patient and her physician completed a VAERS form online for the events experienced by her. The patient was unable to provide the phone number or address for the pharmacy where she was vaccinated.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ultrasound abdomen, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 15th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In September 2018, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, stomach pain, fatigue, nausea, fever and myalgia. The patient was treated with PEPCID. On an unknown date, the outcome of the influenza-like symptoms, chills, fatigue, fever and myalgia were recovered/resolved and the outcome of the stomach pain and nausea were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, chills, stomach pain, fatigue, nausea, fever and myalgia to be related to SHINGRIX. Additional information was reported as follows: The patient was a retired nurse. The patient experienced typical reaction to vaccine with flu like reaction, fever, chills, myalgia and fatigue which had resolved. The patient also experienced nausea and stomach pain which got worsened and eventually on 26th September 2018 the patient had to go to the emergency room. The patient was treated with a high dose of PEPCID of 40 mg twice daily. Two weeks after starting the treatment with PEPCID, she was still continuing the treatment with PEPCID 20mg three times in a day, however the events nausea and stomach pain had not resolved. The patient woke up three mornings in a row of the reporting week due to stomach pain. The patient and her physician completed a VAERS form online for the events experienced by her. The patient was unable to provide the phone number or address for the pharmacy where she was vaccinated.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 15th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In September 2018, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, stomach pain, fatigue, nausea, fever and myalgia. The patient was treated with PEPCID. On an unknown date, the outcome of the influenza-like symptoms, chills, fatigue, fever and myalgia were recovered/resolved and the outcome of the stomach pain and nausea were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, chills, stomach pain, fatigue, nausea, fever and myalgia to be related to SHINGRIX. Additional information was reported as follows: The patient was a retired nurse. The patient experienced typical reaction to vaccine with flu like reaction, fever, chills, myalgia and fatigue which had resolved. The patient also experienced nausea and stomach pain which got worsened and eventually on 26th September 2018 the patient had to go to the emergency room. The patient was treated with a high dose of PEPCID of 40 mg twice daily. Two weeks after starting the treatment with PEPCID, she was still continuing the treatment with PEPCID 20mg three times in a day, however the events nausea and stomach pain had not resolved. The patient woke up three mornings in a row of the reporting week due to stomach pain. The patient and her physician completed a VAERS form online for the events experienced by her. The patient was unable to provide the phone number or address for the pharmacy where she was vaccinated.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 15th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In September 2018, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, stomach pain, fatigue, nausea, fever and myalgia. The patient was treated with PEPCID. On an unknown date, the outcome of the influenza-like symptoms, chills, fatigue, fever and myalgia were recovered/resolved and the outcome of the stomach pain and nausea were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, chills, stomach pain, fatigue, nausea, fever and myalgia to be related to SHINGRIX. Additional information was reported as follows: The patient was a retired nurse. The patient experienced typical reaction to vaccine with flu like reaction, fever, chills, myalgia and fatigue which had resolved. The patient also experienced nausea and stomach pain which got worsened and eventually on 26th September 2018 the patient had to go to the emergency room. The patient was treated with a high dose of PEPCID of 40 mg twice daily. Two weeks after starting the treatment with PEPCID, she was still continuing the treatment with PEPCID 20mg three times in a day, however the events nausea and stomach pain had not resolved. The patient woke up three mornings in a row of the reporting week due to stomach pain. The patient and her physician completed a VAERS form online for the events experienced by her. The patient was unable to provide the phone number or address for the pharmacy where she was vaccinated.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Paraesthesia, Pharyngeal oedema, Pharyngeal paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 35-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. Co-suspect products included steroids nos (Steroids) for an unknown indication and epinephrine, epinephrine (Epi Pen) for an unknown indication. Concurrent medical conditions included eczema and pruritus. On 4th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular). In October 2018, the patient started Steroids at an unknown dose and frequency and Epi Pen at an unknown dose and frequency. On 4th October 2018, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced pain, throat swelling, lethargy, pruritus aggravated, tingling, eczema aggravated, pain in thigh, injection site pain, tingling tongue and tiredness. On an unknown date, the outcome of the pain, throat swelling, lethargy, pruritus aggravated, tingling, eczema aggravated, injection site pain, tingling tongue and tiredness were recovered/resolved and the outcome of the pain in thigh was not recovered/not resolved. It was unknown if the reporter considered the pain, throat swelling, lethargy, pruritus aggravated, tingling, eczema aggravated, pain in thigh, injection site pain, tingling tongue and tiredness to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The caller reported that the patient received FLULAVAL QUADRIVALENT 2018-2019 season on the day before reporting. The patient experienced pain when injected and right away she started feeling tingling in her arm that travelled slowly up her arm to her face. The patient was already at her doctors office to get the vaccine, so she was given steroids. 15 minutes after vaccination, the patient's throat swelled shut. The patient received epi-pen and had some remnant tingling in her tongue and face across her nose. The patient's eczema got worse and started to itch more, and her body hurt really bad. The patient felt tired and lethargic all day. The symptoms have resolved on the day of reporting, though her thighs were still tender.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Eczema, Fatigue, Injection site pain, Lethargy, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 35-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. Co-suspect products included steroids nos (Steroids) for an unknown indication and epinephrine, epinephrine (Epi Pen) for an unknown indication. Concurrent medical conditions included eczema and pruritus. On 4th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular). In October 2018, the patient started Steroids at an unknown dose and frequency and Epi Pen at an unknown dose and frequency. On 4th October 2018, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced pain, throat swelling, lethargy, pruritus aggravated, tingling, eczema aggravated, pain in thigh, injection site pain, tingling tongue and tiredness. On an unknown date, the outcome of the pain, throat swelling, lethargy, pruritus aggravated, tingling, eczema aggravated, injection site pain, tingling tongue and tiredness were recovered/resolved and the outcome of the pain in thigh was not recovered/not resolved. It was unknown if the reporter considered the pain, throat swelling, lethargy, pruritus aggravated, tingling, eczema aggravated, pain in thigh, injection site pain, tingling tongue and tiredness to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The caller reported that the patient received FLULAVAL QUADRIVALENT 2018-2019 season on the day before reporting. The patient experienced pain when injected and right away she started feeling tingling in her arm that travelled slowly up her arm to her face. The patient was already at her doctors office to get the vaccine, so she was given steroids. 15 minutes after vaccination, the patient's throat swelled shut. The patient received epi-pen and had some remnant tingling in her tongue and face across her nose. The patient's eczema got worse and started to itch more, and her body hurt really bad. The patient felt tired and lethargic all day. The symptoms have resolved on the day of reporting, though her thighs were still tender.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Paraesthesia, Paraesthesia oral, Pharyngeal oedema, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 35-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. Co-suspect products included steroids nos (Steroids) for an unknown indication and epinephrine, epinephrine (Epi Pen) for an unknown indication. Concurrent medical conditions included eczema and pruritus. On 4th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular). In October 2018, the patient started Steroids at an unknown dose and frequency and Epi Pen at an unknown dose and frequency. On 4th October 2018, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced pain, throat swelling, lethargy, pruritus aggravated, tingling, eczema aggravated, pain in thigh, injection site pain, tingling tongue and tiredness. On an unknown date, the outcome of the pain, throat swelling, lethargy, pruritus aggravated, tingling, eczema aggravated, injection site pain, tingling tongue and tiredness were recovered/resolved and the outcome of the pain in thigh was not recovered/not resolved. It was unknown if the reporter considered the pain, throat swelling, lethargy, pruritus aggravated, tingling, eczema aggravated, pain in thigh, injection site pain, tingling tongue and tiredness to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The caller reported that the patient received FLULAVAL QUADRIVALENT 2018-2019 season on the day before reporting. The patient experienced pain when injected and right away she started feeling tingling in her arm that travelled slowly up her arm to her face. The patient was already at her doctors office to get the vaccine, so she was given steroids. 15 minutes after vaccination, the patient's throat swelled shut. The patient received epi-pen and had some remnant tingling in her tongue and face across her nose. The patient's eczema got worse and started to itch more, and her body hurt really bad. The patient felt tired and lethargic all day. The symptoms have resolved on the day of reporting, though her thighs were still tender.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 55-year-old female patient who experienced swelling at the site about 10-15 cm in size with redness, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and concomitant medications were not provided. On 11-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA via intramuscular route in the left deltoid. On an unknown date, The patient developed a non-serious swelling at the site about 10-15 cm in size with redness following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included no lab tests.) Final diagnosis was swelling at the site about 10-15 cm in size with redness. As corrective treatment, Patient applied ice and alcohol compress. The patient outcome is reported as Unknown for swelling at the site about 10-15 cm in size with redness.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Hyperhidrosis, Tremor
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to case 2018SA290029. This case involves a 36 years old female patient who experienced was tripping over my own feet, real sweaty and extreme dizziness, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018 15:17, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ009AA, Expiration Date: 30-Jun-2019 via intramuscular route in the right deltoid. On 09-Oct-2018 15:55, the patient developed a non-serious was tripping over my own feet (gait disturbance), real sweaty (hyperhidrosis) and extreme dizziness (dizziness) 38 minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant tests included no lab data. Final diagnosis was extreme dizziness, real sweaty and was tripping over my own feet. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Gait disturbance, Hyperhidrosis
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to case 2018SA290029. This case involves a 36 years old female patient who experienced was tripping over my own feet, real sweaty and extreme dizziness, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018 15:17, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ009AA, Expiration Date: 30-Jun-2019 via intramuscular route in the right deltoid. On 09-Oct-2018 15:55, the patient developed a non-serious was tripping over my own feet (gait disturbance), real sweaty (hyperhidrosis) and extreme dizziness (dizziness) 38 minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant tests included no lab data. Final diagnosis was extreme dizziness, real sweaty and was tripping over my own feet. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Aggression, Amnesia, Anxiety, Blood glucose decreased, Blood magnesium decreased
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case is linked to cases 2018SA290307 and 2018SA292920 (same reporter). This case involves a two patients of unknown age and gender who experienced sweating profusely, diabetic coma and hypoglycemia (reported as experienced same symptoms at different levels) while received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccines and medications not given. On an unknown date, two patients received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA via unknown route in unknown administration site. On an unknown date, patients developed a serious sweating profusely, diabetic coma and hypoglycemia following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. These patients were hospitalized for these event (duration unknown). Lab tests not reported. Final diagnosis was diabetic coma. Corrective treatment not reported. The outcome of all event was unknown at the time of reporting. List of documents held by sender: none. Sender's Comments: This case concerns two patients who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding individual patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patients had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Confusional state, Diabetic coma, Differential white blood cell count, Fear, Full blood count
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case is linked to cases 2018SA290307 and 2018SA292920 (same reporter). This case involves a two patients of unknown age and gender who experienced sweating profusely, diabetic coma and hypoglycemia (reported as experienced same symptoms at different levels) while received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccines and medications not given. On an unknown date, two patients received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA via unknown route in unknown administration site. On an unknown date, patients developed a serious sweating profusely, diabetic coma and hypoglycemia following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. These patients were hospitalized for these event (duration unknown). Lab tests not reported. Final diagnosis was diabetic coma. Corrective treatment not reported. The outcome of all event was unknown at the time of reporting. List of documents held by sender: none. Sender's Comments: This case concerns two patients who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding individual patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patients had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Hyperhidrosis, Hypoglycaemia, Impaired driving ability, Metabolic function test, Troponin I
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case is linked to cases 2018SA290307 and 2018SA292920 (same reporter). This case involves a two patients of unknown age and gender who experienced sweating profusely, diabetic coma and hypoglycemia (reported as experienced same symptoms at different levels) while received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccines and medications not given. On an unknown date, two patients received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA via unknown route in unknown administration site. On an unknown date, patients developed a serious sweating profusely, diabetic coma and hypoglycemia following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. These patients were hospitalized for these event (duration unknown). Lab tests not reported. Final diagnosis was diabetic coma. Corrective treatment not reported. The outcome of all event was unknown at the time of reporting. List of documents held by sender: none. Sender's Comments: This case concerns two patients who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding individual patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patients had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Urine analysis, Vision blurred
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case is linked to cases 2018SA290307 and 2018SA292920 (same reporter). This case involves a two patients of unknown age and gender who experienced sweating profusely, diabetic coma and hypoglycemia (reported as experienced same symptoms at different levels) while received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccines and medications not given. On an unknown date, two patients received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA via unknown route in unknown administration site. On an unknown date, patients developed a serious sweating profusely, diabetic coma and hypoglycemia following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. These patients were hospitalized for these event (duration unknown). Lab tests not reported. Final diagnosis was diabetic coma. Corrective treatment not reported. The outcome of all event was unknown at the time of reporting. List of documents held by sender: none. Sender's Comments: This case concerns two patients who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding individual patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patients had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.