chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness/tender/warmth at (L) deltoid/AUGMENTIN 400mg/57mg/5m.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: After receiving shots I cannot take allergy, cold or pain medications without having reactions. I have been to doctor twice, allergist and dermatologist. Never had this reaction before.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Flushing, Malaise, Paraesthesia oral
Clinical narrative: 5 MINUTES AFTER THE VACCINE, PATIENT REPORTED FEELING UNWELL. PATIENT TOLD HAVING TINGLING IN THE MOUTH AND TONGUE BUT BREATHING NORMAL; FLUSHING AND HOT ALL OVER THE BODY. FEEL DIZZY.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Electroencephalogram, Laboratory test, Nuclear magnetic resonance imaging, Seizure, X-ray
Clinical narrative: Uncontrollable seizures.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Lymphadenopathy, Mass, Neck pain, Pyrexia
Clinical narrative: Golf ball sized raised lump with fever, pain that radiates into armpit and up into the neck. Occurred approximately 3 days after injection. Includes swollen lymph nodes in neck and armpit area. Seen by ED physician, Dr.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Skin test negative
Clinical narrative: Mom reported a 2-3 inch area of redness and swelling at injection site. Area is no painful. History of egg allergy. Does not eat eggs. Passed a scratch test to rule out egg allergy but has not done an oral challenge.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache, Loss of personal independence in daily activities, Malaise, Nausea
Clinical narrative: I am uncertain of the exact type of flu shot though the pharmacy would have that information. Pt woke with a headache, mild body aches. Later he stated that he had also had a tingly feeling in his body at one point in the morning but it went away. He felt mildly nauseated and his stomach hurt a little. Ibuprofin and activated charcoal helped off and on. He came home from school early. This morning he stayed home and has less of the headache but still feels a little 'sick'.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: I am uncertain of the exact type of flu shot though the pharmacy would have that information. Pt woke with a headache, mild body aches. Later he stated that he had also had a tingly feeling in his body at one point in the morning but it went away. He felt mildly nauseated and his stomach hurt a little. Ibuprofin and activated charcoal helped off and on. He came home from school early. This morning he stayed home and has less of the headache but still feels a little 'sick'.
Age: 65.0
Sex: F
Vaccine: CHOL
Symptoms: Abdominal discomfort, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain and redness at injection site, headache, fever, body aches, chills, muscle pain, shivering and upset stomach.
Age: 65.0
Sex: F
Vaccine: CHOL
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Pain and redness at injection site, headache, fever, body aches, chills, muscle pain, shivering and upset stomach.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: Fever, severe malaise, pain, headaches.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Hyperaesthesia, Myalgia
Clinical narrative: Fever, chills, headache, beginning around midnight (10 h post-vaccination). Muscle soreness, joint pain, following a few hrs later (4 am), developed hyperasthesia in late afternoon (3 pm) following day. Fever & chills ceased approx. 10-11 am following morning (20 h post-vaccination), headache treated with aspirin (10 mg, as needed)until evening, muscle soreness, joint pain gradually subsided by 9 pm, hyperasthesia subsided after that all symptoms passed by am of 2/14/19.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, headache, beginning around midnight (10 h post-vaccination). Muscle soreness, joint pain, following a few hrs later (4 am), developed hyperasthesia in late afternoon (3 pm) following day. Fever & chills ceased approx. 10-11 am following morning (20 h post-vaccination), headache treated with aspirin (10 mg, as needed)until evening, muscle soreness, joint pain gradually subsided by 9 pm, hyperasthesia subsided after that all symptoms passed by am of 2/14/19.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Chills, Feeling cold, Feeling hot, Influenza virus test
Clinical narrative: Red, softball size red mark at injection/vaccine site (left arm); Cold chills, fever (felt hot); Migraine frontal - light sensitivity; Arm (left) hurts w/movement; Back pain - spine area (lower).
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Migraine, Pain, Photophobia, Pyrexia
Clinical narrative: Red, softball size red mark at injection/vaccine site (left arm); Cold chills, fever (felt hot); Migraine frontal - light sensitivity; Arm (left) hurts w/movement; Back pain - spine area (lower).
Age: 21.0
Sex: F
Vaccine: FLU4, HEPA, TD
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediatric Hepatitis A dose given to adult.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Hypersensitivity, Muscular weakness, Myalgia, Rash
Clinical narrative: Allergic reaction including rash - hives, extreme weakness and muscle pain and weakness.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Allergic reaction including rash - hives, extreme weakness and muscle pain and weakness.
Age: 1.33
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia
Clinical narrative: Persistent fever since administration.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Aphthous ulcer, Dizziness, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: Night sweats, fever, body aches, stiffed neck, lightheadedness, HA, extreme fatigue, canker sores - from 2/10/19 night till now 2/13/19.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Night sweats, Pain, Pyrexia
Clinical narrative: Night sweats, fever, body aches, stiffed neck, lightheadedness, HA, extreme fatigue, canker sores - from 2/10/19 night till now 2/13/19.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Pruritus, Swelling
Clinical narrative: After PEDIARIX, Hib, PREVNAR, ROTATEQ - 30 minutes after develops swelling, pruritus, and fussiness. All resolved by next morning 12-18 hours later. No problem with Hep B #1 at birth. But unsure of cause: Dtap #1, Hib #1, IPV #1, PREVNAR #1 or ROTATEQ #1. Mother did not come to us then. No respiratory problem nor visible rash. Referring to Allergist.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Redness below the site area and soreness with slight swelling. The patient was taken to the ER and referred back to us as we are who administered the immunizations. Mom stated the evening of the shots the patient complained of a headache and the left arm was a little sore. Mom took the patient to the ER for evaluation because there was some redness and soreness noted. She was referred back to us due to us administering the immunizations. Mom let the patient go back to school on 2/8/2019 and when she picked him up he was presenting with redness and mild edema on the left arm below the site area. It was warm to touch. The ER had treated the patient with cool compress and MOTRIN. Due to the area being warm to touch and the edema she was advised to take him to doctor for evaluation.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity
Clinical narrative: Redness below the site area and soreness with slight swelling. The patient was taken to the ER and referred back to us as we are who administered the immunizations. Mom stated the evening of the shots the patient complained of a headache and the left arm was a little sore. Mom took the patient to the ER for evaluation because there was some redness and soreness noted. She was referred back to us due to us administering the immunizations. Mom let the patient go back to school on 2/8/2019 and when she picked him up he was presenting with redness and mild edema on the left arm below the site area. It was warm to touch. The ER had treated the patient with cool compress and MOTRIN. Due to the area being warm to touch and the edema she was advised to take him to doctor for evaluation.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Medical assistant gave the wrong flu vaccine, doctor called the patient parents, no fever, no symptoms.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: SULFAMETHOXAZOLE-TMP DS TABLETS.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Headache, Musculoskeletal chest pain, Myalgia
Clinical narrative: Redness and swelling from deltoid to elbow, elevated temp, headache, muscle aches, rib pain, wasn't able to rest, started improving 02/10/19. Patient felt symptoms were severe. Used Tylenol, rest, and comfort measures at home.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Redness and swelling from deltoid to elbow, elevated temp, headache, muscle aches, rib pain, wasn't able to rest, started improving 02/10/19. Patient felt symptoms were severe. Used Tylenol, rest, and comfort measures at home.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 5 cm redness, 4 cm edema, soreness, pain at injection site. OTC Ibuprofen for pain/swelling, ice to affected area.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: Redness on site of vaccine, vaccine was given 2 days ago, unknown if fever. Advised to take BENADRYL and MOTRIN TID.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt had redness and swelling that spread up their arm and down the arm. Pt was treated with Benadryl.
Age: 1.25
Sex: M
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Received PCV vaccines left thigh 2 days ago, at night mild redness local, since yesterday increasing in size, no fever. Pt is on AUGMENTIN for ear infection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUC4, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction starting about 8 hours after injection around the Proquad injection with warmth redness swelling and pain.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Headache, achy.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: My upper right arm was red, swollen, and very warm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia, Paraesthesia
Clinical narrative: Patient received the vaccine on 1/17/2019 and complained of the usual muscle soreness for about 3 days after the SHINGRIX Vaccine. On 2/13/2018 patient complained about cramping at the injections site and tingling. Pharmacist spoke to patient on 2/13 and 2/14 to verify symptoms.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient called on 2/10/19, 2 days after receiving the vaccines complaining of red, itchy area around where she received her vaccine on her right arm. Patient declined trouble breathing. Recommend patient to try hydrocortisone cream and bendryl to help with the itching, but to contact her MD office for possible follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Erythema, Feeling hot
Clinical narrative: Pt said she had alternating hot flashes and chills. Face was red and hot. She described flu like symptoms including low energy/dizzy this morning about 10AM (2/14/19).
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Hot flush, Influenza like illness
Clinical narrative: Pt said she had alternating hot flashes and chills. Face was red and hot. She described flu like symptoms including low energy/dizzy this morning about 10AM (2/14/19).
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Cyanosis, Rash, Skin discolouration, Swelling
Clinical narrative: Rash on face, arms and legs which later included swelling and purple extremities and lips.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Few days later patient's left arm has been more sore and experiencing muscle weakness radiating down to her fingers. It has been going on for over a month now. As her if it was nerve pain but she said it's more muscle pain and soreness.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Burning sensation, Headache, Influenza like illness, Limb discomfort
Clinical narrative: Few days later patient's left arm has been more sore and experiencing muscle weakness radiating down to her fingers. It has been going on for over a month now. As her if it was nerve pain but she said it's more muscle pain and soreness.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Few days later patient's left arm has been more sore and experiencing muscle weakness radiating down to her fingers. It has been going on for over a month now. As her if it was nerve pain but she said it's more muscle pain and soreness.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Malaise, Pain
Clinical narrative: General malaise, body aches, chills, soreness at injection site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient showed a red non-raised rash around injection site measuring about 1 1/2" in diameter. Patient states she received vaccine on 2-4-19 and rash appeared the following day on 2-5-19. Pt came in to pharmacy to show rash on 2-8-19 and rash appeared to be resolving. Patient had a doctor from her place of employment look at rash and made a pen circle around rash. Rash had not appeared to grow in size.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Bone contusion, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Reported immediate pain after injection, Injection administered too high, initially had limited range of motion (has improved), continue to have deep pain and limited lifting. Course of treatment has been ant-inflammatory and Medrol pack meds, physical therapy. Most recently MRI ordered 2/5/19 revealed bone contusion and rotator cuff tear.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Nuclear magnetic resonance imaging abnormal, Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: Reported immediate pain after injection, Injection administered too high, initially had limited range of motion (has improved), continue to have deep pain and limited lifting. Course of treatment has been ant-inflammatory and Medrol pack meds, physical therapy. Most recently MRI ordered 2/5/19 revealed bone contusion and rotator cuff tear.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Injection site reaction, Paraesthesia, Pruritus
Clinical narrative: Patient reports itching and rash that started in her head and went to her face, arms and stomach. Rash was tingly to the touch, accompanied by headache and some chills. Patient reported "warp" at the injection site with a rash on her arm.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient reports itching and rash that started in her head and went to her face, arms and stomach. Rash was tingly to the touch, accompanied by headache and some chills. Patient reported "warp" at the injection site with a rash on her arm.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypotonia, Unresponsive to stimuli
Clinical narrative: After immunizations were given, mother nursed baby for 5-6 min, he then went limp, tried to arouse could not, pt had a pulse and was breathing, interrupted physician to see pt, she did and tried to arouse and consulted another physician in practice, Dr., once he came in pt had started to open eyes, mother states this wasn't a sleeping pattern, unsure if he had a seizure or syncopal episode. Dr. consulted the NICU physician he felt no testing needs done unless it happens again, then a neuro consult would be indicated. For future we will give 1 immunization at a time.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Left arm red, swollen and painful. 5-7 cm urticaria non circumferential. No pain on palpation. No tenderness to palpation. No streaking.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Pyrexia
Clinical narrative: Fever; Cold chills; Weakness; Loss of appetite, lasting 2 days and nights.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pain, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Next morning - fever 102 - 103, severe body aches x 24 hrs, red/blotchy rash around inj. site.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site pain, Injection site swelling
Clinical narrative: PNEUMOVAX 23 received at approx 3pm on 2/13/19 in L delt. At approx 7pm site became swollen and tender. Pt awoke at 3am 2/14/19 and felt lightheaded. Pt returned to office 10:45 am on 2/14/19 for assessment. Lightheadedness has resolved. Pt advised to use antihistamine and NSAID as needed for symptom relief.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Impaired work ability, Influenza like illness
Clinical narrative: Extreme tiredness, low grade fever, head ache, stomach ache and muscle ache. I am unable to go to work. Side affects are similar to influenza.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Extreme tiredness, low grade fever, head ache, stomach ache and muscle ache. I am unable to go to work. Side affects are similar to influenza.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Injection site erythema, Injection site pain
Clinical narrative: Left arm started aching around 4 p.m. throughout evening progressively was more bothersome.  Around 9 p.m. fell asleep, at 11 p.m. woke up, extreme chills, shaking, could not get warm, fever 102, room was spinning, woke husband due to moaning/groaning, went on until about 4 a.m. and finally started resting/fever broke. 10/27 aching headache & body all day; temperature slightly elevated 99+. Arm ached for 7+ days, and redness and soreness spread below area of injection. Sent pics and called the Doctor on 1/29, she returned my call on 1/30 with VM that she'd heard of some adverse reactions recently and if it continued I could come in but she wasn't sure at that point what she could do. I have never felt as bad in my life as I did the night of 1/26 into the morning of 1/27/19.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Moaning, Pain, Pain in extremity, Pyrexia
Clinical narrative: Left arm started aching around 4 p.m. throughout evening progressively was more bothersome.  Around 9 p.m. fell asleep, at 11 p.m. woke up, extreme chills, shaking, could not get warm, fever 102, room was spinning, woke husband due to moaning/groaning, went on until about 4 a.m. and finally started resting/fever broke. 10/27 aching headache & body all day; temperature slightly elevated 99+. Arm ached for 7+ days, and redness and soreness spread below area of injection. Sent pics and called the Doctor on 1/29, she returned my call on 1/30 with VM that she'd heard of some adverse reactions recently and if it continued I could come in but she wasn't sure at that point what she could do. I have never felt as bad in my life as I did the night of 1/26 into the morning of 1/27/19.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Vertigo
Clinical narrative: Left arm started aching around 4 p.m. throughout evening progressively was more bothersome.  Around 9 p.m. fell asleep, at 11 p.m. woke up, extreme chills, shaking, could not get warm, fever 102, room was spinning, woke husband due to moaning/groaning, went on until about 4 a.m. and finally started resting/fever broke. 10/27 aching headache & body all day; temperature slightly elevated 99+. Arm ached for 7+ days, and redness and soreness spread below area of injection. Sent pics and called the Doctor on 1/29, she returned my call on 1/30 with VM that she'd heard of some adverse reactions recently and if it continued I could come in but she wasn't sure at that point what she could do. I have never felt as bad in my life as I did the night of 1/26 into the morning of 1/27/19.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Catheterisation cardiac normal, Chest pain, Discomfort, Electrocardiogram, Pericarditis
Clinical narrative: After 2 days of predicted discomfort associated with the vaccine, On the night of 1/30/2019, I suddenly developed severe chest pains only in a very localized area under my upper sternum. On 1/31/2019 I went to my doctor's office to get checked out. After receiving an EKG, I was taken to Hospital and given a heart catherization, which showed no blockages or other serious abnormalities with my heart. However, I was diagnosed with a condition called pericarditis. I was told this pericarditis was caused by an unknown virus that resulted in an inflammation around my heart.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Catheterisation cardiac normal, Chest pain, Echocardiogram abnormal, Electrocardiogram abnormal, Pain
Clinical narrative: After 2 days of predicted discomfort associated with the vaccine, On the night of 1/30/2019, I suddenly developed severe chest pains only in a very localized area under my upper sternum. On 1/31/2019 I went to my doctor's office to get checked out. After receiving an EKG, I was taken to Hospital and given a heart catherization, which showed no blockages or other serious abnormalities with my heart. However, I was diagnosed with a condition called pericarditis. I was told this pericarditis was caused by an unknown virus that resulted in an inflammation around my heart.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pericarditis, Pyrexia
Clinical narrative: After 2 days of predicted discomfort associated with the vaccine, On the night of 1/30/2019, I suddenly developed severe chest pains only in a very localized area under my upper sternum. On 1/31/2019 I went to my doctor's office to get checked out. After receiving an EKG, I was taken to Hospital and given a heart catherization, which showed no blockages or other serious abnormalities with my heart. However, I was diagnosed with a condition called pericarditis. I was told this pericarditis was caused by an unknown virus that resulted in an inflammation around my heart.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Started with body aches like the flu, then fever which was 100.5 when checked late afternoon next day and feel it went up a little higher possibly to 101 during night. Fever broke at 5a.m. February 14.  Today, February 14, just feel wiped out but body aches are subsiding greatly.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Fever up to 102.5 so far, chills, muscle aches throughout body, muscle weakness, tiredness.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Body temperature increased, Emotional distress, Irritability
Clinical narrative: Temporal Scanner: 11:00 PM 02/13/2019 - 99.2; 07:00 AM 02/14/2019 - 99.5; 09:00 AM 02/14/2019 - 100.1 axillary; 10:15 AM 02/14/2019 - 98.8 axillary. Mom reports, "He has been waking up very fussy, hard to settle, and spitting out his pacifier which he never does."
Age: 1.33
Sex: M
Vaccine: FLU4, VARCEL
Symptoms: Influenza virus test negative, Pyrexia, Vomiting
Clinical narrative: 2/7/19 - well visit - VARIVAX and FLULAVAL given. 2/8/19 - phone call from parent - fever "high" no temp avail. gave MOTRIN. 2/9/19 - ER visit high fever Tmax 102.5 exam normal d/c to home. 2/12/19 - phone call from parent - concern for vomiting at 4:30pm. Advice given.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on or about 11-APR-2008 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at a medical center for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on or about 2015 at a medical center as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles, and other complications. The patient was treated at a medical center for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder pain: After his flu shot, his arm hurt right away and hasn't felt the same since. He went home and started getting sore that night, couldn't move his shoulder like normal. Since then, it just hasn't gotten better. Has been persistent every day. Patient has been getting Physical therapy, oral steroids and a steroid injection.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: I administered hep A 1440 el.u instead of 720 el.u to the patient by mistake. I called the manufacture for any possible side effects and they said they had completed studies on toddlers who received the 1440 el.u dose. The only reaction reported was redness at the injection site, headache, and mild swelling at the injection site. I called the mother of the patient and explained what had happened. She understood and had no other questions. I called back the next day and she reported her daughters arm was a little sore but no other side effects noted. I told her to call if she had any other question.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Urticaria
Clinical narrative: Sporadic hives on face, bottom, arms, legs x 4 days. 1 week after injection, site became warm, red, and hard.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Patient was given a PENTACEL and ACTHIB on the same day.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: Muscle pain in forearm, decrease ROM at the elbow.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Developed a rash/red area about 4" x 6" around injection site which began to inch after 2 days. Two weeks later still have faint red area and minor inching.
Age: 77.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Influenza like illness, Insomnia, Pain in extremity
Clinical narrative: Patient reported severe pain in both arms and legs the night after injections. She described the pain as severe and sharp and unbearable, and she was unable to sleep all night. Following day she experienced flu like symptoms.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Grip strength decreased, Pain in extremity
Clinical narrative: Patient stated her arm was very sore the next day. The pain continued and slowly moved down her arm to her elbow and forearm area. She stated that in late November/early December it moved in to her hand and continues to hurt. She is having a hard time gripping. She visited her family doctor on 2/12/19 and they are sending her for a test to see if she has nerve damage.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema
Clinical narrative: Patient reported "chills" the day following the vaccination. Additionally, patient stated she was experiencing redness on her left arm that appeared in a circular fashion that has lasted since the date of vaccination on 2/12. Patient was advised to consult PCP when she presented to the pharmacy on 2/14.
Age: 27.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Fatigue, Headache, Nausea, Pain, Rash
Clinical narrative: Nausea, unusually tired and soreness the first evening. Second day noticed hives in my hands both front and back along with a splitting headache for over 8 hours followed with nausea. The third day experienced further rash/hives and is current.
Age: 27.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Urticaria
Clinical narrative: Nausea, unusually tired and soreness the first evening. Second day noticed hives in my hands both front and back along with a splitting headache for over 8 hours followed with nausea. The third day experienced further rash/hives and is current.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Swelling face, Vomiting
Clinical narrative: Vomiting, stomach pain, swollen face.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Peripheral swelling, Tenderness
Clinical narrative: Approximately 3 days after received 1st dose of SHINGRIX vaccine, patient developed red, swollen, tender right arm. The redness spread from the upper right arm, down towards the hand. She sought medical attention to alleviate symptoms. Patient denies allergic symptoms of rash, hives, or difficulty breathing.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Feeling abnormal, Lymph node pain, Lymphadenopathy, Speech disorder
Clinical narrative: Brain Fog, mental confusion, speech impairment, left armpit lymph node pain/swollen.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Confusional state, Feeling abnormal, Injection site bruising
Clinical narrative: Mom says on 3 different occasions last evening after receiving HAVRIX in office yesterday she reported to Mom that "the house feels like it is floating or that she was floating" and then when she was on the way home from school today she told her Mom she felt "confused today". She is not running a fever. No signs of illness. Injection site is only slightly bruised. Mom is asking if this is a side effect of vaccine, anything to be concerned with. She is acting perfectly fine, otherwise.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Pain
Clinical narrative: Severe rigors, aches and pains for 22 hours. So intense I had to call off work, which I never do.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: PATIENT REPORTED ARM PAIN AT INJECTION SITE THAT LASTED ABOUT 4 WEEKS. SHE SAID IT KEEPS GETTING BETTER, BUT IS STILL SORE AT TIMES. PATIENT SAID SHE WENT TO HER DR WHO SAID IT LOOKS LIKE WE GAVE INJECTION INTO THE LOWER DELTOID, BUT INTO A NERVE FIBER.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac operation, Herpes zoster, Nephrectomy, Pain, Rash
Clinical narrative: This spontaneous report was received from a patient's wife refers to an approximately 74 years old male patient. The patient's pertinent medical history and drug reactions / allergies were reported as none. The patient's concomitant medications included metoprolol, sertraline, atorvastatin and finasteride. On an unknown date in November 2008, the patient was vaccinated with ZOSTAVAX (lot number, expiry date and strength were not reported) 1 injection for shingles prevention. Other suspect therapies included sterile diluent (STERILE DILUENT) one injection (dose, lot number, expiry date, indications are not provided). On an unknown date in 2009, the patients kidney was removed due to cancer. On an unknown date in February 2011, the patient experienced shingles on his right side. On an unknown date in 2012, the patient had an open heart surgery (cardiac operation). On an unknown date in May 2017, the patient experienced shingles again on his left side however the rash was more mild. It was reported that the patient was still experiencing residual pain at the time of this report. Lab diagnostics/studies were not performed. Treatment was given for the adverse events. The patient sought for medical attention by visiting physician. There was no product quality complaint associated with this report. The outcome of the events, nephrectomy, cardiac operation and neoplasm malignant was unknown. The outcome of the event herpes zoster (onset: Unk-FEB-2011) was recovered. The outcome of the events, herpes zoster (Onset: Unk-MAY-2017) and pain was not recovered. The causality assessment was not provided. Upon internal review, the events nephrectomy, cardiac operation and neoplasm malignant was determined to be medically significant.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Renal cancer
Clinical narrative: This spontaneous report was received from a patient's wife refers to an approximately 74 years old male patient. The patient's pertinent medical history and drug reactions / allergies were reported as none. The patient's concomitant medications included metoprolol, sertraline, atorvastatin and finasteride. On an unknown date in November 2008, the patient was vaccinated with ZOSTAVAX (lot number, expiry date and strength were not reported) 1 injection for shingles prevention. Other suspect therapies included sterile diluent (STERILE DILUENT) one injection (dose, lot number, expiry date, indications are not provided). On an unknown date in 2009, the patients kidney was removed due to cancer. On an unknown date in February 2011, the patient experienced shingles on his right side. On an unknown date in 2012, the patient had an open heart surgery (cardiac operation). On an unknown date in May 2017, the patient experienced shingles again on his left side however the rash was more mild. It was reported that the patient was still experiencing residual pain at the time of this report. Lab diagnostics/studies were not performed. Treatment was given for the adverse events. The patient sought for medical attention by visiting physician. There was no product quality complaint associated with this report. The outcome of the events, nephrectomy, cardiac operation and neoplasm malignant was unknown. The outcome of the event herpes zoster (onset: Unk-FEB-2011) was recovered. The outcome of the events, herpes zoster (Onset: Unk-MAY-2017) and pain was not recovered. The causality assessment was not provided. Upon internal review, the events nephrectomy, cardiac operation and neoplasm malignant was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), at a medical facility as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated by at an Urgent Care facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. The outcome of the events were considered to be not recovered. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Malaise, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 45-year-old female patient who received Flu Seasonal QIV Dresden for prophylaxis. The patient's past medical history included influenza (last year had flu twice). Concurrent medical conditions included immune system disorder. On an unknown date, the patient received Influenza vaccine Quadrivalent 2017-2018 season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced sickness, cough and sniffles. On an unknown date, the outcome of the sickness, cough and sniffles were unknown. It was unknown if the reporter considered the sickness, cough and sniffles to be related to Influenza vaccine Quadrivalent 2017-2018 season. Additional information was reported as follows: In 2018, the patient was sick entire winter with coughing and sniffling all the time. The call center representative asked all questions to reporter, but unable to obtain additional information. The patient gave permission for her doctor to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain. The patient was treated with nsaid's (Nonsteroidal Anti-Inflammatories) and non-drug therapy (Heat Therapy). On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the patient who herself was the Nurse. The age at vaccination was not reported. The patient was treated with nonsteroidal anti-inflammatory drugs (NSAIDS) and a heating pad for 1 week. The reporter wanted to know, what was the mechanism that caucused such severe arm pain at the injection site. For tolerance to next dose, refer case US2019GSK025564.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of loss of vision in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced loss of vision (serious criteria GSK medically significant). On an unknown date, the outcome of the loss of vision was unknown. It was unknown if the reporter considered the loss of vision to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient the day after she went to the pharmacy she lost her vision. The patient went to her eye doctor and she said the eye doctor told her it was due to the shot of SHINGRIX she received the day before. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on an unknown date, refer case US2019GSK020885). On 2nd February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the patient who herself was the Nurse. The age at vaccination was not reported. A day before the vaccination, the patient received a 2nd dose of SHINGRIX. The reaction was as bad as 1st dose.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The lot or expiration date of vaccine was unknown. The patient received a dose of SHINGRIX about 2.5 months ago just above deltoid and wanted to know if the dose would be effective, which led to incorrect site of administration. The patient had mild pain at the injection site, since receiving SHINGRIX and wanted to know if this was normal and if he should have it treated with a cortisone shot or if it would go away. The vaccine was administered at a pharmacy. The reporter gave consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included ENTYVIO. On 5th December 2018, the patient received SHINGRIX. On 5th December 2018, 1 hr after receiving SHINGRIX, the patient experienced fever, general body pain and influenza-like symptoms. On an unknown date, the outcome of the fever, general body pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the fever, general body pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The batch number for SHINGRIX was not provided. On 13th November 2018, the patient received an infusion of ENTYVIO at the clinic infusion center. The patient was administered SHINGRIX at an outside facility (local pharmacy) and was not administered by the reporter. The patient experienced fever that began 1 hour after vaccination and lasted for 2 hours. Less than a day after receiving vaccination, the patient experienced body aches and flu-like symptoms which lasted for 1 week. The patient did not experience any injection site reactions. Medications used by the patient to treat their adverse symptoms were not reported. The address of the pharmacy where SHINGRIX was administered was not provided.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Exposure during pregnancy, Laboratory test normal, Mobility decreased, Pain
Clinical narrative: Complete Placenta Previa diagnosed at 20 weeks, cleared at 28 weeks, otherwise normal and healthy pregnancy. Delivered 1 week early with a postpartum hemorrhage. Birth weight was 8 lbs 5 oz. Adverse event: Frozen shoulder/Severe pain for 2 months after the injection. Could not lift arm above hips. Pain with active and passive range of motion with severe limitations. AC glide test was negative.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Periarthritis, Placenta praevia, Postpartum haemorrhage
Clinical narrative: Complete Placenta Previa diagnosed at 20 weeks, cleared at 28 weeks, otherwise normal and healthy pregnancy. Delivered 1 week early with a postpartum hemorrhage. Birth weight was 8 lbs 5 oz. Adverse event: Frozen shoulder/Severe pain for 2 months after the injection. Could not lift arm above hips. Pain with active and passive range of motion with severe limitations. AC glide test was negative.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Cellulitis
Clinical narrative: Pt developed cellulitis of the left arm.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient came into the clinic on 02/13/2019. Mom had noticed redness and swelling in the right thigh on 02/12/2019. No fever. Provider noted erythema and swelling localized around previous bandage and injection site of the INFANRIX on left lateral thigh. The area was warm to touch, tender and a 10 cm diameter. Dr diagnosed the patient with cellulitis and treated with Keflex.
Age: 21.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: PATIENT INDICATED SHE FELT DIZZY RIGHT AFTER I FINISHED INJECTED HPV. SUDDENLY PATIENT  PASS OUT, I WAS ABLE TO SAFELY HELP HER AND  ADJESTED BED AS I YELL FOR HELP. MINDTIME I ELEVATE HER FOOT AND BY THIS TIME SHE WAS ALREDY RECOVERING. DR AND ANOTHER NURSE CAME IN AND HELP ME TO ASSES PATIENT. WE KEPT PT FOR ABOUT 20 MINUTES AFTER SHE STATES SHE FEELS  OKAY AND LEAVE CLINIC WITHOUT DISTRESS. PT DIDN'T HER HERSEF.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Hot flush, Injection site cellulitis, Injection site erythema
Clinical narrative: 4 pm - Hot flashes for 3 hours, 1/3/19 - Extreme joint soreness hips, hands, wrists, shoulders, fingers...extreme tiredness. Red at shot site. 1/4/19 redness spreading toward elbow. Still sore at injection site. 1/10/19 Orthopedic Dr. (appt. for unrelated visit) looked at red site {about the size of a dollar bill} and diagnosed cellulitis and prescribed methylprednisolone. Cellulitis cleared up in about ten days. Ortho Dr. recommended not following up with second shot.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: 4 pm - Hot flashes for 3 hours, 1/3/19 - Extreme joint soreness hips, hands, wrists, shoulders, fingers...extreme tiredness. Red at shot site. 1/4/19 redness spreading toward elbow. Still sore at injection site. 1/10/19 Orthopedic Dr. (appt. for unrelated visit) looked at red site {about the size of a dollar bill} and diagnosed cellulitis and prescribed methylprednisolone. Cellulitis cleared up in about ten days. Ortho Dr. recommended not following up with second shot.