chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Nausea, Peripheral swelling, Vomiting
Clinical narrative: PATIENT COMPLAINED HAD NAUSEA AND VOMITING FROM NEXT DAY EVENING, CAN'T KEEP ANYTHING DOWN. ALSO HAD LEFT ARM SWOLLEN AND LEFT ARM HAD BIG VISIBLE REDNESS ON IT. PATIENT VISITED THE DOCTOR, WAS PRESCRIBED SOME ONDANSETRON TABLET 8MG TO USE EVERY 8 HOURS IF NEEDED, ALSO ADVISED BY DR TO TAKE SOME BENADRYL, USE ICE PACK AND HYDRATION (PHARMACIST SUGGESTED PEDIALYTE). * ALSO PATIENT RECEIVED INFLUENZA VACCINE SAME DAY ON RIGHT ARM INTRAMUSCULAR (FLUARIX PREFILLED SYRINGE- LOT # 5J594 - EXP DATE : 05/05/18).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema
Clinical narrative: Erythema, SOB.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Skin reaction
Clinical narrative: Patient experienced unusual skin reaction. Referred her to pcp. He diagnosed cellulitis. Prescribed antibiotic.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling of leg from upper thigh to knee, visibly larger and erythematous, hot to the touch.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Type III immune complex mediated reaction
Clinical narrative: Red, swollen, mildly bruised right thigh consistent with arthus reaction.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pt had intense pain and swelling with raised red circle starting that night of vaccination. Red circle got increased all the way to elbow from the injection site. Pt went to dr. She received rocephin there and then came to pharmacy and filled 2 rxs for omnicef 300mg bid x 10d, medrol 4mg dosepak.
Age: 61.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: The patient had swelling and redness in his left arm.  He was advised to use acetaminophen , an ice pack, and benadryl to help relieve his symptoms.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient had a very large bruise about 6 inches from below her deltoid to her elbow and what looked like a hematoma above the elbow. The bruise was not at injection site but rather below it by about an inch. The hematoma had disappeared by 9/14/17 but the large bruise was almost all the way around her arm. Patient didn't report pain or heat at injection site.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The area around where the vaccine was administered is red, swollen and itching and is hot to the touch. (He has received the flu shot before & has not had this reaction in the past, that's why they called to let us know).  He has not treated the area as of yet.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site swelling
Clinical narrative: Instantly after the vaccine was injected, injection site swelled up. There was blood that came out after injection but stopped bout 5 seconds later. The swollen area was hard to touch. It looked like a hard boil formed that has a diameter of a quarter. After about 15 minutes, the injection site was not hard anymore. A day after injection, patient reported that the injection site is still not hard and is red.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen, patchy area about 3-4 inches below injection site. She noticed it the next day and the following day it was even lower on her arm. It is better now.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Arm swollen, hard and red.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pruritus, Skin warm
Clinical narrative: Patient is saying arm is itchy, warm to touch, and is bruised (much lower than injection site).
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: MODERATE SWELLING, REDNESS AND TENDERNESS AT IMMUNIZATION SITE AND EXTENDING DISTALLY INTO L ARM OCCURING WITHIN HOURS OF THE IMMUNIZATION. NO FEVER, RESPIRATORY SYMPTOMS.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Headache, all over body ache, fatigue, lost of appetite-flu like symptoms lasted 5 days.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient was fine when given injection, but called and told pharmacist that she felt pain on the injection on day 6, then on day 7, injection site swelled up and is hard and painful. Patient was counseled to put some cold compress and take ibuprofen or TYLENOL for the pain. Patient was also told to contact doctor and pharmacy the next day morning if not better and pharmacy will also contact patient in a few days to follow-up.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Body temperature increased, Chills, Cough, Defaecation urgency
Clinical narrative: On 9/13 he woke up at 11pm with stomach pain and nausea, wheezing. All night vomiting and stomach pain stating felt like he had to have a BM, unable to have a BM. Last vomited at 7:30am. Temp 98.2 at 8am, unable to eat all day- 3:30 cough - temp 99.2 - stated he was cold/chills, wheezing - 7:30 99.8 temp gave Tylenol and inhaler.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Feeding disorder, Feeling cold, Nausea, Vomiting, Wheezing
Clinical narrative: On 9/13 he woke up at 11pm with stomach pain and nausea, wheezing. All night vomiting and stomach pain stating felt like he had to have a BM, unable to have a BM. Last vomited at 7:30am. Temp 98.2 at 8am, unable to eat all day- 3:30 cough - temp 99.2 - stated he was cold/chills, wheezing - 7:30 99.8 temp gave Tylenol and inhaler.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Fatigue, Poor quality sleep, Urticaria
Clinical narrative: Pt said he didn't sleep well Monday 9/11, then on Tue around noon he noticed a large red welt around his right arm at his elbow (not around injection site). I viewed the welt looking for a pierce in his skin because it looked like a welt from a spider bite, but saw no break in his skin. He did report that he had been trimming trees on Monday. He said he had felt tired since getting the immunization too. I advised him to take an antihistamine and ice the welt. He said the welt (which was quite large 6in x 3in) was larger prior to coming to pharmacy. I told him if it got larger again, or if he had additional complications to go to Dr and also report to us.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Injection site warmth, Pain in extremity
Clinical narrative: In addition to a sore arm, which we expected, my daughter started getting a bad headache, later on, the night that she got the shot. The next morning, she got diarrhea and continued to have an upset stomach until the next morning. By mid-afternoon, she had a fever of 100.5. Also, by evening of the first night of the injection, the injection site was extremely hot to the touch. This continued until Tuesday (the shot was on Sunday). By Tuesday morning the sore arm persisted as did the GI discomfort. Everything else had resolved. No one else in the family displayed or had any of these symptoms at any time, either prior to her receiving this vaccine or afterwards.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: In addition to a sore arm, which we expected, my daughter started getting a bad headache, later on, the night that she got the shot. The next morning, she got diarrhea and continued to have an upset stomach until the next morning. By mid-afternoon, she had a fever of 100.5. Also, by evening of the first night of the injection, the injection site was extremely hot to the touch. This continued until Tuesday (the shot was on Sunday). By Tuesday morning the sore arm persisted as did the GI discomfort. Everything else had resolved. No one else in the family displayed or had any of these symptoms at any time, either prior to her receiving this vaccine or afterwards.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood test normal, Dizziness, Dysarthria, Gait disturbance
Clinical narrative: Within 2 days of vaccination, patient reported experiencing  dizziness, stumbling/wobbly, numb left arm from shoulder to ankle, vision disturbance, pain in head, and slurred speech. Went to Emergency Room 09/13/17. Patient reports blood pressure was 199/??. in ER. She was given fluids and a stroke was ruled out. 09/14/17- still experiencing neck/shoulder/back pain, slight headache.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging normal
Clinical narrative: Within 2 days of vaccination, patient reported experiencing  dizziness, stumbling/wobbly, numb left arm from shoulder to ankle, vision disturbance, pain in head, and slurred speech. Went to Emergency Room 09/13/17. Patient reports blood pressure was 199/??. in ER. She was given fluids and a stroke was ruled out. 09/14/17- still experiencing neck/shoulder/back pain, slight headache.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis normal, Visual impairment
Clinical narrative: Within 2 days of vaccination, patient reported experiencing  dizziness, stumbling/wobbly, numb left arm from shoulder to ankle, vision disturbance, pain in head, and slurred speech. Went to Emergency Room 09/13/17. Patient reports blood pressure was 199/??. in ER. She was given fluids and a stroke was ruled out. 09/14/17- still experiencing neck/shoulder/back pain, slight headache.
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia, Muscle disorder, Pain
Clinical narrative: Long lasting pain and numbness in left aft (injection arm). The pain and numbness has lasted since injection. I also have muscle knots in that arm.
Age: 45.0
Sex: U
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging, Radiculitis brachial
Clinical narrative: Brachial neuritis.
Age: 0.83
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Chest X-ray, Diarrhoea, Rash, Vomiting
Clinical narrative: 2 days after immunization pt. developed rash, vomiting and diarrhea. Was seen in ED. F/U with PCP in clinic the following day (3 days after shots).
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Day after vaccination (vaccination given on 8/28/17) Patient developed swelling rash diameter about 4 inches on inside of elbow (around 6 inches from injection site (L) deltoid) - Patient went to urgent care on 8/31/17, was given triamcinolone 0.1% Inj.
Age: 56.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Noted mild warmth and swelling to left upper arm area. Tender to touch. Pt. able to move arm and work but c/o pain to site and tender to underarm.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered at inappropriate site, Injection site pain, Joint crepitation, Nuclear magnetic resonance imaging normal
Clinical narrative: FLUCELAVAX (influenza vaccine) was injected too high. Patient felt pain as soon as the needle entered her arm. Patient was sent to an Ortho surgeon who stated injection was given in her bursa. A year later patient has clicking in her left shoulder joint.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Per provider note on 6/14/2016, PREVNAR R deltoid a week ago. Lump when administered then next day swelling and inflammation surrounding injection site. Has not had PNEUMOVAX in past. No fever or chills, new muscle aches, swelling lips or hands. Ice packs/cold cloths with sl relief. Approximately 8 cm area of inflammation, s/warmth surrounding inj site. Sl tenderness to palpation, no epitrochlear or axillary adenopathy felt. Ice/cold cloth 15 intervals, topical steroids, return if not better. Does not appear infected.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Erythema multiforme, Pruritus, Skin warm, Swelling
Clinical narrative: Patient received pneumococcal polysaccharide vaccine PPSV23 on 6/22/17 and presented with redness, warmth, and itching on 6/23/17. A prescription for prednisone was provided to be filled outside the clinic. Erythema multiform. Urticaria Pruritus. Erythema; Pruritus; Swelling. Prednisone.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Patient received pneumococcal polysaccharide vaccine PPSV23 on 6/22/17 and presented with redness, warmth, and itching on 6/23/17. A prescription for prednisone was provided to be filled outside the clinic. Erythema multiform. Urticaria Pruritus. Erythema; Pruritus; Swelling. Prednisone.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient came to our pharmacy 3 days after vaccine administration. Her left arm had small, flat, red spots down her forearm and up to her deltoid. She stated they were not painful or itchy.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain, X-ray
Clinical narrative: Pt reports (R) shoulder pain started day after shot. Faded 1-2 weeks. Flared up again approximately 10 days later. When shoulder used pain 4-5/10. Experiences no pain when relaxed, laying down, not using arm/shoulder. Also has decreased ROM. Unable to sleep at times. MD at hospital did exercise at clinic increased pain 8/10 is continued. Patient report (R) shoulder pain level = 3-4/10 when inactive/relaxing - increased to 7/10 when reaches to grab something or carries something with weight. Denies numbness or tingling. No response to Ibuprofen and/or TYLENOL. At night, feels like dull, aching pain - no noted weakness.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Bone pain, Dizziness, Headache, Oropharyngeal pain
Clinical narrative: Temperature of 102. 7, bad dizziness, sore throat, very bad headache, bone pain.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Red-warm to touch, swollen and painful and itching.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Pt got vaccine on 9/11/17 in left deltoid. She called today (9/14/17) and reported she has redness, swelling, itching, warmth on the same arm as of 9/13/17. I directed her to see her MD and opened a claim with our company.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood lactic acid normal, Differential white blood cell count abnormal, Full blood count abnormal, Globulin, Headache
Clinical narrative: 9/6/17 1:30 PM Seen in office day of onset. Received PNEUMOVAX and flu shot and had labs drawn for her annual visit. Left clinic abt 3:30. Called about 4:45 same day c/o itching and some red blotches on thighs and arms. No difficulty breathing, sore throat or difficulty swallowing. Advised to take BENADRYL and monitor. Call if needed. On 9/7/17 pt went to ED for triage. Reports painful arm/subjective fevers and nausea and HA. Denied vomiting and abd pain. States she had hives and they resolved w/BENADRYL. No current rash. Has had flu shot multiple times, pneumonia vaccine was 1st time. At ED 9/8 pt received TYLENOL, TORADOL, DILAUDID and Fentanyl, as well as sodium chloride (2) 1,000 mL bolus and ondansetron. Labs and imaging were done for SOB. Impression: Hypoventilatory change. No acute cardiac problems. Labs drawn: CBC w/diff (Abnormal), WBC/MCV and Lymphocytes/Neutros, CMP (Abnormal) total protein and globulin, Procalcitonin: (Abn), Lactic acid: Normal, POCT UA dip: Normal. Suspect that this is reaction to vaccination than anything else. Pt feeling much improved. Dr suspect PNEUMOVAX over Influenza vaccination.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoventilation, Imaging procedure abnormal, Laboratory test abnormal, Lymphocyte count, Mean cell volume
Clinical narrative: 9/6/17 1:30 PM Seen in office day of onset. Received PNEUMOVAX and flu shot and had labs drawn for her annual visit. Left clinic abt 3:30. Called about 4:45 same day c/o itching and some red blotches on thighs and arms. No difficulty breathing, sore throat or difficulty swallowing. Advised to take BENADRYL and monitor. Call if needed. On 9/7/17 pt went to ED for triage. Reports painful arm/subjective fevers and nausea and HA. Denied vomiting and abd pain. States she had hives and they resolved w/BENADRYL. No current rash. Has had flu shot multiple times, pneumonia vaccine was 1st time. At ED 9/8 pt received TYLENOL, TORADOL, DILAUDID and Fentanyl, as well as sodium chloride (2) 1,000 mL bolus and ondansetron. Labs and imaging were done for SOB. Impression: Hypoventilatory change. No acute cardiac problems. Labs drawn: CBC w/diff (Abnormal), WBC/MCV and Lymphocytes/Neutros, CMP (Abnormal) total protein and globulin, Procalcitonin: (Abn), Lactic acid: Normal, POCT UA dip: Normal. Suspect that this is reaction to vaccination than anything else. Pt feeling much improved. Dr suspect PNEUMOVAX over Influenza vaccination.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Metabolic function test abnormal, Nausea, Neutrophil count, Pain in extremity, Procalcitonin abnormal
Clinical narrative: 9/6/17 1:30 PM Seen in office day of onset. Received PNEUMOVAX and flu shot and had labs drawn for her annual visit. Left clinic abt 3:30. Called about 4:45 same day c/o itching and some red blotches on thighs and arms. No difficulty breathing, sore throat or difficulty swallowing. Advised to take BENADRYL and monitor. Call if needed. On 9/7/17 pt went to ED for triage. Reports painful arm/subjective fevers and nausea and HA. Denied vomiting and abd pain. States she had hives and they resolved w/BENADRYL. No current rash. Has had flu shot multiple times, pneumonia vaccine was 1st time. At ED 9/8 pt received TYLENOL, TORADOL, DILAUDID and Fentanyl, as well as sodium chloride (2) 1,000 mL bolus and ondansetron. Labs and imaging were done for SOB. Impression: Hypoventilatory change. No acute cardiac problems. Labs drawn: CBC w/diff (Abnormal), WBC/MCV and Lymphocytes/Neutros, CMP (Abnormal) total protein and globulin, Procalcitonin: (Abn), Lactic acid: Normal, POCT UA dip: Normal. Suspect that this is reaction to vaccination than anything else. Pt feeling much improved. Dr suspect PNEUMOVAX over Influenza vaccination.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Protein total, Pruritus, Pyrexia, Rash macular, Urine analysis normal
Clinical narrative: 9/6/17 1:30 PM Seen in office day of onset. Received PNEUMOVAX and flu shot and had labs drawn for her annual visit. Left clinic abt 3:30. Called about 4:45 same day c/o itching and some red blotches on thighs and arms. No difficulty breathing, sore throat or difficulty swallowing. Advised to take BENADRYL and monitor. Call if needed. On 9/7/17 pt went to ED for triage. Reports painful arm/subjective fevers and nausea and HA. Denied vomiting and abd pain. States she had hives and they resolved w/BENADRYL. No current rash. Has had flu shot multiple times, pneumonia vaccine was 1st time. At ED 9/8 pt received TYLENOL, TORADOL, DILAUDID and Fentanyl, as well as sodium chloride (2) 1,000 mL bolus and ondansetron. Labs and imaging were done for SOB. Impression: Hypoventilatory change. No acute cardiac problems. Labs drawn: CBC w/diff (Abnormal), WBC/MCV and Lymphocytes/Neutros, CMP (Abnormal) total protein and globulin, Procalcitonin: (Abn), Lactic acid: Normal, POCT UA dip: Normal. Suspect that this is reaction to vaccination than anything else. Pt feeling much improved. Dr suspect PNEUMOVAX over Influenza vaccination.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination complication, White blood cell count
Clinical narrative: 9/6/17 1:30 PM Seen in office day of onset. Received PNEUMOVAX and flu shot and had labs drawn for her annual visit. Left clinic abt 3:30. Called about 4:45 same day c/o itching and some red blotches on thighs and arms. No difficulty breathing, sore throat or difficulty swallowing. Advised to take BENADRYL and monitor. Call if needed. On 9/7/17 pt went to ED for triage. Reports painful arm/subjective fevers and nausea and HA. Denied vomiting and abd pain. States she had hives and they resolved w/BENADRYL. No current rash. Has had flu shot multiple times, pneumonia vaccine was 1st time. At ED 9/8 pt received TYLENOL, TORADOL, DILAUDID and Fentanyl, as well as sodium chloride (2) 1,000 mL bolus and ondansetron. Labs and imaging were done for SOB. Impression: Hypoventilatory change. No acute cardiac problems. Labs drawn: CBC w/diff (Abnormal), WBC/MCV and Lymphocytes/Neutros, CMP (Abnormal) total protein and globulin, Procalcitonin: (Abn), Lactic acid: Normal, POCT UA dip: Normal. Suspect that this is reaction to vaccination than anything else. Pt feeling much improved. Dr suspect PNEUMOVAX over Influenza vaccination.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Flu Vaccine - adverse reaction: swollen left arm, warm to touch, pain and soreness, redden.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Injection site is red, hard, warm, and the size of a baseball. She reports it is spreading to her armpits and elbow.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Pallor, Underdose, Vomiting projectile
Clinical narrative: Administered one drop of ROTATEQ and baby projectile vomited. Waited a few minutes and tried another drop and the baby vomited again and became pale. We did not complete the administration of the vaccine and did not give the other vaccines. Baby reassessed and color improved and patient was well appearing.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Dyskinesia, Malaise, Musculoskeletal stiffness, Somnolence
Clinical narrative: Pt started to feel unwell, said I feel like I'm going to faint. Nursing staff reclined pt on exam table to supine position. Within 5 sec of GARDASIL vaccine administration. Pt remained conscious for 15 sec talking w/nurse, then proceeded to have stiffening of body flexion and jerking of arms and legs, incontinence of urine. Episode lasted 45 sec. Pt woke, drowsy and gradually recovered over 20 mins.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Urinary incontinence
Clinical narrative: Pt started to feel unwell, said I feel like I'm going to faint. Nursing staff reclined pt on exam table to supine position. Within 5 sec of GARDASIL vaccine administration. Pt remained conscious for 15 sec talking w/nurse, then proceeded to have stiffening of body flexion and jerking of arms and legs, incontinence of urine. Episode lasted 45 sec. Pt woke, drowsy and gradually recovered over 20 mins.
Age: 25.0
Sex: U
Vaccine: TDAP
Symptoms: Dizziness, Hypoaesthesia, Nausea, Posture abnormal
Clinical narrative: At first patient stressed they were dizzy, pharmacist checked patient's heart rate and it was normal. Few minutes later patient was sitting in uncomfortable position and claimed they were nauseous and lost feeling in arms. Paramedics came and said patient was fine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Pt had a large flat red rash covering approximately 50% of (L) upper arm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Erythema, Nodule, Rash, Skin warm
Clinical narrative: The vaccine had to be given lower than deltoid region due to patient clothing. The next morning she experienced redness/heat on side of her arm and a small nodule. It did not hurt. It looked similar to a rash. It did not itch.
Age: 11.0
Sex: U
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Blood creatine phosphokinase normal, Full blood count normal, Injection site swelling, Red blood cell sedimentation rate normal, Vaccination site reaction
Clinical narrative: Was in office today 9-14-17. Had large swelling of left upper and forearm. Mom stated had similar but milder reaction after flu shot 9-10-16.
Age: 10.0
Sex: M
Vaccine: MENB
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: The patient received the one vaccine in his arm on the 13th. By that evening, the arm started to swell and was very painful. He opted out of football practice and stayed home. The pain was severe and the right arm became numb. He was nauseous all evening and had multiple bouts of dry heaves but never fully vomited. By morning, the numbness resolved, but he still felt mildly nauseous. He was seen at 09:45 on the 14th. The nausea resolved and he did not have any stomach tenderness. The site of Injection was raised, slightly pink and tender. He said he felt better but did not want anyone to touch the arm at the site of injection.
Age: 10.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Retching
Clinical narrative: The patient received the one vaccine in his arm on the 13th. By that evening, the arm started to swell and was very painful. He opted out of football practice and stayed home. The pain was severe and the right arm became numb. He was nauseous all evening and had multiple bouts of dry heaves but never fully vomited. By morning, the numbness resolved, but he still felt mildly nauseous. He was seen at 09:45 on the 14th. The nausea resolved and he did not have any stomach tenderness. The site of Injection was raised, slightly pink and tender. He said he felt better but did not want anyone to touch the arm at the site of injection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt. developed a 2 inch area of mild edema and erythema to right thigh - symptoms lasted 5-6 days. Parent gave BENADRYL and MOTRIN for symptoms.
Age: 77.0
Sex: M
Vaccine: FLUA3, TDAP
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: Swollen/red bicep and arm not at inject site. Patient stated arm is much larger than other arm and bleed a lot at time of injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site nodule, Injection site rash, Rash, Rash macular, Skin warm
Clinical narrative: Rash on Bilat legs, knees, up thighs, knot on R thigh. Rash on stomach blotchy warm to touch. Prescribed Prednisolone 15/5 1.5 tsp po daily x 3 d, cephalexin 250/5 7 mL po BID x 10 d, hydrocortisone oint 2.5% apply topically BID x 10 d. RTC PRN.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine output decreased, Vomiting projectile
Clinical narrative: Low fev. after imm. but increased to 104.2 temporal fev. that started 9/13/17. Has given TYLENOL 9/12 and no help. Today changed to ibuprofen PRN. Increased fev. x 24 hrs.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Low fev. after imm. but increased to 104.2 temporal fev. that started 9/13/17. Has given TYLENOL 9/12 and no help. Today changed to ibuprofen PRN. Increased fev. x 24 hrs.
Age: 1.92
Sex: F
Vaccine: DTAPHEPBIP, MMRV, PNC13, VARCEL, DTAPHEPBIP, MMRV, PNC13, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 1 year old female patient. The patient's pertinent medical history, drug reactions and allergies were not reported. On 13-SEP-2017 the patient was vaccinated with PROQUAD lot # N016113, expiration date 21-NOV-2018 (dose and route of administration were not reported) for prophylaxis and VARIVAX lot # N002203, expiration date 19-JAN-2019 (dose and route of administration were not reported). It was reported that PROQUAD was administered instead of intended M-M-R II. No adverse effects were reported.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pt reported having shooting pain in neck and through her arm after getting the vaccination. Patient called her nurse friend who told the patient that it happens when the nerve gets hit while vaccination is given. Patient reported doing better as of 9/14/2017.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pt reported having shooting pain in neck and through her arm after getting the vaccination. Patient called her nurse friend who told the patient that it happens when the nerve gets hit while vaccination is given. Patient reported doing better as of 9/14/2017.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: I can't even lift my arm. It is completely useless. It is so painful if I move it at all. I have had plenty of vaccines and never had a reaction like this.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Decreased appetite, Diarrhoea, Injection site erythema, Injection site inflammation, Injection site mass
Clinical narrative: That night patient's arm turned bright red and the lump became hot, inflammed, painful and swollen. He complained he couldn't move or use his arm. He couldn't sleep until about 7am on 2/28/17. The following morning around 10am he spiked a fever of 101.2 and wouldn't eat. Patient had diahrea , a fever and couldn't use his arm due to swelling and pain for a week. He missed a week of school. During that time I returned to the doctor concerned and he said this was normal, however I know it was not. Patient never complained about anything. The doctor brushed me off and told me to keep him home for a few days. He examined patient and agreed his arm was hot and was very swollen. After 13 days the swelling and redness in his arm went away. After about 3 weeks patieint was able to use his arm properly again.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site movement impairment, Injection site pain, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: That night patient's arm turned bright red and the lump became hot, inflammed, painful and swollen. He complained he couldn't move or use his arm. He couldn't sleep until about 7am on 2/28/17. The following morning around 10am he spiked a fever of 101.2 and wouldn't eat. Patient had diahrea , a fever and couldn't use his arm due to swelling and pain for a week. He missed a week of school. During that time I returned to the doctor concerned and he said this was normal, however I know it was not. Patient never complained about anything. The doctor brushed me off and told me to keep him home for a few days. He examined patient and agreed his arm was hot and was very swollen. After 13 days the swelling and redness in his arm went away. After about 3 weeks patieint was able to use his arm properly again.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Loss of personal independence in daily activities, Pyrexia
Clinical narrative: That night patient's arm turned bright red and the lump became hot, inflammed, painful and swollen. He complained he couldn't move or use his arm. He couldn't sleep until about 7am on 2/28/17. The following morning around 10am he spiked a fever of 101.2 and wouldn't eat. Patient had diahrea , a fever and couldn't use his arm due to swelling and pain for a week. He missed a week of school. During that time I returned to the doctor concerned and he said this was normal, however I know it was not. Patient never complained about anything. The doctor brushed me off and told me to keep him home for a few days. He examined patient and agreed his arm was hot and was very swollen. After 13 days the swelling and redness in his arm went away. After about 3 weeks patieint was able to use his arm properly again.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an 18 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates in 2015 and 2016, the patient respectively received the first and second dose of GARDASIL 9 (strength, dose, frequency, lot#, expiration date and route were unknown), both for prophylaxis (inappropriate schedule of drug administered). No adverse effects were reported. No product quality complaint (PQC) was involved in this case.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 22-JUN-2017 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L038018, expiration date 13-SEP-2017) and an improperly stored dose of ROTATEQ (lot# M031802, oral) for prophylaxis. Concomitant therapies included DTaP-IPV and PREVNAR 13. No adverse event was reported. This is one of several reports received from the same reporter. Follow up information has been received on 13-SEP-2017 from the nurse referring to the 8 weeks old male patient. The patient was vaccinated with RECOMBIVAX HB intramuscularly in the right thigh. It was reported that the refrigerator was out of temperature range. This is a corrected report.  This report was previously submitted with the incorrect Worldwide unique case identification number 'US-009507513-1707USA006507', and this new follow-up submission is to provide the correct identification number 'US-009507513-1708USA006935'. 'US-009507513-1707USA006507' is an existing case, therefore this safety report is not being nullified, just updated to reflect correct Worldwide Unique Identifier. Sender's Comments: US-009507513-1707USA006507.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 06-JUN-2017 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M031802, oral) for prophylaxis. Concomitant therapies included PREVNAR 13 and HIB CONJ VACCINE (UNSPECIFIED CARRIER). No adverse event was reported. This is one of several reports received from the same reporter. Follow up information has been received on 13-SEP-2017 from the nurse referring to the 9 weeks old male patient. It was reported that the refrigerator was out of temperature range. This is a corrected report. This report was previously submitted with the incorrect Worldwide unique case identification number 'US-009507513-1707USA006507', and this new follow-up submission is to provide the correct identification number 'US-009507513-1708USA006959'. 'US-009507513-1707USA006507' is an existing case, therefore this safety report is not being nullified, just updated to reflect correct Worldwide Unique Identifier. Sender's Comments: US-009507513-1707USA006507.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 07-AUG-2017, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # M042857, expiration date 21-OCT-2018, strength, dose and route unknown) for prophylaxis, the sterile diluent (manufacturer unknown) (lot# and expiration date unknown) used to reconstitute the vaccine above was properly stored. No adverse effects were reported. The vaccines were exposure at the temperature of 12.4 Fahrenheit (6 to 14 Fahrenheit) for 15 hours and 45 minutes. There was no previous temperature excursion. A data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1708USA008578: US-009507513-1709USA007601: US-009507513-1709USA007602: US-009507513-1709USA007603: US-009507513-1709USA007604: US-009507513-1709USA007605.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: Information has been received from a pharmacist via a field employee referring to an unspecified number of unknown age and gender. The patients' medical history included shingles, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients vaccinated with ZOSTAVAX (dose, frequency, route, lot #, expiration date were unknown) which reconstituted with sterile diluent (lot# and expiration date unknown), for prophylaxis. The patients had large lumps around the injection site after the administration of ZOSTAVAX. It was unknown that if the patients had sought for medical attention. The outcome of the event was unknown at the time of this report. The relationship between the event and ZOSTAVAX or sterile diluent were not provided.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 19-AUG-2017, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, frequency, route and indication not reported, lot # M037015 with expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # M035268 with expiration date 19-APR-2019). Temperature that the vaccine exposed to was 40.2 F, the time frame was unknown. There was a previous temperature excursion of 15 F to 46 F for 18 hours and 34 minutes. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1709USA007622: US-009507513-1709USA007623.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified numbers of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored GARDASIL 9 (dose, frequency, route, indication, lot # and expiration not reported). Temperature that the vaccines exposed to was 13.1 C with time frame of 22 minutes. There was a previous temperature excursion of 14C for 22 minutes.  No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007693:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored dose of PNEUMOVAX 23 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit grades range for a time frame of 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007303: US-009507513-1709USA007306: US-009507513-1709USA007304: US-009507513-1709USA007305.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not provided. On an unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of VARIVAX lot number N002204, expiration date 19-JAN-2019 (dose, frequency and administration route were not reported), for prophylaxis. Concomitant therapies included sterile diluent (lot number reported as "N003912" and expiration date 05-JUL-2019) used for reconstitution, which did not undergo a temperature excursion. The data logger registered a temperature of minus (-)58° Fahrenheit (F) to 5°F (-3.10) for 45 minutes, 6°F to 14°F for 2 hours 30 minutes and 15°F to 46°F for 31 hours 15 minutes. There was not previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown dates, the patients were vaccinated with an improperly store dose of M-M-R II (rHA) lot number L035674 and expiration date of 17-SEP-2017 for prophylaxis (dose and route of administration were not reported). The sterile diluent used to reconstitute the M-M-R II was properly stored. No symptoms were reported. The vaccine was exposed to a temperature excursion of 47.5°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. Sender's Comments: US-009507513-1709USA004384.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to an unspecified amount of unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. The patients were vaccinated with an improperly stored dose of RECOMBIVAX HB lot # N009802, expiration date 19-DEC-2019, intramuscularly (strength and dose were not reported) for prophylaxis from a time period starting 28-AUG-2017 until 07-SEP-2017. The administered doses of the vaccine experienced a temperature excursion of 47° Fahrenheit to 77° Fahrenheit (48F) for time frame of 30 minutes. There was no previous temperature excursion and no data logger. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M044717 with an expiration date of 19-JUL-2019, (doses, route of administration were not reported). Administered doses of GARDASIL 9 underwent a temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 11 hours, which was detected by a digital data logger. There was the previous temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 45 minutes reported. No adverse symptoms were reported. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007586:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # reported as N018273, expiration date 17-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47.5 degrees Fahrenheit for 1 hour 30 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007677: US-009507513-1709USA007678: US-009507513-1709USA007679.
Sex: U
Vaccine: HIBV, HPV9, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB lot# N001348 expiration date 31-OCT-2019, lot# N007750 expiration date 29-NOV-2019, lot# N012921 expiration date 28-FEB-2020, or GARDASIL 9 lot# M036059 expiration date 03-JUN-2019, lot# N007931 expiration date 17-NOV-2019, lot# N009173 expiration date 20-NOV-2019, lot# N009801 expiration date 20-NOV-2019, lot# N012093 expiration date 13-JAN-2020, lot# N020352 expiration date 10-APR-2020 or PNEUMOVAX 23 lot# N011491 expiration date 04-NOV-2018, lot# N014188 expiration date 22-NOV-2019 (exact dose, route of administration and anatomical location were not provided). The reporter was unable to identify if the improperly stored dose that was given was LIQUID PEDVAXHIB, GARDASIL 9 or PNEUMOVAX 23. Administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit (47.6 degrees Fahrenheit) for 1 hour and 5 minutes which was detected by a digital data logger. There was no previous excursions reported. No adverse were effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # N008829, expiration date 16-MAR-2019 and N014632, expiration date 11-MAY-2019 (dose, concentration and route of administration were not reported). Concomitant therapies included sterile diluent. There were no adverse symptoms or effects reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 36 hours (not as previously reported 9 degrees Fahrenheit for 9 hours). Previous temperature excursion was of 6 to 14 degrees Fahrenheit for 512 hours. Digital data logger was not involved. Outcome of the event was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 08-SEP-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M042503 with an expiration date of 08-AUG-2017, subcutaneously (exact dose was not provided). Concomitant medication included sterile diluent (MERCK). No adverse events were reported.