chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Cold sweat, Computerised tomogram, Contusion
Clinical narrative: Felt severe nausea, broke out in cold sweat and fainted. This happened about 12 hours after the injection was administered. This happened after the first dosage (7/18) and again 3 months later after the second dosage. Both times I fainted and the second time I hit my head and had to have a CT scan. I currently have a "black" eye on the right where I hit my head. The first time I bruised the tip of my spine when I fainted.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram, Eye contusion, Head injury, Nausea, Syncope
Clinical narrative: Felt severe nausea, broke out in cold sweat and fainted. This happened about 12 hours after the injection was administered. This happened after the first dosage (7/18) and again 3 months later after the second dosage. Both times I fainted and the second time I hit my head and had to have a CT scan. I currently have a "black" eye on the right where I hit my head. The first time I bruised the tip of my spine when I fainted.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Epistaxis, Fatigue, Feeling hot, Headache
Clinical narrative: Approximately an hour after vaccination, she reported lightheadedness, dizziness, severe headache, Warmth (isolated to the head), Fatigue and burning nose w/bleeding when blown. V/S B/P 122/86, Pulse 120, Temp. 98.8. TYLENOL 1000 mg given at 5:45.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Nasal discomfort
Clinical narrative: Approximately an hour after vaccination, she reported lightheadedness, dizziness, severe headache, Warmth (isolated to the head), Fatigue and burning nose w/bleeding when blown. V/S B/P 122/86, Pulse 120, Temp. 98.8. TYLENOL 1000 mg given at 5:45.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Arm was red and painful for 2 weeks.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: I received a call from patient on 10/14/18 at the store. She notified me that day of a potential adverse effect from a flu vaccination received on 10/01/2018. She said that ever since her shot, she has had numbness and tingling all over, but it had localized to arms and legs now. The daughter recalls the vaccine having a pink tint to it and a pharmacist with short hair giving her shot. I spoke with RPh and she did not recall any vaccine that was pink on that day. I have been in touch with mom several times to check on her. I did advise at our first conversation that she be seen by a provider and have some blood drawn. Symptoms have continued and pt is to see a provider on 11/02/18. Mom denies pt ever having a fever.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Headache, Paraesthesia
Clinical narrative: Acute Headache: Unusual for patient. This happened for an hour and occurred several hours after. Fingers tingled: Within an hour after.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Musculoskeletal pain, Pain
Clinical narrative: Pain in shoulder while sleeping the night of 10/28/2018. Upon waking up, upper arm is swollen and tender. Throughout the day I began feeling run down and rested often at work. At home - around 5:10, still felt bad and not hungry. Fever of 100. Put ice on shoulder which helped the pain. Body is achy and joints are painful.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Pain in shoulder while sleeping the night of 10/28/2018. Upon waking up, upper arm is swollen and tender. Throughout the day I began feeling run down and rested often at work. At home - around 5:10, still felt bad and not hungry. Fever of 100. Put ice on shoulder which helped the pain. Body is achy and joints are painful.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Patient reports that the day following the vaccination she received a red band like rash on the upper arm - red and heat has been subsiding and was barely visible today 10/30 (3 days after she noticed the red mark).
Age: 68.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: Patient's wife called to say patient was experiencing a low grade fever or 100.2 and his arm was red and inflamed at the injection site.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Injection site bruising, Injection site haemorrhage, Injection site swelling
Clinical narrative: When pulling needle out of patient's arm, patient bleed more than usual. Blood pooled under the skin at the site of injection and the area of injection swelled. Bleeding stopped quickly with cotton ball and pressure. Area bruised. Called pt a few hours later said area swelled pretty good but has since went down. But area is bruised. Pt also was experiencing some chills.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Injection site bruising, Injection site haemorrhage, Injection site inflammation
Clinical narrative: Pregnancy marked off on consent form, newly pregnant. I gave the shot as I always do, make a "C" on the arm from the shoulder bone and place needle in middle of "C" in the muscle. When I removed the needle there was a stream of blood that came out of injection site. So I immediately applied pressure with cotton ball and held til it stopped in about 10 seconds. I applied a bandaid and wiped patient's arm with cotton ball from blood that ran down arm. I apologized immensely and asked her if she was light headed, she said no. I asked her if I could get her a drink or something to eat. I asked her if she wanted to stay seated to relax she could. I asked if she had been working out or active before her flu shot bc I know that could get blood flowing but she said no. There was a slight inflammation and and bruise at the injection sight after I put the bandaid on. Patient was upset and crying and again I apologized many times.  I advised her to put ice on it when she got home that it would be sore.  An hour later her mother called saying I never apologized saying I gave the flu shot wrong and I shouldnt be giving flu shots. I tried to explain how I handled the situation and the mom hung up on me saying I will take this to the highest level.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Nothing happened to the patient while I gave him the shot or right after but a few hours later he did have a seizure at work. EMS was called and he was taken to the hospital to be observed. When I followed up with the patient he did tell me he has gotten the flu shot before and never had a reaction. I actually gave him his flu shot last year at his employer office also. He did tell me he had brain surgery about 5 years ago for a non cancerous tumor. He sees his neurosurgeon once a year.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Patient notified pharmacy on 10/29/18. When she received the vaccination on 9/7/18 the next day she stated that she had deep body aches not relieved by acetaminophen or ibuprofen that lasted for about 3 weeks, then resolved, then 3 weeks later developed the same muscle aches but not more confined to her arm(s).
Age: 42.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Pyrexia, Rash macular
Clinical narrative: Patient had redness and a low grade fever starting 24 hours after administration. She then went to the Doctor 3 days after administration where she had red blotches around two of the vaccination sites. She believes the only site not affected was the FLUARIX site. She came to the pharmacy and showed 2 large 4 inch in diameter blotches and stated the Doctor diagnosed her with cellulitis. She was prescribed AUGMENTIN for the infection.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: Patient had severe pain in left arm beginning the night of vaccination, describes as 9/10 in severity with any motion. Maintained this level of pain for about 3 days, interrupting his sleep. Experienced numbness and tingling in the R hand intermittently during this time. Now 5 days later, the pain is 2/10 at rest and 7/10 with motion.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Myalgia
Clinical narrative: Patient states he had muscle aches and chills for days.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Muscular weakness, Neurological examination
Clinical narrative: Patient called to state that the day following the immunization, she had muscle weakness and numbness that began in bilateral feet and legs and ascended to her hands and arms. She has since gone to her regular physician and a neurologist. The neurologist stated it was unlikely Guillain-Barre syndrome, but was advised to contact pharmacy to discuss reaction with pharmacy.
Age: 61.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: The patient reported that the site of the SHINGRIX vaccination was red and hot to the touch with swelling. The patient was chilled and achy the day after the vaccination was administered but this only lasted one day. The swelling and redness persisted for approximately two weeks. The patient did not report pain at the site of injection.
Age: 68.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: The patient reported aches, chills and a headache that lasted for one day after receiving the vaccination.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Arm sore/muscle ache. After few days, pt states feels better without muscle ache/soreness.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Musculoskeletal pain, Neck pain
Clinical narrative: Pain in neck and shoulders. Numbness in upper arm, thumb, index finger of right arm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Diarrhoea, Fatigue, Headache, Injection site induration
Clinical narrative: Dose 1 on July, 3, 2018-AEs lymphadenopathy, fever, rash, >101, CRP=23. Dose 2  October 28, 2018 AEs: Tachycardia, Nausea, vomiting, headache, indurated rash at injection site,  severe fatigue, loose stools.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Lymphadenopathy, Nausea, Pyrexia, Rash
Clinical narrative: Dose 1 on July, 3, 2018-AEs lymphadenopathy, fever, rash, >101, CRP=23. Dose 2  October 28, 2018 AEs: Tachycardia, Nausea, vomiting, headache, indurated rash at injection site,  severe fatigue, loose stools.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia, Vomiting
Clinical narrative: Dose 1 on July, 3, 2018-AEs lymphadenopathy, fever, rash, >101, CRP=23. Dose 2  October 28, 2018 AEs: Tachycardia, Nausea, vomiting, headache, indurated rash at injection site,  severe fatigue, loose stools.
Age: 18.0
Sex: F
Vaccine: FLUC4, MMR
Symptoms: Feeling hot, Pyrexia
Clinical narrative: BODY WARM AND FEEL LIKE SYMPTOMS OF FEVER.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Patient had limited range of motion in vaccinated arm, and patient described notable pain the day after receiving the vaccination. However, the pain and stiffness worsened and lasted much longer than normal and patient reported that she was still suffering on 10/30/2018 and noted a doctor visit was required. Pain has lasted 2 weeks now and patient is still suffering from pain and she cannot lift her arm above her head.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient says it was sore the day after and it continues to hurt when raising shoulder affecting her functionality. Recommended she have a physician look at it.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Discomfort, Fatigue
Clinical narrative: After approximately ten hours after the vaccine shot, I felt tired, weak, and uncomfortable. I began to shiver and had a terrible headache. My body felt very heavy and my joints and muscles ached terribly. As I shivered, I also felt feverish. I went to bed and covered myself with blankets but continued to feel these symptoms during the night. After 24 hours, I felt better. Thankfully, I had no redness nor swelling around site of the injection. I would like to know if it is safe for me to have the second vaccine in two months.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia
Clinical narrative: After approximately ten hours after the vaccine shot, I felt tired, weak, and uncomfortable. I began to shiver and had a terrible headache. My body felt very heavy and my joints and muscles ached terribly. As I shivered, I also felt feverish. I went to bed and covered myself with blankets but continued to feel these symptoms during the night. After 24 hours, I felt better. Thankfully, I had no redness nor swelling around site of the injection. I would like to know if it is safe for me to have the second vaccine in two months.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Rash erythematous
Clinical narrative: Patient came back to pharmacy 2 days after vaccine administered. She reported extreme soreness on Monday which had resolved but there was a red rash from her shoulder to her elbow. She was concerned it was more than what should be expected with normal redness at sight.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Hot to touch, RED, big bump.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Dyskinesia, Fall
Clinical narrative: Shortly after receiving FLUZONE QUADRIVALENT vaccine patient's mother states patient fell to ground and hands and feet started jerking.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain, Pyrexia
Clinical narrative: The patient reported to me today (29 days after the vaccine) that he had severe bruising over the entire deltoid area and that he still has pain on the spot where the vaccine was given. The bruise was dark at first but is getting lighter (it was yellow today when I examined it). He said that it still hurts when he touches the area where the vaccine was given. He reported a low fever in the days following the vaccine, but the fever is gone now. There was no visible swelling today, just yellow bruising over the entire deltoid area today. He says that it is improving, but was concerned because it has been so long since he received the vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Nausea, Pyrexia, Vomiting
Clinical narrative: ADR: NAUSEA/VOMITING LASTING WEEKS, LARGE WELT AT SITE LASTING 4 DAYS, FEVER OF greater than 101 F. STILL FEELING NAUSEATED. FEVER AND WELT GONE.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Decreased appetite, Fatigue, Nausea, Pyrexia
Clinical narrative: Fatigue, loss of appetite, nausea, fever.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Eye irritation, Eye pruritus, Feeling abnormal, Headache
Clinical narrative: This was a quadrivalent influenza shot. On Sunday afternoon/evening, about 48h later, she felt poorly. Low appetite, itchy eyes, sore throat, not feeling right. She complained of "fireplace eyes" and said something was wrong with her. Fell asleep at about 8 in a chair, early for her. At 11 PM, I took her temp in armpit, 100.2 and gave her 1.5 tabs ibuprofen to help her fever and headache she said she had. Fever broke. Next day, complained of headache again and again gave ibuprofen. Later in the day she was feeling better. Tuesday, her symptoms have resolved and she is feeling fine.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain
Clinical narrative: This was a quadrivalent influenza shot. On Sunday afternoon/evening, about 48h later, she felt poorly. Low appetite, itchy eyes, sore throat, not feeling right. She complained of "fireplace eyes" and said something was wrong with her. Fell asleep at about 8 in a chair, early for her. At 11 PM, I took her temp in armpit, 100.2 and gave her 1.5 tabs ibuprofen to help her fever and headache she said she had. Fever broke. Next day, complained of headache again and again gave ibuprofen. Later in the day she was feeling better. Tuesday, her symptoms have resolved and she is feeling fine.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced pain, swelling, and redness to the injection site and most of the upper arm within 24 hours of vaccinations. Patient went to her Doctor and was diagnosed with cellulitis. Patient was put on KEFLEX and a pain medication for treatment 3 days after vaccination.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Condition aggravated, Mobility decreased, Musculoskeletal pain, Undifferentiated connective tissue disease
Clinical narrative: Bilateral shoulder bursitis with difficulty lifting arms, bilateral shoulder pain, flare of recurrent connective tissue issues overall.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: Flu shot resulted in severe elbow and shoulder pain. Now entire area is sore with poor range of motion. I have trouble lifting because of weakness. Bending my elbow causes jolts of pain.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Hallucination, Pyrexia
Clinical narrative: Patient started having hallucinations and a 104 fever within 24 hours of receiving the shot. Paramedics were called, the patient didn't want to go to the hospital. Patient did visit the Dr. the following Monday.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: At the site of injection of the new egg-less flu shot, which I received on 10/10/2018, I had a rash and severe itching. The rash and itching remain on 10/30/2018.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: IMOVAX (rabies vaccine) was given via gluteal administration. Per package insert gluteal administration is not recommended due to risk of vaccine failure due to reduced antibody formation.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles two years later. You product does NOT work.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt presented to ED w/erythema and pain of injection site of pneumonia vaccine, received 3 days ago. Received BENADRYL, PEPCID, DECADRON, and PERCOCET discharged scripts.
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Dizziness, Erythema, Nausea, Pain
Clinical narrative: Nausea, dizziness, local erythema/pain Sx persisted at least through 10/30/18 (vaccine given 10/21/18).
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Skin Rash. Treatment: Diphenhydramine 12.5 mg once.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Dyskinesia
Clinical narrative: Flu shot given at another clinic. We are the PCP. Seen today 10-30-18. 10-21-18 - abnormal, involuntary movements began - had occurred everyday. Seen today while here at visit 10-30-18.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: L lower neck swollen lymph node - painful. Rx with Ibuprofen, ice. Resolved 3 days later.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Neck/L lower neck swollen painful lymph node. Resolved with ice/NSAIDs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Oropharyngeal pain, Streptococcus test negative, Urticaria
Clinical narrative: 10/29/18 mom was changing pt's clothing at 6:45pm-and mom noticed a rash on Lt thigh and behind knee. Pt C/O sore throat, and within 15 mins. pt was covered with hives. Pt and mom went to ER.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Gait disturbance, Nausea
Clinical narrative: Pain in arm and all over, extreme pain in left knee. Extremely tired, fever, chills, nausea. I still have extreme pain in my knee and can hardly walk. I use a cane, but it is painful to get around. I have never experienced it as bad as it is now after this shot.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Ultrasound scan, Walking aid user
Clinical narrative: Pain in arm and all over, extreme pain in left knee. Extremely tired, fever, chills, nausea. I still have extreme pain in my knee and can hardly walk. I use a cane, but it is painful to get around. I have never experienced it as bad as it is now after this shot.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: Pain in arm and all over, extreme pain in left knee. Extremely tired, fever, chills, nausea. I still have extreme pain in my knee and can hardly walk. I use a cane, but it is painful to get around. I have never experienced it as bad as it is now after this shot.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypersensitivity, Pruritus generalised, Rash generalised
Clinical narrative: Severe allergic reaction. Rashes, bumps and itchiness all over the entire body. Patient had the symptoms for 2 weeks and finally went to see the doctor. She was prescribed steroid cream.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Rash, Rash erythematous
Clinical narrative: Left upper arm had shoulder pain and swelling. Rash was red on arm for a few days.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient experienced redness/swelling throughout her left arm. It happens the same night patient received the vaccines 10/25. She reported the next day and I suggested her to go see a doctor if the problem did not resolve later of the day. She ended up not seeing a doctor but took couple ALEVE OTC. When I followed up with her on 10/30, she stated the swollen arm has been gone and she has not experienced any other problems at all.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, Pain
Clinical narrative: Patient reported pain to workplace nurse the day after vaccination. Stated the pain kept him from being able to sleep that night. Patient was counseled to try a pain reliever such as ibuprofen or TYLENOL to see if that helped as injection site pain is a common side effect for the first day or two after vaccination. Patient was counseled to seek medical attention if pain lasted longer than that. On 10/23/2018 pt. reported that he still had pain at the injection site and pain with active range of motion. He can lift arm at chest level but has a lot of pain if he tries to go above that. On 10/30/18 pt. still has pain at injection site when he touches it, but he's not having pain all down his arm anymore. He feels like pain has moved because now it hurts him more in the front of his shoulder but only at night. He wakes up due to the pain. He does get relief by taking ibuprofen. Patient rates pain as 4/10. He states he doesn't notice it much during the day, just at night. Patient was again referred to his doctor for evaluation.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmological examination
Clinical narrative: I saw patient today and she is having some symptoms consistent with shingles or herpetic attack but the eye itself is quiet.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient presented to our ER with erythema and pain at site of injection of pneumonia shot (which was received at their pharmacy). Patient received DECADRON, PEPCID, BENADRYL and PERCOCET as discharge prescriptions.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis
Clinical narrative: Patient says flu shot gave her a "frozen" shoulder and she will follow up w/her PCP.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Non itching rash began on left wrist and went to shoulder, within a day rash was also on left arm, wrist to shoulder.
Age: 52.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Infection, Musculoskeletal stiffness, Pain in extremity, Vaccination complication
Clinical narrative: Sore arm, stiffness, infection.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: (L) arm pain since vaccine. Pain radiates from (L) shoulder to (L) elbow. Take Ibuprofen.
Age: 30.0
Sex: U
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site redness and slightly raised. Advised to use ice and ibuprofen.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: All night shaking shivering for 1 hour - very strong, freezing hands and feet, muscle pain - large muscles, headache. Next day: loose stools and weakness.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness, Tremor
Clinical narrative: All night shaking shivering for 1 hour - very strong, freezing hands and feet, muscle pain - large muscles, headache. Next day: loose stools and weakness.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Cold sweat, Erythema, Peripheral swelling, Urticaria
Clinical narrative: R. arm swelled to elbow, very red like a sunburn. 50 cent size hives on R. arm, cold sweats, chills for 2 days.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Bacterial test negative, Blood urine absent, Dehydration, Dizziness, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A 17-year-old female received TRUMENBA (Batch/lot number: T66103; NDC number: 00005010010; Expiry Date: 31Dec2019), on 17Sep2018 at 12:28 intramuscular in the left arm at 0.5 ml single for routine vaccination. Concomitant medication included second single dose of MENVEO (Manufacturer: GlaxoSmithKline, Lot M17076; Expiry date: 31Jul2019) intramuscular in right arm on an unknown date as immunization. The patient previously took first dose of meningococcal vaccine a/c/y/w conj (crm197) for immunisation. Medical history was none. Right after receiving the vaccine, on 17Sep2018 at 12:28, patient experienced arm pain; on 17Sep2018 the patient had fever: when she got home she felt warm and she had a temperature all night. On 18Sep2018 when she woke up in the morning, she experienced lightheaded and always on 18Sep2018 when she was headed to the bus stop she fainted. Events arm pain, fever and lightheaded were non serious. Event fainted was serious as led hospitalization on 18Sep2018. The patient ended up going to the hospital for fainting. She was taken to the emergency room and discharged. The patient landed on one side of her face when she fainted and needed stitches from the fall. She received the stitches on 18Sep2018; the patient had 1.5cm laceration lateral to the right eye. It was reported that patient was late for her well check and needed to get the MENVEO in the right arm. It was her second dose of the meningococcal vaccine a/c/y/w conj (crm197). The physician sent patient to the cardiologist. Patient was visited at physician room on 19Sep2018. She said that the patient has had she had lightheadedness before, but never fainted. The patient's blood work at the hospital came back clear and there was no infection. Patient recovered from arm pain, fever, lightheaded and fainted on 18Sep2018. Sender's Comments: Based on the information currently available, the Company cannot completely exclude that the suspect vaccine meningococcal group B rlp2086 contributed to the development of the reported events syncope, pain in extremity, pyrexia and dizziness.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Face injury, Glucose urine absent, Glycosylated haemoglobin normal, Insomnia, Nitrite urine absent
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A 17-year-old female received TRUMENBA (Batch/lot number: T66103; NDC number: 00005010010; Expiry Date: 31Dec2019), on 17Sep2018 at 12:28 intramuscular in the left arm at 0.5 ml single for routine vaccination. Concomitant medication included second single dose of MENVEO (Manufacturer: GlaxoSmithKline, Lot M17076; Expiry date: 31Jul2019) intramuscular in right arm on an unknown date as immunization. The patient previously took first dose of meningococcal vaccine a/c/y/w conj (crm197) for immunisation. Medical history was none. Right after receiving the vaccine, on 17Sep2018 at 12:28, patient experienced arm pain; on 17Sep2018 the patient had fever: when she got home she felt warm and she had a temperature all night. On 18Sep2018 when she woke up in the morning, she experienced lightheaded and always on 18Sep2018 when she was headed to the bus stop she fainted. Events arm pain, fever and lightheaded were non serious. Event fainted was serious as led hospitalization on 18Sep2018. The patient ended up going to the hospital for fainting. She was taken to the emergency room and discharged. The patient landed on one side of her face when she fainted and needed stitches from the fall. She received the stitches on 18Sep2018; the patient had 1.5cm laceration lateral to the right eye. It was reported that patient was late for her well check and needed to get the MENVEO in the right arm. It was her second dose of the meningococcal vaccine a/c/y/w conj (crm197). The physician sent patient to the cardiologist. Patient was visited at physician room on 19Sep2018. She said that the patient has had she had lightheadedness before, but never fainted. The patient's blood work at the hospital came back clear and there was no infection. Patient recovered from arm pain, fever, lightheaded and fainted on 18Sep2018. Sender's Comments: Based on the information currently available, the Company cannot completely exclude that the suspect vaccine meningococcal group B rlp2086 contributed to the development of the reported events syncope, pain in extremity, pyrexia and dizziness.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Pain in extremity, Pyrexia, Specific gravity urine normal, Syncope, Urinary casts absent
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A 17-year-old female received TRUMENBA (Batch/lot number: T66103; NDC number: 00005010010; Expiry Date: 31Dec2019), on 17Sep2018 at 12:28 intramuscular in the left arm at 0.5 ml single for routine vaccination. Concomitant medication included second single dose of MENVEO (Manufacturer: GlaxoSmithKline, Lot M17076; Expiry date: 31Jul2019) intramuscular in right arm on an unknown date as immunization. The patient previously took first dose of meningococcal vaccine a/c/y/w conj (crm197) for immunisation. Medical history was none. Right after receiving the vaccine, on 17Sep2018 at 12:28, patient experienced arm pain; on 17Sep2018 the patient had fever: when she got home she felt warm and she had a temperature all night. On 18Sep2018 when she woke up in the morning, she experienced lightheaded and always on 18Sep2018 when she was headed to the bus stop she fainted. Events arm pain, fever and lightheaded were non serious. Event fainted was serious as led hospitalization on 18Sep2018. The patient ended up going to the hospital for fainting. She was taken to the emergency room and discharged. The patient landed on one side of her face when she fainted and needed stitches from the fall. She received the stitches on 18Sep2018; the patient had 1.5cm laceration lateral to the right eye. It was reported that patient was late for her well check and needed to get the MENVEO in the right arm. It was her second dose of the meningococcal vaccine a/c/y/w conj (crm197). The physician sent patient to the cardiologist. Patient was visited at physician room on 19Sep2018. She said that the patient has had she had lightheadedness before, but never fainted. The patient's blood work at the hospital came back clear and there was no infection. Patient recovered from arm pain, fever, lightheaded and fainted on 18Sep2018. Sender's Comments: Based on the information currently available, the Company cannot completely exclude that the suspect vaccine meningococcal group B rlp2086 contributed to the development of the reported events syncope, pain in extremity, pyrexia and dizziness.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Urinary sediment present, Urine ketone body absent, Urine leukocyte esterase, Urine protein, quantitative, pH urine normal
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A 17-year-old female received TRUMENBA (Batch/lot number: T66103; NDC number: 00005010010; Expiry Date: 31Dec2019), on 17Sep2018 at 12:28 intramuscular in the left arm at 0.5 ml single for routine vaccination. Concomitant medication included second single dose of MENVEO (Manufacturer: GlaxoSmithKline, Lot M17076; Expiry date: 31Jul2019) intramuscular in right arm on an unknown date as immunization. The patient previously took first dose of meningococcal vaccine a/c/y/w conj (crm197) for immunisation. Medical history was none. Right after receiving the vaccine, on 17Sep2018 at 12:28, patient experienced arm pain; on 17Sep2018 the patient had fever: when she got home she felt warm and she had a temperature all night. On 18Sep2018 when she woke up in the morning, she experienced lightheaded and always on 18Sep2018 when she was headed to the bus stop she fainted. Events arm pain, fever and lightheaded were non serious. Event fainted was serious as led hospitalization on 18Sep2018. The patient ended up going to the hospital for fainting. She was taken to the emergency room and discharged. The patient landed on one side of her face when she fainted and needed stitches from the fall. She received the stitches on 18Sep2018; the patient had 1.5cm laceration lateral to the right eye. It was reported that patient was late for her well check and needed to get the MENVEO in the right arm. It was her second dose of the meningococcal vaccine a/c/y/w conj (crm197). The physician sent patient to the cardiologist. Patient was visited at physician room on 19Sep2018. She said that the patient has had she had lightheadedness before, but never fainted. The patient's blood work at the hospital came back clear and there was no infection. Patient recovered from arm pain, fever, lightheaded and fainted on 18Sep2018. Sender's Comments: Based on the information currently available, the Company cannot completely exclude that the suspect vaccine meningococcal group B rlp2086 contributed to the development of the reported events syncope, pain in extremity, pyrexia and dizziness.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Blood test normal, Dizziness, Fall, Feeling hot, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A 17-year-old female received TRUMENBA (Batch/lot number: T66103; NDC number: 00005010010; Expiry Date: 31Dec2019), on 17Sep2018 at 12:28 intramuscular in the left arm at 0.5 ml single for routine vaccination. Concomitant medication included second single dose of MENVEO (Manufacturer: GlaxoSmithKline, Lot M17076; Expiry date: 31Jul2019) intramuscular in right arm on an unknown date as immunization. The patient previously took first dose of meningococcal vaccine a/c/y/w conj (crm197) for immunisation. Medical history was none. Right after receiving the vaccine, on 17Sep2018 at 12:28, patient experienced arm pain; on 17Sep2018 the patient had fever: when she got home she felt warm and she had a temperature all night. On 18Sep2018 when she woke up in the morning, she experienced lightheaded and always on 18Sep2018 when she was headed to the bus stop she fainted. Events arm pain, fever and lightheaded were non serious. Event fainted was serious as led hospitalization on 18Sep2018. The patient ended up going to the hospital for fainting. She was taken to the emergency room and discharged. The patient landed on one side of her face when she fainted and needed stitches from the fall. She received the stitches on 18Sep2018; the patient had 1.5cm laceration lateral to the right eye. It was reported that patient was late for her well check and needed to get the MENVEO in the right arm. It was her second dose of the meningococcal vaccine a/c/y/w conj (crm197). The physician sent patient to the cardiologist. Patient was visited at physician room on 19Sep2018. She said that the patient has had she had lightheadedness before, but never fainted. The patient's blood work at the hospital came back clear and there was no infection. Patient recovered from arm pain, fever, lightheaded and fainted on 18Sep2018. Sender's Comments: Based on the information currently available, the Company cannot completely exclude that the suspect vaccine meningococcal group B rlp2086 contributed to the development of the reported events syncope, pain in extremity, pyrexia and dizziness.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Pyrexia, Skin laceration, Suture insertion, Syncope
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A 17-year-old female received TRUMENBA (Batch/lot number: T66103; NDC number: 00005010010; Expiry Date: 31Dec2019), on 17Sep2018 at 12:28 intramuscular in the left arm at 0.5 ml single for routine vaccination. Concomitant medication included second single dose of MENVEO (Manufacturer: GlaxoSmithKline, Lot M17076; Expiry date: 31Jul2019) intramuscular in right arm on an unknown date as immunization. The patient previously took first dose of meningococcal vaccine a/c/y/w conj (crm197) for immunisation. Medical history was none. Right after receiving the vaccine, on 17Sep2018 at 12:28, patient experienced arm pain; on 17Sep2018 the patient had fever: when she got home she felt warm and she had a temperature all night. On 18Sep2018 when she woke up in the morning, she experienced lightheaded and always on 18Sep2018 when she was headed to the bus stop she fainted. Events arm pain, fever and lightheaded were non serious. Event fainted was serious as led hospitalization on 18Sep2018. The patient ended up going to the hospital for fainting. She was taken to the emergency room and discharged. The patient landed on one side of her face when she fainted and needed stitches from the fall. She received the stitches on 18Sep2018; the patient had 1.5cm laceration lateral to the right eye. It was reported that patient was late for her well check and needed to get the MENVEO in the right arm. It was her second dose of the meningococcal vaccine a/c/y/w conj (crm197). The physician sent patient to the cardiologist. Patient was visited at physician room on 19Sep2018. She said that the patient has had she had lightheadedness before, but never fainted. The patient's blood work at the hospital came back clear and there was no infection. Patient recovered from arm pain, fever, lightheaded and fainted on 18Sep2018. Sender's Comments: Based on the information currently available, the Company cannot completely exclude that the suspect vaccine meningococcal group B rlp2086 contributed to the development of the reported events syncope, pain in extremity, pyrexia and dizziness.
Age: 65.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Erythema, Injection site warmth, Mobility decreased, Skin discolouration, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 65-year-old female patient. The patient had no known drug allergies and her prior vaccination included PREVNAR 13 No information regarding the patient's pertinent medical history was provided. On 01-OCT-2018, the patient a received dose of PNEUMOVAX 23 lot # R002084, expiration date 26-OCT-2019, intramuscularly, in the left arm (dose was not reported) and dose of unspecified influenza vaccine in the right arm. On 02-OCT-2018, the patient called the pharmacy reporting that an unknown date in October 2018, the she experienced redness, soreness and inability to lift her left arm surrounding PNEUMOVAX 23 injection site. On 04-OCT-2018 the patient came to the pharmacy and her the left arm had red patches surrounding injection site. The patient reported that it was slightly less sore. The patient did not want to be seen by the physician as she did not want to pay her co-pay. The outcome of injected limb mobility decreased, injection site pain and injection site erythema was unknown and causality assessment was not provided.
Age: 65.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 65-year-old female patient. The patient had no known drug allergies and her prior vaccination included PREVNAR 13 No information regarding the patient's pertinent medical history was provided. On 01-OCT-2018, the patient a received dose of PNEUMOVAX 23 lot # R002084, expiration date 26-OCT-2019, intramuscularly, in the left arm (dose was not reported) and dose of unspecified influenza vaccine in the right arm. On 02-OCT-2018, the patient called the pharmacy reporting that an unknown date in October 2018, the she experienced redness, soreness and inability to lift her left arm surrounding PNEUMOVAX 23 injection site. On 04-OCT-2018 the patient came to the pharmacy and her the left arm had red patches surrounding injection site. The patient reported that it was slightly less sore. The patient did not want to be seen by the physician as she did not want to pay her co-pay. The outcome of injected limb mobility decreased, injection site pain and injection site erythema was unknown and causality assessment was not provided.
Age: 60.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Pain, Pain in extremity, X-ray
Clinical narrative: Patient returned on 10/26/18 and informed staff that he was going to get MRI because shoulder/arm sore, in sling, cannot lift above head, needs assistance dressing.
Age: 60.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient returned on 10/26/18 and informed staff that he was going to get MRI because shoulder/arm sore, in sling, cannot lift above head, needs assistance dressing.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Injection site pain, Insomnia, Neck pain, Pain
Clinical narrative: Significant increase in throbbing pain after 2 days, Overall constant pain on left shoulder, difficulty sleeping on it w/o pain. Pain migrated into Left Bicep after approx 7 days. Approx 2 weeks after Vaccine Injection started feeling referred pain in neck and upper back on left side. No treatments suggested by Medical provider other than OTC Alieve. This treatment helped with mild relief, Pain is still present 30 days later.
Age: 79.0
Sex: M
Vaccine: FLUX
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Very severe pain in shoulder. Like a Charley horse but worse. Could not sleep one night, could not move arm for 5 days and still feel sore after 10 days and counting.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Cardiac monitoring, Diarrhoea, Dizziness, Heart rate irregular
Clinical narrative: Approximately 20 minutes after receiving the injection, patient began to feel dizzy and heart was tachycardic in 130s. Patient was put on telemetry. While sitting, heart rate became irregular and variable jumping down to the 60s and seconds later, after a short pause, jumping up to 130s. Blood pressure was elevated at 140s/100. Patient began to have uncontrollable tremors/shakes. Patient was taken to ER at aprox 0500 after the symptoms were resistant to improvement after lying down. 1000cc of normal saline was started and cardiac monitoring was resumed. Patient continued to be dizzy, tremulous and tachycardic. Aprox 0600 patient's symptoms improved and heart rate returned to the 70s and patient discharged home. While at home symptoms returned with variable tachycardia, tremors, dizziness and diarrhea for aprox 2-3 more hours. ZYRTEC was taken aprox 0800. Patient felt more improved around 1300.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Approximately 20 minutes after receiving the injection, patient began to feel dizzy and heart was tachycardic in 130s. Patient was put on telemetry. While sitting, heart rate became irregular and variable jumping down to the 60s and seconds later, after a short pause, jumping up to 130s. Blood pressure was elevated at 140s/100. Patient began to have uncontrollable tremors/shakes. Patient was taken to ER at aprox 0500 after the symptoms were resistant to improvement after lying down. 1000cc of normal saline was started and cardiac monitoring was resumed. Patient continued to be dizzy, tremulous and tachycardic. Aprox 0600 patient's symptoms improved and heart rate returned to the 70s and patient discharged home. While at home symptoms returned with variable tachycardia, tremors, dizziness and diarrhea for aprox 2-3 more hours. ZYRTEC was taken aprox 0800. Patient felt more improved around 1300.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Heart rate increased, Musculoskeletal pain
Clinical narrative: Severe chest, shoulder and neck pain with tension headaches; worsening with twisting or bending of the torso; shortness of breath; rapid heart rate with mild exertion.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Tension headache
Clinical narrative: Severe chest, shoulder and neck pain with tension headaches; worsening with twisting or bending of the torso; shortness of breath; rapid heart rate with mild exertion.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy, Malaise, Oral herpes
Clinical narrative: Cold sore outbreak within hours of receiving vaccine. Swollen glands, general malaise.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Blood test normal, Condition aggravated, Disturbance in attention, Head discomfort
Clinical narrative: Within minutes after vaccine, felt nauseated and shaky. Muscle pain in left arm was intense and lasted 3 days. Headaches, head pressure, neck pain and stiffness, extreme malaise, and difficulty concentrating began 2nd day after vaccine and are still current and worsening. I have had a recent physical with blood work that was perfect. I do have asthma which has been exacerbated since vaccine as well.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Malaise, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Within minutes after vaccine, felt nauseated and shaky. Muscle pain in left arm was intense and lasted 3 days. Headaches, head pressure, neck pain and stiffness, extreme malaise, and difficulty concentrating began 2nd day after vaccine and are still current and worsening. I have had a recent physical with blood work that was perfect. I do have asthma which has been exacerbated since vaccine as well.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Nervousness
Clinical narrative: Within minutes after vaccine, felt nauseated and shaky. Muscle pain in left arm was intense and lasted 3 days. Headaches, head pressure, neck pain and stiffness, extreme malaise, and difficulty concentrating began 2nd day after vaccine and are still current and worsening. I have had a recent physical with blood work that was perfect. I do have asthma which has been exacerbated since vaccine as well.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Large, red welt like rash all over child's body the next morning. Gave BENADRYL as directed by doctor and they went down and next morning child woke up with rash all over again and large welts in all different areas. Large red, bump at injection site.