chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed case of shingles.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Developed red area in a circle around injection. It is warm and it itches. The area is about 3 inches across. I looked at it 4 days after injection.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, sore throat, muscle aches, fever.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Soreness of arm.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pyrexia
Clinical narrative: Acute Allergic reaction; Fever.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Malaise, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Extremely sore at injection site, continuing at least 48 hours. Muscle aches, sore throat, low grade fever, malaise.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe shoulder pain started in L shoulder about 2 hours after receiving seasonal flu vaccine. The pain was different than previous vaccine related pain. Took Bandaid off and realized injection site was too high on shoulder. Pain has persisted for 12 days with limited range of motion and unable to lift, reach for items. No swelling, redness, or bruising. Motrin and heat for treatment. Pain still persists and is different than previous vaccine related pain.
Age: 0.88
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Severe congestion, fever.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dizziness, Influenza like illness, Pharyngeal oedema
Clinical narrative: Patient had severe anaphylactic reaction. It started 4 hours later - had throat swelling, dizziness - took BENADRYL. Developed severe flu-like symptoms which lasted 24 hours. (Fever, shiver, etc.).
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain
Clinical narrative: At 8:30pm several hours after injection, pt had raised/swollen site of injection pt reported minimal pain, but swelling that was going down.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Patient developed body wide rash that's clearing up on 10/08/2015 to 10/23/2015.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt seen at urgent care 10/23/15 c/o (L) arm pain/redness/swelling from deltoid down to elbow. Lateral and posterior reaction. Given KENALOG 40mg IM in office, prednisone 20mg BID x 5 days, ZANTAC 150mg BID x 7 days, loratadine 10mg qd x 7 days.
Age: 28.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Received vaccine on 9/16/15, on morning of 9/17/15 experienced redness, edema at site of injection. Dr recommended BENADRYL 25mg capsule x one, she took it, went home and saw her own doctor next day who gave her prednisone 20mg 2 tab daily for 7 days.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling left bicep. Ibuprofen and ice per ER instructions.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site haemorrhage
Clinical narrative: Vaccine was administered to patient. Injection stie rxn of increased bleeding with minor discoloration.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Vaccine was administered to patient. Injection site reaction of increased bleeding and swelling about the size of a quarter at location of injection. Subsequently went down over 24 hrs per patient.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to an approximately 71 year old female patient. Pertinent medical history and concomitant medications were unspecified. No drug allergies were reported. On 10-OCT-2015, the patient was vaccinated with ZOSTAVAX, lot # K020185, expiry date 27-JAN-2016, 0.65 ml (cc), subcutaneously. The reporter stated that patient called on 14-OCT-2015 (yesterday), she was experiencing chills and lesion on her lower back and just below her navel. The outcome of events was not resolved. Causality assessment was not provided. On 15-OCT-2015 (today), patient was going to see her primary doctor. The patient sought medical attention. No product quality complaint (PQC) was involved. No further adverse event information was provided. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Skin lesion
Clinical narrative: This spontaneous report was received from a pharmacist refers to an approximately 71 year old female patient. Pertinent medical history and concomitant medications were unspecified. No drug allergies were reported. On 10-OCT-2015, the patient was vaccinated with ZOSTAVAX, lot # K020185, expiry date 27-JAN-2016, 0.65 ml (cc), subcutaneously. The reporter stated that patient called on 14-OCT-2015 (yesterday), she was experiencing chills and lesion on her lower back and just below her navel. The outcome of events was not resolved. Causality assessment was not provided. On 15-OCT-2015 (today), patient was going to see her primary doctor. The patient sought medical attention. No product quality complaint (PQC) was involved. No further adverse event information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Presyncope
Clinical narrative: After vaccine administration patient had a vasovagal reaction - no redness or swelling at injection site. States previously no other problems or reactions with previous vaccines. Per pt did not eat any breakfast. No seizure activity noted.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site pain, redness, warmth and swelling on 10/24/15. Pt states doesn't "feel well" and feels like she could pass out.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Injection site pain, redness, warmth and swelling on 10/24/15. Pt states doesn't "feel well" and feels like she could pass out.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Pain in extremity, Vomiting
Clinical narrative: 10-18-15/Vaccine administered, minor dizziness in the PM. 10-20-15/Major dizziness, vomiting. 10-21-15/Dizziness and vomiting continued. 10-22-15/Pain and soreness in the back of the leg, dizziness decreased. 10-24-15/Notified pharmacy - Sept patient to ER.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt developed itching in the upper (L) arm where pt received PREVNAR 13. Pt did not scracth but rubbed the itchy area. The area appeared red (erythema) and swollen. This started the day after vaccination. It appears to be subsiding. Pt will continue to monitor.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This literature marketed report as received from a health professional refers to 4 patients of unknown demographics. The purpose of this study is to evaluate the effect of ZOSTAVAX on the incidence and complications of Herpes Zoster (HZ). The patients' previous history of shingles, vaccination and clinical courses were recorded. Outcome measures were the age of incidence of HZ, ZOSTAVAX vaccination, clinical signs, symptoms and complications of HZ 341 patients (114 males, 227 females) were enrolled, mean age being 56.0 plus or minus 17.6. 165 patients developed HZ; the mean age at the first episode being 59.0 plus or minus 15.6. The mean age of HZ vaccination was significantly higher at 66.7 plus or minus 12.5 (p=0.008). The current cut off of eligibility for ZOSTAVAX is 60 years; number of patients more than 60 was 148. Out of the eligible patients, 112 (75.7%) did not get the vaccine and 47.3% of this group developed shingles, while out of the 36 (24.3%) eligible patients who did get the vaccine, only 4% developed the disease. Relative risk of developing HZ was 3.21 in non-vaccinated group compared to the vaccinated group (p = 0.0008). Ocular involvement was seen in 85% of HZ; with complications such as residual corneal opacities, secondary glaucoma and cataracts seen in 70%, 8.7% and 5%, respectively in 3.7 years follow up. Out of the 4 patients who developed HZ after vaccination (vaccination failure), mean age of incidence was 67 plus or minus 14. ZOSTAVAX can decrease the risk of development of Herpes Zoster by 3 times. In current practice, the mean age of vaccination occurs 8 years later compared to the peak incidence of disease. The article concluded that patients should be encouraged to be vaccinated about ten years earlier to minimize the surge in incidence that occurs in the 5th decade of life. Based on this data, it was indicative that zoster vaccine delayed the age of onset of the first episode of HZ and may result in fewer long term complications even in patients who develop disease after vaccination. Large population studies based on systemic data are required to further elucidate vaccine efficacy. The outcome of vaccination failure is unknown. The reporter considered vaccination failure to be related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since unknown dates from 06-OCT-2015, the patients were inadvertently administered with improperly stored doses of PEDVAXHIB (lot # L014426, expiration date 08-MAR-2018, lot # reported as L012383, expiration date 10-MAR-2018, strength, dose and route unknown). No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since unknown dates from 06-OCT-2015, the patients were inadvertently administered with improperly stored doses of GARDASIL 9 (lot # L013429, expiration date 21-JUL-2017, strength, dose and route unknown). No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since unknown dates from 06-OCT-2015, the patients were inadvertently administered with improperly stored doses of M-M-R II (therapy type: rHA, lot # L009213, expiration date 17-MAR-2017, strength, dose and route unknown). No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3, PPV
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist referring to a 76 year old male patient without pertinent medical history or drug reactions/allergies. On 18-OCT-2015 the patient was vaccinated with a dose of PNEUMOVAX 23, (lot# reported as 1026033, expiration date November 2016) injection, 0.5 ml, intramuscularly in the arm. The pharmacist stated that the patient also received FLUZONE high dose (manufacturer: Sanofi Pasteur) on the "same day as the PNEUMOVAX 23, but in the opposite arm". Concomitant therapies also included zolpidem, omeprazole, losartan potassium (+) hydrochlorothiazide (manufacturer unknown) and SEREVENT DISKUS. The pharmacist reported that the patient developed an unspecified rash underneath both armpits and "soreness" at the injection site (PNEUMOVAX 23 injection site) after receiving PNEUMOVAX 23 (in October 2015). The patient went to the pharmacy on the reporting day (21-OCT-2015) and reported the events to the pharmacist. No lab diagnostics studies were performed. The outcome of the injection site pain and rash was reported as not resolved at the time of this report. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3, PPV
Symptoms: Injection site pain, Rash
Clinical narrative: Information has been received from a pharmacist referring to a 76 year old male patient without pertinent medical history or drug reactions/allergies. On 18-OCT-2015 the patient was vaccinated with a dose of PNEUMOVAX 23, (lot# reported as 1026033, expiration date November 2016) injection, 0.5 ml, intramuscularly in the arm. The pharmacist stated that the patient also received FLUZONE high dose (manufacturer: Sanofi Pasteur) on the "same day as the PNEUMOVAX 23, but in the opposite arm". Concomitant therapies also included zolpidem, omeprazole, losartan potassium (+) hydrochlorothiazide (manufacturer unknown) and SEREVENT DISKUS. The pharmacist reported that the patient developed an unspecified rash underneath both armpits and "soreness" at the injection site (PNEUMOVAX 23 injection site) after receiving PNEUMOVAX 23 (in October 2015). The patient went to the pharmacy on the reporting day (21-OCT-2015) and reported the events to the pharmacist. No lab diagnostics studies were performed. The outcome of the injection site pain and rash was reported as not resolved at the time of this report. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling and soreness of lymph in armpit. Pain and swelling increased the next following mornings 10/24-25/2015. May be the result of aluminum allergy and not being aware aluminum salts were used in Flu vaccinations. Flu shot was administered by a man whose job is to go around the hospital and administer the flu shot. Manufacturer in unknown and will be randomly input.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Sore Shoulder, could move arm back and forth but unable to lift arm up without using other hand, PCP prescribed Medrol dose pack.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Sore Shoulder, could move arm back and forth but unable to lift arm up without using other hand, PCP prescribed Medrol dose pack.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Haemorrhage subcutaneous, Injection site bruising, Injection site reaction, Local reaction
Clinical narrative: A localized reaction occurred the day after the patient recieved an intramuscular injection of Prevnar 13 in his left deltoid. The patient noticed an area just below the injection site which consisted of about a 2 inch diameter area of bruising or bleeding under the skin.  The patient reported no pain or discomfort at the area, only visual signs of bruising.  The patient was being seen by his physician several days later for a routine diabetes check up and asked the doctor about the reaction to the vaccine.  The doctor stated to the patient that the reaction of bruising/bleeding under the skin was normal since he was taking the blood thinner Effient as well as an aspirin every day.  Neither the patient nor the doctor showed any signs of concern and no treatment was provided.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Corneal transplant, Ocular hyperaemia, Transplant rejection, Vision blurred
Clinical narrative: Corneal Transplant Rejection. Severe Burning, Redness of Right eye and extremely blurred vision. Treated with Steroid drops.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Computerised tomogram, Electrocardiogram, Injection site pain, Laboratory test
Clinical narrative: Extreme burning pain at injection site, traveling to elbow, back, shoulder, neck and into scalp. Went to Outpatient care then to Emergency Room and then to Primary Doctor for follow-up.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain of skin
Clinical narrative: Extreme burning pain at injection site, traveling to elbow, back, shoulder, neck and into scalp. Went to Outpatient care then to Emergency Room and then to Primary Doctor for follow-up.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nerve injury, Pain
Clinical narrative: Extreme burning pain at injection site, traveling to elbow, back, shoulder, neck and into scalp. Went to Outpatient care then to Emergency Room and then to Primary Doctor for follow-up.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Severe Shoulder Pain, unable to fully move arm, pain radiating up neck and down arm, tingling sensation into pointer finger and thumb- unable to fully dress self, use bathroom, reach for items, complete normal work and home tasks.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: Severe Shoulder Pain, unable to fully move arm, pain radiating up neck and down arm, tingling sensation into pointer finger and thumb- unable to fully dress self, use bathroom, reach for items, complete normal work and home tasks.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Patient states she has a rash that itches at injection site.
Age: 41.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Arthralgia, Joint range of motion decreased, Joint stiffness, Pain, Paraesthesia
Clinical narrative: A couple of days after the initial soreness (expected) went away, the shoulder joint is painful and has limited range of motion. Adduction and rotation cause pain. the elbow joint is stiff and the forearm and hand are tingly and slightly stiff.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Musculoskeletal discomfort, Nasopharyngitis
Clinical narrative: Felt left shoulder blade discomfort on 10/21/15.  Felt numbness in left index finger on 10/19/2015. Numbness and tingling radiated down from shoulder to arm and to rest of fingers over the next few days.  The discomfort from left should blade down to arm and fingers is on-going and is worsening as of Oct 25, 2015).  I also experienced a mild cold-like symptom started on Oct 15, 2015.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: The day after the vaccination the patient developed an itchy red patch at the injection site.  Two days after, small blisters appeared and it was oozing a little fluid.  The patient came in to inquire if this was normal after vaccination on the third day.  She had not tried any treatments at that time.  I advised her of a couple creams that she could try for the itch.  I also told her that if it seemed to be spreading or appearing elsewhere, or if the redness or itching was getting worse, it might be a good idea to have it checked.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Inflammation, Peripheral swelling
Clinical narrative: The patient came back to the pharmacy where she got Pneumovax 23 and Fluzone Quad presenting inflamed, swollen arm 2 days later. Recommended her to go to ER. Called patient's mom later and found out that the patient had allergic reactions to Pneumovax 23.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Middle insomnia
Clinical narrative: The patient presented to the pharmacy on 10/23/15. He said he felt fine after his shot on 9/30/15, but he woke up in the middle of the night that night and felt "numb" down his arm where he received his shot, and also his back. He said he didn't experience any pain, just a strange numbness that he has never experienced before. When he woke up the following morning, the numbness was gone and he stated he did not experience it again.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Fatigue, Flushing
Clinical narrative: 10/23/15 - Dizziness, flush, increased heart rate, difficulty breathing, tightness in chest within 5 minutes after vaccine being administered. 10/24/15 - experienced fatigue, body aches and pains, headache throughout day. 10/25/15 - hives developed on chest, neck and back.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Heart rate increased, Pain, Urticaria
Clinical narrative: 10/23/15 - Dizziness, flush, increased heart rate, difficulty breathing, tightness in chest within 5 minutes after vaccine being administered. 10/24/15 - experienced fatigue, body aches and pains, headache throughout day. 10/25/15 - hives developed on chest, neck and back.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Hyperhidrosis, Palpitations
Clinical narrative: Sweats, heart racing and pounding.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Excessive eye blinking
Clinical narrative: Son forcibly blinks his eyes 5-10 times in repetition. He will do this out of the blue and while otherwise playing normally. His eyes are not dry and he says they are okay when we ask if they are bothering him. This excessive blinking is completely out of character for him and seems to correlate with him receiving the intranasal Flumist vaccine for the first time.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Blister, Psoriatic arthropathy, Rash
Clinical narrative: Rash on hand and feet blisters like spots.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Tingling down both sides of his neck lasting approximately 10 minutes, starting 10 minutes after administration.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site induration, Injection site pain
Clinical narrative: Patient stated site got hard and was sore and then bruised which is slowly going away-just made us aware today (2 weeks later).
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Confusional state, Heart rate decreased, Loss of consciousness, Presyncope, Syncope
Clinical narrative: Patient became confused a few minutes after her vaccination and the proceeded to pass out.  Her heart rate was in the 50s for a few minutes, but her blood pressure was fine when laying down.  She recovered within 30 minutes.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site rash, Rash erythematous
Clinical narrative: Patient came to pharmacy morning of 10-24-15 and said she had rash on her arm where flu shot was given. She then went to facility and was diagosed as having cellulitis. She was given prescription for clindamycin 300mg every 8 hours for 10 days.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Joint stiffness
Clinical narrative: Severe pain, redness, significant swelling, and hot skin from injection site in mid upper arm to elbow; stiff elbow. These symptoms have persisted through today (10/25/2015), but have moved progressively down my arm; today my hand is swollen.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Severe pain, redness, significant swelling, and hot skin from injection site in mid upper arm to elbow; stiff elbow. These symptoms have persisted through today (10/25/2015), but have moved progressively down my arm; today my hand is swollen.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on legs still after 9 days.
Age: 80.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient says the next day he experienced excessive sweating and some dizziness that lasted until the following morning.
Age: 0.92
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Drooling, Pyrexia
Clinical narrative: Fever 102.4, loss of appetite & drooling.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Patient reports fever, pain and redness at the injection site. Patient reports symptoms have not yet resolved as of 10/25/15.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Dehydration, Disturbance in attention, Dizziness
Clinical narrative: Oct 22-Inability to concentrate, couldn't drive. Sever pain in arm from shot, swollen, red and hot to the touch. Oct. 23-Muscles in legs, arms and back all are painful. Oct. 24- Mild dizziness, aches and pains all over body, dry mouth, fingers were locking up/cramping, feet were cramping. Muscles are twitching, weakness, fatigue. Oct. 25- Taken to emergency room, extremely dizziness. muscles aching in legs, back and arms, dry mouth. Emergency room doctor said I was slightly dehydrated, but she said they couldn't do anything because of the adverse reactions to the flu shot. Wrote me prescription for dizziness meclizine 25 mg and sent me home.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth, Electrocardiogram, Erythema, Fatigue, Impaired driving ability
Clinical narrative: Oct 22-Inability to concentrate, couldn't drive. Sever pain in arm from shot, swollen, red and hot to the touch. Oct. 23-Muscles in legs, arms and back all are painful. Oct. 24- Mild dizziness, aches and pains all over body, dry mouth, fingers were locking up/cramping, feet were cramping. Muscles are twitching, weakness, fatigue. Oct. 25- Taken to emergency room, extremely dizziness. muscles aching in legs, back and arms, dry mouth. Emergency room doctor said I was slightly dehydrated, but she said they couldn't do anything because of the adverse reactions to the flu shot. Wrote me prescription for dizziness meclizine 25 mg and sent me home.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Muscle twitching, Myalgia, Pain, Pain in extremity
Clinical narrative: Oct 22-Inability to concentrate, couldn't drive. Sever pain in arm from shot, swollen, red and hot to the touch. Oct. 23-Muscles in legs, arms and back all are painful. Oct. 24- Mild dizziness, aches and pains all over body, dry mouth, fingers were locking up/cramping, feet were cramping. Muscles are twitching, weakness, fatigue. Oct. 25- Taken to emergency room, extremely dizziness. muscles aching in legs, back and arms, dry mouth. Emergency room doctor said I was slightly dehydrated, but she said they couldn't do anything because of the adverse reactions to the flu shot. Wrote me prescription for dizziness meclizine 25 mg and sent me home.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Skin warm, Urine analysis
Clinical narrative: Oct 22-Inability to concentrate, couldn't drive. Sever pain in arm from shot, swollen, red and hot to the touch. Oct. 23-Muscles in legs, arms and back all are painful. Oct. 24- Mild dizziness, aches and pains all over body, dry mouth, fingers were locking up/cramping, feet were cramping. Muscles are twitching, weakness, fatigue. Oct. 25- Taken to emergency room, extremely dizziness. muscles aching in legs, back and arms, dry mouth. Emergency room doctor said I was slightly dehydrated, but she said they couldn't do anything because of the adverse reactions to the flu shot. Wrote me prescription for dizziness meclizine 25 mg and sent me home.
Age: 59.0
Sex: F
Vaccine: FLUC3
Symptoms: Pruritus, Urticaria
Clinical narrative: The next morning I had welts ion both forearms which are still with me 5 days later.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Balance disorder, Fatigue, Headache, Pyrexia
Clinical narrative: High fever 102.8 at the above time. Fever over 101 lasted 10 hours. But initial symptoms of tiredness, headache and unsteadiness began about a few hours after the vaccine. Called facility for advice after fever peaked at 102.8. My wife, who is a chiropractor, gave me sponge baths and aspirin.
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Blood test normal, Cough, Croup infectious, Dyspnoea
Clinical narrative: It began with runny nose, slight fever, muscle aches on 10/16; swollen left cheek (sinus), complete nasal stoppage, constant mucous dripping out nostrils and down throat and terrible headache added on 10/17; then constant cough and sore throat added on 10/18; then difficulty breathing by 5AM on 10/19. Rushed to ER at 5:30am on 10/19. Given one dose prednisone. Saw pediatrian on 10/20. Rx: prednisone x 3 days, plus prescribed cough and nasal decongestant. She could hardly sleep and missed school all week due to all the symptoms!
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Influenza virus test negative, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: It began with runny nose, slight fever, muscle aches on 10/16; swollen left cheek (sinus), complete nasal stoppage, constant mucous dripping out nostrils and down throat and terrible headache added on 10/17; then constant cough and sore throat added on 10/18; then difficulty breathing by 5AM on 10/19. Rushed to ER at 5:30am on 10/19. Given one dose prednisone. Saw pediatrian on 10/20. Rx: prednisone x 3 days, plus prescribed cough and nasal decongestant. She could hardly sleep and missed school all week due to all the symptoms!
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Pharyngeal oedema, Pyrexia, Rhinorrhoea, Sleep disorder, Streptococcus test negative
Clinical narrative: It began with runny nose, slight fever, muscle aches on 10/16; swollen left cheek (sinus), complete nasal stoppage, constant mucous dripping out nostrils and down throat and terrible headache added on 10/17; then constant cough and sore throat added on 10/18; then difficulty breathing by 5AM on 10/19. Rushed to ER at 5:30am on 10/19. Given one dose prednisone. Saw pediatrian on 10/20. Rx: prednisone x 3 days, plus prescribed cough and nasal decongestant. She could hardly sleep and missed school all week due to all the symptoms!
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face, Upper-airway cough syndrome, X-ray abnormal
Clinical narrative: It began with runny nose, slight fever, muscle aches on 10/16; swollen left cheek (sinus), complete nasal stoppage, constant mucous dripping out nostrils and down throat and terrible headache added on 10/17; then constant cough and sore throat added on 10/18; then difficulty breathing by 5AM on 10/19. Rushed to ER at 5:30am on 10/19. Given one dose prednisone. Saw pediatrian on 10/20. Rx: prednisone x 3 days, plus prescribed cough and nasal decongestant. She could hardly sleep and missed school all week due to all the symptoms!
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dysstasia, Pyrexia, Throat tightness
Clinical narrative: 6-7 hours after getting the shot, patient experienced tightness in the throat, started with the chills and high fever, feel very weak and couldn't stand up. Went to Dr the morning after. Per dr. pt is not tolerating HIGH DOSE.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Patient reports "cellulitis" at injection site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Patient presented for a flu shot. Shot administered on 10/20/15 at 10 am. That evening call into the following day her arm became red and warm to the touch. She was concerned it could be cellulitis as it was warm and red. She presented to walk in care and was prescribed cephalexin 500 4 x a day for 10 days.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Rash, Vaccination site induration, Vaccination site pain
Clinical narrative: Burning/hot at site of vaccination. Grew to the size of a baseball/hard/hot. Rash developed on (L) arm to elbow then next am rash across torso. Progressed to other arm lasted 1 wk - started w/cough/chills 3 days. later - BENADRYL helped/cortisone cream.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: Burning/hot at site of vaccination. Grew to the size of a baseball/hard/hot. Rash developed on (L) arm to elbow then next am rash across torso. Progressed to other arm lasted 1 wk - started w/cough/chills 3 days. later - BENADRYL helped/cortisone cream.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Throat tightness
Clinical narrative: Within 10 mins of vaccination had increased heart rate, felt throat was closing, Went to ER for BENADRYL injection.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: An itchy rash appeared on torso the next afternoon, about 24 hours. after receiving the vaccine the previous day. She was already taking prednisone (for unrelated condition) and I advised her to take some BENADRYL on top of that as well.
Age: 81.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chest pain, Dizziness, Electrocardiogram
Clinical narrative: Patient started feeling light headedd and experienced chest pain about 5 min post vaccination. She has history no heart attack and described the pain similar. Took HTG tab and ambulance was called in. Pt felt fine after being checked out.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified 65 year old patient (gender unknown). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an expired dose of PNEUMOVAX 23, (lot #, expiry date, dose and frequency not reported). No adverse effect reported. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report has been received from a nurse practitioner referring to a female patient of unknown age. The patient had no medical history and concurrent conditions. The patient also had no drug reactions and allergies. On 21-OCT-2015 (reported as today) the patient was vaccinated with her first dose of GARDASIL 9 (0.5 ml, once, lot # reported as K016966, expiry date: 10-MAY-2017) on the left deltoid. There was no concomitant therapy reported. On 21-OCT-2015, the patient was found to be pregnant with gestation age at 8 weeks (vaccine exposure during pregnancy). The last menstrual period (LMP) date was reported as 24-AUG-2015. The estimated date of delivery (EDD) was 30-MAY-2016. Then the nurse practitioner put a registered nurse on the phone and the nurse completed the rest of the reported. The nurse stated that the urine pregnancy test was performed on the same day at their lab and it was positive for pregnancy. The patient was in office for medical attention at the time of call. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck), Lot # K021151 and exp. 02-NOV-2016; Lot #L010141 and exp. 24-SEP-2016; Lot # L019995 and exp. 02-DEC-2016; Lot # L024124 and exp. 30-DEC-3026, (dose and frequency not reported). No adverse effects reported. No product quality (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck), Lot # L013066 and exp. 04-APR-2017; Lot #L019999 and exp. 02-JUN-2017, (dose and frequency not reported). No adverse effects reported. No product quality (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9, lot # K011562, expiry date 08-APR-2017, (dose, frequency and route of administration not reported). No adverse symptoms reported. No product quality complaint (PQC) was involved. No further information provided. This is one of three reports received from the same reporter. Aditional information has been requested.
Age: 2.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 2 year old patient of unknown gender. There was no medical history or drug reaction/allergies reported. The patient was vaccinated with three doses of RECOMBIVAX HB (dose, lot# and route were unknown) on 29-OCT-2008, 03-DEC-2008 and 16-FEB-2009, respectively, which was an inappropriate schedule for this vaccine. No adverse effects were reported. The reporter stated that the patient received the vaccines in another location so lot information was not available. Additional information is not expected since the reporter refused to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ, lot # K016263, expiry date 26-JUN-2015, (dose, frequency and route of administration not reported). No adverse symptoms reported. No product quality complaint (PQC) was involved. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL, lot # L000610, expiry date 31-JAN-2017, (dose, frequency and route of administration not reported). No adverse symptoms reported. No product quality complaint (PQC) was involved. No further information provided. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site urticaria, Vaccination site erythema
Clinical narrative: Hives at the site of vaccination. Red 6x4 area of erythema. Cetrizine 10 mg chewable tablets 9d.
Age: 31.0
Sex: M
Vaccine: HEPAB
Symptoms: Haemoptysis, Productive cough
Clinical narrative: Blood in the mucus when he cough. Started the morning after he received his vaccine. He traveled to another country 2 weeks prior to his vaccination. Advised him to go to ER for check up.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Severe pain and numbness in left shoulder, arm and hand. Flu shot was given in top of shoulder in the joint.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Severe pain and numbness in left shoulder, arm and hand. Flu shot was given in top of shoulder in the joint.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Severe pain and numbness in left shoulder, arm and hand. Flu shot was given in top of shoulder in the joint.
Age: 24.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Eyelid rash, Oropharyngeal pain, Pain
Clinical narrative: Shingles. Rash over left eye. Blood work came positive for shingles. Woke up with rash next day afrter flu shot.
Age: 24.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Eyelid rash, Herpes zoster, Viral test positive
Clinical narrative: Shingles. Rash over left eye. Blood work came positive for shingles. Woke up with rash next day afrter flu shot.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This case wads reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 32-year-old female patient who received FLUARIX Quadrivalent 2015-2016 season) (batch number L94EX, expiry date 30th JUNE 2016). On 5th OCTOBER 2015, the patient received FLUARIX Quadrivalent 2015-2016 season (intramuscular) . 5ml., On 5th OCTOBER 2015, less than a day after receiving FLUARIX Quadrivalent 2015-2016 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unchanged. The reporter considered the injection site paint to be related to FLUARIX Quadrivalent 2015-2016 season. Additional details were provided as follows. The reported injection site was left deltoid. In beginning of 5th OCTOBER 2015, the patient experienced muscle soreness of the left arm and then pain radiated towards the shoulder when lifting her left arm. At the time of reporting, the patient symptoms remained unchanged and no treatment or medical intervention was required.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Myalgia
Clinical narrative: This case wads reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 32-year-old female patient who received FLUARIX Quadrivalent 2015-2016 season) (batch number L94EX, expiry date 30th JUNE 2016). On 5th OCTOBER 2015, the patient received FLUARIX Quadrivalent 2015-2016 season (intramuscular) . 5ml., On 5th OCTOBER 2015, less than a day after receiving FLUARIX Quadrivalent 2015-2016 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unchanged. The reporter considered the injection site paint to be related to FLUARIX Quadrivalent 2015-2016 season. Additional details were provided as follows. The reported injection site was left deltoid. In beginning of 5th OCTOBER 2015, the patient experienced muscle soreness of the left arm and then pain radiated towards the shoulder when lifting her left arm. At the time of reporting, the patient symptoms remained unchanged and no treatment or medical intervention was required.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: The patient was complaining of soreness/ pain in left shoulder where she got the vaccination. The arm is not swollen. She says she has pain when she is reaching up or across her body. The pain then radiates down the left arm.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: The patient was complaining of soreness/ pain in left shoulder where she got the vaccination. The arm is not swollen. She says she has pain when she is reaching up or across her body. The pain then radiates down the left arm.
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Condition aggravated, Injected limb mobility decreased, Injection site pain, Osteoarthritis
Clinical narrative: Initial unsolicited report received from a nurse on 13 October 2015. This case involves a patient (age and gender not reported) who was vaccinated with an injection of FLUZONE HIGH DOSE (batch number: UI456AA, expiry date: 19 April 2016) intramuscularly in right deltoid and with 0.5 ml of prefilled syringe of PREVENAR 13 (manufacturer: other, batch number: L99275, expiry date: 31 March 2017) intramuscularly in left arm both on 08 October 2015 at 15:00 hours. The patient was vaccinated at private doctor's office and with private funds. Medical history included diabetes, degenerative joint disease unknown (both were ongoing and started on an unknown date). It was unknown whether the patient had received any vaccination within four weeks prior to vaccination. The patient had no illness at time of vaccination. Concomitant medications were not reported. On 08 October 2015, two-three hours following the vaccination, the patient had developed severe left deltoid pain/arms are sore, could not move her arm and was diagnosed with degenerative joint disease (triggered an underlying syndrome she may have had). The patient was hospitalized on 08 October 2015 and discharged on 12 October 2015 for the event could not move her arm. The patient required visit to emergency room for severe left deltoid pain and could not move her arm. The patient had previously received seven doses of high dose flu vaccine with no known adverse event. Laboratory data and corrective treatment was not reported. The outcome of the event severe left deltoid pain, could not move her arm were unknown. The outcome of the event degenerative joint disease and that the immunization triggered an underlying syndrome she may have had was not reported. The reporter assessed the causal relationship with both the suspect vaccine as related for the events severe left deltoid pain and could not move her arm. List of documents held by sender: none.
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Condition aggravated, Injected limb mobility decreased, Injection site pain, Osteoarthritis, Pain in extremity
Clinical narrative: Initial unsolicited report received from a nurse on 13 October 2015. This case involves a patient (age and gender not reported) who was vaccinated with an injection of FLUZONE HIGH DOSE (batch number: UI456AA, expiry date: 19 April 2016) intramuscularly in right deltoid and with 0.5 ml of prefilled syringe of PREVENAR 13 (manufacturer: other, batch number: L99275, expiry date: 31 March 2017) intramuscularly in left arm both on 08 October 2015 at 15:00 hours. The patient was vaccinated at private doctor's office and with private funds. Medical history included diabetes, degenerative joint disease unknown (both were ongoing and started on an unknown date). It was unknown whether the patient had received any vaccination within four weeks prior to vaccination. The patient had no illness at time of vaccination. Concomitant medications were not reported. On 08 October 2015, two-three hours following the vaccination, the patient had developed severe left deltoid pain/arms are sore, could not move her arm and was diagnosed with degenerative joint disease (triggered an underlying syndrome she may have had). The patient was hospitalized on 08 October 2015 and discharged on 12 October 2015 for the event could not move her arm. The patient required visit to emergency room for severe left deltoid pain and could not move her arm. The patient had previously received seven doses of high dose flu vaccine with no known adverse event. Laboratory data and corrective treatment was not reported. The outcome of the event severe left deltoid pain, could not move her arm were unknown. The outcome of the event degenerative joint disease and that the immunization triggered an underlying syndrome she may have had was not reported. The reporter assessed the causal relationship with both the suspect vaccine as related for the events severe left deltoid pain and could not move her arm. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Computerised tomogram, Electrocardiogram, Injection site pain, Laboratory test
Clinical narrative: Patient states that shot hit a never and she has been in pain since shot given.