chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: Denies any flu-like symptoms or GI problems. Reports hoarsness but no sore throat. Reports progressive pain and swelling of joints of hands, knees and ankles.  Initially just achiness but progressed to severe throbbing pain mostly in hands and wrists.  Unable to make a fist at the worst point.  Accompanied by burning and numbness of lower extemities and fatigue.  Pain not relieved with advil alternating with Tylenol or by hot/cold.  Improving with prednisone.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Cough, Dizziness, Myalgia
Clinical narrative: Dry cough, shortly followed by temperature rise to 102, Muscle aches, light headedness.
Age: 54.0
Sex: M
Vaccine: FLU3, HEP, PPV
Symptoms: Body temperature increased, Dizziness, Erythema, Local swelling, Pain in extremity
Clinical narrative: Dizziness, lightheadedness, elevated temperature. (R) right arm redness, swelling, pain within a day of injections, lasted 6 days. Elevated arm, cool compresses used. VICODIN used.
Age: 74.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Fatigue, Rash macular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient. On 11-OCT-2014 the patient was vaccinated with ZOSTAVAX (vial 19400 PFU) in the arm (dose and route was unknown). Other suspect therapies included influenza virus vaccine (manufacturer unknown) administered on 11-OCT-2014 (on the opposite arm) (dose and route was unknown). On 11-OCT-2014, the patient experienced tiredness. On 14-OCT-2014 the patient experienced ZOSTAVAX arm red and blotchy and some areas on the patient's arm were darker red. It was reported that there was no pain, raised areas or rash present. Patient sought medical attention, came back to pharmacy. No product quality complaint was involved. On an unknown date in October 2014 ( reporter spoke to the patient on 17-OCT-2014) the outcome of tiredness, some areas on the patient's arm were darker red and ZOSTAVAX injection arm was red and blotchy was reported as recovered. The reporter considered tiredness to be related to Influenza Virus Vaccine (manufacturer unknown) and the relatedness of the events some areas on the patient's arm were darker red and ZOSTAVAX injection arm was red and blotchy with the therapy Influenza Virus Vaccine (manufacturer unknown) was not provided. The relatedness of the events with the therapy ZOSTAVAX was not provided. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza virus test positive, Pain, Pyrexia
Clinical narrative: Initial report received from a consumer on 20 October 2014. A 74 year-old female patient with an allergy to antibiotics had received on an unspecified date in October 2013 an intramuscular dose of FLUZONE HIGH DOSE (lot number and site of administration not reported) and 24 hours later developed an extreme cough, widespread body aches and fever that lasted for 7 days. Then again in March 2014 the patient developed "the same symptoms" and was evaluated by a physician. The patient tested positive for the flu but strain was unknown. Treatment included Tamiflu. No further information was provided at the time of the report. Outcome was recovered. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Hot flush, Malaise, Pyrexia, Syncope, Viral infection
Clinical narrative: Initial report received from a health care professional (pharmacist) on 23 October 2014. A 43-years-old female patient, with no reported medical history, had received an intramuscular dose of FLUZONE QIV (batch number reported as U5196AE, which is not a valid lot number) in the left deltoid on 22 October 2014. She had none known allergies. On 22 October 2014, one hour post-vaccination, she experienced wheezing and hot flashes that lasted into the evening. At 6:30pm, the patient fainted and was taken to the Emergency room. It was stated that the ER diagnosis was "viral syndrome". She continued to experience fever and "not feeling well" on 23 October 2014. The patient had received vaccination through her employee health program, but vaccine was administered through the pharmacy which reported the events. It was not reported whether the patient had received any corrective or concomitant medications. At the time of the report, the patient was not recovered. Document held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Initial report received from a health care professional (pharmacist) on 23 October 2014. A 43-years-old female patient, with no reported medical history, had received an intramuscular dose of FLUZONE QIV (batch number reported as U5196AE, which is not a valid lot number) in the left deltoid on 22 October 2014. She had none known allergies. On 22 October 2014, one hour post-vaccination, she experienced wheezing and hot flashes that lasted into the evening. At 6:30pm, the patient fainted and was taken to the Emergency room. It was stated that the ER diagnosis was "viral syndrome". She continued to experience fever and "not feeling well" on 23 October 2014. The patient had received vaccination through her employee health program, but vaccine was administered through the pharmacy which reported the events. It was not reported whether the patient had received any corrective or concomitant medications. At the time of the report, the patient was not recovered. Document held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Patient reported to the doctors on the 23rd with red, swollen, painful arm.  Dr. told her to put a cold compress on it, use anti-inflammatories, and gave her an antibiotic in case needed.  Patient did not take antibiotic and redness was relieved with ice pack.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Very sore arm, painful to lift arm or to sleep.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain, Pain in extremity, Sensation of heaviness, Tenderness
Clinical narrative: Very sore arm, painful to lift arm or to sleep.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Told nurse that her arm felt heavy after the shot.  Today, she states that her arm is sore when she moves it or sleeps on it.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain, Pain in extremity, Sensation of heaviness, Tenderness
Clinical narrative: Told nurse that her arm felt heavy after the shot.  Today, she states that her arm is sore when she moves it or sleeps on it.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Ear swelling, Influenza like illness, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Pt reports that she experienced flu-like symptoms 10/26/14 pm that were consistent with the affects stated on the VIS for Fluzone HD. The early morning hours of 10/29/14, she experienced swelling of the tongue and ears and redness/swelling at the site of injection of Zostavax. She also experienced itchy scalp and sore abdominal muscles located below the rib cage. Patient did not previously exercise her abdominal muscles.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pruritus, Swollen tongue
Clinical narrative: Pt reports that she experienced flu-like symptoms 10/26/14 pm that were consistent with the affects stated on the VIS for Fluzone HD. The early morning hours of 10/29/14, she experienced swelling of the tongue and ears and redness/swelling at the site of injection of Zostavax. She also experienced itchy scalp and sore abdominal muscles located below the rib cage. Patient did not previously exercise her abdominal muscles.
Age: 55.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Influenza like illness, Local swelling, Pain in extremity
Clinical narrative: Saturday she felt like she had the flu all day and her arm was red and swollen and hurting.
Age: 32.0
Sex: F
Vaccine: FLUN4
Symptoms: Aphasia, Chills, Confusional state, Headache, Hypoaesthesia
Clinical narrative: I experienced facial numbness, headache, chills, confusion, and aphasia for approximately 30 minutes.  Symptoms slowly resolved (gone 90 minutes from onset).
Age: 46.0
Sex: M
Vaccine: TYP
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: These case reports were previously actioned by Crucell (CRX-2013-001116). The data was taken directly from the database repository and entered verbatim (including labeling and causality assessments) on to the safety database. Where labeling and causality assessments were absent, facility took the decision to assign according to company guidelines. This case was forwarded by Crucell with the reference number CVAE-056-2013. Initial spontaneous case received on 11-Sep-2013 from a physician and from the patient and processed together with follow-up information received on 13-Sep2013 from the physician, which concerns a 46-year old male patient who received 3 oral doses of Vivotif (batch 3000421, expiry date not reported), as a prophylactic vaccination. First dose of Vivotif taken on unspecified date in Aug-2013 (24.Aug.2013 and 25.Aug.2013 were reported), second capsule on 27-Aug-2013 and third capsule on 29-Aug-2013 respectively. The patient did not take the fourth capsule. The patient had no medical pre-existent condition. The physician reported the patient had normal physical examination with normal routine chemistries and complete blood count (CBC) before vaccination. Concomitant medication not provided. On 26-Aug-2013, the patient experienced diarrhea. On 27-Aug-2013, he took second dose and experienced intense abdominal pain. On 28.Aug.2013, the pain subsided, but not completely. After intake of the third capsule of Vivotif, on 29-Aug-2013, the patient reported recurrence of intense abdominal pain and diarrhea. Tests showed negative / normal abdominal CT and MRI, normal blood tests after the patient stopped the vaccine course two weeks before the date of this report. No treatment taken for the reported events. The reporting physician was considering antibiotic therapy with azithromycin or ciprofloxacin to treat the patient. As per the physician, at the time of report, the patient still having persistent burning abdominal pain and diarrhea several weeks after vaccine administration. The events were assessed as serious, medically important by the reporter physician. No further details were provided. Follow-up information received from the patient on 04.Oct.2013: The expiry date of the Vivotif capsules used was 31.Jan.2014. The patient had no concomitant medications. The patient reported he was 90% recovered. No medication was prescribed to treat symptoms. After several unspecified tests, which all came out normal, it was determined that the patient was producing excessive gas. Treatment included enema, which helped. Case updated on 11.Mar.2014: Test previously coded as 'CT scan' was recoded to 'computerized tomogram abdomen'. Pharmaceutical form of Vivotif was updated as 'capsule'. Initial receipt date previously reported as 12.Sep.2013 in the narrative was corrected to 11.Sep.2013. Case version [4] was created using [11-MAR-2014] as the date to action case quality corrections to legacy data. The following fields were updated [Country Where Drug Obtained] no other changes were made to the case.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site bruising
Clinical narrative: Bruise at vaccination site, L deltoid.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: ON SITE SWELLING AND PAIN.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: Significant symptoms of influenza (only moderate in severity, but more severe than expected),  plus severe local injection site pain.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain, Pain in extremity, Poor quality sleep
Clinical narrative: Around 8pm, following the injection, my arm got incredibly painful and my ROM was extremely limited. I was unable to lay on my left side for five or six nights. My ROM has since improved some, but there is still a lot of pain, especially when trying to dress, holding anything heavy, or driving. Sleep is still poor. I am in pain nearly three weeks later.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site pain, Injection site warmth
Clinical narrative: Patient reported event on 10/30/2014. Described progressing soreness and heat at injection site that wouldn't resolve with ice. Eventually, patient saw prescribing physician and was hospitalized for diagnosis of cellulitis and treated with antibiotics.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Drug screen, Joint swelling
Clinical narrative: Severe joint pain and swelling.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Area of skin on left deltoid/injection site erythemic, warm and TTP. Size 4.5 x 8 cm. Ibuprofen 600 mg po TID, cool compresses f/u in 24 hrs scheduled.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Pain
Clinical narrative: Started with a headache. Took Tylenol for it. As soon as the Tylenol wore off I started to get body aches, I woke up and my symptoms were worse.
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Abnormal behaviour, Dyspnoea, Heart rate increased, Nausea, Pyrexia
Clinical narrative: Fever of 101.9, rapid heartbeat, labored breathing, nausea, strange behavior - out of it, saying things that didn't make sense.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Aches, Pains, Fatigue and pain at injection site without fever for four days. Pain at injection site ongoing to this date.  Unable to move without pain in arm where injection was administered.
Age: 37.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain, Nausea
Clinical narrative: PATIENT COMPLAINS OF NAUSEA AND ABDOMINAL CRAMPING 24 HOURS POST VACCINATION. SYMPTOMS RELIEVED WITHIN 24 HOURS.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: PATIENT COMPLAINS OF HIVES AND RASH 4 HOURS POST VACCINATION, RECOVERED WITHIN 2 DAYS.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Malaise, Myalgia, Pyrexia, Respiratory tract congestion
Clinical narrative: Within 2 hours of the inactivated vaccine administration, pt complains of fever of 102 F, myalgia, congestion, malaise, injection site pain.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Crying, Eyelid oedema, Irritability, VIIth nerve paralysis
Clinical narrative: This is the 2nd dose for boosting. The first dose was a month ago.  ~11:00 AM, she became very fussy and cried a lot. She seldom cries that much. ~2:00 PM, we found her right facial palsy especially when smiling and swelling eyelid on both sides.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: SWELLING, REDNESS at SITE.  DIAGNOSED WITH CELLULITIS AT URGENT CARE CLINIC.  RECEIVED ORAL ANTIBIOTICS.
Age: 6.0
Sex: M
Vaccine: DTAP, FLU4, MMRV
Symptoms: Ear swelling, Erythema, Rash, Skin warm, Swelling face
Clinical narrative: Rash developed on legs, arms, face.  Redness, swelling and warmth around the eyebrows, nose and ears.  Pt. medicated with po Benadryl in the clinic and observed.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Blood test, Influenza virus test, Mobility decreased, Pain in extremity
Clinical narrative: Fever over 100 and extreme soreness in arm and lack of mobility in arm. Extreme weakness. Fever lasted 4 days, arm soreness is still present after a week. Antibiotic started after two days.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Fever over 100 and extreme soreness in arm and lack of mobility in arm. Extreme weakness. Fever lasted 4 days, arm soreness is still present after a week. Antibiotic started after two days.
Age: 45.0
Sex: M
Vaccine: DTAP, FLUX, PPV
Symptoms: Asthenia, Chills, Dizziness, Injection site erythema, Injection site pain
Clinical narrative: Severe muscle pain in area of injection, soreness and redness around injection site, fever above 100F, weakness, dizziness, chills, the following day (10/30/2014) developed respiratory congestion. Ibuprofen for pain...
Age: 45.0
Sex: M
Vaccine: DTAP, FLUX, PPV
Symptoms: Injection site reaction, Myalgia, Pyrexia, Respiratory tract congestion
Clinical narrative: Severe muscle pain in area of injection, soreness and redness around injection site, fever above 100F, weakness, dizziness, chills, the following day (10/30/2014) developed respiratory congestion. Ibuprofen for pain...
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Received flu shot in Left arm. Entire upper arm swollen, hot to touch and red and blotchy. Didn't check her arm until 24 hrs after shot when realized how bad it was. Diagnosed with cellulitis.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Rash macular
Clinical narrative: Received flu shot in Left arm. Entire upper arm swollen, hot to touch and red and blotchy. Didn't check her arm until 24 hrs after shot when realized how bad it was. Diagnosed with cellulitis.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: Fever 101.8 highest- 101.3 lowest temperature consistent fever.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Injection site pain, Mobility decreased, Swelling
Clinical narrative: Redness, swelling, headache and intense pain at the injection site. Patient states that she could not move her arm.
Age: 46.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Lip swelling, Pruritus, Pyrexia, Urticaria
Clinical narrative: Very itchy Hives that got bigger all over body including head, swollen lips, fever and several chills.
Age: 71.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Inflammation, Injection site inflammation, Ultrasound scan normal
Clinical narrative: This spontaneous report as received from nurse refers to a 71 year old male patient. The patient's medical history included lymphoma. There was no drug reactions/allergies. On 20-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 injection, (lot # K009809, expiration date: 16-MAY-2015, strength and dose unknown) intramuscularly. Concomitant therapies included influenza virus vaccine (unspecified) (also reported as none) started on 20-OCT-2014. On 24-OCT-2014, the patient came back to the office because the arm in which he received the PNEUMOVAX 23 was inflamed down to his wrist. The patient sought medical attention. The reporter stated that they drew a circle around the inflamed area and sent the patient home with BACTRIM. The reporter stated later that day, 24-OCT-2014, the patient's wife called and said that the inflamed area began to extend beyond the circle. It was recommended that patient go to the Hospital - which he did on 24-OCT-2014. While at the emergency room, patient had an ultrasound performed which showed negative for a blood clot. Patient was then discharged to home on 24-OCT-2014. The outcome of the event was not provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chest pain, Cough, Malaise, Throat tightness
Clinical narrative: Sudden onset of cough -> chest pain and feeling of throat constriction -some relief with BENADRYL - sxs continued throughout night. Seen at health services following morning. Currently chief complaint malaise/achy joints - chest pain. Pt is otherwise healthy without meds/med hx.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Diarrhoea, Headache, Nasopharyngitis, Pyrexia
Clinical narrative: 12 hours after administration. Fever approx. 102 F, headache, chills, diarrhea, cold symptoms.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose decreased, Confusional state, Headache, Photophobia, Vomiting
Clinical narrative: Patient claims within 30 min of receiving vaccination, she became extremely confused and couldn't speak her thoughts. Called pharmacist who told her to take 50 mg BENADRYL and go to ER (Rph). 20 min after taking BENADRYL, all symptoms subsided. Next morning patient awoke with vomiting, severe headache, light hurt eyes, sugar dropped. 10-24-14 patient is still having these symptoms.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site coldness, Injection site reaction, Paraesthesia, Peripheral coldness
Clinical narrative: Almost immediately - site to fingertips cold and tingly.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient developed hives and itching about 3 hours after Flu vaccine. Treated w/ 50mg Diphenhydramine and told to follow up if necessary.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: 7 days post-administration-left deltoid slightly raised, bruised (purple/yellow) and painful at touch. Patient was asked many questions by the pharmacist. He is currently taking Aspirin 325mg daily.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: On 10/24 - Right arm became swollen, then on 10/25 - her arm was red and warm to the touch which spread downward. BENADRYL was given which improved the symptoms. By 10/27 the symptoms had resolved.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Arm swollen and red. Went to doctor and got a steroid shot.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site rash, Injection site vesicles, Lymphadenopathy
Clinical narrative: Red raised rash at injection sight with blisters. Very painful. needed to sleep with arm raised. Treated w/numbing topical agent. Joint pain , muscle pain, swollen glands.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Myalgia
Clinical narrative: Red raised rash at injection sight with blisters. Very painful. needed to sleep with arm raised. Treated w/numbing topical agent. Joint pain , muscle pain, swollen glands.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Skin disorder, Vomiting
Clinical narrative: Pt. received Influenza vaccine at 0915 on October 29, 14. She developed a rash on arms and chest around 1330. The rash did not itch, but stated skin felt like sandpaper. The pt ate dinner then began vomiting at 1930 until 2300. Pt had no fever. Rash is gone and pt is asymptomatic on October 30, 2014.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient developed fever - had it for 3 days. Severe nausea and vomiting - lasted almost 3 days. Feeling like diarrhea.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Local swelling
Clinical narrative: As soon as injection was given IM to her right arm, it began to swell. An ice pack was applied a few minutes later.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Patient felt dizzy after administration and then fainted as she got up from chair and then was taken to emergency room.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Arm swelled within 20 min. of injection and turned red and was hot to the touch. It was approximately the size of a golf ball. The next day it swelled to about the size of a softball and stayed that way for about 24-36 hours.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine
Clinical narrative: Patient developed a migraine 1 hour after receiving medication and it lasted for a week.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Injection site erythema, Vaccination site pain
Clinical narrative: FLUZONE HD administered on 10.27.14 to patient. Patient stated it burned a little at the time of administration. Patient came back on 10.30.14 and her arm had a large red area at vaccine site and was very sore. Pt was going to take BENADRYL, TYLENOL and heat area.
Age: 51.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Local swelling, Paraesthesia, Pruritus
Clinical narrative: Patient stated she began feeling tingling and itching in the arm vaccine was given. Also she noted noticeable swelling in her fingers so much her rings had to be taken off because they felt tight. She experienced all symptoms w/in 10 min of vaccine administration.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, heat, redness at injection site and pain. Swelling from elbow to shoulder. Chills, fever, body aches. Only treatment: acetaminophen, rest, time.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain, Pyrexia
Clinical narrative: Swelling, heat, redness at injection site and pain. Swelling from elbow to shoulder. Chills, fever, body aches. Only treatment: acetaminophen, rest, time.
Age: 27.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Joint range of motion decreased, Pain, Pyrexia, Swelling
Clinical narrative: Pain, fever, swelling, loss of range of motion in vaccination arm.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Body temperature increased, Chills, Injection site induration, Injection site warmth, Myalgia
Clinical narrative: Warm indurated injection site (Lt arm). Temp 99.8 associated w/ myalgias and chills. No other cause of infection noted.
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Experienced itching and hives all over body 15 minutes after injection. Administered BENADRYL 50mg and symptoms dissipated. She notified her family doctor and no further action required.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Lt arm to wrist, neck, chest reddened x 1 hr. Denied itching. Took BENADRYL 25mg- Redness reduced over following 3 days until gone.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Right arm upper area, red raised swollen pain all the way down arm.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal disorder, Pain, Sleep disorder, Tendon injury
Clinical narrative: "Needle hit my bone". Pain 5 on 1-10 scale and 3 after taking ibuprofen. Limited ROM Oct. 18, 2014 spoke with 2 doctors who work with her in ER. States one doctor said it tendon injury, it will take a long time to heal. They recommended MOTRIN and warm compresses. Unable to lift heavy objects. Unable to sleep on left side.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Pain, Pain in extremity, Tenderness
Clinical narrative: "Needle hit my bone". Pain 5 on 1-10 scale and 3 after taking ibuprofen. Limited ROM Oct. 18, 2014 spoke with 2 doctors who work with her in ER. States one doctor said it tendon injury, it will take a long time to heal. They recommended MOTRIN and warm compresses. Unable to lift heavy objects. Unable to sleep on left side.
Age: 18.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Diabetic ketoacidosis, Diarrhoea, Exposure during pregnancy, Foetal death, Nausea
Clinical narrative: Day after vaccination, pt developed N/V and diarrhea, 2 days after vaccine pt presented in DKA with Interuterine fetal Death.
Age: 18.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Vomiting
Clinical narrative: Day after vaccination, pt developed N/V and diarrhea, 2 days after vaccine pt presented in DKA with Interuterine fetal Death.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Musculoskeletal discomfort
Clinical narrative: Pt. reports having discomfort in her arm and shoulder since receiving her influenza vaccination 3 weeks ago. (Pt. encouraged to see physician).
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, FLU3, MMRV, PNC13
Symptoms: Decreased appetite, Flushing, Malaise, Pyrexia, Rash
Clinical narrative: Rash began 10/8/14 - started on cheeks and moved downward - Associated symptoms fever at night, decreased appetite and malaise. Follow-up appt 10/15/14 - S/s resolved - only faint flushing remains on cheeks.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Received PF FLUZONE 10-22-14. Noted fever 103.1 10-25-14. Seen urgent care 10-27-14.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Pt. developed diffuse itchy red macular rash over arms - legs - scalp - face - neck - shoulders- upper chest and back. Within 72 hours of receiving the influenza vaccine.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction, Throat irritation
Clinical narrative: Patient was given inactivated flu vaccine. Had egg sensitivity but could still eat eggs. Pt had local reaction and scratchy throat after vaccine administered. Gave 50 mg BENADRYL.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt reported back to me on 10/20/14. (Left arm pain) Stating left arm pain has not gone away since after she got shot. Can not raise arm above shoulder level. Called MD got her appt for the next day.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Accidentally administered High Dose flu vaccine to a client not yet 65 years old. No specific adverse effects from this flu shot according to client.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction, possible infection.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Loss of consciousness
Clinical narrative: Extreme pain from elbow to shoulder, then patient passed out.
Age: 0.59
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Several hours after receiving the flu vaccine his right upper arm began to swell and become reddened.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Food allergy, Injection site erythema, Injection site pain, Rash
Clinical narrative: Patient was given flu vaccine 10/16/14 waited 30 min with no reaction. Mom states overnight he broke out in a rash, had swelling of face, and injection site was red, sore to touch. (1st time for non-preserv. free). Hives, localized erythema. Has egg allergy but has had flu vaccine before 2012, 2013.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling face, Urticaria
Clinical narrative: Patient was given flu vaccine 10/16/14 waited 30 min with no reaction. Mom states overnight he broke out in a rash, had swelling of face, and injection site was red, sore to touch. (1st time for non-preserv. free). Hives, localized erythema. Has egg allergy but has had flu vaccine before 2012, 2013.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site mass, Pain in extremity
Clinical narrative: Patient stated that vaccine did not feel "smooth" going in. She reproted having a lump at injection site as well as a large bruise. her arm was much more sore than normal, but id feeling much better as of 10/24/14.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given KINRIX at age 6 months.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema of eyelid, Eyelids pruritus, Injection site erythema, Injection site haematoma
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient. The patient had no drug reactions or allergies. On 22-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot number K008882 expiry date 20-SEP-2015). On 23-OCT-2014, the patient developed erythema and hematoma around injection site(left arm) a day after ZOSTAVAX administration and after 2,3 days after ZOSTAVAX administration patient developed redness around her left eye, right below her eye brow. There was no treatment rendered for the events. No lab tests were performed. The outcome of the events were reported as not recovered/not resolved. The patient did not seek medical attention. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema of eyelid, Injection site erythema, Injection site haematoma
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient. The patient had no drug reactions or allergies. On 22-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot number K008882 expiry date 20-SEP-2015). On 23-OCT-2014, the patient developed erythema and hematoma around injection site(left arm) a day after ZOSTAVAX administration and after 2,3 days after ZOSTAVAX administration patient developed redness around her left eye, right below her eye brow. There was no treatment rendered for the events. No lab tests were performed. The outcome of the events were reported as not recovered/not resolved. The patient did not seek medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (L) pain, hot to the touch with redness that radiates through upper (L)arm. Given abx to tx cellulitis. Pt presents for a Tdap reaction. Pt was here on Monday and received a Tdap vaccination, Tuesday is when pt started complaining of pain in (L) arm. Pt states this morning is when she noticed heat and redness radiating from arm. Pt denies n/v, diarrhea, and any other symptoms.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Cough, Dysphagia, Headache, Hypoaesthesia
Clinical narrative: Next morning onset: headaches, respiratory distress, site swollen, red, arm pit swollen and very hard up into shoulder, hand swollen and numb, pain in fingers and toes, difficulty swallowing. Later symptoms: started after a cough, infection around sutured wound blistered, pain in lymph nodes in neck, tender and swollen around mastoid bone, numbness in hands after sleeping, or light activity, headaches.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Injection site erythema, Injection site swelling, Local swelling, Lymph node pain
Clinical narrative: Next morning onset: headaches, respiratory distress, site swollen, red, arm pit swollen and very hard up into shoulder, hand swollen and numb, pain in fingers and toes, difficulty swallowing. Later symptoms: started after a cough, infection around sutured wound blistered, pain in lymph nodes in neck, tender and swollen around mastoid bone, numbness in hands after sleeping, or light activity, headaches.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling, Respiratory distress, Tenderness, Wound infection
Clinical narrative: Next morning onset: headaches, respiratory distress, site swollen, red, arm pit swollen and very hard up into shoulder, hand swollen and numb, pain in fingers and toes, difficulty swallowing. Later symptoms: started after a cough, infection around sutured wound blistered, pain in lymph nodes in neck, tender and swollen around mastoid bone, numbness in hands after sleeping, or light activity, headaches.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event
Clinical narrative: No adverse events. No tx.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site hypersensitivity, Vaccination complication
Clinical narrative: This spontaneous report was received from a physician refers to a 62 year old female patient. The patient did not specify her medical history or her medical profile. On 13-OCT-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous. On 13-OCT-2014 patient reported she has an injection-site adverse experience that her physician told her is an allergic reaction to ZOSTAVAX. In October 2014, the patient sought medical attention. The patient did not provide further description of the symptoms of her injection-site adverse experience. The patient did not specify the injection-site adverse experience time of onset, nor did she specify which treatment, if any, as prescribed. Reporting physician stated the adverse event as not serious because the patient was speaking freely, while at home, and denied being in any other distress. The outcome of adverse event is unknown. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccination in a 7-year-old unk patient who received INFANRIX. On an unknown date, the patient received the 1st dose of INFANRIX (injection). On an unknown date, an unknown time after receiving INFANRIX, the patient experienced inappropriate age at vaccination. On an unknown date, the outcome of the inappropriate age at vaccination was unknown. It was unknown if the reporter considered the inappropriate age at vaccination to be related to INFANRIX. Additional information: The nurse reported that a 7 year old received an INFANRIX vaccine. INFANRIX was recommended for children between 6 weeks to 7 years old (prior to seventh birthday). No adverse event reported. No additional information was available. The case was closed.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Feeling abnormal, Hypersomnia
Clinical narrative: This spontaneous report was received from a consumer refers to herself as approximately 56 year old female patient. Concurrent conditions included hypothyroidism. No drug allergies reported. On 01-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 one injection (lot number not reported) through an unspecified route. Concomitant therapies included SYNTHROID. On 02-OCT-2014, the patient experienced what felt like knives traveling throughout her body and she was exhausted for one day following her vaccine injection. The patient slept all day on 02-OCT-2014 and she experienced an elevated amount of fatigue. No lab diagnostics studies performed. The patient did receive unspecified treatment for the adverse events. The outcome of the events was reported as recovered on 03-OCT-2014. The causality for the events was unknown. Medical attention was not sought. Product quality complaint was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Condition aggravated, Erythema, Facial pain, Haemorrhage
Clinical narrative: This spontaneous report was received from a 75 year old female patient and refers to herself. The patient's medical history included having unspecified lab work done from previous years but they didn't say anything that caused allergies. The patient's concomitant medications and past drug history were not reported. In an approximately October 2010 (also reported as 4 years ago) the patient started ZOSTAVAX (route, dose, frequency and lot # not reported) symptoms described as little pimples, redness and hurting. It was reported that in an approximately October 2010 (also reported as 4 years ago) her doctor prescribed her ZOSTAVAX and she was administered the vaccine from a nurse at the pharmacy. On 20-OCT-2014 (also reported as a week ago) the patient got shingles again which included symptoms on her face, swelling, redness, pain, itchy and bloody. The patient stated that ZOSTAVAX injection did not really help with the shingles (on 20-OCT-2014) but it stopped the virus. It was reported that on 24-OCT-2014 the patient went to urgent care and they gave her treatment for the shingles symptoms, which included doxycycline and valacyclovir to take for a week. The doctor at the urgent care advised her to follow up with her primary care physician and optometrist because they want to make sure that nothing would complicate her eyes because it was on her face. There was no relevant laboratory data. It was reported that as of the time of the report (25-OCT-2014) the patient reported that everything was down including swelling being better, symptoms around her face, pain, redness and bleeding. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Swelling face
Clinical narrative: This spontaneous report was received from a 75 year old female patient and refers to herself. The patient's medical history included having unspecified lab work done from previous years but they didn't say anything that caused allergies. The patient's concomitant medications and past drug history were not reported. In an approximately October 2010 (also reported as 4 years ago) the patient started ZOSTAVAX (route, dose, frequency and lot # not reported) symptoms described as little pimples, redness and hurting. It was reported that in an approximately October 2010 (also reported as 4 years ago) her doctor prescribed her ZOSTAVAX and she was administered the vaccine from a nurse at the pharmacy. On 20-OCT-2014 (also reported as a week ago) the patient got shingles again which included symptoms on her face, swelling, redness, pain, itchy and bloody. The patient stated that ZOSTAVAX injection did not really help with the shingles (on 20-OCT-2014) but it stopped the virus. It was reported that on 24-OCT-2014 the patient went to urgent care and they gave her treatment for the shingles symptoms, which included doxycycline and valacyclovir to take for a week. The doctor at the urgent care advised her to follow up with her primary care physician and optometrist because they want to make sure that nothing would complicate her eyes because it was on her face. There was no relevant laboratory data. It was reported that as of the time of the report (25-OCT-2014) the patient reported that everything was down including swelling being better, symptoms around her face, pain, redness and bleeding. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, PPV
Symptoms: Injection site pain
Clinical narrative: Pt was given PNEUMOVAX 23 on Tuesday, October 28, 2014. Pt stated there was pain at the injection site later that evening. Pt's mother applied ice and gave Ibuprofen throughout the next day. Pt came to clinic Thursday, October 30, to report reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patiens of unknown age. On an unknown date, the patients were vaccinated with several unspecified number of doses of improperly stored ZOSTAVAX, (lot number K009770 expiry date 09-OCT-2015) 0.65 ml, subcutaneous. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional (healthcare worker) refers to a 5 week old patient of unknown gender. On 28-OCT-2014 the patient was vaccinated with VAQTA, .5 ml, intramuscular. No adverse experience was reported. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with VAQTA. This case is related to MARRS# 1410USA015558. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional (healthcare worker) refers to a 5 week old patient of unknown gender. On 28-OCT-2014 the patient was vaccinated with VAQTA, .5 ml, intramuscular. No adverse experience was reported. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with VAQTA. This case is related to MARRS# 1410USA015847. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Pain, Skin exfoliation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 23-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was unknown). on 24-OCT-2014, the patient experienced red, scaly skin on both cheeks, widespread bodyaches and swelling at the injection site. On 26-OCT-2014, the patient went to the pharmacy to report the adverse effects. The patient spoke to her unspecified physician while in the pharmacy and the physician prescribed an unspecified topical hydrocortisone cream to be applied to the face. The outcome of the events were unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient with psoriasis. The patient no drug allergies. On 24-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot number K010647, expiry date 30-OCT-2015). There was no concomitant medications reproted. On 26-OCT-2014, the patient experienced redness, warmth, and swelling at the injection site after receiving ZOSTAVAX and described it as looks like a bulls eye. The patient was given massage, cool compress and TYLENOL. There was no lab tests performed. The outcome of redness, warmth, and swelling at the injection site was reported as not recovered/not resolved. The patient did not seek medical attention. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on 16-OCT-2014, expired ZOSTAVAX (lot # J007855, expiry date: 28-SEP-2014, dose, route of administration and anatomical location was unknown) was inadvertently administered to the patient. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No additional information was available. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional (nurse) refers to unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with PEDVAXHIB, intramuscular, which was improperly stored. No adverse symptoms were reported. The temperature excursion for PEDVAXHIB was supported with in-house stability data. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with PEDVAXHIB. This case is related to MARRS# 1410USA015943, 1410USA015944 and 1410USA015945. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional (nurse) refers to unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with VAQTA intramuscular, which was improperly stored. No adverse symptoms were reported. The temperature excursion for VAQTA was supported with in-house stability data. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with VAQTA. This case is related to MARRS# 1410USA015443, 1410USA015944 and 1410USA015945. Additional information has been requested.