chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Angiopathy, Computerised tomogram normal, Diplopia, Visual impairment
Clinical narrative: Received flu shot on 10-15-14 at 830 am. Around 300 pm began double vision in periphery (R) eye. Vision worsened next day. Saw ophthalmologist on 10-17-14. Dx vascular event. On 10-18-14 vision worsened. Went to ER. CT scan WNL. Double vision cont x 2 wks. At this time vision still not perfect.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Lip swelling, Swollen tongue
Clinical narrative: Swelling and redness at injection site - has improved. Swelling of lips and tongue - not till 11/14/14.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Hyporesponsive to stimuli, Hypotonia, Presyncope
Clinical narrative: Near-syncopal episode about 2-5 mins after vaccine, with pt becoming limp and less responsive, but not totally unresponsive. Back to normal after about 10 mins.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Hypoaesthesia, Paraesthesia
Clinical narrative: Received vaccine 11/10/14. That evening Left eye swelled shut. Pt took BENADRYL and swelling decreased. She continued to have tingling sensation around left eye Wednesday, 11/12/14 noticed her left pinky was numb.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Complained of pain in right arm where given, few days after mom looked and noticed area of purple/blue/red and skin in the area was hard. Seen for this 11/18/14, prescribed KEFLEX for possible cellulitis but may have been localized reaction or contusion.
Age: 48.0
Sex: F
Vaccine: FLUN4, HEP, HEPA, TDAP
Symptoms: Chills, Injection site erythema, Injection site rash, Pain, Pyrexia
Clinical narrative: 11/12/2014 Received shots. 11/13 Thursday night felt feverish but did not take temp. She had chills and body aches and went to bed. 11/14 felt better in am. Fever again at 10pm of 101.4 took 2 ibuprofen. 11/15 no fever during the day. Felt fine. Then at 6 pm temp is 101.2. Took 2 ibuprofen. Noticed light pick rash in the left upper arm on medial side. 11/16 felt fine all day. Rash has turned to a red/purple color. Does not itch. Is not warm to the touch. Note: Pt received radioactive iodine in 2007 and a thyroidectomy.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Muscle tightness, Myalgia, Pain
Clinical narrative: Moderate to severe pain in large joints (elbows, primarily knees) and pain/extreme tightness in large muscles (thighs, hamstrings-also ACL of (L) knee, biceps) persistent full body aching with gradual let up over 4-5 days.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Patient developed hives on her face and back after receiving FLUMIST (about 15 min after administration). Patient seen, epipen administered, BENADRYL 5ml given. Patient observed.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site movement impairment, Mobility decreased
Clinical narrative: Pt. came in 11-22-14 and still complained that arm getting worse - hard to move and wondered if frozen arm syndrome - thinks injection site unable to move freely - pt. will see her primary care soon and ask as well.
Age: 1.02
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, VARCEL
Symptoms: Mucosal dryness, Pyrexia, Rash generalised, Rash morbilliform, Rhinorrhoea
Clinical narrative: Measles-like rash all over body along with watery nasal discharge and dry mucus membranes within 10 days following MMR vaccine. Mild fever, otherwise, well child.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injection site pain, Muscular weakness, Neuralgia
Clinical narrative: Shot area still hurts 1 month later (nerve stopped hurting) arm became so weak and painful that I could barely pull a shirt off over my head-that rotating motion pain/weakness began about 2 wks after shot and was at worst point 3-4 wks after. Still a problem.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Shot area still hurts 1 month later (nerve stopped hurting) arm became so weak and painful that I could barely pull a shirt off over my head-that rotating motion pain/weakness began about 2 wks after shot and was at worst point 3-4 wks after. Still a problem.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Pruritus, Swollen tongue
Clinical narrative: Bright red itchy arm. Breathing problems. Swelling of tongue.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Convulsion
Clinical narrative: 5th day post vaccination possible seizures. Duration - 4 second. 6th day another seizure duration 6 seconds. Totally asymptomatic otherwise. Today normal exam.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: Sore throat scalp sweating, chills, chest and sinus congestion, sneezing, cough, headaches, aches (flu shot seemed to damage my immune system).
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Respiratory tract congestion, Sneezing
Clinical narrative: Sore throat scalp sweating, chills, chest and sinus congestion, sneezing, cough, headaches, aches (flu shot seemed to damage my immune system).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Developed herpes zoster on 10/9/14 given valcyclovir on 10/15/14. Post herpetic neuralgiia requiring steroids, amitriptylene and LYRICA. Pain now subsiding.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness, Vaccination site pain
Clinical narrative: Patient experiencing pain and weakness in arm area of vaccination that has not improved after 4 weeks. Patient had not been treated at this point.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fall, Fatigue, Musculoskeletal pain, Nausea
Clinical narrative: Sore arm and shoulder-4 days. Sore throat-8days. Extreme fatigue. Sleepiness-approx. 30 days. Intermittent nausea-approx. 6 weeks. Dizziness-caused fall and visit to ER.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain in extremity, Somnolence
Clinical narrative: Sore arm and shoulder-4 days. Sore throat-8days. Extreme fatigue. Sleepiness-approx. 30 days. Intermittent nausea-approx. 6 weeks. Dizziness-caused fall and visit to ER.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: LA-dull, constant pain from elbow to shoulder. loss of range of motion of arm, painful if laying on that arm.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Pain in extremity, Pyrexia, Rash
Clinical narrative: Rash, sore arm, chills, low grade fever lasting about 4 days. I had a head cold and cough when I was given the shots.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fibromyalgia, Myalgia, Neuralgia, Osteoarthritis
Clinical narrative: High fever, chills, upper neuralgia nerve/muscle pain lasted for a few days. Pt has fibromyalgia and osteoarthritis and ME. Pain started in arm and radiated throughout body. 11/14/14 first day back to normal.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: High fever, chills, upper neuralgia nerve/muscle pain lasted for a few days. Pt has fibromyalgia and osteoarthritis and ME. Pain started in arm and radiated throughout body. 11/14/14 first day back to normal.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reported still having pain in arm with some limitation in movement since receiving immunization and will be following up with visit to physician.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: The right side of body became almost numb after a day or two of taking shot. Most sensation reversed in few days but affects are still on right arm.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site cellulitis, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Patient received vaccine 11/7/2014. She threw up at 2:00 am 11/8/2014. She noticed a bump with redness and swelling below injection site on 11/14/2014. She came to after hours care 11/15/2014 and was treated with AUGMENTIN. Acc by one of her daughters for F/U S/P AH visit 2 days ago. She is currently treated for cellulitis at the site of PREVNAR injection she had 10 days ago. She developed bump at site of the injection w redness and swelling below the injection site that spread down her (L) arm one week after the injection. She took 4 pills of AUGMENTIN so far, and the redness is getting better, but it the swelling is going down to just above her elbow. She threw up at 2 AM last week on Monday, but then OK since then. She has no fever and been eating OK since then.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Patient received vaccine 11/7/2014. She threw up at 2:00 am 11/8/2014. She noticed a bump with redness and swelling below injection site on 11/14/2014. She came to after hours care 11/15/2014 and was treated with AUGMENTIN. Acc by one of her daughters for F/U S/P AH visit 2 days ago. She is currently treated for cellulitis at the site of PREVNAR injection she had 10 days ago. She developed bump at site of the injection w redness and swelling below the injection site that spread down her (L) arm one week after the injection. She took 4 pills of AUGMENTIN so far, and the redness is getting better, but it the swelling is going down to just above her elbow. She threw up at 2 AM last week on Monday, but then OK since then. She has no fever and been eating OK since then.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site rash, Nausea, Pain
Clinical narrative: Feverish, body aches, nausea/vomiting, rash, erythema, site edema and erythema x 3 days.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Feverish, body aches, nausea/vomiting, rash, erythema, site edema and erythema x 3 days.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Two weeks after receiving the ZOSTAVAX vaccine, developed 4 lesions characteristic of chicken pox. No other symptoms noted.
Age: 18.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: Pt is pregnant and was given FLUMIST.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Dysphemia, Immediate post-injection reaction
Clinical narrative: 3 year old female who received FLUMIST on Oct 31 and immediately started to stutter. Mom feels stuttering is secondary to FLUMIST.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Laboratory test, Oral pruritus, Pruritus, Throat irritation
Clinical narrative: Received flu vaccine at around 0940-0945 on Thurs 11/20/14. Left to return to work area. About 15 min later began to experience itching in mouth, back of throat, eyes and ears. Called Employee Health and was directed to ER for supportive care. Was given P.O. BENADRYL with no effectiveness. Followed up with IV BENADRYL and symptom relief. Discharged after 2 1/2-3h ER visit. Off work x 1 day to cont oral BENADRYL treatment.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a 3-year-old male patient who received Influenza vaccine. Previously administered products included MMR, varicella vaccine and dtpa vaccine. Concurrent medical conditions included DiGeorge's syndrome. In 2013, the patient received the 1st dose of Influenza vaccine. In 2013, 1 day after receiving Influenza vaccine, the patient experienced extensive swelling of vaccination limb, arm red and arm hot. On an unknown date, the outcome of the extensive swelling of vaccination limb, arm red and arm hot were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, arm red and arm hot to be related to Influenza vaccine. Additional information received: Mother reports pediatric son experienced what she described as local injection site reaction after receiving a flu vaccine last year. His whole arm became red and hot and swollen the day after receiving a flu vaccine. The issues resolved after a few days. He experienced the same thing during a previous MMR and varicella vaccination. After MMR vaccine and varicella vaccine, the patient also experienced red, hot and swollen arm. No reaction noted after the dtpa vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain of skin, Pyrexia
Clinical narrative: This case was reported by a other health professional and described the occurrence of generalized body aches in a female patient who received FLUARIX QUADRIVALENT. On 22nd September 2014, the patient received FLUARIX QUADRIVALENT .5 ml. On 23rd September 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced generalized body aches, low grade fever and skin soreness. On 26th September 2014, the outcome of the low grade fever was recovered/resolved. On an unknown date, the outcome of the generalized body aches and skin soreness were not recovered/not resolved. The reporter considered the generalized body aches and low grade fever to be probably related to FLUARIX QUADRIVALENT. The reporter considered the skin soreness to be possibly related to FLUARIX QUADRIVALENT. Additional information received: Patient began with low grade fever, generalized body aches and skin soreness 1 day after receiving FLUARIX QIV. HCP was unsure if symptoms are related to FLUARIX QIV 10 days post vaccination.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Imaging procedure, Joint range of motion decreased, Pain, Sleep disorder
Clinical narrative: Patient received flu vaccine on 11-10-14 at a community health flu clinic. After 3 days of soreness, pain worsened. By the middle of last week pain began to limit patient's ROM, has disrupted sleep, and has impacted ADLs. At rest pain described as dull ache (2-3) when moving pain described as 8-9. Seen by MD. Rx 600mg Ibuprofen, ice and tests ordered. MD and RN to check-in with patient to monitor for worsening/improvement.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Respiratory tract congestion, Tongue disorder
Clinical narrative: 1h 1/2 after vaccination. Severe allergic reaction: congestion, tongue heaviness, itching in her skin.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 51.0
Sex: F
Vaccine: FLUC3
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Hives, shortness of breath, itching.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dyspnoea, Nausea, Pain, Peripheral swelling
Clinical narrative: Patient reports she had swelling in her hands, feet and felt like she was having difficulty breathing. This has since improved and denies difficult  breathing. Reports fever 102.7 with chills, body aches, and nausea. Encouraged patient to seek emergency care if rash, swelling, difficulty breathing occur. Advised to take BENADRYL.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Patient reports she had swelling in her hands, feet and felt like she was having difficulty breathing. This has since improved and denies difficult  breathing. Reports fever 102.7 with chills, body aches, and nausea. Encouraged patient to seek emergency care if rash, swelling, difficulty breathing occur. Advised to take BENADRYL.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Leukocytosis, Platelet count normal, White blood cell count increased
Clinical narrative: Leukocytosis - no sign of infection.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Patient experienced chest pain and tightness at night same day of shot. Symptoms lasted about 1 hour and then gone.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Neuropathy peripheral
Clinical narrative: Hematoma, neuropathy.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient contacted pharmacy regarding persistent soreness in shoulder. Patient visited primary physician and thought the injection possibly caused tendonitis.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Injection site pain, Pain in extremity, Pyrexia, X-ray
Clinical narrative: Patient contacted pharmacy regarding persistent soreness in shoulder. Patient visited primary physician and thought the injection possibly caused tendonitis.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: 2 days after receiving the immunization, rash appeared on legs, arms, torso. Relieved with BENADRYL.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site movement impairment, Injection site pain
Clinical narrative: Patient complaining of pain, numbness and decrease range of movement at the side of injection.
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer and described the occurrence of flu-like symptoms in a female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced flu-like symptoms. On an unknown date, the outcome of the flu-like symptoms was recovered/resolved. It was unknown if the reporter considered the flu-like symptoms to be related to Influenza vaccine. Additional information: The patient was vaccinated about 10 years ago. Please refer to case US2014GSK019593 for tolerance to next vaccination.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a other health professional and described the occurrence of swollen arm at the injection site in a 44-year-old male patient who received FLULAVAL (batch number 4597B, expiry date June 2015). This case was associated with a product complaint. Concurrent medical conditions included allergy (to mushrooms). On 27th October 2014, the patient received the 1st dose of FLULAVAL (intramuscular). In October 2014, less than a week after receiving FLULAVAL, the patient experienced swollen arm at the injection site and warm arm at the injection site. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the swollen arm at the injection site and warm arm at the injection site were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the swollen arm at the injection site and warm arm at the injection site to be probably related to FLULAVAL. It was unknown if the reporter considered the pharmaceutical product complaint to be related to FLULAVAL. Additional information about the product complaint received on 19 November 2014: This is one of the 5 cases reported by the same reporter for the same vaccine (with the same lot number).
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Product quality issue
Clinical narrative: This case was reported by a other health professional and described the occurrence of soreness at the injection site in a 51-year-old female patient who received FLULAVAL (batch number 4597B, expiry date June 2015). This case was associated with a product complaint. Concurrent medical conditions included diabetes. On 17th October 2014, the patient received the 1st dose of FLULAVAL (intramuscular). On 18th October 2014, 1 days after receiving FLULAVAL, the patient experienced soreness at the injection site. On an unknown date, the patient experienced pharmaceutical product complaint. On 19th October 2014, the outcome of the soreness at the injection site was recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. The reporter considered the soreness at the injection site to be probably related to FLULAVAL. It was unknown if the reporter considered the pharmaceutical product complaint to be related to FLULAVAL. Additional information about the product complaint received on 19 November u2014: This is one of the 5 cases reported by the same reporter for the same vaccine (with the same lot number).
Sex: F
Vaccine: FLU4
Symptoms: Expired drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a female patient who received FLUARIX QUADRIVALENT (batch number XE294, expiry date 30th June 2014). On 30th September 2014, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to FLUARIX QUADRIVALENT. Additional information received on 30 September 2014: Nurse reported she gave 4 female adult patients an expired dose of flu vaccine. Additional information was either unavailable or not provided at time of report. This is one of the 4 reports received from the same reporter for the same vaccine.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Pt had fever 2 days later and area of arm where she had r'ced PNEUMOVAX was red and sore.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood test, Dehydration, Dizziness, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of flu-like symptoms in a female patient who received FLULAVAL QUADRIVALENT(batch number XP4J2, expiry date 30th April 2015). Previously administered products included flu vaccination with an associated reaction of influenza like illness. Concurrent medical conditions included blood pressure high, lymphoma and drug allergy (allergy to Sulfa). Concomitant products included alprazolam and PNEUMOCOCCAL VACCINE. On 24th October 2014, the patient received FLULAVAL QUADRIVALENT. On 24th October 2014, 0 min after receiving FLULAVAL QUADRIVALENT and an unknown time after starting TYLENOL, the patient experienced flu-like symptoms, fever, dehydrated and woozy. The patient was treated with medication unknown (Fluid) and TYLENOL. On 27th October 2014, the outcome of the flu-like symptoms, fever and dehydrated were recovered/resolved. On an unknown date, the outcome of the woozy was unknown. The reporter considered the flu-like symptoms, fever, dehydrated, and woozy to be not reported if related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the flu-like symptoms, fever, dehydrated and woozy to be related to FLULAVAL. Additional information: With her recent Lymphoma diagnosis, patient's physician recommended a flu shot. The concomitant pneumococcal vaccine was given on 24 October 2014. The patient indicated that on 24 October 2014 during the night or early in the morning she got up to go to bathroom and felt extremely dizzy. She felt like she could have had fever but she did not take her temperature at that time. She also felt woozy and went back to bed. When she got up next morning, she indicated that she felt like she had the flu and slept most of the day. She indicated that she felt a little better that night. The next morning, she still didn't feel right, got panicked and took her temperature (101.2 Deg F). Since she was recently diagnosed with lymphoma she called her oncologist. The oncologist advised for her to go to the emergency room. At the emergency room she was given fluid and TYLENOL and her fever was within the 100 Deg. F-range. She indicated she was very dehydrated, blood tests were run. She followed up with her oncologist the next day. Refer to case US2014GSK023485 for tolerance to previous vaccination.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of hives in a 44-year-old female patient who received FLUARIX QUADRIVALANET (batch number LY2F5, expiry date 30th June 2015). On 7th October 2014, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, unknown after receiving FLUARIZ QUADRIVALENT, the patient experienced hives and itching. The patient was treated with BENADRYL. On an unknown date, the outcome of the hives and itching were unknown. It was unknown if the reporter considered the hives and itching to be related to FLUARIX QUADRIVALENT.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of hives in a 51-year-old female patient who received FLUARIX QUADRIVALENT (batch number 3JE9F, expiry date 30th June 2015). Concomitant products included NEXIUM. On 25th September 2014, the patient received FLUARIX QUADRIVALENT .5 ml. On 27th September 2014, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced hives. On 28th September 2014, the outcome of the hives was recovered/resolved. The reporter considered the hives to be possibly related to FLUARIX QUADRIVALENT. Additional information received on 30 September 2014: The patient had not known relevant medical history. She had already received previous vaccinations and previous fu shots but all without previous reactions. She did seek treatment at the emergency room. This is one of the 3 reports received by the sane reporter for the same vaccine.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional and described the occurrence of swollen arm at the injection site in a 35-year-old female patient who received FLULAVAL (batch number 4597B, expiry date June 2015). This case was associated with a product complaint. On 19th October 2014, the patient received the 1st dose of FLULAVAL (intramuscular). On 16th October 2014, less than a day after receiving FLULAVAL, the patient experienced swollen arm at the injection site, soreness at the injection site, redness at the injection site, headache, nasal congestion and chills. On an unknown date, the patient experienced pharmaceutical product complaint. On 21st October 2014, the outcome of the swollen arm at the injection site, soreness at the injection site, redness at the injection site, headache, nasal congestion and chills were recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. The reporter considered the swollen arm at the injection site, soreness at the injection site, redness at the injection site, headache and nasal congestion to be probably related to FLULAVAL. It was unknown if the reporter considered the chills and pharmaceutical product complaint to be related to FLULAVAL. Additional information about the product complaint received on 19 November 2014: The events required a doctor visit (or an emergency room visit). The is one of the 5 cases reported by the same reporter for the same vaccine (with the same lot number).
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Product quality issue
Clinical narrative: This case was reported by a other health professional and described the occurrence of swollen arm at the injection site in a 35-year-old female patient who received FLULAVAL (batch number 4597B, expiry date June 2015). This case was associated with a product complaint. On 19th October 2014, the patient received the 1st dose of FLULAVAL (intramuscular). On 16th October 2014, less than a day after receiving FLULAVAL, the patient experienced swollen arm at the injection site, soreness at the injection site, redness at the injection site, headache, nasal congestion and chills. On an unknown date, the patient experienced pharmaceutical product complaint. On 21st October 2014, the outcome of the swollen arm at the injection site, soreness at the injection site, redness at the injection site, headache, nasal congestion and chills were recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. The reporter considered the swollen arm at the injection site, soreness at the injection site, redness at the injection site, headache and nasal congestion to be probably related to FLULAVAL. It was unknown if the reporter considered the chills and pharmaceutical product complaint to be related to FLULAVAL. Additional information about the product complaint received on 19 November 2014: The events required a doctor visit (or an emergency room visit). The is one of the 5 cases reported by the same reporter for the same vaccine (with the same lot number).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swollen tongue
Clinical narrative: Red diffcuse itching, tongue swelling.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner refers to 11 unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored dose of VAQTA (lot number, expiry date was unknown). Concomitant medications were not reported. No adverse effects reported. The outcome of the events were unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner refers to 11 unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot number, expiry date was unknown). Concomitant medications were not reported. No adverse effects reported. The outcome of the events were unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Acne, Activities of daily living impaired, Eating disorder, Hearing impaired, Visual impairment
Clinical narrative: Acne, significant increase in visual, auditory aversions that interfere with eating to an eating disorder, and decreased abilities to life function w/o extreme reaction of behavior.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. On an unknown date the patient was vaccinated with GARDASIL (dose, strength and route was not reported). NO concomitant medication was reported. Physician reported that the patient was administered the third dose of GARDASIL series four weeks earlier than recommended in current prescribing information. No adverse events were reported. The outcome of patient was administered the third dose in GARDASIL series 4 weeks earlier than recommended in current prescribing information was unknown. No PQC was involved. No further information was reported. No PQC was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients was vaccinated with (Oka/Merck) PROQUAD (dose, route and lot# was unspecified) which was improperly stored. No adverse effects were reported. No product quality complaint was involved. No additional information to report. This case is  linked to MARRS#1411USA010981 with the same reporter link. 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 licensed nurse practitioner refers to 11 unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (lot number, expiry date was unknown). Concomitant medications were not reported, no adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 04-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K006770, expiry date: 07-NOV-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 77 year old female patient refers to herself. Consumer was part of the Clinical trials for ZOSTAVAX in 2005. In 2005 the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route, lot # and indication were not provided). On 06-NOV-2014 the patient experienced shingles on her left side of her stomach. There was looking for revaccination information. No other information collected. The outcome of shingles on her left side of her stomach was reported as recovering/resolving. No treatment was given for the AE. The patient sought medical attention. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 42 year old female patient. On 18-NOV-2014, the 42 years female patient was vaccinated with a dose of GARDASIL, 0.5 ml, intramuscular (lot number not provided). No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients was vaccinated with VARIVAX (Merck) (dose, route and lot# was unspecified) which was improperly stored. No adverse effects were reported. No product quality complaint was involved. No additional information to report. This case is linked to MARRS # 1411USA004971 with the same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 18-NOV-2014 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, lot#, expiration date and route not reported). No adverse effects were reported. Additional information is not expected because the physician could not be contacted.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 4-year-old male patient who received BOOSTRIX (batch number U4939AA, expiry date 8th January 2017). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the wrong vaccine administered and inappropriate age at vaccine administration to be related to BOOSTRIX. Additional information received: 4 years old patient who received inadvertently administered a dose of BOOSTRIX instead of INFANRIX.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Middle insomnia, Pruritus, Skin warm, Urticaria
Clinical narrative: Woke up 1am-severe itching both legs and arm w/shot. Very red and hot, welts on legs. Called nurse. Inst: BENADRYL, Hydrocortisone and cold wash cloths. 1/2hr later was better, except arm. Arm still red. No infection, per RN.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Severe redness and swelling, low grade fever-high as 103F
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 11-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 lot # K006681, expiration date: 21-OCT-2015, 0..5 ml, intramuscular. On 11-NOV-2014 the patient received 2 doses of PNEUMOVAX 23 on the same day. The patient received two doses of PNEUMOVAX 23 instead of one dose of unspecified flu vaccine and one dose of PNEUMOVAX 23. This was related to staff error and not product confusion. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 19-NOV-2014, the patient was vaccinated with a dose of M-M-R II, 0.5 ml, once, subcutaneously that was expired on 08-NOV-2014 (lot number was not reported). No adverse events were reported. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Pruritus, Rash
Clinical narrative: Rash, localized reaction. KINRIX given 11/18/14. On 11/19/14 pt scratching arm. (L) arm red and swollen. No seizure. No previous reaction to Iz in the past.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 26-OCT-2014 the patient was inadvertently vaccinated with the third dose of M-M-R II (dose, lot# and expiration date not reported) subcutaneously rather than VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history drug allergies or reactions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursions. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 45 year old female patient. In 2012, the patient lost 160 pounds. None concurrent conditions were not provided. On 21-OCT-2014, the patient was vaccinated with a dose of M-M-R II subcutaneous in the upper left arm, 0.5 ml, lot # K005175, expiry date 10-APR-2016. None concomitant medication was reported. On 21-OCT-2014, the patient experienced some tenderness at her injection site of the posterior aspect of the left upper arm since she received her dose of M-M-R II. On Friday, 31-OCT-2014, the patient noticed that the tender area had developed "a hard ball, like a knot under the skin", and the patient sought medical attention by calling the nurse practitioner on Monday, 03-NOV-2014. The patient was examined by the nurse practitioner who describes "the knot" as large-sized and hard. The reporter stated that the patient had some excess adipose tissue beneath her skin. The patient reported that the knot "was not obvious", but the patient developed a fever between 99 degrees F to 101 degrees F on Monday and Tuesday 03-NOV-2014 and 04-NOV-2014. At the time of this report, the patient was currently in the nurse practitioner's office for a follow-up examination. None lab diagnostics studies were performed. The outcome of the patient noticed that the tender area had developed "a hard ball, like a knot under the skin/the knot as large-sized and hard and a patient experienced some tenderness at her injection site was reported as not recovered. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Cellulitis, Injection site discomfort, Injection site induration
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 45 year old female patient. In 2012, the patient lost 160 pounds. None concurrent conditions were not provided. On 21-OCT-2014, the patient was vaccinated with a dose of M-M-R II subcutaneous in the upper left arm, 0.5 ml, lot # K005175, expiry date 10-APR-2016. None concomitant medication was reported. On 21-OCT-2014, the patient experienced some tenderness at her injection site of the posterior aspect of the left upper arm since she received her dose of M-M-R II. On Friday, 31-OCT-2014, the patient noticed that the tender area had developed "a hard ball, like a knot under the skin", and the patient sought medical attention by calling the nurse practitioner on Monday, 03-NOV-2014. The patient was examined by the nurse practitioner who describes "the knot" as large-sized and hard. The reporter stated that the patient had some excess adipose tissue beneath her skin. The patient reported that the knot "was not obvious", but the patient developed a fever between 99 degrees F to 101 degrees F on Monday and Tuesday 03-NOV-2014 and 04-NOV-2014. At the time of this report, the patient was currently in the nurse practitioner's office for a follow-up examination. None lab diagnostics studies were performed. The outcome of the patient noticed that the tender area had developed "a hard ball, like a knot under the skin/the knot as large-sized and hard and a patient experienced some tenderness at her injection site was reported as not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not reported). On an unknown date the patient experienced a severe case of shingles. The outcome of case of shingles was unknown. The patient visited office to seek help. Causality was not reported. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 68 year old patient (gender unknown). On 20-APR-2010 the patient was vaccinated with dose 1 of ZOSTAVAX 0.65 ml, subcutaneously (lot# 665513/0146Z, expiry: 21-APR-2011). On 15-NOV-2014, the patient was inadvertently vaccinated with second dose of ZOSTAVAX (administration details not specified) at the pharmacy. No adverse effects reported. No medical attention sought. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a female patient who received ENGERIX B (batch number AHBVC190AA, expiry date 25th January 2015). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. It was unknown if the reporter considered the incorrect storage of drug to be related to ENGERIX B. Additional information received: Vaccines were stored below recommended temperature ranges. ENGERIX and BOOSTRIX were stored at 25 degree C and administered to patient. Facility unsure of how many other patients were involved.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 22-SEP-2014, the patient was vaccinated with (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (does and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 12-SEP-2014 the patient was vaccinated with a dose of an improperly stored VARIVAX (Merck) (lot J009002, expiration date 19-JUL-2015 reported) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash pruritic, Skin lesion
Clinical narrative: This spontaneous report was received from a currently 71 years old female patient who was sensitive to latex. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot number, expiration date were not reported) in the left arm. Concomitant therapies included antiviral medicine (unspecified) and itching medicine (unspecified). On an unknown date, reported as "about 6 weeks later", the patient experienced a reaction included a rash and it was itchy. The patient got lesions on her right side of the arm and she felt a sunburn sensation. There was unspecified treatment given for the events. The outcome of the events was reported as recovering. Relatedness between the events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 months old child patient and unknown gender. On 01-AUG-2014 the patient was vaccinated with a dose of an improperly stored M-M-R II (lot H020255, expiration date not reported)(dose, route, were not reported). No adverse effect was reported. The outcome of events reproted was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.