chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient said that later that day she started to feel like she had cellulitis.  She was warm to the touch, and had chills and a fever.  She also felt very swollen and sore in the arm.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Patient said that later that day she started to feel like she had cellulitis.  She was warm to the touch, and had chills and a fever.  She also felt very swollen and sore in the arm.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Gait disturbance, Influenza like illness, Injection site pain, Ligament pain
Clinical narrative: Shortly after receiving the vaccine my left shoulder was aching. I didn't think much of it at the time as that was expected. However the next day I felt achy in my knees, hips, shoulders and hands. Kind of like the flu. Again not really concerned as this sometimes is a mild side affect. As the days wore on my joints started aching more and more. It does not feel like it is in the joint per say but the muscles and connective tissue (ligaments and tendons). I am concerned now as it has been almost 3 month and the pain has gotten to the point that it is often hard for me to walk or lift anything.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Myalgia, Pain in extremity, Tendon pain, Weight bearing difficulty
Clinical narrative: Shortly after receiving the vaccine my left shoulder was aching. I didn't think much of it at the time as that was expected. However the next day I felt achy in my knees, hips, shoulders and hands. Kind of like the flu. Again not really concerned as this sometimes is a mild side affect. As the days wore on my joints started aching more and more. It does not feel like it is in the joint per say but the muscles and connective tissue (ligaments and tendons). I am concerned now as it has been almost 3 month and the pain has gotten to the point that it is often hard for me to walk or lift anything.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: Large knot about 4 inches down from site of injection.  Red and hot to touch.  Injection site with red rash at insertion site and rash around site. These symptoms lasted about 4 days. No treatment other than Tylenol and ice packs.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous
Clinical narrative: Large knot about 4 inches down from site of injection.  Red and hot to touch.  Injection site with red rash at insertion site and rash around site. These symptoms lasted about 4 days. No treatment other than Tylenol and ice packs.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Contusion, Erythema
Clinical narrative: Arm was bruised and red to the elbow
Age: 82.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Sunburn
Clinical narrative: Arm was bruised and red to the elbow
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: Patient developed painful red rash at location sight that has lasted over a month.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient developed painful red rash at location sight that has lasted over a month.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling around injection site on left arm. Patient mentioned the area was itching.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin tightness
Clinical narrative: Patient reported tightness in arm at night; morning had increased pain, redness, and swelling but not at injection site (actually right on bicep); patient took Advil and applied an otc pain patch on bicep, then played golf, still painful so came back to pharmacy to report.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia eye, Injection site erythema, Injection site swelling, Migraine, Nausea
Clinical narrative: Migraine headache, numbness behind right eye, vomiting, nausea, red swollen spot at injection site size of quarter.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Migraine headache, numbness behind right eye, vomiting, nausea, red swollen spot at injection site size of quarter.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Muscle twitching, Pallor, Unresponsive to stimuli, Vision blurred
Clinical narrative: Patient: 12 year old receiving Tdap, MCV4, and HPV.  Administered Tdap and MCV4 in the right deltoid.  After administering the HPV vaccine in the left deltoid patient went immediately pale, eyes became unfocused, was not able to respond to verbal questions, jaw and left leg twitched a few times. Gently laid patient on the carpeted floor, continued to ask her questions to observe her level of consciousness. Put cool wash clothes over her forehead and neck. This lasted approximately 30-60 seconds.  Patient came around quickly but had never had an experience like this before.  Parents decided to take her to the ER later that day just to make sure she was okay and she checked out with the Attending Physician just fine.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Blister, Dermatologic examination, Pruritus
Clinical narrative: BLISTERS SPORADICALLY ON HER APPENDAGES THAT ITCHED.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dysphonia, Malaise, Mobility decreased, Nasopharyngitis, Pain in extremity
Clinical narrative: Not sure of time of onset-only date--patient reports sore arm which she cannot raise, welt on arm but not at immunization site, cold symptoms, hoarse throat, feels sick.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: Not sure of time of onset-only date--patient reports sore arm which she cannot raise, welt on arm but not at immunization site, cold symptoms, hoarse throat, feels sick.
Age: 56.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Diarrhoea, Dizziness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Dizziness, faint, vomiting, diarrhea, injection site itchy, red, hot and swollen.
Age: 56.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Syncope, Vomiting
Clinical narrative: Dizziness, faint, vomiting, diarrhea, injection site itchy, red, hot and swollen.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness radiation down from the injection site.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Temperature of 102 deg F red, swollen area on back of left arm that appears to be cellulitis.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chest pain, Crying, Emotional distress, Fall
Clinical narrative: Pt fell forward, seizure-like movement.  I leaned her back against chair.  Her head came up and eyes open.  She started to cry and was upset.  She had seizure-like movement a second time.  BP was 76/51 at 4:15pm.  She reported stomach hurt and chest hurt.  Feet put up in chair.  Paramedics arrived and took over.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure like phenomena
Clinical narrative: Pt fell forward, seizure-like movement.  I leaned her back against chair.  Her head came up and eyes open.  She started to cry and was upset.  She had seizure-like movement a second time.  BP was 76/51 at 4:15pm.  She reported stomach hurt and chest hurt.  Feet put up in chair.  Paramedics arrived and took over.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives first appeared on evening of 9/28 around the injection site of HPV vaccine #2 administered the evening prior.  On the morning of 9/29/16 the hives spread to the rest of her arm.  When the patient called the clinc to report the reaction today (9/29), the patient was advised to take Benadryl or antihistamine.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to  an unspecified number of patients of unknown age and genders. The patient's medical history was not reported. On an unknown dates the patient were vaccinated with improperly stored doses of GARDASIL (route and dosage unknown; lot # reported as M009378, EXP 23-APR-2018). No adverse event was reported. This is one of several reports from the same reporter. Lot number M009378 is an invalid lot number for GARDASIL. Additional information has been requested.
Sex: F
Vaccine: FLU4
Symptoms: Cough, Eye discharge, Headache, Malaise, Ocular hyperaemia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of dry cough in a female patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified). On an unknown date, the patient received Influenza vaccine unspecified at an unknown dose. On an unknown date, 4 hrs after receiving Influenza vaccine unspecified, the patient experienced dry cough, eye red, eye discharge, runny nose, pain, headache and feeling unwell. The patient was treated with naproxen. On an unknown date, the outcome of the dry cough, eye red, eye discharge, runny nose, pain, headache and feeling unwell were unknown. It was unknown if the reporter considered the dry cough, eye red, eye discharge, runny nose, pain, headache and feeling  unwell to be related to influenza vaccine unspecified. Additional details were received as follows: The age at vaccination was not reported. The reporter stated that she had sudden onset of side effects from Flu vaccine 2016. The patient experienced sudden onset of dry cough, red eyes with mattering, runny nose, aches, and headache that had lasted over 24  hours. The reporter stated that, she did not have symptoms before the flu shot and was still feeling badly 36 hours after shot despite taking regular Naproxen.
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of dry cough in a female patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified). On an unknown date, the patient received Influenza vaccine unspecified at an unknown dose. On an unknown date, 4 hrs after receiving Influenza vaccine unspecified, the patient experienced dry cough, eye red, eye discharge, runny nose, pain, headache and feeling unwell. The patient was treated with naproxen. On an unknown date, the outcome of the dry cough, eye red, eye discharge, runny nose, pain, headache and feeling unwell were unknown. It was unknown if the reporter considered the dry cough, eye red, eye discharge, runny nose, pain, headache and feeling  unwell to be related to influenza vaccine unspecified. Additional details were received as follows: The age at vaccination was not reported. The reporter stated that she had sudden onset of side effects from Flu vaccine 2016. The patient experienced sudden onset of dry cough, red eyes with mattering, runny nose, aches, and headache that had lasted over 24  hours. The reporter stated that, she did not have symptoms before the flu shot and was still feeling badly 36 hours after shot despite taking regular Naproxen.
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Erythema, Feeling of body temperature change, Influenza like illness, Pain
Clinical narrative: Day after vaccination (9/25/16) soreness, redness and swelling about size of 50 cent piece. Started w/flu-like symptoms: hot/cold, coughing on 1st or 2nd day. Pt states wheezing. 9/28/16 less red. Pt reported 9/29/16.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Wheezing
Clinical narrative: Day after vaccination (9/25/16) soreness, redness and swelling about size of 50 cent piece. Started w/flu-like symptoms: hot/cold, coughing on 1st or 2nd day. Pt states wheezing. 9/28/16 less red. Pt reported 9/29/16.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen, red patch on left deltoid where PREVNAR 13 was administered. Has tender swollen left axillary lymph nodes.
Sex: F
Vaccine: TDAP
Symptoms: Head injury, Hypersensitivity, Nausea, Suture insertion, Syncope
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a adult female patient who received dTpa vaccine. Concurrent medical conditions included penicillin allergy. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, less than a day after receiving dTpa vaccine at an unknown dose. On an unknown date, less than a day after receiving DTaP vaccine, the patient experienced allergic reaction, nausea, fainting and head injury. On an unknown date, the outcome of the allergic reaction, nausea, fainting and head injury to be related to DTaP vaccine. Additional details were provided as follows: This case was reported by the patient's daughter. The age at vaccination was not reported. The reporter's mother got the vaccine and after she returned home from doctor, she was extremely nauseous and ended up fainting. She hit her head on the fireplace and ended up needing stitches. The reporter consulted some of her nurse friends, some of them thought it was due to the shot and some did not. There were no other issues with the patient when they did tests in the hospital. One of the friend of the reporter who is nurse said that, it could be an allergic reaction from the antibiotic in the shot (the patient was allergic to penicillin). This case has been linked to US2016GSK142670 as reported by the same reporter.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Fatigue, Heart rate increased, Hyperhidrosis, Pain
Clinical narrative: Fast heart rate, Fatigue, Sweating, Chest Pain, Itching, Body Ache, Hives. Took Benadryl at 7:00am.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Fast heart rate, Fatigue, Sweating, Chest Pain, Itching, Body Ache, Hives. Took Benadryl at 7:00am.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site induration in a 18-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site induration, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site induration, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site induration, injection site pain and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced firmness at the injection site, extreme pain, and swelling which was 2 fingers length after receiving a dose of BEXSERO. The lot numbers were unknown. The reporter would like be contacted. This is 1 of the 3 cases reported by same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site infection, Peripheral swelling, Skin warm
Clinical narrative: She noticed her arm swollen, red and hot to the touch on 9/27/2016 then she went to her pcp on 9/28/2016 and was diagnosed with infection at injection site. She was given Augmentin and prednisone, started Augmentin 9/28 in the evening and was starting to improve on 9/29 in the afternoon.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Pain, Rash erythematous
Clinical narrative: Patient developed an itchy red/purple rash near injection site shortly after administration. Patient states she reported to immunizing pharmacy and was told this can be a normal reaction, so she didn't worry about it. Patient reported to different pharmacist she still has a burning sensation and frequent itching at site 13 months later. On 9/23/2016, Pharmacist noted a blotchy reddish/purple area on the back of patient's left arm, and patient states she has pain in that area when lifting her left arm. Please note: Patient states Zostavax was administered in her LEFT arm, and this is where rash was noted. When Rph contacted pharmacist regarding Lot/Exp data for this report, Rph was told it was recorded as vaccine being administered in the RIGHT arm.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Patient developed an itchy red/purple rash near injection site shortly after administration. Patient states she reported to immunizing pharmacy and was told this can be a normal reaction, so she didn't worry about it. Patient reported to different pharmacist she still has a burning sensation and frequent itching at site 13 months later. On 9/23/2016, Pharmacist noted a blotchy reddish/purple area on the back of patient's left arm, and patient states she has pain in that area when lifting her left arm. Please note: Patient states Zostavax was administered in her LEFT arm, and this is where rash was noted. When Rph contacted pharmacist regarding Lot/Exp data for this report, Rph was told it was recorded as vaccine being administered in the RIGHT arm.
Age: 11.0
Sex: M
Vaccine: HEP, HPV4, IPV, MEN, MMRV, TDAP
Symptoms: Dizziness, Headache, Pallor, Pulse abnormal, Vomiting
Clinical narrative: Client c/o a headache, feeling lightheaded, client turned pale and began to vomit. V/S 97.2, pulse was thread, respiration 28, blood pressure 92/64.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Neck pain
Clinical narrative: Pain in the neck and inability to raise arm.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site reaction, Nuclear magnetic resonance imaging
Clinical narrative: BURSITIS OF LEFT DELTOID.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Started out as red line at injection site (left arm), then became red, hot, swollen, very itchy, burned.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site swelling, Nausea
Clinical narrative: Severe Headache. Nausea. Swelling at injection site. Took 2 Benadryl in case it was an allergic reaction.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal discomfort, Abdominal pain upper, Fatigue, Lethargy, Pyrexia
Clinical narrative: Prevnar 13 shot.  Lethargic, upset stomach, tired. Day 2 continued stomach aches, fever 101 at 5:00 PM.  Aspirin, ginger ale, lots, of water, tea, ice packs on head. Felt better when stomach started working in night.  Next morning felt better but stomach still hurt.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: 100 DEGREE FEVER, NAUSEA, SWOLLEN PAINFUL ARM, HOT TO TOUCH.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Patient is complaining of exceesive pain in arm shot was administered. She says it is interfering with sleep and movement.
Age: 82.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Pain at and surrounding injection site and the pain has not resolved after 2 weeks. No swelling, redness, fever. Patient claimed ice pack and tylenol have not helped.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Chest discomfort, Chills, Crying, Dyspnoea
Clinical narrative: Odd episode of crying followed by severe chills (it was a warm night) that lasted several hours, then followed by severe body aches that lasted almost 24 hours. Also some shortness of breath and feeling like chest was tightening. I was 35 weeks pregnant at the time and by the next morning had reduced fetal movement.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal hypokinesia, Pain, Urine analysis
Clinical narrative: Odd episode of crying followed by severe chills (it was a warm night) that lasted several hours, then followed by severe body aches that lasted almost 24 hours. Also some shortness of breath and feeling like chest was tightening. I was 35 weeks pregnant at the time and by the next morning had reduced fetal movement.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, C-reactive protein, Chest X-ray, Chills, Differential white blood cell count
Clinical narrative: 103.8 temp aches head ache chills.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count, Headache, Influenza A virus test, Influenza B virus test, Lipase
Clinical narrative: 103.8 temp aches head ache chills.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Metabolic function test, Pain
Clinical narrative: 103.8 temp aches head ache chills.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 2 months old female patient. The patient had no concomitant medications, pertinent medical history or drug allergies/reactions. On 06-JUL-2016, the patient vomited immediately after vaccination with the first dose ROTATEQ, oral, (strength, dose, frequency, route, lot number and expiration date were unknown). At the same day, the patient sought medical attention by physician office visit and completely recovered, without requiring medical treatment. No lab diagnostics study was performed. Vaccination with ROTATEQ would continued. The causal relationship between vomiting and ROTATEQ was unknown. Additional information is not expected because there was no consent for contact.
Age: 63.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Information has been received from a pharmacist concerning a 63 years old female patient. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included FLUAD. On 07-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (strength, dose and frequency were unknown, lot# L035687, expiration date 16-FEB-2017), intramuscularly in the deltoid area of her left arm. On 08-SEP-2016, the patient experienced swelling and redness "in a straight line, from her deltoid down to her elbow." The patient had called a pharmacist for medical attention, but no treatment was received. No lab diagnostics studies were performed. The outcome of the events was not recovered at the report time. The causal relationship between the events and PNEUMOVAX 23 was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse referring to an adult (exact age unknown) patient of unknown gender. The patient's current conditions, medical history and concomitant medication were not reported. On 30-AUG-2016, the patient was vaccinated 2 pediatric doses of VAQTA (strength, exact dose, frequency, route, lot number and expiration date were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. The patients' medical history was not reported. On an unknown dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (route and dosage unknown; lot # M008551 EXP 21-JUN-2018). No adverse event was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. The patients' medical history was not reported. On an unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (dosage unknown; lot # M025568 EXP 07-NOV-2017). No adverse event was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an 85 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions and concomitant medication were not reported. On 03-JAN-2015, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not provided, lot # K008927, expiration date was not provided). Then, on 13-NOV-2015, patient received another dose of PNEUMOVAX 23 (dose and route were not provided, lot # K021881, expiration date 30-JUL-2016). No adverse event was reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MEN, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse via a company representative refers to a 16-year-old female patient. On 22-AUG-2016, the patient was vaccinated with the first dose of VARIVAX lot number M009768 (dose and route of administration not reported). On 09-SEP-2016, the patient received the second dose of VARIVAX lot number M009768 (dose and route of administration not reported) sooner that the recommended dosing schedule. The nurse also reported that the patient received an unspecified meningococcal vaccine at the same time the second dose of VARIVAX was administered. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant via company representative refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dosing details were not reported). The reporter asked if there was any recommendations regarding revaccination if a patient received PNEUMOVAX 23 three months after receiving PREVNAR 13 or there was any information about adverse events occurring due to the patient receiving PNEUMOVAX 23 three months after receiving PREVNAR 13. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 08-APR-2016, the patient received M-M-R II and then patient inadvertently was administered VARIVAX (dosing details not reported) on 14-APR-2016. No adverse effects were reported. No treatment was given. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a male consumer of unknown age referring himself. The patient's medical history and concurrent conditions were not provided. In approximately 2010 (also reported as "6 or 7 years ago") the patient stated that he was administered with a vial of ZOSTAVAX 1 dose, route of administration reported as "shot" (lot number, expiration date, concentration were unknown), which has a temperature stability excursion when he picked up it at his local pharmacy. It was also stated by the reporter that during the transportation from the pharmacy to his house, the vial experienced a room temperature environment, then the vial of ZOSTAVAX was placed inside of the patient's freezer at an unknown temperature, after that the vial was transported to the physician's office where the vial might have experienced a room temperature environment again. Information regarding concomitant medication was not provided. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's relevant medical history, drug history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # 36301, expiry date: 01-DEC-2017 (strength, dose, route of administration were not provided). There were no concomitant medications reported. The administered vaccine underwent a temperature excursion of 32.1 degree Fahrenheit for 7 hours. The patient did not experience any adverse events. It was unknown if any tests were done. Lot number 36301 is an invalid lot number for GARDASIL 9. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Information has been received from a pharmacist referring to a 69 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 09-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, lot number and expiration date were unknown) subcutaneously. On 11-SEP-2016, the patient's arm had swelled. The patient called the pharmacist to seek medical attention. Treatment was given for the event. The outcome of the event was reported as recovering. The causal relationship between ZOSTAVAX and the event was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product packaging quantity issue
Clinical narrative: Information has been received from a healthcare worker concerning four patients of unknown age and gender. The patients' current conditions, medical history and concomitant medication were not reported. On an unknown date, the physician received an order of PNEUMOVAX 23 vials and five of them were under-filled by 0.1ml, because the vials were under-filled the physician used another vial to withdraw the difference. On unknown dates, four patients were vaccinated with PNEUMOVAX 23 (strength, dose and frequency were unknown, lot # M007769, expiration date 27-JUN-2017 in this manner. No specific adverse event was reported. The product quality complaint was involved in the report. Additional information is not expected as we have no consent to contact the physician.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 1 year old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 09-SEP-2016, the patient was vaccinated with 0.5 ml dose of PROQUAD (lot # L019997, expiration date: 02-DEC-2016) that was improperly stored (temperature: 44F, time frame: 5427 hours). No adverse effects were reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint swelling, Synovitis
Clinical narrative: About 12 hours after vaccination, awoke with mod-severe pain and swelling in multiple joints. Took ibuprofen, better not gone. Today, 3 days later, still with mild wrist synovitis (new for her, has OA but never this).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L036437, expiration date: 18-MAY-2017, 0.5 ml, route of administration was not reported). It was reported that a pharmacist administered PNEUMOVAX 23 to a patient with a cracked syringe. No adverse effect was reported. A product quality complaint was filed for this defect. Additional information is not expected, as there was no consent to contact the physician.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding multiple unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On multiple unspecified dates from 18-JAN-2016 to 28-JUN-2016, the patient was vaccinated with improperly stored VAQTA (dosing details, lot# and expiry date not known). The administered vaccines experienced a temperature excursion of 51.1 degrees Fahrenheit for 18 hours 30 minutes. There was no previous excursions. The call was because of a "data logger". No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a consumer referring to a 50 year old male patient with high blood pressure. There were no drug reactions/allergies. On 21-SEP-2016, the patient was vaccinated with ZOSTAVAX, (dose, frequency, lot number and expiration date not provided), subcutaneous. Concomitant therapies included allopurinol, losartan potassium (manufacturer unknown) and potassium citrate. On an unknown date in September 2016, the patient reported "near injection site, a large area that was swollen, discolored, and painful". She reported "no treatment, no test or labs, no doctor visit, and no hospital visit." She reported he "has not recovered." Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site eczema, Injection site erythema, Injection site pain
Clinical narrative: Developed pain, eczema, erythema (R) deltoid at site of injection. Used ice for treatment.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site - hot, swollen, and itchy. Spread out from inj. site lasted about 1 week, spread about 4-5" diameter.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Muscle atrophy
Clinical narrative: Mother claims muscular atrophy occurred from KINRIX vaccine. She showed me on daughter-claims vaccine was given at distal deltoid. Atrophy is mid body. Area appx. 1 x 2 cm.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood immunoglobulin E, Headache, Induration, Injection site pain, Malaise
Clinical narrative: Pain on site-headache-feeling sick, weakness upper arm swollen red, hot, hard as a rock- Day 2- neck pain-can not turn or move neck, with all above side effects, called doctor, took her in, and the doc laughed. She still having problems.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Monocyte percentage increased, Muscular weakness, Musculoskeletal stiffness, Neck pain, Platelet count normal
Clinical narrative: Pain on site-headache-feeling sick, weakness upper arm swollen red, hot, hard as a rock- Day 2- neck pain-can not turn or move neck, with all above side effects, called doctor, took her in, and the doc laughed. She still having problems.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: Pain on site-headache-feeling sick, weakness upper arm swollen red, hot, hard as a rock- Day 2- neck pain-can not turn or move neck, with all above side effects, called doctor, took her in, and the doc laughed. She still having problems.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever 100.3 next day.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Injection site hypoaesthesia, Injection site swelling
Clinical narrative: Right thigh numb/swelling. 16cm x 16cm right anterior thigh. Since 8/4/16.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Pallor, Rash papular
Clinical narrative: Papular blanching rash on back. 9/27/16, spread to arms, legs, face and abdomen. No difficulty breathing not itching.
Age: 76.0
Sex: U
Vaccine: PPV
Symptoms: Fluid retention, Peripheral swelling, Skin warm
Clinical narrative: 3 and 1/2 hours after receiving PNEUMOVAX 23 vaccine, patient's arm swelled to about twice the normal size and was warm to the touch. Pt did not have a fever. Pt. iced arm, took BENADRYL and IBU. The patient was 10-20% better. Pt. repeated ice, IBU. and BENADRYL on day two with a noted improvement of 50% better. By day three patient's arm back to normal size with some fluid retention. Day 3 - 80% better.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: Rash, severe arm pain for several days.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, body aches, severe arm pain for several days, difficulty moving arm.
Age: 1.42
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: PT. rec'd 0.25 QUAD FLU at O.V. on 9/27/16. Mom reports fever began 9/28/16AM; 102.1 Max. No cough, vomiting. No site reaction noted at return O.V. for fever on 9/28/16. Tx with supportive care.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe arm pain, limited arm movement- still ongoing.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Injection site pain, Neck pain
Clinical narrative: Patient reports pain at injection site traveling to back of neck and head, dizziness and almost fainting.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Large swelling at site, warm. Small clear vesicles around injection site.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Muscular weakness, Pain in extremity, Urticaria
Clinical narrative: My 15 year old son started experiencing hives on Wednesday. September 21st at 6:00 am. The hives could have started earlier, but he was asleep. The next morning he woke up with them again. He also has soreness/weakness in his legs.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Erythema, Local reaction, Lymphadenopathy, Oedema, Rash pustular
Clinical narrative: This unsolicited case was received on 06 September 2016 via a third party query tool search on the VAERS database, under reference number 630917. This case involves a 26-years old female patient who received the following vaccinations on 22 March 2016: A dose of Acam2000 (batch number: VV03019C, manufacturer: Sanofi Pasteur Biologics Co, expiry date and site of administration was not reported) by Intradermal route and dose of Anthrax (batch number, expiry date and site and route of administration was not reported). "Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination". The patient's medical history, current illness history reported as graves disease. Concomitant medications were not reported. On 30 March 2016, eight days following vaccination patient experienced skin warm, rash pustular, lymphadenopathy, erythema, oedema and local reaction. It was reported that patient required emergency visit. Laboratory data was not reported. On an unspecified date, patient received Septra as corrective treatment. On an unspecified date, patient recovered from events. The events of skin warm, rash pustular, lymphadenopathy, erythema, oedema and local reaction were included in the coding from the VAERS database and coded for this case; however only the event of angioedema, cardiac failure, cardiomyopathy, haemodynamic oedema, effusions and fluid overload [broad], haemodynamic oedema, effusions and fluid overload [narrow] hypersensitivity [broad], hypersensitivity [narrow] had been mentioned in the narrative. List of documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Skin warm
Clinical narrative: This unsolicited case was received on 06 September 2016 via a third party query tool search on the VAERS database, under reference number 630917. This case involves a 26-years old female patient who received the following vaccinations on 22 March 2016: A dose of Acam2000 (batch number: VV03019C, manufacturer: Sanofi Pasteur Biologics Co, expiry date and site of administration was not reported) by Intradermal route and dose of Anthrax (batch number, expiry date and site and route of administration was not reported). "Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination". The patient's medical history, current illness history reported as graves disease. Concomitant medications were not reported. On 30 March 2016, eight days following vaccination patient experienced skin warm, rash pustular, lymphadenopathy, erythema, oedema and local reaction. It was reported that patient required emergency visit. Laboratory data was not reported. On an unspecified date, patient received Septra as corrective treatment. On an unspecified date, patient recovered from events. The events of skin warm, rash pustular, lymphadenopathy, erythema, oedema and local reaction were included in the coding from the VAERS database and coded for this case; however only the event of angioedema, cardiac failure, cardiomyopathy, haemodynamic oedema, effusions and fluid overload [broad], haemodynamic oedema, effusions and fluid overload [narrow] hypersensitivity [broad], hypersensitivity [narrow] had been mentioned in the narrative. List of documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Abdominal discomfort, Emotional distress, Erythema, Eye pain, Pain
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 11 August 2016. This case involves a 2 month old male patient who was vaccinated with a dose of DAPTACEL (batch number- C5101AA, expiry date- 26 November 2018, route of administration was not reported) in left deltoid and dose of POLIOMYELITIS VACCINE INACTIVATED (IPV) (other manufacturer, batch number, expiry date, route of administration was not reported) in left deltoid on 10 August 2016. The patient had medical history of eosinophilic esophagitis, and reactive airway diseases and multiple allergies with milk, wheat, egg, tree nuts, soy, fish, shellfish, corn, and oats. The patient receives "allergy shots" twice a week. Concomitant medications were not reported. On 10 August 2016, about 5-10 minutes following the vaccination, the patient began to scream in pain and he was bending over holding his stomach, his eyes and stomach were hurting him. On the same date, screaming increased and he was acting very agitated, vomited once and developed hives on chest and back, had bright red rash and hives erupted all over and eyes were beginning to swell. The office nurse assessed the patient. The patient required ER/doctor visit. Lab was not performed. The patient received corrective treatment with Benadryl  Diphenhydramine hydrochloride) (given by physician), EPI pen (epinephrine), Zyrtec (Cetirizine hydrochloride) and steroids (prednisolone). The patient would be on Prednisolone for few more days. The event eye swelling was (subsided) recovered on unknown date and hives were decreased. The outcome of the event stomach pain, agitation, screaming, vomiting once and painful red eyes were reported as unknown.No respiratory involvement reported. Follow up information received from a consumer on 16 September 2016. Patient's demographic detail was updated. This case involves four-year-old patient who was vaccinated with a dose of POLIOMYELITIS VACCINE (INACTIVATED) (Ipv) (batch number: M/205, manufacturer: Merck, route of administration were not reported). Patient vomited twice and red hives increased in number post vaccination. Patient's corrective treatment included epipen and medications and benadryl was given by nurse. On an unspecified date patient recovered from the events after treatment. List of documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Screaming, Urticaria, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 11 August 2016. This case involves a 2 month old male patient who was vaccinated with a dose of DAPTACEL (batch number- C5101AA, expiry date- 26 November 2018, route of administration was not reported) in left deltoid and dose of POLIOMYELITIS VACCINE INACTIVATED (IPV) (other manufacturer, batch number, expiry date, route of administration was not reported) in left deltoid on 10 August 2016. The patient had medical history of eosinophilic esophagitis, and reactive airway diseases and multiple allergies with milk, wheat, egg, tree nuts, soy, fish, shellfish, corn, and oats. The patient receives "allergy shots" twice a week. Concomitant medications were not reported. On 10 August 2016, about 5-10 minutes following the vaccination, the patient began to scream in pain and he was bending over holding his stomach, his eyes and stomach were hurting him. On the same date, screaming increased and he was acting very agitated, vomited once and developed hives on chest and back, had bright red rash and hives erupted all over and eyes were beginning to swell. The office nurse assessed the patient. The patient required ER/doctor visit. Lab was not performed. The patient received corrective treatment with Benadryl  Diphenhydramine hydrochloride) (given by physician), EPI pen (epinephrine), Zyrtec (Cetirizine hydrochloride) and steroids (prednisolone). The patient would be on Prednisolone for few more days. The event eye swelling was (subsided) recovered on unknown date and hives were decreased. The outcome of the event stomach pain, agitation, screaming, vomiting once and painful red eyes were reported as unknown.No respiratory involvement reported. Follow up information received from a consumer on 16 September 2016. Patient's demographic detail was updated. This case involves four-year-old patient who was vaccinated with a dose of POLIOMYELITIS VACCINE (INACTIVATED) (Ipv) (batch number: M/205, manufacturer: Merck, route of administration were not reported). Patient vomited twice and red hives increased in number post vaccination. Patient's corrective treatment included epipen and medications and benadryl was given by nurse. On an unspecified date patient recovered from the events after treatment. List of documents held by sender: none.