chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 16-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-JAN-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-JUL-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 16-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 15-FEB-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Approximately 4-5 days after receiving the Hepatitis B booster scattered red patches develop on her anterior and posterior chest, abdomen and back. The patches are very slightly elevated and vary in size and aren't uniform. Rash has remained consistent since the time it has developed. Ice pack helps with itching and hot water irritates the rash and makes it more red and itchy. No rash patches are noted anywhere else on her body.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red warm to the touch localized area at injection site. BENADRYL given in office and Hydroxyzine 2.5 ml PO 4 times a day for 14 days and Triamcinolone acetonide cream 0.1% apply topically twice a day for 7 days as needed was prescribed.
Age: 0.17
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: I was vaccinating the patient with his 2 month vaccinations I grabbed the wrong vaccine from the refrigerator. Instead of Hib, I mistakenly drew up and administered MENVEO. The error was detected with weekly counts, the health department was contacted, and now I am reporting this error, charting accordingly in the patient's EMR, and after all of the proper information is obtained on adverse events from the manufacturer, the patient's parent will be contacted and provided with the information. The patient did not experience any symptoms due to the event.
Age: 47.0
Sex: M
Vaccine: HEPAB, TDAP, TYP
Symptoms: Blood pressure decreased, Dizziness, Electrocardiogram abnormal, Feeling abnormal, Grip strength decreased
Clinical narrative: 49 year old male came in to our immunization clinic for three travel related vaccinations with no known history of adverse events/side effects from previous vaccinations. Patient received the vaccinations and waited in the same room while I prepared his immunization record. Patient was pleasant to talk with and appeared to have no immediate issues while we reviewed his record and he gathered his coat and was escorted to the front desk. When I saw our client again, he was on his way back into the clinic area to be assessed for not feeling well. As he came closer, he was pale and diaphoretic walked through the doorway and lost function of his hands at which point he dropped his paperwork. He had a brief syncopal episode that lasted under 10 seconds at which time staff was able to guide him to the floor where we laid him down in right lateral recumbent position. He came to and stated that he was cloudy and dizzy. No anaphylaxis, no tremors noted. He denied chest pain or shortness of breath. He had a pulse of 40 bpm, with a regular rate and rhythm, a manual blood pressure of 80/52, respirations even and easy at 14 and GSC of 15. We called paramedics and they transported him to definitive care as his heart rate on ECG remained in the low 40s.
Age: 47.0
Sex: M
Vaccine: HEPAB, TDAP, TYP
Symptoms: Heart rate decreased, Hyperhidrosis, Malaise, Pallor, Syncope
Clinical narrative: 49 year old male came in to our immunization clinic for three travel related vaccinations with no known history of adverse events/side effects from previous vaccinations. Patient received the vaccinations and waited in the same room while I prepared his immunization record. Patient was pleasant to talk with and appeared to have no immediate issues while we reviewed his record and he gathered his coat and was escorted to the front desk. When I saw our client again, he was on his way back into the clinic area to be assessed for not feeling well. As he came closer, he was pale and diaphoretic walked through the doorway and lost function of his hands at which point he dropped his paperwork. He had a brief syncopal episode that lasted under 10 seconds at which time staff was able to guide him to the floor where we laid him down in right lateral recumbent position. He came to and stated that he was cloudy and dizzy. No anaphylaxis, no tremors noted. He denied chest pain or shortness of breath. He had a pulse of 40 bpm, with a regular rate and rhythm, a manual blood pressure of 80/52, respirations even and easy at 14 and GSC of 15. We called paramedics and they transported him to definitive care as his heart rate on ECG remained in the low 40s.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Antiphospholipid antibodies, Arthralgia, Asthenia, Blood test, Borrelia test
Clinical narrative: Muscle and Joint pain that began in legs and moved to shoulders and arms. Swelling of legs and hands. The worst on left side of body. Has been battling this for over two months now. Received a Corticosteroid shot in left arm on January 8, 2018. The shot helped for a week and a half. The muscle and joint pain and mobility has been debilitating. Difficulty walking, getting out of chair, reaching with arms, and loss of hand strength.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Grip strength decreased, Mobility decreased, Myalgia, Peripheral swelling
Clinical narrative: Muscle and Joint pain that began in legs and moved to shoulders and arms. Swelling of legs and hands. The worst on left side of body. Has been battling this for over two months now. Received a Corticosteroid shot in left arm on January 8, 2018. The shot helped for a week and a half. The muscle and joint pain and mobility has been debilitating. Difficulty walking, getting out of chair, reaching with arms, and loss of hand strength.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Rheumatoid factor
Clinical narrative: Muscle and Joint pain that began in legs and moved to shoulders and arms. Swelling of legs and hands. The worst on left side of body. Has been battling this for over two months now. Received a Corticosteroid shot in left arm on January 8, 2018. The shot helped for a week and a half. The muscle and joint pain and mobility has been debilitating. Difficulty walking, getting out of chair, reaching with arms, and loss of hand strength.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm - redness - swelling - 11cm x 9cm. - warm to touch.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Patient states that her arm still hurts about a month afterwards. She is unable to raise the arm above shoulder level and has pain in her neck, shoulder, and arm.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Patient stated arm was swollen, red and had a hard area. Suggested icing it and to take BENADRYL.
Age: 43.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema multiforme
Clinical narrative: Erythema, multiform.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Ear swelling, Feeling abnormal, Feeling hot, Flushing, Hypoacusis
Clinical narrative: 15 minutes after receiving Tdap she became flushed on left side of neck, progressed to bottom lip becoming numb & burning. Scalp started itching, burning and swelling. Ears felt like they were swelling and hearing became hazy. Back of tongue & throat started swelling, face was hot to touch but no fever, reported o trouble breathing. Took 50 mg benadryl at 5pm & again at 9pm. Pt states symptoms subsided after 15 minutes taking first dose of benadryl. All symptoms were gone by midnight but not felt good today, fells achy. Pt has not seen doctor for adverse event. Encouraged to see her provider, APN, she states she will notify her office now.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia oral, Oral discomfort, Pain, Pharyngeal oedema, Pruritus
Clinical narrative: 15 minutes after receiving Tdap she became flushed on left side of neck, progressed to bottom lip becoming numb & burning. Scalp started itching, burning and swelling. Ears felt like they were swelling and hearing became hazy. Back of tongue & throat started swelling, face was hot to touch but no fever, reported o trouble breathing. Took 50 mg benadryl at 5pm & again at 9pm. Pt states symptoms subsided after 15 minutes taking first dose of benadryl. All symptoms were gone by midnight but not felt good today, fells achy. Pt has not seen doctor for adverse event. Encouraged to see her provider, APN, she states she will notify her office now.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Skin burning sensation, Swelling, Swollen tongue
Clinical narrative: 15 minutes after receiving Tdap she became flushed on left side of neck, progressed to bottom lip becoming numb & burning. Scalp started itching, burning and swelling. Ears felt like they were swelling and hearing became hazy. Back of tongue & throat started swelling, face was hot to touch but no fever, reported o trouble breathing. Took 50 mg benadryl at 5pm & again at 9pm. Pt states symptoms subsided after 15 minutes taking first dose of benadryl. All symptoms were gone by midnight but not felt good today, fells achy. Pt has not seen doctor for adverse event. Encouraged to see her provider, APN, she states she will notify her office now.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Injected limb mobility decreased, Injection site swelling
Clinical narrative: Swelling at injection site, fatigue, took Tylenol with some relief, still swollen but slightly less, pink area, trouble lifting her arm, that is better, pinkness is still present, no worse, told to with heat.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt experienced immediate pain at injection site. Pain continued and progressively-worsened, extending up and down arm and into shoulder and eventually into right arm and shoulder. Several weeks post injection patient began to experience muscular weakness and tremor in left arm, also eventually extending into right arm and shoulder. At which time diagnosis of brachial neuritis made.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Radiculitis brachial, Tremor
Clinical narrative: Pt experienced immediate pain at injection site. Pain continued and progressively-worsened, extending up and down arm and into shoulder and eventually into right arm and shoulder. Several weeks post injection patient began to experience muscular weakness and tremor in left arm, also eventually extending into right arm and shoulder. At which time diagnosis of brachial neuritis made.
Age: 15.0
Sex: M
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: Patient was given the wrong vaccine supposed to receive HPV9 but accidently got PREVNAR 13.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 0930 Injection area turned red and patient complained of it being itchy. No c/o SOB or s/s of distress noted. Dr. with patient. 1015 rechecked injection site. Returned back to normal. At discharge.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives occurred 2 hours after given Hep A vaccine.
Age: 24.0
Sex: M
Vaccine: JEV1, SMALL
Symptoms: Abdominal pain, Nausea, Pharyngitis, Skin reaction, Viral infection
Clinical narrative: Abdominal pain, acute pharyngitis, nausea, viral syndrome, skin reaction. Reported to the Emergency Room within 1 week post vaccination. Amoxicillin 500 mg.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lip blister
Clinical narrative: 60 minutes after oral ROTATEQ vaccine patient returned to clinic with 1 cm oval blisters on upper and lower lips on right of midline. No intra oral lesions. He had not been sucking on anything (like a popsicle) and had no other exposures.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Body temperature, Chest pain, Cough, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Temperature 4 of 5 days, running nose, chest pain, sore throat, cough till today 01/09/18. Temperature from 12/24/17 till 12/29/17. Runny nose, chest pain, cough from 12/24/17 till 01/09/18.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site induration, Injection site pallor
Clinical narrative: The patient was vaccinated on Thursday, 11/30/2017. The day following vaccination 12/1, the patient experienced flu like symptoms of chills, feeling feverish, myalgia and lethargy. On 12/2 the patient self treated at home with ALEVE in the evening which palliated her symptoms. 12/3 she had no symptoms. 12/4 she began to notice that the injection site felt swollen. 12/5 the patient came to our office with concerns as the swelling and induration at the site increased. PE findings were R axillary LAD, 7.5 cm long x 7 cm wide circular pattern of induration without erythema surrounding the site of injection and an area of raised erythema approximately 3 cm below injection site measured at 15.5 cm on the diagonal at its longest. 6.5 cm long (lateral aspect) 7.5 cm long (central) to 8 cm long (medial aspect) with a shape similar to a specific county with serpiginous boundary. This area blanched with pressure and the boundary was surrounded by a white border. Two days later on 12/7 patient reports that swelling has resolved and the white border surrounding the area of erythema has disappeared though the area of erythema shifted and began to move distal on her arm.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Lethargy, Myalgia, Pyrexia
Clinical narrative: The patient was vaccinated on Thursday, 11/30/2017. The day following vaccination 12/1, the patient experienced flu like symptoms of chills, feeling feverish, myalgia and lethargy. On 12/2 the patient self treated at home with ALEVE in the evening which palliated her symptoms. 12/3 she had no symptoms. 12/4 she began to notice that the injection site felt swollen. 12/5 the patient came to our office with concerns as the swelling and induration at the site increased. PE findings were R axillary LAD, 7.5 cm long x 7 cm wide circular pattern of induration without erythema surrounding the site of injection and an area of raised erythema approximately 3 cm below injection site measured at 15.5 cm on the diagonal at its longest. 6.5 cm long (lateral aspect) 7.5 cm long (central) to 8 cm long (medial aspect) with a shape similar to a specific county with serpiginous boundary. This area blanched with pressure and the boundary was surrounded by a white border. Two days later on 12/7 patient reports that swelling has resolved and the white border surrounding the area of erythema has disappeared though the area of erythema shifted and began to move distal on her arm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Injection site pain, Insomnia, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: A couple of hours later noticed shoulders and neck getting stiff and sore. Stiffness progressed to other sites - to other shoulder and down back; whole body was hurting to the point that was not able to sleep last night. Blood pressure spiked to 172/102, normally usually at 130/80. BP stayed up until bedtime and back to normal this morning. Did not take any over the counter medication. This morning feeling better, got a quick back massage and hot shower. Pt. feels 95% better now. At site, soreness but not hard, doesn't hurt to move it anymore, more like a bruise. Husband received same vax with no problem.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain
Clinical narrative: A couple of hours later noticed shoulders and neck getting stiff and sore. Stiffness progressed to other sites - to other shoulder and down back; whole body was hurting to the point that was not able to sleep last night. Blood pressure spiked to 172/102, normally usually at 130/80. BP stayed up until bedtime and back to normal this morning. Did not take any over the counter medication. This morning feeling better, got a quick back massage and hot shower. Pt. feels 95% better now. At site, soreness but not hard, doesn't hurt to move it anymore, more like a bruise. Husband received same vax with no problem.
Sex: F
Vaccine: FLU3
Symptoms: Amniotic cavity infection, Exposure during pregnancy
Clinical narrative: I received one jab during my pregnancy. At first I refused but was told it's highly recommended.  After giving birth it was brought to my attention the baby was born with an infection on the placenta. She was givin a spinal tap at 3 days old to make sure infection didn't reach her brain. She was on antibiotics for 10 days. My pregnancy was 100% healthy. She was born 6 pounds 1oz.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Fatigue, Headache, Nausea, Pain
Clinical narrative: Severe debilitating headache (worse than a migraine, Tylenol didn't help), cold sweats, nausea, body aches, fatigue. Called pharmacy to verify symptoms, severity, and expected duration.
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: O.5 ml Influenza Quad vaccine given to a 6 month old. Discovered during chart immunization audit. No adverse effects noted.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: The shot was administered very high on left arm. Have had low grade pain since. Have contacted my primary care physician twice via his email portal. No treatment prescribed.
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Flu vaccine 0.5 ml given to 20 month old. Discovered during vaccine audit. State Epidemiologist notified. No ill effects.
Age: 66.0
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, X-ray
Clinical narrative: Sore at injection site day one and on day two much more pain and the beginning of limited movement - by day?s end was unable to move right arm at all. Currently can move with great pain, limited range, and inability to lift even small objects if arm extended.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site reaction, Local reaction, Pain in extremity
Clinical narrative: Left upper arm - large local reaction at site of injection - 13 cm. Progressively increase in size of reaction over 48 hours w/ constitutional symptoms: lassitude, chills;  arm pain due to same. No respiratory symptoms.
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Patient came 2 days after vaccination with pain in her right arm and site was red and hot. She went to the doctor's office and he gave her antibiotic for 7 days.
Age: 67.0
Sex: M
Vaccine: YF
Symptoms: Blood pressure increased, Headache
Clinical narrative: Pt wife called today stating 1-5-18 yellow fever shot, 1-7-18 headache and elevated BP 150-160/70-80's. This continued for another week then saw PMD 1-16-18 and was started on HCTZ. Today still has headache and they wondered if it was the vaccine. I explained that it was a low probability and they need to continue follow up with PMD. She stated he wanted him to get a CT scan. I said she should follow the doctors orders. She was very thankful for the discussion. Dr. aware.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Vaccination site pain
Clinical narrative: Continuing pain in left arm at vaccination site.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Delivery, Exposure during pregnancy, Musculoskeletal pain
Clinical narrative: I had an influenza shot, although I am unsure what type. I had a healthy birth, but now have chronic burning pain in my elbow up to that shoulder. Some days it is debilitating.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: I had an influenza shot, although I am unsure what type. I had a healthy birth, but now have chronic burning pain in my elbow up to that shoulder. Some days it is debilitating.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Patient walked into clinic requesting flu vaccine. Pt denied allergy to eggs, stated she has received flu vaccine in the past. Received High-dose flu vaccine for ages 65 and over. Patient states experienced rash on lower extremities with itching later that evening. States used Epsom salt bath to alleviate symptoms. Stated rash had almost completely disappeared by day 4 following the vaccine adm.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal chest pain, Peripheral swelling
Clinical narrative: Swelling and redness all the way down to the elbow. Musculoskeletal pain the the chest on day 5 post vaccination.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Arthralgia, Asthenopia, Burning sensation, Chills
Clinical narrative: About 5 hours or so after FLUZONE QUADRIVALENT shot I had these reactions. Bad migraine, fatigue, dizziness, disoriented, chills, shivers, skin was hurting to my clothes rubbing on it, nervousness, muscle and joint aches and pains, eyes hurt and were swollen, light and movement hurt my eyes, feeling of eye strains, jerky and painful muscle spasms, cough and itchy throat, ears hurting, nerves in arms feel like they are on fire, nausea. Light fever, and all the same aches and pains Saturday, Sunday, Monday, Tuesday, and Wednesday. Called Dr's office Monday, and Tuesday, but operators always busy with other patients. Waited over 30 minutes on the line. Sent them a fax instead and got a call back pretty quick. I was asked to go to their on call Dr. which I did. This female Dr looked me over, asked questions and decided to send me to the ER to get checked for meningitis and flu because of all these symptoms and the length of the migraine. I went to ER and was given a number of medications to deal with the aches and pains benadryl for anxiety, and other meds. I was sent home and missed work for 2 more days. I slept most of 2 days. It has been 21 days now and I still have dizzy spells and my ears hurt. My eyes feel strained and I have been fatigued.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Disorientation, Dizziness, Dyskinesia, Ear pain
Clinical narrative: About 5 hours or so after FLUZONE QUADRIVALENT shot I had these reactions. Bad migraine, fatigue, dizziness, disoriented, chills, shivers, skin was hurting to my clothes rubbing on it, nervousness, muscle and joint aches and pains, eyes hurt and were swollen, light and movement hurt my eyes, feeling of eye strains, jerky and painful muscle spasms, cough and itchy throat, ears hurting, nerves in arms feel like they are on fire, nausea. Light fever, and all the same aches and pains Saturday, Sunday, Monday, Tuesday, and Wednesday. Called Dr's office Monday, and Tuesday, but operators always busy with other patients. Waited over 30 minutes on the line. Sent them a fax instead and got a call back pretty quick. I was asked to go to their on call Dr. which I did. This female Dr looked me over, asked questions and decided to send me to the ER to get checked for meningitis and flu because of all these symptoms and the length of the migraine. I went to ER and was given a number of medications to deal with the aches and pains benadryl for anxiety, and other meds. I was sent home and missed work for 2 more days. I slept most of 2 days. It has been 21 days now and I still have dizzy spells and my ears hurt. My eyes feel strained and I have been fatigued.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pain, Eye swelling, Fatigue, Hyperaesthesia, Hypersomnia
Clinical narrative: About 5 hours or so after FLUZONE QUADRIVALENT shot I had these reactions. Bad migraine, fatigue, dizziness, disoriented, chills, shivers, skin was hurting to my clothes rubbing on it, nervousness, muscle and joint aches and pains, eyes hurt and were swollen, light and movement hurt my eyes, feeling of eye strains, jerky and painful muscle spasms, cough and itchy throat, ears hurting, nerves in arms feel like they are on fire, nausea. Light fever, and all the same aches and pains Saturday, Sunday, Monday, Tuesday, and Wednesday. Called Dr's office Monday, and Tuesday, but operators always busy with other patients. Waited over 30 minutes on the line. Sent them a fax instead and got a call back pretty quick. I was asked to go to their on call Dr. which I did. This female Dr looked me over, asked questions and decided to send me to the ER to get checked for meningitis and flu because of all these symptoms and the length of the migraine. I went to ER and was given a number of medications to deal with the aches and pains benadryl for anxiety, and other meds. I was sent home and missed work for 2 more days. I slept most of 2 days. It has been 21 days now and I still have dizzy spells and my ears hurt. My eyes feel strained and I have been fatigued.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza A virus test positive, Loss of personal independence in daily activities, Migraine, Muscle spasms, Myalgia
Clinical narrative: About 5 hours or so after FLUZONE QUADRIVALENT shot I had these reactions. Bad migraine, fatigue, dizziness, disoriented, chills, shivers, skin was hurting to my clothes rubbing on it, nervousness, muscle and joint aches and pains, eyes hurt and were swollen, light and movement hurt my eyes, feeling of eye strains, jerky and painful muscle spasms, cough and itchy throat, ears hurting, nerves in arms feel like they are on fire, nausea. Light fever, and all the same aches and pains Saturday, Sunday, Monday, Tuesday, and Wednesday. Called Dr's office Monday, and Tuesday, but operators always busy with other patients. Waited over 30 minutes on the line. Sent them a fax instead and got a call back pretty quick. I was asked to go to their on call Dr. which I did. This female Dr looked me over, asked questions and decided to send me to the ER to get checked for meningitis and flu because of all these symptoms and the length of the migraine. I went to ER and was given a number of medications to deal with the aches and pains benadryl for anxiety, and other meds. I was sent home and missed work for 2 more days. I slept most of 2 days. It has been 21 days now and I still have dizzy spells and my ears hurt. My eyes feel strained and I have been fatigued.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Nervousness, Pyrexia, Throat irritation
Clinical narrative: About 5 hours or so after FLUZONE QUADRIVALENT shot I had these reactions. Bad migraine, fatigue, dizziness, disoriented, chills, shivers, skin was hurting to my clothes rubbing on it, nervousness, muscle and joint aches and pains, eyes hurt and were swollen, light and movement hurt my eyes, feeling of eye strains, jerky and painful muscle spasms, cough and itchy throat, ears hurting, nerves in arms feel like they are on fire, nausea. Light fever, and all the same aches and pains Saturday, Sunday, Monday, Tuesday, and Wednesday. Called Dr's office Monday, and Tuesday, but operators always busy with other patients. Waited over 30 minutes on the line. Sent them a fax instead and got a call back pretty quick. I was asked to go to their on call Dr. which I did. This female Dr looked me over, asked questions and decided to send me to the ER to get checked for meningitis and flu because of all these symptoms and the length of the migraine. I went to ER and was given a number of medications to deal with the aches and pains benadryl for anxiety, and other meds. I was sent home and missed work for 2 more days. I slept most of 2 days. It has been 21 days now and I still have dizzy spells and my ears hurt. My eyes feel strained and I have been fatigued.
Age: 0.08
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: My son was wrongly given a Hepatitis A shot instead of Hep B shot at his one month doctor's well check. Fortunately, he had no reaction but could this shot cause harm to him in the future as there are no studies for children under 12 months receiving this shot? I even contacted Merck the manufacturer and they can't tell me anything. Feeling worried.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site discomfort, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Pt states that 24 hours after receiving vaccine he developed a round hard mass at site of injection. It was painful. It was not warm to touch and not red on skin. He denies fever. The mass remained for several weeks and was uncomfortable to sleep on and when lifting weights with his left arm. The mass now 3 months later is about half the size and no longer painful but still there in his left deltoid upon flexion of his muscle.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Discomfort, Gait disturbance, Injection site induration, Injection site mass, Injection site rash
Clinical narrative: Injection site is hard, marble size lump under skin, large rash about the size of a half dollar coin, tiny bumps, child is uncomfortable and not walking well.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Breast pain, Breast swelling, Erythema, Injection site pain, Mobility decreased
Clinical narrative: Soreness at sites of injection right away. After about 2 weeks arm swollen, red and sore. Left breast is swollen and sore. Having problems raising arm.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Soreness at sites of injection right away. After about 2 weeks arm swollen, red and sore. Left breast is swollen and sore. Having problems raising arm.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Eyelid oedema, Eyelids pruritus, Pain in extremity, Pruritus, Rash
Clinical narrative: Received dose #1 of BEXSERO on 1/17/18. On the morning of 1/18/18 eyelids were swollen and itchy. Tops of both hands had pink spots and were painful and itchy. Given cetirizine 10mg and ranitidine 150mg po in clinic and advised to take as needed over the next 2-3 days.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Rash erythematous
Clinical narrative: Received dose #1 of BEXSERO on 1/17/18. On the morning of 1/18/18 eyelids were swollen and itchy. Tops of both hands had pink spots and were painful and itchy. Given cetirizine 10mg and ranitidine 150mg po in clinic and advised to take as needed over the next 2-3 days.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Paraesthesia
Clinical narrative: Wednesday 1/17/2018: Legs felt "weird" and tingly. Thursday 1/18/2018: Tingling in the hands, hands "falling asleep".
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling abnormal, Pallor, Peripheral swelling, Skin discolouration
Clinical narrative: Quickly after got shot, called into room because mom said she wasn't feeling good. Nose was purple, hands got red and swollen, face pale and lips pale and just kept saying when asked "don't feel right". Pulse ox okay, no stridor, wheezing on exam. Talking without difficulty. Given BENADRYL po. Did give DECADRON once IM in office.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain, Peripheral swelling, Pyrexia
Clinical narrative: ARM SWELLED, PATIENT FELT ILL - MILD FEVER, ACHY.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Pt has no known allergies. Got flu shot last year without any issues. 30 seconds after giving shot, pt bleed a little and little swelling occurred right away around site. Monitored for 15-20 minutes no symptoms other than swelling. Given 10ml of diphenahydramine as patient requested. No other symptoms.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site urticaria, Rash
Clinical narrative: The patient went home after her well child exam and several hours later she developed a welt where her injection was given and a rash that extended up her arm and back. Mom was advised to give BENADRYL according to age and weight and apply ice to her injection site. I called the patient back 2 hours after her initial call and the mom stated the rash had resolved.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient received FLUCELVAX QUAD vaccine on 12/2/2017 and the pharmacist in charge gave the patient the vaccine in the right deltoid, intramuscularly. Lot #: 195211, expiration date: 3/31/2018. Patient called the pharmacy on 1/18/2018 and spoke with the pharmacist on duty. Patient complains of progressively worse soreness and pain in the spot the vaccine was administered. Patient also notices a palpable bump at the injection site. She says the pain has gotten progressively worse, and wonders if the pharmacist gave her the shot too high up in the arm. She says previous flu shots, she received the shot lower than what was given. She states she is seeing her doctor about this on 1/19/2018.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Discomfort, Injected limb mobility decreased, Injection site reaction, Neck pain
Clinical narrative: Patient called 1/17/18 to report that she experienced what she believed was "nerve pain" in her right arm the afternoon after I gave her her immunization (1/15/18 ~10:20 AM). She said it started w/ her upper arm on left & that she couldn't lift her arm, but that she wouldn't describe it as sore. Then she said in the evening the pain traveled to her neck and shoulder, then down her left side of her back & her lower left arm. Tuesday she stated she felt a little better but thought she also felt pain on her right side and that she couldn't get comfortable lying down on either side. She called the pharmacy on 1/17/18 at 1:40 PM to report these symptoms and I asked if she could come by the pharmacy for me to check the administration site and/or see her doctor and she said she would try. She stated at the time of the phone call on Wed 1/17 that the pain had reduced significantly and that just her left upper arm was bothering her. I told her I was available here until 8 PM on both 1/17 & 1/18 but she has not returned, so I am moving forward with the report and will follow up with her when I return to work 1/22/18. She stated she wasn't sure if she had a reaction to the vaccine itself or if the pain was from the administration site itself.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Patient called 1/17/18 to report that she experienced what she believed was "nerve pain" in her right arm the afternoon after I gave her her immunization (1/15/18 ~10:20 AM). She said it started w/ her upper arm on left & that she couldn't lift her arm, but that she wouldn't describe it as sore. Then she said in the evening the pain traveled to her neck and shoulder, then down her left side of her back & her lower left arm. Tuesday she stated she felt a little better but thought she also felt pain on her right side and that she couldn't get comfortable lying down on either side. She called the pharmacy on 1/17/18 at 1:40 PM to report these symptoms and I asked if she could come by the pharmacy for me to check the administration site and/or see her doctor and she said she would try. She stated at the time of the phone call on Wed 1/17 that the pain had reduced significantly and that just her left upper arm was bothering her. I told her I was available here until 8 PM on both 1/17 & 1/18 but she has not returned, so I am moving forward with the report and will follow up with her when I return to work 1/22/18. She stated she wasn't sure if she had a reaction to the vaccine itself or if the pain was from the administration site itself.
Age: 1.0
Sex: F
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Cough, Myalgia, Pyrexia, Rash vesicular, Scab
Clinical narrative: Pt. presented at walk in clinic on 1/3/18 w hx of fever, cough, myalgia and vesicular rash for duration of 1 day. Vesicles in various stages, some crusty, some new lesions, greater than 250 lesions. Recommendations were AVEENO, BENADRYL, CALAMINE, TYLENOL. No ASA.
Age: 1.0
Sex: F
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: Pt. presented at walk in clinic on 1/3/18 w hx of fever, cough, myalgia and vesicular rash for duration of 1 day. Vesicles in various stages, some crusty, some new lesions, greater than 250 lesions. Recommendations were AVEENO, BENADRYL, CALAMINE, TYLENOL. No ASA.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Musculoskeletal disorder, Vaccination complication
Clinical narrative: This serious spontaneous case, initially received from other non-health professional (consumer) on 08-Jan-2018, concerns a elderly female patient of an unspecified age. The patient's current conditions included osteoporosis of spine, guttate psoriasis, small patches on skin and arthritic pain. On an unspecified date, the patient was administered with Influenza vaccine (dose, route of administration, batch number, expiry date, manufacturer, trade name and anatomical location: not reported). On an unspecified date, the patient was administered with non-company suspect product CONSENTYX solution (dose: 150 mg, once a month, subcutaneously) for an unknown indication and patient still had arthritic pain. On an unspecified date, after the vaccination, the patient experienced bad reaction to flu shot and had lost the use of her right hand. The outcome of the events was reported as recovered.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore arm for over a month constant pain could hardly use my arm. Just got Flu shot no problem getting injection initially the pain in my arm lasted for over a month. Never had a problem before usually get my Flu shots from my Pharmacy.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt was given flu shot 1-15-18. Later that evening pt. began showing signs of swelling in upper arm w/erythema. Has Hx of injection site reaction, although very minor. Pt was taken to pediatrician and BENADRYL was given. Pt improving but still  has swelling as of 1-18-18.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None - Advised to report so that it could be documented.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Apnoea, Electroencephalogram normal, Eye movement disorder, Hypotension, Hypotonia
Clinical narrative: Began to scream, became unresponsive, opened eyes, then limp. Seemed to stop breathing, became very pale. EMS transferred home to ED -> hospital. Occurred Dec 11, 2017. Apnea and hypotension. Dec 26, 2017 similar episode but did not stop breathing. Jan 1, 2018 eye squinting episode, eyes rolled back.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Pallor, Screaming, Strabismus, Unresponsive to stimuli
Clinical narrative: Began to scream, became unresponsive, opened eyes, then limp. Seemed to stop breathing, became very pale. EMS transferred home to ED -> hospital. Occurred Dec 11, 2017. Apnea and hypotension. Dec 26, 2017 similar episode but did not stop breathing. Jan 1, 2018 eye squinting episode, eyes rolled back.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Computerised tomogram, Cough, Paranasal sinus hypersecretion, Respiratory tract congestion, Seizure
Clinical narrative: The shot was given 30th of Sept 30 2017. My sister got a shot the same day the nurse did not change gloves. 4 times I have had flu shots before they never bother me the 5th time I ended in hospital. It give me head sinus drainage and it went to my chest congest and a bad cough the Dr. treated me. Urgent care. I had flu shots every yr this flu shot was a bad shot I about died I even had a seizure and I don't have seizures.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: X-ray
Clinical narrative: The shot was given 30th of Sept 30 2017. My sister got a shot the same day the nurse did not change gloves. 4 times I have had flu shots before they never bother me the 5th time I ended in hospital. It give me head sinus drainage and it went to my chest congest and a bad cough the Dr. treated me. Urgent care. I had flu shots every yr this flu shot was a bad shot I about died I even had a seizure and I don't have seizures.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red round spot at injection site, warm to touch, no pain, slight itch.
Age: 34.0
Sex: M
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Expired product administered
Clinical narrative: Hep B vaccine expired on 1/17/18-vacc was given one day past exp. date. No tx needed. Spoke to employee at Merck and Co. - stated provider discretion on re-vaccination, but potency of vacc should be okay. Patient notified at 12:40 PM
Age: 34.0
Sex: M
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Hep B vaccine expired on 1/17/18-vacc was given one day past exp. date. No tx needed. Spoke to employee at Merck and Co. - stated provider discretion on re-vaccination, but potency of vacc should be okay. Patient notified at 12:40 PM
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Severe redness, inflammation, and swelling from the upper left arm (injection site) going down to my elbow. I was diagnosed with cellulitis. After 24 hours of antibiotics I am doing much better.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Patient came in for walk-in immunizations at 0800, filled out vaccination screening form, screened by RN. Staff gave the patient the VIS for adult HEP A, verified full name and DOB, allergies and any adverse events in the past. Medication verified and administered to R deltoid IM approximately 0815. Patient instructed to wait in waiting room for 15 minutes before discharge. Patient complained of hives breaking out on arms after 5 minutes, and was taken to procedure room, given EPIPEN by DR. Ambulance was called. 10 minutes after first EPIPEN, patient complained of shortness of breath and difficulty breathing. Dr administered 2nd EPIPEN and oxygen. Ambulance came approximately 20 mins after the call and patient transferred to Medical Center. Patient was able to ambulate by self when ambulance arrived and stated that she felt better, able to breathe easier, no hives present on arms at this time.
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to an adult patient of unknown age and gender. Medical history, concomitant medications and concurrent conditions were not provided. On 19-DEC-2017, the patient was vaccinated with the first dose of PEDVAXHIB lot # M045207, the expiration date: 30-JUN-2019, (dose and route were not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects reported.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to an 11 year old female patient.  Information regarding the patient's medical history, drug reactions or allergies and concurrent was not reported. Concomitant therapies included MENVEO. On 29-DEC-2017, the patient was vaccinated with the first dose of improperly stored GARDASIL 9 lot # N020353, expiration date dose 28-APR-2020, by intramuscular route in the left deltoid, for prophylaxis. The vaccine was exposed to a temperature range of 0.4°C, during a time frame of 14 hours, which was called by a data logger. No previous temperature excursions were reported. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Ophthalmic herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 16-JAN-2017 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was inoculated with ZOSTAVAX vaccine (lot# and route unknown) on or about 22-FEB-2015, administered by a physician, as recommended for routine adult health maintenance, and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-JUL-2016, the patient was treated by a physician for the onset of a severe vesicular rash that had spread into the eye, and was diagnosed as herpes zoster, or shingles of the eye. On or about 27-JUL-2016, the patient was treated by the physician for ongoing and worsening symptoms of herpes zoster, or shingles. The physician prescribed erythromycin Ophthalmic Ointment for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review herpes zoster, or shingles of the eye was considered medically significant. Additional information has been requested.