chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a currently 12 days old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA, lot number N017094 and expiration date of 31-AUG-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1709USA011980: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a currently 3 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA, lot number N017094 and expiration date of 31-AUG-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1709USA011980: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to acurrently 13 months old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA, lot number N017094 and expiration date of 31-AUG-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1709USA011980: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a 23 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA, lot number N017094 and expiration date of 31-AUG-2018 for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1709USA011980: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1710USA006366: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site haemorrhage
Clinical narrative: Initial unsolicited report received from a pharmacist on 22-Sep-2017. This case involves a 75-year-old male patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE (batch number: UI811AD, expiry date was not reported), in left arm via intramuscular route on 07-Sep-2017. The patient's medical history and concomitant medications were not reported. On 07-Sep-2017, same day post vaccination, the patient had large amount of bleeding at injection site. On 22-Sep-2017, 15-day following vaccination, patient had a large hematoma at the injection site of his left arm. No soreness, no pain experienced, no other symptoms reported. The patient's laboratory data was not reported. Corrective treatment includes aspirin. The events outcome reported as unknown. List of documents held by sender: none.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Initial unsolicited report received from consumer on 02 Oct 2017. This case involves 65 years old patient (Gender was not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Frequency: once, batch number, expiry date was not reported) intramuscularly in left deltoid on 22 Sep 2017. The patient's medical history and concomitant medication were not reported. On 23 Sep 2017 one day post vaccination, patient had plastic taste in mouth. Laboratory investigation was not reported. Patient did not received corrective treatment. Patient was not recovered from event. List of documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Immediate post-injection reaction, Injected limb mobility decreased, Injection site inflammation, Injection site pain
Clinical narrative: Initial unsolicited report received from physician on 02 Oct 2017. This case involves 69 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HD (Form: injection, frequency: once, batch number: UI840AA, expiry date was not reported) intramuscularly in the upper area of left deltoid on 20 Sep 2017. The patient's medical history and concomitant medication were not reported. On 20 Sep 2017 in the upper area of the left deltoid immediately after vaccination, patient had below the shoulder and has been experiencing symptoms of bursitis with pain, inflammation and limited ROM. Laboratory investigation and corrective treatment were not reported. Outcome of events was unknown. List of documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: After the patient received the vaccine he developed an area of redness, warmth, and swelling approximately 2.5 inches in diameter that lasted until he presented to our clinic 1 week later. He was advised to take anti-inflammatories, the perimeter of the area was marked and he was advised to seek medical attention if the area grew outside of the marked perimeter of if he developed pain or worsening symptoms. He was seen by an MD who advised him of the same and the area resolved on its own within 2 weeks.
Age: 0.92
Sex: M
Vaccine: FLU4
Symptoms: Crying, Diet refusal, Haematochezia, Irritability, Mucous stools
Clinical narrative: (I am not positive of the name of influenza vaccine, as his records just state "influenza quadrivent preservative free"). At 9:30am on 10/12/17, patient had a bowel movement that was full of visible blood- both large globs of red mucus as well as black strings appearing to be old blood. I called his pediatrician and asked if I could bring the diaper in for hemoccult blood testing because I suspected it to be blood and that he was having a vaccine reaction. They insisted it was impossible for him to be reacting to the eggs in the flu vaccine even if he has an FPIES allergy to eggs, but finally agreed to test the diaper. It tested positive for blood at both sites they tested (one from the red mucus area, one from the black strings). Following this diaper, he had another BM around 4pm with visible blood and a third around 6pm, also with visible blood. He was extremely irritable, and crying without being able to be consoled for most of the evening, and refused to eat dinner. He also refused to sleep in his crib, andI had to sleep with him right next to me in my bed where he slept very restlessly all night.
Age: 0.92
Sex: M
Vaccine: FLU4
Symptoms: Occult blood positive, Poor quality sleep, Restlessness
Clinical narrative: (I am not positive of the name of influenza vaccine, as his records just state "influenza quadrivent preservative free"). At 9:30am on 10/12/17, patient had a bowel movement that was full of visible blood- both large globs of red mucus as well as black strings appearing to be old blood. I called his pediatrician and asked if I could bring the diaper in for hemoccult blood testing because I suspected it to be blood and that he was having a vaccine reaction. They insisted it was impossible for him to be reacting to the eggs in the flu vaccine even if he has an FPIES allergy to eggs, but finally agreed to test the diaper. It tested positive for blood at both sites they tested (one from the red mucus area, one from the black strings). Following this diaper, he had another BM around 4pm with visible blood and a third around 6pm, also with visible blood. He was extremely irritable, and crying without being able to be consoled for most of the evening, and refused to eat dinner. He also refused to sleep in his crib, andI had to sleep with him right next to me in my bed where he slept very restlessly all night.
Sex: M
Vaccine: TDAP
Symptoms: Blood test abnormal, Cough, Malaise, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 64-year-old male patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 4 years after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant), sickness and cough. On an unknown date, the outcome of the vaccination failure, whooping cough, sickness and cough were unknown. The reporter considered the vaccination failure, whooping cough, sickness and cough to be possibly related to dTpa vaccine. Additional details were reported as follows: This case was reported by the patient's wife. A few years before reporting date, the reporter's husband got whooping cough, but had his DTP shot 4 years before vaccination. However, he was deathly sick. The reporter stated that this was so dangerous  to infants but, adults got it because of transmission from other adults and unvaccinated children. The patient was deathly sick, coughing his brains out for a solid month. The blood test was sent to the country health department which confirmed it was in high count and the patient was told not leave the house. The reporter stated it was a dangerous virus and dangerous to everyone. The reporter denied consent to be contacted. The details regarding dose number, batch number and expiry date of the vaccine were unknown. This case was considered as suspected vaccination failure since details of completion of the primary vaccination schedule and confirmatory laboratory test was not provided.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure increased, Dizziness, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: Stated he became very "tired, hands felt tingly, heart rate dropped to 40's, felt light headed". Went to the emergency department, blood pressure elevated. They did labs, EKG, and gave IV fluids. He was later discharged from the emergency department. Spoke with him by phone 10/13/17 and he is feeling better, no continuing symptoms.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Heart rate decreased, Laboratory test, Paraesthesia, Troponin
Clinical narrative: Stated he became very "tired, hands felt tingly, heart rate dropped to 40's, felt light headed". Went to the emergency department, blood pressure elevated. They did labs, EKG, and gave IV fluids. He was later discharged from the emergency department. Spoke with him by phone 10/13/17 and he is feeling better, no continuing symptoms.
Age: 48.0
Sex: M
Vaccine: UNK
Symptoms: Back pain, Eye pruritus, Hypersensitivity, Lacrimation increased, Myalgia
Clinical narrative: Severe allergies, sinus, itchy watering eyes. Low back pain-musculature.
Age: 48.0
Sex: M
Vaccine: UNK
Symptoms: Sinus disorder
Clinical narrative: Severe allergies, sinus, itchy watering eyes. Low back pain-musculature.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site haemorrhage, Tremor
Clinical narrative: Patient received flu vaccine approximately between 2-3 PM. No signs or symptoms reported at time of vaccine administration. No bleeding upon administration. Patient has received flu shots in the past without difficulty. Patient reports approximately 12 hours or so after vaccine she woke up with her hands shaking. States that is all she remembers. Said she was awake but was like she couldn't snap out of shaking. Patients reports husband told her that her entire body was shaking for a few minutes. States she then has had a horrible headache. States she is going to follow up with her physician today. States once she left the clinic she said she had some bleeding at injection site. States she has been tired since waking up and continues with a headache. States she has not done anything different or taken anything different except for this flu shot.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling occurred around the site. Possible allergic reaction.
Age: 50.0
Sex: M
Vaccine: TYP
Symptoms: Headache
Clinical narrative: Pt. c/o headaches that are somewhat resolved with advil ever since he started taking the Typhoid capsules.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Starting morning after receiving the flu shot the patient woke up every day for 1 week with cold sweats, nausea, vomiting, low grade headache, sore muscles in the back and chest. The nausea and vomiting led to an 8 pound weight loss over the course of that 1 week.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Weight decreased
Clinical narrative: Starting morning after receiving the flu shot the patient woke up every day for 1 week with cold sweats, nausea, vomiting, low grade headache, sore muscles in the back and chest. The nausea and vomiting led to an 8 pound weight loss over the course of that 1 week.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Pt has Wagner's disease and after receiving FLUZONE Quad flu shot had joint pain throughout body especially in left arm that received injection.
Age: 26.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Mild redness and edema at injection site. Employee stated she had had similar reactions to the Influenza vaccine. She stated she was allergic to eggs. Recommended ibuprofen, ice to injection site, and 25-50 mg of Diphenhydramine
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Headache, Pain, Pyrexia
Clinical narrative: Fever of 101, body aches, headache, upset stomach.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hepatic enzyme increased
Clinical narrative: Elevated liver enzymes.
Age: 24.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Angioedema, Urticaria
Clinical narrative: Pt began experiencing hives approximately one week after injections. Symptoms were intermittent over 2 days, then began having angioedema. Presented to our office for examinations. Pt treated with Prednisone, Zyrtec and Zantac. Has not had recurrence since then.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Erythema, Flushing, Hyperhidrosis, Pruritus
Clinical narrative: Vaccine administered 09:30, within 30 minutes, at 10:00, left arm became pruritic, red and warm to touch. Also, chest was red, face flushed, sweating, and felt clammy. Alerted co-worker who informed employee health RN. She observed the same symptoms, applied a cold compress for my arm and gave me a 25 mg BENADRYL capsule. Around 12:30 (10/10/17), became flushed and was sweating again. Co-worker called Employee Health RN again. My supervisor administered another cold compress to me. They recommended I call my PCP as they did not want to give me another BENADRYL without her consent. PCP instructed to have my work administer another 25 mg BENADRYL immediately. The PCP instructed to give another 25 mg BENADRYL before bedtime. There were no more reactions to the vaccine after the 12:30 PM flareup.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Vaccine administered 09:30, within 30 minutes, at 10:00, left arm became pruritic, red and warm to touch. Also, chest was red, face flushed, sweating, and felt clammy. Alerted co-worker who informed employee health RN. She observed the same symptoms, applied a cold compress for my arm and gave me a 25 mg BENADRYL capsule. Around 12:30 (10/10/17), became flushed and was sweating again. Co-worker called Employee Health RN again. My supervisor administered another cold compress to me. They recommended I call my PCP as they did not want to give me another BENADRYL without her consent. PCP instructed to have my work administer another 25 mg BENADRYL immediately. The PCP instructed to give another 25 mg BENADRYL before bedtime. There were no more reactions to the vaccine after the 12:30 PM flareup.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inappropriate schedule of drug administration, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Really hurt when pneumonia shot was injected and that night arm hurt and was swollen and beet red and painful!! Didn't even need that shot again. Had it 8 years ago from primary care doctor! I thought it was something new???
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, redness, hardness to injection site, left upper arm.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Influenza, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Patient called pharmacy late on 10/12/17 and reported to pharmacist swelling, redness, warm to touch on left arm. He sent picture of arm to pharmacist and then came in to pharmacy on 10/13 morning to show arm to pharmacist. Left arm was red, swollen, and warm to touch from injection site to above elbow. He reported he could not move arm above his shoulder. He also reported flu symptoms on 10/12 with fever and body ache, lethargic and didn't feel like he could work. His arm was very warm to touch. I instructed patient to take ibuprofen for swelling and inflammation. Also told him to use cold compress twice daily. Pharmacist will call him this evening on 10/13 to see if arm is better.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Lethargy, Loss of personal independence in daily activities, Pain
Clinical narrative: Patient called pharmacy late on 10/12/17 and reported to pharmacist swelling, redness, warm to touch on left arm. He sent picture of arm to pharmacist and then came in to pharmacy on 10/13 morning to show arm to pharmacist. Left arm was red, swollen, and warm to touch from injection site to above elbow. He reported he could not move arm above his shoulder. He also reported flu symptoms on 10/12 with fever and body ache, lethargic and didn't feel like he could work. His arm was very warm to touch. I instructed patient to take ibuprofen for swelling and inflammation. Also told him to use cold compress twice daily. Pharmacist will call him this evening on 10/13 to see if arm is better.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient called pharmacy late on 10/12/17 and reported to pharmacist swelling, redness, warm to touch on left arm. He sent picture of arm to pharmacist and then came in to pharmacy on 10/13 morning to show arm to pharmacist. Left arm was red, swollen, and warm to touch from injection site to above elbow. He reported he could not move arm above his shoulder. He also reported flu symptoms on 10/12 with fever and body ache, lethargic and didn't feel like he could work. His arm was very warm to touch. I instructed patient to take ibuprofen for swelling and inflammation. Also told him to use cold compress twice daily. Pharmacist will call him this evening on 10/13 to see if arm is better.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Rash macular
Clinical narrative: Patient with mild erythema and macular rash on the anterior lateral aspect of left arm approxiamately 1.5 cm in width with no swelling or warmth to site.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Nausea, Pain in extremity
Clinical narrative: Upper arm red from shoulder to elbow. EXTREMELY painful. Nausea. Muscle pain. I took ibuprofen .  This is the 3rd day and is a little better.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site swelling, Skin warm
Clinical narrative: Patient reported to pharmacy on 10/13 morning with swollen arm to elbow, redness, warm to touch in right arm. She had take some Tylenol for pain. She was concerned about redness, swelling. Pharmacist advised her to take ibuprofen today for swelling but she preferred Tylenol. Pharmacist will call to check on patient on evening of 10/13.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperaesthesia, Hypoaesthesia, Injection site discolouration, Injection site reaction, Injection site vesicles
Clinical narrative: Severe pain, tenderness, swelling, of the entire upper arm. Numbness and cold sensation of arm, hand, fingers. 6" x 2" area of dark discoloration surrounding injection site. In 24 hours discolored area progressed to a large blister with sloughing of skin. Treated with prednisone. Symptoms resolved slowly over a week. Sequella of hypopigmentation and hyperesthesia of anterolateral upper arm.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral coldness, Peripheral swelling, Skin exfoliation, Skin hypopigmentation
Clinical narrative: Severe pain, tenderness, swelling, of the entire upper arm. Numbness and cold sensation of arm, hand, fingers. 6" x 2" area of dark discoloration surrounding injection site. In 24 hours discolored area progressed to a large blister with sloughing of skin. Treated with prednisone. Symptoms resolved slowly over a week. Sequella of hypopigmentation and hyperesthesia of anterolateral upper arm.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Severe pain, tenderness, swelling, of the entire upper arm. Numbness and cold sensation of arm, hand, fingers. 6" x 2" area of dark discoloration surrounding injection site. In 24 hours discolored area progressed to a large blister with sloughing of skin. Treated with prednisone. Symptoms resolved slowly over a week. Sequella of hypopigmentation and hyperesthesia of anterolateral upper arm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Right arm turned red and swelled beginning 3 inches below injection sight and extending all the way to the elbow. Diagnosed as Cellulitus. Treatment using Cephalexin was begun immediately.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperventilation, Throat tightness
Clinical narrative: Throat tightening and hyperventilating, lightheaded. Treated in ED with po Benadryl 25 mg x 1 with resolution of symptoms. No additional treatment was required.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Developed left shoulder pain after vaccination.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Pruritus, Rash vesicular
Clinical narrative: Patient came to clinic with varicella like rash that started on the evening of 10/12/17 and injection site redness. Started on his head and is now on abdomen and back. Reports itching and rash. Patient received the VARIVAX vaccination on 9/29/2017 at a pharmacy.
Age: 24.0
Sex: F
Vaccine: DTAP, HPV9
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Severe headache, minor fever, nausea.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Pain
Clinical narrative: LARGE 8CM CIRCULAR ERYTHEMATOUS PATCH WITH CENTRAL INDURATION AND PAIN.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route and lot # were not reported) on or about 26-JUL-2010, as logged in the Immunization Registry, and recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about  18-JAN-2016, the patient was treated at an Urgent Care facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 27-JAN-2016, the patient received subsequent treatment for ongoing and worsening symptoms of shingles outbreaks. The patient has been prescribed acyclovir, prednisone, hydrocodone-acetaminophen, and gabapentin 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, pain and suffering and other damages. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A 66-years-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date (about 3 years before) at single dose in arm with 5/8" needle for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe swelling and pain at injection site and was hot to touch. Patient went to doctor and was prescribed Prednisone. The outcome of the events was unknown.
Age: 76.0
Sex: M
Vaccine: FLUR3, PPV
Symptoms: Cellulitis
Clinical narrative: This is an initial report of an AE, received on 06-Oct-2017, for Protein Sciences Flublok. Subject, a 76 year-old male received FLUBLOK Intramuscular on 04-Oct-2017. On 04-Oct-2017, after receiving FLUBLOK and pneumococcal vaccine, the subject experienced cellulitis. It was unknown if any corrective treatment was provided. At the time of the report, it was unknown the outcome of the event. Medical history was not provided. It was unknown if the subject received Flublok in the past. Concomitant medications included an unspecified pneumococcal vaccine.; Sender's Comments: The companys assessment of the causal relationship between cellulitis and FLUBLOK is related. In summary, this case report does not change the known safety profile of FLUBLOK.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling, Pain, Poor quality sleep, Pyrexia
Clinical narrative: Had flu shot-FLUZONE HD PF 2017-18 INJ SAN woke up at 3:30 am with fever of 100.6 itchy eyes and face swollen, took TYLENOL. Body aches all over. Restless sleep until noon next day. Fever did not break until then but was back that night but low99.7. 10/07/2017 still slight swelling in face and eyes but no fever. Have had regular flu shot every yr prior with no reaction.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Had flu shot-FLUZONE HD PF 2017-18 INJ SAN woke up at 3:30 am with fever of 100.6 itchy eyes and face swollen, took TYLENOL. Body aches all over. Restless sleep until noon next day. Fever did not break until then but was back that night but low99.7. 10/07/2017 still slight swelling in face and eyes but no fever. Have had regular flu shot every yr prior with no reaction.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Aspiration joint normal, Asthenia, Condition aggravated, Gait inability
Clinical narrative: 10-5-2015 woke at 2:30AM throbbing left shoulder, left knee, left baby toe-iced, elevated-arm in sling. Could not walk. 10-13-2015 Saw Dr (internist) labs ordered, Rx: prednisone, Nabumetone and omeprazole. 10-15-2015 Knee worsened-no improvement in shoulder or toe. 10-16-2015 Saw Dr (orthopedist) removed fluid from knee-ran labs for gout or infection (Negative) gave me a cortisone shot which made it possible to barely walk-PT recommended (at home). 10-26-2015 Saw Dr-shoulder worsening-told to sleep upright. 12-3-2015 Saw Dr (finally) orthopedist for shoulders. Sent to PT. 12-26-2015 Saw Dr for cortisone shot in shoulder. 12-29-15 to 4-3-2016 Went away for winter-very debilitated. 4-2016 MRI of left knee showed meniscus tear-PT prescribed by Dr. 9-2016 Dr. did left knee meniscus surgery and Rx PT. 5-2016 Saw Dr (foot ortho)-he referred me to Rheumatology and had Rheum. labs ran. 7-2016 Saw Dr (Rheumatology)-he thought NEGATIVE. Drugs: from 10/16/2015 to 6-2017 Naproxen 500mg 3/day and Omeprazole for all 3 areas of pain. 6-2017 Labs showed I had diminished kidney function so I stopped Naproxen and Omeprazole. Permanent Damage: Swelling in knee caused medial meniscus tear, so needed surgery and soon full replacement. Now I have bone on bone and limited in my movements. My left shoulder required I sleep elevated, and support that arm when sitting or laying down or pain intensifies. Shoe adjustments to accommodate toe pain. Kidney function. Fear of flu shot. Conclusion reached by doctors involved: High dosage shot had 4 times the heavy metals in it and they were attracted to my chronic arthritic sites-causing the FLARES-which in turn caused damage in these joints.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint injection, Joint swelling, Knee operation, Laboratory test normal
Clinical narrative: 10-5-2015 woke at 2:30AM throbbing left shoulder, left knee, left baby toe-iced, elevated-arm in sling. Could not walk. 10-13-2015 Saw Dr (internist) labs ordered, Rx: prednisone, Nabumetone and omeprazole. 10-15-2015 Knee worsened-no improvement in shoulder or toe. 10-16-2015 Saw Dr (orthopedist) removed fluid from knee-ran labs for gout or infection (Negative) gave me a cortisone shot which made it possible to barely walk-PT recommended (at home). 10-26-2015 Saw Dr-shoulder worsening-told to sleep upright. 12-3-2015 Saw Dr (finally) orthopedist for shoulders. Sent to PT. 12-26-2015 Saw Dr for cortisone shot in shoulder. 12-29-15 to 4-3-2016 Went away for winter-very debilitated. 4-2016 MRI of left knee showed meniscus tear-PT prescribed by Dr. 9-2016 Dr. did left knee meniscus surgery and Rx PT. 5-2016 Saw Dr (foot ortho)-he referred me to Rheumatology and had Rheum. labs ran. 7-2016 Saw Dr (Rheumatology)-he thought NEGATIVE. Drugs: from 10/16/2015 to 6-2017 Naproxen 500mg 3/day and Omeprazole for all 3 areas of pain. 6-2017 Labs showed I had diminished kidney function so I stopped Naproxen and Omeprazole. Permanent Damage: Swelling in knee caused medial meniscus tear, so needed surgery and soon full replacement. Now I have bone on bone and limited in my movements. My left shoulder required I sleep elevated, and support that arm when sitting or laying down or pain intensifies. Shoe adjustments to accommodate toe pain. Kidney function. Fear of flu shot. Conclusion reached by doctors involved: High dosage shot had 4 times the heavy metals in it and they were attracted to my chronic arthritic sites-causing the FLARES-which in turn caused damage in these joints.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Meniscus injury, Meniscus operation, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: 10-5-2015 woke at 2:30AM throbbing left shoulder, left knee, left baby toe-iced, elevated-arm in sling. Could not walk. 10-13-2015 Saw Dr (internist) labs ordered, Rx: prednisone, Nabumetone and omeprazole. 10-15-2015 Knee worsened-no improvement in shoulder or toe. 10-16-2015 Saw Dr (orthopedist) removed fluid from knee-ran labs for gout or infection (Negative) gave me a cortisone shot which made it possible to barely walk-PT recommended (at home). 10-26-2015 Saw Dr-shoulder worsening-told to sleep upright. 12-3-2015 Saw Dr (finally) orthopedist for shoulders. Sent to PT. 12-26-2015 Saw Dr for cortisone shot in shoulder. 12-29-15 to 4-3-2016 Went away for winter-very debilitated. 4-2016 MRI of left knee showed meniscus tear-PT prescribed by Dr. 9-2016 Dr. did left knee meniscus surgery and Rx PT. 5-2016 Saw Dr (foot ortho)-he referred me to Rheumatology and had Rheum. labs ran. 7-2016 Saw Dr (Rheumatology)-he thought NEGATIVE. Drugs: from 10/16/2015 to 6-2017 Naproxen 500mg 3/day and Omeprazole for all 3 areas of pain. 6-2017 Labs showed I had diminished kidney function so I stopped Naproxen and Omeprazole. Permanent Damage: Swelling in knee caused medial meniscus tear, so needed surgery and soon full replacement. Now I have bone on bone and limited in my movements. My left shoulder required I sleep elevated, and support that arm when sitting or laying down or pain intensifies. Shoe adjustments to accommodate toe pain. Kidney function. Fear of flu shot. Conclusion reached by doctors involved: High dosage shot had 4 times the heavy metals in it and they were attracted to my chronic arthritic sites-causing the FLARES-which in turn caused damage in these joints.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Renal function test abnormal, Renal impairment
Clinical narrative: 10-5-2015 woke at 2:30AM throbbing left shoulder, left knee, left baby toe-iced, elevated-arm in sling. Could not walk. 10-13-2015 Saw Dr (internist) labs ordered, Rx: prednisone, Nabumetone and omeprazole. 10-15-2015 Knee worsened-no improvement in shoulder or toe. 10-16-2015 Saw Dr (orthopedist) removed fluid from knee-ran labs for gout or infection (Negative) gave me a cortisone shot which made it possible to barely walk-PT recommended (at home). 10-26-2015 Saw Dr-shoulder worsening-told to sleep upright. 12-3-2015 Saw Dr (finally) orthopedist for shoulders. Sent to PT. 12-26-2015 Saw Dr for cortisone shot in shoulder. 12-29-15 to 4-3-2016 Went away for winter-very debilitated. 4-2016 MRI of left knee showed meniscus tear-PT prescribed by Dr. 9-2016 Dr. did left knee meniscus surgery and Rx PT. 5-2016 Saw Dr (foot ortho)-he referred me to Rheumatology and had Rheum. labs ran. 7-2016 Saw Dr (Rheumatology)-he thought NEGATIVE. Drugs: from 10/16/2015 to 6-2017 Naproxen 500mg 3/day and Omeprazole for all 3 areas of pain. 6-2017 Labs showed I had diminished kidney function so I stopped Naproxen and Omeprazole. Permanent Damage: Swelling in knee caused medial meniscus tear, so needed surgery and soon full replacement. Now I have bone on bone and limited in my movements. My left shoulder required I sleep elevated, and support that arm when sitting or laying down or pain intensifies. Shoe adjustments to accommodate toe pain. Kidney function. Fear of flu shot. Conclusion reached by doctors involved: High dosage shot had 4 times the heavy metals in it and they were attracted to my chronic arthritic sites-causing the FLARES-which in turn caused damage in these joints.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, X-ray
Clinical narrative: Pain in shoulder continuous, X-ray on 10/13/2017.
Age: 33.0
Sex: U
Vaccine: FLU3
Symptoms: Contusion, Erythema, Injection site pain, Swelling
Clinical narrative: Patient states she had unusual redness, bruising and swelling since her shot, received 3 days ago. Pain is 6 on scale of 10 and is localized  to injection site- No pain or numbness in rest of arm. patient states injection hurts worse that Anthrax vaccine received.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Chest discomfort, Dyspnoea, Injection site pruritus, Injection site swelling, Pruritus generalised
Clinical narrative: Chest tightness, a little SOB than normal, using inhaler more often than usual, pruritus at site of injection that became more generalized. Swelling at site of injection. Improving but not resolved yet. On prednisone 50 mg x 3D.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Body temperature increased, Headache, Myalgia, Peripheral swelling
Clinical narrative: Arm swelled, temp. of 102, weak and muscle pain on the first day. Second day temp down to just under 100 arm swelling down, but not back to normal, and has a headache. Third day temp still not back to normal, arm still slightly swollen, still has headache and weak.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Hives that spread.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Nausea, restlessness, headache, dizziness. I continue to experience tingling on left extremities, i.e. side of face, arm, hand, leg, and foot; nausea and headache when tingling intensifies; tingling increases during evening hours to point of soreness in leg by time I go to bed; subsides during the night; begins again as I start moving around in the morning and when sitting position. During the day the tingling sensation goes across my chin at various parts of the day.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Restlessness
Clinical narrative: Nausea, restlessness, headache, dizziness. I continue to experience tingling on left extremities, i.e. side of face, arm, hand, leg, and foot; nausea and headache when tingling intensifies; tingling increases during evening hours to point of soreness in leg by time I go to bed; subsides during the night; begins again as I start moving around in the morning and when sitting position. During the day the tingling sensation goes across my chin at various parts of the day.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Vomiting
Clinical narrative: PT EXPERIENCED vomiting , diarrhea and feels tired.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site discomfort, Injection site joint pain, Musculoskeletal pain
Clinical narrative: See below: Persistent shoulder pain x 25 days after flu vaccine. This 42 yo female received her annual influenza vaccine FLUCELVAX (SEQ Lot#195231) to her left deltoid on 9/18/2017. She reports as vaccine given she felt an electrical jolt from her shoulder to all fingertips for 1-2 seconds that resolved when needle pulled out and a band-aid was applied (recalls was placed mid upper deltoid @ 3FB down from shoulder). Approximately 2 hours later her left shoulder hurt and felt like it wanted to pop with gradually worsening joint pain. She was unable to lift the left arm to undress that night due to pain and limited ROM/lifting-pulling. This discomfort persisted over the next 4 days and has remained as of 10/13/2017. She reports she saw her HCP on 10/9/2017 reporting limited ROM with certain positions: i.e. If elbow bent 90deg angle, she cannot raise arm above shoulder due to pain, and if arm extended she can extend arm overhead but feels the shoulder pop at shoulder level both raising and dropping arm which causes pain. She lists the pain as a constant 3-4 ache but gives a 4-7/10 with movements that cause shoulder to pop. Her HCP diagnosed her with nerve impingement and has started her on medrol dose pack and ordered physical therapy. She denies any injury, trauma, site inflammation (redness, swelling, TTP or other systemic reactions), denies exercising or carrying any heavy/bulky objects while at work or prior to vaccination (IE yard work over weekend). No other vaccines given with flu vaccine. Supplemental HPI [use for free text].
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Nerve root compression, Pain, Paraesthesia
Clinical narrative: See below: Persistent shoulder pain x 25 days after flu vaccine. This 42 yo female received her annual influenza vaccine FLUCELVAX (SEQ Lot#195231) to her left deltoid on 9/18/2017. She reports as vaccine given she felt an electrical jolt from her shoulder to all fingertips for 1-2 seconds that resolved when needle pulled out and a band-aid was applied (recalls was placed mid upper deltoid @ 3FB down from shoulder). Approximately 2 hours later her left shoulder hurt and felt like it wanted to pop with gradually worsening joint pain. She was unable to lift the left arm to undress that night due to pain and limited ROM/lifting-pulling. This discomfort persisted over the next 4 days and has remained as of 10/13/2017. She reports she saw her HCP on 10/9/2017 reporting limited ROM with certain positions: i.e. If elbow bent 90deg angle, she cannot raise arm above shoulder due to pain, and if arm extended she can extend arm overhead but feels the shoulder pop at shoulder level both raising and dropping arm which causes pain. She lists the pain as a constant 3-4 ache but gives a 4-7/10 with movements that cause shoulder to pop. Her HCP diagnosed her with nerve impingement and has started her on medrol dose pack and ordered physical therapy. She denies any injury, trauma, site inflammation (redness, swelling, TTP or other systemic reactions), denies exercising or carrying any heavy/bulky objects while at work or prior to vaccination (IE yard work over weekend). No other vaccines given with flu vaccine. Supplemental HPI [use for free text].
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Patient reports itching and tingling on her back, thigh, and buttocks.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site irritation
Clinical narrative: Irritation at injection site. Visited school nurse for a cold compress.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient reported rash started on 10/11/17 on upper torso then developed some rash on legs. Patient reported that she had taken BENADRYL and that symptoms were resolving when seen at clinic on 10/12/17.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Audiogram abnormal, Balance disorder, Deafness unilateral, Decreased activity, Dyspnoea
Clinical narrative: On 10/3/17 I received the flu shot while on duty. I immediately developed a hematoma at the injection site. One and half hours later I started experiencing vertigo and nausea. By the time I got home around 4:00 PM I had to lie down due to my symptoms getting worse. I had difficulty keeping my balance when ever I was working. Getting up one flight of stairs I had SOB. I ended up going to bed early without dinner as my nausea was worsening. The next day symptoms continued. I had to fly on 10/5/17 and while there all my symptoms remained. I had vertigo, nausea, loss of balance. I had to limit my activities 10/5/ to 10/10.  I also starting noticing I was having trouble hearing conversations.  Upon my return my symptoms were slowly improving. I attended a dinner function on 10/11/17 and realized I was having trouble hearing conversation from my R ear. When I awoke yesterday 10/12/17 and I lost all my earing in my R ear.  I managed to get myself into Dr office for a 9:45 AM apt. He assessed me and then I had a audio test down which confirmed a servere loss of hearing in my R ear.  Dr. started me on Predisone 60mg x 10 days and then a taper plus zofran. I then went to Employee Health Center and reported this work injury and was also assessed by a NP.  I absolutely believe the flu shot caused my loss of hearing and all my other symptoms. I have never had any of this kind of thing prior to the this flu shot. I don't believe it is a coincident. My prognosis is the following. 33% chance full recover, 33% chance some improvement without full recovery and 33% chance this is permanent. Today my vertigo and nausea are improving slowly and I have lost my hearing in my R ear. Needless to say I will never take this vaccine again and I have had many in the past with no issues. I have selected disability or permanent damage but I don't know the outcome of my treatment and I don't see a choice that address this. It is a disability right now pending result of treatment which I am on day 2.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoacusis, Immediate post-injection reaction, Injection site haematoma, Nausea, Vertigo
Clinical narrative: On 10/3/17 I received the flu shot while on duty. I immediately developed a hematoma at the injection site. One and half hours later I started experiencing vertigo and nausea. By the time I got home around 4:00 PM I had to lie down due to my symptoms getting worse. I had difficulty keeping my balance when ever I was working. Getting up one flight of stairs I had SOB. I ended up going to bed early without dinner as my nausea was worsening. The next day symptoms continued. I had to fly on 10/5/17 and while there all my symptoms remained. I had vertigo, nausea, loss of balance. I had to limit my activities 10/5/ to 10/10.  I also starting noticing I was having trouble hearing conversations.  Upon my return my symptoms were slowly improving. I attended a dinner function on 10/11/17 and realized I was having trouble hearing conversation from my R ear. When I awoke yesterday 10/12/17 and I lost all my earing in my R ear.  I managed to get myself into Dr office for a 9:45 AM apt. He assessed me and then I had a audio test down which confirmed a servere loss of hearing in my R ear.  Dr. started me on Predisone 60mg x 10 days and then a taper plus zofran. I then went to Employee Health Center and reported this work injury and was also assessed by a NP.  I absolutely believe the flu shot caused my loss of hearing and all my other symptoms. I have never had any of this kind of thing prior to the this flu shot. I don't believe it is a coincident. My prognosis is the following. 33% chance full recover, 33% chance some improvement without full recovery and 33% chance this is permanent. Today my vertigo and nausea are improving slowly and I have lost my hearing in my R ear. Needless to say I will never take this vaccine again and I have had many in the past with no issues. I have selected disability or permanent damage but I don't know the outcome of my treatment and I don't see a choice that address this. It is a disability right now pending result of treatment which I am on day 2.