chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: DTAP, MNQ, TDAP
Symptoms: Blood pressure decreased, Dizziness, Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: Immediately felt sick and like I was going to black out. I got lightheaded and felt heavy everywhere, then I started throwing up and my blood pressure dropped to 96/67.
Age: 84.0
Sex: F
Vaccine: FLUA3
Symptoms: Myalgia
Clinical narrative: Patient is still complaining of muscle soreness in her arm.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site  - told patient to take BENADRYL as directed.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site paraesthesia, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: PATIENT RECEIVED IMMUNIZATIONS ON WED 11/15. FRIDAY EVENING SHE NOTICED THAT HER LEFT ARM FELT HOT. SATURDAY MORNING THE AREA BELOW THE INJECTION SITE (BETWEEN THE MUSCLE AND HER ELBOW ON THE INSIDE OF HER ARM) WAS RED AND SWOLLEN AND STILL FELT HOT AND TINGLY BUT DID NOT HURT. TODAY, MONDAY 11/20 THE HEAT AND TINGLING HAVE RESOLVED, BUT THERE IS STILL A LITTLE REDNESS AROUND THE INSIDE OF THE ELBOW.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient developed a sore arm after the injection, and woke up Thursday to it being sore, warm, and somewhat swollen. Patient began taking Ibuprofen. On Friday 11/17/17 patient's arm had swollen to double its size, it was extremely painful, and she could not move her arm or touch it. It was very warm. Pt took BENADRYL, Ibuprofen, and TYLENOL Thursday and Friday and then slept. Patient came to clinic for assessment on 11/20/17. Arm was still swollen, but arm can be moved. The arm is beginning to itch, and is still very tender to the touch. The injection site is visible, red, and hard. Patient explains the arm has been improving.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Skin warm, Tenderness
Clinical narrative: Patient developed a sore arm after the injection, and woke up Thursday to it being sore, warm, and somewhat swollen. Patient began taking Ibuprofen. On Friday 11/17/17 patient's arm had swollen to double its size, it was extremely painful, and she could not move her arm or touch it. It was very warm. Pt took BENADRYL, Ibuprofen, and TYLENOL Thursday and Friday and then slept. Patient came to clinic for assessment on 11/20/17. Arm was still swollen, but arm can be moved. The arm is beginning to itch, and is still very tender to the touch. The injection site is visible, red, and hard. Patient explains the arm has been improving.
Age: 60.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Burning sensation, Cellulitis, Malaise, Pain in extremity
Clinical narrative: PATIENT PRESENTED TO THE PHARMACY ON SATURDAY (11/11) AND WAS NOT FEELING WELL AND HIS ARM WAS HURTING AND BURNING AND THE PHARMACIST ON DUTY CALLED 911 TO HAVE HIM TAKEN TO THE EMERGENCY ROOM. HE PRESENTED BACK TO THE PHARMACY ON 11/12 WITH TWO PRESCIPTIONS, ONE FOR BACTRIM AND ONE FOR KEFLEX. HE SAID THE DOCTOR SAID HE HAD CELLULITIS.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Full blood count, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: L arm: posteromedial aspect L upper arm 5 x 3 inch oval area of diffuse erythema, warmth and edema, mild TTP, N/V intact. Cellulitis Left Arm prescribed Cephalexin 500mg BID x 7 days quantity 14.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Nausea, Vomiting
Clinical narrative: L arm: posteromedial aspect L upper arm 5 x 3 inch oval area of diffuse erythema, warmth and edema, mild TTP, N/V intact. Cellulitis Left Arm prescribed Cephalexin 500mg BID x 7 days quantity 14.
Age: 54.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Asthenia, Joint range of motion decreased, Myalgia
Clinical narrative: Since having the vaccination two weeks ago in my right arm, I have had chronic muscle aching mid-deltoid, moderate weakness and reduced range of motion of my upper arm.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Received vaccine in the morning, reaction started in the 11/18 in the evening. Swelling was little bit less than half of the upper arm, along with redness. Improving, but still with symptoms.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Disorientation, Dizziness, Hyperventilation, Loss of consciousness, Nausea
Clinical narrative: Patient received her vaccine without incident. She then stood by and watched while her father received his vaccine. After his vaccine was completed (a few minutes after she received her vaccine) and without any warning, she fainted to the floor. She was unconscious for a few seconds before awaking very disoriented. Once she realized what had happened, she began panicking and hyperventilating a little. She reported being dizzy and nauseous. She sat down for approximately 10 minutes after the incident and calmed down a little before she left under her own power with her father.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Panic reaction, Syncope
Clinical narrative: Patient received her vaccine without incident. She then stood by and watched while her father received his vaccine. After his vaccine was completed (a few minutes after she received her vaccine) and without any warning, she fainted to the floor. She was unconscious for a few seconds before awaking very disoriented. Once she realized what had happened, she began panicking and hyperventilating a little. She reported being dizzy and nauseous. She sat down for approximately 10 minutes after the incident and calmed down a little before she left under her own power with her father.
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Pt developed Hives 3 hours after the vaccines were given.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pt called the pharmacy at around 8pm on 11/17,  complaining her arm was very swelling and couldn't move her arm. She noticed her arm was very painful and small degree of swell after 3 to 4 hours after received her vaccination from the pharmacy. Pt used ibuprofen and ice pack, the swelling had gone down and pain gradually vanished.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: She complained of itchy blisters from the elbow down to the hands.
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Syncope that lasted for seconds. Evaluated by paramedics and advised to contact primary provider. Contacting Primary Care on 11-21.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cyanosis, Postictal state, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: 23 hours after vaccination with DTaP and Hib (of note her first in the series were Sanofi vaccines ACTHIB and DAPTACEL. These were GSK as above). She had a BRUE (previously known as ALTE) she had just fallen asleep in the rock n play and the nanny was still rocking it, she stopped breathing (no choking, spitting up or coughing) and turned blue. Nanny tried to swim w/o response, then finger sweep, 3 back blows and 3 rescue breaths. She was seemingly postictal for about 30 minutes. No jerking or rigidity. Was seen at ER, bx BRUE and has neurology follow up. No fever before, during or after the event.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Blister, Herpes zoster, Pain, Rash
Clinical narrative: I came down with a case of SHINGLES 13 days after having this flu shot, and I know of two other people who also came down with shingles within 2 to 3 weeks of having the high-dose flu shot. Symptoms - rash & blisters from the middle of my back to the middle of my front, all on the right side. Extreme pain.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Unevaluable event
Clinical narrative: Patient was seen in clinic, MD recommended ibuprofen and to ice affected area.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Erythema, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: Left arm - itchy, some swelling, redness, tender, a few blisters. Symptoms started developing around 7pm on 11/20/17. Decided on course of treatment to be BENADRYL and a cold compress and then watchful waiting.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: PATIENT REPORTS RED AREA ON UPPER LEFT ARM. Patient states it looks like cellulitis
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Patient was very dizzy for about 30 minutes. Lay down in the pharmacy, but did not lose consciousness. Did not want to seek further medical treatment. Left the pharmacy as soon as dizziness went away.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Adverse event: on 11/17/17, patient reports 3 small bumps on right arm and leg. Does not report pain.  Outcome: Advised patient to follow up with doctor for possible reaction to vaccine.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site rash, Injection site swelling, Pain
Clinical narrative: Pt was just fine after giving shot at 5:15pm on 11/18/17. Told that we have EPIPEN if any allergic reaction that usually happens within 15 minutes. Pt also got a FLUZONE HD and told that he might be achy from it (Sunday 11/19/ 17 he was achy all over). On 11/20/17 he was very swollen below the site injection of PNEUMOVAX and it developed a rash. Pt was going to MD for something else. Pt showed arm and MD wrote for Prednisone. Pt was not upset just showed his allergic reaction.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Depressed level of consciousness, Dizziness, Ear discomfort, Headache, Musculoskeletal stiffness
Clinical narrative: My son had very bad dizziness starting about 5 minutes after flu shot on the left arm, almost passing out while walking to the water fountain. He complained headache, not able to see the road clearly and ear popping, very bad headache, and stiff neck. We were about to call ambulance, but decided to watch him getting better. Staff also provided water and pharmacy staff measured heart rate and pressure. He rested on a chair for about 30 minutes, and we gave him water and lemonade. He felt better after resting about half hour. This could be life-threatening, if he did pass out.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Visual impairment
Clinical narrative: My son had very bad dizziness starting about 5 minutes after flu shot on the left arm, almost passing out while walking to the water fountain. He complained headache, not able to see the road clearly and ear popping, very bad headache, and stiff neck. We were about to call ambulance, but decided to watch him getting better. Staff also provided water and pharmacy staff measured heart rate and pressure. He rested on a chair for about 30 minutes, and we gave him water and lemonade. He felt better after resting about half hour. This could be life-threatening, if he did pass out.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Abscess drainage, Breast abscess, Breast mass, Breast pain, Breast tenderness
Clinical narrative: 1 day after the shot (10/26/17), I felt tenderness in my left breast. 4 days later (10/30/17) I found a painful lump in my left breast. After a week and a half of tests, I was diagnosed & treated for a staphylococcus auerous infection that had developed into an abscess. I had the abscess aspirated via needle & then surgical drained immediately after the aspiration procedure.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Cyst aspiration, Staphylococcal infection, Ultrasound scan abnormal
Clinical narrative: 1 day after the shot (10/26/17), I felt tenderness in my left breast. 4 days later (10/30/17) I found a painful lump in my left breast. After a week and a half of tests, I was diagnosed & treated for a staphylococcus auerous infection that had developed into an abscess. I had the abscess aspirated via needle & then surgical drained immediately after the aspiration procedure.
Sex: U
Vaccine: DTAP
Symptoms: Bordetella test positive, Cough, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and pertussis were unknown. It was unknown if the reporter considered the vaccination failure and pertussis to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, in 2014, there was an outbreak of Pertussis in 5 individuals. The reporter stated that they had all been vaccinated. The patient tested positive, but had no symptoms to minimum symptoms with less coughing. When tested the patient's were pertactin lacking. The reporter was not sure which brand of DTap that was provided. This case was considered as the suspected vaccination failure since the details regarding basic immunization schedule, time to onset for the event were not reported. This case is 1 of the 5 cases which was reported by same reporter.
Sex: U
Vaccine: DTAP
Symptoms: Bordetella test positive, Cough, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), pertussis (serious criteria GSK medically significant) and cough. On an unknown date, the outcome of the vaccination failure, pertussis and cough were unknown. It was unknown if the reporter considered the vaccination failure, pertussis and cough to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, in 2014, there was an outbreak of Pertussis in 5 individuals. The reporter stated that they had all been vaccinated. The patient tested positive, but had no symptoms to minimum symptoms with less coughing. When tested the patient's were pertactin lacking. The reporter was not sure which brand of DTap that was provided. This case was considered as the suspected vaccination failure since the details regarding basic immunization schedule, time to onset for the event were not reported. This case is 1 of the 5 cases which was reported by same reporter.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory symptom, Status epilepticus
Clinical narrative: Patient present in status epilepticus in context of fever and upper respiratory symptoms.
Sex: U
Vaccine: DTAP
Symptoms: Bordetella test positive, Cough, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and cough. On an unknown date, the outcome of the vaccination failure and cough were unknown. It was unknown if the reporter considered the vaccination failure and cough to be related to DTaP vaccine. Additional details were reported as follows: The reporter stated that, the patient had all been  vaccinated. The patient was tested positive, but had no symptoms to minimum symptoms with less coughing. When tested, the patient was pertactin lacking. The reporter was not sure which brand of DTap that was administered to the patient. This is one of the 5 cases, reported by the same reporter.
Sex: U
Vaccine: DTAP
Symptoms: Bordetella test positive, Cough, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), Pertussis (serious criteria GSK medically significant) and cough. On an unknown date, the outcome of the vaccination failure, Pertussis and cough were unknown. It was unknown if the reporter considered the vaccination failure, Pertussis and cough to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, in 2014, there was an outbreak of Pertussis in a patient. The patient tested positive, but had no symptoms to minimum symptoms with less coughing. When tested the patient's were pertactin lacking. The reporter was not sure which brand of DTap that was provided. This case was considered as the suspected vaccination failure since the details regarding basic immunization schedule, time to onset for the event were not reported. This case is 1 of the 5 cases, as reported by same reporter.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Gastrooesophageal reflux disease, Headache, Hypersomnia
Clinical narrative: I received a PREVENAR 13 Pneumonia vaccine, and had a rough reaction. Arm was sore, which I expected, but as the day went on the pain travelled down my arm. Also, my joints got extremely sore, I ached all over, had a fever, acid reflux, tingling in my hands, terrible headache, sick to my stomach, and spent most of a day and a half in bed, sleeping. Two days later, things are much better, although my upper arm remains sore and is quite red. My husband felt, I should report this, just to have it on the record in case other are experiencing similar reactions.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: I received a PREVENAR 13 Pneumonia vaccine, and had a rough reaction. Arm was sore, which I expected, but as the day went on the pain travelled down my arm. Also, my joints got extremely sore, I ached all over, had a fever, acid reflux, tingling in my hands, terrible headache, sick to my stomach, and spent most of a day and a half in bed, sleeping. Two days later, things are much better, although my upper arm remains sore and is quite red. My husband felt, I should report this, just to have it on the record in case other are experiencing similar reactions.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Nodule, Pain in extremity, Purulent discharge, Urticaria
Clinical narrative: Large welts; drained pus. I got the first dose of the GARDASIL shot the week before school started back in August. It had a decent sized welt but I was told it was normal even after the three month period in which I was supposed to get the second shot. The nurse noticed the welt but proceeded with the second dosage. The month after the second shot, both of my arms had a giant bruise. A week ago my arm started draining a yellow pus. It greatly decreased in size. The other arm has not drained yet and is extremely sore still. They both however, still have a knot that seems to be here to stay.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse and described the occurrence of pain in arm in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: This case was reported from a nurse practitioner. The age at vaccination was not reported. The reporter was the parent of the patient and stated that the patient had arm pain after receiving BEXSERO.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injection site erythema, Injection site mass, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site lump in a adolescent female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site lump and injection site erythema. On an unknown date, the outcome of the injection site lump and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site lump and injection site erythema to be related to BEXSERO. Additional details were reported as follows: The patient developed a lump at injection site and redness. The reaction went down the arm and left side of the body. The patient was seen at a local medical center for treatment. No further information was reported regarding the event.
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Erythema, Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of welts in a male patient who received MENVEO. Co-suspect products included FLUZONE. On an unknown date, the patient received MENVEO and FLUZONE. On an unknown date, unknown after receiving MENVEO, the patient experienced welts and erythema. On an unknown date, the outcome of the welts and erythema were unknown. It was unknown if the reporter considered the welts and erythema to be related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported. The patient received MENVEO and FLUZONE in the same arm. The patient developed a large red almost welt on the arm. The reporter
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Injection site erythema, Injection site irritation, Injection site urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 16-year-old male patient who received MENVEO. Concomitant products included Influenza vaccine Quadrivalent. On 31st October 2017, the patient received MENVEO. On an unknown date, less than a week after receiving MENVEO, the patient experienced injection site erythema, injection site irritation and injection site wheal. The patient was treated with Steroids. On an unknown date, the outcome of the injection site erythema, injection site irritation and injection site wheal were recovering/resolving. The reporter considered the injection site erythema, injection site irritation and injection site wheal to be related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported. The patient received MENVEO coadministered with Influenza vaccine Quadrivalent on the left arm. Following administration, the patient experienced local irritation (redness). On 2nd November 2017, 2 days after vaccination, the patient reported knife like welt at the site where MENVEO was administered. The provider treated the patient with cool compress and steroid. The healthcare professional (HCP) followed up with the patient where, his mom reported he was doing fine now. The reporting HCP did not administer the vaccines, but felt MENVEO caused the adverse events (AE). The patient did not require any further care or treatment. The reporter gave consent to be followed up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Local reaction, Product quality issue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a child patient who received KINRIX (batch number 74G79, expiry date 16th August 2019). On an unknown date, the patient received KINRIX. On a unknown date, unknown after receiving KINRIX, the patient experienced injection site reaction and pharmaceutical product complaint. On an unknown date, the outcome of the injection site reaction and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter believed that there was a quality issue with the lot because she had three patients that were administered the KINRIX vaccine and all three patients experienced a severe local injection site reaction. A related product quality complaint was being registered. The physician would retain the product for return to GlaxoSmithKline for investigation. The reporter was requesting GlaxoSmithKline to put a hold on this lot until investigation was completed and requested investigation results. No credit was arranged. The physician refused to provide details and would fax the adverse event information to the Safety Department and also email photos to the Quality Department. The physician already reported the adverse event details to VAERS. This was 1 of 3 cases, reported by same reporter for same events.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injected limb mobility decreased in a 20-year-old female patient who received BEXSERO (batch number 160601A, expiry date July 2018). On 6th November 2017, the patient received BEXSERO .5 ml. On an unknown date, 1 day after receiving BEXSERO, the patient experienced injected limb mobility decreased, injection site pain and injection site lump. On an unknown date, the outcome of the injected limb mobility decreased and injection site lump were unknown and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injected limb mobility decreased, injection site pain and injection site lump to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on unknown arm. The patient experienced soreness at injection site and was barely able to move arm. The patient was seen back at the facility for a follow-up visit, at that time, no further treatment was administered. After 8 days post vaccination, the patient reported that the pain was resolving, however the lump remain unchanged. No further information provided regarding the events.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Local reaction, Product quality issue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a child patient who received KINRIX (batch 74G79, expiry date 16th August 2019). On an unknown, the outcome of the injection site reaction and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician believed that there was a quality issue with this lot because three patients that were administered the KINRIX vaccine and experienced a severe local injection site reaction. The physician would retain the product for return to GlaxoSmithKline for investigation. The physician was requesting that GlaxoSmithKline put a hold on this lot until investigation was completed. The physician was requesting investigation results. No credit was arranged. The physician refused to provide details and will fax the adverse event information to the safety department. The physician would also email photos to the quality department. The physician already reported the adverse events details to VAERS. This case has been linked with US2017175116 and US2017175119 as reported by same reporter for same event.
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received FLUARIX Tetra. On an unknown date, the patient received FLUARIX Tetra at an unknown dose. On an unknown date, 14 days after receiving FLUARIX Tetra, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to FLUARIX Tetra. Additional information provided as follows: The nurse was agreed to take follow up. The nurse had two patients in the hospital. The nurse wondered if this could have been triggered by vaccine. This case has been linked with US2017GSK175535, as reported by the same reporter.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Guillain-Barre syndrome, Laboratory test, Muscular weakness, Nasopharyngitis
Clinical narrative: Patient received the flu vaccine on 10/18/2017. Two weeks later, patient reports coming down with a cold. She went to the Clinic (11/12) and then followed up with her PCP. She was referred to another physician as her symptoms were intensifying. Patient reports blurred vision, muscle weakness and feeling dizzy. She was admitted to the hospital (11/13) overnight patient reports that she has been diagnosed with Guillain Barre syndrome. Patient was told that the syndrome can last 4 to 6 weeks. After hospitalization, patient reports recovering at home.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Vision blurred
Clinical narrative: Patient received the flu vaccine on 10/18/2017. Two weeks later, patient reports coming down with a cold. She went to the Clinic (11/12) and then followed up with her PCP. She was referred to another physician as her symptoms were intensifying. Patient reports blurred vision, muscle weakness and feeling dizzy. She was admitted to the hospital (11/13) overnight patient reports that she has been diagnosed with Guillain Barre syndrome. Patient was told that the syndrome can last 4 to 6 weeks. After hospitalization, patient reports recovering at home.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Swelling and redness at vaccine site prescribed BACTRIM antibiotics and BENADRYL for 10 days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Lymphadenopathy, Rosacea
Clinical narrative: Next day or two noted red lump at injection site and swelling at lymph nodes axilla. Today notes Rosacea outbreak on face, made worse than usual.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Localised infection, Skin warm
Clinical narrative: Pt. received the vaccine 11/13/2017. The next day her arm was very hot to the touch and looked infected - pt's MD treated it as an adverse RXN. Giving BENADRYL, 2 antibiotics and Ibuprofen.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Local reaction, Nodule
Clinical narrative: Local reaction - erythema, palpable knot. Cold compress.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Rash
Clinical narrative: Arm rash, spreading down arm, redness, soreness. Patient saw primary Dr. - said patient had cellulitis. Patient was given a 10 day course of cefadroxil 500 mg. Patient is recovering. (Form was not available until 11/20/17 from our immunization dept.).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives all over body dissipated after 7 days. Patient followed up with primary care provider.
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of adverse reaction in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The patient had a reaction to last year's flu shot. The patient's allergist wanted to know the components of last year's vaccine and this year's vaccine so they can avoid a reaction for this year. The reporter wanted to know if the patient was able to be vaccinate this year.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Flu vaccine administered 11/20/17. Man asked for vaccine today. Nurse made appointment and ordered vaccine. Nurse did not review immunization record to see patient received flu vaccine 9/29/17. No adverse reaction reported at this time.
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 80-year-old male patient who received dTpa vaccine. Previously administered products included dTpa vaccine (In early 2017, 1st dose received (unknown brand)). In October 2017, the patient received the 2nd dose of dTpa vaccine. In October 2017, unknown after received dTpa vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information was reported as follows: The age at vaccination was not reported. In October 2017, after receiving Tdap (brand unknown) in early 2017 the patient might be received a 2nd Tdap at different facility, which lead to extra dose administered.
Age: 29.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthma, Respiratory disorder
Clinical narrative: Developed acute respiratory illness after receiving vaccine. Also experienced worsening of asthma symptoms. Asymptomatic prior to vaccine administration.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV4, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, redness, warm to touch left upper arm. (Deltoid area) Painful Rt injection site. Improving daily.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Lethargy, Myalgia
Clinical narrative: This case was reported by a other health professional and described the occurrence of lethargy in a female patient who received Influenza vaccine. In November 2017, the patient received Influenza vaccine. In November 2017, less than a week after receiving Influenza vaccine, the patient experienced lethargy, muscle pain and joint pain. On an unknown date, the outcome of the lethargy, muscle pain and joint pain were unknown. It was unknown if the reporter considered the lethargy, muscle pain and joint pain to be related to Influenza vaccine. Additional details were provided as follows: The age at the vaccination was not reported. The patient had been feeling extremely lethargic and achy in her muscles joints. The reporter asked was it possible that now she could feel the effects of the vaccine. The reporting health care professional was not willing to provide other personal information. The reporter stated that she was a retired nutritionist who still worked part-time at a nursing home.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Previously gave flushot on 9/8/17. While giving flushots at physician Friday meeting Dr. got a flushot - not remembering she had already had a flushot.
Sex: U
Vaccine: FLU4, HEP, HEPA, RV5
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In 2017 (reported as "on or after 05-JUL-2017"), the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M040423 with expiration date 03-JUL-2019; an improperly stored dose of ROTATEQ per oral, lot # M044396 with expiration date 19-JUN-2018; or an improperly stored dose of VAQTA lot # N005274 with expiration date 03-APR-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the vaccine was exposed to a temperature of 32 to 35 Fahrenheit degrees with a time frame of 1 hour. No previous temperature excursion was reported. The reporter did not know which vaccine was administered to the patient. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1710USA015406: US-009507513-1711USA008229: US-009507513-1711USA008230: US-009507513-1711USA008231: US-009507513-1711USA008233: US-009507513-1711USA008234:
Sex: U
Vaccine: FLU4, HEP, HEPA, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In 2017 (reported as "on or after 05-JUL-2017"), the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M040423 with expiration date 03-JUL-2019; an improperly stored dose of ROTATEQ per oral, lot # M044396 with expiration date 19-JUN-2018; or an improperly stored dose of VAQTA lot # N005274 with expiration date 03-APR-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the vaccine was exposed to a temperature of 32 to 35 Fahrenheit degrees with a time frame of 1 hour. No previous temperature excursion was reported. The reporter did not know which vaccine was administered to the patient. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1710USA015406: US-009507513-1711USA008229: US-009507513-1711USA008230: US-009507513-1711USA008231: US-009507513-1711USA008233: US-009507513-1711USA008234:
Age: 1.25
Sex: U
Vaccine: HEPA, HEPA, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; vaccinated with an improperly stored dose of Liquid PedvaxHib; This spontaneous report was received from a physician referring to 15-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided.  On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # N003536, expiration date 02-NOV-2019; dose and route of administration were not reported) for prophylaxis.  It was reported, that on several dates between 19-JUL-2017 till 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 34 degrees Fahrenheit (F) to 50 F for the period of up to 46 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved.  This is one case from several cases from the same reporter.
Age: 38.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal stiffness
Clinical narrative: This case was reported by a pharmacist vial call center representative and described the occurrence of exacerbation of pain in a 38-year-old male patient who received FLUARIX QUADRIVALENT (batch number 7754T, expiry date 30th July 2018). On 24th October 2017, the patient received FLUARIX QUADRIVALENT. On an unknown date, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced exacerbation of pain and limbs stiffness. On an unknown date, the outcome of the exacerbation of pain and limbs stiffness were unknown. It was unknown if the reporter considered the exacerbation of pain and limbs stiffness to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: No concomitant vaccines were administered. The patient received a dose of FLUARIX in his left deltoid and reportedly developed symptoms including worsening pain and stiffness in his left arm. At the time of reporting, no medical invention has been done.
Age: 38.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: This case was reported by a pharmacist vial call center representative and described the occurrence of exacerbation of pain in a 38-year-old male patient who received FLUARIX QUADRIVALENT (batch number 7754T, expiry date 30th July 2018). On 24th October 2017, the patient received FLUARIX QUADRIVALENT. On an unknown date, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced exacerbation of pain and limbs stiffness. On an unknown date, the outcome of the exacerbation of pain and limbs stiffness were unknown. It was unknown if the reporter considered the exacerbation of pain and limbs stiffness to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: No concomitant vaccines were administered. The patient received a dose of FLUARIX in his left deltoid and reportedly developed symptoms including worsening pain and stiffness in his left arm. At the time of reporting, no medical invention has been done.
Age: 77.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore Left Shoulder and left deltoid.
Age: 77.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: Sore Left Shoulder and left deltoid.
Age: 24.0
Sex: F
Vaccine: DTAP, MNQ, TDAP
Symptoms: Altered state of consciousness, Blood pressure decreased, Discomfort, Dizziness, Immediate post-injection reaction
Clinical narrative: Immediately after receiving Tdap at 11:15, pt c/o feeling dizzy and nauseated. She vomited. I raised her legs and had her take deep breaths. She continued to feel dizzy, sweaty, and vomiting for 15 minutes during which time her B/P dropped to 95/68. She denied having difficulty breathing or swallowing. After 15 minutes her dizziness and vomiting subsided. Her B/P slowly returned to normal range of 118/82 by 11:30. Episode lasted 30 minutes total. After which time she felt well enough to leave clinic.
Age: 24.0
Sex: F
Vaccine: DTAP, MNQ, TDAP
Symptoms: Malaise, Vomiting
Clinical narrative: Immediately after receiving Tdap at 11:15, pt c/o feeling dizzy and nauseated. She vomited. I raised her legs and had her take deep breaths. She continued to feel dizzy, sweaty, and vomiting for 15 minutes during which time her B/P dropped to 95/68. She denied having difficulty breathing or swallowing. After 15 minutes her dizziness and vomiting subsided. Her B/P slowly returned to normal range of 118/82 by 11:30. Episode lasted 30 minutes total. After which time she felt well enough to leave clinic.
Age: 24.0
Sex: F
Vaccine: DTAP, MNQ, TDAP
Symptoms: Blood pressure decreased, Dizziness, Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: Immediately after receiving Tdap at 11:15, pt c/o feeling dizzy and nauseated. She vomited. I raised her legs and had her take deep breaths. She continued to feel dizzy, sweaty, and vomiting for 15 minutes during which time her B/P dropped to 95/68. She denied having difficulty breathing or swallowing. After 15 minutes her dizziness and vomiting subsided. Her B/P slowly returned to normal range of 118/82 by 11:30. Episode lasted 30 minutes total. After which time she felt well enough to leave clinic.
Age: 71.0
Sex: F
Vaccine: HIBV, MNQ
Symptoms: Cataract operation, Corrective lens user, Headache, Hyperacusis, Hyperaesthesia
Clinical narrative: Initially had terrible headache, extensive vomiting, extreme  sensitivity to light, sound, smell & touch.   Also vision disturbances for a few days of seeing colored designs moving all over the walls both during the daylight & dark. On 4/25/16, when I woke everything was dark. I asked to turn on lights & was told they were on. That darkness remains to this day. Dr. was my oncologist while hospitalized & still treats me. He said it was the worse reaction he'd ever seen. While in hospital I saw Ophthalmologist.  I continued to see him thru August when he felt he could do no more for me. From discharge thru December 2016, I was unable to drive due to decreased vision. Ophthalmologist seen Nov 2016. After cataract surgery in December, 2016 & also in March, 2017 along with c lens implants & prescription eyeglasses I am able to  drive some, although the darkness prevails. Dr noted optic nerve damage as well as damage to my iris. Prior to hospitalization in March of 2016 I had my routine eye exam & no surgery was indicated at that time.
Age: 71.0
Sex: F
Vaccine: HIBV, MNQ
Symptoms: Impaired driving ability, Intraocular lens implant, Iris injury, Laboratory test, Optic nerve injury
Clinical narrative: Initially had terrible headache, extensive vomiting, extreme  sensitivity to light, sound, smell & touch.   Also vision disturbances for a few days of seeing colored designs moving all over the walls both during the daylight & dark. On 4/25/16, when I woke everything was dark. I asked to turn on lights & was told they were on. That darkness remains to this day. Dr. was my oncologist while hospitalized & still treats me. He said it was the worse reaction he'd ever seen. While in hospital I saw Ophthalmologist.  I continued to see him thru August when he felt he could do no more for me. From discharge thru December 2016, I was unable to drive due to decreased vision. Ophthalmologist seen Nov 2016. After cataract surgery in December, 2016 & also in March, 2017 along with c lens implants & prescription eyeglasses I am able to  drive some, although the darkness prevails. Dr noted optic nerve damage as well as damage to my iris. Prior to hospitalization in March of 2016 I had my routine eye exam & no surgery was indicated at that time.
Age: 71.0
Sex: F
Vaccine: HIBV, MNQ
Symptoms: Parosmia, Photophobia, Visual impairment, Vomiting
Clinical narrative: Initially had terrible headache, extensive vomiting, extreme  sensitivity to light, sound, smell & touch.   Also vision disturbances for a few days of seeing colored designs moving all over the walls both during the daylight & dark. On 4/25/16, when I woke everything was dark. I asked to turn on lights & was told they were on. That darkness remains to this day. Dr. was my oncologist while hospitalized & still treats me. He said it was the worse reaction he'd ever seen. While in hospital I saw Ophthalmologist.  I continued to see him thru August when he felt he could do no more for me. From discharge thru December 2016, I was unable to drive due to decreased vision. Ophthalmologist seen Nov 2016. After cataract surgery in December, 2016 & also in March, 2017 along with c lens implants & prescription eyeglasses I am able to  drive some, although the darkness prevails. Dr noted optic nerve damage as well as damage to my iris. Prior to hospitalization in March of 2016 I had my routine eye exam & no surgery was indicated at that time.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PPV, RV1
Symptoms: Decreased appetite, Seborrhoeic dermatitis, Skin odour abnormal, Vomiting
Clinical narrative: Decreased eating by half or more. Hard time keeping down fluids. Intense smelling cradle cap/ worsening cradle cap.
Age: 88.0
Sex: M
Vaccine: FLUX
Symptoms: Anxiety, Erythema, Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Extreme arm & shoulder pain (unable to move arm & shoulder, unable to bear weight on arm or shoulder while sleeping, redness from shoulder down to elbow, fever of 102 degrees, anxiety & insomnia due to pain.
Age: 88.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia, Weight bearing difficulty
Clinical narrative: Extreme arm & shoulder pain (unable to move arm & shoulder, unable to bear weight on arm or shoulder while sleeping, redness from shoulder down to elbow, fever of 102 degrees, anxiety & insomnia due to pain.
Age: 21.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Syncope
Clinical narrative: Syncope following immunizations.