chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Pruritus, Skin warm
Clinical narrative: The evening she received the vaccine, her arm was sore and itchy. Next day it was warm to the touch and very sore when lifting arm up. She then took Extra-Strength TYLENOL. Also said it was red all the way to her elbow area.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site pain
Clinical narrative: Patient complained that she has muscle ache on the right arm at site of injection and thought that it will go away after 2 days. Patient complained that she cannot use that arm to turn on her car and cannot lift arm in general. She stated that there is a knot on the area of injection. I contacted the primary care physician who advised patient to go to the emergency room since it has been so long since the shot and issue. Injection was on 10/14/2017.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt experienced erythema at the site of injection. Also felt a lump at site of injection. The site was hot, itchy and sore.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient said that his arm hurt a lot just after getting vaccine and pain continued and got worse. He also said he was unable to lift his arm at all. Still hurts.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Patient reported having a bug bite like, itchy rash on the underside of the left arm starting a few days after his immunization. A few days later, the same rash appeared on his left leg. He's not sure that it was due to the vaccination, but that was the only thing he could think of that could have caused it. He has never had a reaction to the flu shot in the past.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This Vaccine age recommendations are age 18-64. The patient was outside the age recommendations when it was administered.
Age: 76.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Pain
Clinical narrative: Pt states felt chills and under the weather, soreness higher on arm so not shingles which was on same arm subq.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: Pruritic rash on both legs from knees to feet.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient noticed a vivid pink "cuff" midway down upper arm below injection site. It was slightly swollen and sore.
Age: 39.0
Sex: M
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Loss of consciousness
Clinical narrative: Client came in for travel shot for job assignment at 5:00. Client received the following vaccine Hep A, Hep B, Tdap and Typhoid. Client began passing out at 5:30 called for assistance and was given ammonia inhaler. He began coming around the later started passing out again ammonia inhaler was given again. Client came through and was taken to exam room to be monitored vital signs 5:10 115/69 73, 5:20 115/74 75, and 5:30 112/76 72. Client was stable and began taking fluids and crackers. He the reported he had not eaten anything since noon. He also informed staff that he had passed out at the doctor office after arm injection but did not tell anyone. Client was feeling better and stable was dismissed at 5:45.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting projectile
Clinical narrative: Projectile Vomiting and nauseated.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Pruritus, Skin warm, Swelling
Clinical narrative: Localized swelling, urticaria at site, heat, itching.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received both flu and pneumonia shot in her left arm around 2 finger width apart and developed what appeared to be an injection site reaction with swelling, redness, and hot to touch. She followed up with her doctor 2 days later who diagnosed her with cellulitis post the vaccinations and is being treated with keflex.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough
Clinical narrative: I received the flu vaccine on Thursday afternoon. I started having a dry cough Sat night. I still have it. I have not had ANY other symptoms except the cough. (No fever, throat issues, no runny nose, no sputum, no abdominal pain, diarrhea, vomiting, no malaise, etc.) I went to urgent care on 10/21 and received a ZPAK (to make sure it wasn't a case of bacterial bronchitis), TESSALON PERLES, I am now taking DELSYM 30mg cough suppressant dextromethorphan...still coughing.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: My back is covered in bump-like ?hives?
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased, Pyrexia, Swelling
Clinical narrative: Customer returned the next day with localized swelling redness limited ability to left arm and mild fever.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pharyngeal oedema
Clinical narrative: Patient had swelling of the throat (lump in throat) approximately six hours after receiving the vaccinations.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Rigors in one hour. Took Benadryl and symptoms subsided in 30 minutes. Small fever for 15 hours, body aches and felt faint. Feeling normal after 48 hours.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis staphylococcal, Erythema, Injection site warmth, Swelling
Clinical narrative: PT REPORT TO MEDICAL ON 26 OCT 2017 ON 0915, PT PRESENTS WITH 25 CM LOCALIZE REDNESS AND SWELLING, SITE IS WARM TO TOUCH, NO OBSERVATION OF OPEN WOUNDS OR DISCHARGE. PT EVALUATED AND DIAGNOSED WITH MRSA CELLULITIS, PT PROVIDED WITH SEPTRA DS 800-160MG FOR TREATMENT.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Swelling redness most of upper arm mild fever.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Hyperhidrosis, Injection site haemorrhage, Loss of consciousness, Syncope
Clinical narrative: Patient was given influenza immunization at the facility in the afternoon at a workplace imz event. As the needle was withdrawn, his barrier bandage filled with blood and was contained and a second regular type bandage was placed on top of it to secure the bandage in place. Patient got up and walked to his dad and sister and left the facility. They returned approximately 5 min later because the bandage was leaking blood. As he came toward the pharmacist so we could clean the spot of injection he fainted and one of the pharmacist caught him. He blacked out for about 30 seconds and came to and was clammy, cold and sweating. Security was on site and called EMS that was on duty came to the area within a few minutes and assessed the scene. They took vitals and the father declined an ambulance. Patient was given water and vitals checked out to be normal and father took him home.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site nodule, Injection site rash, Lipodystrophy acquired, Nodule, Rash
Clinical narrative: At day 8 post injections, patient was seen in clinic knots/bumps on legs and abdomen. Prior to this appointment child did have generalized hives on his body which resolved with Hydrocortisone cream. Mother of patient states that reaction occurs after every vaccination. Knots appear to be Lipodystrophy.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: At day 8 post injections, patient was seen in clinic knots/bumps on legs and abdomen. Prior to this appointment child did have generalized hives on his body which resolved with Hydrocortisone cream. Mother of patient states that reaction occurs after every vaccination. Knots appear to be Lipodystrophy.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose for about 12 hours.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The patient reported redness on her right arm at the injection site about the size of the palm of her hand that was warm to the touch. She was informed that she could use hydrocortisone on the site and take OTC pain relievers if needed. She was also told to call her doctor if it got worse or did not get better in a couple more days.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Pt states that she started with pain in her arm the day after vaccine and has continued for 12 days, pt has a dr's appointment for something else, but will discuss with them.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Pain, Scab, Swelling
Clinical narrative: One week after vaccination, right armpit began to bother him--stinging, sensitive, but no blisters. Also had some swelling at times in that area. This continued, with some symptoms, including itching spreading to the right upper back. He was eventually seen by his PCP on 10/16/17 with 8 raised pink crust lesions about 1-2 mm size, appear to be resolving with crusting over per PCP. Diagnosed with what appears to be shingles per PCP and was given antiviral med and orders for symptomatic treatment with baking soda or Burow's solution.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Impaired work ability, Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Within 10 minutes my whole arm had this horrible burning sensation go down my entire arm from the point of the shot to my wrist. Then shortly thereafter my arm started to hurt very badly. By the time I left the store it was painful for me to even lift my bags. The pain continued to get worse each day and was difficult to even sleep because the arm was so sore. Here it is 4 weeks later and I still have pain, not as bad as the first few weeks but still I have problems. I have limited mobility with the arm. There are certain tasks that I can't do because I can't move my arm properly. It has affected my work because I cannot lift. My arm will seem good for a time and then out of nowhere the pain returns and it is impossible to do simple things like open a jar, put sheets on the bed or take clothes out of the washer. I have been extremely affected in my day to day life, especially because this is my prominent arm.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Ultrasound scan
Clinical narrative: Within 10 minutes my whole arm had this horrible burning sensation go down my entire arm from the point of the shot to my wrist. Then shortly thereafter my arm started to hurt very badly. By the time I left the store it was painful for me to even lift my bags. The pain continued to get worse each day and was difficult to even sleep because the arm was so sore. Here it is 4 weeks later and I still have pain, not as bad as the first few weeks but still I have problems. I have limited mobility with the arm. There are certain tasks that I can't do because I can't move my arm properly. It has affected my work because I cannot lift. My arm will seem good for a time and then out of nowhere the pain returns and it is impossible to do simple things like open a jar, put sheets on the bed or take clothes out of the washer. I have been extremely affected in my day to day life, especially because this is my prominent arm.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: PAIN, HARD AREA AT INJECTION SITE, REDNESS AT AND SURROUNDING INJECTION SITE.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Insomnia, Mobility decreased, Muscle tightness, Pain in extremity
Clinical narrative: Patient reported pain and numbness in the arm. He is having trouble lifting his arm on his own. He was fine the day of the injection but symptoms started to present the next day. The pain and numbness has made it difficult for the patient to sleep. He notified his healthcare provider and they advised him to take over-the-counter anti-inflammatories for a few days which he has done. He feels the muscle in his arm is very tight. He has not felt much improvement at this point 60 hours since the vaccine was given.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle aches, malaise, onset 6:00pm, resolved by 8:00 am the next day.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Limb discomfort, Skin warm, Tenderness
Clinical narrative: Patient described a small welt rising shortly after injection. By next day it was bigger, red and warm to the touch. She describes her arm as feeling tired and heavy. She reports tenderness in the area of her shoulder/clavical - lymph node? Reports no fever, no problems breathing, no rash on other areas of body.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient described a small welt rising shortly after injection. By next day it was bigger, red and warm to the touch. She describes her arm as feeling tired and heavy. She reports tenderness in the area of her shoulder/clavical - lymph node? Reports no fever, no problems breathing, no rash on other areas of body.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Computerised tomogram normal, Diarrhoea, Malaise, Mobility decreased
Clinical narrative: PT GOT SHOT 10/22 11:30 AM AND PT'S ARM STARTED TO SWELL WITH SORNESS  STARTING AROUND 4PM. AT 8PM PT HAD NAUSEA, VOMITING, DIARRHEA, FEVER, AND CHILLS. ON 10/23 PT STILL DIDN'T FEEL WELL BUT REFUSED TO CONTACT PCP OR GOT TO ER. ON 10/24 CALLED PCP IN THE AM AND THEY INSTRUCTED PT TO GO TO ER IN THE AFTERNOON. PT'S WIFE CONTACTED PHARMACY AND PHARMACIST INSTRUCTED PT TO TAKE BENADRYL AT BEDTIME AND CALL DOC ON WED AM. WED AM PT COULD HARDLY MOVE. PT WENT TO ER ON 10/25. PT WAS PRESCRIBED BY PA AN ANTIBIOTIC, NAUSEA, AND PAIN MEDICINE ON 10/25 FROM ER. PT IS REPORTING TO BE DOING ALOT BETTER. PRESCRIBER REPORTS THAT PT WAS MILDLY DEHYDRATED AND GOT IV FLUIDS.  THEY DIDN'T SEE ANY SWELLING OF ARM. THEY DON'T BELIEVE IT WAS A REACTION TO THE IMMUNIZATIONS. PT IS DOING ALOT BETTER FROM THE ER VISIT AND IS AT HOME RESTING.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia, Urine analysis normal
Clinical narrative: PT GOT SHOT 10/22 11:30 AM AND PT'S ARM STARTED TO SWELL WITH SORNESS  STARTING AROUND 4PM. AT 8PM PT HAD NAUSEA, VOMITING, DIARRHEA, FEVER, AND CHILLS. ON 10/23 PT STILL DIDN'T FEEL WELL BUT REFUSED TO CONTACT PCP OR GOT TO ER. ON 10/24 CALLED PCP IN THE AM AND THEY INSTRUCTED PT TO GO TO ER IN THE AFTERNOON. PT'S WIFE CONTACTED PHARMACY AND PHARMACIST INSTRUCTED PT TO TAKE BENADRYL AT BEDTIME AND CALL DOC ON WED AM. WED AM PT COULD HARDLY MOVE. PT WENT TO ER ON 10/25. PT WAS PRESCRIBED BY PA AN ANTIBIOTIC, NAUSEA, AND PAIN MEDICINE ON 10/25 FROM ER. PT IS REPORTING TO BE DOING ALOT BETTER. PRESCRIBER REPORTS THAT PT WAS MILDLY DEHYDRATED AND GOT IV FLUIDS.  THEY DIDN'T SEE ANY SWELLING OF ARM. THEY DON'T BELIEVE IT WAS A REACTION TO THE IMMUNIZATIONS. PT IS DOING ALOT BETTER FROM THE ER VISIT AND IS AT HOME RESTING.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: PT GOT SHOT 10/22 11:30 AM AND PT'S ARM STARTED TO SWELL WITH SORNESS  STARTING AROUND 4PM. AT 8PM PT HAD NAUSEA, VOMITING, DIARRHEA, FEVER, AND CHILLS. ON 10/23 PT STILL DIDN'T FEEL WELL BUT REFUSED TO CONTACT PCP OR GOT TO ER. ON 10/24 CALLED PCP IN THE AM AND THEY INSTRUCTED PT TO GO TO ER IN THE AFTERNOON. PT'S WIFE CONTACTED PHARMACY AND PHARMACIST INSTRUCTED PT TO TAKE BENADRYL AT BEDTIME AND CALL DOC ON WED AM. WED AM PT COULD HARDLY MOVE. PT WENT TO ER ON 10/25. PT WAS PRESCRIBED BY PA AN ANTIBIOTIC, NAUSEA, AND PAIN MEDICINE ON 10/25 FROM ER. PT IS REPORTING TO BE DOING ALOT BETTER. PRESCRIBER REPORTS THAT PT WAS MILDLY DEHYDRATED AND GOT IV FLUIDS.  THEY DIDN'T SEE ANY SWELLING OF ARM. THEY DON'T BELIEVE IT WAS A REACTION TO THE IMMUNIZATIONS. PT IS DOING ALOT BETTER FROM THE ER VISIT AND IS AT HOME RESTING.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Hyperhidrosis, Hypoacusis, Pallor, Visual impairment
Clinical narrative: The shot felt like it took forever, I walked away to the next building, started sweating profusely and couldn't see straight and could barely hear, Waited about 5 minutes till I could walk again and went back to the clinic, they told me I was very pale and that I was sweating and gave me a juice box and crackers and M and Ms. Then they let me leave, however I felt out of it for the rest of the day.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Depression, Obsessive-compulsive disorder, Pyrexia, Rash, Seizure
Clinical narrative: High fevers, Rashes, Horrible vocal and motor tics, Depression fits, OCD.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Tic
Clinical narrative: High fevers, Rashes, Horrible vocal and motor tics, Depression fits, OCD.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Chills, Diarrhoea, Headache, Injection site pain, Injection site swelling
Clinical narrative: Fever 102.5, terrible headache, chills, nausea, diarrhea, injection sites (especially right arm) very swollen, hot and painful.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Injection site warmth, Nausea, Pyrexia
Clinical narrative: Fever 102.5, terrible headache, chills, nausea, diarrhea, injection sites (especially right arm) very swollen, hot and painful.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Rash
Clinical narrative: On the night of vaccine, patient injection site was bright red and swollen. After 2 days, the rash move down to his for-arm and stay there for 3 days.  He went to see his doctor and got took 6 days of steroid.  Patient felt sore at the arm but didn't feel sick.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Musculoskeletal pain, Pain
Clinical narrative: What I went thought after the shot I got real sore and then so sore that I couldn't touch it. I started having headaches and pains across my shoulders this went on about 1 1/2 months.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Asthenia, Dizziness, Erythema, Nausea, Swelling
Clinical narrative: Weak/nausea/dizzy/red swollen.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Hyperhidrosis
Clinical narrative: Pain in back and sweating after vaccines administration. Call 911 - pt was feeling better after 10 minutes, vitals all w/in normal range.
Age: 61.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Fall, Headache, Injury, Mobility decreased, Neurological examination normal
Clinical narrative: Pt. had a syncopal episode about 3 min. after receiving the injection and fell from the exam table. Mild head and neck trauma assessed by Doctor normal neuro, neck ROM limited to pain - had water and sugar. Went to ER for x-ray did not meet criteria for imaging. Has headache (10/25/17) will go for MRI.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Pt. had a syncopal episode about 3 min. after receiving the injection and fell from the exam table. Mild head and neck trauma assessed by Doctor normal neuro, neck ROM limited to pain - had water and sugar. Went to ER for x-ray did not meet criteria for imaging. Has headache (10/25/17) will go for MRI.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Pruritus
Clinical narrative: Redness, swelling on left arm post flu vaccine. Localized reaction. Started 24 hours post injection. Worse following day. Itching. Patient given prednisolone to treat and symptoms resolved.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea, Feeling cold, Headache, Injection site pruritus
Clinical narrative: Day 10-12-17 was immunized on my left arm with the Influenza Injection just right after not even 1 minute had a rash, hives and itching on site. Took some allergy medication next day still had redness, itchiness and still some hives and started with diarrhea. Days 13th, 14, 15, 16, 17 was still having stomach pain and diarrhea. Tuesday night started feeling sick cold, body aches, Wed still having body aches, headaches.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site urticaria, Malaise, Pain
Clinical narrative: Day 10-12-17 was immunized on my left arm with the Influenza Injection just right after not even 1 minute had a rash, hives and itching on site. Took some allergy medication next day still had redness, itchiness and still some hives and started with diarrhea. Days 13th, 14, 15, 16, 17 was still having stomach pain and diarrhea. Tuesday night started feeling sick cold, body aches, Wed still having body aches, headaches.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of white blood cell count increased in a patient who received BEXSERO. Co-suspect products included BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO and the 2nd dose of BEXSERO. On an unknown date, unknown after received BEXSERO and not applicable after receiving BEXSERO, the patient experienced white blood cell count increased, fever, white blood cell count increased and fever. The patient was treated with antibiotics. On an unknown date, the outcome of the white blood cell count increased and fever were recovered/resolved and the outcome of the white blood cell count increased and fever were unknown. It was unknown if the reporter considered the white blood cell count increased and fever to be related to BEXSERO. It was unknown if the reporter considered the white blood cell count increased and fever to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The sales representative did not know the age of this specific patient but said the reporter was immunizing 16 to 18 years old patients. Recently the patient experienced an elevated white blood count and a fever of 104 degree F. The physician prescribed antibiotics and the symptoms resolved. The events recurrent after 2nd dose of BEXSERO.
Age: 26.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of skin warm in a adult patient who received FLUARIX TETRA. Co-suspect products included FLULAVAL TETRA. On an unknown date, the patient received FLUARIX TETRA at an unknown dose and FLULAVAL TETRA at an unknown dose. On an unknown date, unknown after receiving FLUARIX TETRA and FLULAVAL TETRA, the patient experienced skin warm, local swelling and pain localized. On an unknown date, the outcome of the skin warm, local swelling and pain localized were unknown. It was unknown if the reporter considered the skin warm, local swelling and pain localized to be related to FLUARIX TETRA and FLULAVAL TETRA. Additional details were received as follows: The age at vaccination was not reported. It was reported that the sales representative was not sure if the patient received FLUARIX or FLULAVAL vaccine. The sales representative was not aware of which flu vaccine there was an adverse event associated with. The patient who was an employee had local reaction to flu vaccine as hot to touch, swelling and soreness. The sales representative had not other information and stated that someone could reach out to the nurse to obtain more information on the adverse event. The sales representative would also like the event to be emailed to him if possible. This case has been linked with case US2017GSK162192, reported by the same reporter.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Emotional distress, Injection site pain, Irritability, Pyrexia, Viral test negative
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a infant male patient who received FLULAVAL Tetra (batch number J9PP5, expiry date unknown). On 11th October 2017, the patient received FLULAVAL Tetra. In October 2017, less than a week after receiving FLULAVAL Tetra, the patient experienced fever, irritability, injection site tenderness and emotional distress. In October 2017, the outcome of the fever, irritability, injection site tenderness and emotional distress were recovered/resolved. It was unknown if the reporter considered the fever, irritability, injection site tenderness and emotional distress to be related to FLULAVAL Tetra. Additional details were provided as follows: The health care professional stated that the mom said the patient had the following reactions after receipt of FLULAVAL QIV on Wednesday; high fever (up to 103 F) for 2 to 3 days; irritability, tenderness at the injection site, cranky and inconsolable. These reactions lasted for 2-3 days and had now subsided; the patient was back to normal. The health care professional also stated that the mom brought patient back to the doctor's office last Friday (2 days after receipt of FLULAVAL) because the patient was having the above reactions. They tested for different types of viral infections and found nothing. No further information was provided.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hives in a 44-year-old female patient who received FLULAVAL QUADRIVALENT. Previously administered products included Flu vaccine (received every year). On 11th October 2017, the patient received the 1st dose of FLULAVAL QUADRIVALENT. On 11th October 2017, 8 hrs after receiving FLULAVAL QUADRIVALENT, the patient experienced hives. The patient was treated with hydrocortisone, steroid pack (nos) and BENADRYL (nos). On an unknown date, the outcome of the hives was recovering/resolving. The reporter considered the hives to be possibly related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The reporter (patient for this case) was a social worker for the hospital. The patient received a FLULAVAL QUADRIVALENT on left upper arm at 12:00 hours at lunch time in the hospital last Wednesday, before the reporting date. The patient noted that, she got Flu vaccine every year, but was not sure if she had ever received FLULAVAL vaccine before. About 8 to 10 hours vaccination, hives appeared on her abdomen. The next day the hives were on her elbows, thighs, neck and scalp. The patient was seen on Thursday at urgent care and given a steroid dose pack. The patient also used BENADRYL and hydrocortisone cream. The hives had about resolved at the time of report, just very faint presence was existed. She saw her primary physician on 17th October 2017, who had referred her to an allergist next Monday on 23rd October 2017. The patient did not know the dose and no lot number was available.
Sex: M
Vaccine: FLU4
Symptoms: Headache, Influenza
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of headache in a male patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. In October 2017, 9 days after receiving FLUARIX QUADRIVALENT, the patient experienced headache and influenza. On an unknown date, the outcome of the headache and influenza were unknown. It was unknown if the reporter considered the headache and influenza to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient had headache and symptoms progressed from there. The patient felt like she had flu.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of skin warm in a adult patient who received FLUARIX TETRA. Co-suspect products included FLULAVAL TETRA. On an unknown date, the patient received FLUARIX TETRA at an unknown dose and FLULAVAL TETRA at an unknown dose. On an unknown date, unknown after receiving FLUARIX TETRA and FLULAVAL TETRA, the patient experienced skin warm, local swelling and pain localized. On an unknown date, the outcome of the skin warm, local swelling and pain localized were unknown. It was unknown if the reporter considered the skin warm, local swelling and pain localized to be related to FLUARIX TETRA and FLULAVAL TETRA. Additional details were received as follows: The age at vaccination was not reported. It was reported that the sales representative was not sure if the patient received FLUARIX or FLALAVAL vaccine. The sales representative was not aware of which flu vaccine there was an adverse event associated with. The patient who was an employee had a local reaction to flu vaccine as hot to touch, swelling and soreness. The sales representative had no other information and stated that someone could reach out to the nurse to obtain more information on the adverse event. The sales representative would also like the event to be emailed to him if possible. This case has been linked with case US2017157939, reported by the same reporter.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Dizziness, Peripheral coldness
Clinical narrative: Pt complain of feeling light headed and clammy shortly after the shot. She did not say anything until 10-15 min after shot. I had her rest for awhile. When she left she looked well but said her hands and feet felt a little cold. But she said felt okay overall.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Pt. complained that his arm is red and swollen and showed me his arm which looks red and swolled. He went to his MD. MD states he has cellulitis and Tx pt with cephalexin.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Patient reported leaving pharmacy and having a red rash breakout from shoulder joint to near the elbow. Described rash as red/swollen. Patient says rash has become larger/more red on 10/25/2017.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of the right thigh, extending to the posterior aspect of the thigh which began the day after receiving injection. No fever. Recommended treatment: warm compresses to affected area, MOTRIN prn, Children's BENADRYL every 6 hours prn. If no improvement in symptoms in 3 days, patient's family will notify clinic.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Body temperature increased, Febrile convulsion, Tongue ulceration
Clinical narrative: Patient had a severe seizure the day following his Hep A vaccination. He stopped breathing for at least five minutes - turned blue and almost died. He continued to have a fever of 105 for almost two days. This shot nearly killed our son.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Cyanosis, Pyrexia, Respiratory arrest, Seizure
Clinical narrative: Patient had a severe seizure the day following his Hep A vaccination. He stopped breathing for at least five minutes - turned blue and almost died. He continued to have a fever of 105 for almost two days. This shot nearly killed our son.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Febrile convulsion, Pyrexia, Rash generalised, Roseola
Clinical narrative: Febrile seizure 50 hours after vaccine. Also ended up with rash consistent with roseola 1-2 days after febrile seizure.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Febrile convulsion, Rash, Roseola
Clinical narrative: Febrile seizure 50 hours after vaccine. Also ended up with rash consistent with roseola 1-2 days after febrile seizure.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: C-reactive protein increased, Full blood count normal, Injection site erythema, Injection site warmth, Red blood cell sedimentation rate increased
Clinical narrative: Patient was seen in Urgent Care on 10/21/2017, here is the provider's dictation plan: IMPRESSION/REPORT/PLAN: Right upper extremity cellulitis. Possible vaccine related adverse reaction. PLAN: I have sent a prescription to the patient's preferred pharmacy for BACTRIM double strength 2 times a day for 7 days. Discussed the importance of completing the full course even if her symptoms resolve sooner. We demarcated the area with a skin marking pen today. I advised her that if she has significant extension of the erythematous area beyond the demarcated area after being on antibiotics for 24 hours, that she should seek further medical care as she may require additional intravenous medication. I also discussed with her that this could be a local reaction to her prior vaccination. She has had several flu vaccinations without reactions in the past. She is now just having PNEUMOVAX for the first time 2 days ago. I filled out an online vaccine associated versus reaction event report online and discussed that with her today, that they may contact her regarding that.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Ultrasound scan normal
Clinical narrative: Patient was seen in Urgent Care on 10/21/2017, here is the provider's dictation plan: IMPRESSION/REPORT/PLAN: Right upper extremity cellulitis. Possible vaccine related adverse reaction. PLAN: I have sent a prescription to the patient's preferred pharmacy for BACTRIM double strength 2 times a day for 7 days. Discussed the importance of completing the full course even if her symptoms resolve sooner. We demarcated the area with a skin marking pen today. I advised her that if she has significant extension of the erythematous area beyond the demarcated area after being on antibiotics for 24 hours, that she should seek further medical care as she may require additional intravenous medication. I also discussed with her that this could be a local reaction to her prior vaccination. She has had several flu vaccinations without reactions in the past. She is now just having PNEUMOVAX for the first time 2 days ago. I filled out an online vaccine associated versus reaction event report online and discussed that with her today, that they may contact her regarding that.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: C-reactive protein increased, Cellulitis, Haemoglobin normal, Red blood cell sedimentation rate increased, Ultrasound scan abnormal
Clinical narrative: Patient was seen in Urgent Care on 10/21/2017, here is the provider's dictation plan: IMPRESSION/REPORT/PLAN: Right upper extremity cellulitis. Possible vaccine related adverse reaction. PLAN: I have sent a prescription to the patient's preferred pharmacy for BACTRIM double strength 2 times a day for 7 days. Discussed the importance of completing the full course even if her symptoms resolve sooner. We demarcated the area with a skin marking pen today. I advised her that if she has significant extension of the erythematous area beyond the demarcated area after being on antibiotics for 24 hours, that she should seek further medical care as she may require additional intravenous medication. I also discussed with her that this could be a local reaction to her prior vaccination. She has had several flu vaccinations without reactions in the past. She is now just having PNEUMOVAX for the first time 2 days ago. I filled out an online vaccine associated versus reaction event report online and discussed that with her today, that they may contact her regarding that.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: White blood cell count normal
Clinical narrative: Patient was seen in Urgent Care on 10/21/2017, here is the provider's dictation plan: IMPRESSION/REPORT/PLAN: Right upper extremity cellulitis. Possible vaccine related adverse reaction. PLAN: I have sent a prescription to the patient's preferred pharmacy for BACTRIM double strength 2 times a day for 7 days. Discussed the importance of completing the full course even if her symptoms resolve sooner. We demarcated the area with a skin marking pen today. I advised her that if she has significant extension of the erythematous area beyond the demarcated area after being on antibiotics for 24 hours, that she should seek further medical care as she may require additional intravenous medication. I also discussed with her that this could be a local reaction to her prior vaccination. She has had several flu vaccinations without reactions in the past. She is now just having PNEUMOVAX for the first time 2 days ago. I filled out an online vaccine associated versus reaction event report online and discussed that with her today, that they may contact her regarding that.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT GOT ADMINISTERED PNEUMOVAX 23 AND FLUZONE HD ON 10/19. PATIENT CAME IN AND REPORTED THAT HER ARM WAS RED AND SWOLLEN AND WAS TOLD TO TAKE BENADRYL, TYLENOL AND APPLY ICE 3 TIMES A DAY. ON 10/26 PATIENT REPORTED IT HAD GOTTEN BETTER.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PATIENT GOT ADMINISTERED PNEUMOVAX 23 AND FLUZONE HD ON 10/19. PATIENT CAME IN AND REPORTED THAT HER ARM WAS RED AND SWOLLEN AND WAS TOLD TO TAKE BENADRYL, TYLENOL AND APPLY ICE 3 TIMES A DAY. ON 10/26 PATIENT REPORTED IT HAD GOTTEN BETTER.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Headache, Inflammation, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Nodule at injection site at first. Arm from shoulder to elbow swelled up and is hard within about an hour after injection. Very sore, tender and warm to the touch. Slight fever and general achiness. Fever lasted til about 10 pm the day of injection. Swelling progressed. Three days after swelling going down but still very sore and arm is bruised. Ice helped some with swelling. Took a dose of BENADRYL.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site warmth, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Nodule at injection site at first. Arm from shoulder to elbow swelled up and is hard within about an hour after injection. Very sore, tender and warm to the touch. Slight fever and general achiness. Fever lasted til about 10 pm the day of injection. Swelling progressed. Three days after swelling going down but still very sore and arm is bruised. Ice helped some with swelling. Took a dose of BENADRYL.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Contusion, Induration, Injection site nodule, Pain, Peripheral swelling
Clinical narrative: Nodule at injection site at first. Arm from shoulder to elbow swelled up and is hard within about an hour after injection. Very sore, tender and warm to the touch. Slight fever and general achiness. Fever lasted til about 10 pm the day of injection. Swelling progressed. Three days after swelling going down but still very sore and arm is bruised. Ice helped some with swelling. Took a dose of BENADRYL.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Skin warm, Tenderness
Clinical narrative: Nodule at injection site at first. Arm from shoulder to elbow swelled up and is hard within about an hour after injection. Very sore, tender and warm to the touch. Slight fever and general achiness. Fever lasted til about 10 pm the day of injection. Swelling progressed. Three days after swelling going down but still very sore and arm is bruised. Ice helped some with swelling. Took a dose of BENADRYL.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Syncope, Vomiting
Clinical narrative: Pt had a fever the night of vaccination. The following morning pt experienced vomiting  and fainted once while making coffee.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Dysphagia, Pruritus, Rash, Throat tightness
Clinical narrative: A hour after vaccination, patient reported rash on left arm and chest, dizziness, itching, tightness of throat, difficulty swallowing. Reported to ER at 9:59 am Received promethazine 25 mg IM and triamcinolone acetonide 40 mg IM and condition improved then discharged to home.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Eyelid oedema, Pyrexia
Clinical narrative: Fever 101, Chills and swollen eye lids.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse regarding a 6 year old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of PROQUAD subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The PROQUAD was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013248: US-009507513-1710USA013249: US-009507513-1710USA013250: US-009507513-1710USA013251: US-009507513-1710USA013252: US-009507513-1710USA013253:
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant, referring to a 2 month old patient of unknown gender. The patient's medical history, concomitant therapy, drug and allergy history were not provided. On 05-OCT-2017, the patient was vaccinated with VAQTA injection, 25/0.5 (units were not provided), lot number N020950, expiration date 17-OCT-2018, for prophylaxis (dose, frequency, dose number and administration route were not reported); which was reported as outside of the prescribing information. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a field representative, concerning an adult female patient in her 60's. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On approximately 11-AUG-2017 (reported as "6-8 weeks ago"), the patient was vaccinated with ZOSTAVAX (lot #, expiration date, strength, dose, route of administration, an anatomical location were not provided), for prophylaxis (reported as "vaccination"); and developed diffuse redness at the injection site, an inch to an inch and a half in diameter, and there the skin was elevated. No treatment was given for the events and it was unknown if laboratory diagnostic studies were performed. No product quality complaint (PQC) was involved. The outcome of the injection site erythema and the skin disorder was unknown. The causal relationship between the injection site erythema and the skin disorder with ZOSTAVAX was not provided. This is one of two reports received from the same source. Sender's Comments: US-009507513-1710USA013257.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report was received from a 58 year old female patient, who was reporting on herself. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 04-OCT-2017, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, strength, dose, route of administration, an anatomical location were not provided), for prophylaxis; as well as the influenza virus vaccine inactivated (unspecified) (lot #, expiration date, strength, dose, route of administration, anatomical location, and indication were not reported); both administered in the same spot. On 06-OCT-2017 (reported as "today"), the patient noticed a red rash forming described as "not bumpy", from which she had not recovered. The patient did not seek medical attention. Her laboratory data was unknown. No product quality complaint (PQC) was involved. The causal relationship between the rash erythematous with ZOSTAVAX and influenza virus vaccine inactivated (unspecified) was not provided.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unspecified date in 2013, the patient received the first dose of GARDASIL injection administered intramuscularly (lot number and expiration date were not reported) for prophylaxis. According to the reporter, the patient received the second dose in 2014, a year apart. No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 1 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-OCT-2017, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 lot number M042324 and expiration date of 10-JUN-2018, 0.5 ml, intramuscularly for prophylaxis. No adverse effects were reported.
Age: 34.0
Sex: F
Vaccine: DTAP, FLUX, HEP, HPV9, MMR
Symptoms: Exposure during pregnancy, Maternal exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician, who referred to a 34-year-old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 27-SEP-2017, the patient was inadvertently administered a dose of GARDASIL 9 (lot# N009173 and expiration date: 20-NOV-2019; dose and route of administration were not reported) as prophylaxis. On the same date, the patient also received the following vaccines: M-M-R-II (dose, route of administration, lot# and expiration date were not reported), hepatitis B virus vaccine (unspecified) (dose, route of administration, lot# and expiration date were not reported), influenza virus vaccine (unspecified) (dose, route of administration, lot# and expiration date were not reported) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (dose, route of administration, lot# and expiration date were not reported) as prophylaxis. The physician reported, that at the time of the vaccination, the patient was 16 weeks and 1 day pregnant. The Last Menstrual Period (LMP) date was calculated as 06-JUN-2017 and the Estimated Date of Delivery (EDD) as 13-MAR-2018. The patient was exposed to the suspect products in the second trimester of the pregnancy. At the time of the report, the outcome of the pregnancy was pending and the fetal outcome was unknown. No adverse effects were reported. No treatment was provided and no lab diagnostics/studies were performed. The patient did not seek medical attention. No product quality complaint was involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. On 20-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD injection, lot # M042498 with expiration date 17-APR-2018, therapy type: human recombinant albumin (RHA) (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature excursion ranged from minus 14 to minus 10 degrees Celsius for 15 minutes and to 27 degrees Celsius for 30 minutes. There was no previous excursion. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA013407: US-009507513-1710USA013406: US-009507513-1710USA013408: