chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Epistaxis, Exposure during pregnancy, Fatigue, Full blood count
Clinical narrative: I was one month away from birth. I was healthy with a healthy baby to be born on. On 08/06/19 I was given the Tdap shot.  One week later I began to notice bruises up and down my legs, arms and my pregnant belly. Over the next two weeks I was experiencing daily nose bleeds which I had never had before. I would go to sleep and then wake up with these sudden bruises that were not there the night before. After the two weeks of symptoms, I told my OB who ordered a CBC. I was admitted to the hospital right away with a platelet count of 12. I was diagnosed with ITP. Doctors ruled out HELLP, pre-eclampsia, or infections. I was given two platelet transfusions and four day course of Dexamethasone because my platelet count was critically low and unsafe to have my planned c section. Those treatments were able to get me to a count of 47. The ITP continued to worsen after birth with a count of 7. I began high does Prednisone 70mg with a taper over 5 months. I had four Rituximab chemo infusions. I had to stop breastfeeding which was crushing  and overwhelmingly sad due to the Rituximab. It wasn't safe for baby. I had about nine IVIG infusions. Nothing was working. IVIG would last about two weeks. This went on for several months. I continued to bruise on my arms and legs, and have petechia. I was fatigued. The numbers continued below 20 even after all theses treatments. I then had to have a splenectomy on 01/02/20 and remove a perfectly healthy organ. I lost hair. Gained almost 40 pounds on steroids, continuing to gain weight even after the baby.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: HIV test, Helicobacter test, Immune thrombocytopenia, Immunoglobulin therapy, Petechiae
Clinical narrative: I was one month away from birth. I was healthy with a healthy baby to be born on. On 08/06/19 I was given the Tdap shot.  One week later I began to notice bruises up and down my legs, arms and my pregnant belly. Over the next two weeks I was experiencing daily nose bleeds which I had never had before. I would go to sleep and then wake up with these sudden bruises that were not there the night before. After the two weeks of symptoms, I told my OB who ordered a CBC. I was admitted to the hospital right away with a platelet count of 12. I was diagnosed with ITP. Doctors ruled out HELLP, pre-eclampsia, or infections. I was given two platelet transfusions and four day course of Dexamethasone because my platelet count was critically low and unsafe to have my planned c section. Those treatments were able to get me to a count of 47. The ITP continued to worsen after birth with a count of 7. I began high does Prednisone 70mg with a taper over 5 months. I had four Rituximab chemo infusions. I had to stop breastfeeding which was crushing  and overwhelmingly sad due to the Rituximab. It wasn't safe for baby. I had about nine IVIG infusions. Nothing was working. IVIG would last about two weeks. This went on for several months. I continued to bruise on my arms and legs, and have petechia. I was fatigued. The numbers continued below 20 even after all theses treatments. I then had to have a splenectomy on 01/02/20 and remove a perfectly healthy organ. I lost hair. Gained almost 40 pounds on steroids, continuing to gain weight even after the baby.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Platelet count decreased, Platelet transfusion, Splenectomy, Weight increased
Clinical narrative: I was one month away from birth. I was healthy with a healthy baby to be born on. On 08/06/19 I was given the Tdap shot.  One week later I began to notice bruises up and down my legs, arms and my pregnant belly. Over the next two weeks I was experiencing daily nose bleeds which I had never had before. I would go to sleep and then wake up with these sudden bruises that were not there the night before. After the two weeks of symptoms, I told my OB who ordered a CBC. I was admitted to the hospital right away with a platelet count of 12. I was diagnosed with ITP. Doctors ruled out HELLP, pre-eclampsia, or infections. I was given two platelet transfusions and four day course of Dexamethasone because my platelet count was critically low and unsafe to have my planned c section. Those treatments were able to get me to a count of 47. The ITP continued to worsen after birth with a count of 7. I began high does Prednisone 70mg with a taper over 5 months. I had four Rituximab chemo infusions. I had to stop breastfeeding which was crushing  and overwhelmingly sad due to the Rituximab. It wasn't safe for baby. I had about nine IVIG infusions. Nothing was working. IVIG would last about two weeks. This went on for several months. I continued to bruise on my arms and legs, and have petechia. I was fatigued. The numbers continued below 20 even after all theses treatments. I then had to have a splenectomy on 01/02/20 and remove a perfectly healthy organ. I lost hair. Gained almost 40 pounds on steroids, continuing to gain weight even after the baby.
Age: 83.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: PATIENT RECIEVED 2 VACCINES IN SAME (LEFT) ARM - PREVNAR 13 AND FLUZONE HD - PATIENT STATED CAME BACK ABOUT A WEEK LATER WHEN PICKING UP A PRESCRIPTION TO INFORM US ABOUT HER EXPERIENCE WITH 2 VACCINES IN ONE ARM. THERE WAS A LARGE BUMP THAT FORMED  IN THE INJECTION AREA IN THE BEGINNING THEN SLOWLY CHANGED TO A LARGE DARK BRUISE. PATIENT STATED SHE FEELS OK NOW AND IS NOT UPSET, BUT WANTED TO TELL US TO ADVISE FUTURE PATIENTS TO NOT GET IN THE SAME ARM IN THE FUTURE.
Age: 16.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient received the flu vaccine and came back few hours later with redness and rash on the upper arm around the site of injection.  He did not report any shortness of breath but was concerned. We advised patient to take a benadryl and to also let PCP know about the reaction. Also asked him to go to ER if symptoms get worse
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Patient claims presenting red spots on his back. No fever, itching or pain. (9/11/2020)
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Fatigue, Malaise, Rash
Clinical narrative: I had intestinal distress, was very tired and sick feeling and broke out in rashes
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Hypoaesthesia, Injection site rash, Injection site swelling
Clinical narrative: Within a day of receiving the vaccine, patient developed swelling of his right arm/forearm/hand, developed a rash and swelling across his whole shoulder from the shoulder down to his hand, some numbness in the arm. Patient also experienced fatigue, fever, and chills for 3 days.   After 3 days, the rash and swelling went down and the patient started to feel better.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: Within a day of receiving the vaccine, patient developed swelling of his right arm/forearm/hand, developed a rash and swelling across his whole shoulder from the shoulder down to his hand, some numbness in the arm. Patient also experienced fatigue, fever, and chills for 3 days.   After 3 days, the rash and swelling went down and the patient started to feel better.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Extremely sore arm & swelling. Feeling a little for 2 days
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: PATIENT STATES BELL'S PALSY ON LEFT SIDE OF FACE, WHICH HAPPENED TWO DAYS AFTER THE VACCINE.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Discomfort, Pain, Pruritus, Swelling
Clinical narrative: pt is uncomfortable and experiencing local pruritis, pain and swelling after a week. pt will wait a few more days to see if adverse events subside but will go to see physician if not
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Patient was extremely nervous about receiving vaccine. After patient was calmed down and given the vaccine, she became extremely dizzy and light headed. Patient was instructed to sit and was monitored for various minutes to verify she was okay. After a couple of minutes she was able to stand and wanted to go home.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Abnormal loss of weight, Asthenia, Decreased appetite, Fatigue, Pain
Clinical narrative: Complete exhaustion, no energy, soreness of trunk, loss of appetite, rapid weight loss.  No appetite.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient came to pharmacy reporting injection site reactions (redness, swelling and severe muscular pain) to FLUZONE HD. Patient is a doctor and reporting in good faith.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received both vaccines in the same arm on 09/10/2020.  She called back to the pharmacy on 09/12/2020 and said that her arm was very painful and swollen.  She was encouraged by the pharmacy to take over the counter pain relievers and try using a ice pack to help with the pain and swelling.  She was also encouraged to seek medical attention if the pain/swelling didn't improve or got worse.  Her husband reported to the pharmacy on 09/13/2020 that she had been diagnosed with cellulitis and was given a prescription for an antibiotic and an anti-inflammatory medication.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Blister, Burning sensation, Contusion, Musculoskeletal pain, Pain
Clinical narrative: 8/20 2:00 pm pain in right buttock, like a deep bruise; 8:30 pm noticed rash forming on right buttock 8/21 7:00 am rash grew in patches overnight on buttock and into crotch area, right side.  11:00 am called GYN due to area of rash, informed of rash.  GYN thought I might have had a bad reaction to Shingrix vaccine and prescribed Balacyclovir HCI 1 gm tab nort 2x/day for 5 days.  Began meds 5:30 pm after returning home from moving child into college dorm.  Noticed blisters formed throughout the day on right labia.  In pain throughout Saturday and went to Urgent Care Sunday ~3 pm. 8/23 doctor increased Valacyclovir  to 3x/day and prescribed Gabapentin 300 mg cap nort for pain/discomfort/itching and Asperacream topical for non-rash areas. ~8 pm received some relief from Gabapentin and mild relief from Asperacream.   8/24 Continued all meds as prescribed and increased Gabapentin to 2 doses then 3 for the next 2-3 days then back down to 2 does undtil 8/31 then 1 dose for 3 days then every other day and every 2 days until 9/9 for last dose. 9/3 saw my PCP for a follow up: still have rash, blisters seem to have gone away, right side of torso continues to hurt to touch, both front and back.  Advised to take advil. 9/13 still have some burning in crotch area on right side and rash has not gone away all of the way on right buttock.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Rash
Clinical narrative: 8/20 2:00 pm pain in right buttock, like a deep bruise; 8:30 pm noticed rash forming on right buttock 8/21 7:00 am rash grew in patches overnight on buttock and into crotch area, right side.  11:00 am called GYN due to area of rash, informed of rash.  GYN thought I might have had a bad reaction to Shingrix vaccine and prescribed Balacyclovir HCI 1 gm tab nort 2x/day for 5 days.  Began meds 5:30 pm after returning home from moving child into college dorm.  Noticed blisters formed throughout the day on right labia.  In pain throughout Saturday and went to Urgent Care Sunday ~3 pm. 8/23 doctor increased Valacyclovir  to 3x/day and prescribed Gabapentin 300 mg cap nort for pain/discomfort/itching and Asperacream topical for non-rash areas. ~8 pm received some relief from Gabapentin and mild relief from Asperacream.   8/24 Continued all meds as prescribed and increased Gabapentin to 2 doses then 3 for the next 2-3 days then back down to 2 does undtil 8/31 then 1 dose for 3 days then every other day and every 2 days until 9/9 for last dose. 9/3 saw my PCP for a follow up: still have rash, blisters seem to have gone away, right side of torso continues to hurt to touch, both front and back.  Advised to take advil. 9/13 still have some burning in crotch area on right side and rash has not gone away all of the way on right buttock.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Genital blister, Genital rash, Musculoskeletal pain, Pain in extremity
Clinical narrative: 8/20 2:00 pm pain in right buttock, like a deep bruise; 8:30 pm noticed rash forming on right buttock 8/21 7:00 am rash grew in patches overnight on buttock and into crotch area, right side.  11:00 am called GYN due to area of rash, informed of rash.  GYN thought I might have had a bad reaction to Shingrix vaccine and prescribed Balacyclovir HCI 1 gm tab nort 2x/day for 5 days.  Began meds 5:30 pm after returning home from moving child into college dorm.  Noticed blisters formed throughout the day on right labia.  In pain throughout Saturday and went to Urgent Care Sunday ~3 pm. 8/23 doctor increased Valacyclovir  to 3x/day and prescribed Gabapentin 300 mg cap nort for pain/discomfort/itching and Asperacream topical for non-rash areas. ~8 pm received some relief from Gabapentin and mild relief from Asperacream.   8/24 Continued all meds as prescribed and increased Gabapentin to 2 doses then 3 for the next 2-3 days then back down to 2 does undtil 8/31 then 1 dose for 3 days then every other day and every 2 days until 9/9 for last dose. 9/3 saw my PCP for a follow up: still have rash, blisters seem to have gone away, right side of torso continues to hurt to touch, both front and back.  Advised to take advil. 9/13 still have some burning in crotch area on right side and rash has not gone away all of the way on right buttock.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: 8/20 2:00 pm pain in right buttock, like a deep bruise; 8:30 pm noticed rash forming on right buttock 8/21 7:00 am rash grew in patches overnight on buttock and into crotch area, right side.  11:00 am called GYN due to area of rash, informed of rash.  GYN thought I might have had a bad reaction to Shingrix vaccine and prescribed Balacyclovir HCI 1 gm tab nort 2x/day for 5 days.  Began meds 5:30 pm after returning home from moving child into college dorm.  Noticed blisters formed throughout the day on right labia.  In pain throughout Saturday and went to Urgent Care Sunday ~3 pm. 8/23 doctor increased Valacyclovir  to 3x/day and prescribed Gabapentin 300 mg cap nort for pain/discomfort/itching and Asperacream topical for non-rash areas. ~8 pm received some relief from Gabapentin and mild relief from Asperacream.   8/24 Continued all meds as prescribed and increased Gabapentin to 2 doses then 3 for the next 2-3 days then back down to 2 does undtil 8/31 then 1 dose for 3 days then every other day and every 2 days until 9/9 for last dose. 9/3 saw my PCP for a follow up: still have rash, blisters seem to have gone away, right side of torso continues to hurt to touch, both front and back.  Advised to take advil. 9/13 still have some burning in crotch area on right side and rash has not gone away all of the way on right buttock.
Age: 79.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient got both vaccines in left arm and came in the day after complaining of redness and swelling (started experiencing the day she got the vaccine).  Her arm was swollen and red from her shoulder to her elbow.  She said it was warm to the touch and a little sore.  Patient was doing okay, just wanted me to look at her arm.  I told her she could take benadryl for the redness and swelling or tylenol/ibuprofen for pain or discomfort.  I told her if anything worsened to see the doctor.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Tremor, Vomiting
Clinical narrative: Cold, shaking, and vomiting.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Chills with shivering for several hours, mild fever, slight nausea. All adverse events gone after 48 hours.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: redness and soreness at injection site warm to touch
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Flushing, Syncope
Clinical narrative: After administering the vaccine, pt had said she felt funny...and then she fainted for few seconds.  She was flushed and after few seconds she was conscious and said she feels fine.  911 had already been called. We had offered some water for patient and asked if she would want to continue sitting down for some time. She did agree to sit down for some time.  Paramedics had come quickly and checked the patient out.  She was asked if she would be willing to come to hospital but she declined after saying she feels fine.  The pharmacy tech and I asked her if she was indeed feeling okay and was able to drive. To that she replied she feels allright to drive.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV, TDAP
Symptoms: Erythema, Pain, Pain in extremity, Peripheral coldness, Peripheral swelling
Clinical narrative: LEFT ARM WAS SWOLLEN, RED, PAINFUL, FINGER COLD, BODY ACHES. PT WENT TO HOSPITAL AND GOT PRESCRIBED ANTIBIOTICS AND PREDNISONE.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Myalgia, Pain, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: soreness, tenderness, fever, muscle pain ...no joint pian outerside of atm swollen
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Febrile convulsion, Vomiting
Clinical narrative: PT EXPERIENCED FEBRILE TYPE SEIZURE APPROXIMATELY 9 HOURS POST VACCINATION WITH VOMITING. FELT WEAK FOR 1-2 DAYS FOLLOWING. CONTACTED PCP WHO TOLD HER THEY HAD NEVER HEARD OF THAT HAPPENING.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Poor quality sleep
Clinical narrative: My left arm was very painful from shoulder to elbow. I had fatigue to the point I had to lie down for a while. I did not sleep well and awoke with a frontal headache and muscle soreness throughout my body. I took 2 Tylenol extra strength and was much better the day after the vaccine. I did not have any noticeable symptoms from the first vaccine if the series of two.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: patient reports the area around the injection site became red, swollen and tender. The skin also is extremely itchy, potentially like an allergic reaction
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: PT COMPLAINING ABOUT PROLONGED PAIN ( OVER 6 DAYS) AT INJECTION SITE AFTER IMMUNIZATION
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Atrial fibrillation, Condition aggravated, Electrocardiogram, Erythema, Heart rate increased
Clinical narrative: Rapid heart rate, atrial fibrillation Lasting for over 6 hours Inflammation, redness, itchining, bump, soreness
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Pain, Pruritus, Swelling
Clinical narrative: Rapid heart rate, atrial fibrillation Lasting for over 6 hours Inflammation, redness, itchining, bump, soreness
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever  Sore throat  Body aches Dizziness  Light headed
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient came in to pharmacy and stated she experienced redness, warmth, and 3 days after vaccine experienced  itching on area just below injection site on left arm.
Age: 92.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Fall
Clinical narrative: The patient reported feeling week and falling in her home the evening of the vaccination.  Her granddaughter took her to the ER to be evaluated
Age: 82.0
Sex: M
Vaccine: FLUA4
Symptoms: Rash erythematous
Clinical narrative: Rash with red bumps
Age: 44.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Electrocardiogram, Lumbar puncture
Clinical narrative: Transverse Myelitis developed 10 days later -steroid/plasma exchange 10 day hospital stay-still recovering
Age: 44.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Magnetic resonance imaging, Myelitis transverse, Plasmapheresis
Clinical narrative: Transverse Myelitis developed 10 days later -steroid/plasma exchange 10 day hospital stay-still recovering
Age: 44.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Asthenia, Constipation, Fatigue, Gait inability, Myelitis transverse
Clinical narrative: Transverse Myelitis developed 10 days later -steroid/plasma exchange 10 day hospital stay-still recovering
Age: 44.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Paraesthesia, Plasmapheresis, Pulmonary congestion, SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative
Clinical narrative: Transverse Myelitis developed 10 days later -steroid/plasma exchange 10 day hospital stay-still recovering
Age: 44.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Urinary retention
Clinical narrative: Transverse Myelitis developed 10 days later -steroid/plasma exchange 10 day hospital stay-still recovering
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Fall
Clinical narrative: The patient fell at home the same evening she received the vaccination.  Her daughter took her to the ER to be evaluated.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Patient reports pain and muscle spasm  from shoulder to hand. Patient think a nerve have been pinched.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: ARM WAS EXTREMELY SWOLLEN AND PAINFUL THE DAY ON INJECTION 09/09/20. THE FOLLOWING DAY 09/10/20 SORENESS AND REDNESS SEVERE AND SWELLING AND REDNESS AND HEAT STARTED. I APPLIED ICE PACK. ON THE FOLLOWING DAY, FRIDAY I CALLED THE CLINIC, MY DOCTOR WAS OFF. I WAS DIRECTED TO THE NURSE LINE WHO SENT NOTE TO MY CLINIC. I WAS CALLED AND CLINIC NURSE STATED THE I WOULD BE GETTING A CALL VIRTUAL APPOINTMENT WITH THE NURSE PRACTITIONER. I WAS ASSESSED AND INSTRUCTED TO APPLY ICE PACK, PLACED ON  PREDNISONE 20 MG 2 TABS/DAY FOR 3 DAYS. APPLY ICE PACKS AS NEEDED, TO REPORT TO URGENT CARE IF WORSENS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Headache, Loss of personal independence in daily activities, Myalgia
Clinical narrative: At 4am, the night after receiving the vaccine, I woke up with dizziness and nausea. This continued throughout the entire next day. By Saturday evening I had a fever of 101 degrees, a severe headache and severe nausea, muscle and joint pain. I was in bed that entire day and evening and was unable to go about my normal activities. By Sunday morning, most of the symptoms were gone except a mild headache and fatigue.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: At 4am, the night after receiving the vaccine, I woke up with dizziness and nausea. This continued throughout the entire next day. By Saturday evening I had a fever of 101 degrees, a severe headache and severe nausea, muscle and joint pain. I was in bed that entire day and evening and was unable to go about my normal activities. By Sunday morning, most of the symptoms were gone except a mild headache and fatigue.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Hypersensitivity, Throat tightness, Urticaria
Clinical narrative: Allergic reaction, throat closing, hoarseness, a few hives in mouth/tongue, headed to emergency room for treatment
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Syncope
Clinical narrative: Vasovagal Syncope 4 days after vaccine.  ER visit, IV fluids
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Red raised itchy rash to face, arms, neck
Age: 75.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Administration site swelling, Injection site erythema
Clinical narrative: Patient states her left arm is swollen and red where the vaccines were administered. The Pharmacist recommended a cold compress along with taking Tylenol and Aleve or Motrin. Patient is to monitor symptoms. It doesn't improved in 24 to 48 hours, she needs to follow up with PCP.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Patient described the swelling as a baseball size lump and difficulty moving arm. She reported to the pharmacy at 5:30pm to inquire how to treat. She had placed ice on the location for several hours. She is continuing with the ice and will try Tylenol to help with soreness.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema
Clinical narrative: PT RECEIVED FLUZONE HD ON 9/8/20. SHE STARTED TO SEE REDNESS AROUND THE INJECTION SITE LEFT DELTOID, REDNESS AT HER LOWER LEFT ARM. SHE CAME TO THE PHARMACY AND REPORTED TO RPH ON DUTY. SHE SAW REDNESS ON 9/9/20, AND REPORTED TO US ON 9/10/20. WE CHECKED WITH HER ON THE PHONE ON 9/11/20. SHE SAID THE REDNESS WENT AWAY ON ITS OWN. SHE DIDN'T TAKE ANY OTC NOR APPLY ICE PACK. REDNESS RESOLVED ON IT'S OWN. SHE FELD FINE. NO OTHER SYMPTOMS REPORTED.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Mom called and said that her son's arm was red and swollen the day after he received the flu shot on 9/2/20. She said the red circle was about 3 1/2" in diameter. She mentioned that he has a possible egg allergy but did not indicate that on MR.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: See MD. on question 14
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Inflammation, Mobility decreased, Shoulder injury related to vaccine administration
Clinical narrative: SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (INFLAMMATION, LIMITED MOBILITY); SHOWING IMPROVEMENT ON FOLLOW-UP WITH PATIENT. CONSULTING PHYSICIAN AS A PRECAUTION.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Pruritus, Rash, Urticaria
Clinical narrative: Swollen lips, rash, hives, itching. Pt went to Urgent Care. Took 1 dose of Benadryl, hydrocortisone Cr. topically. No relief, so will try Zyrtec, Benadryl spray. Seeing primary care Dr. on Tuesday 9/15/2020.
Age: 88.0
Sex: F
Vaccine: PPV, FLUA4, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Joint swelling, Peripheral swelling
Clinical narrative: 8/10 Left upper arm swollen from shoulder to Elbow - Cold compress 3xday. 8/11 From Elbow to halfway down to wrist cold compress 3xday. 8/13 To wrist compress 4xday. Arm still swollen to 8/18 - using cold compress at least 2x day Went to MD 8/1 & 8/14 RX Doxycycline 4x@ 100MG 2xday -7 days - also Benedryl Sleep with arm elevated. Arm checked again on 8/24/20. Feels OK. What an inconvenience. As RX & Benedryl had to be taken at different times & taking my vitamins at different times - I'm almost 89yrs of age! I have had previous pneumonia shots with no problem.
Age: 88.0
Sex: F
Vaccine: PPV, FLUA4, PPV
Symptoms: Injection site swelling
Clinical narrative: 8/10 Left upper arm swollen from shoulder to Elbow - Cold compress 3xday. 8/11 From Elbow to halfway down to wrist cold compress 3xday. 8/13 To wrist compress 4xday. Arm still swollen to 8/18 - using cold compress at least 2x day Went to MD 8/1 & 8/14 RX Doxycycline 4x@ 100MG 2xday -7 days - also Benedryl Sleep with arm elevated. Arm checked again on 8/24/20. Feels OK. What an inconvenience. As RX & Benedryl had to be taken at different times & taking my vitamins at different times - I'm almost 89yrs of age! I have had previous pneumonia shots with no problem.
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Lip swelling, Odynophagia, Rash, Swelling of eyelid
Clinical narrative: itchy, uncomfortable bumps; itchy, uncomfortable bumps; papules (mentioned that they looked like the papules of shingles, as reported) in the abdomen more intensely on the left side than in the right side (reported as a dermatome); papules (mentioned that they looked like the papules of shingles, as reported) in the abdomen more intensely on the left side than in the right side (reported as a dermatome); swelling of the upper lip; swelling of the upper lip and eyelids; This case was reported by a physician via call center representative and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included FLUCONAZOLE (FLUZONE (FLUCONAZOLE)) for prophylaxis.   On 25th August 2020, the patient received the 1st dose of Shingrix and the 1st dose of FLUZONE (FLUCONAZOLE). On 27th August 2020, 2 days after receiving Shingrix, the patient experienced itchy rash, papular rash, papule, shingles, lip swelling and swelling of eyelid. The patient was treated with prednisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the itchy rash, papular rash, papule, shingles, lip swelling and swelling of eyelid were recovered/resolved.   It was unknown if the reporter considered the itchy rash, papular rash, papule, shingles, lip swelling and swelling of eyelid to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix and Fluzone, the patient started experiencing itchy, uncomfortable bumps, papules which looked like the papules of shingles in the abdomen more intensely on the left side than in the right side which was reported as a dermatome. The patient also had swelling of the upper lip and eyelids and was afraid she´d lose her airway.  As a measure the patient consulted a telemedicine physician who prescribed 60 mg of Prednisone daily and Benadryl which were ongoing.  The patient was afraid of relapse after withdrawal of the treatment medications. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Herpes zoster, Lip swelling, Papule, Rash papular, Rash pruritic
Clinical narrative: itchy, uncomfortable bumps; itchy, uncomfortable bumps; papules (mentioned that they looked like the papules of shingles, as reported) in the abdomen more intensely on the left side than in the right side (reported as a dermatome); papules (mentioned that they looked like the papules of shingles, as reported) in the abdomen more intensely on the left side than in the right side (reported as a dermatome); swelling of the upper lip; swelling of the upper lip and eyelids; This case was reported by a physician via call center representative and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included FLUCONAZOLE (FLUZONE (FLUCONAZOLE)) for prophylaxis.   On 25th August 2020, the patient received the 1st dose of Shingrix and the 1st dose of FLUZONE (FLUCONAZOLE). On 27th August 2020, 2 days after receiving Shingrix, the patient experienced itchy rash, papular rash, papule, shingles, lip swelling and swelling of eyelid. The patient was treated with prednisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the itchy rash, papular rash, papule, shingles, lip swelling and swelling of eyelid were recovered/resolved.   It was unknown if the reporter considered the itchy rash, papular rash, papule, shingles, lip swelling and swelling of eyelid to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix and Fluzone, the patient started experiencing itchy, uncomfortable bumps, papules which looked like the papules of shingles in the abdomen more intensely on the left side than in the right side which was reported as a dermatome. The patient also had swelling of the upper lip and eyelids and was afraid she´d lose her airway.  As a measure the patient consulted a telemedicine physician who prescribed 60 mg of Prednisone daily and Benadryl which were ongoing.  The patient was afraid of relapse after withdrawal of the treatment medications. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: itchy, uncomfortable bumps; itchy, uncomfortable bumps; papules (mentioned that they looked like the papules of shingles, as reported) in the abdomen more intensely on the left side than in the right side (reported as a dermatome); papules (mentioned that they looked like the papules of shingles, as reported) in the abdomen more intensely on the left side than in the right side (reported as a dermatome); swelling of the upper lip; swelling of the upper lip and eyelids; This case was reported by a physician via call center representative and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included FLUCONAZOLE (FLUZONE (FLUCONAZOLE)) for prophylaxis.   On 25th August 2020, the patient received the 1st dose of Shingrix and the 1st dose of FLUZONE (FLUCONAZOLE). On 27th August 2020, 2 days after receiving Shingrix, the patient experienced itchy rash, papular rash, papule, shingles, lip swelling and swelling of eyelid. The patient was treated with prednisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the itchy rash, papular rash, papule, shingles, lip swelling and swelling of eyelid were recovered/resolved.   It was unknown if the reporter considered the itchy rash, papular rash, papule, shingles, lip swelling and swelling of eyelid to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix and Fluzone, the patient started experiencing itchy, uncomfortable bumps, papules which looked like the papules of shingles in the abdomen more intensely on the left side than in the right side which was reported as a dermatome. The patient also had swelling of the upper lip and eyelids and was afraid she´d lose her airway.  As a measure the patient consulted a telemedicine physician who prescribed 60 mg of Prednisone daily and Benadryl which were ongoing.  The patient was afraid of relapse after withdrawal of the treatment medications. The reporter consented to follow up.
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Blood thyroid stimulating hormone normal, Differential white blood cell count normal, Erythema, Full blood count normal, Injection site pain
Clinical narrative: pain was significant /stung / when touch it hurts; she could not lift the arm; it´s red / red marks going through her biceps; still hurts where shot was placed; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) for prophylaxis.   The patient's past medical history included hypothyroidism.   On 29th August 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, the patient received PREVNAR 13. On 29th August 2020, less than a day after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm, mobility decreased, erythema and injection site pain. On an unknown date, the outcome of the pain in arm, mobility decreased, erythema and injection site pain were unknown.   It was unknown if the reporter considered the pain in arm, mobility decreased, erythema and injection site pain to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Prevnar 23 from the patient was going to get it at the Pfizer site, but she was not going to be at the site and decided to go to . That shot was really bad and she believed it was worse than the Shingles vaccine she had more than a month ago. Unable to provide any product details (NDC, Lot, or expiry) for the Shingles vaccine, but  received that at the agency. The arm has gotten better when lifting the arm, it still hurts where shot was placed. Had red marks going through her biceps and can see red areas and mentions again it hurts when touched. In addition to getting the Prevnar 23 she had the flu shot as well that day and never experienced this with the flu shot. Unable to provide name of flu shot given or NDC, Lot, or expiry. Had  received Prevnar 13 already when in more than 2 years ago before moving here. Unable to provide NDC, Lot, or expiry. No further details provided. Had blood work less than a week ago and all were normal. Vaccine Supplemental Form Patient Details-Patient's address and phone No further details were provided. This case has been linked with case US2020AMR177639, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR177639:same reporter
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Lipids normal, Metabolic function test normal, Mobility decreased, Pain, Tenderness
Clinical narrative: pain was significant /stung / when touch it hurts; she could not lift the arm; it´s red / red marks going through her biceps; still hurts where shot was placed; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) for prophylaxis.   The patient's past medical history included hypothyroidism.   On 29th August 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, the patient received PREVNAR 13. On 29th August 2020, less than a day after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm, mobility decreased, erythema and injection site pain. On an unknown date, the outcome of the pain in arm, mobility decreased, erythema and injection site pain were unknown.   It was unknown if the reporter considered the pain in arm, mobility decreased, erythema and injection site pain to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Prevnar 23 from the patient was going to get it at the Pfizer site, but she was not going to be at the site and decided to go to . That shot was really bad and she believed it was worse than the Shingles vaccine she had more than a month ago. Unable to provide any product details (NDC, Lot, or expiry) for the Shingles vaccine, but  received that at the agency. The arm has gotten better when lifting the arm, it still hurts where shot was placed. Had red marks going through her biceps and can see red areas and mentions again it hurts when touched. In addition to getting the Prevnar 23 she had the flu shot as well that day and never experienced this with the flu shot. Unable to provide name of flu shot given or NDC, Lot, or expiry. Had  received Prevnar 13 already when in more than 2 years ago before moving here. Unable to provide NDC, Lot, or expiry. No further details provided. Had blood work less than a week ago and all were normal. Vaccine Supplemental Form Patient Details-Patient's address and phone No further details were provided. This case has been linked with case US2020AMR177639, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR177639:same reporter
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Thyroxine free normal, Urine analysis normal, Vitamin D
Clinical narrative: pain was significant /stung / when touch it hurts; she could not lift the arm; it´s red / red marks going through her biceps; still hurts where shot was placed; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) for prophylaxis.   The patient's past medical history included hypothyroidism.   On 29th August 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, the patient received PREVNAR 13. On 29th August 2020, less than a day after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm, mobility decreased, erythema and injection site pain. On an unknown date, the outcome of the pain in arm, mobility decreased, erythema and injection site pain were unknown.   It was unknown if the reporter considered the pain in arm, mobility decreased, erythema and injection site pain to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Prevnar 23 from the patient was going to get it at the Pfizer site, but she was not going to be at the site and decided to go to . That shot was really bad and she believed it was worse than the Shingles vaccine she had more than a month ago. Unable to provide any product details (NDC, Lot, or expiry) for the Shingles vaccine, but  received that at the agency. The arm has gotten better when lifting the arm, it still hurts where shot was placed. Had red marks going through her biceps and can see red areas and mentions again it hurts when touched. In addition to getting the Prevnar 23 she had the flu shot as well that day and never experienced this with the flu shot. Unable to provide name of flu shot given or NDC, Lot, or expiry. Had  received Prevnar 13 already when in more than 2 years ago before moving here. Unable to provide NDC, Lot, or expiry. No further details provided. Had blood work less than a week ago and all were normal. Vaccine Supplemental Form Patient Details-Patient's address and phone No further details were provided. This case has been linked with case US2020AMR177639, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR177639:same reporter
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Blood thyroid stimulating hormone normal, Differential white blood cell count, Erythema, Full blood count, Injection site pain
Clinical narrative: pain was significant /stung / when touch it hurts; she could not lift the arm; it´s red / red marks going through her biceps; still hurts where shot was placed; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) for prophylaxis.   The patient's past medical history included hypothyroidism.   On 29th August 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, the patient received PREVNAR 13. On 29th August 2020, less than a day after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm, mobility decreased, erythema and injection site pain. On an unknown date, the outcome of the pain in arm, mobility decreased, erythema and injection site pain were unknown.   It was unknown if the reporter considered the pain in arm, mobility decreased, erythema and injection site pain to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Prevnar 23 from the patient was going to get it at the Pfizer site, but she was not going to be at the site and decided to go to . That shot was really bad and she believed it was worse than the Shingles vaccine she had more than a month ago. Unable to provide any product details (NDC, Lot, or expiry) for the Shingles vaccine, but  received that at the agency. The arm has gotten better when lifting the arm, it still hurts where shot was placed. Had red marks going through her biceps and can see red areas and mentions again it hurts when touched. In addition to getting the Prevnar 23 she had the flu shot as well that day and never experienced this with the flu shot. Unable to provide name of flu shot given or NDC, Lot, or expiry. Had  received Prevnar 13 already when in more than 2 years ago before moving here. Unable to provide NDC, Lot, or expiry. No further details provided. Had blood work less than a week ago and all were normal. Vaccine Supplemental Form Patient Details-Patient's address and phone No further details were provided. This case has been linked with case US2020AMR177639, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR177639:same reporter
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Metabolic function test normal, Mobility decreased, Pain in extremity
Clinical narrative: pain was significant /stung / when touch it hurts; she could not lift the arm; it´s red / red marks going through her biceps; still hurts where shot was placed; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) for prophylaxis.   The patient's past medical history included hypothyroidism.   On 29th August 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, the patient received PREVNAR 13. On 29th August 2020, less than a day after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm, mobility decreased, erythema and injection site pain. On an unknown date, the outcome of the pain in arm, mobility decreased, erythema and injection site pain were unknown.   It was unknown if the reporter considered the pain in arm, mobility decreased, erythema and injection site pain to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Prevnar 23 from the patient was going to get it at the Pfizer site, but she was not going to be at the site and decided to go to . That shot was really bad and she believed it was worse than the Shingles vaccine she had more than a month ago. Unable to provide any product details (NDC, Lot, or expiry) for the Shingles vaccine, but  received that at the agency. The arm has gotten better when lifting the arm, it still hurts where shot was placed. Had red marks going through her biceps and can see red areas and mentions again it hurts when touched. In addition to getting the Prevnar 23 she had the flu shot as well that day and never experienced this with the flu shot. Unable to provide name of flu shot given or NDC, Lot, or expiry. Had  received Prevnar 13 already when in more than 2 years ago before moving here. Unable to provide NDC, Lot, or expiry. No further details provided. Had blood work less than a week ago and all were normal. Vaccine Supplemental Form Patient Details-Patient's address and phone No further details were provided. This case has been linked with case US2020AMR177639, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR177639:same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dry mouth, Fatigue
Clinical narrative: I received two vaccines at the same time - one for the flu and the other for shingles. They were both administered very quickly. Within a couple of hours I was feeling nauseous, dry mouth, headache and swelling and  pain in my shoulder where I received the shingles vaccine. As the evening went on symptoms became worse with chills, weakness, loss of appetite fever, extreme tiredness, unable to sleep.  The next day I was unable to get out of bed except for about 5 minutes at a time.  Continued chills, headache pain, weakness, etc. Extreme tiredness. Injection sight is very hot, hard  and swollen on Sunday evening, two days later. Other symptoms have subsided.