chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Starting at 11:30 pm, 9-22-2018: Fatigue, rapid heart rate, shortness of breath, tightness in chest, nausea, muscle pain where vaccines were administered, pain in both shins.
Age: 58.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Asthenia, Fatigue, Hyperhidrosis, Tremor
Clinical narrative: Sweats, shaking, tired/weak.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient developed red splotchy rash on her trunk about 1 or 2 days after receiving vaccine. Patient is unsure of the exact time of onset.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity
Clinical narrative: Starting after the vaccine, the patient started experiencing intermittent joint pain and pain and/or numbness in his left arm. He has yet to seek out treatment. Symptoms still persist.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Chills, Fatigue, Feeling hot, Nausea
Clinical narrative: Pain in the arm. Extreme fatigue (bedridden on day 2) Chills mixed with extreme warmth. Nausea.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm. Extreme fatigue (bedridden on day 2) Chills mixed with extreme warmth. Nausea.
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Induration, Insomnia, Pain
Clinical narrative: HARD AND HOT, NOT RED, EXTREMELY PAINFUL. HURT EVEN WHEN NOT MOVING. WANTED TO PUT IN A SLING. COULD NOT SLEEP.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Pt says she experienced nausea fever. Swelling, redness in the arm which was vaccinated with PNEUMOVAX 23.
Age: 72.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Axillary pain, Induration, Insomnia, Pain, Skin warm
Clinical narrative: HARD AND HOT, NOT RED, EXTREMELY PAINFUL. HURT EVEN WHEN NOT MOVING. WANTED TO PUT IN A SLING. COULD NOT SLEEP. PAIN WAS ALSO EXPERIENCED IN THE ARMPIT.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation, Rash erythematous, Tenderness
Clinical narrative: Patient presented the next morning after the shots with a rash from her shoulder to her elbow. The rash was tender, red, and inflammed. Instructed patient to take benadryl tablets to help allergic reaction. Instructed her that if it got worse (spread) then she needs to see the doctor and may need a steroid. I will follow up with her tonight to see how she is doing.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pain, Pyrexia, Tremor
Clinical narrative: Patient reported "flu-like" symptoms after vaccination including fever-related shaking, body aches, and overall malaise.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Cough, Feeling abnormal, Increased upper airway secretion, Nausea
Clinical narrative: Roughly 5 hours after administration of vaccine I began to feel upper respiratory constriction. My throat felt rough and it was as if I was producing a lot of mucus. I also developed a rough cough. I laid down and tried to rest. My then developed nausea and went to the bathroom to poop. It was while on the toilet I felt the head rush and turned around and vomited profusely. It was a large amount as if my stomach had been stopped a while. It was only time I vomited. I laid down after the event with uncontrolled shaking. For the rest of the evening and the beginning of this morning I am without energy. I have been keeping food and drink down although I am not eating large quantities.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Throat irritation, Throat tightness, Tremor, Vomiting
Clinical narrative: Roughly 5 hours after administration of vaccine I began to feel upper respiratory constriction. My throat felt rough and it was as if I was producing a lot of mucus. I also developed a rough cough. I laid down and tried to rest. My then developed nausea and went to the bathroom to poop. It was while on the toilet I felt the head rush and turned around and vomited profusely. It was a large amount as if my stomach had been stopped a while. It was only time I vomited. I laid down after the event with uncontrolled shaking. For the rest of the evening and the beginning of this morning I am without energy. I have been keeping food and drink down although I am not eating large quantities.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hypoaesthesia, Pruritus
Clinical narrative: Itchiness and hotness, still itches today after 2 wks, pt using hydrocortisone cream. She said it also caused numbness travelling from upper arm to forefinger but that has resolved.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: ARM BECAME RED, SWOLLEN, AND TENDER/SORE. ABOUT 6 INCH IN DIAMETER RED SWOLLEN MARK.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Patient called pharmacy today, 9/23/18, around 10:45AM, to report pain and redness at injection site following flu shot. She says that her arm has been sore since the injection was given on 9/21/18 around 10AM. She says she gets a flu shot every year and has never experienced this kind of redness. She said "I am more concerned about the redness than the pain." She reported a red circle "almost as big" as her hand. According to her, this morning was the first time she actually looked at her arm, so she does not know when the redness actually started developing, or if it has become better or worse over time.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Dizziness, Injection site erythema, Injection site induration
Clinical narrative: Lethargy, marked induration and erythema at injection site (10 cm), progressing over 12 hours to fever to 103F, rigors, dizziness, anorexia, tachypnea, tachycardia.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pyrexia, Tachycardia, Tachypnoea
Clinical narrative: Lethargy, marked induration and erythema at injection site (10 cm), progressing over 12 hours to fever to 103F, rigors, dizziness, anorexia, tachypnea, tachycardia.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, tenderness, and swelling.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Very red on arm surrounding injection site, also patient stated there was severe itching in the red area.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Injection site pain, Peripheral swelling
Clinical narrative: The patient (one of our pharmacy technicians) was given the vaccine because she is a smoker. There was injection site pain immediately after administration at around 10:45 AM. Over the next few hours the pain worsened. By about 1:30 PM the patient noticed their arm was swollen, red, and rated the pain a 9/10. She took a 200 mg ibuprofen. There were no other symptoms outside of the injection site. I drove the patient to an urgent care clinic where she was given a steroid injection with lidocaine. She was also given a prescription for cetirizine and a three day course of steroids to take by mouth.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Tiredness, shivers, aches throughout entire body, fever.
Age: 50.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Patient's arm started swelling red 30 minutes post vaccine. Pain, and swelling were increasing. Used ice and ADVIL (with food).
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Gait disturbance, Headache, Hyperhidrosis
Clinical narrative: Barely able to walk - 102 degree fever - chills - body sweats - pins/needles - headache - dizziness.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Barely able to walk - 102 degree fever - chills - body sweats - pins/needles - headache - dizziness.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: PATIENT COMPLAINED OF SEVERE BODY ACHE, SWELLING AND REDNESS AT TIME OF INJECTION.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Back pain, Chills, Erythema, Inflammation, Pyrexia
Clinical narrative: Patient has a red, very inflamed, hot arm. She also has a fever with chills and her back hurts. She may seek a doctors care later today.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Skin warm
Clinical narrative: Patient has a red, very inflamed, hot arm. She also has a fever with chills and her back hurts. She may seek a doctors care later today.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Per wife reporting over phone on Sunday: Patient began having muscle pain/aches (flu-like aches) and severe shivering Thursday night (day of vaccine) that continued into Friday and Saturday. Symptoms are improving and not getting worse. When wife ask patient today (Sunday) if he was feeling better patient thought it was improving. When asked if they had talked to a doctor yet they said no and we will be contacting the PCP on Monday to let them know about event incase follow up needed.
Age: 8.0
Sex: U
Vaccine: FLU4
Symptoms: Contusion, Erythema, Skin warm, Tenderness
Clinical narrative: LARGE REDDENED AREA OF 3X5 INCHES WAS NOTED WHEN I PICKED MY SON UP FROM SCHOOL ON FRIDAY. AREA WAS WARM TO THE TOUCH. BY SATURDAY THE AREA HAD GROWN LARGER AND MORE TENDER. CONTACTED HIS PHYSICIANS OFFICE AND WAS TOLD TO CONTTINUE TO MONITOR AND GIVE BENADRYL AND TYLENOL. BY TODAY, SUNDAY, IT IS STILL A LARGE RED AREA WITH HEAT AND STARTING TO BRUISE. THE INJECTION SITE IS VERY FAR BACK ON HIS ARM ALSO LEADING ME TO BELIEVE THAT THE INJECTION WAS NOT ADMINISTERED IM AS STATED ON FORM.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Black/blue swelling at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Skin reaction
Clinical narrative: Patient stated she noticed some pain in shoulder where vaccine was administrated on 2nd day of administration. 3rd day morning she noticed a red spot on her arm but patient not sure if it is a result of vaccine or a bite as she went to a concert the night before. Patient stated on 3rd day she noticed the pain feeling decreasing. I advised the patient to keep an eye on any changes she might observe and report it if she noticed any change. Meanwhile I advised her to use BENADRYL cream for the red spot on her arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain, Palpitations
Clinical narrative: Full body aches, chills, fatigue, heart racing, nausea/vomiting developing morning after vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Full body aches, chills, fatigue, heart racing, nausea/vomiting developing morning after vaccination.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: On 9/15/18 (NIGHT of shot) I NOTICED his arm WAS RED, WARM, GOLF BALL SIZED AREA where shot was given. HE DID NOT COMPLAIN THAT IT HURT. I MARKED the outer diameter WITH A PEN to monitor any changes. I GAVE HIM SOME ZYRTEC AND APPLIED AN ICE PACK. THE NEXT MORNING, SUNDAY, the site was LARGER, ABOUT THE SIZE OF AN ORANGE. STILL NO COMPLAINT OF PAIN, JUST THAT IT ITHCED. I DID APPLY A TOPICAL STEROID. BY MONDAY MORNING IT WAS LOOKING LIKE IT WAS DISSIPATING, AND BY MONDAY EVENING IT WAS COMPLETLY GONE.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Chest pain, Erythema, Fatigue, Heart rate increased, Malaise
Clinical narrative: That evening I had a sore throat and did not feel well. I took less than a half dose of BENADRYL to help me sleep. I awoke at 5:15 AM with my heart rate at 111 beats per minute, verified on my Smart watch. I exercise regularly and have a resting heart rate about 65 or 70. My chest was hurting on the left side. I felt very fatigued all day and tried to exert a low amount of energy at my desk job. After I got home from work, I saw that I had red hives all over my front and back sides. I called a medical friend, who said to take BENADRYL and an antacid. I also took allergy medicine each day and each evening before bedtime for the next four days. The following days, my back was itchy.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Oropharyngeal pain, Pruritus, Urticaria
Clinical narrative: That evening I had a sore throat and did not feel well. I took less than a half dose of BENADRYL to help me sleep. I awoke at 5:15 AM with my heart rate at 111 beats per minute, verified on my Smart watch. I exercise regularly and have a resting heart rate about 65 or 70. My chest was hurting on the left side. I felt very fatigued all day and tried to exert a low amount of energy at my desk job. After I got home from work, I saw that I had red hives all over my front and back sides. I called a medical friend, who said to take BENADRYL and an antacid. I also took allergy medicine each day and each evening before bedtime for the next four days. The following days, my back was itchy.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pain, Pyrexia, Rash
Clinical narrative: Pt reports that she developed fever 100.7, cough, aches and a rash on her abdomen that responded to cortisone cream. Symptoms lasted approximately 2 days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to pharmacy with red bruised area about 3 in in diameter on her left arm (the injection site). Pt stated the injection site started to swell, turn red and become warm the next day. Two days later she stated the left arm was very sore. No other symptoms were present.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Dysstasia, Gait disturbance, Headache
Clinical narrative: Redness and raised wheal at injection site and headache on 9/20/2018. Morning of 9/21/2018 overall joint pain, but most pronounced in sacral area with difficulty in walking and standing up straight. Pain continued throughout day and evening until an anti inflammatory medicine was taken; diclofenac sodium 0.25 mg X 2 taken. Was able about to walk approximately 2 hours after the diclofenac sodium. Morning of 9/22/2018 and 9/23/2018 inability to stand up from bed and held door frames to move into bathroom. Sacral pain on standing and walking until approx. 2 hours after diclofenac sodium 0.25 mg X 2 taken.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Redness and raised wheal at injection site and headache on 9/20/2018. Morning of 9/21/2018 overall joint pain, but most pronounced in sacral area with difficulty in walking and standing up straight. Pain continued throughout day and evening until an anti inflammatory medicine was taken; diclofenac sodium 0.25 mg X 2 taken. Was able about to walk approximately 2 hours after the diclofenac sodium. Morning of 9/22/2018 and 9/23/2018 inability to stand up from bed and held door frames to move into bathroom. Sacral pain on standing and walking until approx. 2 hours after diclofenac sodium 0.25 mg X 2 taken.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dizziness, Headache, Influenza like illness, Neuralgia
Clinical narrative: Patient had no swelling, redness, or pain when given the injection on 9/19/2018. Once she got home, she began to have headache about 2 hours after the shot. This progressed to severe, debilitating headache, dizziness, flu-like symptoms, and an aggravation of her neuropathic pain symptoms. This lasted about 4 days. On the fifth day, she now feels almost back to normal. She did not contact her physician and did not report any of these reactions to me until 9/23/2018 at 4:54pm.
Age: 58.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Nausea, Pain in extremity, Poor quality sleep
Clinical narrative: No adverse events immediately following injection. Patient returned to the pharmacy the following day (almost 24hrs later), and described not sleeping well last night due to major soreness in left arm. And currently feeling nauseous (about 24 hrs post injection) while working outdoors in the heat.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Mobility decreased, Pain in extremity
Clinical narrative: Swollen site on the opposite side of arm (opposite to deltoid where injection was given), warm to touch, pain in left arm and difficulty moving fingers. Spoke to the pt next day - sx seem to be subsiding. He took 2 TYLENOLS the day of and the morning after vaccination.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Injection site pain
Clinical narrative: The day after the vaccine was administered (9/18/18) patient experienced muscle soreness at the site of the injection, overall "great weakness, exhaustion, and chills". All of which subsided within 1-2 days after symptoms appeared.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Injection site pain
Clinical narrative: Patient experienced muscle soreness at the site of the injection starting 1 day after the shot was given in the left deltoid. She also experienced "great weakness, exhaustion, and chills", all of which subsided 1-2 days after symptom onset.
Age: 24.0
Sex: M
Vaccine: FLU4, PPV, TD
Symptoms: Injection site rash, Pyrexia
Clinical narrative: PATIENT ABOUT 24 HOURS AFTER INJECTION DEVELOPED A FEVER (102-104 DEGREES F). THIS PERSISTED FOR ABOUT 1 DAY. THEN HE ALSO DEVELOPED A RASH ON HIS LEFT ARM AROUND THE SITE OF INJECTION AND SURROUNDING AREAS. OTC PAIN/ALLERGY MEDICATIONS RECOMMENDED. PATIENT WAS TOLD IF RASH DOES NOT BEGIN TO RESOLVE, IF IT WORSENS, OR OTHER SYMPTOMS DEVELOP TO SEEK MEDICAL ATTENTION.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: PT NOTICED RED/WARM TO TOUCH ON HER ARM AT INJECTION SITE THIS AM. PER PT LOCAL REACTION STARTED PROBABLY AFTER MIDNIGHT AND SHE NOTICED IT THIS MORNING. PT DID NOT COMPLAIN OF ITCHING. PT WAS ADVISED TO USE HYDROCORTISONE, ICE PACK AND IF NEEDED TO TAKE BENADRYL. PT WAS ADVISED TO FOLLOW UP WITH DR IF SYMPTOMS WORSEN.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Headache, Injection site pain
Clinical narrative: Both shots in the series he got sick 8 hours after getting the shot. The first time the symptoms lasted 2 days. The second time the symptoms lasted one and a half days. Chills, shivering, fever, upset stomach, loss of appetite, severe headache, overall soreness, injection site pain, restlessness night.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Restlessness, Vaccine positive rechallenge
Clinical narrative: Both shots in the series he got sick 8 hours after getting the shot. The first time the symptoms lasted 2 days. The second time the symptoms lasted one and a half days. Chills, shivering, fever, upset stomach, loss of appetite, severe headache, overall soreness, injection site pain, restlessness night.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patients mother, called the pharmacy around 4pm to ask if swelling was normal after getting the flu vaccination. The pts mother was informed it was normal for swelling to occur. The patient's mother described the injection site to be red and raised. She stated that the reaction never occurred in the past. The mother was informed to give patient a BENADRYL and IBU to help with any inflammation and pain. The pharmacist informed the pts mother that he would follow up in the morning to see if anything has gotten better. On 9/23 the pharmacist, contacted patient's mother and asked how patient was doing. Patient's mother stated that it looked like it had gotten a little better but that it was still tender and swollen. Per patient's mother, patient was only given BENADRYL the night before. She was informed to give patient IBU to help with the inflammation and to also use a cold compress for 10 minutes on 10 minutes off. The pharmacist stated that he would follow up on 9/24/18 and asked patient's mother to contact him if things were getting better or worse.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Extra dose administered, Injection site swelling
Clinical narrative: Patient had a little swelling at injection site, Pt had previously already received the one vaccine needed after 65 but pharmacist missed that the patient had received it and revaccinated patient.  This was the second dose within the year.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient experienced an itchy, red, painful rash from shoulder to elbow for about 7 days following his final SHINGRIX dose.
Age: 21.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Neck pain
Clinical narrative: Patient called another pharmacy, Store 9/20/2018. She complained of a sore neck. She was told to try some ibuprofen and call the pharmacy back and let the pharmacist know how she was feeling. On 9/23/2018 she called pharmacy Store and stated her neck was still sore.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Dizziness, Nausea
Clinical narrative: Patient states that she woke up feeling very confused, dizzy and nauseous.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient developed rash on lower arm below the injection site, the area itched, was red, and hot patient went to her doctors office. Patient couldn't remember what the doctor diagnosis her with. She was given an antibiotic and course of steroids.
Age: 75.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pyrexia, Rash
Clinical narrative: Patient got vaccine on 9/10/18 on 9/13/18 patient went to office and was diagnosis with shingles. Patient aches all over and low grade fever for 2 days. Fever and rash on Wednesday after vaccination. Rash was right behind ear and pain from rash went down to upper arm. Pain was like a burning needle like sensation and area burns on touch.
Age: 18.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Hypoacusis, Hypoaesthesia, Visual impairment
Clinical narrative: Patient received shot in left arm. Patient waited to see if adverse event would occur. First patient had dizziness and weakness, followed by impaired vision and hearing, then followed by numbness in both arms. Episode lasted about 15 minutes.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: Arm became red and swollen. I became tired and feverish.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Patient presented with an injection site reaction. It was red around the area and warm to the touch. I recommended for patient to ice the area and take BENADRYL as needed for the itch.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm swollen, red, warm to touch.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt said a few days after she has received the PREVNAR vaccination, she happened to look at her right arm and noticed that her upper arm around the injection site was red and warm to the touch. No pruritus reported. She had also received an influenza vaccination on the same day, but that was on the left deltoid.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Swollen arm from injection site in deltoid muscle down to elbow.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Nerve compression
Clinical narrative: Patient called saying her left shoulder hurting since Friday 9/14 after shot was given. Feels like pinched nerves in her neck as well. Asked patient if she took an NSAID? Patient said she doesn't have any at home. She will start next Monday 9/24/18 when she comes into the store. Follow up call placed 9/22/18 and 9/23/18. Left message and no answer 2nd call.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain, Swelling
Clinical narrative: Headache, muscle aches for 2 days, feeling tired for 3 days, swelling and pain still present on the 3rd day.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm pain and swollen.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Muscle spasms, Musculoskeletal pain, Pain, Sciatica
Clinical narrative: Adverse effects: numbness in bottom of right foot, pain in right buttocks (travels down posterior thigh), cramp in right calf; undergoing physical therapy. Current diagnosis sciatica originating at L5. Started 8-3-18.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 59-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX.  Additional details were provided as follows: The healthcare professional (HCP) experienced fever with a dose of SHINGRIX and stated that he previously reported the adverse event for the first dose of SHINHRIX, but no case was found, so created this case. This case has been linked to the US2018166416, reported by the same reporter for the 2nd dose.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 59-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX.  Additional details were provided as follows: The healthcare professional (HCP) experienced fever with a dose of SHINGRIX and stated that he previously reported the adverse event for the first dose of SHINHRIX, but no case was found, so created this case. This case has been linked to the US2018166416, reported by the same reporter for the 2nd dose.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV, TDAP, VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Pain, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), pain and erythema. On an unknown date, the outcome of the cellulitis, pain and erythema were unknown. It was unknown if the reporter considered the cellulitis, pain and erythema to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient's initials and date of birth were unknown. The reporter agreed to follow up from GlaxoSmithKline. The case was linked to the case US2018GSK169618, reported by the same reporter.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV, TDAP, VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), pain and erythema. On an unknown date, the outcome of the cellulitis, pain and erythema were unknown. It was unknown if the reporter considered the cellulitis, pain and erythema to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient's initials and date of birth were unknown. The reporter agreed to follow up from GlaxoSmithKline. The case was linked to the case US2018GSK169618, reported by the same reporter.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The reporter did not have lot number or expiration date of SHINGRIX. In 2018, the patient developed shingles a week after vaccination. The symptoms were not yet resolved.
Age: 28.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Limb discomfort, Pain, Pain in extremity
Clinical narrative: Patient is describing long standing arm pain from injection, patient went to doctor, doctor believes shot was given too high and thus caused the arm pain. This could be due to the needle penetrating the cartilage/bursa of shoulder. Pain has lasted 11 days post injection. No other effects only the arm pain.
Age: 28.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient is describing long standing arm pain from injection, patient went to doctor, doctor believes shot was given too high and thus caused the arm pain. This could be due to the needle penetrating the cartilage/bursa of shoulder. Pain has lasted 11 days post injection. No other effects only the arm pain.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chest pain, Confusional state, Diarrhoea, Disturbance in attention, Dizziness
Clinical narrative: Yesterday 9/19/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Dysgeusia, Dyspnoea, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Yesterday 9/19/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pain, Palpitations, Pyrexia, Spinal pain
Clinical narrative: Yesterday 9/19/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Abdominal discomfort, Chest pain, Confusional state, Diarrhoea, Disturbance in attention
Clinical narrative: Yesterday 9/19/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Dizziness, Dysgeusia, Dyspnoea, Feeding disorder, Feeling hot
Clinical narrative: Yesterday 9/19/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Hyperhidrosis, Nausea, Pain, Palpitations, Pyrexia
Clinical narrative: Yesterday 9/19/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up.
Age: 26.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Spinal pain
Clinical narrative: Yesterday 9/19/2018 I went to my primary care physician for a flu shot. I received the injectable form without preservatives. Today my heart has been racing off and on and I have had diarrhea since this evening. I have been lightheaded, chest pains, and nauseous as well as having a throbbing sensation in the spine. Had a fever come on earlier that was low grade around 99 and profuse overheating and sweating regardless of external environment temperatures. Shortness of breath and mild confusion and inability to concentrate more so than normal. Unable to drink more than a small sip of water and unable to eat or it upsets the GI issues. Have had a weird sulfur or egg like taste in my mouth today since I woke up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 3 months after receiving SHINGRIX, the patient experienced injection site itching and injection site swelling. On an unknown date, the outcome of the injection site itching and injection site swelling were unknown. It was unknown if the reporter considered the injection site itching and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX about 2 months before the date of reporting. It was reported that, in the past couple of weeks from the date of reporting, he had an itchy bump where he received the SHINGRIX injection.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 3 months after receiving SHINGRIX, the patient experienced injection site itching and injection site swelling. On an unknown date, the outcome of the injection site itching and injection site swelling were unknown. It was unknown if the reporter considered the injection site itching and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX about 2 months before the date of reporting. It was reported that, in the past couple of weeks from the date of reporting, he had an itchy bump where he received the SHINGRIX injection.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Hives/itch; ALLEGRA/ZANTAC. I received my FLULAVAL IIV-4 during our employee flu drive at around 0830. Approximately an hour later, the injection site started to itch. I didn't think much of it as I've had numerous Influenza vaccine in the past, then as the day progress, the itchiness started to become generalized. By the time I got home at 1630, I started to have generalized hives all over my body. My throat was itchy, however, I also suffer from allergies. Around 1635, I took my DYMISTA earlier than my usual time of 2000, and in addition to the DYMISTA, I took 25 mg of BENADRYL and fell asleep. Next morning, itchiness was there, however no hives so I took an ALLEGRA, my morning AM of DYMISTA at around 0530 and went to work. I notice my throat scratchy and itchy but again due to my allergy, I associated it to my allergy symptoms. Then around 1030'ish the itch came back. I didn't notify my chain of command until about 1300 when my supervisor instructed me to go to Occ Health. By then, 1300'ish, hives developed again and was predominantly on my back. Occ Health provider gave me ALLEGRA and ZANTAC and sent me home for the rest of the day, about 1515'ish. I went to pick up my med at the Rx window and took my ALLEGRA and ZANTAC around 1540'ish. When I got home at 1620'ish, I took a cold shower as instructed by Occ Health provider, however, itchiness worsen and I ended up taking a BENADRYL at around 1700 and again feel asleep. The following day Saturday, when I woke up, itchiness was there but no hives, so I took my meds, ALLEGRA, DYMISTA, and ZANTAC as instructed and in addition, 50mg of BENADRYL. Then around 1400, I took an additional 25mg of BENADRYL, followed at 2100 my DYMISTA, ZANTAC, and another 25mg of BENADRYL. Sunday morning came and the itchiness improved. I did take the ALLEGRA, DYMISTA, and ZANTAC, however no BENADRYL. This AM, Monday, I still have some itchiness but not constant anymore - just occasional, generalized. I do not know if it is a true side effect or not since I do suffer from allergy and per my supervisor, I needed to report it, therefore, I am reporting it.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives/itch; ALLEGRA/ZANTAC. I received my FLULAVAL IIV-4 during our employee flu drive at around 0830. Approximately an hour later, the injection site started to itch. I didn't think much of it as I've had numerous Influenza vaccine in the past, then as the day progress, the itchiness started to become generalized. By the time I got home at 1630, I started to have generalized hives all over my body. My throat was itchy, however, I also suffer from allergies. Around 1635, I took my DYMISTA earlier than my usual time of 2000, and in addition to the DYMISTA, I took 25 mg of BENADRYL and fell asleep. Next morning, itchiness was there, however no hives so I took an ALLEGRA, my morning AM of DYMISTA at around 0530 and went to work. I notice my throat scratchy and itchy but again due to my allergy, I associated it to my allergy symptoms. Then around 1030'ish the itch came back. I didn't notify my chain of command until about 1300 when my supervisor instructed me to go to Occ Health. By then, 1300'ish, hives developed again and was predominantly on my back. Occ Health provider gave me ALLEGRA and ZANTAC and sent me home for the rest of the day, about 1515'ish. I went to pick up my med at the Rx window and took my ALLEGRA and ZANTAC around 1540'ish. When I got home at 1620'ish, I took a cold shower as instructed by Occ Health provider, however, itchiness worsen and I ended up taking a BENADRYL at around 1700 and again feel asleep. The following day Saturday, when I woke up, itchiness was there but no hives, so I took my meds, ALLEGRA, DYMISTA, and ZANTAC as instructed and in addition, 50mg of BENADRYL. Then around 1400, I took an additional 25mg of BENADRYL, followed at 2100 my DYMISTA, ZANTAC, and another 25mg of BENADRYL. Sunday morning came and the itchiness improved. I did take the ALLEGRA, DYMISTA, and ZANTAC, however no BENADRYL. This AM, Monday, I still have some itchiness but not constant anymore - just occasional, generalized. I do not know if it is a true side effect or not since I do suffer from allergy and per my supervisor, I needed to report it, therefore, I am reporting it.
Age: 5.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Cough, Injection site erythema, Vaccination site swelling, Wheezing
Clinical narrative: My 5 year old son had the FLUCELVAX flu vaccine. He had an anaphylactic allergic reaction including cough, closing airway, hives, nausea, and became lethargic. We had to use AUVI-Q EPIPEN. This relieved some of his symptoms but he was treated at the hospital with a breathing treatment, steroids, and BENADRYL.
Age: 5.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Anaphylactic reaction, Cough, Lethargy, Nausea, Throat tightness
Clinical narrative: My 5 year old son had the FLUCELVAX flu vaccine. He had an anaphylactic allergic reaction including cough, closing airway, hives, nausea, and became lethargic. We had to use AUVI-Q EPIPEN. This relieved some of his symptoms but he was treated at the hospital with a breathing treatment, steroids, and BENADRYL.
Age: 5.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Urticaria
Clinical narrative: My 5 year old son had the FLUCELVAX flu vaccine. He had an anaphylactic allergic reaction including cough, closing airway, hives, nausea, and became lethargic. We had to use AUVI-Q EPIPEN. This relieved some of his symptoms but he was treated at the hospital with a breathing treatment, steroids, and BENADRYL.
Age: 18.0
Sex: F
Vaccine: SMALL
Symptoms: Condition aggravated, Eczema, Skin plaque
Clinical narrative: Pt did not disclose prior history of eczema throughout screening process and was given the smallpox vaccine. Pt had an eczema flair with small plague on L flexural arm.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Headache, Neck pain, Vomiting
Clinical narrative: Mom reported via the phone on 7/24/18: Patient received Hepatitis A on 7/19/18 and on 7/21/18 in the evening the patient developed tiredness, neck pain and headache. He then began to vomit. All symptoms resolved in 24 hours.
Age: 32.0
Sex: M
Vaccine: JEV1
Symptoms: Urticaria
Clinical narrative: Hives start occurring the next day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Headache, shivering.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Arthralgia
Clinical narrative: Pt called to report that shortly after his vaccination, he started to have pain in his hip which had been operated on in May 2018. He had not previously felt pain in his hip consistently since the time immediately following the surgery. Patient is contacting his physician regarding further actions.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was given influenza vaccine on 2 different occasions (7 days apart) unintentionally.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Acne, Dizziness, Erythema, Headache, Musculoskeletal stiffness
Clinical narrative: Was given shot at about 2PM by 6PM, pain in my upper arm especially when moving, tingling both hands for about 30 seconds, nausea and vomiting during night, dizzy, faint when out of bed. Arm red, swollen from elbow to over shoulder, slight headache. Next day, pain in arm continued, fever 100, n/v subsided, three itchy pimple type areas on chest under affected arm, third day applied heat to arm with relief, pain subsided but still red underneath arm, about 1 wk later, large itchy welts appeared on inner aspect of each thigh lasting for about a day. Then about two wks later, several large about 4 inch diameter itchy welts appeared on back of leg, swollen red with several dark red centers, warm to touch lasting about three days. After itching, the area became sore. Redness and swelling gone, but a week later the area down my leg is still slightly itchy, some mild stiffness on arising in morning. Also, off and on until last week I had several small hive areas on my arm.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Was given shot at about 2PM by 6PM, pain in my upper arm especially when moving, tingling both hands for about 30 seconds, nausea and vomiting during night, dizzy, faint when out of bed. Arm red, swollen from elbow to over shoulder, slight headache. Next day, pain in arm continued, fever 100, n/v subsided, three itchy pimple type areas on chest under affected arm, third day applied heat to arm with relief, pain subsided but still red underneath arm, about 1 wk later, large itchy welts appeared on inner aspect of each thigh lasting for about a day. Then about two wks later, several large about 4 inch diameter itchy welts appeared on back of leg, swollen red with several dark red centers, warm to touch lasting about three days. After itching, the area became sore. Redness and swelling gone, but a week later the area down my leg is still slightly itchy, some mild stiffness on arising in morning. Also, off and on until last week I had several small hive areas on my arm.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Pyrexia, Skin warm, Urticaria, Vomiting
Clinical narrative: Was given shot at about 2PM by 6PM, pain in my upper arm especially when moving, tingling both hands for about 30 seconds, nausea and vomiting during night, dizzy, faint when out of bed. Arm red, swollen from elbow to over shoulder, slight headache. Next day, pain in arm continued, fever 100, n/v subsided, three itchy pimple type areas on chest under affected arm, third day applied heat to arm with relief, pain subsided but still red underneath arm, about 1 wk later, large itchy welts appeared on inner aspect of each thigh lasting for about a day. Then about two wks later, several large about 4 inch diameter itchy welts appeared on back of leg, swollen red with several dark red centers, warm to touch lasting about three days. After itching, the area became sore. Redness and swelling gone, but a week later the area down my leg is still slightly itchy, some mild stiffness on arising in morning. Also, off and on until last week I had several small hive areas on my arm.