chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain
Clinical narrative: Patient complained of sharp pain in the back of her left eye for a couple days (starting Monday 8/17/20). Went into her eye doctor where he checked the back of her eye and noticed the start of a virus attacking her retina. She was prescribed erythromycin ointment and Valtrex 1 gram orally.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Injected limb mobility decreased, Injection site pain
Clinical narrative: The employee says the next morning, the day after the injection, he found it difficult to extend his right arm away from the body. The employee reports performing push-up exercise to help the discomfort but it only made it worst. This nurse observed the injection site on 8/13/2020 and there was no redness or swelling but there was tenderness to touch.  There was still limited extension of the right arm but the employee reports extension progression from the day prior. The employee called the office on 8/20/2020 to report his arm was back at 100% per Staff. This nurse left several messages on the employee phone but has yet to speak with him since 8/13/2020
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Headache, Injection site pain
Clinical narrative: Full body muscle pain, skin pain but no redness, headache, stomach pain. Injection site pain.  Nausea.  Does not appear to be anaphylaxis.  All pain is significantly worse than flu symptoms except nausea which is manageable. Light headed. Weakness.  2nd shot only. First shot was much better tolerated.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain of skin
Clinical narrative: Full body muscle pain, skin pain but no redness, headache, stomach pain. Injection site pain.  Nausea.  Does not appear to be anaphylaxis.  All pain is significantly worse than flu symptoms except nausea which is manageable. Light headed. Weakness.  2nd shot only. First shot was much better tolerated.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Diplopia, Dizziness, Eye pain, Fatigue
Clinical narrative: My daughter, 11yo, received HPV vaccine around 3:30pm.  At 9pm she reported feeling slight nausea.  At 2pm she woke me up reporting acute nausea, dizziness, terrible headache, muscle pain, pain in arms, legs and skin.  She had a fever of 101.   Around 3am she began vomiting , seeing double and saying her eyeballs hurt.  She was very weak and could hardly walk or sit up in bed. She dry heaved on/off for 2 hours. She reported her skin was so painful that it was intolerable for me to gently touch her back or shoulder.  Her symptoms began to improve in the morning.  She was weak, fatigued and nauseous the remainder of the day. By the following day her symptoms were 90% relieved.  Since this event, 4 weeks ago, she has frequently mentioned feeling unusually fatigued, dizzy,  headache, sore skin and pain in the eyes.  She has never had ongoing complaints like this.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Gait disturbance, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: My daughter, 11yo, received HPV vaccine around 3:30pm.  At 9pm she reported feeling slight nausea.  At 2pm she woke me up reporting acute nausea, dizziness, terrible headache, muscle pain, pain in arms, legs and skin.  She had a fever of 101.   Around 3am she began vomiting , seeing double and saying her eyeballs hurt.  She was very weak and could hardly walk or sit up in bed. She dry heaved on/off for 2 hours. She reported her skin was so painful that it was intolerable for me to gently touch her back or shoulder.  Her symptoms began to improve in the morning.  She was weak, fatigued and nauseous the remainder of the day. By the following day her symptoms were 90% relieved.  Since this event, 4 weeks ago, she has frequently mentioned feeling unusually fatigued, dizzy,  headache, sore skin and pain in the eyes.  She has never had ongoing complaints like this.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Retching, Vomiting
Clinical narrative: My daughter, 11yo, received HPV vaccine around 3:30pm.  At 9pm she reported feeling slight nausea.  At 2pm she woke me up reporting acute nausea, dizziness, terrible headache, muscle pain, pain in arms, legs and skin.  She had a fever of 101.   Around 3am she began vomiting , seeing double and saying her eyeballs hurt.  She was very weak and could hardly walk or sit up in bed. She dry heaved on/off for 2 hours. She reported her skin was so painful that it was intolerable for me to gently touch her back or shoulder.  Her symptoms began to improve in the morning.  She was weak, fatigued and nauseous the remainder of the day. By the following day her symptoms were 90% relieved.  Since this event, 4 weeks ago, she has frequently mentioned feeling unusually fatigued, dizzy,  headache, sore skin and pain in the eyes.  She has never had ongoing complaints like this.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose normal, Dyskinesia, Eyelid disorder, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Pt experienced vasovagal syncope right after vaccine. Administered vaccine, initially patient felt fine and stated that he "didn't even feel it." Roughly 30 seconds later, after applying bandage, pt stated that "I'm actually starting to feel queasy." Immunizer looked up and pt had passed out in chair, head rolled back, eyes fluttered, and began having jerking movements. Immunizer designated team member to call 911, at that point pt regained consciousness (symptoms lasted roughly 10-15 seconds). No injuries were sustained, he was slightly nauseous. Pt laid down for a few minutes, drank orange juice. Pt was monitored for 15-20 minutes afterward, paramedics arrived and took vitals. Paramedics cleared pt to leave, pt felt back to normal and was comfortable leaving the store. Provided contact details for any further questions/concerns.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Posture abnormal, Syncope
Clinical narrative: Pt experienced vasovagal syncope right after vaccine. Administered vaccine, initially patient felt fine and stated that he "didn't even feel it." Roughly 30 seconds later, after applying bandage, pt stated that "I'm actually starting to feel queasy." Immunizer looked up and pt had passed out in chair, head rolled back, eyes fluttered, and began having jerking movements. Immunizer designated team member to call 911, at that point pt regained consciousness (symptoms lasted roughly 10-15 seconds). No injuries were sustained, he was slightly nauseous. Pt laid down for a few minutes, drank orange juice. Pt was monitored for 15-20 minutes afterward, paramedics arrived and took vitals. Paramedics cleared pt to leave, pt felt back to normal and was comfortable leaving the store. Provided contact details for any further questions/concerns.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Infant was administered Pediarix -0.5ml:  Hib 0.5ml; Prenvar 13-0.5ml and Rotateq 0.5ml by Medical Assistant.  Doctor  was notified  by this MA.  Doctor advised parents of this incident and parent transported infant to the Hospital.  Charge Nurse was notified .  I contacted the VFC Coordinator.  VFC Coordinator advised to create  AERS immediately.  Doctor contacted Infectious Disease doctor.  According to Doctor, she was advised to monitor patient .  Appointment to see Specialist was made for 08/25/2020.  No s/s of distress or discomfort noted.  Respiration appeared even and unlabored.  Skin color was pink.  Bilateral thigh with bandage noted.  No discoloration or bruising present.
Age: 58.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Dizziness, Fatigue, Pyrexia
Clinical narrative: 101 fever, chills, dizziness, extreme fatigue.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Dizziness, Pallor, Tremor
Clinical narrative: After 5 minutes, she started shaking, hands for about 3 seconds, she became pallor, with dizziness. Blood pressure 90/52 with pulse of 60. After 20 minutes, she felt better and was able to leave with both parents present.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Pruritus, Skin lesion
Clinical narrative: On 8/14, experience extreme itching on my right antecubital area and when I scratched it, I noted a vesicle with clear fluid that popped with scratching.  I then noted two other 1 mm fluid filled lesions on my right forearm that were also itching.  Several hours later, I had the sensation of stinging (as if I was being bitten by an insect)  on my right upper back and three more lesions similar to the ones on my forearm appeared.  There was also another one on the base of my neck on the right side.  The lesions on my right forearm continued to itch for the next week.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cough, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Severe arm swelling, redness, fever,cough arm pain, cough, felt weak 3/21/2020 until 3/25/2020
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe arm swelling, redness, fever,cough arm pain, cough, felt weak 3/21/2020 until 3/25/2020
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal discomfort, Diarrhoea, Haematochezia
Clinical narrative: patient stated that 1.5 hours after she received vaccination, she had abdominal discomfort with one bout of  diarrhea. Appeared to have some red flecks of blood in the stool. Reviewed symptoms with immunization team leader, and called patient back. Encouraged patient to seek treatment if stomach discomfort continued, diarrhea became explosive or if frank red blood continued. Patient stated understanding.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient spoke to pharmacist on duty  and expressed a rash.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Pyrexia
Clinical narrative: Spoke with mom in office regarding Patient's vaccine reaction to Kinrix in her right leg. Mom reports on 8/13 she started fevering 102 and had redness swelling and pain on her leg which resolved 8/14. She had blisters on her leg at injection site that resolved 8/20.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 4 vials of antigen were left in a box without the accompanying adjuvant. At the time the error was discovered, we were unable to determine which 4 patients received an incomplete vaccine dose. All 35 patients who received the lot number in question will be revaccinated. No adverse events were reported by patients.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling, Type IV hypersensitivity reaction
Clinical narrative: Raised, red warm skin 3 days following injection. Delayed hypersensitivity vs immune response from previous Varicella infection. Supportive care, ice pack, monitoring.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Myalgia, Nausea
Clinical narrative: muscle pain, headache, shivering, fever, stomach pain, or nausea
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: muscle pain, headache, shivering, fever, stomach pain, or nausea
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal discomfort, Headache, Nausea
Clinical narrative: about 5 min after receiving the vaccine patient started to feel upset to her stomach and nauseous, patient was moved into an examination room and she then had complaints of a painful headache. Patient was given Zofran 4 mg tablet, Ibuprofen 200 mg 2 tablets after about 20-25 min patient reported that the nausea was gone, the headache pain had decreased but pain not gone
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Dyspnoea, Full blood count, Headache, Hot flush, Malaise
Clinical narrative: Sx's started @ 15:40 with: hot flashes, shortness of breath/dyspnea, malaise, rash on neck, h/a, and pain in jaw.. Pt reported to ED, was given following Tx: @1723 diphenhydramine IVP 25mg, @1724 SOLU-MEDROL IVP 125mg, @1823 NS 1000mL bolus. Pt was discharged @ 1935.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Pain in jaw, Rash, Septic screen
Clinical narrative: Sx's started @ 15:40 with: hot flashes, shortness of breath/dyspnea, malaise, rash on neck, h/a, and pain in jaw.. Pt reported to ED, was given following Tx: @1723 diphenhydramine IVP 25mg, @1724 SOLU-MEDROL IVP 125mg, @1823 NS 1000mL bolus. Pt was discharged @ 1935.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Macule, Papule, Rash pruritic
Clinical narrative: Diffuse pruritic rash with macules and papules covering bilateral upper extremities and chest.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Swelling face
Clinical narrative: Rash on face, face swollen.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Hypopnoea, Neck pain, Pain, Peripheral swelling
Clinical narrative: Swollen arm, and neck was swollen and sore on left side. 1 day 1/2 later my left side was sore and I had shallow breathing, like it was heavy and hard to take breaths.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: Swollen arm, and neck was swollen and sore on left side. 1 day 1/2 later my left side was sore and I had shallow breathing, like it was heavy and hard to take breaths.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Fever 100.1, severe muscle pain in back of legs, pain at vaccination site, 4 inch circular red mark around vaccination site, fatigue.
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Pyrexia
Clinical narrative: Patient reported that he had a 102 degree fever the night of 8/14/20 after receiving the Fluad Quadravalent vaccine on 8/13/20. The fever worsened to 105 degrees the night of 8/15/20. He treated at home with Tylenol and his temperature returned to normal on 8/16/20.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Rash  , redness and itching
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Oedema peripheral, Pain in extremity, Peripheral swelling, Tendon disorder
Clinical narrative: R arm swelling, subcutaneous edema and pain 1 week after administration.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray limb abnormal
Clinical narrative: R arm swelling, subcutaneous edema and pain 1 week after administration.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash macular, Swelling
Clinical narrative: Fever 100.5 Swelling Red blotches upper arm Soreness
Age: 88.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site extravasation, Underdose
Clinical narrative: When giving the immunization the pharmacist noticed that a large quantity of the medication ran down the patients arm. Patient did not get the full amount of the vaccine. There was no way of knowing how much the patient received and how much ran down the patients arm. The pharmacist then gave the immunization again.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Headache, Pain, Peripheral swelling, Skin warm
Clinical narrative: Pt received MENVEO on his right arm on 8/19/20-now arm is red, swollen and warm to the touch. Painful.  Redness started out as quarter size about 30 minutes after injection but since has continued to increase and have a whelp like appearance.  No drainage from site or fever.  Hurts to move arm.  Redness has significantly increased today per mom.  No numbness or tingling. Also, started with a mild headache on after injection yet no vision changes or neck stiffness. Started on Elocon ointment and antibiotic (Augmentin) given in case spreads through the weekend.  Discussed applying ice packs to area.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Pt received MENVEO on his right arm on 8/19/20-now arm is red, swollen and warm to the touch. Painful.  Redness started out as quarter size about 30 minutes after injection but since has continued to increase and have a whelp like appearance.  No drainage from site or fever.  Hurts to move arm.  Redness has significantly increased today per mom.  No numbness or tingling. Also, started with a mild headache on after injection yet no vision changes or neck stiffness. Started on Elocon ointment and antibiotic (Augmentin) given in case spreads through the weekend.  Discussed applying ice packs to area.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site atrophy, Injection site discolouration, Injection site indentation
Clinical narrative: PATIENT HAS A LARGE AREA OF WHAT APPEARS TO BE PERMANENT TISSUE ATROPHY ON THE RIGHT THIGH. MOM STATES IT STARTED OUT AS A FEW GRAYISH COLORED DOTS ON RIGHT THIGH A FEW DAYS AFTER VACCINATIONS. THE DOTS APPEARED TO BE LITTLE INDENTIONS IN THE SKIN PER MOM .MOM ALSO STATES IT GOT WORSE AND NOW IT IS A LARGE AREA ABOUT THE SIZE OF A HALF DOLLAR. MOM DID NOT NOTIFY PHYSICIAN OF SKIN CHANGES SO NO TREATMENT WAS STARTED.
Age: 69.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Haematoma, Urticaria
Clinical narrative: hematoma down left arm, developed hives all over the body that would come and go
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Dyspnoea, Injection site pain, Injection site warmth, Tremor
Clinical narrative: pt had imm. at clinic and a few hours later called to report: tremendous arm pain where injection was given, a little bit of sob, very shaky, very clammy, feeling a little warmer to the site than normal, bicept very painful
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Sinus disorder
Clinical narrative: Patient called on 8/21/2020 to let me know she noticed a swollen right eye and sinuses after her shot yesterday evening.  She took an antihistamine and has had no issues today.  She just wanted it documented.  She states she has idiopathic angiedema and gets swelling for no obvious reason sometimes.  No breathing issues reported at any other time.  Did not feel need to contact md.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Rash
Clinical narrative: Patient called pharmacy and stated that she received the Shingrix vaccine on 8/13/2020.  She reported that on 8/15/2020 she woke up with a rash on both ankles.  She reports swelling in one ankle which started at the same time but she had previously injured that ankle earlier in the month so she believes the swelling may be unrelated but she went to her doctor for both symptoms.  Per the patient the doctor recommended ice and elevation for the swelling which helped along with compression.  Per the patient as of 8/21/2020 she still has no improvement on the rash and will be returning to the physician for reassessment.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Dizziness, Headache, Injection site pain, Mobility decreased
Clinical narrative: No symptoms until the following early morning hours. Woke up extremely sore at injection site. Pain rapidly got worse and spread throughout body as day progressed. Ears started ringing, and got very dizzy mid morning, also experienced odd, shaky movements in vision. Developed a fever towards the evening, fever continued to spike up to 103.1. Developed a severe headache, along with great difficulty moving due to severe pain throughout entire upper body. Felt pain and pressure in my spine. Fever broke and spiked several times throughout the night.  Day 3: Still extremely sore, headache, jaw pain, mild fever on and off.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in jaw, Pyrexia, Spinal pain, Tinnitus
Clinical narrative: No symptoms until the following early morning hours. Woke up extremely sore at injection site. Pain rapidly got worse and spread throughout body as day progressed. Ears started ringing, and got very dizzy mid morning, also experienced odd, shaky movements in vision. Developed a fever towards the evening, fever continued to spike up to 103.1. Developed a severe headache, along with great difficulty moving due to severe pain throughout entire upper body. Felt pain and pressure in my spine. Fever broke and spiked several times throughout the night.  Day 3: Still extremely sore, headache, jaw pain, mild fever on and off.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Visual impairment
Clinical narrative: No symptoms until the following early morning hours. Woke up extremely sore at injection site. Pain rapidly got worse and spread throughout body as day progressed. Ears started ringing, and got very dizzy mid morning, also experienced odd, shaky movements in vision. Developed a fever towards the evening, fever continued to spike up to 103.1. Developed a severe headache, along with great difficulty moving due to severe pain throughout entire upper body. Felt pain and pressure in my spine. Fever broke and spiked several times throughout the night.  Day 3: Still extremely sore, headache, jaw pain, mild fever on and off.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Contraindication to vaccination
Clinical narrative: Pt taking Humira medication
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Within 72 hours of injection, patient developed rash on the forehead which is consistent with herpes zoster.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Chills, Dizziness, Dyspnoea, Flushing
Clinical narrative: Immediately had blurry vision, bright flashes of light, dizziness, lack of balance, difficulty breathing, chills, flushed face.  Vomited a small amount.  After sitting and sipping water, symptoms went away after 10 minutes.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Photopsia, Vision blurred, Vomiting
Clinical narrative: Immediately had blurry vision, bright flashes of light, dizziness, lack of balance, difficulty breathing, chills, flushed face.  Vomited a small amount.  After sitting and sipping water, symptoms went away after 10 minutes.
Age: 83.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED AFTER RECEIVING BOTH THE PREVNAR13 AND FLUAD VACCINE. PATIENT WAS GETTING OUT OF THE CHAIR, STOOD UP AND FAINTED A COUPLE OF SECONDS LATER. A PARAMEDIC WAS IN THE STORE AND CHECKED HIM TO MAKE SURE PATIENT WAS COHERENT AND AWARE OF HIS SURROUNDINGS. THE PATIENT STARTED TO FEEL BETTER IMMEDIATELY AFTER THE FALL AND NO INJURIES WERE PRESENT. THE PATIENT REMAINED SEATED FOR 30 MINUTES AFTER THE FALL. THE PATIENT WAS ABLE TO WALK OUT ON HIS OWN AND HIS WIFE WAS PRESENT TO DRIVE THE PATIENT HOME. THE PATIENT STATED THAT HE HAD FAINTED BEFORE WHEN GETTING BLOODWORK ABOUT 10 YEARS AGO AFTER THE INCIDENT.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia
Clinical narrative: patient complained of overall weakness and joint pain in arms and legs
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Dizziness, Injection site pain, Muscular weakness, Nausea
Clinical narrative: patient complained of overall weakness and joint pain in arms and legs
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: patient complained of overall weakness and joint pain in arms and legs
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Patient complained of swelling and tenderness of the injection site the day following the vaccinations. She described the swelling to be limited to the upper arm that day. She tried applying cold packs and oral acetaminophen, which did not alleviate the swelling. On 8/21/2020 she called again stating that the swelling has now spread down past her elbow but up at the injection site is healed.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Generalized hives, treated with benadryl, improvement of symptoms
Age: 75.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Condition aggravated, Muscle disorder, Nervous system disorder
Clinical narrative: Previously had neurological issue which causes patient to lose control of muscle , he seems to have relapsed. Unsure as a result of vaccine or just timing
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Headache, Nausea, Productive cough, Pyrexia
Clinical narrative: Patient starting coughing up clear fluids around 9pm 8/13/20. Had diarrhea for the first 24 hours. Had nausea which lasted at least 4 days after vaccination. She also had fever and headache which was controlled with Tylenol.  Patient was in contact with PCP as well.
Age: 78.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site rash, Injection site scab
Clinical narrative: Patient presented back to pharmacy with skin rash around injection site that was red, scabbed and bloody.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Pain in extremity, Skin warm
Clinical narrative: While driving my car I suddenly became very dizzy, the lines on the street seemed to be moving and I had to pull over and put my head in my lap.  The rest of the day, I was very tired and my arm was warm and sore.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: raised, red, itchy, & hot circular area of about 4 inch diameter around the pneumovax injection site that was still present 6 days after vaccination
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash on torso
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Reported fatigue, muscle aches, redness, swelling, warmth at the injection site. Benadryl self-administered per patient for relief of symptoms.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Fatigue, Inflammation, Pain, Pyrexia
Clinical narrative: Reported body aches, low grade fever, inflammation, redness, fatigue. Self-treated with acetaminophen. Sought medical attention treated with antibiotics.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue
Clinical narrative: about 4 hours after injection, began fatigue, fatigue worsened, began feeling chills. No elevated temp at that time; elevated temp (99.5F) began about 6-7 hours after injection; temp is the same 8 hours out from injection.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness, swelling, fever, over 2 days post-vaccination. Patient went to the ER and received a prescription for keflex 500 mg tid
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm is swollen, red, hot to the touch. Noticed around 24 hours after injection.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Mobility decreased, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Severe R arm pain that radiates to back of R shoulder with weakness of R upper arm/shoulder lasting at least 8 days at the time of report. Patient unable to lift R arm past 90 degrees
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Confusional state, Cyanosis, Glassy eyes, Mass
Clinical narrative: Possible seizure after vaccines. Referred to neurology. Patient is a 12 month old who presents today for follow up after being seen in the ED last night for BRUE. According to mom, child was with sister in law in the living room and cried out to her that child was not breathing. Sister in law picked him up and ran with him, met mom in the hallway and mom states that the child was blue, stiffened and not breathing. No convulsing was noted. Mom states she took him in and laid him on the floor and he remained stiff and not breathing while the EMS was called. She had no idea how long this event lasted. The EMS responded within 15 minutes and by the time that they got there, child was breathing on his own but he had "glassy eyes" and seemed "out of it" and "confused". This lasted until they got to the ED, and then when he got there, he was behaving normally. ED id no additional testing as he was acting age appropriate and sent him home. He has been fine since and in the office today he is awake, alert and in no distress. He is playful and smiling. He was see in the office three days ago per this provider for well child check and received his 12 month vaccines (MMR, Varicella, Hepatitis A, Prevnar). At that time it was also noted that he had a golf ball sized mass on the right clavicle which mom had noted a week before. Xray of area was normal as was an ultrasound of the area. No past medical history on file.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Musculoskeletal stiffness, Respiratory arrest, Ultrasound scan normal, X-ray normal
Clinical narrative: Possible seizure after vaccines. Referred to neurology. Patient is a 12 month old who presents today for follow up after being seen in the ED last night for BRUE. According to mom, child was with sister in law in the living room and cried out to her that child was not breathing. Sister in law picked him up and ran with him, met mom in the hallway and mom states that the child was blue, stiffened and not breathing. No convulsing was noted. Mom states she took him in and laid him on the floor and he remained stiff and not breathing while the EMS was called. She had no idea how long this event lasted. The EMS responded within 15 minutes and by the time that they got there, child was breathing on his own but he had "glassy eyes" and seemed "out of it" and "confused". This lasted until they got to the ED, and then when he got there, he was behaving normally. ED id no additional testing as he was acting age appropriate and sent him home. He has been fine since and in the office today he is awake, alert and in no distress. He is playful and smiling. He was see in the office three days ago per this provider for well child check and received his 12 month vaccines (MMR, Varicella, Hepatitis A, Prevnar). At that time it was also noted that he had a golf ball sized mass on the right clavicle which mom had noted a week before. Xray of area was normal as was an ultrasound of the area. No past medical history on file.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Was given extra Varicella dose in error
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis, Nephrolithiasis
Clinical narrative: Patient recieved shot on 8-17-20. Went to the hospital on 8-18-20 for kidney stones. While there the Doctors noticed Patient had some cellulitis around the area of the shot and gave Keflex to treat it. Was Discharged on 8-21-20 with a 10 day supply of antibiotics.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient complains of red, swollen, hot to touch arm. Advised to take Tylenol and use ice. Patient will call her doctor.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: I Took pt to get X-Ray done and after grabbed a Tdap vaccine From Fridge. Administered Tdap. Completed order + task and saw Doctor had ordered Dtap.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Erythema, Headache, Influenza like illness, Malaise, Oropharyngeal pain
Clinical narrative: Arm very sore, very red about 4 inches wide from injection area to all around my arm. That night had aches + pains like flu, sore throat, headache, pain in back of my head. was sick all weekend. Felt like worst case of flu ever.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm very sore, very red about 4 inches wide from injection area to all around my arm. That night had aches + pains like flu, sore throat, headache, pain in back of my head. was sick all weekend. Felt like worst case of flu ever.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Pain in extremity
Clinical narrative: Patient reported a localized reaction at injection site which included redness and swelling and pain. They reported pain going down arm as well. Patient called the day after to report these symptoms. Patient was advised by pharmacist to use ice pack, benadryl, hydrocortisone cream to help with reaction. PCP was contacted and made aware of reaction and agreed with recommendation. Patient called back the next day report symptoms were resolving. Pharmacist recommended seeing doctor or urgent care if symptoms worsened.
Age: 11.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: The patient was ordered her first dose of Menactra and received Trumeba instead, No AE; Initial information was received on 10-Aug-2020 regarding an unsolicited valid non-serious case from the other healthcare professional.  This case is linked to case 2020SA209041 (same reporter).  This case involves an 11 year old female patient who was vaccinated with a dose of MENINGOCOCCAL VACCINE B RFHBPA/FHBPB [TRUMENBA] (batch number and other dosing details were not reported) for prophylactic vaccination on 03-Aug-2020 instead of the first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, past medical treatment, concomitant medication, vaccinations and family history were not provided.   It was an actual medication error case due to wrong vaccine administered.  The patient did not experience any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 78.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site haemorrhage, Injection site rash, Injection site scab
Clinical narrative: Patient reported skin rash with bloody/scabbed appearance around the injection site that started after receiving vaccination. He was seen by MD who is treating and following reaction.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Severe joint pain in ALL joints just like it felt when I had interferon injections (many years ago) with a fever of 101* for about 8 hours with the chills. This was my first shot.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient states that her left shoulder pains her when she tries to lift her arm. Patient states this pain began soon after receiving her flu shot.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on abdomen area 2 days after immunization
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Erythema, Feeling cold, Headache, Influenza like illness
Clinical narrative: Swelling at shot site, severe body aches and severe headache, red rings on right side of upper chest and beside shot site, chills (I felt as though I had a case of the flu--I couldn't get warm), shot site and right shoulder still quite sore almost 24 hours.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Swelling at shot site, severe body aches and severe headache, red rings on right side of upper chest and beside shot site, chills (I felt as though I had a case of the flu--I couldn't get warm), shot site and right shoulder still quite sore almost 24 hours.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Rash macular, Swelling, Tenderness
Clinical narrative: states very painful that day, next day developed a blotchy rash that spread 2 d after vaccine. Seen 3 days after vaccine and very tender, red, swollen.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Joint swelling, Peripheral swelling, Pruritus
Clinical narrative: cellulitis like swelling at elbow and forearm with no pain but intense itching. relieved by Benadryl
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Tdap Patient came to the ER one day after receiving Tdap. She complained of left arm pain an tingling since getting her Tdap vaccination. Pt states her left hand is swollen, but myself and the staff do not see any swelling, redness, and it is not hot to touch.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Headache, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Rapid onset of high fever, weakness, body aches, headache  lasted until mid-morning next day
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient skin was red and swollen from the elbow up to the point of injection
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Patient stated she experienced extreme itch, redness, heat
Age: 58.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Feeling abnormal, Headache, Insomnia, Pain in extremity
Clinical narrative: On June 1, 2020, I took first dose of Varicella-zoster vaccine subcutaneous vaccine at my doctor's office. I had sore arm for 2-3 days.  Not too bad since I expected same.  On August 13, 2020 around 9:30am, I took second dose of the vaccine in my left arm at clinic.  I started feeling noticeably bad around 8pm  that evening.  Overnight I slept very little.  My left arm was sore.  But worst overnight symptoms were pounding left temple headache and substantial pain in upper left jaw when my teeth clenched together.  In the morning, I took my temperature twice and each time it was 99.7.  I took first pain medication at 6:00am.  I took more Tylenol at 10:00am and 2:00pm.  I took afternoon shower and by 6:00pm felt good enough to skip any pain medication.  Slept okay second night.  My arm remained very sore for 2-3 days and a little sore for a few more days.  I have felt normal the past week.
Age: 58.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain in jaw
Clinical narrative: On June 1, 2020, I took first dose of Varicella-zoster vaccine subcutaneous vaccine at my doctor's office. I had sore arm for 2-3 days.  Not too bad since I expected same.  On August 13, 2020 around 9:30am, I took second dose of the vaccine in my left arm at clinic.  I started feeling noticeably bad around 8pm  that evening.  Overnight I slept very little.  My left arm was sore.  But worst overnight symptoms were pounding left temple headache and substantial pain in upper left jaw when my teeth clenched together.  In the morning, I took my temperature twice and each time it was 99.7.  I took first pain medication at 6:00am.  I took more Tylenol at 10:00am and 2:00pm.  I took afternoon shower and by 6:00pm felt good enough to skip any pain medication.  Slept okay second night.  My arm remained very sore for 2-3 days and a little sore for a few more days.  I have felt normal the past week.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Erythema, Peripheral swelling
Clinical narrative: Patient reported a red, swollen arm, and bone aches
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Skin disorder, Skin reaction, Skin swelling
Clinical narrative: A 4 inch by 4 inch square of red, raised skin that occurred the day after immunization, sensitive for 1-2 days which has since gone away.  3 days after vaccination, 2 green quarter sized marks on skin appeared on and below chest on the same side of the body as the vaccine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abnormal behaviour, Anger, Emotional disorder, Personality change
Clinical narrative: Fits of rage, extreme change in behavior and personality, loss of emotional control
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Autoimmune disorder, Coeliac disease, Food intolerance, Urticaria
Clinical narrative: Severe hives, new food intolerances, Celiac Disease, and general autoimmune symptoms
Age: 29.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Local reaction, Pain in extremity, Pyrexia
Clinical narrative: Redness, Very sore arm, slight fever (< 101) - saw Dr on Demand due to concerns about return to work in the COVID era - Dr said typical symptoms and prescribed ibuprofen for as needed use. Dr also recommended "icing" on the local reaction.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: red around injection site sore swollen
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza like illness, Myalgia, Nuchal rigidity, Pain
Clinical narrative: Patient called pharmacy today saying that she cannot get out of bed, she feels like she has the flu. No fever, no swelling, no rash. Her body is completely sore from head to toe, muscle aches everywhere and she cannot move arm. Her neck is bothering her (rigid) but she has previous history of neck pain. She was very upset. This started night that she received the shot.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Pruritus, Rash vesicular
Clinical narrative: 10 days after the vaccine I got a shingle type looking rash from my pubic area. radiating outward along my left upper leg, in the crease where your upperleg meets your torso.  11 days after the vaccine i started to get spots like chicken pox on my left flank and back.  12 days after the vaccine i continued to get pox on my left ankle, totally around my entire ankle.   went to doctor to have rash evaluated and was told that I had a case of chicken pox, possibly a rare side effect from the shringix vaccine I had received. I started taking the prescription,  Valacyclovir HCL 500 mg (2 tabs 3 times per day for 7 days) on 8/18/20. As of today, 8/22/20 some of my pox are scabbing over, no pain, just some itchiness and not many new pox are emerging. I use coconut oil with essential oil of tea tree, lavendar and geranium on the spots every morning, I take a colloidal oatmeal bath at night and then apply calamine plus to the pox.  I also experienced a slight headache , fatigue and some lightheadedness on the first 4 days of pox emerging.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: 10 days after the vaccine I got a shingle type looking rash from my pubic area. radiating outward along my left upper leg, in the crease where your upperleg meets your torso.  11 days after the vaccine i started to get spots like chicken pox on my left flank and back.  12 days after the vaccine i continued to get pox on my left ankle, totally around my entire ankle.   went to doctor to have rash evaluated and was told that I had a case of chicken pox, possibly a rare side effect from the shringix vaccine I had received. I started taking the prescription,  Valacyclovir HCL 500 mg (2 tabs 3 times per day for 7 days) on 8/18/20. As of today, 8/22/20 some of my pox are scabbing over, no pain, just some itchiness and not many new pox are emerging. I use coconut oil with essential oil of tea tree, lavendar and geranium on the spots every morning, I take a colloidal oatmeal bath at night and then apply calamine plus to the pox.  I also experienced a slight headache , fatigue and some lightheadedness on the first 4 days of pox emerging.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth, Neck pain
Clinical narrative: Redness with heat at injection site. Along with rash, chills and muscle pain starting at injection site radiating to left side of neck.  Employee took Tylenol for pain with only 2 hours of relief from pain.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Rash
Clinical narrative: Redness with heat at injection site. Along with rash, chills and muscle pain starting at injection site radiating to left side of neck.  Employee took Tylenol for pain with only 2 hours of relief from pain.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got the shingles on my right leg below my calf
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Eruption of rash on neck and chest approximately 36 hours after injection. Diagnosed by dermatologist, Dr. to be shingles. After one week, rash appears to be resolving.
Age: 67.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Atrial fibrillation, Heart rate increased, Respiratory rate increased
Clinical narrative: Patient said she started getting rapid heart rate and rapid breathing about 1 hour after recieving the shots.  She continued to experience these symptoms for several days before ending up in the hospital to be diagnosed with Atrial Fibrillation.  The doctors at the hospital did not think it was due to the vaccines, but she wanted us to report it anyway.  This was the first time she ever had a reaction to any vaccine.
Age: 67.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Cardiac flutter, Dyspnoea
Clinical narrative: Patient said she started getting rapid heart rate and rapid breathing about 1 hour after recieving the shots.  She continued to experience these symptoms for several days before ending up in the hospital to be diagnosed with Atrial Fibrillation.  The doctors at the hospital did not think it was due to the vaccines, but she wanted us to report it anyway.  This was the first time she ever had a reaction to any vaccine.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Condition aggravated, Gait inability, Multiple sclerosis
Clinical narrative: I lost body strength and could not walk or maintain my balance, muscle aches. This also happened on the first shingrex  shot (7/17/2020) but this second was worse. I began to recover about  24 hours after the 2nd  vaccination but itnis now 48 hours and I am not completely back to my normal which is affected by my MS/
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: I lost body strength and could not walk or maintain my balance, muscle aches. This also happened on the first shingrex  shot (7/17/2020) but this second was worse. I began to recover about  24 hours after the 2nd  vaccination but itnis now 48 hours and I am not completely back to my normal which is affected by my MS/
Age: 55.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Hypoacusis
Clinical narrative: Patient received both vaccines on 08/20/2020 and woke up the next morning (08/21/2020) with some hearing issues in one ear. He described sounds being very muffled.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient Called pharmacy on 08/18/2020 and reported Swelling, Redness spreading of approximately 2 to 3 inches of diameter from site of injection. Patient also reported muscle pain and hot to touch. Patient tried icing the area but did not help. Pharmacist on duty referred patient to seek care from Primary care doctor for further management of symptoms. Pharmacist also notified the Primary care doctor on 08/19/2020. Pharmacist followed up with patient and according to patient she has seen her primary care MD on 08/21/2020. She also reported improvement and no further signs/symptoms  of swelling/redness on 08/22/2020 to pharmacist.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Redness and swelling at the injection site, and warm to the touch, but reaction is localized and swelling is improving.
Age: 65.0
Sex: F
Vaccine: FLU4, UNK, VARZOS
Symptoms: Abdominal pain, Abdominal pain upper, Back pain, Fatigue, Injection site pain
Clinical narrative: Low grade fever, nausea, stomach and abdominal pain/cramping, mid back pain, injection site pain/swelling, body aches, fatigue
Age: 65.0
Sex: F
Vaccine: FLU4, UNK, VARZOS
Symptoms: Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Low grade fever, nausea, stomach and abdominal pain/cramping, mid back pain, injection site pain/swelling, body aches, fatigue
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Gait inability, Hyperhidrosis, Muscle spasms, Pain in extremity, Pyrexia
Clinical narrative: patients girlfriend stated when he got home he started vomiting and needed help getting up the steps because he couldn't walk up them alone, she also said he had a fever. Later that day I checked in and she said he stopped vomiting but was sweating and still had leg pain(muscle cramps).