chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Anger, Crying, Eye movement disorder, Hypotonia, Malaise
Clinical narrative: Saturday morning my daughter did not feel well. I had been anticipating this because of her vaccine she got the few days prior. She got more and more upset, and I realized she had a fever. When I checked it, it was 104 F. I put a cool wet cloth on her forehead, and gave her a dose of TYLENOL. I wasn't too worried about her fever being so high because she was willing to drink fluids, and she was responding normal. I held her on the couch after giving her TYLENOL, and she fell asleep. I checked her temperature every 15 minutes or so as she slept in my arms. Her fever went down to 101. She was sleeping when she started whining/crying. She opened her eyes then her eyes rolled back and she went completely limp. I sat her up immediately trying to get her to respond. She woke up immediately and started vomiting. She continued to vomit throughout the day with a fever of about 100. She was responsive the rest of the day, and drinking fluids so I did not take her to urgent care.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Saturday morning my daughter did not feel well. I had been anticipating this because of her vaccine she got the few days prior. She got more and more upset, and I realized she had a fever. When I checked it, it was 104 F. I put a cool wet cloth on her forehead, and gave her a dose of TYLENOL. I wasn't too worried about her fever being so high because she was willing to drink fluids, and she was responding normal. I held her on the couch after giving her TYLENOL, and she fell asleep. I checked her temperature every 15 minutes or so as she slept in my arms. Her fever went down to 101. She was sleeping when she started whining/crying. She opened her eyes then her eyes rolled back and she went completely limp. I sat her up immediately trying to get her to respond. She woke up immediately and started vomiting. She continued to vomit throughout the day with a fever of about 100. She was responsive the rest of the day, and drinking fluids so I did not take her to urgent care.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Inflammation, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The adverse reaction started the morning after the vaccine was given: Redness, hotness and swelling noted in the whole deltoid muscle of the right deltoid. The arm was double the size of the non-vaccinated deltoid. Treated the swelling, redness, and inflammation with MOTRIN, ice and elevation above the level of his heart. No improvement was noted. Continued with MOTRIN every 6 hours, ice and elevation. Minimal improvement noted on the 3rd day after the injection. Note: this child received the quadrivalent vaccine last year and the year before. Two years ago the swelling was from the shoulder to the elbow, the swelling in the arm that was injected was double the size of the non-injected arm. Last year the quadrivalent vaccine was given and the swelling was from the shoulder to the mid-arm and that portion of his arm was double the size of the non-injected arm. The swelling has decreased each year, but is still abnormally swollen and very uncomfortable for the child. Is this a reaction that is seen after the influenza vaccination?
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain
Clinical narrative: Pain developed from the injection site to the pt's elbow the following day. Md dx pt with shingles on 9/25/2017.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of other viral vaccines, initial encounter on 2017-09-26.
Age: 0.33
Sex: F
Vaccine: HPV9
Symptoms: Wrong drug administered
Clinical narrative: Pt was scheduled to receive HIB vaccine and was given HPV vaccine by mistake. Mom was notified of error by Dr.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Vaccination complication
Clinical narrative: Extreme swelling and redness around injection site. When pressed on feels hard. Over the course of two days worsened and spread near groin. Took to urgent care 10/01/2017 at 3:30 pm. Diagnosis were cellulitis of left lower extremity and vaccination reaction, initial encounter. Amoxicillin was prescribed.
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Mom would like to report child the evening of the shots that he started with 102 fever, aches, headache, diarrhea lasted till 10/2/2017.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Rash macular, Vaccination complication
Clinical narrative: Red blotchy patch on left deltoid and extending onto back. No pain or stiffness. Second back to back adverse reaction to this shot within 3 days.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site induration, Injection site mass, Injection site pain, Musculoskeletal pain
Clinical narrative: I received the Tdap vaccine when I was admitted to the hospital for a foot injury/surgery. After the injection my arm was very sore, but I figured the pain would go away in a few days. It has now been about 4 weeks and the pain is worse. My arm and shoulder experience a numbness and pins and needles sensation. When trying to lie down on my back the pain is almost unbearable. There is a continuous ache throughout my arm and shoulder. The injection site is tender to light touch and has a hard lump. The pain radiates from my shoulder down my arm and through my fingertips.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: I received the Tdap vaccine when I was admitted to the hospital for a foot injury/surgery. After the injection my arm was very sore, but I figured the pain would go away in a few days. It has now been about 4 weeks and the pain is worse. My arm and shoulder experience a numbness and pins and needles sensation. When trying to lie down on my back the pain is almost unbearable. There is a continuous ache throughout my arm and shoulder. The injection site is tender to light touch and has a hard lump. The pain radiates from my shoulder down my arm and through my fingertips.
Age: 58.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Injection site erythema, Skin warm
Clinical narrative: Right arm with 5 X4 inch erythematous patch over the deltoid injection site, minimal redness and warmth to the rest of the arm.
Age: 46.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: L arm SQ where PPV23 was administered became painful, hot, red, raised, arm was very painful to move. Pt showed photos of raised red weal extending from just above elbow to the middle of back of upper L arm. Resolving slowly. Pt reports used ice on/off some for relief.
Age: 46.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain
Clinical narrative: L arm SQ where PPV23 was administered became painful, hot, red, raised, arm was very painful to move. Pt showed photos of raised red weal extending from just above elbow to the middle of back of upper L arm. Resolving slowly. Pt reports used ice on/off some for relief.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Rash erythematous, Rash pruritic, Wheezing
Clinical narrative: Acute Shortness of breath, wheezing and pruritic erythematous rash. Treated with BENADRYL 25 mg PO at 10:12, Epinephrine 1 mg/ml (1:1000) -0.3 mg IM at 10:30, SOLU-MEDROL 125 mg IVP at 10:27, Albuterol- ipratropium neb 3 ml at 10:13. Famotidine 40 mg PO at 10:13, Ibuprofen 600 mg PO at 12:48. Monitored in the ED for 6 hours with frequent reassessments with no recurrence.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles, Pruritus
Clinical narrative: Pt had shingles vaccine on 8-9-17 in the R upper arm. That night pt noted redness and swelling, itchiness at injection site. On September 12 pt noted raised bumpy erythematous lesion, +itching R calf on 9/12/17. This past Saturday 9/30 pt noted blister on R upper arm.  Around the same time she also noticed itchiness in R medial back.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Pt had shingles vaccine on 8-9-17 in the R upper arm. That night pt noted redness and swelling, itchiness at injection site. On September 12 pt noted raised bumpy erythematous lesion, +itching R calf on 9/12/17. This past Saturday 9/30 pt noted blister on R upper arm.  Around the same time she also noticed itchiness in R medial back.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Fall, Head injury, Loss of consciousness, Nodule
Clinical narrative: About 10 minutes after receiving the vaccines the patient passed out. She came to fairly quickly but hit her head on the floor during the fall. She had a knot on her head. After checking her out and applying an icepack, her father was advised to carry her to the ER for an evaluation. When she left the clinic she was alert, oriented and her pupils were even and reactive. We have since called to check on her. They said that they took her to the ER and the MD said she was ok and she is not having any problems.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Injection site pain, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Patient had flu shot in the LEFT arm on 9/28/17 in the morning, on the same day in the evening she started having problems. Pt reported the following side effects: Pain in both shoulder but mainly in the RIGHT shoulder, feels like a muscle ache (relieved by squeezing) and pain in the bone, pain also in the back of the neck, but not at the sides of the neck. Pt complains pain still continues as of today (10/2/17) when it was reported. Pt has been taking TYLENOL. I instructed her to take ibuprofen or naproxen and she cannot due to GI disturbances w/ NSAIDS. I instructed her to try and ice the area and continue TYLENOL. I contacted the md office and they will get in touch with pt with further direction. MD office instructed pt to contact the office in the morning if symptoms didn't improve.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Chills, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Received PREVNAR 13 at 11:29am on 9/28/17. Patient reports she began feeling fever, chills, and "sensation of something stuck in her chest" along with redness, swelling, warmth, and itchiness of injection site. States feeling in chest resolved around 1am on 9/29/17 after drinking cold water but the local reaction continued (with some improvement) until today. Denies any chest pain, pain of site, or SOB. Left deltoid area has reddish urticarial area and is slightly warm to touch, no tenderness or fluctuance, no axillary adenopathy, no evidence of cellulitis or abscess. Treatment includes ice pack 4 times a day, diphenhydramine 25mg tab q 8 hrs as needed and ibuprofen 600mg tab three times a day.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site urticaria, Injection site warmth, Local reaction, Pyrexia
Clinical narrative: Received PREVNAR 13 at 11:29am on 9/28/17. Patient reports she began feeling fever, chills, and "sensation of something stuck in her chest" along with redness, swelling, warmth, and itchiness of injection site. States feeling in chest resolved around 1am on 9/29/17 after drinking cold water but the local reaction continued (with some improvement) until today. Denies any chest pain, pain of site, or SOB. Left deltoid area has reddish urticarial area and is slightly warm to touch, no tenderness or fluctuance, no axillary adenopathy, no evidence of cellulitis or abscess. Treatment includes ice pack 4 times a day, diphenhydramine 25mg tab q 8 hrs as needed and ibuprofen 600mg tab three times a day.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Developed hives 8 hours after vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient received a ZOSTAVAX vaccine in the left upper arm and the next day noticed redness in the area that is warm to touch. Patient states that she does take ZYRTEC. Red area is "palm" size and itchy.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Nasal injury, Syncope
Clinical narrative: Pt experienced syncopal episode after her 1st HPV vaccine. Pt hit her nose on a counter. Pt was helped to a wheelchair. Given ice packs, juice and crackers. BP taken. 110/60. Pt recovered and was able to walk out of office with mom.
Age: 70.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Circular and warm swelling at the injection site, like a bubble where the injection was given. Did not go away for 15 minutes, pt was otherwise well. No pain or other adverse effects.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Nausea, Pruritus, Skin tightness, Skin warm
Clinical narrative: NAUSEA, ITCHING, ACHY JOINTS, TIGHT ARM, HOT ARM.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Crying, Gait disturbance, Gait inability, Injection site erythema, Injection site nodule
Clinical narrative: Son unable to walk about 30 minutes after vaccination (after removing from car seat), extremely irritability and crying with fever. Injection site red with a huge knot. All symptoms persisted for 3 days approximately, including the inability to walk. I would put him down to get him to stand and he would cry. Attempted to give MOTRIN for fever and pain. Little relief but still marked fussiness, pain tender to palpation and refusing to walk.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Irritability, Pain, Pyrexia, Tenderness
Clinical narrative: Son unable to walk about 30 minutes after vaccination (after removing from car seat), extremely irritability and crying with fever. Injection site red with a huge knot. All symptoms persisted for 3 days approximately, including the inability to walk. I would put him down to get him to stand and he would cry. Attempted to give MOTRIN for fever and pain. Little relief but still marked fussiness, pain tender to palpation and refusing to walk.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: 12 month old child brought in for vaccines. Mother elected to have child get HepA, MMR, and varicella. RN gave child HepA, varicella and MMRV (PROQUAD) in error; should have given MMR. Error identified when RN attempted to enter doses in system, and lot number discrepancy noted. Child got two doses of varicella vaccine. Child got combination vaccine which can cause increased risk of febrile seizures. Parent was informed, VIS for varicella and combo vaccine (MMR) given. Questions answered. No adverse reaction at this time; RN supervisor will follow up at 24 hr, 48 hr, 5d and 12d.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus
Clinical narrative: Patient reported difficulty breathing and itching a few hours after vaccine was administered. On 10/2/2017 she went to Clinic for itching and was prescribed hydroxyzine HCL.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Pruritus, Urticaria
Clinical narrative: About 3 hrs after injection I started to itch. In about 10 hrs I had a fast heart rate and hives all over my trunk-front and back. I took 2 BENADRYL at 10AM and 2PM. After 24 hrs the hives went away and my heart was at a normal rate. I had an influenza vaccine but I don't know which one it was on your list of flu vaccines.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Patient presented 2 days later with swelling, redness, heat, and radiating pain down towards hands. Patient was recommended to see MD, and did see MD at Urgent Care across the street.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Oropharyngeal pain
Clinical narrative: Patient called today complaining that she woke up with a sore throat. It is not serious and is not intending to seek medical care at this time.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Abdominal pain, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Nausea and vomiting within 24 hours of injection mild abdominal cramp, headache and low grade fevers. These symptoms lasted 24 hours. Hive-like swelling and tenderness with heat and erythema at injection site that lasted greater than 4 days.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site warmth, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea and vomiting within 24 hours of injection mild abdominal cramp, headache and low grade fevers. These symptoms lasted 24 hours. Hive-like swelling and tenderness with heat and erythema at injection site that lasted greater than 4 days.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Computerised tomogram thorax abnormal, Pneumonia, Pneumonitis
Clinical narrative: PATIENT GOT LOBAR PNEUMONITIS WITHIN 8 TO 9 DAYS FOLLOWING VACCINE. THIS IS AN EXTREMELY FIT WOMAN WHO RUNS MARATHONS MULTIPLE TIMES PER YEAR AND NEVER COMES IN WITH ANY TYPE OF RESPIRATORY ILLNESS. SHE HAD NO EXPOSURE TO ANYONE AND HAD NO PRECEDING RESPIRATORY ILLNESS OF ANY KIND. NO RECENT TRAVEL.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Mother stated late afternoon on 09/28/2017 she had noted a red spot on the left arm (Deltoid area) where her son received his vaccination. It appeared to be the size of a golf ball in diameter. It was warm to the touch but not painful no other symptoms where noted. Mother asked what she could do. I advised her to place a cold pack over site on a rotation of 30 minutes on and off. Children's TYLENOL or MOTRIN per label use as needed. If itching occurs can use Children's BENADRYL as needed. If she has more concerns she can contact her doctor or if after hours see a doctor at a local ER.
Age: 68.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient said her arm instantly swelled at the injection site at the time of immunization and the next several days her armed swelled more, was red, brown at injection site, feverish, and itched. Patient went to the doctor 3 days later and was evaluated. The doctor told the patient  to place ice on the arm and take ibuprofen for the pain and fever in the arm.
Age: 68.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient said her arm instantly swelled at the injection site at the time of immunization and the next several days her armed swelled more, was red, brown at injection site, feverish, and itched. Patient went to the doctor 3 days later and was evaluated. The doctor told the patient  to place ice on the arm and take ibuprofen for the pain and fever in the arm.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Angiogram, Asthenia, Blood test normal, Condition aggravated
Clinical narrative: My daughter started feeling weak and having left side/stomach pain in the weeks following the shot.  She fainted for the first time three weeks later and fainted again the following week. A trip to the ER discovered a heart condition (WPW) that we were unaware of. She was having heart rate irregularities, but the cardiologist said they were not typical of WPW. The WPW was fixed on July 17. But her condition only got worse. She has extreme dizziness, fatigue and experiencing migraines for the first time in her life. She has missed tons of school. She was a ballerina and can't dance or do anything anymore. This vaccine has ruined her life.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Echocardiogram, Electrocardiogram, Electroencephalogram, Fatigue
Clinical narrative: My daughter started feeling weak and having left side/stomach pain in the weeks following the shot.  She fainted for the first time three weeks later and fainted again the following week. A trip to the ER discovered a heart condition (WPW) that we were unaware of. She was having heart rate irregularities, but the cardiologist said they were not typical of WPW. The WPW was fixed on July 17. But her condition only got worse. She has extreme dizziness, fatigue and experiencing migraines for the first time in her life. She has missed tons of school. She was a ballerina and can't dance or do anything anymore. This vaccine has ruined her life.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Heart rate irregular, Loss of personal independence in daily activities, Migraine, Nuclear magnetic resonance imaging, Syncope
Clinical narrative: My daughter started feeling weak and having left side/stomach pain in the weeks following the shot.  She fainted for the first time three weeks later and fainted again the following week. A trip to the ER discovered a heart condition (WPW) that we were unaware of. She was having heart rate irregularities, but the cardiologist said they were not typical of WPW. The WPW was fixed on July 17. But her condition only got worse. She has extreme dizziness, fatigue and experiencing migraines for the first time in her life. She has missed tons of school. She was a ballerina and can't dance or do anything anymore. This vaccine has ruined her life.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Wolff-Parkinson-White syndrome
Clinical narrative: My daughter started feeling weak and having left side/stomach pain in the weeks following the shot.  She fainted for the first time three weeks later and fainted again the following week. A trip to the ER discovered a heart condition (WPW) that we were unaware of. She was having heart rate irregularities, but the cardiologist said they were not typical of WPW. The WPW was fixed on July 17. But her condition only got worse. She has extreme dizziness, fatigue and experiencing migraines for the first time in her life. She has missed tons of school. She was a ballerina and can't dance or do anything anymore. This vaccine has ruined her life.
Age: 36.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm - just inferior to what appears to be the puncture wounds from vaccinations, with 3cm x 4cm area of erythema and swelling. With warmth to touch. There is no circumferential swelling noted. FROM of arm. Distal pulses and sensation intact. , seen on 09/29/17 was prescribed Doxycycline for cellulitis. Returned to clinic on 10/01/2017,  he continues to have spreading redness. The redness is almost circumferential. He denies fever, systemic symptoms, no n/v. Not responding to doxy, added rantidine for H2 blockade and benadryl qHS. Patient will return to clinic on 10/03/2017 for further eval.
Age: 36.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Wound
Clinical narrative: Left upper arm - just inferior to what appears to be the puncture wounds from vaccinations, with 3cm x 4cm area of erythema and swelling. With warmth to touch. There is no circumferential swelling noted. FROM of arm. Distal pulses and sensation intact. , seen on 09/29/17 was prescribed Doxycycline for cellulitis. Returned to clinic on 10/01/2017,  he continues to have spreading redness. The redness is almost circumferential. He denies fever, systemic symptoms, no n/v. Not responding to doxy, added rantidine for H2 blockade and benadryl qHS. Patient will return to clinic on 10/03/2017 for further eval.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Burning began at injection site before IM injection was completed. Post-injection, burning and pain started in my left shoulder and progressed through my deltoid toward my elbow. Burning and pain continued for 6 days, the pain and weakness have persisted in my left arm. I have a very sore spot on my upper forearm, adjacent to my elbow. It is approaching 12 days post-injection, yet the pain and weakness in my left arm continue and are not improving.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Headache, Malaise, Nausea
Clinical narrative: Patient describes the event as the same as given during a stress test (internal flushing), nausea, headache, has felt generally ill since the time of the vaccine (>6 weeks).
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Productive cough, Respiratory tract congestion
Clinical narrative: Coughing up phlegm. Chest congestion. Starting 2 hours after administration.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Oropharyngeal pain
Clinical narrative: Patient complains of tenderness and swelling at injection site and an emerging sore throat that seemed coincidental to IMZ administration. Patient has bruise at IMZ site.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac stress test, Chills, Computerised tomogram, Dehydration, Hyperhidrosis
Clinical narrative: Patient stated that he had to go to the hospital 2 days after his flu shot because he was suffering flu-like symptoms. He was feverish and dehydrated. He was sweating profusely with muscle aches and chills. He was admitted and stayed in the hospital for several days. IV's were administered combat dehydration. He was also treated for a urinary tract infection.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Laboratory test, Myalgia, Pyrexia, Urinary tract infection
Clinical narrative: Patient stated that he had to go to the hospital 2 days after his flu shot because he was suffering flu-like symptoms. He was feverish and dehydrated. He was sweating profusely with muscle aches and chills. He was admitted and stayed in the hospital for several days. IV's were administered combat dehydration. He was also treated for a urinary tract infection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site irritation
Clinical narrative: Area around subq ZOSTAVAX shot became red, irritated and firm to the touch.
Age: 52.0
Sex: F
Vaccine: HEPA, MMR, TDAP, TYP
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Pt developed soreness in L deltoid next day 6/29/17 after vaccines given in area where Hepatitis A vaccine was given in Left upper deltoid. Pain has now persisted for 13 weeks no swelling no radiation of pain but has limited ROJM and some L arm weakness with abduction and reaching activities.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: After vaccine was administered, it was discovered that the pt received a High Dose flu shot for 65 and older. Pt is monitoring symptoms at home. Called and checked in with mother today, and she said she is doing fine, nothing to report yet.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Haemorrhage, Pallor, Seizure, Syncope
Clinical narrative: Patient bleed after the shot, she was given ban-aid and she stood up to stand with her mother. Patient appeared to be feeling normal and no adverse signs, then suddenly patient collapsed onto the floor and was convulsing. Appeared pale and blank faced. pt came out about after 30 to 40 seconds. Had patient lied down seemed alert. Paramedic came checked blood pressure and pulse. Everything normal and patient went home.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia
Clinical narrative: Pt laid down (his preference) for 15 min after immunizations then sat briefly and ehn stood at front desk while Mom made appointment. He started feeling weak so Mom made him sit and then we were notified. Had him lay on floor. BP 82/50. Able to take fluids. Provider came to check on him. BP 104/60. Sat up, able to eat some snacks, then able to stand without dizziness. Left with Mom after few more minutes.
Age: 28.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Dizziness, Eye movement disorder, Fall, Fatigue, Headache
Clinical narrative: After the hep a and flu shots pt complained of dizziness, suddenly he passed out his head dropped forward then jerk backward eyes rolled back and fell off the chair. As soon as he hit the floor he regained conscious. Complained of feeling tired and his head hurt. Blood pressure and pulse was checked. Both were normal. Paramedic came out rechecked vital signs again and everything was normal. Patient was taken to the hospital for further evaluation. Tried to contact pt on Oct 2 for follow up but unable to reach pt.
Age: 28.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Loss of consciousness, Posture abnormal
Clinical narrative: After the hep a and flu shots pt complained of dizziness, suddenly he passed out his head dropped forward then jerk backward eyes rolled back and fell off the chair. As soon as he hit the floor he regained conscious. Complained of feeling tired and his head hurt. Blood pressure and pulse was checked. Both were normal. Paramedic came out rechecked vital signs again and everything was normal. Patient was taken to the hospital for further evaluation. Tried to contact pt on Oct 2 for follow up but unable to reach pt.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: A couple days after vaccine administration, pt reported soreness and "pinkness not redness" around the injection site. Pt was counseled to apply a cold compress and take an OTC pain reliever. She is to monitor the site and if it gets worse, then they are to seek medical attention.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Patient experience bruising.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient was given the vaccine during schedule clinic at long term care facility and next day she has redness and soreness in her arm. Patient's daughter in law as complained to pharmacy about adverse reaction and insisted that we file it. I only have information about redness and soreness to injection site which is common reaction to vaccine.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site paraesthesia, Injection site reaction, Skin tightness
Clinical narrative: Patient says she has pain at the injection site still 11 days after her vaccine. She says it is not red and does not look infected. Says that it is more inside her arm and she feels tightness/tingling and pain from her shoulder to her elbow throughout the day. Today was the first that she has contacted anyone about it.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Pain in extremity
Clinical narrative: A pharmacist gave the flu shot too high on the arm and patient complained of arm soreness and pain for over 3 weeks. Patient went to her doctor and was put on prednisone. She said it is hard to move her arm but it is getting better now.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Blood glucose normal, Blood pressure increased, Electrocardiogram normal, Vertigo
Clinical narrative: Severe vertigo lasting approximately 15 minutes, spontaneously resolved.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Blood test, Decreased appetite, Eczema, Fluid intake reduced, Lacrimation increased
Clinical narrative: Seizure, loss of consciousness, fever of 99 degrees for one week, rash from head to toe, watery/red eyes, not eating, not drinking, runny nose, after a week fever of 104 for 5 days, seizure (followed by brief hospitalization) eczema on hands, feet and elbows (he has never had eczema or dry skin prior).
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Loss of consciousness, Ocular hyperaemia, Pyrexia, Rash generalised, Rhinorrhoea
Clinical narrative: Seizure, loss of consciousness, fever of 99 degrees for one week, rash from head to toe, watery/red eyes, not eating, not drinking, runny nose, after a week fever of 104 for 5 days, seizure (followed by brief hospitalization) eczema on hands, feet and elbows (he has never had eczema or dry skin prior).
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Seizure
Clinical narrative: Seizure, loss of consciousness, fever of 99 degrees for one week, rash from head to toe, watery/red eyes, not eating, not drinking, runny nose, after a week fever of 104 for 5 days, seizure (followed by brief hospitalization) eczema on hands, feet and elbows (he has never had eczema or dry skin prior).
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Chest pain, Echocardiogram normal, Ejection fraction normal, Electrocardiogram abnormal, Malaise
Clinical narrative: Vaccinated Mon. 9/25. Felt ill in PM. Had fever Tues and Wed. Thurs. felt OK. Friday had chest pain and admitted to hospital on Sat. with pericarditis/myocarditis. 5 vaccines given on 9/25.
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Myocarditis, Pericarditis, Pyrexia, Troponin increased
Clinical narrative: Vaccinated Mon. 9/25. Felt ill in PM. Had fever Tues and Wed. Thurs. felt OK. Friday had chest pain and admitted to hospital on Sat. with pericarditis/myocarditis. 5 vaccines given on 9/25.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm, Vaccination site cellulitis
Clinical narrative: Cellulitis left arm in the location vaccines were administered. No induration or fluctuance. Erythema and warmth measuring 14 cm x 14 cm.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Head injury, Headache, Loss of consciousness, Nausea
Clinical narrative: Went to work that afternoon and suddenly felt nauseated and passed all the way out (8 pm). Fell and did hit head. EMS called to scene - was checked out "ok all VS WNL". Mom stated refused to go to hospital. Stayed in bed next day with HA and nausea.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Swelling down to knee, red and splotchy, warm to touch.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and redness left upper arm, itchy, parent applied cool compress, used BENADRYL x 24H.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid oedema
Clinical narrative: Per mom that night Rt eyelid swollen went away in 2 days. No problems now.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling/redness around injection site.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized redness (7 cm diameter) and mild swelling over deltoid area beginning few hours after administration of MENACTRA and HPV #2 immunizations IM.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Rash, Rash pruritic, Urticaria
Clinical narrative: Bruising at site of injection; rash on arm and all over torso (arm, neck, trunk, back). Itchy rash and hives - took 1 week to disappear. Patient took BENADRYL for a week - until rash disappeared.
Age: 10.0
Sex: U
Vaccine: FLU4
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient passed out briefly, fell to floor. Was awake thereafter. Supportive support and epinephrine. Was transported to ER via ambulance.
Age: 1.5
Sex: M
Vaccine: FLU4, HEPA
Symptoms: No adverse event
Clinical narrative: After 10 minutes no reaction.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Culture urine negative, Full blood count normal, Seizure, Urine analysis normal
Clinical narrative: Seizure 2 days after vaccines seen at clinic for seizure.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: 15 min. after administration skin around injection turned red, spread to 3 x 4 cm. 90 min. later, did not spread further, pt. taking diphenhydramine.
Age: 26.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site haematoma, Injection site warmth, Pyrexia
Clinical narrative: Redness, warmth and hematoma surrounding injection site. Pt reports subjective fevers. Pt treated with ibuprofen prescription and scheduled for F/U visit. Pt educated on S/S of anaphylaxis and going to ED.
Age: 67.0
Sex: F
Vaccine: PNC13, FLU4, PNC13
Symptoms: Injection site discolouration, Injection site reaction, Injection site warmth, Rash, Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received PREVNAR 13; (lot S06030, NDC number 00005197105) on 24Aug2017 at 18:00, at 0.5 ml single, intramuscular, in right deltoid, for immunization. Medical history was not reported. Previous vaccination included FLUZONE HIGH DOSE given on 03Sep2016 for immunisation. Concomitant vaccination included FLUZONE; (lot UI808AB, Manufacturer: Sanofi Pasteur) given on 24Aug2017, intramuscular, in left deltoid, for immunization. On an unspecified date in Aug2017 the patient experienced darker and scaly skin and on 25Aug2017 skin rash with redness and irritation and hard spot at injection site. No emergency room or physician office were required. At the time of report darker and scaly skin was resolving, skin rash with redness and irritation resolved with sequelae on 28Aug2017 and hard spot at injection site had not yet resolved. In regards to the skin rash and irritation, the patient recovered with lasting effects due to the development of the darker and scaly skin. The reporter assessed the events as non-serious and as related to pneumococcal 13-val conj vac (dipht crm197 protein).
Age: 67.0
Sex: F
Vaccine: PNC13, FLU4, PNC13
Symptoms: Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received PREVNAR 13; (lot S06030, NDC number 00005197105) on 24Aug2017 at 18:00, at 0.5 ml single, intramuscular, in right deltoid, for immunization. Medical history was not reported. Previous vaccination included FLUZONE HIGH DOSE given on 03Sep2016 for immunisation. Concomitant vaccination included FLUZONE; (lot UI808AB, Manufacturer: Sanofi Pasteur) given on 24Aug2017, intramuscular, in left deltoid, for immunization. On an unspecified date in Aug2017 the patient experienced darker and scaly skin and on 25Aug2017 skin rash with redness and irritation and hard spot at injection site. No emergency room or physician office were required. At the time of report darker and scaly skin was resolving, skin rash with redness and irritation resolved with sequelae on 28Aug2017 and hard spot at injection site had not yet resolved. In regards to the skin rash and irritation, the patient recovered with lasting effects due to the development of the darker and scaly skin. The reporter assessed the events as non-serious and as related to pneumococcal 13-val conj vac (dipht crm197 protein).
Age: 67.0
Sex: F
Vaccine: PNC13, FLU4, PNC13
Symptoms: Injection site induration, Rash erythematous, Skin discolouration, Skin exfoliation, Skin irritation
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received PREVNAR 13; (lot S06030, NDC number 00005197105) on 24Aug2017 at 18:00, at 0.5 ml single, intramuscular, in right deltoid, for immunization. Medical history was not reported. Previous vaccination included FLUZONE HIGH DOSE given on 03Sep2016 for immunisation. Concomitant vaccination included FLUZONE; (lot UI808AB, Manufacturer: Sanofi Pasteur) given on 24Aug2017, intramuscular, in left deltoid, for immunization. On an unspecified date in Aug2017 the patient experienced darker and scaly skin and on 25Aug2017 skin rash with redness and irritation and hard spot at injection site. No emergency room or physician office were required. At the time of report darker and scaly skin was resolving, skin rash with redness and irritation resolved with sequelae on 28Aug2017 and hard spot at injection site had not yet resolved. In regards to the skin rash and irritation, the patient recovered with lasting effects due to the development of the darker and scaly skin. The reporter assessed the events as non-serious and as related to pneumococcal 13-val conj vac (dipht crm197 protein).
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abdominal pain upper, Asthenia, Back pain, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable nurse. A 65-year-old female patient received PREVNAR 13 (Lot number S31257, Expire date Jul2018, NDC number 0005-1971-02), intramuscular at 0.5 ml single on 19Sep2017 at 12:00 for immunisation. Medical history included ongoing hypertension, ongoing hyperlipidaemia, ongoing anxiety. Concomitant medication included hydrochlorothiazide at 12.5 mg, 1x/day for hypertension, lisinopril at 20 mg, 1x/day for hypertension, losartan at 50 mg, 1x/day for hypertension, simvastatin at 40 mg, 1x/day for hyperlipidaemia, fluoxetine at 40 mg, 1x/day for axiety, all from on an unspecified date and ongoing. On 21Sep2017, the patient experienced stomachache, backache, felt achey in the rest of her body, was very fatigued and very weak, also had some nausea. The outcome of all events was not recovered. These events were assessed as serious (IME) by reporter.; Sender's Comments: Based on a drug event temporal association, it cannot be fully excluded that the vaccination with PREVENAR 13 might play a contributory role in triggering the occurrence of events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nausea, Poor quality sleep
Clinical narrative: This is a spontaneous report from a contactable nurse. A 65-year-old female patient received PREVNAR 13 (Lot number S31257, Expire date Jul2018, NDC number 0005-1971-02), intramuscular at 0.5 ml single on 19Sep2017 at 12:00 for immunisation. Medical history included ongoing hypertension, ongoing hyperlipidaemia, ongoing anxiety. Concomitant medication included hydrochlorothiazide at 12.5 mg, 1x/day for hypertension, lisinopril at 20 mg, 1x/day for hypertension, losartan at 50 mg, 1x/day for hypertension, simvastatin at 40 mg, 1x/day for hyperlipidaemia, fluoxetine at 40 mg, 1x/day for axiety, all from on an unspecified date and ongoing. On 21Sep2017, the patient experienced stomachache, backache, felt achey in the rest of her body, was very fatigued and very weak, also had some nausea. The outcome of all events was not recovered. These events were assessed as serious (IME) by reporter.; Sender's Comments: Based on a drug event temporal association, it cannot be fully excluded that the vaccination with PREVENAR 13 might play a contributory role in triggering the occurrence of events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abdominal pain upper, Asthenia, Back pain, Fatigue, Nausea
Clinical narrative: This is a spontaneous report from a contactable nurse. A 65-year-old female patient received PREVNAR 13 (Lot number S31257, Expire date Jul2018, NDC number 0005-1971-02), intramuscular at 0.5 ml single on 19Sep2017 at 12:00 for immunisation. Medical history included ongoing hypertension, ongoing hyperlipidaemia, ongoing anxiety. Concomitant medication included hydrochlorothiazide at 12.5 mg, 1x/day for hypertension, lisinopril at 20 mg, 1x/day for hypertension, losartan at 50 mg, 1x/day for hypertension, simvastatin at 40 mg, 1x/day for hyperlipidaemia, fluoxetine at 40 mg, 1x/day for axiety, all from on an unspecified date and ongoing. On 21Sep2017, the patient experienced stomachache, backache, felt achey in the rest of her body, was very fatigued and very weak, also had some nausea. The outcome of all events was not recovered. These events were assessed as serious (IME) by reporter.; Sender's Comments: Based on a drug event temporal association, it cannot be fully excluded that the vaccination with PREVENAR 13 might play a contributory role in triggering the occurrence of events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable nurse. A 65-year-old female patient received PREVNAR 13 (Lot number S31257, Expire date Jul2018, NDC number 0005-1971-02), intramuscular at 0.5 ml single on 19Sep2017 at 12:00 for immunisation. Medical history included ongoing hypertension, ongoing hyperlipidaemia, ongoing anxiety. Concomitant medication included hydrochlorothiazide at 12.5 mg, 1x/day for hypertension, lisinopril at 20 mg, 1x/day for hypertension, losartan at 50 mg, 1x/day for hypertension, simvastatin at 40 mg, 1x/day for hyperlipidaemia, fluoxetine at 40 mg, 1x/day for axiety, all from on an unspecified date and ongoing. On 21Sep2017, the patient experienced stomachache, backache, felt achey in the rest of her body, was very fatigued and very weak, also had some nausea. The outcome of all events was not recovered. These events were assessed as serious (IME) by reporter.; Sender's Comments: Based on a drug event temporal association, it cannot be fully excluded that the vaccination with PREVENAR 13 might play a contributory role in triggering the occurrence of events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Discomfort, Erythema, Injection site erythema, Pain in extremity
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was reporting on herself. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unspecified Friday in 2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, in right arm, lot # N013541with expiry date on 28-MAY-2017 (dose, route of administration and expiration date were not reported). On the same day in the evening, the patient's arm became bright red and she could not move it. On the next day, the patient could not move and her arm became "even redder". On the second day after the vaccination (reported as "on the following day"), the patient experienced flu-like symptoms and her right arm was extremely painful and became swollen by that night (reported as 3 times the size of her left arm). On the third day (reported as "the next day") after the vaccination, the patient visited an emergency room for medical attention. The symptoms were diagnosed as either allergic reaction to PNEUMOVAX 23 or cellulitis. The patient also requested an investigation into the lot # N013541. The outcome of the events was unknown. The event of allergic reaction was considered to be related to PNEUMOVAX 23. The relatedness between the remaining events and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant.