chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient received vaccine on 10/08/15. Stayed the 20mins had no ill effects. The next day the patient's arm started to turn red and swell, got warm. No pain was being experienced. Patient had the reaction the year prior and MD told her to get the vaccination again. She stated that her reaction was worse. I told her to continue to monitor the reaction and reach out to her MD or seek help if she starts having further issues.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Pt came today 10/09/2015 about 6:30PM and said she has big red rash not painful but rash, pt will check with Dr.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Ringing in my left ear. Same side of the injection.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Tinnitus, Tremor, Vomiting
Clinical narrative: PATIENT EXPERIENCED NAUSEA, VOMITING, "FELT LIKE FAINTING", SHAKING, AND RINGING IN THE EARS.  SYMPTOMS LASTED APPROXIMATELY 10 MINUTES.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye discharge, Fatigue, Feeling cold, Headache, Myalgia
Clinical narrative: Extreme Body Cold, Eyes Red and secreting mucus, Head Ache, Legs extreme muscle shooting pain, lasting until 11:00 PM.    Extreme tiredness next day.  By this time on 10/9/2015 at 8:45 PM feelings of tiredness only.  I will see my Neurologist Monday 10/12/2015.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Pain
Clinical narrative: Extreme Body Cold, Eyes Red and secreting mucus, Head Ache, Legs extreme muscle shooting pain, lasting until 11:00 PM.    Extreme tiredness next day.  By this time on 10/9/2015 at 8:45 PM feelings of tiredness only.  I will see my Neurologist Monday 10/12/2015.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Eye discharge, Fatigue, Feeling cold, Headache
Clinical narrative: Extreme Body Cold, Eyes Red and secreting mucus, Head Ache, Legs extreme muscle shooting pain, lasting until 11:00 PM.    Extreme tiredness next day.  By this time on 10/9/2015 at 8:45 PM feelings of tiredness only.  I will see my Neurologist Monday 10/12/2015.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Injection site swelling, Ocular hyperaemia
Clinical narrative: Extreme Body Cold, Eyes Red and secreting mucus, Head Ache, Legs extreme muscle shooting pain, lasting until 11:00 PM.    Extreme tiredness next day.  By this time on 10/9/2015 at 8:45 PM feelings of tiredness only.  I will see my Neurologist Monday 10/12/2015.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Progressive erythema, induration, tenderness, and heat over injection site on left deltoid, ultimately progressing to 11 x 11 cm area.  Back arthralgias and myalgias.  No objective fever, though episodic evening chills.  Systemic symptoms resolved over subsequent 48 hours. Local symptoms/signs resolving over three days.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Myalgia
Clinical narrative: Progressive erythema, induration, tenderness, and heat over injection site on left deltoid, ultimately progressing to 11 x 11 cm area.  Back arthralgias and myalgias.  No objective fever, though episodic evening chills.  Systemic symptoms resolved over subsequent 48 hours. Local symptoms/signs resolving over three days.
Age: 53.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Back pain, Fatigue, Hyperhidrosis, Liver function test
Clinical narrative: Lower back pain while sleeping. Neck pain started on 9/21. Joint pain started 9/23. The neck pain & stiffness has been so severe I was unable to turn my neck by 10/3. Currently experiencing fatigue, joint pain, neck pain & severe stiffness, sweating (no fever) through 10/9/15.
Age: 53.0
Sex: F
Vaccine: FLUC3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain, Red blood cell sedimentation rate, Renal function test
Clinical narrative: Lower back pain while sleeping. Neck pain started on 9/21. Joint pain started 9/23. The neck pain & stiffness has been so severe I was unable to turn my neck by 10/3. Currently experiencing fatigue, joint pain, neck pain & severe stiffness, sweating (no fever) through 10/9/15.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 10/8/2015-patient was vaccinated at her place of work for the county.  Facility administed vaccine.  At 0300 10/7/2015 patient woke a large amount of redness around her injection site.  Area is reported to be raised and tender to touch.  10/9/2015 contacted patient and she reports that she has redness, warmth and tenderness in area.
Age: 27.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Left deltoid discomfort on 10/8, pt took 800mg that night with no relief. On morning of 10/9 increase tenderness and some local swelling with 2-3 spots rash, swelling and tenderness incrase and spread down to mid-bicep region around arm, up into arm pit and on back side of should. Due to increase and spread of swelling pt presented to pharmacy at approx. 6:55pm.  Pt denied any difficulty breathing and no chest tightness. Left deltoid was tender to touch and warm to the extent of swelling as described above. Pt denied a diphenhydramine injection due to the tenderness.  She was give and took 50mg diphenhydramine oral liquid and 150mg oral tablet. She was direct to go to ER for further evaluation and agreed she would.
Age: 27.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Rash, Tenderness
Clinical narrative: Left deltoid discomfort on 10/8, pt took 800mg that night with no relief. On morning of 10/9 increase tenderness and some local swelling with 2-3 spots rash, swelling and tenderness incrase and spread down to mid-bicep region around arm, up into arm pit and on back side of should. Due to increase and spread of swelling pt presented to pharmacy at approx. 6:55pm.  Pt denied any difficulty breathing and no chest tightness. Left deltoid was tender to touch and warm to the extent of swelling as described above. Pt denied a diphenhydramine injection due to the tenderness.  She was give and took 50mg diphenhydramine oral liquid and 150mg oral tablet. She was direct to go to ER for further evaluation and agreed she would.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Hot flush, Neck pain, Pain
Clinical narrative: 9/23/2015 patient reports hot flashes, weakness, dizzy and pain in injected arm.  Patient reports to continue to have pain at time of report on 10/5/2015.  Reports that she continues to have shooting pain down her arm to her wrist and up into her neck on the right side.  Pain is throbbing at rest and sharp with movement.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: 9/23/2015 patient reports hot flashes, weakness, dizzy and pain in injected arm.  Patient reports to continue to have pain at time of report on 10/5/2015.  Reports that she continues to have shooting pain down her arm to her wrist and up into her neck on the right side.  Pain is throbbing at rest and sharp with movement.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Headache, Nausea, Pain in extremity, Pulmonary pain
Clinical narrative: Sore on arm, lung and ear hurting, headache, nausea.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Hyperhidrosis, Migraine, Myalgia
Clinical narrative: Fever, sweating, chills, nausea, extreme body aches and muscle pain, extreme migraine, vomiting. Symptoms lasted 15 hours and were debilitating.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, sweating, chills, nausea, extreme body aches and muscle pain, extreme migraine, vomiting. Symptoms lasted 15 hours and were debilitating.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Chills, Erythema, Fatigue, Feeling abnormal
Clinical narrative: When I got up Saturday morning I had a red bump on my arm approximately size of a penny.  By 6pm it was the size of a dollar coin bright red hot hard.  I started to feel bad that night.  Chills, achy, swollen glands, tired, felt like I was getting sick.  The next morning I felt better however the area of redness had increases in size and was getting brighter.  We marked the outer edge each morning and night to monitor the growth.  I called the dr Monday morning and had an appt that afternoon.  I was told it was cellulitis and was given Keflex 4 times a day for 10 days.  I went in today 10/9 for a follow up as I still have a reddish/purplish tone to the area and a small bump.  I was told that he didn't think it was cellulitis but a reaction to the Prevnar13.  At this point there was no way to know for sure and he gave me another round of Keflex to take at least for 4 more days if not the whole 10 days.  He felt my arm should return to its normal color soon.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Induration, Lymphadenopathy, Malaise, Pain, Peripheral swelling
Clinical narrative: When I got up Saturday morning I had a red bump on my arm approximately size of a penny.  By 6pm it was the size of a dollar coin bright red hot hard.  I started to feel bad that night.  Chills, achy, swollen glands, tired, felt like I was getting sick.  The next morning I felt better however the area of redness had increases in size and was getting brighter.  We marked the outer edge each morning and night to monitor the growth.  I called the dr Monday morning and had an appt that afternoon.  I was told it was cellulitis and was given Keflex 4 times a day for 10 days.  I went in today 10/9 for a follow up as I still have a reddish/purplish tone to the area and a small bump.  I was told that he didn't think it was cellulitis but a reaction to the Prevnar13.  At this point there was no way to know for sure and he gave me another round of Keflex to take at least for 4 more days if not the whole 10 days.  He felt my arm should return to its normal color soon.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Skin discolouration, Skin warm
Clinical narrative: When I got up Saturday morning I had a red bump on my arm approximately size of a penny.  By 6pm it was the size of a dollar coin bright red hot hard.  I started to feel bad that night.  Chills, achy, swollen glands, tired, felt like I was getting sick.  The next morning I felt better however the area of redness had increases in size and was getting brighter.  We marked the outer edge each morning and night to monitor the growth.  I called the dr Monday morning and had an appt that afternoon.  I was told it was cellulitis and was given Keflex 4 times a day for 10 days.  I went in today 10/9 for a follow up as I still have a reddish/purplish tone to the area and a small bump.  I was told that he didn't think it was cellulitis but a reaction to the Prevnar13.  At this point there was no way to know for sure and he gave me another round of Keflex to take at least for 4 more days if not the whole 10 days.  He felt my arm should return to its normal color soon.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Ageusia, Facial paresis, Hypoaesthesia oral, VIIth nerve paralysis
Clinical narrative: Day Of: 3:30 pm-Loss of taste sensation and feeling left side of tongue.  10/07/2015: Continued loss of taste and feeling left side of tongue, followed by weakening of forehead and lip muscles left side of face. Went to ER at 11:00 PM and diagnosed w/ Bell's Palsy.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Urticaria
Clinical narrative: Hives and welts on her body. Asthma attack too.
Age: 61.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Erythema, Local reaction, Pain in extremity, Skin warm, Swelling
Clinical narrative: PATIENT SAYS ARM BEGAN TO FEEL PAINFUL THE DAY AFTER VACCINE WAS GIVEN. PATIENT DESCRIBED LOCALIZED REACTION WHICH INCLUDED SWELLING AND REDNESS AND HOT TO THE TOUCH.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: CSF white blood cell count increased, Enterovirus test negative, Meningitis aseptic, Polymerase chain reaction
Clinical narrative: Developed aseptic meningitis approx. 6 days after vaccinations.
Age: 93.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Dehydration, Dizziness, Hypotension
Clinical narrative: 2 hours after administration, patient experienced dizziness, weakness, low BP, and dehydration resulting in visit to emergency room.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pruritus generalised
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site redness in an adult female patient who received FLUARIX (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX .5 ml. On an unknown date, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On an unknown date, the outcome of the injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever were unknown. It was unknown if the reporter considered the injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever to be related to FLUARIX. Additional details were received as follows: Patient's age range went from around 25-55 years of age. In September 2015, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 1015, the adverse events were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site redness in an adult female patient who received FLUARIX (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX .5 ml. On an unknown date, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On an unknown date, the outcome of the injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever were unknown. It was unknown if the reporter considered the injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever to be related to FLUARIX. Additional details were received as follows: Patient's age range went from around 25-55 years of age. In September 2015, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 1015, the adverse events were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pruritus generalised
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX .5 ml. On an unknown date, less than a week after receiving FLUARIX, the patient experienced injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever to be related to FLUARIX. Additional details were received as follows: Patient's age range went from around 25-55 years of age. In September 2015, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 2015, the patient adverse events were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX (batch number D3AF5, expiry date 9th June 2016). On 21st September 2015, the patient received FLUARIX .5 ml. On an unknown date, less than a week after receiving FLUARIX, the patient experienced injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness, generalized pruritus, injection site swelling and fever to be related to FLUARIX. Additional details were received as follows: Patient's age range went from around 25-55 years of age. In September 2015, less than a week after receiving FLUARIX, the patient experienced injection site redness, injection site induration, injection site tenderness, generalized itching, injection site swelling and fever. On 25th September 2015, the patient adverse events were noted. The date of birth and information on adverse events experienced by individual patients were unknown. Reporter just explained that the most common adverse event experienced was induration at the injection site. Also the patient experienced redness, swelling and tenderness at the injection site. Less commonly reported event was itching throughout the body. The least common reported event was fever. This case was one of the 9 cases reported by same reporter.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Vaccination site bruising
Clinical narrative: Patient reported large bruise on left arm at site of vaccination. Bruise was 3in in diameter. Patient also reports mild discomfort in left arm. These occurred within 24 hours of vaccination.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: Patient's arm became very red following the injection with PREVNAR 13. The redness spread down the arm so patient went to clinic. She was diagnosed with cellulitis. Patient was given BACTRIM and is getting better.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient's arm became very red following the injection with PREVNAR 13. The redness spread down the arm so patient went to clinic. She was diagnosed with cellulitis. Patient was given BACTRIM and is getting better.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Patient received vaccine on 10/6/15-around noon developed severe pain from shoulder to hand and swelling around the injection site since 10/8/15 morning.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Small itchy spots on trunk, legs, arms and head.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Migraine, Urticaria
Clinical narrative: Hives and migraine after receiving flu vaccine. Felt flushed and developed hives (wheals) on her trunk and neck. No SOB, dysphagia, wheeze, tongue swelling.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Erythema and warmth (L) upper arm dx: cellulitis. KEFLEX 500mg 1 PO TID x 7 days.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash vesicular
Clinical narrative: Shortly after receiving immunization, patient experienced a "shingle-like" rash up and down the arm. Treatment given not known. Doctor can provide.
Age: 37.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Redness on deltoid (L) area and sore arm when moved up. He says it is getting better than it was initially.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling w/in 2 hours/redness, hot. 2 1/2" x 3" in 2 hrs. 24 hrs later red - 4" x 3 1/2". Rx for MEDROL Dose Pack/BENADRYL/EPIPEN.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Fatigue, Peripheral swelling, Rhinorrhoea
Clinical narrative: Within a few hours pt. was tired, runny nose, sneezing, lots of coughing, hoarse, swelling in arm for 2 days. DELSYM.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing
Clinical narrative: Within a few hours pt. was tired, runny nose, sneezing, lots of coughing, hoarse, swelling in arm for 2 days. DELSYM.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Had severe pain in left arm to the point when she could not lift her arm the night of the shot. By the time she came into the office, the arm was feeling better. The arm at that point was just sore.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient called the day after immunization and stated her arm was sore. She has trouble moving her arm. She was going to call the Dr. and try to keep moving her arm.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Severe swelling and redness at arm at site below injection. No treatment was started. Patient was advised to be seen by a doctor with urgent care.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Asthenia, Headache, Injection site bruising, Nausea
Clinical narrative: Bruising around the area approximately 1 inch in diameter, also headache, anxiety, shaking, nauseous, and weakness that occurred about 1 week after shot. Bruising were present shortly after vaccine.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Bruising around the area approximately 1 inch in diameter, also headache, anxiety, shaking, nauseous, and weakness that occurred about 1 week after shot. Bruising were present shortly after vaccine.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Crying, Pain, Rash, Rash maculo-papular
Clinical narrative: Child was given HPV and Flu shot. Child feet pain, starting crying, maculopapular rash developed on face and neck area. No resp. distress.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Back pain, Hypoaesthesia, Injection site pain
Clinical narrative: Patient had vaccine on 10/7/15. She woke up at 3 AM on 10/8/15 with pain from top of left shoulder down to the elbow radiating to the mid back below the neck. There is a numbness feeling in the fingers of left hand. She has pain from left shoulder through to axillary region.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus
Clinical narrative: Itching, bruising at injection site. Pain at injection site - resolved but took longer than previous injections.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Hypersensitivity, Loss of consciousness, Nodule
Clinical narrative: Allergic reaction to flu vaccine. Nodule formed within sec. pt was sweating, dizzy, passed out - sweating profusely - called 911 administered EPIPEN 1 shot.
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Eyelid oedema, Eyelid pain, Injection site oedema, Injection site pain, Lip oedema
Clinical narrative: Within 8 hrs of receiving vaccine, she reports pain and edema radiating from (L) upper arm (inj. site) to neck and jaw (L) and (L) eyelid and (L) lip edema.
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Localised oedema, Neck pain, Pain in jaw
Clinical narrative: Within 8 hrs of receiving vaccine, she reports pain and edema radiating from (L) upper arm (inj. site) to neck and jaw (L) and (L) eyelid and (L) lip edema.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling, Vaccination complication
Clinical narrative: Patient called pharmacy 10-7-15 to report adverse event to immunizations given 10-6-15. She received FLUZONE HD and PNEUMOVAX 23 in left arm. Patient reported swelling, redness, pain went to ER received antibiotics.
Age: 55.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Whole arm from shoulder to elbow is inflamed, painful and hot to touch.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Erythematous swollen arm several centimeters beyond injection site.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site reaction, Swelling
Clinical narrative: At site of ZOSTAVAX injection, patient stated the area looked as if it were a cellulitis infection. After a couple of days the swelling went down and no antibiotic treatment was necessary.
Age: 17.0
Sex: F
Vaccine: FLUN4, MNQ
Symptoms: Erythema, Pain in extremity
Clinical narrative: Redness on arm, painful, sore.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site bruising
Clinical narrative: Very large bruise at vac. point, over silver dollar size.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Peripheral swelling, Pyrexia, Skin tightness
Clinical narrative: Patient called pharmacy on 10/9/15 and said she experienced severe swelling on the right side from arm to fingers and toes. She also experienced skin tightness on swollen areas, fever, severe pain. She took 4 ADVILS the night of 10/8/15 and that relieved the pain and warmness. She said swelling decreased but some pain and swelling still there.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction, Tic
Clinical narrative: Focal motor left eye tic - started same day after flu shot. Large local reaction - lasted few day. Note known past allergy to eggs but now eats no symptoms.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Patient called complaining of very swollen and stiff arm. Patient was advised to ice, take anti-inflammatory and antihistamine. Follow up with patient later that evening had showed strong improvement, right arm.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Sensation of foreign body
Clinical narrative: Lump in throat, chills, fever, temperature-relieved by TYLENOL. Symptoms dissipated overnight.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Induration, Pain, Pain in extremity
Clinical narrative: Redness (1/2 dollar-sized), hardness, heat, soreness when lifting arm, itchy.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Redness (1/2 dollar-sized), hardness, heat, soreness when lifting arm, itchy.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Stated (1) hour after vaccine started having itching, redness, swelling and discomfort "sore", from (R) elbow to shoulder. To TYLENOL PM at 8 pm before bedtime. Pain has not subsided, pain (R) wrist to (R) shoulder today 10-9-15.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Musculoskeletal pain
Clinical narrative: Stated (1) hour after vaccine started having itching, redness, swelling and discomfort "sore", from (R) elbow to shoulder. To TYLENOL PM at 8 pm before bedtime. Pain has not subsided, pain (R) wrist to (R) shoulder today 10-9-15.
Age: 1.35
Sex: M
Vaccine: DTAP, FLU3, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 2.8 x 1.5 inch erythematous area on Right thigh at inj site. Area warm non tender.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm swollen and redness and warm to touch from left.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, X-ray normal
Clinical narrative: Pt is complaining of sore arm. No redness or soreness at injection site, but sore inside. She says it is sore or hurts when she moves it or lays on it. We suggested heat/ice to help. She said her Dr has recommended PT.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: After receiving FLUZONE HD pt complain about arm soreness and brusing in area.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: After receiving FLUZONE HD pt complain about arm soreness and brusing in area.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Contusion, Immediate post-injection reaction, Injection site mass, Injection site pain
Clinical narrative: After receiving FLUZONE HD pt complain about arm soreness and brusing in area.
Age: 5.0
Sex: F
Vaccine: DTAP, FLUN4, IPV
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain
Clinical narrative: She had DTaP, IPV. At site of DTaP, she got a significant bruise per mom. It was tender when shot given, bled after.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Pt saw red mark rear area where shot was given. Unsure if shot causesd the irritation.
Sex: U
Vaccine: FLU3
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Fever approximately 104 degrees F, swelling in arm.
Age: 1.07
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash, Rash papular
Clinical narrative: Papular rash on arms, legs and torso. No fever, no blisters and mouth clear. No localized pain and no swelling, no bruising, no blisters. Acting alert and good P.O.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder and arm pain x 15 days out of proportion to the common reaction. No sign of infection, allergy or weakness.
Age: 30.0
Sex: F
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Malaise
Clinical narrative: Sweating, feeling ill.
Age: 53.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Above reaction reported 3/1/13 with resolving symptoms. Injection site pain/redness.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. No information on patient's medical history or concurrent conditions was provided. On 14-NOV-2014, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not provided). No information on patient's concomitant medication was provided. On 05-OCT-2015, the patient came into the office to receive his second dose of GARDASIL. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (Lot# K002921, exp. 25-FEB-2016; Lot# K009901, exp. 08-MAY-2016) (oral, dose and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (Lot# K022265, exp. 22-OCT-2016 Lot# L014878, exp. 17-JAN-2018; Lot# K006262, exp. 17-DEC-2015) (dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored GARDASIL (Lot# K011562, exp. 08-APR-2017; Lot# L004601, exp. 04-NOV-2016; Lot# K007828, exp. 02-MAR-2017; Lot# K006191, exp. 02-FEB-2017, Lot# was reported as L009964, exp. 13-APR-2017) (dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse via web page refers to a child patient of unknown age and gender. No information on patient's medical history or concurrent conditions was provided. On an unknown date (reported as yesterday), the nurse was ordered to vaccinate the patient with varicella virus vaccine live (manufacturer unknown) and M-M-R II. The patient received the varicella virus vaccine live (manufacturer unknown) as ordered but by a mistake he or she received PROQUAD instead of M-M-R II. No information on patient's concomitant medication was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 06-OCT-2015 the patient was vaccinated with 0.5 ml improperly stored (Oka/Merck) VARIVAX lot # L010145, expiration date 24-MAR-2017) via subcutaneous. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patient of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with the doses of improperly stored PNEUMOVAX 23 injection, lot # K018833 with expiration date 20-APR-2016, lot# K021881 with expiration date 30-JUL-2016 and lot# K007262 with expiration date 25-NOV-2016 (dose and route of administration were not reported). No information on patients' concomitant medications was provided. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with the doses of improperly stored MMR II injection, lot # K00614, expiration date 29-APR-2016 (dose and route of administration were not reported). No information on patients' concomitant medication was provided. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with the doses of improperly stored GARDASIL lot # K023432 with expiration date 18-JUN-2016, lot# K006191 with expiration date 02-FEB-2017 and lot# K008213 with expiration date 17-DEC-2016 (dose and route of administration were not reported). No information on patients' concomitant medications was provided. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse (also reported as healthcare worker with a degree of certified medical assistant) referring to a patient of unknown age and gender. On 29-APR-2010 the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot # were not reported). The second, third and fourth dose was administered on 23-JUN-2010, 25-AUG-2010 and 25-OCT-2010, respectively. No adverse effects reported. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 17 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 21-SEP-2015 the patient inadvertently received an adult dose of RECOMBIVAX HB (strength: 10 microgram, lot # reported as L014419 with expiration date 15-APR-2015; dose and route were not reported), instead of a pediatric dose. The reporter reported that this was the patients' third dose in the series and the patient had received two other pediatric doses on unspecified dates. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On 01-SEP-2015 the patient was inadvertently vaccinated with an improperly stored dose of ROTATEQ lot # K024700 with expiration date 30-JUL-2016, orally (dose and dose number were not reported. No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient had no pertinent medical history and no drug reactions/allergies. On 05-JUN-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# reported as 1002130, expiry date: 08-JUL-2016), 0.5 ml, subcutaneously. No concomitant medication was taken. On 06-JUN-2015, the patient experienced an injection site reaction described as "a swollen arm, redness, pain, and warmth to the touch." The patient sought medical attention via office visit and was prescribed an unspecified dose of ibuprofen and doxycycline 100 mg capsule twice a day as treatment. No lab diagnostic studies performed. The patient was recovered from the events in a few days (estimated as an unknown date in June 2015). Lot number 1002130 is an invalid lot number PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 01-OCT-2015, the patient was inadvertently vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, dose, dose number and route were not reported), which expired on 09-JUL-2015. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 06-OCT-2015, the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX lot# L013064, exp. 14-APR-2017 (route of administration and dose were not reported), that had been improperly stored. There was no adverse effects reported. Additional information is not expected as the reporter did not wish further contact.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site induration
Clinical narrative: Left thigh with 1.5 cm area of induration.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash at injection site on left arm that spread to the chest area. Rash was itchy but he had no respiratory symptoms.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV, PNC13
Symptoms: Injection site induration
Clinical narrative: Right anterolateral thigh: 6 x 6 cm induration. Left anterolateral thigh: 9 x 7 cm induration.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Eyelid oedema, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 66 year old female patient. The patient's medical history included fibromyalgia (reported as fibromyalgiam) and gastric bypass surgery. No drug reactions or allergies were reported. On 17-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided). Concomitant therapies included tramadol hydrochloride, SYNTHROI, fluticasone and duloxetine hydrochloride (also reported as "diloxiton"). On an unknown date in September 2015, the patient had a headache, both eyes swollen, right eye swollen shut, redness and swelling at injection site. The patient received BENADRYL, ZYRTEC (also reported as zyrtedc) and cold compresses to the eyes as the treatment for the events. The patient recovered on 29-SEP-2015. The patient sought medical attention. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: After vaccination pt had inconsolable crying for 3+ hours. Nurse advised to have pt further evaluated at hospital or clinic for possible reaction to the vaccine. Mother also states that pt napped and when she awoke crying began again.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report was received from a nurse regarding a 1 year old female patient. No medical history and concurrent conditions were reported. On 01-JUL-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (dose 1), subcutaneously in the left thigh for vaccination against chicken pox. On 21-SEP-2015 the patient experienced vesicle like rash at injection site of (Oka/Merck) VARIVAX (injection site rash, injection site vesicles) (reported by the patient's mother). At the time of reporting the patient was without rash (recovered approximately on an unknown date in September 20155). It was unspecified whether the patient sought medical attention or not. The causality assessment was not provided. No product quality complaint was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 07-OCT-2015 the patient was vaccinated with expired MMR II (strength, frequency were not reported) 0.5 ml (lot # not reported with an expiry date of 26-JUL-2015) subcutaneously. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 86 years old male patient. None pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 16-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose reported as 1 vial, subcutaneously, lot # K010969, expiration date 07-NOV-2015). On approximately 22-SEP-2015 (reported as about 2 weeks ago), the patient started getting a rash that was itchy. The pharmacist reported that the patient returned to the pharmacy on 06-OCT-2015, with a "big rash", later described as being the size of a quarter on both arms. The rash was red, raised and itchy and was not localized at the injection site. The patient sought medical attention - he visited the pharmacy. None lab diagnostics studies were performed and the patient received the treatment with an unspecified hydrocortisone cream. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (Lot# K008879, exp. 30-MAR-2017; Lot# L004738, exp. 10-NOV-2017; Lot# J013943, exp. 14-AUG-2016; Lot# J015435, exp. 13-OCT-2016; Lot# J010382, exp. 28-MAY-2016; Lot# was reported as J008091, exp. 04-APR-2016) (dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact physician.