chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Patient returned to office less than 5 minutes after receiving a flu vaccine with diffuse urticaria and SOB and wheezing and diaphoresis. Chest exam with decreased O2 and wheezing. Given EPIPEN in office and 1 dose of CLARITIN with immediate improvement in symptoms. Taken to ER for observation and further eval.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Prolonged soreness in arm.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in Legs and hands.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fall, Incontinence, Loss of consciousness, Mobility decreased
Clinical narrative: Vomit, fever, extreme dizziness, onset of severe muscle weakness, incontinent, slipped to floor and laid there for 9 hours unable to move not a inch found by family who said I was out of it.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Pyrexia, Vomiting
Clinical narrative: Vomit, fever, extreme dizziness, onset of severe muscle weakness, incontinent, slipped to floor and laid there for 9 hours unable to move not a inch found by family who said I was out of it.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: Area of inject site swelled and became feverish and a large red ring surrounded the injection site; pt reported event today and showed the injection site which is still inflamed and red.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria. Pruritus and hives. Diphenhydramine 25mg every 6 hours PRN mg PRN, Prednisone taper dose (5mg) mg every day.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Child was given flu shot at school. He was taken by parents to PCP office for follow-up care.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 35-year-old male patient who received FLUARIX QUADRIVALENT (batch number 3CG9P, expiry date 22nd June 2017). Previously administered products included FLUARIX QUADRIVALENT with an associated reaction of dizziness (dose received on 5th December 2015, refer case US2016GSK160877). On 15th October 2016, the patient received FLUARIX QUADRIVALENT. On 15th October 2016, 10 min after receiving FLUARIX QUADRIVALENT, the patient experienced dizziness and blood pressure decreased. In October 2016, the outcome of the dizziness and blood pressure decreased were recovered/resolved. The reporter considered the dizziness and blood pressure decreased to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient reported to the pharmacy that he was experiencing severe dizziness shortly after receiving the vaccination. They took his blood pressure and the systolic number was around 90 rather than his normal 120. After about 30 minutes, the patient felt better and left the pharmacy.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site vesicles, Local reaction
Clinical narrative: Rec'd vaccine 10/24/2016. After band aid removed on 10/25/2016 noted a blister and redness at site. Measured 1 x 1/2 cm erythema and blister. No streaking. DX as local reaction.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: Right side of face suddenly quit working, unable to to drink through straw or cup, unable to chew or smile, pain in ear, half face paralyzed.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Double dosage of Flu vaccine given to the patient. No adverse reactions reported. Patients mother is aware.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: ACHY JOINTS ALL OVER, HEADACHE IN THE BACK OF THE HEAD, LOW-GRADE FEVER.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site pruritus, Urticaria
Clinical narrative: Itiching at the injection site (3 weeks after injection) pain at the injection site, small welts appeared a few days after that.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Lymphadenopathy
Clinical narrative: Flu shot was given Sat 10/22/16. Had resultant reaction. Right arm had area around injection site that was indurated, red, warm and painful. Right axillary area was very painful with swollen lymph node in armpit.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported redness, swelling, heat, and pain at injection site (left deltoid) that started the evening of the injection. She said she placed a cold pack on it for approx. 20 minutes and then removed it and went to bed. She said she could not sleep on this arm last night while trying to rest due to pain. This afternoon she reported to the clinic for us to examine this area. Her left deltoid area is red, hot and swollen that extends down the left arm about 2 inches above the elbow. Physician examined it and determined that it did not appear infected. He stated it appears she had a localized reaction to the vaccine. Informed patient to continue to apply cold packs for 20 minutes a few times per day and take anti-inflammatory medications (as per physician.)She will continue to monitor this and will follow up later this week to ensure that it is better.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Peripheral swelling, Rash
Clinical narrative: Patient said that her arm started swelling some up to the bicep and she developed a rash in that area. She has difficulty lifting her arm. She put an ice pack on it from 3am to 5am when the ice pack broke. She visited her provider this morning and they recommended that she take Benadryl and take it easy.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure increased, Myalgia
Clinical narrative: Patient left clinic after receiving vaccine and stated he began to feel intense muscle aches from his neck down to his thighs once he was in his vehicle. Pt called for assistance because the pain was severe and he could not easily move. He was placed in a WC and taken into the clinic where he was further assessed; his vitals were WNL except for elevated BP which is not unusual given his HTN diagnosis.
Age: 49.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Asthenia, Cough, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Started with itchy throat and cough, followed by full sinus congestion (could not breathe through nose at all, swollen throat (had a hard time breathing), dizziness, muscle cramps on right leg, and a general feeling of not being well.  Took 15 ml of Nyquil to try to relieve some of the symptoms, stayed awake the whole night and took seeps of icy cold water, used ice pack on the neck.  Considered calling emergency, but did not do so, as the symptoms started improving toward the morning.  Continued having light flulike symptoms on Saturday and Sunday, still feeling a little bit weak and tired but other than that, everything seems to be back to normal.
Age: 49.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Influenza like illness, Malaise, Muscle spasms, Pharyngeal oedema, Sinus congestion
Clinical narrative: Started with itchy throat and cough, followed by full sinus congestion (could not breathe through nose at all, swollen throat (had a hard time breathing), dizziness, muscle cramps on right leg, and a general feeling of not being well.  Took 15 ml of Nyquil to try to relieve some of the symptoms, stayed awake the whole night and took seeps of icy cold water, used ice pack on the neck.  Considered calling emergency, but did not do so, as the symptoms started improving toward the morning.  Continued having light flulike symptoms on Saturday and Sunday, still feeling a little bit weak and tired but other than that, everything seems to be back to normal.
Age: 49.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Throat irritation
Clinical narrative: Started with itchy throat and cough, followed by full sinus congestion (could not breathe through nose at all, swollen throat (had a hard time breathing), dizziness, muscle cramps on right leg, and a general feeling of not being well.  Took 15 ml of Nyquil to try to relieve some of the symptoms, stayed awake the whole night and took seeps of icy cold water, used ice pack on the neck.  Considered calling emergency, but did not do so, as the symptoms started improving toward the morning.  Continued having light flulike symptoms on Saturday and Sunday, still feeling a little bit weak and tired but other than that, everything seems to be back to normal.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Injection site mass, Injection site rash, Rash
Clinical narrative: Patients mother reports "lump" at injection site and rash that extended across the chest.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pallor, Injection site pruritus, Injection site rash, Injection site reaction, Skin exfoliation
Clinical narrative: Whiteness at injection site with itching. Skin sloughing in the area of whiteness with palpable rash underneath the skin without redness. Persistent itching at the site.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: I woke up at 11:30 sweating and dizzy. After 45 minutes i went back to sleep and woke up later at 3:30 without any sweating or dizziness. This is the first reaction I've had following years of taking flu shoots and other vaccines.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash all over the back and back of neck.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: 2:30pm - headache onset.  Took Excedrin Migraine. 10:00pm - onset of chills. 1:00pm - fever 101.7. 2am on Nov 1, 2016 fever 102, chills continue. Nov 1 - 1:00pm - began feeling better and having more energy.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right shoulder red and slightly raised.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 6x8cm area of redness, warmth and swelling to left upper arm, with central bruising.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased
Clinical narrative: Patient received a flu vaccine on 10/13/16 and presented to the pharmacy on 10/31/16 complaining of not being able to raise her arm at the shoulder. Patient will visit her PCP.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Pt had red, swollen, and itching at site of injection. Pt was given diphenhydramine 50 mg/ml right deltoid IM.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Body temperature decreased, Chills, Cold sweat, Feeling of body temperature change
Clinical narrative: I administered a flu shot to a 16 year old male on 11/1/2016 @ 1730, who has received flu shots without incident in the past from his MD.  Within 60 secounds, he fainted and the other pharmacist and myself moved him to the floor.  He began to regain conciousness.  He laid on the floor for 2-3 minutes and we then assisted him to the chair.  He stated he felt nauseous.  Also, he was very clammy, extremely hot then got extremely cold.  He had dry heaves and was very weak.  The other pharmacist called 911 and I stayed with the patient and his mother.  The paramedics arrived and checked the patients vitals.  Temp was 95F, Blood Sugar 96, BP was normal.  Per his mother's request, he was transported to the nearest hospital for evaluation.  At the time he left, his color was coming back to his face, but he was freezing cold (shaking/teeth chattering).  The mother is a very close patient of mine and I asked her to call me in my cell to let me know how he is.  I will follow up with the mother if she doesn't call back.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Nausea, Retching, Syncope
Clinical narrative: I administered a flu shot to a 16 year old male on 11/1/2016 @ 1730, who has received flu shots without incident in the past from his MD.  Within 60 secounds, he fainted and the other pharmacist and myself moved him to the floor.  He began to regain conciousness.  He laid on the floor for 2-3 minutes and we then assisted him to the chair.  He stated he felt nauseous.  Also, he was very clammy, extremely hot then got extremely cold.  He had dry heaves and was very weak.  The other pharmacist called 911 and I stayed with the patient and his mother.  The paramedics arrived and checked the patients vitals.  Temp was 95F, Blood Sugar 96, BP was normal.  Per his mother's request, he was transported to the nearest hospital for evaluation.  At the time he left, his color was coming back to his face, but he was freezing cold (shaking/teeth chattering).  The mother is a very close patient of mine and I asked her to call me in my cell to let me know how he is.  I will follow up with the mother if she doesn't call back.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Radiculitis brachial
Clinical narrative: Brachial neuritis.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Arm soreness, redness around injection site. Patient states used heating pad on arm.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Shortness of Breath, "heavy" feeling in chest.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Extreme pain/soreness (scale 9 out of 10) in right arm (deltoid). Pt reports being unable to sleep due to pain and took hydrocodone already at home for relief on her own accord not upon recommendation. Patient asked for treatment options today 11-1-16. I recommended using a heating pad to the muscle and ibuprofen if not contraindicated.
Age: 88.0
Sex: M
Vaccine: PNC13
Symptoms: Lymphadenopathy
Clinical narrative: Patient has a knot in his lymph node area under the arm in which he received the PREVNAR vaccination.
Age: 60.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Patient reports that immidiately following administration of Tdap that she had pain at injection site in left arm only. Later that evening she noted reddness around injection site. Patient complaining of arm still painful and reddened area 3 days later.
Age: 62.0
Sex: M
Vaccine: DTAP
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Myalgia, Nodule, Pain
Clinical narrative: Noticed unusual knot in shoulder, which developed into chronic restrictive muscle pain that makes it difficult to perform basic movements without restrictive pain.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Administration error - trivalent influenza vaccine was requested and high dose influenza was administered instead.  No adverse effects experience by patient.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy test, Rash maculo-papular, Urticaria
Clinical narrative: Hives:  "Maculopapular wheals covering entire body".  Treated with prednisone 1 tablet PO daily for 5 days.  Referred to Allergist.
Age: 1.5
Sex: M
Vaccine: DTIPV, DTPHIB, MMR
Symptoms: Strabismus
Clinical narrative: Started having slight crossed eyes at times and has gotten worse and worse.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Severe pain in Left posterior deltoid / RTC that immediately radiated throbbing, numbness down left arm to hand. Residual soreness through week, worsening significantly through week of 10/17/2016. Limited left shoulder ROM and strength secondary to pain.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Severe pain in Left posterior deltoid / RTC that immediately radiated throbbing, numbness down left arm to hand. Residual soreness through week, worsening significantly through week of 10/17/2016. Limited left shoulder ROM and strength secondary to pain.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pyrexia, Somnolence, Vomiting
Clinical narrative: I was very sleepy after receiving the vaccination and took a nap around 7 PM. I woke up with a fever. I took some Advil around 8:30 PM. I started to feel nauseous and proceeded to vomit on and off until around 11:15 PM.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: I got the PNEUMOVAX 23 shot and by the evening about 2 or 3 inches below where the injection site is it began to swell and turn very red. It was hard to move my arm and I was unable to move my arm. By Sunday morning 10/30/16 I had to go to the emergency room for further evaluation as my arm was seriously red and swollen. I am presently still in the emergency room and being evaluated, they have given me steroids and BENADRYL. With no changes so far.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Immediate post-injection reaction, Radioallergosorbent test
Clinical narrative: She was initially referred to clinic for reports of chest "closing in", trouble breathing and lightheadedness almost immediately following receipt of flu vaccine on 11/3/2015 (manuf SKB Lot#497KX) at reserve bldg. She advised she was 5 months pregnant at the time. She advised the staff had her sit, relax and gave her some TYLENOL and monitored for 30 minutes with resolution of all symptoms. She denied having any HA, weakness, wheezing, difficulty swallowing, rash, or other systemic reactions. She did state the building is currently being remediate for mold (2016). She reported she does have PMH of passing out as a child (age 5-10) "a lot" especially if hot and rarely does it today. She returned on 11/1/2016 reporting concerns following receipt FLUARIX vaccination (day 11 after vaccination). She reported immediately as vaccine being injected 10/21/16 she could feel a sensation of the vaccine being pushed throughout her body. She went to the lobby to wait and began to feel throat itchy and was having difficulty swallowing. Staff checked on her at 15 min and she was brought back to nurses station where monitored without worsening of symptoms, no vs done, no exam done, no c/o of shortness of breath, angloedema, chest pain, anxiety, fever, headache, myalgia/arthralgia, et al. She advised 20 min later the sensation of throat closure resolved and she was released home where she took a BENADRYL for continued itching. The itching fully resolved 2 hours after onset and she went to sleep with the BENADRYL. Upon awakening, all symptoms had resolved and they have not returned. She did eat a bagel with cream cheese on 10/21 but has had since w/o issues. She does eat eggs but they must be fully cooked (preference).
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: She was initially referred to clinic for reports of chest "closing in", trouble breathing and lightheadedness almost immediately following receipt of flu vaccine on 11/3/2015 (manuf SKB Lot#497KX) at reserve bldg. She advised she was 5 months pregnant at the time. She advised the staff had her sit, relax and gave her some TYLENOL and monitored for 30 minutes with resolution of all symptoms. She denied having any HA, weakness, wheezing, difficulty swallowing, rash, or other systemic reactions. She did state the building is currently being remediate for mold (2016). She reported she does have PMH of passing out as a child (age 5-10) "a lot" especially if hot and rarely does it today. She returned on 11/1/2016 reporting concerns following receipt FLUARIX vaccination (day 11 after vaccination). She reported immediately as vaccine being injected 10/21/16 she could feel a sensation of the vaccine being pushed throughout her body. She went to the lobby to wait and began to feel throat itchy and was having difficulty swallowing. Staff checked on her at 15 min and she was brought back to nurses station where monitored without worsening of symptoms, no vs done, no exam done, no c/o of shortness of breath, angloedema, chest pain, anxiety, fever, headache, myalgia/arthralgia, et al. She advised 20 min later the sensation of throat closure resolved and she was released home where she took a BENADRYL for continued itching. The itching fully resolved 2 hours after onset and she went to sleep with the BENADRYL. Upon awakening, all symptoms had resolved and they have not returned. She did eat a bagel with cream cheese on 10/21 but has had since w/o issues. She does eat eggs but they must be fully cooked (preference).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: C/O right upper arm pain since getting flu vaccine on 10/11/2016.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Flushing, Pain, Pyrexia, Rash
Clinical narrative: Flushed generalized, fever, aches chills rash.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Skin reaction, Skin warm
Clinical narrative: Hot to touch - red in area Friday afternoon - 28th October. BENADRYL - took pics. Still that way 10-31-16.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm was swollen and had redness down the arm.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: I received the flu vaccine very high on my right shoulder on the morning of Oct 13, 2015. By the afternoon I was having pain in arm and couldn't raise my arm. Proceeded to get worse.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Pt reported 11/1/16 to Medical Assistant that she experienced a rash, and itching at the site of injection - one day after injection given 10/3/16 - Pt said SX started 10/4/16. Reported 11/1/16.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Erythema, Pruritus, Swelling
Clinical narrative: Began slightly itching 4 days after injs w/redness, swelling, at antecubital area then next day bumps appeared (Flat) red colored. Then 3 days later the bumps became fluid filled. Then redness approximately 4 inches going up and down arm from antecubital area. Blisters now gone; bumps have increase in number.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Hypersomnia, Rash, Urticaria
Clinical narrative: Rash on cheek; increased sleep. Reported hives on face.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Began breaking out in hives 10/27/16 - used hydrocortisone cream. Doctor VS. 10/31/16 - ordered oral prednisone and BENADRYL. On oral prednisone at beginning of October 2016 for poison ivy.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Vaccine administered 10/24 and patient's arm is still sore 11/1. Has a hard time moving arm. Patient contacted pharmacy 11/1 via phone.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea
Clinical narrative: Patient got FLULAVAL immunization on 10-28-16. Lot # A3AD2, expiration date 5/31/17. Patient said she was dizzy and nauseous as a result of flu vaccine.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Chest pain, Dysphagia, Injection site pain, Neck pain
Clinical narrative: This patient advised she received annual influenza vaccine on 10/27/2016 to left deltoid. She reported while walking out of clinic her arm was itching and site burned where Band-Aid was applied so she immediately removed thinking it was the Band-Aid (has allergy to latex, but clinic advised using latex free Band-Aids). Over the next hour the tingling burning sensation continued down her arm to fingertips. 2 hours later the vaccine site was swelling and was extremely painful to touch 10/10. She said her index and pointing finger went numb first then progressed to all fingers/thumbs and her fingers looked swollen to her. She had a friend drive her ER but stopped at urgent care as pain was progressing up the left side of her neck and down into her chest and her lips/tongue were tingling. She said she could talk and had no issues breathing at this time. On arrival to urgent care she had to contact insurance for medical clearance (insurance requirement) advising her tongue was now swollen and she was having difficulty swallowing, she could not speak clearly. Once cleared, she was taken immediately to back where providers treated her with epi, IV steroids and discharged 4 hours later with 4 days of oral steroids. This is day 1 post vaccine and her arm still burns with tingling in arm/not fingers, is slightly swollen at vac site but there is no site redness.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Paraesthesia oral, Pruritus, Vaccination site swelling
Clinical narrative: This patient advised she received annual influenza vaccine on 10/27/2016 to left deltoid. She reported while walking out of clinic her arm was itching and site burned where Band-Aid was applied so she immediately removed thinking it was the Band-Aid (has allergy to latex, but clinic advised using latex free Band-Aids). Over the next hour the tingling burning sensation continued down her arm to fingertips. 2 hours later the vaccine site was swelling and was extremely painful to touch 10/10. She said her index and pointing finger went numb first then progressed to all fingers/thumbs and her fingers looked swollen to her. She had a friend drive her ER but stopped at urgent care as pain was progressing up the left side of her neck and down into her chest and her lips/tongue were tingling. She said she could talk and had no issues breathing at this time. On arrival to urgent care she had to contact insurance for medical clearance (insurance requirement) advising her tongue was now swollen and she was having difficulty swallowing, she could not speak clearly. Once cleared, she was taken immediately to back where providers treated her with epi, IV steroids and discharged 4 hours later with 4 days of oral steroids. This is day 1 post vaccine and her arm still burns with tingling in arm/not fingers, is slightly swollen at vac site but there is no site redness.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Painful/sore arm first 3 days less painful but still sore next 4 weeks. Consulted Dr and was put on Prednisone. After 3 days of Prednisone pain is much better.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: Patient had severe back pain. Patient was ok after sitting for awhile with an ice pack.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient complains of pain in shoulder that radiates down to fingers lasting 2 weeks or longer. Patient seeing physician soon.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Patient states that his left shoulder has been hurting since he received his flu shot on 9/28/16. He pointed to the top of the shoulder and towards back of arm.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site arm very swollen, red and painful. Pt contacted MD and was told how to care for it. Currently in this state.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Monoplegia, Pain in extremity
Clinical narrative: Pt. reported that 2 hours after injection arm felt almost paralyzed and extremely painful, more than regular injection site RXN.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Monoplegia, Pain in extremity
Clinical narrative: Pt. reported after 2 hours her arm felt almost paralyzed and extremely painful, more than regular injection site RXN.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Eczema, Lichen striatus, Rash generalised, Rash morbilliform
Clinical narrative: Morbilliform rash generalized initially per pediatrician. Lichen striatus - like eczema right extremity only 10-21-16.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Discomfort, Erythema, Induration, Swelling
Clinical narrative: A few hours after the injection, he developed redness, swelling and mild discomfort. No fever or significant tenderness. Seen 10/31 and found to have 6x8 cm area of mild erythema, induration, in the general shape of the deltoid muscle.
Age: 0.08
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Haematochezia
Clinical narrative: 10-13-16 at 5:31 pm, spoke to mom via phone. Mom had just changed pt's diaper and saw small spots of blood in stool. No other symptoms. Possible reaction to rotovirus.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Pain
Clinical narrative: Patient received the PNEUMOVAX in office on 10/18/16 during a Adult Physical. That evening the (R) arm where injection was given - became swollen, painful with itchy rash. Returned to office on 10/20/16 after tried Antihistamine/Ibuprofen. No cellulitis - had soreness with ROM, red swelling at site.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Rash pruritic
Clinical narrative: Patient received the PNEUMOVAX in office on 10/18/16 during a Adult Physical. That evening the (R) arm where injection was given - became swollen, painful with itchy rash. Returned to office on 10/20/16 after tried Antihistamine/Ibuprofen. No cellulitis - had soreness with ROM, red swelling at site.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Cold sweat, Headache, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Extreme arm pain, headache, vomiting, clammy, swollen red arm at injection site.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Extreme arm pain, headache, vomiting, clammy, swollen red arm at injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 2 patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-SEP-2016, the patient was vaccinated with an improperly stored dose of VARIVAX 0.5 ml, subcutaneously, lot # M023379 with an expiration date: 11-MAY-2018. Administered dose of VARIVAX experienced temperature excursion of 11.1 Celsius degree for 1 hour 40 minutes, on an unknown date. No adverse effects were reported. This is one of several reports received 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 was received on 19-OCT-2016 from a registered nurse who reported that an unspecified number of improperly stored vaccines were administered to an unspecified number of patients (gender and age not specified) on 19-OCT-2016. The patients' pertinent medical history, current conditions and concomitant medications were not reported. An unspecified number of improperly stored vaccines of (Wistar RA 27-3) M-M-R II (Lot number L039551, expiration date 07-OCT-2017) (dose and route of administration not reported) were administered to an unspecified number of patients (gender and age not specified) on 19-OCT-2016. Temperature was reported as 47.8 degrees Fahrenheit. Time frame was reported as 11 hours. There was no previous temperature excursion. The Call was because of data logger. No adverse effects reported. No additional information was available. [The nurse reported the following Lot number L036301 with expiration date of 20-DEC-2017 was for the GARDASIL (MARRS 1611USA000357). (The nurse also reported that this same Lot number and expiration date was for the (Wistar RA 27-3) M-M-R II vaccines (MARRS 1610USA010944]. This is one of several reports received 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 was received on 19-OCT-2016 from a registered nurse who reported that an unspecified number of improperly stored vaccines were administered to an unspecified number of patients (gender and age not specified) on 19-OCT-2016. The patients' pertinent medical history, current conditions and concomitant medications were not reported. An unspecified number of improperly stored vaccines of GARDASIL (dose and route of administration not reported) were administered to an unspecified number of patients (gender and age not specified) on 19-OCT-2016. Temperature was reported as 47.8 degrees Fahrenheit. Time frame was reported as 11 hours. There was no previous temperature excursion. The Call was because of data logger. No adverse effects reported. No additional information was available. The nurse reported the following Lot number L036301 with expiration date of 20-DEC-2017 was for the GARDASIL. [The nurse also reported that this same lot # and expiration date was for the M-M-R II vaccines (Reference MARRS 1610USA010944.)] This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse referring to a unspecified number of patients of unknown age and gender. Patients pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB lot# reported as L029631 and expiration date: 14-AUG-2017, lot # M029233 with expiration date: 19-AUG-2018, lot #: M001578 with expiration date: 21-NOV-2018, lot# L045117 with expiration date: 06-OCT-2018 and lot # M022077 with expiration date: 10-AUG-2019 (dose and route were not provided). No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Serology test
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old male. The patient's medical history, concurrent condition and concomitant therapy were not provided. The pharmacist reported the patient was vaccinated with his first dose of RECOMBIVAX HB lot # K011957, expiration 24-OCT-2016 on 04-FEB-2016. The pharmacist reported that the patient stated, on an unspecified date in "March 2016", he "remembered getting another vaccine at another facility, and he thought it was his second dose of RECOMBIVAX (lot number/expiration date unspecified) but he is not certain". The patient then vaccinated with his first dose RECOMBIVAX HB (M027339, expiration 31-MAY-2018) on an unspecified date in "September 2016". On an unspecified date after the dose the patient received in September 2016, the patient had serologic testing and was found to have 'negative titers'. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a physician referring to multiple patients of unknown age and gender, The patients' pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with GARDASIL (dosage scheduled, route of administration, lot# and expiration date were not provided). There were no concomitant medications reported. On an unspecified dates, the patients experienced unspecified "problems" with GARDASIL. A product quality complaint was not involved. At the time of the reporting the outcome regarding the unspecified "problems" was not reported. The reporter did not provide the causality assessment between the unspecified adverse event and the suspect product. Additional information is not expected as there is not consent to follow-up.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Medical Assistant regarding a case involving VAQTA lot # M001815, expiration date 20-SEP-2017 (MARRS # 1610USA001301) who refers to multiple unknown patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were administered improperly stored doses of RECOMBIVAX HB lot # M001578, expiration date 21-NOV-2018. The vaccines were exposed to temperatures ranging from 33F to 35F for cumulative total time frame of 72 hours out of recommended storage range. There was no previous excursions reported. The data logger was reported as yes. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. This spontaneous report as received from a Medical Assistant who refers to multiple unknown patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were administered multiple unspecified vaccines of improperly stored doses of VAQTA lot # M001815, expiration date 20-SEP-2017 (dosing details were not reported), GARDASIL 9 lot # M007764, expiration date 30-JAN-2018 (dosing details were not reported) (refer to MARRS # XXXX) and RECOMBIVAX HB lot # M001578, expiration date 21-NOV-2018 (refer to MARRS # XXXX) and lot # M010212, expiration date 21-JAN-2019 (refer to MARRS # XXXX) (dosing details were not reported). The vaccines were exposed to temperatures ranging from 33F to 35F for cumulative total time frame of 72 hours out of recommended storage range. There were no previous excursions reported. The data logger was reported as yes. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reported as received from a Licensed Practical Nurse referring to a unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored PNEUMOVAX 23 lot# M022947 and expiration date: 12-NOV-2017 (strength, dose and route were not provided). No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown ages and gender. The patient's pertinent medical history, relevant laboratory data and concurrent conditions were not informed. On 17-OCT-2016 the patients were vaccinated with incorrect storage VAQTA lot # M018644, expiration date 20-SEP-2017, 5 ml administered per intramuscular route. Concomitant therapies were not informed. The medical assistant reported that on unspecified dates, the VAQTA had undergone a temperature excursion. It was informed that at the time of the report, the patients had not experienced any adverse reaction and had not been provided any treatment. It was unknown if the patients continue to receive VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored PROQUAD lot # M015698 and expiration date: 26-SEP-2017 (dose and route were not provided). No adverse event was reported. There was not product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On unspecified dates, the patients were vaccinated with a dose of improperly stored PROQUAD subcutaneously, lot # M022400, expiration date: 01-NOV-2017 (strength and dose were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse referring to a unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored of ROTATEQ orally, lot # L008057 with expiration date: 01-DEC-2016 and lot# L027076 with expiration date: 25-MAY-2017 (dose number and dose were not provided). No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is expected since as there is not consent to follow-up.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse referring to a unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored M-M-R II lot # L009213 with expiration date: 17-MAR-2017 and lot # L027591 with expiration date: 23-JUL-2017 (dose and route were not provided). No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored VARIVAX lot # M014908 with expiration date: 25-MAR-2018 and lot # L045954 with expiration date: 17-NOV-2017 (dose and route were not provided). No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 20 year old patient. On an unknown date the patient was vaccinated with PROQUAD lot # M012986, expiration. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse referring to a unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored of VAQTA lot # m003011 with expiration date: 15-NOV-2017 and lot# M017982 with expiration date: 13-MAR-2017 (dose and route were not provided). No adverse event was reported. There was not product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected since as there is not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patient came into the pharmacy with a prescription for ZOSTAVAX from his unspecified physician. Following vaccination, the patient stated he might have already received ZOSTAVAX (lot# and expiration date were not provided) subcutaneously at the physician's office. It was not clear whether or not the patient received two doses of ZOSTAVAX. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX 0.5 ml, subcutaneously, lot # M023379 with an expiration date: 11-MAY-2018. Administered dose of VARIVAX experienced temperature excursion of 11.1 Celsius degree for 1 hour 40 minutes, on an unknown date. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9, (lot#, expiration date, total dose and route unknown). The pharmacist reported that on an unknown date the patient may have delayed her second dose of GARDASIL 9 as she received a flu shot. No adverse effects were reported. No additional information is available. Additional information is not expected.