chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Rash erythematous
Clinical narrative: I had the same shots last year - same location, both together, and only experienced localized pain. This year my arm swelled by that evening, pain was such that I couldn't put any weight on or touch that area; it also reddened with what looked like a rash;  there was some itchiness; I had fever of 101 degrees two days later. On 3rd day symptoms abated.
Age: 15.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TD, VARCEL
Symptoms: Posture abnormal, Somnolence
Clinical narrative: Patient seen at Immunization Outreach at School requiring 8 vaccines.  Student very nervous before getting vaccines and held her breath during vaccines.  School RN at the clinic helping her get through all of the shots.  At the end was letting head fall forward but didn't faint.  Was escorted to the school nurse's office after the vaccines to be watched by the school RN.  At 12:53 PM, the school RN called the paramedics and she was taken by ambulance to the ER because the school RN said that "she could not keep her awake". Staff spoke with school RN later in day who reported the patient was stable.  No ER note available.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Cellulitis, Erythema, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: Patient described her right arm (the arm that received the shingles vaccine) as swelling up, turning very red, and being very painful.  She reports visiting an emergency department after this occurred where she received an antibiotic for a diagnosis of cellulitis.  Patient reports that the infection appeared to clear up, but she is still with pain in her arm.  She says pain is so bad that it makes sleeping difficult.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Insomnia, Pruritus, Urticaria
Clinical narrative: 10/16/2019 at 12:30 PM--hives noted on left thigh, quickly spread to right leg and arms.  By 1:30 PM, child covered in hives on arms, legs, and trunk.  Taken to doctor's office at 2:30 PM and assessed by ARNP.  Benadryl initiated at approximately 3:00 PM.  Minimal relief from itching and hives.  Benadryl administered every 6 hours through the night.   10/17/2019--oral steroid initiated at 9:00 AM (was prescribed at doctor appointment 10/16), receives total of three doses of Prednisolone 15mg/5mL given over course of day.  Hydrocortisone cream applied topically to hives twice.  Hives reduce in number, but are constantly present and intensely itchy.  Benadryl continued.  Child misses school due to hives, itching, and drowsiness from Benadryl.  Taken to doctor's office at 5:30 PM and assessed by MD; instructed to continue Benadryl and oral steroids as prescribed, referral to be made to pediatric allergy doctor.  Child has difficulty sleeping due to increase in hives after shower, intense itching, and no relief from Benadryl nor hydrocortisone cream and is awake until 2:30 AM.  Ice packs placed around child, dressed in light pajamas (tank top and shorts, two fans circulating air in room, and window open, in an effort to keep cool and reduce hives--does not help. 10/18/2019--Hives continue, reduced in number, and are not as itchy this day.  Receives two doses of Prednisolone this date, Benadryl continued.  Aveno oatmeal bath given. 10/19/2019--No hives noted this day.  Receives two doses of Prednisolone this date. 10/20/2019--No hives.  Received Prednisolone once.
Age: 50.0
Sex: F
Vaccine: FLUC4, MMR
Symptoms: Arthralgia, Contusion, Hypoaesthesia, Injection site erythema, Injection site mass
Clinical narrative: I had a weird pin poke feeling periodically in my right back side of my arm almost right away.  It dissipated after an hour or two.  There was a large (6") oval shaped red irritated area and a lump feeling on my upper right arm that started soon after the injection and got worse over the next few days.  It faded about a week or week and a 1/2 later.  The more significant problems started overnight the 24th and lasted quite some time. Beginning the 24th,  I felt like I had a very bad internal bruise inside my armpit and swelling in my armpit and shoulder. My right shoulder, arm, elbow wrist and  and down to my fingtertips (mostly the pinky, ring, and middle) all began t ached very badly and the 25th and also felt numb at the same time.     I couldn't sleep. Advil, CBD topicals, and ice, together, never helped fully.  Used ice pack on front and back of elbow/upper arm, wrist  and switching with neck.  Made dr appt Tuesday the 27th for soonest available with PA on September 10.  Called doctor on the 27th due to the pain not receding, but getting worse, but no appt until October. scheduled with PA for Sept 10, but that seemed a long time away for the amount of pain.
Age: 50.0
Sex: F
Vaccine: FLUC4, MMR
Symptoms: Insomnia, Musculoskeletal pain, Pain in extremity, Paraesthesia, Swelling
Clinical narrative: I had a weird pin poke feeling periodically in my right back side of my arm almost right away.  It dissipated after an hour or two.  There was a large (6") oval shaped red irritated area and a lump feeling on my upper right arm that started soon after the injection and got worse over the next few days.  It faded about a week or week and a 1/2 later.  The more significant problems started overnight the 24th and lasted quite some time. Beginning the 24th,  I felt like I had a very bad internal bruise inside my armpit and swelling in my armpit and shoulder. My right shoulder, arm, elbow wrist and  and down to my fingtertips (mostly the pinky, ring, and middle) all began t ached very badly and the 25th and also felt numb at the same time.     I couldn't sleep. Advil, CBD topicals, and ice, together, never helped fully.  Used ice pack on front and back of elbow/upper arm, wrist  and switching with neck.  Made dr appt Tuesday the 27th for soonest available with PA on September 10.  Called doctor on the 27th due to the pain not receding, but getting worse, but no appt until October. scheduled with PA for Sept 10, but that seemed a long time away for the amount of pain.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: cellulitis to arm
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Gait disturbance, Headache, Joint stiffness
Clinical narrative: Not sure if you need this info:  NDC 58160-823-11; VIS Date 2/12/2018;  Dose 0.5 mL;  This was dose 1 of the 2 part new Shingrix vaccine.  My left arm was extremely painful which I fully expected.  However,  I had a 100 and 101 fever and chills, headache, very stiff and painful muscles and joints throughout body which impaired my walking.  I had this from about 8pm on 10/18/2019 until 1pm on 10/20/2019.  I would say that the peak / worst time of these bad reactions was from 11pm on 10/18/2018 through 8pm on 10/19/2019.  I took Advil to relieve the symptoms.  I always get a flu shot and have never experienced such adverse reactions. I am curious whether I should expect such adverse reactions for the second dose in 2-6 months.  If so, I will make sure that I have nothing scheduled.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Not sure if you need this info:  NDC 58160-823-11; VIS Date 2/12/2018;  Dose 0.5 mL;  This was dose 1 of the 2 part new Shingrix vaccine.  My left arm was extremely painful which I fully expected.  However,  I had a 100 and 101 fever and chills, headache, very stiff and painful muscles and joints throughout body which impaired my walking.  I had this from about 8pm on 10/18/2019 until 1pm on 10/20/2019.  I would say that the peak / worst time of these bad reactions was from 11pm on 10/18/2018 through 8pm on 10/19/2019.  I took Advil to relieve the symptoms.  I always get a flu shot and have never experienced such adverse reactions. I am curious whether I should expect such adverse reactions for the second dose in 2-6 months.  If so, I will make sure that I have nothing scheduled.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Type IV hypersensitivity reaction
Clinical narrative: PERSISTENT RASH AT INJECTION SITE 14 MONTHS LATER, DELAYED HYPERSENSITIVITY REACTION
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient called and reported that approximately 48 hours after receiving the influenza vaccine, he developed hives on his left arm that traveled up his neck to his face.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: MOC noticed rash on right lateral thigh  Getting bigger according to MOC  Flat, well demarcated, oval, red lesion to R lateral thigh (5cm X 3.5 cm), warm  Treatment options included in plan of care include cold compress and ibuprofen PRN
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Immunisation, Needle issue, No adverse event
Clinical narrative: No adverse event/no signs or symptoms/no actual medical issue. Defective BD Safety Glide Needle 25G X1. When vaccinating the patient, all the contents of the flu vaccine fell out of the needle onto the floor, none went into the patient.  Due to verifying this, patient did receive a vaccine today using a different(non-defective) needle. Patient okay and no issues. Patient content with his vaccine admin. Just wanted to report situation.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Oral mucosal eruption
Clinical narrative: My son developed a rash around his mouth after receiving this vaccine. It has been almost 3 months and we have been on 2 different medications and it has still not cleared up. This  was the first vaccination that he ever received.  We only gave this vaccine because we forced against our will based on new laws banning religious exemptions.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Pt. states vaccine just above elbow. At approximately 9pm became red and inflammed, hot to touch with swelling. Also c/o itching. Over the next few days the redness increased. She had an appointment with Dr. on 10/17/19 and gave pt. antibiotic for infection of L arm. F/u with Dr. on 10/18/2019. Pt was advised to come here to the Clinic for reporting of outcome.  S/s have resolved.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Discomfort, Erythema, Injection site swelling, Pain, Swelling
Clinical narrative: Patient called to report that shoulder became swollen.  Swelling spread down the bicep and over to chest.  Arm was red.  Pain and discomfort.  These symptoms persisted for 3 days and have now subsided.   Now reports itchiness down the arm and using  an OTC anti-itch cream.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient received her flu shot.  She stood up so her Mom could get her shot next.  As she was standing there, she fainted.  911 was called and she was taken to the hospital to be checked out.  The family returned later in the day to inform us that the patient was fine.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Parent reports on 10/21/2019 that child has "warm to touch, swollen thigh for 48 hours."  "No fever or any other symptoms."   RN referred mother to VIS where it states that this is not an unusual side effect.   Also  advised her to take child to PCP if she does not show signs of improvement.  Mother states she already contacted PCP who told her to wait another day for swelling and heat to subside.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Pain and discomfort and swollen red arm that lasted 4 days.  100.5 degree fever that lasted several days.  Was using ibuprofen for pain and fever.  Fever is now gone and pain, redness, and swelling has gone down significantly.  Went to urgent care and was prescribed bactrim and keflex.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Back pain, Dizziness, Erythema, Pain in extremity, Pyrexia
Clinical narrative: Per Pt- Fever of 102 degrees F, low back pain, bilateral arm pain, redness, and swelling, lightheadedness that lasted 2-3 days.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Swelling
Clinical narrative: Per Pt- Fever of 102 degrees F, low back pain, bilateral arm pain, redness, and swelling, lightheadedness that lasted 2-3 days.
Age: 13.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient is 13yrs old and received a Dtap vaccine instead of a Tdap
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Lip swelling, Mouth swelling, Pharyngeal swelling, Pruritus
Clinical narrative: Received vaccine mandated for continuing hospital employment, no history of VZV disease or vaccination Fever to 103 degrees, rash covering >90% of body surface, more severe on back, sides, legs and arms accompanied by systemic itching. Swelling of mouth, lips and throat. Self dispensed 75mg diphenhydramine, 1,000 mg acetaminophen pre arrival to Emergency Department. Stayed for 3 hours for observation, directed to report to Occupational Health the next day. ED gave a diagnosis code of adverse reaction to vaccine, initial encounter and allergic reaction to vaccine. Brief, much more mild recurrence of same exactly three weeks later, resolved with same OTC treatment.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Vaccination complication
Clinical narrative: Received vaccine mandated for continuing hospital employment, no history of VZV disease or vaccination Fever to 103 degrees, rash covering >90% of body surface, more severe on back, sides, legs and arms accompanied by systemic itching. Swelling of mouth, lips and throat. Self dispensed 75mg diphenhydramine, 1,000 mg acetaminophen pre arrival to Emergency Department. Stayed for 3 hours for observation, directed to report to Occupational Health the next day. ED gave a diagnosis code of adverse reaction to vaccine, initial encounter and allergic reaction to vaccine. Brief, much more mild recurrence of same exactly three weeks later, resolved with same OTC treatment.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: HIVES
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: mild urticarial rash on extremities and lower back
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient presented to pharmacy 1 week after receiving the flu vaccination with prescriptions for steroid cream from Dr. Patient stated a rash started after vaccination, starting in arm pit area and moved to entire chest area.  Rash was very red, bumpy, and itchy. No changes were made to diet or medications during time period. MD office stated this was the third case of Fluzone high dose rash (1st from our pharmacy).
Age: 12.0
Sex: F
Vaccine: DTAP, HPV9, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 12yrs old and received Dtap instead of Tdap
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Upper thigh became red, swollen and warm to the touch.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Loss of personal independence in daily activities, Mobility decreased, Pain, Tendonitis
Clinical narrative: Developed pain about 7 pm that night. Pain worsened over next several days. Lost ability to raise arm,  hurts all the time especially at night. Unable to perform normal daily functions. MD diagnosed with bursitis and tendonitis. Patient is taking two OTC ibuprofen twice daily. Pt also gave her a few moderate exercises to do.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Hypersensitivity, Rash erythematous, Urticaria
Clinical narrative: Baby developed  red rash / hives all over stomach approximately 4-6 hours after injection. I called the after-hours nurse line and reported it and both the nurse and doctor on call confirmed it was an allergic reaction due to vaccination.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling hot, Musculoskeletal pain, Myalgia, Pain, Pain in extremity
Clinical narrative: At time of injection, patient reports feeling a "pop" and a "rush" of heat that she felt from the shoulder down to the hand. Said after about 2 hours the heat became painful in the same location. After 24-36 hours pain became more localized to the shoulder and bicep, and after a couple days the pain subsided and became more of a movement pain if lifting her arm higher than shoulder level or in quick motions.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Weight bearing difficulty
Clinical narrative: Left Leg Swelling and pain  According to MOC, child refuse to bear weight on left leg but has resolved by ER visit on 10/11/2019. Patient walking on their own in hospital fever 100.4 F rectal temperature at hospital  Treatment per hospital discharge: Tylenol or Ibuprofen for pain, follow up pcp within 3-5 days if needed, return for worsening of symptoms 10/15/2019- PCP visit at office Symptoms have since resolved. no edema, induration, or erythema present at PCP visit
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: About 24 hours after the shot she had experienced flu like symptoms including mild fever body aches and chills for 4 hours in duration then it resolved and symptoms resolved.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Peripheral swelling, Skin warm
Clinical narrative: Patient reported having a headache the day after the vaccine but took tylenol. Then on 10/20, patient called the pharmacy and reported her arm was swollen, red, and warm to the touch from her shoulder down to her elbow
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Audiogram, Chills, Cough, Deafness, Decreased appetite
Clinical narrative: 10/8/13 fever with cough 10/11/13 doctor appt (fever, chill, loss of appetite, cough, runny nose/congestion, sore throat, postnasal drip), sent home told return if worsens 10/14/13 doctor appt (fever/chills, not sleeping well, runny nose/congestion, ear pain, daytime cough, nighttime cough disturbing sleep, pain with palpitation on sinuses) prescribed Aumentin antibiotic, increase fluids 10/28/13 doctor appt (Not hearing well out of one ear, ear pain, runny nose/congestion, daytime cough, nighttime cough disturbing sleep) prescribed Omnicef antibiotic, just finished Aumentin, increase fluids 11/5/13 doctor appt (whining/crankiness, runny  nose/nasal congestion, sore throat, post nasal drip, change in hearing, nighttime cough disturbing sleep, over one month of symptoms)  prescribed Zithromax antibiotic, increase fluid 11/7/13 ENT appt (chronic ear infection and hearing loss, tinnitus, irritability, lethargy) suggested tube placement 11/20/13 ENT surgery (Myringotomy with insertion of ventilating tube) 12/19/13 ENT appt (symptoms improved)
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Ear infection, Ear pain, Ear tube insertion, Hypoacusis, Irritability
Clinical narrative: 10/8/13 fever with cough 10/11/13 doctor appt (fever, chill, loss of appetite, cough, runny nose/congestion, sore throat, postnasal drip), sent home told return if worsens 10/14/13 doctor appt (fever/chills, not sleeping well, runny nose/congestion, ear pain, daytime cough, nighttime cough disturbing sleep, pain with palpitation on sinuses) prescribed Aumentin antibiotic, increase fluids 10/28/13 doctor appt (Not hearing well out of one ear, ear pain, runny nose/congestion, daytime cough, nighttime cough disturbing sleep) prescribed Omnicef antibiotic, just finished Aumentin, increase fluids 11/5/13 doctor appt (whining/crankiness, runny  nose/nasal congestion, sore throat, post nasal drip, change in hearing, nighttime cough disturbing sleep, over one month of symptoms)  prescribed Zithromax antibiotic, increase fluid 11/7/13 ENT appt (chronic ear infection and hearing loss, tinnitus, irritability, lethargy) suggested tube placement 11/20/13 ENT surgery (Myringotomy with insertion of ventilating tube) 12/19/13 ENT appt (symptoms improved)
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Lethargy, Myringotomy, Oropharyngeal pain, Poor quality sleep, Pyrexia
Clinical narrative: 10/8/13 fever with cough 10/11/13 doctor appt (fever, chill, loss of appetite, cough, runny nose/congestion, sore throat, postnasal drip), sent home told return if worsens 10/14/13 doctor appt (fever/chills, not sleeping well, runny nose/congestion, ear pain, daytime cough, nighttime cough disturbing sleep, pain with palpitation on sinuses) prescribed Aumentin antibiotic, increase fluids 10/28/13 doctor appt (Not hearing well out of one ear, ear pain, runny nose/congestion, daytime cough, nighttime cough disturbing sleep) prescribed Omnicef antibiotic, just finished Aumentin, increase fluids 11/5/13 doctor appt (whining/crankiness, runny  nose/nasal congestion, sore throat, post nasal drip, change in hearing, nighttime cough disturbing sleep, over one month of symptoms)  prescribed Zithromax antibiotic, increase fluid 11/7/13 ENT appt (chronic ear infection and hearing loss, tinnitus, irritability, lethargy) suggested tube placement 11/20/13 ENT surgery (Myringotomy with insertion of ventilating tube) 12/19/13 ENT appt (symptoms improved)
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Respiratory tract congestion, Rhinorrhoea, Sinus pain, Sleep disorder, Tinnitus
Clinical narrative: 10/8/13 fever with cough 10/11/13 doctor appt (fever, chill, loss of appetite, cough, runny nose/congestion, sore throat, postnasal drip), sent home told return if worsens 10/14/13 doctor appt (fever/chills, not sleeping well, runny nose/congestion, ear pain, daytime cough, nighttime cough disturbing sleep, pain with palpitation on sinuses) prescribed Aumentin antibiotic, increase fluids 10/28/13 doctor appt (Not hearing well out of one ear, ear pain, runny nose/congestion, daytime cough, nighttime cough disturbing sleep) prescribed Omnicef antibiotic, just finished Aumentin, increase fluids 11/5/13 doctor appt (whining/crankiness, runny  nose/nasal congestion, sore throat, post nasal drip, change in hearing, nighttime cough disturbing sleep, over one month of symptoms)  prescribed Zithromax antibiotic, increase fluid 11/7/13 ENT appt (chronic ear infection and hearing loss, tinnitus, irritability, lethargy) suggested tube placement 11/20/13 ENT surgery (Myringotomy with insertion of ventilating tube) 12/19/13 ENT appt (symptoms improved)
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Upper-airway cough syndrome
Clinical narrative: 10/8/13 fever with cough 10/11/13 doctor appt (fever, chill, loss of appetite, cough, runny nose/congestion, sore throat, postnasal drip), sent home told return if worsens 10/14/13 doctor appt (fever/chills, not sleeping well, runny nose/congestion, ear pain, daytime cough, nighttime cough disturbing sleep, pain with palpitation on sinuses) prescribed Aumentin antibiotic, increase fluids 10/28/13 doctor appt (Not hearing well out of one ear, ear pain, runny nose/congestion, daytime cough, nighttime cough disturbing sleep) prescribed Omnicef antibiotic, just finished Aumentin, increase fluids 11/5/13 doctor appt (whining/crankiness, runny  nose/nasal congestion, sore throat, post nasal drip, change in hearing, nighttime cough disturbing sleep, over one month of symptoms)  prescribed Zithromax antibiotic, increase fluid 11/7/13 ENT appt (chronic ear infection and hearing loss, tinnitus, irritability, lethargy) suggested tube placement 11/20/13 ENT surgery (Myringotomy with insertion of ventilating tube) 12/19/13 ENT appt (symptoms improved)
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: He received the shot around noon then later on around 11:30pm that same evening  he started experiencing flu like symptoms including mild fever chills body aches that lasted about 5 or 6 hours then resolved.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: After receiving vaccine he go t light headed at the sigh of blood. Shortly after he passed out and hit the floor.  He stated that he has never had a adverse reaction to shots before.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Head discomfort, Injection site erythema, Injection site pruritus
Clinical narrative: Approximately 15 min after injection, patient reported itching and redness at injection site. Diphenhydramine 12.5mg/5mL oral soln given. patient then reported her head felt funny. HR 85 BP 167/102. O2 sat 99% RR 18. After 15 min another Diphenhydramine 12.5mg/5mL given. BP 163/102 HR 82 O2 sat 98%. Pt denied ever having shortness of breath or difficulty breathing. EMS evaluated patient, patient declined transport, was taken home. At home BP was 153/94 HR 73. Pt reported shorter reaction after receiving TDAP in 2015, but has had several influenza vaccines since then without any problems.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash vesicular
Clinical narrative: 48 hr from vaccine developed blistery - vesicular at center.
Age: 52.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Dizziness, Eye movement disorder, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: (1) patient was lightheaded immediately after vaccination (2) patient's eyes rolled back was unconscious for approx. 1 minute about 30 minutes after (3) paramedics were called and attended to her and took her to the hospital
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat and swelling around injections site measuring 4in x3in in diameter. Tender to touch.
Age: 75.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Pain, Rotator cuff syndrome, Swelling
Clinical narrative: SWELLING; SORE, AND PAINFUL SYMPTOMS DID NOT GO AWAY, but, CONTINUED AND GOT WORSE; ROTATOR CUFF - RIGHT ARM - UPPER/SHOULDER - EXTREMELY PAINFUL/HAD P.T.
Sex: M
Vaccine: FLU4
Symptoms: Needle issue, Syringe issue
Clinical narrative: While administering a flu vaccine to the employee, the pre-filled syringe malfunctioned and the vaccine came out around the needle at the hub. The needle felt like it was stripped. The flu ambassador had to administer a second flu vaccine to the employee.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nasopharyngitis, Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: This is the second immunization with shingrix 50 mcG inj (IM) sng dse vl 10pk. Sore arm, fever (chills), runny nose. Happened the same as the first dose. Generally felt like I had a bad cold both times.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This is the second immunization with shingrix 50 mcG inj (IM) sng dse vl 10pk. Sore arm, fever (chills), runny nose. Happened the same as the first dose. Generally felt like I had a bad cold both times.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Chills, Diarrhoea, Dizziness
Clinical narrative: After the vaccine on 10/16/2019 became sore and painful joints that evening with chills, went to bed woke up with a headache, nausea, diarrhea, dizziness, vomiting. Very painful back and shoulder joints.laid in bed for 2 days and took pain and then finally felt better but still nausea. Now my eye has a like floating black dot to the right of my right eye. Never had this before but still not over this week. I received the flu shot ant the prevnar vaccine last year with no side effects.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Nausea, Pain, Visual impairment, Vomiting
Clinical narrative: After the vaccine on 10/16/2019 became sore and painful joints that evening with chills, went to bed woke up with a headache, nausea, diarrhea, dizziness, vomiting. Very painful back and shoulder joints.laid in bed for 2 days and took pain and then finally felt better but still nausea. Now my eye has a like floating black dot to the right of my right eye. Never had this before but still not over this week. I received the flu shot ant the prevnar vaccine last year with no side effects.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; The patient was administered an improperly stored dose of Proquad; This spontaneous report was received from an office manager refers to a patient of unknown age and gender.  Patient's pertinent medical history, concurrent conditions, past drugs and allergies were not reported. Concomitant therapies included sterile diluent.   On 26-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, frequency and route were unknown) (lot number S003868 and expiration date 08-AUG-2020) for prophylaxis. It was reported that the diluent used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored. The temperature excursion was noted with a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.2 Fahrenheit) for 2 hours. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint reported.
Sex: F
Vaccine: MENB
Symptoms: Headache, Neck pain
Clinical narrative: Headache; Neck pain; This is a spontaneous report from a non-contactable consumer (office manager). This report was received via a Pfizer sales representative. A 17-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiry date not reported), via an unspecified route of administration in Apr2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2019, after the first dose of meningococcal group b rlp2086, the patient had neck pain and headache; and ended up in an emergency room. The patient did not want the second dose of meningococcal group b rlp2086, and the reporter wanted to know what they should do regarding the second dose (pending clarification). The outcome of the events, neck pain and headache, was unknown.  Information on the batch/lot number has been requested.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Blood test, Musculoskeletal stiffness, Pain
Clinical narrative: have stiffness in the shoulder that goes to the hand/shoulder stiffening and difficult to bend without pain; gets worse at night; his shoulder is real stiff and it's hard to bend without pain; with pain in the joints; a nerve could have been affected by the 5 inches needle used in the administration of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 29Sep2019 at a single dose for immunization at the physician's office. There were no medical history and concomitant medications. On 29Sep2019, the patient had stiffness in the shoulder that goes to the hand on with pain in the joints. His physician suggested that a nerve could have been affected by the 5 inches needle used in the administration of the vaccine on 29Sep2019. His shoulder was real stiff and it's hard to bend without pain on 29Sep2019. It gets worse at night. The symptoms started twelve hours after he received the shot. He didn't know if there was something he could do. He asked his doctor and he said none of it; the shot can't be the problem. He does not have results to share but he did get blood work on an unspecified date after the shot. He was just wondering how long this will persist. Outcome of the stiffness shoulder and shoulder pain was not recovered while of the remaining events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Cardiac disorder, Catheterisation cardiac, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; cardiac issues unspecified; This is a spontaneous report from a contactable physician via Pfizer Sales Representative.  A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unknown date in May2019 at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, a month later after pneumococcal 13-val conj vaccine was given, the patient had cardiac issues, unspecified. The patient had a cardiac catheterization put in. Unknown to reporter if the Cardiac Cath is the treatment for the cardiac issues (as reported). Not long after that patient developed Guillain-Barre syndrome and "the provider was pretty sure it was not the pneumococcal 13-val conj vaccine" (as reported). The outcome of the events was unknown. Information on batch number has been requested.; Sender's Comments: Based on the information currently available, both serious events cardiac issues and Guillain-Barre syndrome are unrelated to PREVNAR 13; both more likely represent intercurrent medical conditions.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Limb discomfort, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: Patient reports extreme pain, discomfort, and limited range of motion in left arm/shoulder.  Patient was advised to see her doctor which she states she will do but has not yet.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site of injection was sore and 3 days after shot redness around the injection site spread to around 15cm diameter.  the reddness has deminised over the last 3 days and is now just itchy around the edges where the redness was/is.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: One day after, the site was red and warm, two days after, it was swollen, hot, painful with chills, Third day, swollen but bigger area, hot, painful, with fever.  Went to primary doctor and got prescriptions for keflex and ibuprofen and tylenol.  On the fourth day, the swelling is less and no ever.  O n the fifth day, swelling is almost gone.  One week after, patient is good, with not syptoms.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: One day after, the site was red and warm, two days after, it was swollen, hot, painful with chills, Third day, swollen but bigger area, hot, painful, with fever.  Went to primary doctor and got prescriptions for keflex and ibuprofen and tylenol.  On the fourth day, the swelling is less and no ever.  O n the fifth day, swelling is almost gone.  One week after, patient is good, with not syptoms.
Age: 56.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Developed a rash on the trunk of his body today, 10/21/19. Denies itching or burning.  Advised to see PCP for treatment.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: extreme swelling, redness, itching, pain
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: extreme swelling, redness, itching, pain
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pain in extremity, Rash papular
Clinical narrative: patient reported back to the clinic about 2 hours after receiving immunization. Patient reported that her arm was sore and red. On examination the injection site was red and there was a diffuse papular rash on the upper extremities. No evidence of rash on neck, chest, face, abdomen, or legs. patient denied any trouble breathing, trouble swallowing or itching. vital signs were within normal limits and patient was afebrile. 25 mg of Benadryl was administered to patient. Discussed with patient that if any troubles breathing or swallowing to report back to clinic immediately and that if symptoms occur at home or clinic is closed to call 911 immediately. Patient was sent back to class in no acute distress.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: rash around the shot area.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Injection site erythema, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Ran a  low grade fever, 99.4 usually run at 97.6; arm extremely sore a very large red spot around shot area.  As day progressed all my limbs started becoming weak and was unable to push myself out of bed, spine hurt to sit on, husband had to help me walk, get on and off the toilet. Absolutely no strength did do anything either lie in bed all day and sleep off and on.  No appetite but forced myself to eat a half sandwich .  This started at 8AM on Sat 10/19/2019 and lasted until around 11PM that night where I was able to stand and walk alone to bathroom but still needed help getting off toilet.  Fever went to99.1.. Sunday 10/20/2019 felt a little better able to move and use my arms.  Was very tired and laid down for an hr or so.  Did not react to the first shot in this series.. Today my 10/21/2019 my arm is  still red and very sore .
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Spinal pain, Walking aid user
Clinical narrative: Ran a  low grade fever, 99.4 usually run at 97.6; arm extremely sore a very large red spot around shot area.  As day progressed all my limbs started becoming weak and was unable to push myself out of bed, spine hurt to sit on, husband had to help me walk, get on and off the toilet. Absolutely no strength did do anything either lie in bed all day and sleep off and on.  No appetite but forced myself to eat a half sandwich .  This started at 8AM on Sat 10/19/2019 and lasted until around 11PM that night where I was able to stand and walk alone to bathroom but still needed help getting off toilet.  Fever went to99.1.. Sunday 10/20/2019 felt a little better able to move and use my arms.  Was very tired and laid down for an hr or so.  Did not react to the first shot in this series.. Today my 10/21/2019 my arm is  still red and very sore .
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Loss of personal independence in daily activities, Muscular weakness, Pain in extremity
Clinical narrative: PATIENT STATES SHE HAS WEAKNESS IN HER ARM AND IT IS DIFFICULT FOR HER TO LIFT HEAVY OBJECTS. SHE ALSO IS HAVING PAIN DOWN TO HER WRIST.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Eye disorder, Fatigue, Feeling cold, Headache
Clinical narrative: Beginning on the evening of the vaccination and lasting all the next day (October 20) I had strong muscle aches,  headache, eyes felt weird, fatigue, weakness. I kept feeling cold, but didn't have a fever. Of course my arm was sore, but I had been warned about that and iced it right away. So the soreness wasn't too intense, though I didn't want to use my arm for anything heavy. These symptoms were severe enough that I had to cancel my plans for the day.  Today, October 21, the symptoms are much much less. I'm back to walking, exercising, etc.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain in extremity
Clinical narrative: Beginning on the evening of the vaccination and lasting all the next day (October 20) I had strong muscle aches,  headache, eyes felt weird, fatigue, weakness. I kept feeling cold, but didn't have a fever. Of course my arm was sore, but I had been warned about that and iced it right away. So the soreness wasn't too intense, though I didn't want to use my arm for anything heavy. These symptoms were severe enough that I had to cancel my plans for the day.  Today, October 21, the symptoms are much much less. I'm back to walking, exercising, etc.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Oropharyngeal pain, Peripheral swelling, Pruritus
Clinical narrative: Swelling of arm, sore throat, itchy skin
Age: 39.0
Sex: F
Vaccine: FLUR4, FLUA3
Symptoms: Syncope
Clinical narrative: Fainting after injection. Lowered to ground by secretary at desk. No obvious physical injuries. Transported to ER via wheelchair. Vital signs stable at transfer.
Age: 39.0
Sex: F
Vaccine: FLUR4, FLUA3
Symptoms: Dizziness, Erythema, Feeling hot, Flushing, Hyperhidrosis
Clinical narrative: Fainting after injection. Lowered to ground by secretary at desk. No obvious physical injuries. Transported to ER via wheelchair. Vital signs stable at transfer.
Age: 39.0
Sex: F
Vaccine: FLUR4, FLUA3
Symptoms: Hypertension, Hypoaesthesia, Hypoaesthesia oral, Loss of consciousness, Nausea
Clinical narrative: Fainting after injection. Lowered to ground by secretary at desk. No obvious physical injuries. Transported to ER via wheelchair. Vital signs stable at transfer.
Age: 39.0
Sex: F
Vaccine: FLUR4, FLUA3
Symptoms: Syncope
Clinical narrative: I?m not sure which flu vaccine I was given. It was the preservative free.  So the vaccine I picked above the number 17 may not be accurate. I honestly don?t know which brand or manufacturing company  The signs and symptoms started about one minute after my flu shot. My entire body went numb (like when your feet go to sleep after crossing your legs) My face mouth and tongue are the worst of the numbness. I got very hot sweaty dizzy nauseous and passed out. That may be lasted a minute but honestly I?m not sure. Luckily I had nurses around me that took care of me. I guess my face was beet red and flush and my blood pressure was very high compared to my normal somewhere in the 140:70. But I honestly couldn?t tell you the actual numbers. This all lasted approximately 20-ish minutes. It took about 30 minutes for the numbness of my face and mouth to go away
Age: 39.0
Sex: F
Vaccine: FLUR4, FLUA3
Symptoms: Dizziness, Erythema, Feeling hot, Flushing, Hyperhidrosis
Clinical narrative: I?m not sure which flu vaccine I was given. It was the preservative free.  So the vaccine I picked above the number 17 may not be accurate. I honestly don?t know which brand or manufacturing company  The signs and symptoms started about one minute after my flu shot. My entire body went numb (like when your feet go to sleep after crossing your legs) My face mouth and tongue are the worst of the numbness. I got very hot sweaty dizzy nauseous and passed out. That may be lasted a minute but honestly I?m not sure. Luckily I had nurses around me that took care of me. I guess my face was beet red and flush and my blood pressure was very high compared to my normal somewhere in the 140:70. But I honestly couldn?t tell you the actual numbers. This all lasted approximately 20-ish minutes. It took about 30 minutes for the numbness of my face and mouth to go away
Age: 39.0
Sex: F
Vaccine: FLUR4, FLUA3
Symptoms: Hypertension, Hypoaesthesia, Hypoaesthesia oral, Loss of consciousness, Nausea
Clinical narrative: I?m not sure which flu vaccine I was given. It was the preservative free.  So the vaccine I picked above the number 17 may not be accurate. I honestly don?t know which brand or manufacturing company  The signs and symptoms started about one minute after my flu shot. My entire body went numb (like when your feet go to sleep after crossing your legs) My face mouth and tongue are the worst of the numbness. I got very hot sweaty dizzy nauseous and passed out. That may be lasted a minute but honestly I?m not sure. Luckily I had nurses around me that took care of me. I guess my face was beet red and flush and my blood pressure was very high compared to my normal somewhere in the 140:70. But I honestly couldn?t tell you the actual numbers. This all lasted approximately 20-ish minutes. It took about 30 minutes for the numbness of my face and mouth to go away
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: Patient said shortly after leaving the pharmacy she started feeling shortness of breath, and her arm began to swell and become red/heated, didn't seek medical attention, received shot on 10/19/19. returned to the pharmacy on 10/21 saying she wanted us to be aware of reaction she experienced. The reaction she said had significantly improved however, still red and swollen. Told her she should go to her dr to get it checked out and said she would on her way out. Patient also stated that she has appointment on  Wednesday with her provider and will bring it up to him then.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Hypersensitivity, Peripheral swelling, Pyrexia
Clinical narrative: Pt reported a couple hours after vaccination arm became red, swollen, fever of 101.6, and area was hot to the touch. Happened on Saturday morning so on Sunday continued to ice the area. reported on Monday it spread further and after consulting PCP directed her to ER or urgent care. Pt reports that ER md said cellulitis and allergic reaction. Prescribed Bactrim and Keflex to treat the cellulitis.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Skin warm
Clinical narrative: Pt reported a couple hours after vaccination arm became red, swollen, fever of 101.6, and area was hot to the touch. Happened on Saturday morning so on Sunday continued to ice the area. reported on Monday it spread further and after consulting PCP directed her to ER or urgent care. Pt reports that ER md said cellulitis and allergic reaction. Prescribed Bactrim and Keflex to treat the cellulitis.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Flushing, Headache, Influenza like illness, Pain
Clinical narrative: Sore arm, body aches (flu like), slight head ache, feeling hot (flushed), lasted about 6 days.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm, body aches (flu like), slight head ache, feeling hot (flushed), lasted about 6 days.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio normal, Ammonia normal, Aspartate aminotransferase increased, Bacterial test negative
Clinical narrative: Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Base excess negative, Blood albumin normal, Blood alkaline phosphatase normal, Blood bicarbonate normal, Blood bilirubin normal
Clinical narrative: Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine decreased, Blood glucose normal
Clinical narrative: Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Blood lactic acid normal, Blood pH normal, Blood potassium normal, Blood sodium normal, Blood urea normal
Clinical narrative: Patient experienced low muscle tone (unable to walk, support himself, hold his head up,) lethargy, and fussiness after vaccines were administered on 10/14/19. He was seen in urgent care on 10/16, his pediatrician on 10/17, and admitted to hospital on the afternoon of 10/17.  He was discharged on 10/19 after all tests came back within normal limits and he began to improve.