chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site swelling, Pain in extremity, Rash, Vaccination complication
Clinical narrative: Today 11/19/19, patient contacted myself at the pharmacy and reported symptoms. I advised her to seek medical attention. Her symptoms are as follows. On the first day, she experienced shallow breathing and broke out in rash as well as soreness in the arm. The following day she experienced increased swelling at the sight of injection. On the third day the swelling felt like it went further under the skin, decreasing mobility and increasing pain. Today, she expressed that the injection site had turned black and blue and the skin felt rough to the touch. The husband came and reported she had gone to the ER per my recommendation today 11/19/19. The ER confirmed it was an allergic reaction to the Prevnar 13 shot. She was given Clindamycin and Hydrocodone. She is to return for a follow-up appointment in 2 days to make sure it does not need to be drained.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Oral herpes, Pruritus, Pyrexia, Rash vesicular
Clinical narrative: severe headache, fever, itching, rash (looks like shingles), cold sore
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Starting 20 minutes after the shot she started complaining about lifting her arm ever so high, and through the night it got worse and then the swelling started to happen some time in the middle of the night. The next day her arm is swollen, she says it itches and it is very red.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemorrhage
Clinical narrative: PT SAYS THAT VACCINE FLUID TRAVELED TO OPPOSITE SIDE OF IM AREA AND CREATED WHAT APPEARS TO BE BROKEN BLOOD VESSELS.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Night sweats, Nightmare
Clinical narrative: HAD NIGHT SWEATS AND NIGHTMARES THE NIGHT OF VACCINE. FELT "FLU-LIKE" ON DAY 2.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Last evening, his right deltoid area had mild redness w/o pain or itching. This morning, his arm has  large area of redness that is pruritic and sometimes painful, covering most of his right upper arm. Nurse gave him an ice pack, which offered some relief.  No associated systemic symptoms, other than coughing that preceded this injection.  Given flu vaccine with preservative yesterday. Of note ~ Last year, he developed mild redness with firm palpable mass after receiving  his flu vaccine. That reaction did not spread or change in size. Child received preservative free vaccine last year.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, PNC13
Symptoms: Eyelid ptosis, Neurological examination normal, Pyrexia
Clinical narrative: She had left eye drooping, not grasping with her hands or using her legs on saturday morning. By saturday afternoon she started improving. By Sunday afternoon she seemed  back to normal. She had a low grade temp up to 99.4. She had 4 bowel movements and they were normal
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Exposure during pregnancy
Clinical narrative: Patient is newly pregnant and I did not verify this with her.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: SWELLING, REDNESS, ITCHING, PAIN AT INJECTION SITE. BUMP SIZE OF 3INCH X 2 INCH. LASTED FOR ABOUT 1 WEEK.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: After receiving his flu and HPV vaccine, patient became diaphoretic and lost consciousness. Patient was transferred to the exam room bed and cold compresses were applied to neck and forehead. Pulse ox was put on and constantly observed.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Injection site pain, Myalgia
Clinical narrative: Severe Headache, muscle aches, chills, loss of appetite, pain at injection site. Headache etc not relieved by 1000 mg of Tylenol
Age: 63.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: patient complains of ongoing pain in right arm starting 2 days after vaccination given.  Pain originates in shoulder, goes down right side, to the hand.  Pain is constant, intensity varies. Patient has not visited his doctor for this complaint.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Rash, Rash erythematous, Skin warm
Clinical narrative: Got vaccine on 11/4 on right arm around 11am.  Patient reports the next morning she had red dots on her face Red spots are still present. Decribed as painful, warm, and pruritic.  Reported having right arm pain after administration which is now resolved.  No spots are on body. No new creams or lotions. No sun exposure Reports history of acne on face but not significant Has seasonal allergies, but no known allergies to foods No attempted treatment and rash has no resolved.  Denies shortness of breath, fever, palpitations
Age: 61.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: PATIENT REPORTS A BULLS EYE RASH AROUND THE INJECTION SITE MEASURING 6 INCHES IN  DIAMETER.  PATIENT STATES IT WAS A RED HOT ITCHY RASH. THE PATIENT USED CLOBETASOL CREAM/OINTMENT ON THE RASH AND IT CLEARED UP.  PATIENT HAD NO OTHER COMPLAINTS BUT WANTED TO REPORT THE REACTION.  SHE WILL REPORT THE REACTION TO HER ALLERGIST AS WELL.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein, Fatigue, Full blood count, Malaise, Metabolic function test
Clinical narrative: Body aches, malaise, extreme fatigue x 4 days (no resolves as of yet)
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body aches, malaise, extreme fatigue x 4 days (no resolves as of yet)
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Chromaturia, Hepatitis A, Urticaria
Clinical narrative: patient says they were experiencing hives after showering 9recommended taking Benadryl before and after showering to prevent that), patient currently does not have trouble breathing , patient is also experiencing dark urine but that is probably more due to the actual hep a infections
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Cold sweat, Dizziness, Malaise, Nausea
Clinical narrative: Symptoms started approximately 20 mins after administration, employee stated he felt general malaise , lightheaded, dizzy, nauseous, cold sweat, and was notably shivering. Employee was referred for occupational health clinic/ urgent facility for further care.
Age: 23.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Fall, Nausea
Clinical narrative: Patient felt light headed and fell to floor.  No injury reported. Patient sat down and felt nauseated. Was given orange juice to help with symptoms. Patient was then escorted to bathroom for nausea. Patient did not vomit while there. At this point, patient sat down for about 5minutes and felt better. Patient was able to walk out of the store on his own with no issue. Female friend drove patient home.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: Pt experienced flu-like symptoms : , fever, chills, terrible headache, symptom severity of 5-6
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Head injury, Pallor, Syncope
Clinical narrative: After being vaccinated, client stood up walked a few steps withing vaccine room and had an episode of syncope while RN and parent were looking at vaccination sheet.   RN and parent heard thump and looked to see that patient had fallen to the floor and hit her head.  Client came to after a minute and was assisted to sit.  Client was pale but coherent.  Cool compress was applied to client's forehead and back of the neck.  Client stated that she was not in any pain.  Client was given sugary orange drink.  Client's parent stated that client had not eaten anything all morning.  After 10 minutes client stated that she felt better.   Color returned to her face.  When she got up, client felt dizzy again and she started to get pale again.  Paramedics were called to evaluate client.  Client was evaluate by byFire Department.  Client felt better and denied any pain. Fire Department gave okay for client to go home.  Parent also informed of precautions at home for client by Fire Department.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Basal cell carcinoma, Biopsy skin abnormal, Swelling
Clinical narrative: Pt noticed a small bump shortly after receiving the 2nd shot in the shingrix series. Bump slowly grew over the next year. pt went to dr and had is biopsy, diagnosed as basal cell carcinoma.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Electrocardiogram, Erythema, Fatigue, Full blood count
Clinical narrative: Persistent headache, redness thruout entire deltoid,upper arm, "spells of lost time" on Monday", tiredness, malaise, severe soreness at injection site for days
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Malaise, Urine analysis
Clinical narrative: Persistent headache, redness thruout entire deltoid,upper arm, "spells of lost time" on Monday", tiredness, malaise, severe soreness at injection site for days
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Erythema, Fatigue, Feeling abnormal
Clinical narrative: Persistent headache, redness thruout entire deltoid,upper arm, "spells of lost time" on Monday", tiredness, malaise, severe soreness at injection site for days
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Irritability, Pain in extremity, Tenderness
Clinical narrative: Persistent headache, redness thruout entire deltoid,upper arm, "spells of lost time" on Monday", tiredness, malaise, severe soreness at injection site for days
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, X-ray limb
Clinical narrative: patients say that the arm started having some pain after one week. he says that the pain is when he tries to lift the arm above the shoulders
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Fever, chills, full body red itchy rash.  Fever and chills lasted 24 hours.  Rash has persisted although less red and itchy to current time (6 weeks). Treating effects with antihistamines.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient reports sore arm one month after vaccine administaration. She believes it is due to technique.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: pt said arm was swollen and in pain. pt received vaccine over a week ago.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Fainted
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Injection site inflammation, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pain in left arm from shoulder to finger tips. Inflammation from shoulder to elbow. Started feeling pain a week after shot. Has had severe pain since then. Hurts to move arm and hurts to the touch, when touching the arm. The pain is a burning sensation throughout the arm when she is moving her arm. It also is a steady burning sensation when she is resting her arm but not as severe as when she is moving her arm. Any movement in her arm brings her pain, even to just buckle herself up in the car.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Tenderness
Clinical narrative: Pain in left arm from shoulder to finger tips. Inflammation from shoulder to elbow. Started feeling pain a week after shot. Has had severe pain since then. Hurts to move arm and hurts to the touch, when touching the arm. The pain is a burning sensation throughout the arm when she is moving her arm. It also is a steady burning sensation when she is resting her arm but not as severe as when she is moving her arm. Any movement in her arm brings her pain, even to just buckle herself up in the car.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in about 8 hour after receiving the injection and reported an injection site reaction.  She reported swelling at the site of injection and it spread on her arm, warmth and soreness due to inflammation.  We told patient to follow up with a physician as soon as possible to get evaluated and seek treatment.  Patient was going to also ice the site of injection and and take ibuprofen to help with inflammation.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt had redness, swelling and tenderness in the arm where she received the vaccine. This lasted several days.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Anxiety, Disturbance in attention, Mental impairment
Clinical narrative: Hard to think after the vaccination on 7/29/2019. I felt this effect by the end of that day and am only now thinking though most of the day without noticing a deliberate effort to stay on tack or experiencing ?thinking tunnel vision?. Where I do not feel my mind can see the bigger picture only the narrow tack i am straying to focus on. The difference before and after the vaccine is remarkable for the anxiety. It has gotten much better and continues to improve
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient has had persistent pain in her left shoulder since getting her flu shot. It's getting better but still aches with full extension of the arm.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt did not have a reaction to the vaccine but she is less than the recommended age of 4 years old
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Dyskinesia, Electroencephalogram normal, Magnetic resonance imaging normal
Clinical narrative: About 2 weeks after the vaccines were administered, we started noticing a head jerking almost seizure like movement. It was most noticeable when he was tired (nap or night time) and it was scary because he had never done that before to ?self sooth? to get to sleep before his 4 month vaccines.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Discomfort, Hypersomnia, Sneezing, Vomiting
Clinical narrative: 3 HRS AFTER VACCINATION - uncomfortable 4 hrs sneezing 5 hrs shivering 7 hrs propulsive vomiting after vomiting 14hrs (on/off) sleeping
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lymph node pain, Pain in extremity
Clinical narrative: PT WENT TO DOCTOR WITH A SEVERELY RED ARM. MD THOUGHT IT WAS INFECTED AND STARTED HER ON ANTIBIOTICS. SHE STATED IT WAS RED, PAINFUL AND GOING INTO HER LYMPH.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cellulitis, Rash, Rash erythematous
Clinical narrative: message I sent to Doctor:  bumps on the left side of my cheek next to my ear lobe, I initially thought is was a pimple under my skin . I messed with it, now its extremely sore. About 7 more of these bumps have appeared on my neck (right side) and tonight one near my collar bone on my neck front. They are like bumps under my skin, red/ visible but they have not come to a head like a pimple. They don't itch or necessarily hurt , except for the one I messed with by my ear lobe on my cheek. The are about the size of a pencil eraser head. I did get a shingles shot almost 2 weeks ago when I was in your office these bumps are really weird since they are spreading.  Visited a Physicians Assistant who said looked like shingles; itched when touched but no pain. Not traditional shingles symptom but did follow linear nerve path. PA prescribed ValACYcloviir 1000MB tablet 3x day for 7 days .   Small Blister packs formed on chest near throat and single or small blister packs behind hear and down neck and spine area at hairline.    Visited primary physician 4 days after initial diagnosis who took me off the meds. Said I had developed Celulitis from the bumps and put me on a 2x for 10 day dose of Bactrim Antibiotics.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid region of injection became hot and swollen post administration of pneumovax vaccine almost immediately after administration and solumedrol and Benadryl given for treatment
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Musculoskeletal disorder, Myalgia, Pain in extremity
Clinical narrative: Myalgia & RUE pain with LROM/function
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria, Vulvovaginal burning sensation, Vulvovaginal discomfort
Clinical narrative: Had both vaccines in afternoon, had reaction of hives by that PM - body hives, irritation/burning in vaginal area
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness, Myalgia
Clinical narrative: Confusion, Dizziness & Myalgia
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Acarodermatitis, Pruritus, Rash pruritic, Urticaria
Clinical narrative: Per ER note:   SUBJECTIVE: 65-year-old female presented to the emergency department with the above complaint. Reported that she received the Pneumovax and flu shot last week. Shortly thereafter she broke out in itchy raised migratory rash across her lower back, arms, and legs. Was seen in emergency care and given one shot of Decadron without improvement. She returned to the urgent care for reevaluation and was diagnosed scabies and started on permethrin without improvement. She denies any angioedema, dysphagia, dyspnea or wheezing, or any other acute complaints.  ASSESSMENT: Allergic urticaria.   PLAN: 1. Kenalog 60 mg IM. 2. Discharge home with prednisone, Zantac, and Zyrtec.  3. Rest, fluids, avoid known triggers. 4. F/U with PCP or return if symptoms worsen or do not improve. Symptoms: UrticariaPruritus Treatment: RANITIDINE 150 MG BID
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: (L) thigh where proquad was given, became red and itchy immediately after injection administered. (Redness approx. 2" in diameter) Pt was given oral Benadryl (12.5mg/5ml) 2.5ml, itching & most of redness resolved within 20 minutes of taking medication. No respiratory distress was reported
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: < 1 day - shivers, fatigue, Headache
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Confusional state, Dizziness, Erythema, Lethargy, Peripheral swelling
Clinical narrative: Entire arm red and swelling traveling into neck area. Lethargy, dizziness, confusion. Treated with Antihistamine plus steroid
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Entire arm red and swelling traveling into neck area. Lethargy, dizziness, confusion. Treated with Antihistamine plus steroid
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, aches, fever, headache, upset stomach
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Cellulitis at injection site , redness, warmth at site of injection Placed on antibiotics 11/19/19
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Inflammatory marker test, Laboratory test normal
Clinical narrative: Severe joint aches set in on day 3 after the flu shot.  I felt like I had sudden onset arthritis.  It lasted about 3 weeks and it was really bad. I had a similar reaction to a DTAP several years ago but I have had the flu shot often since and never had this happen.  In addition, my mother got this same vaccine and had the same aching joints and both her shoulders hurt badly as well as her hips for more than 2 weeks.  She felt physically ill after the quad vaccine.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Immediate post-injection reaction, Joint range of motion decreased, Pain
Clinical narrative: Immediate discomfort. Pain increased through the night to a level 8/10. ROM reduced, unable to adduct, reach behind back, lift affected arm above 45 degree.
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported in the patient; A child, received a dose of GARDASIL-9 on 7/23/2019; This spontaneous report was received from a physician via a company representative, concerning an 8-year-old patient, whose gender was not reported. The patient's pertinent medical history, drug reactions, allergies, and concomitant medication were not reported.   On 23-JUL-2019, the patient was believed to be 9 years old and was therefore vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (number of dose and frequency of vaccine scheme, route and anatomical location of vaccination, lot number, and expiration date were not reported). However, records received on a later date revealed that the patient was 8 years old at the time of vaccination (product administered to patient of inappropriate age). No adverse effects were reported in the patient.
Sex: F
Vaccine: HPV9
Symptoms: Muscle tightness, Temporomandibular joint syndrome
Clinical narrative: her jaw got really tight described as "TMJ"; Information has been received from a female medical assistant of unknown age via a field representative, referring to herself. Information about concurrent condition, concomitant medication and medical history was not provided.     On an unknown date (reported as a couple months ago), the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, lot# and expiration date were unknown) intramuscularly for prophylaxis.         On the same day, a couple hours after vaccination, the patient's jaw got really tight described as temporomandibular joint (TMJ). It persisted for three days and then resolved without treatment on an unspecified date. The patient talked to her dentist about it but didn't see anyone. The causality assessment was not provided by reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported in the patient.; a patient received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.      On 25-OCT-2019, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dosage detail, strength, lot # and expiration date were not reported) orally for prophylaxis.  Administered doses of vaccine experienced temperature excursion of below 36 Fahrenheit degrees (2 Celsius degree) (also reported as 35 Fahrenheit degrees) for 430 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; the patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant, regarding a 12-month-old patient of unknown gender.   The patient's pertinent medical history, and previous drug reactions or allergies were not reported.   On 11-NOV-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (product storage error), as prophylaxis (lot number: S021925, expiration date:15-JUL-2021; strength, dose, route of administration and anatomical location were not provided). A properly stored sterile diluent was used to reconstitute the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX).   The aforementioned vaccine underwent a temperature excursion from 6 Fahrenheit (F) degrees to 14 F degrees (14F) for 5 hours; and from 15 F degrees to 46 F degrees (15.3F) for 1 hour and 15 minutes, as recorded by a data logger. There was no previous temperature excursion. No product quality complaint was involved. No adverse effects were reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA004612:
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Mobility decreased, Myalgia, Pain in extremity, Wheelchair user
Clinical narrative: had to use a wheelchair to go to the doctor's office; The physician reported on 10/30/2019 the patient experienced difficulty getting out of bed; pain in the right upper extremity; issue with lifting the right arm; myalgia; This spontaneous information has been received from a physician via company representative, concerning a 94-year-old female patient. The patient's pertinent medical history, concomitant medications and previously drug reactions and allergies were unknown by the reporter.  On 29-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in her right arm as prophylaxis (reported as preventive care) (lot number: S006777 with expiration date 28-NOV-2020) (dose, and strength were not provided; route of administration was unknown by the reporter). The patient did not receive any concomitant vaccines that day.  On 30-OCT-2019, the patient experienced difficulty getting out of bed (dysstasia), myalgia, pain in the right upper extremity (pain in extremity), an issue with lifting the right arm (injected limb mobility decreased) and had to use a wheelchair to go to the doctor's office (wheelchair user). The patient sought for medical attention; however, it was unknown by reporter if any laboratory diagnostic or studies were performed or if the patient received any treatment due to the events. The patient fully recovered from the abovementioned adverse events on an unspecified date in 2019.  The causal relationship between the abovementioned adverse events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  Upon internal review, wheelchair user was determined to be a disabling event.
Age: 17.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Syncope
Clinical narrative: fainted; Information has been received from a physician via a company representative referring to a 17-year-old male patient. There were no patient's pertinent medical history, concurrent conditions nor concomitant therapies.  On 09-NOV-2019, the patient received a second dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported) and a dose of influenza virus vaccine (unspecified) (dose, route of administration, lot# and expiration date were not reported), both for prophylaxis.  On the same day, the patient fainted(syncope). The patient was in the physician's office. The patient came around after a few minutes. The patient was given juice and was observed and was fine. There were no lab diagnostics/studies performed. The causality assessment was not provided by the reporter.  Upon internal review, the event of fainted was determined to be medically significant.
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Feeling abnormal, Peripheral swelling, Skin bacterial infection
Clinical narrative: bacterial skin infection in his leg; it was swollen below the knee to ankle and a "solid sheet of red."; it was swollen below the knee to ankle and a "solid sheet of red."; feeling bad; Initial information received on 12-Nov-2019 regarding an unsolicited valid serious case received from a pharmacist.  This case involves a 59 years old male patient who experienced bacterial skin infection (bacterial infection) in his leg and feeling bad (Feeling abnormal) while he received FLUZONE (QUADRIVALENT INFLUENZA VACCINE).  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  Ongoing medical condition: bad diabetic (Diabetes mellitus).  On 01-Nov-2019, the patient received a 0.5 ml dose of suspect received FLUZONE (QUADRIVALENT INFLUENZA VACCINE) lot UJ223AA (Expiry date 30-Jun-2020) via intramuscular route in the left deltoid.  On 02-Nov-2019, the patient developed a serious feeling bad (feeling abnormal) 1 day following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.  On 05-Nov-2019, the patient developed a serious bacterial skin infection in his leg (bacterial infection), swollen below the knee (Peripheral swelling) and solid sheet of red (erythema) 4 days following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant.  Final diagnosis was bacterial skin infection, feeling bad, Extensive swelling of vaccinated limb and Redness of legs.  An antibiotic as corrective treatment was received.  On an unknown date, the event outcome is reported as recovered for all the events.; Sender's Comments: This case involves a 59 years old male patient who presented with bacterial skin infection while he received FLUZONE. The time to onset is compatible with the role of the vaccine. However, patient's medical history, medical condition at time of vaccination and lab test ruling out predisposing etiologies were not reported. Based upon the reported information and considering the infectious nature of the event, the role of the vaccine cannot be assessed.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: woke up with sore throat, extreme fatigue, fever of 101.8; I called and notified the doctor office but haven't received a call back yet.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PATIENT EXPERIENCING PAIN AND LIMITED MOBILITY OF ARM BEGINNING DAY OF VACCINATION AND CONTINUING
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: arm swelling and pain, tiredness, slight fever
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Headache Fever of 102 Lower backache Nausea Tiredness
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given fluzone high dose instead of standard fluvaccination
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Underdose
Clinical narrative: Pt received 0.5 mL of this vaccination for her booster dose instead of the 1.0 mL dose indicated for this reason. No other noted adverse issues; pt will need to get a full booster dose per CDC recommendations by MD
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: The first few days the adverse reaction was just a red slightly swollen area around injection sight and achy body. Then I noticed a rash on my stomach.  Next there was a small rash on my buttocks.  The rash sights which were for the most part just pimple sized bumps began to pop up at various sights mostly on my torso.  They are very itchy.  Some sights are constantly red and irritated.  Others come and go, moving around from site to site..  Recently I started noticing bumps and itchiness on my scalp. I tried various types of creams (hydrocortisone, Benadryl, creams for eczema and psoriasis).  None gave more than temporary relief.  Oatmeal baths sometimes helped.  Witch hazel on spots helped temporarily.  Doctor subscribed hydroxyzine which made rashes worse.  I am trying to get in to see a dermatologist as my family doctor doesn't seem to know what to do to help relieve my symptoms.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Skin irritation
Clinical narrative: The first few days the adverse reaction was just a red slightly swollen area around injection sight and achy body. Then I noticed a rash on my stomach.  Next there was a small rash on my buttocks.  The rash sights which were for the most part just pimple sized bumps began to pop up at various sights mostly on my torso.  They are very itchy.  Some sights are constantly red and irritated.  Others come and go, moving around from site to site..  Recently I started noticing bumps and itchiness on my scalp. I tried various types of creams (hydrocortisone, Benadryl, creams for eczema and psoriasis).  None gave more than temporary relief.  Oatmeal baths sometimes helped.  Witch hazel on spots helped temporarily.  Doctor subscribed hydroxyzine which made rashes worse.  I am trying to get in to see a dermatologist as my family doctor doesn't seem to know what to do to help relieve my symptoms.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: patient is now 5 weeks pregnant and was pregnant at time second dose ofGARDASIL 9 was administered; This spontaneous prospective pregnancy report was received from a nurse and refers to a 23-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in October 2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (lot # and expiration date were not reported)for human papillomavirus (HPV) vaccination.  At the time of the vaccination the patient was pregnant. The patient had ultrasound pregnancy performed and sought medical attention. The patient was 5 weeks pregnant at the time of the report. The last menstrual period (LMP) was calculated as 20-SEP-2019 and estimated date of delivery (EDD) was calculated as 26-JUN-2020. The pregnancy outcome was outcome pending.
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Pneumonia
Clinical narrative: pneumonia; congestive heart failure; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age. No information concerning the pt's medical history, concomitant medications and concurrent conditions was provided. In or around 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered from pneumonia and congestive heart failure. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was related.  Upon internal review, the events of pneumonia and congestive heart failure were determined to be medically significant. The events of pneumonia and congestive heart failure were considered to be disabling.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient called with report of arm swollen after injection and pain in the left arm. Patient was given an immediate appointment. In office patient was assessed Pain, swelling, redness localized to arm vaccine was given in. The Patient was given 50mg of Benadryl when advised to take 25 mg of Benadryl every 4-6hrs and notify us if no improvement.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Hypoaesthesia, Laryngitis, Muscular weakness, Pain in extremity
Clinical narrative: Pain/weakness of arms and legs, SOB, laryngitis, numbness of both arms.
Age: 64.0
Sex: F
Vaccine: TYP
Symptoms: Burning sensation, Contusion, Haemorrhage, Loss of personal independence in daily activities, Mass
Clinical narrative: Bled after injection, hurt, got a lump & bruise afterward. Hurt for weeks afterward. Hurt ever since. "Like a torn muscle" burns every day. Can't swim effectively now & after. Patient now says she was told not to have vaccines (never get annual flu shot) by her doctor because of her many conditions but wanted typhoid because of travel.
Age: 64.0
Sex: F
Vaccine: TYP
Symptoms: Muscle rupture, Pain
Clinical narrative: Bled after injection, hurt, got a lump & bruise afterward. Hurt for weeks afterward. Hurt ever since. "Like a torn muscle" burns every day. Can't swim effectively now & after. Patient now says she was told not to have vaccines (never get annual flu shot) by her doctor because of her many conditions but wanted typhoid because of travel.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: I experienced tiredness. muscle pain, headache, shivering and fever
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: High Fever and severe Chills/shaking. Fever was a high as 103.6 and was over 103 for several hours. Eventually responded to tylenol-- fever dropped after 12 hours to 101 and then after 24 hours to 100.
Age: 55.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Aphasia, Axillary mass, Blood test, Cerebrovascular accident, Hemiparesis
Clinical narrative: Started with very large knot under left arm and ended up in the er with stroke like symptoms Was taken from ER to hospital had an MRI and sent home lost speach as in starting to find the right words to say and a very weak left side  my left side is my dominant side currently using a cane for support
Age: 55.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Magnetic resonance imaging, Walking aid user
Clinical narrative: Started with very large knot under left arm and ended up in the er with stroke like symptoms Was taken from ER to hospital had an MRI and sent home lost speach as in starting to find the right words to say and a very weak left side  my left side is my dominant side currently using a cane for support
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Cellulitis-like reaction at injection site, with erythema and induration, 3.2 x 3.6 x 1.1 cm in size, tender to palpation.  Patient feeling malaise, presyncope, diarrhea.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Presyncope, Ultrasound scan normal
Clinical narrative: Cellulitis-like reaction at injection site, with erythema and induration, 3.2 x 3.6 x 1.1 cm in size, tender to palpation.  Patient feeling malaise, presyncope, diarrhea.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Injection site swelling, Pain in extremity, Vomiting
Clinical narrative: I got the shot at 1:25pm and went home and cooked dinner. I was cooking chicken strips and french fries in a deep fryer. Around 3:30 pm I noticed my arm was starting to hurt more and looked and it was swollen to the size of a baseball. I ate dinner at 6pm and went to bed at 9pm. I don't take any other meds and am allergic to mammal meat. I woke up at 1 am this morning throwing up and having diarrhea uncontrollably. As of 8am on 11/20/2019 the swelling has went down to my elbow and extends up past the injection site to right before my shoulder.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Had rash throughout her body  Rash was itchy, red and painful.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Redness, swelling at injection site. Headache, fever. Prescribed cephalexin and prednisolone.  This is the second occurrence from  the flu shot. Same reaction last year.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen & redness on upper (L) arm deltoid
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt was given Influenza vaccine in error, child was due for deffer ed 4 month vaccines that day. Pt received PO Tylenol in office prior to injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: client presented today at health department with concerns regarding shingrix injection site. area visualized to have mild puffiness, with an area approximately 4inches length by 2 inches  on inner aspect of right upper arm. client denies any fever or malaise, denies any shortness of breath, or throat closure,  but does state the area is "itchy". No angioedema visualized during this visit, client is communicating well and no acute distress noted. Encouraged client to apply cool compress to site, and to take otc antihistamine for the itching if her physician  approves and acetaminophen or Ibuprofen as her physician recommends for any discomforts she may have. client verbalized understanding.--rn
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: According to Mom, that evening patient started with mild temperature elevation (Up to 100.3) and was given Tylenol. The next morning he woke up with significant swelling and redness of the L upper arm. The swelling stretched from his L shoulder to his L elbow. He skin was also very warm to the touch  and tight in this area. When he was seen in our office on 11/20/19 for this reaction, he was started of Benadryl around the clock and encouraged to return to the office tomorrow for follow up.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Skin tightness
Clinical narrative: According to Mom, that evening patient started with mild temperature elevation (Up to 100.3) and was given Tylenol. The next morning he woke up with significant swelling and redness of the L upper arm. The swelling stretched from his L shoulder to his L elbow. He skin was also very warm to the touch  and tight in this area. When he was seen in our office on 11/20/19 for this reaction, he was started of Benadryl around the clock and encouraged to return to the office tomorrow for follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle pain, upset stomach, fatigue. Onset the morning after the vaccine, ongoing.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Viral test, Viral test negative, Vomiting
Clinical narrative: Pt developed bloody stools, vomiting, admitted to hospital.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; a patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.         On 14-OCT-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S015460, expiration date 20-MAY-2021, dosage detail and strength were not provided) subcutaneously for prophylaxis. The vaccine was constituted with MRK sterile diluent. It could not be determined if the MRK sterile diluent was properly stored. Administered doses of vaccine experienced temperature excursion of -11.5 degrees Centigrade (C) for 76 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; the patient was vaccinated with improperly stored Varivax; This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitants was reported.  On 24-OCT-2019, the patient was vaccinated with incorrectly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot# S002395 has been verified to be a valid lot number, expiration date: 23-JAN-2021), (exact dose and route of administration were not provided) for prophylaxis.  The vaccine was stored in temperatures: 15 degrees Fahrenheit (-9 degrees Celsius) to 46 degrees Fahrenheit (8 degrees Celsius) for 1 hour and 44 minutes and 6 degrees Fahrenheit (-14 degrees Celsius) to 14 degrees Fahrenheit (-10 degrees Celsius) for 2 hours and 11 minutes. There was no previous temperature excursion. The digital data logger was involved. There was no adverse effects.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: The patient received improperly stored vaccine; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's concomitant therapies included pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) and hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL). The patient's concurrent condition and historical condition were not provided. On 27-SEP-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, orally, lot number S004251, expiration date 22-SEP-2020 for prophylaxis.   Administered dose of vaccine experienced the temperature excursion of 1.4 degrees Celsius for 20 minutes. Data logger was involved. There was previous excursion reported as 10.5 degrees Celsius for 56 minutes.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; incorrect product storage; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 01-NOV-2019, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1660935, expiration date 06-OCT-2020 (dose was not reported). The vaccine underwent a temperature excursion at 51.28 degrees Fahrenheit for 2 hours and 16 minutes. No adverse event occurred.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: inproperly stored ROTATEQ was inadvertently administered to the one patient; no adverse effect; This spontaneous report as received from a medical assistant refers to a patient of unknown age, gender and ethnicity. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-NOV-2019, the patient was inadvertently vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1658256; expiration date: 18-NOV-2019; dose, frequency and route of administration were not reported) for prophylaxis. The vaccine was stored in above 9 Celsius degrees (9.4 Celsius degrees) within 20 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA002785: US-009507513-1911USA002735: US-009507513-1911USA003130: US-009507513-1911USA002713: