chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Approximately 5 hours after the injection I started having full body shaking with got progressively worse.  I vomited up my dinner twice. I was running a fever of 101.  My wife and I went to the emergency room where I was tested for COVID19. Blood was drawn, urine samples taken. I soon felt better and was sent home the Dr. rulled out food poisoning and said she didn't know what the cause was. We determined by a process of elimination the it was the flu shot.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Bacterial test negative, Blood test, Chest X-ray abnormal, Decreased activity, Hypotonia
Clinical narrative: Vomiting , Fever Rectal Temp 103, gave Tylenol fever reducer on 9/14/2020 two to three hours after immunizations fevers were aggressive between 102 to 103. Called advice nurse 9/15/2020 recommend continue fever reducer every 4 to 5 hours to reduce fevers. On 9/16/2020 fevers were still consistent advice nurse and doctor recommended come to ER. ER visit diagnosed Pnuemonia from X-Ray. At discharge prescribed Amoxicillin 8ml two times a day, fevers continued between 102 and 103 rectal temps.  Chronic Fevers, Limp, Inactive, Non Verbal, Thighs Swelling 9/14/2020 to 9/19/2020 on and off. Chronic Fevers stopped 9/18/2020 started back up 9/20/2020 to 9/22/2020. Treatment at hospital admission 9/21/2020 to 9/23/2020 IV applied, still chronic fevers but they stopped on 8/23/2020 after IV treatment and consistent Tylenol around the clock and discharged after 24 hours no fever on 9/23/2020 around 1:00 pm. Doctor's stated that it was a mystery they don't know why fevers where going on.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site swelling, Pneumonia, Procalcitonin normal, Pyrexia, Respiratory viral panel
Clinical narrative: Vomiting , Fever Rectal Temp 103, gave Tylenol fever reducer on 9/14/2020 two to three hours after immunizations fevers were aggressive between 102 to 103. Called advice nurse 9/15/2020 recommend continue fever reducer every 4 to 5 hours to reduce fevers. On 9/16/2020 fevers were still consistent advice nurse and doctor recommended come to ER. ER visit diagnosed Pnuemonia from X-Ray. At discharge prescribed Amoxicillin 8ml two times a day, fevers continued between 102 and 103 rectal temps.  Chronic Fevers, Limp, Inactive, Non Verbal, Thighs Swelling 9/14/2020 to 9/19/2020 on and off. Chronic Fevers stopped 9/18/2020 started back up 9/20/2020 to 9/22/2020. Treatment at hospital admission 9/21/2020 to 9/23/2020 IV applied, still chronic fevers but they stopped on 8/23/2020 after IV treatment and consistent Tylenol around the clock and discharged after 24 hours no fever on 9/23/2020 around 1:00 pm. Doctor's stated that it was a mystery they don't know why fevers where going on.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rotavirus test negative, SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative, Viral test negative, Vomiting
Clinical narrative: Vomiting , Fever Rectal Temp 103, gave Tylenol fever reducer on 9/14/2020 two to three hours after immunizations fevers were aggressive between 102 to 103. Called advice nurse 9/15/2020 recommend continue fever reducer every 4 to 5 hours to reduce fevers. On 9/16/2020 fevers were still consistent advice nurse and doctor recommended come to ER. ER visit diagnosed Pnuemonia from X-Ray. At discharge prescribed Amoxicillin 8ml two times a day, fevers continued between 102 and 103 rectal temps.  Chronic Fevers, Limp, Inactive, Non Verbal, Thighs Swelling 9/14/2020 to 9/19/2020 on and off. Chronic Fevers stopped 9/18/2020 started back up 9/20/2020 to 9/22/2020. Treatment at hospital admission 9/21/2020 to 9/23/2020 IV applied, still chronic fevers but they stopped on 8/23/2020 after IV treatment and consistent Tylenol around the clock and discharged after 24 hours no fever on 9/23/2020 around 1:00 pm. Doctor's stated that it was a mystery they don't know why fevers where going on.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: White blood cell count increased
Clinical narrative: Vomiting , Fever Rectal Temp 103, gave Tylenol fever reducer on 9/14/2020 two to three hours after immunizations fevers were aggressive between 102 to 103. Called advice nurse 9/15/2020 recommend continue fever reducer every 4 to 5 hours to reduce fevers. On 9/16/2020 fevers were still consistent advice nurse and doctor recommended come to ER. ER visit diagnosed Pnuemonia from X-Ray. At discharge prescribed Amoxicillin 8ml two times a day, fevers continued between 102 and 103 rectal temps.  Chronic Fevers, Limp, Inactive, Non Verbal, Thighs Swelling 9/14/2020 to 9/19/2020 on and off. Chronic Fevers stopped 9/18/2020 started back up 9/20/2020 to 9/22/2020. Treatment at hospital admission 9/21/2020 to 9/23/2020 IV applied, still chronic fevers but they stopped on 8/23/2020 after IV treatment and consistent Tylenol around the clock and discharged after 24 hours no fever on 9/23/2020 around 1:00 pm. Doctor's stated that it was a mystery they don't know why fevers where going on.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site swelling, Throat irritation
Clinical narrative: Swelling and rash around injection site. Also had mild throat itching. Took Benadryl which helped the throat itching. Continued doses and eventually the rash subsided. I was a nursing student at time. I did not see a doctor.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram, Laboratory test, Lethargy
Clinical narrative: Blotchy/Rash appearance on skin, lethargic, chest pressure, shortness of breath
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash macular, SARS-CoV-2 test
Clinical narrative: Blotchy/Rash appearance on skin, lethargic, chest pressure, shortness of breath
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Rash macular, Retching
Clinical narrative: Fever, dry heaving, and blotchy skin on arms and legs
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea, Pain
Clinical narrative: When I woke up around 5:00am I had a massive headache, aches all over my body especially in my legs, and nausea. The nausea went away within a couple of hours and the headache abated (somewhat) later in the day but the muscle achiness continued ALL day and was significant. I took my temperature in the morning and had no fever although it was about 1 degree above my usual normal.  By 8:00pm I was starting to feel a bit better and the next day I felt totally fine again!
Age: 70.0
Sex: F
Vaccine: FLUR4
Symptoms: Pruritus, Rash
Clinical narrative: PATIENT STATED ITCHING AND SKIN RASH COVERING MOST OF BODY
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: Patient developed severe pain and tingling in left arm within 24 hours of administration.  Patient presented to E.R. for treatment because he believed symptoms were a heart attack.  Patient still experiencing numbness and tingling in left arm and numbness in last two fingers of left hand.  Stated that arm felt heavy.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Aggression, Enuresis, Headache
Clinical narrative: Day time enuresis with later having headaches (frontal headache) and aggressive behavior. Had three episodes of the day time enuresis and two episodes of headaches that self-resolved. Mom did give the first time he had a headache. All symptoms resolved by 9/22/2020. No localized erythema, swelling, calor nor point tenderness from the injection site.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythema, edema, and pain at injection site
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Patient developed fever and chills. The next day patient states feeling better.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Paraesthesia
Clinical narrative: Have servere pain and tingling. Can't move or lift arm without help of other hand.  Still pain two days later
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: 16 hours after receiving the vaccine, I started feeling welts on various part of my body and intense itching.  I proceeded to take a dose of Benadryl 25 mg and went back to bed.  I was also feeling achy which I knew to expect.  The itching improved until it wore off 4 hours later.  I continued to take Benadryl every 4 hours throughout the day to keep the welts and itching under control.  I decided to try stoping the Benadryl before bed and it seemed to be ok.  The reaction subsided about 18 hours after it had started.   I contacted my physician the next day and they told me to report what had happened.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Dizziness, Extensive swelling of vaccinated limb, Headache, Injection site erythema, Injection site pain
Clinical narrative: Itching in right arm (Pneumovax 23 inj 25MCG/0.5ML PF SYR, quantity 0.5),  arm hurting from shoulder to wrist, swelling from shoulder to elbow by 6:00 am 09/18/20 (arm swelled 2" more than normal), very red, burning.  3:00 pm 09/18/20, swelling the entire arm, deep burning pain, headache, light headed.  4:00 pm 09/18/20 emergency clinic administered high dose steroids,  prescribed Prednisone 20mg 2xda for 5 days.  Watch for red streaks. Advised I go to ER
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Itching in right arm (Pneumovax 23 inj 25MCG/0.5ML PF SYR, quantity 0.5),  arm hurting from shoulder to wrist, swelling from shoulder to elbow by 6:00 am 09/18/20 (arm swelled 2" more than normal), very red, burning.  3:00 pm 09/18/20, swelling the entire arm, deep burning pain, headache, light headed.  4:00 pm 09/18/20 emergency clinic administered high dose steroids,  prescribed Prednisone 20mg 2xda for 5 days.  Watch for red streaks. Advised I go to ER
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt brought this adverse reaction to this immunization to my attention, she states  that after receiving the immunization shot, there was not response until the  morning of 8/13 that her arm gradually swelled around the injection spot to a f" x  3" red oval raised hard and painful bump.  This bump and redness continued for 2  weeks.  Then the bump and redness gradually subsided. It was not until 9/9/20 36  days after the injection that the redness and bump became undetectable.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Nausea
Clinical narrative: Patient was sitting down after vaccine was given. He stated he felt nauseous and faint while sitting on the couch. Patient was alert and monitored by Registered Nurse. Patient was given juice and crackers. The patient left the clinic without complications.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Shoulder and deltoid swollen twice to the size, red hot painful. Sometimes itchy.  I treated with ice, Tylenol, Motrin.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Pruritus
Clinical narrative: Vaccination at 1500, within 30 minutes Patient complained of redness and itching, initially at face, back and arms.  Diphenhydramine 50 mg administered and kept Patient for 1 hour observation.  VS at 1530:  BP 132/84, HR 99, oxygen saturation 96%.  Lung sounds clear to auscultation anteriorly.  Over the course of 1 hour, itching decreased slightly but no further symptoms developed.  VS at 1630:  BP 138/98, HR 90, oxygen saturation 95%.  Lung sounds remain clear to auscultation anteriorly.  Patient was cleared to leave at 1645.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Blood test, Chest X-ray, Chest pain, Feeling cold
Clinical narrative: Trembling, shaking, chills, inability to talk, extreme joint and muscle pain. Fell asleep at 11:30pm or so. Then woke up at 3am with a fever, high heart rate, pains, terrible headache, and chest pain
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Heart rate increased, Myalgia, Pain, Pyrexia
Clinical narrative: Trembling, shaking, chills, inability to talk, extreme joint and muscle pain. Fell asleep at 11:30pm or so. Then woke up at 3am with a fever, high heart rate, pains, terrible headache, and chest pain
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Speech disorder, Tremor, Urine analysis
Clinical narrative: Trembling, shaking, chills, inability to talk, extreme joint and muscle pain. Fell asleep at 11:30pm or so. Then woke up at 3am with a fever, high heart rate, pains, terrible headache, and chest pain
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Incoherent, Moaning, Pain in extremity
Clinical narrative: I got the shot around 10am. Very achy writes, hands and elbows. I was moaning during sleep per my husband. Low fever. I got up to use the bathroom and got very dizzy. I fainted and fell onto bed. My husband said I wasn't talking coherently.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Syncope
Clinical narrative: I got the shot around 10am. Very achy writes, hands and elbows. I was moaning during sleep per my husband. Low fever. I got up to use the bathroom and got very dizzy. I fainted and fell onto bed. My husband said I wasn't talking coherently.
Age: 78.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: PT GIVEN INJECTION ON 9/22/20  IN SAME ARM THEN PT  CALLED  AND  CAME IN ON 9/24/20  COMPLAINING OF SWELLING IN UNDERARM AND REDNESS AND SLIGHT HEAT TO AREA-NOTHING NOTED AT INJECTION SITES-PT STATED IT WAS GETTING BETTER AND IS CALLING MD IF NOT BETTER TOMORROW- ALSO ADVISED OF BENADRYL  TO TAKE  AND POSSIBLE COLD COMPRESS
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: prevnar and fluzone hd given in each arm at same day sept 19th. patient called on sept 24th stating swollen and painful right arm starting tuesday sept 22nd and it is getting worse per patient.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nodule, Injection site rash
Clinical narrative: PATIENT called the pharmacy and reported that she woke up this morning with a rash and knot at the injection site. She did not have a reaction in the past or on Tuesday when she received her vaccine.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Injection site rash
Clinical narrative: Rash started on left thigh within 8 hours of receiving second Heatitis B vaccination.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Employee/patient had explosive diarrhea and then vomiting 1 hour after Flu injection. Only the one event. No further diarrhea or vomiting. Employee/patient was tested for COVID at a precaution and was negative. She only had the one event.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient states arm was red and swollen the morning after the vaccine.  She took aleve and iced the area.  She presented to the pharmacy in the day after the vaccine was administered at approx. 4pm  there was some redness remaining and no swelling.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure normal, Heart rate normal, Oxygen saturation normal, Syncope
Clinical narrative: I administer 0.5 ml of vaccine to her around 03:20 pm on 09/24/2020 in pharmacy. She was with her father and mother walked to front of pharmacy when I was told that she collapsed. I rushed to front of pharmacy with Epipen 0.15 mg, but it was not administered, both me and father bring her back to consultation room. In the mean time Mom has called EMS and they arrived. He vitals were monitored by EMS and were normal. Parents refused to go to ER or seek any other medical advise. I called her mother again at 05:02 pm today and asked how is patient doing. I was told she is fine and doing her homework.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Pharyngeal erythema, Rash erythematous, Tongue eruption
Clinical narrative: patient noticed red bumps on the back of her tongue and also redness at the back of her throat and difficulty swallowing
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: pt got flu shot. he was standing and watching his dad get his flu shot when he passed out.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site rash
Clinical narrative: Rash on right thigh started the morning after receiving her first pentacel vaccine. No other symptoms were noted.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Reports redness, arm pain to and around insertion site, diarrhea, body aches, fever (low grade) that started about 3 hours after receiving vaccine.   diarrhea has been improving.
Age: 18.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Nausea, Paraesthesia
Clinical narrative: Pt received the vaccine and withing about 5 minutes started feeling dizzy and light headed, tingling in arm and fingers, and nausea.  Sat with pt and provided a bottle of water and an ice pack.  Checked blood pressure after about 10 minutes and it was 133/87 and pulse was 98.  Remained with pt until family member returned and she felt well enough to leave the store.  Refused emergency services.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Audiogram abnormal, Magnetic resonance imaging brain, Sudden hearing loss
Clinical narrative: Sudden R hearing loss moderate per audiogram
Age: 80.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Depressed level of consciousness, Dizziness, Fall, Head injury
Clinical narrative: The patient reported no prior reactions to vaccinations and had no symptoms immediately after vaccination. She grabbed her belongings and headed out of the building and across the parking lot to walk home. Upon reaching the far side of the parking lot she fell backwards hitting her head and losing consciousness. 9-1-1 was called and she was taken away by ambulance. I was not there when the incident happened but was told that as she was leaving she did tell friends she was feeling dizzy.
Age: 26.0
Sex: M
Vaccine: FLUR4
Symptoms: Chills, Dizziness, Hyperhidrosis, Peripheral coldness
Clinical narrative: patient felt light headed, cold skin, sweats and chills
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, SARS-CoV-2 test negative, Vomiting
Clinical narrative: employee/patient vomited and had diarrhea 20 min after flu vaccine was injected. Lasted 3 hours. She was tested for COVID and is neg.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure decreased, Pallor, Syncope
Clinical narrative: Vasovagal syncope 5 minutes following administration.  Patient blood pressure dropped to 140/44, very pale.  After a few minutes, returned to 140/100.  Normal color returned.  Stated this happened following a tattoo once.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Had first dose of Shingrix. Two months later to complete the series. 3-4 days after vaccine, started itching all over her body. Still having continuing itching. Is not taking any medicines just antiitch medicine. Pharmacist recommended Benadryl, feels better but still has the itch.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 4.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: 3 days after administration of vaccine, redness, swelling, mild itchiness, size 55ml x 40ml, warm to touch progressing next day.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Body temperature increased, Gait disturbance, Headache, Muscle spasms
Clinical narrative: Several hours after flu shot, patient reported severe headache, muscle spasms, temperature of 101°, unsteady gait, abdominal cramping. These symptoms lasted for 3 days.  Symptoms did resolve.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Body temperature increased, Chills, Dyspnoea, Wheezing
Clinical narrative: Patient reported having difficulty breathing  and wheezing  chills with temperature up to 101 .  spoke to her the next morning her temperature had subsided and breathing difficulty significantly reduced but pt will be going to get a COVID test to verify symptoms are not COVID  related.
Age: 76.0
Sex: F
Vaccine: FLUA4, PNC13
Symptoms: Erythema, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: Customer reported swelling and spreading redness / discomfort to right arm on 9/23 to pharmacy. She had been experiencing symptoms beginning 9/21/20. She reported symptoms to primary care doctor and was seen on 9/23/20. Obtained RX for antibiotics related to possible skin infection on right arm. Following up with customer, on 9/24/20, she states her arm symptoms are improving, reduced redness, soreness and swelling. Instructed her to follow up with pcp if symptoms do not improve or worsen.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: patient received flu vaccine on Monday afternoon, on Monday night started feeling pain to her left am, reported experiencing pain, swelling and warmth in her left arm since Monday night,  Weds night pain worse.  today (Thursday redness has decreased).  Area painful to touch on exam, denies no fever or chills.  dx cellulitis, given Keflex 500mg QID x 5 days and to use warm compresses then alternate with cool and warm compresses, advised to take Tylenol or motrin as needed for pain relief
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Tenderness
Clinical narrative: Pt had redness and tenderness in arm. Advised to use benadryl and tylenol
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Crying, Dizziness, Emotional distress, Loss of consciousness, Paraesthesia
Clinical narrative: patient received vaccine and seemed fine.  She was holding her sister's hand while her sister received her vaccine and seemed to pass out as her sisters vaccine was being finished up.  Patient was dizzy, complained of tingling in her arm (after becoming more alert which took a very short time).  She was very upset and crying.  911 was called immediately as she seemed to collapse/pass out.  Ambulance arrived fairly quickly and completed an assessment
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: patient received vaccine and seemed fine.  She was holding her sister's hand while her sister received her vaccine and seemed to pass out as her sisters vaccine was being finished up.  Patient was dizzy, complained of tingling in her arm (after becoming more alert which took a very short time).  She was very upset and crying.  911 was called immediately as she seemed to collapse/pass out.  Ambulance arrived fairly quickly and completed an assessment
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired vaccine
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased
Clinical narrative: Patient stated severe immobility in her arm for about 5 hours from pneumonia vaccine. took medicine and had some relief.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated that her reaction started about 2 hours after vaccination.  Patient stated she had redness, swelling, warmth at injection site.  Patient denied that swelling/redness was traveling down arm down to elbow.  Patient denied having a fever.  Symptoms began improving on 9/23 and continued improving through 9/24.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: sweating, dizziness, and nausea within 15 to 20 minutes
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Flushing, Syncope
Clinical narrative: 4 hours after the injection felt sudden extreme body weakness and flushing, then collapsed. Near fainting, but never lost consciousness.  Recovered after sitting in a  chair for several minutes. Went home took my temp and blood pressure. Temp was 97.8,  BP 121/77. Pulse 59. Don't know if there are any other adverse events, too soon to tell. I had the Fluad trivalent flu shot last year, no major issues.but
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, FLUA3, PNC13, RV1
Symptoms: Crying, Decreased activity, Dizziness, Hyperventilation, Pyrexia
Clinical narrative: 102-103 degrees F fever that lowers and comes back, does not want to breastfeed or eat, vomiting, hyperventilating, dizzy, very low activity, crying constantly
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, FLUA3, PNC13, RV1
Symptoms: Selective eating disorder, Vomiting
Clinical narrative: 102-103 degrees F fever that lowers and comes back, does not want to breastfeed or eat, vomiting, hyperventilating, dizzy, very low activity, crying constantly
Age: 75.0
Sex: M
Vaccine: FLUA3
Symptoms: Contusion, Injection site bruising
Clinical narrative: bruising on most of the upper arm
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Pallor, Skin warm
Clinical narrative: The child experience the adverse event 5min after the shot was administered. He was unconscious for 30 seconds then woke up and was talking and breathing fine then all of a sudden he turned really pale and was warm. I immediately called 911 who instructed me on what to do. After ambulance came i was in the background to see if they needed anything. He was not taken to the ER but parents will call pediatrician to see if he needs to be seen.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: I received the Flu Shot on a Tuesday and the next day I awoke to my muscle being swollen and red and hot.  I also received the Pneumonia Shot in the same arm.  That information is:  Pneumovax 23 Syringe, Manufacturer: Merck Sharp & D, Route: Intramuscular, right arm.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Headache, Pyrexia, Urticaria
Clinical narrative: "Fever of 101, chills, hives ,long hot spells and a terrible headache"
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Hyperhidrosis, Influenza like illness, Injection site pain
Clinical narrative: Fever of 99.2 in evening for two nights. Chills then sweating for two nights. Malaise and flu like no energy symptoms. Rash and soreness on injection site for five days. Fever would abate after 1000 mg of Tylenol
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Malaise, Pyrexia
Clinical narrative: Fever of 99.2 in evening for two nights. Chills then sweating for two nights. Malaise and flu like no energy symptoms. Rash and soreness on injection site for five days. Fever would abate after 1000 mg of Tylenol
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Pt started having chest tightness and sob a few minutes after receiving the immunization. The pharmacist administered 12.5 mg (5ml) of diphenhydramine and 0.15mg of epinephrine auto injection pt responded immediately to the epinephrine. 911 was called and Fire Dept showed up and took over.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Product administered at inappropriate site
Clinical narrative: mother called after 4 th days , mother who is nurse said injection was given lower than muscle and thinks that pharmacist give injection lower and may be it was subcutaneous and not intra muscularand her daugher has redness and swelling around the inection site.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
Clinical narrative: shot was given in left arm. right arm went numb immediately. tingly, like sleeping. has been two weeks and right arm is still numb -- from shoulder to wrist. (SHOT WAS DEFINITELY IN LEFT ARM... not sure why right arm is affected.)
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: shot was given in left arm. right arm went numb immediately. tingly, like sleeping. has been two weeks and right arm is still numb -- from shoulder to wrist. (SHOT WAS DEFINITELY IN LEFT ARM... not sure why right arm is affected.)
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pruritus, Pyrexia, Swelling
Clinical narrative: Itchy, swollen, red, fever, bruised
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial test, Debridement, Joint fluid drainage, Joint lock, Pain in extremity
Clinical narrative: Pt had a sore arm starting in the evening of 9/21/20. Pt went to her providers office on 9/22/20 since her arm "locked up", The provider then sent her to the emergency room.  At the emergency room she had to have her arm cut open to debride the tissue and have fluid removed from her arm . The hospital is doing a culture to see what bacteria the patient has an infection from, the patient is currently still in the hospital.
Age: 81.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient had swelling and redness throughout her upper arm. She reported it was warm to the touch and also reported a low grade fever (around 99 degrees).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: pt had joint pain in her finger/thumb, knees, and feet lasting 3 weeks.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Patient received the vaccine Sept 21, 2020. On Sept 24, 2020, she came thru our drivethru saying that she had the shot Monday and was experiencing a hard lump at injection site and warmness. I asked her if she had ever had an allergic reaction to eggs or to flu vaccines before. She said no. I did ask her if she was having any shoulder pain or if she had any pain radiating down arm. She was able to move arm. She said she noticed the lump and heat on Sept 22 but the heat started getting worse today. I did recommend she followup with her physician. She gave me permission to contact her Physician Assistant on file.
Age: 91.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient presented to pharmacy on 9/24/20 after vaccine was administered on 9/23/20. His left arm shows redness and slightly swelling area with a diameter of approximately 2-3 inches. Patient was recommended to use cold compress to reduce redness and swelling as well as topical antihistamine. Patient denied feeling ill due to vaccine, asked for sign and symptoms of fever, difficult breathing, headache which were all denied by patient.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient called to report local itching and swollen arm at site of injection two days after receiving flu shot. Patient received Fluarix two years ago with no complaints. Pt report this has been her first reaction to flu shot.
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Skin discolouration, Urticaria
Clinical narrative: Hives all over the body starting 1-2 days after vaccine. hives look red or pink, above skin. Most are small in 1-2 mm diameter.  Fell itch. No fever. Have had it for 3  days
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Anaphylactic shock, Dysarthria, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: The vaccination was administered around 11:24 am The incident was after patient used the inhaler (combivent). patient was having difficulty breathing. patient took the rescue inhaler albuterol HFA. Patient had experienced anaphylaxis around 2:30 pm patient went to the Er (minor emergency). Patient was slurring, forceful vomiting, breathing heavy. HR was about patient was given steroid, Benadryl and nebulization treatment. (2 treatments)
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Myocardial necrosis marker normal, Tachycardia, Vomiting
Clinical narrative: The vaccination was administered around 11:24 am The incident was after patient used the inhaler (combivent). patient was having difficulty breathing. patient took the rescue inhaler albuterol HFA. Patient had experienced anaphylaxis around 2:30 pm patient went to the Er (minor emergency). Patient was slurring, forceful vomiting, breathing heavy. HR was about patient was given steroid, Benadryl and nebulization treatment. (2 treatments)
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Cellulitis, Fall, Pneumonia, Sepsis
Clinical narrative: Pt received vaccine at 10:08 AM on 9/16/2020. On morning of 9/17/2020 pt felt weak, sat on commode while going to the bathroom, fell onto floor where he laid for 7 1/2 - 8 HRS until his wife got home and called ambulance. He was transported to Hospital where he was admitted for 5 days. Treated for pneumonia, cellulitis, sepsis & R/O MI. Released on 9/21/2020.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Chest pain, Dyspnoea, Hypersensitivity, Injection site warmth
Clinical narrative: Employee experienced a reaction after receiving a flu shot at our facility. The reaction occurred with-in two hours of receiving the vaccine. The injection site was warm to the touch and the employee had weakness and difficulty raising her arm. Notable swelling was noted on her left arm. Employee complained of chest pain and difficulty breathing. Employee was taken to the hospital ER for treatment next door to our facility. She was treated for the allergic reaction and sent home.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: Employee experienced a reaction after receiving a flu shot at our facility. The reaction occurred with-in two hours of receiving the vaccine. The injection site was warm to the touch and the employee had weakness and difficulty raising her arm. Notable swelling was noted on her left arm. Employee complained of chest pain and difficulty breathing. Employee was taken to the hospital ER for treatment next door to our facility. She was treated for the allergic reaction and sent home.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb
Clinical narrative: Extensive Limb Swelling of left thigh, beginning <24hr after vaccine admin. swelling of entire thigh from just below hip to just above knee - no other s/sx. (No pain/sx of infx, etc.) Presented 9/21/20 with report of swelling. Advised to try Benadryl. Upon f/u on 9/22/20 - parent reported significant improvement in symptoms.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Hypersensitivity, Local reaction, Peripheral swelling
Clinical narrative: Severe local allergic rxn (L) arm red, swollen, seen in E.D. Prescribed Prednisone
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Pt was sore at injection site and now has shooting pains in tricep when he exerts himself (lifts weight, etc)
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Soreness, redness, swelling, and skin felt hot to the touch.
Age: 22.0
Sex: M
Vaccine: FLU4, MMR, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Musculoskeletal stiffness, Seizure like phenomena, Staring
Clinical narrative: Patient faint and displayed seizure like symptoms (tremor, body tightening, sweating, staring gaze) for 3-4 seconds after receiving vaccinations. Reaction occurred within seconds of last vaccine. Patient refused emergency care. Patient returned to alert status under 1/2 minute. After sitting for 1/2 hr patient left
Age: 22.0
Sex: M
Vaccine: FLU4, MMR, TDAP, VARCEL
Symptoms: Tremor
Clinical narrative: Patient faint and displayed seizure like symptoms (tremor, body tightening, sweating, staring gaze) for 3-4 seconds after receiving vaccinations. Reaction occurred within seconds of last vaccine. Patient refused emergency care. Patient returned to alert status under 1/2 minute. After sitting for 1/2 hr patient left
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Patient became dizzy, began sweating & became pale in color. The symptoms lasted approximately 10-15 minutes. EMS checked patient: he remained at work afterwards.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth, Nausea
Clinical narrative: Shortly after receiving vaccine patient experienced redness, warmth & aches at injection site. This last a couple of days before a welt developed down the arm towards bicep area. This also was very warm. Patient iced areas and it all resolve 3 days after injection. Patient also experienced nausea.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Rash, Rash papular, Rash pruritic, Seborrhoeic keratosis
Clinical narrative: Papular pruritic rash on torso and extremities that started ~1week after the injection
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy, Product administered at inappropriate site, Rash pruritic, Seborrhoeic keratosis
Clinical narrative: Papular pruritic rash on torso and extremities that started ~1week after the injection
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient reported to us on 9/23 about event. On 9/18 in the evening patient started to get a redness at the injection site and it ended up extending 3-4" down to the elbow area. She reported that is was also itchy. She took benadryl nightly and it resolved by 9/22. We spoke with nurse at Dr's office on 9/24 and informed them of reaction. Patient reported that she had no issues with flu shots previously.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient called pharmacy several days after rcving vaccine and stated that she had redness and itching that would not go away. The redness and itching had spread from injection site up to her shoulder
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red skin site reaction; no pain; Hot/warm to touch
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The day after patient received vaccine she noticed soreness below injection site. The next day this soreness "4 inches" below injection site became red & swollen. It was also warm to the touch. On the 3rd day after injection, site still a little red but resolving.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Patient called on 9/22 and reported to pharmacist that on 9/21 she had redness in multiple areas of the body. She went to the doctor and doctor advised her it was a reaction from the flu shot she received. She proceeded to take 1 dose of BENADRYL and recovered on 9/23/20. On 9/24 the pharmacist spoke with staff at Dr.'s office and she confirmed they are aware of the reaction. Staff reported that patient did not have issues with regular flu shot in the past. She has never received a high dose flu shot.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Medication error
Clinical narrative: a 84 years patient was injected an expired Fluzone High-Dose, No AE; Initial information was received on 02-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist via web inquiry (other).  This case is linked to cases 2020SA241754 and 2020SA241782 (same reporter).  This case involves a 84 years old female patient who was vaccinated with a 0.5 mL once dose of an expired INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (prefilled syringe, lot number UJ299AA and expiration date 30-Jun-2020) via an intramuscular route at an unknown administration site for prophylactic vaccination on 01-Sep-2020.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant therapy were not provided.   It was an actual medication error case due to expired vaccine used (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Cellulitis, Product administered at inappropriate site
Clinical narrative: cellulitis; Initial information was received on 17-Sep-2020 regarding an unsolicited valid serious case from a pharmacist via phone.  This case involves a 66-years-old female patient who developed cellulitis, while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any other vaccine concomitantly during the same visit.    On 10-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (injection, lot UJ460AA and expiration date 30-Jun-2021) via an unknown route for prophylactic vaccination.  It was reported that, the injection was not given in the deltoid muscle but 2-3 inches below that.  On 17-Sep-2020, the patient developed serious cellulitis, 7 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant and patient visited emergency room due to this event.  Details of laboratory data were not reported.  As a corrective treatment, the patient received unspecified antibiotics.  At the time of reporting, the event outcome was reported as unknown.; Sender's Comments: This case concerns a 66-years-old patient who presented with cellulitis, 7 days after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. However, patient's medical condition at the time of vaccination, safety of the vaccination procedure, details of causative organism and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Cellulitis
Clinical narrative: cellulitis; Initial information was received on 17-Sep-2020 regarding an unsolicited valid serious case from a pharmacist via phone.  This case involves a 66-years-old female patient who developed cellulitis, while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any other vaccine concomitantly during the same visit.    On 10-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (injection, lot UJ460AA and expiration date 30-Jun-2021) via an unknown route for prophylactic vaccination.  It was reported that, the injection was not given in the deltoid muscle but 2-3 inches below that.  On 17-Sep-2020, the patient developed serious cellulitis, 7 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant and patient visited emergency room due to this event.  Details of laboratory data were not reported.  As a corrective treatment, the patient received unspecified antibiotics.  At the time of reporting, the event outcome was reported as unknown.; Sender's Comments: This case concerns a 66-years-old patient who presented with cellulitis, 7 days after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. However, patient's medical condition at the time of vaccination, safety of the vaccination procedure, details of causative organism and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: On 09/21/20, 36 yo F presented to clinic for health maintenance visit. During this visit, pt was ordered to receive Flu vaccine age 6 mo  0.5ml dose, preservative free (QUADRIVALENT). Per documentation, pt received 0.5 mL injection in right deltoid at 1236 (Lot #4TM23; Exp: 6/30/2021; NDC #19515-0816-52, manufacturer: ID Biomedical). Pt discharged with no documented problems. On 09/23, pt reported a swollen and painful lymph node in right arm pit with 5/10 pain with movement. Pt reported symptom onset of evening of 09/21. Pt self medicated with ibuprofen 600 mg PO. On 09/24, pt returned to clinic for evaluation. Pt exam found mild fullness and tenderness to palpation of right axilla and upper medial arm. RoM intact. Pt reported a recently diagnosed autoimmune process (elevated ANA; exact diagnosis not reported or documented) and was going to start Plaquenil this week, but has not yet started. Pt advised not to start until acute symptoms resolve. Pt was advised to take Naproxen BID through the weekend to help with inflammation and apply warm compress/heating pad to axillary region. No current indication for antibiotics. Pt to follow-up if symptoms do not resolve.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Inflammation, Injection site pain, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: On 09/21/20, 36 yo F presented to clinic for health maintenance visit. During this visit, pt was ordered to receive Flu vaccine age 6 mo  0.5ml dose, preservative free (QUADRIVALENT). Per documentation, pt received 0.5 mL injection in right deltoid at 1236 (Lot #4TM23; Exp: 6/30/2021; NDC #19515-0816-52, manufacturer: ID Biomedical). Pt discharged with no documented problems. On 09/23, pt reported a swollen and painful lymph node in right arm pit with 5/10 pain with movement. Pt reported symptom onset of evening of 09/21. Pt self medicated with ibuprofen 600 mg PO. On 09/24, pt returned to clinic for evaluation. Pt exam found mild fullness and tenderness to palpation of right axilla and upper medial arm. RoM intact. Pt reported a recently diagnosed autoimmune process (elevated ANA; exact diagnosis not reported or documented) and was going to start Plaquenil this week, but has not yet started. Pt advised not to start until acute symptoms resolve. Pt was advised to take Naproxen BID through the weekend to help with inflammation and apply warm compress/heating pad to axillary region. No current indication for antibiotics. Pt to follow-up if symptoms do not resolve.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Tenderness
Clinical narrative: On 09/21/20, 36 yo F presented to clinic for health maintenance visit. During this visit, pt was ordered to receive Flu vaccine age 6 mo  0.5ml dose, preservative free (QUADRIVALENT). Per documentation, pt received 0.5 mL injection in right deltoid at 1236 (Lot #4TM23; Exp: 6/30/2021; NDC #19515-0816-52, manufacturer: ID Biomedical). Pt discharged with no documented problems. On 09/23, pt reported a swollen and painful lymph node in right arm pit with 5/10 pain with movement. Pt reported symptom onset of evening of 09/21. Pt self medicated with ibuprofen 600 mg PO. On 09/24, pt returned to clinic for evaluation. Pt exam found mild fullness and tenderness to palpation of right axilla and upper medial arm. RoM intact. Pt reported a recently diagnosed autoimmune process (elevated ANA; exact diagnosis not reported or documented) and was going to start Plaquenil this week, but has not yet started. Pt advised not to start until acute symptoms resolve. Pt was advised to take Naproxen BID through the weekend to help with inflammation and apply warm compress/heating pad to axillary region. No current indication for antibiotics. Pt to follow-up if symptoms do not resolve.