chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Flank pain, Herpes zoster, Rash, Sleep disorder
Clinical narrative: Patient was fine until night after receiving vaccine(Sunday night) developed some soreness around waist on right side going to back which grew worse with rash beginning to develop Monday. The rash not go away and had pain/soreness no stinging, burning or itching that caused patient not to be able to sleep for several days. He saw a dermatologist Friday, who confirmed it was case of shingles. Patient was prescribed valacyclovir orally and triamcinolone and acyclovir topically. He reported to us on 11/2/2020 around 4pm still experiencing rash and soreness.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: Provider ordered Pediarix, HIB, PCV13 and Rota virus. The caregiver gave pentacel, pediarix, PCV13 and Rota virus. The patients mother was contacted and stated that the baby was fussy for 36 hours but had no redness or swelling at the injection site and is acting normal now.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: 14 yr old boy was fine after receiving the flu shot.  Stood up and walked to bench to sit down while I administered to other family memeber.  After about 5 minutes after getting vaccine he stood up to talk to his sister and fainted.  He hit the floor but woke up immediately.   We kept him in the laying down position for 10 minutes then sitting for another 15 minutes and administered ice to his head.  As of today, I do not know if he received follow up care but I have left messages with family to inquire.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Hordeolum, Oral herpes, Palpitations, Pyrexia
Clinical narrative: At around midnight to 1 am, patient reports of developing a fever that would not subside, racing heart rate, extreme fatigue, developed a UTI, stye on eye, and cold sores on 10/24 patient went to the emergency room and was told by ER doctor she was having an adverse reaction to the flu vaccination. Patient was prescribed macrobid to treat the UTI and valtrex for the cold sores
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Urinary tract infection, Vaccination complication
Clinical narrative: At around midnight to 1 am, patient reports of developing a fever that would not subside, racing heart rate, extreme fatigue, developed a UTI, stye on eye, and cold sores on 10/24 patient went to the emergency room and was told by ER doctor she was having an adverse reaction to the flu vaccination. Patient was prescribed macrobid to treat the UTI and valtrex for the cold sores
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: inquired about recent pain meds being taken on 10/30/2020 and 11/2/2020 patient said that she had reaction to vaccination on 10/18/2020 pain and swelling at injection site that was unresolved. ask daughter about reaction when she can and picked up medication on 11/02/2020 and she said that her mom had told her later that she was having pain and swelling at site of pneumovax injection( did not say how many days later) asked daughter if she had put ice packs on it  she said she told her mom to put cold and warm compresses on it ( again not sure when this occured) she said she thought she may be having allergic reaction. 10/30/20 dr did give patient cephalexin and tramadol for reaction but not sure if cellulitis or precautionary on cephalexin.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Contusion, Erythema, Fatigue, Headache
Clinical narrative: Massive swelling, redness, bruising, tenderness to shot area, headache, joint pain, tiredness. Took Tylenol OTC helped with joint pain throughout the weekend and into Monday November 2nd. Still having swelling, redness, tenderness, headache and bruising
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Swelling
Clinical narrative: Massive swelling, redness, bruising, tenderness to shot area, headache, joint pain, tiredness. Took Tylenol OTC helped with joint pain throughout the weekend and into Monday November 2nd. Still having swelling, redness, tenderness, headache and bruising
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Peripheral swelling, Secretion discharge
Clinical narrative: Cellulitis in arm, arm was red/swollen/seeping, treatment: antibiotics (unknown), unsure of outcome as it was just reported
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Administration site pain, Pain
Clinical narrative: administration arm is still sore since injection.  movement causes pain
Age: 35.0
Sex: M
Vaccine: FLUR4
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: A welt about a size of a quarter formed immediately when the vaccine contents went in. No redness occurred. The patient stayed and the welt went down to about the size of a nickel. He didn't experience any pain at the injection. He said he had no other symptoms besides the welt.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient claims that the injection hurt really bad and that she is still having pain to this day. Her mom feels that the injection site was to high on the arm.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: redness, swelling, induration at injection site nearly 3 weeks after injection
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: She developed a big, red, hot mark on arm which started to itch. She took Benadryl and then it went away
Age: 43.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Burning sensation, Injection site pain, Injection site swelling, Limb discomfort, Muscular weakness
Clinical narrative: Patient states within hours of receiving pneumovax  in her right arm she experienced a burning sensation, extreme swelling, and severe pain. Her husband put ice on it. She followed up with her physician on 10/19/2020 and was told the person who administered the vaccine hit a vein. As of 10/27/2020, the patient was still unable to mover her arm and states she has weakness. Her husband states her elbow is getting deformed.
Age: 43.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states within hours of receiving pneumovax  in her right arm she experienced a burning sensation, extreme swelling, and severe pain. Her husband put ice on it. She followed up with her physician on 10/19/2020 and was told the person who administered the vaccine hit a vein. As of 10/27/2020, the patient was still unable to mover her arm and states she has weakness. Her husband states her elbow is getting deformed.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: PATIENT HAD A SYNCOPAL REACTION ABOUT A MINUTE AFTER RECEIVING HER VACCINE.  PATIENT LOOKED PALE AND SWEATY.  911 WAS CALLED AND EMT EVALUATED PATIENT. PATIENT RECOVERED AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. PATIENT LEFT WITH HER FRIENDS. PATIENT'S PCP WAS CONTACTED AND PCP INDICATED THAT THEY WOULD FOLLOW UP WITH PATIENT.
Age: 7.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Underdose
Clinical narrative: Gave combination vaccines indicated for 4-6 years of age to 7 year old patient.  No injury or adverse effect noted.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: The entire upper left arm bright red, swollen, and somewhat painful.  Iced the area.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Dyspnoea, X-ray
Clinical narrative: Extreme shortness of breath caused visit to Emergency. Bloodwork, lung xray, chest CT scan all okay. Received intraveneous steroid and 3 albuterol nebulizer treatments.
Age: 1.75
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Rash, Rash morbilliform
Clinical narrative: PATIENT RECEIVED VACCINE ON 9-15. ON FRIDAY 9-25 RASH BEGAN AT INJECTION SITE ON LEG AND CONTINUED TO DOUBLE IN SIZE UNTIL COVERING THE WHOLE BODY (EXCEPT SCALP) BY SUNDAY. PATIENT REVISITED DOCTOR OFFICE AND WAS TOLD BY PRACTITIONER THAT IT WAS A MEASLES RASH, PRESCRIBED HYDROCORTISONE CREAM. WAS NOT EFFECTIVE, SAW DERMATOLOGIST ON 10-23, PRESCRIBED TRIAMCINOLONE WHICH IS REPORTED BY MOTHER TO BE WORKING (NOT QUICKLY, BUT NOTICEABLY).
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: 4 days after her vaccine she developed urticaria on her knees, legs, arms and elbows.   Seen in the office on Day 5 and treated with steroids.  Rash suspicious for SERUM SICKNESS
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm swelling, Redness, warm to the touch
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: Patient states that she is having trouble moving her arm
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: left shoulder pain after vaccine administration
Age: 39.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Eye swelling, Lip swelling, Rash, Swelling face
Clinical narrative: I received a flu shot around 9:45am on 10/30/20, around 4:30am on 10/31/20 I woke up and felt my lips were swollen. I went to the gym and wore a mask during the work out. When I took off the mask around 6:30  the left side of my face was red with bumps, looked like hives. When I got home I noticed it all over my neck, chest and arms. I took three benedryls throughout the day and it helped a little. The next morning on 11/1/20 my eye lips and under the eyes were swollen.  It took a full day for it to umswell.
Age: 39.0
Sex: F
Vaccine: FLUA3
Symptoms: Urticaria
Clinical narrative: I received a flu shot around 9:45am on 10/30/20, around 4:30am on 10/31/20 I woke up and felt my lips were swollen. I went to the gym and wore a mask during the work out. When I took off the mask around 6:30  the left side of my face was red with bumps, looked like hives. When I got home I noticed it all over my neck, chest and arms. I took three benedryls throughout the day and it helped a little. The next morning on 11/1/20 my eye lips and under the eyes were swollen.  It took a full day for it to umswell.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve injury, Neuralgia, Product administered at inappropriate site
Clinical narrative: Pt called and stated that the rph injected the shot too high causing nerve pain/damage
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Malaise, Nausea, Peripheral coldness, Pruritus
Clinical narrative: The patient came to the pharmacy and request a Flu shot for her and her family.  Her vaccine was administer at 5:45pm approximately, after 15 minutes her husband tell to the pharmacy tech that her wife was not feeling well. She has dizziness, nausea, her body was trembling and her hands were cold.  She also feel some itching on her face and throat.  Pharmacy tech call 911 at 6:04 pm  and  stay with the pharmacist to take notes. The patient's husband call her physician and they refuse to administer to her epinephrine 0.3mg inj.  They accept to received diphenhydramine inj. 50mg/1ml, the pharmacist  administer 0.5 ml equivalent  to 25mg of Diphenhydramine intramuscular.  The paramedics arrived at 6:36pm and took the vitals, the oxygen saturation was 98, temperature 36.2, pulse 72, blood pressure 110/80.  The paramedic recommend to go to Emergency room but she refuse to go with them.  When she leaves the pharmacy was calm, she does not show any trembling, was not cold and do not feel itching anymore, she was a little drowsy.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation, Tremor
Clinical narrative: The patient came to the pharmacy and request a Flu shot for her and her family.  Her vaccine was administer at 5:45pm approximately, after 15 minutes her husband tell to the pharmacy tech that her wife was not feeling well. She has dizziness, nausea, her body was trembling and her hands were cold.  She also feel some itching on her face and throat.  Pharmacy tech call 911 at 6:04 pm  and  stay with the pharmacist to take notes. The patient's husband call her physician and they refuse to administer to her epinephrine 0.3mg inj.  They accept to received diphenhydramine inj. 50mg/1ml, the pharmacist  administer 0.5 ml equivalent  to 25mg of Diphenhydramine intramuscular.  The paramedics arrived at 6:36pm and took the vitals, the oxygen saturation was 98, temperature 36.2, pulse 72, blood pressure 110/80.  The paramedic recommend to go to Emergency room but she refuse to go with them.  When she leaves the pharmacy was calm, she does not show any trembling, was not cold and do not feel itching anymore, she was a little drowsy.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient had swelling and redness of arm at the injection site. She spiked a fever the night after given the shot
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills, fever, headache, muscle pain, sinus congestion, weakness x 48 hours
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Sinus congestion
Clinical narrative: Chills, fever, headache, muscle pain, sinus congestion, weakness x 48 hours
Age: 31.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Cyanosis, Dysphagia, Dyspnoea, Lip discolouration, Mouth swelling
Clinical narrative: Left doctor: 3:30pm Noticed hives in throat: 6pm Swelling of mouth: 6:30pm Difficultly breathing/swallowing: 7pm Ate dinner assuming the air quality was bothering me.  Anaphylactic breathing problems, lips turn blue/purple: 8pm Start treating with Benadryl. Shaking involuntarily/Nauseous/feeling shock.  Drove to hospital: 8:45 Waited for symptoms to subside with medication until 10pm.  Not seen.
Age: 31.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Nausea, Shock, Tremor, Urticaria
Clinical narrative: Left doctor: 3:30pm Noticed hives in throat: 6pm Swelling of mouth: 6:30pm Difficultly breathing/swallowing: 7pm Ate dinner assuming the air quality was bothering me.  Anaphylactic breathing problems, lips turn blue/purple: 8pm Start treating with Benadryl. Shaking involuntarily/Nauseous/feeling shock.  Drove to hospital: 8:45 Waited for symptoms to subside with medication until 10pm.  Not seen.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Rash macular, Skin warm
Clinical narrative: Starting around 6 days after the injection: Random red splotchy dots around 3 to 5mm in diameter. Started in chest region,  spread to belly region then arms. Still there today, November 2nd. Not itchy, more pronounced when just out of shower and skin is warm/hot.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient has redness around injection site about the size of a quarter and then a separate, much larger area of redness near her bicep and completely separate from injection site, but on same arm. It is pink and warm. Onset began the day after injection and is still persisting 4 days post-injection. Patient saw PCP who instructed her to take Benadryl at night, any allergy antihistamine in the morning, and Benadryl or hydrocortisone cream if there's any itching.
Age: 19.0
Sex: F
Vaccine: FLUR4
Symptoms: Pallor, Syncope
Clinical narrative: Patient received her vaccination along with 4 other family members. She had received her vaccination 2nd and watched the rest of her family receive theirs. During that time there were no issues or concerns; however, once she left the immunization room she became pale and fainted while seated but regained consciousness rapidly. She was given liquids, wet towels and an ice pack until she felt able to stand up on her own. The entire event lasted about 10-15 minutes. Patient had stated this has only happened one other time and it was while she was getting her blood drawn. Patient left with her family members, walking on her own and color back in her face.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Immediate post-injection reaction, Swelling
Clinical narrative: Patient reported red and swollen reaction almost immediately. She went to her PCP to assess the reaction the same day as the vaccination administration.  She was given a 10 day regimen of Doxycycline Hyclate 100 mg (1 cap. twice daily x 10 days) on 7.14.2020 after the area had not shown any signs of resolution.  Patient reports that the left side of her body down her arm and down her leg all the way to her left foot developed redness and numbness.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash macular
Clinical narrative: Starting on October 17th, 4 days after vaccination: reddish circular, blotchy spots, about 3mm to 5mm in diameter, starting on chest and belly. Did not spread to arms or other parts of body.  Itchy, can tolerate.  Calamine lotion made it better.  Lasted for about 10 days. Still has some spots on her back today, November 2nd.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Erythema, Myalgia, Pruritus, Swelling
Clinical narrative: Muscle pain, joint pain, itchy/red/raised/Hives on entire body
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Muscle pain, joint pain, itchy/red/raised/Hives on entire body
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Dizziness, nausea, vomiting, high fever of 104.3
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9, MNQ, TDAP
Symptoms: Body temperature increased, Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Dizziness, nausea, vomiting, high fever of 104.3
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, C-reactive protein normal, Electromyogram, Full blood count normal, Metabolic function test normal
Clinical narrative: Within 10 minutes - tingling sensation of upper lip which progressed to intermittent tingling sensation of face, arms, legs,   Weakness with shakiness in the mornings Initially treated with Benadryl 50mg 3x daily with no improvement.  3 days later treated with Prednisone 40mg daily x 4days with no improvement.  Prednisone increased to 80mg daily on decreasing dose schedule to 60mg, 40mg, 20mg , 10mg with no improvement in 8 days.  Continuing symptoms.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve conduction studies, Paraesthesia, Paraesthesia oral, Red blood cell sedimentation rate normal, Tremor
Clinical narrative: Within 10 minutes - tingling sensation of upper lip which progressed to intermittent tingling sensation of face, arms, legs,   Weakness with shakiness in the mornings Initially treated with Benadryl 50mg 3x daily with no improvement.  3 days later treated with Prednisone 40mg daily x 4days with no improvement.  Prednisone increased to 80mg daily on decreasing dose schedule to 60mg, 40mg, 20mg , 10mg with no improvement in 8 days.  Continuing symptoms.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound scan, Urine analysis normal
Clinical narrative: Within 10 minutes - tingling sensation of upper lip which progressed to intermittent tingling sensation of face, arms, legs,   Weakness with shakiness in the mornings Initially treated with Benadryl 50mg 3x daily with no improvement.  3 days later treated with Prednisone 40mg daily x 4days with no improvement.  Prednisone increased to 80mg daily on decreasing dose schedule to 60mg, 40mg, 20mg , 10mg with no improvement in 8 days.  Continuing symptoms.
Age: 60.0
Sex: F
Vaccine: FLUR4
Symptoms: Cellulitis
Clinical narrative: Patient claims to have had cellulitis and recieved Augmentin as her treatment on 10/29. There was no symptoms or sign of rash upon reporting to the pharmacy today, 11/2/20
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Feeling hot, Headache, Injection site erythema, Pain
Clinical narrative: Tired, feeling hot, arm redness a little bigger than a quarter around injection site, swelling, body aches and headache.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: Tired, feeling hot, arm redness a little bigger than a quarter around injection site, swelling, body aches and headache.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain, Injection site warmth, Pain, Peripheral swelling
Clinical narrative: Patient called the night of her vaccine and reported swelling half way down her arm, lump on injection spot and painful/warm to touch, hurt/pain when she moves it, lower mobility because of pain. She got her shot at 9 am and called back at 8 p.m. I told her to put ice on it and take tylenol/ibuprofen if it didn't get better or got worse I told her to get medical attention with doctor or er if needed.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF culture negative, CSF test normal, Cerebral hypoperfusion, Computerised tomogram head normal, Death
Clinical narrative: Pt had a well child check and was given immunizations on 9/28/20. He had no fever or other complaints post vaccination. The morning after Pt was given immunizations, he was found unresponsive, "shaking". Was admitted at Hosp where he continued to have Sz-like activity and abnormal EEG so he was  transferred to another hospital.  Despite aggressive anti-epileptic treatment, he  continued with seizures for a few days. MRI of brain on 10/1/20 showed progression of hypoperfusion state indicative of hypoxic ischemic event or status epilepticus. .  After a family meeting on 10/9, Pt's grandmother elected compassionate extubation and he expired on 10/12.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Echocardiogram abnormal, Electroencephalogram abnormal, Hypoxia, Ischaemia, Magnetic resonance imaging brain abnormal
Clinical narrative: Pt had a well child check and was given immunizations on 9/28/20. He had no fever or other complaints post vaccination. The morning after Pt was given immunizations, he was found unresponsive, "shaking". Was admitted at Hosp where he continued to have Sz-like activity and abnormal EEG so he was  transferred to another hospital.  Despite aggressive anti-epileptic treatment, he  continued with seizures for a few days. MRI of brain on 10/1/20 showed progression of hypoperfusion state indicative of hypoxic ischemic event or status epilepticus. .  After a family meeting on 10/9, Pt's grandmother elected compassionate extubation and he expired on 10/12.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Polymerase chain reaction, Seizure, Seizure like phenomena, Skeletal survey normal, Status epilepticus
Clinical narrative: Pt had a well child check and was given immunizations on 9/28/20. He had no fever or other complaints post vaccination. The morning after Pt was given immunizations, he was found unresponsive, "shaking". Was admitted at Hosp where he continued to have Sz-like activity and abnormal EEG so he was  transferred to another hospital.  Despite aggressive anti-epileptic treatment, he  continued with seizures for a few days. MRI of brain on 10/1/20 showed progression of hypoperfusion state indicative of hypoxic ischemic event or status epilepticus. .  After a family meeting on 10/9, Pt's grandmother elected compassionate extubation and he expired on 10/12.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Pt had a well child check and was given immunizations on 9/28/20. He had no fever or other complaints post vaccination. The morning after Pt was given immunizations, he was found unresponsive, "shaking". Was admitted at Hosp where he continued to have Sz-like activity and abnormal EEG so he was  transferred to another hospital.  Despite aggressive anti-epileptic treatment, he  continued with seizures for a few days. MRI of brain on 10/1/20 showed progression of hypoperfusion state indicative of hypoxic ischemic event or status epilepticus. .  After a family meeting on 10/9, Pt's grandmother elected compassionate extubation and he expired on 10/12.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: PATIENT STATED TO DEVELOPING EXTENSIVE RASH THROUGHOUT ENTIRE BODY WHICH STARTED SAME DAY SHE RECEIVED HER INFLUENZA VACCINE ON 10/23/2020.  SHE HAS BEEN UNABLE TO GET EVALUATED BY HER PRIMARY CARE DOCTOR, HOWEVER, SHE IS SELF-TREATING WITH OTC BENADYL AND HYDROCORTISONE.   PATIENT DENIES ANY SWELLING OF THE LIPS, TONGUE, THROAT, SHORTNESS OF BREATH, PROBLEMS BREATHING.  HER DOCTOR IS UNABLE TO SEE HER UNTIL 11/17/2020.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Feeling abnormal
Clinical narrative: Patient received his vaccine and proceeded to his car.  Once in his car, he started to experience tightness in his chest.  He drove home and once he got home he wasn't feeling any better and decided to call 911.  At the hospital, physcian determined the chest tightness was due to high dose flu vaccine.
Age: 66.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Chills, Heart rate increased, Hyperhidrosis, Hypopnoea
Clinical narrative: Within 2 hrs, arm swelled, hard at injection site, red at injection site, joints sore on left side of body. 4 hrs, joints all over body hurt. 6 hrs, muscle pain with weakness all over. 12 hrs, rapid pulse, rapid shallow breath, fever, chills. 18 hrs, continued pain all over, jaw locked or nearly so, much perspiration. Effects slowly reduced through next day. Second day nearly back to normal.
Age: 66.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Myalgia, Pain
Clinical narrative: Within 2 hrs, arm swelled, hard at injection site, red at injection site, joints sore on left side of body. 4 hrs, joints all over body hurt. 6 hrs, muscle pain with weakness all over. 12 hrs, rapid pulse, rapid shallow breath, fever, chills. 18 hrs, continued pain all over, jaw locked or nearly so, much perspiration. Effects slowly reduced through next day. Second day nearly back to normal.
Age: 66.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia, Trismus
Clinical narrative: Within 2 hrs, arm swelled, hard at injection site, red at injection site, joints sore on left side of body. 4 hrs, joints all over body hurt. 6 hrs, muscle pain with weakness all over. 12 hrs, rapid pulse, rapid shallow breath, fever, chills. 18 hrs, continued pain all over, jaw locked or nearly so, much perspiration. Effects slowly reduced through next day. Second day nearly back to normal.
Age: 35.0
Sex: F
Vaccine: FLUR4
Symptoms: Unevaluable event
Clinical narrative: vaccine administered proximal to deltoid
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Patients states he has a sore arm that lasted for more than a month and is having a hard time sleeping
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Pt complained about dizziness aftfr the shot was given she said the dizziness went away after about 5 minutes
Age: 75.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Dizziness
Clinical narrative: Patient was leaving & got dizzy & sat down we called 911 & EMT came and took patient to ER
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Burning sensation, Gait disturbance, Injection site erythema, Injection site pain
Clinical narrative: Redness, soreness, Burning sensation down the arm at the site of Injection Lasting More Than ~ 2 weeks. Weakness causing difficulty to walk, pain Radiates to elBow.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain
Clinical narrative: Redness, soreness, Burning sensation down the arm at the site of Injection Lasting More Than ~ 2 weeks. Weakness causing difficulty to walk, pain Radiates to elBow.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Skin warm, Swelling
Clinical narrative: Mother noted small erythema (R) upper deltoid 24 hours from administration.  Progressed with warmth slight swelling to 21 cm redness the next 2 days, then subsided. Next office visit: 10/13/20 very minimal redness: 0 swelling or tenderness
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Herpes zoster, Incomplete course of vaccination, Laboratory test, Magnetic resonance imaging
Clinical narrative: Severe muscle pain in upper legs (From knees up) and in elbows, upper arms, across shoulders and neck which made it difficult to move, lost 20 lbs and had significant muscle weakness in arms and legs. After seeing three physicians, multiple texts, CRP and sed rate were found to be elevated and finally a diagnosis of polymyalgia rheumatica on March 26, 2020. Treatment of Prednisone resulted in decrease of symptoms and improvement. Currently remains on Prednisone May 18, 2020 outbreak of severe shingles was discovered around abdomen, waist and back Placed on treatment for shingles - oral medication Did not receive 2nd vaccine for shingles
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscular weakness, Myalgia, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Severe muscle pain in upper legs (From knees up) and in elbows, upper arms, across shoulders and neck which made it difficult to move, lost 20 lbs and had significant muscle weakness in arms and legs. After seeing three physicians, multiple texts, CRP and sed rate were found to be elevated and finally a diagnosis of polymyalgia rheumatica on March 26, 2020. Treatment of Prednisone resulted in decrease of symptoms and improvement. Currently remains on Prednisone May 18, 2020 outbreak of severe shingles was discovered around abdomen, waist and back Placed on treatment for shingles - oral medication Did not receive 2nd vaccine for shingles
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Weight decreased, X-ray
Clinical narrative: Severe muscle pain in upper legs (From knees up) and in elbows, upper arms, across shoulders and neck which made it difficult to move, lost 20 lbs and had significant muscle weakness in arms and legs. After seeing three physicians, multiple texts, CRP and sed rate were found to be elevated and finally a diagnosis of polymyalgia rheumatica on March 26, 2020. Treatment of Prednisone resulted in decrease of symptoms and improvement. Currently remains on Prednisone May 18, 2020 outbreak of severe shingles was discovered around abdomen, waist and back Placed on treatment for shingles - oral medication Did not receive 2nd vaccine for shingles
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Gait disturbance, Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: severe pain and stiffness of neck, back and back of head - severe pain, hard to hold up got shot, walked away holding onto to shopping cart 5 minutes later I could hardly walk back to where I received shot held onto a shopping cart. Dr who gave shot gave me another shot - told to sit & wait
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dissociation, Disturbance in attention, Memory impairment
Clinical narrative: Refer to continuation page. Within hours after my vaccination I began feeling slightly detached from what was going on around me, more like I was observing life rather than participating- - although I was active. This feeling continued and was more noticeable the second day before starting to recede. Right after that I began to discover that I had developed both a lack of recall (names, words) and lack of concentration. I would walk across the kitchen, reach a cupboard and could not remember what I went there to get. Or I would unthinkingly open the wrong cupboard or drawer. Also, I would walk off in the middle of doing something and forget about it until I passed by again and saw my unfinished project.  I began making an effort to remind myself of the names of flowers, trees, etc. in our yard. I looked up names of relatives in our family tree (my husband is the youngest of 11 children). Most of that re-learning has stuck with me, but sometimes not until after repeated times of reminding myself. Some problems have toned down but are still with me. Others still happen repeatedly such as misplacing my cell phone. Occasionally I forget to feed our feral outdoors cat until reminded, or I forget a load of dry clothes in the dryer for a day or two. While I don't require entering a senior eldercare facility, these side effects of the Shingrix vaccine have been a real nuisance.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Received Flu vaccine on 10/18/2020, and had no issues until late Saturday, 10/27. Pt is having extreme pain on arm and it radiates up neck. Pt reports that it is excruciating to move her arm. 10/15-10/19 symptoms worsened. She is taking Tylenol every 4-5 hours and gets some relief but it is very painful and she can only raise arm to about eye level. Pt notes no swelling or redness.
Age: 12.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash on torso. No fever, fussiness, change in appetite or other symptoms. Patient provided with samples of Aveeno topical creme for use on rash.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abdominal pain upper, Alopecia, Blood test, Diarrhoea, Erythema
Clinical narrative: Welts, lumps, redness, itching Hair loss, swollen face, soreness excruciating pain all over body and it still comes and goes I never healed yet, diarrhea stomach pain
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Laboratory test, Mass, Pain, Pruritus, Swelling face
Clinical narrative: Welts, lumps, redness, itching Hair loss, swollen face, soreness excruciating pain all over body and it still comes and goes I never healed yet, diarrhea stomach pain
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Urticaria
Clinical narrative: Welts, lumps, redness, itching Hair loss, swollen face, soreness excruciating pain all over body and it still comes and goes I never healed yet, diarrhea stomach pain
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye irritation, Fatigue, Headache, Hypersomnia, Muscle fatigue
Clinical narrative: EXTReMe TiRedNess, MuscLe FATigue, PaiN, H/A Nausea, ? Fever, Slept greater than 12 hRs, Eyes Burning
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: EXTReMe TiRedNess, MuscLe FATigue, PaiN, H/A Nausea, ? Fever, Slept greater than 12 hRs, Eyes Burning
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Mother states right arm developed severe redness, swelling, and warmth or right arm at both injection sites;  noticed 7-9-20 about mid afternoon.  Child ran low grade fever 7-8 through 7-9.  Pictures sent to nurse and redness on most of deltoid area and on right outer aspect of right arm as well. Advised to give child Motrin and use ice packs to arm.  Brought child to clinic on 7-10-2020 and significant improvement but still mild swelling and redness at both injection sites but more localized and not over entire deltoid.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Seizure, Tremor, Vomiting
Clinical narrative: Seizure, violent shaking; chills. Diarrhea & Vomiting
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: R. arm site very sore with redness + swelling by evening, Also, tiredness, muscle pain, poor sleep overnoc with shivering Symptoms lasted 24-36 hours - my instructions were to report any reactions.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Sleep disorder
Clinical narrative: R. arm site very sore with redness + swelling by evening, Also, tiredness, muscle pain, poor sleep overnoc with shivering Symptoms lasted 24-36 hours - my instructions were to report any reactions.
Age: 15.0
Sex: M
Vaccine: DTAP, HEP, MMR, MNQ, VARCEL
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS EXPIRED, NO ADVERSE REACTION Other minors/patients received same vaccine On 10/30/20, called VAER 1800 # spoke to person to report these incidents.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Dehydration, Erythema, Full blood count abnormal, Haematocrit abnormal, Haemoglobin abnormal
Clinical narrative: acute onset of pain in her L anterior neck in the area where she has a left lymph node swelling for the past year. She describes a sharp burning intense pain just above her L mid collar bone at the base of her anterior lateral neck and her skin and L prox arm feels very sensitive to the touch. Movement of head and neck in any direction or changing positions ie. supine to sitting exacerbates her pain. She went to the ER at 11 pm on 4/23/20 and had xrays taken of her Cspine and chest and was told they were normal. She was given Ativan and 600 mg ibuprofen - she received these meds around midnight. She was advised to f/u in Clinic this morning 4/24/20- she went to Clinic and she presented with low grade fever of 99 F - because of her fever, they wouldn't examine here and gave her ibuprofen 800 mg and methocarbamol 750 mg. She took one dose of methocarbamol at 1230 pm.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Hyperaesthesia, Metabolic function test normal, Pain, Red blood cell sedimentation rate normal, Swelling
Clinical narrative: acute onset of pain in her L anterior neck in the area where she has a left lymph node swelling for the past year. She describes a sharp burning intense pain just above her L mid collar bone at the base of her anterior lateral neck and her skin and L prox arm feels very sensitive to the touch. Movement of head and neck in any direction or changing positions ie. supine to sitting exacerbates her pain. She went to the ER at 11 pm on 4/23/20 and had xrays taken of her Cspine and chest and was told they were normal. She was given Ativan and 600 mg ibuprofen - she received these meds around midnight. She was advised to f/u in Clinic this morning 4/24/20- she went to Clinic and she presented with low grade fever of 99 F - because of her fever, they wouldn't examine here and gave her ibuprofen 800 mg and methocarbamol 750 mg. She took one dose of methocarbamol at 1230 pm.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Chest X-ray normal, Neck pain, Pain, Spinal X-ray normal
Clinical narrative: acute onset of pain in her L anterior neck in the area where she has a left lymph node swelling for the past year. She describes a sharp burning intense pain just above her L mid collar bone at the base of her anterior lateral neck and her skin and L prox arm feels very sensitive to the touch. Movement of head and neck in any direction or changing positions ie. supine to sitting exacerbates her pain. She went to the ER at 11 pm on 4/23/20 and had xrays taken of her Cspine and chest and was told they were normal. She was given Ativan and 600 mg ibuprofen - she received these meds around midnight. She was advised to f/u in Clinic this morning 4/24/20- she went to Clinic and she presented with low grade fever of 99 F - because of her fever, they wouldn't examine here and gave her ibuprofen 800 mg and methocarbamol 750 mg. She took one dose of methocarbamol at 1230 pm.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Anosmia, Computerised tomogram, Dizziness, Headache
Clinical narrative: Patient stated that about two months post injection, she started experiencing headaches in the back of her head and loss of senses.  She also stated that her neck has started hurting and remains stiff to this day.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging, Malaise, Nausea, Neck pain, Somnolence
Clinical narrative: Patient stated that about two months post injection, she started experiencing headaches in the back of her head and loss of senses.  She also stated that her neck has started hurting and remains stiff to this day.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: X-ray
Clinical narrative: Patient stated that about two months post injection, she started experiencing headaches in the back of her head and loss of senses.  She also stated that her neck has started hurting and remains stiff to this day.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Endoscopy, Headache, Musculoskeletal stiffness, Neck pain, Sensory loss
Clinical narrative: Patient stated that about two months post injection, she started experiencing headaches in the back of her head and loss of senses.  She also stated that her neck has started hurting and remains stiff to this day.
Age: 15.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old patient was given Flublok with no adverse event; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 15 years old male patient who received 0.5 ml of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2047, expiry date: 30-Jun-2021) via Intramuscular route in right deltoid on 19-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy and family history were not provided. No other vaccines were recieved.  It was an actual medication error due to Inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  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: 15.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 year old patient was given Flublok with no adverse event; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 15 years old male patient who received 0.5 ml of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2047, expiry date: 30-Jun-2021) via Intramuscular route in right deltoid on 19-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy and family history were not provided. No other vaccines were recieved.  It was an actual medication error due to Inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  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: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node in right axilla; cheek swollen; lip were swollen; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18-years-old male patient who experienced swollen lymph node in right axilla (lymphadenopathy), cheek swollen (swelling face) and lip were swollen (lip swelling), while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 07-Aug-2020 (before patient went to college), the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic  vaccination.  In Aug-2020 (when patient had been at college), the patient developed a non-serious cheek swollen (swelling face) and lip were swollen (lip swelling) unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  On an unknown date, the patient developed a non-serious swollen lymph node in right axilla (lymphadenopathy) unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Laboratory details were not reported.   The patient was treated with AMOXICILLIN TRIHYDRATE (AMOXICILLIN [AMOXICILLIN TRIHYDRATE]) but that was discontinued after the patient reported a swollen cheek and lip.  On an unknown date, the patient recovered from swelling face and lip swelling.  The patient had not recovered from lymphadenopathy.  There will be no information available on the batch number for this case.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Lip swelling, Lymphadenopathy, Swelling face
Clinical narrative: swollen lymph node in right axilla; cheek swollen; lip were swollen; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18-years-old male patient who experienced swollen lymph node in right axilla (lymphadenopathy), cheek swollen (swelling face) and lip were swollen (lip swelling), while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 07-Aug-2020 (before patient went to college), the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic  vaccination.  In Aug-2020 (when patient had been at college), the patient developed a non-serious cheek swollen (swelling face) and lip were swollen (lip swelling) unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  On an unknown date, the patient developed a non-serious swollen lymph node in right axilla (lymphadenopathy) unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Laboratory details were not reported.   The patient was treated with AMOXICILLIN TRIHYDRATE (AMOXICILLIN [AMOXICILLIN TRIHYDRATE]) but that was discontinued after the patient reported a swollen cheek and lip.  On an unknown date, the patient recovered from swelling face and lip swelling.  The patient had not recovered from lymphadenopathy.  There will be no information available on the batch number for this case.
Age: 0.5
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: No other adverse event information; HCP calling to report patient was given RECOMBIVAX HB that was recalled; HCP calling to report patient was given RECOMBIVAX HB that was recalled/ improperly stored vaccine administered; This spontaneous report was received from a nurse referring to a 6-month-old patient of unknown gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.  On 23-OCT-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) who was also recalled; at a dose of 0.5 milliliter as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, anatomical location and route of administration were not reported; lot number T007984 and expiration date 01-NOV-2022) (recalled product administered and product storage error).  Information regarding temperature excursion was not reported. No adverse event was reported.