chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Gastrointestinal disorder, Lymphadenopathy, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: Have had progressively worsening issues with several areas beginning with a diagnosis of rheumatoid arthritis, have had digestive issues, swelling of my legs, swollen lymph nodes, TIA
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Have had progressively worsening issues with several areas beginning with a diagnosis of rheumatoid arthritis, have had digestive issues, swelling of my legs, swollen lymph nodes, TIA
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Local reaction, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Local reaction , arm red, hot, swollen and painful for over 4 days
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Moderate erythema below injection site just above the elbow. No other symptoms reported. Appeared one day following injection and still visible three days later.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Rash around next, redness and warm around complete neck and just below.  Noticed Saturday am, two days after I received shot,
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pain
Clinical narrative: cough (3+ days), difficulty breathing (rescue inhaler needed every 2-3 hours), body aches
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site inflammation, Injection site pain
Clinical narrative: Also had flu shot, but I don?t know brand name. The side effects. I have experienced after getting the shrikes shot. Include a fever of 101.5, severe fatigue, muscle, lethargy, intense, headache, injection site pain inflammation, sinus reaction. I feel miserable.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Muscle disorder, Pyrexia, Sinus disorder
Clinical narrative: Also had flu shot, but I don?t know brand name. The side effects. I have experienced after getting the shrikes shot. Include a fever of 101.5, severe fatigue, muscle, lethargy, intense, headache, injection site pain inflammation, sinus reaction. I feel miserable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chest pain, Computerised tomogram, Diarrhoea
Clinical narrative: Ongoing lightheadedness, mild nausea, diarrhea, joint pain, chest pain
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Nausea, Scan with contrast
Clinical narrative: Ongoing lightheadedness, mild nausea, diarrhea, joint pain, chest pain
Age: 63.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Chills, Dyspnoea, Rash
Clinical narrative: Patient broke out in a rash all over his body, felt chills, and had slight difficulty breathing.  He did not go to the ER but self-treated with Benadryl until the symptoms improved.  He was still showing signs of a rash on 9/22 when he reported the reaction.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Urticaria
Clinical narrative: I had severe hives/itching/redness all over my body. My doctor told me to treat it with Bendaryl and Xyrtec, but it did not help. The hives have continued to spread and become painful.
Age: 25.0
Sex: M
Vaccine: COVID19, HEP, TDAP
Symptoms: Chest pain
Clinical narrative: Sharp, substernal chest pain radiating to left shoulder. Exacerbated by inspiration and laying supine. Could auscultate a pericardial friction rub as well, but otherwise normal S1 and S2 with no other abnormal heart sounds. Lungs CTA. Classic presentation for acute pericarditis. Pain lasted 2-3 days before subsiding. Friction rub is still there, but more difficut to auscultate compared to when it began. Did not have time to seek medical attention, so just took ~4 tablets of ibuprofen daily until pain subsided.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hypotension
Clinical narrative: Patient states he experienced dizziness, low blood pressure, and felt like he was going to faint an hour after receiving the vaccine up until he went to sleep. He states he felt fine upon awakening this morning. He previously received Fluzone High Dose from the pharmacy nearby.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effects noted
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities
Clinical narrative: Extreme fatigue since evening of injection. Still extremely fatigued. Activities are limited due to extent of fatigue.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: A few days after I received that vaccine, I began to notice random, painless muscle spasms/twitching in my arms, back, and legs. They continue to present day, but are less intense than when they started. I recently received my second dose of Meningococcal B, and the twitching intensified in the arm I received the vaccine (left).
Age: 21.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Urinary incontinence
Clinical narrative: PATIENT LOST CONSCIOUSNESS WHILE SEATED FOR 1 TO 2 MINUTES AFTER RECEIVING FLUZONE AND COMIRNATY SHOTS IN LEFT ARM. SHE URINATED ON FLOOR, DAD MOVED HER SAFLEY TO CLEAN AREA OF FLOOR, SHE REGAINED CONSCIOUSNESS  AND DID NOT RECALL EVENTS BUT SEEMED OK. EMS WAS CALLED AND TOOK HER TO ER.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: patient got a body rash all over. had to recommend benadryl
Age: 61.0
Sex: M
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Caffeine consumption, Dizziness, Gait disturbance, Vertigo
Clinical narrative: i awoke at around 5 am on thursday morning, 9/19/24, with moderate to strong dizziness and vertigo.  the ceiling was spinning and the room felt as if it were tilting.  i had to old onto furniture to get to the bathroom.  this sensation lasted for most of the morning, diminishing mostly by around 12 noon.  the next morning, i experienced the same sensation and duration.  over the weekend, the symptoms abated somewhat on saturday, but on sunday, the worsened again, but not as pronounced as on 9/19 or 9/20.  i do not drink or take any stimulants aside from caffeine.  i am not on any medications.  i have had no head trauma, and i get plenty of sleep.  i exercise regularly and consider myself in very good physical condition.  i have never before experienced this kind of dizziness or vertigo.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Confusional state, Dehydration, Magnetic resonance imaging head normal, Somnolence
Clinical narrative: This information is coming from the patient's husband.  Patient received vaccine on a Thursday.  Patient was fine the rest of the day Thursday and Friday.  Saturday woke up and immediately went to den to lay on couch.  Patient was not answering the door or phone when relatives came over to visit.  Relative is a nurse and had a hard time waking patient up.  When she did respond she was very confused.  Nurse/relative performed a COVID test and checked blood pressure and blood sugar.  Vitals were all normal so 911 was called and she was admitted to the hospital.  Patient was extremely dehydrated and stayed in the hospital for several days and was given "large amounts" of IV fluids.  CT scans/ MRI done but did not discover anything.  Stroke was ruled out.  Patient was sent home, scheduled for a follow up with primary care physician and it was recommended that she see a neurologist.  Patient's husband said about 2 weeks ago, so right around the time she came in to get the vaccine patient had fallen and hit her head on the concrete but seemed fine so they did not seek medical care at the time.  Husband was not sure the vaccine was the cause.  He was just trying to gather everything that may have changed/happened before the event so he can report it to the doctor at her follow up.   He did not think the event needed to be reported, but told him I would feel more comfortable if we documented it.  He said patient has been improving every day and is doing much better than she was.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Chills, Headache, Nausea, Vomiting
Clinical narrative: Nausea vomiting chills headache  with onset 6 hours after administered lasting  approximately 24 hours.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: i developed a hard red bump about  3" x 3" size at the injection site.  started about 30 minutes to 1 hour after the injection. it was painful to touch and pressure. lasted for about a week.   when the injections was being done I heard the sound of bubbles .  I also had a flu shot at the same time. and heard a bubble sound for that one as well.   I have never had a reaction like that to an injection.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site erythema, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Patient reports that her shot was given too low however on assessment although the shot was given low it was still administered in the deltoid. Patient after receiving the shot developed a swollen, red and hot spot when the vaccine was given.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient said developed shingles after getting shingles vaccine.  Rash has lasted 3 days and is getting worse.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Painful red arm.  After 10 days, arm is still red.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: (COVID-19 mRNA, pf, 12yrs-adult (Pfizer), 30 mcg/0.3mL ) vaccine injected in left arm and the injection site had a raised reddish spot of about 2" across and I began having small red bumps that itched appear in both underarms, and a few on my arms. Using anti-itch/cream that helps.  Not horrible reaction - but I had never had a reaction like this from any of the other vaccines I have received over the years.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Vaccination site nodule, Vaccination site rash, Vaccination site swelling
Clinical narrative: patient reported swelling  or node and rash at site of vaccine administration
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dislocation of vertebra, Radiculopathy, Tendon calcification
Clinical narrative: Vaccination aggravated a pre-existing vertebral subluxation of cervical, thoracic and lumbar spine and a pre-existing radiculopathy to lower extremities
Age: 82.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: patient reports pain in the right arm, numbness in the arm , nerve pain , generalized pain in the injection site and injection arm .
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Rash
Clinical narrative: Patient stated that two days after she received these three vaccines that she started to develop a shingles-like rash on the right side of her back that seems to be starting to travel around her right flank to her front right. It is unclear if the vaccines precipitated the outbreak. Per record the patient received two doses of the Recombinant Zoster vaccine in 2019.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose normal, Syncope
Clinical narrative: patient fainted few minutes after vaccination. when paramedics came and checked his vitals, all numbers were within normal range and his blood sugar was normal. Patient  declined transportation to ER and reported he was feeling better.
Age: 82.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Fatigue
Clinical narrative: extreme fatigue the day following injection (Wed)  all day and part of next day followed by dizzy spell three days later (Sept 14) lasting 12-15 minutes that required sitting w eyes closed
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Mother registered 9YO daughter for flu vaccine. In the registration, it asked if she wanted other vaccines. It was not blocked out, so she registered for a 12+ YO covid vaccine, too. Scheduling system did not flag it as a problem, pharmacy processing system did not flag it as a problem. Pharmacist typing vaccine missed that she was too young. Upon arival at pharmacy, checked in, and Nurse administered.  Error was realized when their neighbor called trying to get a vaccine for their child under 12YO.  Mother was contacted next day.  9YO seemed fine and had been playing like normal. Only complaint was sore arm.
Age: 24.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Hypoaesthesia, Pain, Pruritus, Urticaria
Clinical narrative: Patient presented about 90 minutes post vaccination with hives (approximately 3) on wrists. No other hives anywhere else on body. Patient reports right hand numb and achey and itchy feeling all over body. No problems with breathing and no facial swelling or throat swelling. Advised patient to contact PCP within 24 hours of incident. If reaction gets worse, to seek medical attention. Patient stated she will take benadryl by mouth and will contact pcp the following day. She agreed if her reaction worsens, she will go to urgent care or the emergency room.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Skin burning sensation, Skin exfoliation
Clinical narrative: Red burning Rash on Face and Neck appeared the next morning.   The Rash burns and the skin peels.  Rash is significant and has been present for more than 2 weeks.  Now entering 3rd week.    Have tried to use Triamcinolone Acetonide .1% topical ointment without success.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Heart rate increased, Hypoaesthesia, Injection site pain
Clinical narrative: Patient stated it felt like it was burning while being administered. Once administered, the patient experienced a sudden onset of nausea and almost threw up . Experienced tingling and a "pins and needles" feeling in her left arm in addition to numbness and general weakness. Patients blood pressure dropped significantly and her heart rate increased well above her normal limit. Cause significant pain and distress.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Vomiting
Clinical narrative: Patient stated it felt like it was burning while being administered. Once administered, the patient experienced a sudden onset of nausea and almost threw up . Experienced tingling and a "pins and needles" feeling in her left arm in addition to numbness and general weakness. Patients blood pressure dropped significantly and her heart rate increased well above her normal limit. Cause significant pain and distress.
Age: 76.0
Sex: F
Vaccine: CHIK, COVID19, FLU3
Symptoms: CSF glucose increased, CSF protein normal, CSF red blood cell count positive, CSF test, Computerised tomogram head normal
Clinical narrative: Patient developed acute ascending weakness progressing to quadriparesis and neuromuscular respiratory failure. On 9/19 patient reported feeling like her legs were giving out that led to fall. Since the fall, patient has been unable to walk. Patient arrived at Hospital ED and was admitted. On the morning of 9/20, patient reported to no longer be able to move lower extremities and was unable to lift and hold arms at should height. On the evening of 9/20, patient developed increased work of breathing with worsening NIF and FVC requiring BiPap. On 9/21, progressed to quadriparesis. Patient received plasmapheresis on 9/21 and was then transferred to Hospital neuro ICU. She received her second plasmapheresis treatment on 9/22.
Age: 76.0
Sex: F
Vaccine: CHIK, COVID19, FLU3
Symptoms: Computerised tomogram spine normal, Dyspnoea, Fall, Forced vital capacity, Gait inability
Clinical narrative: Patient developed acute ascending weakness progressing to quadriparesis and neuromuscular respiratory failure. On 9/19 patient reported feeling like her legs were giving out that led to fall. Since the fall, patient has been unable to walk. Patient arrived at Hospital ED and was admitted. On the morning of 9/20, patient reported to no longer be able to move lower extremities and was unable to lift and hold arms at should height. On the evening of 9/20, patient developed increased work of breathing with worsening NIF and FVC requiring BiPap. On 9/21, progressed to quadriparesis. Patient received plasmapheresis on 9/21 and was then transferred to Hospital neuro ICU. She received her second plasmapheresis treatment on 9/22.
Age: 76.0
Sex: F
Vaccine: CHIK, COVID19, FLU3
Symptoms: Gram stain, Injected limb mobility decreased, Intensive care, Mobility decreased, Muscular weakness
Clinical narrative: Patient developed acute ascending weakness progressing to quadriparesis and neuromuscular respiratory failure. On 9/19 patient reported feeling like her legs were giving out that led to fall. Since the fall, patient has been unable to walk. Patient arrived at Hospital ED and was admitted. On the morning of 9/20, patient reported to no longer be able to move lower extremities and was unable to lift and hold arms at should height. On the evening of 9/20, patient developed increased work of breathing with worsening NIF and FVC requiring BiPap. On 9/21, progressed to quadriparesis. Patient received plasmapheresis on 9/21 and was then transferred to Hospital neuro ICU. She received her second plasmapheresis treatment on 9/22.
Age: 76.0
Sex: F
Vaccine: CHIK, COVID19, FLU3
Symptoms: Plasmapheresis, Positive airway pressure therapy, Quadriparesis, Respiratory failure
Clinical narrative: Patient developed acute ascending weakness progressing to quadriparesis and neuromuscular respiratory failure. On 9/19 patient reported feeling like her legs were giving out that led to fall. Since the fall, patient has been unable to walk. Patient arrived at Hospital ED and was admitted. On the morning of 9/20, patient reported to no longer be able to move lower extremities and was unable to lift and hold arms at should height. On the evening of 9/20, patient developed increased work of breathing with worsening NIF and FVC requiring BiPap. On 9/21, progressed to quadriparesis. Patient received plasmapheresis on 9/21 and was then transferred to Hospital neuro ICU. She received her second plasmapheresis treatment on 9/22.
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Accidentally administered MMR instead of varicella.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Condition aggravated, Hyperglycaemia, Syncope
Clinical narrative: Patient experienced hyperglycemia with blood glucose > 200 the morning after vaccination.  Patient experienced syncope with episode lasting about 3 seconds the morning after vaccination.  Patient recovered slowly through the day without any intervention.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Within hours of injection, I experienced severe swelling, heat, and discoloration around injection site, more than in all previous Moderna vaccines and boosters (I have had them all). The next day, the swollen area had increased to approximately 5-6 inches in diameter, with increased heat, redness, and a gray line around the swollen area. Itching also increased.  I began applying an ice pack to the area. By Day 3 the heat began to ebb but swelling and redness persisted. I am now at Day 4 with continued redness, swelling, discoloration and itching, though symptoms seem to be subsiding. I assume this may be "Covid Arm," though my understating of that condition is that it is usually a delayed reaction. My symptoms started  shortly after  injection.
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Patient recieved prevar 20 vaccine in left deltoid on 9/20/24. Patient came to pharmacy on 9/21 complaining of a swollen arm at injection site with redness and pain. Patient was unable to sleep throughout the night, however swelling did go down on 9/22 when patient came back to pharmacy. She had gone to a walk in clinic with prescriber had diagnosed her with a skin infection at the site of injection. Patient was given a course of doxycycline, medrol dosepack as well as clobetasol topical cream. Patient will follow up with PCP on 9/23.
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Skin infection
Clinical narrative: Patient recieved prevar 20 vaccine in left deltoid on 9/20/24. Patient came to pharmacy on 9/21 complaining of a swollen arm at injection site with redness and pain. Patient was unable to sleep throughout the night, however swelling did go down on 9/22 when patient came back to pharmacy. She had gone to a walk in clinic with prescriber had diagnosed her with a skin infection at the site of injection. Patient was given a course of doxycycline, medrol dosepack as well as clobetasol topical cream. Patient will follow up with PCP on 9/23.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Glossodynia, Pruritus
Clinical narrative: Itchiness on skin all over (not just at injection site); itchiness in my eyes; strange feeling in my tongue
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Respiratory disorder
Clinical narrative: Cough and breathing issue
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Bruxism, Condition aggravated, Fatigue, Headache
Clinical narrative: initially fatigue, then severe migraine by 6 pm thru early morning hours.  Took tylenol 500 mg x2 and sumatriptan 50 mg.   This migraine triggered my myofascial pain in head, neck, and shoulders plus teeth grinding at night.  Had accupuncture treatments on 9/18 and 9/20  The treatment helped some but needed 2nd treatment relaxed my muscles but still have some teeth grinding at night that woke me up twice.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Neck pain
Clinical narrative: initially fatigue, then severe migraine by 6 pm thru early morning hours.  Took tylenol 500 mg x2 and sumatriptan 50 mg.   This migraine triggered my myofascial pain in head, neck, and shoulders plus teeth grinding at night.  Had accupuncture treatments on 9/18 and 9/20  The treatment helped some but needed 2nd treatment relaxed my muscles but still have some teeth grinding at night that woke me up twice.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year old was administered Flublok which is approved for 18+ years old.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, nausea, chills, aching muscles, fatigue, malise within 12 hours
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Nausea, Tremor
Clinical narrative: Feeling of shakiness lightheaded nausea and diarrhea later
Age: 71.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Atrioventricular block complete, Dyspnoea exertional, Intensive care
Clinical narrative: dyspnea on exertion x 3 days after the vaccines so was admitted to the ICU on 9/21 for three degree heart block
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Rash
Clinical narrative: RASH ON NECK AND CHEST, "KINDA BURNED", RESOLVED AS OF 9-22-24
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Hives around injection site, warm to touch, itchy
Age: 50.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received two shots in her left arm (prevnar and flublok) on 9/17/24. On 9/22/24, she reported there was swelling and redness and itching that started on her arm just below the site of the two injections the day after the shots. The swelling has since lessened and there is just a bump and some redness.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Blood lactate dehydrogenase, C-reactive protein, Contusion, Differential white blood cell count
Clinical narrative: Patient went to primary care physician.  Discussing rash on feet and bruises on hand along with fatigue.   Blood test was taken and platelet count of 3 was observed and was instructed to go to ER.  Met with hematologist.  Who stated the following:   Thrombocytopenia,only risk factor was recent Covid-19 vaccine So working diagnosis either acute ITP or potentially not idiopathic Potentially secondary thrombocytopenia due to recent Covid-19 vaccine.   Prednisone was given and platelets were at 69 on Sept 22, released from hospital
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, International normalised ratio, Metabolic function test, Platelet count decreased
Clinical narrative: Patient went to primary care physician.  Discussing rash on feet and bruises on hand along with fatigue.   Blood test was taken and platelet count of 3 was observed and was instructed to go to ER.  Met with hematologist.  Who stated the following:   Thrombocytopenia,only risk factor was recent Covid-19 vaccine So working diagnosis either acute ITP or potentially not idiopathic Potentially secondary thrombocytopenia due to recent Covid-19 vaccine.   Prednisone was given and platelets were at 69 on Sept 22, released from hospital
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Prothrombin time, Rash, Red blood cell sedimentation rate, Thrombocytopenia, Urine analysis
Clinical narrative: Patient went to primary care physician.  Discussing rash on feet and bruises on hand along with fatigue.   Blood test was taken and platelet count of 3 was observed and was instructed to go to ER.  Met with hematologist.  Who stated the following:   Thrombocytopenia,only risk factor was recent Covid-19 vaccine So working diagnosis either acute ITP or potentially not idiopathic Potentially secondary thrombocytopenia due to recent Covid-19 vaccine.   Prednisone was given and platelets were at 69 on Sept 22, released from hospital
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Head discomfort, Nausea, Tension headache, Vertigo
Clinical narrative: I got the flu shot on 9/12/2024 around 3 pm. I developed dizzy spinning with motion later that evening. particularly when I am lying down or getting up from supine position. The dizziness also cause nausea. I also experience tight and heavy of my head. The S/S have persisted until today. particularly the dizziness and spinning with motion are really concerning. I have started to take B-complex since 9/20/2024. My tightness and heaviness of my head seemed gone since taking the B-complex, but I still experience dizziness with motion.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Crying, Eye movement disorder, Fear of injection, Loss of consciousness, Pallor
Clinical narrative: I gave the flu shot first and after that, I gave the Novavax vaccine, the lady started sweating while looking at the needle, she was wearing her mask all the time, then started to rolling her eyes back and was unconscious, but with the eyes fully open staring at me and started like shaking for 2 seconds, got pale. I screamed to call 911 and get the epipen.  I pulled her down to the floor, took her mask out and started to check for pulse and breathing.  I don't know how many seconds passed and she started having color or her skin, closed her eyes and then opened them, asking what happened and the reason she was on the floor. I explained to  her and she started crying and wanted to get up. Told her to stay on the floor, she didn't want 911 to come.  She said she was so embarrassed about that. It happened once while she got her TB test. She told me she should have warned that she is afraid of needles, and she had the same episode once already. 911 was on the phone, told to not come. Patient was normal, trying to stand up as soon as she could. I didn't want her to go home alone, she lives literally around the corner of pharmacy. Manager of the store and technicians were witnesses of what happened. I told her to call us as soon as she gets home and she did. She was ok according to the technician.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Tremor
Clinical narrative: I gave the flu shot first and after that, I gave the Novavax vaccine, the lady started sweating while looking at the needle, she was wearing her mask all the time, then started to rolling her eyes back and was unconscious, but with the eyes fully open staring at me and started like shaking for 2 seconds, got pale. I screamed to call 911 and get the epipen.  I pulled her down to the floor, took her mask out and started to check for pulse and breathing.  I don't know how many seconds passed and she started having color or her skin, closed her eyes and then opened them, asking what happened and the reason she was on the floor. I explained to  her and she started crying and wanted to get up. Told her to stay on the floor, she didn't want 911 to come.  She said she was so embarrassed about that. It happened once while she got her TB test. She told me she should have warned that she is afraid of needles, and she had the same episode once already. 911 was on the phone, told to not come. Patient was normal, trying to stand up as soon as she could. I didn't want her to go home alone, she lives literally around the corner of pharmacy. Manager of the store and technicians were witnesses of what happened. I told her to call us as soon as she gets home and she did. She was ok according to the technician.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Erythema, Pain, Pyrexia
Clinical narrative: Approximately 12 hours after getting IM Pfizer-BioNTech Comirnaty the upper arm had large erythema, induration, without pruritus. Patient also had high grade fever of 102-103, several emesis, loss of appetite. Several doses of Advil were given to help with fever, aches and pain. There was pain that spread from the lesion arm to upper neck. Because of potential concern for cellulitis Amoxicillin 500 mg oral dose ws given, cold presses were initiated. Since the lesion also resembled the lesions described as Late onset allergic skin reaction and inoculation site of COVID-19 shot, one dose of Claritin was also given.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Hypoaesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Fever since vaccination, exaggerated localized immune response including erythema, swelling and numbness of distal hand.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal infection, Vulval disorder
Clinical narrative: Vaginal infection - small legion like pimple) on vulva
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Triggered a gout flare up in my right big toe.
Age: 39.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Asthenia, Chills, Lethargy, Nausea, Vomiting
Clinical narrative: Vomiting, nausea, lethargy, weakness, chills lasting for 24 hours (10am to following day)
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: COUDLN'T MOVE ARM UP 3 INCHES-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: IMMEDIATE FIRECRACKER PAIN IN ARM AFTER VACCINE ADMINISTRATION. COULDN'T MOVE ARM UP 3 INCHES. NEUROLOGIST STATED THIS WAS DUE TO NEEDLE TRAUAMA OF AXILLARY NERVE. SHE IS DOING PHYSICAL THERAPY FOR ARM OFF AND ON SINCE THE INJECTION. SHE HAS IMPROVED AND GAINED RANGE IN MOTION BUT NOT FULLY RECOVERED. WITH COMPUTER WORK SHE CAN DO 10-15 MINUTES THEN THE ARM WILL GET TIGHT AND SORE. RECOVERY IS SLOW BUT IS GETTING THERE. PATIENT STATED VACCINATOR GAVE THE VACCINE STANDING UP WHILE SHE WAS SITTING
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Limb injury, Loss of personal independence in daily activities, Nerve injury, Pain in extremity
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: COUDLN'T MOVE ARM UP 3 INCHES-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: IMMEDIATE FIRECRACKER PAIN IN ARM AFTER VACCINE ADMINISTRATION. COULDN'T MOVE ARM UP 3 INCHES. NEUROLOGIST STATED THIS WAS DUE TO NEEDLE TRAUAMA OF AXILLARY NERVE. SHE IS DOING PHYSICAL THERAPY FOR ARM OFF AND ON SINCE THE INJECTION. SHE HAS IMPROVED AND GAINED RANGE IN MOTION BUT NOT FULLY RECOVERED. WITH COMPUTER WORK SHE CAN DO 10-15 MINUTES THEN THE ARM WILL GET TIGHT AND SORE. RECOVERY IS SLOW BUT IS GETTING THERE. PATIENT STATED VACCINATOR GAVE THE VACCINE STANDING UP WHILE SHE WAS SITTING
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Loss of personal independence in daily activities, Muscular weakness, Pain in extremity
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: COUDLN'T MOVE ARM UP 3 INCHES-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: IMMEDIATE FIRECRACKER PAIN IN ARM AFTER VACCINE ADMINISTRATION. COULDN'T MOVE ARM UP 3 INCHES. NEUROLOGIST STATED THIS WAS DUE TO NEEDLE TRAUAMA OF AXILLARY NERVE. SHE IS DOING PHYSICAL THERAPY FOR ARM OFF AND ON SINCE THE INJECTION. SHE HAS IMPROVED AND GAINED RANGE IN MOTION BUT NOT FULLY RECOVERED. WITH COMPUTER WORK SHE CAN DO 10-15 MINUTES THEN THE ARM WILL GET TIGHT AND SORE. RECOVERY IS SLOW BUT IS GETTING THERE. PATIENT STATED VACCINATOR GAVE THE VACCINE STANDING UP WHILE SHE WAS SITTING
Sex: U
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; HCP called to report an expired PROQUAD was administered on 9/13/2024 that expired on 9/8/2024.; This spontaneous report was received from a nurse, referring to a patient of unknown gender and age.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 13-SEP-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, 0.5 milliliter/once, lot #X007358, expiration date: 09-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No temperature excursions and no side effects were reported (no adverse event).
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Inflammation, Oropharyngeal pain, Peripheral swelling, Rhinorrhoea
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: SWELLING-REDNESS-Severe, Additional Details: PATIENT ENDED UP WITH HAVING TO GO TO URGENT CARE FOR SEVERE INFECTION ON LEFT ARM. IMMUNIZATION APPEARS TO HAVE BEEN INJECTED TOO LOW SC. VS IM, CAUSING A SEVERE INFECTION. PATIENT WAS GIVEN DOXYCYCLINE 100MG BID X 7 DAYS. SHE REPORTED INCIDENT TO RPH ON 9/15/24. PATIENT CAME INTO PHARMACY TO SEE ME- RPH ON 9/16/24. SHE WAS SEEING PRIMARY THIS AFTERNOON AND IS NOW COMING DOWN WITH FLU LIGHT COUGH AND CONGESTION/NO SURE IF ITS RELATED.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: SWELLING-REDNESS-Severe, Additional Details: PATIENT ENDED UP WITH HAVING TO GO TO URGENT CARE FOR SEVERE INFECTION ON LEFT ARM. IMMUNIZATION APPEARS TO HAVE BEEN INJECTED TOO LOW SC. VS IM, CAUSING A SEVERE INFECTION. PATIENT WAS GIVEN DOXYCYCLINE 100MG BID X 7 DAYS. SHE REPORTED INCIDENT TO RPH ON 9/15/24. PATIENT CAME INTO PHARMACY TO SEE ME- RPH ON 9/16/24. SHE WAS SEEING PRIMARY THIS AFTERNOON AND IS NOW COMING DOWN WITH FLU LIGHT COUGH AND CONGESTION/NO SURE IF ITS RELATED.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Infection, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: SWELLING-REDNESS-Severe, Additional Details: PATIENT ENDED UP WITH HAVING TO GO TO URGENT CARE FOR SEVERE INFECTION ON LEFT ARM. IMMUNIZATION APPEARS TO HAVE BEEN INJECTED TOO LOW SC. VS IM, CAUSING A SEVERE INFECTION. PATIENT WAS GIVEN DOXYCYCLINE 100MG BID X 7 DAYS. SHE REPORTED INCIDENT TO RPH ON 9/15/24. PATIENT CAME INTO PHARMACY TO SEE ME- RPH ON 9/16/24. SHE WAS SEEING PRIMARY THIS AFTERNOON AND IS NOW COMING DOWN WITH FLU LIGHT COUGH AND CONGESTION/NO SURE IF ITS RELATED.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Product administered at inappropriate site, Respiratory tract congestion
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: SWELLING-REDNESS-Severe, Additional Details: PATIENT ENDED UP WITH HAVING TO GO TO URGENT CARE FOR SEVERE INFECTION ON LEFT ARM. IMMUNIZATION APPEARS TO HAVE BEEN INJECTED TOO LOW SC. VS IM, CAUSING A SEVERE INFECTION. PATIENT WAS GIVEN DOXYCYCLINE 100MG BID X 7 DAYS. SHE REPORTED INCIDENT TO RPH ON 9/15/24. PATIENT CAME INTO PHARMACY TO SEE ME- RPH ON 9/16/24. SHE WAS SEEING PRIMARY THIS AFTERNOON AND IS NOW COMING DOWN WITH FLU LIGHT COUGH AND CONGESTION/NO SURE IF ITS RELATED.
Age: 62.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Off label use
Clinical narrative: No additional AEs were reported.; The patient received GARDASIL 9 because the patient's dermatologist recommended her to try the vaccine because the patient has genital, plantar, and hand warts; This spontaneous report as received from a registered nurse via a company representative refers to a 62-year-old female patient. No information regarding her medical history, concurrent conditions and concomitant medications was reported.  On 30-AUG-2024 (reported as today), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose (exact dose, route and site of administration, lot number and expiration date were not reported) for genital, plantar, and hand warts (Off label use). The vaccination was recommended by the patient's dermatologist even though she was older than recommended age because, according to the dermatologist, the vaccine might help her with the warts. No additional adverse events were reported.  Lot # is being requested and will be submitted if received.
Age: 1.67
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no symptomatic adverse events reported yet; Physician calling to report administration of GARDASIL-9 accidently to a two year old male; This spontaneous report was received from a physician and refers to a 2-year-old male patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 04-SEP-2024, the patient was vaccinated accidentally with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot number 1965046 with expiration date 22-JAN-2026 (dose, route, and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). There were no symptomatic adverse events reported yet.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; HCP called to report patient received a fourth dose of GARDASIL9.  No symptoms reported.  Consent to correspond was given.  No additional AE/No PQC.; This spontaneous report was received from a registered Nurse (R.N) concerning a 24-year-old patient of unknown gender.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  On 14-AUG-2024, the patient was vaccinated with a 4th dose (extra dose administered) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection in pre-filled syringe, lot # 2032274, Expiration date: 19-JAN-20226, 0.5 milliliter (route and frequency were not reported) for prophylaxis.     No additional AE/No PQC (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms were reported; expired PROQUAD vaccine was administered to patient today; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-SEP-2024 (also reported as today), the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The vaccine did not experience any temperature excursions.  No additional symptoms were reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; the second dose of VAQTA series was administered to an adult patient early prior to 6 to 18 months. Pharmacist stated 1st dose of series was administered on 11/4/2022 by her pharmacy, and second dose was administered to patient on 04/21/2023; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 04-NOV-2022, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided); and on 21-APR-2023, with the second dose (no administration details), administered by a different pharmacy early prior to 6 to 18 months (Inappropriate schedule of product administration). No side effects or symptoms reported. No further information provided.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; un-noticed temperature excursion occured; This spontaneous report was received from a registered nurse and refers to a 5-year-old male patient. His medical history, concurrent conditions and concomitant therapies were not provided.  On 14-AUG-2024, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (recombinant Human albumin), lot #Y004547, expiration date: 19-AUG-2025, administered subcutaneously at left arm for prophylaxis (strength was not provided) after un-noticed temperature excursions (temperature -12 C, time frame 37 minutes, previous temperature excursion: yes). The vaccine was administered before vaccine was cleared by manufacturer. The vaccine was cleared for use  (Product storage error). No adverse effects reported.; Sender's Comments:  US-009507513-2409USA005195:2409USA005195 US-009507513-2409USA005205:2409USA005205 US-009507513-2409USA005214:2409USA005214 US-009507513-2409USA005246: US-009507513-2409USA005422:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; un-noticed temperature excursion; This spontaneous report was received from a registered nurse and refers to a 4-year-old female patient. Her medical history, concurrent conditions and concomitant therapies were not provided.  On 01-AUG-2024, the patient was vaccinated with a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (recombinant Human albumin), lot #Y004547, expiration date: 19-AUG-2025, administered subcutaneously at left arm for prophylaxis (strength was not provided); after un-noticed temperature excursions (temperature -12 C, time frame 37 minutes, previous temperature excursion: yes). The vaccine was administered before vaccine was cleared by manufacturer. The vaccine was cleared for use  (Product storage error). No adverse effects reported.; Sender's Comments:  US-009507513-2409USA005182:2409USA005195 US-009507513-2409USA005205:2409USA005205 US-009507513-2409USA005214:2409USA005214 US-009507513-2409USA005246:
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; un-noticed temperature excursion occured; This spontaneous report was received from a registered nurse and refers to a 13-month-old female patient. Her medical history and concurrent conditions were not reported. Concomitant medications included pneumococcal polysaccharide conjugate vaccine (20-valent (+) adsorbed) (reported as PCV 20).   On 26-JUL-2024, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (recombinant Human albumin), lot #Y004547, expiration date: 19-AUG-2025, administered subcutaneously at left thigh for prophylaxis (strength was not provided), after un-noticed temperature excursions (temperature -12 C, time frame 37 minutes, previous temperature excursion: yes). The vaccine was administered before vaccine was cleared by manufacturer. The vaccine was cleared for use (Product storage error). No adverse effects reported.; Sender's Comments:  US-009507513-2409USA005195:2409USA005205 US-009507513-2409USA005182:2409USA005205 US-009507513-2409USA005214:2409USA005214 US-009507513-2409USA005246:
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; un-noticed temperature excursion; This spontaneous report was received from a registered nurse and refers to a 12-month-old female patient. The patient's medical history and concurrent conditions were not provided. Concomitant medications included pneumococcal vaccine conj 20v (crm197) (reported as PCV 20).   On 30-JUL-2024, the patient was vaccinated with a first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #Y004547, expiration date: 19-AUG-2025, administered subcutaneously at left thigh for prophylaxis (strength was not provided); after un-noticed temperature excursions (temperature -12 C, time frame 37 minutes, previous temperature excursion: yes). The vaccine was administered before vaccine was cleared by manufacturer. The vaccine was cleared for use (Product storage error). No adverse effects reported.; Sender's Comments:  US-009507513-2409USA005182:2409USA005214 US-009507513-2409USA005205:2409USA005214 US-009507513-2409USA005195:2409USA005214 US-009507513-2409USA005246: