chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Loss of consciousness, Mobility decreased
Clinical narrative: Patient reports arm soreness starting at 3pm. Patient started to feel very bad at night. She reports she could barely lift her arms and felt bad overall. Patient began feeling body aches. She got up to go the bathroom around 3am and lost consciousness. She tried to go back to sleep when she regained consciousness, but she could not sleep because she felt so bad. She reports chills, profuse sweating, and body aches. She is feeling better today.
Age: 72.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Pain, Sleep disorder
Clinical narrative: Patient reports arm soreness starting at 3pm. Patient started to feel very bad at night. She reports she could barely lift her arms and felt bad overall. Patient began feeling body aches. She got up to go the bathroom around 3am and lost consciousness. She tried to go back to sleep when she regained consciousness, but she could not sleep because she felt so bad. She reports chills, profuse sweating, and body aches. She is feeling better today.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: fatigue, body aches, chills, fever, arthralgia
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral normal, Cerebral infarction, Cerebral small vessel ischaemic disease, Cerebrovascular accident, Computerised tomogram head abnormal
Clinical narrative: Patient received Moderna COVID 19 vaccine at 10 am. Started feeling hot and I?ll around 6 pm. Developed fever of 104 degrees F and altered mental status suspicious for CVA. Patient?s husband called ems and was transferred to medical Center. Had Ct scan of brain done suspicious for cva so another Ct angiogram was done that showed no occlusion. Patient recovered with supportive care and felt better by later that night. Discharged home the next afternoon with no further known complications.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Demyelination, Feeling hot, Mental status changes, Pyrexia
Clinical narrative: Patient received Moderna COVID 19 vaccine at 10 am. Started feeling hot and I?ll around 6 pm. Developed fever of 104 degrees F and altered mental status suspicious for CVA. Patient?s husband called ems and was transferred to medical Center. Had Ct scan of brain done suspicious for cva so another Ct angiogram was done that showed no occlusion. Patient recovered with supportive care and felt better by later that night. Discharged home the next afternoon with no further known complications.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Upper arm pain (at site of injection), headache, chills, nausea, body aches. Started on the morning after injection, continuing through the day.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Next day: small Red rash warm to the touch at injection site, soreness, small swelling. Two days after:  extreme swelling golf ball size, rash spread around arm, intense itching. Took 1 benedryl at night. Three days after: swelling went down a lot, redness less intense but still present, still warm and itchy, new symptom arm pains shooting down from elbow. Sometimes cramp like of sharp pain moving arm. Feeling itchy all over and possible light rash on chest but not severe.  Not sure too seek medical attention or not? I feel perfectly fine otherwise.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site warmth, Muscle spasms, Pain, Pain in extremity, Pruritus
Clinical narrative: Next day: small Red rash warm to the touch at injection site, soreness, small swelling. Two days after:  extreme swelling golf ball size, rash spread around arm, intense itching. Took 1 benedryl at night. Three days after: swelling went down a lot, redness less intense but still present, still warm and itchy, new symptom arm pains shooting down from elbow. Sometimes cramp like of sharp pain moving arm. Feeling itchy all over and possible light rash on chest but not severe.  Not sure too seek medical attention or not? I feel perfectly fine otherwise.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Next day: small Red rash warm to the touch at injection site, soreness, small swelling. Two days after:  extreme swelling golf ball size, rash spread around arm, intense itching. Took 1 benedryl at night. Three days after: swelling went down a lot, redness less intense but still present, still warm and itchy, new symptom arm pains shooting down from elbow. Sometimes cramp like of sharp pain moving arm. Feeling itchy all over and possible light rash on chest but not severe.  Not sure too seek medical attention or not? I feel perfectly fine otherwise.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Peripheral swelling
Clinical narrative: 12:37 PM: PATIENT ARM SWELLED UP WITHIN MINUTE AFTER INJECTION (APPROX. 1 IN. WIDE BY 2 IN. LONG & RAISED 1/4 IN). I APPLIED ICE PACK ON THE SITE APPROX. FOR 15 MINS., THE SWELLING WENT DOWN. PATIENT WAS FEELING FINE NO PAIN. AFTER 15 MINS. THE INJECTION SITE SWELLED UP AGAIN, THE PATIENT WAS FEELING FINE (NORMAL). I DID COUNSEL REGARDING GIVING BENADRYL INJECTION IF SHE EXPERIENCING ANY SYMPTOMS. PATIENT REFUSED BENADRYL INJECTION. AFTER MORE THAN AN HOUR THE INJECTION SITE LOOK MUCH BETTER. I COUNSELED AND GAVE BENADRYL TABLETS AND WATER TO PATIENT AT 1:37 PM, PATIENT SAID SHE WILL TAKE THE BENADRYL IN THE CAR WHILE HER HUSBAND DROVE HER HOME. SHE MENTIONED THAT SHE NORMALLY TAKE 1/4-1/2 TABLET OF BENADRYL BECAUSE SHE DOES NOT LIKE TO BE KNOCK OUT. I COUNSELED HER TO TAKE WHOLE TABLET TO HELP WITH ALLERGIC REACTION. I CALLED HER AT 8:05 PM, SHE SAID IS FINE, NO MORE SWELLEN, NO PAIN. I AM NOT SURE IF THE PATIENT TOOK THE BENADRYL OR NOT CAUSE SHE WAS NOT 100% SURE IF SHE TOOK IT. 10/13/23 1:20 PM: PATIENT IS FINE.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fear, Pain, Pain in extremity, Tremor
Clinical narrative: New COVID 2023-2024 vaccine given. Normal sore arm and body aches. Pt however stated she went to lay down at 12:15am and all of a sudden her whole body started to shake severely and teeth chattering and chills lasting 30minutes and it scared her, She did get her High dose flu vaccine same time.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Client came in for flu vaccine. Discussed with client whether she wanted regular flu or high dose flu vaccine. Client stated wanted high dose vaccine. When inputting into system, most recent flu vaccine in system was given on 10/5/22.  Administered high dose flu vaccine to client. Approximately 20-30 minutes later client calls asking if she received the flu vaccine or COVID vaccine, told client she received the high dose flu vaccine. Client then states that she received the flu vaccine already a few weeks ago and intended to get the COVID vaccine, not the flu vaccine. Told client that I could call her PCP, on her behalf and she agreed to this.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given adult 18 year old flu vaccine instead of pediatric fluzone for 17 year old. No reaction was noted. No treatment required.
Age: 81.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Fall, Groin pain, Pain
Clinical narrative: The patient received the vaccine and there were not issues at the time of vaccination. The patient left the pharmacy and walked to the front of the store. When she got to the front of the store, she fell down. When she was approached, she reported she felt faint and lightheaded and that was why she fell. She did not hit her head or lose consciousness. She was carefully helped into a chair and provided with some water. She sat in the chair for about 20 minutes and tried to stand. When she stood, she felt some pain in her groin and thought she may have pulled a muscle. She did not want to take an ambulance. Her daughter picked her up and took her home. When she left, she was able to walk and was not dizzy or lightheaded anymore.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching.  Palms of hands, feet, torso and hair line along back of head and neck,  a few hives have emerged along ribs, but the itching is  almost unbearable and itching it does not help! Seems to be worse at night, and traveling to other areas . Hoping it will subside in few days.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Rash pruritic, Stomatitis, Throat irritation, Urticaria
Clinical narrative: Within one and one-half hours after flu vaccine random hives developed, then followed by a very bumpy and itchy rash; throat and roof of mouth felt scratchy; tongue felt tingly; took Benadryl and symptoms became less; continues to take Benadryl approximately every 4 hours since after event and today it is 10/13/23 and will continue to take until symptoms go away.
Age: 25.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Confusional state, Hypotonia, Unresponsive to stimuli
Clinical narrative: Patient received both vaccines.  She then slumped down in her chair and was briefly unresponsive. She awoke confused.  She stood and walked to a chair outside the vaccination room and then slumped in the chair again with chin forward.  Emergency services were called from Clinic. Her BP was taken and she was monitored for at minimum 30 minutes. She was sent home with no further explanation.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Dysgeusia, Gingival pain, Headache, Tinnitus
Clinical narrative: Patient received Spikevax on 9/29 and that evening  started experiencing tinnitus, sore gums., headache, metallic taste and loss of taste. She went to the doctor and was prescribed and antiseptic mouthwash.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Respiratory tract congestion, Tinnitus
Clinical narrative: Patient received Spikevax on 9/29 and that evening  started experiencing tinnitus, sore gums., headache, metallic taste and loss of taste. She went to the doctor and was prescribed and antiseptic mouthwash.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Intern was administering a flu vaccine and removed the needle prior to administering the majority of the vaccine.  Loss was excessive. Dose was repeated and successfully administered
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Migraine, Muscle discomfort, Pain in extremity
Clinical narrative: Sore arm, migraine, exhaustion, muscle discomfort throughout body
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood thyroid stimulating hormone normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Cranial nerve paralysis, Facial paralysis, Full blood count normal
Clinical narrative: Cidp. Bilateral facial nerve palsy.  Cranial nerve vii and vi
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Metabolic function test normal, VIth nerve paralysis, Vitamin B12 normal
Clinical narrative: Cidp. Bilateral facial nerve palsy.  Cranial nerve vii and vi
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initially a bump at injection site, followed by redness and hot to touch two days later.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: I developed Shingles the day after receiving the COVID booster and Flu vaccine (I don't know what brand flu vaccine it was). I am on Acyclovir and Prednisone for the shingles. I am 37 years old and have had chicken pox before.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Electrocardiogram, Electroencephalogram, Laboratory test, Magnetic resonance imaging head
Clinical narrative: Member received his COVID vaccine on 10/11/23 and on 10/12/23 was noted laying on the floor unresponsive, blood coming from his mouth with seizure like activity.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Mouth haemorrhage, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Member received his COVID vaccine on 10/11/23 and on 10/12/23 was noted laying on the floor unresponsive, blood coming from his mouth with seizure like activity.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: PHARMACIST BELIEVES SHE MIGHT HAVE GIVEN ADULT COVID SHOT, INTENDED FOR MOTHER, TO 3 YO CHILD. WATCHED CAMERAS AND ATTEMPTED TO CHECK COUNTS BUT UNABLE TO CONFIRM FOR SURE.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ear ringing / tinnitus
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Paraesthesia, Rash, Skin warm
Clinical narrative: Patient describes that she started experiencing redness, rash, tingling, and heat on the upper part of her body (including neck, arms, hands, and face). It happens around once weekly and lasts for a few minutes. It started about a week after her vaccination. She stated that with each episode, the intensity and severity progressively get worse. It does not affect her heart rate or breathing in any way. She has called and left a message with her primary care doctor's office.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient came for covid vaccination  form was filled for covid vaccination .by mistake flue vaccination was administered..after the shot was given  patient mother said patient had flu vaccine at doctor's office .patient did not report any discomfort or any other problems
Age: 60.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Heart rate increased, Hypertension, Rash
Clinical narrative: per pt, has higher than normal blood pressure (175-95), elevated heart rate (did not give value) and rash on stomach; per pt, she treated herself with tylenol and benadryl  and issue resolved within 4-5 hours; pt says she is completely back to her "normal" today, but did want us to report
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 1.83
Sex: F
Vaccine: FLUN4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient not old enough for flu mist
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: pt presented with a rash aproximately palm sized.  stated started the day after the vaccination and had shrunk in size and intensity over the next few days.  reported as being itchy
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: patient says she has been getting significant nose bleeds starting this morning every time she stands up
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Blood potassium decreased, Chest X-ray normal, Chest pain, Cough, Dyspnoea
Clinical narrative: Patient is our employee and she works as Medical Assistant.  She received Fluzone Quad at 0850 on 10/11/2023.   She continue to work her whole 8 hour shift.   After work, she states, she went to the gym.   After gym, around 10:30, while driving  she started to have chest pain and shortness of breath.  Per patient, went to ER  and arrived around 11:00 PM.   She went to ER.  She states,  EKG, blood works, chest x-ray were normal except for low potassium, and elevated WBC.  Per patient, they said symptoms were adverse reaction of the flu vaccine. She was discharged from the hospital at around 3:30 AM 10/12/2023.  No medication was prescribed.  She also complaint of cough post vaccine.  Patient denies redness, bleeding, warmth on the injection site; fever, chills, nausea, vomiting.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Immunisation reaction, White blood cell count increased
Clinical narrative: Patient is our employee and she works as Medical Assistant.  She received Fluzone Quad at 0850 on 10/11/2023.   She continue to work her whole 8 hour shift.   After work, she states, she went to the gym.   After gym, around 10:30, while driving  she started to have chest pain and shortness of breath.  Per patient, went to ER  and arrived around 11:00 PM.   She went to ER.  She states,  EKG, blood works, chest x-ray were normal except for low potassium, and elevated WBC.  Per patient, they said symptoms were adverse reaction of the flu vaccine. She was discharged from the hospital at around 3:30 AM 10/12/2023.  No medication was prescribed.  She also complaint of cough post vaccine.  Patient denies redness, bleeding, warmth on the injection site; fever, chills, nausea, vomiting.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired pneomoccocal polysaccharide vaccine 2 days after expiration date . patient was fine after 15 minutes and was called the next day to inform her she would need to come back for another on. no adverse reactions
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Swelling noted with redness and warmth in the upper right arm where the deltoid is.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Confusional state, Diarrhoea, Fatigue, Headache
Clinical narrative: Pt received Flu vaccine on 10/9/23 at 1130am to Left arm. That night at 7:00pm Pt started to have headache and felt tired. On 10/10/23 when Pt woke up they could not move, had muscle weakness, confusion, joint pain, vomiting and diarrhea for 10 hours. Diarrhea and vomiting resolved 10/12/23. Pt feels better and does not feel needs medical attention at this time.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Muscular weakness, Vomiting
Clinical narrative: Pt received Flu vaccine on 10/9/23 at 1130am to Left arm. That night at 7:00pm Pt started to have headache and felt tired. On 10/10/23 when Pt woke up they could not move, had muscle weakness, confusion, joint pain, vomiting and diarrhea for 10 hours. Diarrhea and vomiting resolved 10/12/23. Pt feels better and does not feel needs medical attention at this time.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Musculoskeletal stiffness, Pruritus
Clinical narrative: Developed itchiness in his left arm that occurs at night.  Also reports his arm and the area around the shot feels stiff
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Initial injection was extremely painful with burning and stinging. Swelling, redness and pain at injection site approximately one hour after injection. Pain and redness spread around the injection site for the next 24 hours. Subsequently, had muscle pain, fever and loss of appetite for the next 24 hours. Used an ice pack on injection site for the next 48 hours. Injection site and surrounding area was red, swollen and painful for about 5 days. All symptoms were gone after one week following the injection.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: Initial injection was extremely painful with burning and stinging. Swelling, redness and pain at injection site approximately one hour after injection. Pain and redness spread around the injection site for the next 24 hours. Subsequently, had muscle pain, fever and loss of appetite for the next 24 hours. Used an ice pack on injection site for the next 48 hours. Injection site and surrounding area was red, swollen and painful for about 5 days. All symptoms were gone after one week following the injection.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Muscle spasms, Ultrasound Doppler abnormal
Clinical narrative: leg cramping started on 10/11, one day after vaccination. patient presented to clinic for evaluation on 10/13. Ultrasound ordered and confirmed DVT
Age: 72.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Dizziness, Feeling abnormal, Hypertension, Sensory disturbance
Clinical narrative: Patient called after having both vaccinations Fluad and Spikevax, indicating that she was driving home and experienced dizziness. She felt as if her "hair was standing on end" and was feeling "weird", but she couldn't fully describe her symptoms. She indicates that things were starting to "float". Confirmed with the patient that she was not having any signs or symptoms of an allergic reaction such as shortness of breath or tongue swelling. She ended up pulling into an urgent care clinic, for fear of driving while she feeling this way. Per patient, the clinic didn't know what to attribute her symptoms to. Patient does mention her blood pressure was high at the clinic, but no other significant symptoms. Patient states that she does suffer from panic attack but "hasn't had one in years". Patient was ensured that there were no stimulant properties within the vaccinations that could've contributed to her symptoms.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 39.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Injection site rash
Clinical narrative: developed red rash below injection site  statring 24 hours after injection, still growing at 96 hours after injection
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Several hours after dose was given patient began with chills ,fever, extreme aches and pains.  Patient was able to rest the remainder of the day.  I told her husband that she could be given extra strength tylenol and continue with fluids
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Heart rate irregular
Clinical narrative: Slight fever, chills, tiredness, headache, slightly clogged nose, a few irregular heartbeats. Slept all day. Doubt cause is anything else. Hadn't been out without a mask and then only briefly. 5:25 pm on the 13th, still feel bad but chills gone.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Hypersomnia, Nasal congestion, Pyrexia
Clinical narrative: Slight fever, chills, tiredness, headache, slightly clogged nose, a few irregular heartbeats. Slept all day. Doubt cause is anything else. Hadn't been out without a mask and then only briefly. 5:25 pm on the 13th, still feel bad but chills gone.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 62.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: RED AND ITCHY AT INJECTION SITE ON LEFT ARM WHERE RSV WAS GIVEN. FEVER WHICH RESPONDED TO TYLENOL. JOINT PAIN.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Fatigue, Feeling abnormal, Hypersomnia
Clinical narrative: limp, wiped out, slept for over 18 hours, no remembrance of going to the bathroom, fever, diarrhea from 10/4 until 10/10 - still feels poorly
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertonia, Pyrexia
Clinical narrative: limp, wiped out, slept for over 18 hours, no remembrance of going to the bathroom, fever, diarrhea from 10/4 until 10/10 - still feels poorly
Age: 24.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Fall, Loss of consciousness, Scratch
Clinical narrative: patient came in to receive flu and covid shot; received covid shot then after receiving flu shot passed out. She fell out of chair and bumped her head and shoulder; She regained consciousness in less than 5 seconds; she sat up on floor and had scratches on her head and shoulder; She denied medical care or us to call 911; She stayed at location for about 30 minutes before leaving with a friend
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: left upper arm and shoulder pain  x 2.5 weeks post vaccine.
Age: 77.0
Sex: F
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event, Product administration error
Clinical narrative: Patient had already received High Dose Fluzone vaccine on 10/5/2023.  Today Flublok Quad was administered in error. No adverse events at this time.  Error was discussed with patient at the time of the incident.  Adverse effects are unlikely.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Disturbance in attention, Ear discomfort, Electric shock sensation, Gait disturbance
Clinical narrative: ever since injection, left arm has been sore, then my left ear became very irriated, which extended down to my left arm and left leg, tingling, shocking sensations, now my left foot i am unable to walk normally, i trip easily, and unable to work, i am unable to use my left hand as i did in the past, no grip to hold on to, my mind mental status has changed, i can not concentrate on daily tasks without forgetting
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Lumbar puncture, Magnetic resonance imaging, Memory impairment, Mental status changes
Clinical narrative: ever since injection, left arm has been sore, then my left ear became very irriated, which extended down to my left arm and left leg, tingling, shocking sensations, now my left foot i am unable to walk normally, i trip easily, and unable to work, i am unable to use my left hand as i did in the past, no grip to hold on to, my mind mental status has changed, i can not concentrate on daily tasks without forgetting
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal disorder, Pain in extremity, Paraesthesia, X-ray
Clinical narrative: ever since injection, left arm has been sore, then my left ear became very irriated, which extended down to my left arm and left leg, tingling, shocking sensations, now my left foot i am unable to walk normally, i trip easily, and unable to work, i am unable to use my left hand as i did in the past, no grip to hold on to, my mind mental status has changed, i can not concentrate on daily tasks without forgetting
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Hypoxia
Clinical narrative: (Rcp)  THERAPIST, RESPIRATORY Specialty:  GENERAL, OTHER Respiratory Therapy    Addendum  Addendum    High Flow Nasal Cannula Shift Summary   Flow rate to be adjusted to reduce WOB and will be weaned as tolerated. Patient has HGH FLOW NASAL CANNULA at 50 L 80% with Oxymask at 12 L. SpO2 is between 90-94 when pulexOx is not being placed with by patient.   Patient confused, not able to give sputum sample at this time.    Admitting Dx: covid 19 pneumonia   Indications for Therapy: HYPOXEMIA    Current settings:     50 LPM  @ FiO2 80% via nasal cannula    Temperature:      37   Patient had trial off HIGH FLOW:    No      Vitals: BP 158/77  | Pulse 70  | Temp 97.6 °F (36.4 °C)  | Resp 22  | Wt 88.9 kg (196 lb)  | SpO2 93%  | BMI 27.34 kg/m²  Current ABG results:     Recent Labs   10/08/23 2252 PH 7.44 PCO2 36 PO2 52* HCO3 24.2 BE 0.8 O2SAT 86.0*     Skin assessment of area in contact with nasal interface: No problem/intact skin, patient refused skin protection.      RCP   10/9/2023   4:41 AM     Note Details  Author (Rcp) File Time 10/9/2023  4:49 AM Author Type THERAPIST, RESPIRATORY Status Addendum Last Editor (Rcp) Specialty GENERAL, OTHER Hospital Acct # Admit Date 10/8/2023  Admission (Current) on 10/8/2023  Admission (Current) on 10/8/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  10/08   Admitted 2138 10/09   Transferred to ICT-INTENSIVE CARE NURSE UNIT 1240 10/11   Transferred out of ICT-INTENSIVE CARE NURSE UNIT 1713  Pt in house
Age: 63.0
Sex: M
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: VACCINATION FOR FLUAD GIVEN. ADMINISTRATOR DID NOT REALIZE HE WAS NOT 65 YEARS OLF.
Age: 74.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered expired vaccine, currently per patient no adverse events. Administration date on 10/13/2023 vaccine expiration date 09/24/2023.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Chills, Fatigue, Myalgia, Pain
Clinical narrative: Low grade fever, chills, body aches, muscle aches, stomach pains, fatigue
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Low grade fever, chills, body aches, muscle aches, stomach pains, fatigue
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy
Clinical narrative: Headache, chills, lethargy
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site rash, Injection site warmth
Clinical narrative: Patient received influenza vaccination on 10/11/23 on her left deltoid. Patient states she had no pain or discomfort after received the vaccine. Patient states she started having a headache later in the day after received a vaccination and has had an intermittent headache since then. Patient stated she noted a "small rash" on her upper left arm the day after the immunization. Patient states she noticed this morning that the rash was significantly larger and had spread further down her arm. Patient denies any additional symptoms since receiving the immunization.    Upon evaluation, patient does have raised rash on left upper arm, below immunization site. Area is warm to the touch with no additional redness or swelling in other areas of the arm. Patient did not present with fever and denies any pain, numbness, tingling, trouble breathing, trouble swallowing. Per PCP photos taken were taken during nurse visit and forwarded to Dr.   Patient advised that notes and images will be forwarded to Dr. and he will provide recommendations. Patient advised to continue using ice and/or warm compress to area as needed to relive any discomfort.Patient if at any time she begins to experience shortness of breath, numbness, tingling, chest pain,trouble swallowing or if current symptoms worsen, please go to nearest ER. Patient was in agreement with plan and verbalized understanding. Notes forwarded to provider.  (See photos and vitals)  Dr. reviewed visit note and is in agreeement with plan. Patient contacted via phone and advised of PCP recommendations. Patient had no questions or concerns.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN  UNAPPROVED STORAGE UNIT
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4, RSV, COVID19, FLU4, RSV
Symptoms: Breast swelling, Injection site induration, Injection site swelling
Clinical narrative: patient complained of swelling and hard tissue at site of injection and breast.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4, RSV, COVID19, FLU4, RSV
Symptoms: Breast induration, Breast swelling, Injection site induration, Injection site swelling
Clinical narrative: patient complained of swelling and hard tissue at site of injection and breast.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4, RSV, COVID19, FLU4, RSV
Symptoms: Breast swelling, Injection site induration, Injection site swelling
Clinical narrative: Patinet complained of swelling and hard tissue at site of injection and breast
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4, RSV, COVID19, FLU4, RSV
Symptoms: Breast induration, Breast swelling, Injection site induration, Injection site swelling
Clinical narrative: Patinet complained of swelling and hard tissue at site of injection and breast
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Myalgia
Clinical narrative: Severe chills started later same day and resolved by morning; muscle aches in back and arms and headache also resolved by next day; redness at injection site extending over top of shoulder (about a 4" x 2" area that looks like a sunburn) still exists after 3 days.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: C/O rash over upper and lower limbs and face noted 24 hours after receiving flu shot on the left arm. denies fever, SOB, facial swelling or hoarseness. Parents deny past vaccine reaction. He was evaluated in the ER (MC) on 10/6/23 for temp of 104.3 and diagnosed with a viral syndrome. fever laster until 10/09/23. He was afebrile when he received te flu shot on 10/11/23. benadryl was given this morning for the rash that has improved per mom.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse events, received an expired flu vaccine
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; paxlovid: Treatment of COVID-19; paxlovid: Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 22Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing); "well controlled diabtes" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "paxlovid: Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 19Sep2023 to 24Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : UM-PFIZER INC-202300321212 Same patient, different drug, different event (Paxlovid case);
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE; a patient who was administered PROQUAD that was reconstituted with STERILE SALINE instead of STERILE DILUENT.; a patient who was administered PROQUAD that was reconstituted with STERILE SALINE instead of STERILE DILUENT.; This spontaneous report has been received from a registered nurse referring to a 4-year-old female patient. Information regarding the patient's medical history, concurrent conditions, concomitant medications, drug allergies or reactions were not provided.   On 11-SEP-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, albumin status rHA, 0.5 milliliter subcutaneously (SC) in her right thigh, lot number: W036941 and expiration date was 19-MAY-2024 for prophylaxis at public health/hospital. Additionally, it was reported that the vaccine was reconstituted with sterile saline instead of sterile water diluent. However, it was reported that the operator was trained. The nurse advised patient's parents she would need re-vaccination after one month and she was rescheduled. No adverse reaction or illness reported by patient's family. No product quality complaint was involved. No temperature excursion occurred as a result of a reading from a Digital Data Logger. This event was reported to the physician and to health department previously.
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered (3rd dose administered on 09-DEC-2013); Inappropriate schedule of vaccine administered (2nd dose administered on 06-OCT-2010); This spontaneous report has been received from a physician, via a medical record (MR) from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (# 2309USA005464) concerning a 2-month-old male patient. Concomitant therapies included haemophilus b conjugate vaccine (meningococcal protein conjugate)(manufacturer unknown), unspecified polio vaccine inactive, rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) and unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP). His historical vaccines included Hepatitis B Immune Globulin. His medical history and concurrent conditions were not provided.       On 02-FEB-2010, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided). On 06-OCT-2010, he was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate schedule of product administered). On 09-DEC-2013, the patient was adminstered the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate schedule of product administered)   This is one of 4 reports referring to the same patient (linked # 2309USA005464, 2309USA008646 and 2309USA008647).; Sender's Comments:  US-009507513-2309USA005464: US-009507513-2309USA008646: US-009507513-2309USA008647:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered (3rd dose administered on 01-JUL-2010); This spontaneous report has been received from a physician via a medical record (MR) from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (MARRS # 2309USA005464) concerning a 2-month-old male patient. Concomitant therapies included haemophilus b conjugate vaccine (meningococcal protein conjugate)(manufacturer unknown), unspecified polio vaccine inactive, unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP) and Hepatitis B Vaccine  (manufacturer unknown). His historical vaccines included unspecified Hepatitis B Immune Globulin. The patient's medical history and concurrent conditions were not provided.       On 02-FEB-2010, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally, (dose, lot # and expiration date were not provided). On 09-APR-2010, he was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally, (dose, lot # and expiration date were not provided). On 01-JUL-2010, the patient was adminstered the third dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally, (dose, lot # and expiration date were not provided) (inappropriate schedule of product administered).   This is one of 4 reports reffering to the same patient (linked # 2309USA005464, 2309USA008645 and 2309USA008647).; Sender's Comments:  US-009507513-2309USA008645: US-009507513-2309USA008647: US-009507513-2309USA005464:
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: extra dose administered; Inappropriate schedule of vaccine administered (3rd dose administered on 01-JUL-2010); This spontaneous report has been received from a physician, via a medical record (MR) from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (# 2309USA005464) concerning a 2-month-old male patient. Concomitant therapies included nspecified polio vaccine inactive, rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP) and hepatitis B vaccine (manufacturer unknown). His historical vaccines included unspecified Hepatitis B Immune Globulin. The patient's medical history and concurrent conditions were not provided.    On 02-FEB-2010, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided). On 09-APR-2010, he was vaccinated with the second dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided). On 01-JUL-2010, he was administered the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided (inappropriate schedule of product administered). On 27-JUN-2011, the patient was vaccinated with the fourth dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown) (extra dose administered).   This is one of 4 reports referring to the same patient (linked # 2309USA005464, 2309USA008646 and 2309USA008645).; Sender's Comments:  US-009507513-2309USA008645: US-009507513-2309USA008646: US-009507513-2309USA005464:
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine, Alopecia
Clinical narrative: Allergy to vaccine; hair loss; This spontaneous report was received from a physician via Pfizer and refers to a patient of unknown age and gender.  The patient's medical history included allergic cough after Ace Inhibitors. The patient's concurrent conditions and concomitant therapies were not reported.  On an unknown date, assessed as in September 2010, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) reported as "pneumococcal vaccine", injection, administered for prophylaxis (strength, dose, dose number, lot #, expiry date, and route of administration were not provided).  On 28-SEP-2010, the patient experienced hair loss and allergy to vaccine. At the time of reporting, the outcome of the events was not provided.   The reporter considered the events to be related to pneumococcal vaccine (manufacturer unknown).
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: HCP called to report that the patient received their first dose of GARDASIL ( quadrivalent) at the age 14 and they received a  dose of GARDASIL 9  today at the age of 28. No additional AE/PQC. No additional information provided.  Operator of device=; Inappropriate schedule of vaccine administered; No additional AE; This spontaneous report was received from a pharmacist and refers to a 28-year-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On an unknown date the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On an unknown date (reported as "today at the age of 28), the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter for prophylaxis (route and site of administration, lot number and expiration date were not provided) (interchange of vaccine products, inappropriate schedule of product administration and no adverse event).
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No symptoms or further details reported. No other AE; 11 year old patient received their second GARDASIL 9 dose too early.  First dose was was on 09/12/2023 and second dose was administered on 10/06/2023; This spontaneous report was received from a medical assistant and refers to an 11-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-SEP-2023, the patient was vaccinated with first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (lot#, expiration date, route of administration, anatomical location, was not reported), then on 06-OCT-2023, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1957404, expiration date: 05-OCT-2025, administered for prophylaxis (strength, anatomical location,  and route of administration were not provided) (Inappropriate schedule of vaccine administered). No symptoms or further details reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: syncope; This spontaneous report was received from an office manager via company representative referring to an 11-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis by a health prefessional (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced syncope after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The event happened at primary care office. The patient had sought medical attention. There were no injuries, and the patient did not need any follow up care. It was unknown if any treatment was given. At the time of reporting, the outcome of the event syncope was unknown.  The causal relationship between syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event syncope was determined to be medically significant.