chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Tongue pruritus
Clinical narrative: Patient had an allergic reaction to vaccine approximately 20-30 minutes from administration. Pt c/o itchy tongue, throat, lips and had visible swelling to eyelids. Denied difficulty breathing.  Administered 50 mg/ml of Dipenhydramine IM and followed up with patient at 12:20 pm, she denied trouble breathing, stated she was no longer itching and only felt her tongue slightly heavy. C/o fatigue from the dipenhydramine.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Throat tightness
Clinical narrative: At 12:28 PM during observation period after receiving her booster dose of Moderna COVID vaccine, the client walked up to the EMT station and reported she had a sensation of "closing of her throat" and feeling like a "cotton mouth." Client was calm, spoke in clear speech, stable on her feet, denied feeling shortness of breath, dizzy or pain. Co-lead nurse advised client to sit down on chair. Client drank some water and reported feeling less "tight" and swallowed a sips of water without any difficulty. Vital sign taken at 12:30 PM: Blood pressure was 138/90,  heart rate 92, respiration rate 18, and oxygen saturation at 98 percent.  Client reported she had a history COVID infection in December 2020, kidney donor (2011), seasonal allergy and not taking any medication. Client reported she had an allergic reaction to vitamin D shot in 2016 with "a swelling of lips and body." She reported she went to ER and was treated there with "Epi-shot." At 12:45 PM blood pressure was taken: 128/100, heart rate 87, respiration rate 18, and oxygen saturation at 98 percent. Co-lead nurse assessed client's throat and mouth and reported throat was soft to touch, denied tenderness to touch and no signs of swelling or inflammation with use of pen light. The client declined for staff to call 911 for further assessment. Co-lead nurse educated client on possible adverse effect, when to seek medical care and register on V-Safe. At 1:00 PM, the client left the facility with steady gait.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient vaccinated per procedure.  Did not mention previous vaccination other than the primary series was received.  When documenting vaccination it was noted that the patient had been vaccinated on 2/4/22 with a dose of Pfizer-BioNTech vaccine.  Followed up with client and their caregiver.  No adverse outcomes noted.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: My Lymph nodes were very large and lasted 3 and half months.  Left arm felt like there was a tennis ball and another large node in my neck. I have not fully recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Computerised tomogram abnormal, Gait disturbance, Joint swelling
Clinical narrative: 11/18/2021 Vaccination-11/23/2021 Went on a trip-11/30/2021 Woke up from sleeping, felt like my calf was going to explode; R leg. I could barely walk on it. By Friday, I called my doctor. He got me in the following Monday. But the weekend, it started swelling around my ankle and calf. That Monday, the Dr. had order for ultra sound for blood clot. It came back positive for blood clog, R leg. Was going from ankle to groin area. He told me to go to the ER. I had to wait 3 hours to be seen. The Dr. in the ER put me on a blood thinner and discharged me home. I called my PCM and he was mad that I was not admitted to the hospital. I didn't get prescription filled till that evening because pharmacy was so backed up. Thursday morning, slight pain under L breast when I woke up; chest pain. I went to the ER that Thursday morning. CT scan; clot on both side of the lungs. Started on heparin drip. I don't know if I still have them but my leg is still swollen. It has been 3 months since diagnosis. They want to see me again in another 3 months. 20 mg of blood thinner 3-6 months (hitting the 3 month mark now). Will repeat ultra sound of lungs in another 3 months and only will repeat CT if I push for it. *I stopped the Birth Control. **COVID 07/2021; late July.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pulmonary thrombosis, Thrombosis, Ultrasound scan abnormal
Clinical narrative: 11/18/2021 Vaccination-11/23/2021 Went on a trip-11/30/2021 Woke up from sleeping, felt like my calf was going to explode; R leg. I could barely walk on it. By Friday, I called my doctor. He got me in the following Monday. But the weekend, it started swelling around my ankle and calf. That Monday, the Dr. had order for ultra sound for blood clot. It came back positive for blood clog, R leg. Was going from ankle to groin area. He told me to go to the ER. I had to wait 3 hours to be seen. The Dr. in the ER put me on a blood thinner and discharged me home. I called my PCM and he was mad that I was not admitted to the hospital. I didn't get prescription filled till that evening because pharmacy was so backed up. Thursday morning, slight pain under L breast when I woke up; chest pain. I went to the ER that Thursday morning. CT scan; clot on both side of the lungs. Started on heparin drip. I don't know if I still have them but my leg is still swollen. It has been 3 months since diagnosis. They want to see me again in another 3 months. 20 mg of blood thinner 3-6 months (hitting the 3 month mark now). Will repeat ultra sound of lungs in another 3 months and only will repeat CT if I push for it. *I stopped the Birth Control. **COVID 07/2021; late July.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events; medical assistant administered Moderna to a 17 year old. The vaccine is only approved for ages 18 and older.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Bilirubin conjugated, Blood alkaline phosphatase, Blood bilirubin
Clinical narrative: Syncope Supraventricular tachycardia Transient loss of consciousness
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium, Blood creatinine, Blood electrolytes, Blood glucose, Blood magnesium
Clinical narrative: Syncope Supraventricular tachycardia Transient loss of consciousness
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urea, Brain natriuretic peptide, C-reactive protein, Differential white blood cell count, Drug screen
Clinical narrative: Syncope Supraventricular tachycardia Transient loss of consciousness
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fibrin D dimer, Full blood count, Human chorionic gonadotropin, Lipase
Clinical narrative: Syncope Supraventricular tachycardia Transient loss of consciousness
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Metabolic function test, Prothrombin time, Red blood cell sedimentation rate, Supraventricular tachycardia
Clinical narrative: Syncope Supraventricular tachycardia Transient loss of consciousness
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Troponin I, Urine analysis
Clinical narrative: Syncope Supraventricular tachycardia Transient loss of consciousness
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cystitis interstitial
Clinical narrative: My IC went out of control I was able to see my doctor every four weeks for installations after getting the vaccine I started having to go twice a week to almost every week. This has been going on for  8 Months now no change no reliefs
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye pain, Headache, Iridocyclitis, Lacrimation increased
Clinical narrative: I woke up the day after receiving my booster with what I thought was pink eye and therefore tried to "let it run its course". My left eye was watery, pink, some pain, and very sensitive to light; so much so that it would give me a headache. The light sensitivity was not as severe after a few days but my eye was still pink. After a little over 2 weeks (19 days) and my eye was not getting better, I decided to go into urgent care. The PA at the Physicians Care Unit there diagnosed me with: 1. ocular pain, left eye and 2. unspecified acute and subacute iridocyclitis. He prescribed me with oral prednisone for 6 days and polytrim eye drops for 7 days. My eye did get better while on the treatment but my eye pain and light sensitivity returned shortly after finishing the treatment. I went in to Vision clinic and saw Dr. on 2/17/22 where he diagnosed me with primary iridocyclitis, left eye. He provided a script for 2 eye drops: Cyclopentolate Hydrochloride Ophthalmic Solution and Prednisolone Acetate Ophthalmic Suspension. I am still currently using the Prednisolone Acetate twice a day. My eye feels so much better but I still experience slight pain from time to time.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: I woke up the day after receiving my booster with what I thought was pink eye and therefore tried to "let it run its course". My left eye was watery, pink, some pain, and very sensitive to light; so much so that it would give me a headache. The light sensitivity was not as severe after a few days but my eye was still pink. After a little over 2 weeks (19 days) and my eye was not getting better, I decided to go into urgent care. The PA at the Physicians Care Unit there diagnosed me with: 1. ocular pain, left eye and 2. unspecified acute and subacute iridocyclitis. He prescribed me with oral prednisone for 6 days and polytrim eye drops for 7 days. My eye did get better while on the treatment but my eye pain and light sensitivity returned shortly after finishing the treatment. I went in to Vision clinic and saw Dr. on 2/17/22 where he diagnosed me with primary iridocyclitis, left eye. He provided a script for 2 eye drops: Cyclopentolate Hydrochloride Ophthalmic Solution and Prednisolone Acetate Ophthalmic Suspension. I am still currently using the Prednisolone Acetate twice a day. My eye feels so much better but I still experience slight pain from time to time.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 2.67
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: MMR vaccine was expired at time of administration. No adverse reactions.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Respiratory tract congestion, Streptococcus test negative
Clinical narrative: So, I became congested in the back of throat. I took allergy medication, and nothing worked. It won't go away. Around May got extremely sore throat can't drink water. I went to express care and there was no viral bacterial infection. I took about three days to subside. Randomly 4 months later it came back did not go to express care; very painful.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Pharyngeal swelling
Clinical narrative: Anaphylaxis, swelling of the throat, unable to breathe within 15 minutes of injection Epinephrine injected into the upper arm
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Alopecia, Alopecia areata, Anaemia, Blood thyroid stimulating hormone normal, C-reactive protein normal
Clinical narrative: Mom reports that on 10/30/2021 after receiving the HPV vaccination, patient noticed increase in hair loss.  Patient was seen in Urgent Care 10/30/2021 -mild anemia noted Hg 11.3 normal MCV. remainder of CBC normal. BMP and TSH normal. ESR 23. CRP normal. Was seen at Dermatology on 11/01/2021. Dx with alopecia aerate. Has tried steroids, etc without improvement. Continues to have ongoing hair loss-lost eye lashes, lost 50% of her hair (lots of patches) remainder of hair very brittle.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Full blood count normal, Haemoglobin normal, Madarosis, Mean cell volume normal, Metabolic function test normal
Clinical narrative: Mom reports that on 10/30/2021 after receiving the HPV vaccination, patient noticed increase in hair loss.  Patient was seen in Urgent Care 10/30/2021 -mild anemia noted Hg 11.3 normal MCV. remainder of CBC normal. BMP and TSH normal. ESR 23. CRP normal. Was seen at Dermatology on 11/01/2021. Dx with alopecia aerate. Has tried steroids, etc without improvement. Continues to have ongoing hair loss-lost eye lashes, lost 50% of her hair (lots of patches) remainder of hair very brittle.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Red blood cell sedimentation rate increased, Trichorrhexis
Clinical narrative: Mom reports that on 10/30/2021 after receiving the HPV vaccination, patient noticed increase in hair loss.  Patient was seen in Urgent Care 10/30/2021 -mild anemia noted Hg 11.3 normal MCV. remainder of CBC normal. BMP and TSH normal. ESR 23. CRP normal. Was seen at Dermatology on 11/01/2021. Dx with alopecia aerate. Has tried steroids, etc without improvement. Continues to have ongoing hair loss-lost eye lashes, lost 50% of her hair (lots of patches) remainder of hair very brittle.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Migraine
Clinical narrative: Very fatigued, didn't happen after 2nd shot. HUGE headache 2/28 and 3/1, with a migraine on 3/1. Pain on top right of head quite strong. I don't generally get migraines. Took 3 Advil
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Immediate post-injection reaction, Syncope, Unresponsive to stimuli
Clinical narrative: Patient received the Moderna booster. Immediately after receiving vaccine, patient had a syncopal episode. Patient slumped over on chair and was unresponsive for approximately 5 seconds. When patient regained became responsive she was immediately moved to a bed and vitals were taken on site. BP 103/56, HR 50, SPO2 98%, A&Ox4. Patient was given water and juice and was monitored for the next 30 minutes. Repeat vitals BP 110/68, HR 70, SPO2 98. Per patient this has happened before in the past. Patient was discharged without further incident.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: hives and rash on arms and chest  fever and headache  nausea  injection site pain and swelling
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives and rash on arms and chest  fever and headache  nausea  injection site pain and swelling
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Condition aggravated, Essential tremor, Fatigue, Myalgia
Clinical narrative: Within 2 hours of injection patient experienced fever of 101 F, fatigue and muscle aches which lasted for 48 hours. Within 5 days patient began to experience exacerbation of essential tremor to the point that she experienced intermittent ataxia. Patient continues to suffer exacerbation of essential tremor.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Within 2 hours of injection patient experienced fever of 101 F, fatigue and muscle aches which lasted for 48 hours. Within 5 days patient began to experience exacerbation of essential tremor to the point that she experienced intermittent ataxia. Patient continues to suffer exacerbation of essential tremor.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: While administering vaccine, pt (5 years old) moved away and only half of the vaccine was administered. Pt's mother requested that the other half to be administered to the right arm.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given day 23 following dose #1
Sex: U
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: shingles after each jab; Initial information  received on 23-Feb-2022 regarding an unsolicited valid Social media non-serious case received from a consumer.  This case involves a patient of unknown demographics who developed shingles each time after administration of vaccine Influenza vaccine.  The patient had no medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (formulation, strength, batch number, expiration date: unknown) via unknown route in unknown administration site for immunization. Information on batch number was requested.  On an unknown date, the reporter reported that his/her friend developed shingles (herpes zoster) (unknown latency) following the administration of Influenza vaccine.  Action Taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (herpes zoster).  At time of reporting, the outcome was Unknown for the event (herpes zoster).
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: gets the flu; Initial information received on 22-Feb-2022 regarding an unsolicited valid non-serious case received from Social Media via consumer/non-health care professional(non-hcp).  This case involves Adult and unknown gender patient who experienced gets the flu while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer at unknown dosage(formulation and strength: unknown) once( lot number and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number is requested.  On an unknown date the patient developed a non-serious gets the flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  It was reported by reporter that one should have gone to a holistic doctor and have never gotten the flu. Further reported as the flu vaccine will eventually make them a sick person. His coworker gets the flu vaccine every year and gets the flu. Also, reported that if he had never got it he would have never got sick.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event Influenza.  At time of reporting, the outcome was Unknown for the event gets the influenza.
Sex: U
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: got it one time and got the flu; Initial information received on 22-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a patient via Digital Media.  This case involves a patient of unknown gender and age who experienced got it one time and got the flu while receiving vaccine influenza USP trival A-B vaccine - unspecified [Fluzone unsp].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza USP trival A-B vaccine - unspecified (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested.  On an unknown date, the patient developed a non-serious event got it one time and got the flu (influenza) (unknown latency) following the administration of influenza USP trival A-B vaccine - unspecified.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for the event influenza.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I had the flu was after my last shot; Initial information was received on 22-Feb-2022 regarding an unsolicited valid Social media non-serious case received from a consumer.  This case involves a patient of unknown demographics who reported that he/she got flu after receiving vaccine Influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (formulation, strength, batch number, expiration date: unknown) via unknown route in an unknown administration site for immunization.  Information on batch number was been requested.  On an unknown date, the patient reported a non-serious that he/she got flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action Taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for the event (influenza).
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: patient was 18 weeks and 6 days pregnant at the time of administration- with no reported adverse event; Initial information received on 21-Feb-2022 regarding an unsolicited valid non-serious case via Other Healthcare professional.  This case involves a 25 years old female patient who was exposed to Diphtheria-2/Tetanus/5 AC Pertusis Vaccine [Adacel] in context of patient was 18 weeks and 6 days pregnant at the time of administration- with no reported adverse event.   The date of last menstrual period was reported as 27-Sep-2021. The estimated due date is 12-Jul-2022.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported patient was exposed to Diphtheria-2/Tetanus/5 AC Pertusis Vaccine at 21 weeks of pregnancy, during second pregnancy trimester.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Feb-2022, the patient received 0.5 ml dose of Diphtheria-2/Tetanus/5 AC Pertusis Vaccine suspension for injection (lot number: U7271AA and expiry date: 12-Jan-2024) once via intramuscular route in an unknown administration site for immunization.  On 14-Feb-2022, patient was 18 weeks and 6 days pregnant at the time of administration- with no reported adverse event (exposure during pregnancy) (latency: same day) following the administration of Diphtheria-2/Tetanus/5 AC Pertusis Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event exposure during pregnancy.  Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Respiratory disorder, Swelling
Clinical narrative: swelling in the respiratory system; Shortness of breath, feeling like she was breathing through a straw; Initial information received on 22-Feb-2022 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who had swelling in the respiratory system and shortness of breath, feeling like she was breathing through a straw after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DOXYCYCLINE (DOXYCYCLINE).  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE with unknown dosing lot number not reported via unknown route in unknown administration site.  On an unknown date the patient had swelling in the respiratory system (respiratory tract inflammation) and shortness of breath, feeling like she was breathing through a straw (dyspnoea) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient was hospitalized for this event.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events  Outcome: Recovered / Resolved on an unknown date for both the events; Sender's Comments: Sanofi company comment dated 24-Feb-2022: This case involves an unknown age female patient who had swelling in the respiratory system and shortness of breath, feeling like she was breathing through a straw after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, latency, medical history, concomitant medications, autopsy findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.
Sex: M
Vaccine: FLU4
Symptoms: Product use issue
Clinical narrative: patient received 3 doses of FLUZONE QUADRIVALENT with no reported adverse event; Initial information from was received on 22-Feb-2022 regarding an unsolicited valid non-serious case received from other health professional via call center.  This case involves a 1years old male patient who received 3 doses of Influenza USP trival A-B high dose subvirion vaccine [Fluzone senior] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and Hepatitis a vaccine (Hepatitis A) for immunization.  It was reported that the patient received first dose of suspect Influenza USP trival A-B high dose subvirion vaccine (batch number: UJ696AA) (formulation, lot number, strength, route of administration, administration site: unknown) on 11-Nov-2021, second dose on 20-Dec-2021 and third dose on 18-Feb-2022 (via intramuscular route in the right thigh) for immunization with no reported adverse event (product use issue).  Action Taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (product use issue).  At time of reporting, the outcome was Unknown for the event (product use issue).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysgeusia, Fatigue, Headache, Injection site erythema
Clinical narrative: Approximately 1 hour after first dose on 1/20/2021, I had metallic taste in my mouth and itchy lips; resolved within 2 hours.  Approximately 5 hours after injection, I had typical "Covid arm" large (3" diameter) red, raised, itchy welt at injection site, which lasted approximately a week then decreased until redness and swelling were gone around the 3 week mark post-injection.  Also developed extreme fatigue, headache, fever of 101, body aches, and chills approximately 5 hours after infection and lasted 2-3 days.  After second dose, approximately 1 hour after injection I developed metallic taste in mouth and tingling lips; resolved within 6 hours, I think.  Approximately 4 hours after injection, I developed a very large (5" diameter) red, raised itchy welt at injection site.  Developed fatigue, lethargy, headache, body aches, general malaise; no fever.  Lethargy, fatigue, headache, body aches, malaise resolved in approximately 48 hours after developing.  Approximately 48 hours after injection, I developed intense itchy over entire body.  Took standard adult-dose of Benadryl, which provided no help.  Scratching would produce hives. Doctor prescribed double the standard dose of OTC Zyrtec, plus a prescription antihistamine, which provided relief.  Both arms now have slightly indented area at injection site.  Before booster dose on 10/26/2021, took double adult-dose of Benadryl and only had the metallic taste and tingling lips, which developed within the first 30 minutes, but did not last past 24 hours.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site indentation, Injection site pruritus, Injection site reaction, Injection site swelling, Lethargy
Clinical narrative: Approximately 1 hour after first dose on 1/20/2021, I had metallic taste in my mouth and itchy lips; resolved within 2 hours.  Approximately 5 hours after injection, I had typical "Covid arm" large (3" diameter) red, raised, itchy welt at injection site, which lasted approximately a week then decreased until redness and swelling were gone around the 3 week mark post-injection.  Also developed extreme fatigue, headache, fever of 101, body aches, and chills approximately 5 hours after infection and lasted 2-3 days.  After second dose, approximately 1 hour after injection I developed metallic taste in mouth and tingling lips; resolved within 6 hours, I think.  Approximately 4 hours after injection, I developed a very large (5" diameter) red, raised itchy welt at injection site.  Developed fatigue, lethargy, headache, body aches, general malaise; no fever.  Lethargy, fatigue, headache, body aches, malaise resolved in approximately 48 hours after developing.  Approximately 48 hours after injection, I developed intense itchy over entire body.  Took standard adult-dose of Benadryl, which provided no help.  Scratching would produce hives. Doctor prescribed double the standard dose of OTC Zyrtec, plus a prescription antihistamine, which provided relief.  Both arms now have slightly indented area at injection site.  Before booster dose on 10/26/2021, took double adult-dose of Benadryl and only had the metallic taste and tingling lips, which developed within the first 30 minutes, but did not last past 24 hours.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Paraesthesia oral, Pruritus, Urticaria
Clinical narrative: Approximately 1 hour after first dose on 1/20/2021, I had metallic taste in my mouth and itchy lips; resolved within 2 hours.  Approximately 5 hours after injection, I had typical "Covid arm" large (3" diameter) red, raised, itchy welt at injection site, which lasted approximately a week then decreased until redness and swelling were gone around the 3 week mark post-injection.  Also developed extreme fatigue, headache, fever of 101, body aches, and chills approximately 5 hours after infection and lasted 2-3 days.  After second dose, approximately 1 hour after injection I developed metallic taste in mouth and tingling lips; resolved within 6 hours, I think.  Approximately 4 hours after injection, I developed a very large (5" diameter) red, raised itchy welt at injection site.  Developed fatigue, lethargy, headache, body aches, general malaise; no fever.  Lethargy, fatigue, headache, body aches, malaise resolved in approximately 48 hours after developing.  Approximately 48 hours after injection, I developed intense itchy over entire body.  Took standard adult-dose of Benadryl, which provided no help.  Scratching would produce hives. Doctor prescribed double the standard dose of OTC Zyrtec, plus a prescription antihistamine, which provided relief.  Both arms now have slightly indented area at injection site.  Before booster dose on 10/26/2021, took double adult-dose of Benadryl and only had the metallic taste and tingling lips, which developed within the first 30 minutes, but did not last past 24 hours.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: Patient reported full body hives started 5 days after her 1st COVID Pfizer vaccine that went away, but when she received her 2nd dose the hives showed back up the same day and did not go away for 9 months when the patient received medical intervention.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Loss of consciousness, Pain in extremity, Pyrexia
Clinical narrative: Vaccine received at 13:30 on February 25.  At 16:45 arm became very sore.  By 21:00 there was a slight fever.  At 06:00 on February 26 I got out of bed to go to the bathroom.  Felt weak and lightheaded.  Tried to return to bed but fainted after a few steps.  Regained consciousness very quickly after hitting the floor.  Weakness and lightheadedness diminished over the next few hours.  Moderate fever also subsided.  Gradually resumed normal activities by midday.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Vaccine received at 13:30 on February 25.  At 16:45 arm became very sore.  By 21:00 there was a slight fever.  At 06:00 on February 26 I got out of bed to go to the bathroom.  Felt weak and lightheaded.  Tried to return to bed but fainted after a few steps.  Regained consciousness very quickly after hitting the floor.  Weakness and lightheadedness diminished over the next few hours.  Moderate fever also subsided.  Gradually resumed normal activities by midday.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine had expired 4 days prior to administration.  Manufacturer contacted and confirmed vaccine still maintained potency to protect properly against Covid-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Confusional state, Fatigue
Clinical narrative: I received the 2nd dose of the COVID-19 vaccine on 9/23/21 at 5:30 pm. I had no side effects for the rest of that day. On 9/24/21 I had a sore arm upon waking. I continued with my normal routine and went to work. The only medication I take is Lexapro 10 mg and a daily multivitamin. I ate meals and snacks this day, drank a normal amount of water and nothing changed in my routine. Around 10:00 AM I started to experience extreme muscle aches, chills, and fatigue. I took 400 mg of Ibuprofen which reduced the severity of these symptoms. Around 3:30 PM I left work and felt the Ibuprofen start to wear off. I was driving on a main road where the speed limit is 55 mph. My body became extremely achy again and I got the chills. As I was driving home from work, my vision started to disappear. A black shadow came from the left into my field of vision and I had just enough time to start pulling over to the side of the road before I passed out. When I came to, my car was on a grassy shoulder of the road, still in park, just inches from a fence. I was able to put my car in park and felt confused. I was sweating and had chills. I got out of my car to inspect for damage and luckily did not hit anything before my car rolled to a stop. I got back into the car and became very tired. I fell asleep for an unknown period of time. When I woke up I still felt clammy and had to sit for a while until I felt oriented. I was scared and confused as to what had happened as I have never experienced a fainting episode in my life. Due to the fear of the unknown, I drove myself the rest of the way home feeling fatigued, achy, and chills. Upon arriving home I took my temperature which was 101. I spent the rest of the night and whole next day in bed or sleeping. I was afraid to drive for days after this in case it should happen again. I was unaware there was a system to report this until now, which is why I am just completing this report today. In hindsight, I should have went to the hospital or doctor and had someone drive me home but I was unable to think logically and was scared.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Hyperhidrosis, Loss of consciousness, Myalgia, Pain
Clinical narrative: I received the 2nd dose of the COVID-19 vaccine on 9/23/21 at 5:30 pm. I had no side effects for the rest of that day. On 9/24/21 I had a sore arm upon waking. I continued with my normal routine and went to work. The only medication I take is Lexapro 10 mg and a daily multivitamin. I ate meals and snacks this day, drank a normal amount of water and nothing changed in my routine. Around 10:00 AM I started to experience extreme muscle aches, chills, and fatigue. I took 400 mg of Ibuprofen which reduced the severity of these symptoms. Around 3:30 PM I left work and felt the Ibuprofen start to wear off. I was driving on a main road where the speed limit is 55 mph. My body became extremely achy again and I got the chills. As I was driving home from work, my vision started to disappear. A black shadow came from the left into my field of vision and I had just enough time to start pulling over to the side of the road before I passed out. When I came to, my car was on a grassy shoulder of the road, still in park, just inches from a fence. I was able to put my car in park and felt confused. I was sweating and had chills. I got out of my car to inspect for damage and luckily did not hit anything before my car rolled to a stop. I got back into the car and became very tired. I fell asleep for an unknown period of time. When I woke up I still felt clammy and had to sit for a while until I felt oriented. I was scared and confused as to what had happened as I have never experienced a fainting episode in my life. Due to the fear of the unknown, I drove myself the rest of the way home feeling fatigued, achy, and chills. Upon arriving home I took my temperature which was 101. I spent the rest of the night and whole next day in bed or sleeping. I was afraid to drive for days after this in case it should happen again. I was unaware there was a system to report this until now, which is why I am just completing this report today. In hindsight, I should have went to the hospital or doctor and had someone drive me home but I was unable to think logically and was scared.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Visual impairment
Clinical narrative: I received the 2nd dose of the COVID-19 vaccine on 9/23/21 at 5:30 pm. I had no side effects for the rest of that day. On 9/24/21 I had a sore arm upon waking. I continued with my normal routine and went to work. The only medication I take is Lexapro 10 mg and a daily multivitamin. I ate meals and snacks this day, drank a normal amount of water and nothing changed in my routine. Around 10:00 AM I started to experience extreme muscle aches, chills, and fatigue. I took 400 mg of Ibuprofen which reduced the severity of these symptoms. Around 3:30 PM I left work and felt the Ibuprofen start to wear off. I was driving on a main road where the speed limit is 55 mph. My body became extremely achy again and I got the chills. As I was driving home from work, my vision started to disappear. A black shadow came from the left into my field of vision and I had just enough time to start pulling over to the side of the road before I passed out. When I came to, my car was on a grassy shoulder of the road, still in park, just inches from a fence. I was able to put my car in park and felt confused. I was sweating and had chills. I got out of my car to inspect for damage and luckily did not hit anything before my car rolled to a stop. I got back into the car and became very tired. I fell asleep for an unknown period of time. When I woke up I still felt clammy and had to sit for a while until I felt oriented. I was scared and confused as to what had happened as I have never experienced a fainting episode in my life. Due to the fear of the unknown, I drove myself the rest of the way home feeling fatigued, achy, and chills. Upon arriving home I took my temperature which was 101. I spent the rest of the night and whole next day in bed or sleeping. I was afraid to drive for days after this in case it should happen again. I was unaware there was a system to report this until now, which is why I am just completing this report today. In hindsight, I should have went to the hospital or doctor and had someone drive me home but I was unable to think logically and was scared.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Cardiac ablation, Cardioversion, Condition aggravated
Clinical narrative: Entered atrial fibrillation during light exercise August 25, 2021.  Self-diagnosed using Kardia DTC EKG monitor.  Began anticoagulant therapy as per doctor's orders: rivaroxaban 20mg daily.  Outpatient DC cardioversion Sept. 1 was successful, and I remained in sinus rhythm.  Then I had a repeat episode of atrial fibrillation beginning the morning of December 4.  Successful cardioversion Dec. 8.  Both cardioversions performed by Dr.    Previous catheter ablation procedure was August 9, 2021 at hospital, requiring an overnight hospital stay.  Procedure successfully resolved premature ventricular contractions arising from two sites.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Exercise tolerance decreased, Ventricular extrasystoles
Clinical narrative: Entered atrial fibrillation during light exercise August 25, 2021.  Self-diagnosed using Kardia DTC EKG monitor.  Began anticoagulant therapy as per doctor's orders: rivaroxaban 20mg daily.  Outpatient DC cardioversion Sept. 1 was successful, and I remained in sinus rhythm.  Then I had a repeat episode of atrial fibrillation beginning the morning of December 4.  Successful cardioversion Dec. 8.  Both cardioversions performed by Dr.    Previous catheter ablation procedure was August 9, 2021 at hospital, requiring an overnight hospital stay.  Procedure successfully resolved premature ventricular contractions arising from two sites.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Antinuclear antibody, C-reactive protein, Clostridium test, Colonoscopy
Clinical narrative: diarrhea, muscle loss, loss 20lbs, stomach pain, nerve pain, electric shocks all over body, eye floaters, pain through out body
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram abdomen, Computerised tomogram pelvis, Culture stool, Diarrhoea
Clinical narrative: diarrhea, muscle loss, loss 20lbs, stomach pain, nerve pain, electric shocks all over body, eye floaters, pain through out body
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Electrophoresis, Full blood count, Metabolic function test, Muscle atrophy
Clinical narrative: diarrhea, muscle loss, loss 20lbs, stomach pain, nerve pain, electric shocks all over body, eye floaters, pain through out body
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Parasite stool test, Stool analysis, Vitreous floaters
Clinical narrative: diarrhea, muscle loss, loss 20lbs, stomach pain, nerve pain, electric shocks all over body, eye floaters, pain through out body
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: diarrhea, muscle loss, loss 20lbs, stomach pain, nerve pain, electric shocks all over body, eye floaters, pain through out body
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Computerised tomogram head, Computerised tomogram neck, Computerised tomogram spine, Disturbance in attention
Clinical narrative: Ringing in ears, dizziness (mild) within one hour of injection. Persistent dizziness over next 10 days worsening to the point of ataxia and gait disturbance.  Presented to ER 2/24/2022 with subsequent Hospital admission, gait disturbance, ataxia, urinary incontinence x 1, difficulty concentrating, mild dysmetria on right side. Symptoms still present but improving as of discharge 2/27/22.   Much improved on 3/1/2022.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysmetria, Electrocardiogram, Gait disturbance, Laboratory test
Clinical narrative: Ringing in ears, dizziness (mild) within one hour of injection. Persistent dizziness over next 10 days worsening to the point of ataxia and gait disturbance.  Presented to ER 2/24/2022 with subsequent Hospital admission, gait disturbance, ataxia, urinary incontinence x 1, difficulty concentrating, mild dysmetria on right side. Symptoms still present but improving as of discharge 2/27/22.   Much improved on 3/1/2022.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging neck, Magnetic resonance imaging spinal, Tinnitus, Urinary incontinence
Clinical narrative: Ringing in ears, dizziness (mild) within one hour of injection. Persistent dizziness over next 10 days worsening to the point of ataxia and gait disturbance.  Presented to ER 2/24/2022 with subsequent Hospital admission, gait disturbance, ataxia, urinary incontinence x 1, difficulty concentrating, mild dysmetria on right side. Symptoms still present but improving as of discharge 2/27/22.   Much improved on 3/1/2022.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Computerised tomogram, Cough, Fatigue, Influenza
Clinical narrative: 1/30/21  Severe chest pain when breathing in. The lobe of my right lunng partially collapsed.  1/31/21 Went to ER.  On 2/22/22 went to ER again due coughing and being tired with 1 day of low grade fever and tested positive for COVID and Influenza A.  I did get the flu shot a work.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Influenza A virus test positive, Painful respiration, Pneumothorax, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 1/30/21  Severe chest pain when breathing in. The lobe of my right lunng partially collapsed.  1/31/21 Went to ER.  On 2/22/22 went to ER again due coughing and being tired with 1 day of low grade fever and tested positive for COVID and Influenza A.  I did get the flu shot a work.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: X-ray
Clinical narrative: 1/30/21  Severe chest pain when breathing in. The lobe of my right lunng partially collapsed.  1/31/21 Went to ER.  On 2/22/22 went to ER again due coughing and being tired with 1 day of low grade fever and tested positive for COVID and Influenza A.  I did get the flu shot a work.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient called today to report hives and itching on arms, chest and back. It started today.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Peripheral swelling
Clinical narrative: Swollen in arm; chills; loss of appetite; temporary temp; fatigue lasted for about 3 weeks.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Lipoma
Clinical narrative: Lipoma on left arm at elbow joint, and a suspected lipoma in right calf. Have experienced erratic heart beats, fatigue, and inflammation in  right leg.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient, 13 years old received on 2/3/22 Pfizer (12 +years)  1st dose , but then on 3/1/22 he came to the pharmacy and by accident the immunizer technician, administered by accident a pediatric Pfizer vaccine. The patient sister (guardian and person who brought the patient to the pharmacy older than 21 yo) got notified by pharmacist about the error. Pharmacist explained after researching the CDC did not recommend to repeat dose in this situation and to wait 5 months for the booster if desired. Patient sister agreed on the recommendation.