chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Pt was vaccinated on 9/7/22 and noticed redness and swelling to injection site on 9/8/22.   Pt seen on 9/9/22 and in no acute distress. Reaction is localized and improving per pt. Mild, localized erythema, edema and tenderness to injection site on right posterior arm.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No Adverse event happened. Patient asked for  the monovalent pfizer booster vaccine since patient did not want to come back next week for the bivalent Pfizer booster vaccine.  Pharmacy administered the monovalent without being aware of the guideline changed recently.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong technique in product usage process
Clinical narrative: The patient received 0.25mL of the Moderna bivalent vaccine instead of 0.5mL on 9/6/2022. The patient came back on 9/7/2022 to receive the second 0.25mL.
Age: 24.0
Sex: M
Vaccine: UNK
Symptoms: Syncope
Clinical narrative: Client experienced syncopal episode before receiving ID jynneos vaccine. Client was provided care and symptoms resolved.  Client did NOT receive the vaccine
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: THE PATIENT RECEIVED 0.25 ML OF THE MODERNA BIVALENT VACCINE INSTEAD OF 0.5 ML ON 9-6-2022.  THE PATIENT CAME BACK ON 9-7-2022 TO RECEIVE THE SECOND 0.25ML.
Age: 100.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated 4 times with the Pfizer product, having received vaccine on 12/30/2020, 01/20/2021, 10/13/2021, and 04/27/2022. They tested positive for COVID-19 on 07/24/2022 and died on 07/25/2022. I have no indication they were hospitalized related to the illness. Death certificate lists COVID-19 pneumonia.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event. Patient asked for 2nd booster Pfizer Monovalent vaccine and did not want to come back for the bivalent due to traveling. Pharmacist gave her the monovalent without realizing the guidelines got changed.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: THE PATIENT RECEIVED 0.25 ML OF THE MODERNA BIVALENT VACCINE INSTEAD OF 0.5 ML ON 9-6-2022.  THE PATIENT CAME BACK ON 9-7-2022 TO RECEIVE THE SECOND 0.25ML.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong technique in product usage process
Clinical narrative: THE PATIENT RECEIVED 0.25 ML OF THE MODERNA BIVALENT VACCINE INSTEAD OF 0.5 ML ON 9-6-2022. THE PATIENT CAME BACK ON 9-7-2022 TO RECEIVE THE SECOND 0.25ML.
Age: 76.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Injection site discolouration, Injection site swelling, Pyrexia
Clinical narrative: Patient called and stated that the 4 hours after receiving the vaccine, she got localized swelling at the site of the injection and mild fever. The swelling area got larger and became little discolored and bluish. She took Acetaminophen 500 mg and went to urgent care next day (Aug 13th). The swelling started to go down on Aug 13th and was resolved the same day. She did not take any medication for swelling.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: THE PATIENT RECEIVED 0.25 ML OF THE MODERNA BIVALENT VACCINE INSTEAD OF 0.5 ML ON 9-6-2022. THE PATIENT CAME BACK ON 9-7-2022 TO RECEIVE THE SECOND 0.25ML.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Received monovalent vs bivalent.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling face
Clinical narrative: Almost 24 hours to the minute  my left cheek started swelling. Overnight my left eye became completely swollen.  It was approximately 20-30 percent open. I needed to go to urgent care and received a cortisone shot in my buttocks to get swelling to go down.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death, Dyspnoea, Hypoxia
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 03/30/2021, 04/21/2021, and 12/11/2021. They were admitted to hospital on 06/24/2022 with  a primary complaint of shortness of breath. COVID-19 test on 06/24/2022 was negative. They were found to be experiencing complications of hypoxia and acute bilateral pulmonary thromboembolic tic disease. They were also diagnosed with mycoplasma pneumonia. A second test on 07/17/2022 was positive.  They were also diagnosed with COVID-19 pneumonia. They remained hospitalized until their death on 07/18/2022.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Pneumonia mycoplasmal, Pulmonary embolism, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Pfizer product on 03/30/2021, 04/21/2021, and 12/11/2021. They were admitted to hospital on 06/24/2022 with  a primary complaint of shortness of breath. COVID-19 test on 06/24/2022 was negative. They were found to be experiencing complications of hypoxia and acute bilateral pulmonary thromboembolic tic disease. They were also diagnosed with mycoplasma pneumonia. A second test on 07/17/2022 was positive.  They were also diagnosed with COVID-19 pneumonia. They remained hospitalized until their death on 07/18/2022.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: CAME FRO BIVALENT AND WAS GIVEN MONOVALENT
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: THE PATIENT RECEIVED 0.25 ML OF THE MODERNA BIVALENT VACCINE INSTEAD OF 0.5 ML ON 9-6-2022.  THE PATIENT CAME BACK ON 9-7-2022 TO RECEIVE THE SECOND 0.25ML.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: On 05/12/2022 Test positive at 11:00PM . My throat was sore; Coughing; Excessive drainage back of my throat. On 05/14/2022  I did a tele health  with my doctor. He prescribed me Paxlovid for 5 days.  Within 48hours of the medication I felt great. It worked very well.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered expired 8/31/22.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: THE PATIENT RECEIVED 0.25 ML OF THE MODERNA BIVALENT VACCINE INSTEAD OF 0.5 ML ON 9-6-2022.  THE PATIENT CAME BACK ON 9-7-2022 TO RECEIVE THE SECOND 0.25ML.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Wrong Vaccine Administered, was supposed to receive bivalent booster and received monovalent vaccine. No side effects noted.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered expired 8/31/22.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: The patient received 0.25mL of the Moderna bivalent vaccine instead of 0.5mL on 9/6/2022. The patient came back on 9/7/2022 to receive the second 0.25mL.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered expired 8/31/22.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered expired 8/31/22.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: THE PATIENT RECEIVED 0.25 ML OF THE MODERNA BIVALENT VACCINE INSTEAD OF 0.5 ML ON 9-6-2022.  THE PATIENT CAME BACK ON 9-7-2022 TO RECEIVE THE SECOND 0.25ML.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered expired on 8/31/2022.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered expired 8/31/2022.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: THE PATIENT RECEIVED 0.25 ML OF THE MODERNA BIVALENT VACCINE INSTEAD OF 0.5 ML ON 9-6-2022. THE PATIENT CAME BACK ON 9-7-2022 TO RECEIVE THE SECOND 0.25ML.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered expired on 8/31/2022.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient came into Vaccine Clinic today for Pfizer 5Y-11Y Covid Vaccine. Patient previously received 2 doses of 6mo-4Y Pfizer which is a three dose series and is switching to the 5Y-11Y for the third dose. Time frame between second and third dose should be 2 months or more. Patient received their 2nd dose on 7/20/2022 and shouldn't be due for third dose until Sept 18th. Vaccine was administered to the patient today, 9 days too early. Information was sent to patient's primary care provider to advise parents if necessary.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered expired on 8/31/2022.
Age: 64.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Blood glucose increased, Chills, Diarrhoea, Influenza virus test negative, Pyrexia
Clinical narrative: Pt called, stating that he had a fever of 101.3 with vomiting and diarrhea. Normal boold sugar spiked to 379, and he had chills.  Once fever reached 103.5, pt went to the ER.  He was discharged after several hours with no admitance.  Pt "feels fine" 09/09/2022
Age: 64.0
Sex: M
Vaccine: SMALLMNK
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: Pt called, stating that he had a fever of 101.3 with vomiting and diarrhea. Normal boold sugar spiked to 379, and he had chills.  Once fever reached 103.5, pt went to the ER.  He was discharged after several hours with no admitance.  Pt "feels fine" 09/09/2022
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered expired on 8/31/2022.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered expired on 8/31/2022.
Age: 12.0
Sex: F
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given outside of the recommended age range, CDC contacted regarding this. They stated there are no concerns.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Muscle spasms, Pyrexia, Tremor
Clinical narrative: At the hour of sleep, the patient reported vigorous shaking, a fever of 100.5, noted feeling as if he had muscle spasms, and had the sensation that he may collapse similar to prior episodes with Guillain Barre syndrome. 24 hours after the vaccine, the patient noted feeling back to normal.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event. Moderna Booster for 18 years of age or older given. Moderna bivalent booster should have been given.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Vertigo
Clinical narrative: Vertigo whenever I stood up/walked somewhere. It was less noticeable the next day.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Patient's mother called in stating patient was complaining of a burning throat (as if she had swallowed hot sauce). I advised mother to go to ER if any swelling of tongue, lips, or throat occurs or if any difficulty breathing were to occur. Also, told mother to check patient's throat for signs of infection such as strep and to consult a qcare clinic or her physician if any signs of infection. Also informed patient's mother to consult the pediatrician if burning did not go away by morning and patient should increase fluid intake to help with burning sensation. Adverse event probably not associated to vaccine, but needs reported. Have not heard from patient's mother since last night for follow-up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt. complains of a warm rash over the injection site and extending down about four inches in an irregular circle. it itches and she rubs it. it was better on day six but still present on day seven.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anxiety, Headache, Incorrect product formulation administered, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT WAS SUPPOSSED TO GET HER 2ND PRIMARY DOSE BUT RECEIVED THE MODERNA BIVALENT BOOSTER  BY MISTAKE . PATIENT FELT ANXIOUS , HEADACHE ( OVERNIGHT ) AND SWELLING/ PAIN IN THE ARM . PATIENT RECOVERED THE DAY AFTER VACCINE WAS GIVEN .
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 55.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Moderna bivalent vaccine was given too early due to cdc guidelines. Her most recent Moderna booster given 7/31/22, and bivalent booster given 9/8/2022, a few weeks before the two month interval. Patient was not experiencing any adverse effects or side effects after administration.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain
Clinical narrative: Patient said he received the first 2 doses of COVID-19 vaccine and a booster dose after that.  He does not remember the exact date of the all the injections. He said recently, he was infected with COVID-19 in August 2022. He said after 1 week of feeling fatigue and sore throat, he was back to normal.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: THE PATIENT RECEIVED 0.25 ML OF THE MODERNA BIVALENT VACCINE INSTEAD OF 0.5 ML ON 9-6-2022.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: THE PATIENT RECEIVED 0.25 ML OF THE MODERNA BIVALENT VACCINE INSTEAD OF 0.5 ML ON 9-6-2022.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was administered outside of BUD on labeled product- dose was determined to be valid by Moderna
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: pt given monovalent covid vaccine instead of bivalent booster.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Dyspnoea, Hyperhidrosis, Pharyngeal swelling, Swelling face
Clinical narrative: Patient's mother came in later in the day to pick up epi-pen and steroid.  I inquired about what happened.  She states that about an hour after her son received the vaccine, he was at school and started to experience an anaphylactic reaction. He developed welps, profuse sweating, swelling of the throat and face, trouble breathing.  The ambulance was called and arrived. Epinephrine was administered and he was rushed to ER where his symptoms began to subside.  He was prescribed an epi-pen and medrol dose pack.  He was referred to an allergist.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Patient's mother came in later in the day to pick up epi-pen and steroid.  I inquired about what happened.  She states that about an hour after her son received the vaccine, he was at school and started to experience an anaphylactic reaction. He developed welps, profuse sweating, swelling of the throat and face, trouble breathing.  The ambulance was called and arrived. Epinephrine was administered and he was rushed to ER where his symptoms began to subside.  He was prescribed an epi-pen and medrol dose pack.  He was referred to an allergist.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: inserted vaccine with a vanish point syringe.  pushed the plunger to inject vaccine vanish point make a load popping sound all vaccine came out the backend at the plunger on  to vaccinators hand patent  was revaccinated without failure of syringe system
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Piloerection
Clinical narrative: DEVELOPED GOOSEBUMP LOOKING BUMPS ON ARMS, STOMACH, LEGS. PT IS DARK SKINNED, SO DOES NOT LOOK RED. NOT WARM TO TOUCH, BUT RATHER SKIN FEELS COOL. PT DID HAVE A SMALL FEVER 99.3. ATYPICAL DERM RXN (NOT HIVES?) RPH COUNSELED FOR PT TO TAKE ANTIHISTAMINE (BENADRYL MOST QUICK ACTING) AND MONITOR. CHANGES IN PAIN, LOCATION OR SIZE, OTHER S/SX. FOLLOW UP WITH RPH OR PRESCRIBER. ALSO OK TO TAKE TYLENOL FOR FEVER IF DISCOMFORT.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Rash, Rash pruritic
Clinical narrative: scattered rash on body , stomach that  itch and swollen eye . she was  given  steriod by her  primary care  physician
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I recieved the covid booster along with the flu shot on september the 7th around 345 and was fine the next day i started on a fluconazole 150mg treatment and soon after i got a rash which lasted a little over 24 hours and I have used fluconazole several time in last few years without issue including around 3 months prior to the booster
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was administered from vial outside of BUD labeled on product- dose was determined to be valid by Moderna.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose administered from vial outside of BUD labeled on product. Dose determined to be valid by Moderna.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was administered from vial outside of BUD labeled on product- dose was determined to be valid by Moderna.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was administered from vial outside of BUD labeled on product
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was administered from vial outside of BUD labeled on product
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: AFTER RECEIVING THE VACCINE AUGUST 27,2022 DONOR HAD NO SYMPTOMS. AUGUST 28, 2022 DONOR FELT SLIGHT SORENESS IN R-DELTOID. ON AUGUST 29,2022 DONOR WOKE UP AROUND 6AM TO GET READY FOR WORK AND NOTICED HIS ARM FELT LOCKED & WAS STIFF, HARD TO MOVE AND SORE. DONOR FELT A KNOT ON HIS ARM AND SAW REDNESS AROUND THE INJECTION SIGHT. BY THE END OF THE DAY DONOR STATED HE FELT LIKE HE HAD A FEVER, HE WAS WARM, WEAK, AND TIRED. AUGUST 30, 2022 THE REDNESS SPREAD TO R-PECTORIAL & UNDER R-ARMPIT. THE REDNESS DIDNT RECEDE TO THE R-DELTOID UNTIL SEPTEMBER 1, 2022. ON SEPTEMBER 2, 2022 THE KNOT GOT A  LITTLE SMALLER. ON SEPTEMBER 4,2022 THE INJECTION SIGHT HAD NO REDNESS OR KNOT PRESENT BUT DID FEEL ITCHY.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pruritus, Mobility decreased, Musculoskeletal stiffness, Pyrexia
Clinical narrative: AFTER RECEIVING THE VACCINE AUGUST 27,2022 DONOR HAD NO SYMPTOMS. AUGUST 28, 2022 DONOR FELT SLIGHT SORENESS IN R-DELTOID. ON AUGUST 29,2022 DONOR WOKE UP AROUND 6AM TO GET READY FOR WORK AND NOTICED HIS ARM FELT LOCKED & WAS STIFF, HARD TO MOVE AND SORE. DONOR FELT A KNOT ON HIS ARM AND SAW REDNESS AROUND THE INJECTION SIGHT. BY THE END OF THE DAY DONOR STATED HE FELT LIKE HE HAD A FEVER, HE WAS WARM, WEAK, AND TIRED. AUGUST 30, 2022 THE REDNESS SPREAD TO R-PECTORIAL & UNDER R-ARMPIT. THE REDNESS DIDNT RECEDE TO THE R-DELTOID UNTIL SEPTEMBER 1, 2022. ON SEPTEMBER 2, 2022 THE KNOT GOT A  LITTLE SMALLER. ON SEPTEMBER 4,2022 THE INJECTION SIGHT HAD NO REDNESS OR KNOT PRESENT BUT DID FEEL ITCHY.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelids pruritus, Injection site erythema, Injection site swelling, Swelling of eyelid
Clinical narrative: Eyelids became swollen and itchy for 48 hours. Improved with Claritin. Site of injection was swollen and red for 72 hours.
Age: 42.0
Sex: M
Vaccine: DTAP
Symptoms: Aggression, Anger, Anxiety, Blood test abnormal, Eosinophil count increased
Clinical narrative: TDaP(ADACEL, Boostrix), 7SY34, IM/LD, shoulder of 0.5 ml was given to me on 06/11/2021 ordered by Doctor wrongfully. A few days  after  the injection was feeling unusual, angry, irritable, argumentative, very talkative, anxious, panicking , feeling extremely cold as if I had thyroid disorders, issues with my male organs as if I had endocrine system issues,  Tinnitus, after all had been treated by urologist, Endocrinologist, Gastroenterologist, Podiatrist ect
Age: 42.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling abnormal, Feeling cold, Irritability, Logorrhoea, Male reproductive tract disorder
Clinical narrative: TDaP(ADACEL, Boostrix), 7SY34, IM/LD, shoulder of 0.5 ml was given to me on 06/11/2021 ordered by Doctor wrongfully. A few days  after  the injection was feeling unusual, angry, irritable, argumentative, very talkative, anxious, panicking , feeling extremely cold as if I had thyroid disorders, issues with my male organs as if I had endocrine system issues,  Tinnitus, after all had been treated by urologist, Endocrinologist, Gastroenterologist, Podiatrist ect
Age: 42.0
Sex: M
Vaccine: DTAP
Symptoms: Panic reaction, Tinnitus, Wrong product administered
Clinical narrative: TDaP(ADACEL, Boostrix), 7SY34, IM/LD, shoulder of 0.5 ml was given to me on 06/11/2021 ordered by Doctor wrongfully. A few days  after  the injection was feeling unusual, angry, irritable, argumentative, very talkative, anxious, panicking , feeling extremely cold as if I had thyroid disorders, issues with my male organs as if I had endocrine system issues,  Tinnitus, after all had been treated by urologist, Endocrinologist, Gastroenterologist, Podiatrist ect
Age: 36.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: INJECTED PATIENT WITH PFIZER BIVALENT BOOSTER DOSE INSTEAD FOR FIRST FULL DOSE OF PFIZER COVID VACCINE.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Product administered to patient of inappropriate age, Vision blurred, Vomiting
Clinical narrative: Patient experienced dizziness,  blurred vision, felt faint, and threw up after receiving the vaccine. We gave her some chocolates and water and after a couple of minutes she was feeling better.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hypertension, Injection site discomfort
Clinical narrative: I received my first dose on 8/15/22 which was uneventful.  My 2nd dose was on 9/7/15 @1300.  That night I experienced severe joint pain and muscle spasms in my upper body.  On 9/8 by noon I was experiencing a dull headache and moderate injection site discomfort.  The headache continued to worsen until it was unbearable.  I also experienced chills, a fever of 101.2, severe hypertension, nausea and severe malaise.  I treated the symptoms with OTC medication the best I could.  Today the dull headache remains, my blood pressure and fever have returned to normal.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Muscle spasms, Nausea
Clinical narrative: I received my first dose on 8/15/22 which was uneventful.  My 2nd dose was on 9/7/15 @1300.  That night I experienced severe joint pain and muscle spasms in my upper body.  On 9/8 by noon I was experiencing a dull headache and moderate injection site discomfort.  The headache continued to worsen until it was unbearable.  I also experienced chills, a fever of 101.2, severe hypertension, nausea and severe malaise.  I treated the symptoms with OTC medication the best I could.  Today the dull headache remains, my blood pressure and fever have returned to normal.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was give the 3rd dose too early (4 weeks from the 2nd dose instead of 8 weeks). Pfizer was contacted and recommended patient to get a 4th dose 8 weeks after the 3rd dose.  Patient contacted and appointment was scheduled.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Developed Excema on both arms 3 weeks after Moderna booster.   Reoccurred 2 weeks after second Moderna booster in July 2022
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event. Moderna Booster for 18 years of age or older given. Moderna bivalent booster should have been given.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event. Moderna Booster for 18 years of age or older given. Moderna bivalent booster should have been given.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event. Moderna booster for 18 years of age or older given. Moderna bivalent booster should have been given.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event.  Moderna Booster for 18 years of age or older given.  Moderna bivalent booster should have been given.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site redness, heat and soreness unlike the three previous doses. Began the morning following the vaccination and is still present approximately 18 hours since first noticed / 32 hours past vaccination.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in the mouth
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion
Clinical narrative: Had a very large bruise on her arm, from her deltoid almost down to her elbow; This spontaneous case was retrieved on 04-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0882543-1), reported by other healthcare professional and concerned a 69-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 24-Aug-2020, the patient was vaccinated with Fluad (TIV) (influenza vaccine inact sag 3v; route of administration: intramuscular (IM), dose: reported as 'one', anatomical location: left arm (LA), indication. not reported). The batch number reported was 279735.  On an unspecified date in 2020, unknown amount of time after receiving Fluad (TIV), the patient had a very large bruise on her arm, from her deltoid almost down to her elbow.  On 07-Sep-2020, 14 days after injection the patient presented to pharmacy with the bruising.   On unspecified date in Sep-2020, the patient recovered from event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 69-year-old, female patient was vaccinated with the suspect product Fluad (TIV). An unknown amount of time following vaccination (within 14 days) the patient developed a very large bruise on her arm, from her deltoid almost down to her elbow. Information regarding the underlying medical history and related diagnostic findings has not been provided. Due to limited information provided, causality is unassessable.; Sender's Comments: A 69-year-old, female patient was vaccinated with the suspect product Fluad (TIV). An unknown amount of time following vaccination (within 14 days) the patient developed a very large bruise on her arm, from her deltoid almost down to her elbow. Information regarding the underlying medical history and related diagnostic findings has not been provided. Due to limited information provided, causality is unassessable.
Age: 66.0
Sex: F
Vaccine: FLUC3
Symptoms: Contusion, Electric shock sensation, Immediate post-injection reaction, Moaning, Pain
Clinical narrative: Moaned in pain during the injection; Bruised arm (upper deltoid area); Moaned in pain during the injection; Felt like electricity traveling down her arm; This spontaneous case was retrieved on 04-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number 0884054-1), reported by other healthcare professional, and concerned a 66-year-old, female patient.  The patient's concurrent conditions included atrial fibrillation and hypothyroidism. The patient's concomitant medications included propafenone, levothyroxine, unspecified vitamin d, Centrum multivitamin, fish oil, Coq10 (ubidecarenone), magnesium citrate and B12 (cyanocobalamin), all used for unreported indications.  On 10-Sep-2020 the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as '1', route of administration: intramuscular (IM), anatomical location: left arm (LA), and indication: not reported). The batch number reported was 276533.  On the same date, during vaccination with Flucelvax Quadrivalent , the patient moaned in pain and it immediately felt like electricity traveling down her arm. She also developed a bruised arm (upper deltoid area).   On 11-Sep-2020, reported as the following day, it ached even more.  On an unspecified date in Sep-2020, the patient recovered from the events, as it was reported the pain consistently improved over the past few days.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 66-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. During the vaccine administration the patient was moaning and experienced paraesthesia of arm. The patient also developed bruising and pain. Based on plausible time relationship, causality is assessed as possibly related.; Sender's Comments: A 66-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. During the vaccine administration the patient was moaning and experienced paraesthesia of arm. The patient also developed bruising and pain. Based on plausible time relationship, causality is assessed as possibly related.
Age: 66.0
Sex: F
Vaccine: FLUC3
Symptoms: Paraesthesia
Clinical narrative: Moaned in pain during the injection; Bruised arm (upper deltoid area); Moaned in pain during the injection; Felt like electricity traveling down her arm; This spontaneous case was retrieved on 04-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number 0884054-1), reported by other healthcare professional, and concerned a 66-year-old, female patient.  The patient's concurrent conditions included atrial fibrillation and hypothyroidism. The patient's concomitant medications included propafenone, levothyroxine, unspecified vitamin d, Centrum multivitamin, fish oil, Coq10 (ubidecarenone), magnesium citrate and B12 (cyanocobalamin), all used for unreported indications.  On 10-Sep-2020 the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as '1', route of administration: intramuscular (IM), anatomical location: left arm (LA), and indication: not reported). The batch number reported was 276533.  On the same date, during vaccination with Flucelvax Quadrivalent , the patient moaned in pain and it immediately felt like electricity traveling down her arm. She also developed a bruised arm (upper deltoid area).   On 11-Sep-2020, reported as the following day, it ached even more.  On an unspecified date in Sep-2020, the patient recovered from the events, as it was reported the pain consistently improved over the past few days.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 66-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. During the vaccine administration the patient was moaning and experienced paraesthesia of arm. The patient also developed bruising and pain. Based on plausible time relationship, causality is assessed as possibly related.; Sender's Comments: A 66-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. During the vaccine administration the patient was moaning and experienced paraesthesia of arm. The patient also developed bruising and pain. Based on plausible time relationship, causality is assessed as possibly related.
Age: 80.0
Sex: F
Vaccine: FLUC3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Very, very sore arm from elbow on up to the shoulder; Loss of use of the arm for two days; This spontaneous case was retrieved on 04-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0885257-1), reported by other healthcare professional and concerned an 80-year-old, female patient.  The patient's concurrent condition included allergy to opioids. The patient's concomitant medication were not reported.  On 09-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM), anatomical location: left arm (LA), dose: reported as '1', indication: not reported). The batch number reported was 276531.  On the same date, after receiving Flucelvax Quadrivalent, the patient developed very, very sore arm from elbow on up to the shoulder and had loss of use of the arm for two days.   On an unspecified date in Sep-2020, the patient recovered from both events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: An 80-year-old, female patient was vaccinated with Flucelvax Quadrivalent. On the same day following vaccination, the patient developed sore arm from elbow up to the shoulder and had loss of use of the arm for two days. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.; Sender's Comments: An 80-year-old, female patient was vaccinated with Flucelvax Quadrivalent. On the same day following vaccination, the patient developed sore arm from elbow up to the shoulder and had loss of use of the arm for two days. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.
Age: 70.0
Sex: F
Vaccine: FLUC3
Symptoms: Dry eye, Eye pruritus, Injection site erythema, Sneezing, Vaccination site erythema
Clinical narrative: Experienced dry, itchy eyes; Excessive sneezing; Warm at site of vaccine; Experienced dry, itchy eyes; 3 inch diameter of hardness and redness around site of vaccination; 3 inch diameter of hardness and redness around site of vaccination; This spontaneous case was retrieved on 04-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0886568-1), reported by other healthcare professional and concerned a 70-year-old, female patient.  The patient's concurrent condition included allergy to non-steroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid (ASA). The patient's concomitant medications were not reported.  On 26-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as '1', route of administration: intramuscular (IM), anatomical location: left arm (LA), indication: not reported). The batch number reported was 276533.  On 27-Sep-2020, one day after receiving Flucelvax Quadrivalent vaccine, the patient experienced excessive sneezing, warmth at site of vaccine, three inch diameter of hardness and redness around site of vaccination and dry, itchy eyes. The patient did not experience fever, runny nose, or cough.  At the time of initial reporting, the patient was recovering from 'vaccination site erythema'. It was reported that three days later redness was subsiding.  The outcome of other events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 70-year-old, female patient was vaccinated with Flucelvax Quadrivalent. One day following vaccination, the patient experienced sneezing, vaccination site warmth, vaccination site induration, vaccination site erythema, dry eyes and itchy eyes. The patient's concurrent condition included allergy to non-steroidal anti-inflammatory drugs and acetylsalicylic acid, as reported. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.; Sender's Comments: A 70-year-old, female patient was vaccinated with Flucelvax Quadrivalent. One day following vaccination, the patient experienced sneezing, vaccination site warmth, vaccination site induration, vaccination site erythema, dry eyes and itchy eyes. The patient's concurrent condition included allergy to non-steroidal anti-inflammatory drugs and acetylsalicylic acid, as reported. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.
Age: 70.0
Sex: F
Vaccine: FLUC3
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: Experienced dry, itchy eyes; Excessive sneezing; Warm at site of vaccine; Experienced dry, itchy eyes; 3 inch diameter of hardness and redness around site of vaccination; 3 inch diameter of hardness and redness around site of vaccination; This spontaneous case was retrieved on 04-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0886568-1), reported by other healthcare professional and concerned a 70-year-old, female patient.  The patient's concurrent condition included allergy to non-steroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid (ASA). The patient's concomitant medications were not reported.  On 26-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as '1', route of administration: intramuscular (IM), anatomical location: left arm (LA), indication: not reported). The batch number reported was 276533.  On 27-Sep-2020, one day after receiving Flucelvax Quadrivalent vaccine, the patient experienced excessive sneezing, warmth at site of vaccine, three inch diameter of hardness and redness around site of vaccination and dry, itchy eyes. The patient did not experience fever, runny nose, or cough.  At the time of initial reporting, the patient was recovering from 'vaccination site erythema'. It was reported that three days later redness was subsiding.  The outcome of other events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 70-year-old, female patient was vaccinated with Flucelvax Quadrivalent. One day following vaccination, the patient experienced sneezing, vaccination site warmth, vaccination site induration, vaccination site erythema, dry eyes and itchy eyes. The patient's concurrent condition included allergy to non-steroidal anti-inflammatory drugs and acetylsalicylic acid, as reported. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.; Sender's Comments: A 70-year-old, female patient was vaccinated with Flucelvax Quadrivalent. One day following vaccination, the patient experienced sneezing, vaccination site warmth, vaccination site induration, vaccination site erythema, dry eyes and itchy eyes. The patient's concurrent condition included allergy to non-steroidal anti-inflammatory drugs and acetylsalicylic acid, as reported. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: ASYMPTOMATIC COVID-19; This spontaneous report received from a consumer via a company representative concerned an adult male. This report did not meet case criteria as there was no reporter reported. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the patient experienced asymptomatic covid-19. Laboratory data included: SARS-CoV-2 test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20210530878, 20210534000, 20210534001, 20210533998, 20210532180, 20210524955 and 20210550155. This report was associated with product quality complaint.  Version created to amend previously reported information on 17-MAY-2021. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to non-valid from the previously incorrect assessment of valid).