chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Influenza virus test negative, Irritability, Lumbar puncture normal, Magnetic resonance imaging head abnormal, Mastoiditis
Clinical narrative: Infant with onset of high fever (103-104) within 8 hours of her second round of vaccinations.  No other symptoms.  By the next morning not only had high fever but was extremely irritable especially if she was moved or lay down.  Had persistent high fever of 102-104 all weekend and presented to my office on 6/13/2022 for evaluation of irritability and high fever.  Still did not have any other symptoms other than irritability.  Exam did not reveal source of infection.  Had a negative COVID and influenza test in the office and then sent to the hospital for further work-up with concern of possible meningitis. Initial evaluation at the local hospital was negative until she had a MRI of her brain due to persistent irritability that showed evidence of a periauricular abscess/mastoiditis.  Due to her young age she was sent to Hospital for ear nose and throat evaluation who elected to drain this abscess and to place bilateral ear tubes due to the presence of bilateral otitis media with mastoiditis.  She was managed with a PICC line and infusions of Rocephin and oral dosing of metronidazole.  She has improved and is in good clinical condition upon follow-up today 6/24/2020
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Metabolic function test normal, Otitis media, Platelet count increased, Procalcitonin, Pyrexia
Clinical narrative: Infant with onset of high fever (103-104) within 8 hours of her second round of vaccinations.  No other symptoms.  By the next morning not only had high fever but was extremely irritable especially if she was moved or lay down.  Had persistent high fever of 102-104 all weekend and presented to my office on 6/13/2022 for evaluation of irritability and high fever.  Still did not have any other symptoms other than irritability.  Exam did not reveal source of infection.  Had a negative COVID and influenza test in the office and then sent to the hospital for further work-up with concern of possible meningitis. Initial evaluation at the local hospital was negative until she had a MRI of her brain due to persistent irritability that showed evidence of a periauricular abscess/mastoiditis.  Due to her young age she was sent to Hospital for ear nose and throat evaluation who elected to drain this abscess and to place bilateral ear tubes due to the presence of bilateral otitis media with mastoiditis.  She was managed with a PICC line and infusions of Rocephin and oral dosing of metronidazole.  She has improved and is in good clinical condition upon follow-up today 6/24/2020
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Red blood cell sedimentation rate increased, Respiratory viral panel, SARS-CoV-2 test negative, White blood cell count increased
Clinical narrative: Infant with onset of high fever (103-104) within 8 hours of her second round of vaccinations.  No other symptoms.  By the next morning not only had high fever but was extremely irritable especially if she was moved or lay down.  Had persistent high fever of 102-104 all weekend and presented to my office on 6/13/2022 for evaluation of irritability and high fever.  Still did not have any other symptoms other than irritability.  Exam did not reveal source of infection.  Had a negative COVID and influenza test in the office and then sent to the hospital for further work-up with concern of possible meningitis. Initial evaluation at the local hospital was negative until she had a MRI of her brain due to persistent irritability that showed evidence of a periauricular abscess/mastoiditis.  Due to her young age she was sent to Hospital for ear nose and throat evaluation who elected to drain this abscess and to place bilateral ear tubes due to the presence of bilateral otitis media with mastoiditis.  She was managed with a PICC line and infusions of Rocephin and oral dosing of metronidazole.  She has improved and is in good clinical condition upon follow-up today 6/24/2020
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was given. Vaccine had been expired for four days.  Moderna has been notified and we are waiting for a response from them as to what the next steps are. Update: Moderna informed Facility today; "The vaccine administered on May 24, 2022 from lot number 033K21-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Influenza virus test negative, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: Tired/extreme fatigue for 5 days after vaccine. Taken to Urgent care on 6/23/22 for sore throat, stomach pain and sleepyness.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Streptococcus test negative
Clinical narrative: Tired/extreme fatigue for 5 days after vaccine. Taken to Urgent care on 6/23/22 for sore throat, stomach pain and sleepyness.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Profuse sweating, loss of consciousness, syncope
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Crying, Pyrexia
Clinical narrative: Crying, Fever
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated, Gastrooesophageal reflux disease, Weight increased
Clinical narrative: Pt is a vague historian but insists that she has had worsening of her baseline asthma since May 2021 with her first Moderna vaccination.  Sought no medical care for this until today (6/24/2022).  Has baseline allergies and asthma may also be worse from weight gain, gerd worsening.  Not sure if related but I reported given patient insisting that it's the vaccine.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Patient called health clinic on 6/24/2022 to report that the evening before she went into A-fib and had to be seen by urgent care. She also was seen on 6/24/2022 by her PCP and talked with her cardiologist on 6/24/2022. She reports she had a prior history of A-fib but has been without an issue for 4 years until last evening. She is still currently in A-fib.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Moderna 0.5 cc 02/03/21 Moderna 0.5 cc 03/03/21 Moderna 0.5 cc 10/01/21 Moderna 0.5 cc 10/29/21  Essentially, this gentleman received 2 separate primary Moderna series. The gentleman was not aware this should not have occurred, he was offered the vaccine by a pharmacy (the 2nd round) and accepted; it appears the pharmacy did not confirm prior vaccination dates. Pharmacy erroneously vaccinated him with an additional primary series of vaccine.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pruritus, Rash, Viral infection
Clinical narrative: Shingles (scalp); was prescribed Valtrex but the symptoms of the shingles had started some time previous to this so didn't help too much. I also took Gabapentin and Betamethasone. I had the Shingrix vaccine on 2019/2020. The shingles is still somewhat present in my scalp with itching some 7 months later.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given a dose of COVID-19 Pfizer Gray Cap Vaccine after the 12 hour use by time. The vaccine had been left out from the day prior, the staff member thought it was a new vial and used it to give a dose of the vaccine to a patient.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: The adverse event undiluted Pfizer vaccine administered to client, at this time no reports of needed treats.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site lymphadenopathy, Injection site pain
Clinical narrative: The adverse event undiluted Pfizer vaccine administered to client, at this time no reports of needed treats.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: The adverse event undiluted Pfizer vaccine administered to client, at this time no reports of needed treats.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Confusional state, Erythema, Mental status changes, Swelling face
Clinical narrative: Patient received shot on Friday and reported that her face started swelling up and became red on Sunday. She went to the emergency room and was admitted. In the hospital she had to be treated for previously undiagnosed a-fib and she stated she had altered mental status while in the hospital with confusion.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Blood test, Computerised tomogram, Confusional state, Disorientation
Clinical narrative: Patient received shot on Friday and reported that her face started swelling up and became red on Sunday. She went to the emergency room and was admitted. In the hospital she had to be treated for previously undiagnosed a-fib and she stated she had altered mental status while in the hospital with confusion.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Hypoaesthesia, Swelling face, Urine analysis
Clinical narrative: Patient received shot on Friday and reported that her face started swelling up and became red on Sunday. She went to the emergency room and was admitted. In the hospital she had to be treated for previously undiagnosed a-fib and she stated she had altered mental status while in the hospital with confusion.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Patient received shot on Friday and reported that her face started swelling up and became red on Sunday. She went to the emergency room and was admitted. In the hospital she had to be treated for previously undiagnosed a-fib and she stated she had altered mental status while in the hospital with confusion.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Tremor
Clinical narrative: Generalized body shaking for 10-15 seconds, tactile fevers
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Blood test abnormal, Cardiac stress test, Electrocardiogram, Hypertension
Clinical narrative: High blood pressure and heart palpitations.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: High blood pressure and heart palpitations.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral herpes
Clinical narrative: Before being vaccinated I had HSV-1 outbreaks (cold sores) maybe once every six months. Since being vaccinated I?ve had non-stop outbreaks. The outbreaks have spread to my chin and finger which has never happened before.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient is not 50 years old and got booster #2 dose.  Patient has no issue or adverse reaction at all after being vaccinated with booster #2
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Chest X-ray, Cough, Dyspnoea
Clinical narrative: Shortness of breath-clogged head and upper chest-O2 level went to 82 with severe cough and fever. Had to go to ER and spent night at hospital and got sent home with Oxygen that a company delivered and 9 day anti viral medication.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Sinus congestion
Clinical narrative: Shortness of breath-clogged head and upper chest-O2 level went to 82 with severe cough and fever. Had to go to ER and spent night at hospital and got sent home with Oxygen that a company delivered and 9 day anti viral medication.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Ultrasound Doppler
Clinical narrative: TINGLING IN MY ARM, LEG PAIN,
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine abnormal, Blood urine present, Chromaturia, Creatinine renal clearance decreased, Glomerular filtration rate normal
Clinical narrative: After the Pfizer covid 19 vaccine I developed acute kidney inflammation and was hospitalized twice, May 5, and May 8, 2021 for kidney glomerulonephritis, urine was brown, white powder was discharged to the toilet when urinating, severe pain and kidney inflammation lasted for over 7 days from May 1 to May 10. Blood in urine was detected and additional tests indicate abnormal creatine, poor eGFR and near complete kidney failure.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Glomerulonephritis, Pain, Protein total increased, Protein urine present, Renal failure
Clinical narrative: After the Pfizer covid 19 vaccine I developed acute kidney inflammation and was hospitalized twice, May 5, and May 8, 2021 for kidney glomerulonephritis, urine was brown, white powder was discharged to the toilet when urinating, severe pain and kidney inflammation lasted for over 7 days from May 1 to May 10. Blood in urine was detected and additional tests indicate abnormal creatine, poor eGFR and near complete kidney failure.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Urethral discharge, Urinary tract inflammation, Urine analysis
Clinical narrative: After the Pfizer covid 19 vaccine I developed acute kidney inflammation and was hospitalized twice, May 5, and May 8, 2021 for kidney glomerulonephritis, urine was brown, white powder was discharged to the toilet when urinating, severe pain and kidney inflammation lasted for over 7 days from May 1 to May 10. Blood in urine was detected and additional tests indicate abnormal creatine, poor eGFR and near complete kidney failure.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Acute kidney injury, Anaemia, Asthenia, Blood bicarbonate
Clinical narrative: Subject presented to the ER with one month history of diarrhea, weakness, fatigue, and abdominal pain. Subject was found to be positive for C. Diff, and positive for E. Coli Pyelonephritis. Patient was assessed and was found to be severely malnourished with weight loss (BMI 18.8kg/m2) and has an acute kidney injury. Patient has chronic anemia in the setting of renal disease and malnutrition. Subject was scheduled to receive IP, but it was never administered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine increased, Blood magnesium, Blood urea increased, Clostridium test positive, Diarrhoea
Clinical narrative: Subject presented to the ER with one month history of diarrhea, weakness, fatigue, and abdominal pain. Subject was found to be positive for C. Diff, and positive for E. Coli Pyelonephritis. Patient was assessed and was found to be severely malnourished with weight loss (BMI 18.8kg/m2) and has an acute kidney injury. Patient has chronic anemia in the setting of renal disease and malnutrition. Subject was scheduled to receive IP, but it was never administered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Escherichia test positive, Fatigue, Haemoglobin decreased, Malnutrition, Nephropathy
Clinical narrative: Subject presented to the ER with one month history of diarrhea, weakness, fatigue, and abdominal pain. Subject was found to be positive for C. Diff, and positive for E. Coli Pyelonephritis. Patient was assessed and was found to be severely malnourished with weight loss (BMI 18.8kg/m2) and has an acute kidney injury. Patient has chronic anemia in the setting of renal disease and malnutrition. Subject was scheduled to receive IP, but it was never administered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil count increased, Weight decreased, White blood cell count increased
Clinical narrative: Subject presented to the ER with one month history of diarrhea, weakness, fatigue, and abdominal pain. Subject was found to be positive for C. Diff, and positive for E. Coli Pyelonephritis. Patient was assessed and was found to be severely malnourished with weight loss (BMI 18.8kg/m2) and has an acute kidney injury. Patient has chronic anemia in the setting of renal disease and malnutrition. Subject was scheduled to receive IP, but it was never administered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase MB increased, Bundle branch block left, COVID-19, Catheterisation cardiac abnormal, Chest discomfort
Clinical narrative: Took sumatriptan 100mg for migraine headache in 10 minutes began with 6/10 chest pressure/pain--lasted 1hr and went to ER with no relief of in ER still had 8/10 chest pain and new left bundle branch block on EKG-plus BP 180/92. (no hx of HTN). Echocardiogram with LV wall motion abnormalities. LV EjFx down to 32% (new) Given metoprolol and diltiazem and sent by ambulance to another hospital for stat heart catheterization. Result was totally clean coronaries but Takotsubo abnormality of heart. EjFx 45% during the cath. Stayed in hospital 24 hrs. Started on lisinopril and metoprolol. Interesting consideration is that patient (who had 4 prior doses of Moderna vaccine) had exposure to Covid 05/28/2022-received bebtelovimab post exposure prophylaxis 05/30/22 and tested PCR positive 06/03/2022. Had fatigue and sweats for 2 days and cleared to negative rapid Ag test by 06/09/2022. Patient had taken sumatriptan many times before (years) for migraine with only a slight brief sense of chest pressure for a few minutes. Is it possible that Covid 19 virus contributed to sensitizing the heart muscle to serious effect of sumatriptan? FYI I am reporting this event and I am the 71 year old female who suffered this event. There have been reports of Takotsubo with acute Covid 19 illness and one with post Covid-19--so I wonder if the preceeding infection with Covid 19 had anything to do with this adverse reaction. I have taken this exact sumatriptan 100mg from the same package in the past without this effect.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal, Exposure to SARS-CoV-2
Clinical narrative: Took sumatriptan 100mg for migraine headache in 10 minutes began with 6/10 chest pressure/pain--lasted 1hr and went to ER with no relief of in ER still had 8/10 chest pain and new left bundle branch block on EKG-plus BP 180/92. (no hx of HTN). Echocardiogram with LV wall motion abnormalities. LV EjFx down to 32% (new) Given metoprolol and diltiazem and sent by ambulance to another hospital for stat heart catheterization. Result was totally clean coronaries but Takotsubo abnormality of heart. EjFx 45% during the cath. Stayed in hospital 24 hrs. Started on lisinopril and metoprolol. Interesting consideration is that patient (who had 4 prior doses of Moderna vaccine) had exposure to Covid 05/28/2022-received bebtelovimab post exposure prophylaxis 05/30/22 and tested PCR positive 06/03/2022. Had fatigue and sweats for 2 days and cleared to negative rapid Ag test by 06/09/2022. Patient had taken sumatriptan many times before (years) for migraine with only a slight brief sense of chest pressure for a few minutes. Is it possible that Covid 19 virus contributed to sensitizing the heart muscle to serious effect of sumatriptan? FYI I am reporting this event and I am the 71 year old female who suffered this event. There have been reports of Takotsubo with acute Covid 19 illness and one with post Covid-19--so I wonder if the preceeding infection with Covid 19 had anything to do with this adverse reaction. I have taken this exact sumatriptan 100mg from the same package in the past without this effect.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Migraine, SARS-CoV-2 test positive, Stress cardiomyopathy
Clinical narrative: Took sumatriptan 100mg for migraine headache in 10 minutes began with 6/10 chest pressure/pain--lasted 1hr and went to ER with no relief of in ER still had 8/10 chest pain and new left bundle branch block on EKG-plus BP 180/92. (no hx of HTN). Echocardiogram with LV wall motion abnormalities. LV EjFx down to 32% (new) Given metoprolol and diltiazem and sent by ambulance to another hospital for stat heart catheterization. Result was totally clean coronaries but Takotsubo abnormality of heart. EjFx 45% during the cath. Stayed in hospital 24 hrs. Started on lisinopril and metoprolol. Interesting consideration is that patient (who had 4 prior doses of Moderna vaccine) had exposure to Covid 05/28/2022-received bebtelovimab post exposure prophylaxis 05/30/22 and tested PCR positive 06/03/2022. Had fatigue and sweats for 2 days and cleared to negative rapid Ag test by 06/09/2022. Patient had taken sumatriptan many times before (years) for migraine with only a slight brief sense of chest pressure for a few minutes. Is it possible that Covid 19 virus contributed to sensitizing the heart muscle to serious effect of sumatriptan? FYI I am reporting this event and I am the 71 year old female who suffered this event. There have been reports of Takotsubo with acute Covid 19 illness and one with post Covid-19--so I wonder if the preceeding infection with Covid 19 had anything to do with this adverse reaction. I have taken this exact sumatriptan 100mg from the same package in the past without this effect.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin I increased
Clinical narrative: Took sumatriptan 100mg for migraine headache in 10 minutes began with 6/10 chest pressure/pain--lasted 1hr and went to ER with no relief of in ER still had 8/10 chest pain and new left bundle branch block on EKG-plus BP 180/92. (no hx of HTN). Echocardiogram with LV wall motion abnormalities. LV EjFx down to 32% (new) Given metoprolol and diltiazem and sent by ambulance to another hospital for stat heart catheterization. Result was totally clean coronaries but Takotsubo abnormality of heart. EjFx 45% during the cath. Stayed in hospital 24 hrs. Started on lisinopril and metoprolol. Interesting consideration is that patient (who had 4 prior doses of Moderna vaccine) had exposure to Covid 05/28/2022-received bebtelovimab post exposure prophylaxis 05/30/22 and tested PCR positive 06/03/2022. Had fatigue and sweats for 2 days and cleared to negative rapid Ag test by 06/09/2022. Patient had taken sumatriptan many times before (years) for migraine with only a slight brief sense of chest pressure for a few minutes. Is it possible that Covid 19 virus contributed to sensitizing the heart muscle to serious effect of sumatriptan? FYI I am reporting this event and I am the 71 year old female who suffered this event. There have been reports of Takotsubo with acute Covid 19 illness and one with post Covid-19--so I wonder if the preceeding infection with Covid 19 had anything to do with this adverse reaction. I have taken this exact sumatriptan 100mg from the same package in the past without this effect.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 1) Fluzone High-Dose Quadrivalent administered to under 65 years. 2) No reported ADR's Reporter's recommendations 1) Verify DOB and highlight ages on consent form when conducting clinic's 2) Monitor pace of the clinic
Sex: U
Vaccine: TDAP
Symptoms: Liquid product physical issue
Clinical narrative: floating particles were found in 1 vial of Boostrix lot #59TH3 and 2 vials of Boostrix LOT#775YF. These products were removed from circulation and all remaining stock was evaluated. Cold chain was reviewed and no deviation in storage temperature was observed.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain, Pruritus, Rash, Rash erythematous
Clinical narrative: On 06/03/2022 a older female patient approached the pharmacy after receiving the second Moderna booster with a large red splotchy rash around the site of injection and down the arm complaining of pain and itching. The patient was advised to take Benadryl and if the rash does not resolve on its own or worsens to seek medical attention.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: On 06/03/2022 a older female patient approached the pharmacy after receiving the second Moderna booster with a large red splotchy rash around the site of injection and down the arm complaining of pain and itching. The patient was advised to take Benadryl and if the rash does not resolve on its own or worsens to seek medical attention.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Heart rate increased, Sinus tachycardia, Ventricular extrasystoles
Clinical narrative: I have experienced "occasion sinus tachardia" several times since my 2nd dose of Pfizer Covid vaccine. On 5/20/2021 - one week after my 2nd dose - I had to call EMT's because of a sudden accelerated heart rate. This happened again on 6/26/2021 and I had to go to the Emergency Room - by the time I got there, it had subsided and they couldn't determine what the problem was. I saw a Cardiologist in July 2021 and they were unable to find any major abnormalities. The same thing happened again in August of 2021, then I have not had any events until Yesterday, 6/21/2022. The EMT's EKG said: Sinus Tachardia w/occasional premature complexes" This is the first time the event was caught in progress. I find it compelling that since I had the 2nd dose of the Pfizer Covid-19 vaccination, I have had  3 events only weeks apart, and then a year later, another event, so I feel I need to report this as it adversely affecting my health, both physically and mentally and also affecting me financially.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Feeling abnormal
Clinical narrative: Father called the pharmacy to report that his son was out of it, had chills, fatigued and just not feeling like his normal self.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Pain, Pyrexia, Vomiting
Clinical narrative: Symptoms began next morning; body aches, fever, fatigue, vomiting
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash, Rash macular
Clinical narrative: * Patient developed blotchy rash on both legs. more on the left
Age: 50.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Dizziness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 2, single (Lot number: EW0161) at the age of 50 years intramuscular, in left arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: EN6205; Anatomical site of injection: Left arm; Route of administration: Intramuscular), administration date: 24Mar2021, for COVID-19 immunization, reaction(s): "High heart rate", "palpitation", "Heart disorder", "Lightheadedness". The following information was reported: HEART RATE INCREASED (non-serious) with onset 16Apr2021, outcome "recovered", described as "High Heart rate"; CARDIAC DISORDER (non-serious) with onset 16Apr2021, outcome "unknown", described as "adrenaline boost to my heart"; PALPITATIONS (non-serious) with onset 16Apr2021, outcome "unknown", described as "heart palpitations"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt odd". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased. Additional information: The patient did not receive other vaccinations within 4 weeks. The patient received two Pfizer shots, both time patient got an adrenaline boost to his/her heart or a heart palpitation within 5 min and several move in the next 30 min. The second shot, patient had to remove his/her mask to relax and breathe, patient felt odd. No relevant test or specific test. The reporter classified the event high heart rate as non-serious. The patient received Moderna vaccine on 15Mar2022 as dose 3, booster (Lot number: 045L21A) intramuscular, in left arm for covid-19 immunization and nothing happened. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202200234987 Same reporter/patient/AE, different dose;
Age: 50.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Feeling abnormal, Heart rate, Heart rate increased, Palpitations
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 2, single (Lot number: EW0161) at the age of 50 years intramuscular, in left arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: EN6205; Anatomical site of injection: Left arm; Route of administration: Intramuscular), administration date: 24Mar2021, for COVID-19 immunization, reaction(s): "High heart rate", "palpitation", "Heart disorder", "Lightheadedness". The following information was reported: HEART RATE INCREASED (non-serious) with onset 16Apr2021, outcome "recovered", described as "High Heart rate"; CARDIAC DISORDER (non-serious) with onset 16Apr2021, outcome "unknown", described as "adrenaline boost to my heart"; PALPITATIONS (non-serious) with onset 16Apr2021, outcome "unknown", described as "heart palpitations"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt odd". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased. Additional information: The patient did not receive other vaccinations within 4 weeks. The patient received two Pfizer shots, both time patient got an adrenaline boost to his/her heart or a heart palpitation within 5 min and several move in the next 30 min. The second shot, patient had to remove his/her mask to relax and breathe, patient felt odd. No relevant test or specific test. The reporter classified the event high heart rate as non-serious. The patient received Moderna vaccine on 15Mar2022 as dose 3, booster (Lot number: 045L21A) intramuscular, in left arm for covid-19 immunization and nothing happened. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202200234987 Same reporter/patient/AE, different dose;
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Urticaria
Clinical narrative: red rash and swelling began on my face; red rash and swelling began on my face; entire body was all red, itchy rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2022 at 11:00 as dose 3 (booster), single (Lot number: FM9992) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Raw Almonds" (unspecified if ongoing), notes: known allergies: Raw Almonds; "Raw Carrots" (unspecified if ongoing), notes: known allergies: Raw Carrots. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LOSARTAN; OMEPRAZOLE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 31Mar2021, when the patient was 56-year-old, for covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 10Mar2021, when the patient was 56-year-old, for covid-19 immunization. The following information was reported: RASH PRURITIC (medically significant) with onset 30Apr2022 at 12:00, outcome "recovering", described as "entire body was all red, itchy rash"; RASH ERYTHEMATOUS (medically significant), SWELLING FACE (medically significant) all with onset 30Apr2022 at 12:00, outcome "recovering" and all described as "red rash and swelling began on my face". The events "red rash and swelling began on my face" and "entire body was all red, itchy rash" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of rash erythematous, swelling face, rash pruritic.  Clinical course : Hours after booster shot injection, red rash and swelling began on my face and within a week, my entire body was all red, itchy rash. Sought medical attention both Emergency and Dermatologist. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash pruritic, Swelling face
Clinical narrative: red rash and swelling began on my face; red rash and swelling began on my face; entire body was all red, itchy rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2022 at 11:00 as dose 3 (booster), single (Lot number: FM9992) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Raw Almonds" (unspecified if ongoing), notes: known allergies: Raw Almonds; "Raw Carrots" (unspecified if ongoing), notes: known allergies: Raw Carrots. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LOSARTAN; OMEPRAZOLE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 31Mar2021, when the patient was 56-year-old, for covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 10Mar2021, when the patient was 56-year-old, for covid-19 immunization. The following information was reported: RASH PRURITIC (medically significant) with onset 30Apr2022 at 12:00, outcome "recovering", described as "entire body was all red, itchy rash"; RASH ERYTHEMATOUS (medically significant), SWELLING FACE (medically significant) all with onset 30Apr2022 at 12:00, outcome "recovering" and all described as "red rash and swelling began on my face". The events "red rash and swelling began on my face" and "entire body was all red, itchy rash" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of rash erythematous, swelling face, rash pruritic.  Clinical course : Hours after booster shot injection, red rash and swelling began on my face and within a week, my entire body was all red, itchy rash. Sought medical attention both Emergency and Dermatologist. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Erythema, Inappropriate schedule of product administration, Skin burning sensation
Clinical narrative: First dose was administered on 27-Jan-2021 and second dose was administered on 25-Feb-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 27-Jan-2021 and second dose was administered on 25-Feb-2022) in a 67-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 024M20A and 032L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Aspirin) and Drug allergy (Simvastatin).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Feb-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 27-Jan-2021 and second dose was administered on 25-Feb-2022). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 27-Jan-2021 and second dose was administered on 25-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient never tested positive for Covid 19.  No treatment information was provided.   This case was linked to MOD-2022-578382, MOD-2022-579381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2022: Follow up received included no new information. On 21-Jun-2022: Follow up received included no new information.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose was administered on 27-Jan-2021 and second dose was administered on 25-Feb-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 27-Jan-2021 and second dose was administered on 25-Feb-2022) in a 67-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 024M20A and 032L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Aspirin) and Drug allergy (Simvastatin).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Feb-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 27-Jan-2021 and second dose was administered on 25-Feb-2022). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 27-Jan-2021 and second dose was administered on 25-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient never tested positive for Covid 19.  No treatment information was provided.   This case was linked to MOD-2022-578382, MOD-2022-579381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2022: Follow up received included no new information. On 21-Jun-2022: Follow up received included no new information.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Gait disturbance, Myalgia, Pain, Pain in extremity
Clinical narrative: muscle pain; joint pain; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 75B29, expiry date 24th August 2023) for prophylaxis.   Concurrent medical conditions included breast cancer, hip replacement and knee replacement. Concomitant products included anastrozole.   On 23rd May 2022, the patient received the 2nd dose of Shingrix. On 23rd May 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On 24th May 2022, the patient experienced muscle pain and joint pain. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the muscle pain and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, muscle pain and joint pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Jun-2022 Reporters comment: The patient received Shingrix on left deltoid. The patient received a dose of Shingrix and experienced sore arm on the day of the injection and on the next day, joint and muscle pain. The reporter was given medical disclaimer. Referred to health care professional (HCP). Spoke per package insert (PI) and content. Provided medical information phone number for HCP reference. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: muscle pain; joint pain; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 75B29, expiry date 24th August 2023) for prophylaxis.   Concurrent medical conditions included breast cancer, hip replacement and knee replacement. Concomitant products included anastrozole.   On 23rd May 2022, the patient received the 2nd dose of Shingrix. On 23rd May 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On 24th May 2022, the patient experienced muscle pain and joint pain. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the muscle pain and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, muscle pain and joint pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Jun-2022 Reporters comment: The patient received Shingrix on left deltoid. The patient received a dose of Shingrix and experienced sore arm on the day of the injection and on the next day, joint and muscle pain. The reporter was given medical disclaimer. Referred to health care professional (HCP). Spoke per package insert (PI) and content. Provided medical information phone number for HCP reference. The reporter consented to follow up.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product use issue
Clinical narrative: Vaccine was given 37 days after refrigerator shelf life; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was given 37 days after refrigerator shelf life) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 prophylaxis.     NKDA (no known drug allergies).  Concurrent medical conditions included Depressive disorder and ADHD (Attention deficit hyperactivity disorder). Concomitant products included AMOXICILLIN, NAPROXEN and TRAZODONE for an unknown indication.    On 18-Mar-2022 at 1:23 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2022 at 1:23 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was given 37 days after refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was given 37 days after refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given 37 days after refrigerator shelf life; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was given 37 days after refrigerator shelf life) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 prophylaxis.     NKDA (no known drug allergies).  Concurrent medical conditions included Depressive disorder and ADHD (Attention deficit hyperactivity disorder). Concomitant products included AMOXICILLIN, NAPROXEN and TRAZODONE for an unknown indication.    On 18-Mar-2022 at 1:23 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2022 at 1:23 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was given 37 days after refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was given 37 days after refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine given 37days after refrigerator shelf life; Vaccine given 37days after refrigerator shelf life; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 37days after refrigerator shelf life) and PRODUCT STORAGE ERROR (Vaccine given 37days after refrigerator shelf life) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 prophylaxis.     It was reported that patient had no known drug allergy.  Concurrent medical conditions included Depressive disorder, Hypertensive (Hypertensive disorder), Osteoporosis, Lung cancer (malignant tumor of lung), Mental disorder, Osteoarthritis, Alcoholism and Bipolar disorder. Concomitant products included CLONAZEPAM, DULOXETINE, ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), FUROSEMID [FUROSEMIDE], METFORMIN HYDROCHLORIDE (METFORMIN ER), SULFADIAZINE SILVER (SSD), TRAMADOL and WARFARIN SODIUM (WARFARIN [WARFARIN SODIUM]) for an unknown indication.    On 18-Mar-2022 at 2:43 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2022 at 2:43 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 37days after refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine given 37days after refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 37days after refrigerator shelf life) and PRODUCT STORAGE ERROR (Vaccine given 37days after refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication reported.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine given 37days after refrigerator shelf life; Vaccine given 37days after refrigerator shelf life; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 37days after refrigerator shelf life) and PRODUCT STORAGE ERROR (Vaccine given 37days after refrigerator shelf life) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 prophylaxis.     It was reported that patient had no known drug allergy.  Concurrent medical conditions included Depressive disorder, Hypertensive (Hypertensive disorder), Osteoporosis, Lung cancer (malignant tumor of lung), Mental disorder, Osteoarthritis, Alcoholism and Bipolar disorder. Concomitant products included CLONAZEPAM, DULOXETINE, ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), FUROSEMID [FUROSEMIDE], METFORMIN HYDROCHLORIDE (METFORMIN ER), SULFADIAZINE SILVER (SSD), TRAMADOL and WARFARIN SODIUM (WARFARIN [WARFARIN SODIUM]) for an unknown indication.    On 18-Mar-2022 at 2:43 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2022 at 2:43 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 37days after refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine given 37days after refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given 37days after refrigerator shelf life) and PRODUCT STORAGE ERROR (Vaccine given 37days after refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication reported.