chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Pain in extremity, Peripheral swelling
Clinical narrative: Pain and swelling in the hands; Swelling in the hands; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain and swelling in the hands) and PERIPHERAL SWELLING (Swelling in the hands) in an 85-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. A57180B5) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     On 11-May-2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain and swelling in the hands) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling in the hands) (seriousness criterion medically significant). The patient was treated with PREDNISONE at a dose of 20 milligram,taper dose. At the time of the report, PAIN IN EXTREMITY (Pain and swelling in the hands) and PERIPHERAL SWELLING (Swelling in the hands) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: osteoarthritis.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient had pain and swelling in the hands. The lab results showed osteoarthritis.  The patient did not experience any additional symptoms/events.  The patient was getting temporary relief from a 20mg taper off Prednisone.   Company comment:  This is a spontaneous case concerning a 85-year-old, male patient with no reported medical history, who experienced the serious (due to medically significant) unexpected events of Pain in extremity and Peripheral swelling. The events occurred on an unknown date after a dose of SPIKEVAX COVID-19 VACCINE NOS (onset dates and dose number were not provided so latency cannot be estimated). Clinical course was not provided. Lab tests results revealed osteo arthritis (no additional details were provided). The patient was treated with prednisone. The outcome of the events was reported as not recovered. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.   Reporter did not allow further contact.
Age: 64.0
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave Fluzone High Dose to a 64 year old with no reported adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 64 years old and unknown gender patient to whom influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] was given with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient of 64 years old received a dose of suspect influenza quadrival A-B high dose HV vaccine (lot number, strength, expiry date, form, dose not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization) with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Extra dose administered, Medication error, No adverse event, Wrong product administered
Clinical narrative: 2 FLUZONE Quadrivalent Np vaccines were given to an 11 year old patient/ patient was to get both the flu and Pneumococcal but got two flu vaccines instead with no reported adverse event; 2 FLUZONE Quadrivalent Np vaccines were given to an 11 year old patient/ patient was to get both the flu and Pneumococcal but got two flu vaccines instead with no reported adverse event; Initial information received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 11-years-old male patient who received 2 doses of influenza quadrival A-B vaccine [Fluzone Quadrivalent] as patient was to get both the flu and Pneumococcal Vaccine but got two flu vaccines instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Oct-2023, the patient received 2 doses of 0.5 mL dose of suspect influenza quadrival A-B vaccine, suspension for injection (batch number and expiry date unknown) (Strength: standard) via intramuscular route in unknown administration site for immunization as patient was to get both the flu and Pneumococcal Vaccine not produced by Sanofi Pasteur (unknown formulation) but got two flu vaccines instead with no reported adverse event (extra dose administered) (wrong product administered) (same day latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: fluzone quad was administered instead of fluzone hd with no reported adverse event; Initial information received on 05-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient where Influenza quadrival a-b vaccine [Fluzone QIV] was administered instead of fluzone hd with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for immunization (wrong product administered) (latency- same day). Information on the batch number was requested.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Asthma, Condition aggravated, Fatigue, Headache
Clinical narrative: Muscle and joint pain for 1 week - intense, headache for three days, fatigue for 1 week, lessening gradually. At the end of the week I also had an asthma episode (usually infrequent)  but not sure whether this s related.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Myalgia
Clinical narrative: Muscle and joint pain for 1 week - intense, headache for three days, fatigue for 1 week, lessening gradually. At the end of the week I also had an asthma episode (usually infrequent)  but not sure whether this s related.
Age: 64.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Injection site oedema, Injection site vesicles, Injection site warmth
Clinical narrative: Patient presented to the office with right arm erythema, edema  and warmth from the Injection at 7:45am.  Symptoms started this  morning at injection site and traveled down to mid bicep are. I booked him an appointment at 10:30am to see one of our physicians. I marked the area to monitor if redness traveled. At 10:30 the redness had spread to the antecubital area and posterior at the tricep area. The area had some blistering as well. Patient was given prednisone taper and vaccine was added to allergy list.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Patient experience redness, edema, warm to the touch, hardness of the area of site. This went from the shoulder to the antecubital area. This lasted about 3-4 days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node under arm is swollen quite significantly
Age: 26.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pt recieved initial flu shot on 29 Sept. Pt reported to immunizations clinic for hepatitis A, but was given a 2nd flu shot inadvertently.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blindness, Chills, Deafness, Dizziness
Clinical narrative: 3-8-22 - racing heartbeat, chills, dizziness, shortness of breath 3-9-22 - increased dizziness and shortness of breath 3-10-22 - progressing dizziness, diagnosed vertigo, weakness in body 3-12-22 - headache, dizziness, vertigo 3-15-22 - extreme headache, vertigo, weakness progressing (left side) 3-20-22 - excruciating headache, vertigo, nausea, weakness, barely walking 3-24-22 - extreme headache, pain all over, left side numb, SOB could barely open my eyes, couldn't see, heart racing, didn't ear for 3 days, could not function at all. Same day was sent to Emergency at hospital and was admitted or six (6) days.  I am still awaiting for my medical records and am willing to send them when I obtain them.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Gait disturbance, Headache, Hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: 3-8-22 - racing heartbeat, chills, dizziness, shortness of breath 3-9-22 - increased dizziness and shortness of breath 3-10-22 - progressing dizziness, diagnosed vertigo, weakness in body 3-12-22 - headache, dizziness, vertigo 3-15-22 - extreme headache, vertigo, weakness progressing (left side) 3-20-22 - excruciating headache, vertigo, nausea, weakness, barely walking 3-24-22 - extreme headache, pain all over, left side numb, SOB could barely open my eyes, couldn't see, heart racing, didn't ear for 3 days, could not function at all. Same day was sent to Emergency at hospital and was admitted or six (6) days.  I am still awaiting for my medical records and am willing to send them when I obtain them.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Palpitations, Vertigo
Clinical narrative: 3-8-22 - racing heartbeat, chills, dizziness, shortness of breath 3-9-22 - increased dizziness and shortness of breath 3-10-22 - progressing dizziness, diagnosed vertigo, weakness in body 3-12-22 - headache, dizziness, vertigo 3-15-22 - extreme headache, vertigo, weakness progressing (left side) 3-20-22 - excruciating headache, vertigo, nausea, weakness, barely walking 3-24-22 - extreme headache, pain all over, left side numb, SOB could barely open my eyes, couldn't see, heart racing, didn't ear for 3 days, could not function at all. Same day was sent to Emergency at hospital and was admitted or six (6) days.  I am still awaiting for my medical records and am willing to send them when I obtain them.
Age: 1.83
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13
Symptoms: Expired product administered
Clinical narrative: Vaccine given had expired on 10/6/2023
Sex: F
Vaccine: COVID19
Symptoms: Tetanus
Clinical narrative: Covid 19 vaccine use for COVID-19 under Emergency Use Authorization (EUA): Development of tetanus after recieving covid 19 vaccine
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Tinnitus
Clinical narrative: increased dose of venlaxafine, also, had shingrix shot  started medication with low blood pressure. now my blood pressure is elevated 130/84 taken on July 5th at urgent care. I took Shingrix shot first dose in March 2023 from Dr. I developed tinnitus in late June 2023.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Aspiration pleural cavity, Chest discomfort, Computerised tomogram thorax abnormal, Diuretic therapy
Clinical narrative: Dyspnea Onset date: 10/1/2023 Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) on 10/17/2022 HOSPITAL COURSE: 10/1/2023 - 10/4/2023. study patient was recently discharged from the hospital after having fluid removed frim his left lung having been admitted for Dyspnea 9/27/2023 - 9/28/2023. Patient started to have issues breathing when lying flat on 9/30/2028. Patient felt pressure through his chest and abdomen, denies pain currently. Patient has been taking his lasix. Patient's last dialysis was Friday 9/29/2023. He denies any cough or leg swelling. HOSPITAL COURSE Study patient presented back to the ED on 10/1/2023 with worsening dyspnea on exertion. Patient was found to intermittently require 2 L of oxygen on admission. Of note, patient with severe aortic stenosis with associated recurrent pleural effusions. Patient has required numerous thoracentesis in the last 3 months. Given persistent thoracentesis requirement, most recently 09/20/2023, decision to place PleurX drain. PleurX placed 10/4/2023. The patient continued on his home diuretic dose of Lasix 40 mg twice daily. He continued his previous hemodialysis given his end stage renal disease (ESRD). Status post-transplant for which he is on prednisone 5 mg daily. 10/3/2023: Patient not requiring any oxygen prior to discharge. Patient to follow-up with Cardiology for further discussions of potential Transcatheter aortic valve replacement. Home health orders for PleurX management placed. Of note, patient with lingular opacity n CT scan. CT scan recommended to be repeated in 4 weeks per pulmonology team. Patient deemed stable for discharge 10/04/2023 status post Transcatheter aortic valve replacement. Study Principal Investigator has assessed the causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Drain placement, Dyspnoea, Dyspnoea exertional, Lung opacity, Pleural effusion
Clinical narrative: Dyspnea Onset date: 10/1/2023 Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) on 10/17/2022 HOSPITAL COURSE: 10/1/2023 - 10/4/2023. study patient was recently discharged from the hospital after having fluid removed frim his left lung having been admitted for Dyspnea 9/27/2023 - 9/28/2023. Patient started to have issues breathing when lying flat on 9/30/2028. Patient felt pressure through his chest and abdomen, denies pain currently. Patient has been taking his lasix. Patient's last dialysis was Friday 9/29/2023. He denies any cough or leg swelling. HOSPITAL COURSE Study patient presented back to the ED on 10/1/2023 with worsening dyspnea on exertion. Patient was found to intermittently require 2 L of oxygen on admission. Of note, patient with severe aortic stenosis with associated recurrent pleural effusions. Patient has required numerous thoracentesis in the last 3 months. Given persistent thoracentesis requirement, most recently 09/20/2023, decision to place PleurX drain. PleurX placed 10/4/2023. The patient continued on his home diuretic dose of Lasix 40 mg twice daily. He continued his previous hemodialysis given his end stage renal disease (ESRD). Status post-transplant for which he is on prednisone 5 mg daily. 10/3/2023: Patient not requiring any oxygen prior to discharge. Patient to follow-up with Cardiology for further discussions of potential Transcatheter aortic valve replacement. Home health orders for PleurX management placed. Of note, patient with lingular opacity n CT scan. CT scan recommended to be repeated in 4 weeks per pulmonology team. Patient deemed stable for discharge 10/04/2023 status post Transcatheter aortic valve replacement. Study Principal Investigator has assessed the causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Transcatheter aortic valve implantation
Clinical narrative: Dyspnea Onset date: 10/1/2023 Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) on 10/17/2022 HOSPITAL COURSE: 10/1/2023 - 10/4/2023. study patient was recently discharged from the hospital after having fluid removed frim his left lung having been admitted for Dyspnea 9/27/2023 - 9/28/2023. Patient started to have issues breathing when lying flat on 9/30/2028. Patient felt pressure through his chest and abdomen, denies pain currently. Patient has been taking his lasix. Patient's last dialysis was Friday 9/29/2023. He denies any cough or leg swelling. HOSPITAL COURSE Study patient presented back to the ED on 10/1/2023 with worsening dyspnea on exertion. Patient was found to intermittently require 2 L of oxygen on admission. Of note, patient with severe aortic stenosis with associated recurrent pleural effusions. Patient has required numerous thoracentesis in the last 3 months. Given persistent thoracentesis requirement, most recently 09/20/2023, decision to place PleurX drain. PleurX placed 10/4/2023. The patient continued on his home diuretic dose of Lasix 40 mg twice daily. He continued his previous hemodialysis given his end stage renal disease (ESRD). Status post-transplant for which he is on prednisone 5 mg daily. 10/3/2023: Patient not requiring any oxygen prior to discharge. Patient to follow-up with Cardiology for further discussions of potential Transcatheter aortic valve replacement. Home health orders for PleurX management placed. Of note, patient with lingular opacity n CT scan. CT scan recommended to be repeated in 4 weeks per pulmonology team. Patient deemed stable for discharge 10/04/2023 status post Transcatheter aortic valve replacement. Study Principal Investigator has assessed the causality as not study related.
Sex: F
Vaccine: FLU4, RSV
Symptoms: Headache
Clinical narrative: received rsv and flu vaccine , one to 2 hours later headache occurred aleve relieves the headache but the headache recurs every 12 hours
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Aspiration pleural cavity, Atelectasis, Breath sounds abnormal, Chest discomfort
Clinical narrative: Initial Report. Adverse event: worsening dyspnea, Onset date: 10/1/2023, Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) administered on 10/17/2022. subject was recently discharged from the hospital on 9/28/2023 for shortness of breath (Dyspnea) and ongoing pleural effusion. Patient had fluid removed from left lung. Patient said he started to have issues breathing when lying flat the night of 9/30/2023. Patient felt pressure through his chest and abdomen. Patient denies any pain currently. He has been taking his lasix. His last dialysis was Friday 9/29/2023. He denies any cough or leg swelling. Assessment and Plan on 10/1/2023 shortness of breath. Vitals stable. Has diminished lung sounds to left lower lobe. Suspect reacccumulation of pleural fluid. Will obtain cardiac labs, basic labs. Will obtain CXR. Dispo pending results. 10/2/2023 pulmonary consulted patient has chronic recurrent left-sided pleural effusion, which has been tapped 4 times in the past, most recently end of September, analysis has been consistent with transudative pleural effusion, and cytology was negative for malignant cells, patient reports symptomatic improvement after drainage of fluid. Recommendations: -Discussed with patient potential benefits and risks of PleurX catheter insertion, and he is agreeable to proceed,Order has been placed for procedure, timing to be determined. -Discussed Lingular opacity with radiology team , likely related to rounded atelectasis related to nearby compressing left-sided pleural effusion, patient will need follow-up imaging with CT scan of the chest in 4 weeks after drainage of the effusion .
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Cytology normal, Diabetes mellitus, Dialysis, Discomfort
Clinical narrative: Initial Report. Adverse event: worsening dyspnea, Onset date: 10/1/2023, Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) administered on 10/17/2022. subject was recently discharged from the hospital on 9/28/2023 for shortness of breath (Dyspnea) and ongoing pleural effusion. Patient had fluid removed from left lung. Patient said he started to have issues breathing when lying flat the night of 9/30/2023. Patient felt pressure through his chest and abdomen. Patient denies any pain currently. He has been taking his lasix. His last dialysis was Friday 9/29/2023. He denies any cough or leg swelling. Assessment and Plan on 10/1/2023 shortness of breath. Vitals stable. Has diminished lung sounds to left lower lobe. Suspect reacccumulation of pleural fluid. Will obtain cardiac labs, basic labs. Will obtain CXR. Dispo pending results. 10/2/2023 pulmonary consulted patient has chronic recurrent left-sided pleural effusion, which has been tapped 4 times in the past, most recently end of September, analysis has been consistent with transudative pleural effusion, and cytology was negative for malignant cells, patient reports symptomatic improvement after drainage of fluid. Recommendations: -Discussed with patient potential benefits and risks of PleurX catheter insertion, and he is agreeable to proceed,Order has been placed for procedure, timing to be determined. -Discussed Lingular opacity with radiology team , likely related to rounded atelectasis related to nearby compressing left-sided pleural effusion, patient will need follow-up imaging with CT scan of the chest in 4 weeks after drainage of the effusion .
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Lung opacity, Pleural effusion, Pleural fluid analysis abnormal
Clinical narrative: Initial Report. Adverse event: worsening dyspnea, Onset date: 10/1/2023, Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) administered on 10/17/2022. subject was recently discharged from the hospital on 9/28/2023 for shortness of breath (Dyspnea) and ongoing pleural effusion. Patient had fluid removed from left lung. Patient said he started to have issues breathing when lying flat the night of 9/30/2023. Patient felt pressure through his chest and abdomen. Patient denies any pain currently. He has been taking his lasix. His last dialysis was Friday 9/29/2023. He denies any cough or leg swelling. Assessment and Plan on 10/1/2023 shortness of breath. Vitals stable. Has diminished lung sounds to left lower lobe. Suspect reacccumulation of pleural fluid. Will obtain cardiac labs, basic labs. Will obtain CXR. Dispo pending results. 10/2/2023 pulmonary consulted patient has chronic recurrent left-sided pleural effusion, which has been tapped 4 times in the past, most recently end of September, analysis has been consistent with transudative pleural effusion, and cytology was negative for malignant cells, patient reports symptomatic improvement after drainage of fluid. Recommendations: -Discussed with patient potential benefits and risks of PleurX catheter insertion, and he is agreeable to proceed,Order has been placed for procedure, timing to be determined. -Discussed Lingular opacity with radiology team , likely related to rounded atelectasis related to nearby compressing left-sided pleural effusion, patient will need follow-up imaging with CT scan of the chest in 4 weeks after drainage of the effusion .
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Aspiration pleural cavity, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Dialysis
Clinical narrative: Adverse Event: Dyspnea Onset date: 9/27/2023 Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) on 10/17/2022 HOSPITAL COURSE: 9/27/2023-9/28/2023 study patient went to the hospital instead of his dialysis appointment due to shortness of breath at rest on 9/27/2023. In the ED, he had elevated, but flat troponins (141, 134, 127). CT scan showed. loculated pleural effusion in the left long, worse than previous scan in June(has ongoing AE of Plural. Nephrology was consulted, and dialysis was performed on 9/27/23. He was given twice his normal dose of Lasix and thoracentesis was performed. on 9/28/2023. He was discharged on 9/28/2023 with improvement of symptoms. Study Principal Investigator has assessed the causality as not study related.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Dyspnoea at rest, Left ventricular hypertrophy, Pleural effusion, Troponin increased
Clinical narrative: Adverse Event: Dyspnea Onset date: 9/27/2023 Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) on 10/17/2022 HOSPITAL COURSE: 9/27/2023-9/28/2023 study patient went to the hospital instead of his dialysis appointment due to shortness of breath at rest on 9/27/2023. In the ED, he had elevated, but flat troponins (141, 134, 127). CT scan showed. loculated pleural effusion in the left long, worse than previous scan in June(has ongoing AE of Plural. Nephrology was consulted, and dialysis was performed on 9/27/23. He was given twice his normal dose of Lasix and thoracentesis was performed. on 9/28/2023. He was discharged on 9/28/2023 with improvement of symptoms. Study Principal Investigator has assessed the causality as not study related.
Sex: U
Vaccine: COVID19
Symptoms: Product label issue
Clinical narrative: MODERNA COVID-19 Vaccine 2023-2024 Formula for 6 months - 11 years use for COVID-19 under Emergency Use Authorization (EUA): "Moderna COVID-19 Vaccine 2023-2024 Formula for 6 months - 11 years" is improperly filled for volume / improperly labeled for volume. The pharmacy received a box of 10 vials labeled "0.25 ml Single Dose Vial".0.25 ml is the proper dose for this age group as indicated on the CDC website. Upon drawing up the contents of the vial into a syringe, however, it was noted that the actual volume was 0.55 ml - more than double the intended dose. This could result in high risk of overdose within the toddler and child category for this vaccine. Particularly when standard procedure for any single dose vial is to draw up and administer the full vial contents, and the provider is not expecting such a variation in volume. Moderna was informed of this discovery on 10/6/23 via telephone, and the pharmacy was instructed to quarantine the remainder of the box until further investigation and notice. As of 10/9/23 no update or additional information was available from Moderna to the original reporter. Lot number of product in question AU5555B and expiration date 2024-06-07.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Bacterial infection, Condition aggravated, Insomnia, Neck pain
Clinical narrative: I have developed tetanus, severe neck pain, seizures, anxiety, and insomnia from the covid vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product contamination, SARS-CoV-2 test, Seizure, Tetanus
Clinical narrative: I have developed tetanus, severe neck pain, seizures, anxiety, and insomnia from the covid vaccine
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tetanus
Clinical narrative: Pfizer BioNTech covid vaccine use for COVID-19 under Emergency Use Authorization (EUA): Developed tetanus after covid vaccine
Age: 60.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Restless legs syndrome, Vertigo
Clinical narrative: On 10/4/23, I had a Spivax 50 MCG/0.5 SUSY vaccination and also a Fluarix Quad .5 ML flu vaccine. Almost 48 hours later, I suddenly experienced a case of extreme fatigue, restless legs, and vertigo. This lasted about 12 hours. Vertigo is something I have never experienced before. It occurred almost exactly 29 hours after I have the flu/Covid (Moderna) shots.
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Purpura, Rash, Rash pruritic, Scratch
Clinical narrative: I developed a rash in May 2021 that was extremely itchy and would bleed after scratching. I sought medical attention beginning in June 2021 and was treated with several medications. After treatment, the rash would return. No odor including dermatologist (several visits), allergist, urgent care, PCP could diagnose the rash. I learned I also had a high CRP which doctors though was most likely related. I had the COVID-19 Pfizer vaccine in Feb 2021 and always wondered if this was related. I still have the rash to this day but not as bad as 2021.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Device leakage, Incorrect dose administered
Clinical narrative: While giving the vaccine to the patient, the medication leaked out from the connection point between needle and syringe. I believe that over half of the dose was wasted. I gave a replacement vaccine in the other arm.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Palpitations
Clinical narrative: Patient reported that 2 days after his vaccination he experience heart palpitations for 2 to 3  hours in the evening.  He felt this was caused by his vaccine because he doesn't frequently have heart palpitations.
Age: 19.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Dizziness, Dyspnoea, Educational problem, Feeling abnormal, Head injury
Clinical narrative: Patient reported this information to her teacher and the teacher reported the informaton to HD on 10/5/2023. Since patient got vaccines on 9/27/2023, she stated she develped a strong allergy and missed school on 9/27, 9/28.  She returned to school on 10/2 and reported feeling bad to her teacher.  Teacher stated that patient's face appeared swollen.  The teacher asked patient if she had eaten or drank any new foods, if she had been playing with an animal or was using a new shampoo, soap or fabric detergent or if patient had been gardening at home.  Patient answered No to all questions.  Patient told her teacher that she also fainted at home on 9/27/2023 and hit her head on a chair and remembered waking up and having difficulty breathing.  Patient told her teacher that she crawled to  her night stand and grabbed a glass of water.  Patient stated that the water helped her.  Patient asked teacher if she could leave school on 10/2 due to body itching and feeling dizzy.  Patient started taking Benadryl every 8 hours and Bendadryl ointment and started to feel better.  On 10/5/2023 patient told her teacher that if she didn't take the Benadryl she felt her skin allergy and itch would come back.  After incident was reported to HD by the teacher, Public health nurse instructed teacher that patient should follow up with a health care provider and should take vaccine records with her to her appoinment.  Teacher stated she would help patient get and appt with a health care provider.
Age: 19.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Hypersensitivity, Pruritus, Swelling face, Syncope
Clinical narrative: Patient reported this information to her teacher and the teacher reported the informaton to HD on 10/5/2023. Since patient got vaccines on 9/27/2023, she stated she develped a strong allergy and missed school on 9/27, 9/28.  She returned to school on 10/2 and reported feeling bad to her teacher.  Teacher stated that patient's face appeared swollen.  The teacher asked patient if she had eaten or drank any new foods, if she had been playing with an animal or was using a new shampoo, soap or fabric detergent or if patient had been gardening at home.  Patient answered No to all questions.  Patient told her teacher that she also fainted at home on 9/27/2023 and hit her head on a chair and remembered waking up and having difficulty breathing.  Patient told her teacher that she crawled to  her night stand and grabbed a glass of water.  Patient stated that the water helped her.  Patient asked teacher if she could leave school on 10/2 due to body itching and feeling dizzy.  Patient started taking Benadryl every 8 hours and Bendadryl ointment and started to feel better.  On 10/5/2023 patient told her teacher that if she didn't take the Benadryl she felt her skin allergy and itch would come back.  After incident was reported to HD by the teacher, Public health nurse instructed teacher that patient should follow up with a health care provider and should take vaccine records with her to her appoinment.  Teacher stated she would help patient get and appt with a health care provider.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Injection site pain, Pyrexia, Vision blurred
Clinical narrative: Sore injection site, 102.5 degree fever, dizziness, fatigue, blurred vision.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hyperhidrosis, Injection site bruising, Injection site induration, Injection site pain
Clinical narrative: Headache, Sweats, warm injection site, hard injection site, sore injection site, bruised injection site, eye pressure
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Ocular discomfort
Clinical narrative: Headache, Sweats, warm injection site, hard injection site, sore injection site, bruised injection site, eye pressure
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Product administered at inappropriate site
Clinical narrative: The patient experienced pain in her upper left arm.  She went to the doctor and was diagnosed with bursitis as the vaccine was apparently given too high in her arm.  Our pharmacy was alerted to this adverse event on 10/6/23. She was still experiencing some pain at the time of this form completion.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against and then tested positive for COVID19
Age: 5.0
Sex: M
Vaccine: MMR, DTAP, HEPA, MMR
Symptoms: Parotitis
Clinical narrative: Developed severe parontitis
Age: 5.0
Sex: M
Vaccine: MMR, DTAP, HEPA, MMR
Symptoms: Mumps, Peritonitis, Swelling face
Clinical narrative: Developed severe parontitis
Age: 1.08
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired ActHIB vaccine administered on 10/9/23.  Saline diluent expired 10/7/2023.  ActHIB expired 10/8/2023
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Expired product administered
Clinical narrative: Vaccine given was expired on September 30th, 2023. Vaccine Given on 10/10/2023.  No treatment,  or no adverse outcome observed
Age: 75.0
Sex: M
Vaccine: FLUA4
Symptoms: Dysphonia, Lip swelling
Clinical narrative: Swollen lips, very hoarse
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Ageusia, Anosmia, Insomnia, Pain
Clinical narrative: Severe body ache, loss of taste, and smell, insomnia.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Pain in extremity
Clinical narrative: The patient had pain her arm and went to the doctor where they diagnosed her with bursitis. She said at this time of reporting it is still hard for her to drive due to the pain.  The patient said she thinks the vaccine was given too high in her arm.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was due for next pneumonia vaccine. Rph misread the report and administered Prevnar20 which pt had already had last year instead of pneumonvax
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram normal, Metabolic function test normal, Sinus rhythm, Troponin normal
Clinical narrative: Chest pain, nonradiating - possible myocarditis. Admitted to hospital for observation
Age: 75.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Anticoagulant therapy, Asthenia, Cardiac pharmacologic stress test abnormal, Carditis, Catheterisation cardiac normal
Clinical narrative: She got her vaccines, she felt fine.  She went to sleep Friday night, her husband tried to wake her up saturday morning.  She was sweating, she was too weak to wake up.  She went back to sleep, he woke her up once or twice to drink or eat, and could not get one bite of toast down.  At 2:45 Sunday morning she woke up and felt drained.  She was still extremely tired and she went back to sleep.  She woke up again around 8:00 AM and she could tell that she was feeling better, and around 11:00 AM she got out of bed, I wrapped up some meat she had bought on Friday.  She told him that she had to go back to bed, didn't have the normal sweating or nausea.  The next thing she knows she woke up on the floor, she had slipped on the floor, busted her lip open and her husband said it was enough and that your going to the hospital.  He called 911, they took her to the ER, Hospital and took x-rays but noticed her troponins were very very high.  They did not have a cardiac unit at that hospital and was transferred to different Hospital.  They put her on Heparin because they were not sure if she had a heart attack or not.  They did an echocardiogram, a chemical stress test and showed something blocking behind her heart, and did a heart catheter and it was normal, said it was an anomoly.  Her heart was in good shape but diagnosed her with myocarditis as her BP was very low and felt that the inside of her heart was inflamed.   She was supposed to have an MRI of her heart, but her insurance did not cover it, and feels that nobody should take these two shots together as it was too much for her heart.  They did not put her on any new medications.  She is supposed to see a cardiologist on 10/20/23.    She had her high dose flu shot 2-3 weeks prior to these two vaccines.
Age: 75.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Coronary artery occlusion, Echocardiogram abnormal, Fall, Fatigue, Feeding disorder
Clinical narrative: She got her vaccines, she felt fine.  She went to sleep Friday night, her husband tried to wake her up saturday morning.  She was sweating, she was too weak to wake up.  She went back to sleep, he woke her up once or twice to drink or eat, and could not get one bite of toast down.  At 2:45 Sunday morning she woke up and felt drained.  She was still extremely tired and she went back to sleep.  She woke up again around 8:00 AM and she could tell that she was feeling better, and around 11:00 AM she got out of bed, I wrapped up some meat she had bought on Friday.  She told him that she had to go back to bed, didn't have the normal sweating or nausea.  The next thing she knows she woke up on the floor, she had slipped on the floor, busted her lip open and her husband said it was enough and that your going to the hospital.  He called 911, they took her to the ER, Hospital and took x-rays but noticed her troponins were very very high.  They did not have a cardiac unit at that hospital and was transferred to different Hospital.  They put her on Heparin because they were not sure if she had a heart attack or not.  They did an echocardiogram, a chemical stress test and showed something blocking behind her heart, and did a heart catheter and it was normal, said it was an anomoly.  Her heart was in good shape but diagnosed her with myocarditis as her BP was very low and felt that the inside of her heart was inflamed.   She was supposed to have an MRI of her heart, but her insurance did not cover it, and feels that nobody should take these two shots together as it was too much for her heart.  They did not put her on any new medications.  She is supposed to see a cardiologist on 10/20/23.    She had her high dose flu shot 2-3 weeks prior to these two vaccines.
Age: 75.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Feeling abnormal, Heart disease congenital, Hyperhidrosis, Hypotension, Insurance issue
Clinical narrative: She got her vaccines, she felt fine.  She went to sleep Friday night, her husband tried to wake her up saturday morning.  She was sweating, she was too weak to wake up.  She went back to sleep, he woke her up once or twice to drink or eat, and could not get one bite of toast down.  At 2:45 Sunday morning she woke up and felt drained.  She was still extremely tired and she went back to sleep.  She woke up again around 8:00 AM and she could tell that she was feeling better, and around 11:00 AM she got out of bed, I wrapped up some meat she had bought on Friday.  She told him that she had to go back to bed, didn't have the normal sweating or nausea.  The next thing she knows she woke up on the floor, she had slipped on the floor, busted her lip open and her husband said it was enough and that your going to the hospital.  He called 911, they took her to the ER, Hospital and took x-rays but noticed her troponins were very very high.  They did not have a cardiac unit at that hospital and was transferred to different Hospital.  They put her on Heparin because they were not sure if she had a heart attack or not.  They did an echocardiogram, a chemical stress test and showed something blocking behind her heart, and did a heart catheter and it was normal, said it was an anomoly.  Her heart was in good shape but diagnosed her with myocarditis as her BP was very low and felt that the inside of her heart was inflamed.   She was supposed to have an MRI of her heart, but her insurance did not cover it, and feels that nobody should take these two shots together as it was too much for her heart.  They did not put her on any new medications.  She is supposed to see a cardiologist on 10/20/23.    She had her high dose flu shot 2-3 weeks prior to these two vaccines.
Age: 75.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Lip injury, Myocarditis, Somnolence, Troponin increased, X-ray
Clinical narrative: She got her vaccines, she felt fine.  She went to sleep Friday night, her husband tried to wake her up saturday morning.  She was sweating, she was too weak to wake up.  She went back to sleep, he woke her up once or twice to drink or eat, and could not get one bite of toast down.  At 2:45 Sunday morning she woke up and felt drained.  She was still extremely tired and she went back to sleep.  She woke up again around 8:00 AM and she could tell that she was feeling better, and around 11:00 AM she got out of bed, I wrapped up some meat she had bought on Friday.  She told him that she had to go back to bed, didn't have the normal sweating or nausea.  The next thing she knows she woke up on the floor, she had slipped on the floor, busted her lip open and her husband said it was enough and that your going to the hospital.  He called 911, they took her to the ER, Hospital and took x-rays but noticed her troponins were very very high.  They did not have a cardiac unit at that hospital and was transferred to different Hospital.  They put her on Heparin because they were not sure if she had a heart attack or not.  They did an echocardiogram, a chemical stress test and showed something blocking behind her heart, and did a heart catheter and it was normal, said it was an anomoly.  Her heart was in good shape but diagnosed her with myocarditis as her BP was very low and felt that the inside of her heart was inflamed.   She was supposed to have an MRI of her heart, but her insurance did not cover it, and feels that nobody should take these two shots together as it was too much for her heart.  They did not put her on any new medications.  She is supposed to see a cardiologist on 10/20/23.    She had her high dose flu shot 2-3 weeks prior to these two vaccines.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Palpitations
Clinical narrative: Chills, fever, severe joint pain, heart palpitation, fatigue,  dizziness
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Chills, fever, severe joint pain, heart palpitation, fatigue,  dizziness
Age: 79.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Death
Clinical narrative: unclear
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13, RSV
Symptoms: Respiratory distress
Clinical narrative: RESPIRATORY DISTRESS, MULTIPLE HOSPITALIZATIONS
Age: 70.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: red arm, swelling, warm to touch
Age: 69.0
Sex: M
Vaccine: FLU4, PNC20, RSV, VARZOS
Symptoms: Asthenia, Dizziness, Nausea, Pain
Clinical narrative: Pt complains of weakness, dizziness, aches nausea.  No fever
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Severe muscle pain in back of thighs beginning October 10, much  worse today October11.  Can hardly stoop down to pick up things on floor.  No treatment at this time.   Hope symptoms will abate soon.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid 19 Breakthrough Infection
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Pt had syncopal episode. Placed patient laying down on mat on floor with feet elevated. BP: 121/68, P 50 in Left arm, BP: 110/61, P 56 in Right arm. Pt responded quickly after laying on floor and able to stand up after 5minutes. Patient sat in chair for 15min before leaving. She was AAOX4.
Age: 1.08
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Accidentally received 3rd dose of covid vaccine twice. Pt came in with dad for flu shot but gave the nurse a consent form for flu and covid. Nurse asked if supposed to be getting covid too and dad said yes. Nurse checked EMR and it said "dose due" however patient had already received dose with mom and wcc on 9/2/23. We identified a glitch in our EMR where the new covid vaccines are not populating  into the vaccine schedule page even though they are charted on the vaccine history page. This was brought to tech support's attention and they are working on fixing it.
Age: 45.0
Sex: U
Vaccine: UNK
Symptoms: Lip blister, Lymphadenopathy, Peripheral swelling, Swelling, Swollen tongue
Clinical narrative: blisters on lips developed the next morning and persisted for days, swelling in arms and lymph nodes, neck and tongue
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: PATIENT WAS ERRONEOUSLY GIVEN PFIZER BIVALENT VACCINE ON 9/12/2023  after FDA ended the EUA on September 11, 2023 and an email was sent notifying clinics to discontinue use of that vaccine.
Age: 0.75
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: patient was given a covid bivalent vaccine two days after vaccine no longer autjorized.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine was given.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Vaccine was given to patient in left thigh; vaccine had expired on 9/30/2023; once this was recognized the provider was informed as well as the operations manager; manufacturer was called and case was opened.  Manufacturer stated that case would have to be escalated to vaccine department with a f/u timeframe of 10 days
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: PATIENT WAS ERRONEOUSLY GIVEN PFIZER BIVALENT VACCINE ON 9/12/2023  after FDA ended the EUA on September 11, 2023 and an email was sent notifying clinics to discontinue use of that vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability
Clinical narrative: I have experienced moderate to severe fatigue since receiving the injection. I missed one day of work as a result. I have experienced some improvement since Day 0 (day of injection). I am submitting this form on Day 12 and still experiencing moderate fatigue.
Age: 75.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Rash started on my hands Sept. 28, then I then began breaking out in hives on Sept. 30, which have continued, but are now beginning to subside.