chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Daptacel that has been expired for 9 hours was administered with no reported adverse event; Initial information received on 27-Feb-2023 and live follow up was processed on the same day regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a patient of unknown age and gender and it was reported that diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] that has been expired for 9 hours was administered with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 27-Feb-2023 at 09:00 hours, 0.5 mL of the suspect diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] suspension for injection (batch/lot number: c5816aa and expiry date: 26-Feb-2023; strength, route: unknown) in unknown administration site for prophylactic vaccination (immunization) that has been expired for 9 hours was administered with no reported adverse event (expired product administered) (latency: same day).   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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: administered an extra dose of Daptacel with no reported adverse event; Initial information received on 27-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old male patient who was administered an extra dose of daptacel with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (prevnar) for immunisation; hepatitis b vaccine (hepatitis b [hepatitis b vaccine]); diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (pentacel); and rotavirus vaccine (rotavirus vaccine) for immunization (for all concomitants).  On 27-Feb-2023, the patient received 0.5 ml QD (daily) dose 2 of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (batch number- C5980AB and expiration date-06-Apr-2024) via intramuscular route in the left vastus lateralis (strength: not provided) for Immunisation.  On 27-Feb-2023 the patient was administered an extra dose of daptacel with no reported adverse event (extra dose administered) (latency- same day) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the 2 vaccines, had shingles/Suspected vaccination failure; Recovering from shingles; Worst pain, still painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the pain was not recovered/not resolved.   The reporter considered the vaccination failure, shingles and pain to be possibly related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 24-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient did had the vaccine, 2 in fact and was recovering from shingles right now. This was the worst pain, the patient have ever had, even worse than having a baby. After 2 weeks it was still painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 1.58
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: It was caused from the Vx/ suspected vaccination failure; It is rare, it; 19 MO received Shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 19-month-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure, shingles and inappropriate age at vaccine administration were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 24-Feb-2023 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that no, the patient had her vaccination and her pediatrician said that it was rare but it was caused from the vaccination. Additional supportive information: The patient received Shingles vaccine at an inappropriate age, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Based upon the pediatrician statement causality was captured as yes.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Ear pain, Herpes zoster, Neck pain, Ophthalmic herpes zoster
Clinical narrative: Had both shots, still got shingles/Suspected vaccination failure; Shingles on neck, shoulder, left ear; Shingles on neck, shoulder, left ear; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 24-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient received both shingle shots and still got shingles on his/her neck and shoulder and left ear, very painful. The patient stated that would-it had been worse without the shots. The patient did not know.  Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Vaccination failure
Clinical narrative: Had both shots, still got shingles/Suspected vaccination failure; Shingles on neck, shoulder, left ear; Shingles on neck, shoulder, left ear; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 24-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient received both shingle shots and still got shingles on his/her neck and shoulder and left ear, very painful. The patient stated that would-it had been worse without the shots. The patient did not know.  Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently given Kinrix instead of Infanrix; 18 MO received Kinrix; This case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a 18-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date unknown) for prophylaxis.   On 24th February 2023, the patient received Kinrix. On 24th February 2023, unknown after receiving Kinrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 24-FEB-2023 Reporter's comment: The patient was inadvertently given Kinrix instead of Infanrix. The reporter needs to know what needs to be done to make sure there was no harm and also that he was covered. The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive Information: The patient received Kinrix instead of Infanrix, which led to wrong vaccine administered. 13 months old patient received Kinrix vaccine, which led to inappropriate age at vaccine administration.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Vaccine positive rechallenge
Clinical narrative: patient experienced pain in the arm where the vaccine was given (Left arm); Body aches, everything hurts, all over; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer case US2023AMR029771).   On 20th February 2023, the patient received the 2nd dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced pain in arm and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR029771   Additional Information: GSK receipt date: 21-FEB-2023 Reporter comment: The reporter was the patient. The patient received the second dose of shingrix and experienced pain in the arm where the vaccine was given (Left arm).    The patient also experiences aches all over her body. The patient experienced the same events from the first vaccine (arm pain and body aches), but the body aches are more over body (aches all over everything hurts) with the second dose. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR029771:Same reporter
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A 2 month-old given Hiberix, Pediarix, Rotarix on 1/30/2023 and again on 02/21/23; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 3-month-old male patient who received Hib (Hiberix) (batch number 7FZ57, expiry date 30th December 2023) for prophylaxis.   Co-suspect products included Rota (Rotarix lyophilized formulation) (batch number 959LS, expiry date 17th February 2025) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 15th April 2024) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (HIBERIX), LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX) and PEDIARIX.   On 21st February 2023, the patient received the 2nd dose of Hiberix, the 2nd dose of Rotarix lyophilized formulation, Rotarix Oral Applicator Device, the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 21st February 2023, unknown after receiving Hiberix, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 21-FEB-2023 Reporter comment: The reporter reported that, the 2 month old patient was given Hiberix, Pediarix, and Rotarix on 30th January 2023 and then again on 21st February 2023. The reporter consented to follow up. Additional Supportive Information:  The patient received 2nd dose of Hiberix, Pediarix, and Rotarix  shorter than the recommended interval, which led to shortening of the vaccine schedule.
Sex: F
Vaccine: HEP, HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: 1 dose HepA in 2003, not finish series; 1 dose HepB in 2003, not finish series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (received 1st dose of Hepatitis A vaccine in 2003) and Hepatitis B vaccine (received 2nd dose of Hepatitis B vaccine in 2003).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis A vaccine and the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination and incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 22-FEB-2023 Reporter's Comment: The reporter had patient who were traveling to Morocco and she wanted to finish the hepatitis B and hepatitis A series before this trip.  The patient received only one dose of Hepatitis A and Hepatitis B in 2003 but did not finish the series. The vaccines administered were the generic versions of Hepatitis A and Hepatitis B because healthcare professional could not confirm brand names. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Hepatitis A vaccine and Hepatitis B vaccine, which led to incomplete course of vaccination. The case had been linked to US2023AMR030354, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR030354:Same reporter
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccination failure
Clinical narrative: Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (Lack of efficacy) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION FAILURE (Lack of efficacy). At the time of the report, VACCINATION FAILURE (Lack of efficacy) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Patient year of birth reported as 1968.  No concomitant medications were reported.   It was unknown if the event cause the patient to seek medical care.  No treatment medication was provided. Company Comment: This is a spontaneous case concerning an adult male patient, with no reported medical history, who experienced the non-serious unexpected event of Vaccination failure (reported as Lack of efficacy), which occurred on an unknown date after a dose of mRNA-1273.214 (Original/Omicron BA.4/BA.5) vaccine (unknown COVID-19 vaccination schedule). No further information was disclosed. The benefit-risk relationship of mRNA-1273.214 (Original/Omicron BA.4/BA.5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-712903 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712903:cluster case for colleague
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Concomitant medication not reported. The Patient was vaccinated with the Moderna COVID-19 vaccine sometime between February 2021 and January 2022, and experienced symptom of arm soreness for an undisclosed period of time after taking the vaccine. Unknown whether the event caused the patient to seek medical care. Treatment medication not reported.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: nurse a administered MENQUADFI to a pt that was supposed to get Bexerio,with no reported adverse event; Initial information received on 27-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 19 years old male patient to whom nurse administered meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] who was supposed to get bexerio, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Feb-2023, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (Strength: standard) (lot: U7459AE; expiry date: 03-Nov-2024) via intramuscular route in the right deltoid for immunization who was supposed to get bexerio,with no reported adverse event (wrong product administered) (same day latency).  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  At time of reporting, the outcome was Unknown for the event nurse a administered menquadfi to a pt that was supposed to get bexerio,with no reported adverse 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Lymphadenopathy, Pain
Clinical narrative: Soreness in the injection site, swollen armpit lymph nodes by the injection site, chills, bodey aches, fatigue.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, Product label confusion
Clinical narrative: mislabled the product as having an expiraiton date of 11/31/23 instead of 1/30/23.; Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult male patient who received HAV (Havrix) (batch number unknown, expiry date 31st January 2023) for prophylaxis.   On 20th February 2023, the patient received the 1st dose of Havrix. On 20th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the patient experienced product label confusion. On an unknown date, the outcome of the expired vaccine used and product label confusion were unknown.   Additional Information: GSK receipt date: 21-FEB-2023 Reporter comment: The pharmacist reports a dose of Havrix was administered to a male patient on 20th February 2023, and then realized the expiration date was 31st Januray 2023.   The pharmacist stated someone from the facility had mislabled the product as having an expiraiton date of 31st January 2023 instead of 30th January 2023.   This was the patients first dose in the series.   At the time of reporting, the pharmacist did not have the lot number of the dose.   The pharmacist states the patient is in his 50's but did not have an exact age or date of birth.   The pharmacist did not have the patient's initials at the time of the call.   At the time of reporting, the dose has not been repeated. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Havrix vaccine which led to expired vaccine used and mislabled the product as having an expiraiton date of 31st January 2023 instead of 30th January 2023, which led to  product label confusion.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; Maternal exposure before pregnancy; This spontaneous prospective pregnancy case was reported by a patient family member or friend and describes the occurrence of NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure before pregnancy) in a 36-year-old female patient (gravida 1) who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71708) for COVID-19 prophylaxis.     The patient's past medical history included Alcohol use (1-3 drinks/week) on 12-Jan-2023. Concurrent medical conditions included Food allergy and Food allergy.   On 21-Feb-2023 at 5:00 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. The patient's last menstrual period was on 06-Jan-2023 and the estimated date of delivery was 13-Oct-2023. On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure before pregnancy). The patient received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) beginning around the  sixth week of the pregnancy.  At the time of the report, NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure before pregnancy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2023, Pregnancy test: Positive.   No concomitant and treatment medications were reported.  Patient's husband reported that patient was 6.5 weeks pregnant and had an appointment for a COVID booster at 5:00 PM that day.  Company comment: This spontaneous case concerns a 36-year-old pregnant female patient with no relevant medical history reported, who received the first booster dose of mRNA-1273.222 (BA.4/BA.5) vaccine and no adverse event was reported. Maternal exposure during pregnancy was reported at 6.5 weeks gestation. The patient's last menstrual period was almost 1.5 months before the vaccine and the estimated date of delivery was approximately 7 months after the vaccine. The outcome of pregnancy is pending at the time of report. There is no further clinical information provided for medical review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2023: Follow up information received on 27-Feb-2023, contains significant information. Reporter details, patient demographics, medical history, lab data and suspect product details were updated.
Age: 1.25
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the Pfizer Bivalent vaccine as an initial dose instead of the monovalent.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Got Covid-vaccinated
Age: 15.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Computerised tomogram normal, Dyskinesia, Magnetic resonance imaging normal, Tic
Clinical narrative: Precisely 3 weeks post-administration of vaccines a TIC disorder developed.  An uncontrollable head movement developed. Continues as of March 2, 2023, but with varying degrees of frequency and unsuccessful medical management.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Joint stiffness, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: Fever 101.3 Muscle aches back & neck Stiff joints (shoulders/ rotator cuff)
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Hyperthyroidism
Clinical narrative: On approximately 10/01/2022, I had labs done and they diagnosed me with Hyperthyroidism. It was during a regular check. I had to stop what I was taking and continue monitoring labs. Then I had to take another medication. I am ok now. I have to have surgery now on March 28, 2023.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Electrocardiogram, Erythema, Full blood count, Headache
Clinical narrative: The patient began experiencing  left arm numbness on 4/8/21. Five days later she noticed a red spot on top of her left eyelid and bruising in her right arm and leg and she immediately went to urgent care. She was informed her symptoms were not severe.   She has a slight headache today and thinks it is due her allergies. She rates the headache 2/10, mild, achy above the eyebrows more on the left side. She is still feeling intermittent numbness more noticeable on her fingers (pinky and ring finger) on her left hand.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, International normalised ratio, Magnetic resonance imaging head, Prothrombin time
Clinical narrative: The patient began experiencing  left arm numbness on 4/8/21. Five days later she noticed a red spot on top of her left eyelid and bruising in her right arm and leg and she immediately went to urgent care. She was informed her symptoms were not severe.   She has a slight headache today and thinks it is due her allergies. She rates the headache 2/10, mild, achy above the eyebrows more on the left side. She is still feeling intermittent numbness more noticeable on her fingers (pinky and ring finger) on her left hand.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, Wrong product administered
Clinical narrative: Patient was scheduled to receive DTaP.  Staff member assigned to give accidentally grabbed vaccine from adjacent box, that was Hepatitis B, which was then administered to patient. This was discovered on 3/1/2023, as vaccines were being inventoried.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block second degree, Bradycardia, COVID-19, Catheterisation cardiac abnormal, Chest tube insertion
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/10/2023 Discharge Date: 2/27/2023  PRESENTING PROBLEM: NSTEMI (non-ST elevated myocardial infarction) CAD in native artery   HOSPITAL COURSE: Patient is a 78 y.o. who on 2/9 presented to outside hospital with complaints of cough and worsening dyspnea. She had elevated troponins, nT proBNP, and +covid. She was transferred. 2nd degree AVB was present. Cardiac cath demonstrated severe multivessel CAD. Her echo demonstrates LVEF 55%, with basal inferior and basal inferolateral wall segments appearing severely hypokinetic. Previous medical history includes HTN, DM2, HLD, CVA in 2018, brain surgery for meningioma in 2005 and 2015, seizure disorder. CABG scheduled pending Plavix washout.   2/20 CABG 2/21: Holding betablocker for bradycardia, transfer to 7H 2/22: Start low dose beta blocker, increase activities. Remove cordis and left mediastinal chest tube this PM. 2/23; Remove pacer wire and all chest tubes. CXR in AM. Increase activities. Anticipate discharge in 1-2 days.  2/24: All surgical tubes removed. Increase activities. Trending hypertensive, adjust blood pressure medications. 2/25: Hemoglobin 7.9 today, recheck H&H 2/26: NSR/SB overnight, HR in the 40s. Stop beta blocker and monitor HR overnight. Anticipate home tomorrow if no significant bradycardia
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Coronary artery bypass, Coronary artery disease, Cough, Dyspnoea
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/10/2023 Discharge Date: 2/27/2023  PRESENTING PROBLEM: NSTEMI (non-ST elevated myocardial infarction) CAD in native artery   HOSPITAL COURSE: Patient is a 78 y.o. who on 2/9 presented to outside hospital with complaints of cough and worsening dyspnea. She had elevated troponins, nT proBNP, and +covid. She was transferred. 2nd degree AVB was present. Cardiac cath demonstrated severe multivessel CAD. Her echo demonstrates LVEF 55%, with basal inferior and basal inferolateral wall segments appearing severely hypokinetic. Previous medical history includes HTN, DM2, HLD, CVA in 2018, brain surgery for meningioma in 2005 and 2015, seizure disorder. CABG scheduled pending Plavix washout.   2/20 CABG 2/21: Holding betablocker for bradycardia, transfer to 7H 2/22: Start low dose beta blocker, increase activities. Remove cordis and left mediastinal chest tube this PM. 2/23; Remove pacer wire and all chest tubes. CXR in AM. Increase activities. Anticipate discharge in 1-2 days.  2/24: All surgical tubes removed. Increase activities. Trending hypertensive, adjust blood pressure medications. 2/25: Hemoglobin 7.9 today, recheck H&H 2/26: NSR/SB overnight, HR in the 40s. Stop beta blocker and monitor HR overnight. Anticipate home tomorrow if no significant bradycardia
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Haemoglobin decreased, Hypertension, N-terminal prohormone brain natriuretic peptide increased, SARS-CoV-2 test positive
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/10/2023 Discharge Date: 2/27/2023  PRESENTING PROBLEM: NSTEMI (non-ST elevated myocardial infarction) CAD in native artery   HOSPITAL COURSE: Patient is a 78 y.o. who on 2/9 presented to outside hospital with complaints of cough and worsening dyspnea. She had elevated troponins, nT proBNP, and +covid. She was transferred. 2nd degree AVB was present. Cardiac cath demonstrated severe multivessel CAD. Her echo demonstrates LVEF 55%, with basal inferior and basal inferolateral wall segments appearing severely hypokinetic. Previous medical history includes HTN, DM2, HLD, CVA in 2018, brain surgery for meningioma in 2005 and 2015, seizure disorder. CABG scheduled pending Plavix washout.   2/20 CABG 2/21: Holding betablocker for bradycardia, transfer to 7H 2/22: Start low dose beta blocker, increase activities. Remove cordis and left mediastinal chest tube this PM. 2/23; Remove pacer wire and all chest tubes. CXR in AM. Increase activities. Anticipate discharge in 1-2 days.  2/24: All surgical tubes removed. Increase activities. Trending hypertensive, adjust blood pressure medications. 2/25: Hemoglobin 7.9 today, recheck H&H 2/26: NSR/SB overnight, HR in the 40s. Stop beta blocker and monitor HR overnight. Anticipate home tomorrow if no significant bradycardia
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased, Ventricular hypokinesia
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/10/2023 Discharge Date: 2/27/2023  PRESENTING PROBLEM: NSTEMI (non-ST elevated myocardial infarction) CAD in native artery   HOSPITAL COURSE: Patient is a 78 y.o. who on 2/9 presented to outside hospital with complaints of cough and worsening dyspnea. She had elevated troponins, nT proBNP, and +covid. She was transferred. 2nd degree AVB was present. Cardiac cath demonstrated severe multivessel CAD. Her echo demonstrates LVEF 55%, with basal inferior and basal inferolateral wall segments appearing severely hypokinetic. Previous medical history includes HTN, DM2, HLD, CVA in 2018, brain surgery for meningioma in 2005 and 2015, seizure disorder. CABG scheduled pending Plavix washout.   2/20 CABG 2/21: Holding betablocker for bradycardia, transfer to 7H 2/22: Start low dose beta blocker, increase activities. Remove cordis and left mediastinal chest tube this PM. 2/23; Remove pacer wire and all chest tubes. CXR in AM. Increase activities. Anticipate discharge in 1-2 days.  2/24: All surgical tubes removed. Increase activities. Trending hypertensive, adjust blood pressure medications. 2/25: Hemoglobin 7.9 today, recheck H&H 2/26: NSR/SB overnight, HR in the 40s. Stop beta blocker and monitor HR overnight. Anticipate home tomorrow if no significant bradycardia
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Computerised tomogram thorax abnormal, Condition aggravated
Clinical narrative: Patien is an 85 y.o. female who presented to the local Hospital ED from an independent living facility  on 2/4/2023 with increasing shortness of breath and worsening cough following recent SARS-CoV-2/COVID-19 diagnosis.  Patient was found to be in acute hypoxic respiratory failure and required heated high flow O2.  Pulmonology/critical care evaluated and assisted with management.  Despite aggressive medical management, patient's hypoxia and shortness of breath persisted while on heated high flow.  On 2/10 morning, patient discussed with family that she did not want to continue aggressive treatment.  At that time, patient was sound of body and mind.  Family agreed to withdraw care and proceed with comfort care.  Patient expired 2/10/2023.  Family was at bedside.  Acute hypoxemic respiratory failure -Secondary to COVID-19 pneumonia and superimposed bacterial pneumonia with pre-existing interstitial lung disease -Despite aggressive treatment while on heated high flow oxygen, patient did not improve -Family agreed to comfort care.   COVID-19 Presumed bacterial pneumonia -Presented with cough and shortness of breath - Symptom onset: 1/27/2023 - Positive COVID-19: 1/28/23 at a HCF facility - Vaccination status: Vaccinated + boosters - CTPE on admission showed ground glass mid-upper lung changes, and dependent lower lobe consolidation.  No PE. - Oxygen status: Heated high flow -Status: Not improving - Decadron: Patient was treated with Decadron during hospitalization - Remdesivir: No.  Completed antiviral therapy with nirmatrelvir/ritonavir -Tocilizumab: No.  Patient did not qualify.  Acute encephalopathy -Secondary to sleep deprivation, sundowning, and respiratory issues   Hyponatremia -Most likely related to decreased oral in setting of acute illness +/- mild SIADH in setting of active pulmonary process  -Resolved    Elevated troponin -Likely related to hypoxemia and demand ischemia.   Hypokalemia -Resolved   Primary myelofibrosis -Follows with Dr. at a HCF, treated with Jakafi, with reduced dosing (50% reduction) for recent nirmatrelvir/ritonavir use -Jakafi was on hold during hospitalization since patient was on steroids  Interstitial lung disease Suspected, initial diagnosis in fall of 2022 after hospitalization at RMH, possibly drug-induced (macrobid). -Follows with pulmonology (Dr.).   Essential hypertension   Pulmonary hypertension With echo in fall of 2022 revealing RVSP of 55 mg Hg.  Possibly related to chronic lung disease
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Death, Delirium, Dyspnoea, Encephalopathy
Clinical narrative: Patien is an 85 y.o. female who presented to the local Hospital ED from an independent living facility  on 2/4/2023 with increasing shortness of breath and worsening cough following recent SARS-CoV-2/COVID-19 diagnosis.  Patient was found to be in acute hypoxic respiratory failure and required heated high flow O2.  Pulmonology/critical care evaluated and assisted with management.  Despite aggressive medical management, patient's hypoxia and shortness of breath persisted while on heated high flow.  On 2/10 morning, patient discussed with family that she did not want to continue aggressive treatment.  At that time, patient was sound of body and mind.  Family agreed to withdraw care and proceed with comfort care.  Patient expired 2/10/2023.  Family was at bedside.  Acute hypoxemic respiratory failure -Secondary to COVID-19 pneumonia and superimposed bacterial pneumonia with pre-existing interstitial lung disease -Despite aggressive treatment while on heated high flow oxygen, patient did not improve -Family agreed to comfort care.   COVID-19 Presumed bacterial pneumonia -Presented with cough and shortness of breath - Symptom onset: 1/27/2023 - Positive COVID-19: 1/28/23 at a HCF facility - Vaccination status: Vaccinated + boosters - CTPE on admission showed ground glass mid-upper lung changes, and dependent lower lobe consolidation.  No PE. - Oxygen status: Heated high flow -Status: Not improving - Decadron: Patient was treated with Decadron during hospitalization - Remdesivir: No.  Completed antiviral therapy with nirmatrelvir/ritonavir -Tocilizumab: No.  Patient did not qualify.  Acute encephalopathy -Secondary to sleep deprivation, sundowning, and respiratory issues   Hyponatremia -Most likely related to decreased oral in setting of acute illness +/- mild SIADH in setting of active pulmonary process  -Resolved    Elevated troponin -Likely related to hypoxemia and demand ischemia.   Hypokalemia -Resolved   Primary myelofibrosis -Follows with Dr. at a HCF, treated with Jakafi, with reduced dosing (50% reduction) for recent nirmatrelvir/ritonavir use -Jakafi was on hold during hospitalization since patient was on steroids  Interstitial lung disease Suspected, initial diagnosis in fall of 2022 after hospitalization at RMH, possibly drug-induced (macrobid). -Follows with pulmonology (Dr.).   Essential hypertension   Pulmonary hypertension With echo in fall of 2022 revealing RVSP of 55 mg Hg.  Possibly related to chronic lung disease
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Essential hypertension, Hypokalaemia, Hyponatraemia, Inappropriate antidiuretic hormone secretion, Interstitial lung disease
Clinical narrative: Patien is an 85 y.o. female who presented to the local Hospital ED from an independent living facility  on 2/4/2023 with increasing shortness of breath and worsening cough following recent SARS-CoV-2/COVID-19 diagnosis.  Patient was found to be in acute hypoxic respiratory failure and required heated high flow O2.  Pulmonology/critical care evaluated and assisted with management.  Despite aggressive medical management, patient's hypoxia and shortness of breath persisted while on heated high flow.  On 2/10 morning, patient discussed with family that she did not want to continue aggressive treatment.  At that time, patient was sound of body and mind.  Family agreed to withdraw care and proceed with comfort care.  Patient expired 2/10/2023.  Family was at bedside.  Acute hypoxemic respiratory failure -Secondary to COVID-19 pneumonia and superimposed bacterial pneumonia with pre-existing interstitial lung disease -Despite aggressive treatment while on heated high flow oxygen, patient did not improve -Family agreed to comfort care.   COVID-19 Presumed bacterial pneumonia -Presented with cough and shortness of breath - Symptom onset: 1/27/2023 - Positive COVID-19: 1/28/23 at a HCF facility - Vaccination status: Vaccinated + boosters - CTPE on admission showed ground glass mid-upper lung changes, and dependent lower lobe consolidation.  No PE. - Oxygen status: Heated high flow -Status: Not improving - Decadron: Patient was treated with Decadron during hospitalization - Remdesivir: No.  Completed antiviral therapy with nirmatrelvir/ritonavir -Tocilizumab: No.  Patient did not qualify.  Acute encephalopathy -Secondary to sleep deprivation, sundowning, and respiratory issues   Hyponatremia -Most likely related to decreased oral in setting of acute illness +/- mild SIADH in setting of active pulmonary process  -Resolved    Elevated troponin -Likely related to hypoxemia and demand ischemia.   Hypokalemia -Resolved   Primary myelofibrosis -Follows with Dr. at a HCF, treated with Jakafi, with reduced dosing (50% reduction) for recent nirmatrelvir/ritonavir use -Jakafi was on hold during hospitalization since patient was on steroids  Interstitial lung disease Suspected, initial diagnosis in fall of 2022 after hospitalization at RMH, possibly drug-induced (macrobid). -Follows with pulmonology (Dr.).   Essential hypertension   Pulmonary hypertension With echo in fall of 2022 revealing RVSP of 55 mg Hg.  Possibly related to chronic lung disease
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lung consolidation, Lung opacity, Malaise, Myocardial ischaemia, Pneumonia bacterial
Clinical narrative: Patien is an 85 y.o. female who presented to the local Hospital ED from an independent living facility  on 2/4/2023 with increasing shortness of breath and worsening cough following recent SARS-CoV-2/COVID-19 diagnosis.  Patient was found to be in acute hypoxic respiratory failure and required heated high flow O2.  Pulmonology/critical care evaluated and assisted with management.  Despite aggressive medical management, patient's hypoxia and shortness of breath persisted while on heated high flow.  On 2/10 morning, patient discussed with family that she did not want to continue aggressive treatment.  At that time, patient was sound of body and mind.  Family agreed to withdraw care and proceed with comfort care.  Patient expired 2/10/2023.  Family was at bedside.  Acute hypoxemic respiratory failure -Secondary to COVID-19 pneumonia and superimposed bacterial pneumonia with pre-existing interstitial lung disease -Despite aggressive treatment while on heated high flow oxygen, patient did not improve -Family agreed to comfort care.   COVID-19 Presumed bacterial pneumonia -Presented with cough and shortness of breath - Symptom onset: 1/27/2023 - Positive COVID-19: 1/28/23 at a HCF facility - Vaccination status: Vaccinated + boosters - CTPE on admission showed ground glass mid-upper lung changes, and dependent lower lobe consolidation.  No PE. - Oxygen status: Heated high flow -Status: Not improving - Decadron: Patient was treated with Decadron during hospitalization - Remdesivir: No.  Completed antiviral therapy with nirmatrelvir/ritonavir -Tocilizumab: No.  Patient did not qualify.  Acute encephalopathy -Secondary to sleep deprivation, sundowning, and respiratory issues   Hyponatremia -Most likely related to decreased oral in setting of acute illness +/- mild SIADH in setting of active pulmonary process  -Resolved    Elevated troponin -Likely related to hypoxemia and demand ischemia.   Hypokalemia -Resolved   Primary myelofibrosis -Follows with Dr. at a HCF, treated with Jakafi, with reduced dosing (50% reduction) for recent nirmatrelvir/ritonavir use -Jakafi was on hold during hospitalization since patient was on steroids  Interstitial lung disease Suspected, initial diagnosis in fall of 2022 after hospitalization at RMH, possibly drug-induced (macrobid). -Follows with pulmonology (Dr.).   Essential hypertension   Pulmonary hypertension With echo in fall of 2022 revealing RVSP of 55 mg Hg.  Possibly related to chronic lung disease