chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Pyrexia, Tenderness, Urine analysis
Clinical narrative: Decreased oral intake; There was a little local reaction only slight tenderness; He had diarrhea; Was very fussy; Within 4 hours baby had a fever of 102.9; Full blood count; Laboratory Test; Urine analysis; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2577947-1. The original narrative from the sender is as follows:  Within 4 hours baby had a fever of 102.9 and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events of "diarrhea, hypophagia, irritability, tenderness and pyrexia". The causal relationship between Vaxelis and the events of "full blood count, laboratory test and urine analysis" was not applicable due to the nature of the events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Blood culture, Culture urine, Diarrhoea, Full blood count, Hypophagia
Clinical narrative: Decreased oral intake; There was a little local reaction only slight tenderness; He had diarrhea; Was very fussy; Within 4 hours baby had a fever of 102.9; Full blood count; Laboratory Test; Urine analysis; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2577947-1. The original narrative from the sender is as follows:  Within 4 hours baby had a fever of 102.9 and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events of "diarrhea, hypophagia, irritability, tenderness and pyrexia". The causal relationship between Vaxelis and the events of "full blood count, laboratory test and urine analysis" was not applicable due to the nature of the events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Irritability, Local reaction, Pyrexia, Tenderness, Urine analysis
Clinical narrative: Decreased oral intake; There was a little local reaction only slight tenderness; He had diarrhea; Was very fussy; Within 4 hours baby had a fever of 102.9; Full blood count; Laboratory Test; Urine analysis; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2577947-1. The original narrative from the sender is as follows:  Within 4 hours baby had a fever of 102.9 and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events of "diarrhea, hypophagia, irritability, tenderness and pyrexia". The causal relationship between Vaxelis and the events of "full blood count, laboratory test and urine analysis" was not applicable due to the nature of the events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Local reaction, Pyrexia, Tenderness, Urine analysis
Clinical narrative: Decreased oral intake; There was a little local reaction only slight tenderness; He had diarrhea; Was very fussy; Within 4 hours baby had a fever of 102.9; Full blood count; Laboratory Test; Urine analysis; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2577947-1. The original narrative from the sender is as follows:  Within 4 hours baby had a fever of 102.9 and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events of "diarrhea, hypophagia, irritability, tenderness and pyrexia". The causal relationship between Vaxelis and the events of "full blood count, laboratory test and urine analysis" was not applicable due to the nature of the events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Breath holding, Crying, Posture abnormal, Respiration abnormal, Skin discolouration
Clinical narrative: He seemed to hold his breath for 30-45 seconds; He threw his head back and then got very quiet; Mom took him to the ER because she was worried about his sleepiness and that she did not think his breathing looked normal.; Mom said he looked gray.; he started crying really loudly; Somnolence; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2578050-1. The original narrative from the sender is as follows:  Grandma gave him a hot bath in the evening, put lotion on, and he started crying really loudly, he threw his head back and then got very quiet. He seemed to hold his breath for 30-45 seconds. Mom said he looked gray. His color returned pretty quickly when the brought him back. Called emergency services, paramedics checked him out, did not transport. He seemed to be more sleepy after that. Mom took him to the ER because she was worried about his sleepiness and that she did not think his breathing looked normal. His temperature has been around 99.9 - 100. His temperature got up to 100.1.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events of "breath holding, crying, posture abnormal, respiration abnormal, skin discolouration and somnolence."  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Somnolence
Clinical narrative: He seemed to hold his breath for 30-45 seconds; He threw his head back and then got very quiet; Mom took him to the ER because she was worried about his sleepiness and that she did not think his breathing looked normal.; Mom said he looked gray.; he started crying really loudly; Somnolence; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2578050-1. The original narrative from the sender is as follows:  Grandma gave him a hot bath in the evening, put lotion on, and he started crying really loudly, he threw his head back and then got very quiet. He seemed to hold his breath for 30-45 seconds. Mom said he looked gray. His color returned pretty quickly when the brought him back. Called emergency services, paramedics checked him out, did not transport. He seemed to be more sleepy after that. Mom took him to the ER because she was worried about his sleepiness and that she did not think his breathing looked normal. His temperature has been around 99.9 - 100. His temperature got up to 100.1.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events of "breath holding, crying, posture abnormal, respiration abnormal, skin discolouration and somnolence."  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: C-reactive protein increased, Coagulation test normal, Peripheral swelling, Ultrasound Doppler normal, X-ray normal
Clinical narrative: swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; This case was retrieved during monitoring on 12-APR-2023 with the following Primary 2590836-1. The original narrative from the sender is as follows:  swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: C-reactive protein increased, Coagulation test normal, Computerised tomogram limb, Peripheral swelling, Ultrasound Doppler
Clinical narrative: swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; This case was retrieved during monitoring on 12-APR-2023 with the following Primary 2590836-1. The original narrative from the sender is as follows:  swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: X-ray
Clinical narrative: swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23; This case was retrieved during monitoring on 12-APR-2023 with the following Primary 2590836-1. The original narrative from the sender is as follows:  swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23".  No further information is expected.
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, PNC13, DTAPIPVHIB, DTPPVHBHPB, PNC13
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Vaccination site erythema
Clinical narrative: Vaccination site erythema; Circumstance or information capable of leading to medication error; Extra dose administered; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary 2591946-1. The original narrative from the sender is as follows:  Patient here for 12 month well child exam.  Originally physician ordered Pentacel, Prevnar and Varivax but after chart review it was determined that child missed the 6 month well child exam and was in need of 3rd dose of Vaxelis.  The consent form (paper) had been prepared based on the original orders of Pentacel, Prevnar and Varivax.  When the medical assistant asked the MD to sign the order, the MD said (per the MA) we are giving VAXELIS, instead of Varivax.  Per the MA, the MD watched the MA cross out VARIVAX and add VAXELIS as well as having the PENTACEL checked off.  The MD then signed the order.  MA administered the vaccines and upon documentation in the medical record, noted a different set of orders in the chart that DID NOT include the Pentacel but did include the Varivax.  The MA did notify the physician and myself right away. The parent was notified of the event and was advised to monitor for increase in fever, irritability, or local reaction.  I apologized for the experience and that I would be looking into how this occurred in spite of our careful attention to safety.  I gave her my name to call for any additional questions.  Parent did bring child to the  ED for evaluation about 2 hrs after the incident.  ED diagnosis of 'parental concern'. after the dual vaccinations received. Vital signs at that visit WNL with no fever. All other physical exam WNL except for '3 Vaccine sites notes with mild surrounding erythema but no tenderness'.   The department on call physician was notified in case there were any further concern overnight which there were not.  No subsequent calls were made to the office since then and no further ED evaluations noted.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events. No further information is expected.
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, PNC13, DTAPIPVHIB, DTPPVHBHPB, PNC13
Symptoms: Vaccination site erythema
Clinical narrative: Vaccination site erythema; Circumstance or information capable of leading to medication error; Extra dose administered; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary 2591946-1. The original narrative from the sender is as follows:  Patient here for 12 month well child exam.  Originally physician ordered Pentacel, Prevnar and Varivax but after chart review it was determined that child missed the 6 month well child exam and was in need of 3rd dose of Vaxelis.  The consent form (paper) had been prepared based on the original orders of Pentacel, Prevnar and Varivax.  When the medical assistant asked the MD to sign the order, the MD said (per the MA) we are giving VAXELIS, instead of Varivax.  Per the MA, the MD watched the MA cross out VARIVAX and add VAXELIS as well as having the PENTACEL checked off.  The MD then signed the order.  MA administered the vaccines and upon documentation in the medical record, noted a different set of orders in the chart that DID NOT include the Pentacel but did include the Varivax.  The MA did notify the physician and myself right away. The parent was notified of the event and was advised to monitor for increase in fever, irritability, or local reaction.  I apologized for the experience and that I would be looking into how this occurred in spite of our careful attention to safety.  I gave her my name to call for any additional questions.  Parent did bring child to the  ED for evaluation about 2 hrs after the incident.  ED diagnosis of 'parental concern'. after the dual vaccinations received. Vital signs at that visit WNL with no fever. All other physical exam WNL except for '3 Vaccine sites notes with mild surrounding erythema but no tenderness'.   The department on call physician was notified in case there were any further concern overnight which there were not.  No subsequent calls were made to the office since then and no further ED evaluations noted.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events. No further information is expected.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Extreme pain in the entire upper right arm where vaccine was injected. Pain comes with anything that requires me to raise the arm above my head, pulling my clothes back up after a bathroom trip, or just using ordinary strength from before the vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain, Ultrasound Doppler
Clinical narrative: Extreme pain in the entire upper right arm where vaccine was injected. Pain comes with anything that requires me to raise the arm above my head, pulling my clothes back up after a bathroom trip, or just using ordinary strength from before the vaccine.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; Vaccine expired on 06/18/2023 and was administered on 06/20/2023.; This spontaneous report was received from a medical assistant, referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 20-JUN-2023, the patient was vaccinated with first and expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) rHA injection (lot #U019290 was valid, expiration date not reported but upon internal reviewwas established as 18-JUN-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). Patient had not reported signs/symptoms of adverse effects. No additional adverse event (AE) (No adverse event) and product quality complaint (PQC).
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Vaccine expired on 06/18/2023 and was administered on 06/20/2023.; This spontaneous report was received from a medical assistant, referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 20-JUN-2023, the patient was vaccinated with first and expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) rHA injection (lot #U019290 was valid, expiration date not reported but upon internal reviewwas established as 18-JUN-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). Patient had not reported signs/symptoms of adverse effects. No additional adverse event (AE) (No adverse event) and product quality complaint (PQC).
Sex: M
Vaccine: PNC15, PPV
Symptoms: Antibody test negative, Neutropenia, Neutrophil count decreased, Pyrexia
Clinical narrative: negative pneumococcal, tetanus and diphtheria vaccine titers despite vaccination (Antibody test negative); 13-month old vaccinated with pneumococcal vaccine; This literature marketed report has been received from the authors of a published article titled as stated below concerning a 13-month-old full term male patient. His medical history included reactive airway disease and recurrent infections including multiple bouts of acute otitis media, hand -foot-mouth, and viral upper respiratory illnesses.   On an unknown date, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) as prophylaxis (dose, frequency, lot number, expiration date, route and site of administration was not reported) (inappropriate age at vaccine administration).   On an unknown date, the patient presented to the emergency department with fever and neutropenia with an absolute neutrophil count lower than 100 cells/microL. He was hospitalized and he underwent evaluation for an underlying inborn error of immunity with the following pertinent findings: negative pneumococcal vaccine (manufacturer unknown) titers despite vaccination (antibody test negative). At the time of the report, the outcome of the adverse event was unknown.   The authors considered the event to be related to pneumococcal vaccine (manufacturer unknown).   Literature Report.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; AE related to a 17-year-old patient receiving PROQUAD; This spontaneous report was received from a nurse referring to a 17-year-old patient of unspecified gender whose medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose (lot number: W035472, which was verified to be valid with expiration date: 06-MAY-2024), administered for prophylaxis (strength, dose, frequency, vaccination injection site, and route of administration were not provided) (product administered to patient of inappropriate age).  No additional adverse events were reported.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: As per narrative patient took 2 Bivalent booster doses; A single additional age appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine;; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (As per narrative patient took 2 Bivalent booster doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A single additional age appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine;) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 059F22A and AS7145B) for COVID-19 prophylaxis.     Concurrent medical conditions included Rheumatoid arthritis.   On 12-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Dec-2022, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (As per narrative patient took 2 Bivalent booster doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A single additional age appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine;). At the time of the report, EXTRA DOSE ADMINISTERED (As per narrative patient took 2 Bivalent booster doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A single additional age appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine;) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   This case was created for female patient involved in this report.  Concomitant medication was not provided. Treatment information was not reported.   This case was linked to MOD-2023-730066 (Patient Link).
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: DAPTACEL was incorrectly administered to 11 year old male patient instead of ADACEL with no reported adverse event; DAPTACEL was incorrectly administered to 11 year old male patient instead of ADACEL with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves medication error Diphtheria-15/Tetanus/5 AC pertussis vaccine [Daptacel] was incorrectly administered to 11 year old male patient instead of adacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal Vaccine A/C/Y/W CONJ (DIP TOX) (Menactra) for and HPV vaccine both for Prophylactic vaccination.  On 03-Jun-2023, the patient of 11 years received a dose 0.5 ml of suspect with standard strength Diphtheria-15/Tetanus/5 AC pertussis vaccine suspension for injection (frequency: twice) (lot: U7549AA, Expiry date: 04-Nov-2024) via intramuscular route in the left arm for immunization instead of adacel with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day). The information on the batch number will not be 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.
Age: 4.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: given adacel instead of daptacel with no reported adverse event; Initial information received on 21-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who was given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] instead of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (CRM197) (MENVEO) for Prophylactic vaccination (immunization).  On 21-Jun-2023, the patient received a dose 1  dose 0.5 ml of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection lot 2CA18C1 expiry date: 29-Nov-2024 via intramuscular route in the left arm for prophylactic vaccination (immunization) and was  given adacel instead of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine  with no reported adverse event (wrong product administered) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event given adacel instead of daptacel 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 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.; Sender's Comments:  US-SA-2023SA191326:
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE
Age: 0.75
Sex: F
Vaccine: COVID19, HEP
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Moderna Bivalent Booster dose given as vaccine #1 in Primary series rather than the Bivalent dose designated for Primary Series.
Age: 0.8
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient Received Moderna Bivalent Booster dose given as vaccine #1 in Primary series Rather than the Bivalent dose designated For Primary Series
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was not given 28 days after administration of MMR vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma, Brain fog, COVID-19, Condition aggravated, Fatigue
Clinical narrative: I had a sore arm for about a day after receiving the vaccine.  I felt fatigued and a runny nose a couple of days before testing positive for COVID-19 on 11/25/2022. I contacted my doctor, and she did not recommend Paxlovid. This COVID-19 infection made my long COVID-19 symptoms worse. I am taking physical therapy and try to rest as much as possible. My asthma is worse again since having long COVID-19. I have trouble with foggy brain symptoms.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had a sore arm for about a day after receiving the vaccine.  I felt fatigued and a runny nose a couple of days before testing positive for COVID-19 on 11/25/2022. I contacted my doctor, and she did not recommend Paxlovid. This COVID-19 infection made my long COVID-19 symptoms worse. I am taking physical therapy and try to rest as much as possible. My asthma is worse again since having long COVID-19. I have trouble with foggy brain symptoms.
Age: 5.0
Sex: F
Vaccine: DTPPVHBHPB, HEPA, DTPPVHBHPB, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: On 6/2/23, PHN administered Vaxelis as a 4th dose of DTaP to a 5 year old patient. Vaxelis is not approved for 4th dose of DTaP or children over the age of 5 years. Clinic aware of error and clinic notified Regional Director, and Immunization Program nurse of the error. Per nurset, the dose can be considered valid with no revaccination necessary. On 6/7/23, Patient's mother was contacted by PHN and notified of error. Mother verbalized no adverse reaction to vaccine administration.
Age: 5.0
Sex: F
Vaccine: DTPPVHBHPB, HEPA, DTPPVHBHPB, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: On 6/2/23, PHN administered Vaxelis as a 4th dose of DTaP to a 5 year old patient. Vaxelis is not approved for 4th dose of DTaP or children over the age of 5 years. Clinic aware of error and clinic notified Regional Director, and Immunization Program nurse of the error. Per nurset, the dose can be considered valid with no revaccination necessary. On 6/7/23, Patient's mother was contacted by PHN and notified of error. Mother verbalized no adverse reaction to vaccine administration.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/15/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Disease complication, SARS-CoV-2 test positive
Clinical narrative: 3rd COVID vaccine received 9/17/2021. Patient COVID + 09/06/2022, died 10/19/2022 from complications.
Age: 21.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Nausea
Clinical narrative: Pt states he felt dizzy, lightheaded, and nauseous  approximately 2 minutes after vaccine. After about 20 minutes all symptoms subsided.
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram, Heart rate irregular, Oxygen saturation decreased
Clinical narrative: de saturation irregular heart rate
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Interchange of vaccine products, Product preparation error
Clinical narrative: Wrong vaccine given.  Gave .2mls of undiluted Pfizer Bivalent 5-11 yrs  instead of Moderna 6mos-5yrs
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Dizziness, Headache
Clinical narrative: Dizziness, Headache, Contusion on Head.
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident
Clinical narrative: ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic valve incompetence, Cardiac failure congestive, Condition aggravated, Hypoxia
Clinical narrative: HYPOXIA 3/31/2023 CHF EXACERBATION, UNSPECIFIED HYPOXIA 3/31/2023 AORTIC VALVE REGURGITATION
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE RESPIRATORY FAILURE 11/29/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 30.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Erythema, Full blood count, Induration, Nodule, Pyrexia
Clinical narrative: Pt developed a hard knot on left arm, measuring 3in x 2in.  Along with the knot there was redness surrounding the knot, that was hot to the touch. Pt had a fever over 101 for three days. Provider drew a CBC when pt came back for nurse to look at the vaccine. Pt to following up in three days.
Age: 30.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Skin warm
Clinical narrative: Pt developed a hard knot on left arm, measuring 3in x 2in.  Along with the knot there was redness surrounding the knot, that was hot to the touch. Pt had a fever over 101 for three days. Provider drew a CBC when pt came back for nurse to look at the vaccine. Pt to following up in three days.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic kidney disease, Glomerular filtration rate, Gouty arthritis, Haematuria
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 4/24/2023 HEMATURIA J96.00 ACUTE RESPIRATORY FAILURE 4/24/2023 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 4/24/2023 CKD STAGE 3B (GFR 30-44) J96.00 ACUTE RESPIRATORY FAILURE 4/24/2023 GOUTY ARTHROPATHY
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pemphigoid
Clinical narrative: I95.89 CHRONIC HYPOTENSION 5/4/2023 BULLOUS PEMPHIGOID
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Chronic obstructive pulmonary disease, Pulmonary mass
Clinical narrative: ANGINA, UNSPECIFIED 4/28/2023 SOLITARY PULMONARY NODULE ANGINA, UNSPECIFIED 4/28/2023 CHEST PAIN COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)  ANGINA, UNSPECIFIED 4/28/2023 ANGINA, UNSPECIFIED
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sleep apnoea syndrome, Symptom recurrence
Clinical narrative: SLEEP APNEA 11/22/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm, Hypoxia, Pneumonia
Clinical narrative: R09.02 HYPOXIA 4/14/2023 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART R09.02 HYPOXIA 4/14/2023 BILAT PNEUMONIA
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MILD
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Neuropathy peripheral, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT STATES NERVE PAIN RADIATING DOWN TO FINGER, SWOLLEN FINGER, NERVE PAIN RADIATING DOWN LEG, EVEN 3 MONTHS AFTER VACCINATION
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Pulmonary embolism, Symptom recurrence
Clinical narrative: HYPOTENSION ACUTE PULMONARY EMBOLISM 11/5/2022  -  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 69.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: I had a sore arm for about a day after receiving the vaccine. I tested positive for COVID-19 on 05/27/2023. I had bad headaches and fever. I had a telehealth visit with an urgent care provider and got a prescription for Paxlovid. I tolerated the medication without any complications. I have noticed that I get tired a little more than I use to after having COVID-19. The taste of salt seems to be stronger after having COVID-19.
Age: 69.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: SARS-CoV-2 test positive, Taste disorder
Clinical narrative: I had a sore arm for about a day after receiving the vaccine. I tested positive for COVID-19 on 05/27/2023. I had bad headaches and fever. I had a telehealth visit with an urgent care provider and got a prescription for Paxlovid. I tolerated the medication without any complications. I have noticed that I get tired a little more than I use to after having COVID-19. The taste of salt seems to be stronger after having COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Pruritus, Rash
Clinical narrative: Allergic reaction: itching hands, feet, extreme rash, difficulty swallowing, fatigue. Benadryl for a week, Epi pens on hand
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization Patient admitted here transitional care following testing positive prior to proposed d/c to SNF.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperglycaemia, Hypoxia, Type 2 diabetes mellitus
Clinical narrative: HYPOXIA 4/5/2023 DM 2 W HYPERGLYCEMIA HYPOXIA 4/5/2023 DM 2 W HYPERGLYCEMIA
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident, Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: PATIENT REPORTED RASH AT SITE OF INJECTION 2 DAYS AFTER RECEIVING FIRST DOSE; ON THIRD DAY, PATIENT REPORTED RASH ON CHIN (SEPARATE-NOT CONTINUOUS)
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Infarction, Pulmonary embolism
Clinical narrative: I26.92 SADDLE PULMONARY EMBOLISM 3/28/2023 PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED I26.99 ACUTE PULMONARY EMBOLISM 3/22/2023 PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 3/22/2023 PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Atrial flutter
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/16/2023 ATRIAL FLUTTER, UNSPECIFIED
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: pt had hives all down her leg
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: THE PATIENT RECEIVED THIS COVID BIVALENT VACCINE BOOSTER DOSE 5 DAYS AFTER THE POSTED EXPIRATION DATE OF THE LOT USED. THERE HAVE BEEN NO ADVERSE REACTIONS REPORTED.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident, Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: THE PATIENT RECEIVED THIS COVID BIVALENT BOOSTER DOSE 5 DAYS AFTER THE POSTED EXPIRATION DATE OF THE LOT USED. THERE HAVE BEEN NO ADVERSE REACTIONS REPORTED.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Neuropathy peripheral
Clinical narrative: NEUROPATHY 4/13/2023 HERPES SIMPLEX
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Nausea, Neurological symptom, Parosmia, Taste disorder
Clinical narrative: In August (three months later) I developed Parosmia. Noticed it once I was cooking and felt nauseous because I couldn't stand the smell. Still to this day I can't eat/smell anything with garlic, onions and other ingredients without it tasting unexplainably horrible.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Chest pain
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 3/22/2023 CHEST PAIN I21.4 ACUTE NON ST ELEVATION MI 3/22/2023 HX OF CABG
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchial hyperreactivity, Hypoxia
Clinical narrative: Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------------------------- HYPOXIA 4/18/2023 REACTIVE AIRWAY DISEASE, UNSPECIFIED
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram abnormal, Echocardiogram abnormal, Hypotonia, Magnetic resonance imaging abnormal
Clinical narrative: I was driving in my car and my husband who I had called asked me if I had been drinking but I had not and I noticed my left hand was drooping or wanting to pill the steering wheel to the left so  my husband called my physician and she said it sounded like a stroke and I was told to seek medical attention being by a fire station I pulled in but did not go in and went to my mothers house instead and then went to sleep after going home my husband took me to the ER.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: THE PATIENT RECEIVED THIS COVID BIVALENT VACCINE BOOSTER DOSE 4 DAYS AFTER THE POSTED EXPIRATION DATE OF THE LOT USED. THERE HAVE BEEN NO ADVERSE REACTIONS REPORTED.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient tolerated well no reaction, dose was given after vial has been in fridge longer than 30 days.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: THE PATIENT RECEIVED THIS COVID BIVALENT VACCINE BOOSTER DOSE 4 DAYS AFTER THE POSTED EXPIRATION DATE OF THE LOT USED. THERE HAVE BEEN NO ADVERSE REACTIONS REPORTED.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient tolerated well no adverse reaction, dose was given from vial kept in fridge longer than 30 days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site warmth, Myalgia, Toothache
Clinical narrative: Shivers, then muscle ache, teeth ache on side of shot, shivers again. Pain in place of shot, warm and tenderness.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy artery, Blood test, Gingivitis, Magnetic resonance imaging, Optic ischaemic neuropathy
Clinical narrative: 10/09/2022: Viral gum infection, right side only, upper and lower, 11/02/2022 Non Arteritic Ischemic  Optic Neuropathy affecting right optic nerve, resulting in partial blindness in R eye.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Viral infection, Visual field tests, Visual impairment
Clinical narrative: 10/09/2022: Viral gum infection, right side only, upper and lower, 11/02/2022 Non Arteritic Ischemic  Optic Neuropathy affecting right optic nerve, resulting in partial blindness in R eye.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blindness unilateral, Gingivitis, Herpes zoster, Optic ischaemic neuropathy, Oral herpes zoster
Clinical narrative: 10/09/2022: Viral gum infection, right side only, upper and lower, 11/02/2022 Non Arteritic Ischemic  Optic Neuropathy affecting right optic nerve, resulting in partial blindness in R eye.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Vaccination failure, Visual impairment
Clinical narrative: 10/09/2022: Viral gum infection, right side only, upper and lower, 11/02/2022 Non Arteritic Ischemic  Optic Neuropathy affecting right optic nerve, resulting in partial blindness in R eye.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: THE PATIENT RECEIVED THIS BIVALENT VACCINE BOOSTER DOSE 1 DAY AFTER THE POSTED EXPIRATION DATE OF THE LOT USED. THERE HAVE BEEN NO ADVERSE REACTIONS REPORTED.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Skin discolouration
Clinical narrative: Spots all over the skin lasted for about 2 weeks. Reported by mother of Pt.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE MI
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiogenic shock, Neuropathy peripheral, Symptom recurrence
Clinical narrative: PERIPHERAL NEUROPATHY CARDIOGENIC SHOCK 2/23/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 23.0
Sex: F
Vaccine: HEPAB, HPV9
Symptoms: Underdose
Clinical narrative: No actual adverse event noted. Patient given a pediatric dose in error. Should have gotten an adult dose. Patient made aware and will return to  receive correct dose.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: Has hive all over body
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Essential hypertension, Obstructive sleep apnoea syndrome, Renal mass
Clinical narrative: G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MILD 4/21/2023 ESSENTIAL HTN RENAL MASS G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MILD 4/21/2023 RENAL MASS
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Urge incontinence
Clinical narrative: I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/30/2023 URGE INCONTINENCE
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Coronary artery disease, Dyspnoea, Myocardial injury
Clinical narrative: ACUTE NON ST ELEVATION MI 4/11/2023 SHORTNESS OF BREATH ACUTE NON ST ELEVATION MI 4/11/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE NON ST ELEVATION MI 4/11/2023 NON-ISCHEMIC MYOCARDIAL INJURY ACUTE NON ST ELEVATION MI 4/11/2023 ACUTE NON ST ELEVATION MI
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Cerebral artery occlusion, Cerebrovascular accident, Condition aggravated, Pulmonary embolism
Clinical narrative: I26.99 ACUTE PULMONARY EMBOLISM 4/13/2023 CHF EXACERBATION, UNSPECIFIED I63.531 ACUTE STROKE DUE TO OCCLUSION OF RIGHT POSTERIOR CEREBRAL ARTERY 5/4/2023 CHF EXACERBATION, UNSPECIFIED
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Patient was a participant at the Olympics and arrived at our community clinic located at the event. Patient stated he wanted a COVID vaccine, he was able to answer all questions, i.e. address, DOB, and medical screening questions. Patient consented to being vaccinated. The nurse vaccinated the patient. Thirty minutes later a very upset parent arrived and stated the patient was not his own guardian and should not have received a vaccine without the guardians consent.
Age: 8.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Vaccination error
Clinical narrative: Vaccine given in error.  Patient did not have any reaction to receiving.