chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered ACTHIB that was reconstituted with expired diluent with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] that was reconstituted with expired diluent 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 PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  On 01-Nov-2022, the patient received 0.5 mL dose of suspect HIB (PRP/T) VACCINE (lot UJ604AA and expiry date: 13-Mar-2023) which was reconstituted with diluent (lot U7172AB and expiry date: 29-Oct-2022) via intramuscular route in the right leg for prophylactic vaccination.  On 01-Nov-2022, (latency: same day) the patient was administered acthib that was reconstituted with expired diluent with no reported adverse event (expired product administered).  It was reported, they gave a patient an expired ACT-HIB vaccine. The caller stated the box says 29-Oct-2022 but the diluent part does not expire until 13-Mar-2023. A patient was administered ACTHIB that was reconstituted with expired diluent. The ACTHIB portion of the vaccine was not expired but the diluent was, which expired 29-Oct-2022. This situation is reported as a medication error due to a patient being administered ACTHIB that was reconstituted with expired diluent.   Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: tenivac being administered accidentally instead of adacel with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who  reported  DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] being administered accidentally 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.    On 09-NOV-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength, formulation, route, lot number not reported) in unknown administration site for prophylactic vaccination.  On 09-NOV-2022 same  day, the patient developed a non-serious event DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (tenivac) being administered accidentally instead of adacel with no reported adverse event (wrong product administered)    Action taken: not applicable.   At time of reporting, the outcome was Not Recovered / Not Resolved 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: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: two doses of Fluzone High Dose QIV within the same season with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 84 years old female patient who recieved two doses of fluzone high dose qiv (INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE)within the same season 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 COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 28-Oct-2022 the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot UJ932AB via unknown route in unknown administration site as immunization.  On 09-Nov-2022, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot UJ917AB, Expiration date: 30-Jun-2023 via unknown route in the left deltoid as immunization.  On 09-NOV-2022 the patient received another dose (total 2 doses) of fluzone high dose qiv within the same season with no reported adverse event (extra dose administered) 12 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient was not using the product at the time of report.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (two doses of Fluzone High Dose QIV within the same season with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered expired acthib to a patient, with no reported adverse event; Initial information was received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 12 months old male patient who experienced administered expired acthib to a patient, with no reported adverse event while receiving vaccine hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 07-Nov-2022, the patient received a DOSE 4 of suspect hib (prp/t) vaccine Powder and solvent for solution for injection at a dosage of 0.5 ml (lot UJ594AAA, expiry date - 26-Oct-2022) via intramuscular route in the right thigh for immunization.  On 07-Nov-2022 the patient developed a non-serious event of administered expired acthib to a patient, with no reported adverse event (expired product administered) (latency: same day) following the administration of hib (prp/t) vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered expired acthib to a patient, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event administered expired acthib to a patient, 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.
Age: 0.58
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was administered expired ActHIB with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old female patient was administered expired HIB (PRP/T) VACCINE [ACT-HIB] 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and POLIO VACCINE INACT (IPV) for Immunisation.  On 04-Nov-2022, the patient received a  third dose 0.5 ml of suspect HIB (PRP/T) VACCINE once  (lot UJ574AA; expiry date: 24-SEP-2022) via intramuscular route in the right thigh for prophylactic vaccination.   On 04-NOV-2022 the patient reported a non-serious event  patient was administered expired HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event (expired product administered).    Action taken:not applicable.   At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Neuralgia
Clinical narrative: 3 days later she experienced awful nerve pain; trouble moving her arm; Initial information received on 09-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 70 years old female patient who 3 days later experienced awful nerve pain and trouble moving her arm after receiving vaccine Influenza Quadrival A-B high Dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza Quadrival A-B high dose HV vaccine of lot no: UJ925AB and expiry date: 30-Jun-2023; at a dose of 0.7 ml (strength, formulation, frequency, lot number and expiry date: not reported) via intramuscular route in the right deltoid as Immunisation.  On an unknown date, the patient developed non-serious event 3 days later she experienced awful nerve pain (neuralgia) and trouble moving her arm (limb discomfort) (unknown latency) following the administration of Influenza Quadrival A-B High dose HV vaccine.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for both events.  Outcome: Unknown for both events.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: extra dose of ACTHIB was inadvertently administered to a patient with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old and unknown gender patient  to whom extra dose of HIB (PRP/T) VACCINE [ACT-HIB] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Nov-2022 extra dose 0.25 ml (once) dose of suspect HIB (PRP/T) VACCINE (formulation: unknown) (lot UJ636AA , strength, standard) via unknown route in the thigh NOS (not otherwise specified) for immunization was inadvertently administered to a patient with no reported adverse event (extra dose 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 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: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 15 month old was administered expired DAPTACEL with no adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15-month-old female patient was administered expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] with no adverse event while receiving vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR and varicella zoster vaccine (Varicella Vaccine) both for Immunisation.    On 09-Nov-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml once (lot C5774BA, expiry date: 18-Sep-2022) via intramuscular route in right thigh for Immunization.  On 09-Nov-2022 15-month-old was administered expired daptacel with no adverse event (expired product administered, same day latency).  Action taken: Not applicable.  Outcome: Unknown.   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: 79.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Cardiac discomfort, Heart rate increased, Hypotension
Clinical narrative: Hearth fells weaker; Blood pressure went really low; Pulse rate double; Felt really weak/Weakness; This spontaneous case was received on 24-Oct-2022 from other healthcare professional via Communications (reference number: SEQW22-04950) and concerned a 79-year-old, male patient.   The patient's concurrent conditions included blood pressure. The patient's concomitant medications included amlodipine and lisinopril, both used for unreported indication for several years.  On 07-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration and anatomical location: not reported) for prevention of influenza disease. The batch number was not reported.  On the same day, after receiving Fluad Quadrivalent, the patient's blood pressure went really low, he stopped taking pill. The patient experienced weakness, his pulse rate double and hearth felt weaker.   On 24-Oct-2022, the patient recovered from the events of 'cardiac discomfort', 'blood pressure low', and 'pulse rate increased'.   At the time of the initial reporting, the patient had not recovered from the event of 'asthenia'. As reported, the patient was still feeling weak.  The reporter did not provide a causality assessment.  Company comment: A 79-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient experienced hypotension, increased heart rate, asthenia and cardiac discomfort (reported as hearth fells weaker). Information regarding the related diagnostic findings was not provided. The patient's concurrent conditions included blood pressure, as reported. Based on plausible time relationship, causality is assessed as possibly related.; Sender's Comments: A 79-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient experienced hypotension, increased heart rate, asthenia and cardiac discomfort (reported as hearth fells weaker). Information regarding the related diagnostic findings was not provided. The patient's concurrent conditions included blood pressure, as reported. Based on plausible time relationship, causality is assessed as possibly related.
Age: 91.0
Sex: F
Vaccine: UNK
Symptoms: Discomfort, Pain, Pruritus, Urticaria
Clinical narrative: but then hives appeared and she was itching all over; Aching all over/hurting so bad; Had a very bad night with the discomfort; This spontaneous case was received on 26-Oct-2022 from consumer via Communications (reference number: SEQW22-05056) and concerned a 91-year-old, female patient.  The patient's concurrent conditions included atrial fibrillation and bad back. The patient's past medical history included surgeries. The patient's concomitant medications included amiodarone and Kreon 24000 (pancreatin), both used for unreported indications. The patient's historical vaccine included unspecified influenza vaccine (reported as 'flu shot') which caused a little soreness in the arm.  On 29-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for active immunization of persons 65 years of age and older against influenza subtypes A and B contained in the vaccine. The batch number reported was 346335 and expiration date was 13-Apr-2023.  On the same day, a few hours after Fluad Quadrivalent administration, the patient started aching all over and in the evening it just got worse, it hurt so bad all over her body that she could not even wash her face. The patient went to bed, but walking down the hall she was hurting so bad that she had to be very careful during walking and then just fell into bed. She had a very bad night with the discomfort.  On 30-Sep-2022, the next morning after Fluad Quadrivalent administration, the patient was not hurting so bad, but then hives appeared and she was itching all over. About two and half days later, the patient had no symptom. The itching, the hives, and the aching stopped.  The patient did not take any medication to deal with the reported symptoms.  On 02-Oct-2022, the patient had recovered from the events of 'hives', 'discomfort' and 'general body pain'.  The reporter assessed the events to be related to Fluad Quadrivalent.  The case was assessed as non-serious.  This case is linked to case 202206470 (the same patient/reporter).  Company comment: A 91-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent. As reported, a few hours after vaccination the patient developed general body pain, urticaria and discomfort. Based on plausible time relationship, causality is assessed as possibly related.; Reporter's Comments: The reporter assessed the events to be related to Fluad Quadrivalent.; Sender's Comments: A 91-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent. As reported, a few hours after vaccination the patient developed general body pain, urticaria and discomfort. Based on plausible time relationship, causality is assessed as possibly related.
Age: 36.0
Sex: M
Vaccine: FLUC3
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Product administration error
Clinical narrative: Muscle and joint pain; Muscle and joint pain; Headache; Fatigue; Flucelvax Quadrivalent and COVID-19 Vaccine were administered on the same date, in the same arm; This spontaneous case was received on 03-Nov-2022 from other health professional via Regulatory Communications (reference number: SEQW22-05366) and concerned a 36-year-old, male patient.  The patient's concurrent condition included diabetes, gout, hypertension, obesity. The patient's historical drug included unspecified drug after which the patient experienced allergic reaction (reported as 'allergic reaction to an unnamed drug in the past'). The patient's concomitant medications were not reported.  On 18-Oct-2022, the patient received a non-company, co-suspect COVID-19 vaccine (brand not specified; anatomical location: left arm, dose: reported as 'four', route of administration, and indication: not reported. The batch number reported was 6J259.  On the same date, the patient was vaccinated with Flucelvax Quadrivalent (influence vaccine inact sag 4v; anatomical location: left arm; dose: 0.5 ml; route of administration: not reported) (explicitly coded as 'Product administration error') for prevention of influenza disease caused by influenza virus subtypes A and B. The batch number reported was 942431.  On 19-Oct-2022, one day after receiving Flucelvax Quadrivalent and COVID-19 vaccine, the patient experienced a severe headache along with fatigue, severe muscle and joint pain. No treatment was received for the events.  At the time of initial reporting, on 03-nov-2022, the patient had not recovered from the events.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: The events of muscle pain, joint pain, fatigue and headache are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship. Product administration error is assessed as not related to Flucelvax Quadrivalent as per company conventions.; Sender's Comments: The events of muscle pain, joint pain, fatigue and headache are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship. Product administration error is assessed as not related to Flucelvax Quadrivalent as per company conventions.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a media via a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy before. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, administered 1 in total for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported administered 1 in total for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). Reported that "my ex MIL died after getting her booster. She was healthy before." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0- 20221132412-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Got sick for almost a week; Initial information received on 06-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced got sick for almost a week while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic Vacciantion.  On an unknown date the patient developed a non-serious got sick for almost a week (illness) (unknown latency) following the administration of influenza vaccine.  It was reported "This case was received from social media. Never get the flu shot. Hardly ever in 54 years had the flu. No covid shot, still in great health. Wife got a flu shot for her employment years ago. Got sick for almost a week. So taking good vitamins and eating well makes a difference".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Got sick for almost a week).  At time of reporting, the outcome was Unknown for the event got sick for almost a week.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Confusional state
Clinical narrative: Systemic: Confusion-Mild
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Skin discolouration, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Additional Details: patient was given the flu shot first, followed by the moderna vaccine.  She told me she was just "nervous" and then turned very white and passed out.  I was able to stand beside her immediately so she did not fall out of chair or hit her head on anything.  Her father was with her at hte time of vaccination as well my intern pharmacist.  The two helped me move her gently to the floor and bend her legs.  She was responsive within about 15 seconds.  She was then able to tell me her name, etc.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: RAISED RASH AT INJECTION SITE-Medium
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient received flu injection yesterday at office. Noticed while she was driving from office that her arm started to swell, become warm, developed itching. She pulled over to the side of the road. Stated that the swelling came to the size of a golf ball. She was able then to drive home. She took Benadryl when she got home which brought the swelling down and relieved some of the itch. She had no respiratory distress or anaphylactic symptoms. Today she slept until 11 am. She has full use of her arm. She spoke with our nurse today who advised her to monitor symptoms and apply ice if needed to the swelling. Physician was advised for further recommendations.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: bad reaction to bivalent COVID vaccine - fever 102 and chills, severe fatigue and headache
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Product dose omission issue
Clinical narrative: Patient skipped medication after feeling ill due to flu vaccine
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow abnormal, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: Patient received the Johnson and Johnson vaccine. After vaccination, she presented to clinic with a platelet count of 48,000. She was diagnosed with ITP by bone marrow biopsy on 1/28/22.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Severe
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Paraesthesia, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Pt presented to pharmacy 11-12-2022 displaying localized bruise around injection site and described tenderness and pain x a "few days." Counseled patient for at-home care as well as to seek medical attention PRN.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain upper, Heart rate increased, Hypoaesthesia, Hypoaesthesia oral, Swelling face
Clinical narrative: Facial swelling, hives, numbness of face and mouth, increased heart rate, stomach cramps.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Facial swelling, hives, numbness of face and mouth, increased heart rate, stomach cramps.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neurological symptom
Clinical narrative: S&S of stroke
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: fever, runny nose
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Full blood count normal, Headache, Inflammatory marker test, Metabolic function test normal
Clinical narrative: Child was receiving none dilute dose for booster per mom.  Mom report child has had intermittent fever, and headache since vaccination.  Presented to ED 2x due to concern with extensive work up unremarkable.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation error, Pyrexia
Clinical narrative: Child was receiving none dilute dose for booster per mom.  Mom report child has had intermittent fever, and headache since vaccination.  Presented to ED 2x due to concern with extensive work up unremarkable.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Child was receiving none dilute dose for booster per mom.  Mom report child has had intermittent fever, and headache since vaccination.  Presented to ED 2x due to concern with extensive work up unremarkable.
Age: 16.0
Sex: M
Vaccine: IPV, MENB, TD
Symptoms: Dysstasia, Head injury, Mouth haemorrhage, Presyncope, Skin laceration
Clinical narrative: pt stood up and walked out the door, experienced vasovagal syncope ~2 minutes after vaccination while still in clinic waiting room. Pt had not eaten or drank anything all day.  Pt struck head, experienced laceration above right eye, and bleeding to right front tooth, unclear if tooth affected.
Age: 16.0
Sex: M
Vaccine: IPV, MENB, TD
Symptoms: Syncope
Clinical narrative: pt stood up and walked out the door, experienced vasovagal syncope ~2 minutes after vaccination while still in clinic waiting room. Pt had not eaten or drank anything all day.  Pt struck head, experienced laceration above right eye, and bleeding to right front tooth, unclear if tooth affected.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was never vaccinated for COVID-19. Came into the office for a first time COVID vaccine, and was mistakenly given the Moderna Bivalent Booster vaccine, instead of the Monovalent (which we do not carry)
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, COVID-19, Cardiogenic shock, Condition aggravated, Coronary artery disease
Clinical narrative: I am the epidemiologist reporting on behalf of 76 year-old male patient. Patient received five doses of the Pfizer vaccine (Dose 1 = 1/27/21, Dose 2 =2/17/21, Dose 3 = 10/7/21, Dose 4 = 4/22/22, and Dose 5 (bivalent) = 10/26/22). On 11/2/22, seven (7) days after receiving the Pfizer bivalent booster, patient tested positive for COVID via PCR after being admitted to hospital (reasons not specified). Case?s wife told contact tracer that patient is ?very, very ill?. The patient died on 11/3/22 (8 days after booster) and the cause of death is listed as multiorgan failure (primary), cardiogenic shock (secondary), acute myocardial infarction (secondary), and coronary artery disease (secondary). Case is currently being enumerated as a death due to COVID-19 although it is unclear to what extent COVID and/or vaccination may have contributed to the patient?s condition. I have limited information on the patient?s health status prior to this event.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death, Illness, Multiple organ dysfunction syndrome, SARS-CoV-2 test positive
Clinical narrative: I am the epidemiologist reporting on behalf of 76 year-old male patient. Patient received five doses of the Pfizer vaccine (Dose 1 = 1/27/21, Dose 2 =2/17/21, Dose 3 = 10/7/21, Dose 4 = 4/22/22, and Dose 5 (bivalent) = 10/26/22). On 11/2/22, seven (7) days after receiving the Pfizer bivalent booster, patient tested positive for COVID via PCR after being admitted to hospital (reasons not specified). Case?s wife told contact tracer that patient is ?very, very ill?. The patient died on 11/3/22 (8 days after booster) and the cause of death is listed as multiorgan failure (primary), cardiogenic shock (secondary), acute myocardial infarction (secondary), and coronary artery disease (secondary). Case is currently being enumerated as a death due to COVID-19 although it is unclear to what extent COVID and/or vaccination may have contributed to the patient?s condition. I have limited information on the patient?s health status prior to this event.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Immediate post-injection reaction, Mobility decreased, Pain in extremity
Clinical narrative: On the Fifteenth of November 2021 immediately after the dose I had a two inch red mark or whelp and my arm was quite painful and my entire shoulder was in pain as well and the pain has never really went away like something is wrong  in my should this condition has progressed to the point where I can no longer raise my shoulder .My doctor will order an MRI on my next visit and I am currently taking PT as well.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: On the Fifteenth of November 2021 immediately after the dose I had a two inch red mark or whelp and my arm was quite painful and my entire shoulder was in pain as well and the pain has never really went away like something is wrong  in my should this condition has progressed to the point where I can no longer raise my shoulder .My doctor will order an MRI on my next visit and I am currently taking PT as well.
Age: 29.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient received covid booster when she should have received a flu shot.  Patient presented covid card at the time of vaccination and told vaccinator after that she was here for the flu shot
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Neuralgia, Pain, Rash
Clinical narrative: rash to arm with bruising nerve pain, soreness
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was never vaccinated for COVID-19. Came into the office for a first time COVID vaccine, and was mistakenly given the Moderna Bivalent Booster vaccine, instead of the Monovalent (which we do not carry)
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Ear discomfort, Headache, Hyperacusis, Nausea, Tinnitus
Clinical narrative: Significant Tinnitus, pressure in ears, headache, nausea, sensitivity to noise
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Malaise
Clinical narrative: I did not have a reaction to the vaccine. On 07/05/2022, I wasn't feeling well with fatigue, muscle aches, chills, cough and sore throat. On 07/06/2022, I tested positive for COVID-19. I contacted my doctor and was not given a prescription for PAXLOVID because of my age. I am a physician and prescribed myself PAXLOVID.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I did not have a reaction to the vaccine. On 07/05/2022, I wasn't feeling well with fatigue, muscle aches, chills, cough and sore throat. On 07/06/2022, I tested positive for COVID-19. I contacted my doctor and was not given a prescription for PAXLOVID because of my age. I am a physician and prescribed myself PAXLOVID.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itchy, red bumps on torso
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Monoplegia, Walking aid user
Clinical narrative: Adverse issues - leg paralysis, both legs, unable to walk without walker.   Treatment - rest & icing.   Outcome - no improvement so far
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bronchitis, COVID-19, Cough, Fatigue, Poor quality sleep
Clinical narrative: My sister who had been traveling, came to stay with me. She had a bit of a cough, but we didn't think much of it until it had lasted around 3 days. At that point, on 10/12/2022, we each tested ourselves for COVID-19 and were positive. I contacted my doctor and had a phone consultation. He called in a prescription for PAXLOVID. I began taking that the day after I tested positive. I was feeling really tired but couldn't nap. I had a lot of head congestion and an unproductive cough. However, after the five days of the PAXLOVID, I was feeling fine. I continued to mask for the following five days. I did still have some congestion but was feeling good. After the additional five days of isolating, I felt much better and was able to go to the grocery store. After the recommended isolation time, I tested myself again and was negative. Three days after testing negative, I wanted to go see my elderly mother, so I tested myself again and I was actually positive. I went to my doctor's office to do a drive thru COVID-19 test and it was also positive. Two days before I tested positive again, I had spoken with my doctor who told me that it sounded like I was developing bronchitis. He called in a Z PAK and prednisone which I took to completion. When I tested positive again, my doctor told me that I could not take the PAXLOVID again, so he suggested a cold and flu medication and MUCINEX. 12 days after testing positive again, I was feeling better and tested negative again. I am still feeling a bit of fatigue in the evenings, but I am very active. Also, through all of this illness, I have not been able to sleep well. I have been tired, but unable to sleep through the night. I will sleep for a few hours and wake up and have trouble going back to sleep. Last night was the first night in some time that I was able to sleep for 5-6 hours straight.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Sleep disorder
Clinical narrative: My sister who had been traveling, came to stay with me. She had a bit of a cough, but we didn't think much of it until it had lasted around 3 days. At that point, on 10/12/2022, we each tested ourselves for COVID-19 and were positive. I contacted my doctor and had a phone consultation. He called in a prescription for PAXLOVID. I began taking that the day after I tested positive. I was feeling really tired but couldn't nap. I had a lot of head congestion and an unproductive cough. However, after the five days of the PAXLOVID, I was feeling fine. I continued to mask for the following five days. I did still have some congestion but was feeling good. After the additional five days of isolating, I felt much better and was able to go to the grocery store. After the recommended isolation time, I tested myself again and was negative. Three days after testing negative, I wanted to go see my elderly mother, so I tested myself again and I was actually positive. I went to my doctor's office to do a drive thru COVID-19 test and it was also positive. Two days before I tested positive again, I had spoken with my doctor who told me that it sounded like I was developing bronchitis. He called in a Z PAK and prednisone which I took to completion. When I tested positive again, my doctor told me that I could not take the PAXLOVID again, so he suggested a cold and flu medication and MUCINEX. 12 days after testing positive again, I was feeling better and tested negative again. I am still feeling a bit of fatigue in the evenings, but I am very active. Also, through all of this illness, I have not been able to sleep well. I have been tired, but unable to sleep through the night. I will sleep for a few hours and wake up and have trouble going back to sleep. Last night was the first night in some time that I was able to sleep for 5-6 hours straight.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Hypersensitivity, Swelling face, Urticaria
Clinical narrative: Was exhausted and couldn't keep my eyes open for more than four hours until Tuesday, experienced severe facial swelling and hives on neck and chest consistent with an allergic reaction begining on Satuday through Tuesday morning despite taking OTC antihistamines. Saught medical treatment Tuesday morning where I received a 6-day sterioid treatment. Hives continued through Tuesday night and swelling / skin seems to have gone back to 80% normal by Wednesday morning.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Paraesthesia, Pruritus, Visual impairment
Clinical narrative: Injection given at 0915 and at 0918 employee had complaint of vision disturbance and light headedness. Employee laid down on bed and stated symptoms subsiding at 0920. At 0930 employee states "itchy/tingling/pin prick sensation all over body"
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, C-reactive protein, Full blood count, Hyperaesthesia, Hypersensitivity
Clinical narrative: At approximately 4am on Sunday 11/13 (~6 days post vaccination) I woke up with right knee pain and swelling. Later that same day, the pain and swelling spread to my bilateral shoulders, bilateral knees, bilateral ankles, bilateral wrists, and finger joints. I also developed welts on my skin when anything touched it, as well as a diffuse red macular rash on my chest on neck. I felt feverish but did not check my temperature. On Tuesday 11/15 I went to the ER and was diagnosed with a suspect delayed hypersensitivity reaction to the booster. I was given IV fluids, steroids, and antihistamines. I was started on a steroid and antihistamine course and symptoms are resolving at the time of writing this report, but are still moderately present. The ER I presented to was ER. The booster I received on 11/7 was my 4th vaccination overall -- my others were the Pfizer vaccines done on 12/20/2020, 1/6/2021, and 10/13/2021.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inflammatory marker test, Joint swelling, Metabolic function test, Pain in extremity, Peripheral swelling
Clinical narrative: At approximately 4am on Sunday 11/13 (~6 days post vaccination) I woke up with right knee pain and swelling. Later that same day, the pain and swelling spread to my bilateral shoulders, bilateral knees, bilateral ankles, bilateral wrists, and finger joints. I also developed welts on my skin when anything touched it, as well as a diffuse red macular rash on my chest on neck. I felt feverish but did not check my temperature. On Tuesday 11/15 I went to the ER and was diagnosed with a suspect delayed hypersensitivity reaction to the booster. I was given IV fluids, steroids, and antihistamines. I was started on a steroid and antihistamine course and symptoms are resolving at the time of writing this report, but are still moderately present. The ER I presented to was ER. The booster I received on 11/7 was my 4th vaccination overall -- my others were the Pfizer vaccines done on 12/20/2020, 1/6/2021, and 10/13/2021.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Rash, Rash erythematous, Rash macular, Red blood cell sedimentation rate
Clinical narrative: At approximately 4am on Sunday 11/13 (~6 days post vaccination) I woke up with right knee pain and swelling. Later that same day, the pain and swelling spread to my bilateral shoulders, bilateral knees, bilateral ankles, bilateral wrists, and finger joints. I also developed welts on my skin when anything touched it, as well as a diffuse red macular rash on my chest on neck. I felt feverish but did not check my temperature. On Tuesday 11/15 I went to the ER and was diagnosed with a suspect delayed hypersensitivity reaction to the booster. I was given IV fluids, steroids, and antihistamines. I was started on a steroid and antihistamine course and symptoms are resolving at the time of writing this report, but are still moderately present. The ER I presented to was ER. The booster I received on 11/7 was my 4th vaccination overall -- my others were the Pfizer vaccines done on 12/20/2020, 1/6/2021, and 10/13/2021.