chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: COVID19, FLU4, COVID19, FLU3
Symptoms: Accidental overdose, Incorrect dose administered, Vaccination site erythema
Clinical narrative: The medical assistant that prepared and administered the COVID vaccine diluted the vaccine in the vial and then drew up the entire vial which is a three dose vial. She administered all three doses from the vial at once. It is estimated that patient received 9-10 mcg of vaccine rather than the 3 mcg dose indicated for his age. Additionally, the vaccine was administered on the far lateral thigh rather than the correct location. The next day, he developed a fever of 100.5 prior to receiving ibuprofen/Tylenol for the next few days. He also experienced significant body aches, fatigue, and irritability. He developed a significant red and hot injection site reaction that progressed from 24-48 hours after the injection before nearly completely resolving 72 hours after the vaccine was administered.  I do have pictures of the rash and the progression if needed. About 72 hours after the injection, he had mostly returned to normal.
Age: 25.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Premature delivery, Premature labour, Twin pregnancy
Clinical narrative: Pre-term delivery. Pregnancy with di/di twins, no complications noted throughout pregnancy. Water broke and labor started day after vaccine given. Was set to deliver 38w2d on November 21 2023. Delivered at 34w0d. Baby A birth weight 4lb 7oz Baby B birth weight 4lb 14oz
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Diarrhoea, Fatigue, Hypertension
Clinical narrative: 1 week after vaccine,  I still feel very sick and exhausted with sore throat, swollen glands making me feel crummy, diarrhea, nausea, anxiety, high blood pressure, achey, chills
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Nausea, Oropharyngeal pain, Pain
Clinical narrative: 1 week after vaccine,  I still feel very sick and exhausted with sore throat, swollen glands making me feel crummy, diarrhea, nausea, anxiety, high blood pressure, achey, chills
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: I woke up at approx. 7:30 AM on 7-4-23 with uncontrollable shaking. I called EMS. The ambulance drivers said I needed a Benadryl but wouldn't give me one unless I agreed to be transported. I refused, they left, I got a Benadryl from a neighbor and slept it off. On 7-5-23, I woke up shaking again but it quickly subsided. There were no other issues.
Age: 1.5
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Vaccine was not diluted before 0.3mL was administered from MDV of 3 doses  No known adverse reaction As of 10/21/23 ~5pm - No reported side effects                          per mother
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, General symptom, Headache, Immunisation reaction
Clinical narrative: New daily persistent headache
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Migraine
Clinical narrative: New daily persistent headache
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: New daily persistent headache
Clinical narrative: New daily persistent headache
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: Syncope
Clinical narrative: Loss of feeling in lower back which then spread to the legs. Could not feel legs. Couldn't walk or stand up. Taken to the emergency room and was diagnosed as adverse reaction to the vaccinations. Followed up with PCP and given the same diagnosis. Fell over in bathroom and had family navigate getting me up off the floor.
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: C-reactive protein, Differential white blood cell count, Dysstasia, Fall, Full blood count
Clinical narrative: Loss of feeling in lower back which then spread to the legs. Could not feel legs. Couldn't walk or stand up. Taken to the emergency room and was diagnosed as adverse reaction to the vaccinations. Followed up with PCP and given the same diagnosis. Fell over in bathroom and had family navigate getting me up off the floor.
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: Gait inability, Hypoaesthesia, Immunisation reaction, Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Loss of feeling in lower back which then spread to the legs. Could not feel legs. Couldn't walk or stand up. Taken to the emergency room and was diagnosed as adverse reaction to the vaccinations. Followed up with PCP and given the same diagnosis. Fell over in bathroom and had family navigate getting me up off the floor.
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: Respiratory pathogen panel, Urine analysis
Clinical narrative: Loss of feeling in lower back which then spread to the legs. Could not feel legs. Couldn't walk or stand up. Taken to the emergency room and was diagnosed as adverse reaction to the vaccinations. Followed up with PCP and given the same diagnosis. Fell over in bathroom and had family navigate getting me up off the floor.
Age: 71.0
Sex: M
Vaccine: FLU4, PNC20, FLUX, PPV, FLU4, PNC20
Symptoms: Blood test, Hypoaesthesia
Clinical narrative: Loss of feeling in lower back which then spread to the legs. Could not feel legs. Couldn't walk or stand up. Taken to the emergency room and was diagnosed as adverse reaction to the vaccinations. Followed up with PCP and given the same diagnosis. Fell over in bathroom and had family navigate getting me up off the floor.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX had undergone TE and it was administered after the TE.; No reported adverse reactions; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.      On an unknown date, the patient was vaccinated with an improper store dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # w039294, expiration date 11-DEC-2024  for prophylaxis (dose and route were not reported) (product storage error). No reported adverse reactions and nor product quality complaint.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; HCP calling to report AE for patient who received improperly stored PROQUAD; This spontaneous report was received from other health professional, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 04-OCT-2023, the patient was vaccinated with an improperly stored dose of with improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, for prophylaxis (lot number: 05-JAN-2025, which has been verified to be valid, expiration date not reported, but upon internal validation established as 05-JAN-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered dose was stored at a temperature of -9.8 degrees Celsius (C), during a time frame of 12 minutes (product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.; Sender's Comments:  US-009507513-2310USA007934:
Age: 8.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered to a patient under the age of 9; soreness around the area of administration; This spontaneous report was received from a healthcare professional (HCP) referring to an 8-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were unknown.   On 17-OCT-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age).  On an unknown date in October 2023, the patient developed soreness around the area of administration. The outcome of the event was unknown. The causal relationship between the event and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: patient had already received the whole series of Havrix . HCP reports that the patient accidently received a 3dr dose of Havrix today; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 3-year-old male patient who received HAV (Havrix 720 Junior) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis.   Previously administered products included Havrix 720 Junior (received whole series).   On 13-OCT-2023, the patient received the 3rd dose of Havrix 720 Junior (intramuscular). On 13-OCT-2023, an unknown time after receiving Havrix 720 Junior, the patient experienced extra dose administered (Verbatim: patient had already received the whole series of Havrix . HCP reports that the patient accidently received a 3dr dose of Havrix today).  The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-OCT-2023 The reporter was a nurse (health care professional).  The HCP reported patient had already received the whole series of Havrix and accidently received a 3rd dose of Havrix on the day of reporting, which led to extra dose administered. No additional information was provided.  The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: patient hasn't yet received dose 2.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 46-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 1st May 2023 with batch number 79S54 and expiry date 4th April 2025).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: patient hasn't yet received dose 2.). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-OCT-2023 Registered nurse (RN) reported patient had not yet received dose 2. Lot and expiration date were for dose 1, since 2 had not been given yet. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Engerix-B, which led to incomplete course of vaccination.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Hiberix was reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Hiberix was reconstituted with sterile water).  The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 13-OCT-2023 The nurse reported Hiberix was reconstituted with sterile water and administered to a patient. Details about vaccine and patient were asked and declined; hcp stated was not at facility so had no access to the information. The Vaccine Administration Facility is the same as Primary Reporter. HCP stated sterile water used to reconstitute Hiberix was the diluent that comes with Merck´s MMR vaccine, which led to wrong solution used in drug reconstitution. The reporter consented to follow up via email agreed.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: patient received a fourth dose of HepB (Engerix-B).; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received HBV (Engerix B) (batch number A9349, expiry date 19-APR-2024) for prophylaxis.   On 02-OCT-2023, the patient received the 4th dose of Engerix B. On 02-OCT-2023, an unknown time after receiving Engerix B, the patient experienced extra dose administered (Verbatim: patient received a fourth dose of HepB (Engerix-B).). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-OCT-2023 A pharmacist reported that a patient received a fourth dose of Hepatitis B (Engerix-B), which led to extra dose administered. The health care professional (HCP) asked for any side effects. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Pyrexia
Clinical narrative: malaise; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (malaise) and PYREXIA (low grade fever) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU Shot on 27-Sep-2023. Past adverse reactions to the above products included No adverse event with FLU Shot. Concurrent medical conditions included Tremor and Insomnia. Concomitant products included PROPRANOLOL for Tremor.    On 13-Oct-2023 at 3:10 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Oct-2023, the patient experienced MALAISE (malaise) and PYREXIA (low grade fever). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, MALAISE (malaise) and PYREXIA (low grade fever) had resolved.            Patient had Reflux disease. Patient's all previous shots were from Moderna and she never had any problems in the past.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Feeling cold, Pruritus, Rash, Sleep disorder
Clinical narrative: Patient had itching on the Left arm; Patient had rash on the Left arm; Rash on neck, back, and legs; the patient had itching neck, back, and legs; cold; fever; patient is so upset; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (the patient had itching neck, back, and legs), NASOPHARYNGITIS (cold), FEELING ABNORMAL (patient is so upset), INJECTION SITE PRURITUS (Patient had itching on the Left arm) and VACCINATION SITE RASH (Patient had rash on the Left arm) in a 31-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer Vaccine; for COVID-19 prophylaxis: Moderna Covid-19 vaccine (2 doses). Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine and Pfizer Vaccine.    On 13-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PYREXIA (fever). On 15-Oct-2023, the patient experienced PRURITUS (the patient had itching neck, back, and legs), NASOPHARYNGITIS (cold), INJECTION SITE PRURITUS (Patient had itching on the Left arm), VACCINATION SITE RASH (Patient had rash on the Left arm) and RASH (Rash on neck, back, and legs). In October 2023, the patient experienced FEELING ABNORMAL (patient is so upset). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (the patient had itching neck, back, and legs), NASOPHARYNGITIS (cold), INJECTION SITE PRURITUS (Patient had itching on the Left arm), VACCINATION SITE RASH (Patient had rash on the Left arm) and RASH (Rash on neck, back, and legs) had not resolved, FEELING ABNORMAL (patient is so upset) outcome was unknown and PYREXIA (fever) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient stated that, still battling the rash and could not sleep on her back. She felt a little cold, tried to place a blanket on her but it makes her itch, so she had to remove the blanket. She can could not wear long sleeve because of the rash and itching. She has to go to school and all that, but she couldn't even do anything. Her situation was horrible.  The cream has not improved her situation. Urgent care said it was a side effect of the vaccine and it may take a few weeks for it to go away. She was also taking Benadryl, but it was not helping. She bought Allegra.   Reporter did not allow further contact
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD QIV was administered to a 20 month old infant with no reported adverse event; patient did not get the full 0.7mL so probably it was 0.5mL with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 20 months old male patient who was administered Influenza Quadrival A-B High dose HV Vaccine [Fluzone High-dose Quadrivalent] with no reported adverse event and patient did not get the full 0.7ml so probably it was 0.5ml 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 MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination and Chicken Pox vaccine.  On 12-Oct-2023, the patient of 20 months did not get the full 0.7ml so probably it was 0.5ml  dose of suspect Influenza Quadrival A-B High dose HV Vaccine (lot U8156DA, Expiry date: 30-Jun-2024 with unknown strength and form) via intramuscular route in the right thigh as prophylactic vaccination with no reported adverse event (incorrect dose administered) (product administered to patient of inappropriate age) (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.
Sex: M
Vaccine: TD
Symptoms: Administration site laceration, Expired product administered, No adverse event
Clinical narrative: received an expired dose of tenivac with no reported adverse event; Initial information received on 13-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age male patient who had received an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Oct-2023, the patient received an expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot number, strength, dosage- not reported) (expiry date- 24-SEP-2023) via unknown route in unknown administration site for lacerations (Skin laceration) with no reported adverse event (expired product administered) (latency- same day). Information on the batch number was requested.  Reportedly, Caller wanted to know about what to do next. Caller received the TENIVAC on 12Oct2023, due to consumer having some lacerations.  Action taken 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: FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administering the product in the wrong route with no adverse event; Initial information was received on 13-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient to whom influenza quadrival A-B vaccine [Fluzone QIV] was administered in the wrong route with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Oct-2023, the patient received an unknown dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot UT8109KA, expiry date: 30-Jun-2024, strength, was unknown) via unknown route in unknown administration site for Influenza(Influenza Immunization) and had administering the product in the wrong route with no adverse event (incorrect route of product administration) (latency: same day).  It was reported "Nurse declined to provide any patient information. Only saying it was given a couple of days ago. FLUZONE QUADRIVALENT "  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: 73.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Fluzone Quad instead of Fluzone HD with no reported adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 73 years old female patient who received Influenza Quadrival A-B Vaccine [Fluzone Qiv] instead of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Oct-2023, the patient received suspect Influenza Quadrival A-B Vaccine, suspension for injection (strength: unknown) [Fluzone Qiv] (lot U8096BA, expiry date: 03-Jun-2024, via intramuscular in left deltoid for prophylactic vaccination (immunization), instead of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose], Suspension for injection in pre-filled syringe (strength: unknown) (lot number, expiry date: not reported via unknown route in unknown administration site for prophylactic vaccination (immunization), with no reported adverse event (wrong product administered) (latency: same day). Information on the batch number was requested for fluzone high dose.  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Fluzone high dose QIV was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event; Fluzone high dose QIV was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA321113(CLUSTER), 2023SA319649(CLUSTER), 2023SA321127(CLUSTER), 2023SA318839(CLUSTER) and 2023SA319055(CLUSTER).  This case involves a 73 years old male patient who was administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] and was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received a dose of 0.7 ml of suspect influenza quadrival A-B high dose HV vaccine (lot: U8162BA; strength: high dose; expiry date: Jun-2024) (formulation unknown) via intramuscular route in left deltoid for Immunization.  On 16-Oct-2023 the influenza quadrival A-B high dose HV vaccine was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  Action taken was 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: 68.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Fluzone high dose QIV was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event; Fluzone high dose QIV was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA318835(CLUSTER), 2023SA318839(CLUSTER), 2023SA321113(CLUSTER), 2023SA321127(CLUSTER) and 2023SA319055(CLUSTER).  This case involves a 68 years old female patient who was administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] and was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received a dose of 0.7 ml once of suspect influenza quadrival A-B high dose HV vaccine (lot: U8162BA; strength: high dose; expiry date: Jun-2024) (formulation unknown) via intramuscular route in left deltoid for Immunization.  On 16-Oct-2023 the influenza quadrival A-B high dose HV vaccine was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  Action taken was 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: 20.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: fluzone qiv np was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and administered post excursion with no reported adverse event; fluzone qiv np was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and administered post excursion with no reported adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA318835(CLUSTER), 2023SA318839(CLUSTER), 2023SA319649(CLUSTER), 2023SA321113(CLUSTER) and 2023SA321127(CLUSTER).  This case involves a 20 years old female patient who was administered influenza quadrival A-B vaccine [Fluzone QIV] which was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received a dose of 0.5 ml once of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: U8192BA; expiry date: Jun-2024; strength: standard) via intramuscular route in the right deltoid for Immunization.  On 16-Oct-2023 influenza quadrival A-B vaccine was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and administered post excursion with no reported adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  Action taken was 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: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion for punctured IPOL, fridge has been dipping to 35 F occasionally and product reached 35 F lowest temperature reached 33.98 F (1.1 C) with no reported adverse event; IPOL has been administered post excursion with no reported adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 years old male patient and reporter reported temperature excursion for punctured IPV (VERO) [IPOL], fridge has been dipping to 35 f occasionally and product reached 35 f lowest temperature reached 33.98 f (1.1 c) with no reported adverse event and IPOL has been administered post excursion 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 measles vaccine live (enders-edmonston), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (PROQUAD) for Immunisation; influenza vaccine live reassort 3V (Flumist) for Immunisation; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Immunisation.  Caller reported that punctured IPV (VERO) was exposed to temperature excursion, fridge has been dipping to 35 f occasionally and product reached 35 f lowest temperature reached 33.98 f (1.1 c) with no reported adverse event (product storage error) (unknown latency).  On 12-Oct-2023, the patient was administered a standard dose 4 of suspect IPV (VERO) Suspension for injection at a dose of 0.5 mL (lot W1A191M, expiry date- 16-FEB-2025 ) via intramuscular route in the left thigh for Immunization post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Caller stated that their fridge has been dipping to 35 F occasionally. The caller was unsure how often or how long the product reached 35 F. She said the temperature would come right back up. However, on 11OCT2023, the lowest temperature reached 33.98 F (1.1 C). The caller was unsure how long the product was out of range.   Action taken was 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: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Loss of personal independence in daily activities, Myocarditis, Peripheral swelling
Clinical narrative: Heart failure. Myocarditis.  I was perfectly fine, but then started having swelling of my lower extremities and by June I wasn't able to fit into my shoes with my socks on.  I am now on Valsartan, metoprolol, chlorthalidone and furosemide. I was taking nothing and was absolutely fine prior to the vaccine.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Fatigue, Headache, Nausea, Pain, Rash
Clinical narrative: Pt woke complaining of headache, body ache (particularly his arms), fatigue and severe nausea.  He did not vomit.  Sxs lasted 2 days and were followed on the 3rd day by a patchy, hive-like rash (without raised welts) on the whole upper right arm (MCV side).  No swelling.  Rash lasted 2 more days, then self resolved.
Age: 22.0
Sex: M
Vaccine: JEV1
Symptoms: Cardio-respiratory arrest, Feeling cold, Hyperhidrosis, Pallor, Unresponsive to stimuli
Clinical narrative: 22 y/o male came in the clinic for his TB skin test and JEV # 2. During check-in/screening, he mentioned that he has passed out previously after getting his immunizations in the past. Instructed to lean his back on the wall and raise his feet on the bed during vaccine administration. TB skin test placed on LFA and JEV # 2 administered on left deltoid without incident. Patient verbalized that he was "okay" after administration, talked to the patient for a couple more minutes then instructed him to seat in the waiting room and alert the immunization's staff if he starts to feel unwell, verbalized understanding. About 5 mins later, patient was observed to be very pale. Approached patient, observed to be in a sitting position very pale, cool to touch, diaphoretic, unresponsive, a code blue was called. While waiting for the code team, patient regained consciousness, became alert/oriented, assessed by PA and brought to acute care clinic for further evaluation.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vial contains .5ml and is labeled as "single dose", staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vial contains .5ml and is labeled as "single dose", staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vial contains .5ml and is labeled as "single dose", staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered, No adverse event, Product dispensing error
Clinical narrative: Vial contains .5ml and is labeled as "single dose", staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vial contains .5ml and is labeled as "single dose", staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vial contains .5ml and is labeled as "single dose", staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vial contains .5ml and is labeled as "single dose", staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vial contains .5ml and is labeled as "single dose", staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product dispensing error
Clinical narrative: Vial contains .5ml and is labeled as "single dose", staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Age: 4.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: Child received flu vaccine in one thigh and COVID vaccine in the other thigh. At site of one of these injections (unsure which vaccine), large 2-2.5? diameter), slightly raised, and warm-to-the-touch  redness/swelling occurred (about 27 hours after vaccine). At about 35 hours post vaccine, child experienced vomiting.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Injection site reaction, Malaise, Muscle spasms, Myalgia, Neuralgia
Clinical narrative: spasms on his left arm; nerve pain; general malaise; fever; muscle aches; This non-serious case was reported by a nurse via call center representative and described the occurrence of general malaise in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-SEP-2023, the patient received Arexvy (intramuscular, left arm). On 20-SEP-2023, less than a day after receiving Arexvy, the patient experienced general malaise (Verbatim: general malaise), fever (Verbatim: fever) and muscle pain (Verbatim: muscle aches). On an unknown date, the patient experienced spasms (Verbatim: spasms on his left arm) and nerve pain (Verbatim: nerve pain).  The outcome of the general malaise, fever and muscle pain were resolved (duration 2 days) and the outcome of the spasms and nerve pain were not resolved.   It was unknown if the reporter considered the general malaise, fever, muscle pain, spasms and nerve pain to be related to Arexvy.     It was unknown if the company considered the general malaise, fever, muscle pain, spasms and nerve pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-OCT-2023 The reporter reported that the patient received Arexvy vaccine and on first day of vaccination patient had general malaise, fever, muscle aches, which was lasted for 2 days. The reporter also reported that the patient had spasms on his left arm and nerve pain from the left deltoid area all the way down to the fingers, which was not resolved. Not all information was available. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: spasms on his left arm; nerve pain; general malaise; fever; muscle aches; This non-serious case was reported by a nurse via call center representative and described the occurrence of general malaise in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-SEP-2023, the patient received Arexvy (intramuscular, left arm). On 20-SEP-2023, less than a day after receiving Arexvy, the patient experienced general malaise (Verbatim: general malaise), fever (Verbatim: fever) and muscle pain (Verbatim: muscle aches). On an unknown date, the patient experienced spasms (Verbatim: spasms on his left arm) and nerve pain (Verbatim: nerve pain).  The outcome of the general malaise, fever and muscle pain were resolved (duration 2 days) and the outcome of the spasms and nerve pain were not resolved.   It was unknown if the reporter considered the general malaise, fever, muscle pain, spasms and nerve pain to be related to Arexvy.     It was unknown if the company considered the general malaise, fever, muscle pain, spasms and nerve pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-OCT-2023 The reporter reported that the patient received Arexvy vaccine and on first day of vaccination patient had general malaise, fever, muscle aches, which was lasted for 2 days. The reporter also reported that the patient had spasms on his left arm and nerve pain from the left deltoid area all the way down to the fingers, which was not resolved. Not all information was available. The reporter consented to follow up.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: medication error due to accidental administration of an expired PENTACEL dose with no reported adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 months old female patient who experienced medication error due to accidental administration of an expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) (Frequency = once) (Strength = standard) (lot UJ791AA and expiry date: 10-Oct-2023) via unknown route in the left thigh for immunization.  On 16-Oct-2023, the patient experience medication error due to accidental administration of an expired pentacel dose with no reported adverse event (expired product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  It was reported that "Medical assistant states they inadvertently administered an expired PENTACEL dose to one of their patient today. She asks for manufacturer's guidelines and asks how soon can they re-vaccinate."  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 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: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vial contains .5ml and is labeled as "single dose", staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered, No adverse event, Product dispensing error
Clinical narrative: Vial contains .5ml and is labeled as "single dose", staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Seizure
Clinical narrative: Within about 24 hours of receiving the vaccine patient experienced a seizure.  Patient has been stable on his current medication for many months without any seizure activity and denies any changes to his regiment prior to acute seizure activity.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Extra dose administered, Headache
Clinical narrative: vaccinator inadvertantly administered a Moderna spikevax into left and right arms.  Patient received 2 doses of covid vaccination patient was made aware of error.  was monitored for 15 minutes and was ok.  1 hr later patient called pharmacy of feeling a headache and woozie but no problems breathing or elevated heart rate or other symptoms.  Pharmacist recommended some tylenol..  Pharmacy called patient the next morning and patient was feeling much better