chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Magnetic resonance imaging, Malaise, Pain
Clinical narrative: Pt reports that upon administration of Shingrix shot in Left Arm he experienced sharp pain. He felt sick for 2 days and the injection site was swollen and red. This much was normal. However, the swelling continued and his entire left arm for the past 2 weeks has been swollen without resolution and tender to the touch. He had not told the pharmacy staff of his previous lymph node removal in the left arm and side and has never had an issue after an immunization there. He has been evaluated by Dr who had him get a series of MRI's for which he is awaiting the results.
Age: 79.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Pt reports that upon administration of Shingrix shot in Left Arm he experienced sharp pain. He felt sick for 2 days and the injection site was swollen and red. This much was normal. However, the swelling continued and his entire left arm for the past 2 weeks has been swollen without resolution and tender to the touch. He had not told the pharmacy staff of his previous lymph node removal in the left arm and side and has never had an issue after an immunization there. He has been evaluated by Dr who had him get a series of MRI's for which he is awaiting the results.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Hypoglycaemia, SARS-CoV-2 test positive, Type 1 diabetes mellitus
Clinical narrative: Date of Admission: 7/31/2023   Medical Diagnosis: Covid-19 infection, DM1 hypoglycemia   Date of Surgery/Procedure: not applicable    Precautions: Enhanced Respiratory Precautions (Droplet + Contact + Eye protection)   PPE Worn:  Provider: Gown and PAPR Patient masked? Yes   Covid-19 Testing:  Lab Results Component Value Date/Time   CORONAVIRUS COVID DETECTED (A) 07/31/2023 02:14 AM
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Sore arm, redness and swelling
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Myalgia, Nausea, Pain in extremity, Vomiting
Clinical narrative: Patient received shot around 3:00pm on 8/14 and muscle soreness in the arm was felt that evening.  It was the next day (8/15/23) around noon that she started feeling nausea with mild fever and eventually vomited a few times.  Patient felt better later that night.  Fever was less than 100 but above 99.  She called around 6:55pm on 8/16/23 to report the symptoms.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, RV5, UNK, DTPPVHBHPB, RVX, UNK
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient develop Red color rash over trunk and chest wall.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Syncope
Clinical narrative: patient felt light headed about 3 minutes after administration of immunization. She fainted and I caught her and lowered her to the floor with her mom. I elevated her legs and she was alert very quickly in about 10 seconds. She remained on the floor for approximately 5 minutes with her legs elevated and ice on the back of her neck. She then sat up and moved to a chair where she said she was feeling fine. Had patient sit for approximately 10-15 minutes. She stated that she was fine. Had patient stand for a few minutes with no adverse reaction and said she was fine. Her mother then took her home. I spoke to patients mom at 8:10pm and said she was doing well with no additional adverse reaction.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Fatigue, Headache, Poor quality sleep
Clinical narrative: Chills in the evening and headache.  Poor sleep.  Headache the next day and fatigue.
Age: 8.0
Sex: F
Vaccine: COVID19-2, COVID19-2, HEP, IPV, TDAP
Symptoms: Extra dose administered
Clinical narrative: NONE LISTED
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: After the vaccines I did not experience any pain...then mid March of 2023 I lost my sense of smell and taste up to date..
Age: 20.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pallor, Syncope
Clinical narrative: After about 10 minutes of injection the patient fainted and looked very pale. He was able to sit in a few minutes he took some water and snacks.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: patient reports developing fever w/temp 104.2 with myalgia.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Pt. reports that the muscle of her left deltoid has not recovered from vaccine. She reports consistent pain in the muscle of her arm. Area is lower than shoulder joint. She does not report any altered sensation in the arm.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine with beyond use date of 8/14/23.  Vaccine was given on 8/16/23 around 10:30am but should have been discarded 58hrs prior.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Gait disturbance, Headache, Impaired work ability, Myalgia
Clinical narrative: Headache for about 12 hours; extreme fatigue such that hard to work , needed to take breaks to alt down; extreme muscle soreness particularly in legs and arms . Hard to walk   Lasted for entire day after shot. When I woke up next day, was totally fine. So lasted about 36 hours.
Age: 59.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: RSV vaccine was given to a patient at age 59.  Per patient, no major adverse reaction besides soreness around injection site.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Dyspnoea, Febrile convulsion, Influenza virus test negative, Oxygen saturation decreased, Pyrexia
Clinical narrative: Shortly following, developed fever, then increased work of breathing tmax 100. Then blank/fixed stare, desaturated to 88% Transferred to ER, diagnosed with febrile seizure and viral URI, fever (7/21/23) 7/22/23: Rectal temp 104.1. Fever broke 7/23/22.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: SARS-CoV-2 test negative, Staring, Viral upper respiratory tract infection
Clinical narrative: Shortly following, developed fever, then increased work of breathing tmax 100. Then blank/fixed stare, desaturated to 88% Transferred to ER, diagnosed with febrile seizure and viral URI, fever (7/21/23) 7/22/23: Rectal temp 104.1. Fever broke 7/23/22.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR, PNC15, VARCEL
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: fever a few days after vaccine. The at day four post vaccine administration rash appeared
Age: 27.0
Sex: F
Vaccine: HEP, HPV9, MMR, VARCEL
Symptoms: Impaired work ability, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Patient called 8/16/2023, stated R upper arm/deltoid area, sore, hard to raise all the way up. Started 1st couple of days following the injection and has continued and soreness has not improved. Stated feels bruised. Work at dental office and feels interferring with work. Advised to see PCP and report back. States she is planning on trying to see PCP tomorrowinterfering
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eczema, Impetigo, Rash, Rash erythematous
Clinical narrative: Excessive eczema on my ears and recently a red, bumpy, swollen and sore rash on my skin that I've never experience prior to getting the covid vaccines. I had mild eczema on my neck before, but never on my ears and not severe eczema.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Excessive eczema on my ears and recently a red, bumpy, swollen and sore rash on my skin that I've never experience prior to getting the covid vaccines. I had mild eczema on my neck before, but never on my ears and not severe eczema.
Age: 0.17
Sex: M
Vaccine: UNK, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia
Clinical narrative: Patient was taken to Medical Center on 7/9/2023, had petechiae and after labs of hemoglobin 8.8 & Platelets of 11, was transferred to Hospital. Followed by Dr. of Hematology and Oncology. He was discharged from on 7/14/2023. Had follow up on 7/25/2023.
Age: 0.17
Sex: M
Vaccine: UNK, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haemoglobin, Petechiae, Platelet count decreased
Clinical narrative: Patient was taken to Medical Center on 7/9/2023, had petechiae and after labs of hemoglobin 8.8 & Platelets of 11, was transferred to Hospital. Followed by Dr. of Hematology and Oncology. He was discharged from on 7/14/2023. Had follow up on 7/25/2023.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported; MMR IiIadministered on 6/27/2023 and VARIVAX given on 7/18/2023; This spontaneous report was received from a medical assistant referring to a 13-month-old male patient of unknown gender. The patient was not immune to rubeola based on a titer. The patient's concurrent conditions and concomitant medications were not provided.   On 27-JUN-2023, the patient received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus vaccine, Live (M-M-R II) at a dose of 0.5 milliliter (lot # 3247X was not valid, expiration date reported as 11-MAY-2024; dose number, route of administration, anatomical location were not provided), then on 18-JUL-2023 (also reported as non-simultaneously and within a shorter window of the required 28 days between doses), the patient received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (Inappropriate schedule of product administration) at a dose of 0.5 milliliter administered subcutaneously (single dose vaccine, lot # W025273 was determined to be valid, expiration date 10-AUG-2024; dose number was not provided) at the doctor's office; both administered as prophylaxis. The patient's mother and the company was informed of the occurrence, and the patient had no adverse reaction.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported vaccine administered after temperature excursions.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug allergies or reactions, concurrent conditions, and concomitant drugs were not reported.   On 03-AUG-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) injection (0.5 ml, lot#: W038809, expiration date: 04-JUN-2024; strength was not provided) administered intramuscularly (IM) for prophylaxis. The vaccine administered experienced temperature excursion before of 18.3F for 1 hour and 5 minutes (product storage error). No additional AEs (adverse events) (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient Received First Dose a Month and a Half Ago, Was Refused Second Dose; Initial Report Received on 26-May-2023.  A nurse reported that a 19-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient did not get the second dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unspecified site.   On 26-May-2023, one and a half months after having been vaccinated with HEPLISAV-B, the patient presented to a pharmacy and was told she could not get the second dose because she "isn't 20 years old."   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Serology test, Vaccination failure, Viral titre decreased
Clinical narrative: Received Two Doses of Heplisav-B, Not Immune; Initial report received on 26-May-2023.  A physician's assistant reported that a 24 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient is not immune to hepatitis B after completing the series.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 21-Nov-2022, the patient received the first dose of HEPLISAV-B (Lot # 937230, expiration date 11-Sep-2023, and NDC # 43528-003-01) intramuscularly in the left deltoid. On 19-Dec-2022, the patient received the second dose of HEPLISAV-B (Lot # 937782, expiration date 23-Sep-2023, and NDC # 43528-003-01) intramuscularly in the right deltoid.  On 15-Feb-2023, 59 days after receiving the second dose and 87 days after having received the first dose of HEPLISAV-B, the patient was not immune to hepatitis B. A titer was drawn on 15-Feb-2023 and 21-Feb-2023 and both were low. No other adverse side effects reported. No pregnancy reported.  No additional information was reported.    Company Comment:  The company assessed the event as non-serious. The event was not immunologically confirmed for vaccine failure since the serological marker and titer results were not reported.; Sender's Comments: The company assessed the event as non-serious. The event was not immunologically confirmed for vaccine failure since the serological marker and titer results were not reported.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Pregnancy; Initial Report Received on 30-May-2023.  This spontaneous report was received from the HEPLISAV-B pregnancy registry.  A healthcare professional reported that a female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.  No relevant medical history or concomitant medications were reported.  On 27-Apr-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported).  The patient was 6 months pregnant when she received the first dose.  The patient was at her primary care (PCP) office today (30-May-2023) to receive a second vaccine when she was advised that she received HEPLISAV-B on 27-Apr-2023 in error.   The patient was currently 7 months pregnant.  The patient asked not to be followed up on but said she would consider calling back to learn more about the pregnancy registry.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Received Temperature Excursion HEPLISAV-B; Initial Report Received on 20-Jun-2023  A registered pharmacist reported that a 22-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion.   Medical history and medications at the time of vaccination were not reported. The patient had no known allergies.   On 13-Jun-2023, the patient received a dose of HEPLISAV-B vaccine (Lot # 941579, expiration date 04-Jan-2025, and NDC # 43528-003-05) intramuscularly (injection site not reported). The HEPLISAV B vaccine underwent a temperature excursion, described as being higher than the recommended temperature for 15 hours. No adverse reactions were reported.   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Loss of consciousness
Clinical narrative: Passed Out; Anxiety Attack, Upset; Received First Dose Heplisav-B, 2nd Dose Received Engerix; Initial Report Received on 26-Jun-2023  A registered pharmacist reported that his daughter, a 27-year-old female patient (race and ethnicity unknown), received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose, Engerix-B as the second dose, and passed out.   Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known allergies.   On 23-May-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot # 941591; expiration date 31-Aug-2025, NDC # 43528-003-05; route and injection site not reported).  On 24-Jun-2023, 33 days after having been vaccinated with HEPLISAV-B, the patient was given Engerix B (no details reported) as the second dose. After receiving the Engerix B vaccine, the patient passed out. The reporter believed it was due to the patient being so upset as she just started school and was worried that she would have to start the hepatitis vaccination series all over. The patient had an anxiety attack. There were no other remaining ramifications.  No additional information was provided.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Full Body Hives and hives on neck and cheeks of the face. Very red and hot to the touch. Hives started appearing around 12pm. Then around 7-8p.m. hives became severe. Took all clothing off and applies cool compress all over body. Also gave Benadryl orally. Hives subsided momentarily but the bumps continued to stay for two days.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood iron decreased, Condition aggravated, Dyskinesia, Laboratory test abnormal
Clinical narrative: Involuntary movements to both feet while feet off of floor. Constant and non stopping . It?s getting worse over time and now both arms/hands have the involuntary movements. Trier Gabapentin, Slow Fe, Amantadine, Cogentin.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored administered ROTATEQ; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-JUN-2023, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent temperature excursion for 6 hours 34 minutes 0 seconds in temperature 34.9 F (-17.7 Celsius degrees). On 03-JUL-2023, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent temperature excursion for 7 hours 33 minutes 0 seconds in temperature 51.4 F (10.7 Celsius degrees). On 04-JUL-2023, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent temperature excursion for 24 hours 0 minutes 0 seconds in 51.1 F (10.6 Celsius degrees). On 05-JUL-2023, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent temperature excursion for 9 hours 27 minutes 0 seconds in 50.7 F (10.4 Celsius degrees).  On 06-JUL-2023, this rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to a patient, oral liquid, at dose of 2 milliliter, route of administration defaulted to oral, lot #1968385 was valid, expiration date 22-MAY-2023 for prophylaxis (product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009292:mother case US-009507513-2307USA009885:
Age: 46.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no additional AE; HCP called stating a 46-year-old patient was supposed to receive an MMRII vaccine today but was inadvertently given VARIVAX.; This spontaneous report has been received from a nurse referring to a 46-year-old patient of unknown gender. The patient's concurrent conditions, concomitant medications and drug reactions or allergies were not reported. The patient's only vaccination history was routine childhood vaccines.  On 19-JUL-2023 (reported as today), the patient was supposed to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, lot#, expiry date, route and anatomical location were not reported) but was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (1 dosage form (reported as 1 dose); strength, lot#, expiry date, route and anatomical location were not reported) for prophylaxis (wrong product administered). The patient was monitored for unspecified amount of time post vaccination and was asymptomatic. No additional information was provided. No additional adverse event and no PQC was provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical assistant reported a 19 year old patient received two doses of pediatric VAQTA.; Medical assistant reported a 19 year old patient received two doses of pediatric VAQTA.; no additional AE; This spontaneous report was received from a medical assistant and refers to a 19-year-old patient of unknown gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.  On an unknown date, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (exact dose, route, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient received the second pediatric dose of hepatitis a vaccine, inactivated (VAQTA) lot # 1971534, expiration date 06-OCT-2024 (product administered to patient of inappropriate age, incorrect dose administered) (exact dose, route and anatomical location were not reported). No additional adverse events reported.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix normal, Vaccination failure
Clinical narrative: why her HPV vaccine from 2006 "did not work"; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 31-year-old female patient with a history of MDD.  On an unknown date in 2006, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (exact dose, dose #, route, anatomical location, lot # and expiration date were not reported).  On an unknown date, at the time of the report, she presented to clinic to discuss her pap smear/HPV results. She had a normal pap smear but tested positive for HPV, with her genotype negative for 16, 18, 45  the most high-risk variants. It was determined that the patient should have a repeat HPV/pap in one year based on a 5 year CIN3+ risk of 4.8%. The patient was distraught when she received her results  she felt shame, was concerned about cancer, confused why her HPV vaccine from 2006 "did not work," (vaccination failure) and felt unsure about how to discuss these results with her new heterosexual male partner. She experienced reassurance with education about the transient, common nature of HPV infection and the knowledge that higher risk strains are responsible for the majority of HPV-associated cancers. The outcome of the event was not reported.  The author considered the event of vaccination failure to be related to suspect vaccine.   Literature report.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; HCP calling to report GARDASIL 9 was inadvertently administered after it's expiration date. HCP reports the vaccine had no previous temperature excursions. No side effects reported with the administered dose. No additional AE/PQC.; This spontaneous report was received from Other Health Professional and refers to a 19-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-AUG-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot #U008316, expiration date: 15-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 16-AUG-2023, HCP called to report GARDASIL 9 was inadvertently administered after it's expiration date. HCP reports the vaccine had no previous temperature excursions. No side effects reported with the administered dose. No additional AE/PQC.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received Menveo powder reconstituted with sterile water at the end of June 2023; received Menveo powder reconstituted with sterile water at the end of June 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In JUN-2023, the patient received Menveo. In JUN-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: received Menveo powder reconstituted with sterile water at the end of June 2023) and inappropriate dose of vaccine administered (Verbatim: received Menveo powder reconstituted with sterile water at the end of June 2023). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 14 August 2023: Pharmacist reported a patient received Menveo powder reconstituted with sterile water at the end of June 2023. The reporter consented to follow up. The patient received Menveo powder reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 2-year-old patient received a dose of Kinrix on 31/Jul/2023; 2-year-old patient received a dose of Kinrix on 31/Jul/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 31-JUL-2023, the patient received Kinrix. On 31-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2-year-old patient received a dose of Kinrix on 31/Jul/2023) and inappropriate schedule of vaccine administered (Verbatim: 2-year-old patient received a dose of Kinrix on 31/Jul/2023). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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: 14th August 2023 The medical assistant called to inform that a 2-year-old patient received a dose of Kinrix. The reporter told that it was the 4th dose of the series of the patient, intention was to give dtap and ipv. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  2 years old patient received a dose of Kinrix as 4th dose of the series of the patient which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: August 12 an expired dose of Twinrix was administered for a patient's first dose in the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number J477Y, expiry date 20-MAY-2023) for prophylaxis.   On 12-AUG-2023, the patient received the 1st dose of Twinrix. On 12-AUG-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: August 12 an expired dose of Twinrix was administered for a patient's first dose in the series). The outcome of the expired vaccine used 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 14th August 2023: Pharmacist stated that an expired dose of Twinrix was administered for a patient's first dose in the series. The reporter did not consent to follow-up. The reporter did not have more information and declined follow-up. The patient received an expired dose of Twinrix which led to expired vaccine used.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: HCP stated the system block her from administering a second dose to the patient. HCP stated she was unsure if the system blocked her because of the patient age or insurance.; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (HCP stated the system block her from administering a second dose to the patient. HCP stated she was unsure if the system blocked her because of the patient age or insurance.) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     HCP did not describe any relevant medical history or conditions.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (HCP stated the system block her from administering a second dose to the patient. HCP stated she was unsure if the system blocked her because of the patient age or insurance.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (HCP stated the system block her from administering a second dose to the patient. HCP stated she was unsure if the system blocked her because of the patient age or insurance.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (HCP stated the system block her from administering a second dose to the patient. HCP stated she was unsure if the system blocked her because of the patient age or insurance.).    Concomitant medication not reported.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication not reported.   Reporter did not allow further contact
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Breath holding, Confusional state, Decreased appetite, Feeling abnormal, Irritability
Clinical narrative: My daughter received pentacel for the first time along with Prevnar 13(which she previously had several doses of) for her 15 month check up. She was administered the vaccine at 3:30 p.m. on 08/15/2023. We stopped to pick up a few groceries on the way home and by the time I got her home at 5:30 to put her in the bath, I took of her diaper and saw huge whelts and hives localized to the lower left side of her back. We knew she had not been bit or strung, and that she had not had any new foods so we could rules out any of those things and knew it was a reaction to the new vaccine. She had a breath-holding spell upon adminsitration of the vaccine, was fussy in between the doctor's office and home. Once we identified the reaction, we sent photos to the after hours triage nurse and were told at first that itt probably wasn't a reaction since it was localized, however, then they asked us about the vaccines they did send the photos to the doctor and they advised ibuprofen, we also gave pt. benadryl because we knew she was having an allergic reaction based on other family member's history of anaphylaxis due to other sources. Pt. would not drink her milk that evening before bed. The next morning she seemd okay, but upon waking up from her nap at 11:45 a.m. Pt. seemed very dazed and confused, and her whole body was covered with hives, whelts and her face swollen. I called the doctor's office and they advised that I give her benadryl and take her to the ER since they could not see her right away. I gave her 6mg of benadryl. Upon arrival to the hospital her symptoms were subsiding however she had a 101.4 fever. They took her vitals and gave her the appropriate dose of ibuprofen. The ER doctor was able to rule out any other causes of the reaction and said that it was from the vaccine. However, he kept saying that she had a rash to us and in his notes even though the photos indicate hives and whelts, as well as a high fever. Upon discharging from the ER and returning home at 3:30 p.m., I took pt. out of the car and she was having an outbreak of welts and hives again on her legs and arms. I called the doctor's office again and they told me to give her another dose of benadryl since itw as almost 4 hours since she had it. The doctor then prescribed prednison to take for 6 days to help alleviate pt.'s symptoms.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia, Rash, Swelling face, Urticaria
Clinical narrative: My daughter received pentacel for the first time along with Prevnar 13(which she previously had several doses of) for her 15 month check up. She was administered the vaccine at 3:30 p.m. on 08/15/2023. We stopped to pick up a few groceries on the way home and by the time I got her home at 5:30 to put her in the bath, I took of her diaper and saw huge whelts and hives localized to the lower left side of her back. We knew she had not been bit or strung, and that she had not had any new foods so we could rules out any of those things and knew it was a reaction to the new vaccine. She had a breath-holding spell upon adminsitration of the vaccine, was fussy in between the doctor's office and home. Once we identified the reaction, we sent photos to the after hours triage nurse and were told at first that itt probably wasn't a reaction since it was localized, however, then they asked us about the vaccines they did send the photos to the doctor and they advised ibuprofen, we also gave pt. benadryl because we knew she was having an allergic reaction based on other family member's history of anaphylaxis due to other sources. Pt. would not drink her milk that evening before bed. The next morning she seemd okay, but upon waking up from her nap at 11:45 a.m. Pt. seemed very dazed and confused, and her whole body was covered with hives, whelts and her face swollen. I called the doctor's office and they advised that I give her benadryl and take her to the ER since they could not see her right away. I gave her 6mg of benadryl. Upon arrival to the hospital her symptoms were subsiding however she had a 101.4 fever. They took her vitals and gave her the appropriate dose of ibuprofen. The ER doctor was able to rule out any other causes of the reaction and said that it was from the vaccine. However, he kept saying that she had a rash to us and in his notes even though the photos indicate hives and whelts, as well as a high fever. Upon discharging from the ER and returning home at 3:30 p.m., I took pt. out of the car and she was having an outbreak of welts and hives again on her legs and arms. I called the doctor's office again and they told me to give her another dose of benadryl since itw as almost 4 hours since she had it. The doctor then prescribed prednison to take for 6 days to help alleviate pt.'s symptoms.
Age: 16.0
Sex: M
Vaccine: COVID19-2, HEP, IPV, MMR, TDAP, COVID19-2, HEP, IPV, MMR, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor, Vision blurred
Clinical narrative: Nurse providing vaccines and leading bandaid/recorder: RN Nurse witness and assist with bandaid: RN Client involved:  Witness present: Client's mother  8/16/23 at 10:55am, client was brought back to office, verified name and DOB, client had no allergies or PMH, and vaccines were starting to be administered. Client was to receive following: COVID BV, Polio, MMR, Hepatitis B peds, TDAP, and Varicella. After 5 vaccines were administered (Varicella NOT administered), client stated he was feeling dizzy. Client had pallor, stated he had blurry vision and stated he was dizzy. Client looked diaphoretic. RN paused providing the Varicella vaccine, and immediately grabbed an ice pack and applied it to the back of client's neck. RN also had a fan available and started having that blow on client's face. RN asked client if he had eaten anything. Client stated around 8am he had a piece of toast. RN provided client with a graham cracker snack to start eating. Client stated he wanted water, RN was able to provide small bottle of water. RN grabbed blood pressure cuff and purple chair for client. Bandaid was sent at 11:03am (phone system not set up and unable to call overhead). Client's BP was taken at 11:08am and was 105/64, HR 64, RR 14. Client's BP was taken second time at 11:11am, 100/60, HR 76, RR 12. Client stated he was starting to feel better. Bandaid was completed at 11:15am. Client sat in chair until 11:30, at which point client's color had returned to face, diaphoresis had resolved, and client stated vision was no longer blurry and client was no longer dizzy. Client and mother were counseled for client to eat large meal, hydrate well, and get good night's sleep before next appointment, to aid in preventing episode from happening again. Client verbalized understanding. Client and mother were counseled to inform nurse at next appointment about this episode, so that nurse would be able to prepare for potential episode. Client and mother verbalized understanding of all aforementioned information.
Age: 16.0
Sex: M
Vaccine: COVID19-2, HEP, IPV, MMR, TDAP, COVID19-2, HEP, IPV, MMR, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor, Vision blurred
Clinical narrative: 8/16/23 at 10:55am, client was brought back to office, verified name and DOB, client had no allergies or PMH, and vaccines were starting to be administered. Client was to receive following: COVID BV, Polio, MMR, Hepatitis B peds, TDAP, and Varicella. After 5 vaccines were administered (Varicella NOT administered), client stated he was feeling dizzy. Client had pallor, stated he had blurry vision and stated he was dizzy. Client looked diaphoretic. RN paused providing the Varicella vaccine, and immediately grabbed an ice pack and applied it to the back of client's neck. RN also had a fan available and started having that blow on client's face. RN asked client if he had eaten anything. Client stated around 8am he had a piece of toast. RN provided client with a graham cracker snack to start eating. Client stated he wanted water, RN was able to provide small bottle of water. RN grabbed blood pressure cuff and purple chair for client. Bandaid was sent at 11:03am (phone system not set up and unable to call overhead). Client's BP was taken at 11:08am and was 105/64, HR 64, RR 14. Client's BP was taken second time at 11:11am, 100/60, HR 76, RR 12. Client stated he was starting to feel better. Bandaid was completed at 11:15am. Client sat in chair until 11:30, at which point client's color had returned to face, diaphoresis had resolved, and client stated vision was no longer blurry and client was no longer dizzy. Client and mother were counseled for client to eat large meal, hydrate well, and get good night's sleep before next appointment, to aid in preventing episode from happening again. Client verbalized understanding. Client and mother were counseled to inform nurse at next appointment about this episode, so that nurse would be able to prepare for potential episode. Client and mother verbalized understanding of all aforementioned information.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: The adverse reaction began on the morning of 8/13/23. Patient started with a red, itchy rash and swelling to her cheeks. Benadryl was given throughout the day and rash remained the same. The following morning, the patient woke with her entire face red, itchy, and swollen, and she had a rash on other areas of her body including her chest, back, arms, legs, and hands. A dose of Benadryl was given and she was brought to the ER. In the ER, they gave her a dose of Claritin without improvement in symptoms and was then started on a 5 day course of prednisone. At the time of her office visit on 8/16/23, three doses of prednisone had been given and the rash was beginning to improve but was not fully resolved.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Swelling face
Clinical narrative: The adverse reaction began on the morning of 8/13/23. Patient started with a red, itchy rash and swelling to her cheeks. Benadryl was given throughout the day and rash remained the same. The following morning, the patient woke with her entire face red, itchy, and swollen, and she had a rash on other areas of her body including her chest, back, arms, legs, and hands. A dose of Benadryl was given and she was brought to the ER. In the ER, they gave her a dose of Claritin without improvement in symptoms and was then started on a 5 day course of prednisone. At the time of her office visit on 8/16/23, three doses of prednisone had been given and the rash was beginning to improve but was not fully resolved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Prinzmetal angina, Symptom recurrence
Clinical narrative: PRINZMETAL ANGINA ACUTE NON ST ELEVATION MI 4/4/2022 & 5/1/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Abnormal faeces, Full blood count, Pyrexia, Respiratory pathogen panel, Ultrasound scan
Clinical narrative: Vaccine administered 7/31/23. 08/05/23 stool changed substantially. 08/12/23 vomiting started and continued intermittently until hospitalization on 8/15/23 with fever of 101.3. Digestive supporting care was provided including IV fluids and food restriction. Not yet fully resolved.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Vomiting, X-ray
Clinical narrative: Vaccine administered 7/31/23. 08/05/23 stool changed substantially. 08/12/23 vomiting started and continued intermittently until hospitalization on 8/15/23 with fever of 101.3. Digestive supporting care was provided including IV fluids and food restriction. Not yet fully resolved.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, Hypoxia
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Ischaemic stroke, Respiratory failure
Clinical narrative: ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: RIGHT BELLS PALSY
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Catheterisation cardiac normal, Chest pain, Dyspnoea, Ejection fraction decreased, Fatigue
Clinical narrative: Symptoms: chest pain, shortness of breath, fatigue, irregular heart beat beginning October 2022, worsening steadily. Diagnosis: Myocarditis diagnosed after cardiac catheterization (March 2023) showed no blockages and cardiac perfusion MRI (April 2023) showed edema in heart wall, reduced ejection fraction. Treatment: rest, no alcohol or caffeine, no strenuous activity or heavy meals Followup MRI scheduled for 8-30-2023.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Heart rate irregular, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart, Myocarditis, Pericardial effusion
Clinical narrative: Symptoms: chest pain, shortness of breath, fatigue, irregular heart beat beginning October 2022, worsening steadily. Diagnosis: Myocarditis diagnosed after cardiac catheterization (March 2023) showed no blockages and cardiac perfusion MRI (April 2023) showed edema in heart wall, reduced ejection fraction. Treatment: rest, no alcohol or caffeine, no strenuous activity or heavy meals Followup MRI scheduled for 8-30-2023.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 12/29/2022,  1/4/2023,  2/23/2023,  1/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given adult Vaqta dose instead of pediatric dose.  No signs, symptoms or adverse effects noted.
Age: 12.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Dizziness
Clinical narrative: He got his vaccine, he was fine, but when he walked out and when he was sitting on the chair he felt a little dizzy.  His father and the pharmacist was looking at him and he got dizzy.  One of the staff called the ambulance.  He was assessed and got better, and was put on the stretcher.  He was then taken from the pharmacy to go to the hospital, but the pharmacist did not know which one he went to.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI 3/18/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Urticaria chronic
Clinical narrative: Patient stated that about 10 days after her vaccine she started getting hives all over. She now has chronic hives and oral trreatment was not working so she is taking xolair to treat the urticaria
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: SADDLE PULMONARY EMBOLISM ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Confusional state, Hypertension, Pyrexia
Clinical narrative: Fever, hypertension and confusion
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness, swelling, and pain at the injection site. patient reported 2 days after vaccine was given.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: redness, swelling, and pain at the injection site. patient reported 2 days after vaccine was given.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given adult dose of Vaqta instead of pediatric dose.  No signs, symptoms or adverse effects noted.
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Fatigue, Laboratory test, Pulmonary embolism, Shock haemorrhagic, Syncope
Clinical narrative: After vaccination the patient had fatigue and was laying on couch/bed more during the day (his wife also passed away a few months prior).  3 days after vaccination the patient had a syncopal episode in a parking lot. was admitted to hospital was found to have bilateral saddle pulmonary embolism/hemorrhagic shock. Admitted 7/28-8/7/23 and discharged home.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Partial seizures
Clinical narrative: PARTIAL EPILEPSY
Age: 13.0
Sex: F
Vaccine: HPV9, MMR, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects. Patient was given wrong vaccine (varivax). Provider, patient and mother was notified of the error. Correct vaccine (MMR) was then given.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Body temperature increased, Chills, Eye pain, Headache
Clinical narrative: Chills,upset stomach, head ache, eye ache, elevated temperature, whole body ache.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: Chills,upset stomach, head ache, eye ache, elevated temperature, whole body ache.