chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; patient received GARDASIL 9 instead of Quadracel; This spontaneous report was received from a health care professional concerning a 5-year-old female patient. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On 23-JUN-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot #1780878, expiration date 02-DEC-2023, for prophylaxis (dose, route of administration, and injection anatomical location was not provided), instead of diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL); it was stated that the wrong vaccine was administered (Wrong product administered). No additional adverse event was reported (No adverse event).
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report temperature excursion for ROTATEQ that was administered to a patient. No additional AE/PQC.  ?    Names of vaccines involved (including lot/exp): ROTATEQ, lot/expiration unknown by reporter ?    Temperature: (9.1C) ?    Tim; This spontaneous report was received from a medical assistant and refers to a 6-months-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-JUL-2023, the patient was vaccinated with an improperly storage rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered for prophylaxis (dose, frequency, strength, lot #, expiry date, and route of administration were not provided). Temperature excursion occurred at 9.1 C for 5 hours. No previous temperature excursion was reported. No additional information or adverse event was reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Dose 1/Dose 2: Moderna; Dose 3: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Nov2022 as dose 5 (booster), single (Lot number: 910446) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Feb2021 as dose 1, single (Lot number: 013L20A), on 02Mar2021 as dose 2, single (Lot number: 010M20A) and on 08Jul2022 as dose 4 (booster), single (Lot number: 088A22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medications included: COQ10 [UBIDECARENONE]; FISH OIL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Nov2021, outcome "unknown", described as "Dose 1/Dose 2: Moderna; Dose 3: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid 5-day dose from 26Jun2023 to 01Jul2023.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pneumonia, SARS-CoV-1 test, Vaccination site pain
Clinical narrative: Went to outdoor wedding in Maine last September and got pneumonia from kids running around; Then had more, the 4th in Apr2022. A little fatigued and a little soreness at site; Then had more, the 4th in Apr2022. A little fatigued and a little soreness at site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (ongoing), notes: Osteoporosis, takes Prolia 60mg subcutaneous injection twice a year. diagnosed 7 years ago.; "Arthritis" (unspecified if ongoing); "Left branch bundle blockage" (unspecified if ongoing); "Post traumatic stress syndrome" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: XANAX taken for stress, anxiety, start date: 2004 (ongoing); ALBUTEROL HFA taken for asthma (ongoing). Vaccination history included: BNT162b2 (Dose 1, Lot No: ER2613), administration date: 19Mar2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot No: EW0153), administration date: 09Apr2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose 3, Lot No: FH8020), administration date: 19Oct2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Apr2022, outcome "unknown" and all described as "Then had more, the 4th in Apr2022. A little fatigued and a little soreness at site"; PNEUMONIA (medically significant) with onset Sep2022, outcome "unknown", described as "Went to outdoor wedding last September and got pneumonia from kids running around". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Negative covid. Therapeutic measures were taken as a result of pneumonia.  Clinical course details: The patient went to outdoor wedding last September and got pneumonia from kids running around. 6 other people at wedding got pneumonia in their 40's. Thought had Covid and went to hospital and did test. She was Negative covid but it was pneumonia and she was put on 2 types antibiotics and a steroid prednisone to help deal with it.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: moderate soreness at injection site; swelling and soreness of infraclavicular lymph node; swelling and soreness of infraclavicular lymph node; Dose: 4 Moderna, Dose: 5 Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE: 3, Lot Number: FC3181), administration date: 21Aug2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "swelling and soreness of infraclavicular lymph node", "swelling and soreness of infraclavicular lymph node", "moderate soreness at injection site"; BNT162b2 (DOSE: 2, Lot Number: EN6200), administration date: 17Feb2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "swelling and soreness of infraclavicular lymph node", "moderate soreness at injection site", "swelling and soreness of infraclavicular lymph node"; BNT162b2 (DOSE: 1, Lot Number: EL9262), administration date: 28Jan2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "moderate soreness at injection site", "swelling and soreness of infraclavicular lymph node", "swelling and soreness of infraclavicular lymph node"; moderna coviD-19 mrna (Dose: 4, Lot Number: 002M21A), administration date: 04Apr2022, when the patient was 71-year-old, for COVID-19 Immunization, reaction(s): "swelling and soreness of infraclavicular lymph node", "moderate soreness at injection site", "swelling and soreness of infraclavicular lymph node". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 09Sep2022, outcome "unknown", described as "Dose: 4 Moderna, Dose: 5 Pfizer"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "moderate soreness at injection site"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "swelling and soreness of infraclavicular lymph node".  Additional information: Vaccination Facility Type: Doctor's Office/Urgent Care. Vaccine was not administered at Military Facility. Moderate soreness at injection site. Swelling and soreness of infraclavicular lymph node experienced with each of the 6 COVID injections. Prior vaccinations, relevant tests and specific relevant test for thromboembolic events with thrombocytopenia were reported as none. No one in family has had adverse reaction to vaccines of any kind.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Moderna, Dose: 3 / Pfizer, Dose: 4; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Activity induced asthma" (unspecified if ongoing), notes: Activity induced asthma; "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL, start date: 26Jun2023, stop date: 29Jun2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna, Dose: 3 / Pfizer, Dose: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2023) Positive, notes: Positive  antigen tests through 04Jul; (05Jul2023) Negative, notes: Antigen test negative 05Jul; (06Jul2023) Positive, notes: Positive test again 06Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient Paxlovid Treatment from 27Jun2023 to 01Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300242788 Same patient, different drug, different event;
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 35 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8737), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obese" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken (Paxlovid) as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I had a shingles breakout after the first vaccination (booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "not recovered", described as "I had a shingles breakout after the first vaccination (booster)".  Additional information: The patient had a shingles breakout after the first vaccination (booster) and continue to update the injection. Would getting the Shingrex vaccine prior to the next vaccination help detour this, the patient realize it is undetermined if shingles can be a side effect of the vaccine, but the patient do have an increase in shingles pain post vaccine.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling hot, Near death experience, Pyrexia
Clinical narrative: like by day 5 I'm dying or getting close to it; tired/exhausted/disabling fatigue; joint pain; heat; fevers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing), notes: I've had this disease for 18 years but I'm working full time I'm so grateful for Xeljanz. The patient's concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "like by day 5 I'm dying or getting close to it"; FATIGUE (non-serious), outcome "unknown", described as "tired/exhausted/disabling fatigue"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; FEELING HOT (non-serious), outcome "unknown", described as "heat"; PYREXIA (non-serious), outcome "unknown", described as "fevers". Clinical course: A 64-year-old RA patient that had this disease for 18 years but working full time. Every time she got a vaccine, she had to go 8 without Xeljanz and methotrexate and all the other stuff. So, she knew like by day 5 she was dying or getting close to it, like she was feeling it. She really can't. She was really tired, exhausted. She had disabling fatigue. She had joint, she don't had deformities. She had joint pain. She had (inaudible) nodes, heat and fevers.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201151993 Same patient, different drug/ event;US-PFIZER INC-PV202300118874 Same patient, different drug/ event;
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Lot number: gj3277) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: el8982), in left arm, on 12Feb2021 as dose 2, single (Lot number: en6204), in left arm and on 04Oct2021 as dose 3 (booster), single (Lot number: ew0191), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had Paxlovid Treatment from 25Jun2023 to 29Jun2023; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300244276 Same patient, different drug, different event;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: moderate soreness at injection site; swelling and soreness of infraclavicular lymph node; swelling and soreness of infraclavicular lymph node; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9262) at the age of 69 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "moderate soreness at injection site"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "swelling and soreness of infraclavicular lymph node".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199952 same patient, similar events with different dose;US-PFIZER INC-202300243142 same patient, similar events with different dose;US-PFIZER INC-202300243143 same patient, similar events with different dose;US-PFIZER INC-202300243144 same patient, similar events with different dose;US-PFIZER INC-202300243141 same patient, similar events with different dose;
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest discomfort, Cough, Illness, Influenza
Clinical narrative: Pain; Really bad feeling in chest; not able to do anything physical till now; Heart issues; With the Pfizer vaccine I got sick for 7-10 days; Flu symptoms; felt like I had a flu; Coughing; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001010.  A 57-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: ER2613) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Illness" (ongoing); "Lung disorder" (ongoing). The patient's concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset Mar2021, outcome "unknown", described as "Coughing"; PYREXIA (non-serious) with onset Mar2021, outcome "unknown", described as "Fever"; INFLUENZA (non-serious) with onset Mar2021, outcome "unknown", described as "Flu symptoms; felt like I had a flu"; CARDIAC DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "Heart issues"; CHEST DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "Really bad feeling in chest; not able to do anything physical till now"; ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "With the Pfizer vaccine I got sick for 7-10 days"; PAIN (non-serious), outcome "unknown".  Additional information: The individual reported Pfizer BioNTech COVID-19 vaccine as the suspect product for the events of Illness, Influenza, Cough, Pyrexia, Pain, Chest discomfort, and Cardiac disorder and Moderna Covid-19 Vaccine as the suspect product for the events Pyrexia, Illness, Vaccination site pain, and Influenza.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Pain; Really bad feeling in chest; not able to do anything physical till now; Heart issues; With the Pfizer vaccine I got sick for 7-10 days; Flu symptoms; felt like I had a flu; Coughing; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001010.  A 57-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: ER2613) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Illness" (ongoing); "Lung disorder" (ongoing). The patient's concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset Mar2021, outcome "unknown", described as "Coughing"; PYREXIA (non-serious) with onset Mar2021, outcome "unknown", described as "Fever"; INFLUENZA (non-serious) with onset Mar2021, outcome "unknown", described as "Flu symptoms; felt like I had a flu"; CARDIAC DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "Heart issues"; CHEST DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "Really bad feeling in chest; not able to do anything physical till now"; ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "With the Pfizer vaccine I got sick for 7-10 days"; PAIN (non-serious), outcome "unknown".  Additional information: The individual reported Pfizer BioNTech COVID-19 vaccine as the suspect product for the events of Illness, Influenza, Cough, Pyrexia, Pain, Chest discomfort, and Cardiac disorder and Moderna Covid-19 Vaccine as the suspect product for the events Pyrexia, Illness, Vaccination site pain, and Influenza.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: 1 month later had covid/last booster Nov2022; 1 month later had covid/last booster Nov2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL3249), on 30Jan2021 as dose 2, single (Lot number: EN5318), on 01Sep2021 as dose 3 (booster), single (Lot number: FC3183) and on 12May2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "1 month later had covid/last booster Nov2022".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300075639 same patient, different vaccine dose/event (Dose 2);
Sex: U
Vaccine: COVID19
Symptoms: Ocular vascular disorder, Type 1 diabetes mellitus
Clinical narrative: diabetes - straight to insulin dependent; stroke in one the veins in one of my eyes.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TYPE 1 DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes - straight to insulin dependent"; OCULAR VASCULAR DISORDER (medically significant), outcome "unknown", described as "stroke in one the veins in one of my eyes.".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Abdominal pain upper, Asthenia, Headache, Urticaria
Clinical narrative: developed hives on his back 2 days later; stomachache; felt weak; headache; Initial information received on 03-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old male patient who developed hives on his back 2 days later, stomachache, felt weak and headache after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2023, the patient received unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (Solution for injection) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactical vaccination (Immunization). Information on the batch number was requested.  On an unknown date the patient developed events of hives on his back 2 days later (urticaria), stomachache (abdominal pain upper), felt weak (asthenia) and headache (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  It was reported that "Caller is asking if this is ca common occurrence with this vaccine or if others have experienced the same reactions. Notified the caller that we would not be able to see other reports for MENQUADFI patients, but we could report the issue to the manufacturer."  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all the events.    At time of reporting, the outcome was Unknown for all the events.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine was accidentally administered to 5 patients with no reported adverse event; Initial information was received on 05-Jul-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves 1 years old female patient who experienced expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was accidentally administered to 5 patients with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 22-Jun-2023, the patient received a dose 4 of expired suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection at dose of 0.5 ml total once (lot number: C5893AA) in the right thigh (strength, route, expiration date: Unknown) for Immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  It was reported that "The doses were all administered by medical assistants. It was not the same medical assistant who gave the expired doses to the five patients."  No lab data reported.  Action taken: not applicable.  Outcome was Unknown for the event expired vaccine was accidentally administered to 5 patients with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA206040:01679483 US-SA-2023SA206040:01679488 US-SA-2023SA206010:01679494 US-SA-2023SA206040:01679504
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered expired Daptacel in her left thigh with no reported adverse event; Initial information received on 05-Jul-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 years old female patient where patient was administered expired diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] in her left thigh with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and polio vaccine for Prophylactic vaccination.  On 28-Jun-2023, the patient received 0.5 ml (TOTAL) dose 5 of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (batch number- C5893AA and expiration date- 21-Jun-2023)  via unknown route in the left thigh (strength: not provided) for Immunisation.  On 28-Jun-2023 the patient was administered expired daptacel in her left thigh with no reported adverse event (expired product administered) (latency- same day) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Vaccine that had expired June 21,2023 was accidentally administered to 5 patients. Product used : Used Still using product : No  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 23.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: Received vaccines at 6 weeks gestation, 1st pregnancy, ultrasound scans and other checks showed healthy status (self) and fetus. At 8 weeks gestation, miscarried baby, reason unknown.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, redness, swelling for 3 + days.  patient prescribed prednisone.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered Kinrix to a 1 year 3 month old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 03-JUL-2023, the patient received Kinrix (left arm). On 03-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered Kinrix to a 1 year 3 month old patient). The outcome of the inappropriate age at vaccine administration 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: 3-JUL-2023 License practical nurse called to inquire what to look for in the patient and how to proceed. LPN reported they inadvertently administered Kinrix (prefilled syringe) to a 1 year 3 month old patient. LPN declined follow-up from safety. Did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Lip ulceration
Clinical narrative: patient developed a vermilion border lower lip ulcer; This non-serious case was reported by a nurse via call center representative and described the occurrence of lip ulcer in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 2739M, expiry date 06-OCT-2024) for prophylaxis.   Concurrent medical conditions included hiv infection (The patient does have HIV, but with long-term suppression.). Additional patient notes included The patient had no prior history of oral herpes simplex or herpes zoster..   On 21-JUN-2023, the patient received the 1st dose of Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced lip ulcer (Verbatim: patient developed a vermilion border lower lip ulcer). The outcome of the lip ulcer was not resolved.   It was unknown if the reporter considered the lip ulcer to be related to Shingrix.     It was unknown if the company considered the lip ulcer to be related to Shingrix.   Additional Information: GSK Receipt date: 05-JUL-2023 Nurse Practitioner reported that over this past weekend the patient developed a vermilion border lower lip ulcer.  The patient had no prior history of oral herpes simplex or herpes zoster.  The patient does have HIV, but with long-term suppression. The Vaccine Administration Facility is the same as Primary Reporter. The Nurse Practitioner plans to prescribe Valtrex, but this has not yet been initiated. The reporter consented to follow up.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: patient was administered (5-July-2023 priorix after a below temperature excursion inadvertently; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 43-year-old female patient who received MMR (Priorix) (batch number AA25SS, expiry date 01-NOV-2024) for prophylaxis.   On 05-JUL-2023, the patient received the 2nd dose of Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: patient was administered (5-July-2023 priorix after a below temperature excursion inadvertently). The outcome of the incorrect storage of drug 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 5 Jul 2023 Nurse reported that the patient was administered priorix after a below temperature excursion inadvertently. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient was administered priorix after a below temperature excursion inadvertently which led to incorrect storage of drug.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient received Menveo expired first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA713A, expiry date 30-JUN-2023) for prophylaxis.   On 05-JUL-2023, the patient received the 1st dose of Menveo. On 05-JUL-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient received Menveo expired first dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2023 The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up.  The patient received Menveo expired dose, which led to expired vaccine used.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: noticed that the Infanrix vaccine was expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 03-JUL-2023, the patient received Infanrix (injection). On 03-JUL-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: noticed that the Infanrix vaccine was expired). 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: 06-JUL-2023 The reporter who was reporting for the clinic where she worked. The reporter asked another nurse to get her an Infanrix dose out of the system. The reporter retrieved the vaccine and gave it to the account manager as instructed. CMA administered the vaccine to the patient unknown location. After administration, CMA noticed that the Infanrix vaccine was expired. The parents of infant had not called to report any adverse reaction to vaccine at present time.  The parents had not been notified of expired vaccine at present time. The reporter would notify parents after speaking to MI. The reporter consented to follow up. The patient received expired dose of Infanrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 1st dose of Shingrix in 2019 and dose 2 in March 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2019).   In MAR-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Received 1st dose of Shingrix in 2019 and dose 2 in March 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 The reporter did not want to provide any other information. The reporter did not consent to follow up. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally received a dose of Kinrix instead of Pediarix; inappropriate age at vaccine administered; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number 69N2M, expiry date 14-APR-2024) for prophylaxis.   On 06-JUL-2023, the patient received Kinrix. On 06-JUL-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: accidentally received a dose of Kinrix instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administered). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 6 July 2023: A physician called in to reported that a patient accidentally received a dose of Kinrix instead of Pediarix and wished to know if there was any information available. Information about the patient, vaccines and event given. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The 5 month patient accidentally received a dose of Kinrix instead of Pediarix which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late dose). The outcome of the drug dose administration interval too long 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: 06-JUL-2023 The patient received dose two of Twinrix 6 months after dose 1.  The reporter consented to follow up. The reporter did not provide lot number, expiration date, or patient details.  No additional information provided. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023092925:Same reporter
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received the Shingrix adjuvant only on 06Jul2023; received the Shingrix adjuvant only on 06Jul2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number Y77XY, expiry date 21-AUG-2024) for prophylaxis.   On 06-JUL-2023, the patient received Shingrix. On 06-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received the Shingrix adjuvant only on 06Jul2023) and inappropriate dose of vaccine administered (Verbatim: received the Shingrix adjuvant only on 06Jul2023). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 6 Jul 2023: A pharmacist reported that a the patient received the Shingrix adjuvant only. The reporter consented to follow up via email. The patient received Shingrix adjuvant only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo - Use of sterile water for reconstitution.; Menveo - Use of sterile water for reconstitution.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 06-JUL-2023, the patient received Menveo. On 06-JUL-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo - Use of sterile water for reconstitution.) and inappropriate dose of vaccine administered (Verbatim: Menveo - Use of sterile water for reconstitution.). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 6-JUL-2023 A CMA called in to asked for information regarding a patient who received a dose of Menveo reconstituted with sterile water instead of the (MenCYW-135) liquid component. The HCP asked for any side effects. The reporter declined to share information regarding the patient. Data about the Menveo dose was not provided (lot number, expiry date). Due to the nature of the call permission for follow up was not requested.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Liquid portion only; Liquid portion only; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA768A, expiry date 31-DEC-2023) for prophylaxis.   On 03-JUL-2023, the patient received the 2nd dose of Menveo. On 03-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Liquid portion only) and inappropriate dose of vaccine administered (Verbatim: Liquid portion only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 The reporter reported that a patient accidentally received an incomplete dose of Menveo, receiving only the adjuvant and wished to know how to proceed.  The information about the vaccine, patient and event collected. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The patient accidentally received an incomplete dose of Menveo, receiving only the adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received a 2nd late dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: a patient received a 2nd late dose of Twinrix). The outcome of the drug dose administration interval too long 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 6 Jul 2023: A health care professional reported that a patient received a 2nd late dose of Twinrix, The patient consented to follow up. The patient received 2nd late dose of Twinrix which led to drug dose administration interval too long. This case has been linked with case US2023092918 reported by same reporter.; Sender's Comments:  US-GSK-US2023092918:Same reporter