chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: a 36 hour excruciating migraine headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "a 36 hour excruciating migraine headache". The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "a 36 hour excruciating migraine headache".  Additional information: It was reported that each time, after receiving both primary series doses of the COVID-19 Vaccine, as well as their first booster shot (monovalent) the patient reported having "a 36 hour excruciating migraine headache"   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-PV202300095351 same patient and event, different dose;US-PFIZER INC-202300205272 same patient and event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: a 36 hour excruciating migraine headache/Extended Migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "a 36 hour excruciating migraine headache"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "a 36 hour excruciating migraine headache". The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "a 36 hour excruciating migraine headache/Extended Migraine".  Additional information : Each time, after receiving both primary series doses of the COVID-19 Vaccine, as well as their first booster shot (monovalent) the patient reported having "a 36 hour excruciating migraine headache" (No dates of receipt nor which manufacturer were specified). The reporter consider event as caused by suspect product(s) was not known for extended migraine.  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-PV202300095351 same patient and event, different dose;US-PFIZER INC-202300205271 same patient and event, different dose;
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19/Nasal Swab: Positive; tested positive for COVID-19/Nasal Swab: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Feb2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years 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 had no relevant medical history. The patient was 37 weeks pregnant at the event onset. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "recovered" (2023) and all described as "tested positive for COVID-19/Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive; (Feb2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Reported as, Patient received the Pfizer booster at 37 weeks of pregnancy and tested positive for COVID-19 while in the hospital to give birth 3 weeks later.  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: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Have had hives since Nov2021, after 1st booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 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: URTICARIA (non-serious) with onset Nov2021, outcome "unknown", described as "Have had hives since Nov2021, after 1st booster".  Additional information: Many people are suffering long term hives after booster, myself included. Have had hives since Nov2021, after 1st booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Patient had experienced heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received BNT162b2 (BNT162B2 NOS), 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: PALPITATIONS (non-serious), outcome "unknown", described as "Patient had experienced heart palpitations".  Additional information: After being vaccinated, patient had experienced heart palpitations and other issues.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: a 36 hour excruciating migraine headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received BNT162b2 (BNT162B2), as dose 1, 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: MIGRAINE (non-serious), outcome "unknown", described as "a 36 hour excruciating migraine headache".  Additional information: It was reported that each time, after receiving both primary series doses of the COVID-19 Vaccine, as well as their first booster shot (monovalent) the patient reported having "a 36 hour excruciating migraine headache.  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-202300205271 same patient and event, different dose;US-PFIZER INC-202300205272 same patient and event, different dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: getting COVID/Contracted COVID after vaccination; getting COVID/Contracted COVID after vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (202041). The reporter is the patient.  A 65-year-old female patient 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; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "getting COVID/Contracted COVID after vaccination".  Clinical course: Patient mentioned being fully vaccinated and boosted with Pfizer's COVID-19 vaccination and still getting COVID in Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose".  Additional information: Patient did not get her booster shot due to a runny nose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: HCP was not aware of new Bivalent vaccine available administered Monovalent after recommended date by the State.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: HCP was not aware of new Bivalent vaccine available administered Monovalent after recommended date by the State.
Age: 71.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Erythema
Clinical narrative: Pt developed  a red rectangle about 2inchesx 4inches around the middle of the upper arm (bicep/tricep area) on both arms and applied ice to the area. Still red today when the came back into the pharmacy today 5/31/23, recommended they go to their doctor to have it looked at.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given past experation of vaccine.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given after experation date
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Confusional state, Electrocardiogram normal, Incoherent, Laboratory test normal
Clinical narrative: The day after the vaccine in the evening she became confused and her husband couldn't understand her so he took her to the emergency room and she doesn't remember anything after that.  She was in the hospital for 3 days.  She had no illness prior.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis normal
Clinical narrative: The day after the vaccine in the evening she became confused and her husband couldn't understand her so he took her to the emergency room and she doesn't remember anything after that.  She was in the hospital for 3 days.  She had no illness prior.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given after expiration date.
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: On Friday 05/26/2023 patient was vaccinated Moderna Bivalent Lot # 067H22A with expiration date of 09/15/2023 @ 11:43 am.   It was then discovered it was from a Vial that was punctured on 05/25/2023 @ 11:50 AM. By the time it was discovered the patient had left.  It was reported to Moderna on Friday05/26/2023, to see if the patient needed to repeat dose and was given Case #. Was told it can take between 3 to 5 days. Received response on 05/31/2023 from Moderna that the vaccine has been deemed usable and has maintained activity against a Covid-19 infection, therefore patient does not need to repeat the dose. Patient is being contact to make sure they are not exhibiting any signs of infection at injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: Administration error: less than 1/2 of 0.5 ml dose given because needle was not screwed on tightly enough. patient left the site and was later called by phone by administering pharmacist to tell her that the dose could be readministered at patient's convenience.
Age: 65.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Urticaria
Clinical narrative: Urticaria appeared on both legs about 4-5 hours after the injections were given and were still present the following day.  She does not have a history of urticaria.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient  requested a Shingrix vaccination and was given a dose. However afterwards we found out the patient had already received  the 2 dose series back in 2018/2019.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: The patient came to the pharmacy for a Shingrix Vaccination , filled out the paperwork, and was given the vaccine, However after the vaccination was given we found out the patient had already received both doses in the series in 2018/2019.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Rash on neck, across the top of shoulders, neck and both sides of face.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) 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 UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml).    No concomitant medication information was reported.  This case was reported for patient 4.  It was reported that they administered the Moderna bivalent to 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml.  No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:(Elderly Patient no 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Discomfort, Pyrexia, Tremor
Clinical narrative: Discomfort was due to a vaccine which was so high; I had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me; I had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (Discomfort was due to a vaccine which was so high), TREMOR (I had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) and PYREXIA (I had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE and Coronavac. Past adverse reactions to the above products included No adverse event with Coronavac and PFIZER BIONTECH COVID-19 VACCINE.    On 24-May-2023, the patient received fifth 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 DISCOMFORT (Discomfort was due to a vaccine which was so high), TREMOR (I had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) and PYREXIA (I had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me). At the time of the report, DISCOMFORT (Discomfort was due to a vaccine which was so high), TREMOR (I had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) and PYREXIA (I had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient had been vaccinated with the fourth dose, with the same Moderna, both times it gave a terrible fever to the point where it was difficult for me to stay calm with the tremors caused by the fever. This was happened only with 4th and 5th doses of moderna vaccine and not earlier vaccines that was received in the same process against covid-19. No treatment medications were reported.    This case was linked to MOD-2023-726764 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2023: Live Follow up: Start date of the drug was updated.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: pain at the injection site; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (for 1st dose refer case US2023AMR074729).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site) and fever (Verbatim: fever). Rechallenge with Shingrix was positive. The outcome of the injection site pain and fever were unknown.   It was unknown if the reporter considered the injection site pain and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain and fever to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR074729   Additional Information: GSK Receipt Date: 25-MAY-2023 The reporter was the twin sister of the patient. It was reported that the patient received second dose of Shingrix vaccine and experienced pain at the injection site the second dose hurt worse than the first dose and experienced fever from the vaccine but unknown after which dose. The reporter provided limited information. Did not consent to follow-up.; Sender's Comments:  US-GSK-US2023AMR074729:Same patient, different dose
Sex: U
Vaccine: HEP, HEP
Symptoms: Expired product administered
Clinical narrative: 3rd Dose of Hepatitis B Vaccine Adminsitered; Recevied an Expired Dose; Initial Report Received on 18-Jan-2023 and VAERS report retrieved on 08-Feb-2023 from FDA VAERS from the Centers for Disease Control and Prevention (VAERS ID #2562251-1) and was noted as being reported to VAERS on 18-Jan-2023.   A registered nurse reported that a 36-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had expired.  Medical history included hypertension and the patient had no known drug allergies at the time of vaccination. .   Concomitant medications included labetalol and an unspecified diuretic.    On 17-Jan-2023, the patient received dose 3 of HEPLISAV-B that had expired (Lot # 935849, expiration date 13-Jan-2023, and NDC # 43528000305) intramuscularly in the right arm.The reported indicated that the patient did not report any adverse effects.  No further information was provided.   The event outcome was not reported, and the event was reported as non-serious.  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, HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 3rd Dose of Hepatitis B Vaccine Adminsitered; Recevied an Expired Dose; Initial Report Received on 18-Jan-2023 and VAERS report retrieved on 08-Feb-2023 from FDA VAERS from the Centers for Disease Control and Prevention (VAERS ID #2562251-1) and was noted as being reported to VAERS on 18-Jan-2023.   A registered nurse reported that a 36-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had expired.  Medical history included hypertension and the patient had no known drug allergies at the time of vaccination. .   Concomitant medications included labetalol and an unspecified diuretic.    On 17-Jan-2023, the patient received dose 3 of HEPLISAV-B that had expired (Lot # 935849, expiration date 13-Jan-2023, and NDC # 43528000305) intramuscularly in the right arm.The reported indicated that the patient did not report any adverse effects.  No further information was provided.   The event outcome was not reported, and the event was reported as non-serious.  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, HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received An Expired Dose; Initial Report Received on 01-Feb-2023 and 15-Feb-2023 (VAERS retrieval). A VAERS report was retrieved from FDA VAERS (VAERS ID 2573362-1) and was noted as being reported to VAERS on 01-Feb-2023 with additional information.   A licensed practical nurse reported that a 70-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history at the time of vaccination was reported as diabetes mellitus type II, chronic kidney disease, hyperlipidemia, and hypertension. The patient had no known allergies.  Medications at the time of vaccination was reported as amlodipine, aspirin, atorvastatin, dapagliflozin, Trulicity (dulaglutide), hydrochlorothiazide, lisinopril, metformin, and testosterone.   On 30-Nov-2022, dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot #, expiration date, NDC #, and route not provided) was administered in the left deltoid.  On 01-Feb-2023, 64 days after having been vaccinated with dose 1 of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (Lot # 935849, expiration date 13-Jan-2023, and NDC # 43528-003-01) intramuscularly in the left deltoid. The dose 2 administered was expired. The patient was reported to not have any adverse effects.  The event outcome was reported as unknown, and the event was non-serious.   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, HEP
Symptoms: Expired product administered
Clinical narrative: Received An Expired Dose; Initial Report Received on 01-Feb-2023 and 15-Feb-2023 (VAERS retrieval). A VAERS report was retrieved from FDA VAERS (VAERS ID 2573362-1) and was noted as being reported to VAERS on 01-Feb-2023 with additional information.   A licensed practical nurse reported that a 70-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history at the time of vaccination was reported as diabetes mellitus type II, chronic kidney disease, hyperlipidemia, and hypertension. The patient had no known allergies.  Medications at the time of vaccination was reported as amlodipine, aspirin, atorvastatin, dapagliflozin, Trulicity (dulaglutide), hydrochlorothiazide, lisinopril, metformin, and testosterone.   On 30-Nov-2022, dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot #, expiration date, NDC #, and route not provided) was administered in the left deltoid.  On 01-Feb-2023, 64 days after having been vaccinated with dose 1 of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (Lot # 935849, expiration date 13-Jan-2023, and NDC # 43528-003-01) intramuscularly in the left deltoid. The dose 2 administered was expired. The patient was reported to not have any adverse effects.  The event outcome was reported as unknown, and the event was non-serious.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, FLU3
Symptoms: Antinuclear antibody, Arthralgia, Blood thyroid stimulating hormone, Haematology test, Pyrexia
Clinical narrative: Triggered onset of rheumatoid arthritis.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 24 years, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 17Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN CALCIUM; ESCITALOPRAM OXALATE; YAZ. Vaccination history included: BNT162b2 (Dose 3 (booster), Single, Batch/Lot No: FF2590, Anatomical Location: Arm Right), administration date: 19Nov2021, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Batch/Lot No: EW0151, Anatomical Location: Arm Right), administration date: 01May2021, for COVID-19 immunization; BNT162b2 (Dose 1, Single, Batch/Lot No: ER8729, Anatomical Location: Arm Right), administration date: 09Apr2021, for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 17Oct2022, outcome "not recovered", described as "Triggered onset of rheumatoid arthritis.". The event "triggered onset of rheumatoid arthritis." required physician office visit. Therapeutic measures were taken as a result of rheumatoid arthritis. Clinical Course: Extreme joint pain with increased rheumatoid factors. Triggered onset of rheumatoid arthritis. Treatment Included: NSAIDs, Levothyroxine. Patient was not tested positive  for COVID-19 post vaccination or had COVID-19 prior vaccination.
Age: 24.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, FLU3
Symptoms: Rheumatoid arthritis, Rheumatoid factor increased
Clinical narrative: Triggered onset of rheumatoid arthritis.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 24 years, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 17Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN CALCIUM; ESCITALOPRAM OXALATE; YAZ. Vaccination history included: BNT162b2 (Dose 3 (booster), Single, Batch/Lot No: FF2590, Anatomical Location: Arm Right), administration date: 19Nov2021, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Batch/Lot No: EW0151, Anatomical Location: Arm Right), administration date: 01May2021, for COVID-19 immunization; BNT162b2 (Dose 1, Single, Batch/Lot No: ER8729, Anatomical Location: Arm Right), administration date: 09Apr2021, for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 17Oct2022, outcome "not recovered", described as "Triggered onset of rheumatoid arthritis.". The event "triggered onset of rheumatoid arthritis." required physician office visit. Therapeutic measures were taken as a result of rheumatoid arthritis. Clinical Course: Extreme joint pain with increased rheumatoid factors. Triggered onset of rheumatoid arthritis. Treatment Included: NSAIDs, Levothyroxine. Patient was not tested positive  for COVID-19 post vaccination or had COVID-19 prior vaccination.
Age: 24.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, FLU3
Symptoms: Rheumatoid arthritis
Clinical narrative: Triggered onset of rheumatoid arthritis.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 24 years, in right arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 17Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN CALCIUM; ESCITALOPRAM OXALATE; YAZ. Vaccination history included: BNT162b2 (Dose 3 (booster), Single, Batch/Lot No: FF2590, Anatomical Location: Arm Right), administration date: 19Nov2021, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Batch/Lot No: EW0151, Anatomical Location: Arm Right), administration date: 01May2021, for COVID-19 immunization; BNT162b2 (Dose 1, Single, Batch/Lot No: ER8729, Anatomical Location: Arm Right), administration date: 09Apr2021, for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 17Oct2022, outcome "not recovered", described as "Triggered onset of rheumatoid arthritis.". The event "triggered onset of rheumatoid arthritis." required physician office visit. Therapeutic measures were taken as a result of rheumatoid arthritis. Clinical Course: Extreme joint pain with increased rheumatoid factors. Triggered onset of rheumatoid arthritis. Treatment Included: NSAIDs, Levothyroxine. Patient was not tested positive  for COVID-19 post vaccination or had COVID-19 prior vaccination.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received An Expired Dose; Initial Report Received on 31-Jan-2023   A pharmacist reported that a female patient (age, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had expired.  Medical history at the time of vaccination was reported as HIV positive.   Concomitant medications and allergies at the time of vaccination were not reported.  On 31-Jan-2023, the patient received a dose of HEPLISAV-B vaccine (Lot # 037231, expiration date 30 Jan-2023, NDC # 43528-003-05) intramuscularly (injection site unknown). The HEPLISAV-B vaccine that was given to the patient had expired the day before.  No additional 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: Hepatitis B antigen positive
Clinical narrative: Received Heplisav-B Dose 4 Days Ago, Tested Postive For Hepatitis B Antigen; Initial Report Received on 06-Feb-2023  A registered nurse reported that a patient (age, gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and tested positive for hepatitis B antigen four days after the vaccination.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B vaccine (details not provided). Four days after the HEPLISAV-B vaccination, the patient was screened for hepatitis B and tested positive for the hepatitis B antigen.  No additional 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: Expired product administered
Clinical narrative: Received An Expired Dose; Initial Report Received on 08-Mar-2023  A nurse reported that a 36-year-old female received HEPLISAV-B for hepatitis B immunization.    Medical history was reported as unknown.   No concomitant medications were reported.    On 07-Mar-2023, the patient received a dose of HEPLISAV-B (Lot #937232, NDC 4352-003-05, Expiration 04-Mar-2023) intramuscularly in the right deltoid. The dose of HEPLISAV-B administered was 3 days past the expiration date.  The reported denied that the patient had reported any adverse effects related to this.   No other information is available.   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: Expired product administered, No adverse event
Clinical narrative: Received An Expired Dose; Initial Report Received on 13-Mar-2023  A pharmacist reported that a 48-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was expired.   Medical history, allergies, and concomitant medications were unknown at the time of vaccination.  On 12-Mar-2023, the patient received a dose of HEPLISAV-B vaccine (Lot # 937232, expiration date 04-Mar-2023, NDC # 43528-0002-01) intramuscularly in the left deltoid. The HEPLISAV-B vaccine had expired 8 days before the injection. No adverse effects were reported by the patient.   No further information was available.  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: Expired product administered
Clinical narrative: Received An Expired Dose; Initial Report Received on 13-Mar-2023  A registered nurse reported that a 46-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was expired.   Medical history, allergies, and concomitant medications at the time of vaccination were not reported.  On 13-Mar-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot # 937233, expiration date 11-Mar-2023, NDC # 43528-003-05) intramuscularly in the right deltoid. The HEPLISAV-B vaccine had expired 2 days before the injection. Additional vaccines received on the same day included typhoid, tetanus, diphtheria, and pertussis (TDAP), and hepatitis A vaccines (no details provided) in preparation for traveling and prophylaxis.  No additional information was provided at the time of the report.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 8.0
Sex: M
Vaccine: HEP, IPV, VARCEL
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode soon after receiving the Hepatitis B vaccine. FNP-C was alerted of the situation, and she assessed the patient. Patient was laid down on the bed with his legs elevated and patient woke up shortly (in about 30-60 seconds). Patient was monitored to make sure he felt okay before proceeding with the remaining vaccines. Discussed with the patient's parents whether they want to continue with the remaining vaccines (Varivax and IPV) or hold off on them - patient's parents indicated that they wanted us to continue and complete all the vaccines today, so the remaining vaccines (Varivax and IPV) were administered with no further issues. Patient was monitored after getting all the vaccines and no further issues occurred. Patient's parents have been instructed to seek emergency care  in cases of any emergency or with concerning symptoms.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Gait disturbance, Inappropriate schedule of product administration, Loss of personal independence in daily activities
Clinical narrative: I need to know what side effects to be looking for and for how long.  AND for pharmacy to never let this happen again
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia
Clinical narrative: I need to know what side effects to be looking for and for how long.  AND for pharmacy to never let this happen again
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: full body urticaria, treated with Prednisone, Benedryl, Pepcid, unknown outcome at this time
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Fever of 99.5, headache, muscle pain, chills
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Frequent bowel movements, Vomiting
Clinical narrative: Excessive vomiting, unable to keep down food since 0600 on 5/31. Sometimes able to keep down breastmilk.  Extremely loose and frequent diarrhea. Very watery.
Sex: U
Vaccine: RV1
Symptoms: Product preparation issue
Clinical narrative: New formulation and proceeded to mix it with the vial of the old formulation; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate reconstitution technique in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate reconstitution technique (Verbatim: New formulation and proceeded to mix it with the vial of the old formulation). The outcome of the inappropriate reconstitution technique 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: 25-MAY-2023 The reporter reported that the new formulation was proceeded and mixed it with the vial of the old formulation. She wanted information on, if a patient was essentially double dosed.  Additionally, if this was patients first dose what was the recommendation for a second dose. Request was made through system. The new formulation was proceeded and mixed it with the vial of the old formulation which led to inappropriate reconstitution technique.
Sex: U
Vaccine: COVID19-2
Symptoms: Aplastic anaemia, Full blood count
Clinical narrative: Aplastic anemia
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: severe headache low grade fever chills severe body aches
Sex: U
Vaccine: PNC13
Symptoms: Kawasaki's disease, Pyrexia
Clinical narrative: KAWASAKI'S DISEASE; PYREXIA; A spontaneous report has been received from the regulatory authority concerning a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    On an unknown date the patient received Influenza Vaccines (influenza vaccines), via nasal route, for prophylaxis.     On an unknown date the patient started treatment with Pneumococcal Vaccine 13v (pneumococcal vaccine 13v) for prophylaxis.     An unknown administered INFLUENZA VACCINES. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced kawasaki's disease (preferred term: Kawasaki's disease). On an unknown date, the patient experienced pyrexia (preferred term: Pyrexia).     It was unknown if any action was taken with Influenza Vaccines and Pneumococcal Vaccine 13v.    The outcome of the events of kawasaki's disease and pyrexia was unknown.     The reporter assessed the event of kawasaki's disease and pyrexia to be serious due to seriousness criteria of hospitalization and important medical event.     For regulatory reporting purposes, if an event is spontaneously reported, at least a reasonable possibility of a causal relationship is implied by the reporter, even if the relationship is unknown or unstated.    Device Information:     Combination Product Report: Yes    Product As Reported: INFLUENZA VACCINES  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction on 31-May-2023: Hospitalization required selected for events kawasaki's disease and pyrexia. Narrative amended.    Minor correction on 01-Jun-2023: Minor correction on 01-Jun-2023: Treatment Facility (checking in association with Reporter User Facility) was linked to each individual Serious/Hospitalization event. Nullflavours added for event dates. Narrative amended.; Sender's Comments: Kawasaki's disease and pyrexia are not listed in the company core data sheet of Q/LAIV(Quadrivalent/ live attenuated influenza vaccine). Kawasaki's disease could be considered as contributory risk factor for pyrexia. Due to limited information on circumstances leading to events, start date of suspect drug, complete patient demographics, onset date and outcome of events, clinical course, treatment provided, risk factors, relevant medical history, concurrent conditions, concomitant medications, detailed diagnostic and etiologic workup, the evaluation did not find the evidence to suggest a causal relationship between the events and suspect drug.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Condition aggravated, Laboratory test, Pain, Pain in extremity
Clinical narrative: Within a couple of weeks of receiving  the second covid vaccine pain in my hands and new symptoms in my feet had  gotten worse. Bedtime was excruciating. Rheumatoid doctor had diagnosed me  with Fibromyalgia but referred me to a neurologist once I developed new symptoms and chronic pain was worse.  After multiple tests and biopsy's the neurologist diagnosed me with small fiber neurology.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Small fibre neuropathy
Clinical narrative: Within a couple of weeks of receiving  the second covid vaccine pain in my hands and new symptoms in my feet had  gotten worse. Bedtime was excruciating. Rheumatoid doctor had diagnosed me  with Fibromyalgia but referred me to a neurologist once I developed new symptoms and chronic pain was worse.  After multiple tests and biopsy's the neurologist diagnosed me with small fiber neurology.
Age: 95.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac failure congestive, Condition aggravated
Clinical narrative: CHF exacerbation
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Angina unstable, Neuropathy peripheral
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE NEUROPATHY UNSTABLE ANGINA ANGINA, UNSPECIFIED
Age: 7.0
Sex: U
Vaccine: DTAP, HEP, HEPA, IPV, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NONE
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Dressler's syndrome, Hypotension, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, UNSPECIFIED PERICARDITIS POST ACUTE MI HYPOTENSION 8/15/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Blood test, Computerised tomogram, Hypertension, Nausea
Clinical narrative: I experienced nausea, high blood pressure and pain in my lower right abdomen .
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Injection site pain, Loss of personal independence in daily activities, Nausea, Pain
Clinical narrative: The patient has been c/o right arm pain since receiving the MenQuadfi vaccine on 05/26/23, x 5 days, noted pain in right arm the day after immunization, felt nausea/dizziness in the evening after immunization, used Motrin for arm pain for few days after inmmunizations, no redness noted at injection site, pain constant in right upper arm, pain scale 1-2/10, pain most noticeable when moves and used right arm, pain scale 4-6/10, no numbness or tingling of right arm, denies weakness, lifting back pack causes pain or getting dressed and undressed, painful if lies on right side for sleep, c/o sharp shooting pain down right arm this afternoon, resolved on its own and not precipitated by anything in particular. No rash noted, no itching
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, X-ray
Clinical narrative: The patient has been c/o right arm pain since receiving the MenQuadfi vaccine on 05/26/23, x 5 days, noted pain in right arm the day after immunization, felt nausea/dizziness in the evening after immunization, used Motrin for arm pain for few days after inmmunizations, no redness noted at injection site, pain constant in right upper arm, pain scale 1-2/10, pain most noticeable when moves and used right arm, pain scale 4-6/10, no numbness or tingling of right arm, denies weakness, lifting back pack causes pain or getting dressed and undressed, painful if lies on right side for sleep, c/o sharp shooting pain down right arm this afternoon, resolved on its own and not precipitated by anything in particular. No rash noted, no itching
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Abscess drainage, COVID-19, Chest X-ray normal, Cholecystitis, Computerised tomogram liver abnormal
Clinical narrative: 10/11/2022- present to ED from SNF, for AMS. Covid + test. Placed on 3L NC 87% on RA. . CXR-no evidence of acute cardiopulmonary disease. UTI. Afebrile. Start Remdesivir, decadron, doxy and Rocephin. New liver mass on CT. Admit AMS.  10/14/2022- Maintaining 02 on RA. WBC-WNL.  10/16/2022- Repeat CT mass-cholecystitis with liver abscess. Finished remdesivir. contine with decadron and rocephin. Spo2 above 95% on RA.  10/20/2022-liver abscess drained.  10/25/2022-Cont. IV rocephin and doxy, completed remdesivir and on RA.  10/27/2022- D/c to SNF.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Hepatic mass, Liver abscess, Mental status changes, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: 10/11/2022- present to ED from SNF, for AMS. Covid + test. Placed on 3L NC 87% on RA. . CXR-no evidence of acute cardiopulmonary disease. UTI. Afebrile. Start Remdesivir, decadron, doxy and Rocephin. New liver mass on CT. Admit AMS.  10/14/2022- Maintaining 02 on RA. WBC-WNL.  10/16/2022- Repeat CT mass-cholecystitis with liver abscess. Finished remdesivir. contine with decadron and rocephin. Spo2 above 95% on RA.  10/20/2022-liver abscess drained.  10/25/2022-Cont. IV rocephin and doxy, completed remdesivir and on RA.  10/27/2022- D/c to SNF.