chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: received Infanrix on 14-MAR-2024, however the vaccines was expired on 3-MAR-2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received DTPa (Infanrix) (batch number 3M9Y7, expiry date 03-MAR-2024) for prophylaxis.   On 14-MAR-2024, the patient received Infanrix. On 14-MAR-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: received Infanrix on 14-MAR-2024, however the vaccines was expired on 3-MAR-2024). 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: 14-MAR-2024 The nurse reported that a patient received an expired dose of Infanrix vaccine, which led to expired vaccine used. The reporter consented to follow up
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Administered expired dose of Infanrix.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On 15-MAR-2024, the patient received the 1st dose of Infanrix. On 15-MAR-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administered expired dose of Infanrix.). 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: 15-Mar-2024 The reporter request information about the administration of and expired dose of Infanrix and recommendations.  The vaccine administration facility was the same as primary reporter. The patient received Infanrix vaccine which was already expired, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: had covid twice and had Paxlovid both times; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had covid twice and had Paxlovid both times) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included COVID-19 in 2021.   In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In 2023, the patient experienced COVID-19 (had covid twice and had Paxlovid both times). At the time of the report, COVID-19 (had covid twice and had Paxlovid both times) outcome was unknown.            Concomitant medication information was not reported.  The patient had Covid in 2021 and in 2023 and was surprised because the patient took the shots and had Covid before. It was stated that, the patient had taken two of the Moderna shots.  Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Similarly, the pain in my hand and neck was reduced after the second shot; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 Immunization, reaction(s): "my arthritis pain began to diminish". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Similarly, the pain in my hand and neck was reduced after the second shot".  Additional information: This is sort of an incredible story. The patient didn't want to get the COVID vaccine. He/she relented, however, because his/her husband had pulmonary fibrosis and had contracted a severe case of COVID. Much to his/her surprise, the patient's  arthritis pain began to diminished. He/she no longer had to get pain shots in his/her ankle. Similarly, the pain in his/her hand and neck was reduced after the second shot. After the third shot, the patient went for his/her 6 month sinvisc shot which always caused him/her extreme pain but he/she suffered no pain at all. Amazing.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After the third shot, I went for my 6 month sinvisc shot (which always causes my extreme pain) and I suffered no pain at all; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "my arthritis pain began to diminish"; Bnt162b2 (Dose 2), for COVID-19 immunisation, reaction(s): "Similarly, the pain in my hand and neck was reduced after the second shot". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "After the third shot, I went for my 6 month sinvisc shot (which always causes my extreme pain) and I suffered no pain at all".  Additional information: This is sort of an incredible story. The patient didn't want to get the COVID vaccine. He/she relented, however, because his/her husband had pulmonary fibrosis and had contracted a severe case of COVID. Much to his/her surprise, the patient's arthritis pain began to diminished. He/she no longer had to get pain shots in his/her ankle. Similarly, the pain in his/her hand and neck was reduced after the second shot. After the third shot, the patient went for his/her 6 month SINVISC shot, which always caused him/her extreme pain, but he/she suffered no pain at all. Amazing.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site erythema, Injection site swelling, Myalgia, Peripheral swelling
Clinical narrative: arm was red and that it looked like cellulitis but its not/redness started to expand toward her arm; whole deltoid area pretty pinkish red; the arm was warm to touch, swollen toward and close to the elbow area; the arm was warm to touch; moderate muscle pain; it has gone down with the inside of her arm a little tender to touch when you press into it.; at the marking, it is a little raised/bumpy; arm was red and that it looked like cellulitis but its not; This is a spontaneous report received from a Pharmacist from medical information team.  A 64-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Mar2024 as dose number unknown, single (Batch/Lot number: unknown), in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious) with onset 13Mar2024, outcome "unknown", described as "arm was red and that it looked like cellulitis but its not/redness started to expand toward her arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 13Mar2024, outcome "unknown", described as "whole deltoid area pretty pinkish red"; VACCINATION SITE SWELLING (non-serious) with onset Mar2024, outcome "unknown", described as "at the marking, it is a little raised/bumpy"; PAIN IN EXTREMITY (non-serious) with onset Mar2024, outcome "unknown", described as "it has gone down with the inside of her arm a little tender to touch when you press into it."; MYALGIA (non-serious) with onset Mar2024, outcome "unknown", described as "moderate muscle pain"; FEELING HOT (non-serious) with onset Mar2024, outcome "unknown", described as "the arm was warm to touch"; PERIPHERAL SWELLING (non-serious) with onset Mar2024, outcome "unknown", described as "the arm was warm to touch, swollen toward and close to the elbow area".  Additional information: Pharmacist was calling on behalf of patient, stated on 13Mar2024 she started to notice that her arm was red and that it looked like cellulitis but it's not. The patient started tracking it and noticed the redness started to expand toward her arm. Stated the patient came back and showed her arm to the caller (timing unclear); the arm was warm to touch, swollen toward and close to the elbow area and whole deltoid area pretty pinkish red. Stated it looked like cellulitis but its not. There was no oozing from the injection site and it didn't look infected. Confirmed no systemic issues.ie no fever or joint pain. Also reported moderate muscle pain. Caller stated she looked up case reports with similar reactions including in the PI . Stated it was better and it had gone down with the inside of her arm a little tender to touch when you press into it. Stated at the marking, it was a little raised/bumpy. Stated the patient asking when she should start seeing getting better.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Skin warm, Tenderness
Clinical narrative: arm was red and that it looked like cellulitis but its not/redness started to expand toward her arm; whole deltoid area pretty pinkish red; the arm was warm to touch, swollen toward and close to the elbow area; the arm was warm to touch; moderate muscle pain; it has gone down with the inside of her arm a little tender to touch when you press into it.; at the marking, it is a little raised/bumpy; arm was red and that it looked like cellulitis but its not; This is a spontaneous report received from a Pharmacist from medical information team.  A 64-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Mar2024 as dose number unknown, single (Batch/Lot number: unknown), in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious) with onset 13Mar2024, outcome "unknown", described as "arm was red and that it looked like cellulitis but its not/redness started to expand toward her arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 13Mar2024, outcome "unknown", described as "whole deltoid area pretty pinkish red"; VACCINATION SITE SWELLING (non-serious) with onset Mar2024, outcome "unknown", described as "at the marking, it is a little raised/bumpy"; PAIN IN EXTREMITY (non-serious) with onset Mar2024, outcome "unknown", described as "it has gone down with the inside of her arm a little tender to touch when you press into it."; MYALGIA (non-serious) with onset Mar2024, outcome "unknown", described as "moderate muscle pain"; FEELING HOT (non-serious) with onset Mar2024, outcome "unknown", described as "the arm was warm to touch"; PERIPHERAL SWELLING (non-serious) with onset Mar2024, outcome "unknown", described as "the arm was warm to touch, swollen toward and close to the elbow area".  Additional information: Pharmacist was calling on behalf of patient, stated on 13Mar2024 she started to notice that her arm was red and that it looked like cellulitis but it's not. The patient started tracking it and noticed the redness started to expand toward her arm. Stated the patient came back and showed her arm to the caller (timing unclear); the arm was warm to touch, swollen toward and close to the elbow area and whole deltoid area pretty pinkish red. Stated it looked like cellulitis but its not. There was no oozing from the injection site and it didn't look infected. Confirmed no systemic issues.ie no fever or joint pain. Also reported moderate muscle pain. Caller stated she looked up case reports with similar reactions including in the PI . Stated it was better and it had gone down with the inside of her arm a little tender to touch when you press into it. Stated at the marking, it was a little raised/bumpy. Stated the patient asking when she should start seeing getting better.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Injection site hypersensitivity, Vaccination site erythema, Vaccination site swelling, Vaccination site vesicles
Clinical narrative: patient had an allergy site reaction to Abrysvo/ Patient had a site reaction of redness, swelling and blisters. Site was for the arm, unknown side; patient had an allergy site reaction to Abrysvo/ Patient had a site reaction of redness, swelling and blisters. Site was for the arm, unknown side; patient had an allergy site reaction to Abrysvo/ Patient had a site reaction of redness, swelling and blisters. Site was for the arm, unknown side; patient had an allergy site reaction to Abrysvo/ Patient had a site reaction of redness, swelling and blisters. Site was for the arm, unknown side; This is a spontaneous report received from a Physician from medical information team.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (medically significant), VACCINATION SITE VESICLES (medically significant), VACCINATION SITE SWELLING (medically significant), VACCINATION SITE ERYTHEMA (medically significant), outcome "unknown" and all described as "patient had an allergy site reaction to Abrysvo/ Patient had a site reaction of redness, swelling and blisters. Site was for the arm, unknown side". Therapeutic measures were taken as a result of allergy to vaccine, vaccination site vesicles, vaccination site swelling, vaccination site erythema. Clinical course: HCP advised a patient had an allergy site reaction to Abrysvo, there was redness along with blisters and swelling. HCP already recommended Hydrocortisone 1% and Benadryl and would like to ask if Pfizer had any recommendations for the said side effects.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: There is a reasonable possibility that the reported events were related to ABRYSVO based on known drug safety profile, temporal relationship, and location.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Apathy, Brain fog
Clinical narrative: brain fog; lack of motivation; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot: EN6200), administration date: 29Mar2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot: EW0162), administration date: 26Apr2021, when the patient was 55-year-old, for COVID-19 immunization. The following information was reported: BRAIN FOG (non-serious), outcome "unknown"; APATHY (non-serious), outcome "unknown", described as "lack of motivation". Additional information: There were complications that aroused from receiving this vaccine, such as brain fog and the lack of motivation and the virus keeps mutating and I intend on suing Pfizer for the lack of instruction,  which is located on my website. The "vaccine" was pushed into the general public at an alarming rate and consequences from receiving the vaccine must called into question and that should also include monetary damages.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400068366 same patient, different dose/event;US-PFIZER INC-202300450887 same patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: My arm swelled up; my arm got very red; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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 (Primary immunization done (in 2021 or 2022 patient had other 4 or 5 Pfizer COVID-19 vaccine adminstered)), for COVID-19 immunisation, reaction(s): "pain". The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "My arm swelled up"; ERYTHEMA (non-serious), outcome "unknown", described as "my arm got very red". Additional information: patient had 5 or 6 of the vaccine of the Pfizer and the last time patient had, in the fall of last year, the arm swelled up, arm got very red and swollen and it lasted about a month at least.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little sore; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: PAIN (non-serious), outcome "unknown", described as "a little sore". Additional information: The patient had 5 or 6 of the vaccine of the Pfizer (Suspect clarified as Pfizer COVID-19 Vaccine) and the patient never had other than a little sore.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Nurse.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "UTI" (unspecified if ongoing), notes: Had UTI at time of Covid; "Arthritis" (unspecified if ongoing); "Low IGG" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Started on Paxlovid about day 4 of Covid. After second dose extreme and violent diarrhea, vomiting, nausea. Drug discontinued after 3 doses. Also experienced Covid rebound on Day 9 of the original 10 day count. Test was negative on day 7 8 Abd then positive on Day 9. Symptoms also re-emerged. It as also reported that as medical history, the patient had traveled and contracted COVID there. Also have arthritis, low IGG, asthma.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 31.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Exposure during pregnancy, Injection site rash
Clinical narrative: Rash at vaccine injection site; This is a spontaneous report received from a Physician.  A 31-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 15Mar2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 31 years, in arm for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 15Mar2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing). The patient was 32 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05May2024. Concomitant medication(s) included: LABETALOL; INSULIN; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; ASPIRIN [ACETYLSALICYLIC ACID]; CELEXA [CELECOXIB]; WELLBUTRIN. Past drug history included: Doxycycline, reaction(s): "known allergies: doxycycline". The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "Rash at vaccine injection site". Therapeutic measures were taken as a result of vaccination site rash.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Heart rate increased, Injection site pain, Pain
Clinical narrative: Heart rate is like between 112 to 116; Sore at the injection site; Chills; Body ache; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 18Mar2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC; GLYNASE [GLIBENCLAMIDE]; LANTUS. The following information was reported: PAIN (non-serious) with onset Mar2024, outcome "recovering", described as "Body ache"; CHILLS (non-serious) with onset Mar2024, outcome "recovered"; VACCINATION SITE PAIN (non-serious) with onset Mar2024, outcome "not recovered", described as "Sore at the injection site"; HEART RATE INCREASED (non-serious) with onset 18Mar2024, outcome "not recovered", described as "Heart rate is like between 112 to 116". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased.  Additional information: No investigations. Consumer stated she had all the side-effects like she had chills, had this body aches and everything and now she was checking, it's been more than 24 hours, she got the vaccine but the pain and aches were almost gone but she just noticed that her heart rate was like between 112 to 116 but she meant resting blood, resting pulse. Stated she had never had this heart rate high so, she was wondering if the vaccine is doing that or what? Other medical conditions: Consumer stated, 'Glynase' 1000 mg night time and day time (Not clarified further, pending clarification), Ozempic once a week, Lantus 10 units everyday (Not clarified further, pending clarification). Outcome (Chills, Body aches and heart rate): Consumer stated, No, the chills went away already, the body ache was gone too, it's still sore at the injection site but she was concerning about her heart rate. Reassurance: Consumer stated, "No".  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Neoplasm malignant, SARS-CoV-2 test
Clinical narrative: Cancer developed- Mass developed on my right arm pit; administration dates: dose 1: 14Apr2021/dose 2: 14Apr2021; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 at 09:30 as dose 2, single (Lot number: ER8729) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER8728, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 14Apr2021, when the patient was 58-year-old, for Covid-19 Immunization. The following information was reported: NEOPLASM MALIGNANT (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 14Jan2023 at 09:00, outcome "recovered with sequelae", described as "Cancer developed- Mass developed on my right arm pit"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "administration dates: dose 1: 14Apr2021/dose 2: 14Apr2021". The patient was hospitalized and prolonged hospitalization for neoplasm malignant (hospitalization duration: 18 days). The event "cancer developed- mass developed on my right arm pit" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) Negative, notes: Nasal Swab/Pfizer. Therapeutic measures were taken as a result of neoplasm malignant. Clinical course: Vaccine facility type was Other. There are no other vaccine in four weeks and no other medications in two weeks. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. The patient recovered with lasting effects. The patient received chemo treatment. The patient has no covid prior to vaccination. The patient was tested for covid tested post vaccination. The patient has no known allergies.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from an Other HCP.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Aug2021 as dose 1, single (Lot number: FA7485), in left arm, on 30Aug2021 as dose 2, single (Lot number: FC3183), in left arm and on 03Mar2022 as dose 3 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Feb2024, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Feb2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, the patient received paxlovid.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: my arthritis pain began to diminish; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "my arthritis pain began to diminish". Additional information: The patient didn't want to get the COVID vaccine, however because the husband had pulmonary fibrosis and had contracted a severe case of COVID. Much to the patient's surprise, the arthritis pain began to diminished. The patient no longer had to get pain shots in the ankle. Similarly, the pain in the hand and neck was reduced after the second shot. After the third shot, the patient went for his/her 6 month sinvisc shot which always caused extreme pain but suffered no pain at all. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Respiratory syncytial virus infection, Respiratory syncytial virus test positive
Clinical narrative: she got the Abrysvo vaccine and then tested  positive for RSV three days later; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY SYNCYTIAL VIRUS INFECTION (non-serious), outcome "unknown", described as "she got the Abrysvo vaccine and then tested  positive for RSV three days later". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient said she just wanted to make sure that the test can still be interpreted in the same way as if it has not been vaccinated.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: FLUA4
Symptoms: Pruritus, Rash
Clinical narrative: Rash; Itching; This spontaneous case was received on 18-Mar-2024 from other non-healthcare professional (consumer) (reference number: SEQW24-00948) and concerned an elderly, male patient.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included Fluad Quadrivalent (influenza vaccine inact sag 4v) received on an unknown date in 2021, after which the patient experienced rash and itching.  On an unspecified date in 2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date in 2022, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced rash and itching.   The outcome of the events of rash and itching was not reported.  This case was assessed as non-serious.  This case is linked with cases 202401670 and 202401672 (the same patient).  Company comment: Causality for the events of rash and itching is unassessable due to unclear temporal relationship.; Sender's Comments: Causality for the events of rash and itching is unassessable due to unclear temporal relationship.
Sex: M
Vaccine: FLUA4
Symptoms: Pruritus, Rash
Clinical narrative: Rash; Itching; This spontaneous case from United States was received on 18-Mar-2024 from other non-healthcare professional (consumer) via Communications (reference number: SEQW24-00948) and concerned a 67-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in 2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced rash and itching. The patient's treatment medications included valaciclovir at a dose of 1g, twice a day for seven days.  On an unspecified date, the patient recovered from the events.  This case was assessed as non-serious.  This case is linked with cases 202401670 and 202401671 (the same patient).  Company comment: Due to lack of information about events and unclear temporal relationship, causality for rash and 'itching' is assessed as unassessable.; Sender's Comments: Due to lack of information about events and unclear temporal relationship, causality for rash and 'itching' is assessed as unassessable.
Age: 15.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Antibody test negative, Contraindication to vaccination, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: The event is that patient was administered live vaccine while on Stelara without prior immunity. This was realized when provider was documenting visit afterwards. Provider was in contact with team that night, met the following day with discussion and guidance. Pt was watched for a few days. Friday team met again once more information was gathered. After thorough discussion it was felt that patient is otherwise healthy teen with well controlled plaque psoriasis and rather than going ahead to do IVIG we would watch and support as indicated. Pt and his father were involved in this decision.
Age: 51.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 73.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: PT GOT DIZZY RIGHT AFTER SHE RECEIVED BOTH VACCINES,  SHE NEVER FAINTED, BUT GOT DIZZY. SHE STATED AFTER SHE FELT DIZZY THAT SHE IS SCARED OF NEEDLES AND SHE LOST CONCIOUS  WHEN SHE GOT IV CONECTED TO HER BEFORE, AND ALSO WHEN SHE HAD A VACCINE AT HER DR'S OFFICE BEFORE. SHE DID NOT MENTION THE HX OF DIZZINESS/FAINTING AND FEAR OF NEEDLES BEFORE THE VACCINES WERE ADMINISTERED. PARAMEDICS ARRIVED AND ALL HER VITALS WERE STABLE. SHE REFUSED TO GO TO THE HOSPITAL. HER CONDITION IMPROVED AND SHE LEFT AFTER I MADE SURE SHE IS OK AND ALART
Age: 56.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: Patient has long red stripe on arm approx 2 inchesX 4 inches down arm, occurred right after imz, but pt did not report it to us until today, approx 4 months later.  Patient did not have any other symptoms, just the red stripe.  However, it feels like a burn when it gets warm (in sun, etc) or when she is heated up.   Patient did discuss with her doctor.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest X-ray, Electrocardiogram abnormal, Electrocardiogram ambulatory, Exercise tolerance decreased
Clinical narrative: Severe tachycardia (myocarditis) began after dinner 2 weeks after injection on 12/12/23. I brushed it off, but it worsened, and when I had routine labs at the end of the month I told me PCP and he ordered more testing. I also have subacute thyroid issues (hyperthyroidism) .  I'm still not able to walk more than a few minutes without my heart racing. My EKG remains abnormal!!!
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism, Laboratory test, Myocarditis, Palpitations, Tachycardia
Clinical narrative: Severe tachycardia (myocarditis) began after dinner 2 weeks after injection on 12/12/23. I brushed it off, but it worsened, and when I had routine labs at the end of the month I told me PCP and he ordered more testing. I also have subacute thyroid issues (hyperthyroidism) .  I'm still not able to walk more than a few minutes without my heart racing. My EKG remains abnormal!!!
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound neck, Ultrasound thyroid
Clinical narrative: Severe tachycardia (myocarditis) began after dinner 2 weeks after injection on 12/12/23. I brushed it off, but it worsened, and when I had routine labs at the end of the month I told me PCP and he ordered more testing. I also have subacute thyroid issues (hyperthyroidism) .  I'm still not able to walk more than a few minutes without my heart racing. My EKG remains abnormal!!!
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diplacusis, Tinnitus
Clinical narrative: Sound-induced tinnitus/diplacusis; came on 2 weeks after vaccine; adventitious high-pitched sound accompanies sounds in range between middle C and high C above it.  No tinnitus in quiet.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, X-ray
Clinical narrative: painful left shoulder for 5 months
Age: 50.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, X-ray
Clinical narrative: injection site pain for 5 months
Age: 85.0
Sex: F
Vaccine: MENB, PNC20
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Pt reports by phone red itchy swollen arm, warm to touch, but no hives.  Start at shoulder and go to wrist.  Shots administered 3/18/24 and phone call to the pharmacy occurred 3/21/24. Pt advised to take diphenhydramine and acetaminophen.  Patient was following up with a doctor.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Blister rupture, Lip blister, Oral herpes, Pain
Clinical narrative: severe blistering on hands, inside of lips and legs. blisters leading to cracking and opening of the blisters as well as lots of pain. large cold sores lining inside the lip.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Dizziness, Impaired work ability, Joint swelling
Clinical narrative: Day after vaccine I was weak and dizzy.  Could not work.  I had muscle aches, headache.  Symptoms improved next day except for muscle aches.  Then I started having severe joint pain especially the right hip and right wrist.   My right wrist is swollen and very painful.  Got much worse on 3/18  and still swollen and painful on 3/21/24.  Right hip also very painful.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Day after vaccine I was weak and dizzy.  Could not work.  I had muscle aches, headache.  Symptoms improved next day except for muscle aches.  Then I started having severe joint pain especially the right hip and right wrist.   My right wrist is swollen and very painful.  Got much worse on 3/18  and still swollen and painful on 3/21/24.  Right hip also very painful.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Inflammation, Loss of personal independence in daily activities, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, inflammation and pain in both feet from pressure (shoes, gloves...).  Sent to Rheumatology by primary care physician.  Diagnosis: Inflammatory Osteoarthritis.  The condition occurred suddenly approximately 3 weeks after receiving my second Covid vaccine.  The condition resolved after two weeks.  During that time I was unable to wear shoes except soft slippers due to the pain and swelling.  Now three years later, I continue to have the same problem recurring frequently with typically a two week resolution.  My hands are now beginning to have the same trouble with swelling periodically with a two week resolution. I continue to be monitored by a Rheumatologist.  He has said that he has never seen a presentation such as this in his practice.
Age: 0.58
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Underdose
Clinical narrative: Covid vaccine amount given was only 0.20 ml instead of the required 0.25 ml.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Vaccine for Havrix A Pediatric formulation expired on 11/30/2023
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Crying, Disturbance in attention, Impaired work ability, Tearfulness
Clinical narrative: I had two vaccines today. One was my second dose of Shingles.  The other was the Covid 23-24 vaccine. Within 3 hours of the vaccine I was in complete tears and it was uncontrollable. I was diagnosed with manic depression in my 20s and have been on medication with no troubles like today unless I've not taken my medication for 2-3 days. So, I was like in a state of no depression medication and had to leave work early cause I was crying uncontrollably over anything and everything unable to concentrate, and wanted silence.
Age: 14.0
Sex: F
Vaccine: COVID19, IPV, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: At 11:28AM 14 years old female patient received Polio lot# W1C751M, Pfizer lot#HN0478 and Tdap lot# U7948BA.  At 11:31 AM patient experienced nausea and vomiting.  Vitals were taken at 11:31AM, Heart Rate 58, Blood Pressure 90/57.  At 11:44 AM Heart Rate 61 Blood Pressure 90/62. At 11:55 AM, vitals were Heart rate 62, Blood Pressure 90/64. Patient was conscious, alert and oriented to person, place, time and situation. She was able to speak and stated back her phone number.  Patient vitals were taken one more time before leaving while she was being observed at 12:15PM Blood Pressure was 98/65. Patient stated she felt fine and good to go back home. Patient's mother stated that her daughter did not have breakfast and was empty stomach before getting the vaccines. Provider was notified.  Ambulance was not called. Patient was told that she will receive a follow up phone call within 24 hours.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PATIENT STATES HE DEVELOPED AND NOTICED A RASH THE MORNING OF 03/21/24. VACCINE WAS ADMINISTERED 03/18/24. NO PAIN OR ITCHINESS ACCOMPANIED BY THE RASH
Age: 19.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Injection site erythema, Injection site reaction, Rash macular, Urticaria
Clinical narrative: Immediate skin itching at injection site followed by blotchy red itchy ash at the site that spread to chest and left shoulder.  Patient also reports throat cleating and when asked she notes mild dizziness and seeing floaters.   Patient given benadryl.  The dizziness and floaters resolved within an hour.  The itching and rash resolved within a couple hours.  The throat clearing persisted until the next day.
Age: 19.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness, Immediate post-injection reaction, Injection site pruritus, Injection site reaction, Rash
Clinical narrative: Immediate skin itching at injection site followed by blotchy red itchy ash at the site that spread to chest and left shoulder.  Patient also reports throat cleating and when asked she notes mild dizziness and seeing floaters.   Patient given benadryl.  The dizziness and floaters resolved within an hour.  The itching and rash resolved within a couple hours.  The throat clearing persisted until the next day.
Age: 19.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Rash erythematous, Rash macular, Throat clearing, Vitreous floaters
Clinical narrative: Immediate skin itching at injection site followed by blotchy red itchy ash at the site that spread to chest and left shoulder.  Patient also reports throat cleating and when asked she notes mild dizziness and seeing floaters.   Patient given benadryl.  The dizziness and floaters resolved within an hour.  The itching and rash resolved within a couple hours.  The throat clearing persisted until the next day.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE; VARIVAX was reconstituted with normal saline instead of the Merck sterile diluent and was then administered to a patient.; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-FEB-2024, the patient was vaccinated with varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, 1 dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). However, the vaccine was reconstituted with normal saline instead of the company sterile diluent (Product preparation error). Reporter stated no patient symptoms have been reported.   Lot # is being requested and will be submitted if received.  This is one of two reports from the same reporter.
Age: 13.0
Sex: U
Vaccine: HPV9, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 13-year-old patient.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of dose of varicella virus vaccine live (oka/merck) (VARIVAX) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of dose of varicella virus vaccine live (oka/merck) (VARIVAX) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes.   On 04-DEC-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection,  lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided); and with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1957405, expiration date: 11-NOV-2025, administered intramuscularly for prophylaxis (strength and route of administration were not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2401USA016206: