chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Nausea, Pallor, Snoring
Clinical narrative: mild syncope episode after 4th vaccine (influenza) was administered, patient turned pale, slumped to his left side, snored about 2-3 seconds, sat back up and stated he felt dizzy and nauseous, I laid patient on his left side and called PA-C into room. *Blood pressure: #1 after episode @ 11:15 a.m. 65/44 (left arm/ sitting) 62 (bpm) *Blood Pressure: #2 after episode @ 11:25 a.m. 96/66 (left arm/sitting) 78 (bpm) PA-C was in room with patient, mom, sister and I until patient was cleared to leave. As per mom patient had not had breakfast yet. @ around 11:45 a.m. patient was able to stand and walk out of room with mom.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: mild syncope episode after 4th vaccine (influenza) was administered, patient turned pale, slumped to his left side, snored about 2-3 seconds, sat back up and stated he felt dizzy and nauseous, I laid patient on his left side and called PA-C into room. *Blood pressure: #1 after episode @ 11:15 a.m. 65/44 (left arm/ sitting) 62 (bpm) *Blood Pressure: #2 after episode @ 11:25 a.m. 96/66 (left arm/sitting) 78 (bpm) PA-C was in room with patient, mom, sister and I until patient was cleared to leave. As per mom patient had not had breakfast yet. @ around 11:45 a.m. patient was able to stand and walk out of room with mom.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disorder" (unspecified if ongoing); "Known allergies: Trouble digesting some foods" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received anti-viral treatment of Covid-19 product Paxlovid from 16Dec2023 to 20Dec2023.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: Ff8839) at the age of 36 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing); "interstitial cystitis" (unspecified if ongoing); "ptsd" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Heparin, reaction(s): "known allergies: heparin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid for the treatment of COVID-19.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old male patient received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment with Paxlovid, Treatment start date was on16Dec2023, Treatment stop date was on 21Dec2023. Vaccine administration time was10:00 AM.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  An 85-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received anti-viral treatment of Covid-19 product Paxlovid from 17Dec2023 to 21Dec2023.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from an Other HCP.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: Tested positive again after testing negative for several days; Negative, notes: Tested positive again after testing negative for several days. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: COVID 19 Treatment included Paxlovid (start date=17Dec2023, stop date=21Dec2023).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162b2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OLMESARTAN MEDOXOMIL, start date: Mar2020; ATORVASTATIN, start date: Jan2016. Vaccination history included: pfizer / biontech (DOSE NUMBER UNKNOWN, Lot number: en6190), administration date: 05Mar2021, for Covid-19 Immunization; pfizer / biontech (DOSE NUMBER UNKNOWN, Lot number: Unknown), administration date: 26Mar2021, for Covid-19 Immunization; pfizer / biontech (DOSE NUMBER UNKNOWN, Lot number: 30145ba), administration date: 06Oct2021, for Covid-19 Immunization; moderna (DOSE NUMBER UNKNOWN, Lot number: 065k21a), administration date: 14Apr2022, for Covid-19 Immunization; pfizer / biontech (DOSE NUMBER UNKNOWN, Lot number: gj2524), administration date: 07Sep2022, for Covid-19 Immunization; pfizer / biontech (DOSE NUMBER UNKNOWN, Lot number: gj6743, Anatomical location: Left arm), administration date: 15Mar2023, for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Negative, notes: had two negative readings 24 hours apart 5 days after starting Paxlovid; Negative, notes: had two negative readings 24 hours apart 5 days after starting Paxlovid; Positive, notes: tested positive with worse symptom 3 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received other vaccination and medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 16Dec2023 to 22Dec2023.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Vaccination site pain
Clinical narrative: Soreness at injection site; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 as dose 1, single (Lot number: HG2649) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19"; VACCINATION SITE PAIN (non-serious) with onset 25Oct2023, outcome "recovered" (28Oct2023), described as "Soreness at injection site". Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient did not receive any other medication in 2weeks. Paxlovid started in Nov2023 and stopped in Nov2023 on an unknown date for Treatment of COVID-19. Patient experienced Soreness at injection site, body aches, fatigue on 25Oct2023 which were recovered on 28Oct2023. No treatment was received for these events. Other medical history: COVID.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose: 1, 2, 3: Pfizer/Dose: 4, 5: Moderna; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6207), in right arm, on 07Apr2021 at 14:15 as dose 2, single (Lot number: EW0151), in right arm and on 09Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 30 years, in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 15Sep2022 as dose 4 (booster), single (Lot number: AS7143C), in right arm and on 18Sep2023 at 18:15 as dose 5 (booster), single (Lot number: 202F23A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Childhood asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "generalized anxiety" (unspecified if ongoing); "benign macular amyloidosis" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Allergic to Cashews and Pistachios" (unspecified if ongoing), notes: known allergies: Allergic to Cashews and Pistachios. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "Dose: 1, 2, 3: Pfizer/Dose: 4, 5: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2023) Positive, notes: I retested on 21Dec2023 after completing PAXLOVID the previous day. While the test still technically came back positive,; (24Dec2023) Positive, notes: I tested positive today (24Dec2023) with a fairly dark positive line on my Binax test; (14Dec2023) Positive, notes: first tested positive for COVID on 14Dec2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti viral details:COVID 19 Treatment, Paxlovid from 15Dec2023 to 20Dec2023 Lot number GJ6048. I'm experiencing a rebound of symptoms similar in type and severity to when I first tested positive for COVID on 14Dec2023. This includes primarily mild chest congestion and mild sore throat. I retested on 21Dec2023 after completing PAXLOVID the previous day. While the test still technically came back positive, the positive line on my Binax test was extremely faint and almost non-existent, and symptoms had basically disappeared. Symptoms started coming back on 23Dec2023, and I tested positive today (24Dec2023) with a fairly dark positive line on my Binax test.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "BPHD" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received anti-viral treatment of Covid-19, product Paxlovid from 14Dec2023 to 18Dec2023.   Clinical information: No known allergies reported.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis and anti-phospholipid syndrome" (unspecified if ongoing); "Rheumatoid arthritis and anti-phospholipid syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for COVID-19 immunization; Covid-19 vaccine (Dose 4), for COVID-19 immunization; Covid-19 vaccine (Dose 5), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Paxlovid from 13Dec2023 to 21Dec2023 for Covid-19 treatment. Rebound two days after taking Paxlovid. Took Paxlovid for 8 days. Symptoms were mild with round 1 but heart racing and chest pain. Same symptoms with round 2 so far.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GJ5346) at the age of 50 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Jan2021 as dose 1, single (Lot number: 028L20A), in left arm, on 23Feb2021 as dose 2, single (Lot number: 013M20A), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: 039D21A), in left arm, on 09Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm and on 21Oct2023 as dose 6 (booster), single (Lot number: 3031894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Dec2023) Positive, notes: Tested positive at home for Covid, Started Covid that day. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid from 16Dec2023 to 20Dec2023 or the treatment of COVID-19. Patient had no known allergies.
Sex: U
Vaccine: RSV
Symptoms: Chronic obstructive pulmonary disease
Clinical narrative: COPD; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: caught COVID; caught COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: I got COPD and I got it really bad. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "caught COVID".  Clinical information: Phone call received from the patient seeking assistance with Abrysvo (Respiratory Syncytial Virus Vaccine). During the call, the patient stated, "I work with a 21-month-old, and I work with a 4-year-old that I take into preschool everyday cause I'm a professional nanny. I bring home sickness from these little kids too. I work with a 21-month-old, all 1 family, and a withheld that just turned 2-months-old and that little boy; I get any type of sickness from him. I caught COVID off him. Even though I get vaccinations and everything, but this RSV is a serious thing, and I don't want to get it. I just hope I don't get sick from this. I'm trying very hard not to get this and that's probably what upsets me the most, you know. I got COPD and I got it really bad and that's why I'm concerned about this".  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, Drug ineffective
Clinical narrative: She had COVID shots before and now she have COVID; She had COVID shots before and now she have COVID; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had COVID shots before and now she have COVID".  Clinical course: The caller called in because she was diagnosed with COVID-19 and she cannot get her prescription for Paxlovid. The caller said the pharmacy told her to get some kind of something from Pfizer because it used to be free and now her (withheld) won't pay for it. The caller mentioned she had COVID shots before and now she has COVID.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Squamous cell carcinoma
Clinical narrative: Also developed a squamous cancer cell on left leg that had be removed. This is 12 days after covid shot on 04Mar2021; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 at 14:15 as dose 1, single (Lot number: EN6198) intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SQUAMOUS CELL CARCINOMA (medically significant) with onset 16Mar2021, outcome "unknown", described as "Also developed a squamous cancer cell on left leg that had be removed. This is 12 days after covid shot on 04Mar2021". Therapeutic measures were taken as a result of squamous cell carcinoma.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101425665 Same patient/same product, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: had several rounds of AFib; 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)), in Sep2023 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: ATRIAL FIBRILLATION (medically significant) with onset 2023, outcome "unknown", described as "had several rounds of AFib". Clinical course: Patient and others after getting the latest COVID-19 booster in Sep2023 a few weeks after had several rounds of AFib. Was there a relationship.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I just tested positive for Covid 19. I received your useless vaccine for Covid 19 back in the Fall of 2021. Since then , I have contracted the Covid 19 virus Twice; I just tested positive for Covid 19. I received your useless vaccine for Covid 19 back in the Fall of 2021. Since then , I have contracted the Covid 19 virus Twice; I just tested positive for Covid 19. I received your useless vaccine for Covid 19 back in the Fall of 2021. Since then , I have contracted the Covid 19 virus Twice; 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), in 2021 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "I just tested positive for Covid 19. I received your useless vaccine for Covid 19 back in the Fall of 2021. Since then , I have contracted the Covid 19 virus Twice". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I just tested positive for Covid 19.  Clinical course:  I just tested positive for Covid 19. I received your useless vaccine for Covid 19 back in the Fall of 2021. Since then, I have contracted the Covid 19 virus Twice. And my body has never been the same after I was FORCED to take your lethal poison. And since my Holidays are now ruined I just wanted to ask you WHAT was the point of creating this poison that doesn't do anything at all except make people sick? What was the point? Besides (dollar) Profit!! I would love to hear your response. THX  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I am double vaxxed with both Pfizer covid vaccines and have had COVID 3 times!; I am double vaxxed with both Pfizer covid vaccines and have had COVID 3 times!; 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)), in 2023 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 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "I am double vaxxed with both Pfizer covid vaccines and have had COVID 3 times!". Clinical course: Patient was double vaxxed with both Pfizer covid vaccines and have had COVID 3 times. Patient was never been sicker in life.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: developed full- body raised rash shortly after receiving Comirnaty vaccine; 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. The following information was reported: RASH PAPULAR (non-serious), outcome "unknown", described as "developed full- body raised rash shortly after receiving Comirnaty vaccine".  Clinical curse: On 25Dec2023 in (Redacted country), relative shared case of a friend who developed full- body raised rash shortly after receiving Comirnaty vaccine. Reporting individual did not know any other details of case.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: IMOVAX vaccine but was incorrectly administered the rabies immunoglobulin pre-exposure instead kedrab, with no reported adverse event; Initial information received on 18-Dec-2023 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves an unknown age and unknown gender patient where rabies (hdc) vaccine [Imovax rabies] vaccine but was incorrectly administered the rabies immunoglobulin pre-exposure instead kedrab, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect rabies (hdc) vaccine Powder and solvent for suspension for injection lot number not reported via unknown route in unknown administration site and received a dose of suspect Kedrab not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (formulation, strength and expiration date: not provided) for Immunisation (wrong product administered) (latency- same day).  Action taken: not applicable.   Outcome: Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Additional information was received on 18-Dec-2023 from Pharmacist: Case was updated from Non case to Valid case; text amended accordingly (Actual Follow-up (FU) CSD is 16-Dec-2023, i.e., prior to Initial receipt date (18-Dec-2023) hence FU CSD captured as18-Dec-2023 (as the Initial receipt date) in General tab
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: Nurse states a patient only received the diluent portion of the ACTHIB vaccine instead of the reconstituted product with no reported adverse event; Initial information received on 20-Dec-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 years old female patient for whom nurse states a patient only received the diluent portion of the HIB (PRP/T) vaccine [ACT-HIB] vaccine instead of the reconstituted product with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR): VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 01-Dec-2023, the patient received 0.5 ml  dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (strength not reported) (Lot # diluent UJ862AA; EXP: 24-May-2024 ? Lot # aCTHIB UJ855AA; EXP: 22-Mar-2024) via unknown route in the thigh nos (not otherwise specified) for Immunization nurse states a patient only received the diluent portion of the acthib vaccine instead of the reconstituted product with no reported adverse event (product preparation error) (on same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Medication error, No adverse event, Product administration error, Underdose
Clinical narrative: accidental administration of Pentacel vaccine that was not reconstituted, with no reported adverse event; patient receiving the incomplete dose, with no reported adverse event; it resulted to the patient receiving the incomplete dose (with no reported adverse event); Initial information received on 21-Dec-2023 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves an unknown age and unknown gender patient who experienced accidental administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] vaccine that was not reconstituted, with no reported adverse event, patient receiving the incomplete dose, with no reported adverse event and it resulted to the patient receiving the incomplete dose (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (product preparation error), (incorrect dose administered) and (underdose).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: Electric shock sensation, Nerve conduction studies, Neuralgia
Clinical narrative: Electric shock nerve pain; Electric shock nerve pain; This spontaneous case was received on 20-Dec-2023 from other non-healthcare professional (consumer) via Communications (reference number SEQW23-04961) and concerned a 65-year-old, male patient.     The patient's medical history and concomitant medications were not reported.   On 26-Sept-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location not reported), for active immunization of persons 65 years of age and older against influenza caused by influenza virus subtypes A and B contained in the vaccine. The batch number was not reported.  On 28-Sep-2023, reportedly within 48 hours, the patient started experiencing all over electric shock nerve pain. The patient had been undergoing testing through his neurologist in search of a cause to no avail.  At the time of the initial reporting on 20-Dec-2023, the patient had not recovered from the events of 'electric shock sensation' and 'nerve pain'. As reported, the patient was desperate for relief.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 65-year-old patient was vaccinated with Fluad Quadrivalent. Two days following vaccination, the patient experienced electric shock sensation and neuralgia. The patient's medical history, concomitant medications and neurological testing results were not reported. Based on chronological plausibility, causality is assessed as possible for both events.; Sender's Comments: A 65-year-old patient was vaccinated with Fluad Quadrivalent. Two days following vaccination, the patient experienced electric shock sensation and neuralgia. The patient's medical history, concomitant medications and neurological testing results were not reported. Based on chronological plausibility, causality is assessed as possible for both events.
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Chronic wrist pain both wrists; It (pain) radiates to my right hand fingers / It has been very painful; This spontaneous case was received on 26-Dec-2023 from a other non-healthcare professional (consumer) via Communications (reference number: SEQW23-05025) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.   On 24-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4V; dose 0.5 ml; route of administration: intramuscular (IM) and anatomical location: left deltoid (LD)) for prevention of influenza disease. The batch number reported was 371598 and expiry date was 22-May-2024.  On an unspecified date in Oct-2023, reported as since flu shot, the patient suffered quite chronic wrist pain and it radiated to her right hand fingers, also got much worse while sleeping. The patient took prednisone (reported as 'predni'), but didn't relieve it much, as reported. Reportedly, the patient consulted her doctor.    At the time of initial reporting, on 26-Dec-2023, the patient had not recovered from the events. The patient stated that she would never get a flu shot again, it was very painful and showed no sign of letting up.  The reported did not provide the causality assessment.  The case was assessed as non-serious.  Company Comment: The patient developed chronic wrist pain on both wrists, radiating to right hand fingers. Reportedly, the patient has been experiencing the events since vaccine administration. Causal role of the vaccine is assessed as possibly related for both events of ''wrist pain' and 'pain in fingers' due to plausible temporal relationship.; Sender's Comments: The patient developed chronic wrist pain on both wrists, radiating to right hand fingers. Reportedly, the patient has been experiencing the events since vaccine administration. Causal role of the vaccine is assessed as possibly related for both events of ''wrist pain' and 'pain in fingers' due to plausible temporal relationship.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Blister, Hypersensitivity, Rash
Clinical narrative: IST DAY- RASH IN WHOLE ARM, 2ND DAY PT GOT A BIG BLISTER. pt went to the doctor's office and he suggested Allegra because he said it was an allergic reaction.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received Pfizer vaccine  1 day beyond BUD.  According to Pfizer manufacturer research data, vaccine is stable and effective up to 2 days after BUD.  Patient is feeling well, no concerns.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Allergy to vaccine, Erythema, Peripheral swelling
Clinical narrative: No adverse events or treatments noted.  Adverse reaction wasn't reported until patients next appointment on 12/6/23.
Age: 30.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Blood urine present, Malaise
Clinical narrative: About 3 days later, pt started to pass blood in urine, she did not feel well.  She went to urgent care and saw her primary care but they were unable to find any other diagnosis.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer vaccine  1 day beyond BUD.  According to Pfizer manufacturer research data, vaccine is stable and effective up to 2 days after BUD.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Patient did not inform Pharmacy that he is very afraid of needles and has panic attacks after shots that cause him to pass out.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer vaccine  1 day beyond BUD.  According to Pfizer manufacturer research data, vaccine is stable and effective up to 2 days after BUD.  Patient is feeling well, no concerns.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer vaccine  2 days beyond BUD.  According to Pfizer manufacturer research data, vaccine is stable and effective up to 2 days after BUD.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Dyspnoea, Hypersensitivity, Productive cough, Pyrexia
Clinical narrative: PT  told me  that she had allergic reaction TO AREXVY VACAINATION  : PT  EXPLAINED THAT SHE HAD FEVER ,SOB , DIZZY :  HAD COUGH WITH MUCUS ,  ENQUIRED WEA THER THE PT HAD CONTACTED HER PRIMARY CARE MD AS PER  PT SHE DID  BUT THEY  TOLD HER TO GO TO ER WHICH PT  DIDNT DO IT BOZ SHE DOESNT WANT TO GO TO THE ER . I HAD CONSULED THE PT  IT MIGHT BE A UPPER RESPITATORY TRACT INFECTION  , ANDF SHE NEEDS TO SEE MD
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Deafness unilateral, Influenza like illness, Lymphadenopathy, Nasal ulcer, Tinnitus
Clinical narrative: patient stated feeling flu like symptoms and swollen lymph nodes within 36 hours. This resulted in loss of hearing in right ear for three days. the issue resolved but now two weeks later still has clicking sound in ear.  Also caused sores in nostrils which have still not resolved patient has been using ointment. Has not talked to her dr but planned on telling her doctor at next dr visit.
Age: 78.0
Sex: F
Vaccine: UNK
Symptoms: Discomfort, Erythema, Pain, Pain in extremity
Clinical narrative: Patient reports pain and redness in her left arm.  She report the discomfort is responsive to ibuprofen and topical benadryl.  She can move her arm though she says it is very painful.  The pain began 6 days after the vaccine and has persisted.  Advised patient to contact physician and rule out any other problems like a blood clot or traumatic injury.
Age: 23.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Feeling hot, Flushing
Clinical narrative: Influenza and Td IM given per protocol observing proper technique. Patient tolerated procedure well. Observed for 15 min. felt flushed and hot at 2 pm and asked for water. Pt. stated she has not eaten breakfast nor lunch as well. Felt better at 2:17 pm, no fainting, not in any distress. Vital signs stable. Oxygen saturation on room air 98%. Awake/alert, oriented to person, place and time. NP notified of events, and pt. cleared to go home. At 2:35 pm Pt. stated she felt completely better, no dizziness, no other complaints. Vital signs stable. Instructed to go to Emergency room or call EMS if symptoms return. Pt. verbalized understanding. Discharged with mother, in stable condition.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer vaccine  2 days beyond BUD.  According to Pfizer manufacturer research data, vaccine is stable and effective up to 2 days after BUD.
Age: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Pt had already received the flu shot (duplicate dose)
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer vaccine  7 days beyond BUD.  According to Pfizer manufacturer research data, vaccine is stable and effective up to 2 days after BUD.  Waiting for more stability data from PFIZER to determine if revaccination is necessary.
Age: 11.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Nursing staff noted after the administration of the vaccine that the patient received DTaP instead of Td. Healthcare provider reviewed with nursing supervisor and there is no indication to re-dose per immunization system. Error noted that patient is over 7years old and should not have received DTaP so this is considered an off-label administration thus prompting the VAERS report. Patient had no acute reaction or adverse effects reported to Healthcare Provider.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Pfizer vaccine  7 days beyond BUD.  According to Pfizer manufacturer research data, vaccine is stable and effective up to 2 days after BUD.  Waiting for more stability data from PFIZER to determine if revaccination is necessary.
Age: 27.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Angina pectoris, Chest pain, Dyspnoea
Clinical narrative: Pain in left side of chest, sharp pain in heart when inhaling, shortness of breath. Lasting 1 hour. Starting 20 minutes after vaccine shot.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: 12-8-23: patient informed the pharmacy of arm swelling and that he was scheduled for an MRI 12-15-23: patient informed the pharmacy that he was "feeling much better"
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Blood test, Injected limb mobility decreased, Injection site pain, Laboratory test, Magnetic resonance imaging
Clinical narrative: increase pain for 3 weeks in upper left arm, followed by significant loss of arm mobility (unable to raise arm between 45 degrees). After one month of loss of mobility, slight improvement.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Nerve injury, X-ray
Clinical narrative: increase pain for 3 weeks in upper left arm, followed by significant loss of arm mobility (unable to raise arm between 45 degrees). After one month of loss of mobility, slight improvement.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Computerised tomogram head normal, Dizziness, Gait inability
Clinical narrative: Woke up the next morning with extreme dizziness. Unable to walk. Am still dizzy as of 12/28 but it has improved.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received high dose flu shot when they should have received regular dose. Patient did not report any unusual side effects.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage in pregnancy, Subchorionic haemorrhage, Ultrasound scan
Clinical narrative: In-utero stroke causing hydrocephalus in fetus. Baby had shunt surgery a few days after birth. Baby suffers developmental delays. Mother (myself) continuing to  experience pregnancy bleeding abnormalities (subchorionic hemorrhage) in subsequent 3rd pregnancy. No issues with that for first pregnancy before vaccine.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Appendicitis, Asthenia, Biopsy skin, Blood test
Clinical narrative: GI issues, lost 25lbs with in a week, small fiber neuropathy, weakness, muscle loss, tinnitus, eye floaters,  cervical instability, inflamed appendix, pain, histamine issues, burning skin, tachycardia.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Electromyogram, Gastrointestinal disorder, Histamine abnormal, Magnetic resonance imaging
Clinical narrative: GI issues, lost 25lbs with in a week, small fiber neuropathy, weakness, muscle loss, tinnitus, eye floaters,  cervical instability, inflamed appendix, pain, histamine issues, burning skin, tachycardia.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle atrophy, Nerve conduction studies, Pain, Skin burning sensation, Small fibre neuropathy
Clinical narrative: GI issues, lost 25lbs with in a week, small fiber neuropathy, weakness, muscle loss, tinnitus, eye floaters,  cervical instability, inflamed appendix, pain, histamine issues, burning skin, tachycardia.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal instability, Tachycardia, Tinnitus, Vitreous floaters
Clinical narrative: GI issues, lost 25lbs with in a week, small fiber neuropathy, weakness, muscle loss, tinnitus, eye floaters,  cervical instability, inflamed appendix, pain, histamine issues, burning skin, tachycardia.