chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: hot at injection site; Bumpy rash; itching; Big red rash; Tiredness; Low fever; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-NOV-2023, the patient received the 1st dose of Shingrix. In NOV-2023, an unknown time after receiving Shingrix, the patient experienced injection site warmth (Verbatim: hot at injection site), papular rash (Verbatim: Bumpy rash), pruritus (Verbatim: itching), red rash (Verbatim: Big red rash), tiredness (Verbatim: Tiredness), fever (Verbatim: Low fever) and chills (Verbatim: Chills). The outcome of the injection site warmth, tiredness, fever and chills were unknown and the outcome of the papular rash was resolved and the outcome of the pruritus and red rash were not resolved.   It was unknown if the reporter considered the injection site warmth, papular rash, pruritus, red rash, tiredness, fever and chills to be related to Shingrix.     It was unknown if the company considered the injection site warmth, papular rash, pruritus, red rash, tiredness, fever and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-Nov-2023 The patient was self-reported this case. The patient received Shingrix vaccine and experienced chills, low fever, tiredness, big red rash, bumpy rash, hot at the injection site and itching. Patient reported that the bumps had resolved but the rash and the itching have not resolved.  The patient reported that the person that injected the vaccine squeezed the injection site for more than a minute before administering the vaccine.  The reporter stated that she was a nurse and this was not a known practice. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: haven't gotten the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th March 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: haven't gotten the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date-30-NOV-2023 The patient have not got the second dose. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 0.75
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 9 month old received the Kinrix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 28-NOV-2023, the patient received Kinrix. On 28-NOV-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 9 month old received the Kinrix vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-NOV-2023 A health care professional (HCP) reported that 9 month old received the Kinrix vaccine, which led to inappropriate age at vaccine administration. No reactions reported. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: RN didn't reconstitute Menveo and just gave only liquid portion of 2 vial presentation; RN didn't reconstitute Menveo and just gave only liquid portion of 2 vial presentation; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa957a, expiry date 30-SEP-2024) and (batch number amva957a, expiry date 30-SEP-2024) for prophylaxis.   On 30-NOV-2023, the patient received Menveo. On 30-NOV-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: RN didn't reconstitute Menveo and just gave only liquid portion of 2 vial presentation) and inappropriate dose of vaccine administered (Verbatim: RN didn't reconstitute Menveo and just gave only liquid portion of 2 vial presentation). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 30-NOV-2023 A nurse practitioner (NP) reported that today (on the day of reporting) an registered nurse (RN) did not reconstitute Menveo and just gave only liquid portion of 2 vial presentation, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Getting over cough; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Getting over cough) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Getting over cough). At the time of the report, COUGH (Getting over cough) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medications were reported.  A Moderna Clinical Trial participant (past participant) contacted and reported an adverse event. Patient was in a past RSV trial and currently getting over a cough.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at injection site but it began 48 hours after the injection; redness and swelling at injection site but it began 48 hours after the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness and swelling at injection site but it began 48 hours after the injection) and INJECTION SITE SWELLING (redness and swelling at injection site but it began 48 hours after the injection) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3033048) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 17-Nov-2023, the patient experienced INJECTION SITE ERYTHEMA (redness and swelling at injection site but it began 48 hours after the injection) and INJECTION SITE SWELLING (redness and swelling at injection site but it began 48 hours after the injection). At the time of the report, INJECTION SITE ERYTHEMA (redness and swelling at injection site but it began 48 hours after the injection) and INJECTION SITE SWELLING (redness and swelling at injection site but it began 48 hours after the injection) had not resolved.        Concomitant and treatment medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Fatigue, Paraesthesia
Clinical narrative: There is pinching all over his body.; bone pain; itchiness a week after the vaccine; tiredness; chills; his joints are hurting crazy; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (There is pinching all over his body.), BONE PAIN (bone pain), PRURITUS (itchiness a week after the vaccine), FATIGUE (tiredness) and CHILLS (chills) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had no relevant medical history/conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (one month before) in 2023. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE.    On 26-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced PARAESTHESIA (There is pinching all over his body.), BONE PAIN (bone pain), PRURITUS (itchiness a week after the vaccine), FATIGUE (tiredness), CHILLS (chills) and ARTHRALGIA (his joints are hurting crazy). In November 2023, PRURITUS (itchiness a week after the vaccine) had resolved. At the time of the report, PARAESTHESIA (There is pinching all over his body.), BONE PAIN (bone pain), FATIGUE (tiredness), CHILLS (chills) and ARTHRALGIA (his joints are hurting crazy) had not resolved.            No concomitant medication was reported. The patient had 5 previous doses of the Moderna vaccines. It was reported that the patient initially had itchiness a week after the vaccine but this resolved within a week. Then the patient had tiredness, chills, fatigue and the most prominent was the bone pain especially when the patient was lying down. The joints are hurting crazy. There was pinching all over his body. The patient was told that this can go on for 3 weeks but this was the 5th week already and the patient still hah them. The dosage text was reported as unknown. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: There is pinching all over his body.; bone pain; itchiness a week after the vaccine; tiredness; chills; his joints are hurting crazy; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (There is pinching all over his body.), BONE PAIN (bone pain), PRURITUS (itchiness a week after the vaccine), FATIGUE (tiredness) and CHILLS (chills) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had no relevant medical history/conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (one month before) in 2023. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE.    On 26-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced PARAESTHESIA (There is pinching all over his body.), BONE PAIN (bone pain), PRURITUS (itchiness a week after the vaccine), FATIGUE (tiredness), CHILLS (chills) and ARTHRALGIA (his joints are hurting crazy). In November 2023, PRURITUS (itchiness a week after the vaccine) had resolved. At the time of the report, PARAESTHESIA (There is pinching all over his body.), BONE PAIN (bone pain), FATIGUE (tiredness), CHILLS (chills) and ARTHRALGIA (his joints are hurting crazy) had not resolved.            No concomitant medication was reported. The patient had 5 previous doses of the Moderna vaccines. It was reported that the patient initially had itchiness a week after the vaccine but this resolved within a week. Then the patient had tiredness, chills, fatigue and the most prominent was the bone pain especially when the patient was lying down. The joints are hurting crazy. There was pinching all over his body. The patient was told that this can go on for 3 weeks but this was the 5th week already and the patient still hah them. The dosage text was reported as unknown. No treatment medication was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Nasal congestion, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling and redness and heat at injection site. Stuffy nose.; Swelling and redness and heat at injection site. Stuffy nose.; Swelling and redness and heat at injection site. Stuffy nose.; Swelling and redness and heat at injection site. Stuffy nose.; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Swelling and redness and heat at injection site. Stuffy nose.), VACCINATION SITE WARMTH (Swelling and redness and heat at injection site. Stuffy nose.), VACCINATION SITE SWELLING (Swelling and redness and heat at injection site. Stuffy nose.) and INJECTION SITE ERYTHEMA (Swelling and redness and heat at injection site. Stuffy nose.) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 80777-0102-93) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 06-Dec-2023, the patient experienced NASAL CONGESTION (Swelling and redness and heat at injection site. Stuffy nose.), VACCINATION SITE SWELLING (Swelling and redness and heat at injection site. Stuffy nose.) and INJECTION SITE ERYTHEMA (Swelling and redness and heat at injection site. Stuffy nose.). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Swelling and redness and heat at injection site. Stuffy nose.). At the time of the report, NASAL CONGESTION (Swelling and redness and heat at injection site. Stuffy nose.), VACCINATION SITE SWELLING (Swelling and redness and heat at injection site. Stuffy nose.) and INJECTION SITE ERYTHEMA (Swelling and redness and heat at injection site. Stuffy nose.) had not resolved and VACCINATION SITE WARMTH (Swelling and redness and heat at injection site. Stuffy nose.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  It was unknown if the patient experienced any additional symptoms or events.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I started itching about three or four hours later; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (I started itching about three or four hours later) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced PRURITUS (I started itching about three or four hours later). At the time of the report, PRURITUS (I started itching about three or four hours later) outcome was unknown.            No concomitant medication was reported.  It was reported that patient had four shots before then and nothing happened. It was reported that patient was going crazy. No treatment medication was reported.   Reporter did not allow further contact
Age: 44.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Asthenia, Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Weakness; Headaches; Fatigue; Muscle Soreness; Soreness at vaccine location; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weakness), HEADACHE (Headaches), FATIGUE (Fatigue), MYALGIA (Muscle Soreness) and VACCINATION SITE PAIN (Soreness at vaccine location) in a 44-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE injection for an unknown indication.    Concurrent medical conditions included Disability (100% Disabled patient, with lots of different heath conditions).   On 05-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started INFLUENZA VACCINE (unknown route) at an unspecified dose. On 06-Dec-2023, the patient experienced ASTHENIA (Weakness), HEADACHE (Headaches), FATIGUE (Fatigue), MYALGIA (Muscle Soreness) and VACCINATION SITE PAIN (Soreness at vaccine location). At the time of the report, ASTHENIA (Weakness), HEADACHE (Headaches), FATIGUE (Fatigue), MYALGIA (Muscle Soreness) and VACCINATION SITE PAIN (Soreness at vaccine location) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       It was reported that, patient received the Covid-19 and Flu vaccines separately, in each upper arms.  Concomitant medications were not reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Allergic reaction to excipient, Cough, Dyspnoea, Unevaluable event, Wheezing
Clinical narrative: Experienced mild reactions; at the hospital; Allergic to some of the ingredients presented in the vaccine; Wheeze; Cough; Difficulty breathing; On 29-NOV-2023, this non-serious spontaneous case was received from a health professional via the contact center.   This case was assessed as Invalid based on: Incomplete ICSR: no identifiable adverse drug reaction.  On 01-DEC-2023, significant additional information was received by Novavax from a health professional via the contact center. A valid adverse event was populated, and this case was reassessed as valid. A valid narrative was generated as follows:  On 29-NOV-2023, this non-serious spontaneous case was received from a health professional via the contact center. Significant additional information was received on 01-DEC-2023, from a health professional via the contact center.  A female of an unspecified age and race was vaccinated with intramuscular use Novavax COVID-19 Vaccine, Adjuvanted 10 ug/mL suspect COVID-19 vaccine dose 1 on an unspecified date and dose 2 on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the individual had mild reactions, and was allergic to some of the ingredients presented in the vaccine (PT: Allergic reaction to excipient). On an unspecified date, after dose 1, the individual was at the hospital (PT: Unevaluable event) (Serious: Hospitalization) (which was reported to be not related to getting the first dose of the Novavax vaccine) and had her second dose. On an unspecified date, after she was discharged from the hospital, she began to wheeze (PT: Wheezing), cough (PT: Cough), and had difficulty breathing (PT: Dyspnoea). The individual was sprayed with albuterol as treatment, and she got better.  At the time of reporting, the event outcome of Unevaluable event and Allergic reaction to excipient were unknown, and the event outcomes of Wheezing, Cough, and Dyspnoea were recovered/resolved.  Lot number was not provided in the report.; Sender's Comments: This female of an unspecified age experienced: Unevaluable event, Allergic reaction to excipient, Cough, Dyspnoea and Wheezing after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Unevaluable event was assessed as serious. The events Allergic reaction to excipient, Cough, Dyspnoea and Wheezing were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Blindness, Deafness, Magnetic resonance imaging, Tinnitus
Clinical narrative: Somatic pulsatile tinnitus, hearing loss, vision loss
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was given, in addtion to above vaccines, a dose of adult RSV vaccine Abrysvo.  NCD # 49281-575-00   LOT #   HF5016   intramuscular,  Left Thigh,  dose in series: 1
Age: 56.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: RSV shot given to patient under 60 years old.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Employee reported to EHN on 11/02/2023: "my left arm is feeling weak and from my ring finger pain 6/10 that irradiates up to injection site but am not been evaluated".
Age: 45.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: rsv shot given to patient under 60
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood culture, COVID-19, Culture, Glucose tolerance impaired
Clinical narrative: Date of Admission: 11/11/2023   Date of Discharge: 11/13/2023   Issues to be Addressed at Follow-up: Covid Tx  Hematology follow up Monitor CBC    Pending Study Results at Discharge: Unresulted Lab Orders    Date and Time Order Name Status Specimen Source   11/11/2023  2:40 PM RESPIRATORY CULTURE Preliminary SPUTUM   11/11/2023  8:42 AM BLOOD CULTURE 2 Preliminary BLOOD   11/11/2023  7:29 AM BLOOD CULTURE Preliminary BLOOD       Final Diagnoses: Active Hospital Problems   Diagnosis   ? (Principal) ACUTE RESPIRATORY FAILURE   ? COVID-19 DISEASE   ? SEPSIS WO ACUTE ORGAN DYSFUNCTION   ? PREDIABETES
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Date of Admission: 11/11/2023   Date of Discharge: 11/13/2023   Issues to be Addressed at Follow-up: Covid Tx  Hematology follow up Monitor CBC    Pending Study Results at Discharge: Unresulted Lab Orders    Date and Time Order Name Status Specimen Source   11/11/2023  2:40 PM RESPIRATORY CULTURE Preliminary SPUTUM   11/11/2023  8:42 AM BLOOD CULTURE 2 Preliminary BLOOD   11/11/2023  7:29 AM BLOOD CULTURE Preliminary BLOOD       Final Diagnoses: Active Hospital Problems   Diagnosis   ? (Principal) ACUTE RESPIRATORY FAILURE   ? COVID-19 DISEASE   ? SEPSIS WO ACUTE ORGAN DYSFUNCTION   ? PREDIABETES
Age: 0.5
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: in addition to above vaccines pt received adult RSV vaccine Abyrsvo,  NDC # 0069-0207-01,  LOT #  HF5016,  intramuscular, Right Thigh, dose 1 in series
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Contusion, Peripheral swelling
Clinical narrative: SWOLLEN ARM AND BRUISES
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Laboratory test
Clinical narrative: Feet feel numb
Age: 59.0
Sex: M
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Site pain within an hour. The next day, left arm severely sore. Then came high degree of pain and numbing & tingling. Numbing and tingling all the way to the fingers.
Age: 15.0
Sex: M
Vaccine: COVID19, FLU4, HEPA
Symptoms: Expired product administered
Clinical narrative: Patient was given COVID-19 vaccine that had expiration date of 12/06/2023 (refrigerated expiration date).
Age: 73.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Death, Pain in extremity
Clinical narrative: Patient's brother came by today and stated that patient passed away on 12/2/23.  He stated that patient had no symptoms from the 2 vaccines since getting the vaccines and seemed to be doing great.  Brother found patient dead on 12/2 after seeing patient earlier that morning.  He stated the only complaint the patient had that day was her leg was hurting.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Device leakage
Clinical narrative: lurer lock of diluent on the adapter would bend backwards and not lock; The syringe ended up popping out of the lurer lock ring and subsequently lost diluent and some of vaccine; The lurer lock separated into two pieces; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5021) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE CONNECTION ISSUE (non-serious), outcome "unknown", described as "lurer lock of diluent on the adapter would bend backwards and not lock"; DEVICE LEAKAGE (non-serious), outcome "unknown", described as "The syringe ended up popping out of the lurer lock ring and subsequently lost diluent and some of vaccine"; DEVICE BREAKAGE (non-serious), outcome "unknown", described as "The lurer lock separated into two pieces". Additional information: Reporter had two retailers who reported product defect or malfunctions with the product and looking to see about getting replacement. The lurer lock of diluent on the adapter would bend backwards and not lock. The syringe ended up popping out of the lurer lock ring and subsequently lost diluent and some of vaccine. The lurer lock separated into two pieces. To her understanding there was issues with the lurer lock syringe where it was instances where it was cracking when put on and attach. Beyond this caller is not sure of further details. They did lose some diluent and the vaccine and had to discard remaining formula. Later confirmed this happened only one time; only one syringe. Reporter indicated she went over with re-instructions and they felt comfortable with the reconstitution method and have not reached out since. They have carton, think got rid of other components because it was broken and lost formula. Complainant does not have the product with them at the time of call.  The reporter considered "lurer lock of diluent on the adapter would bend backwards and not lock", "the syringe ended up popping out of the lurer lock ring and subsequently lost diluent and some of vaccine" and "the lurer lock separated into two pieces" not related to rsv vaccine prot.subunit pref 2v. Causality for "lurer lock of diluent on the adapter would bend backwards and not lock", "the syringe ended up popping out of the lurer lock ring and subsequently lost diluent and some of vaccine" and "the lurer lock separated into two pieces" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 25.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 26-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 25 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "notably depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "pernicious anemia" (unspecified if ongoing); "lactose" (unspecified if ongoing), notes: Known allergies: lactose. The patient's concomitant medications were not reported. Past drug history included: Carbemazepine, reaction(s): "known allergies"; Prednisone, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 24Nov2023 to 28Nov2023.  Based on investigation result conclusion: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GJ2524. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency (Site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Age: 65.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: Tiredness; Headache; Muscle pain; Fever; Nausea; Feeling unwell; Decreased appetite; Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Nov2023 at 14:30 as dose 1, single (Lot number: HG4664) at the age of 65 years, in right arm for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 30Nov2023 at 14:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (Dose 1, single, lot number: ER8737), administration date: 31Mar2021, when the patient was 62-year-old, for COVID-19 immunization; bnt162b2 (Dose 2, single, lot number: FJ4991), administration date: 15Jul2022, when the patient was 64-year-old, for COVID-19 immunization; moderna booster (Dose 3 (Booster), single), administration date: 14Dec2022, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: DECREASED APPETITE (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered"; DIZZINESS (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered"; MALAISE (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered", described as "Feeling unwell"; PYREXIA (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered"; MYALGIA (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered", described as "Muscle pain"; NAUSEA (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered"; FATIGUE (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered", described as "Tiredness".  Additional information: All events started around the same time. The patient started to get more and more tired. At 7:30pm he got in bed and went to sleep from 8:00PM-8:00 AM, but he was  still tired. He nodded out again later today (01Dec2023) even after sleeping for 12 hours. He was too sick to go out.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 , rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300429338 same patient and different drug dose/events.;
Age: 65.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Tiredness; Headache; Muscle pain; Fever; Nausea; Feeling unwell; Decreased appetite; Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Nov2023 at 14:30 as dose 1, single (Lot number: HG4664) at the age of 65 years, in right arm for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 30Nov2023 at 14:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (Dose 1, single, lot number: ER8737), administration date: 31Mar2021, when the patient was 62-year-old, for COVID-19 immunization; bnt162b2 (Dose 2, single, lot number: FJ4991), administration date: 15Jul2022, when the patient was 64-year-old, for COVID-19 immunization; moderna booster (Dose 3 (Booster), single), administration date: 14Dec2022, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: DECREASED APPETITE (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered"; DIZZINESS (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered"; MALAISE (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered", described as "Feeling unwell"; PYREXIA (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered"; MYALGIA (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered", described as "Muscle pain"; NAUSEA (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered"; FATIGUE (non-serious) with onset 30Nov2023 at 17:00, outcome "not recovered", described as "Tiredness".  Additional information: All events started around the same time. The patient started to get more and more tired. At 7:30pm he got in bed and went to sleep from 8:00PM-8:00 AM, but he was  still tired. He nodded out again later today (01Dec2023) even after sleeping for 12 hours. He was too sick to go out.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 , rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300429338 same patient and different drug dose/events.;
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial Fib" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "known allergies: Penicillin, Ceclor" (unspecified if ongoing); "known allergies: Shell Fish" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS, start date: Sep2022, stop date: 16Nov2023; METOPROLOL AUROBINDO, start date: Nov2022. Vaccination history included: bnt162b2 (DOSE 2, SINGLE, Lot number: EN6201), administration date: 13Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Lot number: 035c21a), administration date: 26Oct2021, when the patient was 72-year-old, for COVID-19 Immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: FK9729, Anatomical location: Left arm), administration date: 06May2022, when the patient was 73-year-old, for COVID-19 Immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Lot number: GH9694, Anatomical location: Left arm), administration date: 16Sep2022, when the patient was 73-year-old, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3302), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Nov2023 at 11:30, outcome "recovered" (24Nov2023) and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2023) Positive; (24Nov2023) Negative; (28Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient was taking Paxlovid treatment form 18NOv2023 to 24Nov2023. antigen test: positive 18Nov, then negative 24Nov and neg 28Nov.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccine failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Negative, notes: Tested negative 4 days after initial symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 24Nov2023 to 29Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3 (booster); manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 4 (booster); manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: The patient had no known allergies. Patient received treatment for COVID-19 (Paxlovid), from 19Nov2023 to 23Nov2023  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pregnant 30-32 weeks" (ongoing); "known allergies: Shellfish" (unspecified if ongoing); "asthma" (unspecified if ongoing); "obese" (unspecified if ongoing). Date of last menstrual period: 20Apr2023. The patient was 22 weeks pregnant at the time of exposure to bnt162b2 omi xbb.1.5. The patient was 22 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 25Jan2024. Concomitant medication(s) included: FLUOXETINE, start date: 01May2023, stop date: 03Dec2023. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 27Sep2023, outcome "unknown", described as "Maternal Exposure During Pregnancy, second trimester"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 19Nov2023 to 24Nov2023. Clinical course: Patient (pregnant) received Moderna, on 03Oct2023 as dose 6, single (Batch/Lot number: unknown), in left arm for covid-19 immunization.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 24Nov2023 to 29Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Nov2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had Covid symptoms on 23Nov for four days started to feel better and then on 1Dec began to have symptoms again and today 3Dec. She felt as bad as she did when she first had Covid minus the fever. Patient had no known allergies. Patient received Anti-viral drug Paxlovid treatment started on 23Nov2023 and stopped on 28Nov2023 for the treatment of COVID-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: received the Pfizer covid vaccines and has since developed polymyalgia rheumatica which came on suddenly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient in her 70's received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Caller has a female family member in her late 70s who has cancer" (ongoing). The patient's concomitant medications were not reported. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as "received the Pfizer covid vaccines and has since developed polymyalgia rheumatica which came on suddenly".  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.