chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No medical History was reported.  It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 24-Sep-2022 at 1:46 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 24-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    No concomitant medicine were reported. No treatment medicine were reported.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; Refridgeration excursions identified; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jul-2022 at 11:02 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2022 at 11:02 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified).    No concomitant information was reported. Injection site given as Deltoid. Dose/volume given as 0.25 Product was reported as Monovalent. Storage condition at the time of the excursion was Refrigerator. Date the vial moved from freezer to refrigerator was 7Sep2022, monovalent vaccine. it was reported that unbroken carton, vials were not visualized and None proposed. There were excursions noted. No adverse reactions reported to reporters knowledge for patient. No treatment information was reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Refridgeration excursions identified; No adverse event; There were excursions noted; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (There were excursions noted), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 2:33 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 2:33 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (There were excursions noted). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (There were excursions noted), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (There were excursions noted) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    Allergies to medications, food, and other products were not provided.  On an unknown date, patient had received dose 1, dose 2, dose 3 of moderna vaccines. Route was Intramuscular and body site was deltoid for all three doses. Patient had received on deltoid body site for dose 4.  No concomitant medication was provided.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. Storage condition at the time of the excursion-Refrigerator There were 2 unbroken cartons and 20 vials. The vials moved from freezer to refrigerator on 7-SEP-2022. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. It was reported that no adverse reactions were reported to their knowledge for any patients. It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.  Treatment medication was not provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 1:59 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Sep-2022 at 1:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients).    Patient received vaccine in deltoid. No concomitant product reported by the reporter.  Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Patient received 0.5 of Bivalent vaccine No adverse reactions experienced by the patient. It was unknown if patient had ever been diagnosed or tested positive for COVID-19.  No treatment medication reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient was administered vaccine which had undergone several temperature excursions.; No adverse event; patient was administered vaccine which had undergone several temperature excursions.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event) in a 25-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19. Patient had no allergies to medications, food, and other products.     On 25-Sep-2022 at 12:33 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Sep-2022 at 12:33 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.).    Concomitant product use was not provided by the reporter.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. It was reported that the vaccines had undergone several temperature excursions in August 2022. Vials were moved from freezer to refrigerator on 7SEP2022 It was reported that Refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department made aware of the situation.  The vial size was reported as 5.5ml.  Treatment information was not provided.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Blindness, Eye pain, Fatigue, Headache, Photophobia
Clinical narrative: Lost vision in both eyes; Eyes started hurting; Sensitive to light; She was a little tired; Has a headache; This serious, initial spontaneous safety report was received by Novavax on 07-NOV-2022 from a consumer via contact center.   A 16 year-old female of an unspecified race was vaccinated with intramuscular Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 1 on 04-NOV-2022.  No medical history was reported.  No concomitant medications were reported.  On 04-NOV-2022, the same day after vaccination, the individual experienced feeling a little tired (PT: Fatigue). On 07-NOV-2022, reported as about 30 minutes ago, the individual experienced headache (PT: Headache), sensitive to light (PT: Photophobia), eyes started hurting (PT: Eye pain) and lost vision in both eyes (PT: Blindness) (Serious: Medically Significant). Additionally, the reporter asked if they should take their daughter to the Emergency Room.  At the time of reporting, the event outcome of Fatigue was Unknown and event outcomes of Eye pain, Blindness, Photophobia and Headache were Not Recovered/Not Resolved.  Lot number was not provided in the report.  No additional information was provided.; Sender's Comments: This 16 year-old female experienced: Blindness, Fatigue, Eye pain, Headache and Photophobia after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Blindness was assessed as serious. The events Fatigue, Eye pain, Headache and Photophobia 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.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: The patient developed whole body hives with the booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [MOMETASONE FUROATE]; AZ [AZITHROMYCIN]. Past drug history included: Cephalasporins, reaction(s): "known allergies: cephalosporins"; Tetracycline, reaction(s): "known allergies: Tetracycline"; Ketamine, reaction(s): "known allergies: ketamine". 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. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "The patient developed whole body hives with the booster".  Additional information: The patient did not receive any other vaccine within four weeks prior to vaccination. The patient did not have Covid prior to vaccination. The patient was not tested for Covid post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 1=Moderna, Dose 2= Moderna, Dose 3= Moderna, Dose 4= Pfizer/BioNTech, Dose 5= Pfizer/BioNTech; Dose 1=Moderna, Dose 2= Moderna, Dose 3= Moderna, Dose 4= Pfizer/BioNTech, Dose 5= Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 63 years, in right arm for covid-19 immunization; BNT162b2 (BNT162B2), on 25Feb2022 as dose 4 (booster), single (Lot number: FM0698), in right arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 14Jan2021 as dose 1, single (Lot number: 028L20A), in right arm, on 11Feb2021 as dose 2, single (Lot number: 016M20A), in right arm and on 31Aug2021 as dose 3 (booster), single (Lot number: 059EZ14), in right arm for covid-19 immunization. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cimzia, reaction(s): "Allergy_cimzia". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), OFF LABEL USE (medically significant) all with onset 2022, outcome "unknown" and all described as "Dose 1=Moderna, Dose 2= Moderna, Dose 3= Moderna, Dose 4= Pfizer/BioNTech, Dose 5= Pfizer/BioNTech"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Investigation results: 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 GH9702 and FM0698. 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. PGS # 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.; 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: 66.0
Sex: M
Vaccine: 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 contactable reporter(s) (Nurse).  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 4 (booster), single (Lot number: E49702) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 25Oct2021 as dose 2, single (Lot number: 014F21A) and on 26Apr2022 as dose 3 (booster), single (Lot number: 056A22A) for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 09Mar2021 as dose 1, single (Lot number: 1805022) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Clobetasol proprionate, notes: Occasional use of clobetasol, proprionate. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2022) Positive; (22Oct2022) Positive; (26Oct2022) Positive; (01Nov2022) Negative; (05Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Healthy adult 66 y/o adult male. Physically active an in good health. No oral medications.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2, BNT162B2 OMIBA. 4-5 to drug ineffectiveness and COVID-19 cannot be ruled out.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: WI9266), in left arm, on 06Mar2021 as dose 2, single (Lot number: EN6202), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 23Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing); "Penicillin: Allergy" (unspecified if ongoing); "Sulfa: Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 31Oct2022 to 04Nov2022.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness, Lethargy, Lymph node pain
Clinical narrative: flu-like symptoms; lethargy; lingering pain in left arm pit lymph node; Soreness at injection site; fever/chills; fever/chills; whole body muscle/joint aches; whole body muscle/joint aches; This is a spontaneous report received from a 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 04Nov2022 at 19:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 28Oct2022 as dose 1, single; TDAP taken for immunisation, on 28Oct2022 as dose 1, single; SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MIDNITE; AIRBORNE. Past drug history included: Neosporin, reaction(s): "known allergies: Neosporin"; Possibly aspirin, reaction(s): "Known allergies: possibly aspirin". Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization, reaction(s): "Joint pain", "Tiredness", "Headache", "Migraine", "Stiff neck", "Shaky feelings", "Ache", "Vomiting"; Bnt162b2 (DOSE 3 (BOOSTER)), for COVID-19 Immunization, reaction(s): "Arthralgia", "Back pain", "COVID-19", "Chills", "Exposure to SARS-CoV-2", "Hyperhidrosis", "Hypoaesthesia", "Lymph node pain", "Lymphadenopathy", "Pain", "Vaccination failure". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Nov2022 at 06:00, outcome "recovering", described as "Soreness at injection site"; CHILLS (non-serious), PYREXIA (non-serious) all with onset 05Nov2022 at 06:00, outcome "recovering" and all described as "fever/chills"; INFLUENZA LIKE ILLNESS (non-serious) with onset 05Nov2022 at 06:00, outcome "recovering", described as "flu-like symptoms"; LETHARGY (non-serious) with onset 05Nov2022 at 06:00, outcome "recovering"; LYMPH NODE PAIN (non-serious) with onset 05Nov2022 at 06:00, outcome "recovering", described as "lingering pain in left arm pit lymph node"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 05Nov2022 at 06:00, outcome "recovering" and all described as "whole body muscle/joint aches". Therapeutic measures were taken as a result of influenza like illness, lethargy, lymph node pain, vaccination site pain, chills, pyrexia, myalgia, arthralgia.  Additional information: Zero prior events (four Pfizer shots). Soreness at injection site and flu-like symptoms (whole body muscle/joint aches, lethargy, fever/chills) resolved by Tylenol, lingering pain in left arm pit lymph node. Tylenol rapid release every 6-8 hours. Covid was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: flu-like symptoms; lethargy; lingering pain in left arm pit lymph node; Soreness at injection site; fever/chills; fever/chills; whole body muscle/joint aches; whole body muscle/joint aches; This is a spontaneous report received from a 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 04Nov2022 at 19:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 28Oct2022 as dose 1, single; TDAP taken for immunisation, on 28Oct2022 as dose 1, single; SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MIDNITE; AIRBORNE. Past drug history included: Neosporin, reaction(s): "known allergies: Neosporin"; Possibly aspirin, reaction(s): "Known allergies: possibly aspirin". Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization, reaction(s): "Joint pain", "Tiredness", "Headache", "Migraine", "Stiff neck", "Shaky feelings", "Ache", "Vomiting"; Bnt162b2 (DOSE 3 (BOOSTER)), for COVID-19 Immunization, reaction(s): "Arthralgia", "Back pain", "COVID-19", "Chills", "Exposure to SARS-CoV-2", "Hyperhidrosis", "Hypoaesthesia", "Lymph node pain", "Lymphadenopathy", "Pain", "Vaccination failure". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Nov2022 at 06:00, outcome "recovering", described as "Soreness at injection site"; CHILLS (non-serious), PYREXIA (non-serious) all with onset 05Nov2022 at 06:00, outcome "recovering" and all described as "fever/chills"; INFLUENZA LIKE ILLNESS (non-serious) with onset 05Nov2022 at 06:00, outcome "recovering", described as "flu-like symptoms"; LETHARGY (non-serious) with onset 05Nov2022 at 06:00, outcome "recovering"; LYMPH NODE PAIN (non-serious) with onset 05Nov2022 at 06:00, outcome "recovering", described as "lingering pain in left arm pit lymph node"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 05Nov2022 at 06:00, outcome "recovering" and all described as "whole body muscle/joint aches". Therapeutic measures were taken as a result of influenza like illness, lethargy, lymph node pain, vaccination site pain, chills, pyrexia, myalgia, arthralgia.  Additional information: Zero prior events (four Pfizer shots). Soreness at injection site and flu-like symptoms (whole body muscle/joint aches, lethargy, fever/chills) resolved by Tylenol, lingering pain in left arm pit lymph node. Tylenol rapid release every 6-8 hours. Covid was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect dose administered, Neck pain, Vaccination site pain
Clinical narrative: Severe pain and soreness from injection site; Severe pain hrough  shoulder muscle and joint up to neck muscles.; Severe pain hrough  shoulder muscle and joint up to neck muscles.; dose 4 lot FJ9943/ dose 5 lot GJ3277 (both bivalent); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PAD" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: XARELTO; CLOPIDOGREL; LISINOPRIL; ATORVASTATIN. Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (Dose: 4, product=Pfizer, lot number=FJ9943, vaccine location=left arm), for COVID-19 immunization; Bnt162b2 (Dose: 3, product=Pfizer, lot number=FF841, vaccine location=Left arm), for COVID-19 immunization; Bnt162b2 (Dose: 2, product=Pfizer, lot number=EN6201, vaccine location=left arm), for COVID-19 immunization; Bnt162b2 (Dose: 1, product=Pfizer, lot number=EL9265, vaccine location=left arm), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 24Oct2022, outcome "unknown", described as "dose 4 lot FJ9943/ dose 5 lot GJ3277 (both bivalent)"; VACCINATION SITE PAIN (non-serious) with onset 26Oct2022, outcome "not recovered", described as "Severe pain and soreness from injection site"; ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 26Oct2022, outcome "not recovered" and all described as "Severe pain hrough  shoulder muscle and joint up to neck muscles.". Therapeutic measures were not taken as a result of vaccination site pain, arthralgia, neck pain.
Age: 59.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PROCARDIA [NIFEDIPINE]; LEXAPRO; METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Electroencephalogram, Encephalitis, Magnetic resonance imaging
Clinical narrative: encephalitis; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team, Program ID: (Unknown). The reporter is the parent.  A 14-year-old male patient received BNT162b2 (COMIRNATY), on 18Mar2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 14 years, in left deltoid (reported as left shoulder) for covid-19 immunisation. The patient's relevant medical history included: "Cold" (unspecified if ongoing); "flus" (unspecified if ongoing). The patient was prior a healthy kid, has never been sick and was never in the hospital except for her giving birth to him. He had the cold and flus like every other kid. He was lean and not overweight and no medical history whatsoever (as reported). He is a server and an avid swimmer, on the swim team and a surfer; the specialists can't tell what cause it. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, Lot: EW0196, Anatomical Location: Left upper arm shoulder), administration date: 09Jul2021, when the patient was 13-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, Lot: FA7485, Anatomical location: Left upper shoulder), administration date: 09Aug2021, when the patient was 13-year-old, for COVID-19 Immunization. The following information was reported: ENCEPHALITIS (hospitalization) with onset 25May2022, outcome "recovering". The patient was hospitalized for encephalitis (start date: 24May2022, discharge date: Jun2022). Also reported that he was at the hospital from 25May2022 to 16Jun2022 or 17Jun2022. After his booster he was hospitalized with encephalitis. The patient got all three shots from Pfizer. The first two normal vaccinations and then he was vaccinated with the bivalent (as reported) booster dose maybe a month (as reported) before he got encephalitis. The patient underwent the following laboratory tests and procedures: Chest X-ray: Unknown results; Electroencephalogram: Unknown results; Magnetic resonance imaging: Unknown results. Outcome was reported as improving. He does have the infection anymore (as reported) and he has a long road to recovery. Treatment indicated that the patient was in the ICU for two weeks and home for a week and a half and had to live in rebab for 2 weeks. Now, he was home, and he has so much therapy and he is supposed to be a freshmen in high school and only attends one class.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Illness, Nasopharyngitis
Clinical narrative: I had the second booster on Friday and I have been sick ever since; I have a cold; I have had the chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I had the second booster on Friday and I have been sick ever since"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "I have a cold"; CHILLS (non-serious), outcome "unknown", described as "I have had the chills".  Additional information: it was reported as the patient had a COVID shot (Clarified as Pfizer COVID 19 Vaccine), the second booster shot on Friday (as reported), had been sick ever since. The patient wanted to know how long was that going to last. The patient went to bed Saturday night at 19:00, three blankets were on and had a cold. There was nothing wrong with the patient when going to get the shot, had been sick ever since and how long was it going to last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eye inflammation
Clinical narrative: experienced inflammation in eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: EYE INFLAMMATION (non-serious), outcome "unknown", described as "experienced inflammation in eyes".  Additional information: It was reported that the patient had all of the boosters with Pfizer and had experienced inflammation in his eyes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure
Clinical narrative: seizure type of reaction; high fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 3 (booster), single (Lot number: GJ2524) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as dose number unknown, single. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FF8839), administration date: 12Nov2021, when the patient was 79-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6200), administration date: 23Feb2021, when the patient was 79-year-old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 05Nov2022 at 23:00, outcome "recovered", described as "high fever"; SEIZURE (medically significant) with onset 05Nov2022 at 23:00, outcome "recovered", described as "seizure type of reaction". Therapeutic measures were not taken as a result of seizure, pyrexia. Clinical courses is as follows: The patient received other vaccine flu  in 4 weeks. The patient experienced covid prior vaccination. Covid wasn't test post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiffness in arm/stiffness in a couple of her fingers; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed but manufacturer unknown), for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiffness in arm/stiffness in a couple of her fingers".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201282842 similar report from same reporter;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She wanted to know if Paxlovid could be used very soon after the vaccination with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap; She wanted to know if Paxlovid could be used very soon after the vaccination with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 26-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She wanted to know if Paxlovid could be used very soon after the vaccination with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap".Caller on behalf of a 26-year-old female patient. She wanted to know if Paxlovid could be used very soon after the vaccination with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 "over holiday weekend and  was hospitalized; COVID 19 "over holiday weekend and  was hospitalized; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 19Apr2022 as dose 4 (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 (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "COVID 19 "over holiday weekend and  was hospitalized". The events "covid 19 "over holiday weekend and  was hospitalized" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Her husband took primary series of Covid-19 vaccine and he had covid went to ER and she would like to know if he is immunocompromised and if he can take the booster dose. Caller stated her husband received his Primary Pfizer-BioNTech COVID-19 Vaccine series 10Feb2021 and 21Mar2021. Her husband also received 2 Primary Pfizer-BioNTech COVID-19 booster doses  and last booster dose was 19Apr2022. The caller stated her husband had COVID 19 "over holiday weekend and was hospitalized on the following Wednesday after holiday." The caller stated he received the IV medicine while he was hospitalized. He just finished rehab for 5 weeks following his hospitalization for COVID 19 . The caller asked when can he get the bivalent booster dose? Is he considered immunocompromised from already getting booster doses and should he wait?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Lymphadenopathy
Clinical narrative: He is now experiencing a swollen lymphnode; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 04Nov2022 as dose 1, single (Lot number: FP7140) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE; EMPAGLIFLOZIN. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06Nov2022, outcome "not recovered", described as "He is now experiencing a swollen lymphnode". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: Patient received his first COVID vaccine ever on Friday 04Nov2022, monovalent adult formulation. He was now (at the time of this report) experiencing a swollen lymph node. He had no questions, just wanted to report the side effect that was swollen lymph node. No investigations were conducted. Patient thought there was one more. Patient thought it was 325 plus VACD0T, it might be an O. It was Pfizer Mono SB 7140. Patient did not know if it was clinical trial or not. Patient just had a swollen lymph node. Patient did not take anything. Patient had put down below it ice and that was it. Everything was okay other than just swollen lymph nodes. Patient had lab work done that was previous. Patient did not have done prior vaccination. The case was reported as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: mild fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-month-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "mild fever". Therapeutic measures were taken as a result of pyrexia.  Additional information: children, vaccinated at 6 and 7 months, also Pfizer, had the kind of mild fever "that a single paracetamol solved"  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.