chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PNC13
Symptoms: Chronic myeloid leukaemia, Expired product administered
Clinical narrative: has CML (Chronic myelogenous leukemia); patient received the expired dose of Prevnar 13/after giving the vaccine, it was noticed that it expired 2 months ago; This is a spontaneous report received from contactable reporter (Other HCP and Consumer or other non HCP) from medical information team.  A 23-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 12Apr2022 as dose number unknown, single (Batch/Lot number: unknown, Expiration Date: Feb2022) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 12Apr2022, outcome "unknown", described as "patient received the expired dose of Prevnar 13/after giving the vaccine, it was noticed that it expired 2 months ago"; CHRONIC MYELOID LEUKAEMIA (medically significant), outcome "unknown", described as "has CML (Chronic myelogenous leukemia)".  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Chronic myelogenous leukemia represents an intercurrent medical condition unrelated to PREVNAR 13.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: PNC20
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "she was in bed with flu-like symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Description of Event: Patient received Prevnar 20 at office visit and contacted the Dr. the following day stating she was in bed with flu-like symptoms and sore arm. Additional Information: Awareness Date: 12Apr2022. Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Multisystem inflammatory syndrome in children
Clinical narrative: Multisystem inflammatory syndrome in children; This is a literature report for the following literature source(s):  A child patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s) : US-PFIZER INC-202200572120 Same article/ drug/event and different Patient
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Experienced swelling in the face; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 80 years intramuscular 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; Bnt162b2 (dose:3, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: SWELLING FACE (hospitalization) with onset 13Apr2022, outcome "unknown", described as "Experienced swelling in the face".  Clinical information: Pharmacist stated, "They did well it was reported by the facility that they were taken to the hospital to get look at another word what treatment they might receive. That's what were reported to us that they were taken for the hospital to get test, yes that's what we were told.  Causality: Pharmacists stated, "In my medical opinion I think it's unlikely just because how long after the experiencing reactions and because the unsteady gaits which was reported is not necessary be I don't think actually report unsteady gaits haven't see in fact either all of the patients who did that have a history of falls and you know they are more elderly so unsteady gaits may not be related in my opinion, I say unlikely.; Sender's Comments: Based on the available information in the case, the causal association between the event swelling face and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: PNC13
Symptoms: COVID-19, Cough, Drug ineffective, Pneumonia
Clinical narrative: DRUG INEFFECTIVE; pneumonia; COVID; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 3-month-old patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE/ PNEUMONIA (hospitalization, medically significant), outcome "unknown"; COVID-19 (hospitalization), outcome "unknown", described as "COVID". The patient was hospitalized for pneumonia, covid-19 (hospitalization duration: 5 day(s)). Clinical course: The patient ended up being hospitalized with pneumonia 1 month after receiving their first dose of Prevnar 13. The patient also contracted Covid. The patient was in the hospital for 5 days and was discharged. The patient still has a cough. They did not know what caused the pneumonia.  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  COVID infection represents a conincidental viral infection during the pandemic unrelated to the vaccine use.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion/Lethargy-Severe, Systemic: Cough-Medium, Additional Details: patient tested positive for COVID-19 on 4/7/2022.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, SARS-CoV-2 test positive
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion/Lethargy-Severe, Systemic: Cough-Medium, Additional Details: patient tested positive for COVID-19 on 4/7/2022.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Systemic: Patient developed shingles after getting shingrix vaccine-Medium, Additional Details: pt reported he wanted report done.  he got shingles from the shingrix vaccine. told him i would do report so there can be a record of it
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Systemic: Patient developed shingles after getting shingrix vaccine-Medium, Additional Details: pt reported he wanted report done.  he got shingles from the shingrix vaccine. told him i would do report so there can be a record of it
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Area is swollen, raised red, itchy, warm: sore when touch cover with 1 inch x 3 inch bandage. Pharmacist at 1339 instructed patient to take Claritin and Hydrocortisone to area. If worsens, instructed to contact MD. She reports no problem in movement.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Condition aggravated, Dizziness, Dyspnoea
Clinical narrative: Client presented at vaccination site for her Pfizer COVID booster vaccine. Client reported she received Pfizer COVID dose #1 (4/2/21; lot: EW0150) at the clinic without any issues. Client reported with Pfizer COVID dose 2 (4/23/21; lot: EW0161) at the clinic, within five minutes she had difficulty breathing with her throat closing, SOB, & facial numbness (lasted 20 minutes). Client reported at the observation area for the 2nd dose, she was laid down, and drank juice and water provided. She stated no medicines given and no emergency number called. She reported she had dizziness and lightheadedness within four hours of Pfizer COVID dose 2 and she reported she ate before received her Pfizer COVID dose 2. She reported she stayed at the observation area for 45 minutes then her son drove her home. She stated she ate today at 1100 and drinking water while waiting for approval. She said she had fever for 48 hours (took Tylenol with help) for Pfizer COVID dose 2. Client also said she had chest pressure and chest pain started the next day after Pfizer COVID dose 2. She said she followed up with PCP after day 2 of her Pfizer COVID dose 2. She said her PCP told her it was normal reactions that she had and to continue taking Tylenol for her fever as needed. Had HTN and taking Lisinopril 20 mg daily. She took Lisinopril this morning. At 1230, PHN took client?s current vitals: BP 136/86, HR 100, O2 Sat. 96%. Client reported her normal BP is 130/80. Client is requesting Pfizer booster approval today. PHN submitted a medical consult via text message to clinical project coordinator, requesting to proceed with the Pfizer COVID booster vaccine. Per the doctor, approval to proceed with Pfizer COVID booster vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received Pfizer COVID vaccine, LOT#: FF8841 on 11/14/21 at 1312 by RN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1342 unassisted and with a steady gait.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia, Pyrexia, Throat tightness
Clinical narrative: Client presented at vaccination site for her Pfizer COVID booster vaccine. Client reported she received Pfizer COVID dose #1 (4/2/21; lot: EW0150) at the clinic without any issues. Client reported with Pfizer COVID dose 2 (4/23/21; lot: EW0161) at the clinic, within five minutes she had difficulty breathing with her throat closing, SOB, & facial numbness (lasted 20 minutes). Client reported at the observation area for the 2nd dose, she was laid down, and drank juice and water provided. She stated no medicines given and no emergency number called. She reported she had dizziness and lightheadedness within four hours of Pfizer COVID dose 2 and she reported she ate before received her Pfizer COVID dose 2. She reported she stayed at the observation area for 45 minutes then her son drove her home. She stated she ate today at 1100 and drinking water while waiting for approval. She said she had fever for 48 hours (took Tylenol with help) for Pfizer COVID dose 2. Client also said she had chest pressure and chest pain started the next day after Pfizer COVID dose 2. She said she followed up with PCP after day 2 of her Pfizer COVID dose 2. She said her PCP told her it was normal reactions that she had and to continue taking Tylenol for her fever as needed. Had HTN and taking Lisinopril 20 mg daily. She took Lisinopril this morning. At 1230, PHN took client?s current vitals: BP 136/86, HR 100, O2 Sat. 96%. Client reported her normal BP is 130/80. Client is requesting Pfizer booster approval today. PHN submitted a medical consult via text message to clinical project coordinator, requesting to proceed with the Pfizer COVID booster vaccine. Per the doctor, approval to proceed with Pfizer COVID booster vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received Pfizer COVID vaccine, LOT#: FF8841 on 11/14/21 at 1312 by RN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1342 unassisted and with a steady gait.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Diabetes mellitus, Maternal exposure during pregnancy
Clinical narrative: she got diabetes; sugar levels spiked immediately after having first dose of Pfizer vaccine during 25th week of her pregnancy; 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 29-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 15May2021 at 12:00 as dose 1, single (Lot number: EW0172) at the age of 29 years, in left arm for covid-19 immunisation. Date of last menstrual period: 17Nov2020. The patient was 25 weeks pregnant at the time of exposure to BNT162b2. The patient was 25 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 24Aug2021. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (hospitalization) with onset 16May2021 at 12:00, outcome "not recovered", described as "she got diabetes"; BLOOD GLUCOSE INCREASED (hospitalization) with onset 16May2021 at 12:00, outcome "not recovered", described as "sugar levels spiked immediately after having first dose of Pfizer vaccine during 25th week of her pregnancy"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Maternal Exposure During Pregnancy, second trimester". The patient was hospitalized for diabetes mellitus, blood glucose increased (hospitalization duration: 1 day(s)). Therapeutic measures were not taken as a result of diabetes mellitus, blood glucose increased. clinical course: Received BNT162b2 on 18May2021 at12:00 as dose 2 ,single (Lot number: EW0185), vaccinated to left arm. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, COVID-19, Influenza virus test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive Covid for the 2nd time; positive Covid for the 2nd time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 25Apr2021 as dose 2, single (Lot number: ER8736), in right arm and on 26Jun2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing); "Cardiac" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for diabetes mellitus, blood cholesterol, stop date: 10Apr2022; ENALAPRIL taken for type 1 diabetes mellitus; HUMALOG taken for type 1 diabetes mellitus; LANTUS taken for type 1 diabetes mellitus; ASPIRIN [ACETYLSALICYLIC ACID] taken for type 1 diabetes mellitus, cardiac disorder; PREVNAR 20 taken for immunisation, on 05Apr2022; FLU taken for immunisation. Vaccination history included: afluria (influenza vaccine), administration date: 26Nov2021, for immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Aug2021, outcome "unknown" and all described as "positive Covid for the 2nd time". The patient underwent the following laboratory tests and procedures: Blood glucose: (unspecified date) High; Influenza virus test: (unspecified date) Negative; SARS-CoV-2 test: (unspecified date) Negative; (13Apr2022) Positive; (26Aug2021) Positive; (unspecified date) Negative; (unspecified date) Negative. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient was having a really metallic, almost bile taste, in her saliva on 13Apr2022. Simvastatin: started 7 years ago and stopped taking it 10Apr2022 and they require her cholesterol to be below 150. Humalog: up to 5 injections a day. dose determined by meal plan and high glucose episodes. on average day does not exceed 25 units. Started taking about 20 years ago. Lantus: started 5-6 years, quarter grain aspirin: started about 10 years, it is low dose aspirin. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) were reported as none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, IgA nephropathy
Clinical narrative: IgAN relapses; Gross Hematuria; This is a literature report.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (MANUFACTURER UNKNOWN)), for COVID-19 immunisation. The following information was reported: IGA NEPHROPATHY (medically significant), outcome "unknown", described as "IgAN relapses"; HAEMATURIA (non-serious), outcome "recovered", described as "Gross Hematuria".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the event IgAN relapse and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202200589675 Same article/drug/event and different patient
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, IgA nephropathy, Proteinuria
Clinical narrative: IgAN relapses; Subnephrotic Range Proteinuria; Gross hematuria; This is a literature report.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "severe acute respiratory syndrome coronavirus 2" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE), for covid-19 immunization. The following information was reported: IGA NEPHROPATHY (medically significant), outcome "unknown", described as "IgAN relapses"; HAEMATURIA (non-serious), outcome "recovered"(Duration: 3 days), described as "Gross hematuria"; PROTEINURIA (non-serious), outcome "unknown", described as "Subnephrotic Range Proteinuria".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the event IgAN relapses and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202200589587 Same article/drug/event and different patient
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: has tested positive; has tested positive; runny nose; aches and pains; teeth hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Apr2022, outcome "unknown", described as "aches and pains"; RHINORRHOEA (non-serious) with onset Apr2022, outcome "unknown", described as "runny nose"; TEETHING (non-serious) with onset Apr2022, outcome "unknown", described as "teeth hurting"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 17Apr2022, outcome "unknown" and all described as "has tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive.  Clinical Course: She received her booster dose last Monday and she has tested positive for COVID infection yesterday. She has contacted her HCP and the receptionist has scheduled her for Monoclonal infusion. Her concern was that, she has gotten the booster dose, she has the infection and she would like to know if its beneficial for her to receive the monoclonal infusion too would her body's Antibody level become too much. She has an option for Monoclonal antibody and Paxlovid but she does not know which she should take given that she and her husband both tested positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200591780 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202200591781 Same reporter/ drug/ event for different patients.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Teething
Clinical narrative: has tested positive; has tested positive; runny nose; aches and pains; teeth hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Apr2022, outcome "unknown", described as "aches and pains"; RHINORRHOEA (non-serious) with onset Apr2022, outcome "unknown", described as "runny nose"; TEETHING (non-serious) with onset Apr2022, outcome "unknown", described as "teeth hurting"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 17Apr2022, outcome "unknown" and all described as "has tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive.  Clinical Course: She received her booster dose last Monday and she has tested positive for COVID infection yesterday. She has contacted her HCP and the receptionist has scheduled her for Monoclonal infusion. Her concern was that, she has gotten the booster dose, she has the infection and she would like to know if its beneficial for her to receive the monoclonal infusion too would her body's Antibody level become too much. She has an option for Monoclonal antibody and Paxlovid but she does not know which she should take given that she and her husband both tested positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200591780 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202200591781 Same reporter/ drug/ event for different patients.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: covid-19 positive after the administration of the all three doses.; covid-19 positive after the administration of the all three doses.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Lot number: F18757) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Mar2021 as dose 1, single (Lot number: 012A21A), in left arm and on 30Mar2021 as dose 2, single (Lot number: 039A21A), in left arm for covid-19 immunisation. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jan2022, outcome "unknown" and all described as "covid-19 positive after the administration of the all three doses.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (17Mar2022) Positive, notes: Blood test; SARS-CoV-2 test: (27Jan2022) Positive, notes: Nasal Swab.; 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 to the drug ineffective(LOE) cannot be ruled out
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Headache, Illness, Nausea, Pain in extremity
Clinical narrative: quite ill; nausea; headache; fever; I felt weakness; pain in my upper thighs in the Back of my legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: ILLNESS (non-serious), outcome "recovered", described as "quite ill"; NAUSEA (non-serious), outcome "recovered"; HEADACHE (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever"; ASTHENIA (non-serious), outcome "recovered", described as "I felt weakness"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "pain in my upper thighs in the Back of my legs".  Additional information: Patient concerned about getting a second booster dose of the Pfizer Covid vaccine. Patient got quite ill with the booster with nausea headache fever. After about four or five days patient felt weakness and pain in my upper thighs in the Back of my legs. This did subside after a few days and I am fine now. Is this a normal reaction to the Pfizer vaccine or should I not get a booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: quite ill; nausea; headache; fever; I felt weakness; pain in my upper thighs in the Back of my legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: ILLNESS (non-serious), outcome "recovered", described as "quite ill"; NAUSEA (non-serious), outcome "recovered"; HEADACHE (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever"; ASTHENIA (non-serious), outcome "recovered", described as "I felt weakness"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "pain in my upper thighs in the Back of my legs".  Additional information: Patient concerned about getting a second booster dose of the Pfizer Covid vaccine. Patient got quite ill with the booster with nausea headache fever. After about four or five days patient felt weakness and pain in my upper thighs in the Back of my legs. This did subside after a few days and I am fine now. Is this a normal reaction to the Pfizer vaccine or should I not get a booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: old sore clear up on my lip;  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  , Manufacturer- Unknown, Dose no- 1 and 2), for COVID-19 Immunization; Herpes viruses (I have historically been vulnerable to herpes viruses), for Immunization, reaction(s): "historically been vulnerable to herpes viruses". The following information was reported: ORAL HERPES (non-serious), outcome "unknown", described as "old sore clear up on my lip".  Additional information: Verbatim: Is there any info you can provide as to whether I should take the second Pfizer booster approximately 5 days after having a cold sore clear up on my lip. I have historically been vulnerable to herpes viruses and am concerned about the potential side effects of getting the booster after having had a cold sore.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.   Follow-up (18Apr2022): New information received from a contactable consumer reported that included verbatim and additional information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Macule, Rash
Clinical narrative: a rash yesterday 17Apr2022 on the right side of his body, shoulder, joint where arm bends, and on stomach; a few spots on his left leg; 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 69-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm 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 but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (3rd Dose/Booster, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: MACULE (non-serious) with onset 17Apr2022, outcome "unknown", described as "a few spots on his left leg"; RASH (non-serious) with onset 17Apr2022, outcome "unknown", described as "a rash yesterday 17Apr2022 on the right side of his body, shoulder, joint where arm bends, and on stomach". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): CMOD22-01935.  A female patient received BNT162b2 (BNT162B2), in 2021 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "COVID-19". Clinical course: Patient reported that she got SARS-Antibody blood test in lab and the last one she had done in mid Jan showed 150 on the range of antibodies. Patient had COVID in mid Nov021. Patient was only half vaccinated with Pfizer when she got COVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Additional information: patient stated that her friend was prescribed with paxlovid medication that hard to come by. she know that paxlovid can be received if tested positive for covid and its very hard to come by. she had a friend that had to go to multiple stores.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200591001 Same reporter/ drug/ event for different patients.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Still got Covid-19; Still got Covid-19; 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 (age 19 unit not reported) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Still got Covid-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: paxlovid start on 09Apr2022 Treatment of COVID-19; paxlovid start on 09Apr2022 Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: Unknown), in left arm, in Jan2021 as dose 2, single (Lot number: Unknown), in left arm and in Sep2021 as dose 3 (booster), single (Lot number: Unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "copd" (unspecified if ongoing); "gerd" (unspecified if ongoing); "mold" (unspecified if ongoing); "grass" (unspecified if ongoing); "dust" (unspecified if ongoing). Concomitant medication(s) (also reported as patient received other medication in 2weeks) included: ALBUTEROL HFA, start date: Jan2015, stop date: Apr2022; SINGULAIR, start date: Jan2010, stop date: 18Apr2022; ALLEGRA, start date: Jan2010, stop date: Apr2022; SYMBICORT, start date: Jan2020, stop date: Apr2022; PREVACID, start date: Jan2008; GABAPENTIN, start date: May2021, stop date: Apr2022; MELATONIN, start date: May2021, stop date: Apr2022. Past drug history included: Sulfa drugs, reaction(s): "Allergy".   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "paxlovid start on 09Apr2022 Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Anti-viral paxlovid (lot number=FX4465) started on 09Apr2022 to 11Apr2022. Reported that, with paxlovid, on 10Apr2022 at 15:00, Patient experienced double vision. patient could close one eye and see fine. With both eyes open, most but not all things were double vision. No treatment received for the event and it was recovered on 12Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Stopped menstruating for a couple of months; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMENORRHOEA (non-serious), outcome "unknown", described as "Stopped menstruating for a couple of months".  Additional information: The PA reports that the daughter of one of his patients stopped menstruating for a couple of months after receiving the Pfizer COVID vaccine. Subject stopped menstruating for a few months after receiving the Pfizer COVID vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Cough, Loss of consciousness, X-ray
Clinical narrative: passed out; bad cough; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4263104-00.  An 88-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as 40 mg,1 in 2 wk (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (prolonged hospitalization) with onset 25Jan2022, outcome "recovered" (2022), described as "passed out"; COUGH (non-serious) with onset 2022, outcome "unknown", described as "bad cough". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (2022) Unknown result; X-ray: (2022) Unknown result. The action taken for BNT162b2 and adalimumab was unknown.   Causality for Humira (Adalimumab): The reporter's causality for the events of passed out and bad couch was not provided. The other company's opinion is that the events of passed out and bad couch are not assessable.  Causality for Pfizer Biontech covid-19 vaccine (Tozinameran): The reporter's assessment of the causal relationship of "passed out" was Possible and "bad cough" was not provided with the suspect product(s) BNT162b2 at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 10Apr2022, outcome "recovered" (Apr2022); FATIGUE (non-serious) with onset 10Apr2022, outcome "recovered" (Apr2022). Therapeutic measures were not taken as a result of chills, fatigue.  Additional Information: Dose received 3 Administration date=16Apr2022, If COVID prior vaccination: No If COVID tested post vaccination: No If Other vaccine in four weeks: No Device timestamp: 18Apr2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered at inappropriate site, Product temperature excursion issue, Rhinitis allergic
Clinical narrative: administered 1 doses of the Pfizer-BioNTech COVID-19 Vaccine beyond the BUD; Received vaccine past beyond use date was refrigerated at recommended temperature 16 days; Anatomical site of injection, Left thigh; Allergic rhinitis; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 7-year-old patient received BNT162b2 (BNT162B2), on 11Apr2022 at 10:34 as dose 1, single (Lot number: FL8094) intramuscular, in left thigh for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHINITIS ALLERGIC (non-serious) with onset 11Apr2022, outcome "unknown", described as "Allergic rhinitis"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 11Apr2022 at 10:34, outcome "unknown", described as "Anatomical site of injection, Left thigh"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 11Apr2022 at 10:34, outcome "recovered", described as "Received vaccine past beyond use date was refrigerated at recommended temperature 16 days"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 11Apr2022 at 10:34, outcome "recovered", described as "administered 1 doses of the Pfizer-BioNTech COVID-19 Vaccine beyond the BUD". Therapeutic measures were not taken as a result of poor quality product administered, product temperature excursion issue, product administered at inappropriate site. Therapeutic measures were taken as a result of rhinitis allergic.  Additional information: The caller reported a patient was administered the Pfizer Pediatric Covid Vaccine after the 10 week expiration date. Caller had questions regarding the safety of patient receiving the Pfizer Pediatric Covid Vaccine after the 10 week expiration date. The caller confirmed that the vaccine was administered to patient, Vaccination Facility Type was doctor's Office/Urgent care. Patient received treatment drug was Loratadine orally 10mg for event Allergic rhinitis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200572850 same reporter/drug/AE, different patient
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: arm swelling and soreness-Severe
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort, Pain
Clinical narrative: Systemic: Chest Tightness/Heaviness/Pain-Mild.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: The reccomended dose for children between the ages of 5 to 11 is (.2) and the patient was given the vaccine for a 12+child in the amount of (.3).
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Psychogenic movement disorder, Tremor
Clinical narrative: I started developing tremors in my left arm two months after I got the shot. Eventually a neurologist diagnosed with functional movement disorder. I have researched that COVID vaccines can cause FMD and maybe that is why I was diagnosed with it.  When my tremors were so bad I thought of going on disability.