chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Pain
Clinical narrative: sore; tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (sore) and FATIGUE (tired) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (2nd shot) in 2021 and Moderna covid-19 vaccine (1st shot) in 2021. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On 16-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (sore) and FATIGUE (tired). At the time of the report, PAIN (sore) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as booster dose. No treatment information was provided.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 28-MAR-2023, Dose administered on 01-MAY-2023; No adverse event; 68-year-old patient received expired Bivalent first booster dose of Moderna COVID-19 vaccine on 01MAY2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (68-year-old patient received expired Bivalent first booster dose of Moderna COVID-19 vaccine on 01MAY2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 28-MAR-2023, Dose administered on 01-MAY-2023) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (68-year-old patient received expired Bivalent first booster dose of Moderna COVID-19 vaccine on 01MAY2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 28-MAR-2023, Dose administered on 01-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (68-year-old patient received expired Bivalent first booster dose of Moderna COVID-19 vaccine on 01MAY2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 28-MAR-2023, Dose administered on 01-MAY-2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (68-year-old patient received expired Bivalent first booster dose of Moderna COVID-19 vaccine on 01MAY2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 28-MAR-2023, Dose administered on 01-MAY-2023).    No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 28-MAR-2023. The vial did not undergo any temperature excursions. Expiration date was reported as 15-JUN-2023 No treatment information was reported.
Age: 0.58
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; pediatric patient was administered a dose from the Multiple-Dose Vial with Dark Pink Cap and Label with Yellow Box, instead of Multiple-Dose Vial with Dark Blue Cap and Label with Gray Border.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (pediatric patient was administered a dose from the Multiple-Dose Vial with Dark Pink Cap and Label with Yellow Box, instead of Multiple-Dose Vial with Dark Blue Cap and Label with Gray Border.) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (pediatric patient was administered a dose from the Multiple-Dose Vial with Dark Pink Cap and Label with Yellow Box, instead of Multiple-Dose Vial with Dark Blue Cap and Label with Gray Border.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (pediatric patient was administered a dose from the Multiple-Dose Vial with Dark Pink Cap and Label with Yellow Box, instead of Multiple-Dose Vial with Dark Blue Cap and Label with Gray Border.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (pediatric patient was administered a dose from the Multiple-Dose Vial with Dark Pink Cap and Label with Yellow Box, instead of Multiple-Dose Vial with Dark Blue Cap and Label with Gray Border.).    No concomitant medications were reported.  The patient had not reported any adverse reactions at this time.  No treatment medications were reported.    Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerato on 07Feb2023 and administered on 27Mar2023; No adverse event; Administrative Assistant reporting that she has few Moderna vaccines administered after the 30-day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administrative Assistant reporting that she has few Moderna vaccines administered after the 30-day beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerato on 07Feb2023 and administered on 27Mar2023) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Mar-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administrative Assistant reporting that she has few Moderna vaccines administered after the 30-day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerato on 07Feb2023 and administered on 27Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administrative Assistant reporting that she has few Moderna vaccines administered after the 30-day beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerato on 07Feb2023 and administered on 27Mar2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administrative Assistant reporting that she has few Moderna vaccines administered after the 30-day beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerato on 07Feb2023 and administered on 27Mar2023).    No concomitant medication details was reported. Individual vials was used and vial size was 2.5ml. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-722188 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722188:
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; More than 35 days in between administration of the Moderna Covid-19 vaccine primary series.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between administration of the Moderna Covid-19 vaccine primary series.) and NO ADVERSE EVENT (No adverse event) in a child female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was unknown that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 28-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Apr-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between administration of the Moderna Covid-19 vaccine primary series.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between administration of the Moderna Covid-19 vaccine primary series.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between administration of the Moderna Covid-19 vaccine primary series.).    No concomitant medication details was reported. No treatment medication details was reported.  It was reported that On 10-Dec-2022, the patient received first dose of moderna vaccine and batch number was reported as AS1414B. Patient received Moderna Covid-19 vaccine from a freezer where the temperature had not been checked each day since April 13, 2023. It was not believed that the freezer had not gone out of range during this time however it was also not known if the freezer went out of range during this time. The freezer does had an alarm on it that had not gone off since April 13, 2023.
Age: 1.33
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received Moderna Covid-19 vaccine from a freezer where the temperature had not been checked each day since April 13, 2023; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine from a freezer where the temperature had not been checked each day since April 13, 2023) and NO ADVERSE EVENT (No Adverse Event) in a 16-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccine 4 weeks prior to COVID-19 vaccine.     On 28-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine from a freezer where the temperature had not been checked each day since April 13, 2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine from a freezer where the temperature had not been checked each day since April 13, 2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine from a freezer where the temperature had not been checked each day since April 13, 2023).    No concomitant medications was reported. No treatment drug details was reported. It was reported that the patient received first dose of the Moderna Covid-19 vaccine on 26-June-2022 lot number and expiration date, site of vaccination was not known. No Adverse Reactions was reported. Received second dose of the Moderna Covid-19 vaccine on 26-jul-2022, lot number and expiration date, site of vaccination was not known. No adverse reactions were reported. No other adverse reactions were reported for booster dose as well. Patient received Moderna Covid-19 vaccine from a freezer where the temperature had not been checked each day since April 13, 2023. It was not believed that the freezer had not gone out of range during that time however it was also not known if the freezer went out of range during that time. The freezer does have an alarm on it that has not gone off since April 13, 2023.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 04/24/23 and given 05/05/23. No immediate symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dry skin, Rash, Skin burning sensation
Clinical narrative: Patient said she got a burning rash on her neck that started the day after her immunization and lasted for about 3 days. Patient used coconut oil to alleviate the rash. Rash is still there but now it is like a dry skin - rash and burning has gone away. Patient said she had this kind of rash after her J& J vaccine and lasted for about 3 months and then it cleared.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test abnormal, Computerised tomogram heart abnormal, Echocardiogram abnormal, Pericardial effusion
Clinical narrative: On January 20, 2022 I had a Cardiac Calcium Score (CT) done, and the results were forwarded to my physician. It showed a "Small Concentric Pericardial Effusion". I was referred to a cardiologist, and have had three echocardiograms done, and also a treadmill stress test. The second echo showed that the effusion had improved, but not resolved. The third echo showed the same amount of fluid as the second. I have had an echocardiogram in the past which did not show an effusion, and have not had any viral illnesses which could have caused this effusion. There has been no treatment done other than to monitor my cardiac function, and a probable echo in one year.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hot flush, Throat irritation
Clinical narrative: customer reported: hot flashes, stomach cramping and burn in her throat.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, COVID-19, Cardiac arrest, Illness, Resuscitation
Clinical narrative: Moderna booster vaccine with positive covid-19 almost kill me. On December 3, 2021 my husband did CPR  on me, because my heart stopped. The heart stopped several times in the hospital as well. I was hospitalized in local Hospital and alternate Hospital for one week. It is a long story. I didn't know I had covid-19, because I felt fine, no symptoms and I did the Moderna booster vaccine on Wednesday, December 1, 2021.My husband also had covid so he stayed at home. On December 3, 2021, if not for the help of my husband and his cardiopulmonary resuscitation, I would be dead by now. I'm very angry. Why didn't they warn people to check themselves before the vaccine booster that they don't have covid ? Why ?Nowhere.I was sick over a year. I wouldn't go if I knew I had covid.  Did Moderna Company announce and where for people to check if they have covid before taking booster vaccine? That they do covid tests. I felt fine no symptoms and had covid and took booster vaccine and I was fighting for my life.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Moderna booster vaccine with positive covid-19 almost kill me. On December 3, 2021 my husband did CPR  on me, because my heart stopped. The heart stopped several times in the hospital as well. I was hospitalized in local Hospital and alternate Hospital for one week. It is a long story. I didn't know I had covid-19, because I felt fine, no symptoms and I did the Moderna booster vaccine on Wednesday, December 1, 2021.My husband also had covid so he stayed at home. On December 3, 2021, if not for the help of my husband and his cardiopulmonary resuscitation, I would be dead by now. I'm very angry. Why didn't they warn people to check themselves before the vaccine booster that they don't have covid ? Why ?Nowhere.I was sick over a year. I wouldn't go if I knew I had covid.  Did Moderna Company announce and where for people to check if they have covid before taking booster vaccine? That they do covid tests. I felt fine no symptoms and had covid and took booster vaccine and I was fighting for my life.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site reaction, Malaise, Nausea, Urticaria
Clinical narrative: Large red circular welt at injection site that is very firm and hot to the touch. Redness keeps spreading each day.  24 hours post injection, patient started feeling nauseous and vomiting excessively. It is now 36 hours post injection and patient is still vomiting and feeling ill.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Expired product administered
Clinical narrative: Vaccine, pediarix, given was expired. Per manufacturer potency of vaccine is good for 30 days. Per CDC recommendations repeat as soon as possible.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Headache, Injection site pain, Irritability, Pyrexia, Sluggishness
Clinical narrative: Had fever on 4-26-23 & irritable, sore at injection site. He was sluggish & w/ headache 3 days post vaccination. After 5 days, post vaccination he had hives on torso & spread to his arms, thighs & face Hives - off & on, did not completely went away Mom was giving Vit C, home remedy - cool baths & compress
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: Had fever on 4-26-23 & irritable, sore at injection site. He was sluggish & w/ headache 3 days post vaccination. After 5 days, post vaccination he had hives on torso & spread to his arms, thighs & face Hives - off & on, did not completely went away Mom was giving Vit C, home remedy - cool baths & compress
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Pt developed hives to entire body including face and had some shortness of breath so went to urgent care. Was given steroid injection and oral steroids and symptoms resolved. Hives developed approx 36 hours after vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Emotional distress, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: I HAD THE FIRST VACCINE DONE 8/17/2021 NO SEVERE REACTION. I ONLY HAD A SORE ARM. ON 10/2/2021; I HAD THE SECOND VACCINE DONE ON THE SAME ARM. THE NEXT DAY, ON 10/3/2021; I AWOKE TO PAIN UNDER MY LEFT ARMPIT! (LYMPH NODE AREA.) I CALLED MY IMAGING CENTER. THEY TOLD ME I HAVE MY YEARLY APPOINTMENT ON 11/26/2021 AND I WOULD BE EXAMINED AT THAT TIME REGARDING MY CONCERNS. I ALSO CALLED MY GYNECOLOGY OFFICE AND COMPLAINED TO THEM OF MY PAIN. I SAW P.A. AT THE OFFICE ON NOVEMBER 2, 2021. I WAS EXAMINED THERE AND I WAS TOLD THE SWOLLEN LYMPH NODE WAS ONLY TEMPORARY. IT REMAINS AND SO DOES THE PAIN! I VISTED IMAGING FOR MY APPOINTMENT. THEY DID AN ULTRASOUND USING THE WAND UNDER MY LEFT ARMPIT. IT WAS PAINFUL. I WAS TOLD EVERYTHING WAS NORMAL/MEANING THEY SAW NO CANCER AND THAT THE LUMP WAS ONLY TEMPORARY! IT'S NOT! I CONTINUE TO HAVE PAIN EVERY DAY! IT'S PAINFUL TO SHOWER. I CAN'T USE DEODORANT. ALMOST TWO YEARS NOW SINCE I'VE BEEN TRAUMATIZED BY THIS OCCURRENCE. I TRUSTED THE SCIENCE, PHARMACIST AND PFIZER!! THERE IS NO TREATMENT AVAILABLE FOR WHAT HAPPENED TO ME! I WANT TO KNOW WHAT PFIZER IS GOING TO DO ABOUT IT?
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound breast, Ultrasound lymph nodes
Clinical narrative: I HAD THE FIRST VACCINE DONE 8/17/2021 NO SEVERE REACTION. I ONLY HAD A SORE ARM. ON 10/2/2021; I HAD THE SECOND VACCINE DONE ON THE SAME ARM. THE NEXT DAY, ON 10/3/2021; I AWOKE TO PAIN UNDER MY LEFT ARMPIT! (LYMPH NODE AREA.) I CALLED MY IMAGING CENTER. THEY TOLD ME I HAVE MY YEARLY APPOINTMENT ON 11/26/2021 AND I WOULD BE EXAMINED AT THAT TIME REGARDING MY CONCERNS. I ALSO CALLED MY GYNECOLOGY OFFICE AND COMPLAINED TO THEM OF MY PAIN. I SAW P.A. AT THE OFFICE ON NOVEMBER 2, 2021. I WAS EXAMINED THERE AND I WAS TOLD THE SWOLLEN LYMPH NODE WAS ONLY TEMPORARY. IT REMAINS AND SO DOES THE PAIN! I VISTED IMAGING FOR MY APPOINTMENT. THEY DID AN ULTRASOUND USING THE WAND UNDER MY LEFT ARMPIT. IT WAS PAINFUL. I WAS TOLD EVERYTHING WAS NORMAL/MEANING THEY SAW NO CANCER AND THAT THE LUMP WAS ONLY TEMPORARY! IT'S NOT! I CONTINUE TO HAVE PAIN EVERY DAY! IT'S PAINFUL TO SHOWER. I CAN'T USE DEODORANT. ALMOST TWO YEARS NOW SINCE I'VE BEEN TRAUMATIZED BY THIS OCCURRENCE. I TRUSTED THE SCIENCE, PHARMACIST AND PFIZER!! THERE IS NO TREATMENT AVAILABLE FOR WHAT HAPPENED TO ME! I WANT TO KNOW WHAT PFIZER IS GOING TO DO ABOUT IT?
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Error: Expired Product Administered-
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: SOB; had increased Dizziness; CBC HgB norm low; RCD norm high; CBC HCT norm low; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old patient received BNT162b2 (BNT162B2), on 19Mar2021 at 09:00 as dose 2, 30 ug single (Lot number: EN6207) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "OSA mild CPAP occasional use", start date: 01Jan2012, stop date: 01Jan2020, notes: Pertinent Details: Borderline; "Urethral fascial sling repair removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Pertinent Details: sling broken in muscle; "Asthma" (unspecified if ongoing); "Vaginal atrophy" (unspecified if ongoing). Concomitant medication(s) included: FLUTICASONE + SALMETEROL taken for asthma, start date: 2019 (ongoing); ATROVENT taken for asthma, start date: 2019 (ongoing); ALBUTEROL HFA taken for asthma, start date: 2019 (ongoing); ESTRADIOL topical taken for vaginal disorder, start date: 2015 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: 14:00, Anatomical Site of injection: Left upper Arm, Route of administration: Intramuscular, Batch/Lot number: EZ9266), administration date: 21Feb2021, for COVID-19 immunization, reaction(s): "Lip and tongue swelling", "Lip and tongue swelling", "Vision became dim", "Dizzy", "Headaches", "cataract spots". The following information was reported: HAEMATOCRIT ABNORMAL (non-serious) with onset 25Jun2021, outcome "unknown", described as "CBC HCT norm low"; HAEMOGLOBIN ABNORMAL (non-serious) with onset 25Jun2021, outcome "unknown", described as "CBC HgB norm low"; RED CELL DISTRIBUTION WIDTH ABNORMAL (non-serious) with onset 25Jun2021, outcome "unknown", described as "RCD norm high"; DYSPNOEA (non-serious), outcome "unknown", described as "SOB"; DIZZINESS (non-serious), outcome "unknown", described as "had increased Dizziness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had increased Dizziness and SOB c each Covid evet. Prior to vaccine patient had no cataracts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020988 same patient, different vaccine dose/event;US-PFIZER INC-202300176772 Same patient, same product, different events (Dose 2);
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Dizziness, Dyspnoea, Full blood count, Haematocrit
Clinical narrative: SOB; had increased Dizziness; CBC HgB norm low; RCD norm high; CBC HCT norm low; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old patient received BNT162b2 (BNT162B2), on 19Mar2021 at 09:00 as dose 2, 30 ug single (Lot number: EN6207) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "OSA mild CPAP occasional use", start date: 01Jan2012, stop date: 01Jan2020, notes: Pertinent Details: Borderline; "Urethral fascial sling repair removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Pertinent Details: sling broken in muscle; "Asthma" (unspecified if ongoing); "Vaginal atrophy" (unspecified if ongoing). Concomitant medication(s) included: FLUTICASONE + SALMETEROL taken for asthma, start date: 2019 (ongoing); ATROVENT taken for asthma, start date: 2019 (ongoing); ALBUTEROL HFA taken for asthma, start date: 2019 (ongoing); ESTRADIOL topical taken for vaginal disorder, start date: 2015 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: 14:00, Anatomical Site of injection: Left upper Arm, Route of administration: Intramuscular, Batch/Lot number: EZ9266), administration date: 21Feb2021, for COVID-19 immunization, reaction(s): "Lip and tongue swelling", "Lip and tongue swelling", "Vision became dim", "Dizzy", "Headaches", "cataract spots". The following information was reported: HAEMATOCRIT ABNORMAL (non-serious) with onset 25Jun2021, outcome "unknown", described as "CBC HCT norm low"; HAEMOGLOBIN ABNORMAL (non-serious) with onset 25Jun2021, outcome "unknown", described as "CBC HgB norm low"; RED CELL DISTRIBUTION WIDTH ABNORMAL (non-serious) with onset 25Jun2021, outcome "unknown", described as "RCD norm high"; DYSPNOEA (non-serious), outcome "unknown", described as "SOB"; DIZZINESS (non-serious), outcome "unknown", described as "had increased Dizziness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had increased Dizziness and SOB c each Covid evet. Prior to vaccine patient had no cataracts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020988 same patient, different vaccine dose/event;US-PFIZER INC-202300176772 Same patient, same product, different events (Dose 2);
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Haematocrit abnormal, Haemoglobin, Haemoglobin abnormal, Metabolic function test, Red blood cell abnormality
Clinical narrative: SOB; had increased Dizziness; CBC HgB norm low; RCD norm high; CBC HCT norm low; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old patient received BNT162b2 (BNT162B2), on 19Mar2021 at 09:00 as dose 2, 30 ug single (Lot number: EN6207) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "OSA mild CPAP occasional use", start date: 01Jan2012, stop date: 01Jan2020, notes: Pertinent Details: Borderline; "Urethral fascial sling repair removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Pertinent Details: sling broken in muscle; "Asthma" (unspecified if ongoing); "Vaginal atrophy" (unspecified if ongoing). Concomitant medication(s) included: FLUTICASONE + SALMETEROL taken for asthma, start date: 2019 (ongoing); ATROVENT taken for asthma, start date: 2019 (ongoing); ALBUTEROL HFA taken for asthma, start date: 2019 (ongoing); ESTRADIOL topical taken for vaginal disorder, start date: 2015 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: 14:00, Anatomical Site of injection: Left upper Arm, Route of administration: Intramuscular, Batch/Lot number: EZ9266), administration date: 21Feb2021, for COVID-19 immunization, reaction(s): "Lip and tongue swelling", "Lip and tongue swelling", "Vision became dim", "Dizzy", "Headaches", "cataract spots". The following information was reported: HAEMATOCRIT ABNORMAL (non-serious) with onset 25Jun2021, outcome "unknown", described as "CBC HCT norm low"; HAEMOGLOBIN ABNORMAL (non-serious) with onset 25Jun2021, outcome "unknown", described as "CBC HgB norm low"; RED CELL DISTRIBUTION WIDTH ABNORMAL (non-serious) with onset 25Jun2021, outcome "unknown", described as "RCD norm high"; DYSPNOEA (non-serious), outcome "unknown", described as "SOB"; DIZZINESS (non-serious), outcome "unknown", described as "had increased Dizziness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had increased Dizziness and SOB c each Covid evet. Prior to vaccine patient had no cataracts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020988 same patient, different vaccine dose/event;US-PFIZER INC-202300176772 Same patient, same product, different events (Dose 2);
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Red cell distribution width abnormal, Visual field tests
Clinical narrative: SOB; had increased Dizziness; CBC HgB norm low; RCD norm high; CBC HCT norm low; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old patient received BNT162b2 (BNT162B2), on 19Mar2021 at 09:00 as dose 2, 30 ug single (Lot number: EN6207) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "OSA mild CPAP occasional use", start date: 01Jan2012, stop date: 01Jan2020, notes: Pertinent Details: Borderline; "Urethral fascial sling repair removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Pertinent Details: sling broken in muscle; "Asthma" (unspecified if ongoing); "Vaginal atrophy" (unspecified if ongoing). Concomitant medication(s) included: FLUTICASONE + SALMETEROL taken for asthma, start date: 2019 (ongoing); ATROVENT taken for asthma, start date: 2019 (ongoing); ALBUTEROL HFA taken for asthma, start date: 2019 (ongoing); ESTRADIOL topical taken for vaginal disorder, start date: 2015 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: 14:00, Anatomical Site of injection: Left upper Arm, Route of administration: Intramuscular, Batch/Lot number: EZ9266), administration date: 21Feb2021, for COVID-19 immunization, reaction(s): "Lip and tongue swelling", "Lip and tongue swelling", "Vision became dim", "Dizzy", "Headaches", "cataract spots". The following information was reported: HAEMATOCRIT ABNORMAL (non-serious) with onset 25Jun2021, outcome "unknown", described as "CBC HCT norm low"; HAEMOGLOBIN ABNORMAL (non-serious) with onset 25Jun2021, outcome "unknown", described as "CBC HgB norm low"; RED CELL DISTRIBUTION WIDTH ABNORMAL (non-serious) with onset 25Jun2021, outcome "unknown", described as "RCD norm high"; DYSPNOEA (non-serious), outcome "unknown", described as "SOB"; DIZZINESS (non-serious), outcome "unknown", described as "had increased Dizziness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had increased Dizziness and SOB c each Covid evet. Prior to vaccine patient had no cataracts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020988 same patient, different vaccine dose/event;US-PFIZER INC-202300176772 Same patient, same product, different events (Dose 2);
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: had 1st bivalent in September and was infected with Covid last month; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had 1st bivalent in September and was infected with Covid last month) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced COVID-19 (had 1st bivalent in September and was infected with Covid last month). At the time of the report, COVID-19 (had 1st bivalent in September and was infected with Covid last month) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported by reporter. Suspect product dosage text was reported as initial booster. It was reported that patient had Paxlovid and had no symptoms. No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Patient got the 1st Moderna Covid-19 vaccine and it was the worst decision they made because they were sick for 2 months and was still experiencing lingering effects close to 2 years now.  No treatment medication was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; received 0.2mL Bivalent dose ( Lot- 215K22A) from the pink cap vial on 28Apr2023 instead instead of the vial with a blue cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received 0.2mL Bivalent dose ( Lot- 215K22A) from the pink cap vial on 28Apr2023 instead instead of the vial with a blue cap) and NO ADVERSE EVENT (No adverse event) in an infant female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 28-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 28-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (received 0.2mL Bivalent dose ( Lot- 215K22A) from the pink cap vial on 28Apr2023 instead instead of the vial with a blue cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received 0.2mL Bivalent dose ( Lot- 215K22A) from the pink cap vial on 28Apr2023 instead instead of the vial with a blue cap) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received 0.2mL Bivalent dose ( Lot- 215K22A) from the pink cap vial on 28Apr2023 instead instead of the vial with a blue cap).    Concomitant medication was not provided.  Patient received MODERNA COVID-19 VACCINE (Dose 1 andAS1417B) on 22-Mar-2023. Treatment information was not provided.
Sex: M
Vaccine: PNC20
Symptoms: Accidental exposure to product, Device breakage, Incorrect dose administered by product, Syringe issue
Clinical narrative: some of it squirted out during administration; the patient only received part of the dose; The syringe was cracked at the top; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from agency.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 27Apr2023 as dose number unknown, single (Lot number: GM9410, Expiration Date: 20Aug2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious) with onset 27Apr2023, described as "The syringe was cracked at the top"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious) with onset 27Apr2023, described as "some of it squirted out during administration"; INCORRECT DOSE ADMINISTERED BY PRODUCT (non-serious) with onset 27Apr2023, described as "the patient only received part of the dose". Additional information: A nurse administered Prevnar 20 to the patient.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5, on 10Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 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: "Asthmatic" (unspecified if ongoing); "leukemia survivor" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Scratch, Urticaria, Wrong product administered
Clinical narrative: Hives; Itching; Rash; Scratches on her arms/Scratches all over her body; Was her first ever dose of the Pfizer Covid 19 Bivalent vaccine. Was a primary dose; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Apr2023 as dose 1, single (Lot number: GJ3270) at the age of 76 years intramuscular, in left deltoid for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: URTICARIA (medically significant) with onset 27Apr2023, outcome "recovered" (28Apr2023), described as "Hives"; PRURITUS (non-serious) with onset 27Apr2023, outcome "not recovered", described as "Itching"; RASH (non-serious) with onset 27Apr2023, outcome "recovered" (28Apr2023); SCRATCH (non-serious) with onset 27Apr2023, outcome "not recovered", described as "Scratches on her arms/Scratches all over her body"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 27Apr2023, outcome "unknown", described as "Was her first ever dose of the Pfizer Covid 19 Bivalent vaccine. Was a primary dose". Therapeutic measures were taken as a result of urticaria, pruritus, rash. Therapeutic measures were not taken as a result of scratch. Clinical course: Reporter stated that patient received her first ever dose of the Pfizer Covid 19 Bivalent vaccine. Was a primary dose. Was her first vaccine ever of the Covid vaccine. Treatment received Benadryl for Hives, Itching and Rash. Investigations: No, Other Products: No. Reporter stated events pruritus, rash, Scratch as not serious and event urticaria as serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162b2, BNT162b2 omi ba.4-5 to the event hives cannot be excluded based on the plausible temporal relationship and product profile. 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: COVID19
Symptoms: Tinnitus
Clinical narrative: had no symptoms until early March/I have tinnitus; 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 patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: TINNITUS (non-serious), outcome "unknown", described as "had no symptoms until early March/I have tinnitus".  Additional information: Patient had tinnitus. One day after patient received COVID booster and tinnitus disappeared. The second day after receiving booster, it came back. Patients previous vaccine was on Oct2022. Patient had no symptoms until patient came back from in early March. In afternoon after patient got booster it disappeared and then it came back the next afternoon, on the second day  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She also mentions that her sister in law first got covid recovered with no problems and got more sick when she got the vaccine; She also mentions that her sister in law first got covid recovered with no problems and got more sick when she got the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She also mentions that her sister in law first got covid recovered with no problems and got more sick when she got the vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose number unknown (booster), single (Lot number: GJ6738) at the age of 38 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Dec2021 as dose number unknown, single (Lot number: FJ8760) 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 13Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Feb2023) Positive, notes: on day 1 of testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes: Paxlovid from 14Feb2023 to 18Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (28Apr2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Positive, notes: positive tests; (28Apr2023) Negative, notes: tests had been negative since 28Apr. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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-202300178219 same patient, different drug/ event;