chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient accidentally received 1 dose of Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series on 14Feb2023; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient accidentally received 1 dose of Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series on 14Feb2023) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     The patient was not received any other vaccines in the 4 weeks prior to COVID-19.     On 14-Feb-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 14-Feb-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 (patient accidentally received 1 dose of Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series on 14Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient accidentally received 1 dose of Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series on 14Feb2023) 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 (patient accidentally received 1 dose of Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series on 14Feb2023).    No concomitant medications were reported. No treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 16:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 had no relevant medical history. No known allergies and no other medical history. Concomitant medication(s) included: METFORMIN, start date: 01Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID 19 Treatment included Paxlovid (Treatment start date=08Feb2023, Treatment stop date=12Feb2023).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 13:15 as dose 5 (booster), single (Lot number: GH9694) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 at 14:30 as dose 1, single (Lot number: EL9262), in left arm, on 15Feb2021 at 14:00 as dose 2, single (Lot number: EN6201), in left arm, on 18Sep2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 30Mar2022 at 13:00 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "basil cell carcinoma on skin - mose surgery" (unspecified if ongoing), notes: Other medical history: Fairly healthy basil cell carcinoma on skin - mose surgery; "basil cell carcinoma on skin - mose surgery" (unspecified if ongoing), notes: Other medical history: Fairly healthy basil cell carcinoma on skin - mose surgery. Concomitant medication(s) included: OMEGA 3 ACID ETHYL ESTERS, start date: 01Feb2016; VIT D3, start date: 01Mar2020; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PHOSPHATE;CHROMIC CHLORIDE;COLECALCIFEROL;CUPRIC OXIDE;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;POTASSIUM CHLORIDE;POTA, start date: 01Apr2014; LOSARTAN, start date: 02Sep2016. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course:The patient is treated with paxlovid for covid -19 from 02Feb2023, to 07Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Pain in extremity
Clinical narrative: just a sore arm; This is a spontaneous report received from contactable reporter (Consumer) from medical information team. The reporter is the patient. A 75-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6199) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Cirrhosis From Hepatitis C", start date: 1983 (unspecified if ongoing), notes:  was in a car accident and they didn't screen the blood for Hepatitis C; "Encephalopathy" (unspecified if ongoing), notes: too much ammonia that goes into the brain/ended up in hospital; "She was in a car accident" (unspecified if ongoing); "cirrhosis liver" (unspecified if ongoing). Concomitant medication(s) included: XIFAXAN taken for encephalopathy, start date: 2020; ZINC; GENERLAC taken for hepatic cirrhosis; LACTULOSE taken for hepatic cirrhosis. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Mar2021, outcome "recovered", described as "just a sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter assessed the case as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300073682 same reporter/patient/drug, different events/timeline/dose;
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 10:15 as dose 4 (booster), single (Lot number: FE3590) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2021 at 10:15 as dose 1, single (Lot number: ER8732), in left arm, on 19Apr2021 at 10:45 as dose 2, single (Lot number: EW0164), in left arm and on 26Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 13:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis only" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medications in 2 weeks. Patient did not had known allergies. Patent received Anti viral Paxlovid treatment for Covid-19 from 04Feb2023 to 09Feb2023with lot number: 660133.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Drug ineffective, Influenza virus test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 15Jul2021 as dose 1, single (Lot number: FA6780), in left arm and on 05Aug2021 as dose 2, single (Lot number: FA7485) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing); "HLD" (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 "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Chest X-ray: (18Feb2023) Normal, notes: CXR normal today; Influenza virus test: (unspecified date) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid Treatment start date: 08Feb2023, Treatment stop date: 13Feb2023. No known allergies.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine,  cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 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: "asthma" (unspecified if ongoing); "HBP" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known allergies: compazine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, 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: Thrombosis
Clinical narrative: Blood clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown), for COVID-19 immunization. The following information was reported: THROMBOSIS (hospitalization), outcome "unknown", described as "Blood clots".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Ageusia
Clinical narrative: I lost my sense of taste; not smell but taste; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 93-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hearing problem" (unspecified if ongoing), notes: Hearing problem. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Primary immunization series complete, NDC number, UPC number, Expiry Date were Unknown), for COVID-19 immunization. The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "I lost my sense of taste; not smell but taste". The event "i lost my sense of taste; not smell but taste" required physician office visit.  Additional information: This was not anything serious. All the time, the patient had Moderna (Unspecified Shot) but the last one was Pfizer; the patient got the booster shot (Unspecified Booster shot) last month; the patient got from Pfizer. NDC number, UPC number, Expiry Date of Unspecified Booster Shot was Unknown. She (Doctor) thought that the patient had a mild reaction to it which left patient; they said the patient loose sense of taste not from the shot that the patient got a case of it which the patient never got sick, never had one symptom but in the past let's just said past 6, 8, 9, 10 months, the patient lost sense of taste. Okay, not smell but taste and when the patient went to the doctor, she said well the patient probably had a mild reaction and it did not leave any reaction. The patient does not have enough strength to talk on the phone as the patient was 93 years old; the patient had no strength anyway.  The patient queried if the people that have had the virus would left out with sense of their taste or smell.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, 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.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes PAXLOVID (COVID-19 treatment) from 11Feb2023 to 16Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna, vaccine dose number=3; vaccine brand=Pfizer / BioNTech,vaccine dose number=4; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2022 as dose 4 (booster), single (Lot number: Git9702) at the age of 68 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Feb2021 as dose 1, single (Lot number: 015M20A), in right arm, on 24Mar2021 as dose 2, single (Lot number: 031A21A), in right arm and on 12Jan2022 as dose 3 (booster), single (Lot number: 032H21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer survivor" (unspecified if ongoing), notes: Breast cancer survivor; "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Meperghan, reaction: "known allergies: Meperghan"; Reglan, reaction: "known allergies: Reglan"; Ketek, reaction: "known allergies: Ketek". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2022, outcome "unknown", described as "vaccine brand other=Moderna, vaccine dose number=3; vaccine brand=Pfizer / BioNTech,vaccine dose number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jan2023) Positive; (08Feb2023) Positive; (14Feb2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had all my Pfizer shots and boosters (Unspecified Shot); I took a test and I was positive; I had all my Pfizer shots and boosters (Unspecified Shot); I took a test and I was positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Feb2023, outcome "unknown" and all described as "I had all my Pfizer shots and boosters (Unspecified Shot); I took a test and I was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient stated, "I just have a question. So, for the first, I had all my Pfizer shots and boosters (Name of Shot was not clarified over the call, hence captured as Unspecified Shot) and all and today I took a test and I was positive. So, my doctor called in Paxlovid for me and I took one, I misunderstood but I took it at 12:15 this afternoon and then 8 hours later, I took at 8 O'clock tonight, 8.15 and then I am worried that, I found out after the first there should be 12 hours between. Should I be worried or what should I do?." Patient again stated, "Yes, so it's been 8 hours, I misunderstood."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Initial positive by PCR/ COVID 19 Treatment; Initial positive by PCR/ COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 15:30 as DOSE 5 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 48 years, administered in the left arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "Insulin resistance/sensitivity" (unspecified if ongoing); "Various allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Feb2023, outcome "unknown" and all described as "Initial positive by PCR/ COVID 19 Treatment." The patient underwent the following laboratory tests and procedures: RT-PCR (SARS-CoV-2 test): (07Feb2023) Positive, notes: Initial positive by PCR 2/7/23; COVID-19 treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 61 years for COVID-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3247), on 09Feb2021 as dose 2, single (Lot number: EL9264), on 28Sep2021 as dose 3 (booster), single (Lot number: FF2588) and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9893) for COVID-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Feb2023) Positive; (16Feb2023) Negative. Therapeutic measures were taken as a result of vaccination failure, COVID-19 which included Paxlovid from 09Feb2023 to 14Feb2023. Clinical course: 4 days after testing negative and experiencing resolving symptoms (6 days after completing treatment), symptoms reappeared and an Ag test was positive.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: had COVID after having Pfizer COVID vaccines; had COVID after having Pfizer COVID vaccines; 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 76-year-old male patient received BNT162b2 (BNT162B2), in Nov2020 as dose 1, single (Lot number: EL8982), in arm, on 14Feb2021 as dose 2, single (Lot number: EN9581), in arm and on 06Jan2022 as dose 3 (booster), single (Lot number: PJ8757, Expiration Date: Feb2022) at the age of 75 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Stroke", start date: 2014 (unspecified if ongoing), notes: Stroke, is thinking this was about 8 years ago in about 2014; "Heart attack" (unspecified if ongoing), notes: Heart attack; "pacemaker placed", start date: 2017 (unspecified if ongoing), notes: pacemaker placed 6 years ago; "operations he has had was his tonsils and adenoid" (unspecified if ongoing), notes: the only operations he has had was his tonsils and adenoid at age 12.; "operations he has had was his tonsils and adenoid" (unspecified if ongoing), notes: the only operations he has had was his tonsils and adenoid at age 12. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "had COVID after having Pfizer COVID vaccines". The patient underwent the following laboratory tests and procedures: Lumbar puncture: Unknown results, notes: they did pre-diagnosis was a spinal tap; Magnetic resonance imaging: Unknown results, notes: they did several MRIs on him before the diagnosis. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient treated with Paxlovid. Pfizer COVID vaccines: 1st dose administered probably in Nov2020 but they did not write the date on his card and it has lot EL8982; 2nd dose was on 14Feb2021 with lot EN9581; 3rd dose was on 06Jan2022 with lot PJ8757 and thinks that is the lot with this handwriting and expiry date of Feb2022; also has written for the 3rd booster dose looks like #or C and think E 409 then 00; they did not include the NDC or other expiry dates for his patient card.  Prior Vaccinations (within 4 weeks) was None. Patient remembers the Pfizer COVID booster dose was administered to him around 11:00am and all of his COVID vaccines were in his arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300076344 Same patient/vaccine, different dose/event;
Age: 35.0
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). The reporter is the patient.  A 35-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, on 18Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Feb2023) Positive, notes: First symptoms began Wednesday 08Feb and tested positive the next morning; (12Feb2023) Negative, notes: I tested negative starting Sunday, 12Feb; (17Feb2023) Positive, notes: 16Feb and I tested positive the next day. Therapeutic measures were taken as a result of drug ineffective, covid-19 which is Paxlovid from 09Feb2023 to 12Feb2023.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Patient received Moderna vaccine for Dose 1 and 2 and Pfizer vaccine for Dose 3, 4, and 5; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 at 12:30 as DOSE 5 (BOOSTER), SINGLE (lot number: GH9693) at the age of 61 years old, administered in the left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 16Jul2022 as DOSE 4 (BOOSTER), SINGLE (lot number: FP7135), administered in the left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 12Dec2021 as DOSE 3 (BOOSTER), SINGLE (lot number: 33030BD), administered in the right arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 11Jan2021 as DOSE 1, SINGLE (lot number: O12L20A), administered in the left arm and on 08Feb2021 as DOSE 2, SINGLE (lot number: O29L20A), administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Dec2021, outcome "unknown" described as "Patient received Moderna vaccine for Dose 1 and 2 and Pfizer vaccine for Dose 3, 4, and 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment." The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): (Feb2023) Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 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 had no relevant medical history. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I was sick for like 3 days after both shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 09Jun2021 as dose 1, single (Lot number: EW0187) at the age of 34 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE; HYDROXYZINE HCL. The following information was reported: ILLNESS (non-serious) with onset Jun2021, outcome "unknown", described as "I was sick for like 3 days after both shots".  Additional information: Patient stated he took 2 Pfizer shots, got an initial Pfizer shot and then got a booster shot and had never felt good again after taking those shots. when patient took the shots, First he was super sick, by the way he was sick for like 3 days after both shots and then when, so the first shot was on 09Jun2021 (09Jun2021), the second shot was on 30Jun2021 and have never felt like this, he have like heart palpitation. He has just never, he has never felt the same.  When they gave him the shot, he was sick initially and then kind of, got over the like because he could not leave out of the bed and then it just, everything just started to tear him, he was off on one level and then ever since he has had the shots, his heart has declined tremendously. He has not gone to the Doctor in years.
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). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "wet AMD" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received covid-19 treatment with Anti-viral Product, Brand Pfizer (Lot number GF1137) from 13Feb2023 till 17Feb2023. Vaccine lot unknown reason for suspect product (dose 5) was stated as Misplaced/discarded. Patient Known allergies stated as NKA.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 24.0
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 24-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Dec2022 as dose 5 (booster), single (Lot number: GJ6743) at the age of 24 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FK9896), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cyclic neutropenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Tested negative after finishing; Positive, notes: Tested recently and the results were positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid started on 10Feb2023 and stopped on 15Feb2023.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=MODERNA US INC/ vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Jan2021 as dose 1, single (Lot number: 042L20A), in left arm, on 15Feb2021 as dose 2, single (Lot number: 022M20A), in left arm, on 18Aug2021 as dose 3 (booster), single (Lot number: 052E21A), in left arm and on 01Feb2022 as dose 4 (booster), single (Lot number: 084021A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "colon cancer" (unspecified if ongoing); "sinus infection" (unspecified if ongoing). Concomitant medication included: CEPHALEXIN [CEFALEXIN], start date: 03Feb2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022, outcome "unknown", described as "Vaccine brand other=MODERNA US INC/ vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: initial positive test; (19Feb2023) Positive, notes: tested positive for COVID-19 7 days after completing a round of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 08Feb2023 to 12Feb2023.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 50 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 12Mar2021 as dose 2, single (Lot number: EN6198), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication included: LISINOPRIL, start date: 25Aug2016. Past drug history included: Codeine, reaction: "Known allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, COVID-19 which included Paxlovid started on 19Feb2023.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Mental fatigue, Vaccination site pain
Clinical narrative: Minor soreness 2nd instant, before the needle was out; First dose extreme mental fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2022 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes; "overweight" (unspecified if ongoing), notes: Other medical history: overweight; "work stress" (unspecified if ongoing), notes: Other medical history: work stress. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Jan2022, outcome "not recovered", described as "Minor soreness 2nd instant, before the needle was out"; MENTAL FATIGUE (non-serious) with onset Jan2022, outcome "not recovered", described as "First dose extreme mental fatigue". Therapeutic measures were not taken as a result of mental fatigue, vaccination site pain.  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: Malaise
Clinical narrative: taking a "sick day."/could be making him sick/causing him to be ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male 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 Immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "taking a "sick day."/could be making him sick/causing him to be ill". It was unknown if therapeutic measures were taken as a result of malaise. Additional information: Patient was taking a "sick day." Then sent several text messages to the reporter asking if the vaccine could be making him sick. Then sent messages inferring that he felt the vaccines were "shady" and causing him to be ill.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 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: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: EVENITY [ROMOSOZUMAB AQQG]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which is Paxlovid from 07Feb2023 to 11Feb2023.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) and on 28Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "prediabetic" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "lung scarring from pneumonia" (unspecified if ongoing); "pleurisy", start date: 2019 (unspecified if ongoing); "pneumonia" (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 "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 09Feb2023 to 14Feb2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in right arm 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: "known allergies: Sulfides" (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". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment/COVID-19 positive; COVID 19 Treatment/COVID-19 positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 16:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 50 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: other medical history: N/a. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment/COVID-19 positive". 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; patient was treated with PAXLOVID.  No follow-up attempts are possible. No further information is expected.