chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: 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 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 09:30 as dose 5 (booster), single (Lot number: GH9702) at the age of 44 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 03Apr2021 as dose 2, single (Lot number: ER8734), in left arm, on 03Nov2021 at 15:45 as dose 3 (booster), single (Lot number: 32030BD) and on 29Mar2022 at 15:00 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "Known allergies: seasonal allergies" (unspecified if ongoing), notes: Known allergies: seasonal allergies. Concomitant medication(s) included: JUNEL FE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not 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: Treatment of COVID-19; (02Dec2022) Negative, notes: Tested negative on day 9 of isolation; (05Dec2022) Positive, notes: Had positive test 05Dec; (10Dec2022) Positive, notes: am still testing positive on 10Dec. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid; Treatment start date: 25Nov2022, Treatment stop date: 29Nov2022).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 51 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 12Jan2021 as dose 2, single (Lot number: EJ1686), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FC3592), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa based medications" (unspecified if ongoing), notes: Sulfa based medications. Concomitant medication(s) included: OMEPRAZOLE, start date: 12May2022; CLARITIN [CLARITHROMYCIN]; ESTROGEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Retested and was positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Rebound covid symptoms starting 08Dec2022, 4 days after finishing round of Paxlovid. Retested and was positive again.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the "Vaccination failure (LOE) and COVID-19" cannot be ruled out.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 29 years 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: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2022) Positive, notes: On the sixth day after treatment, I tested positive for covid again. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: During the treatment, covid symptoms resolved. Four days after finishing the treatment, symptoms began returning. On the sixth day after treatment, patient tested positive for covid again. During this entire time, she did not leave the house so could not have been re-exposed. Paxlovid taken as a treatment of Covid-19, started on 29Nov2022 till 04Dec2022. Adverse events noted from 08Dec2022, 08:00 PM. Prednisone taken from 05Nov2022 till 30Nov2022. Methotrexate taken on 05Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19; (2022) Negative, notes: Rebound COVID 3 days after and a few negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient taken treatment (Product: Paxlovid) from 04Dec2022 to 09Dec2022 for treatment of COVID-19.Patient did not received Other medication in 2weeks.  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, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: TRI-SPRINTEC; FLOVENT HFA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If Vaccine received: Yes. Other medication in 2weeks: Yes (Tri-sprintec, Flovent HFA 110mcg). The patient was treated with Paxlovid from 28Nov2022 to 03Dec2022 with lot number 1921153A. Rebound COVID-19 7 days post completion of Paxlovid, symptoms include sore throat and cough.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 65.0
Sex: M
Vaccine: 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 66-year-old male patient received BNT162b2 (BNT162B2), on 20May2022 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Contrast dye used for CT scans" (unspecified if ongoing), notes: Known allergies: Contrast dye used for CT scans; "Diabetic" (unspecified if ongoing); "high blood pressure" (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.  Clinical course: There was no other medication in 2 weeks. Vaccine lot unknown as unable to locate or read the details.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
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 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 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 was not reported. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Dec2022) Positive, notes: Rebound after taking full course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. If vaccine received: Yes, other medication in 2weeks: No. On 27Nov2022 patient received Paxlovid for COVID 19 treatment till 03Dec2022.   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: M
Vaccine: PNC20
Symptoms: Chromaturia
Clinical narrative: I had to go pee and I noticed in the toilet it was lightly tinted green; 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 male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Dec2022 as dose nomber unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHROMATURIA (non-serious), outcome "unknown", described as "I had to go pee and I noticed in the toilet it was lightly tinted green". Additional information: patient that states the following: "I just got my shot [PREVNAR 20] about 20 minutes ago at (institute name withheld) I came home because I had to go pee and I noticed in the toilet it was lightly tinted green and I was like, what is that? Has this been reported as a side effect of PREVNAR 20?  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 3 Pfizer vaccine and Dose 4 Moderna vaccine; 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 44-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Oct2022 as dose 4 (booster), single (Lot number: AS7162B), 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 and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Oct2022, outcome "unknown", described as "Dose 3 Pfizer vaccine and Dose 4 Moderna vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Positive COVID antigen test two days after series of negative tests; (11Dec2022) Positive, notes: Positive COVID antigen test two days after series of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: after the 3rd dose, both of them experiences soreness; 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 male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), for COVID-19 immunization, reaction(s): "they got the first 2 doses 2 weeks apart". The following information was reported: PAIN (non-serious), outcome "recovered", described as "after the 3rd dose, both of them experiences soreness".  Additional information: It was reported that the patient and his wife had both the series of Pfizer injections where they got the first 2 doses 2 weeks apart and then got the 3rd, 4th and 5th booster, reporter stated they had a total of 5 injections. Patient stated after the 3rd dose, both of them experienced soreness that went away after 3 or 4 days. Patient stated after the 4th dose in the 4th month of this year (Apr2022), about 10 to14 days after it made his wife's skin got brown and they thought it was bruising. Patient stated her skin was dark and it started making like an indentation where it kept sinking where the injection site was. Patient stated the indentation was then around the size of a nickel that was dark and had been getting deeper in indentation. Patient stated it had gotten deeper over the last month. Patient stated when they went to get their 5th injection, the pharmacist said she had never seen that before.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201368860 same patient and drug, different dose and event;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: after the 3rd dose, both of them experiences soreness/Soreness of right arm after each injection 1-4/both had arm soreness after each injection, not just the 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 20Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 301558A) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA taken for colitis. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6199; Anatomical location: Left arm; Vaccination time: 11:00), administration date: 06Mar2021, for COVID-19 immunization, reaction(s): "Soreness of right arm after each injection 1-4"; BNT162b2 (DOSE 2, SINGLE; Lot number: EP6955; Anatomical location: Left arm; Vaccination time: 11:00), administration date: 27Mar2021, for COVID-19 immunization, reaction(s): "Soreness of right arm after each injection 1-4", "first 2 doses 2 weeks apart". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Oct2021, outcome "recovered" (Oct2021), described as "after the 3rd dose, both of them experiences soreness/Soreness of right arm after each injection 1-4/both had arm soreness after each injection, not just the 3rd dose".  Additional information: Reporter was reporting for his wife. Patient had no other Conditions. Patient had other products. They had both had the series of Pfizer injections where they got the first 2 doses 2 weeks apart. After the 3rd dose, both of them experiences soreness that went away after 3 or 4 days. Patient had arm soreness after each injection, not just the 3rd dose. Each time they had injection they had soreness of arm. All injections for wife on same arm, left arm. All soreness started the evening of the injection, and really noticed it the next day. Eventually in a couple or 3 days, the soreness was gone. She only took one other medication, which he stated was Humira 40mg/0.4ml Injection twice monthly, every 2 weeks given in leg for Colitis. Patient started Humira about 2 years ago (from the day of this report) that last November. Soreness of right arm after each injection 1-4. No Investigations were conducted. There was no family Medical History Relevant to Adverse Events (AEs). The report was not related to a study or programme.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201368860 same reporter and drug, different patient and event;
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Injection site indentation
Clinical narrative: The indentation is now around the size of a nickel that is dark and has been getting deeper in indentation; The indentation is now around the size of a nickel that is dark and has been getting deeper in indentation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), when the patient was 72 years old, for COVID-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: unknown), for COVID-19 immunization, reaction(s): "soreness"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: unknown), administration date: Apr2022, for COVID-19 immunization, reaction(s): "Bruising", "Her skin is dark and it started making like an indentation where it kept sinking where the injection site was", "Skin got brown", "Her skin is dark and it started making like an indentation where it kept sinking where the injection site was". The following information was reported: INJECTION SITE INDENTATION (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "The indentation is now around the size of a nickel that is dark and has been getting deeper in indentation".  Additional information: Reporter stated that they had both had the series of Pfizer injections where they got the first 2 doses 2 weeks apart and then got the 3rd, 4th and 5th booster, caller stated they had a total of 5 injections. Caller stated after the 3rd dose, both of them experiences soreness that went away after 3 or 4 days. Caller stated after the 4th dose in the 4th month of this year, about 10-14 days after it made his wife's skin got brown and they thought it was bruising. Reporter stated her skin was dark and it started making like an indentation where it kept sinking where the injection site was. Reporter stated the indentation was then around the size of a nickel that was dark and had been getting deeper in indentation. Reporter stated it had gotten deeper over the last month. Reporter stated when they went to get their 5th injection, the pharmacist said she had never seen that before.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201368860 Same reporter and patient, different event;
Age: 62.0
Sex: M
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) (Physician) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 62 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's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (orally) from 01Dec2022 to 06Dec2022.  Clinical information: Patient didn't received other medication in 2 weeks. The patient didn't taking any other medications/products within 2 weeks of starting COVID-19 treatment. Known allergies was NKDA. Serious: No. Seriousness criteria-Results in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect was no.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizures; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Seizures".  Clinical course: The [Pfizer COVID-19] vaccine made reporter so sick for months. Then reporter middle daughter gets the vaccine and now gets seizures. Reporter think they should be prosecuted and pay. Patient Age was 59 (unit unknown).  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
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 1,  Dose 2, Dose 3, Dose 4= Moderna, Dose 5=Pfizer/BioNTech; 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 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 72 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Mar2021 as dose 1, single (Lot number: 027A21A), on 01Apr2021 as dose 2, single (Lot number: 028A21A), on 23Oct2021 as dose 3 (booster), single (Lot number: 027C21A) and on 09Apr2022 as dose 4 (booster), single (Lot number: 001M21A) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Lymphocytic colitis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing), notes: High cholesterol. The patient's concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "Allergy_Vicodin", notes: Allergy_Vicodin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Oct2022, outcome "unknown", described as "Dose 1, Dose 2, Dose 3, Dose 4= Moderna, Dose 5=Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and received Paxlovid, from 03Dec2022 to 08Dec2022
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; 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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years 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: "Known allergies: sulfa" (unspecified if ongoing); "birth control" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN taken for contraception.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 at 12:30 as dose 3 (booster), single (Lot number: FF2587) at the age of 58 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Mar2021 at 11:00 as dose 1, single (Lot number: 036A21A), in left arm, on 06Apr2021 at 11:45 as dose 2, single (Lot number: 037A21B), in left arm, on 19Feb2022 at 10:15 as dose 4 (booster), single (Lot number: 083J21A), in left arm and on 09Sep2022 at 16:45 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "known allergies: Shrimp" (unspecified if ongoing), notes: known allergies: Food: Shrimp. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2021 at 12:30, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid (lot number: GFG450) from 03Dec2022 to 08Dec2022.
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased
Clinical narrative: She has experienced issues with restriction of motion in her left arm; 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 63-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "She has experienced issues with restriction of motion in her left arm". The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "She has experienced issues with restriction of motion in her left arm".  Additional information: With her previous Pfizer BioNTech COVID-19 vaccinations and boosters she had issue with restriction of motion of her left arm. The caller asked Do any clinical trials support the bivalent COVID-19 booster administration in buttocks or other muscles in the gluteus area.  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-202201368440 same patient, drug, event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased
Clinical narrative: she has experienced issues with restriction of motion in her left arm; 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 63-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown, ), for COVID-19 immunization, reaction(s): "She has experienced issues with restriction of motion in her left arm"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown, ), for COVID-19 immunization, reaction(s): "She has experienced issues with restriction of motion in her left arm". The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "she has experienced issues with restriction of motion in her left arm".  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-202201368440 same patient/drug/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased
Clinical narrative: she has experienced issues with restriction of motion in her left arm; 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 63-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown), for COVID-19 immunization, reaction(s): "issues with restriction of motion in her left arm"; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), for COVID-19 immunization, reaction(s): "issues with restriction of motion in her left arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: unknown), for COVID-19 immunization, reaction(s): "issues with restriction of motion in her left arm". The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "she has experienced issues with restriction of motion in her left arm".  Additional information: Caller referred to an inquiry asking if any clinical trials supported the bivalent COVID-19 booster administration in buttocks or other muscles in the gluteus area. The caller referred that with the previous COVID-19 vaccines and boosters, which had all been Pfizer's, she had experienced issues with restriction of motion in her left arm.  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) :PFIZER INC-202201368440 Same patient, drug, event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased
Clinical narrative: restriction of motion in her left arm; 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 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "she has experienced issues with restriction of motion in her left arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "she has experienced issues with restriction of motion in her left arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "she has experienced issues with restriction of motion in her left arm"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "she has experienced issues with restriction of motion in her left arm". The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "restriction of motion in her left arm".  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): PFIZER INC-202201368440 same patient and event, different drug and dose;
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Fatigue, Malaise
Clinical narrative: Tiredness; Feeling unwell; Body ache; Light-headed; I had decrease of appetite; Diarrhea; 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), on 09Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 27Nov2022, stop date: 05Dec2022, notes: I had COVID-19 back in 27Nov2022 and I was diagnosed clear on 05Dec2022. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "COVID-19"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "COVID-19"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "COVID-19"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: PAIN (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Body ache"; DIARRHOEA (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Diarrhea"; MALAISE (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Feeling unwell"; DECREASED APPETITE (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "I had decrease of appetite"; DIZZINESS (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Light-headed"; FATIGUE (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Consumer stated, "I am calling regarding the vaccination of Pfizer, I had it on Friday and apparently I had told the nurse that I just came off COVID. I had COVID-19 back in 27Nov2022 and I was diagnosed clear on 05Dec2022, and she said you could take the vaccine (Pfizer COVID-19 vaccine), So I did it (event captured conservatively), but I have some side-effects. My side-effects were tiredness, feeling unwell, body ache, lightheaded, I had decrease of appetite and diarrhea from Friday to Saturday and I never had any side-effects from any other vaccines of Pfizer (further clarification unknown). This is number 5, the vaccine number 5 that I got, and I have a question. Can you still get vaccinated even though you have just gone through COVID-19, 5 days later?". Further probing could not be done as the consumer hung up the call abruptly. Hence limited information was available over the call.  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-202201369444 same patient/drug, different AE/dose;
Sex: U
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Tiredness; Feeling unwell; Body ache; Light-headed; I had decrease of appetite; Diarrhea; 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), on 09Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 27Nov2022, stop date: 05Dec2022, notes: I had COVID-19 back in 27Nov2022 and I was diagnosed clear on 05Dec2022. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "COVID-19"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "COVID-19"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "COVID-19"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: PAIN (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Body ache"; DIARRHOEA (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Diarrhea"; MALAISE (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Feeling unwell"; DECREASED APPETITE (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "I had decrease of appetite"; DIZZINESS (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Light-headed"; FATIGUE (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Consumer stated, "I am calling regarding the vaccination of Pfizer, I had it on Friday and apparently I had told the nurse that I just came off COVID. I had COVID-19 back in 27Nov2022 and I was diagnosed clear on 05Dec2022, and she said you could take the vaccine (Pfizer COVID-19 vaccine), So I did it (event captured conservatively), but I have some side-effects. My side-effects were tiredness, feeling unwell, body ache, lightheaded, I had decrease of appetite and diarrhea from Friday to Saturday and I never had any side-effects from any other vaccines of Pfizer (further clarification unknown). This is number 5, the vaccine number 5 that I got, and I have a question. Can you still get vaccinated even though you have just gone through COVID-19, 5 days later?". Further probing could not be done as the consumer hung up the call abruptly. Hence limited information was available over the call.  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-202201369444 same patient/drug, different AE/dose;
Age: 61.0
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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 at 10:00 as dose 1, single (Lot number: ER8730) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Apr2022 at 10:00 as dose 3 (booster), single (Lot number: 939904), in left arm and on 16Sep2022 at 12:00 as dose 4 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "known allergies: Sulfur based drugs" (unspecified if ongoing), notes: known allergies: Sulfur based drugs. 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 "Treatment of COVID-19". 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.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID:   A 33-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: CHILLS (non-serious), outcome "unknown".  Additional information: It was reported the "He got the 1st 2 like a few months after they became available to the general public beyond the front-line workers and he was fine after those, he had the usually expected like chills. The last one he got a few months ago like 3 months ago for the booster". No Prior Vaccinations (within 4 weeks). No Family Medical History Relevant to Adverse Events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202201368953 same patient/drug, different AE/ dose; PFIZER INC-202201369624 same patient/drug/AE, different dose.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID:   A 33-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cold" (unspecified if ongoing), notes: Never had anything in his life other than regular cold in cold season; "droopy eyelid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "chills". The following information was reported: CHILLS (non-serious), outcome "unknown".  Additional Information: It was reported that does not know dates of vaccines. He got the first two like a few months after they became available to the general public beyond the front line workers and he was fine after those, he had the usually expected like chills. Patient was ocular he has a droopy eyelid and usually within 2-3 years will progress generalized to other muscles. She thinks it was his left eye and started like 5 weeks ago.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202201369613 same patient/drug/AE, different dose; PFIZER INC-202201368953 same patient/drug,different AE/ dose;
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 at 12:30 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 79 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 06Dec2022, outcome "recovering", described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhea.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: 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) from product quality group. The reporter is the patient.  A female patient in her 50's (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Nov2022 at 12:00 as dose number unknown (booster), single (Lot number: GH9703) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Dec2021 as dose number unknown, single (Lot number: 320308D), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure (HBP)" (unspecified if ongoing), notes: Controlled HBP (High blood pressure) with Lisinopril 10mg. Concomitant medication(s) included: MUCINEX DM, start date: 01Dec2022, stop date: 13Dec2022; LISINOPRIL taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.