chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Interchange of vaccine products
Clinical narrative: He previously received all the Moderna vaccines, but the last booster was the Pfizer COVID-19 vaccine; Despite receiving all the vaccines against COVID he got COVID about three weeks ago.; Despite receiving all the vaccines against COVID he got COVID about three weeks ago.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "He previously received all the Moderna vaccines, but the last booster was the Pfizer COVID-19 vaccine"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Despite receiving all the vaccines against COVID he got COVID about three weeks ago.".  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) : PFIZER INC-202300015950 same product, patient, different events;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: He previously received all the Moderna vaccines, but the last booster was the Pfizer COVID-19 vaccine; Despite receiving all the vaccines against COVID he got COVID about three weeks ago.; Despite receiving all the vaccines against COVID he got COVID about three weeks ago.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "He previously received all the Moderna vaccines, but the last booster was the Pfizer COVID-19 vaccine"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Despite receiving all the vaccines against COVID he got COVID about three weeks ago.".  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) : PFIZER INC-202300015950 same product, patient, different events;
Sex: F
Vaccine: UNK
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) (Other HCP).  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), 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. Clinical course: Paxlovid was given from 31Dec2022 to 04Jan2023. It was unknown if patient received any other medications within 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19 with the suspect can not be ruled out completely.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use
Clinical narrative: Her son was given the bivalent booster although his primary series was Moderna and it was not recommended; Her son was given the bivalent booster although his primary series was Moderna and it was not recommended; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the parent.  A 3-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 as dose 3 (maroon cap), single (Lot number: GK1667) at the age of 3 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY taken for seasonal allergy. Vaccination history included: Moderna coviD-19 vaccine (Dose 1, single), administration date: 01Jul2022, when the patient was 3-year-old, for COVID-19 immunization; Moderna coviD-19 vaccine (Dose 2, single), administration date: 23Aug2022, when the patient was 3-year-old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 06Jan2023, outcome "unknown" and all described as "Her son was given the bivalent booster although his primary series was Moderna, and it was not recommended".  Additional information: It was reported that the mother of the patient did the Inquiry that her son was given the bivalent booster although his primary series was Moderna, and it was not recommended, and she wanted to get information about it. Reporter mentioned she knows this was not recommended and that this was a mistake, and she was concerned about the safety. Reporter asked if there was anything she needs to look out for as far a safety, also mentioned that the dose was administered on 06Jan2023. The primary series with Moderna's vaccine were administered on 01Jul2022 and 23Aug2022. Reporter was uncertain about the formulation of the vaccine her son received. Th vaccine was given to the patient in left arm. Specific Relevant Test: For Thromboembolic events with Thrombocytopenia: N/A. Emergency room: No, Physician's office: No.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Apr2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 09Sep2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovered" (07Jan2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Negative; (28Dec2022) Positive; (07Jan2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient did not received other medication in 2 weeks of vaccination. Anti-viral details included Product: COVID 19 treatment, brand: Pfizer, started on 21Dec2022 to 25Dec2022. The patient tested negative on 26Dec2022 (day after Paxlovid treatment ended). Tested positive on 28Dec2022. Finally tested negative on 07Jan2023. Device timestamp 12Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
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) (Other HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 69 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL8982), in right arm, on 01Mar2021 as dose 2, single (Lot number: EN6202), in right arm and on 27Sep2021 as dose 3 (booster), single (Lot number: 301458A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (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 Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "VACCINATION FAILURE " and "COVID-19 ".
Age: 54.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Apr2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 28Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication in 2 weeks. Patient took COVID 19 Treatment of Paxlovid from 30Dec2022 to 05Jan2023. No known allergies. Device timestamp: 12Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 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: "Heart murmur" (unspecified if ongoing); "latex allergy" (unspecified if ongoing), notes: Known allergies: latex. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not pregnant at the time of vaccination. Other medication in 2 weeks was reported as yes. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 29Dec2022 and stopped on 02Jan2023, Indication: Treatment of 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.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events Drug Ineffective, COVID-19 and the suspect drug cannot be completely excluded.
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) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: Er87376031), in right arm, on 23Apr2021 as dose 2, single (Lot number: H2ew0171), in right arm and on 04Jan2022 at 10:45 as dose 3 (booster), single (Lot number: 33036BD) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Known allergies: Flaxseed" (unspecified if ongoing), notes: Known allergies: Flaxseed. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" 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. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was not pregnant at the time of vaccination. No other medications reported in 2 weeks. It was reported that, about 4 days after finished Paxlovid, the patient got feverish again and got all COVID symptoms again and was even sicker the second time. Therapeutic measures included Anti-viral details, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 12Nov2022 and stopped on 17Nov2022, Indication: Treatment of COVID-19.
Age: 65.0
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) (Physician). 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 14Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years 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: "Cancer" (unspecified if ongoing); "antiphospholipid syndrome" (unspecified if ongoing); "Allergic Rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lipitor, reaction(s): "Known allergies: Lipitor", notes: Known allergies: Lipitor. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported other medication in 2weeks reported as yes; the Paxlovid treatment start date: 03Jan2023 and stop date: 08Jan2023. Adverse event: Recurrent symptoms of Covid especially cough, post nasal drip, Rhinorrhea, and myalgias.   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: 78.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Lot number: J6739) at the age of 78 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6205), in left arm, on 19Aug2021 as dose 3 (booster), single (Lot number: FC3183), in left arm and on 25Jan2022 as dose 4 (booster), single (Lot number: FJ5682), in left arm for covid-19 immunisation. The patient's relevant medical history included: "autoimmune hepatitis" (unspecified if ongoing); "mastectomy" (unspecified if ongoing), notes: mastectomy 1986. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. From 27Dec2022 to 31Dec2022, the patient received Paxlovid as treatment of COVID-19.
Age: 62.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 5 (booster), single (Lot number: Gj6796) 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 had no relevant medical history. There were no concomitant medications. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered with sequelae" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (27Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Covid-19 treatment with Paxlovid from 21Dec2022 to 26Dec2022. It was reported that the patient recovered with lasting effects.
Age: 59.0
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) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 at 13:00 as dose 1, single (Lot number: EN6700), in left arm, on 25Mar2021 at 13:00 as dose 2, single (Lot number: ER8733), in left arm, on 06Oct2021 at 09:00 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 25Apr2022 at 08:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "History of Ovarian Cancer" (unspecified if ongoing); "Lichen Sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Known Allergy: Doxycycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Sep2022, outcome "recovered" (11Sep2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Sep2022) Positive; (11Sep2022) Negative, notes: Tested negative on Sunday 11Sep. Therapeutic measures were taken as a result of vaccination failure, covid-19 from 06Sep2022 to 10Sep2022. Clinical course: Patient began taking the Paxlovid as soon as she was Covid positive on 06Sep2022 through Saturday 10Sep2022. Tested negative on Sunday 11Sep2022.
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; 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 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Mar2021 as dose 1, single (Lot number: 032M20A), in right arm, on 05Apr2021 as dose 2, single (Lot number: 019B21A), in right arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 011F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "bronchitis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX SINUS [OXYMETAZOLINE HYDROCHLORIDE]; NIGHTTIME COLD & FLU RELIEF. Past drug history included: Clindamycin, reaction(s): "Allergy"; Gantrisin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (08Jan2023) Negative, notes: Tested negative 08Jan2023; (10Jan2023) Positive, notes: Runny nose, sneezing, cough , congestion tarted again 10Jan2023; (11Jan2023) Positive, notes: Tested positive for Covid 11Jan2023. Therapeutic measures were taken as a result of vaccination failure, covid-19, which includes Paxlovid (lot: GF9573) from 31Dec2022 to 04Jan2023.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GF400) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 4, Batch/Lot No: FK9893, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 27Apr2022, when the patient was 70-year-old, for COVID-19 Immunization; Covid-19 vaccine (Dose number :3, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number :2, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number :1, Unknown manufacturer), for COVID-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Sep2022, outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient had no known allergies. Patient did not receive other medication in 2 weeks. Sender's Comments: Linked Report(s) : PFIZER INC-202300018678 Same patient, different vaccine dose/event.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GF400) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 4, Batch/Lot No: FK9893, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 27Apr2022, when the patient was 70-year-old, for COVID-19 Immunization; Covid-19 vaccine (Dose number :3, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number :2, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number :1, Unknown manufacturer), for COVID-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Sep2022, outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient had no known allergies. Patient did not receive other medication in 2 weeks. Sender's Comments: Linked Report(s) : PFIZER INC-202300018678 Same patient, different vaccine dose/event.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
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 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GF400) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FK9893), 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 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 Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course details: Patient received treatment with Paxlovid on 03Jan2023 and stopped on 08Jan2023. Lot number was GF4000. The patient had no other medical history and no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300018274 Same patient, different vaccine dose/event.;
Age: 70.0
Sex: F
Vaccine: COVID19, 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 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GF400) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FK9893), 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 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 Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course details: Patient received treatment with Paxlovid on 03Jan2023 and stopped on 08Jan2023. Lot number was GF4000. The patient had no other medical history and no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300018274 Same patient, different vaccine dose/event.;
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), administration date: 2020, for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "shingles".  Additional information: Caller clarifies she has had both Covid 19 vaccine primary doses in 2020 and one booster in 2021. In 2022 she did not get her second booster. She had shingles that year and different stuff going on so she did not get the second booster. This year, she went to get the second booster at (Facility name) and they were no longer giving it. They have moved on to the latest shot Pfizer has out. Wanted to know if she could skip the second booster or does she need to get it?   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received
Sex: F
Vaccine: COVID19-2
Symptoms: Arterial disorder, Cardiac disorder
Clinical narrative: Heart disease; Different arterial diseases; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 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; Bnt162b2 (Dose 2, Single), for COVID-19 immunization; Bnt162b2 (Dose 3 (Booster), Single), for COVID-19 immunization; Bnt162b2 (Dose 4 (Booster), Single), for COVID-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart disease"; ARTERIAL DISORDER (non-serious), outcome "unknown", described as "Different arterial diseases".  Additional Information: The reporter reported she had four previous Pfizer COVID-19 vaccines and had her first bivalent booster dose was administered Sep2022. The reporter said she has different health conditions, including heart disease, and wanted to make sure she was up to date on her vaccines. She had a lot of health problems and different arterial diseases. She wanted to know when she can get the next shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cerebrovascular accident, Periarthritis, SARS-CoV-2 test
Clinical narrative: Stroke in 2022; Frozen shoulder; Shoulder pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 at 08:00 as dose 3 (booster), single (Lot number: Ewa53721) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Ew0171821, Location of injection: Arm Left), administration date: 13May2021, when the patient was 45-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: 3302680, Location of injection: Arm Left), administration date: 13Apr2021, when the patient was 45-year-old, for COVID-19 Immunization. The following information was reported: PERIARTHRITIS (disability) with onset 01Dec2021, outcome "not recovered", described as "Frozen shoulder"; ARTHRALGIA (disability) with onset 01Dec2021, outcome "not recovered", described as "Shoulder pain"; CEREBROVASCULAR ACCIDENT (disability, medically significant) with onset 01Dec2021, outcome "not recovered", described as "Stroke in 2022". The events "stroke in 2022", "frozen shoulder" and "shoulder pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident, periarthritis, arthralgia.  Clinical course: Patient has no Known allergies.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Stroke in 2022; Frozen shoulder; Shoulder pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 at 08:00 as dose 3 (booster), single (Lot number: Ewa53721) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Ew0171821, Location of injection: Arm Left), administration date: 13May2021, when the patient was 45-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: 3302680, Location of injection: Arm Left), administration date: 13Apr2021, when the patient was 45-year-old, for COVID-19 Immunization. The following information was reported: PERIARTHRITIS (disability) with onset 01Dec2021, outcome "not recovered", described as "Frozen shoulder"; ARTHRALGIA (disability) with onset 01Dec2021, outcome "not recovered", described as "Shoulder pain"; CEREBROVASCULAR ACCIDENT (disability, medically significant) with onset 01Dec2021, outcome "not recovered", described as "Stroke in 2022". The events "stroke in 2022", "frozen shoulder" and "shoulder pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident, periarthritis, arthralgia.  Clinical course: Patient has no Known allergies.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cerebrovascular accident, Periarthritis, SARS-CoV-2 test
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: 3302680), in left arm, on 13May2021 as dose 2, single (Lot number: Ew0171821), in left arm and on 11Nov2021 at 08:00 as dose 3 (booster), single (Lot number: Ewa53721) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications in two weeks. The patient did not receive any other vaccine in four weeks. No Covid prior to vaccination. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Aug2022, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Positive, notes: covid test type post vaccination = Nasal Swab; covid test name post vaccination = Binex.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: 3302680), in left arm, on 13May2021 as dose 2, single (Lot number: Ew0171821), in left arm and on 11Nov2021 at 08:00 as dose 3 (booster), single (Lot number: Ewa53721) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications in two weeks. The patient did not receive any other vaccine in four weeks. No Covid prior to vaccination. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Aug2022, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Positive, notes: covid test type post vaccination = Nasal Swab; covid test name post vaccination = Binex.
Age: 54.0
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 contactable reporters (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 at 12:00 as dose 1, single (Lot number: EN6198), in left arm, on 29Jun2021 at 13:00 as dose 2, single (Lot number: ER8732), in left arm and on 10Jan2022 at 10:00 as dose 3 (booster), single (Lot number: FL3198) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 23Dec2019 (unspecified if ongoing), notes: Considered himself a long hauler. On 23Dec2019, positive for COVID-19 was admitted. The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "known allergies: Compazine", notes: known allergies: Compazine; Zofran, reaction(s): "known allergies: Zofran", notes: known allergies: Zofran. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2019) Positive. Therapeutic measures were taken as a result of drug ineffective and covid-19 with the treatment of Paxlovid 300 mg, 100 mg dose pack from 28Nov2022 to 03Dec2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300018632 Same reporter, patient; different vaccine dose and events;US-PFIZER INC-202300018630 Same reporter, patient; different vaccine dose and events;
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporters (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 at 12:00 as dose 1, single (Lot number: EN6198), in left arm, on 29Jun2021 at 13:00 as dose 2, single (Lot number: ER8732), in left arm and on 10Jan2022 at 10:00 as dose 3 (booster), single (Lot number: FL3198) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 23Dec2019 (unspecified if ongoing), notes: Considered himself a long hauler. On 23Dec2019, positive for COVID-19 was admitted. The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "known allergies: Compazine", notes: known allergies: Compazine; Zofran, reaction(s): "known allergies: Zofran", notes: known allergies: Zofran. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2019) Positive. Therapeutic measures were taken as a result of drug ineffective and covid-19 with the treatment of Paxlovid 300 mg, 100 mg dose pack from 28Nov2022 to 03Dec2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300018632 Same reporter, patient; different vaccine dose and events;US-PFIZER INC-202300018630 Same reporter, patient; different vaccine dose and events;
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Shortness of breath; Headaches; Pressure on my chest; Foggy brain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 10Jan2022 at 10:00 as dose 3 (booster), single (Lot number: FL 3198) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Allergy"; Zofran, reaction(s): "Allergy". Vaccination history included: BNT162b2 (Dose:01, vaccine administration time=12:00 AM, vaccine lot number=EN 6198, vaccine location=Left arm), administration date: 08Mar2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (Dose:02, vaccine administration time=01:00 PM, vaccine lot number=ER 8732, vaccine location=Left arm), administration date: 29Jun2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "Dose 1 vaccine administration date=08Mar2021/Dose 2 vaccine administration date=29Jun2021". The following information was reported: FEELING ABNORMAL (non-serious) with onset 11Jan2022, outcome "unknown", described as "Foggy brain"; HEADACHE (non-serious) with onset 11Jan2022, outcome "unknown", described as "Headaches"; CHEST DISCOMFORT (non-serious) with onset 11Jan2022, outcome "unknown", described as "Pressure on my chest"; DYSPNOEA (non-serious) with onset 11Jan2022, outcome "unknown", described as "Shortness of breath". Additional information: It was reported that one day After booster injection, patient had symptoms of shortness of breath, headaches, pressure on his chest and foggy brain.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300018632 Same patient, different vaccine dose/event.;US-PFIZER INC-202300018343 Same patient/different drug/events;
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: Shortness of breath; Headaches; Pressure on my chest; Foggy brain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 10Jan2022 at 10:00 as dose 3 (booster), single (Lot number: FL 3198) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Allergy"; Zofran, reaction(s): "Allergy". Vaccination history included: BNT162b2 (Dose:01, vaccine administration time=12:00 AM, vaccine lot number=EN 6198, vaccine location=Left arm), administration date: 08Mar2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (Dose:02, vaccine administration time=01:00 PM, vaccine lot number=ER 8732, vaccine location=Left arm), administration date: 29Jun2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "Dose 1 vaccine administration date=08Mar2021/Dose 2 vaccine administration date=29Jun2021". The following information was reported: FEELING ABNORMAL (non-serious) with onset 11Jan2022, outcome "unknown", described as "Foggy brain"; HEADACHE (non-serious) with onset 11Jan2022, outcome "unknown", described as "Headaches"; CHEST DISCOMFORT (non-serious) with onset 11Jan2022, outcome "unknown", described as "Pressure on my chest"; DYSPNOEA (non-serious) with onset 11Jan2022, outcome "unknown", described as "Shortness of breath". Additional information: It was reported that one day After booster injection, patient had symptoms of shortness of breath, headaches, pressure on his chest and foggy brain.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300018632 Same patient, different vaccine dose/event.;US-PFIZER INC-202300018343 Same patient/different drug/events;
Age: 26.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 26 years 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: "Chronic sinusitis" (unspecified if ongoing); "Non-CF bronchiectasis" (unspecified if ongoing), notes: Non-CF bronchiectasis. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2023) Positive; (08Jan2023) Negative; (09Jan2023) Negative; (13Jan2023) Positive, notes: Tested positive immediately, woke up on 13Jan. Therapeutic measures were taken as a result of drug ineffective, covid-19. clinical course: Paxlovid given as covid19 treatment .Tested positive 03Jan on PCR Tested negative on rapids: 08Jan and 09Jan. No symptoms after completion of Paxlovid. However on 11Jan2023, started to have nasal discomfort and pressure. Thought it may be a sinus infection but I hadn't completed my 10-day quarantine. On 12Jan2023, sinus pressure increased until I lost my sense of smell for a few hours. Tested positive immediately, woke up on 13Jan with fatigue and chills once again.