chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient 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 Apr2021, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: anti viral details included COVID 19 Treatment from 15Apr2021. No known allergies.  The information on the batch/lot number for BNT162b2 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 and the suspect drug cannot be completely excluded.
Age: 86.0
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) (Physician).  An 87-year-old male patient received BNT162b2 (BNT162B2 NOS), on 01Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 86 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATENOLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in two weeks. On 20Jan2023 he took Paxlivid treatment for Covid-19. The patient had no known allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE  & COVID-19 and The suspected drug cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. 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: Negative, notes: Tested positive with symptoms 3 days after negative test; Positive, notes: Tested positive with symptoms 3 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not received other medications in two weeks. Patient had tested positive with symptoms 3 days after negative test. Patient had not known allergies. Patient was administered Paxlovid for ae treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 64 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Lot number: FM), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "2 MIs" (unspecified if ongoing), notes: Other medical history: 2 MIs; "Lymphoma" (unspecified if ongoing). Patient had no known allergies. 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 "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: COVID 19 Treatment; (19Jan2023) Negative, notes: 2 negative tests on days 9 and 10; (20Jan2023) Negative, notes: negative tests on days 9 and 10; (22Jan2023) Positive, notes: Symptoms and positive test Day 12; (27Jan2023) Positive, notes: Still positive on Day 6 of rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 11Jan2023 to 16Jan2023, started on day 0).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GH7694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 16Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 31Aug2021 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crontic obesity  " (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Afib" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). 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". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 27Jan2023 to 28Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, 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 48-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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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. Clinical course: Known allergies and other medical history were none. No other medication in 2 weeks. Paxloid started on 16Jan2023 and stopped on 20Jan2023 for treatment of COVID-19 The information on the batch/lot number for [BNT162B2 NOS], has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction, Overdose, Product administered to patient of inappropriate age
Clinical narrative: he has had quite a reaction to it which he did not have to the Moderna shot; He is only 4 years 10 months old but I think they may have provided him the Bivalent booster; overdose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 4-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Jan2023 as dose number unknown (orange cap; booster), single (Lot number: GK1657) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete but manufacturer unknown), for COVID-19 Immunization.  The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 28Jan2023, outcome "unknown", described as "He is only 4 years 10 months old but I think they may have provided him the Bivalent booster"; OVERDOSE (non-serious) with onset 28Jan2023, outcome "unknown"; IMMUNISATION REACTION (non-serious), outcome "unknown", described as "he has had quite a reaction to it which he did not have to the Moderna shot".  Additional Information: Reporter stated, "I need to check with you what type of vaccine my son got yesterday at a (facility name withheld). He is only 4 years 10 months old but I think they may have provided him the Bivalent booster and so, I have the LOT# and I am hoping you can check that for me to tell me what kind of shot he did receive and then if in fact it was done incorrectly, then I want to not that for your record.". Reporter stated, "I am sorry, so you can't look that up in your line because if in fact he was given the wrong, then it would be a vaccine safety issue because he has had quite a reaction to it which he did not have to the Moderna shot (COVID-19 Vaccine). So I followed the information in the PDF that I found online to call you. So I just wanted to confirm that I am not going to talk to them and then they are going to make me call you guys tomorrow." So again, on a recorded line I am telling you that I am only filing a safety report if I know what was injected into my son and you are telling me that you are not able to look up for the information which I fully understand. You only have what is available on the screen in front of you. So I will now make another call to Pfizer tomorrow morning and get that information  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. 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 (Lot number: GH9694) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 06Feb2021 as dose 2, single (Lot number: EM9809), in left arm and on 24Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jan2023) Negative, notes: I tested negative on 23Jan2023 and 24Jan2023; (24Jan2023) Negative, notes: I tested negative on 23Jan2023 and 24Jan2023; (29Jan2023) Positive, notes: I tested positive today, 29Jan2023. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Patient tested negative on 23Jan2023 and 24Jan2023. Patient tested positive today, 29Jan2023. Patient noticed that she sounded more nasal as the week went on but didn't think much of it.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 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. Concomitant medication(s) included: ROSUVASTATIN CALCIUM, start date: 01Jan2000. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", 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.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 57.0
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 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 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), 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: "High BP" (unspecified if ongoing); "High Cholesterol" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 17Jan2023 to 22Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 4 (booster), single (Lot number: GJ6739), 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), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid for COVID 19 treatment from 13Jan2023 to 17Jan2023. Patient had no known allergies.
Age: 77.0
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 reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. 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: negative, notes: After 5 days with Paxlovid; positive, notes: 5 days after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID 19 Treatment with Paxlovid, start on 16Jan2023 and stop on 20Jan2023. After 5 days with Paxlovid the rapid test came negative but became positive again 5 days after completing Paxlovid with very mild symptoms and no fever. No Known allergies reported. Patient did not take Other medication in two weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 32.0
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) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received COVID-19 treatment with Paxlovid, started on 18Jan2023 and stopped on 23Jan2023. Patient completed the paxlovid and 3 days later on 26Jan2023, he experienced congestion, cough and fatigue.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2021 as dose 3 (booster), single (Lot number: 301308A), in right arm, on 01Jul2022 as dose 4 (booster), single (Lot number: FN2908), in right arm and on 29Nov2022 at 11:30 as dose 5 (booster), single (Lot number: GH9703 FMMJ) at the age of 58 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Dec2020 as dose 1, single (Lot number: EL0142), in right arm and on 22Jan2021 as dose 2, single (Lot number: EL3249), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN; "Thyroid disorder" (unspecified if ongoing); "Nerve Damage" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Sinus disorder" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE] taken for asthma; GABAPENTIN taken for nerve injury; MUCINEX taken for sinus disorder; PROTONIX [OMEPRAZOLE] taken for gastrooesophageal reflux disease; SYNTHROID taken for thyroid disorder. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid taken from 17Jan2023 to 22Jan2023.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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: (28Jan2023) Positive, notes: Tested positive this morning. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 17Jan2023 to 23Jan2023.
Age: 60.0
Sex: M
Vaccine: COVID19, 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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Sep2022 at 10:00 as dose 5 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies penicillin. There were no concomitant medications. Past drug history included: Known allergies: aspirin, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022 at 10:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medication in 2weeks. Other medical history: None. Anti viral details: product: COVID 19 Treatment. Brand: Paxlovid. Treatment start date: 18Jan2023 and Treatment stop date: 23Jan2023. Indication: Treatment of COVID-19.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 62-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 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: "CAD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergy: Aspirin". 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: Patient received Paxlovid as treatment for covid-19 start date was 10Jan2023 and stop date was 15Jan2023, Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion,  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Drug ineffective, Suspected COVID-19, Vision blurred
Clinical narrative: I did and guess what I got Covid; I did and guess what I got Covid; vison's blurry; my back hurts; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I did and guess what I got Covid"; VISION BLURRED (non-serious), outcome "unknown", described as "vison's blurry"; BACK PAIN (non-serious), outcome "unknown", described as "my back hurts". Clinical course: Patient is having all these side effects, that actually are worse than covid itself.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 1 ; Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 62-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 62 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FH8027) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Lot number: 013L20A) and on 19Feb2021 as dose 2, single (Lot number: 023M20A) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "known allergies: Sulpha drugs" (unspecified if ongoing), notes: known allergies: Sulpha drugs. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Dec2021, outcome "unknown", described as "Dose Number: 1 ; Moderna"; 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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 43.0
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 44-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2 , single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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: (Jul2022) Positive, notes: then test returned to being strongly Positive with nasal congestion for further Seven days; (Jul2022) Negative, notes: Rebound of COVID symptoms eight days After initial symptoms and two days after Final PAXLOVID dose tested negative; (Jul2022) Negative, notes: Rebound of COVID symptoms eight days After initial symptoms and two days after Final PAXLOVID dose tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2weeks: No. Known allergies: No. Other medical history: None  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: ischemic stroke; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: BENAZEPRIL; AMLODIPINE; ATENOLOL; ATORVASTATIN. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ISCHAEMIC STROKE (hospitalization, medically significant) with onset 28Dec2022, outcome "unknown", described as "ischemic stroke". The patient was hospitalized for ischaemic stroke (hospitalization duration: 2 day(s)). Therapeutic measures were taken as a result of ischaemic stroke.  Clinical course: Patient did not received other vaccine in four weeks. On 28Dec2022, the patient sufferred an ischemic stroke of unknown origin. A provider suggested vaccine as a potential cause. To date no other cause has been identified. My relatively young age was perplexing those involved in my care. Patient had no COVID prior vaccination. Patient did not test COVID post vaccination. Patient had no known allergies.    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: As there is limited information in the case provided, the causal association between the reported event ischemic stroke with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, FLU4
Symptoms: Haemorrhagic stroke, Paralysis, Speech disorder, Wrong product administered
Clinical narrative: occupational, physical and speech; No use to left arm, leg; right basal ganglia cerebrovascular-stroke; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 12:15 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMORRHAGIC STROKE (hospitalization, disability, medically significant) with onset 25Oct2022 at 15:45, outcome "not recovered", described as "right basal ganglia cerebrovascular-stroke"; SPEECH DISORDER (hospitalization, disability, medically significant), outcome "not recovered", described as "occupational, physical and speech"; PARALYSIS (hospitalization, disability, medically significant), outcome "not recovered", described as "No use to left arm, leg"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Wrong vaccine administered". The patient was hospitalized for haemorrhagic stroke, speech disorder, paralysis (hospitalization duration: 22 day(s)). The events "right basal ganglia cerebrovascular-stroke", "occupational, physical and speech" and "no use to left arm, leg" required emergency room visit. Therapeutic measures were taken as a result of haemorrhagic stroke, speech disorder, paralysis.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, FLU4
Symptoms: Aphasia, Blood test, Cerebrovascular accident, Computerised tomogram, Dysphagia
Clinical narrative: occupational, physical and speech; No use to left arm, leg; right basal ganglia cerebrovascular-stroke; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 12:15 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMORRHAGIC STROKE (hospitalization, disability, medically significant) with onset 25Oct2022 at 15:45, outcome "not recovered", described as "right basal ganglia cerebrovascular-stroke"; SPEECH DISORDER (hospitalization, disability, medically significant), outcome "not recovered", described as "occupational, physical and speech"; PARALYSIS (hospitalization, disability, medically significant), outcome "not recovered", described as "No use to left arm, leg"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Wrong vaccine administered". The patient was hospitalized for haemorrhagic stroke, speech disorder, paralysis (hospitalization duration: 22 day(s)). The events "right basal ganglia cerebrovascular-stroke", "occupational, physical and speech" and "no use to left arm, leg" required emergency room visit. Therapeutic measures were taken as a result of haemorrhagic stroke, speech disorder, paralysis.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, FLU4
Symptoms: Economic problem, Laboratory test, Loss of personal independence in daily activities, Magnetic resonance imaging, Musculoskeletal disorder
Clinical narrative: occupational, physical and speech; No use to left arm, leg; right basal ganglia cerebrovascular-stroke; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 12:15 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMORRHAGIC STROKE (hospitalization, disability, medically significant) with onset 25Oct2022 at 15:45, outcome "not recovered", described as "right basal ganglia cerebrovascular-stroke"; SPEECH DISORDER (hospitalization, disability, medically significant), outcome "not recovered", described as "occupational, physical and speech"; PARALYSIS (hospitalization, disability, medically significant), outcome "not recovered", described as "No use to left arm, leg"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Wrong vaccine administered". The patient was hospitalized for haemorrhagic stroke, speech disorder, paralysis (hospitalization duration: 22 day(s)). The events "right basal ganglia cerebrovascular-stroke", "occupational, physical and speech" and "no use to left arm, leg" required emergency room visit. Therapeutic measures were taken as a result of haemorrhagic stroke, speech disorder, paralysis.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Interchange of vaccine products
Clinical narrative: she finished the Moderna primary series over a year ago.; she had a fast heartbeat after receiving the Pfizer COVID-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine moderna (Primary Immunization series complete), for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "she finished the Moderna primary series over a year ago."; HEART RATE INCREASED (non-serious), outcome "unknown", described as "she had a fast heartbeat after receiving the Pfizer COVID-19 Vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient who got the booster was asking if it was okay to take dreps/drops as well. She stated she finished the Moderna primary series over a year ago. She then mentioned that she had a fast heartbeat after receiving the Pfizer COVID-19 Vaccine. She stated "it wakes me up at 7 o clock in the morning".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cardiac flutter, Dehydration, Palpitations, Stress
Clinical narrative: fluttering issues; heart racing; attributed by the cardiologist to stress, anxiety and dehydration; attributed by the cardiologist to stress, anxiety and dehydration; attributed by the cardiologist to stress, anxiety and dehydration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FK9729) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FLUTTER (medically significant), outcome "unknown", described as "fluttering issues"; PALPITATIONS (non-serious), outcome "unknown", described as "heart racing"; STRESS (non-serious), ANXIETY (non-serious), DEHYDRATION (non-serious), outcome "unknown" and all described as "attributed by the cardiologist to stress, anxiety and dehydration".  Clinical course: The reporter stated her 19-year-old daughter got the Pfizer BioNTech COVID-19 vaccine in May2021 and had some heart racing and fluttering issues that were not immediate after the administration of the vaccine. These symptoms, that happened when the reporter's daughter was 17-year-old, were attributed by the cardiologist to stress, anxiety and dehydration however, reporter stated that upon checking the VAERS reports, the lot numbers that her daughter was administered (EW0170 and FK9729) counted more than 3000 reports of side effects while her mother-in-law three lot numbers had only 124 reports. She now had learned to manage the anxiety a lot better, she was drinking the water she should, and she was still having these problems. Caller also stated, "Your fact sheet should be more factual."; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300046062 same patient/vaccine/event, different doses;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: we all get infected with a severe symptoms; we all get infected with a severe symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "we all get infected with a severe symptoms".  Clinical information: For the second winter after got the vaccine patient got infected with a severe symptoms. Reporter reported "If you care about your business (let alone your families if you have any ) then you may not neglect my message. I'm sure it is not a unique one."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. 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 20Oct2022 at 16:45 as dose 5 (booster), single (Lot number: GH90702) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: BISOPROLOL [BISOPROLOL FUMARATE], start date: Jan1994; CALCIUM CITRATE WITH VITAMIN D3, start date: Jan1989; CHLORTHALIDONE, start date: Jan2004; ESTRADIOL [ESTRADIOL BENZOATE] vaginal, start date: Jan2004; LEVOTHYROXINE [LEVOTHYROXINE SODIUM], start date: Jan1994; LISINOPRIL [LISINOPRIL DIHYDRATE], start date: Jan2004; MULTIVITAMIN [VITAMINS NOS]; OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]; VITAMIN B [VITAMIN B NOS], start date: Jan1989; VITAMIN C [CALCIUM ASCORBATE], start date: Jan1989. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; treatment with Paxlovid.
Age: 39.0
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) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Nov2022 at 12:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 2, single) and second regimen (Batch/Lot number: unknown) at single (dose 1, single) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PORTIA-28 oral taken for contraception, start date: 01Dec2022, stop date: 30Jan2023. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine.  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 information: At home test rapid test for COVID was positive on 06Jan2023. Took Paxlovid from 06Jan2023-11Jan2023. Tested negative on 14Jan2023 and 15Jan2023 (at home rapid test).   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.