chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
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). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years 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. 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: (unspecified date) Unknown Result; (14Jun2022) Positive, notes: 4-5 days after completing the treatment the symptoms reoccurred and I tested positive again. 7 AM. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2weeks. product COVID 19 Treatment, brand was Pfizer, treatment started on 04Jun2022, treatment stopped on 09Jun2022. No known allergies. 4-5 days after completing the treatment the symptoms reoccurred and I tested positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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) all with onset 13Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (04Jun2022) Negative, notes: Resolution of symptoms at day 5, RAT negative; (13Jun2022) Positive, notes: recrudescence of symptoms more severe than initial symptoms at day 14, RAT positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive other medication in 2 weeks. The patient was treated with Paxlovid, treatment start date: 31May2022 and treatment stop date: 04Jun2022. for COVID-19. The patient had no known allergies. Paxlovid Rebound. Resolution of symptoms at day 5, RAT negative, recrudescence of symptoms more severe than initial symptoms at day 14, RAT positive.  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, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Drug ineffective and COVID-19 cannot be completely excluded.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "ASD" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; BUPROPION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid, lot number: GA1529 given on 13Jun2022 for the treatment of COVID-19.  Clinical course: No known allergies. Within 2 days patient already 95 percentage improved. Only side effect was extremely bad taste in patient's mouth after taking Paxlovid.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had rebound of covid symptoms and re-tested positive; had rebound of covid symptoms and re-tested positive; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 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. No known allergy noted. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "had rebound of covid symptoms and re-tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: re-tested positive (after testing negative; Negative, notes: re-tested positive (after testing negative; Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral treatment drug Paxlovid, starting from 10May2022 till 14May2022. Clinical course: Patient had rebound of covid symptoms and re-tested positive (after testing negative and being asymptomatic at the completion of his paxlovid 5 day course).  The information on the batch/lot number for BNT162b2 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 events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Caller stated that she knows 2 patients who have died and 2 patients who had stroke.; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Caller stated that she knows 2 patients who have died and 2 patients who had stroke.". The following death information was reported, despite no fatal outcome. It was not reported if an autopsy was performed.  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 current available limited information in the case provided, the causal association between the event cerebrovascular accident and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: 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) (Nurse).  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 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: "SLE" (unspecified if ongoing), notes: SLE , endometriosis, migraine HA; "endometriosis" (unspecified if ongoing); "migraine HA" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022, outcome "recovered" (15Jun2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took Oral Anti viral as Paxlovid for Covid-19 Treatment. The treatment started on 28May2022 and stop on 01Jun2022.  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, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Drug ineffective and COVID-19 cannot be completely excluded.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Eye swelling, Pruritus, SARS-CoV-2 test
Clinical narrative: right eye swelled up; Itchy all over; could not breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old patient received BNT162b2 (BNT162B2), on 23Sep2021 as dose 2, single (Lot number: FC3184) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FC3184; Anatomical location: Arm Right), administration date: 31Aug2021, when the patient was 49-year-old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 23Sep2021 at 01:45, outcome "recovered with sequelae", described as "Itchy all over"; DYSPNOEA (non-serious) with onset 23Sep2021 at 01:45, outcome "recovered with sequelae", described as "could not breathe"; EYE SWELLING (non-serious) with onset 23Sep2021 at 01:45, outcome "recovered with sequelae", described as "right eye swelled up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of eye swelling, pruritus, dyspnoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not  received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The report was not serious.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersensitivity
Clinical narrative: He would like to report that he has been sweating profusely; he had side effects like allergic reactions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 08May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (UNKNOWN MANUFACTURER, DOSE NUMBER 3), for COVID-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (UNKNOWN MANUFACTURER, DOSE NUMBER 2), for COVID-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (UNKNOWN MANUFACTURER, DOSE NUMBER 1), for COVID-19 Immunization, reaction(s): "Covid-19". The following information was reported: HYPERHIDROSIS (non-serious) with onset May2022, outcome "unknown", described as "He would like to report that he has been sweating profusely"; HYPERSENSITIVITY (non-serious) with onset May2022, outcome "unknown", described as "he had side effects like allergic reactions".  Additional information: Patient would like to report that he had been sweating profusely since then like he had heat exhaustion. Caller references a gang several times and stated he might have caught something from them because they had broken in to his complex several times and are circling his street continuously. He was asking if the sweating/heat exhaustion was from the vaccine. He had side effects like allergic reactions.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: with the 1st shot she didn't feel great; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Levothyroxine, notes: 75mcg once a day; Bupropion hydrochloride, notes: 300mg once a day; Clonazepam, notes: 1mg once a day. The following information was reported: FEELING ABNORMAL (non-serious) with onset 12Jun2022, outcome "not recovered", described as "with the 1st shot she didn't feel great". Additional information- She noticed the horrible taste in her mouth pretty quickly, she started the Paxlovid Friday and noticed the taste Saturday, she did not recall what time of day. States she was counting the days until she was off the stuff. Started Paxlovid afternoon dose on Friday 10Jun2022. States the box calls them tablets but she would say they were capsules. It was reported that, she also lost her appetite a bit and did not know if that was from not feeling well or not. She noticed that this Sunday for sure, it is persisting, got a bit worse and she did not know if it's linked to the taste in her mouth. She takes Wellbutrin, Bupropion Hydrochloride and she thought it's supposed to give a bump of energy and she has not noticed that. She was a teacher so she was medicated.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: New positive home antigen test; New positive home antigen test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: FH8020), in right arm and on 02May2022 as dose 4 (booster) , single (Lot number: FK9893) at the age of 67 years, in right 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. Concomitant medication(s) included: SERTRALINE; LAMOTRIGINE; ATORVASTATIN; BUPROPION; L-METHYLFOLATE. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "New positive home antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: New positive home antigen test. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Investigation of conclusion: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FH8020 and FK9893 were investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. RA concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  additional information: Known allergies: No, Other medication in 2weeks: Yes.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid symptoms reappeared on 14Jun2022; Covid symptoms reappeared on 14Jun2022; 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 49-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0162), in left arm and on 14Dec2021 at 15:45 as dose 3 (booster), single (Lot number: 330308D) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Covid symptoms reappeared on 14Jun2022". Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6205 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0162 was investigated, The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0162, fill lot EP8695,and the bulk formulated drug product EP8592. Manufacturing and packaging batch records were reviewed for the reported complaint lot. A complaint sample was not return ,and photographs were not received.   Conclusion of Previously Completed Investigation: The complaint for a Lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot 33030BD was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk and is manufactured, labeled and packaged by Pfizer. The final scope was determined to be lot 33030BD. No quality issues were identified during the investigation. There is no impact on product quality.  No follow up attempts are needed. No Further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Contracted covid; Contracted covid; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 51 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 15Jun2022, outcome "unknown" and all described as "Contracted covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If Covid tested post vaccination: Yes. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19, FLUX, COVID19
Symptoms: Illness, Loss of personal independence in daily activities, Malaise, Sleep deficit
Clinical narrative: She woke early and didn't feel well, she couldn't do anything; She woke early and didn't feel well, she couldn't do anything; She woke early and didn't feel well, she couldn't do anything; she was really pretty awful sick the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 02Oct2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: 31Dec2021) at the age of 64 years, in left arm for covid-19 immunisation; influenza vaccine (FLU), on 02Oct2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; LEVOTHYROXINE; BUPROPION HYDROCHLORIDE; CLONAZEPAM. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot/batch number: EP7533), administration date: 08Apr2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Lot/batch number: EP7534), administration date: 18Mar2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "with the 1st shot she didn't feel great". The following information was reported: ILLNESS (non-serious) with onset 03Oct2021, outcome "unknown", described as "she was really pretty awful sick the next day"; MALAISE (non-serious), SLEEP DEFICIT (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovered" and all described as "She woke early and didn't feel well, she couldn't do anything".  Additional information: After received the booster dose at around 6 pm in her left arm and flu shot at the same time and wouldn't recommend it. The patient was really pretty awful sick the next day. The patient felt horrible with booster dose and flu shot at the same time that might have caused it. On 03Oct2021 Sunday, the patient woke up early and did not felt well, could not do anything. The patient did not require medical attention, she knew that it was a reaction.   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, FLUX, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She woke early and didn't feel well, she couldn't do anything; She woke early and didn't feel well, she couldn't do anything; She woke early and didn't feel well, she couldn't do anything; she was really pretty awful sick the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 02Oct2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: 31Dec2021) at the age of 64 years, in left arm for covid-19 immunisation; influenza vaccine (FLU), on 02Oct2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; LEVOTHYROXINE; BUPROPION HYDROCHLORIDE; CLONAZEPAM. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot/batch number: EP7533), administration date: 08Apr2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Lot/batch number: EP7534), administration date: 18Mar2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "with the 1st shot she didn't feel great". The following information was reported: ILLNESS (non-serious) with onset 03Oct2021, outcome "unknown", described as "she was really pretty awful sick the next day"; MALAISE (non-serious), SLEEP DEFICIT (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovered" and all described as "She woke early and didn't feel well, she couldn't do anything".  Additional information: After received the booster dose at around 6 pm in her left arm and flu shot at the same time and wouldn't recommend it. The patient was really pretty awful sick the next day. The patient felt horrible with booster dose and flu shot at the same time that might have caused it. On 03Oct2021 Sunday, the patient woke up early and did not felt well, could not do anything. The patient did not require medical attention, she knew that it was a reaction.   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, FLUX, COVID19
Symptoms: Illness, Loss of personal independence in daily activities, Malaise, Sleep deficit
Clinical narrative: get Covid; get Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), on 08Apr2021 as dose 2, single (Lot number: EP7533) and on 02Oct2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: 31Dec2021) at the age of 64 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; BUPROPION HYDROCHLORIDE; LEVOTHYROXINE; CLONAZEPAM; TETANUS VACCINE; FLU, on 02Oct2021 in her left arm. Prior Vaccinations (within 4 weeks): none. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "get Covid". Therapeutic measures were taken as a result of covid-19 with Paxlovid (NDC number: 0069-1085-30 and Expiry Date: Feb2023) on 10Jun2022. Clinical Course: The patient didn't get Covid badly at all, she had vaccinations and booster and her doctor said not to bother with the 2nd booster, he doesn't seem to have great faith in them. She got booster dose around 6pm in her left arm on 02Oct2021. She got the flu shot at the same time and wouldn't recommend it, she was really pretty awful sick the next day. The patient with the 1st shot she didn't feel great, not too good for a few days. The 2nd shot was no problem. The booster on 02Oct2021 was horrible, she had the flu shot at the same time that might have caused it. States it lasted one day, Sunday. She woke early and didn't feel well, she couldn't do anything. The patient stated it did not require medical attention, she knew it was a reaction. The patient was prescribed for Paxlovid, and she doesn't know if it's from her age. she wasn't that sick, she thought it was a sinus infection was why she went in, that was how it felt like allergies and sinus infection. Stated she doesn't know what variant she had. . 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, FLUX, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: get Covid; get Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), on 08Apr2021 as dose 2, single (Lot number: EP7533) and on 02Oct2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: 31Dec2021) at the age of 64 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; BUPROPION HYDROCHLORIDE; LEVOTHYROXINE; CLONAZEPAM; TETANUS VACCINE; FLU, on 02Oct2021 in her left arm. Prior Vaccinations (within 4 weeks): none. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "get Covid". Therapeutic measures were taken as a result of covid-19 with Paxlovid (NDC number: 0069-1085-30 and Expiry Date: Feb2023) on 10Jun2022. Clinical Course: The patient didn't get Covid badly at all, she had vaccinations and booster and her doctor said not to bother with the 2nd booster, he doesn't seem to have great faith in them. She got booster dose around 6pm in her left arm on 02Oct2021. She got the flu shot at the same time and wouldn't recommend it, she was really pretty awful sick the next day. The patient with the 1st shot she didn't feel great, not too good for a few days. The 2nd shot was no problem. The booster on 02Oct2021 was horrible, she had the flu shot at the same time that might have caused it. States it lasted one day, Sunday. She woke early and didn't feel well, she couldn't do anything. The patient stated it did not require medical attention, she knew it was a reaction. The patient was prescribed for Paxlovid, and she doesn't know if it's from her age. she wasn't that sick, she thought it was a sinus infection was why she went in, that was how it felt like allergies and sinus infection. Stated she doesn't know what variant she had. . The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound of COVID after negative. test; Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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). 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Report about covid treatment. Return of symptoms and retesting positive 5 days after ending Paxlovid. Anti-viral treatment for Covid-19, start date: 03Jun2022 and stop date 08Jun2022. Device timestamp was 15Jun2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13May2022 at 17:30 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Plantains" (unspecified if ongoing), notes: known allergies: Plantains. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I had a rebound of covid 3 days after completing the meds and testing negative; Positive, notes: Symptoms started again I tested positive e again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient did not receive any other medication in 2 weeks. Anti-viral details: Product-COVID 19 Treatment, Brand-Paxlovid, Treatment start date on 01Jun2022 and treatment stop date on 06Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 24.0
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 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 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: "Anaemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: Anti-viral details: product: COVID 19 treatment, brand: Paxlovid, treatment start date: 08Jun2022,, treatment stop date: 12Jun2022,, indication: treatment of COVID-19.  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
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: I was really sick on 05Jun2022 and tested positive for covid; I was really sick on 05Jun2022 and tested positive for covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6199), in left arm and on 24Sep2021 as dose 3 (booster) , single (Lot number: FC3184) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 05Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 05Jun2022, outcome "not recovered" and all described as "I was really sick on 05Jun2022 and tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (05Jun2022) Positive, notes: I was really sick on 05Jun2022 and tested positive for covid; (15Jun2022) Positive, notes: I tested positive for covid today, 15Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was really sick on 05Jun22 and tested positive for covid. Started Paxlovid that same day from 05Jun2022  to 09Jun2022. Patient was miraculously better the next day (06Jun) and felt great for the next 8 days. Then 9 days after first testing positive for covid on 05Jun, Patient started feeling stuffy and extremely tired on 14Jun. Patient tested positive for covid today, 15Jun. Patient relapsed and not sure why.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for Covid, had 2 Pfizer vaccines; positive for Covid, had 2 Pfizer vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for Covid, had 2 Pfizer vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient has had all the vaccines but if was not known if patient had the booster shot. He also developed a headache and was coughing and took Nyquil PM. The reporter was asking about interactions Paxlovid may have with Dextromethorphan and Guaifenesin. Patient has taken the Paxlovid as treatment for 2 days started it Sunday.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6198), in left arm and on 12Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; ATORVASTATIN; DOXAZOSIN MESYLATE; ASPIRIN (E.C.). The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive at home test but I never had a negative test since starting Paxlovid on 6/6/22. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received vaccine and took other medication in 2weeks. Anti-viral details were Brand was Paxlovid, Treatment start date was 06Jun2022 and stop date was 10Jun2022, Indication for Treatment of COVID-19. Cough, runny nose, low-grade fever, extreme tiredness. These symptoms are worse than original symptoms on 06Jun22. No AE treatment was received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: El8982), in left arm and on 03Mar2021 as dose 2, single (Lot number: EN6203) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Nov2021 as dose 3 (booster), single (Lot number: 067F21), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MILI [ETHINYLESTRADIOL; NORGESTIMATE], start date: 03May2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19; Negative, notes: and testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 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: "Recent pregnancy Mar2022", start date: Mar2022 (unspecified if ongoing), notes: Other medical history: Recent pregnancy Mar2022; "Known allergies: Cantaloupe" (unspecified if ongoing), notes: Known allergies: Cantaloupe, honeydew; "Known allergies: honeydew" (unspecified if ongoing), notes: Known allergies: Cantaloupe, honeydew. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks: No.  Clinical Course: The patient received COVID 19 Treatment (Paxlovid) from 01Jun2022 to 06Jun2022 for the Treatment of COVID-19. Patient received other medication in 2 weeks.  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 and covid 19  cannot be ruled out.
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: 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: Unknown Result; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No Known allergies. On 29May2022 patient received other medication in 2weeks it was Tylenol stopped on 05Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.