chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Heart rate, Nasopharyngeal swab
Clinical narrative: the ground started feeling like it was moving; pale; trouble walking; heart rate while napping was 136-173; face felt numb and pins and needles on the left side/whole left arm went numb; face felt numb and pins and needles on the left side; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "Allergy: Penicillin" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: PARAESTHESIA (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "face felt numb and pins and needles on the left side"; HYPOAESTHESIA (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "face felt numb and pins and needles on the left side/whole left arm went numb"; HEART RATE INCREASED (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "heart rate while napping was 136-173"; PALLOR (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "pale"; VERTIGO (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "the ground started feeling like it was moving"; GAIT DISTURBANCE (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "trouble walking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, pallor, gait disturbance, heart rate increased, hypoaesthesia, paraesthesia.  Additional information: There was no other vaccine in 4 weeks. About 24 hours after the bivalent vaccine the ground started feeling like it was moving and the patient became pale and had trouble walking. The patient got to bed and felt asleep. According to her watch the patient's heart rate while napping was 136-173. The patient's normal resting heart rate was in the 60s. The patient woke up about 2-3 hours later and face felt numb and pins and needles on the left side and whole left arm went numb. The patient felt back asleep. This time heart rate was 78-164 bpm. When the patient woke up again, started feeling better by about an hour later.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac monitoring, Vaccination site pain
Clinical narrative: little heart arrhythmia; Never had a reaction, other than tenderness at injection site nothing real significant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 80-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", described as "little heart arrhythmia"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Never had a reaction, other than tenderness at injection site nothing real significant". The event "little heart arrhythmia" required physician office visit. Age adverse event(s) started: Was just 3 weeks ago and is 80. Hadn't taken any prescription medication in probably 10 years. Noticed a little heart arrhythmia and the doctor checked him out and was on a 30 day heart monitor. Then they put him on this medication. Vaccine Supplemental Form: Covid-19 vaccine: First Dose: 26Jan2021, LOT: FL9265 or maybe EL9265. NDC, EXP: Unknown. Did any AE(s) require a visit to: Emergency Room: No; Physician Office: No. Prior Vaccinations (within 4 weeks): No. AE(s) following prior vaccinations: None. Never had a reaction, other than tenderness at injection site nothing real significant. Patient's Medical History (including any illness at time of vaccination) was None. Family Medical History Relevant to AE(s): No, don't think so. Relevant Tests were none. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact was not provided. The patient underwent the following laboratory tests and procedures: Cardiac monitoring: was on a 30 day heart monitor. Therapeutic measures were taken as a result of arrhythmia.  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: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: successfully avoided contracting Covid until 15Sep2022 when we both got very sick/ very ill this fall after having the first three Pfizer vaccinations; successfully avoided contracting Covid until 15Sep2022 when we both got very sick/ very ill this fall after having the first three Pfizer vaccinations; This is a spontaneous report received from a contactable Consumer (patient's wife). A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 included: "Type I diabetic" (unspecified if ongoing), notes: for 60 years; "has had four bypasses", start date: 2001 (unspecified if ongoing). The patient's concomitant medications were not reported. Patient's wife reported that they successfully avoided contracting Covid until 15Sep2022 when they both got very sick. While they were taking care of each other and carefully assessing whether or not to take mitigating medication-they both came to the conclusion that without the vaccinations that they both took-they likely would have ended up in the hospital. And that is the purpose of this email. Patient's wife recalled their emotional gratitude when they finally received their first inoculation that was difficult to secure back then. They both were so grateful to have gotten that protection in such a fear-filled time. And now, having gotten very ill this fall after having the first three Pfizer vaccinations and getting to the other side of it, they simply felt how thankful they are for the brilliant scientists at Pfizer for providing them with the protection that enabled them to weather this hideous virus. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results. Outcome of the events was unknown.   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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200088446 Same reporter/vaccine/event, different patients;
Age: 44.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Body temperature increased, Chills, Feeling cold, Off label use
Clinical narrative: slight soreness in my right arm; feel extremely cold; chills; body aches; temperature is 99.0 degrees; brand=Phyzer, administration date=21Oct2022/other vaccine same date product=Flu, other vaccine same date vaccine date=21Oct2022; brand=Phyzer, administration date=21Oct2022/other vaccine same date product=Flu, other vaccine same date vaccine date=21Oct2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2022 at 10:00 as dose 1, single (Lot number: Gh9693) at the age of 44 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 21Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 21Oct2022, outcome "unknown" and all described as "brand=Phyzer, administration date=21Oct2022/other vaccine same date product=Flu, other vaccine same date vaccine date=21Oct2022"; PAIN (non-serious) with onset 22Oct2022 at 06:00, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 22Oct2022 at 06:00, outcome "not recovered"; FEELING COLD (non-serious) with onset 22Oct2022 at 06:00, outcome "not recovered", described as "feel extremely cold"; PAIN IN EXTREMITY (non-serious) with onset 22Oct2022 at 06:00, outcome "not recovered", described as "slight soreness in my right arm"; BODY TEMPERATURE INCREASED (non-serious) with onset 22Oct2022 at 06:00, outcome "not recovered", described as "temperature is 99.0 degrees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, feeling cold, chills, pain, body temperature increased.  Additional information: Patient not been received any other vaccine in four weeks. Patient not been had Covid prior to vaccination and not tested covid post vaccination. Patient had received shots around 10am on 21Oct2022, Pfizer (booster) and flu shot in the same arm. Had some slight soreness in right arm and continued into next morning. Following morning, patient started to feel extremely cold and have chills. This also included unusual body aches.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain, Pain in extremity, Product use issue
Clinical narrative: slight soreness in my right arm; feel extremely cold; chills; body aches; temperature is 99.0 degrees; brand=Phyzer, administration date=21Oct2022/other vaccine same date product=Flu, other vaccine same date vaccine date=21Oct2022; brand=Phyzer, administration date=21Oct2022/other vaccine same date product=Flu, other vaccine same date vaccine date=21Oct2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2022 at 10:00 as dose 1, single (Lot number: Gh9693) at the age of 44 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 21Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 21Oct2022, outcome "unknown" and all described as "brand=Phyzer, administration date=21Oct2022/other vaccine same date product=Flu, other vaccine same date vaccine date=21Oct2022"; PAIN (non-serious) with onset 22Oct2022 at 06:00, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 22Oct2022 at 06:00, outcome "not recovered"; FEELING COLD (non-serious) with onset 22Oct2022 at 06:00, outcome "not recovered", described as "feel extremely cold"; PAIN IN EXTREMITY (non-serious) with onset 22Oct2022 at 06:00, outcome "not recovered", described as "slight soreness in my right arm"; BODY TEMPERATURE INCREASED (non-serious) with onset 22Oct2022 at 06:00, outcome "not recovered", described as "temperature is 99.0 degrees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, feeling cold, chills, pain, body temperature increased.  Additional information: Patient not been received any other vaccine in four weeks. Patient not been had Covid prior to vaccination and not tested covid post vaccination. Patient had received shots around 10am on 21Oct2022, Pfizer (booster) and flu shot in the same arm. Had some slight soreness in right arm and continued into next morning. Following morning, patient started to feel extremely cold and have chills. This also included unusual body aches.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "orthopedic surgeries" (unspecified if ongoing), notes: Other medical history: orthopedic surgeries. 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient did not received any other medication in 2 weeks nor having any known allergies. He received paxlovid treatment from 08Oct2022 to 12Oct2022 for covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling
Clinical narrative: breast swelling; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: FH8028212822) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "Yes--I have predicatable immune responses to all vaccines" (unspecified if ongoing), notes: Yes--I have predicatable immune responses to all vaccines. This is different. Environmental; "Environmental" (unspecified if ongoing), notes: Yes--I have predicatable immune responses to all vaccines. This is different. Environmental. Concomitant medication(s) included: ZOCOR. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EJ1685, ), administration date: 22Dec2020, when the patient was 55-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EL3248, ), administration date: 12Jan2021, when the patient was 55-year-old, for Covid-19 Immunization. The following information was reported: BREAST SWELLING (non-serious), outcome "unknown".  Follow-Up (26Oct2022): Follow-up attempts are completed. No further information is expected.
Age: 63.0
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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 63 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. Concomitant medication(s) included: LEVOTHYROXINE, start date: Jan2013, stop date: Jan2013; VITAMIND3 VICOTRAT, start date: Jan2015, stop date: Jan2015; CETIRIZINE, start date: Dec2019, stop date: Dec2019. 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: (unspecified date) Positive; (22Oct2022) Negative; (23Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FK9893. 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. (Name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  Clinical information: The patient received other medication in 2weeks product are Aller-Tec, start date: Dec2019, and lot number 1ME1971C.
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.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MIRENA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: COVID 19 Treatment; (Oct2022) Positive, notes: Rebound covid infection. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported as treatment Paxlovid for COVID 19 Treatment, treatment start date: 14Oct2022 and treatment stop date: 19Oct2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cardiac disorder" (unspecified if ongoing), notes: Caller also stated she has APS and is a cardiac patient too.; "APS" (unspecified if ongoing), notes: Caller also stated she has APS and is a cardiac patient too. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "Nausea", "vomiting"; Bnt162b2 (DOSE 2, SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "Nausea", "vomiting". The following information was reported: NAUSEA (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered".  Additional information: Patient mentioned she was vaccinated with the primary series and two boosters, all from Pfizer. She mentioned she got a reaction a couple of times, with nausea and vomiting all night, until 7:30 am. She mentioned she was concerned about getting the Omicron vaccine and that she was allergic to something vaccine. Caller asked if in stoppers or syringes might have latex. Caller also mentioned she just recently received a Flu shot and asked how long she should wait to get the new Omicron vaccine. Caller also mentioned there were new two variants that had come out so that was totally absurd, because the virus was constantly mutating, and that people were still getting COVID and Omicron, so it did not prevent anything. Caller expressed her main concern was if she should talk it or not because she was afraid of getting the reaction and to be up all night. She also mentioned her Doctors did not know how to treat or prevent the side effects from these vaccines. She asked if the Pfizer Product get into the valves of the heart. Caller also mentioned her last booster was in Jul2022 and asked when she could receive the bivalent vaccine.  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: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Caller stated she has APS and is a cardiac patient too" (unspecified if ongoing), notes: Caller stated she has APS and is a cardiac patient too; "Caller stated she has APS and is a cardiac patient too" (unspecified if ongoing), notes: Caller stated she has APS and is a cardiac patient too; "she is allergic to something vaccine." (unspecified if ongoing); "Caller asked if in stoppers or syringes may have latex." (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization, reaction(s): "Nausea", "Vomiting"; Bnt162b2 (DOSE 2), for Covid-19 immunization, reaction(s): "Nausea", "Vomiting"; Bnt162b2 (DOSE 3), for Covid-19 immunization, reaction(s): "Nausea", "Vomiting". The following information was reported: NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown". Additional information: The patient mentioned that she was vaccinated with the primary series and two boosters, all from Pfizer. She mentioned she got a reaction a couple of times, with nausea and vomiting all night, until 7:30 am. Last booster was in Jul2022. She was concerned about getting the Omicron vaccine and that she was allergic to something vaccine. It was asked whether stoppers or syringes might have latex. She just recently received a Flu shot and asked how long she should wait to get the new Omicron vaccine. It was said there were new two variants that have come out, so that was totally absurd, because the virus was constantly mutating, and that people were still getting COVID and Omicron, so it did not prevent anything. It was the main concern if she should talk it or not because she was afraid of getting the reaction and to be up all night. She also mentioned her doctors did not know how to treat or prevent the side effects from these vaccines. She had APS and was a cardiac patient too. She asked if the Pfizer Product got into the valves of the heart. Her last booster was in Jul2022 and asked when she could receive the bivalent vaccine. The patient asked how sick the people did who received that new bivalent vaccine, when they got infected with COVID. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Covid symptoms started Again and I tested positive once again; A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing), notes: Other medical history Hashimotos Thyroiditis. 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"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "Covid symptoms started Again and I tested positive once again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication=Treatment of COVID-19; (11Oct2022) Positive, notes: I started Paxlovid on 11Oct2022 (same day As Covid-19 symptoms appeared and Tested positive); (16Oct2022) Negative, notes: I tested negative on 16Oct2022; (22Oct2022) Positive, notes: On 22Oct2022, Covid symptoms started Again and I tested positive once again. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical course: Patient started Paxlovid on 11Oct2022 and stop date was 15Oct2022, Lot number gf1750, (same day As Covid-19 symptoms appeared and Tested positive). Symptoms cleared up and patient tested negative on 16Oct2022. Then, on 22Oct2022, Covid symptoms started again and she tested positive once again. (she Isolated herself for 10 days and was not Exposed to anyone, she did so as not to Infect anyone else, so she can only Imagine this was a "rebound" of Covid). Other medication in 2 weeks, No known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; vaccine brand=Pfizer/BioNTech; vaccine dose number=2 / vaccine brand other=Moderna; vaccine dose number=3; 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EP6955) and on 07Apr2021 as dose 2, single (Lot number: ER8733) at the age of 59 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Aug2022 as dose 3 (booster), single (Lot number: 002M214) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis (off treatment for vaccines)" (unspecified if ongoing). Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]; ZOLOFT; CAMPRAL; LOSARTAN; MELATONIN; MAGNESIUM; STELARA, stop date: 07Jul2022; Multivitamin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Aug2022, outcome "unknown", described as "vaccine brand=Pfizer/BioNTech; vaccine dose number=2 / vaccine brand other=Moderna; vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "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: It was reported that patient had no known allergies. Patient had treatment with Paxlovid from 14Oct2022 to 18Oct2022.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: ER8131), in left arm, on 30Mar2021 as dose 2, single (Lot number: EW0175), in left arm, on 11Nov2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 14Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 64 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CALCIUM CITRATE; CHONDROITIN; FISH OIL OMEGA 3; GLUCOSAMINE; VITAMIN D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. He received other medication in two weeks as Multivitamin. Patient was treated with Paxlovid (anti-viral) for covid-19 from 11Oct2022 to 16Oct2022.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: my brother had high fevers when he got his booster, but he also had delta in December of last year; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An elderly male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Suspected COVID-19", start date: Dec2021, stop date: Dec2021, notes: he also had delta in December of last year, right around Christmas,. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed unknown manufacturer.), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "my brother had high fevers when he got his booster, but he also had delta in December of last year".  Additional Information: DR report side effects of COVID vaccine in herself and multiple other people. DR stated that she have seen very little issues, she had two patients that she absolutely will not give a booster to and recommend against boosters because they had a reaction to their vaccine. Um, one of them came in the following year and got her flu shot and had another reaction, so we're pretty sure at this point she's going to have to, and she was going to have to write her a note for work this year and say that she can't have either. Um, but for the most part, she had very few patients who can't have the vaccine. And she had been fortunate in that she had no reactions to any of her vaccines. she now had the primary series in two boosters, all Pfizer. Um, her brother had high fevers when he got his booster, but he also had delta in December of last year, right around Christmas, he got it because he travels for work.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201252017 same patient, different AE;
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness postural, Vertigo positional
Clinical narrative: feeling like this weird dizziness but its only like when I am sitting or I am at my rest; if I am at sitting still and reading it is like my head is spinning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose number unknown (booster), single (Lot number: 6H9693) at the age of 24 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (First Booster dose), administration date: 2021, for COVID-19 immunization. The following information was reported: DIZZINESS POSTURAL (non-serious) with onset 15Oct2022, outcome "unknown", described as "feeling like this weird dizziness but its only like when I am sitting or I am at my rest"; VERTIGO POSITIONAL (non-serious) with onset 15Oct2022, outcome "unknown", described as "if I am at sitting still and reading it is like my head is spinning". Therapeutic measures were not taken as a result of dizziness postural, vertigo positional.  Additional Information: Consumer stated, I got a Pfizer Vaccine last week at my Health Center and I start feeling like this weird dizziness but it is only like when I am sitting or I am at my rest. It is not like when I am walking around or some exercising, it goes away but like if I am at sitting still and reading it is like my head is spinning I guess but I do not have nausea and my vitals are okay. So, I do not know if that is from vaccine but that has been happening one day after I got the Vaccine and then it still happening like 7 days later, so. Consumer stated, Yes, it is like I am just wondering how long would the side effects last or also like. Prior Vaccination within 4 weeks consumer stated, No, the patient last booster shot was in 2021, this is his first one this year. Yeah, it is his second booster shot but the first one was last year. When again clarified the name of the product, consumer stated, I guess it is but the sheet that health center gave me says it is a Comirnaty and it is the Pfizer BioNTech. I am pretty sure that is the new one. The patient is not taking any medications and Consumer stated, no treatment received. Consumer stated, I just want to clarify on my report that these symptoms kind of go away whenever I am moving around. So, it is not the dizziness where I lose my balance or I am at nausea or any of that stuff. Consumer was informed that same will be added to the report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pyrexia, Vomiting
Clinical narrative: Right now her fever only about 100; she is shivering and freezing; vomiting; she is shivering and freezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 09:00 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "semi-okay"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "chills", "really not well", "she got pretty bad high fever"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "chills", "really not well", "she got pretty bad high fever"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "chills", "really not well", "she got pretty bad high fever". The following information was reported: PYREXIA (non-serious) with onset 22Oct2022, outcome "unknown", described as "Right now her fever only about 100"; CHILLS (non-serious), FEELING COLD (non-serious) all with onset 22Oct2022, outcome "unknown" and all described as "she is shivering and freezing"; VOMITING (non-serious) with onset 22Oct2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: reporter stated that we got the Omicron, my girlfriend and I got the Omicron shot, here it says shot at 9am. She woke up having serious reactions right now. Right now her fever only about 100 but she is shivering and freezing and it has been since last few hours and vomiting too.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201253010 same product, patient, different AEs, different dose;US-PFIZER INC-202201253011 same product, patient, different AEs, different dose;US-PFIZER INC-202201253008 same product, patient, different AEs, different dose;US-PFIZER INC-202201253009 same product, patient, different AEs, different dose;
Sex: F
Vaccine: 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) (Nurse).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of Paxlovid for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive Wednesday for Covid 19.; Tested positive Wednesday for Covid 19.; This is a spontaneous report received from a contactable reporter consumer or other non HCP from product quality group. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Lot number: FE3590), as dose 4 (booster), single (Batch/Lot number: unknown) and in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive Wednesday for Covid 19.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive Wednesday for Covid 19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller stated that she kept everything within the Pfizer family was twice vaccinated and had three booster shots since then. Had her final booster in Sep. Had basic symptoms but did not have problems worth reporting. Stayed in the Pfizer family because of it. Tested positive Wednesday for Covid 19. Almost did not test because she had a little bit of a scratchy throat and did not think much of it. Wednesday morning had scratchy throat that progressed to laryngitis. Almost did not test because she did not have any symptoms.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Moderna (previously Pfizer); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Sep2022, outcome "unknown", described as "Moderna (previously Pfizer)"; 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: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: previously testing negative; (24Oct2022) Positive, notes: Positive test after previously testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medications in 2 weeks, Patient was treated with Product Paxlovid from 13Oct2022 to 17Oct2022 for COVID 19 Treatment, Positive test after previously testing negative, 8 days after finishing Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 58 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 at 08:00 as dose 1, single (Lot number: EL9264), in right arm, on 25Feb2021 at 09:00 as dose 2, single (Lot number: EN 5318), in right arm and on 18Jul2022 at 15:00 as dose 3 (booster), single (Lot number: FP7139), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "heart rhythm" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL; IRBESARTAN. The following information was reported: VACCINATION FAILURE (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: (23Oct2022) Positive, notes: Return of covid symptoms 7 days after completing course of paxlovid. Positive test for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with Paxlovid.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of covid-19; Treatment of covid-19; Pfizer / BioNTech - Dose Number: 5, Moderna - Dose number: 4; 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 (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH97C2) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Dec2020 as dose 1, single (Lot number: 039k20a), in left arm, on 26Jan2021 as dose 2, single (Lot number: 029L20A), in left arm, on 23Oct2021 as dose 3 (booster), single (Lot number: 025C21A), in left arm and on 11May2022 as dose 4 (booster), single (Lot number: 028K21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown", described as "Pfizer / BioNTech - Dose Number: 5, Moderna - Dose number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: If vaccine received was yes. Other medication in 2 weeks was no. Known allergies: KNA. Other medical history: None.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: sore arm; headache; floating feeling; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, ), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 23Oct2022, outcome "recovering"; FEELING ABNORMAL (non-serious) with onset 23Oct2022, outcome "recovering", described as "floating feeling"; HEADACHE (non-serious) with onset 23Oct2022, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 23Oct2022, outcome "recovering", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity, headache, feeling abnormal, chills.  Additional information: Facility type vaccine: Doctor's office/urgent care. If other vaccine in four weeks: No. Other medication in two weeks: No. If treatment: No. If covid Prior vaccination: No. If covid tested post vaccination: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Nov2021 as dose number unknown (booster), single (Lot number: 32030bd) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (16Oct2022) Negative; (18Oct2022) Negative; (20Oct2022) Negative; (22Oct2022) Negative; (24Oct2022) Positive, notes: Tested Positive 24Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that no other medication in 2 weeks. Patient took Paxlovid for 5 days -11Oct2022 through 16Oct2022. Patient covid-19 test was negative on 16Oct, 18Oct, 20Oct and 22Oct. Patient symptoms returned on 22Oct evening and tested positive on 24Oct2022. No other medical history. Patient had known allergies.