chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19/ Rebound testing positive after 10 days; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 at 09:30 as dose 1, single (Lot number: EL1283), in right arm, on 13Feb2021 at 09:00 as dose 2, single (Lot number: EN5318), in right arm and on 14Dec2021 at 09:45 as dose 3 (booster), single (Lot number: 33BoBA) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05May2022 at 10:00 as dose 4 (booster), single (Lot number: 049231A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma and breast cancer; "breast cancer" (unspecified if ongoing), notes: Other medical history: Asthma and breast cancer; "Known allergies: Eggs" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", described as "Treatment of COVID-19/ Rebound testing positive after 10 days"; COVID-19 (medically significant), outcome "not recovered", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (Aug2022) Positive, notes: Rebound testing positive after 10 days after paxlovid meds. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Rebound testing positive after 10 days after paxlovid meds. Still unable to breathe. AE treatment: Breathing treatments and steroids. Known allergies: Eggs. Other medical history: Asthma and breast cancer. COVID 19 Treatment start ate 24Jul2022 and Stop date of treatment 28Jul2022, Lot number GE1498. The patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 63 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: "Bilateral Duane Syndrome" (unspecified if ongoing); "Penicillan" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 Included Paxlovid from 21Jul2022 to 26Jul2022.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 at 14:00 as dose 1, single (Lot number: EV6202) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Aortic aneurysm" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Peripheral neuropathy" (unspecified if ongoing); "Complication HCV infection" (unspecified if ongoing), notes: the infection has resolved. Concomitant medication(s) included: GABAPENTIN; OMEPRAZOLE; ZOLPIDEM. 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 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had also received other medication in 2 weeks. The patient had no known allergies. The patient had received Paxlovid as COVID-19 treatment from 12Jul2022 to 17Jul2022.; 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 drug ineffectiveness and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. No other medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with anti-viral Paxlovid from 27Jul2022 to 31Jul2022 for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient states she had covid; patient states she had covid; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID: (054550). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient states she had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: Patient states she had covid during christmas last year. 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.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 at 16:00 as dose 1, single (Lot number: el3246), in left arm, on 02Feb2021 at 15:00 as dose 2, single (Lot number: el9262), in left arm, on 04Oct2021 at 16:00 as dose 3 (booster), single (Lot number: rr2589), in left arm and on 18May2022 at 12:30 as dose 4 (booster), single (Lot number: rm7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Condition" (unspecified if ongoing); "Stage 3 Kidney Disease" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. The case was reported as non-serious. There was no other medication in 2 weeks. The patient received Paxlovid (lot number= ge1498) from 01Aug2022 to 04Aug2022 for COVID-19 treatment. On a ship (withheld) 23Jul2022 - 30Jul2022. The patient had no known allergies.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 01Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FM1073), in left arm and on 07Jul2022 at 16:30 as dose 4 (booster), single (Lot number: FF8841) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. No other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jul2022 at 22:00, outcome "not recovered" and all described as "COVID 19 Treatment". Using OTC BinaxNow antigen tests, he tested negative for four days after completing his Paxlovid course on 25Jul2022. But cough and nasal congestion returned on evening of 29Jul2022, and he again tested positive on morning of 30Jul2022. While symptoms continue to be mild, he was still testing positive five later on 04Aug2022, repeatedly producing dark bold positive lines on BinaxNow tests within 60 seconds of inserting the swab in the test. Infection does not seem to be wanting. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: repeatedly producing dark bold positive lines on BinaxNow tests within 60 seconds of inserting the swab in the test; (29Jul2022) Negative, notes: I tested negative for four days after completing my Paxlovid course on 25Jul2022; (30Jul2022) Positive, notes: tested positive on morning of 30Jul2022; (04Aug2022) Positive, notes: testing positive five later on 04Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Heart rate, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes." (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; TRULICITY taken for diabetes mellitus, start date: 10Jan2022. Past drug history included: Esomeprazole magnesium, start date: 01Jan2017, notes: Other medication in 2weeks product- Esomeprazole magnesium 40 mg, Other medication in 2weeks start date- 01Jan2017; Zyrtec, start date: 01Jan2017, notes: Other medication in 2weeks product- Zyrtec 10mg, Other medication in 2weeks start date- 01Jan2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Heart rate: (unspecified date) Heart rate was elevated; SARS-CoV-2 test: (unspecified date) Negative, notes: I had tested positive again after testing negative; (unspecified date) Positive, notes: I had tested positive again after testing negative; (30Jul2022) Positive, notes: On 30Jul, day 10 after initial Covid symptoms I experienced full blown Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event: Rebound covid- he was prescribed the paxaloid on 21Jul, start to feel better by 25Jul. Resumed work on 28Jul, starting to feel unwell on 29Jul which would have been nine days after the initial Covid symptoms. On 30Jul, day 10 after initial Covid symptoms he experienced full blown Covid again with mew symptoms he never had before including sore throat severe headach. Sinus pressure amd congrstion. He had tested positive again after testing negative. He was seen by a virtual Dr visit on 29Jul and was directed to go to the ER was his heart rate was elevated, this was attributed to current onset of COVID-19. The cause of the new symptoms was described as rebound Covid associated with Paxaloid treatment. Patient received anti-viral drug Paxlovid from 21Jul2022 to 25Jul2022 for treatment of COVID-19. Adverse event start date was reported as 29Jul2022 at 03:00 PM and no treatment received for the adverse events and adverse events were recovering.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received
Age: 27.0
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) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2022) negative, notes: previously testing negative; (2022) positive, notes: a positive test after taking paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had no other medication in 2weeks. Paxlovid treatment from 26Jul2022 to 31Jul2022 for COVID 19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Statin, notes: She was on statins, but she hasn't been on them. Vaccination history included: BNT162b2 (Dose Number: 1, Lot Number: EN5318), administration date: 21Feb2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs", "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs"; BNT162b2 (Dose Number: 2, Lot number: EN6205), administration date: 16Mar2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs", "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs"; BNT162b2 (Dose Number: 3, Lot Number: FA7484), administration date: 18Aug2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs", "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs". The following information was reported: PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious) all with onset 2022, outcome "recovered" (2022) and all described as "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs".
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Statin, notes: She was on statins, but she hasn't been on them. Vaccination history included: BNT162b2 (Dose Number: 1, Lot Number: EN5318), administration date: 21Feb2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs", "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs"; BNT162b2 (Dose Number: 2, Lot number: EN6205), administration date: 16Mar2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs", "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs"; BNT162b2 (Dose Number: 3, Lot Number: FA7484), administration date: 18Aug2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs", "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs". The following information was reported: PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious) all with onset 2022, outcome "recovered" (2022) and all described as "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs".
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). An adult patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA 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: "anxiety disorder" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; SPRINTEC. Past drug history included: Codeine, reaction(s): "Drug Allergy", notes: known Allergies: codeine. The following information was reported: 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient codeine known allergies and other medical history: included anxiety disorder, depression. Other medication in 2weeks product was Lexapro & sprintec. Patient had COVID 19 Treatment with brand Paxlovid. Treatment start date was 23Jul2022  & stop date was 27Jul2022 via oral indication treatment of COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70-year-old female patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Lot number: FA7484) at the age of 69 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. Past drug history included: Statins, notes: She was on statins. Vaccination history included: BNT162b2 (Dose 1, single, Lot: EN5318), administration date: 21Feb2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Sore arm", "Headachy"; BNT162b2 (Dose 2, single, Lot: EN6205), administration date: 16Mar2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Sore arm", "Headachy". The following information was reported: PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious), outcome "recovered" and all described as "Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs".
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs; AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 2, single (Lot number: EN6205) at the age of 69 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: She was on statins, notes: She was on statins but she hasn't been on them. Vaccination history included: BNT162b2 (Dose 1; Lot number: EN5318), administration date: 21Feb2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs", "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs". The following information was reported: PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs".
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN5318) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Statins, notes: She was on statins, but she hasn't been on them. The following information was reported: PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "AE(s) following prior vaccinations: Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs". Additional information: Patient received no other vaccines within 4 weeks prior to the first administration date of the suspect vaccine. The reporter reported that, she did travel overseas this past spring and had to have an antigen test. It was all fine and she was able to travel. Primary infection site was Covid-19. Had been on an airplane in front of an unmasked passenger who coughed the entire flight. Took a train to the airport as well. Her and her husband travel a lot and stay in hotels. The reporter wanted to specify Antipyretic Use (around the date(s) of Vaccination). She took Tylenol after the vaccine. Not something she likes to take, but she did. Went through the packet to find a number to call to report her rebound symptoms. Read that rebound happen near 1-10%. She was guessing its more than that.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Lot number: ER2613, Expiration Date: Jul2021) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01, Lot number: EN6202, Home test positive), administration date: 25Feb2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "COVID-19", "experienced only mild arm soreness with the vaccinations as well as minimal fatigue", "experienced only mild arm soreness with the vaccinations as well as minimal fatigue". The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "experienced only mild arm soreness with the vaccinations as well as minimal fatigue".
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Somnolence
Clinical narrative: Headache; Temperature 100; very sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Aug2022 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 5 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies " (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 02Aug2022 at 19:15, outcome "not recovered"; BODY TEMPERATURE INCREASED (non-serious) with onset 02Aug2022 at 19:15, outcome "not recovered", described as "Temperature 100"; SOMNOLENCE (non-serious) with onset 02Aug2022 at 19:15, outcome "not recovered", described as "very sleepy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, body temperature increased, somnolence. No other vaccine in four weeks. AE treatment was Tylenol. Unknown for covid prior vaccination. No covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: 001M21A), in left arm, on 22Feb2021 as dose 2, single (Lot number: FC3181), in left arm and on 04Oct2021 as dose 3 (booster), single (Lot number: EN6198) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure (BP)" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, 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) Positive, notes: After COVID positive rapid and PCR tests,; (02Aug2022) Negative, notes: Negative rapid tests on 02Aug and 03Aug; (03Aug2022) Negative, notes: Negative rapid tests on 02Aug and 03Aug; (unspecified date) Positive, notes: After COVID positive rapid and PCR tests,; (04Aug2022) Positive, notes: I have tested positive again on 04Aug. Therapeutic measures were taken as a result of covid-19.  Clinical Course: No Results in death, Life threatening: No, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect: No Other medication in 2 weeks: Yes. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid Treatment start date :25Jul2022 Treatment stop date :30Jul2022, Indication: Treatment of COVID-19. Other medication details: Other medication in 2 weeks product: Hydrochlorothiazide. Adverse event: After COVID positive rapid and PCR tests, I completed Paxlovid course, felt better and had neg rapid tests on -2Aug and 03Aug. I have tested positive again on 04Aug with runny nose and head congestion Adverse event start date: 04Aug2022 AE resulted in: None of the above. If Patient recovered: Not recovered. If treatment AE: No. Device Date : 04Aug2022
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6200), in left arm, on 04Apr2021 as dose 2, single (Lot number: EP7533), in left arm, on 22Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: F4989) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing); "known allergies : sulfa" (unspecified if ongoing), notes: known allergies : sulfa. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: After receiving Paxlovid 5 days, tested negative until 31Jul2022; (unspecified date) Positive, notes: then tested positive; (2020) Unknown results, notes: I probably got COVID before there were tests for it in early 2020. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid from 22Jul2022 to 27Jul2022 for COVID 19 Treatment. The patient did not take other medications in 2 Weeks.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure, X-ray
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2022 at 15:00 as dose 1, single (Lot number: fm0698), in right arm and on 11Mar2022 at 15:00 as dose 2, single (Lot number: fm0698) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: cinnamon, all spice, cloves" (unspecified if ongoing), notes: Known allergies: cinnamon, all spice, cloves; "Allergies" (unspecified if ongoing), notes: Allergies; "Asthma" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "Thyroid nodules" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lortab, reaction(s): "Allergy_Lortab"; Percocet, reaction(s): "Allergy_Percocet"; Biaxin, reaction(s): "Allergy_Biaxin"; Claritin, reaction(s): "Allergy_Claritin"; Allegra, reaction(s): "Allergy_Allegra"; Aspirin, reaction(s): "Allergy_Aspirin"; Azithromycin, reaction(s): "Allergy_Azithromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: X-ray: Unknown results. Therapeutic measures were taken as a result of covid-19.  Clinical information: the patient wasn't taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Antiviral details: paxlovid, started on 21Jul2022 and treatment stop date was 25Jul2022. The patient was put on mucinex, benzonatate, and had X-ray. Device Date: 04Aug2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events Vaccination failure and Covid 19 and the suspect product bnt162b2 cannot be ruled out.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9895) 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 included: "rheumatoid artritis" (unspecified if ongoing), notes: rheumatoid artritis; "known allergies: penicilline" (unspecified if ongoing), notes: known allergies: penicilline. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: in total for 3 weeks; (20Jul2022) Negative, notes: after 3 days from the end of the treatment. Therapeutic measures were taken as a result of covid-19. Paxlovid was given as anti viral therapy from 13Jul2022 to 17Jul2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jul2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma/ Seizures" (unspecified if ongoing); "Asthma/ Seizures" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "capers allergy" (unspecified if ongoing). 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral therapy of paxlovid was given from 01Aug2022 to 04Aug2022.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jun2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Over weight" (unspecified if ongoing). 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medication in 2 weeks and had no known allergies. The patient was being treated for COVID-19 with Paxlovid from 26Jul2022 to 30Jul2022. After taking a dose of Paxlovid, the patient would have horrible taste in her mouth. The patient would lesson as time went on and would come back when she took the next dose and took almost 5 days for it to be completely gone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/ Rebound positive test; COVID 19 Treatment/ Rebound positive test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment/ Rebound positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (01Aug2022) Positive, notes: Rebound positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment for covid-19 form 24Jul2022 to 29Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: Fh8020) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: PANTOPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has taken Multivitamin medication in 2 weeks vaccine. Treatment of COVID-19 with Paxlovid, started from27Jul2022 to 01Aug2022.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 18Mar2021 as dose 2, single (Lot number: EW6246), in left arm and on 08Nov2021 as dose 3 (booster), single (Lot number: 3203080) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "general allergies" (unspecified if ongoing); "interstitial cystitis" (unspecified if ongoing); "Known allergies: sulfa based drugs" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing). Concomitant medication(s) included: SPIRIVA RESPIMAT, start date: Apr2019; ARNUITY ELLIPTA, start date: Aug2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: First day of paxlovid, extreme nausea. Next day, followed with bitter taste in mouth. Throughout felt dizzy and woozy. Ae treatment: zofran for nausea only. Patient received the paxlovid for COVID, treatment start date was 30Jul2022 and treatment stop date was 03Aug2022.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Jan2021 at 15:45 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Oct2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "asthma" (unspecified if ongoing); "lung disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Levaquin, reaction(s): "Known allergies: Levaquin"; Morphine, reaction(s): "Known allergies: morphine". The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 12Jul2022, outcome "recovered" (28Jul2022) and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) positive, notes: I was covid positive on 12Jul2022; (Jul2022) positive, notes: test was positive; (28Jul2022) negative, notes: 28Jul2022 retested and was negative; (23Jul2022) positive, notes: Did home test on 23Jul2022 showed positive again. Therapeutic measures were taken as a result of covid-19.  The course of the events were reported as the patient was covid positive on 12Jul2022 and was prescribed paxlovid on the same day. The patient took her medication for the week, went back to work on 18Jul2022 saw doctor in the morning advising him that the patient was still having fevers but the patient was told to go back. Wednesday of that week, the patient was getting pain behind her ears and throat had a white coating. The throat started hurting Friday night. Got worse Saturday along with chest pressure, fatigue, fever. The patient did home test on 23Jul2022 showed positive again went to urgent care on the Sunday and was given steroid shot and was told to take mucinex and netty pot and test was positive and the patient was out another week of work until 28Jul2022, retested and was negative. The patient saw her doctor who gave her antibiotics.  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, 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 46-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) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID-19 treatment with Paxlovid from 26Jul2022 till 31Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.