chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (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 suspected covid-19, drug ineffective; patient had received anti-viral drug Paxlovid as treatment of COVID-19. Treatment start date was 24May2022 and stop date was 29May2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: day 1; (31May2022) negative, notes: antigen day 8; (05Jun2022) positive, notes: antigen day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19. Potential COVID-19 rebound after completing Paxlovid treatment. First day of symptoms is Day 0. Positive test day 1, began Paxlovid day 2, completed Paxlovid day 6. Tested negative (antigen) day 8, symptom reemergence day 12, positive test (antigen) day 13. The treatment Antiviral details included for the COVID 19 Treatment and the start date 24May2022 and the end date was on 28May2022.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac stress test, Chest X-ray, Chest pain, Spinal pain
Clinical narrative: It went all the way into to her heart; It went all the way into her chest; felt like she was being stabbed through the spine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 2, single (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 43 years for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot no: EN6204, Expiration date: 30Jun2021), administration date: 04Mar2021, when the patient was 43-year-old, for COVID-19 immunization, reactions: "very cold like freezing", "very very tired", "severe pain that radiated from her spine to the right and left side", "It went all the way into her chest", "It went all the way into her heart". The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "It went all the way into to her heart"; CHEST PAIN (non-serious), outcome "unknown", described as "It went all the way into her chest"; SPINAL PAIN (non-serious), outcome "unknown", described as "felt like she was being stabbed through the spine". The patient underwent the following laboratory tests and procedures: Cardiac stress test: (01Jun2021) Unknown results; Chest X-ray: (unspecified date) Unknown results. She had reactions with the Covid vaccines and with each dose, it actually got worse. It was always with the arm. With the first one, she got very cold, like freezing and those symptoms lasted about 2 or 3 days. She was very very tired and had this very weird sensation. The doctor sent her for a chest Xray with the second one. With the first one, she had severe pain that radiated from her spine to the right and left side. It went all the way into her chest, to her heart. She had severe pain. This all happened with all 3 vaccines. With the second one, she felt like she was being stabbed through the spine.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Chest pain, Spinal pain
Clinical narrative: It went all the way into to her heart; It went all the way into her chest; she felt like she was being stabbed through the spine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 44 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No Additional Vaccines were Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. Vaccination history included: BNT162b2 (First Dose, LOT: EN6204, EXP: 30Jun2021), administration date: 04Mar2021, when the patient was 43-year-old, for Covid-19 immunization, reaction(s): "very cold like freezing", "very very tired", "severe pain that radiated from her spine to the right and left side", "It went all the way into her chest", "It went all the way into her heart"; BNT162b2 (Second Dose, LOT: EP6955, EXP: 30Jun2021), administration date: 24Mar2021, when the patient was 43-year-old, for Covid-19 immunization, reaction(s): "It went all the way into her chest", "It went all the way into her heart", "she felt like she was being stabbed through the spine". The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "It went all the way into to her heart"; CHEST PAIN (non-serious), outcome "unknown", described as "It went all the way into her chest"; SPINAL PAIN (non-serious), outcome "unknown", described as "she felt like she was being stabbed through the spine". Clinical course: Caller worked in a hospital with patients and went to medical school. Clarified that the caller is not licensed as a physician. The third dose was administered at a Vaccine Center. Patient had reactions with the Covid vaccines and with each dose, it actually got worse. It was always with the arm. With the first one, she got very cold, like freezing and those symptoms lasted about 2 or 3 days. She was very very tired and had this very weird sensation. The doctor sent her for a chest Xray with the second one. With the first one, she had severe pain that radiated from her spine to the right and left side. It went all the way into her chest, to her heart. She had severe pain. This all happened with all 3 vaccines. With the second one, she felt like she was being stabbed through the spine. With the third one, it felt the same but it wasn't as strong the previous one.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cardiac stress test, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: It went all the way into to her heart; It went all the way into her chest; she felt like she was being stabbed through the spine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 44 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No Additional Vaccines were Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. Vaccination history included: BNT162b2 (First Dose, LOT: EN6204, EXP: 30Jun2021), administration date: 04Mar2021, when the patient was 43-year-old, for Covid-19 immunization, reaction(s): "very cold like freezing", "very very tired", "severe pain that radiated from her spine to the right and left side", "It went all the way into her chest", "It went all the way into her heart"; BNT162b2 (Second Dose, LOT: EP6955, EXP: 30Jun2021), administration date: 24Mar2021, when the patient was 43-year-old, for Covid-19 immunization, reaction(s): "It went all the way into her chest", "It went all the way into her heart", "she felt like she was being stabbed through the spine". The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "It went all the way into to her heart"; CHEST PAIN (non-serious), outcome "unknown", described as "It went all the way into her chest"; SPINAL PAIN (non-serious), outcome "unknown", described as "she felt like she was being stabbed through the spine". Clinical course: Caller worked in a hospital with patients and went to medical school. Clarified that the caller is not licensed as a physician. The third dose was administered at a Vaccine Center. Patient had reactions with the Covid vaccines and with each dose, it actually got worse. It was always with the arm. With the first one, she got very cold, like freezing and those symptoms lasted about 2 or 3 days. She was very very tired and had this very weird sensation. The doctor sent her for a chest Xray with the second one. With the first one, she had severe pain that radiated from her spine to the right and left side. It went all the way into her chest, to her heart. She had severe pain. This all happened with all 3 vaccines. With the second one, she felt like she was being stabbed through the spine. With the third one, it felt the same but it wasn't as strong the previous one.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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) 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 for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Tested positive for Covid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 at 08:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient did not received other medication in 2 weeks. Patient did not have known allergies. Patient anti-viral details: Paxlovid (Lot number: unknown), start date was 22May2022 and stop date was 26May2022 for COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). An 81-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. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient took Blood Pressure medication (unspecified) in 2 weeks, had no known allergies. The patient took COVID-19 treatment with Paxlovid (treatment start date- 25May2022, treatment stop date- 29May2022). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EJ1686), on 12Feb2021 as dose 2, single (Lot number: EL1283), on 21Oct2021 as dose 3 (booster), single (Lot number: FF8839) and on 20Apr2022 as dose 4 (booster), single (Lot number: PJ4989) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "over weight" (unspecified if ongoing); "asthma" (unspecified if ongoing); "sinus tachycardia" (unspecified if ongoing). Concomitant medications in 2 weeks included: EFFEXOR; SYNTHROID; VITAMIN D NOS; FISH OIL; METOPROLOL; MVI [ASCORBIC ACID;DEXPANTHENOL;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]. Past drug history included: Neosporin, reaction(s): "Known allergies: Neosporin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included anti viral - covid-19 treatment product.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 44.0
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). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 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). The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Negative, notes: after testing negative day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had Paxlovid for indication of COVID-19 treatment start date on 24May2022 and treatment stop date on 28May2022.Other medication Amlodipine 2weeks start date on 02May2019.Adverse event: Rebound Covid day 13 (after testing negative day 9) Symptoms returned day 13 after initial infection - 6 days after completing paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: I have Covid19 now; I have Covid19 now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 62-year-old patient received BNT162b2 (BNT162B2, solution for injection), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04Jun2022, outcome "unknown" and all described as "I have Covid19 now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (04Jun2022) Positive, notes: now my doctor prescribed me Paxlovid because I have Covid19 now. I just got it today, it was tested,. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Consumer stated, "I was wondering , you know the Paxlovid, for Covid19. I had two Pfizer shots in the beginning and two booster. I am 62 but I take different Medicine. I want to know this could be interact, If I take Oxycodone. What will happen if I take Paxlovid with Oxycodone. Can it hurt my liver or anything like that". Consumer stated, "No, not all together, I have taken two vaccines, Pfizer, then I took 2 Pfizer boosters. Okay, now my doctor prescribed me Paxlovid because I have Covid19 now. I just got it today, it was tested, the doctor prescribed now. I want to make sure because I read few things that, if I took Paxlovid with my Oxycodone, it might get me more high or it might get me more or can hurt my liver. I want to find out about that."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 52 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Latex" (unspecified if ongoing), notes: latex; "honeydew melon, pineapple" (unspecified if ongoing), notes: honeydew melon, pineapple. Concomitant medication(s) included: PROGESTERONE. Past drug history included: Chlorine, reaction(s): "known allergies: chlorine", notes: known allergies: chlorine. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of Covid-19, drug ineffective. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from 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 15Apr2021 as dose 1  single (Lot number: EP2553), in left arm and on 06May2021 as dose 2 single (Lot number: EW0167) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Lot number: 029H21B), in left arm 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 "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.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Aug2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 05Sep2020 as dose 2, single (Batch/Lot number: unknown), in right arm and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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: Drug ineffective depends on many factors, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "lymphatic leukemia on no therapy (LGL)" (unspecified if ongoing), notes: lymphatic leukemia on no therapy (LGL). There were no concomitant medications in 2 weeks. The following information was reported: VACCINATION FAILURE (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: (02Jun2022) Positive, notes: Home test positive x 2 on 02Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details: COVID 19 Treatment, Paxlovid, from 19May2022 to 25May2022, Oral.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 45.0
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). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 45 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: "known allergies: NSAIDs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (non-serious), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Continue to have positive rapid test; Positive, notes: Continue to have positive rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No other medication in 2weeks. Anti-viral details: Product- COVID 19 Treatment, Brand- Paxlovid, treatment start date- 24May2022, treatment stop date- 29May2022, indication- treatment of COVID-19. Adverse event: On 2Jun, I had a headache and a low fever (99.5) and some congestion. Continue to have positive rapid test. I completed the course of paxlovid treatment in the morning of 29May.
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.  An adult male patient received BNT162b2 (BNT162B2), on 19Nov2021 at 18:00 as dose 3 (booster), single (Lot number: FJ8757), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin", notes: Known allergies: Augmentin; Steroids, reaction(s): "Known allergies: Steriods", notes: Known allergies: Steriods. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: Tested Positive for COVID on 30May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: daughter sick from school Sunday 29May2022, then MR had sx of allergies scratchy throat and stuffy nose02Jun2022, then Ag + test 03Jun2022; daughter sick from school Sunday 29May2022, then MR had sx of allergies scratchy throat and stuffy nose02Jun2022, then Ag + test 03Jun2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the parent.  A 43-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL3247), on 16Mar2021 as dose 2, single (Lot number: EL3247) and on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 03Jun2022, outcome "unknown" and all described as "daughter sick from school Sunday 29May2022, then MR had sx of allergies scratchy throat and stuffy nose02Jun2022, then Ag + test 03Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, asymptomatic covid-19  Clinical course details: It was reported, daughter sick from school on 29May2022, then had symptoms of allergies scratchy throat and stuffy nose 02Jun2022, then Ag Plus test 03Jun2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from 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 06Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 30155BA) at the age of 29 years, in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Jan2021 as dose 1, single (Lot number: 027L20A), in left arm and on 11Feb2021 at 11:00 as dose 2, single (Lot number: 016M20A), in left arm for covid-19 immunization. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing); "stress-related heart palpitations" (unspecified if ongoing), notes: stress-related heart palpitations; "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 25May2022, stop date: 05Jun2022, also reported as other medication in 2 weeks. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Penicillin, reaction(s): "Known allergies:Penicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: Continuing to test positive on Binax rapid at-home tests; (01Jun2022) Negative, notes: Tested negative on Wednesday and Thursday; (02Jun2022) Negative, notes: Tested negative on Wednesday and Thursday; (03Jun2022) Positive, notes: on Friday night and tested positive again; (Jun2022) Unknwon results. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Anti-viral treatment for COVID-19 with Paxlovid from 26May2022 to 31May2022. Clinical course was reported as, Patient had Rebound symptoms started on 03Jun2022 at 19:15. Tested negative on Wednesday and Thursday following course of 5-day Paxlovid treatment, then fever and sore throat returned on Friday night and tested positive again. Continuing to recover from symptoms now and isolating for another 5 days. Continuing to test positive on Binax rapid at-home tests. Patient was not recovered from symptoms and no treatment received for symptoms.
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) (Physician).  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Lot number: EW0178) 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: "Glaucoma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sulfa, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (non-serious), outcome "recovering" and all described as "COVID 19". Recurrent symptoms included congestion, runny nose, fatigue on 29May2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive. Patient received oral Anti-viral product (Pfizer) as COVID 19 treatment from 16May2022 to 20May2022.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events Drug ineffective  ,covid 19 cannot be completely excluded based on temporal association.
Age: 39.0
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 39-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 39 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's relevant medical history included: "LGL and PMBCL (in complete remission)" (unspecified if ongoing); "LGL and PMBCL (in complete remission)" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE. Past drug history included: Amoxycillin, reaction(s): "Known allergies: Amoxycillin". 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: Positive, notes: initial diagnosis. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient experienced Paxlovid rebound of COVID-19 with a positive test on Day 12 (from initial diagnosis), where Paxlovid treatment began on Day 1 and ended on Day 5. Treatment start date=23May2022, Treatment stop date=27May2022. No symptoms of disease. Patient had allergy experienced from amoxycillin.  No follow-up attempts are possible. No further information is expected.
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) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), 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: "asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing), notes: seasonal allergies; "obesity" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR, start date: Jan2019; ARMOUR THYROID, start date: Jan1996. 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient was treated with Paxlovid (Lot number GA8200) from 24May2022 to 01Jun2022. Continued to have a sore throat, cough, fatigue and swollen glands throughout treatment, though was improving. 2 days later return of nasal congestion/sneezing, sore throat, cough, fatigue and swollen glands  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: Er2613), in left arm, on 23Apr2021 as dose 2, single (Lot number: Ew0175), in left arm, on 04Dec2021 as dose 3 (booster), single (Lot number: F31620), in left arm and on 20May2022 at 12:30 as dose 4 (booster), single (Lot number: Pm7553) at the age of 58 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative on day 5; Positive, notes: On day 10 I started feeling symptoms again and tested positive. Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  Addition information: Known allergies was none. Treatment start date was 25May2022. Treatment stop date was 30May2022.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 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: "Asthma" (unspecified if ongoing); "Dysthymia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine, Keflex; Keflex, reaction(s): "known allergies: Keflex", notes: known allergies: Keflex. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: The consumer started Paxlovid on 25May2022 for treatment of COVID-19 and stopped on 30May2022. Finished course of Paxlovid 5 days ago. Felt mostly back to normal yesterday but this morning had severe fatigue, mild headache, mild productive cough. Consumer had underlying asthma which was also slightly triggered.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for COVID-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "HIV positive" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Grass" (unspecified if ongoing); "Known allergies: Trees" (unspecified if ongoing); "Known allergies: dogs, cats" (unspecified if ongoing). Concomitant medications included: VALACYCLOVIR HCL; TRIUMEQ; ROSUVASTATIN, stop date: 19May2022; FLUTICASONE PROPIONATE, stop date: 19May2022. 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: COVID-19 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 18May2022 to 23May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Batch/Lot number: unknown), on 02Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Over weight" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. It was reported that, on 24May2022, the patient started Paxlovid as a treatment for the event COVID-19, taken till 27May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2, solution for injection), on 29Oct2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea syndrome" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE, start date: 15Apr2020, stop date: 18May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (24May2022) Negative; (27May2022) Positive; (01Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks: Yes. Product- COVID 19 Treatment, Brand- Pfizer, Treatment start date- 19May2022, Treatment stop date- 23May2022, Lot number- Unknown, Indication- Treatment of COVID-19. Adverse event: After completing, the five day course of Paxlovid on 23May, and having greatly reduced symptoms and a negative Covid test on 24May, my symptoms returned worse than they had originally been and I tested positive again on 27May. I was still testing positive on 01Jun, and symptoms have lessened but not gone away by today, 03Jun. Adverse event start date: 25May2022 Adverse event start time: 06:00 AM Ae resulted in: [None of the above] If patient recovered: Recovering If treatment ae: No Known allergies: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Mar2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Nov2021 at 18:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other medication in 2 weeks. No known allergies were reported The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, 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: I also tested negative on days 6-8 on at home Covid tests; (24May2022) Positive, notes: started paxlovid same day I tested positive for Covid; (01Jun2022) Positive, notes: 4 days after completing my paxlovid treatment, I began having Covid symptoms again, and tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient started paxlovid same day she tested positive for Covid and had symptoms. She completed the 5 day course of paxlovid, and her symptoms went away by day 5. She also tested negative on days 6-8 on at home Covid tests.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received