chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19 using paxlovid; Treatment of COVID-19 using paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 27 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: ER8735), in left arm, on 07May2021 as dose 2, single (Lot number: EW0168), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: EW0185), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST, start date: 05Aug2022; LEVOCETIRIZINE, start date: 25Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19 using paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative, notes: Had a positive test after 3 negative tests following treatment; (2022) Negative, notes: Had a positive test after 3 negative tests following treatment; (2022) Negative, notes: Had a positive test after 3 negative tests following treatment; (2022) Positive, notes: Had a positive test after 3 negative tests following treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 50 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EL0142), on 28Jan2021 as dose 2, single (Lot number: EN5318), on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) and on 22Jul2022 as dose 4 (booster), single (Lot number: FP7139) 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), COVID-19 (medically significant) all with onset 25Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Oct2022) positive, notes: first positive test on 25Oct2022; (02Nov2022) negative, notes: Had negative rapid test on 02Nov2022; (04Nov2022) positive, notes: had positive rapid test on 04Nov2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid treatment from 26Oct2022 to 31Oct2022.; Sender's Comments: Based on available information, a possible causal relationship cannot be excluded between the suspect vaccines (bnt162b2, bnt162b2 omi ba.4-5 and bnt162b2) and events.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I had COVID the first time, in January of 2022; I had COVID the first time, in January of 2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EL0142), on 28Jan2021 as dose 2, single (Lot number: EN5318) and on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 49 years for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "I had COVID the first time, in January of 2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: treatment of COVID-19. Therapeutic measures were not taken as a result of vaccination failure, COVID-19.  Additional information: The patient had no known allegrgies.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood testosterone, Blood testosterone abnormal, Chest pain, Discomfort, Fatigue
Clinical narrative: Covid 19 Nasal Swab/ Positive/ Sep2022; Covid 19 Nasal Swab/ Positive/ Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 11Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 33 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 Nasal Swab/ Positive/ Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Nasal Swab. Additional information: Facility type vaccine: Pharmacy or Drug Store. There were no other vaccine in four weeks and no other medications in two weeks.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymph gland infection, Lymph node calcification, Lymphadenopathy, Musculoskeletal chest pain, Pain
Clinical narrative: Covid 19 Nasal Swab/ Positive/ Sep2022; Covid 19 Nasal Swab/ Positive/ Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 11Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 33 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 Nasal Swab/ Positive/ Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Nasal Swab. Additional information: Facility type vaccine: Pharmacy or Drug Store. There were no other vaccine in four weeks and no other medications in two weeks.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary pain
Clinical narrative: Covid 19 Nasal Swab/ Positive/ Sep2022; Covid 19 Nasal Swab/ Positive/ Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 11Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 33 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 Nasal Swab/ Positive/ Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Nasal Swab. Additional information: Facility type vaccine: Pharmacy or Drug Store. There were no other vaccine in four weeks and no other medications in two weeks.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid 19 Nasal Swab/ Positive/ Sep2022; Covid 19 Nasal Swab/ Positive/ Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 11Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 33 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 Nasal Swab/ Positive/ Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Nasal Swab. Additional information: Facility type vaccine: Pharmacy or Drug Store. There were no other vaccine in four weeks and no other medications in two weeks.
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: immune system issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 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. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: Feb2021, for COVID-19 immunization; Bnt162b2 (Dose 2, single), administration date: Feb2021, for COVID-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "recovered", described as "immune system issues".  Additional information: The patient reports receiving the primary series for the Pfizer COVID-19 vaccine, original formulation, in around Feb2021. Then she had the Pfizer COVID-19 booster exactly 1 year ago. The consumer reports skipping the second booster this spring because she has immune system issues and was having a bad time, so she did not want to get a second booster then. She has since recovered, recovery date not specified. The consumer received the Pfizer COVID-19 bivalent booster as dose 4 (booster), single 02Nov2022 (Wednesday) for covid-19 immunisation.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: He got the first two and then he had gotten COVID; He got the first two and then he had gotten COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the parent.  An infant (almost 23 months) male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The reporter wanted to know when her son could take the third booster shot. Her son was under 2-year-old. He got the first two and then he had gotten COVID, so they pushed it back a week and then the doctor's office cancelled, and now they were having trouble finding a location that will administer it. She was wondering how long until he wouldn't be valid anymore to get the third dose. The doctor said any time after the 8 weeks was fine but she did not want to as it has been 3 months at the time of report. Outcome of the events was unknown.  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: Headache, Pain in extremity
Clinical narrative: I had pain in the arm after the 4 days; slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ongoing allergy problems/allergies" (ongoing), notes: I have medical problems and allergies/ongoing allergy problems. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, 4 days after the suspect product(s) administration, outcome "unknown", described as "I had pain in the arm after the 4 days"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "slight headache".  Additional information: it was reported as the patient wanted to get the Pfizer COVID-19 booster for adults. I have not been able to get it for ongoing allergy problems. My pharmacist said I have to wait until I'm not flaring up. I would assume this is accurate. Additionally, I'm trying to find out with the ingredients of the new Pfizer booster that I might have an adverse reaction to. The pharmacy said I need to have another two boosters to get the new booster. The caller requested information on whether flaring allergies are a contraindication for the Pfizer-BioNTech COVID-19 vaccine, Bivalent.  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: Dyskinesia, Sensory disturbance, Vibration syndrome
Clinical narrative: she has been experiencing "internal vibrations", "weird sensations", as her whole body is pulsing.; she has been experiencing "internal vibrations", "weird sensations", as her whole body is pulsing.; she has been experiencing "internal vibrations", "weird sensations", as her whole body is pulsing.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Nov2021 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DYSKINESIA (non-serious), VIBRATION SYNDROME (non-serious), SENSORY DISTURBANCE (non-serious), outcome "unknown" and all described as "she has been experiencing "internal vibrations", "weird sensations", as her whole body is pulsing.". Additional information: She explained that she received the third dose of this vaccine in Nov2021. Since then, she has been experiencing internal vibrations, weird sensations, as her whole body is pulsing. She wanted to know if similar cases have been reported before.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Off label use, Product use issue, Pyrexia
Clinical narrative: It was the same time I got the Pfizer vaccine I also got the shingles vaccine; It was the same time I got the Pfizer vaccine I also got the shingles vaccine; Had a slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), on 02Nov2022 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 02Nov2022, outcome "unknown" and all described as "It was the same time I got the Pfizer vaccine I also got the shingles vaccine"; PYREXIA (non-serious) with onset Nov2022, outcome "not recovered", described as "Had a slight fever".  Additional information: She explained that she had a slight fever after receiving the Pfizer-BioNTech COVID-19 Vaccine, bivalent, on Wednesday (02Nov2022). However, by today (Friday) (05Nov2022), she still felt the slight fever. She wanted to know if this was a normal symptom. Consumer stated that, this might not be important for your that it was the same time she got the bivalent vaccine and also got a shingles vaccine so this might not work for you.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Seizure
Clinical narrative: Seizure; Patient received Janssen as dose 1, Moderna as dose 2, and Pfizer bivalent as dose 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 14:00 as DOSE 3 (BOOSTER), SINGLE (lot number: GH9703) at the age of 23 years, administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "Autism" (unspecified if ongoing). There were no concomitant medications; patient did not receive other vaccine in four weeks and did not receive other medication in two weeks. Patient had no known allergies. Patient was not diagnosed with Covid prior to vaccination. Vaccination history included: Moderna (second dose (not bivalent), via an unspecified route of administration, administered in the left arm, on 20Nov2021 at 14:00 (batch/lot number: 065F21A) as DOSE 2, SINGLE), when the patient was 22 years old, for COVID-19 Immunization; Janssen (first dose (not bivalent), via an unspecified route of administration, administered in the left arm, on 08Apr2021 at 14:00 (batch/lot number: 043A21A) as DOSE 1, SINGLE), when the patient was 21 years old, for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Oct2022 at 14:00, outcome "unknown" described as "Patient received Janssen as dose 1, Moderna as dose 2, and Pfizer bivalent as dose 3"; SEIZURE (medically significant) with onset 25Oct2022 at 16:45, outcome "recovered with sequelae." The event "seizure" required emergency room visit or urgent care and patient recovered with lasting effects. Therapeutic measures were not taken as a result of seizure., Patient was not covid tested post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Off label use, Product use issue, Syncope, Vomiting
Clinical narrative: Fainting; vomiting; Other vaccine same date product: Flu vaccine; Other vaccine same date product: Flu vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2022 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 04Nov2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Bipolar" (unspecified if ongoing); "Known allergies: Yes (penicillin)" (unspecified if ongoing); "Known allergies: other antibiotics" (unspecified if ongoing). Patient did not have COVID-19 prior to vaccination and was not tested post vaccination. There were no concomitant medications. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 04Nov2022, outcome "unknown" and all described as "Other vaccine same date product: Flu vaccine"; SYNCOPE (medically significant) with onset 04Nov2022 at 18:45, outcome "recovered", described as "Fainting"; VOMITING (non-serious) with onset 04Nov2022 at 18:45, outcome "recovered". The events "fainting" and "vomiting" required emergency room visit. Therapeutic measures were not taken as a result of syncope, vomiting.  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: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness".  Additional information: No Covid-19 prior vaccination. Post-vaccination, the patient was not tested with COVID-19.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under left armpit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Lot number: GH9697), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE , lot number: ER2613, vaccine location=Left arm), administration date: Apr2021, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE , lot number: ER2613, vaccine location=Left arm), administration date: Mar2021, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph node under left armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment/COVID test: Positive; COVID-19 Treatment/COVID test: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 56 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). There were no concomitant medications. 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/COVID test: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The event was assessed as non-serious by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Vaccination brand other: Moderna/Vaccination brand other: Pfizer / BioNTech; This is a spontaneous report received from 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 17Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 12Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 07Oct2021 as dose  3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "not recovered", described as "Vaccination brand other: Moderna/Vaccination brand other: Pfizer / BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 97-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 at 14:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 97 years, in right arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 17Jan2021 at 14:15 as dose 1, single (Lot number: EK4176), in left arm, on 07Feb2021 at 13:45 as dose 2, single (Lot number: EL9263), in right arm, on 02Nov2021 at 13:45 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 18Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FK9729), in left arm for COVID-19 immunization. The patient's relevant medical history included: "dementia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "CHF" (unspecified if ongoing), notes: CHF; "BPH" (unspecified if ongoing); "major depressive disorder" (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 Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, COVID-19.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine products BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 09:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: Tested positive for COVID 5 days after finishing paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 06May2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, 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, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: taking Paxlovid for Covid-19 treatment; taking Paxlovid for Covid-19 treatment; had 2 of the Pfizer vaccines then switched to Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single and as dose 2, single for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), 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 "taking Paxlovid for Covid-19 treatment"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "had 2 of the Pfizer vaccines then switched to Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Limb discomfort
Clinical narrative: Pfizer vaccines and 2 weeks after caller's 2nd Pfizer shot caller got Bell's palsy; she got calves pulsing after she got the second shot; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 04Nov2022, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: BELL'S PALSY (medically significant), 2 weeks after the suspect product(s) administration, described as "Pfizer vaccines and 2 weeks after caller's 2nd Pfizer shot caller got Bell's palsy"; LIMB DISCOMFORT (non-serious), 2 weeks after the suspect product(s) administration, described as "she got calves pulsing after she got the second shot". It was reported that the patient received 2 shots of the Pfizer COVID-19 vaccine. Two weeks after the second shot, the patient experienced her calves pulsing. Her doctor then switched her to Moderna after that. Now, the patient takes Paxlovid (has taken 6 pills) and she was wondering if there are similar ingredients in the Paxlovid and the vaccine that could cause the same reaction because she wanted to check the lists ingredient by ingredient. On 04Nov2022, it was reported that 2 weeks after the second shot of Pfizer COVID-19 vaccine, the patient got Bell's palsy. The doctor didn't have a way to prove if the Bell's palsy was from the vaccine or not. So, the patient was told to get the Moderna. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
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). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 19Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests: SARS-CoV-2 test: (2022) Negative; (2022) Positive. 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.
Age: 70.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hiatal hernia" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 48.0
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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jul2022 at 14:00 as dose 4 (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), 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: "Shellfish allergy" (unspecified if ongoing); "Peanuts allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Naproxen, reaction(s): "known allergy: Naproxen", notes: known allergy: Naproxen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested positive for COVID after a negative rapid AND PCR test; (04Nov2022) Positive, notes: Tested positive for COVID after a negative rapid AND PCR test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was given Paxlovid for Covid-19 treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201280013 Same patient/reporter; different drug/AE;
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster), single (Lot number: BBOSSTA) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibuprophen, reaction(s): "Allergy". 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 73-year-old male patient received BNT162b2 (BNT162B2), on 15Jun2022 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left 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 had no relevant medical history. There were no concomitant medications. In 2022, the patient had COVID-19. The patient received PAXLOVID (lot#: 300691085301) from 31Oct2022 until 04Nov2022 as treatment for COVID-19. Outcome of the events were unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from 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 25Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0161), in left arm, on 08Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 17May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 07Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid treatment from 25Oct2022 to 30Oct2022.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza virus test, SARS-CoV-2 test, Streptococcus test, Vaccination failure
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer), Program ID: (172086). The reporter is the patient. A 65-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6204), on 23Mar2021 as dose 2, single (Lot number: EP6955) and on 02Dec2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 64 years for COVID-19 immunization. The patient's relevant medical history included: "long Covid", start date: Jun2020 (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL TRANSDERMAL. It was mentioned that the patient has been healthy as a horse before this. The patient had COVID-19 the first time before the vaccine was out and had long COVID-19 back then too. In 2022, the patient was tested for the flu and strep (unknown results). It was thought that she had strep because her throat was hurting so bad but was tested positive for COVID-19 (vaccination failure) in Jul2022 at the office and on her home test. Two days earlier in 2022, she was negative on the home COVID-19 test. The patient started PAXLOVID (NDC number: 0069-1085-30) from 02Jul2022 until 06Jul2022 as treatment for COVID-19. Outcome of the events were unknown.
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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2022 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Drug allergy" (unspecified if ongoing), notes: Relevant past drug history:, Name of Drug as Reported: No, Reaction: Allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Positive test 2 days after completing treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 23Oct2022 to 27Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19 using paxlovid; Treatment of COVID-19 using paxlovid; This is a spontaneous report received from non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE; LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19 using paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Oct2022) Positive, notes: Rebound COVID with positive Ag test 3 days after completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Age: 61.0
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 63-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8733), on 22Apr2021 as dose 2, single (Lot number: EW0175) and on 08Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 61 years for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 20Jul2022 as dose 4 (booster), single (Lot number: 055A22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LOSARTAN; ATORVASTATIN, stop date: 20Oct2022; PALMETTO PLUS [EPILOBIUM PARVIFLORUM;SERENOA REPENS;URTICA DIOICA]. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: tested negative x2 done 48 hours apart; (2022) Negative, notes: tested negative x2 done 48 hours apart; (2022) Positive, notes: tested positive for COVID again on day 10. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid and tested negative x2 done 48 hours apart then 9 days after last dose of Paxlovid, started coughing again and tested positive for COVID again on day 10.