chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid bounce back 6 days after finishing 5-day course of Paxlovid; Covid bounce back 6 days after finishing 5-day course of Paxlovid; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid bounce back 6 days after finishing 5-day course of Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Covid bounce back 6 days after finishing 5-day course of Paxlovid. Same symptoms plus insomnia. Mild first case of Covid; mild 2nd case of covid (both in the same 2 weeks). NOTE: I have all of my booster info and Dx from urgent care but didn't have time to look them up for this form, but I can provide them  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister
Clinical narrative: Covid bounce back 6 days after finishing 5-day course of Paxlovid; Covid bounce back 6 days after finishing 5-day course of Paxlovid; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid bounce back 6 days after finishing 5-day course of Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Covid bounce back 6 days after finishing 5-day course of Paxlovid. Same symptoms plus insomnia. Mild first case of Covid; mild 2nd case of covid (both in the same 2 weeks). NOTE: I have all of my booster info and Dx from urgent care but didn't have time to look them up for this form, but I can provide them  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, 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. Vaccination history included: BNT162b2 (DOSE 6 (BOOSTER), SINGLE, vaccine brand: Pfizer / BioNTech , vaccine administration date: 27Jan2023 , vaccine lot number: GLO447, vaccine dose number: 6, vaccine location: Right arm), administration date: 27Jan2023, for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization. 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 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, RAB
Symptoms: Allergy to vaccine, Feeling hot, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Pt had an allergic reaction to vaccine; arm was very sore; arm is very swollen; arm is very swollen, very very hot and itchy; arm is very swollen, very very hot and itchy; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 80-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; rabies vaccine (RABIES VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Pt had an allergic reaction to vaccine"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm was very sore"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm is very swollen"; FEELING HOT (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "arm is very swollen, very very hot and itchy".  Additional information: Pt had an allergic reaction to vaccine. She wants to know some of the basic ingredients because she is also allergic to the Rabies vaccine. She said that she received the vaccine twice along with other two available vaccines for Covid. She said that the first time she received the vaccine, her arm was very sore and it took 2 weeks before the soreness was gone. "This tome my arm is very swollen, very very hot and itchy. It hurts when I try to reach it." She also said that in the case that she has to take another shot, she won't take the shot anymore.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 68.0
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 Consumer or other non HCP from product quality group.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 02:30 as dose 1, single (Lot number: HG2282) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no known allergies. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2; BNT162b2 omi ba.4-5 (Dose Number unknown, Batch/Lot No: GH9694), administration date: 15Sep2022, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2 (Dose Number unknown, Batch/Lot No: FR9894), administration date: 08Apr2022, when the patient was 67-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (Dose Number unknown, Batch/Lot No: 029L20A), administration date: 11Nov2021, when the patient was 66-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (Dose Number: 1, Batch/Lot No: 012L20A), administration date: 11Jan2021, when the patient was 66-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19". It was reported that Covid-19 symptoms appearing again after symptom-free period during taking of Paxlovid. She finished Paxlovid Thursday morning and by Friday afternoon was feeling she was coming down with a cold: scratchy throat, sneezing. Positive COVID test just now on 08Jan2024 (Monday) at 9: 00 am. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2024) Positive, notes: Covid-19 rebound. Treatment (Paxlovid 300-100mg dose pack) was taken as a result of covid-19 from 30Dec2023 to 04Jan2024. Other medication received included Ibuprofen, Pepcid and Megaflor Probiotic from Jan2024 to Jan2024.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Small fibre neuropathy
Clinical narrative: A couple of weeks after taking vaccine patient developed small fiber neuropathy.; This is a spontaneous report received from a Physician from a sales representative.  An adult male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "A couple of weeks after taking vaccine patient developed small fiber neuropathy.". Therapeutic measures were taken as a result of small fibre neuropathy. Additional Information: Unknown drug allergy.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 56.0
Sex: F
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 Consumer or other non HCP from product quality group.  A 56-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (Dose Number: 5, Batch/Lot No: AS7143C, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 07Sep2022, when the patient was 55-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (Dose Number: 4, Batch/Lot No: 066K21A, Location of injection: Arm Left, Vaccine Administration Time: 05:30 PM), administration date: 06Apr2022, when the patient was 54-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FJ1611, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 18Nov2021, when the patient was 54-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 22Apr2021, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW1050, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 01Apr2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures included Paxlovid from  27Dec2023 to 01Jan2024 were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 54.0
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 Consumer or other non HCP from product quality group.  A 55-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 1, single (Lot number: hg4671) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild heart disease" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: 12Oct2023, stop date: 28Dec2023. Past drug history included: Tetracycline, reaction(s): "Allergy: tetracycline". Vaccination history included: BNT162b2 (Dose 5 (booster), single, vaccine lot number=gh9693, vaccine location=Right arm), administration date: 23Sep2022, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (Dose 4 (booster), single, vaccine lot number=fk9895, vaccine location=Right arm), administration date: 14Apr2022, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (booster), single, vaccine lot number=Fe3590, vaccine location=Right arm), administration date: 22Oct2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, vaccine lot number=EW0151, vaccine location=Right arm), administration date: 14Apr2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, single, vaccine lot number=EP7534, vaccine location=Right arm), administration date: 23Mar2021, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2023) Positive. After having symptoms for about 24 hours, patient then took Paxlovid from the night of 28Dec2023 until the morning of 02Jan2024.
Age: 31.0
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 Consumer or other non HCP from product quality group.  A 31-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Lot number: HG4928) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Narcolepsy w/Cataplexy" (unspecified if ongoing); "Narcolepsy w/Cataplexy" (unspecified if ongoing); "Moderate Asthma" (unspecified if ongoing); "Inappropriate Sinus Tachycardia" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Known allergies: Corn protein" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prochlorperazine edisylate, reaction(s): "Known allergies: Prochlorperazine Edisylate"; Sulfamethoxazole-trimethoprim, reaction(s): "Known allergies: Sulfamethoxazole-Trimethoprim". Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (dose 4, vaccine lot number=GH9702,, vaccine location=Right arm), administration date: 20Oct2022, when the patient was 30-year-old, for COVID-19 immunization; Covid-19 vaccine (dose 1 unknown manufacturer), reaction(s): "COVID-19 immunization"; Covid-19 vaccine (dose 2 unknown manufacturer), reaction(s): "COVID-19 immunization"; Covid-19 vaccine (dose 3 unknown manufacturer), reaction(s): "COVID-19 immunization". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2024) Negative; (06Jan2024) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure included Paxlovid from 29Dec2023 to 03Jan2024.
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 Consumer.  A 51-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Sep2023 at 13:00 as dose 1, single (Lot number: HH7595), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient has no known allergies. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE ; Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2023) Positive, notes: Treatment of Covid-19; (09Jan2024) Positive, notes: I tested positive on morning of 09Jan2024. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted COVID-19; contracted COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID-19".  Clinical course: They contracted COVID-19 after they were vaccinated by Pfizer COVID-19 vaccines  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400003099 Same reporter, same drug and events, different patients.;
Sex: F
Vaccine: RSV
Symptoms: Drug ineffective, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
Clinical narrative: 2 patients positive RSV post RSV vaccine.; 2 patients positive RSV post RSV vaccine; This is a spontaneous report received from a Physician from a sales representative.  A female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "2 patients positive RSV post RSV vaccine."; RESPIRATORY SYNCYTIAL VIRUS INFECTION (medically significant), outcome "unknown", described as "2 patients positive RSV post RSV vaccine". The patient underwent the following laboratory tests and procedures: RSV: Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, respiratory syncytial virus infection. Clinical course: 2 patients (husband and wife) positive RSV post RSV vaccine.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between th event lack of effect (RSV infection) with RSV VACCINE PROT.SUBUNIT PREF 2V can not be fully excluded.,Linked Report(s) : US-PFIZER INC-202400009789 same reporter/drug/event, different patient.;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bone densitometry, Osteoporosis
Clinical narrative: osteoporosis; This is a spontaneous report received from a Physician.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 25Sep2023 as dose number unknown, single) intramuscular, in right arm for immunisation. The patient's relevant medical history included: "Atrial fib", start date: Jun2019 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose Number: 4, Batch/Lot No: FK9729, Location of injection: Arm Left, Intramuscular), administration date: 06May2022, when the patient was 73-year-old, for COVID-19 immunisation; Moderna COVID-19 vaccine (Dose Number: 3, Batch/Lot No: 035C21A, Intramuscular), administration date: 26Oct2021, when the patient was 72-year-old, for COVID-19 immunisation; Comirnaty (Dose Number: 2, Batch/Lot No: EN6201, Intramuscular), administration date: 13Feb2021, when the patient was 71-year-old, for COVID-19 immunisation; Comirnaty (Dose Number: 1, Batch/Lot No: EL3302, Intramuscular), administration date: 22Jan2021, when the patient was 71-year-old, for COVID-19 immunisation. The following information was reported: OSTEOPOROSIS (non-serious) with onset 25Sep2023, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: coughing; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, 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: COUGH (non-serious) with onset 2023, outcome "unknown", described as "coughing".  Additional information: Patient age was reported as 60-64 years. On Dec2023, it was recorded that the patient experienced coughing after taking COVID vaccine. The patient received the vaccine two weeks ago from the day of recording (2023). The patient told the doctor that he didn't have problems right now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: I have been consistently sick with respiratory issues; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "I have been consistently sick with respiratory issues". Additional information: "I have been consistently sick with respiratory issues after being administered with your vaccine. It's not long Covid, because I had Covid way before being forced to get your vaccine and completely recovered. Do you have a remedy to counteract your vaccine?"  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: HEADACHE (non-serious), outcome "unknown".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID around the same time, in 2022, after we were vaccinated; got COVID around the same time, in 2022, after we were vaccinated; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  An 8-year-old female patient received BNT162b2 (COMIRNATY), 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), as dose 4 (booster), single (Batch/Lot number: unknown) and in 2022 as dose 5 (booster),single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "got COVID around the same time, in 2022, after we were vaccinated".  Additional information: The reporter stated, "We all got COVID around the same time, in 2022, after we were vaccinated. It was mild." She received 5 Pfizer COVID vaccines/boosters over the years.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he had taken all the Pfizer vaccine and yet he still got Covid.; he had taken all the Pfizer vaccine and yet he still got Covid.; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer vaccine (DOSE NUMBER UNKNOWN, SINGLE, Batch/Lot number not reported), for covid -19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "he had taken all the Pfizer vaccine and yet he still got Covid.".  Clinical Course: Caller is calling in and said that he had taken all the Pfizer vaccine and yet he still got Covid. Caller is ranting why is the medication Paxlovid to save lives is so expensive, caller said that he is uninsured and asking since it is uninsured then should it let it be since he cannot afford the medication to wait and die.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had avoided Covid even though I had been around people with it until - 21Dec2023; had avoided Covid even though I had been around people with it until - 21Dec2023; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Oct2023 as dose 1, 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 NUMBER UNKNOWN, SINGLE), administration date: 02Oct2021, for Covid-19 immunization; BNT162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 05Oct2022, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Dec2023, outcome "recovering" and all described as "had avoided Covid even though I had been around people with it until - 21Dec2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jan2024) Negative. Clinical course: The patient received Pfizer Covid-19 2023-24 vaccine on 28Oct2023. Also, on 02Oct2021 and 05Oct2022. The patient had avoided Covid even though the patient had been around people with it until - 21Dec2023. The patient has recovered but still coughing, finally testing negative today (05Jan2024). The patient didn't know if any agency is keeping track of cases any longer or if Pfizer would want to know about positive cases in spite of vaccination.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Breast operation
Clinical narrative: had breast surgery; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 01), for Covid-19 Immunization; Bnt162b2 (Dose Number: 02), for Covid-19 Immunization; Bnt162b2 (Dose Number: 03 (Booster)), for Covid-19 Immunization; Bnt162b2 (Dose Number: 04 (Booster)), for Covid-19 Immunization. The following information was reported: BREAST OPERATION (medically significant), outcome "unknown", described as "had breast surgery". Therapeutic measures were taken as a result of breast operation.  Clinical course: The caller had five doses of Pfizer so far and worked out very well with the COVID-19 vaccine and is ready for the update. The caller doesn't know if she should call it a booster or the latest. The caller mentioned that there was a complication. The caller had breast surgery, so she cannot have the injection in her arm and needs to get it in another part of her body like her leg or buttocks. The caller needs to know if she can either give her a facility where she could have this done or if her primary care physician is willing to give the injection if they have the vaccine from a pharmacy and bring it to her on ice. Either a place where the caller can get it on a part of her body other than her arms or a pharmacy that will give her the medication so the caller can bring it to her doctor.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had taken all the Pfizer vaccine and yet he still got Covid; had taken all the Pfizer vaccine and yet he still got Covid; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID:.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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 number unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had taken all the Pfizer vaccine and yet he still got Covid".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: caught COVID twice; caught COVID twice; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD (Chronic obstructive pulmonary disease)" (unspecified if ongoing), notes: I have COPD (Chronic obstructive pulmonary disease) asthma and etc (extra); "Asthma" (unspecified if ongoing), notes: I have COPD (Chronic obstructive pulmonary disease) asthma and etc (extra). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "caught COVID twice".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive on Dec2023; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, 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 (DOSE 1, SINGLE; Manufacturer unknown), for COVID-19 immunization. The following information was reported: COVID-19 (non-serious) with onset Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "tested positive on Dec2023". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Malaise
Clinical narrative: not feeling well; Initial information received on 04-Jan-2024 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Adult female patient (79 kg) who was not feeling well after receiving influenza vaccine and COVID-19 Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug allergy with Augmentin, ciprofloxacin, codeine, codeine sulfate, diclofenac, dicyclomine, hydrocodone, monosodium glutamate, oxycodone hcl, sulfa (sulfonamide antibiotics).   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer and COVID-19 VACCINE not produced by Sanofi Pasteur via unknown route in unknown administration site for prophylactic vaccination (strength, doe, batch number and expiry date- unknown). Information on the batch number was requested.  On an unknown date the patient was not feeling well (malaise) (unknown latency).  It is unknown if there were lab data/results available  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Night sweats, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Woke at midnight with high fever of 102.5 uncontrollable shakes for an hour. Joint pain in hips and legs.  High fever until 4am. Had some night sweats and fever went down to 99.9. Fever has lasted all day between 99-101. Right arm is very sore and a little swollen.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Tremor
Clinical narrative: Woke at midnight with high fever of 102.5 uncontrollable shakes for an hour. Joint pain in hips and legs.  High fever until 4am. Had some night sweats and fever went down to 99.9. Fever has lasted all day between 99-101. Right arm is very sore and a little swollen.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Ringing in both ears. I went to sleep at 10p and woke up at 3 am with this sound in my ears.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Insomnia, Myalgia, Restless legs syndrome
Clinical narrative: MUSCLE PAIN; LOWER BACK PAIN; RESTLESS LEGS; INSOMNIA; COVID-19; This spontaneous report received from a consumer by a Business partner (Pfizer Inc.) on 11-DEC-2023 was received on 11-DEC-2023 and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and fibromyalgia. The patient experienced allergy when treated with penicillin nos for tetanus, and allergy when treated with tetanus vaccine.  The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered in 12-NOV-2021 01:00 to Left Arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date in 2023, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced covid-19. On 04-DEC-2023, the patient experienced muscle pain, lower back pain, restless legs, and insomnia (Dose number in series 1). . Treatment medications included: nirmatrelvir/ritonavir. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, lower back pain, restless legs, and insomnia, and the outcome of covid-19 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Moderate fatigue with some interference with activity; Mild muscle pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)), FATIGUE (Moderate fatigue with some interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)), FATIGUE (Moderate fatigue with some interference with activity) and MYALGIA (Mild muscle pain and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)), FATIGUE (Moderate fatigue with some interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) outcome was unknown.            The AutoCruitment Subject ID was reported.  The RTI-HS Subject ID was reported.  Concomitant and treatment medications were not reported.  Reported that patient had mild injection site pain and no interference with activity, moderate injection site tenderness (tenderness with movement), moderate fatigue with some interference with activity, mild malaise/feeling sick and no interference with activity, mild muscle pain and no interference with activity which occurred on Thursday, Dec 21, 2023, and Friday, Dec 22, 2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 18 out of 87
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Moderate fatigue with some interference with activity; Mild muscle pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Moderate fatigue with some interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Moderate fatigue with some interference with activity) and MYALGIA (Mild muscle pain and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Moderate fatigue with some interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) outcome was unknown.            Concomitant and treatment medications were not reported.  The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on 22-Dec-2023 and 23-Dec-2023.  The Subject ID was reported as 5472844.  The Agency Subject ID was reported as 88595-49896.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 20 out of 87
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: Mild injection site tenderness (tender to touch); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: < 100.4 degree F.         The Database Subject ID was reported as 5470026.  The Regulatory Authority Subject ID was reported as 23048-60733.  Concomitant medications were not reported.  Patient had experienced vaccination site pain, myalgia, fatigue, headache anytime during the 2 days after your COVID-19 vaccination, which occurred on Thursday, Dec 16, 2023 and Friday, Dec 17, 2023.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Patient 7 out of 49
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild injection site tenderness (tender to touch); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: < 100.4 degree F.         The Database Subject ID was reported as 5470026.  The Regulatory Authority Subject ID was reported as 23048-60733.  Concomitant medications were not reported.  Patient had experienced vaccination site pain, myalgia, fatigue, headache anytime during the 2 days after your COVID-19 vaccination, which occurred on Thursday, Dec 16, 2023 and Friday, Dec 17, 2023.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Patient 7 out of 49