chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Tremor
Clinical narrative: I woke up felling hot; I feel hot and its not hot; Shaking; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  An 89-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 89 years 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: FEELING HOT (non-serious) with onset 21Dec2022, outcome "not recovered", described as "I woke up felling hot; I feel hot and its not hot"; TREMOR (non-serious) with onset 21Dec2022, outcome "not recovered", described as "Shaking".  Additional information: Consumer stated, "I am having a reaction to the Pfizer shot, the newest the latest one, Covid19 vaccine, bivalent one, the original one. I woke up feeling hot and I am shaking and I feel hot and its not hot."  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: F
Vaccine: COVID19
Symptoms: Colitis microscopic, Colonoscopy
Clinical narrative: Biopsy by colonoscopy was positive for Lymphocytic Colitis; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 70-year-old female patient received BNT162b2 (BNT162B2), 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 ), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE ), for COVID-19 immunization. The following information was reported: COLITIS MICROSCOPIC (medically significant), outcome "unknown", described as "Biopsy by colonoscopy was positive for Lymphocytic Colitis". The patient underwent the following laboratory tests and procedures: Colonoscopy: positive, notes: Biopsy by coloscopy was positive for Lymphocytic Colitis.  Clinical course: Patient started to develop symptoms 4 months after third Pfizer COVID vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event colitis microscopic  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; dose #1: Pfizer/ dose #2: Pfizer / dose #3: Pfizer / dose #4 Pfizer / dose #5 Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Sep2022 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Sep2022, outcome "unknown", described as "dose #1: Pfizer/ dose #2: Pfizer / dose #3: Pfizer / dose #4 Pfizer / dose #5 Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Covid rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks was no, the patient received Paxlovid treatment for COVID 19 treatment from 12Dec2022 to 16Dec2022. There were no known allergies and other medical history was none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Vaccine brand other=Moderna/ Vaccine brand=Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 34 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Lot number: 020B21A), on 28Apr2021 as dose 2, single (Lot number: 002C21A) and on 22Nov2021 as dose 3 (booster), single (Lot number: G27H21B) for covid-19 immunisation. The patient's relevant medical history included: "General Anxiety Disorder" (unspecified if ongoing); "ovarian cysts" (unspecified if ongoing); "suspected endometriosis" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE HCL; JENCYCLA. Past drug history included: Ceclor, reaction(s): "known allergies Ceclor", notes: known allergies Ceclor. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand other=Moderna/ Vaccine brand=Pfizer/BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Medication:paxlovid; Medication:paxlovid; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Adhesive Tape" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Medication: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: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID treatment; COVID treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non 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 26Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other Medical history: High blood pressure. Concomitant medication(s) included: VALSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) positive; (22Dec2022) line was faint; (23Dec2022) line was strong again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received the treatment with Paxlovid from 14Dec2022 to 19Dec2022 for covid-19. Patient received Valsartan (Amneal) in last 2 weeks. No known allergies. COVID symptoms went away during treatment. Cough and sore throat came back 22Dec.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/has had all 5 Covid 19 shots from Pfizer/She has not gotten Covid in 3 years until now/it was positive; Treatment of COVID-19/has had all 5 Covid 19 shots from Pfizer/She has not gotten Covid in 3 years until now/it was positive; 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 71-year-old 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; BNT162b2 (BNT162B2), 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: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Dec2022, outcome "unknown" and all described as "Treatment of COVID-19/has had all 5 Covid 19 shots from Pfizer/She has not gotten Covid in 3 years until now/it was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Negative, notes: home test that was negative; (Dec2022) Positive, notes: it was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has had all 5 Covid 19 shots from Pfizer and the flu shot. She has not gotten Covid in 3 years until now. She usually wears 3 masks but took it off for a moment and thinks that's when she contracted Covid. She relays taking a home test that was negative. Followed by more tests and it was positive but her nose bled so she was not sure if it was accurate. She reported issues opening parts of the Covid test kits. The patient also reported symptoms starting on Sunday night 18Dec2022. Monday not feeling so well. She has been prescribed Paxlovid and started taking it Thursday 22Dec2022 at 2:15 pm. She began with the morning dose. She took her second dose on Friday 23Dec2022 at 2:15 am.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive at home COVID antigen test; positive at home COVID antigen test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 1, single (Lot number: FK5618), on 03Dec2021 as dose 2, single (Lot number: FK5618) and on 19Jun2022 as dose 3 (orange cap; booster), single (Lot number: FL8095) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (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 22Dec2022, outcome "recovering" and all described as "positive at home COVID antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) Positive, notes: Nasal Swab, positive at home COVID antigen test. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: The prior vaccinations within 4 weeks were reported as none. Prior to the vaccination the patient was not diagnosed with COVID-19.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 at 09:45 as dose 4 (booster), single (Lot number: GJ3275) at the age of 47 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster), single (Lot number: FJ1620), in right 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), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Dec2022) Negative, notes: Day 1; (Dec2022) Negative, notes: Day 4; (Dec2022) Positive, notes: 5 days after end of Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication in 2weeks. No known allergies. The patient received Paxlovid for COVID 19 Treatment from 13Dec2022 to 18Dec2022. Positive COVID test with symptoms 5 days after end of Paxlovid course. Negative tests on Day 1 and day 4.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: The site was swollen; Strictly an unusual injection site reaction-severe itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 14:15 as dose 5 (booster), single (Lot number: b1h9693) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "pre-diabetic" (unspecified if ongoing); "known allergies: all sulfa drugs" (unspecified if ongoing), notes: known allergies: all sulfa drugs. Concomitant medication(s) included: OXYBUTYNIN; LOSARTAN; OMEPRAZOLE; AREDS 2 VISUAL ADVANTAGE. Past drug history included: Hydrochlorothiazide, reaction(s): "known allergies:hydrochlorothiazide", notes: known allergies:hydrochlorothiazide. Vaccination history included: Covid-19 vaccine (Dose 1 Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2 Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 Manufacturer: Unknown), for COVID-19 Immunization; Flu shot (I am very glad I waited about 10 days to get my flu shot afterwards-and I got that in the right arm), for Immunization. The following information was reported: INJECTION SITE PRURITUS (non-serious) with onset 22Sep2022, outcome "recovered" (Sep2022), described as "Strictly an unusual injection site reaction-severe itching"; INJECTION SITE SWELLING (non-serious) with onset 22Sep2022 at 14:15, outcome "recovered" (Sep2022), described as "The site was swollen". Therapeutic measures were not taken as a result of injection site swelling. Therapeutic measures were taken as a result of injection site pruritus.  Additional information: Patient reported that strictly an unusual injection site reaction-severe itching starting a few hours after the shot and lasting 5-7 days. So bad she put Hydrocortisone cream on it so she could sleep, the first night. After that she just kept taking Acetaminophen and/or Ibuprofen the next few days to take the edge off. she was afraid that the Hydrocortisone might interact with the shot so she only tried that the first night. The sight was swollen but flattened out and returned to normal by the 7th day. The previous 4 doses did not bother me at all, so she was surprized by this experience. she was very glad she waited about 10 days to get her flu shot afterwards-and she got that in the right arm just in case. Patient received Other medications in two weeks Oxybutynin, Losartan, Omeprazole, Areds2, Multivitamin
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Heart rate increased, Palpitations, SARS-CoV-2 test
Clinical narrative: After my booster, I developed heart palpitations/fluttering a few months after; After my booster, I developed heart palpitations/fluttering a few months after; I went to the emergency room twice due to my fast heart beat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Endometriosis" (unspecified if ongoing), notes: Other medical history: Endometriosis/ Fibroid; "Fibroid" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number: 2, Vaccine location: Left arm, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 08Apr2021, when the patient was 42-year-old, for COVID-19 immunization; BNT162b2 (Dose number: 1, Vaccine location: Left arm, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 18Mar2021, when the patient was 42-year-old, for COVID-19 immunization. The following information was reported: CARDIAC FLUTTER (medically significant), PALPITATIONS (non-serious) all with onset 20Jun2022, outcome "not recovered" and all described as "After my booster, I developed heart palpitations/fluttering a few months after"; HEART RATE INCREASED (non-serious) with onset 20Jun2022, outcome "not recovered", described as "I went to the emergency room twice due to my fast heart beat". The events "after my booster, i developed heart palpitations/fluttering a few months after" and "i went to the emergency room twice due to my fast heart beat" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive, notes: Nasal swab. Therapeutic measures were not taken as a result of cardiac flutter, palpitations, heart rate increased. Clinical details: It was reported, After booster, on 20Jun2022 the patient developed heart palpitations/fluttering a few months after. She went to the emergency room twice due to fast heartbeat. The patient was Not recovered. No treatment given. COVID prior vaccination was No. COVID was tested positive post vaccination with Nasal swab PCR test on 08Oct2022. Known allergies include Penicillin. Other medical history include Endometriosis/ Fibroid. No other vaccine in four weeks. No other medications in two weeks.  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: Fatigue
Clinical narrative: Fatigue, terrible fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "don't smoke"; "don't drink". The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue, terrible fatigue". The event "fatigue, terrible fatigue" required physician office visit. Therapeutic measures were not taken as a result of fatigue. Additional information: 2 or 3 days later like almost immediately, the patient experienced fatigue. The patient did not connect it to the shot at first and then she got the second one. The patient definitely feel and the patient's doctor also agreed that he had other cases that are experiencing the same thing.The patient also talk to the doctors and the doctor say well you just have to work through it, they don't seem to have any treatment. The patient don't drink and don't smoke. She was a good person. She like to workout. She like to take care of her home and take care of this but she can't. She was just too tired all the time. She have a hard time to get dressed in the morning. She would like some kind of help because she don't know where to turn.  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-202201393742 same patient/vaccine, different event/dose;US-PFIZER INC-202201265296 same patient/vaccine, different event/dose;US-PFIZER INC-202201265277 same patient/vaccine, different event/dose;
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 23 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 and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2022) Negative, notes: no symptoms; (21Dec2022) Positive, notes: symptoms started. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 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: "Thyroid disease" (unspecified if ongoing), notes: Thyroid disease; "Osteoporosis" (unspecified if ongoing); "Parathyroid disease" (unspecified if ongoing); "Knee and hip Replacements" (unspecified if ongoing), notes: Knee and hip Replacements; "Knee and hip Replacements" (unspecified if ongoing), notes: Knee and hip Replacements; "Back surgery" (unspecified if ongoing); "known allergies:Latex" (unspecified if ongoing); "known allergies:adhesives" (unspecified if ongoing). Concomitant medication(s) included: TRAMADOL; OXYCODONE, start date: 05Oct2022; TYLENOL, start date: 05Oct2022. Past drug history included: Gluten, reaction(s): "known allergies: gluten", notes: Latex and adhesives, gluten sensitivity. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 from 14Dec2022 to 19Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm very sore throughout the day.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 18-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 at 11:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 18 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. 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: PAIN IN EXTREMITY (non-serious) with onset 23Dec2022, outcome "recovering", described as "Left arm very sore throughout the day.". Additional information: Left arm very sore throughout the day. Complaint arose because he didn't feel he could lift weights/exercise until this resolved. Known allergies: No, If COVID prior vaccination No, If COVID tested post vaccination: No, Other medical history: None. If other vaccine in four weeks: No, If other vaccine in two weeks: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: came down with COVID; came down with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unnown , 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) with onset 13Dec2022, outcome "recovered", COVID-19 (medically significant) with onset 13Dec2022, outcome "recovered" and all described as "came down with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2022) Positive; (20Dec2022) positive again; (Dec2022) Negative; (13Dec2022) Positive, notes: When to MD office and the results were replicated. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021326262 same patient, different dose (1st dose) different event.;
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 14-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 14 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: "Chairi malformation" (unspecified if ongoing), notes: Chairi malformation, trim 71, Hematomacrosis; "Hematomacrosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Other medication in 2 weeks was reported as No. Anti-viral details: product, COVID 19 Treatment, brand, Paxlovid, treatment start date, 17Dec2022, treatment stop date, 21Dec2022, indication, Treatment of COVID-19,administrator route, Oral was reported. It was reported as Rebound covid19 infection 2 days after med finished, adverse event start date was reported as 24Dec2022, patient had Not recovered, treatment was received, the patient previously received a COVID-19 Vaccine.  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: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 4: Pfizer vaccine and Dose 3,2 are Moderna vaccine and Dose 1 Janssen vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Nov2021 as dose 2 (booster), single (Lot number: 050CZ1A), in right arm and on 30Mar2022 as dose 3 (booster), single (Lot number: 048L21A), in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Lot number: 1805018), 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 09Sep2022, outcome "recovered", described as "Dose 4: Pfizer vaccine and Dose 3,2 are Moderna vaccine and Dose 1 Janssen vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Positive rapid test 48hrs after negative test. Asymptomatic, at this time. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Near Negative; (Dec2022) Solid positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 13Dec2022 to 18Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "Multiple sclerosis" (unspecified if ongoing); "lupus" (unspecified if ongoing); "sjogren syndrome" (unspecified if ongoing); "APL antibodies" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE], start date: 20Jun2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Dec2022) Positive, notes: Positive; (24Dec2022) Positive, notes: Positive at 9:30 am. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient had no known allergies. Patient received other medication in 2 weeks. The patient received Paxlovid (anti-viral drug) from 12Dec2022 to 17Dec2022 for the treatment of COVID-19. The patient tested positive for COVID on 11Dec2022 and took Paxlovid for treatment of COVID. Did not test negative until 21Dec2022. Symptoms began on 23Dec2022 early evening. Tested positive for COVID again on 24Dec22 9:30 am. Symptoms: fever, cough, congestion, dry mouth, extreme fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
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 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Negative; (09Dec2022) Positive; (15Dec2022) Negative; (21Dec2022) Positive. 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.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand: Pfizer/BioNTech / vaccine brand other: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Sep2022 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2021, outcome "unknown", described as "vaccine brand: Pfizer/BioNTech / vaccine brand other: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 17Dec2022, Treatment stop date: 21Dec2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand Other: Moderna, Vaccine administration date: 07Sep2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN6202), in left arm, on 20Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 15Dec2022; TADALAFIL, stop date: 15Dec2022. Past drug history included: Lisinopril, reaction(s): "Known allergies: lisinopril". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022, outcome "unknown", described as "Vaccine brand Other: Moderna, Vaccine administration date: 07Sep2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Dec2022) Positive, notes: Positive test five days after completing treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 65 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. 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.
Age: 32.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster)., single (Lot number: GJ5342) at the age of 32 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6207), on 07Apr2021 as dose 2, single (Lot number: EW0151) and on 22Oct2021 as dose 3 (booster), single (Lot number: 301358) 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 15Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Dec2022) Positive; (21Dec2022) Negative; (22Dec2022) Negative; (24Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient took paxlovid for COVID 19 Treatment from 15Dec2022 to 20Dec2022. Rebound after completing Paxlovid prescription. Tested positive initially on 15Dec2022 and started prescription. Completed prescription 20Dec2022. Tested negative 21Dec2022-22Dec2022. Tested positive with sore throat 24Dec2022.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Negative.  Clinical Course: Anti-viral details: Product: COVID 19 Treatment, Treatment start date: 14Dec2022 Treatment stop date: 18Dec2022 Indication: Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna, vaccine brand=Pfizer / BioNTech; vaccine brand other=Moderna, vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 at 10:00 as dose 1, single (Lot number: EL3302), in right arm and on 02Mar2021 at 10:00 as dose 2, single (Lot number: EM9809) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 058E21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin & hydrocodone. There were no concomitant medications. Past drug history included: Hydrocodone, reaction(s): "known allergies: Hydrocodone", notes: known allergies: Penicillin & hydrocodone. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 19Nov2021 at 14:00, outcome "unknown" and all described as "vaccine brand other=Moderna, vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: Tested and was negative two days in a row; Negative, notes: Tested and was negative two days in a row. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Known allergies was reported as Penicillin & hydrocodone. Other medical history was None. Patient took no regular meds. Other medication in 2 weeks was reported as No. Anti viral details (Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 14Dec2022, Treatment stop date: 19Dec2022, Lot number: GG2065, Indication: Treatment of COVID-19) was reported. Adverse event was reported as Paxlovid rebound. Took the paxlovid as directed. Tested and was negative two days in a row. Symptoms restarted without fever, but burning sinuses, congestion, dry cough, fatigue, metallic taste returned to mouth. Patient had Not recovered. No treatment was taken for adverse event.