chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: CD4 lymphocytes, CD4 lymphocytes abnormal, Fatigue, Pain in extremity
Clinical narrative: CD4 is the one out of whack; Horrible fatigue; Soreness in arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: ER8735) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CD4 LYMPHOCYTES ABNORMAL (non-serious), outcome "unknown", described as "CD4 is the one out of whack"; FATIGUE (non-serious), outcome "unknown", described as "Horrible fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He had been in touch back in 2021. He is one of the ones that had bad reaction to the Pfizer COVID 19 vaccine ER8735, expiration unknown first one he got. Seen 16 different doctors. Been with a hematologist for 6 months. CD4 is the one out of whack. Just got re-tested and it is over the 254. Since his vaccines from 2021, he is still dealing with horrible issues. Horrible fatigue.  Doctor would have to call to talk if anything can be done or anything working on this. He is a little better. There was something in one of those regarding Prednisone. They were using Prednisone to see if it might help. Make sure they both coincide with the Pfizer COVID 19 vaccine report. One of the letters said BNT162B2 on it as well. Sent list of everything he had filed. Lot ER8735 was the first one. There were many VAERs and several deaths and disabilities from that one.  He was close to death and has been fighting. He does not know of any of the individuals that had similar issues. His wife works in (hospital name withheld) and one of her colleagues had the same. He did not have any information for any others.  The 2nd Pfizer COVID 19 vaccine lot EU10150, expiration unknown. He did not get immediate symptoms after the first one. He felt something like bad allergies after the first. Soreness in arm which was fine.  His gradually got worse at weeks went on.  Regarding the Prednisone, he stopped it. He was on high alert and it just made him feel worse. He does not have a lot or expiration of the Prednisone. He confirmed he did not receive anything to send one back in. He wants to know who should his doctor call for this information and will they be able to pull up his previous reports to talk with him. Is there a separate number for a doctor to call in.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Apr2021 as dose 2, single (Lot number: CW0151), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (20Feb2023) Negative. Therapeutic measures, Paxlovid from 12Feb2023 to 16Feb2023, were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Brain fog, COVID-19, Disturbance in attention, Fatigue, Oropharyngeal pain
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 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Apr2021 as dose 2, single (Lot number: CW0151), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (20Feb2023) Negative. Therapeutic measures, Paxlovid from 12Feb2023 to 16Feb2023, were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing, Vaccine breakthrough infection
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 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Apr2021 as dose 2, single (Lot number: CW0151), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (20Feb2023) Negative. Therapeutic measures, Paxlovid from 12Feb2023 to 16Feb2023, were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Moderna, Dose Number: 1, 2, 3 ; Pfizer/BioNTech, Dose Number: 4, 5; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 76 years, in right leg for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Mar2022 as dose 4 (booster), single (Lot number: FJ6369), in right leg for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Mar2021 as dose 1, single (Lot number: 036A21A), in left leg, on 03Apr2021 as dose 2, single (Lot number: 025B21A), in right leg and on 17Sep2021 as dose 3 (booster), single (Lot number: 040C21A), in right leg for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "BP" (unspecified if ongoing); "past Ca hx" (unspecified if ongoing); "Breast& Melanoma stage 1 scalp" (unspecified if ongoing); "Bronchiaectasis" (unspecified if ongoing); "known allergies: antibiotics" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: BAYERS ASPIRIN, start date: Jan2014; EXEMESTANE, start date: May2018; IBUPROFEN; METOPROLOL SUCCINATE, start date: Apr2021; NIACINAMIDE, start date: Apr2019; ROSUVASTIN, start date: Jun2018; SPIRONOLACTONE, start date: May2018; THERATEARS, start date: May2020; COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], start date: Dec2022; STIOLTO RESPIMAT, start date: Nov2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Mar2022, outcome "unknown", described as "Moderna, Dose Number: 1, 2, 3 ; Pfizer/BioNTech, Dose Number: 4, 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid (COVID 19 Treatment) from 27Jan2023 to 31Jan2023.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccines,  cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product 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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer covid vaccine: positive for covid with fever; Pfizer covid vaccine: positive for covid with fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL9269, Expiration Date: 31May2021), on 04Mar2021 as dose  2, single (Lot number: EN6198, Expiration Date: 30Jun2021), on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 02Aug2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: high blood pressure diagnosed about 5 years ago; "covid", start date: 06Nov2020 (unspecified if ongoing), notes: Covid (prior to vaccination) & then covid was not detected on 03Dec2020. No symptoms. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Feb2023, outcome "not recovered" and all described as "Pfizer covid vaccine: positive for covid with fever". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2023) positive, notes: positive for covid; (Feb2023) positive, notes: tested for covid three days in a row; (Feb2023) positive, notes: tested positive for covid three days in a row; (Feb2023) positive, notes: tested positive for covid three days in a row. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that dose 3 lot number - 320308D or 320308P, last letter might be a D (he was looking on vaccine record card).Started Paxlovid on day 1 of covid positive test, clarified started Paxlovid on 08Feb2023. Completed treatment (all 30 pills).He was prescribed Paxlovid when he had a fever, with his initial covid illness, he ran a fever for a day and a half and then cleared up.   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-202300082945 Same patient, different product, different event;
Age: 66.0
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) from product quality group. The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FK9874), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prinzmetal angina" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "prior MI" (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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (21Feb2023) Negative, notes: Rebound-5 days after completing paxlovid and 2 days after a negative test; (23Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 14Feb2023 to 18Feb2023; lot number: GF3895).  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4 ; moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 12:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 at 14:45 as dose 1, single (Lot number: EN6207), in left arm, on 02Apr2021 at 15:15 as dose 2, single (Lot number: FW0150), in left arm and on 08Oct2021 at 15:15 as dose 3 (booster), single (Lot number: 30155BA), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2022 at 13:00 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2022 at 13:00, outcome "unknown", described as "Dose Number: 4 ; moderna"; 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: (14Feb2023) Positive, notes: COVID 19 Treatment; (19Feb2023) Negative, notes: I took an at-home covid test and was negative; (23Feb2023) Positive, notes: Four (4) days later I tested positive again for covid,. 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: 78.0
Sex: F
Vaccine: 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) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2022 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Chronic pain" (unspecified if ongoing); "Known Allergies: Penicillins" (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 Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL1283), in right arm, on 20Feb2021 as dose 2, single (Lot number: EN6202), in right arm and on 24Sep2021 at 10:45 as dose 3 (booster), single (Lot number: FF2588) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: (unspecified if ongoing); "Full Spleen Removal" (unspecified if ongoing); "Back Isuess" (unspecified if ongoing); "Known allergies: Latex" (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 Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures, Paxlovid from 20Feb2023 to 25Feb2023, were taken as a result of vaccination failure, covid-19.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye discharge, Maternal exposure during pregnancy, Swelling of eyelid
Clinical narrative: is pregnant Yes/ 36 weeks; left unilateral eyelid swelling and discharge; left unilateral eyelid swelling and discharge; This is a spontaneous report received from a contactable reporter (Pharmacist). The reporter is the patient.  A 33-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Feb2023 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pregnancy" (unspecified if ongoing). Date of last menstrual period: 16Jun2022. The patient was 35 weeks pregnant at the time of exposure to BNT162b2, BNT162b2 omi ba.4-5. The patient was 36 weeks pregnant at the event onset. The patient is expected to deliver a baby on 20Mar2023. Concomitant medications included: PRENATAL [FOLIC ACID;IRON]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (Dose number: 1, Unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose number: 2, Unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose number: 3, Unknown manufacture), for COVID-19 immunization. The following information was reported: SWELLING OF EYELID (non-serious) with onset 23Feb2023 at 06:00, outcome "recovering", EYE DISCHARGE (non-serious) with onset 23Feb2023 at 06:00, outcome "recovered" (24Feb2023 at 06:00) and all described as "left unilateral eyelid swelling and discharge"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "is pregnant Yes/ 36 weeks". The events "left unilateral eyelid swelling and discharge" required physician office visit. Therapeutic measures were taken as a result of swelling of eyelid, eye discharge.  Additional information: On Thursday 23Feb, woke up with left unilateral eyelid swelling and discharge. Initially thought due to infection and received antibiotic drops. Primary care thought a stye was developing but never localized. Friday evening, right eye developed swelling with discharge. Same presentation - no stye formation. Discharge resolved after 24 hours. Swelling persisted. The patient had no COVID prior to vaccination and not tested for COVID post vaccination. The patient has no known allergies.  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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer vaccine: 26Oct2021 and Moderna vaccine: 09May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 as dose number unknown, single (Lot number: 320308D) at the age of 63 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09May2022 as dose number unknown, single (Lot number: 057M21A) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09May2022, outcome "unknown", described as "Pfizer vaccine: 26Oct2021 and Moderna vaccine: 09May2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 67.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 67 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 included: "Osteopenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ranitidine, reaction(s): "Known allergies: ranitidine", notes: Known allergies: ranitidine; Indocine, reaction(s): "known allergies Indocine", notes: known allergies: Indocine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 14Feb2023 to 18Feb2023).
Age: 37.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Nov2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "Gastroparesis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Bi-Polar" (unspecified if ongoing); "peripheral neuropathy" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "chronic migraines" (unspecified if ongoing); "extremely lactose intolerant" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Geodon, reaction(s): "Drug allergy: Geodon"; Abilify, reaction(s): "Drug allergy: Abilify". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Feb2023 to 24Feb2023.  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: 73.0
Sex: M
Vaccine: COVID19, COVID19-2, FLU4
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: CHLORTHALIDONE (manufacturer reported), start date: 01Oct2020, stop date: 25Feb2023; LOSARTAN POTASSIUM (manufacturer), start date: 01Jun2017, stop date: 25Feb2023. Past drug history included: Levaquin, reaction(s): "known allergies Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Feb2023, outcome "recovering" and all described as "Contracted COVID in ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (2023) Positive; (2023) Negative; (2023) Negative; (2023) Negative; (2023) Negative.  Therapeutic measures were taken as a result of drug ineffective, covid-19 included administration of Paxlovid (lot number GF7285) from 17Feb2023 to 21Feb2023). It was reported that the patient had both positive and negative home tests (positive and negative) after four days of negative home tests. Contracted COVID, had four days of negative tests before returning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19-2, FLU4
Symptoms: COVID-19, Fatigue, Foreign travel, Nasal congestion, Patient isolation
Clinical narrative: Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: CHLORTHALIDONE (manufacturer reported), start date: 01Oct2020, stop date: 25Feb2023; LOSARTAN POTASSIUM (manufacturer), start date: 01Jun2017, stop date: 25Feb2023. Past drug history included: Levaquin, reaction(s): "known allergies Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Feb2023, outcome "recovering" and all described as "Contracted COVID in ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (2023) Positive; (2023) Negative; (2023) Negative; (2023) Negative; (2023) Negative.  Therapeutic measures were taken as a result of drug ineffective, covid-19 included administration of Paxlovid (lot number GF7285) from 17Feb2023 to 21Feb2023). It was reported that the patient had both positive and negative home tests (positive and negative) after four days of negative home tests. Contracted COVID, had four days of negative tests before returning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19-2, FLU4
Symptoms: SARS-CoV-2 test positive, Throat irritation
Clinical narrative: Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: CHLORTHALIDONE (manufacturer reported), start date: 01Oct2020, stop date: 25Feb2023; LOSARTAN POTASSIUM (manufacturer), start date: 01Jun2017, stop date: 25Feb2023. Past drug history included: Levaquin, reaction(s): "known allergies Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Feb2023, outcome "recovering" and all described as "Contracted COVID in ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (2023) Positive; (2023) Negative; (2023) Negative; (2023) Negative; (2023) Negative.  Therapeutic measures were taken as a result of drug ineffective, covid-19 included administration of Paxlovid (lot number GF7285) from 17Feb2023 to 21Feb2023). It was reported that the patient had both positive and negative home tests (positive and negative) after four days of negative home tests. Contracted COVID, had four days of negative tests before returning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
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; Vaccine brand other= Moderna/Vaccine administration date= 09Dec2021, Vaccine dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Dec2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 07Apr2021 as dose 2, single (Lot number: EL8982), in left arm and on 19Jul2022 as dose 4 (booster), single (Lot number: EP7139), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Dec2021 as dose 3 (booster), single (Lot number: 007C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 09Dec2021, outcome "unknown", described as "Vaccine brand other= Moderna/Vaccine administration date= 09Dec2021, Vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Feb2023) Positive; (21Feb2023) Negative; (24Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient becomes positive and symptomatic; Patient becomes positive and symptomatic; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing); "Known allergies: Sulfa drugs" (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 "not recovered" and all described as "Patient becomes positive and symptomatic". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Postive, notes: COVID 19 Treatment; Negative, notes: Negative after completion of paxlovid; positive, notes: positive and symptomatic. 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.
Age: 59.0
Sex: M
Vaccine: COVID19
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 at 12:30 as dose 1, single (Lot number: Er2613), in right arm, on 12Apr2021 at 14:15 as dose 2, single (Lot number: Ew0162), in left arm, on 09Apr2022 at 12:15 as dose 3 (booster), single (Lot number: Fic9893), in right arm and on 12Apr2022 at 14:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Nov2021 at 15:45 as dose 4 (booster), single (Lot number: 069f21a), in right arm and on 07Oct2022 at 13:15 as dose 6 (booster), single (Lot number: 053d22a), in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Apr2022 at 14:30, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Treatment of COVID-19; (Feb2023) positive, notes: positive covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Antiviral details included COVID 19 Treatment with Brand Paxlovid (Treatment start date: 07Feb2023, Treatment stop date: 12Feb2023) for Indication Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose number unknown (booster), single (Lot number: GH9702) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FINASTERIDE, start date: 01Jan2012. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid (COVID 19 Treatment) from 15Feb2023 to 20Feb2023.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 76-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Lot number: GLO446 5450), in left arm for covid-19 immunisation; BNT162b2 (COMIRNATY), on 15Mar2021 as dose 1, single (Lot number: EP6455), in left arm, on 05Apr2021 as dose 2, single (Lot number: ER8732), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 11Jul2022 as dose 4 (booster), single (Lot number: FP7150), in left 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information, a possible causal relationship cannot be excluded between the suspect vaccines (bnt162b2 and bnt162b2, bnt162b2 omi ba.4-5) and both events Vaccination failure and COVID-19.
Age: 51.0
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 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Spicy foods" (unspecified if ongoing), notes: Spicy foods; "sulfa meds" (unspecified if ongoing), notes: sulfa meds. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: Negative 4 days; Negative; Negative; Negative. 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.
Age: 46.0
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 47-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: ewo277) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: testing negative; Positive, notes: Rebound positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment for the event from 15Feb2023 to 19Feb2023. Outcome of the events was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer). 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 03Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 26Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 16Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 23Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 25Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: Mold" (unspecified if ongoing). Concomitant medication(s) included: TRELEGY, start date: 26Apr2020. Past drug history included: Asprin, reaction(s): "Known allergies: Asprin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 23Dec2021, outcome "unknown", described as "Interchange of vaccine products "; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of vaccination failure and COVID-19 which was PAXLOVID.  Clinical information: It was reported that the patient had treatment of COVID-19 (noted in 2023) which was PAXLOVID which was from 12Feb2023 until 17Feb2023.   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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Dose Number: 2 Moderna; Dose 3, Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 13:00 as dose 3 (booster), single (Lot number: GH9694) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Oct2021 as dose 2, single (Lot number: 011F21A), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 09Apr2021 as dose 1, single (Lot number: 205A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies". The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Sep2022 at 13:00, outcome "unknown", described as "Dose Number: 2 Moderna; Dose 3, Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19 and included treatment with Paxlovid.