chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment/ mild symptoms, runny nose, sneezing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 02Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "Known allergies: sensitivity to peanuts" (ongoing), notes: Known allergies: sensitivity to peanuts and peppers; "Known allergies: sensitivity to peppers" (ongoing), notes: Known allergies: sensitivity to peanuts and peppers. Concomitant medication(s) included: ROSUVASTATIN, start date: 03Jan2022, stop date: 15Jul2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown", described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset Jul2022, outcome "unknown", described as "COVID 19 Treatment/ mild symptoms, runny nose, sneezing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 treated with Paxlovid started on 15Jul2022 and stopped on 19Jul2022.  Clinical course: Adverse events reported were mild symptoms, runny nose, sneezing which started on 25Jul2022 07:00 AM and was recovering.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6204) and on 31Mar2021 as dose 2, single (Lot number: EP6955) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 29Sep2021 as dose 3 (booster), single (Lot number: 301558) and on 30Mar2022 as dose 4 (booster), single (Lot number: 048l21A) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: GABAPENTIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (20Mar2022) Negative; (27Mar2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received treatment with COVID-19 antiviral treatment from 15Jul2022 to 19Jul2022. COVID rebound. The patient received other medication in 2 weeks was yes. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3247), in left arm and on 11Feb2021 as dose 2, single (Lot number: EN9581) at the age of 80 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: O37F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "gout" (unspecified if ongoing); "hyperlipidemia" (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 "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: COVID 19 Treatment; (Jul2022) Positive, notes: One week later my testing remains positive; (15Jul2022) Negative, notes: I had been negative on 15Jul; (19Jul2022) Positive, notes: Then on evening of 19Jul had low grade fever, just as before, SEVERE runny nose and positive home test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, Anti-viral were taken as treatment from 10Jul2022 to 14Jul2022 for the treatment of COVID-19. After completing course on 15Jul2022, patient felt well, only some fatigue. Then on evening of 19Jul2022 had low grade fever, just as before, severe runny nose and positive home test. Patient had been negative on 15Jul2022. Some tiredness. One week later her testing remains "positive". Had some nasal congestion, at times patient had large amounts of mucus. Otherwise, she feel well.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 54 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: "history of ovarian cancer 2016", start date: 2016 (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; ZINC; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (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: (unspecified date) Positive, notes: COVID 19 Treatment; (19Jul2022) Negative, notes: previously tested negative; (26Jul2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Rebound (tested positive again on 26Jul2022) previously tested negative on 19Jul2022. Mild congestion and sore throat.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, Skin exfoliation
Clinical narrative: my arm is swollen; a real bad rash on it that is really red and puffy like.; First it itch and then it burns,; very itchy like and its scaly like scale.; 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), on 21Jul2022 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. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), Unknown manufacturer), for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Jul2022, outcome "unknown", described as "First it itch and then it burns,"; RASH (non-serious) with onset Jul2022, outcome "unknown", described as "a real bad rash on it that is really red and puffy like."; PERIPHERAL SWELLING (non-serious) with onset Jul2022, outcome "unknown", described as "my arm is swollen"; SKIN EXFOLIATION (non-serious) with onset Jul2022, outcome "unknown", described as "very itchy like and its scaly like scale.".  Additional information: On the 21st which was last Thursday patient had second Pfizer Booster shot. Patient was having a reaction from it, my arm was swollen and it has a real bad rash on it that was really red and puffy like. I wanted to know if this is normal or what should I do, do I need to go back to the hospital or what. My arm was swollen and it has a real bad rash on it that was really red and puffy like; it itch and then it burns, very itchy like and its scaly like scale.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Endoscopy, Gastric pH, Gastric pH decreased, Heart rate, Heart rate increased
Clinical narrative: gastric increases; heart rate increases; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A patient (no qualifiers provided) 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: Covid-19 vaccine (DOSE 1, SINGLE (Manufactruer Unknown)), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE (Manufactruer Unknown)), for Covid-19 immunization. The following information was reported: GASTRIC PH DECREASED (non-serious), outcome "unknown", described as "gastric increases"; HEART RATE INCREASED (non-serious), outcome "recovering", described as "heart rate increases". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastric ph decreased.  Additional information: It was reported that patient received the Pfizer COVID-19 vaccine booster and then experienced gastric increases and heart rate increases. Has been almost 5 months now. Patient wanted to know when the vaccine will be out of body. Heart concerns are now better. Has been taking medicine for stomach issues and caller had an endoscopy for stomach.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pruritus, Rash
Clinical narrative: Headache; Muscle pain; Rash; arm pain; it's achy all over; Itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 20Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; TYLENOL. Vaccination history included: Covid-19 vaccine (Primary immunization series complete. MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (First BOOSTER, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset Jul2022, outcome "unknown"; PRURITUS (non-serious) with onset Jul2022, outcome "unknown", described as "Itching"; MYALGIA (non-serious) with onset Jul2022, outcome "unknown", described as "Muscle pain"; RASH (non-serious) with onset Jul2022, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "unknown", described as "arm pain"; MYALGIA (non-serious) with onset Jul2022, outcome "unknown", described as "it's achy all over". The events "headache", "muscle pain", "rash", "arm pain", "it's achy all over" and "itching" required physician office visit. Therapeutic measures were taken as a result of headache, myalgia, rash, pain in extremity, myalgia, pruritus.  Additional information: Consumer stated that she went to doctor and she was told to hold. She was taking antihistamines, She was taking Tylenol, alternatively most with Ibuprofen, hydrocortisone cream, about the, Cold compressive." Consumer stated that no other medications administered just regular multi-vitamins and Tylenol and Ibuprofen." Consumer stated, that this was her second booster dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL1284), in left arm, on 04Feb2021 as dose 2, single (Lot number: EN9581), in left arm, on 23Sep2021 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 16Jun2022 at 01:00 as dose 4 (booster), single (Lot number: FP7531) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; GABAPENTIN; OMEGA 3-6-9. The following information was reported: 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: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: EW0172) at the age of 36 years, 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: "Chronic Prostatitis" (unspecified if ongoing), notes: Other medical history: Chronic Prostatitis; "Moderate Asthma" (unspecified if ongoing), notes: Other medical history: Moderate Asthma; "High Blood Pressure" (unspecified if ongoing), notes: Other medical history: High Blood Pressure; "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity; "Sulfa Drugs" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs. Concomitant medication(s) included: TYLENOL, start date: 11Jul2022, stop date: 14Jul2022. Past drug history included: Bactrum, reaction(s): "Drug allergy: Bactrum", notes: Known allergies: Bactrum. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: completed the treatment on Day 5, tested positive through Day 9; Negative, notes: Tested negative on Days 10 and 11; Negative, notes: Tested negative on Days 10 and 11; Positive, notes: and then felt worse (head cold) again on Day 12 and tested positive; Positive, notes: Still testing strongly positive on Day 17. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event Rebound exactly one week (7 days) after completing the treatment. Patient completed the treatment on Day 5, tested positive through Day 9. Tested negative on Days 10 and 11, and then felt worse (head cold) again on Day 12 and tested positive. still positive on Day 17, still with head cold symptoms. Symptoms are less than original (no fever), but consistent and unabating. Still tested strongly positive on Day 17 (Day 5 of rebound). Adverse event start date was reported as 22Jul2022.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech  Apr2022/ Paxlovid Treatment of COVID-19 19Jul2022; Pfizer / BioNTech  Apr2022/ Paxlovid Treatment of COVID-19 19Jul2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech  Apr2022/ Paxlovid Treatment of COVID-19 19Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID 19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 03Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; ZETIA. Past drug history included: Actonel, reaction(s): "known aleergies: Actonel". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid..  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nasopharyngeal swab, Ultrasound scan, Vaccination site swelling
Clinical narrative: Then a week later my left lymph node swelled; the injection sight swelled; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 28Nov2021 at 13:00 as dose 1, single (Lot number: FF2593) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colloidal cyst removal from brain" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Dec2021 at 06:00, outcome "not recovered", described as "Then a week later my left lymph node swelled"; VACCINATION SITE SWELLING (non-serious) with onset 05Dec2021 at 06:00, outcome "not recovered", described as "the injection sight swelled". The events "then a week later my left lymph node swelled" and "the injection sight swelled" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, vaccination site swelling.  Additional information: A week later left lymph node swelled. Still today (8 months later) it is still swollen. treatment: Sonographic evaluation of left breast and axilla. Post and prior vaccination patient was covid tested. Nasal Swab tested type post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ew0150), on 23Apr2021 as dose 2, single (Lot number: ew0164) and on 27Aug2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (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 "not 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; (Jul2022) Positive, notes: had a positive covid-19 test +9 days after finishing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient developed covid-19 symptoms plus 9 days after finishing Paxlovid and had a positive covid-19 test plus 9 days after finishing Paxlovid.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; his is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: EKS730), in left arm, on 20Jan2021 as dose 2, single (Lot number: EL3246), in left arm and on 01Aug2021 as dose 3 (booster), single (Lot number: EW0198) at the age of 65 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 11Jan2022 as dose 4 (booster), single (Lot number: 1855190), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "NAFLD" (unspecified if ongoing); "hairy cell leukemia" (unspecified if ongoing); "CAD" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2015 taken in 2 weeks. The following information was reported: 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: (unspecified date) Positive, notes: COVID 19 Treatment; (26Jul2022) Positive, notes: positive rapid Covid test again 26Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment included Paxlovid from 14Jul2022 to 18Jul2022.  Clinical course: No known allergies were reported. Rebound Covid infection (completed 5d of Paxlovid 18Jul, symptoms came back on 24Jul, positive rapid Covid test was performed again on 26Jul symptoms persist but no evidence of severe disease at present.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 at 12:00 as dose 1, single (Lot number: EN6201), in right arm and on 02Mar2021 at 15:00 as dose 2, single (Lot number: EN6204) at the age of 32 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: product=COVID 19 Treatment, brand=Paxlovid; (Jul2022) Negative, notes: After testing negative for 2 days; (Jul2022) strongly positive, notes: Began testing strongly positive using at home rapid tests; (27Jul2022) Unknown results, notes: covid rebound occurred. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not take any other medication in 2weeks. Patient had no know allergies. Patient treated with anti viral Paxlovid for COVID 19 Treatment from 18Jul2022 to 23Jul2022. After testing negative for 2 days, covid rebound occurred. Began testing strongly positive using at home rapid tests on 27Jul2022 at 09:00 AM. Mild head congestion only symptom.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6198), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Neutropenia" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; SANDOZ ADAPALENE/BENZOYL PEROXIDE, start date: 27Dec2021. The following information was reported: VACCINATION FAILURE (medically significant) with onset 24Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 24Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Negative; (24Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Reportedly, the patient received a COVID 19 treatment with anti viral Paxlovid form 14Jul2022 to 19Jul2022. It was reported that, the symptoms returned and patient tested positive 24Jul2022 after testing negative/ symptom free on 20Jul2022. Have fever, congestion, runny nose, sneezing and cough. Feel worse than original infection. AE treatment was reported with antibiotics Doxycline.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EN5318), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN5318), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "chronic migraines" (unspecified if ongoing); "depression" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Doxycycline, reaction(s): "Drug Allergy".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022 at 16:30, outcome "not recovered" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Negative, notes: Nasal Swab; (25Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient tested positive for Covid-19 after being fully vaccinated and boosted. The treatment included Prednisone. COVID tested post vaccination and Covid tested prior to vaccination. No other vaccine in 4 weeks.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. 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 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reportedly the patient did not had any known allergies. No Other medication in 2weeks. On 17Jul2022 the patient started receiving Paxlovid for the treatment for COVID-19 (therapy stop date 21Jul2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 at 12:00 as dose 1, single (Lot number: ER8735), in left arm, on 04May2021 at 12:00 as dose 2, single (Lot number: ER8735), in left arm and on 22Nov2021 at 13:00 as dose 3 (booster), single (Lot number: EW0173) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V Leiden" (unspecified if ongoing), notes: other medical history: Factor V Leiden; "high blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure; "migraines" (unspecified if ongoing), notes: other medical history: migraines; "seasonal allergies" (unspecified if ongoing), notes: other medical history: seasonal allergies; "known allergies: Sulfa based" (unspecified if ongoing), notes: known allergies: Sulfa based. Concomitant medication(s) included: METOPROLOL, start date: 01Jan2005; LOSARTAN, start date: 01Jan2005; WARFARIN, start date: 15Jun2009; ALLEGRA, start date: 01Jan2005. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was reported about covid treatment. Yes, other medication was taken in 2 weeks. Paxlovid was taken as COVID-19 treatment from 23Jun2022 till 25Jun2022 (Lot# 1917995A). Patient received BNT162b2 (BNT162B2), on 25Jul2022 at 02:30 PM as dose 4 (Lot# FN2908) in right arm.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 17:30 as dose 1, single (Lot number: EM9810), in right arm, on 03Mar2021 at 15:00 as dose 2, single (Lot number: EN6202), in right arm and on 17Dec2021 at 15:00 as dose 3 (booster), single (Lot number: FD7218) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies Yes" (unspecified if ongoing), notes: known allergies Yes. Concomitant medication(s) included: AMLODIPINE BESYLATE; ARMOUR THYROID; VITAMIN C [ASCORBIC ACID]; METHENAMINE HIPPURATE; GLYCOPYRROLATE; VENLAFAXINE. The following information was reported: VACCINATION FAILURE (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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid Treatment start date=25Jul2022,Lot number= 1917017A.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: ek5730), on 09Jan2021 as dose 2, single (Lot number: e11283), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: 301356a), in left arm and on 03Apr2022 as dose 4 (booster), single (Lot number: fk9893) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; XYZAL; MONTELUKAST; BREO ELLIPTA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive; (22Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received other medication in 2 weeks: Losartan, Xyzal, Montelukast and Breo. Patient had no known allergies. Patient received Paxlovid (anti-viral) from 12Jul2022 to 17Jul2022 for COVID-19 treatment. Patient reported positive abbot home test 12Jul2022 after 5 days Paxlovid resolution symptoms followed return of symptoms on 22Jul2022 and positive test. Symptoms mild runny nose no fever.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Headache, Myalgia, Nasal congestion
Clinical narrative: Cough; Sore throat; Stuffy nose; Dry heaving; Fever; Muscle pain; Severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 20Jul2022 at 14:00 as dose 1, 0.3 ml single (Lot number: FM0173, Expiration Date: 06Dec2022) at the age of 29 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 26Jul2022, outcome "recovered" (27Jul2022), described as "Fever"; MYALGIA (non-serious) with onset 26Jul2022, outcome "unknown", described as "Muscle pain"; HEADACHE (non-serious) with onset 26Jul2022, outcome "not recovered", described as "Severe headache"; COUGH (non-serious) with onset 27Jul2022, outcome "not recovered"; RETCHING (non-serious) with onset 27Jul2022, outcome "not recovered", described as "Dry heaving"; OROPHARYNGEAL PAIN (non-serious) with onset 27Jul2022, outcome "not recovered", described as "Sore throat"; NASAL CONGESTION (non-serious) with onset 27Jul2022, outcome "unknown", described as "Stuffy nose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got first vaccine on 20Jul2022 and had really bad reactions the day before this report. The patient spent most of the day before this report from 4am-12 pm with a 102 fever and was in so much pain from muscle pain and headache.The fever started at 4am in the morning and broke the day before this report about 1 pm and then got another one that started last night and broke about 4am this morning. Still had headache and the fever broke around 2am in the morning on the day of reporting. The patient worked in animal medicine.There was no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. There were no AEs following prior vaccinations. No family history relevant to AEs. There were no relevant lab tests. The events did not result in emergency room/physician visit.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain assessment, Pyrexia, Retching
Clinical narrative: Cough; Sore throat; Stuffy nose; Dry heaving; Fever; Muscle pain; Severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 20Jul2022 at 14:00 as dose 1, 0.3 ml single (Lot number: FM0173, Expiration Date: 06Dec2022) at the age of 29 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 26Jul2022, outcome "recovered" (27Jul2022), described as "Fever"; MYALGIA (non-serious) with onset 26Jul2022, outcome "unknown", described as "Muscle pain"; HEADACHE (non-serious) with onset 26Jul2022, outcome "not recovered", described as "Severe headache"; COUGH (non-serious) with onset 27Jul2022, outcome "not recovered"; RETCHING (non-serious) with onset 27Jul2022, outcome "not recovered", described as "Dry heaving"; OROPHARYNGEAL PAIN (non-serious) with onset 27Jul2022, outcome "not recovered", described as "Sore throat"; NASAL CONGESTION (non-serious) with onset 27Jul2022, outcome "unknown", described as "Stuffy nose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient got first vaccine on 20Jul2022 and had really bad reactions the day before this report. The patient spent most of the day before this report from 4am-12 pm with a 102 fever and was in so much pain from muscle pain and headache.The fever started at 4am in the morning and broke the day before this report about 1 pm and then got another one that started last night and broke about 4am this morning. Still had headache and the fever broke around 2am in the morning on the day of reporting. The patient worked in animal medicine.There was no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. There were no AEs following prior vaccinations. No family history relevant to AEs. There were no relevant lab tests. The events did not result in emergency room/physician visit.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Muscular weakness, Myalgia, Stress
Clinical narrative: Guillain-Barre syndrome; stressed; muscular pain; weakness in muscles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 38-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant) with onset Jul2022, outcome "unknown"; MYALGIA (non-serious) with onset Jul2022, outcome "unknown", described as "muscular pain"; STRESS (non-serious) with onset Jul2022, outcome "unknown", described as "stressed"; MUSCULAR WEAKNESS (non-serious) with onset Jul2022, outcome "unknown", described as "weakness in muscles". The events "guillain-barre syndrome" and "muscular pain" required physician office visit. Clinical course: It was stated that a consumer calling on behalf of his 38 years old son that received the Pfizer COVID19 vaccine. The patient said his son is suffering from Guillain-Barre syndrome. It was reported that patient is asking if Pfizer has any program for patients that experienced side effects from the vaccine. Caller stated he is not seeking compensation. Caller is calling about the COVID-19 vaccine and is calling for his son who is 38 years old. His son is suffering with neuro issues with his muscles. He saw a doctor and was told his son has Guillain-Barre syndrome. Caller would like to get advice if there is any options to deal with Pfizer directly. He asked does the patient have Pfizer have a program to deal with the side effects. His son is very fit and this just happened 2 weeks ago and his son is very stressed. Caller clarifies his son started to feel the affects on his muscular pain and weakness in muscles. His son saw a Dr. and this up to date and last test the doctor suspects Guillain-Barre syndrome and the caller wants to put his son in the right program.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he tested on Sunday positive for covid 19.; he tested on Sunday positive for covid 19.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 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), outcome "unknown" and all described as "he tested on Sunday positive for covid 19.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Calle reports he started with a cough on Friday that continued on to Saturday, he tested on Sunday positive for covid 19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Caller reported that he was fully vaccinated and has had 2 boosters. He got the J&J in Mar2021 (last year) and both boosters of Pfizer covid 19 vaccine; the first booster was November last year (2021) and the second booster was in April of this year (2022). Caller reported he started with a cough on Friday that continued on to Saturday, he tested on Sunday positive for covid 19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: 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-healthcare professional). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 at 13:00 as dose 1, single (Batch/Lot number: Unknown), in left arm, on 23Apr2021 at 13:00 as dose 2, single (Batch/Lot number: Unknown), in left arm and on 22Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: Unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient relevant medical history included: "Thalassemia Beta" (unspecified if ongoing), "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Adverse event: she got sick with Covid symptoms worse 4 days after taking Paxlovid. No Received other medication in 2 weeks. Patient received COVID-19 Treatment as Paxlovid, treatment start date: 08Jul2022 and treatment stop date: 12Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.