chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Blindness, Blood test, Central venous catheter removal, Central venous catheterisation
Clinical narrative: Pancreatitis; kidney failure; Diabetes Ketoacidosis; legal blindness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Birth control" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Product: COVID 19, Brand: Pfizer,, Lot unknown reason: Unable to locate or read the details, Administration date: Oct2021, Vaccine location: Left arm), administration date: Oct2021, for COVID-19 immunization. The following information was reported: DIABETIC KETOACIDOSIS (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "Diabetes Ketoacidosis"; PANCREATITIS (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae"; RENAL FAILURE (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "kidney failure"; BLINDNESS (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "legal blindness". The patient was hospitalized for pancreatitis (hospitalization duration: 16 day(s)); for renal failure, diabetic ketoacidosis, blindness (hospitalization duration: 16 day(s)). The events "pancreatitis", "kidney failure", "diabetes ketoacidosis" and "legal blindness" required emergency room visit. Therapeutic measures were taken as a result of pancreatitis, renal failure, diabetic ketoacidosis, blindness.  Clinical course: There was no other vaccine in four weeks. Other medications in two weeks for birth control. Patient was hospitalized with resulting dialysis, vision changes resulting in legal blindness. Patient was hospitalized for 16 days. The patient was recovered with lasting effects. There was treatment for AE included hospitalization, dialysis, insulin therapy. There was no COVID prior vaccination. There was no COVID tested post vaccination. There was no known allergies. There was no other medical history prior to adverse reaction.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diabetes mellitus, Diabetic ketoacidosis, Dialysis, Electrolyte imbalance, Hypertension
Clinical narrative: Pancreatitis; kidney failure; Diabetes Ketoacidosis; legal blindness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Birth control" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Product: COVID 19, Brand: Pfizer,, Lot unknown reason: Unable to locate or read the details, Administration date: Oct2021, Vaccine location: Left arm), administration date: Oct2021, for COVID-19 immunization. The following information was reported: DIABETIC KETOACIDOSIS (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "Diabetes Ketoacidosis"; PANCREATITIS (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae"; RENAL FAILURE (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "kidney failure"; BLINDNESS (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "legal blindness". The patient was hospitalized for pancreatitis (hospitalization duration: 16 day(s)); for renal failure, diabetic ketoacidosis, blindness (hospitalization duration: 16 day(s)). The events "pancreatitis", "kidney failure", "diabetes ketoacidosis" and "legal blindness" required emergency room visit. Therapeutic measures were taken as a result of pancreatitis, renal failure, diabetic ketoacidosis, blindness.  Clinical course: There was no other vaccine in four weeks. Other medications in two weeks for birth control. Patient was hospitalized with resulting dialysis, vision changes resulting in legal blindness. Patient was hospitalized for 16 days. The patient was recovered with lasting effects. There was treatment for AE included hospitalization, dialysis, insulin therapy. There was no COVID prior vaccination. There was no COVID tested post vaccination. There was no known allergies. There was no other medical history prior to adverse reaction.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Pancreatitis, Pneumonia, Renal failure, Unresponsive to stimuli
Clinical narrative: Pancreatitis; kidney failure; Diabetes Ketoacidosis; legal blindness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 23 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Birth control" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Product: COVID 19, Brand: Pfizer,, Lot unknown reason: Unable to locate or read the details, Administration date: Oct2021, Vaccine location: Left arm), administration date: Oct2021, for COVID-19 immunization. The following information was reported: DIABETIC KETOACIDOSIS (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "Diabetes Ketoacidosis"; PANCREATITIS (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae"; RENAL FAILURE (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "kidney failure"; BLINDNESS (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "legal blindness". The patient was hospitalized for pancreatitis (hospitalization duration: 16 day(s)); for renal failure, diabetic ketoacidosis, blindness (hospitalization duration: 16 day(s)). The events "pancreatitis", "kidney failure", "diabetes ketoacidosis" and "legal blindness" required emergency room visit. Therapeutic measures were taken as a result of pancreatitis, renal failure, diabetic ketoacidosis, blindness.  Clinical course: There was no other vaccine in four weeks. Other medications in two weeks for birth control. Patient was hospitalized with resulting dialysis, vision changes resulting in legal blindness. Patient was hospitalized for 16 days. The patient was recovered with lasting effects. There was treatment for AE included hospitalization, dialysis, insulin therapy. There was no COVID prior vaccination. There was no COVID tested post vaccination. There was no known allergies. There was no other medical history prior to adverse reaction.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Feeling like shingles trying to start on back/shingles attempting to begin; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 19th April 2022, the patient received the 1st dose of Shingrix. On 28th April 2022, 9 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comments: On the day of reporting, the patient felt like shingles was trying to start on patient's back, where it was appeared previously. The patient asked if it was normal for shingles attempting to begin 9 days after vaccination. Follow up would not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose almost 3 year ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose with batch number: 24359, almost 3 year before reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-Apr-2022 Reporter's Comments: The reporter was looking information if a non-immunocompromised patient received Shingrix first dose almost 3 year before reporting in other Pharmacy. The reporter consented to follow up via personal e-mail. Additional Supportive Information: The patient had not received the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 21months female patient received Kinrix; Kinrix dose by error as a 4th Datp dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 21-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Apr-2022 Reporter's Comments: The reporter wanted to know if Kinrix could be consider a 4th Dtap dose because a 21 months female patient received on April 4th 2022 a Kinrix dose by error as a 4th Datp dose. The reporter did not consent to follow-up. Additional Supportive Information: The 21 months patient received Kinrix dose by error as a 4th Datp dose, which led to inappropriate age at vaccine administration, Inappropriate schedule of vaccine administered. This case has been linked to US2022071360 and US2022071352, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022071360:Same reporter US-GLAXOSMITHKLINE-US2022071352:Same reporter
Sex: F
Vaccine: COVID19, UNK
Symptoms: Herpes zoster, Infection, Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS AGGRAVATED; INFECTION; SHINGLES; This spontaneous report received from a consumer via other manufacture (Abbvie) concerned a 65 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (NOV-2020), and another strain of covid-19 (FEB-2021), and concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, and expiry: unknown) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced rheumatoid arthritis aggravated, shingles, and infection of other kind. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the shingles, infection and rheumatoid arthritis aggravated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220506412-covid-19 vaccine ad26.cov2.s- rheumatoid arthritis aggravated. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy Skin; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy Skin) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy Skin) (seriousness criterion medically significant). At the time of the report, PRURITUS (Itchy Skin) had not resolved.            No concomitant medications were reported.  It was reported that after reviewing the second dose, patient have been to the emergency room for 3 times and consulted a dermatologist for itchy skin. They prescribed a topical medicine but the condition was not improved. That problem was affected every aspect of patients life. Its been almost a year.  Company comment- This is a spontaneous case concerning a patient of unknown gender and age with no medical history reported, who experienced the serious (medically significant), unexpected event of pruritus after a second dose of mRNA-1273 vaccine was administered. It was reported that patient have been to the emergency room 3 times and consulted a dermatologist for itchy skin. They prescribed a topical medicine, but the condition has not improved. That problem affected every aspect of patient´s life for almost a year. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2022: Follow up document received contains case type was updated and seriousness updated.; Sender's Comments: This is a spontaneous case concerning a patient of unknown gender and age with no medical history reported, who experienced the serious (medically significant), unexpected event of pruritus after a second dose of mRNA-1273 vaccine was administered. It was reported that patient have been to the emergency room 3 times and consulted a dermatologist for itchy skin. They prescribed a topical medicine, but the condition has not improved. That problem affected every aspect of patient´s life for almost a year. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested negative on last day of treatmentTested positive following day Symptoms returned Still symptomic; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested negative on last day of treatmentTested positive following day Symptoms returned Still symptomic) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) from January 2001 to an unknown date, ESZOPICLONE (LUNESTA) from January 2014 to an unknown date and ATORVASTATIN CALCIUM (LIPITOR) from January 2005 to an unknown date for an unknown indication.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022 at 2:00 PM, the patient experienced COVID-19 (Tested negative on last day of treatmentTested positive following day Symptoms returned Still symptomic). At the time of the report, COVID-19 (Tested negative on last day of treatmentTested positive following day Symptoms returned Still symptomic) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2022, SARS-CoV-2 test: negative (Negative) negative. On 26-Apr-2022, SARS-CoV-2 test: positive (Positive) positive.          Co-suspect product included non-company product, unspecified Pfizer medication for treatment of COVID-19. The patient received an unspecified Pfizer medication (unknown route) from  21-Apr-2022 to 25-Apr-2022 at an unspecified dose.  Treatment was not received.  Company comment- This spontaneous case concerns a 63-year-old female, with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19  approximately 5 months after vaccination with a third dose of mRNA-1273. No further information was provided. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old female, with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19  approximately 5 months after vaccination with a third dose of mRNA-1273. No further information was provided. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  One of the medical assistants or nurses gave a Moderna COVID-19 vaccination after its expiration date. The expiration date tool states it is 29 Apr 2022 and they administered it on 03 May 2022. Vial did not  undergo any temperature excursions.  No treatment medications were reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Head discomfort, Headache, Limb discomfort
Clinical narrative: Arm and head were killing him; Arm and head were killing him; No energy whatsoever, has been drained, it's like it took everything out of him; Upset stomach; He had also a headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm and head were killing him), HEAD DISCOMFORT (Arm and head were killing him), ASTHENIA (No energy whatsoever, has been drained, it's like it took everything out of him), ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (He had also a headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (patient had COVID 1 year ago and it almost killed him.) in 2021. Previously administered products included for Product used for unknown indication: Pfizer (Patient administered primary series and first booster were from Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Diabetes, Drug allergy (Allergy to metformin) and Thyroid disorder. Concomitant products included INSULIN INJECTION for Diabetes.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2022, the patient experienced LIMB DISCOMFORT (Arm and head were killing him), HEAD DISCOMFORT (Arm and head were killing him), ASTHENIA (No energy whatsoever, has been drained, it's like it took everything out of him), ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (He had also a headache). At the time of the report, LIMB DISCOMFORT (Arm and head were killing him), HEAD DISCOMFORT (Arm and head were killing him), ASTHENIA (No energy whatsoever, has been drained, it's like it took everything out of him), ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (He had also a headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) positive.         Patient taking concomitant as thyroid pill and a pill for Diabetes. Patient was allergic to other medicines. The patient had not gone to HCP and no treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: No new information added.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Arm and head were killing him; Arm and head were killing him; No energy whatsoever, has been drained, it's like it took everything out of him; Upset stomach; He had also a headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm and head were killing him), HEAD DISCOMFORT (Arm and head were killing him), ASTHENIA (No energy whatsoever, has been drained, it's like it took everything out of him), ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (He had also a headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (patient had COVID 1 year ago and it almost killed him.) in 2021. Previously administered products included for Product used for unknown indication: Pfizer (Patient administered primary series and first booster were from Pfizer). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Diabetes, Drug allergy (Allergy to metformin) and Thyroid disorder. Concomitant products included INSULIN INJECTION for Diabetes.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2022, the patient experienced LIMB DISCOMFORT (Arm and head were killing him), HEAD DISCOMFORT (Arm and head were killing him), ASTHENIA (No energy whatsoever, has been drained, it's like it took everything out of him), ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (He had also a headache). At the time of the report, LIMB DISCOMFORT (Arm and head were killing him), HEAD DISCOMFORT (Arm and head were killing him), ASTHENIA (No energy whatsoever, has been drained, it's like it took everything out of him), ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (He had also a headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) positive.         Patient taking concomitant as thyroid pill and a pill for Diabetes. Patient was allergic to other medicines. The patient had not gone to HCP and no treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: No new information added.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 15Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022 at 20:00, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative, notes: Symptoms improved and I tested negative; (29Apr2022) Positive, notes: I tested positive again 6 days later. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Plaxovid for the full course. Symptoms improved and patient tested negative. Then some symptoms returned 4 days later, and tested positive again 6 days later.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: product COVID 19 Treatment; product COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 05Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: STELARA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: It was reported that COVID 19 Treatment was provided as Paxlovid with treatment start date as 20Apr2022 and treatment stop date as 24Apr2022. adverse event COVID recurrence positive test and symptoms) 6 days after completing Paxlovid. On final day of paxlovid treatment and for several days after, I tested negative for COVID and experienced no symptoms. adverse event start date 30Apr2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 26-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Positive, notes: Adverse event: Rebound positive case. Therapeutic measures were taken as a result of covid-19.  Clinical course: other medication in 2 weeks product: Vitamin C supplement, Other medication in 2 weeks product: Tylenol. Anti-viral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 20Apr2022, Treatment stop date: 25Apr2022. Known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; 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), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; piroxicam (PAXIL [PIROXICAM]), (Batch/Lot number: unknown). The patient's relevant medical history included: "Known allergies: Shellfish" (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". 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 which included Paxlovid from 22Apr2022 to 27Apr2022. The patient finished the antiviral meds on Wednesday 27Apr2022 and was feeling great. On 01May2022, the patient experienced the cold symptoms with a vengeance.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Began taking Paxlovid within 12 hours of onset of Covid symptoms; Began taking Paxlovid within 12 hours of onset of Covid symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 25Apr2021 as dose 1, single (Lot number: EW0171), in left arm and on 23May2021 as dose 2, single (Lot number: EW0185) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Dec2021 as dose 3 (booster), single (Lot number: 021C21A) for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulfa drugs" (unspecified if ongoing); "Known Allergies: Penicillin" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Began taking Paxlovid within 12 hours of onset of Covid symptoms". The event "began taking paxlovid within 12 hours of onset of covid symptoms" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not hospitalized due to the events. Reporter assessed seriousness as non-serious. Since the vaccination, the patient was not tested for COVID-19.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had both the booster shots for Pfizer (Pfizer COVID-19 Vaccine), I tested positive.; I had both the booster shots for Pfizer (Pfizer COVID-19 Vaccine), I tested positive.; 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), as dose 3 (booster), single (Batch/Lot number: unknown) and 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had both the booster shots for Pfizer (Pfizer COVID-19 Vaccine), I tested positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive; Negative, notes: it came back negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that patient had both shots and had both the booster shots for Pfizer (Clarified as Pfizer COVID-19 Vaccine) and was kind of feeling kind of sluggish yesterday and got one of those tests and it came back negative so called the doctor and and he said taken your pills (Paxlovid) and the patient wanted to know what are the side effects of pills is to be is like kind of, like lazy oozing often and stuff like that is that normal. Consumer stated, It's the tablet, trying to figure with it what they gave Paxlovid. When Probed for testing Positive for COVID: Consumer stated, That's the medicine the doctor prescribed yes, but right tested positive that's why he prescribed this medicine. yeah I mean like, I will be sitting in the chair and I am oozing off you know oozing off like you I just feel to sluggish I just want to if this part of medicine (Paxlovid). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU 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: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: tested positive; spent the whole day yesterday with their Son. the son tested negative for Covid previously however he tested positive Today; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, ID: (159558). The reporter is the patient.  A 91-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 91 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary vaccination series completed (Manufacturer unknown)), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 02May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "spent the whole day yesterday with their Son. the son tested negative for Covid previously however he tested positive Today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive.  Clinical information: Consumer and his wife on the line to say they have scheduled their second booster for Pfizer Covid-19 and they found out they tested positive today. This report is regarding reporter who is also patient. Caller clarified that he is scheduled to have his second booster of Pfizer Covid-19 later this afternoon at the pharmacy. Caller verified that he tested positive today, 02May2022. Caller was talking to his son today; his son spent the whole day with reporter and wife on 01May2022 and last night on 01May2022 his son tested again and was positive. Caller is very elderly; he is in his 90s. He just wants a yes or no of should they go to the appointment for the second booster today or take a rest, wait first relative to testing positive  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-202200650625 same reporter/drug/AE with different patient
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Dry mouth, Erythema, Muscle enzyme, Muscle necrosis
Clinical narrative: discomfort in the injection site; extreme itching; redness in the entire bicep; tingling in the lips and dry mouth.; tingling in the lips and dry mouth.; Pain in arm; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (COMIRNATY), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2, Manufacturer: Pfizer-BioNTech), for Covid-19 Immunization, reaction(s): "no side effects or adverse reactions"; Bnt162b2 (Dose:1, Manufacturer: Pfizer-BioNTech), for Covid-19 Immunization, reaction(s): "no side effects or adverse reactions". The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), outcome "not recovered", described as "discomfort in the injection site"; PRURITUS (non-serious), 72 hrs after the suspect product(s) administration, outcome "recovered", described as "extreme itching"; ERYTHEMA (non-serious), 72 hrs after the suspect product(s) administration, outcome "recovered", described as "redness in the entire bicep"; PARAESTHESIA ORAL (non-serious), DRY MOUTH (non-serious), outcome "unknown" and all described as "tingling in the lips and dry mouth."; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that, patient received the first 2 doses of Pfizer-BioNTech covid-19 Vaccine and presented no side effects or adverse reactions. On Oct2021, he received the first booster dose, injected into his deltoid, and experienced some adverse reactions. Patient was fine after the Booster until 3 days later. 72 hours after receiving the booster dose, he developed extreme itching and redness in the entire bicep and rock hard. He had no fever but also had tingling in the lips and dry mouth. The redness and itching were resolved after 1 month and he only felt now discomfort in the injection site. Patient wanted to know if, based on this side effects, he should receive the second booster dose. Patient wanted to know if this is considered as a serious adverse reaction or an anaphylactic reaction and if it was contraindicated to receive another dose of the vaccine and explained to patient that non-severe allergic reactions such as itching, injection side redness and injection site pain were reported side effects after vaccination with any dose and also explained that the only scenarios where Pfizer does not recommend to get another dose of the vaccine were when severe allergic reactions occur or when a patient is allergic to an ingredient of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia oral, Pruritus, Vaccination site discomfort
Clinical narrative: discomfort in the injection site; extreme itching; redness in the entire bicep; tingling in the lips and dry mouth.; tingling in the lips and dry mouth.; Pain in arm; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (COMIRNATY), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2, Manufacturer: Pfizer-BioNTech), for Covid-19 Immunization, reaction(s): "no side effects or adverse reactions"; Bnt162b2 (Dose:1, Manufacturer: Pfizer-BioNTech), for Covid-19 Immunization, reaction(s): "no side effects or adverse reactions". The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), outcome "not recovered", described as "discomfort in the injection site"; PRURITUS (non-serious), 72 hrs after the suspect product(s) administration, outcome "recovered", described as "extreme itching"; ERYTHEMA (non-serious), 72 hrs after the suspect product(s) administration, outcome "recovered", described as "redness in the entire bicep"; PARAESTHESIA ORAL (non-serious), DRY MOUTH (non-serious), outcome "unknown" and all described as "tingling in the lips and dry mouth."; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that, patient received the first 2 doses of Pfizer-BioNTech covid-19 Vaccine and presented no side effects or adverse reactions. On Oct2021, he received the first booster dose, injected into his deltoid, and experienced some adverse reactions. Patient was fine after the Booster until 3 days later. 72 hours after receiving the booster dose, he developed extreme itching and redness in the entire bicep and rock hard. He had no fever but also had tingling in the lips and dry mouth. The redness and itching were resolved after 1 month and he only felt now discomfort in the injection site. Patient wanted to know if, based on this side effects, he should receive the second booster dose. Patient wanted to know if this is considered as a serious adverse reaction or an anaphylactic reaction and if it was contraindicated to receive another dose of the vaccine and explained to patient that non-severe allergic reactions such as itching, injection side redness and injection site pain were reported side effects after vaccination with any dose and also explained that the only scenarios where Pfizer does not recommend to get another dose of the vaccine were when severe allergic reactions occur or when a patient is allergic to an ingredient of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Drug ineffective, Suspected COVID-19
Clinical narrative: contracted Covid; contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (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 series of Vaccination completed (Manufacturer unknown)), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted Covid". The patient underwent the following laboratory tests and procedures: Body temperature: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical information: Subject:  Thanks and gratitude for your efforts to keep us healthy. I'm 76 Covid vaccination and booster contracted Covid was symptomatic cough low temp exhaustion horrid taste in my mouth. I'm on day 5 still positive symptomatic but the Paxlovid helped me so much I wish to thank you all of you for your continued efforts to help humanity.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Vaccination site haemorrhage
Clinical narrative: she told me that 'site' was bleeding like blood was flowing; The person who gave me the shot made a mistake, she told me that it was bleeding like blood was flowing and she says that she might have touched the capillary or artery.; 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 30Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but unknown manufacturer.), for Covid-19 immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset 30Apr2022, outcome "unknown", described as "The person who gave me the shot made a mistake, she told me that it was bleeding like blood was flowing and she says that she might have touched the capillary or artery."; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 30Apr2022, outcome "unknown", described as "she told me that 'site' was bleeding like blood was flowing".  Clinical course:The patient had Booster shot about an hour ago and the person who gave the shot made a mistake and she said that 'site' was bleeding like blood was flowing and she said that she might have touched the capillary or artery.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.