chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: they have pain; after their second dose of the Moderna covid19 vaccine their arm was swollen real bad/ left arm was extremely swollen; left arm was extremely swollen and sore and red.; left arm was extremely swollen and sore and red.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (they have pain), VACCINATION SITE SWELLING (after their second dose of the Moderna covid19 vaccine their arm was swollen real bad/ left arm was extremely swollen), VACCINATION SITE ERYTHEMA (left arm was extremely swollen and sore and red.) and VACCINATION SITE PAIN (left arm was extremely swollen and sore and red.) in an 88-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Pneumonia and Tetanus. Concurrent medical conditions included Allergy NOS (could not remember to what was allergy to).    In June 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (they have pain), VACCINATION SITE SWELLING (after their second dose of the Moderna covid19 vaccine their arm was swollen real bad/ left arm was extremely swollen), VACCINATION SITE ERYTHEMA (left arm was extremely swollen and sore and red.) and VACCINATION SITE PAIN (left arm was extremely swollen and sore and red.). At the time of the report, PAIN (they have pain), VACCINATION SITE SWELLING (after their second dose of the Moderna covid19 vaccine their arm was swollen real bad/ left arm was extremely swollen), VACCINATION SITE ERYTHEMA (left arm was extremely swollen and sore and red.) and VACCINATION SITE PAIN (left arm was extremely swollen and sore and red.) had resolved.            Patient never had Covid-19 or tested. No concomitant medications was reported. No treatment medications was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Overdose
Clinical narrative: after the written date on the vial; recent dose was 0.5 mL; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (after the written date on the vial) and OVERDOSE (recent dose was 0.5 mL) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 018F21A, 036A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (after the written date on the vial) and OVERDOSE (recent dose was 0.5 mL). At the time of the report, EXPIRED PRODUCT ADMINISTERED (after the written date on the vial) and OVERDOSE (recent dose was 0.5 mL) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. It was reported that most recent dose was 0.5 mL dose given from a vial with a red cap and a label with a light blue border. The patient had not reported any symptoms after receiving the Moderna COVID-19 vaccine.  It was unknown when vial was initially stored in the refrigerator and vial did not undergo temperature excursions. No additional medications or treatments had been administered to patient since the time of that excursion.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired 2nd Booster beyond MFG Expiry date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired 2nd Booster beyond MFG Expiry date) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired 2nd Booster beyond MFG Expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired 2nd Booster beyond MFG Expiry date) outcome was unknown.            No Concomitant medications were provided. It was reported that patient does not had any side effects and was very concerned. No treatment medications were provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Feeling abnormal, Feeling hot, Nasopharyngitis
Clinical narrative: Feeling hot; aches or pain; FEEELING OFF; Decreased or no appetite; Sore throat; Cough; Cold; possible upper respiratory infection symptoms; CONGESTION; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling hot), PAIN (aches or pain), FEELING ABNORMAL (FEEELING OFF), DECREASED APPETITE (Decreased or no appetite) and OROPHARYNGEAL PAIN (Sore throat) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 24-Jun-2022, the patient experienced FEELING HOT (Feeling hot), PAIN (aches or pain), FEELING ABNORMAL (FEEELING OFF), DECREASED APPETITE (Decreased or no appetite), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), NASOPHARYNGITIS (Cold), UPPER RESPIRATORY TRACT INFECTION (possible upper respiratory infection symptoms) and UNEVALUABLE EVENT (CONGESTION). At the time of the report, FEELING HOT (Feeling hot), PAIN (aches or pain), FEELING ABNORMAL (FEEELING OFF), DECREASED APPETITE (Decreased or no appetite), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), NASOPHARYNGITIS (Cold), UPPER RESPIRATORY TRACT INFECTION (possible upper respiratory infection symptoms) and UNEVALUABLE EVENT (CONGESTION) was resolving.            No concomitant medications was provided by the reporter. On 26-Jun-2022, symptoms resolved by late but not feeling 100 percent. on 27-Jun-2022 closer to 90 percent. She had relatively same reaction but with more severe and longer symptoms with covid vaccines.  The reporter's causality for the event(s) of hot, aches/pain, feeling off, decreased/no appetite, sore throat, cough, cold, possible upper respiratory infection symptoms and congestion with skyrizi(risankizumab) was a reasonable possibility. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications was provided by the reporter.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Unevaluable event, Upper respiratory tract infection
Clinical narrative: Feeling hot; aches or pain; FEEELING OFF; Decreased or no appetite; Sore throat; Cough; Cold; possible upper respiratory infection symptoms; CONGESTION; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling hot), PAIN (aches or pain), FEELING ABNORMAL (FEEELING OFF), DECREASED APPETITE (Decreased or no appetite) and OROPHARYNGEAL PAIN (Sore throat) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 24-Jun-2022, the patient experienced FEELING HOT (Feeling hot), PAIN (aches or pain), FEELING ABNORMAL (FEEELING OFF), DECREASED APPETITE (Decreased or no appetite), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), NASOPHARYNGITIS (Cold), UPPER RESPIRATORY TRACT INFECTION (possible upper respiratory infection symptoms) and UNEVALUABLE EVENT (CONGESTION). At the time of the report, FEELING HOT (Feeling hot), PAIN (aches or pain), FEELING ABNORMAL (FEEELING OFF), DECREASED APPETITE (Decreased or no appetite), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), NASOPHARYNGITIS (Cold), UPPER RESPIRATORY TRACT INFECTION (possible upper respiratory infection symptoms) and UNEVALUABLE EVENT (CONGESTION) was resolving.            No concomitant medications was provided by the reporter. On 26-Jun-2022, symptoms resolved by late but not feeling 100 percent. on 27-Jun-2022 closer to 90 percent. She had relatively same reaction but with more severe and longer symptoms with covid vaccines.  The reporter's causality for the event(s) of hot, aches/pain, feeling off, decreased/no appetite, sore throat, cough, cold, possible upper respiratory infection symptoms and congestion with skyrizi(risankizumab) was a reasonable possibility. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications was provided by the reporter.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Pain
Clinical narrative: Ache on bones; Pain; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Ache on bones) and PAIN (Pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 032M20A and 032L620A) for COVID-19 vaccination.     Patient did not have any allergies related to medications, food and other products. Patient never diagnosed with COVID-19 or tested positive. Patient did not received other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Diabetes since 2000, Blood pressure high since 2000, Prostatic disorder, Blood cholesterol abnormal, Unspecified functional disorder of stomach and Anxiety. Concomitant products included SERTRALINE for Anxiety, ATORVASTATIN for Blood cholesterol abnormal, METOPROLOL for Blood pressure high, GLIPIZIDE, GABAPENTIN and METFORMIN for Diabetes, FINASTERIDE for Prostatic disorder, OMEPRAZOLE for Unspecified functional disorder of stomach.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Ache on bones) and PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BONE PAIN (Ache on bones) and PAIN (Pain) had resolved.            Patient received the vaccine on left shoulder.   This case was linked to MOD-2022-604652, MOD-2022-604653 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Caller is confused if the Moderna shot was the 2nd primary shot or first booster; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller is confused if the Moderna shot was the 2nd primary shot or first booster) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen Vaccine (Primary series) in April 2021 and Janssen Vaccine. Past adverse reactions to the above products included No adverse event with Janssen Vaccine and Janssen Vaccine.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller is confused if the Moderna shot was the 2nd primary shot or first booster). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller is confused if the Moderna shot was the 2nd primary shot or first booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It is reported that age of the patient was < 50-year. No concomitant medications were reported.  Patient stated like that J&J came out with a 2nd vaccine but she was not sure if the 2nd J&J vaccine was a booster or a primary dose, in which case the Moderna Shot might had been part of primary shots mixed with J & J.  No treatment medications were reported.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: seven patients received a dose from an expired Moderna vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (seven patients received a dose from an expired Moderna vial) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 043B21A and 032B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (seven patients received a dose from an expired Moderna vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (seven patients received a dose from an expired Moderna vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2022-604813 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received a dose from an expired Moderna vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 030H21B, 032B21A and 003A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: HCP reports that a patient received a dose from an expired Moderna vial.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP reports that a patient received a dose from an expired Moderna vial.) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A and 076C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP reports that a patient received a dose from an expired Moderna vial.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP reports that a patient received a dose from an expired Moderna vial.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: They have remained in a refrigerated state this entire time within the temperature range required to maintain stability.; Expired Vaccine Administration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administration) and PRODUCT STORAGE ERROR (They have remained in a refrigerated state this entire time within the temperature range required to maintain stability.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jun-2022 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Jun-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They have remained in a refrigerated state this entire time within the temperature range required to maintain stability.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administration) and PRODUCT STORAGE ERROR (They have remained in a refrigerated state this entire time within the temperature range required to maintain stability.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient had taken booster dose. It was reported that reporter received vaccines on 05-MAY-2022. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Drug ineffective, SARS-CoV-2 test
Clinical narrative: died 2 weeks later; was diagnosed w COVID; was diagnosed w COVID; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An 80-year-old female patient received BNT162b2 (BNT162B2), 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: DEATH (death), outcome "fatal", described as "died 2 weeks later"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "was diagnosed w COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: diagnosed w COVID, notes: was diagnosed w COVID. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The clinical course was reported as follows: elderly woman 80 years-old who was fully vaccinated with Pfizer's vaccine otherwise healthy traveled this summer to visit family. Upon return home was diagnosed with COVID and died 2 weeks later. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: died 2 weeks later
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Off label use
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4356269-00. A 44-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years intramuscular for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: Unknown, Route of administration: Intra-muscular), administration date: 23Aug2021, when the patient was 43-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Lot number: Unknown, Route of administration: Intra-muscular), administration date: 15Apr2021, when the patient was 43-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 1, SINGLE, Lot number: Unknown, Route of administration: Intra-muscular.), administration date: 16Mar2021, when the patient was 43-year-old, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 07Feb2022, outcome "unknown" and all described as "Fourth dose"; ARTHRALGIA (non-serious) with onset 07Feb2022, outcome "recovered" (07Feb2022), described as "sore shoulder". Additional Information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. other relevant history was Not Reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (07Jul2022): This is a follow-up solicited report based on information received by Pfizer [Mfr Control No.: 22K-163-4356269-00]. A contactable consumer (patient) reported that: Updated information: Event information (Event added). Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound- tested positive 04Jul after negative on 29Jun. Mild or no symptoms; Rebound- tested positive 04Jul after negative on 29Jun. Mild or no symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 at 10:00 as dose 1, single (Lot number: EN6198), in right arm, as dose 2 , single (Lot number: EN6204), in right arm, on 28Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FF2588), in right arm and on 29Mar2022 at 16:00 as dose 4 (booster), single (Lot number: FR9813) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "overweight" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Phenergan, reaction(s): "Known allergies: phenergan". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022 at 21:00, outcome "recovering" and all described as "Rebound- tested positive 04Jul after negative on 29Jun. Mild or no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Negative, notes: Rebound- tested positive 04Jul after negative on 29Jun; (04Jul2022) Positive, notes: Rebound- tested positive 04Jul after negative on 29Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Start date of treatment for COVID-19 was 22Jun2022. Stop date of treatment for COVID-19 was 26Jun2022.
Sex: M
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) (Physician).  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "HTN" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (unspecified date) Negative, notes: Rebound symptoms after testing negative ; (Jun2022) Positive, notes: Testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Reporter type: Healthcare Professional reporting for a patient. No known allergies were reported. Antiviral treatment was given to the patient via oral route of administration for treatment of COVID-19. No Other medications in 2 weeks were reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Almost instantly after getting her 4th Shot, her mouth filled with a pronounced metallic taste.; 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 female patient received BNT162b2 (BNT162B2), on 16May2022 at 18:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EP7534), administration date: 16Mar2021, for COVID-19 Immunization, reaction(s): "No adverse effect"; BNT162b2 (DOSE 2, SINGLE, Lot number: ER8734), administration date: 06Apr2021, for COVID-19 Immunization, reaction(s): "No adverse effect"; BNT162b2 (DOSE 3, SINGLE, Lot number: FF8839), administration date: 11Oct2021, for COVID-19 Immunization, reaction(s): "No adverse effect". The following information was reported: DYSGEUSIA (non-serious) with onset 16May2022, outcome "recovered" (17May2022), described as "Almost instantly after getting her 4th Shot, her mouth filled with a pronounced metallic taste.". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: Almost instantly after getting her 4th Shot, the patient experienced mouth filled with a pronounced metallic taste. Patient stated that it was like her sense of smell from taste smelled like burning rot like something rotten was on fire. It started when she had just sat down to wait 15 minutes. The event tapered off over the course of that day evening. She woke up the next morning it was recovered. She didn't experience palpitations or anything. Metallic taste lasted for 12 hours or less. Patient did not required emergency Room or physician Office visit.
Age: 28.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: 331308A) at the age of 28 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Mar2021 as dose 1, single (Lot number: 006P21A), in right arm and on 20Apr2021 as dose 2, single (Lot number: 039B21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products", start date: 20Dec2021, stop date: 20Dec2021. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive, notes: Tested positive again for COVID 11 days after ending Paxlovid treatment regimen. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound of Covid after completion of Paxlovid. Return of symptoms and Positive test on 06Jul2022 (5 days after completion of Paxlovid); Rebound of Covid after completion of Paxlovid. Return of symptoms and Positive test on 06Jul2022 (5 days after completion of Paxlovid); This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2020 as dose 1, single (Lot number: EK9321), in left arm, on 16Jan2021 as dose 2, single (Lot number: EL3246), in left arm and on 28Aug2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Jackfruit allergy" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: 01Nov2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound of Covid after completion of Paxlovid. Return of symptoms and Positive test on 06Jul2022 (5 days after completion of Paxlovid)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (03Jul2022) Negative, notes: Negative test on 03Jul2022; (06Jul2022) Positive, notes: Return of symptoms and Positive test on 06Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.The adverse event resulted in none. Paxlovid Covid-19 treatment received from 27Jun2022 to 01Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.; 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Lot number: 010M20A), on 11Mar2021 as dose 2, single (Lot number: 027A21A) and on 01Nov2021 as dose 3 (booster), single (Lot number: 939906) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN; GABAPENTIN; IRBESARTAN; TRIAMTERENE & HCTZ; ZOLPIDEM. Past drug history included: Sulfadiazine, reaction(s): "Known allergies: sulfadiazine". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received anti-viral treatment via oral route from 22Jun2022 till 27Jun2022 for COVID-19. Patient experienced rebound covid symptoms; about 10 days after paxlovid treatment started.  Patient symptoms was improving at the time of this report. AE resulted in none of the above (details unspecified).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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 male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EM9809), in right arm, on 01Apr2021 as dose 2, single (Lot number: ER8727), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: EN0182), in right arm and on 10Apr2022 as dose 4 (booster), single (Lot number: IK9895), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: High BP; "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; LISINOPRIL; HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 09Jun2022 to 13Jun2022. Clinical course: The event did not result in any other seriousness criteria.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: In Mar2021, the patient experienced COVID; In Mar2021, the patient experienced COVID; This is a solicited report received from contactable reporters (Consumer or other non-HCP). The reporter is the patient. Other Case identifiers: 22K-163-4359071-00.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1157153), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2021, outcome "unknown" and all described as "In Mar2021, the patient experienced COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2021) experienced COVID, notes: In Mar2021, the patient experienced COVID. The action taken for upadacitinib was unknown. Clinical course: Solicited report from (name country) by a consumer of a 64-year-old female with events of non-serious FELT LIKE GAINING WEIGHT FROM RINVOQ/HAD NOT FIGURED OUT WHEN TO STOP EATING THROUGHOUT THE DAY, WEIGHT LOSS and COVID with RINVOQ (UPADACITINIB). There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's assessment of the causal relationship of "in mar2021, the patient experienced covid" with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's causality for the events of COVID was not provided with respect to RINVOQ (UPADACITINIB).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and vaccination failure.
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hi BP" (unspecified if ongoing), notes: Hi BP; "Known Allergies: Penicillin" (unspecified if ongoing), notes: Known Allergies: Penicillin. The patient's concomitant medications were not reported. The patient did not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine reported as yes.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) negative, notes: day 8; (2022) positive, notes: day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19. Reported Event: On day 8 patient was antigen neg on day 9 patient became again antigen positive and started to experience worsening COVID symptoms. Symptoms continue to worsen to day 12 (today). For the 1st 8 days, essentially had no Symptoms feeling just fine. By day 11 patient was as sick as patient can remember in a long time. Anti-viral details: product COVID-19 Treatment, brand Paxlovid, treatment start date was 25Jun2022, treatment stop date was 29Jun2022 and indication was Treatment of COVID-19. It was reported that, Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating and Seriousness criteria-Congenital anomaly/birth defect reported as no.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), on 25Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 31May2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing). Concomitant medication(s) included: RUKOBIA; SELZENTRY; TIVICAY. Past drug history included: Codeine, reaction(s): "Drug Allergy"; Azt, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE , COVID-19 outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Negative; (06Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: If vaccine received: Yes, Other medication in 2weeks: Yes. Anti-viral details: product; COVID 19 Treatment, brand; Paxlovid, treatment start date; 27Jun2022, treatment stop date; 01Jul2022, indication; Treatment of COVID-19. Other medication details: other medication in 2weeks product; Rukobia, other medication in 2weeks product; Selzentry, other medication in 2weeks product; Tivicay. Adverse event: On 05Jul tested negative, finally. Then thru the night developed typical Covid symptoms & tested positive again 06Jul AM. Adverse event start date: 06Jul2022. Adverse event start time: 02:00 AM. Known allergies: Codeine, AZT, Other medical history: HIV.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: rebound Covid case followed; rebound Covid case followed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 10Jun2022, outcome "recovering" and all described as "rebound Covid case followed". Therapeutic measures were not taken as a result of covid-19, drug ineffective.  Clinical course: vaccine received. No other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2020 at 11:00 as dose 1, single (Lot number: EIH9099), in left arm, on 06Jan2021 at 09:00 as dose 2, single (Lot number: el0142), in left arm, on 06Oct2021 at 16:00 as dose 3 (booster), single (Lot number: ff2587), in left arm and on 26Apr2022 at 13:00 as dose 4 (booster), single (Lot number: fk4989) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: indication: Treatment of COVID-19; (29Jun2022) positive, notes: Day 8 still positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Antiviral details, Paxlovid (Lot number: GC2897) for COVID 19 Treatment, from 22Jun2022 to 26Jun2022. When taking the 5days course started to feel better. Day 8 still positive for COVID. About day 10 or 11 symptoms increased with congestion, fever and body aches. Now on Day 14 and continue with congestion cough and fatigue. I believe this situation may represent a rebound effect.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2020 at 11:00 as dose 1, single (Lot number: EIH9099), in left arm, on 06Jan2021 at 09:00 as dose 2, single (Lot number: el0142), in left arm, on 06Oct2021 at 16:00 as dose 3 (booster), single (Lot number: ff2587), in left arm and on 26Apr2022 at 13:00 as dose 4 (booster), single (Lot number: fk4989) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: indication: Treatment of COVID-19; (29Jun2022) positive, notes: Day 8 still positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Antiviral details, Paxlovid (Lot number: GC2897) for COVID 19 Treatment, from 22Jun2022 to 26Jun2022. When taking the 5days course started to feel better. Day 8 still positive for COVID. About day 10 or 11 symptoms increased with congestion, fever and body aches. Now on Day 14 and continue with congestion cough and fatigue. I believe this situation may represent a rebound effect.