chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 24 Apr 2022, expired vaccine administerd on 25 Apr 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 24 Apr 2022, expired vaccine administerd on 25 Apr 2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 077C12B and 022J21A) for COVID-19 vaccination.     Patient has never been diagnosed or tested positive for COVID-19. No acute illness reported at the time of vaccination and up to one month before it. Chronic or long standing health condition was reported as unknown. Prescription, over the counter medications, dietary supplements or herbal medicines being taken at the time of vaccination or at the time of adverse event was reported as unknown.  Concurrent medical conditions included Penicillin allergy, Drug allergy (Amlodipine), Drug allergy (Lisinopril) and Drug allergy (Losartan).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 10:50 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 10:50 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 24 Apr 2022, expired vaccine administerd on 25 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 24 Apr 2022, expired vaccine administerd on 25 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 24 Apr 2022, expired vaccine administerd on 25 Apr 2022) to be related.    No concomitant medication information provided. No treatment medication information provided. Adverse event did not cause patient to seek medical care. There were no other potential causes of adverse events. it was reported that patient has not experienced any other similar events in the past.  Patients were given with the expired Moderna booster dose which they thought the expiry date was 26 Apr 2022 however the actual expiry date was 24 Apr 2022.  It was reported in the Source document that the HCP stated that a few months ago the Vial Expiration Look up Tool displayed 26 Apr 2022 as the expiration date for Lot number: 022J21A, so they administered 10 patients on 25Apr2022 with that vaccine, and now that they checked the expiration date again in the tool, the new expiration date was reported as 24Apr2022, HCP stated that the expiration date has changed. 10 patients were administered with an expired dose on 25 Apr 2022.  No temperature excursion at the time of vaccination reported.   This case was linked to MOD-2022-554190 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 019F21A, 030L20A and 011L20A) for COVID-19 vaccination.     It was reported that the patient did not have any Acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Drug allergy (Sulfa).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 3:15 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 3:15 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022).    Concomitant medication was not provided.  It was reported that there were no other potential causes.  The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-554190 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound-COVID symptoms returned) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F211A) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Allergy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication. On 03-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 18-Apr-2022, the patient experienced COVID-19 (Rebound-COVID symptoms returned). At the time of the report, COVID-19 (Rebound-COVID symptoms returned) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2022, SARS-CoV-2 test: tested positive in antigen test (Positive) Rebound-COVID symptoms returned, tested positive in antigen test. Device date : 27Apr2022. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient taking other medications or products within 2 weeks of starting COVID-19 treatment but unaware of the name. The patient also previously received a unknown COVID-19 vaccine. The patient had a Rebound-COVID symptoms returned, and found positive in antigen test. The device date 27-Apr-2022. No treatment drug details was reported. Company comment: This is a Spontaneous case concerning a 67-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, approximately 5 months and 16 days after the administration of a dose of the mRNA-1273 vaccine (of an unknown dose and scheme of vaccination). Relevant test was performed: COVID-19 antigen test positive. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event assessed as non-serious. Sender's Comments: This is a Spontaneous case concerning a 67-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, approximately 5 months and 16 days after the administration of a dose of the mRNA-1273 vaccine (of an unknown dose and scheme of vaccination). Relevant test was performed: COVID-19 antigen test positive. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event assessed as non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Hair growth abnormal
Clinical narrative: patient reports that her hair started to fall out after the second dose/lost 4 inches in the length of her hair/hair has thinned out/patient feels that she has half the hair that she used to have; patient also reports that the hair on her legs is not growing as rapidly as it once was./Before the vaccine the patient had to shave her legs each day/After the vaccine the patient has to shave her legs every 3 days.; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (patient reports that her hair started to fall out after the second dose/lost 4 inches in the length of her hair/hair has thinned out/patient feels that she has half the hair that she used to have) and HAIR GROWTH ABNORMAL (patient also reports that the hair on her legs is not growing as rapidly as it once was./Before the vaccine the patient had to shave her legs each day/After the vaccine the patient has to shave her legs every 3 days.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HAIR GROWTH ABNORMAL (patient also reports that the hair on her legs is not growing as rapidly as it once was./Before the vaccine the patient had to shave her legs each day/After the vaccine the patient has to shave her legs every 3 days.). On 30-Aug-2021, the patient experienced ALOPECIA (patient reports that her hair started to fall out after the second dose/lost 4 inches in the length of her hair/hair has thinned out/patient feels that she has half the hair that she used to have). At the time of the report, ALOPECIA (patient reports that her hair started to fall out after the second dose/lost 4 inches in the length of her hair/hair has thinned out/patient feels that she has half the hair that she used to have) and HAIR GROWTH ABNORMAL (patient also reports that the hair on her legs is not growing as rapidly as it once was./Before the vaccine the patient had to shave her legs each day/After the vaccine the patient has to shave her legs every 3 days.) outcome was unknown.            No concomitant medication was provided.  Patient received the vaccine in her left arm shoulder deltoid muscle.  Patient reported that, patient hair started to fall out after the second dose of the Moderna Covid-19 vaccine.  The hair on leg before the vaccine the patient had to shave her legs each day. After the vaccine the patient has to shave her legs every 3 days.  Patient tried using shampoo and conditioner with biotene and minerals to try and promote hair growth.   This case was linked to MOD-2022-558287 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 019F21A, 030L20A and 025J20A) for COVID-19 vaccination. The patient never been diagnosed with or tested positive for COVID-19. Acute illness at the time of vaccination and up to one month before was reported as unknown. Chronic or long standing health conditions were unknown. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients were administered with an expired dose) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) 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 a few months ago the Vial Expiration Look up Tool displayed 26-Apr-2022 as the expiration date for Lot number: 022J21A, so they administered 10 patients on 25-Apr-2022 with that vaccine, and after that they checked the expiration date again in the tool, the new expiration date is 24-Apr-2022, HCP stated that the expiration date had changed. The date at which the vial was initially stored in the refrigerator was 25-Apr-2022. The vial did not undergo any temperature excursions. No treatments medication were reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022; Expired vaccine administered to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 004M20A and 025J20A) for COVID-19 vaccination.     Patient has no acute illness at the time of vaccination and up to one month before. It was unknown that patient ever tested positive or diagnosed with COVID-19. It was also unknown that if patient had any chronic conditions. Patient had no known drug allergy.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Apr-2022 at 1:50 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 1:50 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) to be related.    The race of the patient was reported. Concomitant medication information was unknown. The vials were initially stored in refrigerator on 25-Apr-2022. The vials has not undergone temperature excursion. It was reported Moderna booster was given on 25-Apr-2022, thinking that expiration date was 27-Apr-2022. Later noticed that vaccine expiration date was 24-Apr-2022. No treatment medication information was given.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of diarrhea and headache(s) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On May 3, 2022, patient received the fourth dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 4, 2022, patient experienced diarrhea and headache(s). At the time of the report, diarrhea and headache(s) outcome: unknown. No concomitant medication or treatment information reported. The patient woke up in the morning (May 4, 2022) with headache(s) and diarrhea. No further contact allowed.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (developed a sore injection site arm after receiving their primary series of the Moderna COVID-19 vaccine) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pain (developed a sore injection site arm after receiving their primary series of the Moderna COVID-19 vaccine). At the time of the report, vaccination site pain (developed a sore injection site arm after receiving their primary series of the Moderna COVID-19 vaccine) outcome: unknown.  No concomitant medication or treatment information provided. This case linked to MOD-2022-559046 (patient link). Most recent follow-up information incorporated: May 4, 2022: Follow-up received contained no new information.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea
Clinical narrative: Malaise; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), HEADACHE (Headache) and NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer, Pfizer (Dose 2 (2 doses of Pfizer Biontech COVID-19 vaccine).) and PFIZER BIONTECH COVID-19 VACCINE (Dose 1 (2 doses of Pfizer Biontech COVID-19 vaccine).). Past adverse reactions to the above products included Headache with PFIZER BIONTECH COVID-19 VACCINE; Malaise with Pfizer; and Nausea with Pfizer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, MALAISE (Malaise), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported. The patient received J and J as a fourth dose and the side effects from the J and J shot were worse than the first three, but far greater intensity.  No treatment medications were reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Lower respiratory tract infection, Respiratory symptom
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYMPTOM (Symptoms of an upper respiratory) and LOWER RESPIRATORY TRACT INFECTION (Chest cold) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A, 011M20A and 027L20A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 treatment. The patient's past medical history included Heart disorder (treated by a stint 6 years ago, and valve replacement one and a half years ago) and Heart valve replacement (valve replacement one and a half years ago). Concurrent medical conditions included Allergy. On 13-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021 at 10:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 20-Apr-2022 at 8:00 AM, the patient experienced RESPIRATORY SYMPTOM (Symptoms of an upper respiratory) and LOWER RESPIRATORY TRACT INFECTION (Chest cold). At the time of the report, RESPIRATORY SYMPTOM (Symptoms of an upper respiratory) and LOWER RESPIRATORY TRACT INFECTION (Chest cold) had not resolved. No concomitant medication information was provided. It was reported that the patient had symptoms of an upper respiratory and chest cold and a resulting positive test after and had tested negative after receiving Paxlovid. Device date was reported as 27-Apr-2022. No treatment medication were provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was given on 15-Jan-2021 and 2nd dose administered on 04-Feb-2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025J20A) for COVID-19 vaccination. Patient had been diagnosed with and tested positive. There were none acute illness at the time of vaccination and up to one month before. Chronic or long-standing health condition were unknown. Prescriptions, over-the counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination or at the time of adverse event were unknown. The patient's past medical history included COVID-19. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was given on 15-Jan-2021 and 2nd dose administered on 04-Feb-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was given on 15-Jan-2021 and 2nd dose administered on 04-Feb-2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2022-554190 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of  hypersensitivity (allergic reaction) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hypersensitivity (allergic reaction). At the time of the report, hypersensitivity (allergic reaction) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, due to allergic reaction with first dose, patient did not complete the series. On May 9, 2021, patient administered second dose of Janssen COVID-19 vaccine (off-label use purpose). On Nov 12, 2021, patient administered the third dose of Janssen COVID-19 vaccine. The time gap between second and third dose was 6 months 3 days hence patient administered an inappropriate schedule of vaccine. The outcome for both off-label use and inappropriate schedule of vaccine: unknown at the time of report. It was unknown whether patient had any adverse events following third vaccination.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 booster doses of Moderna Covid-19 vaccine were given beyond 12 hrs., but less than 24 hrs. of exposure to room temperature) and PRODUCT STORAGE ERROR (Vaccine punctured on 04-May-2022 and administered on 05-May-2022, 23 hours and 2 minute after puncture) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 vaccination. No Medical History information was reported. On 05-May-2022 at 9:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-May-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 booster doses of Moderna Covid-19 vaccine were given beyond 12 hrs., but less than 24 hrs. of exposure to room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine punctured on 04-May-2022 and administered on 05-May-2022, 23 hours and 2 minute after puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 booster doses of Moderna Covid-19 vaccine were given beyond 12 hrs., but less than 24 hrs. of exposure to room temperature) and PRODUCT STORAGE ERROR (Vaccine punctured on 04-May-2022 and administered on 05-May-2022, 23 hours and 2 minute after puncture) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provider by the reporter. Dose administered greater than 12(US)/24(CA) hours post puncture. The vial was initially stored in the refrigerator at 10:38 am on 04-May-2022. On 04-May-2022, at 10:58 am vial was first punctured. On 05-May-2022, at 09:40 am vaccine administered. The vial was stored in Room temp, out of direct light post puncture. The vial not underwent any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was reported as 23hrs 2 min, beyond 12 hours, but less than 24hrs of exposure to room temperature. No treatment drug were reported. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Follow up document contain no new information.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 booster doses of Moderna Covid-19 vaccine were given beyond 12 hrs., but less than 24hrs of exposure to room temperature.) and PRODUCT STORAGE ERROR (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 23hrs 2 min/initially stored in the refrigerator: 10:38am 04May2022) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 vaccination. No Medical History information was reported. On 05-May-2022 at 9:40 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 booster doses of Moderna Covid-19 vaccine were given beyond 12 hrs., but less than 24hrs of exposure to room temperature.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 23hrs 2 min/initially stored in the refrigerator: 10:38am 04May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 booster doses of Moderna Covid-19 vaccine were given beyond 12 hrs., but less than 24hrs of exposure to room temperature.) and PRODUCT STORAGE ERROR (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 23hrs 2 min/initially stored in the refrigerator: 10:38am 04May2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine (Unknown), the reporter did not provide any causality assessments. Dose administered >12(US)/24(CA) hours post puncture. The vial was initially stored in the refrigerator at 10:38 am on 04-May-2022. On 04-May-2022, at 10:38 am vial was first punctured. On 05-May-2022, at 09:40 am administration of vaccine. The vial was stored in Room temp, out of direct light post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was reported as 23hrs 2 min. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Follow up contains no new information.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tinnitus
Clinical narrative: Time interval between Dose 1 and Dose 2 was more than 30 days; I  have had incessant ringing since the first shot, and it increased in loudness after the second shot.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (I  have had incessant ringing since the first shot, and it increased in loudness after the second shot.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time interval between Dose 1 and Dose 2 was more than 30 days) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 007B2I1A) for COVID-19 vaccination.     Patient had never been diagnosed with or tested positive for COVID-19. Patient not had acute illnesses at the time of vaccination and up to one month before.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TINNITUS (I  have had incessant ringing since the first shot, and it increased in loudness after the second shot.). On 09-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time interval between Dose 1 and Dose 2 was more than 30 days). At the time of the report, TINNITUS (I  have had incessant ringing since the first shot, and it increased in loudness after the second shot.) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time interval between Dose 1 and Dose 2 was more than 30 days) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. It was reported that there was no other potential cause for the event tinnitus.   This case was linked to MOD-2021-155644 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 76-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Moderately high blood pressure; "Cholesterol" (unspecified if ongoing), notes: cholesterol being treated. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 02Jan2018; ATORVASTATIN, start date: 03Jan2022, stop date: 12Apr2022; FLAXSEED OIL NATURE MADE, start date: 03Mar2022; MATURE MULTIVITAMINS, start date: 07Jul2015; GLUCOSAMINE & CHONDORITIN, start date: 07Jul2015; COQ10 [UBIDECARENONE], start date: 07Jul2015; B12, start date: 07Jul2015; TURMERIC [CURCUMA LONGA ROOT], start date: 07Jul2015; ASPIRIN 81, start date: 07Jul2015; PROSTATE HEALTH [SERENOA REPENS], start date: 07Jul2015; D3, start date: 07Jul2015. Vaccination history included: Covid-19 vaccine (dose 1), for COVID-19 Immunization; Covid-19 vaccine (dose 2), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Apr2022 at 15:00, outcome "recovered" (01May2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Negative; (27Apr2022) Positive; (01May2022) Negative; (28Apr2022) positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical Comment: Patient's husband took Paxlovid for five days until 16Apr2022. His symptoms gradually disappeared and then on 20Apr2022 he tested negative on the antigen test. He felt fine until 27Apr when symptoms returned. He tested positive that evening on 27Apr antigen test. He was given a PCR test at (name withheld) on 28Apr and the results came out positive. His symptoms this time have been very mild. Today, 01May, he tests negative on the antigen test and feels completely better. We will go into a (name withheld) tomorrow to get another PCR test. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19 pneumonia, Drug ineffective
Clinical narrative: This is a literature report, Program ID: Unknown for the following literature source(s): "Severe COVID pneumonia and undetectable B cells after vaccination in patients previously treated with rituximab: a case series". A 63-year-old male 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 included: "former smoker" (unspecified if ongoing), notes: a former smoker (105 pack years); "glomerulonephritis" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown", described as "his 2nd dose two and half weeks after 1st dose"; COVID-19 PNEUMONIA (hospitalization, medically significant), outcome "recovering", described as "developed COVID-19 pneumonia". The patient underwent the following laboratory tests and procedures: Body mass index: 45.8. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: The reported COVID-19 pneumonia after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient. Other Case identifier(s): 2022-0572117. A 58-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; Ambrisentan (AMBRISENTAN), since 08Jun2020 (ongoing) (Lot number: 28382, Expiration Date: 30Nov2023) at 10 mg 1x/day for pulmonary hypertension; docusate sodium, sennoside A+B (LAXATIVE STOOL SOFTENER WITH SENNA), (Batch/Lot number: unknown) for constipation. The patient's relevant medical history included: "Pulmonary hypertension Secondary" (ongoing), notes: current condition; "Connective tissue disorder" (ongoing), notes: current condition; "Scleroderma" (ongoing), notes: current condition; "right ventricular dysfunction" (ongoing), notes: current condition; "Dysphagia" (ongoing), notes: current condition; "Interstitial lung disease" (ongoing), notes: current condition; "hypertension" (ongoing), notes: current condition. Concomitant medication(s) included: TYVASO (ongoing); REVATIO (ongoing); SILDENAFIL [SILDENAFIL CITRATE] taken for interstitial lung disease (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has both vaccines and did not have this reaction when she had Covid last year". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Patient diagnosed with COVID last Wednesday; she had Covid last year. The action taken for Ambrisentan was dosage not changed; for docusate sodium, sennoside A+B was unknown. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient diagnosed with COVID last Wednesday and started taking Paxlovid and is now having side effects like heart rate going up and oxygen level going down along with swelling. She started she has both vaccines and did not have this reaction when she had Covid last year so believes it is due to Paxlovid. No further details provided. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: If vaccine received: Yes/ vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment, brand: Paxlovid; If vaccine received: Yes/ vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment, brand: Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 06Apr2021 as dose 2, single (Lot number: EW0150), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; FAMOTIDINE; CETRIZINE; ESCITALOPRAM; DICLOFENAC SODIUM; HYDROCHLOROTHIAZIDE; CALCIUM CITRATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "recovering" and all described as "If vaccine received: Yes/ vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment, brand: Paxlovid". 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 course: Other medication in 2 weeks product: Vitamins, No known allergies reported. On 26Apr2022 Recurrence of covid symptoms and increased viral load after completion of Paxlovid five day course and apparent recovery   Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-BioNTech Covid-19 Vaccine lot FH8028, EW0150 and EN6207 were investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8028, fill lot FH4341 and the bulk formulated drug product lot FH4347 and lot EW0150, fill lot EP8690 and the formulated drug product lot EP8587 and lot EN6207, fill lot EN5340, and the formulated drug product lot EN5328. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or ADR were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: If vaccine received Yes/vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment, brand: Paxlovid; If vaccine received Yes/vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment, brand: Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUOXETINE; WELLBUTRIN; FINASTERIDE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for covid 19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "If vaccine received Yes/vaccine brand: Pfizer / BioNTech/product: COVID 19 Treatment, brand: Paxlovid". 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 course:Metallic taste in mouth during treatment. Cold like symptoms (running nose, cough) returned 4 days after stopped treatment.  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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 at 07:30 as dose 1, single (Lot number: ER5730), on 20Jan2021 at 09:30 as dose 2, single (Lot number: Tl8982) and on 22Oct2021 at 09:30 as dose 3 (booster), single (Lot number: 30155BA), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Graves disease" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: RASUVO; COSENTYX; OMEPRAZOLE; LEVOTHYROXINE; FOLIFAST. Past drug history included: Gadolinium, reaction(s): "known allergies; Gadolinium". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 19Jan2022, outcome "not recovered" and all described as "Covid test result Positive". The event "Covid test result positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of Covid-19, vaccination failure. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "cold sores" (unspecified if ongoing); "herpes simplex mostly due to sun exposure" (unspecified if ongoing), notes: herpes simplex mostly due to sun exposure; "Interchange of vaccine products" (unspecified if ongoing), notes: had the two initial Pfizer vaccine shots, one Moderna booster and one Pfizer booster. There were no concomitant medications. Past drug history included: Poison ivy, notes: he got into poison ivy and got a shot, that was several years ago, 2-3 years ago. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Moderna (First Booster); Flu shot (Caller states he did get the flu shot this past fall, like 6 months ago around the same time he got the first 2 Pfizer shots). The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "It makes sense that the vaccine is helping with the cold sores since they are caused by a virus". Additional information: Caller reported what he thinks is a good side effect or benefit of the COVID vaccine. Since he was a child, he has had cold sores, herpes simplex around his mouth and that he was a 61-year-old male. The caller added that after the vaccine shots he had not been presenting cold sores so he was wanting to report. He had not changed his lifestyle, no medications whatever, the only thing that changed was he was poked 4 times with the vaccine. He was theorizing that it was possible that it has had an effect on the herpes. He tried to look it up and if we have several people that have mentioned this maybe, since there was no cure. He was thrilled about this, he hated it and he had not changed anything. He noticed cold sores not presenting, caller states that typically in spring and fall he got the cold sores and he had not had any. Stated they were due mainly to sun exposure and he had been outside a lot. Stated the last few months he would usually have had 1-2 by this time. Caller stated he did get the flu shot this past fall, like 6 months ago around the same time he got the first 2 Pfizer shots. He did not even take vitamins. The last he was at the doctor was because he got into poison ivy and got a shot, that was several years ago, 2-3 years ago. Caller stated his 1st booster was Moderna COVID-19 vaccine and his 2nd booster was Pfizer COVID-19 vaccine. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none, Prior Vaccinations (within 4 weeks) None and Relevant Tests: None. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.