chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient through other manufacturer (Pfizer Inc.) concerned a 44 year old male. Initial information was processed along with the additional information received on 13-APR-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and penicillin allergy. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 03-MAY-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 23-OCT-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 42 years old. Concomitant medications included salbutamol for unknown indication.  On an unspecified date in 2023, the patient experienced covid-19 infection (Confirmed covid-19 Infection) (Dose number in series 2)  for which patient received non-company suspect drug Paxlovid, (nirmatrelvir/ritonavir) (pill, route of admin, and batch number were not reported) dose and frequency were not reported from 24-MAR-2023 to 29-MAR-2023 for covid-19 treatment. Patient felt better 2 days after taking paxlovid and was tested negative on 29-MAR-2023 (last day of pills). On 04-APR-2023 10:00, 6 days after last dose patient felt stuffy and cough and tested positive which led to confirmed clinical vaccination failure (Dose number in series 2). On 29-MAR-2023, Laboratory data included: COVID-19 virus test Negative. On 04-APR-2023, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000278873.; Sender's Comments: V0: 20230425035- confirmed clinical vaccination failure . The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT RECEIVED HALF DOSE (0.25 ML); This spontaneous report received from a health care professional concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 18-FEB-2023) .25 ml, administered on 14-DEC-2021 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 63 years old. No concomitant medications were reported. On 14-DEC-2021, the patient experienced patient received half dose (0.25 ml). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient received half dose (0.25 ml) was not reported. This report was non-serious. This case, involving the same patient is linked. This case, from the same reporter is linked.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious. This case, from the same reporter is linked.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on JAN-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient recently experienced suspected covid-19 infection (dose number in series 2) and stated that she got it while helping a patient from a doctor's office. The patient had got over COVID-19, and it has been lingering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: BLACK SPOTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 2023, the patient experienced black spots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of black spots was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine used; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 002F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that expired vaccine was given to the patients past the expiration date. After being vaccinated, there were no complaints regarding any of the patient's health. No treatment medications were reported.  On 14-Apr-2023, case was made as invalid due to other patients involved without particular patient identifier.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 2nd patient out of 6 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719555 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719555:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023).    No concomitant medications were reported.     The patients did not report any adverse event.  No treatment medications were reported.  This case contains information for the 4th of 6th patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719555 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719555:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023).    No concomitant medication were reported.  HCP did not have patients' information at the time of the call. No patients have reported adverse event. No treatment information was provided by the reporter.  This case was of patient 5 of 6 patients, as mentioned by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719555 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719555:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023. This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.).    No concomitant medications was reported.  It was reported that the reporter asked for a stability letter from Moderna for the 6 doses of bivalent vaccine that had been administered beyond the published expiration date. No patients had reported adverse event.  No treatment details were reported.  This case was reported for Patient 6 out of 6 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719555 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719555:Master case
Sex: F
Vaccine: COVID19-2
Symptoms: Tooth abscess, Tooth infection
Clinical narrative: Tooth infection; The initial tooth infection created abscess in the childs mouth which led to having multiple surgeries; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) and TOOTH ABSCESS (The initial tooth infection created abscess in the childs mouth which led to having multiple surgeries) in a child female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTH INFECTION (Tooth infection) (seriousness criterion hospitalization) and TOOTH ABSCESS (The initial tooth infection created abscess in the childs mouth which led to having multiple surgeries) (seriousness criterion hospitalization). The patient was treated with Surgery (Multiple surgeries) for Tooth abscess. At the time of the report, TOOTH INFECTION (Tooth infection) and TOOTH ABSCESS (The initial tooth infection created abscess in the childs mouth which led to having multiple surgeries) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient was hospitalized for health aliments inline with a tooth infection. It was reported that the child missed over 3 weeks of school as a result of symptoms. Treatment medication was not provided. Company Comment: This is a spontaneous case concerning child female patient with no reported medical history, who experienced the serious (hospitalization) unexpected, events of tooth infection and tooth abscess, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273.222 (Original/Omicron BA.4/BA.5) vaccine (unknown COVID-19 vaccination schedule). It was reported that the initial tooth infection created abscess in the child´s mouth which led to having multiple surgeries. Child missed over 3 weeks of school because of symptoms. The outcome of the event was reported as recovered. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/BA.5) is not affected by this report.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Pruritus, Vaccination site erythema
Clinical narrative: Red raised skin around the injection site on the left arm present for the past 6 days. Redness covers half of the upper arm up to the shoulder; Redness covers half of the upper arm up to the shoulder. Also itchy, but no pain or burning; chills; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Red raised skin around the injection site on the left arm present for the past 6 days. Redness covers half of the upper arm up to the shoulder), PRURITUS (Redness covers half of the upper arm up to the shoulder. Also itchy, but no pain or burning), CHILLS (chills) and FATIGUE (fatigue) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 06-Apr-2023, the patient experienced VACCINATION SITE ERYTHEMA (Red raised skin around the injection site on the left arm present for the past 6 days. Redness covers half of the upper arm up to the shoulder), PRURITUS (Redness covers half of the upper arm up to the shoulder. Also itchy, but no pain or burning), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE ERYTHEMA (Red raised skin around the injection site on the left arm present for the past 6 days. Redness covers half of the upper arm up to the shoulder), PRURITUS (Redness covers half of the upper arm up to the shoulder. Also itchy, but no pain or burning), CHILLS (chills) and FATIGUE (fatigue) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had a doctor's appointment on April 11, 2023. It was unknown if the patient experienced any additional symptoms/events.   No treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Caller received the first Moderna shot on 03Jan2023; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Caller received the first Moderna shot on 03Jan2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.  On 03-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Caller received the first Moderna shot on 03Jan2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Caller received the first Moderna shot on 03Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Caller received the first Moderna shot on 03Jan2023).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  No treatment medications were reported.  Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted, Product availability issue
Clinical narrative: I got my fist dose primary vaccine, but it looks like the second dose is not available anywhere; but it looks like the second dose is not available anywhere.; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (I got my fist dose primary vaccine, but it looks like the second dose is not available anywhere), PRODUCT AVAILABILITY ISSUE (but it looks like the second dose is not available anywhere.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (I got my fist dose primary vaccine, but it looks like the second dose is not available anywhere), PRODUCT AVAILABILITY ISSUE (but it looks like the second dose is not available anywhere.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (I got my fist dose primary vaccine, but it looks like the second dose is not available anywhere), PRODUCT AVAILABILITY ISSUE (but it looks like the second dose is not available anywhere.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTRATION INTERRUPTED (I got my fist dose primary vaccine, but it looks like the second dose is not available anywhere) and PRODUCT AVAILABILITY ISSUE (but it looks like the second dose is not available anywhere.).    No concomitant medication were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry.Vaccine expiration date: 01Apr2023Vaccine administration date: 03Apr2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry.Vaccine expiration date: 01Apr2023Vaccine administration date: 03Apr2023) and NO ADVERSE EVENT (No adverse event) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Dose 1 and lot number: 071B22A) on 28-Feb-2023. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On 03-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry.Vaccine expiration date: 01Apr2023Vaccine administration date: 03Apr2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry.Vaccine expiration date: 01Apr2023Vaccine administration date: 03Apr2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry.Vaccine expiration date: 01Apr2023Vaccine administration date: 03Apr2023).    No concomitant medications were reported.     Patient did not report any side effects after receiving the vaccine.  No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted, Product availability issue
Clinical narrative: If there are no Monovalent adult doses of Moderna anymore in my facility to complete my 2nd dose of the primary series; Product administration interrupted; No Adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT AVAILABILITY ISSUE (If there are no Monovalent adult doses of Moderna anymore in my facility to complete my 2nd dose of the primary series), PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (If there are no Monovalent adult doses of Moderna anymore in my facility to complete my 2nd dose of the primary series), PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT AVAILABILITY ISSUE (If there are no Monovalent adult doses of Moderna anymore in my facility to complete my 2nd dose of the primary series), PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT AVAILABILITY ISSUE (If there are no Monovalent adult doses of Moderna anymore in my facility to complete my 2nd dose of the primary series) and PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted).    No concomitant medications were reported. Patient was not able to complete the 2nd dose from primary series of vaccination and was asking if can get a Pfizer Monovalent adult dose instead. It had been more than 36 days after the first dose was received. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2023: follow up received, contains non significant information.
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.).    No concomitant medications were reported. No patients had reported adverse event. No treatment details were reported. This case was reported for Patient 1 out of 6 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719560, US-MODERNATX, INC.-MOD-2023-719564, US-MODERNATX, INC.-MOD-2023-719565, US-MODERNATX, INC.-MOD-2023-719566, US-MODERNATX, INC.-MOD-2023-719567 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719567:Patient 6 of 6 US-MODERNATX, INC.-MOD-2023-719560:Patient 2 of 6 US-MODERNATX, INC.-MOD-2023-719565:Patient 4 of 6 US-MODERNATX, INC.-MOD-2023-719566:Patient 5 of 6 US-MODERNATX, INC.-MOD-2023-719564:Patient 3 of 6
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: no adverse event; he took his 1st Moderna shot on 27-Oct-2022, no 2nd dose yet after the 1st dose (more than 36 days); This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (he took his 1st Moderna shot on 27-Oct-2022, no 2nd dose yet after the 1st dose (more than 36 days)) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (he took his 1st Moderna shot on 27-Oct-2022, no 2nd dose yet after the 1st dose (more than 36 days)). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (he took his 1st Moderna shot on 27-Oct-2022, no 2nd dose yet after the 1st dose (more than 36 days)) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (he took his 1st Moderna shot on 27-Oct-2022, no 2nd dose yet after the 1st dose (more than 36 days)).    No concomitant medications was reported. No treatment drug details was reported.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; 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 female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 12Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2021 (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 01Apr2023 to 05Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300151489 same patient, different drug/AE;
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing), notes: Other medical history: DM depression; "DM" (unspecified if ongoing), notes: Other medical history: DM depression. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No allergies were known of the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300151941 same reporter/patient, different product/AE;
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), outcome "unknown", described as "stroke".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 7 days after second shot rash appeared on right arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 IMMUNIZATION, reaction(s): "3 days after first shot in right arm rash developed on upper arm". The following information was reported: RASH (non-serious), outcome "unknown", described as "7 days after second shot rash appeared on right arm".  Additional information: Reporters wife had delayed reaction. 7 days after second shot rash appeared on right arm, however second shot was administered in left arm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Lot number: Gh9703) at the age of 77 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: PF12ER), in left arm, on 06Feb2021 as dose 2, single (Lot number: EL9581), in left arm, on 30Aug2021 as dose 3 (booster), single (Lot number: EW0168), in right arm and on 05May2022 as dose 4 (booster), single (Lot number: FM0173), in left leg for covid-19 immunisation. The patient's relevant medical history included: "Auto Immune" (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; TAMSULOSIN; DULOXETINE DR; BREO ELLIPTA; LASIX [FUROSEMIDE]; LOSARTAN HCTZ. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Mar2023, outcome "recovered" (29Mar2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Mar2023) Positive, notes: taken covid test at home, tested positive 22Mar; (23Mar2023) Positive, notes: tested again 24 hours later tested positive 23Mar2023; (29Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 23Mar2023 to 28Mar2023. Started showing symptoms 21Mar2023 found out patient was exposed to family member who was diagnosed with Covid. Began taken covid test at home, tested positive 22Mar tested again 24 hours later tested positive 23Mar2023. Contacted Doctor, based on patient medical history prescribed Paxlovid. Began showing improvement within 24 hours (really worked well) Tested negative 29Mar felt great for 7 days. There were no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300152906 Same reporter/patient,different dose/AE.;US-PFIZER INC-202300152261 Same reporter/patient,different drug/AE.;US-PFIZER INC-202300154355 Same reporter/patient,different dose/AE.;
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: Gh9694), in left arm and on 15Mar2023 as dose 5 (booster), single (Lot number: AJ6743) at the age of 69 years, in left arm for COVID-19 immunisation; COVID-19 VACCINE (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Breast cancer", stop date: 2020, notes: Cancer free for 3 years; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication included: ARIMIDEX, start date: Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2023) Negative; (12Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient took Paxlovid from 01Apr2023 to 06Apr2023 for treatment of COVID-19. She tested positive for COVID on 12Apr2023 after completing five days of Paxlovid and testing negative on 07Apr2023.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Eye pain, Eye pruritus, Ocular hyperaemia, Sinus disorder
Clinical narrative: serious sinus issues; severe coughing; itchy red sore eyes; itchy red sore eyes; itchy red sore eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUS DISORDER (non-serious), outcome "unknown", described as "serious sinus issues"; COUGH (non-serious), outcome "unknown", described as "severe coughing"; EYE PRURITUS (non-serious), OCULAR HYPERAEMIA (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "itchy red sore eyes".  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, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: COVID 19 treatment; COVID 19 treatment; 27 weeks pregnant; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (pregnant) received BNT162b2 (BNT162B2 NOS), on 17Mar2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years for COVID-19 immunisation. The patient's relevant medical history included: "Known allergies: Ni" (unspecified if ongoing). Date of last menstrual period: 18Sep2022. The patient was 27 weeks pregnant at the time of exposure to BNT162b2. The patient was 27 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 11Jul2023. 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"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "27 weeks pregnant". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 03Apr2023 to 07Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Pfizer/BioNTech Dose Number: 4 / Moderna Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 38 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20May2022 as dose 3 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Oct2022, outcome "unknown", described as "Pfizer/BioNTech Dose Number: 4 / Moderna Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (29Mar2023) Negative, notes: testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE), COVID-19 and Interchange of vaccine products cannot be ruled out.