chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) 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 (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and the agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) 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 (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) 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 (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; 56 adults patients received doses after its expiration date Jul 13, 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022). At the time of the report, NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) 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 (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant and treatment medications were reported.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was stated that there were no remaining vials unused of that lot number and reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions. It was unknown if the vial was initially stored in the refrigerator.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) 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 (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant and treatment medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and the agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adult patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adult patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adult patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adult patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adult patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.  This case belonged to patient 38 out of 56 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) 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 (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) 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 (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided. This case belongs to patient number 39 out of 56 patients.    This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: exhausted & very tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (exhausted & very tired) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:*Declined to share name/initials, age/DOB,.     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 FATIGUE (exhausted & very tired). At the time of the report, FATIGUE (exhausted & very tired) 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.   No concomitant and treatment medications were reported   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: The patient also reports a sore left injection site arm.; patient received her first booster bivalent dose on October 28, 2022/ patient received his second Moderna Covid 19 vaccine booster bivalent dose on January 19, 2023; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (The patient also reports a sore left injection site arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her first booster bivalent dose on October 28, 2022/ patient received his second Moderna Covid 19 vaccine booster bivalent dose on January 19, 2023) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7185B and 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jan-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2023, the patient experienced VACCINATION SITE PAIN (The patient also reports a sore left injection site arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her first booster bivalent dose on October 28, 2022/ patient received his second Moderna Covid 19 vaccine booster bivalent dose on January 19, 2023). At the time of the report, VACCINATION SITE PAIN (The patient also reports a sore left injection site arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received her first booster bivalent dose on October 28, 2022/ patient received his second Moderna Covid 19 vaccine booster bivalent dose on January 19, 2023) 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.   The patient received her first Moderna covid 19 vaccine primary series on 31-Mar-2021 with lot number 039A21A and expiration date was 14- Sep-2021 in left arm and did not have adverse reactions. The patient received her second Moderna covid 19 vaccine primary series on 30-April-2021 with lot number 004C21A and expiration date was 19-Oct-2021 in left arm and did not have adverse reactions. The patient received her first Moderna covid 19 vaccine booster dose on 16- Jun-2022 with lot number 056M21A and expiration date was 12-Aug-2022 in left arm and did not have adverse reactions. The Nurse thought that the patient was counting injections rather than identifying monovalent versus bivalent vaccine and that this led to the error. The patient also reports a sore left injection site arm.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Suspected product contamination, Suspected product quality issue
Clinical narrative: Patient may have received a cloudy vaccine; Patient may have received a cloudy vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of SUSPECTED PRODUCT CONTAMINATION (Patient may have received a cloudy vaccine), SUSPECTED PRODUCT QUALITY ISSUE (Patient may have received a cloudy vaccine) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced SUSPECTED PRODUCT CONTAMINATION (Patient may have received a cloudy vaccine), SUSPECTED PRODUCT QUALITY ISSUE (Patient may have received a cloudy vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, SUSPECTED PRODUCT CONTAMINATION (Patient may have received a cloudy vaccine), SUSPECTED PRODUCT QUALITY ISSUE (Patient may have received a cloudy vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) 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 SUSPECTED PRODUCT CONTAMINATION (Patient may have received a cloudy vaccine) and SUSPECTED PRODUCT QUALITY ISSUE (Patient may have received a cloudy vaccine).    Concomitant and treatment medications were not reported.  Patient had no allergies and unknown for diseases.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Pharmacist was not sure if the vaccine administered was cloudy. The next 2 vials from that box have been cloudy once thaw form the freezer. Patient may have received a cloudy vaccine.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Respiratory disorder
Clinical narrative: dizzy; her respiratory system started acting up after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and RESPIRATORY DISORDER (her respiratory system started acting up after getting the vaccine) in a 69-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) 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 DIZZINESS (dizzy) and RESPIRATORY DISORDER (her respiratory system started acting up after getting the vaccine). At the time of the report, DIZZINESS (dizzy) and RESPIRATORY DISORDER (her respiratory system started acting up after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered DIZZINESS (dizzy) to be related. No further causality assessment was provided for RESPIRATORY DISORDER (her respiratory system started acting up after getting the vaccine).    Patient stated that vaccine made her dizzy for the 3 weeks till reporting. She also mentioned that her respiratory system started acting up after getting the vaccine. Concomitant and Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     The patient's past medical history included Non-smoker.    On 22-Dec-2022, the patient received fourth 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,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) 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.   Concomitant and Treatment medication was not provided.   Patient received her 4th Bivalent booster and approximately 10 days later she caught COVID-19. Patient was experiencing sore throat, running nose, sinus congestion and nagging cough and was still recovering for the past 3 weeks. Patient  primary problem was Head congestion and discolored mucus.   This case was linked to MOD-2021-065563 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were administer after 30 days of being in the refrigerator; Vaccines were administer after 30 days of being in the refrigerator; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were administer after 30 days of being in the refrigerator), PRODUCT STORAGE ERROR (Vaccines were administer after 30 days of being in the refrigerator) 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)) (batch no. ASKU) 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 (Vaccines were administer after 30 days of being in the refrigerator), PRODUCT STORAGE ERROR (Vaccines were administer after 30 days of being in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were administer after 30 days of being in the refrigerator), PRODUCT STORAGE ERROR (Vaccines were administer after 30 days of being in the refrigerator) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines were administer after 30 days of being in the refrigerator) and PRODUCT STORAGE ERROR (Vaccines were administer after 30 days of being in the refrigerator).    No concomitant and treatment medications were not reported.  It was reported that bivalent booster box was placed on refrigerator and vaccines were administer after 30 days of being in the refrigerator.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: not feeling well; experiencing a cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and NASOPHARYNGITIS (experiencing a cold) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well) and NASOPHARYNGITIS (experiencing a cold). At the time of the report, MALAISE (not feeling well) and NASOPHARYNGITIS (experiencing a cold) had not resolved.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   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 No treatment medications were reported.
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: felt horrible; she was going to pass out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 10Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt horrible"; DIZZINESS (non-serious), outcome "unknown", described as "she was going to pass out".   Additional information: Caller was "injected with" Prevnar 20 on 10Nov2022 and the next am she felt horrible like she was going to pass out and she wants to know if this is a side effect of the product. As warm transfer was completed, the line remained connected, however the caller did not speak on the other end to confirm or deny connection.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Lot number: gj6665) at the age of 34 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: er8737), in left arm, on 27Apr2021 as dose 2, single (Lot number: er8735), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: fg3527), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lamictal, reaction(s): "Known allergies: Lamictal", notes: Known allergies: Lamictal. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: testing negative at that time; Positive, notes: positive test is a mild cough. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was unknown if the patient had receive other medication in 2weeks. The patient received Antiviral Product brand Paxlovid for COVID 19 Treatment started on 12Jan2023 and stopped on 16Jan20232. Rebound covid approximately 4 days following completion of paxlovid and testing negative at that time. At the time of writing this the only symptom along with positive test is a mild cough.
Sex: F
Vaccine: UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She got COVID; She got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She got COVID".   Clinical course: Caller stated her question doesn't relate specifically to the Pfizer-Biontech COVID vaccine. Caller said "what I've been reading is people that have been vaccinated with whatever or when they're tested and they have symptoms, they're not showing positive right away; it takes a couple days because the vaccine is kicking in or the antibodies are kicking in." Caller mentioned "my mother is in assisted living, and she got COVID. So, I'm trying to get information on what's going on with COVID so I can inform their people if they're not up to date on it. This is something I read in several places and trying to get it officiated so I can let them know that its not something general I read." Caller is asking if Pfizer has some information on what she read. Call got remotely disconnected.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Symptomatic Covid infection confirmed by home antigen test ~4 months after booster.; Symptomatic Covid infection confirmed by home antigen test ~4 months after booster.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jan2023, outcome "not recovered" and all described as "Symptomatic Covid infection confirmed by home antigen test ~4 months after booster.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Petechiae, Rash, SARS-CoV-2 test
Clinical narrative: Petechiae; Immediately developed a rash on left side in the stomach area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 at 10:30 as dose 1, single (Lot number: EN6200) at the age of 79 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. The following information was reported: RASH (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Immediately developed a rash on left side in the stomach area"; PETECHIAE (non-serious) with onset 27Feb2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of petechiae, rash.  Additional information: After the first injection in 25Feb2021, patient immediately developed a rash on left side in the stomach area. To this day, the rash, petechiae, is still present. Other medications the patient received within 2 weeks of vaccination included Vitamin Daily and Ibuprofen. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19 as negative. Patient had no known allergies. Patient received dose 2 of BNT162B2 (lot number: ER2613) on 18Mar2021 at 09:15 AM in the Right arm. Patient received Dose 3 of BNT162B2 (lot number: EWO175) on 01Nov2021 at 10:00 AM, in the Left arm.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID Positive test; COVID Positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8730), in left arm, on 24Apr2021 as dose 2, single (Lot number: EW0171), in left arm and on 29Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 39 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Food: Shellfish Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jan2023, outcome "unknown" and all described as "COVID Positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: I've had a fever over 99F and a major body ache for the entire day (21Jan2023). I've had to take 2 Tylenols in the past 10 hours to help with fever and pain management.; I've had a fever over 99F and a major body ache for the entire day (21Jan2023). I've had to take 2 Tylenols in the past 10 hours to help with fever and pain management.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jan2023 at 15:00 as dose 4 (booster), single (Lot number: GL0446) at the age of 26 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1,SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2,SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER),SINGLE), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), PAIN (non-serious) all with onset 21Jan2023 at 08:00, outcome "not recovered" and all described as "I've had a fever over 99F and a major body ache for the entire day (21Jan2023). I've had to take 2 Tylenols in the past 10 hours to help with fever and pain management.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain.  Additional information: patient was reported that I have had a fever over 99F and a major body ache for the entire day (1/21). I've had to take 2 Tylenols in the past 10 hours to help with fever and pain management. COVID prior vaccination, COVID tested post vaccination, Other medical history and Known allergies was reported as 'no'. The patient received treatment with Tylenol for the adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2 NOS), on 17Nov2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Testicular cancer" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment and patient previously receive a COVID-19 Vaccine. Patient had no known allergies. Patient received treatment from 12Jan2023 to 17Jan2023. It was reported that Finished Paxlovid on 17Jan. Patient had no symptoms. On 21Jan I developed a sore throat and cough and chills. I tested positive on a home test  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Hypersensitivity, Rash, Swelling, Thermal burn
Clinical narrative: rash; Allergies; burns; swelling; Acne; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2023 at 02:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: TOPAMAX. The following information was reported: ACNE (non-serious) with onset 13Jan2023, outcome "not recovered"; HYPERSENSITIVITY (non-serious) with onset 13Jan2023, outcome "not recovered", described as "Allergies"; THERMAL BURN (non-serious) with onset 13Jan2023, outcome "not recovered", described as "burns"; RASH (non-serious) with onset 13Jan2023, outcome "not recovered"; SWELLING (non-serious) with onset 13Jan2023, outcome "not recovered". The events "rash", "allergies", "burns", "swelling" and "acne" required physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of rash, hypersensitivity, thermal burn, swelling, acne.  Additional information: Reported as Serious: Yes. Seriousness criteria-Disabling/Incapacitating: Yes. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Topamax within 2 weeks of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, the patient been tested for COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 at 14:30 as dose 1, single (Lot number: EP7534), in left arm, on 15Apr2021 at 14:30 as dose 2, single (Lot number: ER8734), in left arm, on 21Oct2021 at 14:30 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 20May2022 at 14:30 as dose 4 (booster), single (Lot number: FK9894) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC, start date: 22Jul2022; SYNTHROID, start date: 25Mar2022; CYTOMEL, start date: 21Jan2022. Past drug history included: Valium, reaction(s): "known allergies: Valium". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11Jan2023 to 15Jan2023.