chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on 15-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient had tested positive or diagnosed with COVID-19 previously.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) 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 EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    Concomitant medications of the patient were not reported.  The vial was initially stored in the refrigerator on 14-Mar-2023. The vial did not undergo any temperature excursions.  HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-Mar-2023. There was potentially a second lot number that was expired and was administered to patients on 03-Mar-2023, but HCP did not have any details on this event at the time of reporting.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) 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 EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023).    No concomitant medications were reported.  This lot number 060B22A of vaccine was administered to patients with a count of in between 75 and 125.  It was also reported that there was potentially a second lot number of vials that had expired on 28-Feb-2023 and was administered to patients on 03-Mar-2023, but the healthcare provider did not have any details of that event at that time.  The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master Case
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) 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 EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023).    No concomitant medications were reported.  This lot number 060B22A of vaccine was administered to patients with a count of in between 75 and 125.  It was also reported that there was potentially a second lot number of vials that had expired on 28-Feb-2023 and was administered to patients on 03-Mar-2023, but the healthcare provider did not have any details of that event at that time.  The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master Case
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she really had was a sore arm each time she got the injection.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (she really had was a sore arm each time she got the injection.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 013L20A and 026L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (she really had was a sore arm each time she got the injection.). At the time of the report, PAIN IN EXTREMITY (she really had was a sore arm each time she got the injection.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient had received two shots of Pfizer and most recent shot was on Sep-2022 and received Pfizer booster on Feb-2022 and was very careful had not gotten COVID yet. It was reported that patient had some filler injections two weeks ago around her mouth and on Friday last week, started getting hives right around the area where patient got the injections. Patient said that they were like hard bumps with little white heads on them and very itchy. Patient was not sure if it was some kind of allergic reaction to the filler injection. Patient received it from dermatologist and it was an injection called Juvederm. No treatment information was provided.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Pulmonary function test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 01FH22A) 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. In November 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pulmonary function test: Fine.     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 was not feeling well since getting over COVID first week in November 2022. She had runny nose, headache, shortness of breath. She had receive 2 primary series vaccines and 2 boosters. Doctor sent her to pulmonologist test were ran and results were fine. Still experiencing shortness of breath and nausea. Doctor thought she may have issues with gallbladder scheduled to see gallbladder surgeon. Concomitant medication not reported. Treatment medication not reported.   This case was linked to MOD-2021-022860 (Patient Link).
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Hypersensitivity
Clinical narrative: HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).) 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)) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Gluten sensitivity (Gluten allergy) and Allergy (sea salt allergy).    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 HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).). At the time of the report, HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).) to be not related.    No concomitant medication was reported. The dosage text of the suspect was reported as unknown. HCP reported that the patient actually did not have reaction to or after the Moderna Covid19 vaccines. The patient was concerned with allergies and if they were in the new vaccine. HCP checks and reports that the patient already received a Bivalent vaccine last fall so they should be good.  No treatment medication was reported.   This case was linked to MOD-2023-724815 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Condition aggravated, Gluten sensitivity
Clinical narrative: HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).) 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)) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Gluten sensitivity (Gluten allergy) and Allergy (sea salt allergy).    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 HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).). At the time of the report, HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.).) to be not related.    No concomitant medication was reported. The dosage text of the suspect was reported as unknown. HCP reported that the patient actually did not have reaction to or after the Moderna Covid19 vaccines. The patient was concerned with allergies and if they were in the new vaccine. HCP checks and reports that the patient already received a Bivalent vaccine last fall so they should be good.  No treatment medication was reported.   This case was linked to MOD-2023-724815 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Helicobacter infection
Clinical narrative: infections from h.pylori; This spontaneous case was reported by an other health care professional and describes the occurrence of HELICOBACTER INFECTION (infections from h.pylori) 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.     It  was unknown if patient  received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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 HELICOBACTER INFECTION (infections from h.pylori). At the time of the report, HELICOBACTER INFECTION (infections from h.pylori) 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 information was reported. Suspect product dosage text was reported as unknown. It was reported that patient had infections from h.pylori and was going to take some herbal supplement with the active ingredient thymoquinone and active biological substance of Nigella Sativa in Black Seed Oil.   This case was linked to US-MODERNATX, INC.-MOD-2023-724906 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724906:90 Year Old Patient)
Age: 90.0
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Helicobacter infection
Clinical narrative: infections from h.pylori; This spontaneous case was reported by an other health care professional and describes the occurrence of HELICOBACTER INFECTION (infections from h.pylori) in a 90-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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second 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 HELICOBACTER INFECTION (infections from h.pylori). At the time of the report, HELICOBACTER INFECTION (infections from h.pylori) 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 information was reported.  The reporter was a caregiver and was stated about to get the patient who was 90 years old a second Moderna vaccine shot as well as themselves. They both had infections from h.pylori. They were going to take some herbal supplement with the active ingredient thymoquinone and active biological substance of Nigella Sativa in Black Seed Oil.   This case was linked to US-MODERNATX, INC.-MOD-2023-724834 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724834:(Adult Patient)
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Inflammation, Myalgia
Clinical narrative: took the 2nd Moderna bivalent and have been having some issues after that/inflammation throughout their body; have generalized joint and muscle pain; have generalized joint and muscle pain; This spontaneous case was reported by a patient and describes the occurrence of INFLAMMATION (took the 2nd Moderna bivalent and have been having some issues after that/inflammation throughout their body), MYALGIA (have generalized joint and muscle pain) and ARTHRALGIA (have generalized joint and muscle pain) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 067H22A and AS7140C) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy (does not have allergic reactions to any vaccine).   On 12-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-May-2023, received sixth 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 an unknown date, the patient experienced INFLAMMATION (took the 2nd Moderna bivalent and have been having some issues after that/inflammation throughout their body), MYALGIA (have generalized joint and muscle pain) and ARTHRALGIA (have generalized joint and muscle pain). At the time of the report, INFLAMMATION (took the 2nd Moderna bivalent and have been having some issues after that/inflammation throughout their body) and MYALGIA (have generalized joint and muscle pain) had not resolved and ARTHRALGIA (have generalized joint and muscle pain) 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 did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  The events occurred one week after getting the 2nd bivalent Moderna vaccine. Caller stated that they already consulted with their HCP on 15May2023 and was given an anti-inflammatory but they did not mention that they had the vaccine.   This case was linked to MOD-2023-724866 (Patient Link).   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acne, Vaccination site pain, Vaccination site reaction
Clinical narrative: left arm injection site started having a reaction; red pimple; it is the size of a lima bean and very painful; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (left arm injection site started having a reaction), ACNE (red pimple) and VACCINATION SITE PAIN (it is the size of a lima bean and very painful) 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 no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-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 an unknown date, the patient experienced VACCINATION SITE REACTION (left arm injection site started having a reaction), ACNE (red pimple) and VACCINATION SITE PAIN (it is the size of a lima bean and very painful). At the time of the report, VACCINATION SITE REACTION (left arm injection site started having a reaction), ACNE (red pimple) and VACCINATION SITE PAIN (it is the size of a lima bean and very painful) had not 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 medication details was reported. Patient received First Primary monovalent dose on 26-MAR-2021, Lot number- 007B21A. Second Primary monovalent dose on 23-APR-2021 Lot number- 006C21A. First Monovalent Booster dose on 14-DEC-2021 Lot number- 060H21A.  No treatment medication details was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Pruritus
Clinical narrative: I know 3 people that also had Moderna & they also are itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (I know 3 people that also had Moderna & they also are itching) 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)) 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 PRURITUS (I know 3 people that also had Moderna & they also are itching). At the time of the report, PRURITUS (I know 3 people that also had Moderna & they also are itching) outcome 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 information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided. This case is reported for patient 1 out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-724918, US-MODERNATX, INC.-MOD-2023-724915 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724918:(Patient 3) US-MODERNATX, INC.-MOD-2023-724915:(Patient 2)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered after published expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after published expiration date) 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. AS7145B) 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 (Vaccine was administered after published expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after published expiration date) 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 (Vaccine was administered after published expiration date).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. Treatment medications were not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: His wife feels like she had been beaten up for 3 days after having the Moderna vaccine/his wife had reactions which we typically hear about; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (His wife feels like she had been beaten up for 3 days after having the Moderna vaccine/his wife had reactions which we typically hear about) 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)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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 IMMUNISATION REACTION (His wife feels like she had been beaten up for 3 days after having the Moderna vaccine/his wife had reactions which we typically hear about). At the time of the report, IMMUNISATION REACTION (His wife feels like she had been beaten up for 3 days after having the Moderna vaccine/his wife had reactions which we typically hear about) 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.   Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. It was reported that patient had reactions and felt like was beaten up for 3 days after having vaccine.  Treatment medications were not provided.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: No adverse event; the vaccine leak during administration; Vaccine underdose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (the vaccine leak during administration), UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient did not provide their medical history, conditions, allergy, concomitant diseases and risk factor.  The patient's past medical history included COVID-19 in January 2023.    On 17-May-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 17-May-2023, the patient experienced DEVICE CONNECTION ISSUE (the vaccine leak during administration) and UNDERDOSE (Vaccine underdose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (the vaccine leak during administration), UNDERDOSE (Vaccine underdose) 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 DEVICE CONNECTION ISSUE (the vaccine leak during administration) and UNDERDOSE (Vaccine underdose).    No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test negative, Drug ineffective, Ear infection, Infection, Pneumonia pneumococcal
Clinical narrative: Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; This is a spontaneous report received from contactable reporter (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), 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), PNEUMONIA PNEUMOCOCCAL, EAR INFECTION (medically significant), outcome "unknown" and all described as "Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series"; SINUSITIS (medically significant), outcome "unknown", described as "recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series". The patient underwent the following laboratory tests and procedures: Antibody test: Negative, notes: Antibody titers negative after completed series.  Clinical course details: Recurring infection (ear sinus, and s pneumo). Antibody titers negative after completed series.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202300086882 same reporter/drug/event, different patient;
Sex: U
Vaccine: PNC13
Symptoms: Sinusitis
Clinical narrative: Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series; This is a spontaneous report received from contactable reporter (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), 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), PNEUMONIA PNEUMOCOCCAL, EAR INFECTION (medically significant), outcome "unknown" and all described as "Recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series"; SINUSITIS (medically significant), outcome "unknown", described as "recurring infection (ear sinus, and s pneumo. antibody titers negative after completed series". The patient underwent the following laboratory tests and procedures: Antibody test: Negative, notes: Antibody titers negative after completed series.  Clinical course details: Recurring infection (ear sinus, and s pneumo). Antibody titers negative after completed series.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202300086882 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid started on 15May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, the reported event COVID-19 is considered related to BNT162b2, BNT162b2 omi ba.4-5 and BNT162b2.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient not received other medication in 2 weeks. Patient received treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the events Drug ineffective and COVID-19 are assessed as related to BNT162B2 administration.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 33 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive any other medication in 2 weeks. Treatment included Paxlovid from 06May2023 to 10May2023. Symptoms include sneezing, runny / stuffy nose, itchy eyes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Headache, Nausea
Clinical narrative: Fatigue; body aches; fever; chills; headache for 4 days; nausea; entire left side of body from arm pit to hip felt like I was beaten up; fainting; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Apr2023 at 10:30 as dose 1, single (Lot number: GJ6743) at the age of 64 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. Concomitant medication(s) included: RESTASIS; ROSUVASTATIN. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 21Apr2023 at 10:30, outcome "unknown", described as "Wrong vaccine administered"; FATIGUE (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered"; PAIN (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered", described as "body aches"; CHILLS (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered"; DISCOMFORT (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered", described as "entire left side of body from arm pit to hip felt like I was beaten up"; SYNCOPE (medically significant) with onset 22Apr2023 at 05:00, outcome "recovered", described as "fainting"; PYREXIA (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered" (26Apr2023), described as "headache for 4 days"; NAUSEA (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered". Therapeutic measures were not taken as a result of syncope, fatigue, pain, pyrexia, chills, headache, nausea, discomfort. Clinical course: If other vaccine in four weeks: No. Other medications in two weeks: Yes, Restasis and Rosuvastatin & vitamin supplement. No covid prior vaccination and covid not tested post vaccination. No known allergies or other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Syncope, Wrong product administered
Clinical narrative: Fatigue; body aches; fever; chills; headache for 4 days; nausea; entire left side of body from arm pit to hip felt like I was beaten up; fainting; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Apr2023 at 10:30 as dose 1, single (Lot number: GJ6743) at the age of 64 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. Concomitant medication(s) included: RESTASIS; ROSUVASTATIN. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 21Apr2023 at 10:30, outcome "unknown", described as "Wrong vaccine administered"; FATIGUE (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered"; PAIN (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered", described as "body aches"; CHILLS (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered"; DISCOMFORT (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered", described as "entire left side of body from arm pit to hip felt like I was beaten up"; SYNCOPE (medically significant) with onset 22Apr2023 at 05:00, outcome "recovered", described as "fainting"; PYREXIA (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered", described as "fever"; HEADACHE (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered" (26Apr2023), described as "headache for 4 days"; NAUSEA (non-serious) with onset 22Apr2023 at 05:00, outcome "recovered". Therapeutic measures were not taken as a result of syncope, fatigue, pain, pyrexia, chills, headache, nausea, discomfort. Clinical course: If other vaccine in four weeks: No. Other medications in two weeks: Yes, Restasis and Rosuvastatin & vitamin supplement. No covid prior vaccination and covid not tested post vaccination. No known allergies or other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 57 years 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 had no relevant medical history. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information : The patient received paxlovid from 10May2023 till 13May2023 (lot number Gg0198) for Covid-19. Vaccine was received. Received other medications in 2 weeks.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 6 (booster), single (Lot number: GJ5342) at the age of 57 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "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), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Additional information: The patient was treated with anti-viral for COVID 19 from 03May2023 to 08May2023.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Sep2022 as dose 5 (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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin"; Celexa, reaction(s): "Known allergies: Celexa". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid for the treatment of COVID-19 on 04May2023 and stop on 09May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the events Drug ineffective and COVID-19 are assessed as related to BNT162B2 administration.