chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Blood test, Gait disturbance, Loss of personal independence in daily activities
Clinical narrative: CANT PUT ON SOCKS; TROUBLE WALKING/HARD TO GET UP AND DOWN THOSE STAIRS/WRONG MOTION; PAIN IN ALL OF JOINTS; HIVES FOREARMS ALL THE WAY TO SHOULDERS LEGS, ANKLES TO THIGH AREAS.; BLISTERS ON FOREARMS ALL THE WAY TO SHOULDERS LEGS, ANKLES TO THIGH AREAS.; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 187 pounds, and height was 70 inches. The patient's concurrent conditions included: shot on head, alcohol user, post-traumatic stress disorder (ptsd), high blood pressure, depression, bipolar, pain all over body (Worse all the time. It's gotten bad in a short period of time.), tramadol allergy (really awful, blisters and hives, and more rash than anything.), and vision lost (About 25 years ago.), and other pre-existing medical conditions included: The patient used to play 5 days a week was in very good shape, playing full court basketball. The patient had not changed any diet. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 58 years old. No concomitant medications were reported. On MAY-2021, the patient experienced blisters on forearms all the way to shoulders legs, ankles to thigh areas. On MAY-2021, the patient experienced hives forearms all the way to shoulders legs, ankles to thigh areas. On an unspecified date, the patient experienced cant put on socks, trouble walking/hard to get up and down those stairs/wrong motion, and pain in all of joints. Laboratory data (dates unspecified) included: Blood test stopped, Indefinite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blisters on forearms all the way to shoulders legs, ankles to thigh areas., pain in all of joints, cant put on socks, trouble walking/hard to get up and down those stairs/wrong motion, and hives forearms all the way to shoulders legs, ankles to thigh areas. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: CANT PUT ON SOCKS; TROUBLE WALKING/HARD TO GET UP AND DOWN THOSE STAIRS/WRONG MOTION; PAIN IN ALL OF JOINTS; HIVES FOREARMS ALL THE WAY TO SHOULDERS LEGS, ANKLES TO THIGH AREAS.; BLISTERS ON FOREARMS ALL THE WAY TO SHOULDERS LEGS, ANKLES TO THIGH AREAS.; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 187 pounds, and height was 70 inches. The patient's concurrent conditions included: shot on head, alcohol user, post-traumatic stress disorder (ptsd), high blood pressure, depression, bipolar, pain all over body (Worse all the time. It's gotten bad in a short period of time.), tramadol allergy (really awful, blisters and hives, and more rash than anything.), and vision lost (About 25 years ago.), and other pre-existing medical conditions included: The patient used to play 5 days a week was in very good shape, playing full court basketball. The patient had not changed any diet. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 58 years old. No concomitant medications were reported. On MAY-2021, the patient experienced blisters on forearms all the way to shoulders legs, ankles to thigh areas. On MAY-2021, the patient experienced hives forearms all the way to shoulders legs, ankles to thigh areas. On an unspecified date, the patient experienced cant put on socks, trouble walking/hard to get up and down those stairs/wrong motion, and pain in all of joints. Laboratory data (dates unspecified) included: Blood test stopped, Indefinite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blisters on forearms all the way to shoulders legs, ankles to thigh areas., pain in all of joints, cant put on socks, trouble walking/hard to get up and down those stairs/wrong motion, and hives forearms all the way to shoulders legs, ankles to thigh areas. This report was non-serious.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Off label use
Clinical narrative: TWO YEARS LATER STILL HAVING MAJOR ISSUES; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a company representative concerned a 5 decade old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-JAN-2021 for covid-19 prophylaxis. The drug was associated with Off label use. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 45 years old. No concomitant medications were reported. On 05-JAN-2021, the patient experienced off label dosing frequency. On an unspecified date, the patient experienced two years later still having major issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two years later still having major issues, and the outcome of off label dosing frequency was not reported. This report was non-serious.
Age: 1.08
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; HCP reporting a male patient aged 13 months old received his first dose of ROTATEQ yesterday, 26-JAN-2023.; This spontaneous report has been received from a consumer, concerning a 13-months-old male patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 26-JAN-2023 (also reported as yesterday), the patient was administered with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid (vial) (Product administered to patient of inappropriate age) 2 ml as prophylaxis (lot #: 1925936 which had been verified to be a valid lot # for Rotavirus Vaccine, Live, Oral, Pentavalent [ROTATEQ] and expired date: 28-MAR-2024) (route of administration and anatomical location were not provided). Moreover, the reporter confirmed that the patient had not experienced any side effects associated with the vaccination. No additional information and no additional adverse event (AE) (no adverse event) were reported.
Sex: F
Vaccine: COVID19
Symptoms: Squamous cell carcinoma
Clinical narrative: Squamous cell carcinoma around the right eye; This spontaneous case was reported by a patient and describes the occurrence of SQUAMOUS CELL CARCINOMA (Squamous cell carcinoma around the right eye) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third 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 SQUAMOUS CELL CARCINOMA (Squamous cell carcinoma around the right eye) (seriousness criterion medically significant). The patient was treated with Surgery (Procedure around a delicate part of her eye for the carcinoma) for Squamous cell carcinoma. At the time of the report, SQUAMOUS CELL CARCINOMA (Squamous cell carcinoma around the right eye) outcome was unknown.            Concomitant medication was not provided. Treatment information was not reported. Patient had a serious underlying eye condition. Patient was administered with primary serious of Moderna and her 2nd booster was Pfizer BioNTech COVID-19 vaccine. Company comment: This spontaneous case concerns an elderly female patient, with no reported medical history, who experienced the unexpected, serious (medically significant) event of squamous cell carcinoma after a dose of mRNA-1273 Bivalent vaccine. The patient received Moderna vaccine as primary series and first booster. A procedure around a delicate part of her eye for the carcinoma was performed. No further details for medical review were reported.  At the time of the latest report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Bivalent vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-702511 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-702511:(Case for friends)
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: mild COVID symptoms for 2 days then felt worse on day 3; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (mild COVID symptoms for 2 days then felt worse on day 3) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    On an unknown date, the patient received third 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 COVID-19 (mild COVID symptoms for 2 days then felt worse on day 3). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (mild COVID symptoms for 2 days then felt worse on day 3) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         Concomitant medication of the patient was not reported.  The patient received dose 1 and dose 2 of Moderna COVID-19 vaccine.  The patient had HA, body aches, mild cough/runny nose and malaise. The patient was self-quarantined himself. He had a virtual appointment where he was prescribed Paxlovid which he started the next day. After that the patient had quick resolution of COVID symptoms.  It was reported that 5-7 days after completing the course of Paxlovid, the patient experienced chest tightness, BP of 200/120, HR of 117 at rest which prompted to visit the Emergency Department. ECG, MRI and blood work all unremarkable and symptoms self-resolved after 3-4 hours in the ED. Anxiety assessment was negative and the patient was discharged with instructions to follow with PCP. Since then, the patient had experienced periodic brief episodes, where he "feels off" or "not quite right" but did not describe anything specific.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 047B21A and 001B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome 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 (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medicine were reported. Lot number 004M21A, expiration date 13Jul2022, Date of administration of vaccine were -26Jul2022 (40 doses), 04Aug2022 (1dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medicine were reported.   This case was linked to MODERNATX, INC.-MOD-2023-704260, MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-704260:(Master case) MODERNATX, INC.-MOD-2023-704260:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 and Date of administration of vaccine was 26Jul2022; 1st dose on 27-Jun-2022 and 2nd dose on 04-Aug-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 and Date of administration of vaccine was 26Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 27-Jun-2022 and 2nd dose on 04-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 004M21A and 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 and Date of administration of vaccine was 26Jul2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 27-Jun-2022 and 2nd dose on 04-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 and Date of administration of vaccine was 26Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 27-Jun-2022 and 2nd dose on 04-Aug-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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 and Date of administration of vaccine was 26Jul2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 27-Jun-2022 and 2nd dose on 04-Aug-2022).    No concomitant product was reported. It was reported by a pharmacy staff that 51 doses were inadvertently administered of the monovalent vaccines with lot number 004M21A, expiration date 13-Jul-2022. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 6 years through 11 years of age dose was given to adult, instead of the Moderna Bivalent vaccine given as booster dose to Adult; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (6 years through 11 years of age dose was given to adult, instead of the Moderna Bivalent vaccine given as booster dose to Adult) 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. AR6965B) 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 WRONG PRODUCT ADMINISTERED (6 years through 11 years of age dose was given to adult, instead of the Moderna Bivalent vaccine given as booster dose to Adult) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (6 years through 11 years of age dose was given to adult, instead of the Moderna Bivalent vaccine given as booster dose to Adult) and NO ADVERSE EVENT (no adverse event) outcome 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 WRONG PRODUCT ADMINISTERED (6 years through 11 years of age dose was given to adult, instead of the Moderna Bivalent vaccine given as booster dose to Adult).    No concomitant medications were reported.  The dose of Moderna COVID-19 vaccine reported as additional booster. Vial as was navy blue cap with purple border.  No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A and 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medications were reported. Patient received Moderna vaccine beyond the 30 days beyond use date. Beyond use date for lot 053C21A was 01-Jul-2021 (Vaccine received on 28-Jul-2021) and for lot 042J21A was 17-Feb-2022 (vaccine received on 02-Mar-2022). No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Non significant Follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Age: 3.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: Received two doses of primary pfizer patient got to another clinic and got Moderna; Received two doses of primary pfizer patient got to another clinic and got Moderna; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received two doses of primary pfizer patient got to another clinic and got Moderna), COVID-19 IMMUNISATION (Received two doses of primary pfizer patient got to another clinic and got Moderna) and NO ADVERSE EVENT (No adverse event) in a 3-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.     Previously administered products included for Product used for unknown indication: Pfizer-BioNTech COVID-19 vaccine (The patient received two doses of the primary Pfizer, one in June and one in July.), Pfizer-BioNTech COVID-19 vaccine (The patient received two doses of the primary Pfizer and one in June and one in July). Past adverse reactions to the above products included No adverse event with Pfizer-BioNTech COVID-19 vaccine and Pfizer-BioNTech 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 INTERCHANGE OF VACCINE PRODUCTS (Received two doses of primary pfizer patient got to another clinic and got Moderna), COVID-19 IMMUNISATION (Received two doses of primary pfizer patient got to another clinic and got Moderna) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received two doses of primary pfizer patient got to another clinic and got Moderna), COVID-19 IMMUNISATION (Received two doses of primary pfizer patient got to another clinic and got Moderna) 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 INTERCHANGE OF VACCINE PRODUCTS (Received two doses of primary pfizer patient got to another clinic and got Moderna) and COVID-19 IMMUNISATION (Received two doses of primary pfizer patient got to another clinic and got Moderna).    Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by 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)) 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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by 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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case pertains to the 111 patient of the total 190 patients. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Shoulder still hasn't healed from shitty vaccine after more than a year; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Shoulder still hasn't healed from shitty vaccine after more than a year) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 22-Sep-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Shoulder still hasn't healed from shitty vaccine after more than a year). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Shoulder still hasn't healed from shitty vaccine after more than a year) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment medication was provided.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Abdominal pain upper, Dyspepsia, Pyrexia, Vomiting
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (some stomach discomfort), DYSPEPSIA (indigestion), ABDOMINAL PAIN UPPER (stomach was sore), PYREXIA (Fever) and VOMITING (threw up) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Cancer (cancer survivor Cancer in 2021) and COVID-19 (Had fever every day from 23-Dec-2022 until 04Jan-2023.) from 23-Dec-2022 to 04-Jan-2023. Previously administered products included for COVID-19 vaccination: Pfizer (First dose, LOT: EL1283) on 26-Feb-2021, Pfizer (Second dose, LOT: EN6208. patient slept unbelievably for long period of time) on 19-Mar-2021, Pfizer (fourth dose and LOT: FP7138) on 04-Aug-2022. Past adverse reactions to the above products included Adverse drug reaction with Pfizer; No adverse event with Pfizer; and Sleepiness with Pfizer.       DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2023, Pyrexia: 98.4 and 100.         No concomitant medications were reported.  Patient received Moderna (third dose and LOT: 017F21A) on 26-Oct-2021.  Had fever the whole time, Could taste food but couldn't eat. Had fever every day from 23-Dec-2022 until 04Jan-2023. Had difficulty breathing in middle of night, had to use allergy medicine to be able to find relief breathing, including steam. Dad diarrhea and could only eat ice chips for a period time. Was miserable.Was extremely uncomfortable, difficulty with almost every symptom of Covid. Did have taste and smell but, did have something slight that she couldn't smell.  It was reported that patient had some issues with Moderna and the Pfizer vaccines. The Moderna gave patient the problem. Had a very strong, not anaphylactic reaction but, strong reaction to the Moderna vaccine. It gave patient a lot of uncomfortability. Last night, patient had something to eat and, right after patient ate, had some stomach discomfort that continued into this morning. Patient came home from work  early. Oral thermometer showed temperature was 98.4 and with mercury thermometer it was 100. Patient either took the vaccine too early or, was having some other kind of stomach   issues over something patient ate.     It was reported that patient had shingles shot before this Moderna Booster. Would have been after 04-Aug-2022 and 20-Jan-2023. Patient had the first dose of the shingles shot despite the vaccines patient had extremely uncomfortable, difficulty with almost every symptom of Covid.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 06-Dec-2022 and vaccine administered on 06-Jan-2023; No adverse event; Dose was given a day after the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given a day after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Dec-2022 and vaccine administered on 06-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given a day after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Dec-2022 and vaccine administered on 06-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given a day after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Dec-2022 and vaccine administered on 06-Jan-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose was given a day after the 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Dec-2022 and vaccine administered on 06-Jan-2023).    On 12-May-2021, patient received first dose of Moderna, Second dose of Moderna on 09-Jun-2021, Moderna (unknown whether booster or primary) on 24-May-2022.  On 06-Jan-2023, patient received moderna bivalent additional booster dose.  No concomitant medication information was provided.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The nurse confirmed that a dose was given a day after the 30-day use by date. The nurse reports that the patient didn't report adverse reaction. The nurse wants to know if the patient needs to be re-vaccinated.  The vial did not undergo any temperature excursions.  No treatment medications were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: patient who has only received the 1st dose of the Moderna COVID-19 monovalent primary series and never got a 2nd dose; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (patient who has only received the 1st dose of the Moderna COVID-19 monovalent primary series and never got a 2nd dose) and NO ADVERSE EVENT (No Adverse Event) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (patient who has only received the 1st dose of the Moderna COVID-19 monovalent primary series and never got a 2nd dose) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (patient who has only received the 1st dose of the Moderna COVID-19 monovalent primary series and never got a 2nd dose) 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 assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (patient who has only received the 1st dose of the Moderna COVID-19 monovalent primary series and never got a 2nd dose).    Concomitant products were not provided. Treatment medication were not reported.  Patient has only received the 1st dose of the Moderna COVID-19 monovalent primary series and never got a 2nd dose.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Depressed mood, Vaccination complication, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (feeling depressed), VACCINATION COMPLICATION (had problems) and VACCINATION SITE PAIN (Following vaccination soreness in her arm) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. CUS245) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose, lot no: EN6208 ) on 04-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose, lot no: EW0151 ) on 09-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (1st booster and Lot no: SJ5683 ) on 08-Mar-2022.   On 24-Jan-2023, 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 24-Jan-2023, the patient experienced DEPRESSED MOOD (feeling depressed), VACCINATION COMPLICATION (had problems) and VACCINATION SITE PAIN (Following vaccination soreness in her arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DEPRESSED MOOD (feeling depressed) and VACCINATION SITE PAIN (Following vaccination soreness in her arm) had resolved and VACCINATION COMPLICATION (had problems) 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.   It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. In the afternoon patient started experiencing adverse events.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: stored in the fridge and experienced multiple warm excursions; Temperature data showed the vaccine was above 46.4F for a total of 36 hours (above 46F for 54 hours). The max temperature reached was 48.4F; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (stored in the fridge and experienced multiple warm excursions), PRODUCT STORAGE ERROR (Temperature data showed the vaccine was above 46.4F for a total of 36 hours (above 46F for 54 hours). The max temperature reached was 48.4F) 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. 046H22A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (stored in the fridge and experienced multiple warm excursions), PRODUCT STORAGE ERROR (Temperature data showed the vaccine was above 46.4F for a total of 36 hours (above 46F for 54 hours). The max temperature reached was 48.4F) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (stored in the fridge and experienced multiple warm excursions), PRODUCT STORAGE ERROR (Temperature data showed the vaccine was above 46.4F for a total of 36 hours (above 46F for 54 hours). The max temperature reached was 48.4F) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (stored in the fridge and experienced multiple warm excursions) and PRODUCT STORAGE ERROR (Temperature data showed the vaccine was above 46.4F for a total of 36 hours (above 46F for 54 hours). The max temperature reached was 48.4F).    Concomitant medication was not reported. Moderna (Bivalent vaccine) was delivered on 12/21/2022 and placed in the freezer upon delivery. Lot was relocated to fridge on 1/15/2023. Lot was quarantined on 1/18/2023. This request was for fridge excursion only. Impacted product was possibly used until 1/18/2023.  Treatment drug was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2023: Upon receipt of follow-up information received on 25-Jan-2023, it was identified that case MOD-2023-704414 is a duplicate to an already existing case MOD-2023-705542. All information from case MOD-2023-704414 has been incorporated into case MOD-2023-705542. Hence, case MOD-2023-704414 will be deleted from the safety database. Patient's age group added.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse Event; 3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022) and NO ADVERSE EVENT (No Adverse Event) in a 50-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     Patient had no relevant conditions.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) in September 2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5).    On 20-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Jan-2023, the patient experienced EXTRA DOSE ADMINISTERED (3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXTRA DOSE ADMINISTERED (3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022) 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 EXTRA DOSE ADMINISTERED (3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022).    No concomitant information was reported. HCP stated 3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022. Reporter mentioned no AEs were reported for patient number 1. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-705243, US-MODERNATX, INC.-MOD-2023-705947 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705243: US-MODERNATX, INC.-MOD-2023-705947:
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Patient received 1 COVID-19 Vaccine Bivalent booster on 20-Jan-2023 but later realized that patient already received a previous bivalent booster on Sep-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received 1 COVID-19 Vaccine Bivalent booster on 20-Jan-2023 but later realized that patient already received a previous bivalent booster on Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 20-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (bivalent booster) in September 2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5).    On 20-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Jan-2023, the patient experienced EXTRA DOSE ADMINISTERED (Patient received 1 COVID-19 Vaccine Bivalent booster on 20-Jan-2023 but later realized that patient already received a previous bivalent booster on Sep-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received 1 COVID-19 Vaccine Bivalent booster on 20-Jan-2023 but later realized that patient already received a previous bivalent booster on Sep-2022) 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 EXTRA DOSE ADMINISTERED (Patient received 1 COVID-19 Vaccine Bivalent booster on 20-Jan-2023 but later realized that patient already received a previous bivalent booster on Sep-2022).    No concomitant product was reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was stated by HCP that 3 patients received 1 COVID-19 Vaccine Bivalent booster on 20-Jan-2023 but then realized that patients already received a previous bivalent booster on Sep-2022.  No treatment information was reported.  This case contains information for the 2nd of 3 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-705945, US-MODERNATX, INC.-MOD-2023-705243 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705945:Patient 3 US-MODERNATX, INC.-MOD-2023-705243:Patient 1
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Inappropriate schedule of product administration, Night sweats, Vaccination site pain
Clinical narrative: night sweats; First dose on March 19, 2021, Second dose April 12, 2021; injection site arm soreness; chills; The patient has had 2 cases of Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), COVID-19 (The patient has had 2 cases of Covid-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on March 19, 2021, Second dose April 12, 2021), VACCINATION SITE PAIN (injection site arm soreness) and CHILLS (chills) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 037A21B and 031H21A) for COVID-19 prophylaxis.     Concomitant products included ROSUVASTATIN, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE 40), MELOXICAM and HYDROXYCHLOROQUINE (HYDROXYCHLOROQUIN) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced COVID-19 (The patient has had 2 cases of Covid-19). On an unknown date, the patient experienced NIGHT SWEATS (night sweats), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on March 19, 2021, Second dose April 12, 2021), VACCINATION SITE PAIN (injection site arm soreness) and CHILLS (chills). At the time of the report, NIGHT SWEATS (night sweats), COVID-19 (The patient has had 2 cases of Covid-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on March 19, 2021, Second dose April 12, 2021), VACCINATION SITE PAIN (injection site arm soreness) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient receive other vaccines in the 4 weeks prior to COVID-19. No treatment medications were provided.    This case was linked to MOD-2023-705065 (Patient Link).