chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for Covid) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010m20a, 027b21a and 013F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Migraine, Anemia, Chronic pain, Fibromyalgia, Arthritis and Drug allergy (Macrobid).   On 09-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: (Positive) tested positive for Covid..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient took elderberry, prevacid, multivitamin medications within 2 weeks of vaccination with Dose 4 Pfizer booster, Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.  It was reported that patient experienced symptoms such as oral ulcers, roof of mouth pain (feeling of rawness) and throat pain that were more extreme, she could not eat or drink anything for days because her mouth was so raw and painful inside.  On 23-SEP-2022 00:00 patient administered Dose 4 with Pfizer booster of LOT or Batch number GJ5342 on left arm  and felt like the exact same symptoms only much milder and tested negative for COVID-19 on 26-SEP-2022.  No treatment medication were reported.   This case was linked to MOD-2022-651445 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Administered 1st dose on 21Mar2021 and 2nd dose on 09Apr2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered 1st dose on 21Mar2021 and 2nd dose on 09Apr2021) and NO ADVERSE EVENT (no adverse event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered 1st dose on 21Mar2021 and 2nd dose on 09Apr2021). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered 1st dose on 21Mar2021 and 2nd dose on 09Apr2021) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered 1st dose on 21Mar2021 and 2nd dose on 09Apr2021).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-651138 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Adult patient received Moderna COVID-19 Vaccine for 6 months to 5 years instead of the bivalent booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Adult patient received Moderna COVID-19 Vaccine for 6 months to 5 years instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 (Adult patient received Moderna COVID-19 Vaccine for 6 months to 5 years instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Adult patient received Moderna COVID-19 Vaccine for 6 months to 5 years instead of the bivalent booster) 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 (Adult patient received Moderna COVID-19 Vaccine for 6 months to 5 years instead of the bivalent booster).    Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse event; 2.5ml dose administered instead of a 0.5ml dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (2.5ml dose administered instead of a 0.5ml dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 15-Sep-2022, the patient experienced ACCIDENTAL OVERDOSE (2.5ml dose administered instead of a 0.5ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (2.5ml dose administered instead of a 0.5ml dose) 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 ACCIDENTAL OVERDOSE (2.5ml dose administered instead of a 0.5ml dose).    No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Patient experienced Fever with Moderna; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Patient experienced Fever with Moderna) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Patient experienced Fever with Moderna). At the time of the report, PYREXIA (Patient experienced Fever with Moderna) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 F.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2022-651165 (Patient Link).
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; patient received a COVID booster of the bivalent vaccine and received a 0.25 mL instead of the 0.5 mL dose; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (patient received a COVID booster of the bivalent vaccine and received a 0.25 mL instead of the 0.5 mL dose) and NO ADVERSE EVENT (No adverse event) in a 38-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 27-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Sep-2022, the patient experienced UNDERDOSE (patient received a COVID booster of the bivalent vaccine and received a 0.25 mL instead of the 0.5 mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient received a COVID booster of the bivalent vaccine and received a 0.25 mL instead of the 0.5 mL dose) 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 UNDERDOSE (patient received a COVID booster of the bivalent vaccine and received a 0.25 mL instead of the 0.5 mL dose).    Concomitant product use was not provided by the reporter.  The patient received a COVID booster of the bivalent vaccine today and received a 0.25 mL instead of the 0.5 mL dose.  She requested for a call back for guidance for this patient.  Treatment information was not provided.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received 0.5 ml  Bivalent booster dose instead of first primary Monovalent dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received 0.5 ml  Bivalent booster dose instead of first primary Monovalent dose) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2022, 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 27-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received 0.5 ml  Bivalent booster dose instead of first primary Monovalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received 0.5 ml  Bivalent booster dose instead of first primary Monovalent dose) 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 WRONG PRODUCT ADMINISTERED (Received 0.5 ml  Bivalent booster dose instead of first primary Monovalent dose).    Concomitant medication was not provided.  Treatment information was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sinusitis
Clinical narrative: Patient got a sinus infection; Patient got COVID-19; This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (Patient got a sinus infection) and COVID-19 (Patient got COVID-19) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Blood pressure high (No Recent change in status such as improvement or worsening).   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2022, the patient experienced SINUSITIS (Patient got a sinus infection) and COVID-19 (Patient got COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. On 27-Aug-2022, SINUSITIS (Patient got a sinus infection) and COVID-19 (Patient got COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant medication was reported as unspecified blood pressure medication.  It was reported that patient had 4 doses of Moderna COVID-19 Vaccine but did not remember dates. Patient did not experienced any adverse events after any of the vaccines.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-269961, US-MODERNATX, INC.-MOD-2022-651195 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-269961:second dose US-MODERNATX, INC.-MOD-2022-651195:
Age: 20.0
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 19JUL2022 and vaccine administered on 29AUG2022; No adverse event; Received expired 2nd Primary dose, after 30-day Use By Date Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Primary dose, after 30-day Use By Date Expiry), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19JUL2022 and vaccine administered on 29AUG2022) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 011B22A and 011B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Primary dose, after 30-day Use By Date Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19JUL2022 and vaccine administered on 29AUG2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd Primary dose, after 30-day Use By Date Expiry), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19JUL2022 and vaccine administered on 29AUG2022) 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 (Received expired 2nd Primary dose, after 30-day Use By Date Expiry) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19JUL2022 and vaccine administered on 29AUG2022).    No concomitant medications were reported. The vial size was reported as 5.5 mL. The vial was initially stored in the refrigerator on 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: For the original Moderna Covid-19 vaccine, do you have  a day, or two, after the beyond use date to use it, still; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (For the original Moderna Covid-19 vaccine, do you have  a day, or two, after the beyond use date to use it, still) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (For the original Moderna Covid-19 vaccine, do you have  a day, or two, after the beyond use date to use it, still) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (For the original Moderna Covid-19 vaccine, do you have  a day, or two, after the beyond use date to use it, still) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (For the original Moderna Covid-19 vaccine, do you have  a day, or two, after the beyond use date to use it, still).    No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sinusitis
Clinical narrative: COVID-19; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and SINUSITIS (Sinus infection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was Unknown if patient had received any other vaccine within 1 month prior to Moderna COVID-19 Vaccine.  Concurrent medical conditions included Seasonal allergy (Seasonal allergies) and Myasthenia gravis (Since she was in her 20's, under control). Concomitant products included GAMMA GLOBULIN for Myasthenia gravis.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2022, the patient experienced COVID-19 (COVID-19) and SINUSITIS (Sinus infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. On 27-Aug-2022, COVID-19 (COVID-19) and SINUSITIS (Sinus infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2022, SARS-CoV-2 test: (Positive) Positive.         Patient received 4 doses of Moderna COVID-19 Vaccine but did not remember dates. Patient did not experienced any adverse events after any of the vaccines. Adverse event caused patient to seek medical care. Patient visited doctor.  The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-651177 (E2B Linked Report).; Sender's Comments:  MOD-2022-651177:Husband's case
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Depressed mood, Dysstasia, Feeling abnormal, Myalgia
Clinical narrative: made the arthritis in both shoulder feel bad; knocked him down; could not even stand up; made the arthritis in both shoulder feel bad; Made the ringing in his ears a lot worse; muscles hurt so bad; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (made the arthritis in both shoulder feel bad), DEPRESSED MOOD (knocked him down), DYSSTASIA (could not even stand up), ARTHRITIS (made the arthritis in both shoulder feel bad) and TINNITUS (Made the ringing in his ears a lot worse) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71460) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ringing in ears (ringing in the ear), Cancer (NOS) (cancer twice) and Shoulder arthritis (arthritis in both shoulders). Concurrent medical conditions included Asthma and Type 2 diabetes mellitus.    On 22-Sep-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. In September 2022, the patient experienced FEELING ABNORMAL (made the arthritis in both shoulder feel bad), DEPRESSED MOOD (knocked him down), DYSSTASIA (could not even stand up), ARTHRITIS (made the arthritis in both shoulder feel bad), TINNITUS (Made the ringing in his ears a lot worse) and MYALGIA (muscles hurt so bad). In September 2022, TINNITUS (Made the ringing in his ears a lot worse) had resolved. At the time of the report, FEELING ABNORMAL (made the arthritis in both shoulder feel bad), DEPRESSED MOOD (knocked him down), DYSSTASIA (could not even stand up), ARTHRITIS (made the arthritis in both shoulder feel bad) and MYALGIA (muscles hurt so bad) outcome was unknown.            Concomitant medication included medication or inhalers (unspecified) for the asthma.  After receiving Moderna booster, the patient stated that it made the ringing in ears a lot worse but it has now gone back to normal. Caller reports it felt like he took a bunch of aspirin.  The 3rd shot and the Bivalent really knocked him down, muscles hurt so bad, couldn't even stand up, made the arthritis in both shoulder feel bad. Patient recommended that for the older people that Moderna should split those doses.  No Treatment medication as reported.   This case was linked to MOD-2022-651284, MOD-2022-651287 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: made the arthritis in both shoulder feel bad; knocked him down; could not even stand up; made the arthritis in both shoulder feel bad; Made the ringing in his ears a lot worse; muscles hurt so bad; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (made the arthritis in both shoulder feel bad), DEPRESSED MOOD (knocked him down), DYSSTASIA (could not even stand up), ARTHRITIS (made the arthritis in both shoulder feel bad) and TINNITUS (Made the ringing in his ears a lot worse) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71460) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ringing in ears (ringing in the ear), Cancer (NOS) (cancer twice) and Shoulder arthritis (arthritis in both shoulders). Concurrent medical conditions included Asthma and Type 2 diabetes mellitus.    On 22-Sep-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. In September 2022, the patient experienced FEELING ABNORMAL (made the arthritis in both shoulder feel bad), DEPRESSED MOOD (knocked him down), DYSSTASIA (could not even stand up), ARTHRITIS (made the arthritis in both shoulder feel bad), TINNITUS (Made the ringing in his ears a lot worse) and MYALGIA (muscles hurt so bad). In September 2022, TINNITUS (Made the ringing in his ears a lot worse) had resolved. At the time of the report, FEELING ABNORMAL (made the arthritis in both shoulder feel bad), DEPRESSED MOOD (knocked him down), DYSSTASIA (could not even stand up), ARTHRITIS (made the arthritis in both shoulder feel bad) and MYALGIA (muscles hurt so bad) outcome was unknown.            Concomitant medication included medication or inhalers (unspecified) for the asthma.  After receiving Moderna booster, the patient stated that it made the ringing in ears a lot worse but it has now gone back to normal. Caller reports it felt like he took a bunch of aspirin.  The 3rd shot and the Bivalent really knocked him down, muscles hurt so bad, couldn't even stand up, made the arthritis in both shoulder feel bad. Patient recommended that for the older people that Moderna should split those doses.  No Treatment medication as reported.   This case was linked to MOD-2022-651284, MOD-2022-651287 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gout, Immunisation reaction, Pain in extremity, Swelling
Clinical narrative: like a flare up of gout; swollen; weird reaction; excruciating pain in toe, couldn't even put a sheet on it,toe was still sore,couldn't get shoe/sneakers on in the morning, toe was just a little sore.; This spontaneous case was reported by a patient and describes the occurrence of GOUT (like a flare up of gout), SWELLING (swollen), IMMUNISATION REACTION (weird reaction) and PAIN IN EXTREMITY (excruciating pain in toe, couldn't even put a sheet on it,toe was still sore,couldn't get shoe/sneakers on in the morning, toe was just a little sore.) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS715B) for COVID-19 prophylaxis.     The patient's past medical history included Pain in toe.    On 26-Sep-2022, 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 26-Sep-2022, the patient experienced GOUT (like a flare up of gout), SWELLING (swollen), IMMUNISATION REACTION (weird reaction) and PAIN IN EXTREMITY (excruciating pain in toe, couldn't even put a sheet on it,toe was still sore,couldn't get shoe/sneakers on in the morning, toe was just a little sore.). At the time of the report, GOUT (like a flare up of gout), SWELLING (swollen), IMMUNISATION REACTION (weird reaction) and PAIN IN EXTREMITY (excruciating pain in toe, couldn't even put a sheet on it,toe was still sore,couldn't get shoe/sneakers on in the morning, toe was just a little sore.) outcome was unknown.            Patient did not take any medications after the effect but drank lots of water. Patient has had this big pain in their toe in the past but never connected it with a vaccine. The patient received first dose on 16 Jan 2022 Lot no: 030620A, second dose on 13 Feb 2021 Lot no: 030M20A, first booster dose on 26 Aug 2021 Lot no 062E21A, second booster dose on 30 Mar 2022 Lot no 066K21A.   No Concomitant medication was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Burning sensation, Inflammation, Insomnia
Clinical narrative: The underarm skin burning of my left arm; Inflammation; The underarm skin burning of my left arm and inflammation that involves the harm and pain; Lack of sleep; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (The underarm skin burning of my left arm), INFLAMMATION (Inflammation), AXILLARY PAIN (The underarm skin burning of my left arm and inflammation that involves the harm and pain) and INSOMNIA (Lack of sleep) 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 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (The underarm skin burning of my left arm), INFLAMMATION (Inflammation), AXILLARY PAIN (The underarm skin burning of my left arm and inflammation that involves the harm and pain) and INSOMNIA (Lack of sleep). At the time of the report, BURNING SENSATION (The underarm skin burning of my left arm), INFLAMMATION (Inflammation), AXILLARY PAIN (The underarm skin burning of my left arm and inflammation that involves the harm and pain) and INSOMNIA (Lack of sleep) had not resolved.            No concomitant medication was reported. It was stated that adverse events impacted the patient for 18 months. The burning  the pain and the lack of sleep was unbearable. Unusual side effects have come to light, including underarm pain as a result of swollen lymph nodes. No treatment medication was reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Inflammation, Insomnia, Skin burning sensation
Clinical narrative: The underarm skin burning of my left arm; Inflammation; The underarm skin burning of my left arm and inflammation that involves the harm and pain; Lack of sleep; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (The underarm skin burning of my left arm), INFLAMMATION (Inflammation), AXILLARY PAIN (The underarm skin burning of my left arm and inflammation that involves the harm and pain) and INSOMNIA (Lack of sleep) 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 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (The underarm skin burning of my left arm), INFLAMMATION (Inflammation), AXILLARY PAIN (The underarm skin burning of my left arm and inflammation that involves the harm and pain) and INSOMNIA (Lack of sleep). At the time of the report, BURNING SENSATION (The underarm skin burning of my left arm), INFLAMMATION (Inflammation), AXILLARY PAIN (The underarm skin burning of my left arm and inflammation that involves the harm and pain) and INSOMNIA (Lack of sleep) had not resolved.            No concomitant medication was reported. It was stated that adverse events impacted the patient for 18 months. The burning  the pain and the lack of sleep was unbearable. Unusual side effects have come to light, including underarm pain as a result of swollen lymph nodes. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Musculoskeletal stiffness, Pain
Clinical narrative: Felt stiff; sore; very tired on the 21st; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Felt stiff), PAIN (sore) and FATIGUE (very tired on the 21st) in an elderly 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.     The patient's past medical history included COVID-19 (second week of June, struggling with what seemed to be a very mild form of Long Covid.) in June 2022 and Fatigue.    On 20-Sep-2022, 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 21-Sep-2022, the patient experienced MUSCULOSKELETAL STIFFNESS (Felt stiff), PAIN (sore) and FATIGUE (very tired on the 21st). At the time of the report, MUSCULOSKELETAL STIFFNESS (Felt stiff), PAIN (sore) and FATIGUE (very tired on the 21st) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: nothing was a miss, and the GP reckoned the same - symptoms came on after Covid..         The patient was over 70.  The patient had the booster on the afternoon.  No concomitant medication was reported.  Halfway through the morning of the 22nd, the patient suddenly felt loads better, as though the sun had come out. The patient was in a rehearsal. The patient was a musician and the whole mindset got changed; played better too. And since then it was as though never had a problem. Still on the go now after a 16 hour day.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: side effect after receiving the Moderna Covid19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (side effect after receiving the Moderna Covid19 Vaccine) 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.     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 IMMUNISATION REACTION (side effect after receiving the Moderna Covid19 Vaccine). At the time of the report, IMMUNISATION REACTION (side effect after receiving the Moderna Covid19 Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient was not a clinical trial participant. No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received First dose on 09-Dec-2021 and second dose on 13-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First dose on 09-Dec-2021 and second dose on 13-May-2022) and NO ADVERSE EVENT (No adverse event) in a 47-year-old female patient who received mRNA-1273  (batch nos. 027b21a and 013F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Migraine, Anemia, Chronic pain, Fibromyalgia and Arthritis. Concomitant products included SAMBUCUS NIGRA FRUIT (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), LANSOPRAZOLE (PREVACID) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 09-Dec-2021, the patient received first dose of mRNA-1273  (unknown route) 1 dosage form. On 13-May-2022, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 13-May-2022,  after starting mRNA-1273 the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First dose on 09-Dec-2021 and second dose on 13-May-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First dose on 09-Dec-2021 and second dose on 13-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First dose on 09-Dec-2021 and second dose on 13-May-2022).    No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Flu) 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.     Concurrent medical conditions included Cancer (the patient was recovering from cancer).    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 INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) had resolved.            Concomitant product use was not provided by the reporter. The patient had a tiny bruise at the injection site after her first 2 shots. She had a mild case of the flu for 14 hours after the first booster.  The patient did not take any medications to help with symptoms.   This case was linked to MOD-2022-651191 (Patient Link).   Reporter did not allow further contact
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022; No adverse event; beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022).    No concomitant medication were reported.  It was reported that one of the vials beyond used date was on 24-Sep-2022 and they used it and made an error. Four patients were given doses from that vial (Monovalent). Individual vial of size 2.5 ml. The vial was initially stored in the refrigerator on 25-Aug-2022. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-651828, US-MODERNATX, INC.-MOD-2022-651830, US-MODERNATX, INC.-MOD-2022-651832 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651828:same reporter US-MODERNATX, INC.-MOD-2022-651830:same reporter US-MODERNATX, INC.-MOD-2022-651832:same reporter
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022 after 30 day Use By Date; No adverse event; beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022 after 30 day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 9-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022 after 30 day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022 after 30 day Use By Date) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error, Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022 after 30 day Use By Date).    No concomitant medication were reported. It was reported that one of the vials beyond used date was on 24-Sep-2022 and they used it and made an error. Four patients were given doses from that vial (Monovalent). Individual vial of size 2.5 ml. The vial was initially stored in the refrigerator on 25-Aug-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-651820 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651820:same reporter
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 25-Aug-2022 and was administered on 26-Sep-2022; No adverse event; beyond used date was on 24Sep2022 and they used it and made an error/Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 25-Aug-2022 and was administered on 26-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 15-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 25-Aug-2022 and was administered on 26-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 25-Aug-2022 and was administered on 26-Sep-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error/Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 25-Aug-2022 and was administered on 26-Sep-2022).    No concomitant medication was reported.  On 25-Aug-2022, the vial was initially stored in the refrigerator. It was reported that one of the vials beyond used date was on 24-Sep-2022 and they used it and made an error yesterday. Four patients were given doses from that vial.   Vial size was reported as 2.5 mL.  The vial did not underwent any temperature excursions.  No treatment medication was reported.