chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram
Clinical narrative: SWOLLEN ENLARGED LYMPH NODES DEEP IN UPPER ARM; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced swollen enlarged lymph nodes. Laboratory data (dates unspecified) included: Mammogram (NR: not provided) swollen enlarged lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swollen enlarged lymph nodes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and 1816022 expiry: UNKNOWN) dose was not reported, administered on NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced out of specification product use. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INJECTION GIVEN AFTER 6 HOUR PUNCTURE EXPIRY TIME BY 15 MINUTES; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18228811, and expiry: 20-MAR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-NOV-2021, the patient experienced injection given after 6 hour puncture expiry time by 15 minutes. On 18-NOV-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection given after 6 hour puncture expiry time by 15 minutes and incorrect product storage was not reported. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Dizziness
Clinical narrative: FEVER; WEAK LIKE GOING TO PASS OUT; DIZZY/CANT TURN HEAD; PALPITATIONS; SLIGHT BLURRED VISION; SLIGHT DIFFICULTY BREATHING; EXTREME JOINT PAIN; UNCONTROLLABLE CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's past medical history included: brain tumor, and concurrent conditions included: migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-NOV-2021, the patient experienced dizzy/cant turn head. On 17-NOV-2021, the patient experienced palpitations. On 17-NOV-2021, the patient experienced slight blurred vision. On 17-NOV-2021, the patient experienced slight difficulty breathing. On 17-NOV-2021, the patient experienced extreme joint pain. On 17-NOV-2021, the patient experienced uncontrollable chills. On 17-NOV-2021, the patient experienced headache. On 17-NOV-2021, the patient experienced weak like going to pass out. On 18-NOV-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from uncontrollable chills on 18-NOV-2021, was recovering from extreme joint pain, and had not recovered from dizzy/cant turn head, slight difficulty breathing, headache, slight blurred vision, fever, weak like going to pass out, and palpitations. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Palpitations, Pyrexia, Vision blurred
Clinical narrative: FEVER; WEAK LIKE GOING TO PASS OUT; DIZZY/CANT TURN HEAD; PALPITATIONS; SLIGHT BLURRED VISION; SLIGHT DIFFICULTY BREATHING; EXTREME JOINT PAIN; UNCONTROLLABLE CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's past medical history included: brain tumor, and concurrent conditions included: migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-NOV-2021, the patient experienced dizzy/cant turn head. On 17-NOV-2021, the patient experienced palpitations. On 17-NOV-2021, the patient experienced slight blurred vision. On 17-NOV-2021, the patient experienced slight difficulty breathing. On 17-NOV-2021, the patient experienced extreme joint pain. On 17-NOV-2021, the patient experienced uncontrollable chills. On 17-NOV-2021, the patient experienced headache. On 17-NOV-2021, the patient experienced weak like going to pass out. On 18-NOV-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from uncontrollable chills on 18-NOV-2021, was recovering from extreme joint pain, and had not recovered from dizzy/cant turn head, slight difficulty breathing, headache, slight blurred vision, fever, weak like going to pass out, and palpitations. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE GIVEN 15 MINUTES AFTER EXPIRED BASED ON THE 6 HOUR WINDOW AFTER PUNCTURE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: UNKNOWN) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-NOV-2021, the patient experienced vaccine given 15 minutes after expired based on the 6 hour window after puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given 15 minutes after expired based on the 6 hour window after puncture was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED 1 HOUR AFTER THE ALLOWED 6 HOUR WINDOW AFTER INITIAL PUNCTURE (WITHOUT ANY ASSOCIATED ADVERSE EVENT); This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: UNKNOWN) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-NOV-2021, the patient experienced vaccine administered 1 hour after the allowed 6 hour window after initial puncture (without any associated adverse event). On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered 1 hour after the allowed 6 hour window after initial puncture (without any associated adverse event) and incorrect product storage was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 45 TOTAL VIALS INVOLVED IN TEMPERATURE EXCURSION; ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: 11/APR/2022) dose was not reported, administered on 16-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-NOV-2021, the patient experienced administration of expired vaccine. On an unspecified date, the patient experienced 45 total vials involved in temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and 45 total vials involved in temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20211143090 and 20211139494.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 45 TOTAL VIALS INVOLVED IN TEMPERATURE EXCURSION; ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2021) dose was not reported, administered on 16-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-NOV-2021, the patient experienced administration of expired vaccine. On an unspecified date, the patient experienced 45 total vials involved in temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and 45 total vials involved in temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20211143086 and 20211139494.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Patient was very cold), HYPERHIDROSIS (Woke up in a pool of sweat), PAIN IN EXTREMITY (Arm is very painful) and PYREXIA (Today she feels feverish inside) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A and 939906) for COVID-19 vaccination. Concurrent medical conditions included Stomach ache and Reflux gastritis (Yesterday, the ball came back and then patient had the vaccine and it was gone). Concomitant products included OMEPRAZOLE for Stomach ache and Reflux gastritis. On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm is very painful). On 10-Nov-2021, the patient experienced PYREXIA (Today she feels feverish inside). In November 2021, the patient experienced FEELING COLD (Patient was very cold) and HYPERHIDROSIS (Woke up in a pool of sweat). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in November 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (Patient was very cold), HYPERHIDROSIS (Woke up in a pool of sweat), PAIN IN EXTREMITY (Arm is very painful) and PYREXIA (Today she feels feverish inside) outcome was unknown. The pain in arm was reported as hurting more than the first dose. The patient had stomach ache, and had reflux and felt like a ball in the stomach but this was even before the first dose.On 09 Nov 2021, the ball came back and then patient had the vaccine and it was gone.During the night the patient very cold and woke up in a pool of sweat.The patient used sweater because she was very cold.This case was linked to MOD-2021-382980 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 days expired moderna vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Nov-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 days expired moderna vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (2 days expired moderna vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Reporter stated that no side effect experienced by the patient . No concomitant medications were reported. No treatment medications were reported. Vials were taken out of freezer on the same day doses were administered (08-Nov-2021). Patient had received booster dose. Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non-significant follow up received, address and contact information updated. On 12-Nov-2021: Significant follow up received, patient's demographics, vaccination details and event verbatim updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (received expired vaccine of Moderna COVID-19) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 046C21A) for COVID-19 immunization. No medical history reported. On Nov 8, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine, unknown route; 0.25 milliliter. On Nov 8, 2021, patient administered expired product (received expired vaccine of Moderna COVID-19). On Nov 8, 2021, administered expired product (received expired vaccine of Moderna COVID-19) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. No adverse event for the patient. Most recent follow-up information incorporated  included: On Nov 11, 2021: Document received on Nov 11, 2021 updated the narrative supplement.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: 2nd dose were a little stronger in that she was more tired & more achy//feeling tired/feeling weak/After her booster dose she was tired; 2nd dose were a little stronger in that she was more achy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (2nd dose were a little stronger in that she was more tired & more achy//feeling tired/feeling weak/After her booster dose she was tired) and MYALGIA (2nd dose were a little stronger in that she was more achy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) from 13-May-2021 to an unknown date for Rheumatoid arthritis.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (2nd dose were a little stronger in that she was more tired & more achy//feeling tired/feeling weak/After her booster dose she was tired) and MYALGIA (2nd dose were a little stronger in that she was more achy). At the time of the report, FATIGUE (2nd dose were a little stronger in that she was more tired & more achy//feeling tired/feeling weak/After her booster dose she was tired) and MYALGIA (2nd dose were a little stronger in that she was more achy) outcome was unknown.            No treatment details reported.   This case was linked to MOD-2021-381984, MOD-2021-382082 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A nurse administered a dose of the Moderna Covid-19 vaccine that was expired.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A nurse administered a dose of the Moderna Covid-19 vaccine that was expired.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A nurse administered a dose of the Moderna Covid-19 vaccine that was expired.). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (A nurse administered a dose of the Moderna Covid-19 vaccine that was expired.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.The Vaccine was removed from fridge and the first puncture was at 03:00 pm on 09-Nov-2021.The doses were administered on 10-Nov-2021 at 09:00 am and 09:08 am as there were 2 patients who were administered with expired Moderna vaccine for their booster doses. Both doses were booster doses 0.25mL. No concomitant medications were provided.  No treatment medications were provided.Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up document received on 12-NOV-2021 contains No new information. On 16-Nov-2021: Follow-up document received on 16-Nov-2021 (Non Significant FU) include New information in Narrative updated.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Lower respiratory tract infection
Clinical narrative: Infection due to COPD/Infection in lower lobes; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (Infection due to COPD/Infection in lower lobes) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD (COPD for 10 years) and Hypertension. Concomitant products included LISINOPRIL for Hypertension.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced LOWER RESPIRATORY TRACT INFECTION (Infection due to COPD/Infection in lower lobes). The patient was treated with LEVOFLOXACIN for Infection, at a dose of 750 milligram once a day. At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Infection due to COPD/Infection in lower lobes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: abnormal (abnormal) showed infection in lower lobes.         The booster dose was scheduled for 11-Nov-2021.  The patient had taken levofloxacin for 7 days for that infection. The patient was not sure if the infection was gone or not.  The patient has completed the antibiotic regimen therapy.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received, contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients that received vaccines from the affected lots after the temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that received vaccines from the affected lots after the temperature excursion) in a  patient of an unknown age and 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients that received vaccines from the affected lots after the temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that received vaccines from the affected lots after the temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients that received vaccines from the affected lots after the temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients that received vaccines from the affected lots after the temperature excursion) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.The correct number of patients that received vaccines from the affected lots after the temperature excursion occurred was only 3 (three). No concomitant medication was reported. No treatment information was reported.Most recent FOLLOW-UP information incorporated above includes:On 12-Nov-2021: Follow-up received contains significant information. No of patients received expired product has been updated.On 12-Nov-2021: Follow up information received contains No New Information.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Feels like she ran over by a mac truck,that she was aching in places that she didn't even know she had. She feels like she overworked at the gym, even her toes. Everything is achy/She has aches and pains) and HEADACHE (Has a headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced MYALGIA (Feels like she ran over by a mac truck,that she was aching in places that she didn't even know she had. She feels like she overworked at the gym, even her toes. Everything is achy/She has aches and pains). In November 2021, the patient experienced HEADACHE (Has a headache). At the time of the report, MYALGIA (Feels like she ran over by a mac truck,that she was aching in places that she didn't even know she had. She feels like she overworked at the gym, even her toes. Everything is achy/She has aches and pains) and HEADACHE (Has a headache) outcome was unknown.  No concomitant medications were reported.No treatment medications were reported.The patient reported that It wasn't until 10 Nov 2021 that she was aching in places that she didn't even know she had. This case was linked to MOD-2021-382861 (Patient Link). Reporter did not allow further contact.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm is very painful, it also hurt for the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is very painful, it also hurt for the first dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 034F21A) for COVID-19 vaccination.     The patient's past medical history included Stomach ache (Had reflux and felt like a ball in the stomach).   On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is very painful, it also hurt for the first dose). At the time of the report, VACCINATION SITE PAIN (Arm is very painful, it also hurt for the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.  No treatment information was provided.   This case was linked to MOD-2021-383028 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID (swab); lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID (swab)) and DRUG INEFFECTIVE (lack of efficacy) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088O21A, 014M20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer (10 years ago) in 2011, Kidney stones and Gallbladder stones. Concurrent medical conditions included Hypertension, Blood cholesterol abnormal, Asthma, Acid reflux (oesophageal), Stomach ache and Allergy. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), LEVOCETIRIZINE for Allergy, FLUTICASONE PROPIONATE;SALMETEROL for Asthma, VENLAFAXINE for Stomach pain, LOSARTAN, CHLORTHALIDONE and POTASSIUM CITRATE for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced COVID-19 (tested positive for COVID (swab)) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, COVID-19 (tested positive for COVID (swab)) and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, SARS-CoV-2 test: negative (Negative) negative, tested via self test a few days back.         No treatment drugs were reported.  The patient was not immunocompromised.  It was reported that patient did not have any adverse reaction to any of the doses of the vaccines.  COVID symptoms started 3 days ago and included dry cough, lightheadedness (previous day), low level like sinus headache, funny taste in mouth, stomach discomfort, and nausea. The physician had recommended the patient to take the booster dose and the patient took it.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up document received on 10-NOV-2021 contains no new information. On 13-Nov-2021: Follow up document received on 15-NOV-2021 includes no new information. On 16-Nov-2021: Follow-up received on 16-Nov-2021: Added missed information : current conditions added.; Sender's Comments: This is a spontaneous case concerning a 72-year-old male patient with no relevant medical history, who experienced non serious, AESI, unexpected event of COVID 19; lack of efficacy was considered as an additional event. The event COVID 19 occurred 2 months 22 days after the third dose of mRNA-1273 vaccine. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: excursion from the freezer/administered to 118 patients(25Oct2021- 49 given ); excursion from the freezer/administered to 118 patients(25Oct2021- 49 given ); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) and EXPIRED PRODUCT ADMINISTERED (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.  On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) and EXPIRED PRODUCT ADMINISTERED (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) and EXPIRED PRODUCT ADMINISTERED (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-383439 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant Follow up contains patient  and suspect details
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia
Clinical narrative: Experienced a loss in her voice for a few days; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Experienced a loss in her voice for a few days) in a 3-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced APHONIA (Experienced a loss in her voice for a few days). In November 2021, APHONIA (Experienced a loss in her voice for a few days) had resolved.            Concomitant medication was not provided. Treatment medication was not provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 027L20A and 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non Significant follow up received
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Dysphonia, Illness, Oropharyngeal discomfort
Clinical narrative: Nagging cough; Tickle in my throat; I go hoarse really easily; I was sick for about 3 days after the booster; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Nagging cough), OROPHARYNGEAL DISCOMFORT (Tickle in my throat), DYSPHONIA (I go hoarse really easily), ILLNESS (I was sick for about 3 days after the booster) and PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced COUGH (Nagging cough), OROPHARYNGEAL DISCOMFORT (Tickle in my throat), DYSPHONIA (I go hoarse really easily), ILLNESS (I was sick for about 3 days after the booster), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, COUGH (Nagging cough), OROPHARYNGEAL DISCOMFORT (Tickle in my throat) and DYSPHONIA (I go hoarse really easily) had not resolved and ILLNESS (I was sick for about 3 days after the booster), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No concomitant medication was reported.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nagging cough; Tickle in my throat; I go hoarse really easily; I was sick for about 3 days after the booster; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Nagging cough), OROPHARYNGEAL DISCOMFORT (Tickle in my throat), DYSPHONIA (I go hoarse really easily), ILLNESS (I was sick for about 3 days after the booster) and PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced COUGH (Nagging cough), OROPHARYNGEAL DISCOMFORT (Tickle in my throat), DYSPHONIA (I go hoarse really easily), ILLNESS (I was sick for about 3 days after the booster), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, COUGH (Nagging cough), OROPHARYNGEAL DISCOMFORT (Tickle in my throat) and DYSPHONIA (I go hoarse really easily) had not resolved and ILLNESS (I was sick for about 3 days after the booster), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No concomitant medication was reported.  No treatment medication was reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: Vaccine administered to 2 patients from a vial that was post temperature excursion.; Vaccine administered to 2 patients from a vial that was post temperature excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to 2 patients from a vial that was post temperature excursion.) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients from a vial that was post temperature excursion.) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 008B21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug hypersensitivity (Codeine).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 11-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to 2 patients from a vial that was post temperature excursion.) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients from a vial that was post temperature excursion.). On 11-Nov-2021, PRODUCT STORAGE ERROR (Vaccine administered to 2 patients from a vial that was post temperature excursion.) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients from a vial that was post temperature excursion.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received on 16-nov-2021 and contains Patients race information, patients allergic substances, medical history and booster doses route of adminstration, lot number and date of administration.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tenderness after first two Moderna vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness after first two Moderna vaccines) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Over many years). Past adverse reactions to the above products included Vaccination site tenderness with Flu shot. Concurrent medical conditions included Penicillin allergy, Hypertension (Normal readings with medication. Lowered to 150 mg) since 06-Jan-1999, Asthma since 04-Jan-2006 and Sleep apnea (changing from CPAP to oral device) since 03-Jan-2020. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT HFA) from 04-Jan-2006 to an unknown date and MONTELUKAST from 04-Jan-2006 to an unknown date for Asthma, IRBESARTAN from 06-Jan-1999 to an unknown date and HYDROCHLOROTHIAZIDE for Hypertension, COLECALCIFEROL (D3) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Tenderness after first two Moderna vaccines). At the time of the report, VACCINATION SITE PAIN (Tenderness after first two Moderna vaccines) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-367382, MOD-2021-385495 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate, Illness
Clinical narrative: experienced varying episodes of arrhythmia; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (experienced varying episodes of arrhythmia) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 047A21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arrhythmia. Concomitant products included APIXABAN (ELIQUIS), VALSARTAN, AMLODIPINE, CHLORTALIDONE (CHLORTHALIDONE), DEXLANSOPRAZOLE (DEXILANT), ATORVASTATIN, ZINC and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 15-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 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (experienced varying episodes of arrhythmia) (seriousness criterion medically significant) and ILLNESS (felt sick). At the time of the report, ARRHYTHMIA (experienced varying episodes of arrhythmia) and ILLNESS (felt sick) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Heart rate: high (High) 145 bpm.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter. The patients heart rate went to 145, getting rapid heart beat occurred on April 2021. Patient has ECG device continuously attached.  Company comment: This case concerns a 63-year-old male patient with no relevant medical history, who experienced the unexpected event of Arrhythmia. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-385656 (Patient Link).; Sender's Comments: This case concerns a 63-year-old male patient with no relevant medical history, who experienced the unexpected event of Arrhythmia. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Vaccination complication
Clinical narrative: strong reaction to the full dose booster; Full dose booster; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (strong reaction to the full dose booster) and ACCIDENTAL OVERDOSE (Full dose booster) in a  patient of an unknown age and 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced VACCINATION COMPLICATION (strong reaction to the full dose booster) and ACCIDENTAL OVERDOSE (Full dose booster). At the time of the report, VACCINATION COMPLICATION (strong reaction to the full dose booster) outcome was unknown and ACCIDENTAL OVERDOSE (Full dose booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Lymphadenopathy
Clinical narrative: breast tenderness; lump in armpit; This spontaneous case was reported by a consumer and describes the occurrence of BREAST TENDERNESS (breast tenderness) and LYMPHADENOPATHY (lump in armpit) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST TENDERNESS (breast tenderness) and LYMPHADENOPATHY (lump in armpit). At the time of the report, BREAST TENDERNESS (breast tenderness) and LYMPHADENOPATHY (lump in armpit) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna vaccine). On 15-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little pain in the arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid activity decreased (less active thyroid) and Blood pressure.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little pain in the arm). At the time of the report, PAIN IN EXTREMITY (little pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were unspecified 0.5mcg thyroid medication for less active thyroid, Metabolic supplement multivitamin for twice, daily, not to get infections/inflammations natural products. regulates blood pressure. The treatment information was unknown. Patient got 2 shots of the Moderna vaccine already and has an appointment to get the booster dose next Monday.   This case was linked to MOD-2021-385764 (Patient Link).