chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after manufacturer date of expiry) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  It was reported that the vial was stored in the refrigerator on 05-Mar-2022. Vial did not undergo any temperature excursions.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-532744, MOD-2022-532663, MOD-2022-532745 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Depression, Disorientation, Feeling abnormal, Mental disorder
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of DISORIENTATION (she was significantly more disorientated), DEPRESSION (significant depression), MENTAL DISORDER (mental acuity) and FEELING ABNORMAL (She has been sitting around really spaced out and can't follow instructions) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 029K20A and 011J20A) for COVID-19 vaccination. Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication. It was reported that patient is not pyretic. The patient's past medical history included Dementia (History of early dementia). On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced DISORIENTATION (she was significantly more disorientated), DEPRESSION (significant depression), MENTAL DISORDER (mental acuity) and FEELING ABNORMAL (She has been sitting around really spaced out and can't follow instructions). At the time of the report, DISORIENTATION (she was significantly more disorientated), DEPRESSION (significant depression), MENTAL DISORDER (mental acuity) and FEELING ABNORMAL (She has been sitting around really spaced out and can't follow instructions) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that patient experienced two episodes, which were the same occurring after the 3rd and 4th doses of the vaccine and received flu vaccine simultaneously with the 3rd dose of the vaccine. No medications or treatments have been provided for patient current symptoms. This case was linked to MOD-2022-532977 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered 1 day past it's expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 1 day past it's expiration date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 1 day past it's expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 1 day past it's expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   The vaccine given was within the allowed/accepted temperature range and right timing. Number of doses/vials was 1 dose. Date the vial was initially stored in the refrigerator 23 Mar 2022. The vial did not undergo any temperature excursions. This was their first booster dose of the Moderna COVID-19 vaccination.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: vial was punctured more than 20 times.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (vial was punctured more than 20 times.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 PRODUCT ADMINISTRATION ERROR (vial was punctured more than 20 times.). At the time of the report, PRODUCT ADMINISTRATION ERROR (vial was punctured more than 20 times.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was given.   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial past the 30 day use by date) and PRODUCT STORAGE ERROR (Date of refrigeration 24Feb2022 and Date of administration 04April2022) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination. No Medical History information was reported. On 04-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial past the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date of refrigeration 24Feb2022 and Date of administration 04April2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial past the 30 day use by date) and PRODUCT STORAGE ERROR (Date of refrigeration 24Feb2022 and Date of administration 04April2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details were reported. Reporter stated that the date of refrigeration was 24-Feb-2022 and the vial did not undergo any temperature excursions. And the dose was Patient's booster dose. No treatment medication details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Nerve block
Clinical narrative: Occipital nerve block happened after the booster; This spontaneous case was reported by a consumer and describes the occurrence of NERVE BLOCK (Occipital nerve block happened after the booster) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NERVE BLOCK (Occipital nerve block happened after the booster). The patient was treated with TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) on 01-Mar-2022 for Nerve block, at an unspecified dose and frequency. At the time of the report, NERVE BLOCK (Occipital nerve block happened after the booster) outcome was unknown.            No concomitant medication was reported by reporter. On 01-Mar-2022 patient got a steroid injection (Kenalog) for an occipital nerve block.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash, chronic rash; chronic welts; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash, chronic rash) and URTICARIA (chronic welts) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash, chronic rash) and URTICARIA (chronic welts). At the time of the report, RASH (rash, chronic rash) and URTICARIA (chronic welts) had not resolved.            No concomitant medications were reported.  Treatment information was not provided.  Patient received second dose of the Moderna COVID-19 vaccine and reported that she had a rash that turned to chronic rash and got chronic welts. Patient reported that it has been 4.5 months since the start of the events.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in an adult female patient 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 VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.            Patient was reported  in mid-fifties. No concomitant medication information was provided. Patient experienced vertigo in the evening after receiving the Moderna booster. Patient also had been drinking alcohol that evening so patient wasn't sure it was the booster. No treatment medication were provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm hurt a little bit) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21B) for COVID-19 vaccination. Allergy includes Cat, dogs, penicillin and some other antibiotics. The patient's past medical history included Glaucoma (for 35 years). Concurrent medical conditions included Allergy to animal, Allergy to animal, Penicillin allergy and Allergy to antibiotic. On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm hurt a little bit). At the time of the report, VACCINATION SITE PAIN (Left arm hurt a little bit) outcome was unknown. Concomitant medications included anti-glaucoma drops. Treatment information included Sea sick pills. This case was linked to MOD-2022-532669 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given an expired dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given an expired dose of the Moderna COVID19 vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given an expired dose of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given an expired dose of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment medication information provided.  Dose was administered after 30-day Use By Date or after manufacturer date of expiry. Date the vial was initially stored in the refrigerator was reported as 16 Mar 2022. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow up received contains significant information Patient details were added. On 04-Apr-2022: Follow up received contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Depression, Headache, Impaired work ability
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (debilitating anxiety), DEPRESSION (depression), IMPAIRED WORK ABILITY (haven't been able to work) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (debilitating anxiety), DEPRESSION (depression), IMPAIRED WORK ABILITY (haven't been able to work) and HEADACHE (headache). At the time of the report, ANXIETY (debilitating anxiety), DEPRESSION (depression), IMPAIRED WORK ABILITY (haven't been able to work) and HEADACHE (headache) outcome was unknown. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.  The patient had no known allergies to food, medications and other products. It was unknown if the patient diagnosed or tested positive for COVID-19. It was unknown if the patient had acute illness at the time of vaccination or up to one month before. Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension and Sleep apnea.   On 22-Oct-2021 at 7:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were reported.  Patient has no known allergies.  No treatment medications were reported.  This case was linked to MOD-2022-522998 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt only a little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt only a little tired) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt only a little tired). At the time of the report, FATIGUE (Felt only a little tired) outcome was unknown.            No concomitant medication was provided by the reporter.  It was reported that patient received first, second and booster Moderna Covid-19 and stated she has no problems with the Moderna's Covid-19 vaccine but stated she felt only a little tired after receiving one of the doses but did not  did not clarify which one. Patient stated that she heard rumors and read information that stated that the Moderna's Covid-19 vaccine can weaken the immune natural system of patients who received it and they are more likely to get the flu, fever, etc after vaccinated.   No treatment medication was provided by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was refrigerated on 25-Mar-2022, it got expired on 01-Dec-2021 but was administered on 04-Apr-2022; The vaccine was refrigerated on 25-Mar-2022, it got expired on 01-Dec-2021 but was administered on 04-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was refrigerated on 25-Mar-2022, it got expired on 01-Dec-2021 but was administered on 04-Apr-2022) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Mar-2022, it got expired on 01-Dec-2021 but was administered on 04-Apr-2022) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was refrigerated on 25-Mar-2022, it got expired on 01-Dec-2021 but was administered on 04-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Mar-2022, it got expired on 01-Dec-2021 but was administered on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was refrigerated on 25-Mar-2022, it got expired on 01-Dec-2021 but was administered on 04-Apr-2022) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 25-Mar-2022, it got expired on 01-Dec-2021 but was administered on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient received the second booster dose.  The vaccine was expired on 01-Dec-2021, but was refrigerated on 25-Mar-2022 and was latter administered on 04-Apr-2022.  Vial did not undergo any temperature excursions.  Treatment medication was not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Erythema, Incorrect route of product administration
Clinical narrative: Patient reported their arm being red; Patient who received this vaccine via subcutaneous route instaed of intramuscular; Administer higher dose than authorized; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Patient reported their arm being red), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient who received this vaccine via subcutaneous route instaed of intramuscular) and ACCIDENTAL OVERDOSE (Administer higher dose than authorized) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 04-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) .5 milliliter. On 04-Apr-2022, the patient experienced ERYTHEMA (Patient reported their arm being red), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient who received this vaccine via subcutaneous route instaed of intramuscular) and ACCIDENTAL OVERDOSE (Administer higher dose than authorized). On 04-Apr-2022, ERYTHEMA (Patient reported their arm being red) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient who received this vaccine via subcutaneous route instaed of intramuscular) and ACCIDENTAL OVERDOSE (Administer higher dose than authorized) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Went in to get 3rd dose, was given a half dose (0.25mls); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Went in to get 3rd dose, was given a half dose (0.25mls)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Went in to get 3rd dose, was given a half dose (0.25mls)). At the time of the report, ACCIDENTAL UNDERDOSE (Went in to get 3rd dose, was given a half dose (0.25mls)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) in a 75-year-old female patient 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 EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient took 2nd booster dose. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow up received contains no new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: After her first dose her injection arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After her first dose her injection arm was very sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was reported that the patient had never been diagnosed with/tested positive for COVID-19.  Patient did not have chronic or long standing health conditions or acute illness at the time of vaccination month before. .  Concurrent medical conditions included Drug allergy (Aspirin).    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (After her first dose her injection arm was very sore). At the time of the report, VACCINATION SITE PAIN (After her first dose her injection arm was very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided.  No treatment medication was provided.   This case was linked to MOD-2022-533243 (Patient Link).   Reporter did not allow further contact
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Menstruation delayed, SARS-CoV-2 test
Clinical narrative: Since she got the first shot, she haven't had her period for 3 months; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Since she got the first shot, she haven't had her period for 3 months) in a 30-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Tested positive for Covid-19) in July 2021. Concurrent medical conditions included Blood pressure high (has high blood pressure since she was born). Concomitant products included AMLODIPINE for Blood pressure high.    On 07-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 07-Feb-2022, the patient experienced MENSTRUATION DELAYED (Since she got the first shot, she haven't had her period for 3 months). At the time of the report, MENSTRUATION DELAYED (Since she got the first shot, she haven't had her period for 3 months) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Blood test: normal (normal) Did a blood work and everything is fine.     mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged.       It was reported that patient had no allergies but was sensitive to everything. Patient always had to take the lowest doses of medications, if not patient will experience the worst side effect. Patient did not receive any other vaccine within one month prior to Moderna.   No treatment medications were reported.   This case was linked to MOD-2022-533259 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Feeling Sick/she does not feel well.; Muscle Pain; Joint Pain; Left Arm injection site pain; Fever 99.9 F; Chills; Headache; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Feeling Sick/she does not feel well.), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), INJECTION SITE PAIN (Left Arm injection site pain) and PYREXIA (Fever 99.9 F) in a 72-year-old female patient 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.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, the patient experienced MALAISE (Feeling Sick/she does not feel well.), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), INJECTION SITE PAIN (Left Arm injection site pain), PYREXIA (Fever 99.9 F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). On 05-Apr-2022, MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), INJECTION SITE PAIN (Left Arm injection site pain), PYREXIA (Fever 99.9 F), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, MALAISE (Feeling Sick/she does not feel well.) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2022, Body temperature: 99.9 (High) Fever 99.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient reported that she received 4 doses of  Moderna COVID-19  She remembers that all 4 shots were Moderna COVID-19 vaccine brand and her first booster shot (3rd shot) was administered about 4.5 months ago. After the 2nd booster she was feeling better on 05-Apr-2021 but she was still feeling fatigue and she does not feel well.  No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Myalgia, Pyrexia
Clinical narrative: Feeling Sick/she does not feel well.; Muscle Pain; Joint Pain; Left Arm injection site pain; Fever 99.9 F; Chills; Headache; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Feeling Sick/she does not feel well.), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), INJECTION SITE PAIN (Left Arm injection site pain) and PYREXIA (Fever 99.9 F) in a 72-year-old female patient 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.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, the patient experienced MALAISE (Feeling Sick/she does not feel well.), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), INJECTION SITE PAIN (Left Arm injection site pain), PYREXIA (Fever 99.9 F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). On 05-Apr-2022, MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), INJECTION SITE PAIN (Left Arm injection site pain), PYREXIA (Fever 99.9 F), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, MALAISE (Feeling Sick/she does not feel well.) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2022, Body temperature: 99.9 (High) Fever 99.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient reported that she received 4 doses of  Moderna COVID-19  She remembers that all 4 shots were Moderna COVID-19 vaccine brand and her first booster shot (3rd shot) was administered about 4.5 months ago. After the 2nd booster she was feeling better on 05-Apr-2021 but she was still feeling fatigue and she does not feel well.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeding disorder, Headache, Malaise, Nausea
Clinical narrative: Arm was very sore; In bed a lot, didn't feel like getting out of it; Lost 3 pounds because she hardly ate.; She hardly ate; Really bad headache that was different from any other she ever had/lower down headache; Had a temperature of 101° F for a good amount of time; Had very mild nausea, but hardly at all; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was very sore), MALAISE (In bed a lot, didn't feel like getting out of it), WEIGHT DECREASED (Lost 3 pounds because she hardly ate.), FEEDING DISORDER (She hardly ate) and HEADACHE (Really bad headache that was different from any other she ever had/lower down headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (ASPIRIN).   On 17-Oct-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (Arm was very sore), MALAISE (In bed a lot, didn't feel like getting out of it), WEIGHT DECREASED (Lost 3 pounds because she hardly ate.), FEEDING DISORDER (She hardly ate), HEADACHE (Really bad headache that was different from any other she ever had/lower down headache), PYREXIA (Had a temperature of 101° F for a good amount of time) and NAUSEA (Had very mild nausea, but hardly at all). In October 2021, PAIN IN EXTREMITY (Arm was very sore), MALAISE (In bed a lot, didn't feel like getting out of it), WEIGHT DECREASED (Lost 3 pounds because she hardly ate.), FEEDING DISORDER (She hardly ate), HEADACHE (Really bad headache that was different from any other she ever had/lower down headache), PYREXIA (Had a temperature of 101° F for a good amount of time) and NAUSEA (Had very mild nausea, but hardly at all) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101° F. On an unknown date, Weight: lost 3 pounds Lost 3 pounds.         No relevant concomitant medications were reported.  Patient started to experience approximately half a day after the second shot and the events persisted for a day and a half.  No treatment information was provided.   This case was linked to MOD-2022-533223 (Patient Link).   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Weight, Weight decreased
Clinical narrative: Arm was very sore; In bed a lot, didn't feel like getting out of it; Lost 3 pounds because she hardly ate.; She hardly ate; Really bad headache that was different from any other she ever had/lower down headache; Had a temperature of 101° F for a good amount of time; Had very mild nausea, but hardly at all; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was very sore), MALAISE (In bed a lot, didn't feel like getting out of it), WEIGHT DECREASED (Lost 3 pounds because she hardly ate.), FEEDING DISORDER (She hardly ate) and HEADACHE (Really bad headache that was different from any other she ever had/lower down headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (ASPIRIN).   On 17-Oct-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (Arm was very sore), MALAISE (In bed a lot, didn't feel like getting out of it), WEIGHT DECREASED (Lost 3 pounds because she hardly ate.), FEEDING DISORDER (She hardly ate), HEADACHE (Really bad headache that was different from any other she ever had/lower down headache), PYREXIA (Had a temperature of 101° F for a good amount of time) and NAUSEA (Had very mild nausea, but hardly at all). In October 2021, PAIN IN EXTREMITY (Arm was very sore), MALAISE (In bed a lot, didn't feel like getting out of it), WEIGHT DECREASED (Lost 3 pounds because she hardly ate.), FEEDING DISORDER (She hardly ate), HEADACHE (Really bad headache that was different from any other she ever had/lower down headache), PYREXIA (Had a temperature of 101° F for a good amount of time) and NAUSEA (Had very mild nausea, but hardly at all) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101° F. On an unknown date, Weight: lost 3 pounds Lost 3 pounds.         No relevant concomitant medications were reported.  Patient started to experience approximately half a day after the second shot and the events persisted for a day and a half.  No treatment information was provided.   This case was linked to MOD-2022-533223 (Patient Link).   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy. Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP), OMEPRAZOLE, VITAMIN C [ASCORBIC ACID] and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication. On 04-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient had no acute and chronic illnesses at the time of vaccination. It was unknown if patient ever had COVID test or diagnosis. It was reported that Booster dose of an outdated Moderna Covid-19 Vaccine was administered to a patient. The vial was first punctured on 01 Apr 2022, and the dose was administered on 04 Apr 2022. The patient was not experiencing any symptoms after receiving the vaccine. No treatment drug was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy (she was concerned the dose had eggs in it.).    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). At the time of the report, PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       Concomitant medications was not provided by the reporter.  It was reported for the first couple of shots she had just mild reactions fever, headache, chills. Treatment information was not provided.   This case was linked to MOD-2022-533282, MOD-2022-533292 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy (she is allergic to eggs).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). At the time of the report, PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-533282, MOD-2022-533290 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: staff administer an  expired Moderna covid19 vaccine on the 2apr2022 that was expired on the 1apr2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (staff administer an  expired Moderna covid19 vaccine on the 2apr2022 that was expired on the 1apr2022) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 026l21b) for COVID-19 vaccination.     History relating to mentioned AE and both Acute and chronic illness at the time of vaccination: NO. Other vaccine given within 1 month prior to moderna covid-19 vaccine: NO.     On 02-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (staff administer an  expired Moderna covid19 vaccine on the 2apr2022 that was expired on the 1apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (staff administer an  expired Moderna covid19 vaccine on the 2apr2022 that was expired on the 1apr2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator on 31March2022 and vial did not undergo any temperature excursions. Symptoms have been improved. No treatment information was reported.   This case was linked to MOD-2022-533307 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: staff administer an  expired Moderna covid19 vaccine on the  2apr2022 that was expired on the 1apr2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (staff administer an  expired Moderna covid19 vaccine on the  2apr2022 that was expired on the 1apr2022) in a 52-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026l21b) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (staff administer an  expired Moderna covid19 vaccine on the  2apr2022 that was expired on the 1apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (staff administer an  expired Moderna covid19 vaccine on the  2apr2022 that was expired on the 1apr2022) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-533297 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia
Clinical narrative: Chills; Pain in the entire body; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Pain in the entire body) and ARTHRALGIA (Joint pain) in an 83-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 0223J21A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma (Started 10 years ago.), Leg cramps, Muscle pain, Tinnitus (Start Date: at the age of 45) and Spinal disorder NOS (Started at the age of 45.). Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for Muscle pain, ALPRAZOLAM (XANAX) for an unknown indication.   On 03-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 31-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, the patient experienced CHILLS (Chills), MYALGIA (Pain in the entire body) and ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Myalgia, at a dose of 2 Advil pills of 200mg each, and 1 more pill during the afternoon. On 01-Apr-2022, CHILLS (Chills), MYALGIA (Pain in the entire body) and ARTHRALGIA (Joint pain) had resolved.            The patient was using 3 different glaucoma drops concomitantly.  After getting 1st dose, patient did not experience any symptom. After the 2nd dose patient woke up at 5 a.m. in the morning experienced events. Patient stayed in bed all day.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received a full dose as a first booster Moderna Covid-19 vaccine dose and she is not an immunocompromised patient; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received a full dose as a first booster Moderna Covid-19 vaccine dose and she is not an immunocompromised patient) in an 80-year-old female patient 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 ACCIDENTAL OVERDOSE (Received a full dose as a first booster Moderna Covid-19 vaccine dose and she is not an immunocompromised patient). At the time of the report, ACCIDENTAL OVERDOSE (Received a full dose as a first booster Moderna Covid-19 vaccine dose and she is not an immunocompromised patient) outcome was unknown.            No Concomitant Drug details were reported.  No Treatment information was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arms was sore; patient was tired the whole day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arms was sore) and FATIGUE (patient was tired the whole day) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 039K20-2A) for COVID-19 vaccination.     The patient did not have COVID-19 disease prior to or after the getting the vaccines. The patient was not immunocompromised.  Previously administered products included for Flu: Flu vaccine (the patient had received the annual flu vaccine). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Blood pressure high (had concomitant high blood pressure but controlled with a lot of medications).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (arms was sore) and FATIGUE (patient was tired the whole day). At the time of the report, PAIN IN EXTREMITY (arms was sore) and FATIGUE (patient was tired the whole day) outcome was unknown.            Concomitant medications included unspecified blood pressure controlling medications.  On 01-Apr-2022, the patient received the second booster dose of the vaccine.  The patient experienced the symptoms of sore arms and tiredness in Apr-2022 after receiving the second booster dose.  No treatment information was reported.   This case was linked to MOD-2022-533357, MOD-2022-533519 (Patient Link).