chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of SHINGRIX in February of 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in February 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's comment: Reporter was the pharmacist. The pharmacist reported that he has a patient that had her first dose of Shingrix and was inquiring about further dosing. AE (Adverse event) filed. Warm transferred to Medical Information. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Foot operation
Clinical narrative: FOOT SURGERY; This spontaneous report received from a patient via other manufacturer concerned an elderly patient of an unspecified sex age and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry was not reported) dose 40 mg/0.4 ml, citrate free, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced foot surgery. It was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of foot surgery was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220434284-COVID-19 VACCINE AD26.COV2.S-Foot surgery. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer stage I, Magnetic resonance imaging
Clinical narrative: STAGE 1 BREAST CANCER; This spontaneous report received from a patient concerned a 59 year old female. 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: 206A21A, and expiry: 18-FEB-2022) dose was not reported, 1 total administered to left arm on 07-APR-2021 for prophylactic vaccination. Age at time of vaccination 58 years old. No concomitant medications were reported. On 01-APR-2022, the patient was diagnosed with stage 1 breast cancer. On APR-2022, after magnetic resonance imaging (MRI), three lesions on right breast were present and that had not been biopsied at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stage 1 breast cancer. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220434355-COVID-19 VACCINE AD26.COV2.S  Stage 1 breast cancer. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a female of unspecified age, race and ethnicity. 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 (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 27-OCT-2021, the patient received additional non-company suspect vaccine Comirnaty (tozinameran) (dose number in series 2) (form of admin, route of admin were not reported, batch number: FH8020 and expiry: Unknown) dose was not reported, administered on 27-OCT-2021 for prophylactic vaccination. On an unspecified date, the patient had fever, sore throat, fatigue and body aches (coded as suspected covid-19 infection) (dose number in series 2). The patient tested positive for covid-19 infection with a home test (coded as suspected clinical vaccination failure) (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested.; Sender's Comments: V0: 20220434768-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: SEPSIS; This spontaneous report received from a physician concerned a 68 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had no allergies and no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 and expiry: 04-AUG-2021) .5 ml, 1 total administered in left deltoid, on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced sepsis, and was hospitalized (date unspecified). The number of days of hospitalization was not reported and it was unsure the patient discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sepsis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, involving the same patient is linked to 20220316804.; Sender's Comments: 20220435730 -COVID-19 VACCINE Ad26.COV2.S- Sepsis. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Gait disturbance
Clinical narrative: HAVE HAD CHEST PAIN FOR THE LAST SIX MONTHS AFTER RECEIVING VACCINE; WENT FROM EXERCISING 3 TIMES PER WEEK TO BARELY ABLE TO WALK; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced have had chest pain for the last six months after receiving vaccine, and went from exercising 3 times per week to barely able to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from have had chest pain for the last six months after receiving vaccine, and the outcome of went from exercising 3 times per week to barely able to walk was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: had difficulty with all of the shots; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (had difficulty with all of the shots) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had difficulty with all of the shots). At the time of the report, VACCINATION COMPLICATION (had difficulty with all of the shots) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No known allergies were reported.  No treatment medications were reported.   This case was linked to MOD-2022-538666, MOD-2022-538668 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: 2nd dose received on 11 Mar 2021 and 1st booster dose on 19 Aug 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 11 Mar 2021 and 1st booster dose on 19 Aug 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A, 032M20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She had COVID before receiving any vaccinations). Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 11 Mar 2021 and 1st booster dose on 19 Aug 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 11 Mar 2021 and 1st booster dose on 19 Aug 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication was provided by the reporter.   This case was linked to MOD-2022-538945, MOD-2021-034786 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Had swelling in legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Had swelling in legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21-A) for COVID-19 vaccination.     The patient's past medical history included Hip replacement (last year (before vaccine).) in 2021.    On 20-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Had swelling in legs). At the time of the report, PERIPHERAL SWELLING (Had swelling in legs) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date.       No concomitant products were reported. It was reported that patient postponed the second dose. Greater than 35 days since first dose.Had swelling in legs. Had taken some water pills. Hip replacement last year (before vaccine).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received 0.25 ml of 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 0.25 ml of Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 14-Apr-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received 0.25 ml of Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received 0.25 ml of Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The reporter was a clinic manager.  Concomitant medication of the patient was not reported.  The reporter reported that, the patient did not experience any side effects and was following up with the patient's mother later on 14-Apr-2022.  No treatment information was provided by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza
Clinical narrative: currently has the flu; diagnosed with COVID-19 after Moderna vaccination; Moderna Booster 23Oct2021. Diagnosed with COVID 01Feb2022; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (currently has the flu), COVID-19 (diagnosed with COVID-19 after Moderna vaccination) and DRUG INEFFECTIVE (Moderna Booster 23Oct2021. Diagnosed with COVID 01Feb2022) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2021. Previously administered products included for Product used for unknown indication: JNJ vaccine (COVID in August 2021.) on 31-Mar-2021. Past adverse reactions to the above products included COVID-19 with JNJ vaccine.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced COVID-19 (diagnosed with COVID-19 after Moderna vaccination) and DRUG INEFFECTIVE (Moderna Booster 23Oct2021. Diagnosed with COVID 01Feb2022). In April 2022, the patient experienced INFLUENZA (currently has the flu). At the time of the report, INFLUENZA (currently has the flu) had not resolved and COVID-19 (diagnosed with COVID-19 after Moderna vaccination) and DRUG INEFFECTIVE (Moderna Booster 23Oct2021. Diagnosed with COVID 01Feb2022) outcome was unknown.            No relevant concomitant medications were reported. The patient stated that currently she had flu and was sicker now than when she had COVID. Treatment information was unknown.  Company comment This is a spontaneous case concerning 59-year-old female patient with no relevant medical history, previously received JNJ COVID-19 vaccine, who experienced the non-serious, unexpected event of COVID-19 (AESI) and influenza. Interchange of vaccine products was considered an additional event. COVID-19 was diagnosed approximately 3 months and 9 days after the 3rd dose of mRNA-1273. Influenza occurred on an unknown date and is ongoing. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning 59-year-old female patient with no relevant medical history, previously received JNJ COVID-19 vaccine, who experienced the non-serious, unexpected event of COVID-19 (AESI) and influenza. Interchange of vaccine products was considered an additional event. COVID-19 was diagnosed approximately 3 months and 9 days after the 3rd dose of mRNA-1273. Influenza occurred on an unknown date and is ongoing. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: very sharp pain in his right arm jumped up from his seat may have been because of the injection technique by the vaccinator; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (very sharp pain in his right arm jumped up from his seat may have been because of the injection technique by the vaccinator) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (very sharp pain in his right arm jumped up from his seat may have been because of the injection technique by the vaccinator). At the time of the report, VACCINATION SITE PAIN (very sharp pain in his right arm jumped up from his seat may have been because of the injection technique by the vaccinator) outcome was unknown.            The patient does not report any adverse events or side effects to his first Moderna Covid-19 vaccine.  The patient received his second Moderna Covid-19 vaccine in his right arm shoulder deltoid muscle.  No concomitant medication was reported.    No treatment information was reported.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Metastases to lung, Oxygen saturation
Clinical narrative: Woke up the following night and couldn't breathe/Had hard time breathing, like couldn't catch breathe/It felt like could not get enough oxygen and was gasping for air; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Woke up the following night and couldn't breathe/Had hard time breathing, like couldn't catch breathe/It felt like could not get enough oxygen and was gasping for air) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     The patient's past medical history included Nephrectomy (One of kidneys removed). Concurrent medical conditions included Blood pressure, Immunocompromised, Renal cell carcinoma and Metastases to lung (Cancer was metastasized to lungs and started a treatment of Keytruda 2 days after the booster (20-Jan-2022)).   On 18-Jan-2022, the patient 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 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 19-Jan-2022, the patient experienced DYSPNOEA (Woke up the following night and couldn't breathe/Had hard time breathing, like couldn't catch breathe/It felt like could not get enough oxygen and was gasping for air). The patient was treated with PEMBROLIZUMAB (KEYTRUDA) on 20-Jan-2022 for Metastases to lung, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Woke up the following night and couldn't breathe/Had hard time breathing, like couldn't catch breathe/It felt like could not get enough oxygen and was gasping for air) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 93/94% O2 levels were 93/94%.  Patient took concomitant medications for blood pressure.  Patient report that after getting the Moderna booster dose, he began to experience some side effects. He woke up the following night and could not breathe. He had hard time breathing, like he could not catch my breathe. It felt like could not get enough oxygen and was gasping for air. He indicated that he was still having same problem but not as bad at the time of report. He also stated that he had been to the ER, they could not anything wrong. He stated that his cancer was metastasized to his lungs and started a treatment of Keytruda. Keytruda can also cause respiratory issues, but patient was experiencing these before he got that treatment.  Treatment for the event included inhaler.   This case was linked to MOD-2022-541254.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Oxygen saturation
Clinical narrative: Woke up the following night and couldn't breathe/Had hard time breathing, like couldn't catch breathe/It felt like could not get enough oxygen and was gasping for air; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Woke up the following night and couldn't breathe/Had hard time breathing, like couldn't catch breathe/It felt like could not get enough oxygen and was gasping for air) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     The patient's past medical history included Nephrectomy (One of kidneys removed). Concurrent medical conditions included Blood pressure, Immunocompromised, Renal cell carcinoma and Metastases to lung (Cancer was metastasized to lungs and started a treatment of Keytruda 2 days after the booster (20-Jan-2022)).   On 18-Jan-2022, the patient 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 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 19-Jan-2022, the patient experienced DYSPNOEA (Woke up the following night and couldn't breathe/Had hard time breathing, like couldn't catch breathe/It felt like could not get enough oxygen and was gasping for air). The patient was treated with PEMBROLIZUMAB (KEYTRUDA) on 20-Jan-2022 for Metastases to lung, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Woke up the following night and couldn't breathe/Had hard time breathing, like couldn't catch breathe/It felt like could not get enough oxygen and was gasping for air) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 93/94% O2 levels were 93/94%.  Patient took concomitant medications for blood pressure.  Patient report that after getting the Moderna booster dose, he began to experience some side effects. He woke up the following night and could not breathe. He had hard time breathing, like he could not catch my breathe. It felt like could not get enough oxygen and was gasping for air. He indicated that he was still having same problem but not as bad at the time of report. He also stated that he had been to the ER, they could not anything wrong. He stated that his cancer was metastasized to his lungs and started a treatment of Keytruda. Keytruda can also cause respiratory issues, but patient was experiencing these before he got that treatment.  Treatment for the event included inhaler.   This case was linked to MOD-2022-541254.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Cough, Nasal congestion, Pyrexia
Clinical narrative: small cough; chest hurt; felt a little stuffy for about a week; 103-104 fever for 3 or 4 days; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (small cough), CHEST PAIN (chest hurt), NASAL CONGESTION (felt a little stuffy for about a week) and PYREXIA (103-104 fever for 3 or 4 days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced COUGH (small cough), CHEST PAIN (chest hurt), NASAL CONGESTION (felt a little stuffy for about a week) and PYREXIA (103-104 fever for 3 or 4 days). At the time of the report, COUGH (small cough) and CHEST PAIN (chest hurt) outcome was unknown and NASAL CONGESTION (felt a little stuffy for about a week) and PYREXIA (103-104 fever for 3 or 4 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103-104 (High) 103-104 fever.         No Concomitant product use was reported.  The patient after getting the Moderna booster dose on 18-Jan-2022, began to experience side effects as well. The patient had a 103-104 fever for 3 or 4 days and also stated that the patient had a small cough, their chest hurt, and the patient felt a little stuffy for about a week.  No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Peripheral swelling
Clinical narrative: Left arm swelled up after receiving 2nd Moderna's booster dose; Left arm red up to elbow after receiving 2nd Moderna's booster dose; Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm swelled up after receiving 2nd Moderna's booster dose), ERYTHEMA (Left arm red up to elbow after receiving 2nd Moderna's booster dose) and INFLAMMATION (Inflammation) in a 79-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 PERIPHERAL SWELLING (Left arm swelled up after receiving 2nd Moderna's booster dose), ERYTHEMA (Left arm red up to elbow after receiving 2nd Moderna's booster dose) and INFLAMMATION (Inflammation). At the time of the report, PERIPHERAL SWELLING (Left arm swelled up after receiving 2nd Moderna's booster dose), ERYTHEMA (Left arm red up to elbow after receiving 2nd Moderna's booster dose) and INFLAMMATION (Inflammation) outcome was unknown.            No concomitant medications were reported. The patient had no allergies. Treatment included Antibiotic to stop Inflammation which worked.   This case was linked to MOD-2022-541363 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Patient saw something red in her left eye, like blood; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Patient saw something red in her left eye, like blood) 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 15-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2022, the patient experienced OCULAR HYPERAEMIA (Patient saw something red in her left eye, like blood). At the time of the report, OCULAR HYPERAEMIA (Patient saw something red in her left eye, like blood) had not resolved.            No concomitant drug details were reported.  It was reported that approximately 50 minutes after the 2nd booster dose, patient saw something red in her left eye, like blood.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: received half dose instead of full dose while being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (received half dose instead of full dose while being immunocompromised) 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 (mild to moderate) and IgG subclass deficiency (mild to moderate).   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 (received half dose instead of full dose while being immunocompromised). At the time of the report, ACCIDENTAL UNDERDOSE (received half dose instead of full dose while being immunocompromised) outcome was unknown.            No concomitant medications were reported No treatment medications were reported  The doctor was not sure if patient should get the half or the full dose at the time so patient went with the half even though her doctor thought patient should have received the full dose.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Oral mucosal blistering
Clinical narrative: Easily bruising after 2nd primary shot; Blisters in the mouth after 2nd primary shot; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Easily bruising after 2nd primary shot) and ORAL MUCOSAL BLISTERING (Blisters in the mouth after 2nd primary shot) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced CONTUSION (Easily bruising after 2nd primary shot) and ORAL MUCOSAL BLISTERING (Blisters in the mouth after 2nd primary shot). At the time of the report, CONTUSION (Easily bruising after 2nd primary shot) and ORAL MUCOSAL BLISTERING (Blisters in the mouth after 2nd primary shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment was reported.   This case was linked to MOD-2022-541772 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen left arm; sore left arm, but not a lot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen left arm) and PAIN IN EXTREMITY (sore left arm, but not a lot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 059D21A and 088D21A) for COVID-19 vaccination.     No  allergies (medications, food and other products) reported and no history of relating to mentioned AE and both Acute and Chronic illnesses at the time of  vaccination. Patient did not test positive COVID test or diagnosis.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient experienced PERIPHERAL SWELLING (Swollen left arm) and PAIN IN EXTREMITY (sore left arm, but not a lot). At the time of the report, PERIPHERAL SWELLING (Swollen left arm) and PAIN IN EXTREMITY (sore left arm, but not a lot) was resolving.            The patient did not experience a similar event in the past.  She was not under any concomitant or regular medication.  After the 1st booster dose on 12 APR 2022, she experienced a swollen and sore left arm, but not a lot, still ongoing but was improving. Adverse event did not cause patient to seek medical care. It was reported adverse event outcome as ongoing arm swollen, slightly painful. Symptoms were improved, a bit better.    Patient did not take any treatment for her symptoms.   This case was linked to MOD-2022-541687 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Feeling hot, Influenza, Malaise
Clinical narrative: Malaise; Flu; Hotness/heat; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), INFLUENZA (Flu), FEELING HOT (Hotness/heat) and BACK PAIN (Back pain) in a 51-year-old male 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, 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 MALAISE (Malaise), INFLUENZA (Flu), FEELING HOT (Hotness/heat) and BACK PAIN (Back pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, MALAISE (Malaise), INFLUENZA (Flu), FEELING HOT (Hotness/heat) and BACK PAIN (Back pain) outcome was unknown.            No concomitant medications were mentioned. It was reported that patient had sometimes experienced the same symptoms, because of the changing weather.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Swelling of fingers; Few mildly itchy hives on the arms; Mild fever; Achiness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of fingers), URTICARIA (Few mildly itchy hives on the arms), PYREXIA (Mild fever), MYALGIA (Achiness) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 026D21A, 029120A and 039K20A) for COVID-19 vaccination.     Patient had not test or diagnosis with COVID-19.  Previously administered products included for Product used for unknown indication: SHINGRIX. Past adverse reactions to the above products included Allergic reaction with SHINGRIX.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2022, the patient experienced PERIPHERAL SWELLING (Swelling of fingers), URTICARIA (Few mildly itchy hives on the arms), PYREXIA (Mild fever), MYALGIA (Achiness) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (Swelling of fingers), URTICARIA (Few mildly itchy hives on the arms), PYREXIA (Mild fever), MYALGIA (Achiness) and FATIGUE (Fatigue) outcome was unknown.            Patient states concomitant medication included number of things.  Patient did not receive treatment.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: first two were pretty bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (first two were pretty bad) 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 first 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. On an unknown date, the patient experienced VACCINATION COMPLICATION (first two were pretty bad). At the time of the report, VACCINATION COMPLICATION (first two were pretty bad) had resolved.            No concomitant medications were provided.  The patient stated that first two shots were pretty bad for about 24 hours.  No treatment medications were reported.   This case was linked to MOD-2022-542343 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; just a headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), HEADACHE (just a headache) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 015M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pneumonia vaccine (After receiving the second dose of the pneumonia vaccine.). Past adverse reactions to the above products included Hives with Pneumonia vaccine. Concurrent medical conditions included Rheumatoid arthritis, Egg allergy (Allergy to egg yolk), Fruit allergy (Papaya allergy), Fruit allergy (Banana allergy), Allergy to nuts and Fish allergy. Concomitant products included FLECAINIDE ACETATE for Cardiac disorder NOS.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-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 COVID-19 (Tested positive for COVID-19), HEADACHE (just a headache) and PYREXIA (Fever). At the time of the report, COVID-19 (Tested positive for COVID-19), HEADACHE (just a headache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was on cardiac medication.  No treatment medications was reported.  Company comment: This spontaneous case concerns a 73-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19. The event occurred unknown days after the second dose of mRNA-1273 Vaccine. The clinical course and treatment details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-542346, MOD-2022-542350, MOD-2022-542351 (Patient Link).; Sender's Comments: This spontaneous case concerns a 73-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19. The event occurred unknown days after the second dose of mRNA-1273 Vaccine. The clinical course and treatment details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Insomnia, Movement disorder, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having trouble breathing, having trouble breathing when laying down, sleeping in a chair for the last 6 months), INSOMNIA (couldn't sleep well because of that, sleeping in a chair for the last 6 months), MOVEMENT DISORDER (having trouble getting into higher vehicles like SUVs, having trouble going from the kitchen to the bathroom) and PERIPHERAL SWELLING (legs started swelling & are still swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 045A21A and 040A21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DYSPNOEA (having trouble breathing, having trouble breathing when laying down, sleeping in a chair for the last 6 months), INSOMNIA (couldn't sleep well because of that, sleeping in a chair for the last 6 months), MOVEMENT DISORDER (having trouble getting into higher vehicles like SUVs, having trouble going from the kitchen to the bathroom) and PERIPHERAL SWELLING (legs started swelling & are still swollen). At the time of the report, DYSPNOEA (having trouble breathing, having trouble breathing when laying down, sleeping in a chair for the last 6 months), INSOMNIA (couldn't sleep well because of that, sleeping in a chair for the last 6 months), MOVEMENT DISORDER (having trouble getting into higher vehicles like SUVs, having trouble going from the kitchen to the bathroom) and PERIPHERAL SWELLING (legs started swelling & are still swollen) was resolving. No concomitant medications were provided by the reporter. It was reported that patient visited a heart doctor and there was no problem with her heart. Patient now went to a lung doctor. Patient was taken Water pills.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a 69-year-old male 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 fourth 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). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient received second booster dose of moderna COVID-19 vaccine. It was reported that the product was expired 4 days prior. The patient had no further information about the storage or other information about the vaccine. No treatment medication was reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after manufacturer date of expiry; The vial first expired on 12-Apr-2022 and was then stored in the refrigerator on 14-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial first expired on 12-Apr-2022 and was then stored in the refrigerator on 14-Apr-2022) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial first expired on 12-Apr-2022 and was then stored in the refrigerator on 14-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial first expired on 12-Apr-2022 and was then stored in the refrigerator on 14-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  The patient had received the second booster dose of the vaccine.  It was reported that the vial had not undergone any temperature excursion issues. The reporter asked about what plan of action needs to be taken for the patient.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna dose administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna dose administered to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna dose administered to a patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter don't had the exact date it was moved from the freezer to refrigerator but it was definitely after 17-Mar-2022. Product was not pulled out of the refrigerator when it expired on 16-Apr-2022 so was accidently administered to a patient on 18-Apr-2022. It was reported that vial did not underwent any temperature excursions.  No treatment medications were reported.