chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 06-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1).  The patient was previously treated with booster dose of covid-19 vaccine ad26. cov2. s (Dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 10-NOV-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with booster dose of covid-19 vaccine ad26. cov2.s (Dose number in series 2).  The patient additionally received secondary booster of covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 08-SEP-2022) dose was not reported, 1 total administered on 24-APR-2022 for prophylactic vaccination which was inappropriate schedule of vaccine administered and off label use (Dose number in series 3). No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate schedule of vaccine administered and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymphoma, Magnetic resonance imaging
Clinical narrative: AGGRESSIVE LYMPHOMA; This spontaneous report received from a patient concerned female of unspecified age. 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, batch number: 042AZ1A, and expiry: unknown) dose was not reported, 1 total, administered on 03-JUN-2021 for prophylactic vaccination on left arm, however patient was not sure if it was the number "one" or the letter "I" in batch number. No concomitant medications were reported. On the first week of AUG-2021, the patient experienced some swelling in her left eyelid which turn out to be a cyst. Patient went to see her doctor. Patient saw all kinds of doctor concerning her eyelids and they thought that it was related to allergies in the beginning. Patient had cyst that burst once and then doctor performed Laboratory data: Magnetic resonance imaging (MRI) (NR: not provided) unknown and Computed tomography (CT) scan (NR: not provided) unknown to obtain more information on her condition. After several tests they diagnosed an aggressive lymphoma (cancer). Patient asked her doctor when her symptoms started and the doctor told her that the lymphoma has been there for about 2 months as per patient this was around the time she received the Janssen vaccine. The patient visited to physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aggressive lymphoma. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220447795- covid-19 vaccine ad26.cov2.s- Aggressive lymphoma. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: INJURED; 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 injured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injured was not reported. This report was non-serious. This case, from the same reporter is linked to 20220447899.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SYMPTOM OF COVID; This spontaneous report received from a patient concerned a 37 year old male. 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: 1808986, expiry: 01-MAR-2022) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. Age at time of vaccination 37 years old. No concomitant medications were reported. On an unspecified date, the patient experienced symptom of covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptom of covid was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Wrong product administered
Clinical narrative: HEALTH CARE PROFESSIONAL ACCIDENTALLY GAVE 0.3 ML INSTEAD OF 0.5 ML; HEALTH CARE PROFESSIONAL ACCIDENTALLY GAVE 0.3 ML DOSE TAKEN FROM A JANSSEN VIAL INSTEAD OF A PFIZER VIAL.; This spontaneous report received from a pharmacist concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient was previously treated with tozinameran for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 08-SEP-2022) dose was not reported, administered on 25-APR-2022 for prophylactic vaccination. Age at time of vaccination 49 years old. No concomitant medications were reported. On 25-APR-2022, the patient experienced health care professional accidentally gave 0.3 ml instead of 0.5 ml, and health care professional accidentally gave 0.3 ml dose taken from a janssen vial instead of a pfizer vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the health care professional accidentally gave 0.3 ml instead of 0.5 ml and health care professional accidentally gave 0.3 ml dose taken from a janssen vial instead of a pfizer vial. was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022; received a vaccine past the 30 day storage on the refrigerator.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (received a vaccine past the 30 day storage on the refrigerator.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (ASA), Allergic reaction to analgesics (Morphine) and Diabetes. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LORATADINE, TRIAMCINOLONE, LOVASTATIN, SALBUTAMOL (VENTOLIN [SALBUTAMOL]), FLUTICASONE PROPIONATE (FLOVENT), GLIMEPIRIDE, LISINOPRIL and METFORMIN for an unknown indication.    On 06-Apr-2022 at 9:07 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 9:07 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine past the 30 day storage on the refrigerator.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (received a vaccine past the 30 day storage on the refrigerator.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was not COVID positive within last month.  On 25-Feb-2022 vial was initially stored in the refrigerator.  It was reported the patients were vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022   Vial did not undergo any temperature excursions  HCP confirmed that the patients were not experiencing any side effects yet.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Follow-up received, report type changed (Invalid to Valid) spontaneous, reporter type updated, contact information added. Patient details, medical history, dosage details and concomitant medication added.
Sex: M
Vaccine: COVID19
Symptoms: Lymphoma, Mass, Peripheral arterial occlusive disease
Clinical narrative: Lymphoma after receiving the 2nd dose; Occlusion in leg; Lump the size of a golf ball that never went away; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (Lymphoma after receiving the 2nd dose), PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (Occlusion in leg) and MASS (Lump the size of a golf ball that never went away) in a male 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 second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHOMA (Lymphoma after receiving the 2nd dose) (seriousness criterion medically significant), PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (Occlusion in leg) (seriousness criterion medically significant) and MASS (Lump the size of a golf ball that never went away) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (Lymphoma after receiving the 2nd dose) and PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (Occlusion in leg) outcome was unknown and MASS (Lump the size of a golf ball that never went away) had not resolved.            No concomitant medications reported.  The patient under oncologic treatment. Company comment: This spontaneous case concerns a male patient of unknown age, who experienced the unexpected, serious event of Lymphoma ,mass and pheripheral artery occlusion (seriousness criteria medically significant) which occurred on an unspecified date after receiving the second dose of mRNA 1273 vaccine. It was reported that after vaccination patient developed lymphoma and which was a mass grown to the size of a golf ball with Occlusion in leg and was reported to be under oncologic treatment.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-065289.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age, who experienced the unexpected, serious event of Lymphoma ,mass and pheripheral artery occlusion (seriousness criteria medically significant) which occurred on an unspecified date after receiving the second dose of mRNA 1273 vaccine. It was reported that after vaccination patient developed lymphoma and which was a mass grown to the size of a golf ball with Occlusion in leg and was reported to be under oncologic treatment.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: A lot of vertigo after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (A lot of vertigo after booster dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 006B21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (she gave birth to a healthy baby on 19APR2021) from 2020 to 19-Apr-2021 and Normal birth (Patient delivered a child(Boy)) on 19-Apr-2021.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced VERTIGO (A lot of vertigo after booster dose). On 31-Dec-2021, VERTIGO (A lot of vertigo after booster dose) had resolved.            No concomitant medication reported. Patient received Moderna COVID-19 booster vaccine after her child was born. Patient did not breastfeed at all No treatment medication reported.   This case was linked to MOD-2022-546451 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: A lot of vertigo after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (A lot of vertigo after booster dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 006B21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (she gave birth to a healthy baby on 19APR2021) from 2020 to 19-Apr-2021 and Normal birth (Patient delivered a child(Boy)) on 19-Apr-2021.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced VERTIGO (A lot of vertigo after booster dose). On 31-Dec-2021, VERTIGO (A lot of vertigo after booster dose) had resolved.            No concomitant medication reported. Patient received Moderna COVID-19 booster vaccine after her child was born. Patient did not breastfeed at all No treatment medication reported.   This case was linked to MOD-2022-546451 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) 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.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2022: Follow up document contain secondary reporter, patient name, DOB, age gender, VAERS confirmation numbers and date of administration were updated
Age: 65.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Asthenia, Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: Feeling weak; Patient doesn't feel good.; Fever of 100; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling weak), FEELING ABNORMAL (Patient doesn't feel good.) and PYREXIA (Fever of 100) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Shingles.    Patient's concurrent medical conditions also  included bladder issue.  The patient's past medical history included COVID-19 in 2021. Concurrent medical conditions included Panic attacks, Depression and Cholesterol.   On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. In April 2022, the patient experienced ASTHENIA (Feeling weak), FEELING ABNORMAL (Patient doesn't feel good.) and PYREXIA (Fever of 100). At the time of the report, ASTHENIA (Feeling weak), FEELING ABNORMAL (Patient doesn't feel good.) and PYREXIA (Fever of 100) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) fever of 100.         Patient's concomitant medications included pill for Cholesterol, bladder, panic attacks, depression.  Patient took Shingles booster on the same day as Moderna Booster in the other arm. Patient hasn't gone to the doctor.  Patient did not take any treatment medicine.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patients that received a vaccine past the 30 day storage on the refrigerator.; patients that received a vaccine past the 30 day storage on the refrigerator.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients that received a vaccine past the 30 day storage on the refrigerator.) and PRODUCT STORAGE ERROR (patients that received a vaccine past the 30 day storage on the refrigerator.) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     It was reported that patient had no known drug allergies (NKDA).  Concomitant products included TRIAMCINOLONE and MELATONIN for an unknown indication.    On 20-Apr-2022 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients that received a vaccine past the 30 day storage on the refrigerator.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patients that received a vaccine past the 30 day storage on the refrigerator.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients that received a vaccine past the 30 day storage on the refrigerator.) and PRODUCT STORAGE ERROR (patients that received a vaccine past the 30 day storage on the refrigerator.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 25-Feb-2022.The vial did not undergo any temperature excursions.HCP confirmed that the patients are not experiencing any side effects yet.  No treatment information was provided.   This case was linked to MOD-2022-545267 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received a vaccine past the 30 day storage on the refrigerator; Doses administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator) in a 42-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     It was reported that patient had no known allergies. Patient was not tested positive for COVID within last month.  Concomitant products included SODIUM FLUORIDE and TRIAMCINOLONE ACETONIDE for an unknown indication.    On 06-Apr-2022 at 3:04 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022 at 3:04 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in refrigerator 25-Feb-2022. The vial did not undergo any temperature excursions. HCP confirmed that the patients were not experiencing any side effects at the time of this report. Expiry date of vaccine was reported as 25-Mar-2022.  No treatment details were provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 25 Feb 2022 and administered on 06 Apr 2022; Received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25 Feb 2022 and administered on 06 Apr 2022) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     The patient had no known allergies.  Concurrent medical conditions included GERD and Hyperlipidemia. Concomitant products included OMEPRAZOLE and SIMVASTATIN for an unknown indication.    On 06-Apr-2022 at 11:17 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 11:17 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25 Feb 2022 and administered on 06 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25 Feb 2022 and administered on 06 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial did not undergo any temperature excursions It was reported the patients were vaccinated with the Moderna Vaccine after the expiration of 25 Mar 2022. Reporter confirmed that the patients were not experiencing any side effects yet. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID) 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 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 (Got COVID). At the time of the report, COVID-19 (Got COVID) outcome was unknown.            No concomitant medication was provided by the reporter.  It was reported that patient had a Moderna shot and then a booster shot and then got the COVID reporter wanted to know that if patient can get vaccinated with the second booster.  No treatment medication was provided by the reporter.  Company Comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19. The event occurred on an unknown date after receiving a dose (the event may have occurred after the booster dose of mRNA-1273 as stated that the patient had Moderna shot then Booster shot then got COVID) of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19. The event occurred on an unknown date after receiving a dose (the event may have occurred after the booster dose of mRNA-1273 as stated that the patient had Moderna shot then Booster shot then got COVID) of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash following Moderna booster / rash about the size of a baseball on my chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash following Moderna booster / rash about the size of a baseball on my chest) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson (First shot). Past adverse reactions to the above products included No adverse event with Johnson and Johnson.   In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced RASH (rash following Moderna booster / rash about the size of a baseball on my chest). At the time of the report, RASH (rash following Moderna booster / rash about the size of a baseball on my chest) outcome was unknown.  No concomitant medications were reported. No treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Illness, Myalgia
Clinical narrative: achy joints; achiness; patient had a headache for 2 days; heart was racing; got sick; was tired; felt like she had a fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was racing), ILLNESS (got sick), FATIGUE (was tired), PYREXIA (felt like she had a fever) and ARTHRALGIA (achy joints) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PALPITATIONS (heart was racing), ILLNESS (got sick), FATIGUE (was tired), PYREXIA (felt like she had a fever) and HEADACHE (patient had a headache for 2 days). On an unknown date, the patient experienced ARTHRALGIA (achy joints) and MYALGIA (achiness). On 14-Sep-2021, HEADACHE (patient had a headache for 2 days) had resolved. At the time of the report, PALPITATIONS (heart was racing) had not resolved and ILLNESS (got sick), FATIGUE (was tired), PYREXIA (felt like she had a fever), ARTHRALGIA (achy joints) and MYALGIA (achiness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient went to the hospital. No treatment medications were reported.   This case was linked to MOD-2022-547014, MOD-2022-547015 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: achy joints; achiness; patient had a headache for 2 days; heart was racing; got sick; was tired; felt like she had a fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was racing), ILLNESS (got sick), FATIGUE (was tired), PYREXIA (felt like she had a fever) and ARTHRALGIA (achy joints) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PALPITATIONS (heart was racing), ILLNESS (got sick), FATIGUE (was tired), PYREXIA (felt like she had a fever) and HEADACHE (patient had a headache for 2 days). On an unknown date, the patient experienced ARTHRALGIA (achy joints) and MYALGIA (achiness). On 14-Sep-2021, HEADACHE (patient had a headache for 2 days) had resolved. At the time of the report, PALPITATIONS (heart was racing) had not resolved and ILLNESS (got sick), FATIGUE (was tired), PYREXIA (felt like she had a fever), ARTHRALGIA (achy joints) and MYALGIA (achiness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient went to the hospital. No treatment medications were reported.   This case was linked to MOD-2022-547014, MOD-2022-547015 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: tiredness/felt tired; headache; achiness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness/felt tired), HEADACHE (headache) and MYALGIA (achiness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 017E21A) for COVID-19 vaccination.     The patient had no history of Myocarditis/pericarditis and COVID-19 infection.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced FATIGUE (tiredness/felt tired), HEADACHE (headache) and MYALGIA (achiness). At the time of the report, FATIGUE (tiredness/felt tired), HEADACHE (headache) and MYALGIA (achiness) outcome was unknown.  No treatment information was reported.   This case was linked to MOD-2022-547011, MOD-2022-547015 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He had some residual pain in the arm the second day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (He had some residual pain in the arm the second day) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006H21A and 03H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (He had some residual pain in the arm the second day). At the time of the report, PAIN IN EXTREMITY (He had some residual pain in the arm the second day) outcome was unknown.            No concomitant medications were reported.  It was reported that patient got first booster shot on 08-Nov-2021 (lot:034F21A), second booster on 20-April-2022 (lot: 065J21A-B) in the left deltoid.  No treatment medications were reported.   This case was linked to MOD-2022-547026 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gait disturbance, Headache, Myalgia
Clinical narrative: Difficulty walking out of the chair or bed/ difficulty taking his first two steps when walking/ took two steps and almost fell; Fatigue; Severe headache; Joint pain; Muscle pain/Extreme body pain; Woke up this morning to an extremely fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Woke up this morning to an extremely fast heartbeat), GAIT DISTURBANCE (Difficulty walking out of the chair or bed/ difficulty taking his first two steps when walking/ took two steps and almost fell), FATIGUE (Fatigue), HEADACHE (Severe headache) and ARTHRALGIA (Joint pain) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065J21A-B, 034F21A, 006H21A and 03H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation (Patient was taking Warfarin for atrial fibrillation.). Concomitant products included WARFARIN for Atrial fibrillation, PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (Woke up this morning to an extremely fast heartbeat). On an unknown date, the patient experienced GAIT DISTURBANCE (Difficulty walking out of the chair or bed/ difficulty taking his first two steps when walking/ took two steps and almost fell), FATIGUE (Fatigue), HEADACHE (Severe headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain/Extreme body pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fatigue and Headache, at a dose of Two tylenol. At the time of the report, TACHYCARDIA (Woke up this morning to an extremely fast heartbeat), GAIT DISTURBANCE (Difficulty walking out of the chair or bed/ difficulty taking his first two steps when walking/ took two steps and almost fell), FATIGUE (Fatigue), HEADACHE (Severe headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain/Extreme body pain) was resolving.            Patient woke up with extremely fast heartbeat on 22-Apr-2022.   This case was linked to MOD-2022-547021 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Difficulty walking out of the chair or bed/ difficulty taking his first two steps when walking/ took two steps and almost fell; Fatigue; Severe headache; Joint pain; Muscle pain/Extreme body pain; Woke up this morning to an extremely fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Woke up this morning to an extremely fast heartbeat), GAIT DISTURBANCE (Difficulty walking out of the chair or bed/ difficulty taking his first two steps when walking/ took two steps and almost fell), FATIGUE (Fatigue), HEADACHE (Severe headache) and ARTHRALGIA (Joint pain) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065J21A-B, 034F21A, 006H21A and 03H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation (Patient was taking Warfarin for atrial fibrillation.). Concomitant products included WARFARIN for Atrial fibrillation, PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (Woke up this morning to an extremely fast heartbeat). On an unknown date, the patient experienced GAIT DISTURBANCE (Difficulty walking out of the chair or bed/ difficulty taking his first two steps when walking/ took two steps and almost fell), FATIGUE (Fatigue), HEADACHE (Severe headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain/Extreme body pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fatigue and Headache, at a dose of Two tylenol. At the time of the report, TACHYCARDIA (Woke up this morning to an extremely fast heartbeat), GAIT DISTURBANCE (Difficulty walking out of the chair or bed/ difficulty taking his first two steps when walking/ took two steps and almost fell), FATIGUE (Fatigue), HEADACHE (Severe headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain/Extreme body pain) was resolving.            Patient woke up with extremely fast heartbeat on 22-Apr-2022.   This case was linked to MOD-2022-547021 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Diarrhoea, Headache, Nausea
Clinical narrative: bone pain; pain when lifting arm, pain when moving arm, painful to move arm up and down; pain from arm to elbow to shoulder; joint pain, shoulder pain; slight headache; felt nauseated; had loose stools; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain), PAIN (pain when lifting arm, pain when moving arm, painful to move arm up and down), DIARRHOEA (had loose stools), PAIN IN EXTREMITY (pain from arm to elbow to shoulder) and ARTHRALGIA (joint pain, shoulder pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-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 21-Apr-2022, the patient experienced DIARRHOEA (had loose stools) and NAUSEA (felt nauseated). On an unknown date, the patient experienced BONE PAIN (bone pain), PAIN (pain when lifting arm, pain when moving arm, painful to move arm up and down), PAIN IN EXTREMITY (pain from arm to elbow to shoulder), ARTHRALGIA (joint pain, shoulder pain) and HEADACHE (slight headache). At the time of the report, BONE PAIN (bone pain), PAIN (pain when lifting arm, pain when moving arm, painful to move arm up and down), DIARRHOEA (had loose stools), PAIN IN EXTREMITY (pain from arm to elbow to shoulder), ARTHRALGIA (joint pain, shoulder pain), NAUSEA (felt nauseated) and HEADACHE (slight headache) outcome was unknown.            No concomitant medications were reported.  Patient stated that she usually does not get headaches.  No treatment medications were reported.   This case was linked to MOD-2022-547032, MOD-2022-547037 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: bone pain; pain when lifting arm, pain when moving arm, painful to move arm up and down; pain from arm to elbow to shoulder; joint pain, shoulder pain; slight headache; felt nauseated; had loose stools; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain), PAIN (pain when lifting arm, pain when moving arm, painful to move arm up and down), DIARRHOEA (had loose stools), PAIN IN EXTREMITY (pain from arm to elbow to shoulder) and ARTHRALGIA (joint pain, shoulder pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-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 21-Apr-2022, the patient experienced DIARRHOEA (had loose stools) and NAUSEA (felt nauseated). On an unknown date, the patient experienced BONE PAIN (bone pain), PAIN (pain when lifting arm, pain when moving arm, painful to move arm up and down), PAIN IN EXTREMITY (pain from arm to elbow to shoulder), ARTHRALGIA (joint pain, shoulder pain) and HEADACHE (slight headache). At the time of the report, BONE PAIN (bone pain), PAIN (pain when lifting arm, pain when moving arm, painful to move arm up and down), DIARRHOEA (had loose stools), PAIN IN EXTREMITY (pain from arm to elbow to shoulder), ARTHRALGIA (joint pain, shoulder pain), NAUSEA (felt nauseated) and HEADACHE (slight headache) outcome was unknown.            No concomitant medications were reported.  Patient stated that she usually does not get headaches.  No treatment medications were reported.   This case was linked to MOD-2022-547032, MOD-2022-547037 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Fatigue) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A and 034F21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Johnson and Johnson (primary dose). Past adverse reactions to the above products included No adverse event with Johnson and Johnson. Family history included Asthma (wife regularly uses a nebulizing inhaler) since an unknown date. Concurrent medical conditions included Cancer (NOS). On 10-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. Patient has been married for almost 40 years. He and his wife received all doses on the same dates from the same lot numbers. They did not experience any symptoms until 14-APR-2022. Patient did not experience nausea. No treatment drug were reported. This case was linked to MOD-2022-547521 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm after first dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Yearly IM Flu vaccine Fall 2021). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Penicillin allergy and Blood pressure high (No change reported. Patient took unspecified medication for high blood pressure.).    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore left arm after first dose). At the time of the report, VACCINATION SITE PAIN (sore left arm after first dose) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  No treatment drug details was reported. Patient experienced similar event in the past.   This case was linked to MOD-2022-547050, MOD-2022-547040, MOD-2022-547048 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of The Moderna Covid 19 Vaccine from an expired vial.) and PRODUCT STORAGE ERROR (Received vaccine from a vial that had expired on 16Apr2022) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 091D21, 016M20A and 032L20A) 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) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of The Moderna Covid-19 Vaccine from an expired vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine from a vial that had expired on 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of The Moderna Covid-19 Vaccine from an expired vial) and PRODUCT STORAGE ERROR (Received vaccine from a vial that had expired on 16Apr2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications stated that patient was on concomitant medication, but did not specify on what type of medication. The patient had not reported any side effects yet. No treatment details were reported.