chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Mediacal assistant reported that, they had administered an expired dose of Twinrix to the patient (1 month out of the expiration date as reported), which led to expired vaccine used. When asked about expiration date and lot number HCP (health care professional) stated this was urgent and she was not the person who administered the vaccine.    No more details were reported. The reporter consented to follow-up via email.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental overdose, No adverse event
Clinical narrative: received 2 doses on 23Mar2022; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 2-year-old male patient who received HAV (Havrix) (batch number 4CY9H, expiry date 28th April 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 23rd March 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 23rd March 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that a patient accidentally received 2 doses of Havrix on the day of reporting, which led to accidental overdose. No symptoms were reported. The reporter consented to follow up via email.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Overdose
Clinical narrative: Received 2 doses on the same day; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix and Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details reported were as follows: The age at vaccination was not reported. The patient received 2 doses of Shingrix on the same day, which led to overdose. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: SERIOUS HEART PROBLEM; This spontaneous report received from a consumer via a company representative concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy until vaccination. The patient had 3 para and 3 gravida. 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 serious heart problem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious heart problem was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Amnesia, Contusion, Inappropriate schedule of product administration, Off label use, Pain in extremity
Clinical narrative: MEMORY LOSS; BRUISE IN PALM OF HAND; LEFT HAND SWOLLEN; ARM SENSITIVE; LEFT HAND PAIN; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis.  The patient received two doses of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on 09-MAR-2021 and on an unspecified date in 2021 for prophylactic vaccination which was off label use as inappropriate use of vaccine administered. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient experienced memory loss, bruise in palm of hand with the following two doses of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient had non company suspect as adalimumab (form of admin not reported, subcutaneous, batch number was not reported) dose was not reported, administered on an unspecified date for rheumatoid arthritis.  The patient received booster dose of Moderna Covid-19 vaccine (Elasomeran) (Dose number in series 2) (form of admin not reported, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. On an unspecified date patient had left hand swollen, left hand pain and arm sensitive  with the following Moderna Covid-19 vaccination (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from arm sensitive, and the outcome of memory loss, bruise in palm of hand, left hand swollen, left hand pain, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Peripheral swelling, Sensitive skin
Clinical narrative: MEMORY LOSS; BRUISE IN PALM OF HAND; LEFT HAND SWOLLEN; ARM SENSITIVE; LEFT HAND PAIN; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis.  The patient received two doses of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on 09-MAR-2021 and on an unspecified date in 2021 for prophylactic vaccination which was off label use as inappropriate use of vaccine administered. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient experienced memory loss, bruise in palm of hand with the following two doses of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient had non company suspect as adalimumab (form of admin not reported, subcutaneous, batch number was not reported) dose was not reported, administered on an unspecified date for rheumatoid arthritis.  The patient received booster dose of Moderna Covid-19 vaccine (Elasomeran) (Dose number in series 2) (form of admin not reported, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. On an unspecified date patient had left hand swollen, left hand pain and arm sensitive  with the following Moderna Covid-19 vaccination (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from arm sensitive, and the outcome of memory loss, bruise in palm of hand, left hand swollen, left hand pain, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Emotional disorder, General physical condition abnormal, Mental disorder
Clinical narrative: PHYSICAL SIDE EFFECTS; EMOTIONAL SIDE EFFECTS; MENTAL SIDE EFFECTS; This spontaneous report received from a patient concerned a 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, 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 physical side effects, emotional side effects, and mental side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the physical side effects, emotional side effects and mental side effects was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned a non Hispanic or Latino male of an unspecified age and race. 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, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, right after the vaccination, the patient experienced a stroke and was partially paralyzed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220349302-Covid-19 vaccine ad26.cov2.s-Stroke. 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.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MANY SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned a 57 year old male of unspecified race and ethnic origin. 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, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced many side effects (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of many side effects was not reported. The patient additionally received non-company vaccine Tozinameran (Pfizer) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose was not reported, administered on unspecified date for prophylactic vaccination. It was unknown whether the patient had any adverse events following vaccination with Tozinameran (dose number in series 2). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 died from an unknown cause of death. The reporter stated the youngest daughter's best friends mother died right in front of my daughter and her friend after getting the same one I got by J&J that's the main reason she refused and still refuses to be vaxxed. It was unknown if an autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220350556. Sender's Comments: V0. 20220350892-Covid-19 vaccine ad26.cov2.s -Died. 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. Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antiphospholipid antibodies, Pain, Rash, Sunburn, Swelling face
Clinical narrative: SWOLLEN FACE; PAIN; SHUT PAIN WAS LIKE SUNBURN; RASH ON FACE; This spontaneous report received from a patient concerned a 73 year elderly female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies and no relevant medical history. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number : unknown expiry: unknown) dose was not reported, 1 total administered on 12-JUN-2021 for prophylactic vaccination.  It was unknown if the patient experienced any adverse reaction following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient had non-company suspect drug as adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1158967 expiry: unknown) dose, frequency, and therapy dates were not reported for unknown indication. The patient did not receive any concomitant medications. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown expiry: unknown) dose was not reported, 1 total administered on 15-JAN-2022 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On 30-JAN-2022, the patient experienced rash on face. On an unspecified date, the patient experienced swollen face, pain and sunburn (reported as shut pain was like sunburn) (dose number in series 2). Laboratory data included: Lupus anticoagulant (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The patient was recovering from rash on face, and the outcome of swollen face, pain and sunburn was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Stress
Clinical narrative: STRESS; STOMACH CRAMPS; This spontaneous report received from a patient concerned a 6 decade old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) first dose, 1 total, 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. The patient received non-company suspect drugs included: adalimumab (suspension for injection in pre-filled pen, subcutaneous, batch number: unknown, expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease.  On an unspecified date in 2022, the patient experienced stress and stomach cramps (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from stomach cramps, and the outcome of stress was not reported. The patient received Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin was not reported, intramuscular, and batch number: unknown, expiry: unknown) booster dose, 1 in once, dose, start therapy date were not reported for covid-19 vaccination. No concomitant medications were reported.  No adverse events were reported following administration of Moderna covid-19 vaccine (dose number in series 2). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Depression, Pharyngeal disorder, Speech disorder
Clinical narrative: TROUBLE SPEAKING; FELT DEPRESSED; ISSUE WITH THROAT AND VOICE; This spontaneous report received from a patient concerned a male 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced trouble speaking, felt depressed, and issue with throat and voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from trouble speaking, and issue with throat and voice, and the outcome of felt depressed was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: FOIL WRAP OR CAP OF VACCINE VIAL WAS REMOVED AND STORED IN FRIDGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, expiry: UNKNOWN) dose was not reported, administered on 20-FEB-2022 for prophylactic vaccination. No concomitant medications were reported. On 20-FEB-2022, the patient experienced out of specification product use, and foil wrap or cap of vaccine vial was removed and stored in fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and foil wrap or cap of vaccine vial was removed and stored in fridge was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The patient's past medical history included Heart attack in 2006. Concurrent medical conditions included Drug allergy (Ativan), Brain injury and Short-term memory loss (Brain injury resulting in short term memory loss). On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In March 2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). The patient died on 23-Mar-2021. The reported cause of death was Heart attack. An autopsy was performed. No concomitant medication provided. No treatment information mentioned. Patients wife reported that patient died 4 days after he was in the hospital. Patient had a heart attack as per autopsy and died at home. No other vaccines were given a month prior to Moderna. Has never had a COVID positive test or diagnosis. Company comment. This spontaneous fatal case concerns a 63-year-old, male subject with a medical history of heart attack (2006) and brain injury that resulted in short-term memory loss, who experienced the unexpected serious (Results in death, medically significant) AESI of Myocardial infarction. The event occurred approximately 5 days after the first dose of mRNA-1273 VACCINE and had a fatal outcome. As reported, 5 days after vaccination, patient died at home, cause of death was heart attack, and an autopsy was done.  However, autopsy result was not provided. The patient's age and medical history of heart attack and brain injury, which has the same risk factors as myocardial infarction, remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous fatal case concerns a 63-year-old, male subject with a medical history of heart attack (2006) and brain injury that resulted in short-term memory loss, who experienced the unexpected serious (Results in death, medically significant) AESI of Myocardial infarction. The event occurred approximately 5 days after the first dose of mRNA-1273 VACCINE and had a fatal outcome. As reported, 5 days after vaccination, patient died at home, cause of death was heart attack, and an autopsy was done. However, autopsy result was not provided. The patient's age and medical history of heart attack and brain injury, which has the same risk factors as myocardial infarction, remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Heart attack.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: patient stopped having menustration after getting the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (patient stopped having menustration after getting the Moderna vaccine) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced AMENORRHOEA (patient stopped having menustration after getting the Moderna vaccine). At the time of the report, AMENORRHOEA (patient stopped having menustration after getting the Moderna vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was reported.  It had been one year since the patient had the last menstrual period.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received half booster dose instead of 3rd full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received half booster dose instead of 3rd full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received half booster dose instead of 3rd full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received half booster dose instead of 3rd full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after the 30-day beyond use date of 18-Mar-2022; patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and PRODUCT STORAGE ERROR (Vaccine administered after the 30-day beyond use date of 18-Mar-2022) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 012H21B and 068H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after the 30-day beyond use date of 18-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and PRODUCT STORAGE ERROR (Vaccine administered after the 30-day beyond use date of 18-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  On 24-Feb-2022, the vaccine was moved from the freezer to the refrigerator. On 21-Mar-2022, at 04:00 P.M., the vaccine vial was opened.   This case was linked to MOD-2022-520795 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: flu like symptoms for 16 hours after her booster dose; patient had a sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms for 16 hours after her booster dose) and PAIN IN EXTREMITY (patient had a sore right arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F2A, 029K20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms for 16 hours after her booster dose) and PAIN IN EXTREMITY (patient had a sore right arm). In 2021, INFLUENZA LIKE ILLNESS (flu like symptoms for 16 hours after her booster dose) and PAIN IN EXTREMITY (patient had a sore right arm) had resolved.            No concomitant was provided by the reporter. No treatment information was provided by the reporter. The patient reports no adverse reactions or side effects to the first vaccine.   This case was linked to MOD-2022-521056 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore injection site arm; feeling tired after the first Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (feeling tired after the first Moderna Covid-19 vaccine.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (feeling tired after the first Moderna Covid-19 vaccine.). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (feeling tired after the first Moderna Covid-19 vaccine.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment medication were provided. Patient had a sore injection site arm and feeling tired after the first Moderna Covid-19 vaccine.   This case was linked to MOD-2022-521319, MOD-2022-521320 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after the booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 010M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm after the booster dose). At the time of the report, PAIN IN EXTREMITY (sore arm after the booster dose) outcome was unknown.            No concomitant medications were reported It was reported that the patient did not remember which arm patient received the booster dose in. No treatment drugs were reported   This case was linked to MOD-2022-521319, MOD-2022-521217 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: administration of an expired vaccine; second dose administered >36 days after the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered >36 days after the first dose) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 012H21B and 012H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered >36 days after the first dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of an expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered >36 days after the first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: positive (Positive) POSITIVE. On 04-Jan-2022, SARS-CoV-2 test: positive (Positive) POSITIVE.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient received Second dose which was expired. The Patient had not experienced any symptoms after receiving the expired dose.  The patient was tested and also diagnosed with COVID on 18-Jan-2021 and 04-Jan-2022.   The patient not had known allergies. The patient also not had any history relating to mentioned events and both acute and Chronic illnesses at the time of vaccination. The patient not received any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  No concomitant medications was reported. No treatment drug details was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 009C21A and 048B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 04-Dec-2020.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that reporter doesn´t know if the patients are on any concomitant medication. It was reported that vaccine was expired for three days and had not undergone any temperature excursions. The patients didn´t have any allergies, acute or chronic illnesses at the time of vaccination, and no other vaccines were administered 1 month prior to Moderna Covid-19 Vaccine. The patient had no symptoms after receiving the expired dose. No treatment details were reported.   This case was linked to MOD-2022-521598, MOD-2022-521636, MOD-2022-521490 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 03Jan2022 and administered to the patient on 16Feb2022; receiving doses after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Jan2022 and administered to the patient on 16Feb2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Jan2022 and administered to the patient on 16Feb2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Jan2022 and administered to the patient on 16Feb2022) 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 medications were reported.  Beyond Use Date was reported as 02-Feb-2022. It was reported that the vial was initially stored in the refrigerator on 03-Jan-2022. The vials had not underwent temperature excursion.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: reaction when eating red meat products; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction when eating red meat products) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2022, the patient experienced VACCINATION COMPLICATION (reaction when eating red meat products). At the time of the report, VACCINATION COMPLICATION (reaction when eating red meat products) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Immunisation reaction
Clinical narrative: side effects, hit him pretty hard; pretty sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects, hit him pretty hard) and ILLNESS (pretty sick) 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 first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects, hit him pretty hard) and ILLNESS (pretty sick). At the time of the report, VACCINATION COMPLICATION (side effects, hit him pretty hard) had not resolved and ILLNESS (pretty sick) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       It was reported that the patient was having side effects. He was pretty sick after getting the shot and had hit him pretty hard.   No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2022-522567 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow up contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: Yucky feeling after first two doses; Sore arm after first two doses; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Yucky feeling after first two doses) and VACCINATION SITE PAIN (Sore arm after first two doses) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Parkinson's disease.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced FEELING ABNORMAL (Yucky feeling after first two doses) and VACCINATION SITE PAIN (Sore arm after first two doses). In 2021, FEELING ABNORMAL (Yucky feeling after first two doses) and VACCINATION SITE PAIN (Sore arm after first two doses) had resolved.            No concomitant  and treatment medication were reported. The patient had a sore arm and yucky feeling. It didn't last very long.   This case was linked to MOD-2022-521969, MOD-2022-521546 (Patient Link).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly, Product administered to patient of inappropriate age
Clinical narrative: his heart in enlarged/two weeks later (after shot) hearts getting enlarged; Child was 16 years old; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMEGALY (his heart in enlarged/two weeks later (after shot) hearts getting enlarged) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child was 16 years old) in a 16-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIOMEGALY (his heart in enlarged/two weeks later (after shot) hearts getting enlarged). an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child was 16 years old). At the time of the report, CARDIOMEGALY (his heart in enlarged/two weeks later (after shot) hearts getting enlarged) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child was 16 years old) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient played football, basketball and baseball. It was reported that two weeks after shot, his heart got enlarged.  No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow up contains no new information.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: The first two was like somebody punched them in the arm for 2,3,4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The first two was like somebody punched them in the arm for 2,3,4 days) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Back injury, Herniated disc (Ruptured disc), Fragmented intervertebral disc (floating fragments), Pinched nerve and Surgery (Patient had a former back injury which he had surgery for in the past for ruptured disc, floating fragments and pinched nerve). Concurrent medical conditions included Gout and Kidney stones. Concomitant products included ALLOPURINOL for Gout and Kidney stones, GABAPENTIN (GABAPENTIN "PCD") for Shooting pain, LISINOPRIL and SIMVASTATIN for an unknown indication.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (The first two was like somebody punched them in the arm for 2,3,4 days). In March 2021, VACCINATION SITE PAIN (The first two was like somebody punched them in the arm for 2,3,4 days) had resolved.            Treatment information was not reported.   This case was linked to MOD-2022-522804, MOD-2022-522968 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow-up recieved. Added batch number and updated date of vaccination.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Confusional state, Contusion, Insomnia, Limb discomfort
Clinical narrative: The first two was like somebody punched them in the arm for 2,3,4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The first two was like somebody punched them in the arm for 2,3,4 days) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Back injury, Herniated disc (Ruptured disc), Fragmented intervertebral disc (floating fragments), Pinched nerve and Surgery (Patient had a former back injury which he had surgery for in the past for ruptured disc, floating fragments and pinched nerve). Concurrent medical conditions included Gout and Kidney stones. Concomitant products included ALLOPURINOL for Gout and Kidney stones, GABAPENTIN (GABAPENTIN "PCD") for Shooting pain, LISINOPRIL and SIMVASTATIN for an unknown indication.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (The first two was like somebody punched them in the arm for 2,3,4 days). In March 2021, VACCINATION SITE PAIN (The first two was like somebody punched them in the arm for 2,3,4 days) had resolved.            Treatment information was not reported.   This case was linked to MOD-2022-522804, MOD-2022-522968 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow-up recieved. Added batch number and updated date of vaccination.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Myalgia, Osteoarthritis, Tendonitis, X-ray
Clinical narrative: The first two was like somebody punched them in the arm for 2,3,4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The first two was like somebody punched them in the arm for 2,3,4 days) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Back injury, Herniated disc (Ruptured disc), Fragmented intervertebral disc (floating fragments), Pinched nerve and Surgery (Patient had a former back injury which he had surgery for in the past for ruptured disc, floating fragments and pinched nerve). Concurrent medical conditions included Gout and Kidney stones. Concomitant products included ALLOPURINOL for Gout and Kidney stones, GABAPENTIN (GABAPENTIN "PCD") for Shooting pain, LISINOPRIL and SIMVASTATIN for an unknown indication.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (The first two was like somebody punched them in the arm for 2,3,4 days). In March 2021, VACCINATION SITE PAIN (The first two was like somebody punched them in the arm for 2,3,4 days) had resolved.            Treatment information was not reported.   This case was linked to MOD-2022-522804, MOD-2022-522968 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow-up recieved. Added batch number and updated date of vaccination.