chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got vaccinated and got shingles/suspected vaccination failure; shingles. Had to go to urgent care. Was not happy; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2020, the patient received Shingles vaccine. In April 2021, between 6 and 8 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got vaccinated with Shingles vaccine and got shingles.  The physician said they could not see the patient, the patient had to go to urgent care, so the patient was not happy. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure/got both shingles shots 2 years, but have had shingles twice now; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received both shingles shots 2 years ago, but had shingles twice now in 2 months. The pain was real and it was horrible. For occurrence of 2nd episode of shingles, refer case US2021AMR241290. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241290:same patient, 2nd episode
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got both shingles shots 2 years, but have had shingles twice now/suspected vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (1st episode after vaccination, refer case US2021AMR241267).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got both shingles shots 2 years, but had shingles now at the time of reporting. The pain was real and it was horrible. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. No contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241267:same patient, 1st episode
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood immunoglobulin G, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 01-JUN-2023) dose was not reported, 1 total administered on 28-MAY-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  The patient reported, she did three antibody tests that all came back negative. The first test was done on 13-OCT-2021, Laboratory data included: Immunoglobulin G (NR: not provided) Non reactive. The second test was done on 02-NOV-2021 and it was a spike test (possible Immunoglobulin A) that came back negative. On 16-NOV-2021, had the T detect test which was negative (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product quality complaint number 90000203678.; Sender's Comments: V0; 20211152159-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with the vaccine from a vial punctured for more than 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial punctured for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial punctured for more than 12 hours). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial punctured for more than 12 hours) had resolved.        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.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: Patient received 0.25mL dose for their 2nd dose/Patient did not receive full 2nd dose of 0.5mL/Full 2nd dose not yet received; More than 35 days since 1st dose received/1st dose received in Feb,2021; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25mL dose for their 2nd dose/Patient did not receive full 2nd dose of 0.5mL/Full 2nd dose not yet received) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since 1st dose received/1st dose received in Feb,2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 16-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25mL dose for their 2nd dose/Patient did not receive full 2nd dose of 0.5mL/Full 2nd dose not yet received) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since 1st dose received/1st dose received in Feb,2021). On 16-Nov-2021, ACCIDENTAL UNDERDOSE (Patient received 0.25mL dose for their 2nd dose/Patient did not receive full 2nd dose of 0.5mL/Full 2nd dose not yet received) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since 1st dose received/1st dose received in Feb,2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter declined to provide concomitant medication  and patient information details.  Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired Moderna COVID 19 vaccine to 6 patients this morning; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 vaccine to 6 patients this morning) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 vaccine to 6 patients this morning). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID 19 vaccine to 6 patients this morning) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: One of nurse gave a dose of the Moderna Covid-19 vaccine that was expired to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of nurse gave a dose of the Moderna Covid-19 vaccine that was expired to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of nurse gave a dose of the Moderna Covid-19 vaccine that was expired to a patient). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (One of nurse gave a dose of the Moderna Covid-19 vaccine that was expired to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Action taken was updated from previous source document.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Vaccination site rash
Clinical narrative: predominant on the left side which is the same side patient; having a rash on both arms more intense on the left side/rash all around the waist more intense on the left side; this is an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of RASH (having a rash on both arms more intense on the left side/rash all around the waist more intense on the left side), HYPERSENSITIVITY (this is an allergic reaction) and VACCINATION SITE RASH (predominant on the left side which is the same side patient) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 004M20A and 011L20) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-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. In November 2021, the patient experienced RASH (having a rash on both arms more intense on the left side/rash all around the waist more intense on the left side) and HYPERSENSITIVITY (this is an allergic reaction). On an unknown date, the patient experienced VACCINATION SITE RASH (predominant on the left side which is the same side patient). At the time of the report, RASH (having a rash on both arms more intense on the left side/rash all around the waist more intense on the left side), HYPERSENSITIVITY (this is an allergic reaction) and VACCINATION SITE RASH (predominant on the left side which is the same side patient) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Little sore arm left arm injection; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little sore arm left arm injection) and HEADACHE (headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Little sore arm left arm injection) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Little sore arm left arm injection) and HEADACHE (headache) outcome was unknown.            No concomitant medication was provided.  Husband called to report that  he had a little sore arm left arm injection and a headache.  Reports his wife has had swelling, hardness and redness at left arm injection site since receiving booster dose. States his wife had a headache all day yesterday.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pruritus, Vaccination site reaction
Clinical narrative: Broke out with blisters all over the body including wrist, arm, and back; Blisters are itching; injection arm is all knotted up; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Broke out with blisters all over the body including wrist, arm, and back), PRURITUS (Blisters are itching) and VACCINATION SITE REACTION (injection arm is all knotted up) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced BLISTER (Broke out with blisters all over the body including wrist, arm, and back) and PRURITUS (Blisters are itching). In November 2021, the patient experienced VACCINATION SITE REACTION (injection arm is all knotted up). At the time of the report, BLISTER (Broke out with blisters all over the body including wrist, arm, and back), PRURITUS (Blisters are itching) and VACCINATION SITE REACTION (injection arm is all knotted up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. The patient could not locate the information for first and second dose. The patient stated he was been applying cortisone creme to make it stop itching and applying baby powder as well.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: Caller states her husband got the moderna booster dose. He does not feel well; He does not feel well and is achy all over; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Caller states her husband got the moderna booster dose. He does not feel well) and MYALGIA (He does not feel well and is achy all over) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Caller states her husband got the moderna booster dose. He does not feel well) and MYALGIA (He does not feel well and is achy all over). At the time of the report, MALAISE (Caller states her husband got the moderna booster dose. He does not feel well) and MYALGIA (He does not feel well and is achy all over) outcome was unknown.            No treatment and concomitant medications were provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Vaccination complication
Clinical narrative: Sick; something doesn't feel right/doesn't feel good; so nauseated, major nausea for 3-4 days; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Sick), FEELING ABNORMAL (something doesn't feel right/doesn't feel good) and NAUSEA (so nauseated, major nausea for 3-4 days) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A, 032F21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-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. In November 2021, the patient experienced ILLNESS (Sick), FEELING ABNORMAL (something doesn't feel right/doesn't feel good) and NAUSEA (so nauseated, major nausea for 3-4 days). At the time of the report, ILLNESS (Sick), FEELING ABNORMAL (something doesn't feel right/doesn't feel good) and NAUSEA (so nauseated, major nausea for 3-4 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment was provided by the reporter.  It was reported that it was almost the same as the second dose, might be worse. She stated that she was not pregnant or breastfeeding. She wanted to know if that a side effect of generally not feeling good and nausea. She stated it's just odd.   This case was linked to MOD-2021-390064 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with the vaccine from a vial which is past its 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which is past its 30 day use by date) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which is past its 30 day use by date). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which is past its 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  Reporter stated that they accidentally administered the Moderna Covid-19 vaccine from a vial which was past its 30 day use by date, vaccine was initially placed in the refrigerator on 15-Oct-2021 and administered on 17-Nov-2021.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Patient demographics were updated.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Interchange of vaccine products, Pyrexia
Clinical narrative: Chills; I began to experience feverishness; Headache; Patient received Moderna Covid-19 Booster after receiving Pfizer for initial doses; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (I began to experience feverishness), HEADACHE (Headache) and INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna Covid-19 Booster after receiving Pfizer for initial doses) 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: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (I began to experience feverishness), HEADACHE (Headache) and INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna Covid-19 Booster after receiving Pfizer for initial doses). At the time of the report, CHILLS (Chills), PYREXIA (I began to experience feverishness) and HEADACHE (Headache) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna Covid-19 Booster after receiving Pfizer for initial doses) had resolved. Not Provided          No concomitant medicines were reported No treatment medicines were reported
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Myalgia, Vaccination complication, Vaccination site pain
Clinical narrative: Problems since they got the second dose; Difficult to sleep; Interfering with daily activities; Muscle pain got worse and past few weeks it has stayed the same; Sharp pain through the vaccine site going down the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Problems since they got the second dose), INSOMNIA (Difficult to sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfering with daily activities), MYALGIA (Muscle pain got worse and past few weeks it has stayed the same) and VACCINATION SITE PAIN (Sharp pain through the vaccine site going down the arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Problems since they got the second dose). In October 2021, the patient experienced INSOMNIA (Difficult to sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfering with daily activities) and MYALGIA (Muscle pain got worse and past few weeks it has stayed the same). October 2021, the patient experienced VACCINATION SITE PAIN (Sharp pain through the vaccine site going down the arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in October 2021 for Muscle pain, at an unspecified dose and frequency; Manual therapy (Heat on arm) for Myalgia and Manual therapy (Heat on arm) for Vaccination site pain. At the time of the report, VACCINATION COMPLICATION (Problems since they got the second dose), INSOMNIA (Difficult to sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfering with daily activities) and VACCINATION SITE PAIN (Sharp pain through the vaccine site going down the arm) outcome was unknown and MYALGIA (Muscle pain got worse and past few weeks it has stayed the same) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Patient stated he did not take regular medications and tried the treatments for a week.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 5 patients received a Moderna booster shot of 0.5ml not 0.25ml; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml not 0.25ml) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml not 0.25ml). On 29-Oct-2021, ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml not 0.25ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis viral
Clinical narrative: Got a stomach virus after her 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of GASTROENTERITIS VIRAL (Got a stomach virus after her 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09K20A) for COVID-19 vaccination.     The patient's past medical history included Lymph node disorder, Knee replacement (left knee problems-   replaced 8 weeks ago.) and Lymph node excision (lymph nodes removed in right arm). Previously administered products included for Flu: flu vaccine (Guillain-Barre Syndrome from a flu shot 10 years ago.). Past adverse reactions to the above products included Guillain-Barre syndrome with flu vaccine.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROENTERITIS VIRAL (Got a stomach virus after her 1st dose). At the time of the report, GASTROENTERITIS VIRAL (Got a stomach virus after her 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported. The patient got a stomach virus after her 1st dose and that's why she put the 2nd dose off by a couple of weeks. No treatment drugs were reported.   This case was linked to MOD-2021-390427, MOD-2021-390455 (Patient Link).
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) had resolved.            No Concomitant product use was reported. No treatment information was provided.  It was stated that, patient received 3 doses of Moderna and only had sore arm and more fatigue for a while.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 infection in October; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 infection in October) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced COVID-19 (COVID-19 infection in October). At the time of the report, COVID-19 (COVID-19 infection in October) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information Regeneron was provided.. This is a spontaneous case concerning a elderly male patient of unknown age with no reported medical history, who experienced the non-serious  unexpected event of special interest COVID-19. The event occurred on an unknown date after vaccination with mRNA-1273. Patient received Regeneron as treatment.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a elderly male patient of unknown age with no reported medical history, who experienced the non-serious  unexpected event of special interest COVID-19. The event occurred on an unknown date after vaccination with mRNA-1273. Patient received Regeneron as treatment.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with the vaccine from vial which has been punctured for more than 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that 12 patients received vaccine punctured more than 12 hrs.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm was very swollen and red; Skin and the muscle were red; Skin and the muscle were hard; Skin and the muscle were red and hard and hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm was very swollen and red), VACCINATION SITE ERYTHEMA (Skin and the muscle were red), VACCINATION SITE INDURATION (Skin and the muscle were hard) and VACCINATION SITE WARMTH (Skin and the muscle were red and hard and hot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A., 017B321A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D NOS, IRON, VITAMIN B12 NOS and CALCIUM for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Arm was very swollen and red), VACCINATION SITE ERYTHEMA (Skin and the muscle were red), VACCINATION SITE INDURATION (Skin and the muscle were hard) and VACCINATION SITE WARMTH (Skin and the muscle were red and hard and hot). At the time of the report, VACCINATION SITE SWELLING (Arm was very swollen and red) and VACCINATION SITE ERYTHEMA (Skin and the muscle were red) outcome was unknown and VACCINATION SITE INDURATION (Skin and the muscle were hard) and VACCINATION SITE WARMTH (Skin and the muscle were red and hard and hot) had resolved.            The patient also took Centroid drug and an unknown medication for high blood pressure as Concomitant medication.  No treatment information was provided.  The patient post receiving the Moderna booster shot reported that their arm was very swollen, red, and the skin and the muscle were red and hard and hot for 8 days. On 05-Nov-2021 it began to go down. The patient stated that they did not have any reactions after the first two doses and wondered if this should be reported and if this time the injection was correctly administered.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Headache, Pain in extremity
Clinical narrative: taste changes /regular coffee tastes horrible to her now; stomach hurt; sick to her stomach; very weak / felt like Jell-O all over; sore arm; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of TASTE DISORDER (taste changes /regular coffee tastes horrible to her now), ABDOMINAL PAIN UPPER (stomach hurt), ABDOMINAL DISCOMFORT (sick to her stomach), ASTHENIA (very weak / felt like Jell-O all over) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (taste changes /regular coffee tastes horrible to her now), ABDOMINAL PAIN UPPER (stomach hurt), ABDOMINAL DISCOMFORT (sick to her stomach), ASTHENIA (very weak / felt like Jell-O all over), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, TASTE DISORDER (taste changes /regular coffee tastes horrible to her now), ABDOMINAL PAIN UPPER (stomach hurt), ABDOMINAL DISCOMFORT (sick to her stomach), ASTHENIA (very weak / felt like Jell-O all over), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: taste changes /regular coffee tastes horrible to her now; stomach hurt; sick to her stomach; very weak / felt like Jell-O all over; sore arm; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of TASTE DISORDER (taste changes /regular coffee tastes horrible to her now), ABDOMINAL PAIN UPPER (stomach hurt), ABDOMINAL DISCOMFORT (sick to her stomach), ASTHENIA (very weak / felt like Jell-O all over) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (taste changes /regular coffee tastes horrible to her now), ABDOMINAL PAIN UPPER (stomach hurt), ABDOMINAL DISCOMFORT (sick to her stomach), ASTHENIA (very weak / felt like Jell-O all over), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, TASTE DISORDER (taste changes /regular coffee tastes horrible to her now), ABDOMINAL PAIN UPPER (stomach hurt), ABDOMINAL DISCOMFORT (sick to her stomach), ASTHENIA (very weak / felt like Jell-O all over), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave an expired lot to 85 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave an expired lot to 85 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave an expired lot to 85 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave an expired lot to 85 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter mentioned that his facility had a vaccination clinic on 10-Nov-2021 and 15-Nov-2021, where a total of 85 doses were administered to patients from an expired lot of the Moderna COVID-19 vaccine. Lot # 046C21A expired on 6-Nov-2021 per Moderna's online lookup tool. On 10-Nov-2021, 4 doses were administered as 1st and 2nd doses and 73 doses were administered as booster doses. On 15-Nov-2021, 6 doses were administered as 1st and 2nd doses and 2 doses were administered as booster doses. Per the reporter, no adverse reactions have been reported by any patients so far. Caller did not have any patient identifiers at this time. It was also reported that the vial did not underwent any temperature excursions.  No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received contains no new information.
Age: 46.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of the glands in the armpits; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling of the glands in the armpits) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    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 and dose of INFLUENZA VACCINE (FLU) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (Swelling of the glands in the armpits). At the time of the report, LYMPHADENOPATHY (Swelling of the glands in the armpits) outcome was unknown. Not Provided          Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.; Sender's Comments: This case concerns a 46-year-old male patient with no relevant medical history, who experienced the expected event of Lymphadenopathy. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine and Co-suspect Influenza Vaccine at an unspecified dose. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Skin infection
Clinical narrative: Skin infection; Received second dose more than 42 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN INFECTION (Skin infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 42 days after first dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 42 days after first dose). On an unknown date, the patient experienced SKIN INFECTION (Skin infection). The patient was treated with CLINDAMYCIN on 07-Aug-2021 for Adverse event, at a dose of 150 mg and MUPIROCIN for Adverse event, at an unspecified dose and frequency. On 27-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 42 days after first dose) had resolved. At the time of the report, SKIN INFECTION (Skin infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. The patient had recently started an antibiotic for a skin infection  It was reported that patient was not immunocompromised.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Unfortunately we did use this beyond the use date of 10/9/21.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment received by the patient This case concerns a 55-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-391718 (Patient Link).; Sender's Comments: This case concerns a 55-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided. No treatment information was provided.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided