chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: First dose more than 25 days before second dose; Half dose received as second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose more than 25 days before second dose) and ACCIDENTAL UNDERDOSE (Half dose received as second dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 27-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose more than 25 days before second dose) and ACCIDENTAL UNDERDOSE (Half dose received as second dose). On 27-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose more than 25 days before second dose) and ACCIDENTAL UNDERDOSE (Half dose received as second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No Treatment information was reported.  It was reported that, patient who received her first Moderna dose on 20Aug2021. When she returned to the same pharmacy for the second dose on 27-Oct-2021, they inadvertently gave her a booster dose, which was a half dose. The pharmacist looked up the CDC guidance, and their wording was tripping her up. She was hoping for clarification. CDC stated the patient can get another half dose on the same clinic date. The pharmacist states it was been three weeks since the patient received the half dose.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021.    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 (Received expired dose of the vaccine) 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.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). In November 2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Expired vaccine has been administered from  06-NOV-2021 to 16-NOV-2021. No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Discomfort, Headache
Clinical narrative: Mild discomfort; Nausea; Intense stomach pain; Low grade fever; Headache; Pain in abdomen; Bloating; Soreness/muscle pain left arm injection site/ injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Pain in abdomen), ABDOMINAL PAIN UPPER (Intense stomach pain), ABDOMINAL DISTENSION (Bloating), DISCOMFORT (Mild discomfort) and NAUSEA (Nausea) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 01J20A and 01J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced ABDOMINAL PAIN (Pain in abdomen), ABDOMINAL DISTENSION (Bloating), VACCINATION SITE PAIN (Soreness/muscle pain left arm injection site/ injection site soreness) and HEADACHE (Headache). On 17-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Intense stomach pain) and PYREXIA (Low grade fever). On an unknown date, the patient experienced DISCOMFORT (Mild discomfort). an unknown date, the patient experienced NAUSEA (Nausea). In November 2021, ABDOMINAL PAIN (Pain in abdomen), VACCINATION SITE PAIN (Soreness/muscle pain left arm injection site/ injection site soreness), PYREXIA (Low grade fever) and HEADACHE (Headache) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Intense stomach pain), ABDOMINAL DISTENSION (Bloating), DISCOMFORT (Mild discomfort) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient experienced pain in abdomen, bloating, nausea, and soreness/muscle pain left arm injection site. The patient received the shot on 16-Nov-2021 with minimal pain and soreness. The patient also experienced low grade fever the following day with intense stomach pain. Reportedly, the pain had mitigated on 18-Nov-2021 but was still feeling discomfort.  No Concomitant product use was reported.  No medical treatment was received.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up information received on 23-NOV-2021,Reporter details, facility information, patient details, dosing details, events outcome, action taken updated and events were added.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Mild discomfort; Nausea; Intense stomach pain; Low grade fever; Headache; Pain in abdomen; Bloating; Soreness/muscle pain left arm injection site/ injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Pain in abdomen), ABDOMINAL PAIN UPPER (Intense stomach pain), ABDOMINAL DISTENSION (Bloating), DISCOMFORT (Mild discomfort) and NAUSEA (Nausea) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 01J20A and 01J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced ABDOMINAL PAIN (Pain in abdomen), ABDOMINAL DISTENSION (Bloating), VACCINATION SITE PAIN (Soreness/muscle pain left arm injection site/ injection site soreness) and HEADACHE (Headache). On 17-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Intense stomach pain) and PYREXIA (Low grade fever). On an unknown date, the patient experienced DISCOMFORT (Mild discomfort). an unknown date, the patient experienced NAUSEA (Nausea). In November 2021, ABDOMINAL PAIN (Pain in abdomen), VACCINATION SITE PAIN (Soreness/muscle pain left arm injection site/ injection site soreness), PYREXIA (Low grade fever) and HEADACHE (Headache) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Intense stomach pain), ABDOMINAL DISTENSION (Bloating), DISCOMFORT (Mild discomfort) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient experienced pain in abdomen, bloating, nausea, and soreness/muscle pain left arm injection site. The patient received the shot on 16-Nov-2021 with minimal pain and soreness. The patient also experienced low grade fever the following day with intense stomach pain. Reportedly, the pain had mitigated on 18-Nov-2021 but was still feeling discomfort.  No Concomitant product use was reported.  No medical treatment was received.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up information received on 23-NOV-2021,Reporter details, facility information, patient details, dosing details, events outcome, action taken updated and events were added.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        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.   Concomitant products were not provided. Treatment medication were not reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received an expired vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) 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 (patients received an expired vaccine). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. This is a case of Expired Product Administered concerning a 61-year-old male patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a 61-year-old male patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Keratitis, Ocular hyperaemia, Vision blurred
Clinical narrative: Patients vision from left eye was very blurry; The left eye was swollen; The left eye was red; The left eye was pain; Developed an inflamed left eye Cornea.; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Patients vision from left eye was very blurry), EYE SWELLING (The left eye was swollen), OCULAR HYPERAEMIA (The left eye was red), EYE PAIN (The left eye was pain) and KERATITIS (Developed an inflamed left eye Cornea.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Corneal disorder (history of Cornea problems starting 40 years ago due to a history of a virus in her eyes) and Corneal transplant (two times). Concomitant products included ACYCLOVIR [ACICLOVIR] and LOTEPREDNOL ETABONATE (LOTEMAX) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced VISION BLURRED (Patients vision from left eye was very blurry), EYE SWELLING (The left eye was swollen), OCULAR HYPERAEMIA (The left eye was red), EYE PAIN (The left eye was pain) and KERATITIS (Developed an inflamed left eye Cornea.). In June 2021, KERATITIS (Developed an inflamed left eye Cornea.) was resolving. At the time of the report, VISION BLURRED (Patients vision from left eye was very blurry), EYE SWELLING (The left eye was swollen), OCULAR HYPERAEMIA (The left eye was red) and EYE PAIN (The left eye was pain) outcome was unknown.            The patient's medication kept her cornea stable. The patient received acyclovir 5 times a day.  The patient's cornea was improved 5 weeks later.  The patient had to get newcontact lenses after the inflammation stopped.  No treatment medication were provided.  The patient's doctor told her that several patients have came to the doctors office with similar complaints after receiving Covid - 19 vaccines.   The doctor did not specify about manufacturers.  The patient comments to the agent that this ordeal was getting expensive cost of eye drops.   This case was linked to MOD-2021-391819, MOD-2021-391835 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash erythematous, Skin mass, Swelling
Clinical narrative: Lump in the collarbone area; Red rash going down the to the armpit; Red circle the size of a quarter and raised; Red circle raised; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red circle the size of a quarter and raised), SWELLING (Red circle raised), SKIN MASS (Lump in the collarbone area) and RASH ERYTHEMATOUS (Red rash going down the to the armpit) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) 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) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced ERYTHEMA (Red circle the size of a quarter and raised) and SWELLING (Red circle raised). On 19-Nov-2021, the patient experienced SKIN MASS (Lump in the collarbone area) and RASH ERYTHEMATOUS (Red rash going down the to the armpit). At the time of the report, ERYTHEMA (Red circle the size of a quarter and raised), SWELLING (Red circle raised), SKIN MASS (Lump in the collarbone area) and RASH ERYTHEMATOUS (Red rash going down the to the armpit) outcome was unknown.            Concomitant information was not provided.   No treatment was received.   Reporter states that she completed the Moderna primary series prior to receiving her booster.   Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Pain in extremity, Rash, Urticaria
Clinical narrative: fingers are stiff in the joint/knees are stiff in the joint; Rash comes and goes; hives on neck, shoulder, knees, fingers/welts on neck; mild left arm pain/pain in lower leg; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (fingers are stiff in the joint/knees are stiff in the joint), PAIN IN EXTREMITY (mild left arm pain/pain in lower leg), URTICARIA (hives on neck, shoulder, knees, fingers/welts on neck) and RASH (Rash comes and goes) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced PAIN IN EXTREMITY (mild left arm pain/pain in lower leg). On 14-Nov-2021, the patient experienced URTICARIA (hives on neck, shoulder, knees, fingers/welts on neck). On 18-Nov-2021, the patient experienced JOINT STIFFNESS (fingers are stiff in the joint/knees are stiff in the joint) and RASH (Rash comes and goes). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 07-Nov-2021, PAIN IN EXTREMITY (mild left arm pain/pain in lower leg) had resolved. At the time of the report, JOINT STIFFNESS (fingers are stiff in the joint/knees are stiff in the joint) and RASH (Rash comes and goes) had not resolved and URTICARIA (hives on neck, shoulder, knees, fingers/welts on neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO concomitant drugs were provided. She has taken antihistamines for welts on her neck.as treatment but not clearing up. Started with Zyrtec and then switched to taking Benadryl over the counter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle swelling, Oedema, Pain in extremity, Peripheral swelling, Spider vein
Clinical narrative: spider veins; legs ankles, calves swelled up/ swollen like balloons; edema; muscles swelled up; slight pain in her left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of SPIDER VEIN (spider veins), PAIN IN EXTREMITY (slight pain in her left arm), PERIPHERAL SWELLING (legs ankles, calves swelled up/ swollen like balloons), OEDEMA (edema) and MUSCLE SWELLING (muscles swelled up) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Nov-2021, the patient experienced PAIN IN EXTREMITY (slight pain in her left arm). On 09-Nov-2021, the patient experienced PERIPHERAL SWELLING (legs ankles, calves swelled up/ swollen like balloons), OEDEMA (edema) and MUSCLE SWELLING (muscles swelled up). On 12-Nov-2021, the patient experienced SPIDER VEIN (spider veins). On 09-Nov-2021, PAIN IN EXTREMITY (slight pain in her left arm) had resolved. On 12-Nov-2021, PERIPHERAL SWELLING (legs ankles, calves swelled up/ swollen like balloons), OEDEMA (edema) and MUSCLE SWELLING (muscles swelled up) had resolved. At the time of the report, SPIDER VEIN (spider veins) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  Patient has not taken any medications or treatments for her symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received an expired vaccine; 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 (patient received an expired vaccine) in a  patient of an unknown age and 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company comment include This case concerns a patient with unknown age and gender with no reported medical history , who experienced Non-serious event of Expired product administered which occurred on an unknown date and with an unknown dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge is not applicable in relation to the nature of the event. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a patient with unknown age and gender with no reported medical history , who experienced Non-serious event of Expired product administered which occurred on an unknown date and with an unknown dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge is not applicable in relation to the nature of the event. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysphonia, Influenza, Taste disorder
Clinical narrative: Lack of taste/taste buds have not came back like they used to; Her voice is changed; Tastes different; Had the flu; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lack of taste/taste buds have not came back like they used to), DYSPHONIA (Her voice is changed), TASTE DISORDER (Tastes different) and INFLUENZA (Had the flu) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 029A21) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced AGEUSIA (Lack of taste/taste buds have not came back like they used to), DYSPHONIA (Her voice is changed), TASTE DISORDER (Tastes different) and INFLUENZA (Had the flu). At the time of the report, AGEUSIA (Lack of taste/taste buds have not came back like they used to), DYSPHONIA (Her voice is changed) and TASTE DISORDER (Tastes different) had not resolved and INFLUENZA (Had the flu) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported. This case concerns a 62-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected, AESI event of ageusia. The event occurred  on unknown date after second dose of mRNA 1273 vaccine. The patient felt that she has lack of taste, her taste is different, and her voice changed ever since she received the vaccine, she also had the flu. Events are still on going and she is hesitant to get the booster. The rechallenge is not applicable as events are not resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-392343 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received contains no new information.; Sender's Comments: This case concerns a 62-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected, AESI event of ageusia. The event occurred  on unknown date after second dose of mRNA 1273 vaccine. The patient felt that she has lack of taste, her taste is different, and her voice changed ever since she received the vaccine, she also had the flu. Events are still on going and she is hesitant to get the booster. The rechallenge is not applicable as events are not resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in both ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in both ears) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced TINNITUS (Ringing in both ears). At the time of the report, TINNITUS (Ringing in both ears) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Everyone reports soreness in their injection site arm after receiving their vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Everyone reports soreness in their injection site arm after receiving their vaccine) in a  patient of an unknown age and 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Everyone reports soreness in their injection site arm after receiving their vaccine). At the time of the report, INJECTION SITE PAIN (Everyone reports soreness in their injection site arm after receiving their vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported   No treatment information was provided  This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the expected non serious event of injection site pain. The event injection site pain exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the expected non serious event of injection site pain. The event injection site pain exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Peripheral swelling, Pyrexia, Rash, Vaccination site erythema
Clinical narrative: Caused blisters on the chest the night of the injection; Developed bumps along the abdomen; Feverish (red & warm); Feverish; Feverish (red & warm); patient had arm swelling; had swelling at the spot of the arm; This spontaneous case was reported by an other health care professional and describes the occurrence of BLISTER (Caused blisters on the chest the night of the injection), VACCINATION SITE WARMTH (Feverish (red & warm)), PERIPHERAL SWELLING (patient had arm swelling), VACCINATION SITE SWELLING (had swelling at the spot of the arm) and RASH (Developed bumps along the abdomen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In October 2021, the patient experienced VACCINATION SITE WARMTH (Feverish (red & warm)), PERIPHERAL SWELLING (patient had arm swelling), VACCINATION SITE SWELLING (had swelling at the spot of the arm), VACCINATION SITE ERYTHEMA (Feverish (red & warm)) and PYREXIA (Feverish). On 18-Oct-2021, the patient experienced BLISTER (Caused blisters on the chest the night of the injection) and RASH (Developed bumps along the abdomen). At the time of the report, BLISTER (Caused blisters on the chest the night of the injection), VACCINATION SITE WARMTH (Feverish (red & warm)), PERIPHERAL SWELLING (patient had arm swelling), VACCINATION SITE SWELLING (had swelling at the spot of the arm), RASH (Developed bumps along the abdomen), VACCINATION SITE ERYTHEMA (Feverish (red & warm)) and PYREXIA (Feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  Patient's second dose was scheduled on 15-NOV-2021. However the patient did not receive second dose.  The pharmacist stated that some people term it "feverish" and by that mean red and warm.  No treatment medication was reported by the reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Caused blisters on the chest the night of the injection; Developed bumps along the abdomen; Feverish (red & warm); Feverish; Feverish (red & warm); patient had arm swelling; had swelling at the spot of the arm; This spontaneous case was reported by an other health care professional and describes the occurrence of BLISTER (Caused blisters on the chest the night of the injection), VACCINATION SITE WARMTH (Feverish (red & warm)), PERIPHERAL SWELLING (patient had arm swelling), VACCINATION SITE SWELLING (had swelling at the spot of the arm) and RASH (Developed bumps along the abdomen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In October 2021, the patient experienced VACCINATION SITE WARMTH (Feverish (red & warm)), PERIPHERAL SWELLING (patient had arm swelling), VACCINATION SITE SWELLING (had swelling at the spot of the arm), VACCINATION SITE ERYTHEMA (Feverish (red & warm)) and PYREXIA (Feverish). On 18-Oct-2021, the patient experienced BLISTER (Caused blisters on the chest the night of the injection) and RASH (Developed bumps along the abdomen). At the time of the report, BLISTER (Caused blisters on the chest the night of the injection), VACCINATION SITE WARMTH (Feverish (red & warm)), PERIPHERAL SWELLING (patient had arm swelling), VACCINATION SITE SWELLING (had swelling at the spot of the arm), RASH (Developed bumps along the abdomen), VACCINATION SITE ERYTHEMA (Feverish (red & warm)) and PYREXIA (Feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  Patient's second dose was scheduled on 15-NOV-2021. However the patient did not receive second dose.  The pharmacist stated that some people term it "feverish" and by that mean red and warm.  No treatment medication was reported by the reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm that it was mildly, when raise arm feel a little bit the day of the first doses; This spontaneous case was reported by a consumer and describes the occurrence of   in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028a21a and 012a21a) for COVID-19 vaccination.     No medical history reported.  Concomitant products included CHOLESTEROL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.            Concomitant medication also includes blood pressure, and anti reflects medications. No treatment medication reported.   This case was linked to MOD-2021-392078, MOD-2021-392066 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 66-year-old, male patient with relevant medical history of experiencing pain in extremity after the first dose of mRNA-1273 vaccine who experienced the unexpected non serious event of pain in extremity. The event pain in extremity occurred the same day with the second dose of mRNA-1273 vaccine administration. The rechallenge is positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: pop up rashes over his lower abdomen and chest. It looks like hives; Itching on his head, arms, wrists, feet and legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on his head, arms, wrists, feet and legs) and URTICARIA (pop up rashes over his lower abdomen and chest. It looks like hives) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced PRURITUS (Itching on his head, arms, wrists, feet and legs). On 19-Nov-2021, the patient experienced URTICARIA (pop up rashes over his lower abdomen and chest. It looks like hives). At the time of the report, PRURITUS (Itching on his head, arms, wrists, feet and legs) and URTICARIA (pop up rashes over his lower abdomen and chest. It looks like hives) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: He felt a little bit off, but did not have anything specific; Sore arm after both doses; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (He felt a little bit off, but did not have anything specific) and VACCINATION SITE PAIN (Sore arm after both doses) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (He felt a little bit off, but did not have anything specific) and VACCINATION SITE PAIN (Sore arm after both doses). At the time of the report, FEELING ABNORMAL (He felt a little bit off, but did not have anything specific) and VACCINATION SITE PAIN (Sore arm after both doses) outcome was unknown.      Concomitant medications include medicines for diabetes and blood pressure. No treatment medications provided.   This case was linked to MOD-2021-392116, MOD-2021-392113 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; 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 (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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.  This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia
Clinical narrative: Had very low back pain, not a big deal; A sore arm, no big deal at all.; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Had very low back pain, not a big deal) and MYALGIA (A sore arm, no big deal at all.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced BACK PAIN (Had very low back pain, not a big deal) and MYALGIA (A sore arm, no big deal at all.). At the time of the report, BACK PAIN (Had very low back pain, not a big deal) and MYALGIA (A sore arm, no big deal at all.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-392450 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site haemorrhage
Clinical narrative: he bled from the injection site at the time of injection and that had never happened to him before; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (he bled from the injection site at the time of injection and that had never happened to him before) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer Covid-19 Vaccine (Batch Number Pfizer) on 17-Feb-2021 and Pfizer Covid-19 Vaccine (2nd dose) on 10-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer Covid-19 Vaccine and Pfizer Covid-19 Vaccine.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (he bled from the injection site at the time of injection and that had never happened to him before) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 19-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (he bled from the injection site at the time of injection and that had never happened to him before) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Feeling sick after COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling sick after COVID vaccine) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included EMICIZUMAB (HEMLIBRA [EMICIZUMAB]) for an unknown indication.    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 VACCINATION COMPLICATION (Feeling sick after COVID vaccine). At the time of the report, VACCINATION COMPLICATION (Feeling sick after COVID vaccine) outcome was unknown.            No Treatment Medications details were provided.  This is a spontaneous case concerning a 28-year-old, male patient with relevant concomitant medication of Emicizumab (Hemlibra), who experienced the unexpected, non serious event of vaccination complication (vaccination related malaise). The event vaccination complication (vaccination related malaise) exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The concomitant medication of Emicizumab (Hemlibra) remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 28-year-old, male patient with relevant concomitant medication of Emicizumab (Hemlibra), who experienced the unexpected, non serious event of vaccination complication (vaccination related malaise). The event vaccination complication (vaccination related malaise) exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The concomitant medication of Emicizumab (Hemlibra) remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: gave a full dose (0.5ml) for the booster instead of the half dose (0.25ml) to a non-immunocompromised patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (gave a full dose (0.5ml) for the booster instead of the half dose (0.25ml) to a non-immunocompromised patient) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (gave a full dose (0.5ml) for the booster instead of the half dose (0.25ml) to a non-immunocompromised patient). On 19-Nov-2021, PRODUCT ADMINISTRATION ERROR (gave a full dose (0.5ml) for the booster instead of the half dose (0.25ml) to a non-immunocompromised patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  Pharmacist stated that they accidentally gave a full booster dose (0.5ml) instead of the half dose (0.25ml) to a  patient who is not immunocompromised. The patient got the primary series of the Moderna Covid-19 Vaccine around January 2021 time period.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore arm; tired for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tired for a day) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired for a day). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (tired for a day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   This case was linked to MOD-2021-392275, MOD-2021-392282 (Patient Link).
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 years old received the Moderna COVID 19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old received the Moderna COVID 19 vaccine.) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old received the Moderna COVID 19 vaccine.). On 18-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old received the Moderna COVID 19 vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.; Sender's Comments: Non-serious Case